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Submitted URL: https://doi.org/10.1002/14651858.CD006207.pub5
Effective URL: https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub5/full
Submission: On February 03 via api from US — Scanned from DE
Effective URL: https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub5/full
Submission: On February 03 via api from US — Scanned from DE
Form analysis 9 forms found in the DOM
POST https://www.cochranelibrary.com/en/content?p_auth=GNQicIHW&p_p_id=scolarissearchportlet_WAR_scolarissearch&p_p_lifecycle=1&p_p_state=normal&p_p_mode=view&_scolarissearchportlet_WAR_scolarissearch_scolarisAction=redirectSearchResult
<form
action="https://www.cochranelibrary.com/en/content?p_auth=GNQicIHW&p_p_id=scolarissearchportlet_WAR_scolarissearch&p_p_lifecycle=1&p_p_state=normal&p_p_mode=view&_scolarissearchportlet_WAR_scolarissearch_scolarisAction=redirectSearchResult"
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<fieldset class="fieldset">
<legend class="sr-only">Basic Search</legend>
<div class="select search-by"> <select title="Search by options" aria-label="Search by options" name="searchBy" class="custom-select-enabled search-type select-hidden">
<option value="1">Title Abstract Keyword</option>
<option value="2">Record Title</option>
<option value="3">Abstract</option>
<option value="4">Author</option>
<option value="5">Keyword</option>
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<option value="10">Accession Number</option>
<option value="11">Trial Registry Number</option>
<option value="12">Cochrane Group</option>
<option value="13">Cochrane Topic</option>
</select>
<div class="select-styled">Title Abstract Keyword</div>
<ul class="select-options">
<li rel="1">Title Abstract Keyword</li>
<li rel="2">Record Title</li>
<li rel="3">Abstract</li>
<li rel="4">Author</li>
<li rel="5">Keyword</li>
<li rel="6">All Text</li>
<li rel="7">Publication Type</li>
<li rel="8">Source</li>
<li rel="9">DOI</li>
<li rel="10">Accession Number</li>
<li rel="11">Trial Registry Number</li>
<li rel="12">Cochrane Group</li>
<li rel="13">Cochrane Topic</li>
</ul>
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<div class="search-select-crg-container select" style="display: none;"> <select class="search-select-crg-list select-hidden">
<option value="Acute Respiratory Infections">Acute Respiratory Infections</option>
<option value="Airways">Airways</option>
<option value="Anaesthesia">Anaesthesia</option>
<option value="Back and Neck">Back and Neck</option>
<option value="Bone, Joint and Muscle Trauma">Bone, Joint and Muscle Trauma</option>
<option value="Breast Cancer">Breast Cancer</option>
<option value="Child Health">Child Health</option>
<option value="Childhood Cancer">Childhood Cancer</option>
<option value="Cochrane Australia">Cochrane Australia</option>
<option value="Cochrane Brazil">Cochrane Brazil</option>
<option value="Cochrane Canada">Cochrane Canada</option>
<option value="Cochrane Germany">Cochrane Germany</option>
<option value="Cochrane Iberoamerica">Cochrane Iberoamerica</option>
<option value="Cochrane Nordic">Cochrane Nordic</option>
<option value="Cochrane South Asia">Cochrane South Asia</option>
<option value="Cochrane Thailand">Cochrane Thailand</option>
<option value="Cochrane UK">Cochrane UK</option>
<option value="Colorectal">Colorectal</option>
<option value="Common Mental Disorders">Common Mental Disorders</option>
<option value="Complementary Medicine">Complementary Medicine</option>
<option value="Consumers and Communication">Consumers and Communication</option>
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<option value="Dementia and Cognitive Improvement">Dementia and Cognitive Improvement</option>
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<option value="Emergency and Critical Care">Emergency and Critical Care</option>
<option value="ENT">ENT</option>
<option value="Epilepsy">Epilepsy</option>
<option value="Eyes and Vision">Eyes and Vision</option>
<option value="Fertility Regulation">Fertility Regulation</option>
<option value="Gut">Gut</option>
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<option value="Heart">Heart</option>
<option value="Hepato-Biliary">Hepato-Biliary</option>
<option value="HIV/AIDS">HIV/AIDS</option>
<option value="Hypertension">Hypertension</option>
<option value="Incontinence">Incontinence</option>
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<option value="Injuries">Injuries</option>
<option value="Kidney and Transplant">Kidney and Transplant</option>
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<option value="Metabolic and Endocrine Disorders">Metabolic and Endocrine Disorders</option>
<option value="Methodology">Methodology</option>
<option value="Movement Disorders">Movement Disorders</option>
<option value="Multiple Sclerosis and Rare Diseases of the CNS">Multiple Sclerosis and Rare Diseases of the CNS</option>
<option value="Musculoskeletal">Musculoskeletal</option>
<option value="Neonatal">Neonatal</option>
<option value="Neuromuscular">Neuromuscular</option>
<option value="Oral Health">Oral Health</option>
<option value="Pain, Palliative and Supportive Care">Pain, Palliative and Supportive Care</option>
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<option value="Public Health">Public Health</option>
<option value="Schizophrenia">Schizophrenia</option>
<option value="Sexually Transmitted Infections">Sexually Transmitted Infections</option>
<option value="Skin">Skin</option>
<option value="Stroke">Stroke</option>
<option value="Tobacco Addiction">Tobacco Addiction</option>
<option value="Upper GI and Pancreatic Diseases">Upper GI and Pancreatic Diseases</option>
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<div class="select-styled">Acute Respiratory Infections</div>
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<li rel="Anaesthesia">Anaesthesia</li>
<li rel="Back and Neck">Back and Neck</li>
<li rel="Bone, Joint and Muscle Trauma">Bone, Joint and Muscle Trauma</li>
<li rel="Breast Cancer">Breast Cancer</li>
<li rel="Child Health">Child Health</li>
<li rel="Childhood Cancer">Childhood Cancer</li>
<li rel="Cochrane Australia">Cochrane Australia</li>
<li rel="Cochrane Brazil">Cochrane Brazil</li>
<li rel="Cochrane Canada">Cochrane Canada</li>
<li rel="Cochrane Germany">Cochrane Germany</li>
<li rel="Cochrane Iberoamerica">Cochrane Iberoamerica</li>
<li rel="Cochrane Nordic">Cochrane Nordic</li>
<li rel="Cochrane South Asia">Cochrane South Asia</li>
<li rel="Cochrane Thailand">Cochrane Thailand</li>
<li rel="Cochrane UK">Cochrane UK</li>
<li rel="Colorectal">Colorectal</li>
<li rel="Common Mental Disorders">Common Mental Disorders</li>
<li rel="Complementary Medicine">Complementary Medicine</li>
<li rel="Consumers and Communication">Consumers and Communication</li>
<li rel="Cystic Fibrosis and Genetic Disorders">Cystic Fibrosis and Genetic Disorders</li>
<li rel="Dementia and Cognitive Improvement">Dementia and Cognitive Improvement</li>
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<li rel="Drugs and Alcohol">Drugs and Alcohol</li>
<li rel="Effective Practice and Organisation of Care">Effective Practice and Organisation of Care</li>
<li rel="Emergency and Critical Care">Emergency and Critical Care</li>
<li rel="ENT">ENT</li>
<li rel="Epilepsy">Epilepsy</li>
<li rel="Eyes and Vision">Eyes and Vision</li>
<li rel="Fertility Regulation">Fertility Regulation</li>
<li rel="Gut">Gut</li>
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<li rel="Haematology">Haematology</li>
<li rel="Heart">Heart</li>
<li rel="Hepato-Biliary">Hepato-Biliary</li>
<li rel="HIV/AIDS">HIV/AIDS</li>
<li rel="Hypertension">Hypertension</li>
<li rel="Incontinence">Incontinence</li>
<li rel="Infectious Diseases">Infectious Diseases</li>
<li rel="Injuries">Injuries</li>
<li rel="Kidney and Transplant">Kidney and Transplant</li>
<li rel="Lung Cancer">Lung Cancer</li>
<li rel="Metabolic and Endocrine Disorders">Metabolic and Endocrine Disorders</li>
<li rel="Methodology">Methodology</li>
<li rel="Movement Disorders">Movement Disorders</li>
<li rel="Multiple Sclerosis and Rare Diseases of the CNS">Multiple Sclerosis and Rare Diseases of the CNS</li>
<li rel="Musculoskeletal">Musculoskeletal</li>
<li rel="Neonatal">Neonatal</li>
<li rel="Neuromuscular">Neuromuscular</li>
<li rel="Oral Health">Oral Health</li>
<li rel="Pain, Palliative and Supportive Care">Pain, Palliative and Supportive Care</li>
<li rel="Pregnancy and Childbirth">Pregnancy and Childbirth</li>
<li rel="Public Health">Public Health</li>
<li rel="Schizophrenia">Schizophrenia</li>
<li rel="Sexually Transmitted Infections">Sexually Transmitted Infections</li>
<li rel="Skin">Skin</li>
<li rel="Stroke">Stroke</li>
<li rel="Tobacco Addiction">Tobacco Addiction</li>
<li rel="Upper GI and Pancreatic Diseases">Upper GI and Pancreatic Diseases</li>
<li rel="Urology">Urology</li>
<li rel="Vascular">Vascular</li>
<li rel="Work">Work</li>
<li rel="Wounds">Wounds</li>
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<div class="search-select-topic-container select" style="display: none;"
data-topic-list-url="https://www.cochranelibrary.com/en/content?p_p_id=scolaristopics_WAR_scolaristopics&p_p_lifecycle=2&p_p_state=normal&p_p_mode=view&p_p_resource_id=topics-list&p_p_cacheability=cacheLevelPage"> <select
class="search-select-topic-list select-hidden">
<option value="Allergy & intolerance">Allergy & intolerance</option>
<option value="Blood disorders">Blood disorders</option>
<option value="Cancer">Cancer</option>
<option value="Child health">Child health</option>
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<option value="Dentistry & oral health">Dentistry & oral health</option>
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<option value="Effective practice & health systems">Effective practice & health systems</option>
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<option value="Gynaecology">Gynaecology</option>
<option value="Health & safety at work">Health & safety at work</option>
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<option value="Heart & circulation">Heart & circulation</option>
<option value="Infectious disease">Infectious disease</option>
<option value="Insurance medicine">Insurance medicine</option>
<option value="Kidney disease">Kidney disease</option>
<option value="Lungs & airways">Lungs & airways</option>
<option value="Mental health">Mental health</option>
<option value="Methodology">Methodology</option>
<option value="Neonatal care">Neonatal care</option>
<option value="Neurology">Neurology</option>
<option value="Orthopaedics & trauma">Orthopaedics & trauma</option>
<option value="Pain & anaesthesia">Pain & anaesthesia</option>
<option value="Pregnancy & childbirth">Pregnancy & childbirth</option>
<option value="Public health">Public health</option>
<option value="Reproductive & sexual health">Reproductive & sexual health</option>
<option value="Rheumatology">Rheumatology</option>
<option value="Skin disorders">Skin disorders</option>
<option value="Tobacco, drugs & alcohol">Tobacco, drugs & alcohol</option>
<option value="Urology">Urology</option>
<option value="Wounds">Wounds</option>
</select>
<div class="select-styled">Allergy & intolerance</div>
<ul class="select-options">
<li rel="Allergy & intolerance">Allergy & intolerance</li>
<li rel="Blood disorders">Blood disorders</li>
<li rel="Cancer">Cancer</li>
<li rel="Child health">Child health</li>
<li rel="Complementary & alternative medicine">Complementary & alternative medicine</li>
<li rel="Consumer & communication strategies">Consumer & communication strategies</li>
<li rel="Dentistry & oral health">Dentistry & oral health</li>
<li rel="Developmental, psychosocial & learning problems">Developmental, psychosocial & learning problems</li>
<li rel="Diagnosis">Diagnosis</li>
<li rel="Ear, nose & throat">Ear, nose & throat</li>
<li rel="Effective practice & health systems">Effective practice & health systems</li>
<li rel="Endocrine & metabolic">Endocrine & metabolic</li>
<li rel="Eyes & vision">Eyes & vision</li>
<li rel="Gastroenterology & hepatology">Gastroenterology & hepatology</li>
<li rel="Genetic disorders">Genetic disorders</li>
<li rel="Gynaecology">Gynaecology</li>
<li rel="Health & safety at work">Health & safety at work</li>
<li rel="Health professional education">Health professional education</li>
<li rel="Heart & circulation">Heart & circulation</li>
<li rel="Infectious disease">Infectious disease</li>
<li rel="Insurance medicine">Insurance medicine</li>
<li rel="Kidney disease">Kidney disease</li>
<li rel="Lungs & airways">Lungs & airways</li>
<li rel="Mental health">Mental health</li>
<li rel="Methodology">Methodology</li>
<li rel="Neonatal care">Neonatal care</li>
<li rel="Neurology">Neurology</li>
<li rel="Orthopaedics & trauma">Orthopaedics & trauma</li>
<li rel="Pain & anaesthesia">Pain & anaesthesia</li>
<li rel="Pregnancy & childbirth">Pregnancy & childbirth</li>
<li rel="Public health">Public health</li>
<li rel="Reproductive & sexual health">Reproductive & sexual health</li>
<li rel="Rheumatology">Rheumatology</li>
<li rel="Skin disorders">Skin disorders</li>
<li rel="Tobacco, drugs & alcohol">Tobacco, drugs & alcohol</li>
<li rel="Urology">Urology</li>
<li rel="Wounds">Wounds</li>
</ul>
</div>
<div class="search-text-container">
<div class="control-group control-group-inline search-input-wrapper"> <input type="text" size="30" class="field browser-search search-text ui-autocomplete-input" value="" aria-label="Enter search term" id="searchText" name="searchText"
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<div id="autocomplete-results">
<ul class="ui-autocomplete ui-front ui-menu ui-widget ui-widget-content" id="ui-id-1" tabindex="0" style="display: none;"></ul>
</div>
</div>
<div class="control-group control-group-inline search-button-wrapper">
<button type="submit" class="searchByBtn" aria-label="Search">
<i class="fa fa-search" aria-hidden="true"></i>
</button>
</div>
</div>
</fieldset>
</form>GET
<form class="download-citation-form" method="GET" target="citation-download-iframe"
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<input name="p_p_id" type="hidden" value="scolariscontentdisplay_WAR_scolariscontentdisplay"><input name="p_p_lifecycle" type="hidden" value="2"><input name="p_p_state" type="hidden" value="normal"><input name="p_p_mode" type="hidden"
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type="hidden" value="1"> <button class="btn primary wide pull-right" type="submit">Download</button>
<div class="inline-checkbox pull-right"> <label title=" for=" withabstract"=""> <input class="checkbox" type="checkbox" name="withAbstract" checked=""> <span class="checkbox-label">Include abstract</span> </label> </div>
</form>GET
<form class="download-stats-data-form" method="GET" target="_blank"> <input type="hidden" name="content-disposition" value="attachment"> <input type="hidden" name="mime-type" value="application/octet-stream">
<p class="print-options-controls"> <input type="checkbox" class="download-stats-data-toc-check-box" aria-label="I agree to these terms and conditions"> <span class="checkbox-label" aria-hidden="true">I agree to these terms and conditions</span>
<button class="btn primary download-stats-data pull-right" disabled=""><i class="fa fa-download" aria-hidden="true"></i> Download data</button> </p>
</form>Name: hrefFm — POST #
<form action="#" id="hrefFm" method="post" name="hrefFm">
<span></span>
</form>POST https://www.cochranelibrary.com/en/content?p_auth=GNQicIHW&p_p_id=scolarissearchportlet_WAR_scolarissearch&p_p_lifecycle=1&p_p_state=normal&p_p_mode=view&_scolarissearchportlet_WAR_scolarissearch_scolarisAction=redirectSearchResult
<form
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<fieldset class="fieldset">
<legend class="sr-only">Basic Search</legend>
<div class="select search-by"> <select title="Search by options" aria-label="Search by options" name="searchBy" class="custom-select-enabled search-type select-hidden">
<option value="1">Title Abstract Keyword</option>
<option value="2">Record Title</option>
<option value="3">Abstract</option>
<option value="4">Author</option>
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<div class="select-styled">Title Abstract Keyword</div>
<ul class="select-options">
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<div class="search-select-topic-container select" style="display: none;"
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<div class="search-text-container">
<div class="control-group control-group-inline search-input-wrapper"> <input type="text" size="30" class="field browser-search search-text ui-autocomplete-input" value="" aria-label="Enter search term" id="searchText" name="searchText"
placeholder="Search">
<div id="autocomplete-results"></div>
</div>
<div class="control-group control-group-inline search-button-wrapper">
<button type="submit" class="searchByBtn" aria-label="Search">
<i class="fa fa-search" aria-hidden="true"></i>
</button>
</div>
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</form>Name: _58_INSTANCE_MODAL_fm — POST https://www.cochranelibrary.com/en/content?p_p_id=58_INSTANCE_MODAL&p_p_lifecycle=1&p_p_state=normal&p_p_mode=view&_58_INSTANCE_MODAL_struts_action=%2Flogin%2Flogin
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<div class="checkbox-list pull-left">
<div class="checkbox-list-item">
<div class="control-group form-inline input-checkbox-wrapper"> <label for="_58_INSTANCE_MODAL_rememberMeCheckbox"> <input id="_58_INSTANCE_MODAL_rememberMe" name="_58_INSTANCE_MODAL_rememberMe" type="hidden" value="true"> <input checked=""
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</div>
</div>
<div class="pull-right"> <a href="https://onlinelibrary.wiley.com/user/forgottenpassword" target="_blank" class="external">Forgotten password?</a> </div>
</div>
<div class="login-form-footer clearfix">
<div class="pull-left"> <button type="submit" class="btn primary">Sign in</button> <a href="https://onlinelibrary.wiley.com/user-registration" target="_blank" class="btn secondary external">Register</a> </div>
<div class="pull-right">
<a class="institutional-login-form-button" href="https://www.cochranelibrary.com/en/content?p_p_id=scolariscontentdisplay_WAR_scolariscontentdisplay&p_p_lifecycle=0&p_p_state=normal&p_p_mode=view&_scolariscontentdisplay_WAR_scolariscontentdisplay_action=institution-access">Institutional login</a>
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</form>POST /shibboleth
<form method="post" action="/shibboleth" id="institutionLoginForm">
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Can physical interventions help reduce the spread of respiratory viruses?
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PHYSICAL INTERVENTIONS TO INTERRUPT OR REDUCE THE SPREAD OF RESPIRATORY VIRUSES
* Tom Jefferson
* Chris B Del Mar
* Liz Dooley
* Eliana Ferroni
* Lubna A Al-Ansary
* Ghada A Bawazeer
* Mieke L van Driel
* Mark A Jones
* Sarah Thorning
* Elaine M Beller
* Justin Clark
* Tammy C Hoffmann
* Paul P Glasziou
* John M Conly
Authors' declarations of interest
Version published: 20 November 2020 Version history
https://doi.org/10.1002/14651858.CD006207.pub5
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ABSTRACT
available in
English Español فارسی Français ภาษาไทย 简体中文
BACKGROUND
Viral epidemics or pandemics of acute respiratory infections (ARIs) pose a
global threat. Examples are influenza (H1N1) caused by the H1N1pdm09 virus in
2009, severe acute respiratory syndrome (SARS) in 2003, and coronavirus disease
2019 (COVID‐19) caused by SARS‐CoV‐2 in 2019. Antiviral drugs and vaccines may
be insufficient to prevent their spread. This is an update of a Cochrane Review
published in 2007, 2009, 2010, and 2011. The evidence summarised in this review
does not include results from studies from the current COVID‐19 pandemic.
OBJECTIVES
To assess the effectiveness of physical interventions to interrupt or reduce the
spread of acute respiratory viruses.
SEARCH METHODS
We searched CENTRAL, PubMed, Embase, CINAHL on 1 April 2020. We searched
ClinicalTrials.gov, and the WHO ICTRP on 16 March 2020. We conducted a backwards
and forwards citation analysis on the newly included studies.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) and cluster‐RCTs of trials
investigating physical interventions (screening at entry ports, isolation,
quarantine, physical distancing, personal protection, hand hygiene, face masks,
and gargling) to prevent respiratory virus transmission. In previous versions of
this review we also included observational studies. However, for this update,
there were sufficient RCTs to address our study aims.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. We used GRADE
to assess the certainty of the evidence. Three pairs of review authors
independently extracted data using a standard template applied in previous
versions of this review, but which was revised to reflect our focus on RCTs and
cluster‐RCTs for this update. We did not contact trialists for missing data due
to the urgency in completing the review. We extracted data on adverse events
(harms) associated with the interventions.
MAIN RESULTS
We included 44 new RCTs and cluster‐RCTs in this update, bringing the total
number of randomised trials to 67. There were no included studies conducted
during the COVID‐19 pandemic. Six ongoing studies were identified, of which
three evaluating masks are being conducted concurrent with the COVID pandemic,
and one is completed.
Many studies were conducted during non‐epidemic influenza periods, but several
studies were conducted during the global H1N1 influenza pandemic in 2009, and
others in epidemic influenza seasons up to 2016. Thus, studies were conducted in
the context of lower respiratory viral circulation and transmission compared to
COVID‐19. The included studies were conducted in heterogeneous settings, ranging
from suburban schools to hospital wards in high‐income countries; crowded inner
city settings in low‐income countries; and an immigrant neighbourhood in a
high‐income country. Compliance with interventions was low in many studies.
The risk of bias for the RCTs and cluster‐RCTs was mostly high or unclear.
Medical/surgical masks compared to no masks
We included nine trials (of which eight were cluster‐RCTs) comparing
medical/surgical masks versus no masks to prevent the spread of viral
respiratory illness (two trials with healthcare workers and seven in the
community). There is low certainty evidence from nine trials (3507 participants)
that wearing a mask may make little or no difference to the outcome of
influenza‐like illness (ILI) compared to not wearing a mask (risk ratio (RR)
0.99, 95% confidence interval (CI) 0.82 to 1.18. There is moderate certainty
evidence that wearing a mask probably makes little or no difference to the
outcome of laboratory‐confirmed influenza compared to not wearing a mask (RR
0.91, 95% CI 0.66 to 1.26; 6 trials; 3005 participants). Harms were rarely
measured and poorly reported. Two studies during COVID‐19 plan to recruit a
total of 72,000 people. One evaluates medical/surgical masks (N = 6000)
(published Annals of Internal Medicine, 18 Nov 2020), and one evaluates cloth
masks (N = 66,000).
N95/P2 respirators compared to medical/surgical masks
We pooled trials comparing N95/P2 respirators with medical/surgical masks (four
in healthcare settings and one in a household setting). There is uncertainty
over the effects of N95/P2 respirators when compared with medical/surgical masks
on the outcomes of clinical respiratory illness (RR 0.70, 95% CI 0.45 to 1.10;
very low‐certainty evidence; 3 trials; 7779 participants) and ILI (RR 0.82, 95%
CI 0.66 to 1.03; low‐certainty evidence; 5 trials; 8407 participants). The
evidence is limited by imprecision and heterogeneity for these subjective
outcomes. The use of a N95/P2 respirator compared to a medical/surgical mask
probably makes little or no difference for the objective and more precise
outcome of laboratory‐confirmed influenza infection (RR 1.10, 95% CI 0.90 to
1.34; moderate‐certainty evidence; 5 trials; 8407 participants). Restricting the
pooling to healthcare workers made no difference to the overall findings. Harms
were poorly measured and reported, but discomfort wearing medical/surgical masks
or N95/P2 respirators was mentioned in several studies. One ongoing study
recruiting 576 people compares N95/P2 respirators with medical surgical masks
for healthcare workers during COVID‐19.
Hand hygiene compared to control
Settings included schools, childcare centres, homes, and offices. In a
comparison of hand hygiene interventions with control (no intervention), there
was a 16% relative reduction in the number of people with ARIs in the hand
hygiene group (RR 0.84, 95% CI 0.82 to 0.86; 7 trials; 44,129 participants;
moderate‐certainty evidence), suggesting a probable benefit. When considering
the more strictly defined outcomes of ILI and laboratory‐confirmed influenza,
the estimates of effect for ILI (RR 0.98, 95% CI 0.85 to 1.13; 10 trials; 32,641
participants; low‐certainty evidence) and laboratory‐confirmed influenza (RR
0.91, 95% CI 0.63 to 1.30; 8 trials; 8332 participants; low‐certainty evidence)
suggest the intervention made little or no difference. We pooled all 16 trials
(61,372 participants) for the composite outcome of ARI or ILI or influenza, with
each study only contributing once and the most comprehensive outcome reported.
The pooled data showed that hand hygiene may offer a benefit with an 11%
relative reduction of respiratory illness (RR 0.89, 95% CI 0.84 to 0.95;
low‐certainty evidence), but with high heterogeneity. Few trials measured and
reported harms.
There are two ongoing studies of handwashing interventions in 395 children
outside of COVID‐19.
We identified one RCT on quarantine/physical distancing. Company employees in
Japan were asked to stay at home if household members had ILI symptoms. Overall
fewer people in the intervention group contracted influenza compared with
workers in the control group (2.75% versus 3.18%; hazard ratio 0.80, 95% CI 0.66
to 0.97). However, those who stayed at home with their infected family members
were 2.17 times more likely to be infected.
We found no RCTs on eye protection, gowns and gloves, or screening at entry
ports.
AUTHORS' CONCLUSIONS
The high risk of bias in the trials, variation in outcome measurement, and
relatively low compliance with the interventions during the studies hamper
drawing firm conclusions and generalising the findings to the current COVID‐19
pandemic.
There is uncertainty about the effects of face masks. The low‐moderate certainty
of the evidence means our confidence in the effect estimate is limited, and that
the true effect may be different from the observed estimate of the effect. The
pooled results of randomised trials did not show a clear reduction in
respiratory viral infection with the use of medical/surgical masks during
seasonal influenza. There were no clear differences between the use of
medical/surgical masks compared with N95/P2 respirators in healthcare workers
when used in routine care to reduce respiratory viral infection. Hand hygiene is
likely to modestly reduce the burden of respiratory illness. Harms associated
with physical interventions were under‐investigated.
There is a need for large, well‐designed RCTs addressing the effectiveness of
many of these interventions in multiple settings and populations, especially in
those most at risk of ARIs.
PLAIN LANGUAGE SUMMARY
available in
English Deutsch Español فارسی Français Hrvatski 日本語 Bahasa Malaysia Русский
ภาษาไทย 简体中文 繁體中文
DO PHYSICAL MEASURES SUCH AS HAND‐WASHING OR WEARING MASKS STOP OR SLOW DOWN THE
SPREAD OF RESPIRATORY VIRUSES?
What are respiratory viruses?
Respiratory viruses are viruses that infect the cells in your airways: nose,
throat, and lungs. These infections can cause serious problems and affect normal
breathing. They can cause flu (influenza), severe acute respiratory syndrome
(SARS), and COVID‐19.
How do respiratory viruses spread?
People infected with a respiratory virus spread virus particles into the air
when they cough or sneeze. Other people become infected if they come into
contact with these virus particles in the air or on surfaces on which they have
landed. Respiratory viruses can spread quickly through a community, through
populations and countries (causing epidemics), and around the world (causing
pandemics).
How can we stop the spread of respiratory viruses?
Physical measures to try to stop respiratory viruses spreading between people
include:
· washing hands often;
· not touching your eyes, nose, or mouth;
· sneezing or coughing into your elbow;
· wiping surfaces with disinfectant;
· wearing masks, eye protection, gloves, and protective gowns;
· avoiding contact with other people (isolation or quarantine);
· keeping a certain distance away from other people (distancing); and
· examining people entering a country for signs of infection (screening).
Why we did this Cochrane Review
We wanted to find out whether physical measures stop or slow the spread of
respiratory viruses.
What did we do?
We searched for studies that looked at physical measures to stop people catching
a respiratory virus infection.
We were interested in how many people in the studies caught a respiratory virus
infection, and whether the physical measures had any unwanted effects.
Search date: This is an update of a review first published in 2007. We included
evidence published up to 1 April 2020.
What we found
We identified 67 relevant studies. They took place in low‐, middle‐, and
high‐income countries worldwide: in hospitals, schools, homes, offices,
childcare centres, and communities during non‐epidemic influenza periods, the
global H1N1 influenza pandemic in 2009, and epidemic influenza seasons up to
2016. No studies were conducted during the COVID‐19 pandemic. We identified
six ongoing, unpublished studies; three of them evaluate masks in COVID‐19.
One study looked at quarantine, and none eye protection, gowns and gloves, or
screening people when they entered a country.
We assessed the effects of:
· medical or surgical masks;
· N95/P2 respirators (close‐fitting masks that filter the air breathed in, more
commonly used by healthcare workers than the general public); and
· hand hygiene (hand‐washing and using hand sanitiser).
What are the results of the review?
Medical or surgical masks
Seven studies took place in the community, and two studies in healthcare
workers. Compared with wearing no mask, wearing a mask may make little to no
difference in how many people caught a flu‐like illness (9 studies; 3507
people); and probably makes no difference in how many people have flu confirmed
by a laboratory test (6 studies; 3005 people). Unwanted effects were rarely
reported, but included discomfort.
N95/P2 respirators
Four studies were in healthcare workers, and one small study was in the
community. Compared with wearing medical or surgical masks, wearing N95/P2
respirators probably makes little to no difference in how many people have
confirmed flu (5 studies; 8407 people); and may make little to no difference in
how many people catch a flu‐like illness (5 studies; 8407 people) or respiratory
illness (3 studies; 7799 people). Unwanted effects were not well reported;
discomfort was mentioned.
Hand hygiene
Following a hand hygiene programme may reduce the number of people who catch a
respiratory or flu‐like illness, or have confirmed flu, compared with people not
following such a programme (16 studies; 61,372 people). Few studies measured
unwanted effects; skin irritation in people using hand sanitiser was mentioned.
How reliable are these results?
Our confidence in these results is generally low for the subjective outcomes
related to respiratory illness, but moderate for the more precisely defined
laboratory‐confirmed respiratory virus infection, related to masks and N95/P2
respirators. The results might change when further evidence becomes available.
Relatively low numbers of people followed the guidance about wearing masks or
about hand hygiene, which may have affected the results of the studies.
Key messages
We are uncertain whether wearing masks or N95/P2 respirators helps to slow the
spread of respiratory viruses.
Hand hygiene programmes may help to slow the spread of respiratory viruses.
VISUAL SUMMARY
AUTHORS' CONCLUSIONS
IMPLICATIONS FOR PRACTICE
The evidence summarised in this review on the use of masks is largely based on
studies conducted during traditional peak respiratory virus infection seasons up
until 2016. We will incorporate relevant published studies in COVID‐19 when
their results are available. The observed lack of effect of mask wearing in
interrupting the spread of ILI or influenza in our review has many potential
reasons, including: poor study design; insufficiently powered studies arising
from low viral circulation in some studies; lower compliance with mask wearing,
especially among children; quality of the masks used; self‐contamination of the
mask by hands; lack of protection from eye exposure from respiratory droplets
(allowing a route of entry of respiratory viruses into the nose via the lacrimal
duct); saturation of masks with saliva from extended use (promoting virus
survival in proteinaceous material); and risk compensation behaviour leading to
an exaggerated sense of security (Brosseau 2020; Canini 2010; Cassell 2006;
MacIntyre 2015; Rengasamy 2010; Zamora 2006).
Our findings show that hand hygiene has a modest effect as a physical
intervention to interrupt the spread of respiratory viruses, but several
questions remain. First, the high heterogeneity between studies may suggest that
there are differences in the effect of different interventions. The poor
reporting limited our ability to extract the information needed to assess any
'dose response' relationship, and there are few head‐to‐head trials comparing
hand hygiene materials (such as alcohol‐based sanitiser or soap and water).
Second, the sustainability of hand hygiene is unclear where participants in some
studies achieved 5 to 10 hand‐washings per day, but compliance may have
diminished with time as motivation decreased, or due to adverse effects from
frequent hand‐washing. Third, there is little evidence about the effectiveness
of combinations of hand hygiene with other interventions, and how those are best
introduced and sustained. Finally, some interventions were intensively
implemented within small organisations, and involved education or training as a
component, and the ability to scale these up to broader interventions is
unclear.
Our findings with respect to hand hygiene should be considered generally
relevant to all viral respiratory infections, given the diverse populations
where transmission of viral respiratory infections occurs. The participants were
adults, children and families, and multiple congregation settings including
schools, childcare centres, homes, and offices. Most respiratory viruses,
including the pandemic SARS‐CoV‐2, are considered to be predominantly spread via
respiratory droplets or contact routes, or both (WHO 2020c). Data from studies
of SARS‐CoV‐2 contamination of the environment based on the presence of viral
ribonucleic acid (RNA) suggest significant fomite contamination from the virus
(Ong 2020; Wu 2020). Hand hygiene would be expected to be beneficial in reducing
the spread of SARS‐CoV‐2 similar to other beta coronaviruses (SARS‐CoV‐1, Middle
East respiratory syndrome (MERS), and human coronaviruses), which are very
susceptible to the concentrations of alcohol commonly found in most hand
sanitiser preparations (Rabenau 2005; WHO 2020c). Support for this effect is the
finding that poor hand hygiene, despite the use of full PPE, was independently
associated with an increased risk of SARS‐CoV‐2 transmission to healthcare
workers in a retrospective cohort study in Wuhan, China in both a high‐risk and
low‐risk clinical unit for patients infected with COVID‐19 (Ran 2020). The
practice of hand hygiene appears to have a consistent effect in all settings,
and should be an essential component of other interventions.
The highest‐quality cluster‐RCTs indicate that the most effect on preventing
respiratory virus spread from hygienic measures occurs in younger children. This
may be because younger children are least capable of hygienic behaviour
themselves (Roberts 2000), and have longer‐lived infections and greater social
contact, thereby acting as portals of infection into the household (Monto 1969).
Additional benefit from reduced transmission from them to other members of the
household is broadly supported by the results of other study designs where the
potential for confounding is greater.
Routine long‐term implementation of some of the interventions covered in this
review may be problematic, particularly maintaining strict hygiene and barrier
routines for long periods of time. This would probably only be feasible in
highly motivated environments, such as hospitals. Many of the trial authors
commented on the major logistical burdens that barrier routines imposed at the
community level. However, the threat of a looming epidemic may provide stimulus
for their inception.
IMPLICATIONS FOR RESEARCH
Public health measures and physical interventions can be highly effective to
interrupt the spread of respiratory viral infections, especially when they are
part of a structured and co‐ordinated programme that includes instruction and
education, and when they are delivered together. Our review has provided
important insights into research gaps that need to be addressed with respect to
these physical interventions and their implementation. The 2014 WHO
document 'Infection prevention and control of epidemic‐ and pandemic‐prone acute
respiratory infections in health care' identified several research gaps as part
of their GRADE assessment of their infection prevention and control
recommendations, which remain very relevant (WHO 2014). Research gaps identified
during the course of our review and the WHO 2014 document may be considered from
the perspective of both general and specific themes.
A general theme identified was the need to provide outcomes with explicitly
defined clinical criteria for acute respiratory infections (ARIs) and discrete
laboratory‐confirmed outcomes of viral ARIs using molecular diagnostic tools
which are now widely available. Our review found large disparities between
studies with respect to the clinical outcome events, which were imprecisely
defined in several studies, and there were differences in the extent to which
laboratory‐confirmed viruses were included in the studies that assessed them.
Another general theme identified was the lack of consideration of sociocultural
factors that might affect compliance with the interventions, especially those
employed in the community setting. In addition, the cost and resource
implications of the physical interventions employed in different settings would
have important relevance for low‐ to middle‐income countries. Resources have
been a major issue with the COVID‐19 pandemic, with global shortages of several
components of PPE. Several specific research gaps related to physical
interventions were identified within the WHO 2014 document and are congruent
with many of the findings of our current update, including the following:
transmission dynamics of respiratory viruses from patients to healthcare workers
during aerosol‐generating procedures; a lack of precision with regards to
defining aerosol‐generating procedures; the safety of cohorting of patients with
the same suspected but unconfirmed diagnosis in a common unit or ward with
patients infected with the same known pathogen in healthcare settings; the
optimal duration of the use of physical interruptions to prevent spread of ARI
viruses; use of spatial separation or physical distancing (in healthcare and
community settings, respectively) alone versus spatial separation or physical
distancing with the use of other added physical interventions coupled with
examining discrete distance parameters (e.g. 1 metre, 2 metres, or > 2
metres); the effectiveness of respiratory etiquette (i.e. coughing/sneezing into
tissues or a sleeved bent elbow); the effectiveness of triage and early
identification of infected individuals with an ARI in both hospital and
community settings; use of frequent disinfection techniques appropriate to the
setting (high‐touch surfaces in the environment, gargling with oral
disinfectants, and virucidal tissues or clothing) alone or in combination with
facial masks and hand hygiene; the use of ultraviolet light germicidal
irradiation for disinfection of air in healthcare and selected community
settings; and the use of widespread compliance with effective vaccination
strategies.
There is a clear requirement to conduct large, pragmatic trials to evaluate the
best combinations in the community and in healthcare settings with multiple
respiratory viruses and in different sociocultural settings. RCTs with a
pragmatic design, similar to the Luby 2005 trial, should be conducted whenever
possible. Alternately, large population‐based cohort studies may also be
considered if individual RCTs prove to be too expensive or less practical,
depending on the issue that is being addressed.
Several specific research gaps deserve expedited attention and may be
highlighted within the context of the COVID‐19 pandemic. The use of facial masks
in the community setting represents one of the most pressing needs to address,
given the polarised opinions around the world. Both broad‐based ecological
studies, adjusting for confounding and high‐quality randomised trials, may be
necessary to determine if there is an independent contribution to their use as a
physical intervention, and how they may best be deployed to optimise their
contribution. The type of fabric and weave used in the face mask is an equally
pressing concern, given that surgical masks with their cotton‐polypropylene
fabric appear to be effective in the healthcare setting, but there are questions
about the effectiveness of simple cotton masks. In addition, these masking
intervention studies should focus on measuring not only benefits but also
compliance, harms, and risk compensation if the latter may lead to a lower
protective effect. In addition, although the use of surgical masks versus N95
respirators demonstrates no differences in clinical effectiveness to date, their
use needs to be studied in the setting of a new pandemic such as COVID‐19, and
with concomitant measurement of harms, which to date have been poorly studied.
Physical distancing represents another major research gap which needs to be
addressed expediently, especially within the context of the COVID‐19 pandemic
setting as well as in future epidemic settings. The use of quarantine and
screening at entry ports needs to be investigated in well‐designed, high‐quality
studies. We found only one RCT of quarantine, and no trials of screening at
entry ports or physical distancing. Given that this is one of the primary
strategies applied globally in the face of the COVID‐19 pandemic, future trials
should be conducted within the context of this pandemic, as well as in future
epidemics with other respiratory viruses of less virulence.
The variable quality and small scale of some studies is known from descriptive
studies (Aiello 2002; Fung 2006; WHO 2006b), and systematic reviews of selected
interventions (Meadows 2004). In summary, more high‐quality studies are needed
to evaluate the most effective strategies to implement successful physical
interventions in practice, both on a small scale and at a population level.
Finally, we emphasise that more attention should be paid to describing and
quantifying the harms of the interventions assessed in this review and their
relationship with compliance.
SUMMARY OF FINDINGS
Open in table viewer
Summary of findings 1. Medical/surgical masks compared to no masks for
preventing the spread of viral respiratory illness
Randomised studies: medical/surgical masks compared to no masks for preventing
the spread of viral respiratory illness
Patient or population: general population and healthcare workers
Setting: community and hospitals
Intervention: medical/surgical masks
Comparison: no masks
Outcomes
Anticipated absolute effects* (95% CI)
Relative effect
(95% CI)
№ of participants
(studies)
Certainty of the evidence
(GRADE)
Comments
Risk with no masks
Risk with randomised studies: masks
Viral illness ‐ influenza‐like illness
Study population
RR 0.99
(0.82 to 1.18)
3507 (9 RCTs)
⊕⊕⊝⊝
LOWa,b
160 per 1000
158 per 1000
(131 to 189)
Viral illness ‐ laboratory‐confirmed influenza
Study population
RR 0.91
(0.66 to 1.26)
3005 (6 RCTs)
⊕⊕⊕⊝
MODERATEb
40 per 1000
36 per 1000
(26 to 50)
Influenza‐like illness in healthcare workers
Study population
RR 0.37
(0.05 to 2.50)
1070 (2 RCTs)
⊕⊕⊝⊝
LOWa,b
Studies in healthcare workers only
40 per 1000
15 per 1000
(2 to 100)
Adverse events
‐
‐
(3 RCTs)
⊕⊝⊝⊝
VERY LOWa,c
Adverse events were not reported consistently and could not be meta‐analysed.
Adverse events reported for masks included warmth, discomfort, respiratory
difficulties, humidity, pain, and shortness of breath, in up to 45% of
participants.
*The risk in the intervention group (and its 95% confidence interval) is based
on the median observed risk in the comparison group of included studies and the
relative effect of the intervention (and its 95% CI).
CI: confidence interval; RCT: randomised controlled trial; RR: risk ratio
GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of
the estimate of the effect.
Moderate certainty: We are moderately confident in the effect estimate: the true
effect is likely to be close to the estimate of the effect, but there is a
possibility that it is substantially different.
Low certainty: Our confidence in the effect estimate is limited: the true effect
may be substantially different from the estimate of the effect.
Very low certainty: We have very little confidence in the effect estimate: the
true effect is likely to be substantially different from the estimate of effect.
aStudy limitations (lack of blinding).
bImprecision (wide confidence intervals).
cImprecision: 2 steps (only 3 studies enumerated adverse events; another study
mentioned no adverse events).
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Summary of findings 2. N95 respirators compared to medical/surgical masks for
preventing the spread of viral respiratory illness
Randomised studies: N95 respirators compared to medical/surgical masks for
preventing the spread of viral respiratory illness
Patient or population: healthcare workers and general population
Setting: hospitals and households
Intervention: N95 masks
Comparison: medical/surgical masks
Outcomes
Anticipated absolute effects* (95% CI)
Relative effect
(95% CI)
№ of participants
(studies)
Certainty of the evidence
(GRADE)
Comments
Risk with medical masks
Risk with randomised studies: N95
Viral illness ‐ clinical respiratory illness
Study population
RR 0.70
(0.45 to 1.10)
7799 (3 RCTs)
⊕⊝⊝⊝
VERY LOWa,b,c
All studies were conducted in hospital settings with healthcare workers.
120 per 1000
84 per 1000
(54 to 132)
Viral illness ‐ influenza‐like illness
Study population
RR 0.82
(0.66 to 1.03)
8407 (5 RCTs)
⊕⊕⊝⊝
LOWa,b
1 study was conducted in households (MacIntyre 2009).
50 per 1000
41 per 1000
(33 to 52)
Viral illness ‐ laboratory‐confirmed influenza
Study population
RR 1.10
(0.90 to 1.34)
8407 (5 RCTs)
⊕⊕⊕⊝
MODERATEb
1 study was conducted in households (MacIntyre 2009).
70 per 1000
77 per 1000
(63 to 94)
Adverse events
‐
‐
(5 RCTs)
⊕⊝⊝⊝ VERY LOWa,b,c
There was insufficient consistent reporting of adverse events to enable
meta‐analysis.
Only 1 study reported detailed adverse events: discomfort was reported in 41.9%
of N95 wearers versus 9.8% of medical mask wearers (P < 0.001); headaches were
more common with N95 (13.4% versus 3.9%; P < 0.001); difficulty breathing was
reported more often in the N95 group (19.4% versus 12.5%; P = 0.01); and N95
caused more problems with pressure on the nose (52.2% versus 11.0%; P < 0.001).
4 RCTs either reported no adverse events or only reported on comfort wearing
masks.
*The risk in the intervention group (and its 95% confidence interval) is based
on the median risk in the comparison group and the observed relative effect of
the intervention (and its 95% CI).
CI: confidence interval; RCT: randomised controlled trial; RR: risk ratio
GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of
the estimate of the effect.
Moderate certainty: We are moderately confident in the effect estimate: the true
effect is likely to be close to the estimate of the effect, but there is a
possibility that it is substantially different.
Low certainty: Our confidence in the effect estimate is limited: the true effect
may be substantially different from the estimate of the effect.
Very low certainty: We have very little confidence in the effect estimate: the
true effect is likely to be substantially different from the estimate of effect.
aStudy limitations (lack of blinding).
bImprecision (wide confidence interval or no meta‐analysis conducted).
cInconsistency of results (heterogeneity).
Open in table viewer
Summary of findings 3. Hand hygiene compared to control for preventing the
spread of viral respiratory illness
Hand hygiene compared to control for preventing the spread of viral respiratory
illness
Patient or population: prevention of spread of viral respiratory illness
Setting: schools, childcare centres, homes, offices
Intervention: hand hygiene
Comparison: control
Outcomes
Anticipated absolute effects* (95% CI)
Relative effect
(95% CI)
№ of participants
(studies)
Certainty of the evidence
(GRADE)
Comments
Risk with control
Risk with hand hygiene
Acute respiratory illness
Study population
RR 0.84
(0.82 to 0.86)
44,129 (7 RCTs)
⊕⊕⊕⊝
MODERATEa
380 per 1000
319 per 1000
(312 to 327)
Influenza‐like illness
Study population
RR 0.98
(0.85 to 1.13)
32,641 (10 RCTs)
⊕⊕⊝⊝
LOWa,b
90 per 1000
88 per 1000
(77 to 102)
Laboratory‐confirmed influenza
Study population
RR 0.91
(0.63 to 1.30)
8332 (8 RCTs)
⊕⊕⊝⊝
LOWb,c
80 per 1000
73 per 1000
(50 to 104)
Composite of acute respiratory illness, influenza‐like illness, influenza
Study population
RR 0.89
(0.84 to 0.95)
61,372 (16 RCTs)
⊕⊕⊝⊝
LOWa,b
200 per 1000
178 per 1000
(168 to 190)
Adverse events
‐
‐
(2 RCTs)
⊕⊝⊝⊝
VERY LOWa,b,c
Data were insufficient to conduct meta‐analysis.
1 study reported that no adverse events were observed, and another study
reported that skin reaction was recorded for 10.4% of participants in the hand
sanitiser group versus 10.3% in the control group.
*The risk in the intervention group (and its 95% confidence interval) is based
on the median observed risk in the comparison groups of included studies and the
relative effect of the intervention (and its 95% CI).
CI: confidence interval; RCT: randomised controlled trial; RR: risk ratio
GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of
the estimate of the effect.
Moderate certainty: We are moderately confident in the effect estimate: the true
effect is likely to be close to the estimate of the effect, but there is a
possibility that it is substantially different.
Low certainty: Our confidence in the effect estimate is limited: the true effect
may be substantially different from the estimate of the effect.
Very low certainty: We have very little confidence in the effect estimate: the
true effect is likely to be substantially different from the estimate of effect.
aStudy limitation (majority of studies were unblinded, with participant‐assessed
outcome).
bInconsistent results across studies.
cImprecision (wide confidence interval or no meta‐analysis conducted).
BACKGROUND
DESCRIPTION OF THE CONDITION
Epidemic and pandemic viral infections pose a serious threat to people
worldwide. Epidemics of note include severe acute respiratory syndrome (SARS) in
2003 and the Middle East respiratory syndrome (MERS), which began in 2012. Major
pandemics include the H1N1 influenza caused by the H1N1pdm09 virus in 2009 and
the coronavirus disease 2019 (COVID‐19) caused by SARS‐CoV‐2.
Even non‐epidemic acute respiratory infections (ARIs) place a huge burden on
healthcare systems around the world, and are a prominent cause of morbidity (WHO
2017). Furthermore, ARIs are often antecedents to lower respiratory tract
infections caused by bacterial pathogens (i.e. pneumonia), which cause millions
of deaths worldwide, mostly in low‐income countries (Schwartz 2018).
High viral load, high levels of transmissibility, susceptible populations, and
symptomatic patients are considered to be the drivers of such epidemics and
pandemics (Jefferson 2006a). Preventing the spread of respiratory viruses from
person to person may be effective at reducing the spread of outbreaks. Physical
interventions, such as the use of masks and physical distancing measures, might
prevent the spread of respiratory viruses which are transmitted by large
droplets from infected to susceptible people. This review assumes that physical
interventions used to prevent transmission of respiratory viruses are similar
for most viral ARIs.
DESCRIPTION OF THE INTERVENTION
Single measures of intervention (Demicheli 2018a; Demicheli 2018b; Jefferson
2014; Jefferson 2018; Thomas 2010), such as the use of vaccines or antivirals,
may be insufficient to contain the spread of influenza, but combinations of
interventions may reduce the reproduction number to below 1. For some
respiratory viruses there are no licensed interventions, and a combination of
social and physical interventions may be the only option to reduce the spread of
outbreaks, particularly those that may be capable of becoming epidemic or
pandemic in nature (Luby 2005). Such interventions were emphasised in the World
Health Organization's latest Global Influenza Strategy 2019 to 2030, and have
several possible advantages over other methods of suppressing ARI outbreaks
since they may be instituted rapidly and may be independent of any specific type
of infective agent, including novel viruses. In addition, the possible
effectiveness of public health measures during the Spanish flu pandemic of 1918
to 1919 in US cities supports the impetus to investigate the existing evidence
on the effectiveness of such interventions (Bootsma 2007), including quarantine
(such as isolation, physical distancing) and the use of disinfectants. We also
considered the major societal implications for any community adopting these
measures (CDC 2005a; CDC 2005b; WHO 2006b; WHO 2020a; WHO 2020b).
HOW THE INTERVENTION MIGHT WORK
Epidemics and pandemics are more likely during antigenic change (changes in the
viral composition) in the virus or transmission from animals (domestic or wild)
when there is no natural human immunity (Bonn 1997). High viral load, high
levels of transmissibility, and symptomatic patients are considered to be the
drivers of such epidemics and pandemics (Jefferson 2006b).
Physical interventions, such as the use of masks, physical distancing measures,
school closures, and limitations of mass gatherings, might prevent the spread of
the virus transmitted by large droplets or aerosols from infected to susceptible
individuals. The use of hand hygiene, gloves, and protective gowns can also
prevent the spread by limiting the transfer of viral particles onto and from
fomites (inanimate objects such as flat surfaces, tabletops, utensils, porous
surfaces, or nowadays cell phones, which can transmit the agent if
contaminated). Such public health measures were widely adopted during the
Spanish flu pandemic and have been the source of considerable debate (Bootsma
2007).
WHY IT IS IMPORTANT TO DO THIS REVIEW
Although the benefits of physical interventions seem self‐evident, given the
global importance of interrupting viral transmission, having up‐to‐date
estimates of their effectiveness is necessary to inform planning,
decision‐making, and policy. The outbreak of COVID‐19 has prompted this update.
Physical methods have several possible advantages over other methods of
suppressing ARI outbreaks, including their rapid deployment and ability to be
independent of the infective agent, including novel viruses.
The last update of this review in 2011, Jefferson 2011, identified 23 trials on
physical interventions that might interrupt or reduce the spread of respiratory
viruses. Because of poor reporting and heterogeneity, and the relatively small
number of included trials, it was not possible to perform a meta‐analysis.
Case‐control studies were sufficiently homogenous to permit meta‐analysis, which
provided evidence that hand‐washing for a minimum of 11 times daily prevented
cases of SARS during the 2003 epidemic (odds ratio 0.54, 95% confidence interval
0.44 to 0.67). Many randomised trials have been published in the past decade,
prompting us to focus only on these for the current update.
This is the fourth update of a Cochrane Review first published in 2007
(Jefferson 2007; Jefferson 2009; Jefferson 2010; Jefferson 2011).
OBJECTIVES
To assess the effectiveness of physical interventions to interrupt or reduce the
spread of acute respiratory viruses.
METHODS
CRITERIA FOR CONSIDERING STUDIES FOR THIS REVIEW
TYPES OF STUDIES
For this 2020 update we only considered individual‐level RCTs, or cluster‐RCTs,
or quasi‐RCTs for inclusion.
In previous versions of the review we also included observational studies
(cohorts, case‐controls, before‐after, and time series studies). However, for
this update there were sufficient randomised studies to address our study aims,
so we excluded observational studies (which are known to be at a higher risk of
bias).
TYPES OF PARTICIPANTS
People of all ages.
TYPES OF INTERVENTIONS
We included randomised controlled trials (RCTs) and cluster‐RCTs of trials
investigating physical interventions (screening at entry ports, isolation,
quarantine, physical distancing, personal protection, hand hygiene, face masks,
and gargling) to prevent respiratory virus transmission compared with doing
nothing or with another intervention.
TYPES OF OUTCOME MEASURES
For this 2020 update we added one outcome: adverse events related to the
intervention, and we split the outcomes into primary and secondary outcomes.
PRIMARY OUTCOMES
1. Numbers of cases of viral illness (including ARIs, influenza‐like illness
(ILI), and laboratory‐confirmed influenza, or other viral pathogens).
2. Adverse events related to the intervention.
SECONDARY OUTCOMES
1. Deaths.
2. Severity of viral illness as reported in the studies.
3. Absenteeism.
4. Hospital admissions.
5. Complications related to the illness, e.g. pneumonia.
SEARCH METHODS FOR IDENTIFICATION OF STUDIES
ELECTRONIC SEARCHES
For this 2020 update, we refined the original search strategy using a
combination of previously included studies and automation tools (Clark 2020). We
converted this search using the Polyglot Search Translator (Clark 2020), and ran
the searches in the following databases:
1. the Cochrane Central Register of Controlled Trials (CENTRAL) (2020, Issue
3), which includes the Acute Respiratory Infections Group's Specialised
Register (searched 1 April 2020) (Appendix 1);
2. PubMed (2010 to 1 April 2020) (Appendix 2);
3. Embase (2010 to 1 April 2020) (Appendix 3);
4. CINAHL (Cumulative Index to Nursing and Allied Health Literature) (2010 to 1
April 2020) (Appendix 4);
5. US National Institutes of Health Ongoing Trials Register
ClinicalTrials.gov (January 2010 to 16 March 2020); and
6. World Health Organization International Clinical Trials Registry
Platform (January 2010 to 16 March 2020).
We combined the database searches with the Cochrane Highly Sensitive Search
Strategy for identifying randomised trials in MEDLINE: sensitivity‐ and
precision‐maximising version (2008 revision) (Lefebvre 2011). Details of
previous searches are available in Appendix 5.
SEARCHING OTHER RESOURCES
We conducted a backwards‐and‐forwards citation analysis in Scopus on all newly
included studies to identify other potentially relevant studies.
DATA COLLECTION AND ANALYSIS
SELECTION OF STUDIES
The search and citation analysis results were initially screened via the
RobotSearch tool (Marshall 2018) to exclude all studies that were obviously not
RCTs. We scanned the titles and abstracts of studies identified by the searches.
We obtained the full‐text articles of studies that either appeared to meet our
eligibility criteria or for which there was insufficient information to exclude
it. We then used a standardised form to assess the eligibility of each study
based on the full article.
DATA EXTRACTION AND MANAGEMENT
Three pairs of review authors (MJ/EF, LA/GB, EB/TOJ) independently applied the
inclusion criteria to all identified and retrieved articles, and extracted data
using a standard template that had been developed for and applied to previous
versions of the review, but was revised to reflect our focus on RCTs and
cluster‐RCTs for this update. Any disagreements were resolved through
discussion. We extracted and reported descriptions of interventions using the
Template for Intervention Description and Replication (TIDieR) template ( Table
1).
Open in table viewer
Table 1. Description of interventions in included studies, using the items from
the Template for Intervention Description and Replication (TIDieR) checklist
Author, year
Brief name
Recipient
Why
What (materials)
What (procedures)
Who provided
How
Where
When and how much
Tailoring
Modification of intervention throughout trial
Strategies to improve or maintain intervention fidelity
Extent of intervention fidelity
Masks compared to either no masks or different mask types
Barasheed 2014
Supervised mask use
Religious pilgrims ≥ 15 years
Prevent respiratory virus infections at mass gatherings through mask use
Plain surgical face masks (3M Standard Tie‐On Surgical Mask, Cat No: 1816)
manufactured by 3M company, USA; 5 masks per day
Written instructions on face mask use
Special polythene bags for disposal
Masks provided to index case and their contacts with advice on mask use (before
prayers, in seminars, and after meals).
Written instructions provided on face mask use, need to change them, and
disposal.
Not described, presumably the medical researchers
Face‐to‐face provision of masks, instructions, and reminders
Tents of pilgrimage site (Mina Valley, Saudi Arabia)
Advice on mask use given throughout pilgrimage stay (5 days)
None reported.
None reported.
The medical researchers followed pilgrims each day to remind participants about
recording their mask usage in health diary.
Face mask use: mask group: 56/75 (76%), control group: 11/89 (12%)
(P < 0.001)
76% of intervention tents wore masks.
10 of 75 (13%) pilgrims in ‘mask’ tents wore face masks during sleep.
Canini 2010
Surgical face masks
Householders (over 5 years)
Limit transmission of influenza transmission by large droplets produced during
coughing in households
Initial supply of 30 masks:
for adults and children > 10: surgery masks with earloops, 3 plys, anti fog
(AEROKYN, LCH medical products, Paris, France)
Children 5 to 10: face mask KC47127, (Kimberly‐Clark, Dallas, TX, USA)
Closed plastic bags for disposal
Masks given immediately on home visit by attending general practitioner with
demonstration of proper use and instruction to be worn for 5 days in presence of
another household member or in confined space (e.g. car) and to change every 3
hours or if damaged.
General practitioners
Face‐to‐face individually
Households in France
One‐off provision of masks worn for 5 days
None described.
None described.
Not described, but reported mask usage was measured
34/51 (66%)
wore masks > 80% of the duration.
Reported mask‐wearing: 11 ± 7.2 masks during 4.0 ± 1.6 days with an average use
of
2.5 ± 1.3 masks per day and duration of use of 3.7 ± 2.7 hours/day
Jacobs 2009
Face masks
Hospital healthcare providers (nurses, doctors, and co‐medical personnel)
Decrease risk of infection through limiting droplet spread through masks
Hospital‐standard disposable surgical
Mask MA‐3 (Ozu Sangyo, Tokyo, Japan); quantity not specified
Provision of masks and instructions for use
Not described, presumably research team
Face‐to‐face
Tertiary care hospital in Tokyo, Japan
Face masks worn whilst on hospital property.
77 days
None described.
None described.
Self‐reported compliance
Self‐reported compliance for both groups reported as good, with full compliance
by 84.3% and remainder complying 79.2% to 98.7%.
Loeb 2009
2 active interventions
A. surgical masks
B. N95 respirators
Healthcare workers (nurses)
Reduce transmission of influenza in healthcare settings through coughing or
sneezing with protective masks
A. Surgical masks
B. N95 respirators
Provision of masks or N95 respirators
Instruction in use and proper placement of devices
Fit‐testing and demonstration of positioning of N95 using standard protocol and
procedure (details provided)
Qualitative fit‐testing using saccharin or Bitrex protocol[1]
Provided by research team (not further described)
Fit‐testing by technician for N95
In‐person face‐to‐face
Tertiary hospitals in Ontario, Canada
1 influenza season (12 weeks)
Use of mask as required[2] when providing care to or within 1 m of patient with
febrile respiratory illness, ≥ 38 °C, and new or worsening cough or shortness of
breath
Nurses to wear N95 when caring for patients with “febrile respiratory illness”
Fit‐testing of nurses not already fit‐tested
Ceased before end of season
Compliance audits during peak of season by trained auditor who stood short
distance from patient isolation room
18 episodes:
N95: 6/7 participants (85.7%) wearing assigned device versus 100% for masks
MacIntyre 2009
2 active interventions in addition to infection control guidelines
A. Surgical masks (SM)
B. P2 masks (P2)
Householders with a child with fever and respiratory symptoms
Prevent or reduce respiratory virus transmission in the community through
non‐pharmaceutical interventions
A. 3M surgical mask, catalogue no. 1820;
St Paul, MN, USA for adults
B. P2 masks (3M flat‐fold P2 mask, catalogue no. 9320; Bracknell, Berkshire, UK)
A and B: health guidelines and pamphlets about infection control
Provision of masks and pamphlets and education about infection prevention and
mask use
Telephone calls and exit interviews to record adherence to mask use
All groups: health guidelines, pamphlets about infection control were provided
Not described, presumably research team
Face‐to‐face and by telephone
Households in Sydney, Australia
2 winter seasons (3 months and 6 months)
2 weeks of follow‐up
Masks to be worn at all times
when in same room as index child, regardless of
distance from child
None described.
None described.
Daily telephone calls to record mask use throughout day
Exit interviews about adherence
Reported mask use:
Day 1
SM: 36/94 (38%)
P2: 42/92 (46%) stated wearing “most or all” of the time. Other participants
were wearing face masks rarely or never.
Day 5:
SM: 29/94 (31%)
P2: 23/92 (25%)
MacIntyre 2011
3 active interventions
A. Medical masks
B. N95 respirators fit‐tested
C. N95 respirators non‐fit‐tested
Healthcare workers
Protect HCWs by preventing transmission of influenza and other respiratory
viruses from patients through mask wearing
Daily supply of
A. 3 medical masks (3M medical mask, catalogue number 1820, St Paul, MN, USA)
2 respirators:
B. N95 fit‐tested mask (3M flat‐fold N95 respirator, catalogue number 9132)
fit‐tested with 3M FT‐30 Bitrex Fit Test kit according to manufacturer's
instructions (3M, St Paul, MN, USA)
C. N95 non‐fit‐tested mask (3M flat‐fold N95 respirator, catalogue number 9132)
Diary cards for usage recording
Supply of masks or respirators.
Instruction in when to wear it, correct fitting, and storage (in paper bag in
personal locker)
Instruction in importance of hand hygiene before and after removal
For fit‐tested group: fit‐testing procedure
Masks provided to hospitals.
Training of staff provided by 1 member of research team.
Masks and training provided face‐to‐face, not described if training was
individually or in groups.
Emergency departments and respiratory wards in hospitals in Beijing, China
Entire work shift for 4 weeks
Taken off for toilet and meal breaks and at end of shift
None described.
Mask ⁄ respirator use monitored by:
(i) observed compliance by head ward nurse recorded daily;
(ii) self‐report diary cards carried during day recording;
(i) no. hours;
(ii) usage.
Exit interviews
Adherence for usage was high for all and not significantly
different amongst arms.
Medical mask: 76%, 5 hours
N95 fit‐tested: 74%, 5.2 hours
N95 non‐fit‐tested: 68%, 4.9 hours
MacIntyre 2013
3 active interventions
A. N95 respirators at all times
B. N95 respirators targeted use
C. Medical masks
Healthcare workers (nurses and doctors)
Protect HCWs from respiratory infections from patients through mask use
Daily supply of:
A. and B.
2 respirators
(3M Health Care
N95 Particulate Respirator; catalogue number 1860)
3M FT‐30 Bitrex Fit Test Kit
C. 3 masks
3 masks
(3M Standard Tie‐On Surgical Mask catalogue number mask 1817; 3M, St Paul, MN,
USA)
Pocket‐sized diary card with tick boxes for mask use
Supply of respirators
Instructions in use including times and fit
Fit‐testing procedure according to the manufacturer’s instructions (3M)
For targeted N95:
checklist of defined high‐risk procedures, including common aerosol‐generating
procedures
3M supplied respirators and masks.
Provider of instructions not specified.
Masks and training provided face‐to‐face, not described if training was
individually or in groups.
Emergency departments and respiratory wards of tertiary hospitals in Beijing,
China
For 4 weeks,
A and B worn at all times on shift;
B. targeted (intermittent) use of N95 respirators only whilst performing
high‐risk procedures or barrier.
None described.
None described.
Self‐reported daily record of number of hours worked, mask or respirator use,
number of high‐risk procedures undertaken collected by study staff.
Compliance highest for targeted
N95 (82%; 422/516) versus N95 (57%; 333/581)
versus medical mask (66%; 380/572).
MacIntyre 2015
2 active interventions
A. Cloth masks
B. Medical masks
Hospital
healthcare workers
Prevent respiratory infections in HCWs from patients through mask‐wearing
A. 5 cloth masks for study duration (2‐ layer, cotton)
B. 2 medical masks daily for each 8‐hour shift for study duration (3 layers,
non‐woven material)
All masks locally manufactured.
Written instructions on cleaning cloth masks
Cloth or medical masks to be worn at all times on shift.
Cloth masks to be washed with soap and water daily after shifts, and the process
of cleaning to be documented.
Provision of written instructions for cloth mask cleaning
Researchers arranged supply of masks and instructions and any training of staff
assisting the delivery.
Masks and written instructions provided face‐to‐face.
Hospital wards in Vietnam
4 weeks (25 days) of face mask use
Masks not worn while in the toilet or during tea or lunch breaks.
None described.
Monitored compliance with mask use by
self‐report diary card and exit survey and interviews with a sub‐sample
(ACTRN12610000887077)
Mask‐wearing compliance:
cloth mask: 56.8%; medical mask: 56.6%;
Reported cloth mask washing: 23/25 days (92%)
MacIntyre 2016
Medical mask use
Sick householders with ILI (index cases) and their well contacts of the same
household
Protect well people in the community from transmission of respiratory pathogens
by contacts with ILI through mask use
21 medical masks (3M 1817 surgical mask)
Diary cards for mask use
Supply of masks
Instructions for mask wearing and hand‐washing protocol
Provision of diary cards
Study staff member provided masks and instructions in use.
Masks and instructions provided face‐to‐face and individually.
Fever clinics of major hospitals in Beijing, China
3 masks/day for 21 days
Mask wearing: whenever in the same room as a household member or a visitor to
the household
Hand‐washing: before putting on and after taking off
Allowed to remove their masks during mealtimes and whilst asleep and to cease
wearing once symptoms resolved
None reported.
Self‐reported daily record of mask use using diary card
Mask use: mask group: 4.4 hours; control group: 1.4 hours
Radonovich 2019
2 active interventions
A. N95 respirators (N95)
B. Medical masks (MM)
Healthcare personnel of outpatient sites within medical centres
Prevent HCP from acquiring
workplace viral respiratory infections and transmitting them to others by
effective respiratory protection by N95 respirators which reduce aerosol
exposure and inhalation of small airborne particles, meet filtration
requirements, and fit tightly
A. N95 respirators:
3M Corporation 1860, 1860S, and 1870 (St Paul, MN, USA) or Kimberly Clark
Technol Fluidshield
PFR95‐270, PFR95‐274 (Dallas, TX, USA)
B. Medical mask Precept 15320 (Arden, NC, USA) or
Kimberly Clark Technol Fluidshield 47107 (Dallas, TX, USA).
Reminder signs posted at each site
A portable computer equipped with data recording software (HandyAudit; Toronto,
Canada) to document adherence (Radonovich 2016)
Participants instructed to wear assigned protective devices whenever they were
positioned within
6 feet (1.83 m) of patients with suspected or confirmed
respiratory illness and to don a new N95/MM with each patient interaction.
Hand hygiene recommended
to all participants in accordance with Centers for Disease Control
and Prevention guidelines.
Infection prevention policies
were followed at each study site.
Reminder signs posted at sites and emails sent.
Annual fit‐testing conducted for all participants.
Filtration testing performed on the device models in the study. Further details
in protocol (Radonovich 2016).
Centres provided device supplied by study to HCP.
Study personnel posted reminder signs and emails and conducted adherence
observations.
Face‐to‐face individual provision of devices and adherence observations
Onsite posting of signs
Other reminders by email
Outpatient sites within medical centres in USA
As instructed, for each new patient interaction during 12‐week period of peak
viral respiratory illness each year for 4 years (total of 48 weeks)
Fitting of N95 masks
None described.
Reminder signage posted at study sites, and emails sent by study personnel.
Self‐reported daily device wearing of “always”, “sometimes”, “never”, or “did
not recall"
Observation of device‐wearing behaviours as participants entered and exited care
rooms conducted during unannounced, inconspicuous visits to randomly selected
sites documented on portable computer
Device wearing:
N95: 89.4% reported “always” or “sometimes” versus MM: 90.2%
“Never”
N95: 10.2%
MM: 9.5%
Hand hygiene
Alzaher 2018
Hand hygiene workshop
Primary school girls
Targeted school children to improve hand hygiene to reduce school absences due
to upper respiratory infection and spread of infection in schools and to
families
6‐minute video‐clip of 2 siblings that attended school‐based health education
about hand hygiene
Short interactive lecture about:
common infections in schools,
methods of transmission, hand‐washing procedure using soap and water including
when to wash hands
Puzzle games related to hand hygiene
Posters with cartoon princesses’ picture promoting hand‐washing
Delivery of workshop and distribution of supporting materials (games and
posters) to school and students
Study investigator delivered workshop.
Delivered face‐to‐face in group format for the workshop
2 primary girls’ schools in Saudi Arabia
1‐hour once‐off workshop; posters and games provided to school
Not described
Not described
Posters in restrooms as reminders of hand‐washing hygiene during 5‐week
follow‐up period after workshop
Not reported
Arbogast 2016
Multimodal hand hygiene intervention programme in addition to control of brief
video
Office buildings and the employees of health insurance company
Reduce hand‐to‐mouth germ transmission from shared workspaces and workplace
facilities and thereby healthcare claims and absenteeism through improved
workplace hand hygiene
Alcohol‐based hand sanitiser (PURELL Advanced, GOJO Industries Inc, Akron, OH,
USA) installed as wall‐mounted dispensers, stands, or free‐standing bottles
One 8‐ounce bottle of hand sanitiser (PURELL Advanced) per cubicle
One 100‐count canister of hand wipes (PURELL Wipes) per cubicle
Replenishment products stored in supply room
(in addition to existing foam hand wash (GOJO Green Certified Foam Handwash) and
an alcohol‐based hand sanitiser foam wall‐mounted dispenser (PURELL, GOJO
Industries) already provided near the restroom exits prior to intervention)
Identical soap in all restrooms
Intervention and control group:
brief (< 1‐minute educational video) about proper hand hygiene technique, for
both washing and sanitising hands
‘‘Wash Your Hands’’, signage promoting hand hygiene compliance, was already
posted next to restroom exits at both the control and intervention sites.
Hand hygiene supplies installed in offices.
Replenishment product was made easily available to individual employees upon
request via a simple process.
Monitoring of product shipments into sites
Physical collection and full replacement of soap, sanitiser, and wipes
Intervention and control group:
educational video embedded at end of baseline online knowledge survey
Not described, presumably study investigators arranged installations
Hand hygiene supplies provided in office environments and individually at staff
cubicles/offices.
Video provided individually via email.
High‐traffic common areas of 2 US health insurance company offices (e.g. near
elevators, at entrances) and appropriate public spaces (e.g. coffee area, break
rooms, conference rooms, training rooms, lobbies, reception areas); individual
staff cubicles of mostly open plan offices (average 309 square feet).
Office restrooms
13.5 months overall
One‐off email video
11 days before study hand hygiene supplies installed.
13 months of provision of supplies
2 times evening collection and full replacement of products
Sanitiser installed in high‐use areas of the offices.
Not described
Employee survey at 4 months included questions about hand hygiene practice
compliance.
Monitoring of product
shipments into the sites and physical collection of the soap, sanitiser, and
wipes products 2 times in the study; collected samples were measured and usage
rates were
estimated
Intervention group employees: reported 40% more cleaning of work area regularly;
significantly more likely to keep the hand sanitiser with them and use it
throughout the day; significant increases in hand sanitiser use for at‐risk
activities[3]
Estimated use by average employee from sample collection:
sanitiser 1.8 to 3.0 times/day,
soap
2.1 to 4.4 times/day,
wipes at their desk 1.4 to 1.5 times/week
Azor‐Martinez 2016
Hand‐washing programme
Primary school children and their parents and teachers
Prevent transmission of upper respiratory infections in schools and to families
through non‐pharmaceutical
intervention of hand‐washing programme in schools
Brochure about hand‐washing awareness and habits
Workshop content materials
Stories, songs, and classroom posters about hand hygiene and infection
transmission
Hand sanitiser (ALCO ALOE GEL hand sanitiser by Americo Govantes Burguete, S.L.
Madrid, Spain containing 0.2% chlorhexidine digluconate, 1% phenoxyethanol, 0.1%
benzalkonium chloride, 5% aloe barbadensis, 70% denat ethyl alcohol, excipients
quantity sufficient for 100 mL alcohol 70%, pH 7.0 to 7.5)
Informational poster about when and how to wash hands
Written and verbal guidance to teachers, parents, and students on properties,
possible side effects, and precautionary measures for gel use and storage
Brochure sent to parents by mail with study information sheet.
Workshop provided for pupils and teachers:
frequent infections in schools, transmission and prevention, instructions on
correct hand‐washing (water and soap, soaping > 20 s, drying hands),
use of hand sanitisers and possible side effects
Classroom activities linked to hand hygiene and infection transmission
Reinforcement of hand hygiene by teachers
Hand sanitiser dispensers fixed to walls with an informational poster about
hand‐washing
Supervision of younger children when using hand sanitiser and administration of
sanitiser if needed
Instruction of children in hand‐washing procedures after toilet and when dirty
and correct hand sanitiser use[4]
Brochure sent by school administration.
Workshop and verbal and written information presumably provided by the study
research assistant.
Classroom activities provided by research assistant and teachers.
Supervision and administration of hand sanitiser for younger children by
teachers
Brochure sent by mail to individual parents.
Workshops and classroom activities delivered in groups face‐to‐face.
Teacher reinforcement of hand hygiene provided to class face‐to‐face.
Hand sanitiser use supervision was provided individually and face‐to‐face.
Primary school classes in Spain (details not provided)
8 months overall
One‐off brochure and installation of hand sanitiser dispensers
2‐hour workshop held 1 month before study commencement
Fortnightly classroom activities
As required, teacher supervision and administration of hand sanitiser
Daily reinforcement of hand hygiene by teachers
Supervision and administration of hand sanitiser as needed by teachers,
especially for younger children
Not described
Daily reinforcement by teachers of hand hygiene
Fortnightly support by research assistant promoting hand‐washing
Self‐reported correct hand‐washing procedure (water and soap, soaping > than 20
s, drying hands)
Self‐reported correct hand‐washing included in analysis but not separately
reported.
Azor‐Martinez 2018
Educational and hand hygiene programme
2 active interventions:
A. soap and water
B. hand sanitiser
Day care centres and their attending children, their parents, and DCC staff
Prevent transmission of respiratory infections by improved hand hygiene of
children, parents, and staff through hand‐washing practices and use of hand
sanitiser due to its bactericide and virucide properties
A. Liquid soap (no specific antibacterial components (pH = 5.5))
OR
B. Hand sanitiser (70% ethyl alcohol (pH = 7.0 to 7.5)) for home use and in
dispensers for school classroom
Workshop content handout
Stories, songs, and posters about hand hygiene and infection transmission
Installation of liquid soap or hand sanitiser dispensers in classrooms
Supervision and administration of hand sanitiser if required
3 hand hygiene workshops for parents and DCC staff:
1. Hand‐washing practices, hand sanitiser use, possible side effects and
precautionary measures (HSG only)
2. RIs and their treatments
3. Fever
Instructions to children, parents, and DCC staff on usual hand‐washing practices
and protocol [5]
Classroom activities (stories and songs) about hand hygiene and infection
transmission
Workshop delivered by researchers.
Research assistant provided hand hygiene materials to DCCs and parents.
Parents and staff supervised and administered sanitiser where indicated.
Workshops delivered face‐to‐face in groups to parents and staff.
Workshop content emailed to attendees individually.
Individual face‐to‐face supervision of hand sanitiser use, as indicated
Classroom of DCCs (in Spain) for child interventions
Workshops provided at DCCs.
8 months overall
Initial 1‐hour workshop 1 month before study commencement
3 further identical sessions/DCC provided again 1 month apart
Fortnightly classrooms and DCC activities
One‐off installation of dispensers
As‐needed supervision of hand sanitiser use
Dose of sanitiser: 1 to 2 mL/disinfection
Administration of hand sanitiser in the case of young children
DCC staff could attend training at other DCC if unable to attend at own DCC.
Not described
Not described
Reported that no monitoring of compliance
through continuous observation of hand hygiene
behaviours was done, but amount of hand sanitiser was measured
Families or DCC staff, or both, used 1660 L of hand sanitiser, estimated use by
each child of dose 6 to 8 times/day.
Biswas 2019
Hand sanitiser and respiratory hygiene education
Primary schools and their students and staff
Reduce community‐wide influenza virus transmission by improving hand‐washing and
respiratory hygiene and use of sanitiser in schoolchildren as contributors to
community‐wide virus transmission
Hand sanitiser
(63% ethyl alcohol) in colourless, transparent 1.5‐litre local plastic bottles
(manufactured by a local pharmaceutical company and was available commercially
in Bangladesh (price: USD 5.75/L))
Video clip on respiratory hygiene practices
Behavioural change materials – 3 colour posters (see Appendix of paper)
Curriculum materials for hygiene classes
Installation of hand sanitiser in wall dispensers in all classrooms and outside
all toilets, refilled by field staff as needed
Encouragement of use of sanitiser at 5 key times during the day[6]
Hand and respiratory hygiene education provided.[7]
Integration of hygiene messages into school’s hygiene curriculum
Delivery of video clip on respiratory hygiene practice
Behaviour change materials distributed and placed around schools.
Use of sanitiser by classroom teachers after training
Training of selected teachers in consultation with head of school and management
committee in key messages
Communication of key messages by the selected teachers to other teachers
Selected teachers responsible for dissemination of intervention messages
throughout were trained over 2 days in these messages, behaviour change
communication, sanitiser use, and practices for preventing spread of respiratory
secretions.
Classroom teachers conveyed intervention messages during regular hygiene
classes.
Field staff replaced supplies as needed.
Hand sanitiser and education materials provided to schools.
Education provided in classrooms in groups and face‐to‐face.
Primary schools (in Bangladesh)
Sanitiser in each classroom and outside toilets
Education in classroom
10 weeks
Intervention messages conveyed in classrooms 3 times/week.
Refills provided as needed.
Not described
Structured field observation by 2 field staff of 5 hours/school observing
hand‐washing and respiratory hygiene behaviours of children at 2 different
locations in a classroom or outside
Every other day, field staff measured the level of hand sanitiser in the morning
and in the afternoon to calculate amount of hand sanitiser used/day/school and
enrolled children.
Hand‐washing observed opportunities:
IG 604/921 (66%) vs CG 171/802 (21%)
Hand sanitiser used in 91% of observed hand‐washing events in intervention
schools.
Average
consumption of hand sanitiser/child/day: 4.3 mL
Observation of proper cough or sneeze etiquette: IG: 33% vs CG: 2%
Correa 2012
Alcohol‐based hand rubs
Childcare centres and their staff and children
Reduce incidence and transmission of infection in children by improved hand
hygiene where water is scarce including provision of ABH and training in hand
hygiene teaching techniques
Dispensers of alcohol‐based hand rubs with ethanol 62.0% (PURELL, GOJO
Industries, Akron, OH, USA)
Workshop materials[8]
Visual reminders on ABH techniques in bathrooms and next to dispensers
ABH and training
on proper use to staff and children
Pre‐trial ABH use workshop to teachers that followed recommended HH teaching
techniques and instructed teachers to add ABH to routine HH and give preference
to hand‐washing with soap and water if hands visibly soiled
Continuous refilling of ABH
ABH technique refresher workshops (8/centre)
Monitoring of safety, proper use of ABH, amount of ABH used
Local representative
of GOJO Industries Inc.
provided dispensers and dispenser
installations free of charge.
Fieldwork team delivered other components.
Face‐to‐face training and provision of materials; group training
Childcare centres in Colombia (centres or community homes)
ABH in centres, classrooms, and common areas depending on size
Visual reminders
in bathrooms
and next to dispensers
Workshops and training presumably provided in centres.
8 months overall
1 ABH dispenser per centre with < 14 children;
1 per classroom in larger centres; 1 per classroom +
1 for common areas in centres with > 28 children
1 workshop pre‐trial to staff
Monthly 30‐minute ABH technique refresher training (8 per centre)
Biweekly monitoring
Refilled ABH as needed
Not described
Visual reminders and monthly refresher training
Monitoring of safety, proper use of ABH, amount of ABH used
Semi‐structured survey on completion of teachers' perceptions
about changes in HH practices and use of HSW and ABH.
Measurement of consumption
of resources and costs related to ABH use and HSW
Teachers at 7
intervention centres reported almost
complete substitution of HSW with ABH, and HSW decreased from 3 times per day to
1 per day, and ABH rose to 6 per day. Teachers at remaining 14 centres reported
partial substitution of HSW with ABH.
Controls reported HSW 3 times per day.
Median number of ABH applications per child
rose from 3.5 to 4.5 in preschools and 3.5 to 5.5 in community centres.
DiVita 2011
Household hand‐washing promotion
Householders with index patient with ILI
Prevent influenza transmission in households in resource‐poor settings through
provision of hand‐washing facilities and use of them at critical times for
pathogen transmission
Hand‐washing stations with soap
Provision of hand‐washing stations
Hand‐washing motivation to wash at critical times for pathogen transmission
(e.g. after coughing or sneezing)
Not specifically described, presumably the researchers
Face‐to‐face provision of facilities in households
"Motivation" not described
Household in Bangladesh
Over 2 influenza seasons
One‐off provision of hand‐washing facilities
Frequency of “motivation” not described
Not described
Not described
Not described
Not described
Feldman 2016
2 active interventions
A. Hand disinfection with chlorhexidine gluconate + hygiene education
B. Hygiene education
Naval ships and their sailors
Reduced infection transmission and improved hand hygiene in sailors who are at
increased risk due to closed environments, contact with shared surfaces, and
poor HH culture
Septadine solution (Floris, Misgav, Israel) 70% alcohol and 0.5% CHG; inactive
materials: purified water, glycerin, propylene glycol, and methylene blue
Installation of CHG disinfection devices on ships alongside regular soap and
water
Supply and replenishment of CHG (sent to ships regardless of replenishment
demands)
Hygiene instruction by a naval physician (to both intervention groups and study
control group)
Provision of CHG presumably by study team and funds
Hygiene instruction by naval physician
CHG sent to ships directly.
Mode of hygiene instruction not described.
Navy fast missile boats and patrol boats of naval base in Israel
Dispensers installed in key locations onboard (adjacent to heads (toilets), mess
decks
(dining rooms), common areas).
4 months
Unlimited supply of CHG replenished on demand for 4 to 5 months.
Automatic amount dispensed: 3 mL
CHG replenished on demand.
Not described
Total amount of CHG dispensed was tallied.
Mean volume CHG:
8.2 mL per sailor per day (projected yearly cost USD 45 per sailor)
Gwaltney 1980
A. Virucidal hand preparation
B. Placebo (no control)
Healthy young adults
Reduce infection rates by interrupting viral spread by hand or self‐inoculation
route
A. Virucidal hand preparation:
aqueous iodine (2% iodine and 4% potassium iodide)
B. Placebo: aqueous solution
of food colours (Kroger; Kroger Co., Cincinnati, OH, USA) mixed to resemble the
colour of iodine with 0.01% iodine and 0.02% potassium iodide to give an odour
of iodine
Masks
Immersion of each finger and thumb of both hands to proximal interphalangeal
joint (interphalangeal joint of thumb) into designated preparation for 5 seconds
then air‐dried for 5 to 6 min
Exposure of recipients to donors either immediately after treatment or after
2‐hour delay by hand contact with donor stroking fingers for 10 s
Masks worn by donors and recipients during procedure.
Recipients placed in single isolation rooms after second exposure till end of
experiment.
Researchers
Face‐to‐face and individually
US university
Exposure to donors on 3 consecutive days (days 2, 3, and 4) after initial
exposure
Not described
Not described
Reported knowledge of hand preparation use as active, placebo, or don't know
Active (n = 24):
6 active
2 placebo
16 don't know
Placebo (n = 22):
6 active
7 placebo
9 don't know
Hubner 2010
Alcoholic hand disinfection
Employees (administrative officers)
Reduce absenteeism and spread of infection in administration employees with
frequent customer contact and work with paper documents through improved hand
hygiene
2 alcohol‐based hand rubs (500 mL bottles) for desktop use to ensure minimal
effort for use:
1. Amphisept E (Bode Chemie, Hamburg, Germany) ethanol (80% w/w) based formula
with antibacterial, antifungal, and limited virus inactivating activity.
2. For participants with skin problems:
Sterillium (Bode Chemie, Hamburg, Germany) 2‐propanol (45% w/w), 1‐propanol (30%
w/w), and mecetronium etilsulfate (0.2% w/w), with a refatting effect and has
activity against bacteria, fungi and enveloped viruses.
Hand cream: Baktolan balm, water‐in‐oil emulsion with no non‐antibacterial
properties (Bode Chemie, Hamburg, Germany)
Provision of hand rub and instruction on use as needed at work only and in
accordance with prevailing standard[7]: at least 5 times per day, especially
after toileting, blowing nose, before eating, and after contact with ill
colleagues, customers, and archive material
Presumably provided or arranged by study team
In person to staff
Administration offices in Germany
Hand rubs used at desk or work (not outside of work).
12 months overall
Hand rub used as much needed for complete wetting of the hands (at least 3 mL or
a palmful)[8] at least 5 times per day.
Hand rub use especially after toileting, blowing nose, before eating, and after
contact with ill colleagues, customers, and archive material
Not described
Self‐reported compliance with hand hygiene measures
Reported mean hand disinfection frequency times per day:
> 5: 19%
3 to 5: 59.8%
1 to 2: 20.5%
< 1: 0.7%
Ladegaard 1999
(translated from Danish)
Hand hygiene programme
Daycare centres and their staff, children, and parents of children
Reduce risk of infection in child care through increased hygienic education of
daycare professionals, motivation of daycare facilities for regular hand
hygiene, and informing parents about hand hygiene
Personnel guide on recommendations for: hygiene, ventilation, out‐of‐stay care,
stricter hygienic regulations in cases with selected diseases
Fairy tale and poster “The Princess Who Won't Wash Hands”
Colouring in drawings
“Wash hands” song and rhymes
T‐shirt for children with the inscription “Clean hands ‐ yes thank you”
Diploma for children and book “The Princess Who Won't Wash Hands” to also be
used by parents with their child
Informational leaflet for parents in envelope
Staff meeting in each DCC and training in microbiological cause of infection
spread guided by National Board of Health and Hygiene
Education of children in hand‐washing (about bacteria and why and when to wash
hands)
Practical hand‐washing classes with 4 to 5 children at a time
Provision of t‐shirt, book, and diploma to children
Provision of leaflet for parents
Research team presumably provided training.
Face‐to‐face with training and activities by group with staff and children
Information sent home to parents via children.
Onsite in DCCs
2‐month intervention period
1‐hour training of children
None described.
None described.
None described.
None reported.
Little 2015
Web‐based hand‐washing intervention
Householders (over 18) who were general practice patients
Prevent transmission of respiratory tract infections through improved hand
hygiene to reduce spread via close contact (via droplets) and hand‐to‐face
contact
Website‐based programme: provided information about the importance of influenza
and role of hand‐washing;
developed a plan to maximise intention formation for hand‐washing;
reinforced helpful attitudes and norms;
addressed negative beliefs
(URL provided for demonstration version no longer active; see
www.lifeguideonline.org)
Provision of link to website for direct log in
Automated emails prompted participants to use sessions and complete monthly
questionnaires and maintain hand‐washing.
Researchers delivered web‐based programme and emails.
Online individually
Households in England
4 months overall
4 weekly web‐based sessions
Monthly email questions to maintain hand‐washing over 4 months
Tailored feedback provided within web programme
None described.
Emailed questions monthly to maintain hand‐washing
None reported.
Luby 2005
Hand‐washing promotion at neighbourhood level with 2 interventions at household
level
A. Antibacterial soap
B. Plain soap
Neighbourhoods and their households
Improve hand‐washing and bathing with soap in settings where communicable
diseases are leading causes of childhood morbidity and mortality
Slide shows, videotapes, and pamphlets illustrating health problems from
contaminated hands and specific hand‐washing instructions
Soaps: 90‐gram white bars without brand names or symbols, same smell with
identical generic white wrappers with serial numbers matched to households
A. Households: 2 to 4 white bars of 90‐gram antibacterial soap containing 1.2%
triclocarban (Safeguard Bar Soap: Procter & Gamble Company (Cincinnati, OH, USA)
B. Households: plain soap (no triclocarban)
Soap packets
Hand‐washing promotion to neighbourhoods:
Neighbourhood meetings of 10 to 15 householders (mothers) from nearby homes and
monthly meetings for men
Soap to households
Fieldworker home visits: discussed importance of and correct hand‐washing (wet
hands, lather them completely with soap, rub them together for 45 seconds, and
rinse off completely) technique and promote regular hand‐washing habits[11]
Encouragement of daily bathing with soap and water
Research team in collaboration with Health Oriented Preventive Education
(HOPE)[12]
Fieldworkers were trained in interviewing and hand‐washing promotion.
Face‐to‐face in small groups and individually
Neighbourhoods and homes in Karachi, Pakistan
1‐year weekly household visits
30‐ to 45‐minute neighbourhood meetings 2 to 3 times/week first 2 months then
weekly for months 2 to 9, then monthly
Monthly men’s meetings first 3 months
Weekly household visits
Soap replaced regularly.
None described.
None described, though soap use measured.
Households' mean use of study soap per week: 3.3 bars
Average use per resident per day: 4.4 g
Millar 2016 additional details from Ellis 2010
Skin and soft‐tissue infection prevention intervention in addition to SSTI brief
on entry also provided to control
A. Enhanced standard
B. Chlorhexidine
Military trainees
Improve personal hygiene practices to prevent infection, especially acute
respiratory
infection in military trainees who are at increased risk
A. Enhanced standard: supplemental materials (a pocket card and posters in the
barracks)
B. CHG: CHG‐based body wash (Hibiclens, Mölnlycke Heath Care, Norcross, GA, USA)
Provision of education and hygiene‐based measures in addition to standard SSTI
prevention brief
upon entry:
Enhanced standard:
supplemental
materials
CHG: as for enhanced standard group, plus a CHG‐based body wash and instructions
for use
Not described, presumably the researchers
Face‐to‐face and individually for body wash and pocket card
Mode of education not described.
US military training base
One‐off education on entry to training
CHG: use of wash 1 per week for entire training period (14 weeks)
None described.
None described.
None described.
None described.
Morton 2004
Healthy hands (alcohol gel as hand‐washing adjunct)
Elementary schools and their children and staff
Prevent infections in elementary school‐age children who are particularly
vulnerable through adjunct use of alcohol gel and education based on Health
Belief Model (HBM) (Kirscht 1974)
Alcohol gel and dispensers:
AlcoSCRUB (60% ethyl alcohol) supplied by Erie Scientific Company, Portsmouth,
NH, USA
‘‘Healthy Hands Rules’’ protocol[13]
(Figure 3 in paper)
Healthy Hand Resource Manual for school nurse, available for parents
Monthly newsletters to parents
‘‘Healthy Hands’’ refrigerator magnet for families (see Figure 2 in paper)
Informational letter to local primary care providers, paediatricians, family
practitioners, and advanced practice nurses
“Germ Unit” curriculum and materials including Germ models and Glo Germ
Healthy hands protocol introduced after "Germ unit" education in classes
Daily reminders to children on public address system (in first week) then weekly
reminders
Review of protocol in each classroom after vacation by school nurse
2 classroom visits from school nurse
“Healthy Hands” magnet provided to parents and guardians.
“Hand Checks on Wednesdays” to identify adverse effects of gel
Gel provided by suppliers.
Research team provided educational aspects.
Classroom teachers responsible for encouraging use of gel and reinforcing
protocol
School nurse assisted in monitoring and hand checks for adverse effects.
Face‐to‐face training in classes and individual information giving and
monitoring
Elementary schools in USA
Wall‐mounted near door entrance of each classroom at age‐appropriate height
46 days
0.5 mL dispensed per application.
Use of “special soap” according to “Healthy Hands Protocol” (Figure 3 in paper)
Reinforcement teaching provided if gel usage indicated that it was needed.
Germ unit education tailored for each grade level.
1 student was concerned gel was making her sick, so school nurse provided
additional classroom visit to allay concerns.
Usage of gel calculated.
5 gel applications per day
1 dispenser lasted 1 month.
Nicholson 2014
Hand‐washing with
soap
Households with 5‐year‐olds and their mothers
Targeted 5‐year‐old children and their mothers as change agents to reduce
incidence of respiratory infections (and diarrhoeal disease) through
hand‐washing using behaviour change principles (Claessen 2008), including social
norms for child and mother (Perkins 2003), using fear of contamination and
disgust (Curtis 2001), peer pressure (Sidibe 2003), morale boosting, and
networking support
Initial supply of 5 bars of free soap (90‐gram Lifebuoy bars) replenished on
submission of empty wrappers.
Environmental cue reminders (wall hangers, danglers)
Rewards (e.g. stickers, coins, toy animals)
Provision of soap and social marketing programme (Sidibe 2009) (Lifebuoy
branding) to educate, motivate, and reward children for HWWS at key times
Weeks 1 to 17: hand‐washing occasions, germ education, soap’s importance in germ
removal
Week 18 onward: encouragement of HWWS on 5 key occasions supported by
environmental cues
"Classrooms" for children
Home visits for mothers
Parents’ evenings to boost morale, build networks, and run competition for
compliance, assignment completion, and folder decoration
Establishment of a "Good Mums" club for sharing HWWS tips
Rewards provided by mothers.
Children encouraged to advocate HWWS within families before meals.
Establishment of social norms for child and mother with pledges in front of
peers
Dedicated team of "promoters" delivered education and home visits.
Mothers provided supplied rewards.
Face‐to‐face in groups
Individually by mother to child
"Classrooms" held in community buildings
Home visits of households in Mumbai, India
41 weeks
Weekly "classrooms" after school and home visits
HWWS encouraged 5 key occasions: after defecation, before each of 3 meals, and
during bathing.
Week 18 onward: hand‐washing on 5 occasions for 10 consecutive days
6 weekly parents’ meetings
Mothers were asked to provide and share hand‐washing tips with other mothers,
competitions held for mothers.
Technical difficulties with "soap acceleration sensors" to measure HWWS
behaviours prevented successful use.
Registers for "classrooms" and home visits where 3‐week gaps in attendance
triggered supervisors to ask participants to resume or be withdrawn
Monitoring of soap resale on open market by use of unique identifiers on soap
wrappers and twice weekly checks in local shops
Collection of used soap wrappers as soap consumption measure
Soap consumption:
IG vs CG:
235 g vs 45 g
Pandejpong 2012
3 active interventions (no control) different time‐interval applications of
alcohol hand gel
A. Every 60 min
B. Every 120 min
C. Once before lunch
Preschool classes (students and teachers) and their parents
Targeted preschool children who can have high infection rates in ILI; have close
interaction so at risk of airborne, droplet, and contact transmission; and are
of increasingly younger ages through hand gel as a single strategy of convenient
and effective disinfection
1 container of alcohol hand gel per classroom (active ingredients: ethyl
alcohol, 70%; chlorhexidine gluconate,1%; Irgasan (triclosan), 0.3%)
Cost of hand gel every 60
minutes was USD 6.39 per child per 12‐week period
Leaflet describing risk factors for ILI for each family
Teachers instructed to:
assist each child with dispensing hand gel at required
time interval,
store hand gel properly, and refill gel as needed.
Monitoring of hand gel use at specified times
Teachers supervised, stored, and refilled hand gel.
Instructions to teachers presumably provided by researchers.
Leaflets distributed through school.
Monitoring of use by 2 research assistants
Face‐to‐face to schools, teachers and children
Individual assistance to children with hand gel
Leaflets given to each family.
Kindergarten school in Bangkok, Thailand
12 weeks overall
1 pump of gel per child per disinfection round at 1 of 3 time intervals of
school day:
A. every 60 min
B. every 120 min
C. once only before lunch, the school standard for hand hygiene
None described.
Students whose families declined to participate were not asked
to use alcohol hand gel.
These students remained in their classrooms
and continued to follow the school standard for hand
hygiene.
2 research
assistants monitored hand gel use every 60 or 120 minutes for the duration of
study.
Classroom teachers were required to co‐sign after each disinfection
round.
Reported that compliance was ensured for each intervention
group
Cost of hand gel every 60
minutes was USD 6.39 per child per 12‐week period.
Priest 2014
Hand sanitiser provision (in addition to hand hygiene education session also
provided to control group)
Primary schools and their students, teachers, and administrative staff
Reduce person‐to‐person community transmission of infectious disease by
targeting improved and additional hand hygiene of school children through
supervised hand sanitiser provision as an alternative to improving and
maintaining bathroom facilities
‘‘No touch’’ dispensers
(> 60% ethanol) for each classroom that dispensed dose when hands were placed
under an infrared sensor
Supply of top‐up sanitiser as needed
Dispensers installed into each classroom.
Teachers asked to ensure that the children
used sanitiser at particular times and to oversee general use (McKenzie 2010).
Weekly classroom visits to top‐up of sanitiser and measure quantity used
30‐minute in‐class hand hygiene education session provided (also to control
group) plus instruction in hand sanitiser use.
School liaison research assistants topped‐up sanitiser.
Teachers
Installation of dispensers to classrooms
Supervision of children by teachers delivered face‐to‐face individually and as a
class.
City schools in New Zealand
20 weeks (2 school terms)
Sanitiser to be used by students at least after coughing/sneezing, blowing their
nose, and as they leave for morning break and for
lunch break.
Approximately 0.45 mL of sanitiser dispensed per wash.
Weekly top‐up of sanitiser
Children were able to use the sanitiser at any time they wished as well as at
key times (McKenzie 2010).
Change of sanitiser after week 10 to flavourless type of the same % ethanol in
41 of 396
classrooms (10%) (in 9 of 34 schools)
due to children tasting it when eating, affecting use.
Weekly classroom visits by school liaison research assistants who recorded
quantity of sanitiser used
Total amount of sanitiser per classroom was measured.
Compliance defined as dispensing a volume equivalent to at least
45 mL per child of hand sanitiser solution over the trial period.
100% dispensing 45 mL per child
Average hand sanitiser dispensed/child for 34
schools: 94 mL
Median classroom difference in sanitiser usage between first 10 weeks and second
10 weeks amongst classes that
switched products was 220 mL.
Ram 2015
Soap and intensive hand‐washing promotion
Household compounds and its householders (adults and children) that had a
householder with ILI
Reduce household transmission of ILI and influenza by promoting hand‐washing in
households with householder with ILI as other householders who are well are at
highest risk of exposure due to crowded and poorly ventilated homes.
Followed constructs of Social Cognitive Theory and the Health Belief Model
(Glanz 2008) and behaviour change communication using social marketing concepts
Hand‐washing station in central location of each compound using:
large water container with a tap;
plastic case for soap;
bar of soap.
Cue cards depicting critical times for hand‐washing:
after coughing or sneezing;
after cleaning one’s nose or child’s nose,
after defecation;
after clearing a child who has defecated;
before food preparation or serving;
before eating.
Hand‐washing station in each compound
Didactic and interactive group‐level education and skills training describing
influenza symptoms, transmission, and prevention, promoting health and
non‐health benefits of hand‐washing with soap and identification of barriers and
proposed solutions to hand‐washing with soap
Daily surveillance including weighing of soap and replacing if ≥ 20 g and
resupply of water in container if needed
Posting of cue cards
Asking householders to demonstrate hand‐washing with soap technique
Intervention staff arranged provision of hand‐washing station and presumably
provided education.
Intervention staff conducted daily surveillance and reinforcement visits.
All elements delivered face‐to‐face but at compound (facilities), group
(education), and individual levels (reinforcement).
Household compounds in a rural area of Bangladesh consisting of several
households with common courtyard, shared latrine, water source, and cooking
facilities
Initiation of intervention within 18 hours of study enrolment, then daily visits
until 10 days following resolution of index case patient’s symptoms
Day 1 set up of hand‐washing station
Daily surveillance included observation of individual hand‐washing reinforcement
and modelling as needed.
None described.
Daily surveillance of facilities and reinforcement and modelling of hand‐washing
behaviours including observed hand‐washing
Cue cards in common areas of courtyard
Presence or absence of soap during each of first 10 days of surveillance from
180 household compounds
Patterns and amount of soap use measured.[14]
Soap present for at least 7 days in all compounds and on all 10 days in 133
compounds (74%).
Soap and water together were present 7 or more of first 10 days in 99% of
compounds, with water and soap observed together on all 10 days in 99 compounds
(55%)
Soap consumption per capita:
median: 2.3 g
maximal: 5 g (on Day 7)
Roberts 2000
Education about infection control measures, hand‐washing, and aseptic nose
wiping
Childcare centres and their staff and children
Reduce transmission of respiratory infections in childcare centres through
improved infection control procedures
GloGerm (GloGerm, Moab, UT, USA)
Newsletters to staff
Songs and rhymes on hand‐washing
Plastic bags (sandwich bags available at supermarkets) to cover hand for nose
wiping
Staff training in good health (developed by Kendrick 1994) and practical
exercise of hand‐washing with GloGerm
Fortnightly visits and newsletter to reinforce training and to communicate
techniques
Recommended hand‐washing technique as per guidelines of the time[15] and after
toileting, before eating, after changing diaper (staff and child), and after
wiping nose unless barrier used
Teaching of technique to children and wash hands for infants
Training and reinforcement activities provided by 1 of the researchers.
Teachers delivered training to children based on their training.
Face‐to‐face in groups for training and classes and individually as needed to
children or staff
Childcare centres in Canberra, Australia
8 months overall
3‐hour training in evening or 1‐hour during lunch for new staff after study
start
Duration of hand‐washing: “count to 10” to wash and “count to 10” to rinse
Training for new staff provided as needed.
None described.
6‐weekly compliance measured by recorded observation of recommended practice for
3 hours in morning in each centre, graded by quantiles of frequency of
recommended hand‐washing by children.
Compliance was reported only in relation to analysis of outcomes.
High compliance reported for nose wiping and child hand‐washing.
Sandora 2005
Healthy Hands Healthy Families
Families with an index child in out‐of‐home childcare
Reduce illness transmission in the home through multifactorial campaign centred
on hand hygiene education and hand sanitiser
Alcohol‐based hand sanitiser: active ingredient: 62% ethyl alcohol (PURELL
Instant Hand Sanitizer; GOJO Industries, Inc, Akron, OH, USA)
Hand hygiene educational materials at home (fact sheets, toys, games)
Supply of hand sanitiser and hand hygiene materials
Biweekly telephone calls
Biweekly educational materials
Study investigator
Not stated whether materials mailed or delivered in person
Homes in USA
Sanitiser use in home
5 months overall
Biweekly educational materials
Sanitiser dispensed 1 mL each pump.
None described.
None described.
Recorded amount of hand sanitiser used (as reported by the primary caregiver)
Median frequency of reported times of hand sanitiser use: 5.2 per day
38% used > 2 ounces of hand sanitiser per fortnight = 4 to 5 uses per day
Savolainen‐Kopra 2012
further details from Savolainen‐Kopra 2010
STOPFLU
Enhanced hygiene
2 active interventions
IR1. Soap and water wash
IR2. Alcohol‐based hand rub
Office workers of office work units
Prevent transmission of respiratory infections in workplaces through enhanced
hand hygiene with behavioural recommendations to reduce transmission by droplets
during coughing or sneezing
IR1: Liquid hand soap (“Erisan Nonsid” by Farmos Inc., Turku,
Finland)
IR2: in addition:
Alcohol‐based hand rub, 80% ethanol (“LV” by Berner Inc., Helsinki, Finland)
Bottles of hand hygiene product (free of charge) to be used at home and in the
office (IR2).
Written instructions on hygiene for further reference
Toilets equipped with liquid hand soap (all groups) or alcohol‐based hand rub
(IR2).
Guidance on other ways to limit transmission of infections, e.g. frequent
hand‐washing in office and at home, coughing, sneezing into disposable
handkerchief or sleeve, avoiding hand‐shaking
Visits to work clusters and monitoring of materials availability
Monthly electronic “information spot” about viral diseases for motivation to
maintain hygiene habits
Adherence activities
In collaboration with occupational health clinics servicing the corporation
Specially trained research nurse provided guidance and visited worker clusters
throughout intervention period.
In‐person provision of soap or hand rub
Guidance and written instructions given personally.
Face‐to‐face visits by study nurse
Office work units in corporations in Helsinki, Finland
15 to 16 months overall
Monthly visits by nurse throughout
Nurses assisted with any practical problems with intervention as they arose.
New employees received guidance on hand hygiene and habits.
None described.
Adherence assessed by
an electronic self‐report survey of transmission‐limiting habits 3 times (more
details in protocol).
Use of soap (IR1) and alcohol‐based disinfectant
(IR2) for
personal use was recorded.
Study nurse checked availability of soap and alcohol rub.
Avoiding hand‐shaking became more common and remained high in both groups.
Recorded use for personal use smaller than predicted use based on hand hygiene
instructions.
Soap or disinfectant usage per participant:
IR1: 6.1
IR2: 6.9
Stebbins 2011
“WHACK the Flu”
(hand sanitiser and training in hand and respiratory hygiene)
Elementary schools and their students and homeroom teachers
Targeted school‐aged children as important sources of influenza transmission
through improved cough etiquette and hand hygiene in schools including sanitiser
as potential inexpensive non‐pharmaceutical
interventions
Hand sanitiser dispensers
with 62% alcohol‐based hand sanitiser from PURELL (GOJO Industries, Inc, Akron,
OH, USA) automatically dispensing 1 dose
Delivery of grade‐specific presentations on “WHACK the Flu” concepts and proper
hand‐washing technique and sanitiser use:
(W)ash or sanitise your hands often; (H)ome is where you stay when you are sick;
(A)void touching your eyes, nose and mouth; (C)over your coughs and sneezes; and
(K)eep your distance from sick people
(provided URL no longer active)
Desired frequency of hand wash use taught to student (see When and how much)
Installation of hand sanitiser dispensers
Refresher training at each school
Reinforcement of message and monitoring of sanitiser
Project staff provided education.
Home room teachers reinforced message and monitored proper use of sanitiser.
Face‐to‐face at schools, presumably as a group in classes
Elementary schools (Pittsburgh, USA)
Dispensers installed in each classroom and all major common areas.
Whole intervention over 1 influenza season
One‐off installation of hand sanitiser dispensers
One‐off 45‐minute education presentation and one‐off refresher training at onset
of influenza season
Goal of use of 1 dose (0.6 mL) of sanitiser 4 times per day[16]
Encouraged to wash hands or use additional doses of hand sanitiser, or both, as
needed
None reported.
Monthly teacher surveys of observed NPI‐related behaviour in their students
before, during, and after influenza season
Measurement of hand sanitiser use at 2‐week intervals throughout the
intervention period
Teacher surveys of observed classroom NPI behaviour indicated successful
adoption and maintenance of behaviours throughout influenza season.
Average sanitiser use: 2.4 times per day
Talaat 2011
Intensive hand hygiene campaign
Schools and their students, teachers, and parents
Reduce or prevent transmission of influenza viruses amongst children through
intensive hand hygiene intervention campaign
Soap supplied as needed.
Grade‐specific student booklets each including a set of 12 games and fun
activities that promoted hand‐washing
Hand hygiene activities materials including:
games (e.g. how to escape from the germs);
puzzles;
soap activities (e.g. soap drawing);
song specially developed to promote hand hygiene
Teachers’ guidebook including detailed description of the students’ activities
and methods to encourage students to practice these activities.
Posters with messages to wash hands with soap and water upon arriving at school,
before and after meals, after using the bathroom, and after coughing or
sneezing.
Informational flyers for parents reinforcing the messages delivered at the
schools.
Establishment of a hand hygiene team in each school
Provision of hand hygiene activities:
weekly exercises (e.g. games, aerobics, songs, experiments); school activities,
(e.g. obligatory hand‐washing under supervision, morning broadcast, parent
meetings, students‐parents information transfer);
specific school initiatives: (e.g. competitions and awards, hand‐washing
committee, school trips to soap factory and water purification plant)
More details in Table 1 of paper
Song played regularly.
Social worker weekly visits
Distribution of flyers to parents
Hand hygiene team (3 teachers from social studies, arts, and sports and the
school nurse) ensured that all pre‐designed activities for the hand hygiene
campaign were implemented.
6 independent social workers visited the schools.
Delivered face‐to‐face in groups and individually
Elementary schools (grades 1 to 3) in Cairo, Egypt
In school environment and classrooms
Poster near sinks in classrooms and on playground
12 weeks overall
Weekly hand hygiene campaign activities
Weekly visits by social workers
Twice‐daily obligatory supervised hand‐washing required by students for about 45
seconds, followed by proper rinsing and drying with a clean cloth towel.
Soap and hand‐drying material provided by school administration if children did
not bring their own as was the custom or families could not afford it.
Schools could create own motivating activities such as selecting a weekly hand
hygiene champion, developing theatre plays, and launching school contests for
drawings and songs.
None described.
Observation by social workers of hand hygiene activities, availability of soap
and drying material, and students’ hand‐washing during the day
Schools created own activities to improve compliance.
About 93% of the students had soap and drying material available.
All but 2 intervention schools “had a rigorous system of ensuring that
schoolchildren were washing their hands at least twice daily”.
Temime 2018
Multifaceted hand hygiene programme (including alcohol‐based hand rub)
Nursing home staff, residents, visitors, and outside care providers
Nursing homes and their residents, staff, and visitors and external providers
have an increased risk of person‐to‐person transmission of pathogens, and HH is
a simple and cost‐effective tool for infection control; however, compliance with
HH is poor in nursing homes.
Dispensers and pocket‐sized containers of hand rub solution
Posters promoting hand hygiene
Developed local HH guidelines
eLearning module on infection control and HH training with online quizzes
requiring sufficient performance
Facilitated access to hand rub solution
Campaign to promote HH with posters and event organisation
Formation of local work groups in each NH
Development of local HH guidelines
Staff education using eLearning
Monitoring of quantity of hand rub solution used
Same nurse provided HH training for all NHs.
Provision of hand rub by NH
Local work group developed guideline.
eLearning module and posters presumably developed by research team.
Provision of materials face‐to‐face
Education and quizzes via eLearning
Nursing homes in France
1 year overall
One‐off provision of hand rub
One‐off eLearning repeated if unsatisfactory performance.
If staff did not score sufficiently on online quiz, they were invited to repeat
the eLearning.
None described.
Estimated mean amount of hand rub solution used per resident per day assessed as
proxy for HH frequency, based on quantity of hand rub solution bought by NH
(which was routinely monitored in all the NHs).
Hand rub solution used:
baseline quantity of consumed hand rub solution was 4.5 mL per resident per day.
Over the 1 year, mean quantity consumed was significantly higher in intervention
NH (7.9 mL per resident per day) than control (5.7 per resident per day).
Turner 2004a
Clinical trial 1
3 active interventions (no control)
Product:
A. Ethanol
B. Salicylic acid
C. Salicylic acid with pyroglutamic acid
Healthy volunteers
Assess the residual virucidal activity of organic acids used in currently
available over‐the‐counter skin products for the prevention of experimental
rhinovirus colds
1.7 mL of hand products:
A. 62% ethanol, 1% ammonium lauryl sulphate, and 1% Klucel)
B. 3.5% salicylic acid, or vehicle containing
C. 1% salicylic acid and
3.5% pyroglutamic acid
Disinfection of hands then application of test product then allowed to dry.
15 min later, fingertips of each hand contaminated with 155 TCID50
of rhinovirus type 39 in a volume of 100 μL.
Hands air‐dried for 10 min.
Intentional attempted inoculation with virus by contact with fingers,
conjunctiva, and nasal mucosa with fingers of right hand.
Left hand eluted in 2 mL of virus‐collecting broth.
Researchers
Face‐to‐face individually
Communities in Manitoba, Canada
1.7 mL of product applied.
See What for timing
Not described
Not described
Not described
Not described
Turner 2004b
Clinical trial 2
2 active interventions (no control)
Skin cleaner wipe product:
A. Pyroglutamic acid
B. Ethanol
Healthy volunteers
Assess the residual virucidal activity of organic acids used in currently
available over‐the‐counter skin products for the prevention of experimental
rhinovirus colds
Skin cleanser wipe containing:
A. 4% pyroglutamic acid formulated with 0.1% benzalkonium chloride
B. 62% ethanol
Application of product to hands with towelette then allowed to dry.
15 min later, fingertips of each hand contaminated with 106 TCID50
of rhinovirus type 39 in a volume of 100 μL.
Intentional attempted inoculation with virus by contact with fingers,
conjunctiva, and nasal mucosa with fingers of right hand.
Left hand eluted in 2 mL of virus‐collecting broth.
Researchers
Face‐to‐face individually
Communities in Manitoba, Canada
Dose not reported; see What for timing
Additional group challenged 1 h after application; final group challenged 3 h
after application (remained at study site and not allowed to use or wash hands
between).
Not described
Not described
Not described
Not described
Turner 2012
Antiviral hand lotion
Healthy adults
Reduce rhinovirus infection and illness through hand disinfection with ethanol
and organic acid sanitiser
Lotion containing 62% ethanol, 2% citric acid, and 2% malic acid
Daily diary
Provision of lotion and instructions for use
Meetings with participants to check compliance
Staff of study site presumably supplied lotion.
Study site staff met with participants.
Face‐to‐face and presumably individually, but not specified
Study site at university community in the USA
9 weeks
Every 3 hours whilst awake
and after hand‐washing for 9 weeks
Compliance meetings twice weekly for first 5 weeks then weekly meetings with
participants
None reported.
None reported.
Self‐reported daily diary of time of each product application
Twice weekly for 5 weeks then weekly meetings with participants to reinforce
compliance with treatment
“All subjects … applied at least 90% of the expected amount of hand treatment”
(p.1424)
Yeung 2011
Multifaceted hand hygiene programme (including alcohol‐based hand rub)
Long‐term care facilities and their healthcare workers
Promote use of alcohol‐based hand rub by staff in LTCFs as an effective, timely,
and low‐irritant method of hand hygiene in a high‐risk environment
Free supply of pocket‐sized containers of alcohol‐based antiseptic hand rub
(either WHO formulation I (80% ethanol) or II (80% propanol) carried by each HCW
(supplier: Vickmans Laboratories)
Replacement hand rub as required
Hand hygiene seminar content
Reminder materials (3 to 5 posters and specially designed ballpoint pens)
Provision of materials
Provision of hand hygiene seminars to HCWs covering:
indications, proper method, and importance of antiseptic hand rubbing and
washing according to WHO 2006a) guidelines
Provision of feedback session
Direct, unobtrusive observation of hand hygiene adherence
Training of observation staff
Study team delivered the materials, seminars, and observer training.
Administrative staff of LTCF provided replacement hand rub and communicated with
HCWs.
6 registered nurses conducted direct observation of adherence after 2‐hour
training (100% interrater reliability).
Delivered face‐to‐face and individually for hand rub and pens; not described if
education was individually or by group, but seminar implies as a group
LTCFs in Hong Kong
Posters posted in common areas.
Adherence observations occurred in common rooms and resident rooms but not
bathing or toilet areas.
7 months overall
Initial 2‐week intervention period, then 7 months of hand rub provision and
reminders
3 identical seminars at start of intervention; each staff member to attend once
Feedback session 3 months after start of intervention
2‐hour training of observers
Adherence observations either 9 am to 12 pm or 3 pm to 6 pm, 1 LTCF at a time
Replacement of hand rub as required
As adherence dropped off in the middle months, the feedback session was
delivered.
Direct observation of HCW adherence to hand‐washing and antiseptic hand rubbing
(recorded separately and anonymously) during bedside procedures or physical
contact with residents
3300 hand hygiene opportunities during 248.5 hours of observation on 92 days
90% attendance of seminars
Hand rubbing with gel increased significantly from 1.5% to 15.9%.
Hand‐washing decreased significantly from 24.3% to 17.4%.
Control: 30%
Overall hand‐washing adherence increased from 25.8% to 33.3%.
Zomer 2015
Hand hygiene products and training
Daycare centres and their caregivers (staff)
Reduce infections in children attending DCCs through improved access to HH
materials (Zomer 2013a) and compliance of their DCC caregivers to hand hygiene
guidelines based on socio‐cognitive and environmental determinants of
caregivers’ HH behaviour[17] (Zomer 2013b)
HH products:
dispensers for paper towels, soap, alcohol‐based hand sanitiser, and hand cream,
with refills for 6 months
Reminder posters and stickers for children and DCC caregivers
Training materials including booklet
Provision of free HH products sponsored by SCA Hygiene Products, Sweden.
Provision of posters and stickers for children and staff
Provision of training about RIVM 2011 for mandatory HH[18]
Distribution of training booklet
Team training sessions aimed at goal‐setting and formulating HH improvement
activities (Erasmus 2011; Huis 2013)
Study team arranged supply of HH products and presumably provided training.
Products provided to DCCs in person for staff use.
Mode of training not specified.
DCCs in regions of the Netherlands
6 months overall
Initial one‐off supply of products
3 training sessions with 1‐month interval
2 team training sessions
Replacement hand hygiene provided as required.
None described.
6‐month follow‐up observation of whether intervention dispensers and
posters/stickers in use
Survey of DCC caregivers
HH guidelines compliance observed at 1, 3, and 6 months' follow‐up:
no. of HH actions/no. of opportunities
2 DCCs did not use any HH products.
Sanitiser products used in at least 1 of 2 groups in 94%, 89%, 86%, and 45% of
intervention DCCs.
Posters used in 86%, stickers in 74%.
DCC survey results:
79% attended at least 1 training session; 77% received HH guidelines booklet.
HH compliance at 6 months:
IG: 59% vs CG: 44% (Zomer TP, et al, unpublished data)
All intervention DCCs received guidelines training; all but 2 received at least
1 team training.
Hang hygiene and masks
Aelami 2015
Hygienic education and package
Religious pilgrims
Prevent influenza‐like illness by reduced infection transmission through
personal hygiene measures
Hygiene package of:
alcohol‐based hand rub (gel or spray)
surgical masks
soap
paper handkerchiefs
user instructions
Not clearly described, but it appears that packages may have been distributed by
trained physicians before departure to or on site of country of pilgrimage
Not specifically described
Not described, but it appears that packages were distributed face‐to‐face and
individually
Not described if before departure (from Iran) or on site (in Saudi Arabia)
One‐off during Hajj season
Not described
Not described
Not described
None described
Aiello 2010
2 active interventions:
A. Face mask (FM)
B. Face mask and hand hygiene (FM + HH)
Students living in university residences
Reduce the incidence of and mitigate ILI by use of non‐pharmaceutical
interventions of personal protection measures
7 face masks (standard medical procedure masks with ear loops TECNOL procedure
masks; Kimberly‐Clark)
7 resealable plastic bags for mask storage when not in use (e.g. eating) and for
disposal
Alcohol‐based hand sanitiser
(62% ethyl alcohol in a gel base, portable 2‐ounce squeeze bottle, 8‐ounce pump)
Hand hygiene education (proper hand hygiene practices and cough etiquette) via
emailed video, study website, written materials detailing appropriate hand
sanitiser and mask use
Weekly supply of masks through student mailboxes
Provision of basic hand hygiene education through an email video link, the study
website, and written materials; instruction to wear mask as much as possible;
education in correct mask use, change of masks daily, use of provided resealable
bags for mask storage and disposal
Provision of replacement supplies which students signed for upon receipt
Not described, except education provided via study website (URL not provided)
“Trained staff” for compliance monitoring
Study‐affiliated residence hall staff provided replacement supplies.
Education via email and study website; provision of masks and sanitiser in
person to residences
University residence halls in the USA
One‐off education, 6 weeks (excluding spring break) of face mask and/or hand
hygiene measures which commenced at “the beginning of the influenza season just
after identification of the first case of influenza on campus” (p.496).
Replacement supplies provided as needed.
Mask wearing during sleep optional and encouraged outside of residence.
University spring break occurred during weeks 4 and 5 of the study, with most
students leaving campus and travelling; they were not required to continue
protective measures at that time.
Weekly web‐based student survey included: self‐reported average number of times
hands washed/day and average duration of hand‐washing to obtain composite
"optimal handwashing” score (at least 20 s ≥ 5/day);
average no. of mask hours/day/week; average hand sanitiser use/day/week and
amount used.
Trained staff in residence hall common areas observed silently and anonymously
improper mask use, instances of hand sanitiser use.
Average mask use hours/day:
FM + HH 2.99 vs FM 3.92
Average hand‐washing times/day:
FM + HH 6.11 vs FM 8.18 vs control group 8.75
Daily washing seconds/day:
FM + HH 20.65 vs FM 23.15 vs control 22.35
Hand sanitiser use times/day:
FM + HH: 5.2 vs FM 2.31 vs control 2.02
No. of proper mask wearing participants/hour of observation:
FM + HH 2.26 vs
FM 1.94
Aiello 2012
2 interventions:
A. Face mask (FM)
B. Face mask and hand sanitiser (FM + HH)
Students living in university residences
Prevent ILI and laboratory‐confirmed influenza by use of non‐pharmaceutical
interventions of personal protection measures (e.g. face masks and hand hygiene)
Packets of 7 standard medical procedure masks with ear loops (TECNOL procedure
masks, Kimberly‐Clark, Roswell, GA, USA) and plastic bags for storage during
interruptions in mask use (e.g. whilst eating, sleeping) and for daily disposal
Hand sanitiser (2‐ounce squeeze bottle, 8‐ounce pump bottle with 62% ethyl
alcohol in a gel base)
Replacement face masks and hand sanitiser
Educational video: proper hand hygiene and use of standard medical procedure
face masks
Intervention materials and educational video provided.
Supply of masks and instructions on wearing
Provision of replacement masks or sanitisers as needed on site
Trained study staff available at tables in each residence hall for surplus masks
and sanitiser and for observing compliance
Hygiene packs delivered to student mailboxes; face‐to‐face supply also available
University residence halls in the USA
One‐off educational video at start
Weekly supply of hygiene packs
Masks to be worn at least 6 hours/day
Study staff available onsite with replacement supplies as needed for duration of
intervention (6 weeks, excluding spring break)
Students encouraged but not obliged to wear masks outside of residence hall.
1‐week university spring break during the study when majority of students left
campus
Weekly student survey including compliance (e.g. masks hours/day, frequency and
amount of sanitiser use, number of hand washes/day, duration of hand‐washing
(seconds)
Observed compliance completed by trained study staff who daily and anonymously
observed mask wearing in public areas of residences.
Self‐reported mask wearing: no significant difference
Sanitiser use:
significantly more in FM + HH than FM or control groups
More results in S1 of paper.
Staff observed an average of 0.0007 participants properly wearing a mask for
each hour of observation.
Cowling 2009
2 active interventions in addition to control of lifestyle education:
A. Enhanced hand hygiene (HH)
B. Face masks and enhanced hygiene (FM + HH)
Householders with index patient with influenza
Reduce transmission of influenza in households through personal protective
measures
A. and B.
Liquid soap for each kitchen and bathroom: 221 mL Ivory liquid hand soap
(Proctor & Gamble, Cincinnati, OH, USA)
Alcohol hand rub in individual small bottles (100 mL) WHO recommended
formulation I, 80% ethanol, 1.45% glycerol, and 0.125% hydrogen peroxide
(Vickmans Laboratories, Hong Kong, China)
B. Adults: box of 50 surgical face masks (Tecnol–The Lite One (Kimberly‐Clark,
Roswell, GA, USA) to each household member or C. Children 3 to 7: box of 75
paediatric masks
Home visits
Provision of soap, hand rub, and masks as applicable and when to use them
HH: education about efficacy of hand hygiene
Demonstration of proper hand‐washing and antisepsis techniques
+ FM: education about efficacy of surgical face masks in reducing disease spread
to household contacts if all parties wear masks
Demonstration of proper wearing and hygienic disposal
All groups: provision of education about the importance of a healthy diet and
lifestyle, both in terms of illness prevention (for household contacts) and
symptom alleviation (for the index case)
Trained study nurse provided interventions.
Face‐to‐face to householders
Households in Hong Kong
Initial home visit scheduled within 2 days (ideally 12 h) of index case
identification.
Further home visits day 3 and 6, 7‐day follow‐up
HH: use of liquid soap after every washroom visit, sneezing or coughing, when
their hands were soiled. Use rub when first returning home and immediately after
touching any potentially contaminated surfaces
FM: masks worn as often as possible at home (except eating or sleeping) and when
the index patient was with the household members outside of the household
Not described
Not described
Monitoring of adherence during home visits
Evaluation of adherence on final visit by interview or self‐reported practices
and counting of amount of soap and rub left in bottles and remaining masks for
FM group
Most initial visits completed within 12 h.
Intervention groups “reported
higher adherence … than the
control group. Self‐reported data were consistent with measurements of amount of
soap, alcohol hand rub,
and face masks used” (p.443) (see Table 6 in paper).
“Adherence to the hand hygiene intervention was
slightly higher in the hand hygiene group than the face mask
plus hand hygiene group.”
Median masks used:
Index: 9
Contact: 4
More details in paper and Appendices
Larson 2010
2 active interventions in addition to control of URI education:
A. Alcohol‐based hand sanitiser (HS)
B. Face masks and hand sanitiser (FM + HS)
Hispanic householders with at least 1 preschool or elementary school child
Reduce incidence and secondary transmission of URIs and influenza through
non‐pharmaceutical household level interventions
A. and B.
2‐month supply of hand sanitiser in 8‐, 4‐, and 1‐ounce containers:
PURELL (Johnson & Johnson, Morris
Plains, NJ, USA)
B. 2‐month supply of masks:
Procedure
Face Masks for adults and children (Kimberly‐Clark, Roswell, GA, USA)
Replacement supplies at least once every 2 months
Disposable thermometers
Educational materials about URI prevention, treatment, and vaccination (written
in Spanish or English language)
Provision of materials and instructions for when to use including demonstration
of use and observation of return demonstration by householder
A. Mask worn when householder had: “temperature of ≥37.8°C and cough and/or sore
throat in the absence of a known cause other than influenza” (CDC definition of
influenza‐like illness at the time).
Home visits to reinforce adherence, replenish supplies and record use, answer
questions
B. Telephone calls to reinforce mask use
All groups received URI educational materials.
4 trained bilingual research assistants (RAs) with minimum baccalaureate degree
and experience in community‐based research; procedures were practised with each
other until demonstrated proficiency
Face‐to‐face to householders
Households in New York, USA
19‐month follow‐up
Initial home visit, then at least every 2 months
Sanitiser for use at home, work, and school
B. Telephone calls days 1, 3, 6
Masks worn for 7 days when within 3 feet of person with ILL or no symptoms.
Change masks between interactions with person with ILL
Householders' questions and misconceptions addressed on home visits.
None described.
RA home visits for adherence with random accompaniment by project manager, who
also made random calls to householders
Telephone calls to reinforce mask use
Used bottles or face masks, or both, monitored for usage.
Sanitiser use (mean ounces/month)
HH: 12.1
FM + HH: 11.6
Mask compliance was “poor”: 22/44 (50%) used within 48 hours of onset.
Mask users reported mean mask use of 2.
Simmerman 2011
2 active interventions:
A. Hand‐washing education and hand‐washing kit (HW)
B. Hand‐washing education, hand‐washing kit, and face masks (HW + FM)
Households with a febrile, influenza‐positive child
Decrease influenza virus transmission in household with a febrile
influenza‐positive child through promoted use of hand‐washing or hand‐washing
with face mask use
A. and B.
Hand‐washing kit per household including graduated dispenser with standard
unscented liquid hand soap (Teepol brand. Active ingredients: linear alkyl
benzene sulfonate, potassium salt, and sodium lauryl ether sulphate)
Replacement soap as needed
Written materials from education including pamphlets and posters attached near
sinks in household.
B. Box of 50 standard paper surgical face masks and 20 paediatric
face masks (Med‐con company, Thailand #14IN‐20AMB‐30IN)
A. and B.
Provision of intensive hand‐washing education on initial home visit to household
members with 5 approaches: discussion, individual hand‐washing training,
self‐monitoring diary, provision of soap, and provision of written materials
(Kaewchana 2012)
Individual hand‐washing training ("why to wash", "when to wash", and "how to
wash" in 7 hand‐washing steps described in Thailand Ministry of Public Health
guidelines)
B. Provision of education of benefits of and appropriate face mask wearing
Soap replaced as needed.
More details (Kaewchana 2012)
Study nurse conducted home visits, provided education and monitoring activities.
Education provided face‐to‐face as a group to household member and individually
for hand‐washing training.
In homes (in Bangkok, Thailand)
One‐off provision of kits at initial home visit conducted within 24 hours of
enrolment
Subsequent home visits on days 3, 7, and 21
90‐day supply of hand‐washing supplies
30‐minute education provided at initial home visit
B. No face masks whilst eating or sleeping as impractical and could hinder
breathing in ill child
Impromptu education and training provided by nurses as questions arose.
None described.
Self‐monitoring diary recording hand‐washing frequency > 20 s and face mask use
for that group
Reinforcement of messages by nurses on subsequent home visits
Amount of household liquid soap and number of face masks used
Reported average hand‐washing episodes/day:
HW: 4.7
HW + FM: 4.9
Parents had highest frequency (5.7), others (4.8), siblings (4.3), index cases
(4.1).
Average soap used/week:
HW: 54 mL/person
HW + FM: 58.1 mL/person
B. Mask use:
12/person/week
Mask wearing median minutes/day: 211
Parents 153,
other relations
59, index patients 35, siblings 17
Suess 2012
2 active interventions in addition to written information:
A. Mask/hygiene (MH)
B. Mask (M)
Households with an influenza‐positive index case in the absence of
further respiratory illness within the preceding 14 days
Prevent influenza transmission in
households through easily applicable and accessible non‐pharmaceutical
interventions
such as face masks or hand hygiene measures
A. Alcohol‐based hand rub (Sterilium, Bode Chemie, Germany)
A. and B.
Surgical face masks in 2 different sizes:
children < 14 years (Child’s Face Mask, Kimberly‐Clark, USA) and adults (Aérokyn
Masques, LCH Medical Products, France)
Written information provided on correct use of intervention and on infection
prevention (Seuss 2011) (Tips and information on the new flu A/H1N1)
(URL provided is no longer active)
Digital tympanic thermometer
General written information on infection prevention
A. Provision of hand rub and masks
A. and B. Provision of masks only
Provision of thermometer and how to use it
Mask fit assessed (at first household visit)
Information provided by telephone and written instructions at home visit on
proper use of interventions and recommendations to sleep in a different room
than the index patient, not to take meals with the index patient, etc. (Seuss
2011)
In‐person demonstration of interventions at first home visit
All participating households received general written information on infection
prevention.
Study personnel arranged provision of materials, rang the participants, visited
the homes, demonstrated and assessed fit of masks.
Provision of materials in person to households
Initial telephone delivery of information
Face‐to‐face home visits
Households in Berlin, Germany
Over 2 consecutive flu seasons
Day 1 households received all necessary material instructions.
Household visits no later than 2 days after symptom onset of the index case,
then days 2, 3, 4, 6, 8 (5 times) or on days 3, 4, 6, 8 (4 times) depending on
the day of recruitment
Hand rub use: after direct contact
with the index patient (or other symptomatic household
members), after at‐risk activities or contact[19]
Mask use: at all times when index patient and/or any other household member with
respiratory symptoms were together in 1 room
Regular change of face masks, not worn during the night or outside the household
Adult masks worn if
masks for under 14‐year‐olds
did not fit properly.
If other household members developed fever (> 38.0 °C), cough, or sore throat,
they were asked to adopt the same preventive behaviour as the index patient.
In the season 2010/11 participants also recorded number of masks used per day.
Self‐reported daily adherence with face masks, i.e. if they wore masks “always”,
“mostly”, “sometimes”, or “never” as instructed.
Participants of the MH households additionally noted the number of hand
disinfections per day.
Exit questionnaire about (preventive) behaviour during the past 8 days, general
attitudes towards NPI, the actual amount of used intervention materials, and, if
applicable, problems with wearing
face masks.
Used intervention material per household member was calculated by dividing the
amount used per household by the number of household members.
See paper and Suess 2011 for more details.
Face mask use (median/individual):
MH: 12.6
M: 12.9
Daily adherence was good, reaching a plateau of over 50% in nearly all groups
from the third day on.
MH hand rub use (median):
87 mL (Seuss 2011)
MH mean frequency of daily hand disinfection: 7.6 (SD 6.4) times per day
See paper and Suess 2011 for more results.
Hand hygiene and surface/object disinfection
Ban 2015
Hand hygiene and surface cleaning or disinfection
Kindergartens and the families of their students
Reduce transmission of infection in young children from contaminated surfaces or
hands through hand hygiene and surface cleaning or disinfection
Antibacterial products for hand hygiene and surface cleaning or disinfection:
liquid antimicrobial soap for hand‐washing (0.2% to 0.3% parachlorometaxylenol).
Instant hand sanitiser for hand disinfecting (72% to 75% ethanol), antiseptic
germicide (4.5% to 5.5% parachlorometaxylenol, diluting before use).
Bleach (4.5% to 5.0% sodium hypochlorite, diluting before use) for surface
disinfecting.
Produced by Whealthfields Lohmann (Guangzhou) Company Ltd.
Provision of products to kindergartens and families
Instruction of parents or guardians and teachers in hand hygiene techniques and
use of antibacterial products
Daily cleaning of kindergartens with products
At least twice/week cleaning of homes and weekly cleaning or disinfecting of
items such as children’s toys, house furnishings, frequently touched objects
(doorknobs, tables or desks), kitchen surfaces (utensils, cutlery, countertops,
chopping boards, sinks, floors, etc.), bathroom surfaces (toilet, sink, floor,
etc.)
Monitoring activities
Research team provided products and instructions and monitoring.
Materials provided to kindergartens and families in person and presumably
instructions in person to families and staff.
In kindergartens (hard surfaces) and families’ homes (Xiantao, China)
1 year overall
Daily hand‐washing with soap before eating, after using bathroom, nose blowing,
and outdoor activities
Hand sanitiser carried daily.
Kindergarten cleaning daily
Home cleaning at least twice/week
Families and teachers could contact study management at any time as needed.
Exchange of empty bottles for new ones at any time
Not described
Close contact with teachers and families for monitoring, e.g. unscheduled
parents’ meetings, quarterly home visits, phone interviews, and monthly cell
phone messages
Monthly survey of consumption of products by volume, total usage, person usage
Consumption of products by person (mL/person/day).
Liquid soap: 7.7
Sanitiser: 1.4
Bleach: 25.0
Antiseptic‐germicide: 12.5
Carabin 1999
Hygiene programme
Daycare centres and their staff and children
Reduce infections in at‐risk children (under 3 years old) in DCCs with
inexpensive, easily implementable and practical interventions
Hygiene materials and documents, e.g. colouring books, hand‐washing posters,
hygiene videotapes
Materials for training
Reimbursement of equivalent of 1 full‐time educator’s salary
Bleach (diluted 1:10) for toy and play area cleaning
Provision of comprehensive hygiene training session to entire DCC staff,
especially the educators of participating classrooms
Training in recommendations for hygiene practices:
i. toy cleaning
ii. hand‐washing technique and schedule
iii. use of creative reminder cues for hand‐washing
iv. open window for daily period
v. sandbox and play area cleaning
Payment of salary of educator for the day to encourage participation
DCC meetings to discuss training session with all staff
Training appears to have been provided by study team.
Appears staff trained as a group, i.e. “entire DCC staff”
Daycare centres in Canada
Location of training not described, except may have been off‐site from DCCs
since 1 DCC did not “send” staff to training.
15‐month trial
One‐off 1‐day training
Toy cleaning at least every 2 days
Hand‐washing at least after DCC arrival, after outside play, after bathroom,
before lunch
Open windows at least 30 min/day
Biweekly cleaning of sandbox/play area
Teachers to use creative reminder cues for hand‐washing with children
Not described
Follow‐up telephone questionnaire for DCC directors about following training
recommendations
Use of materials: colouring book: 22/24
poster: 23/24
videotapes: 18/24
staff meetings: 19/24
Increased frequency of toy cleaning: 6/24
Use of rake and shovel for sandpit: 17/24
Frequency of cleaning sandbox: 14/24
Kotch 1994
Hygiene
Caregivers at child daycare centres (CDCCs)
Develop feasible, multicomponent hygienic intervention to reduce infections in
children at CDCCs who are at increased risk
Hygiene curriculum for caregivers
Availability of soap, running water, and disposable towels
Waterless disinfectant scrub (Cal Stat) used only if alternative was not washing
at all.
Handouts posted in CDCC.
Delivery of hygiene curriculum to caregivers through initial training session
which required demonstration of participants’ hand‐washing and diapering skills
Local procedures:
Hand‐washing of children and staff
Disinfection of toilet and diapering areas
Physical separation of diapering areas from food preparation and serving areas
Hygienic diaper disposal
Daily washing and disinfection of toys, sinks, kitchen and bathroom floors
Daily laundering of blankets, sheets, dress‐up clothes
Hygienic preparation, serving, and clean up of food
Separate training of food handlers
As‐required induction training for new staff
Onsite follow‐up training reinforcing adaptations, demonstrations and discussion
of hygiene techniques, responding to questions, and review of handouts
Monthly meeting with centre directors to encourage leadership and support
Research team delivered training.
Scrub donated by Calgon Vetal Laboratories.
Face‐to‐face training and follow‐up group and individually
Classrooms of child daycare centres in the USA
8 months overall
3‐hour initial training session
Cleaning schedules as described in column What (procedures)
Onsite follow‐up training 1 week and 5 weeks later
Follow‐up sessions addressed questions and local adaptations to procedures.
As‐required induction training
During intervention, research team encouraged directors to address physical
barrier to hygiene practice, such as distance between sink and diapering areas
and sink access in rooms.
Follow‐up sessions reinforced training.
Meeting with directors
5 weekly unobtrusive recorded observation by training staff
Rate of compliance to barrier modification was better in younger centres, which
were more likely to have written guidelines.
McConeghy 2017
Multifaceted hand‐washing and surface‐cleaning intervention
Nursing homes and their staff
Reduce exposure to pathogens
and person‐person transmission in high‐risk facility of close environment and
potentially contaminated surfaces through multifaceted intervention equipping
staff to protect residents from infection within the “culture” of care
Education and launch materials
Online module for certified nursing assistants about: infection prevention,
product, and monitoring
"Essential bundle" of hygiene products supplied at no cost:
‐ hand sanitiser gel and foam
‐ antiviral facial tissues
‐ disinfecting spray
‐ hand and face wipes
Plus additional:
‐ 4 skin cream and wipe products
iPads for compliance audits
Newsletters for support during intervention
Pre‐intervention:
NH administrators required to:
‐ identify a "Heroes In Prevention" champion and team
‐ allow all staff participation in education
‐ iPad use for staff in each floor or community
‐ ask staff to incorporate intervention into workflow
Delivery of 3 components:
‐ education
‐ cleaning products
‐ compliance audit and feedback
Education:
Launch event for all staff to publicise programme and explain roles
Intensive training of "hygiene monitors" for data collection and compliance
audit and feedback tool
Training of site champion
Training of select group of certified nursing assistants (online module)
Audit and feedback activities
Ongoing support during intervention:
‐ newsletter with best practices
‐ teleconferences with each NH
‐ "onboarding" education of new staff
Study personnel equipped staff with knowledge and tools and support.
NH staff (e.g. champion, hygiene monitors, nursing assistants) delivered aspects
of interventions after specific training.
Face‐to‐face interaction with staff for planning and some aspects and delivery
of products
Some aspects delivered online (e.g. nursing modules, compliance auditing)
Nursing homes in the USA
Onsite and at unit/team levels
Online training
6 months overall: training period: 3 months
1‐hour launch event
1 or 2 hygiene monitors/site
1 champion/site
1‐hour online module for selected nursing assistants
iPads for each community or floor
Weekly teleconferences
initially decreased in frequency over time.
Weekly measurement of product consumption
Sites could use existing comparable products from another vendor and fill in any
gaps with study products.
New staff provided with education, as needed and came onboard.
Retraining of sites with low training participation rates
2 sites retrained due to low training participation rate.
Cloud‐based audit and feedback system via secure login to web browsers on NHs’
existing computers or via iPads included weekly product consumption to get
measure:
weekly count of product units consumed x no. of hand hygiene occasions
Online training participation rates:
> 90% for 3/5 sites,
13% and 23% for 2/5
Administrators demonstrated high fidelity in reporting measures of
hand‐washing (> 80% of time).
Hand‐washing rates in Figure 1B in paper reported as “relatively constant” and
“not ideal in the first few months”, but improved significantly over time.
Sandora 2008
Multifactorial intervention, including alcohol‐based hand sanitiser and surface
disinfection
Elementary school and its students
Reduce transmission of infections in schoolchildren through improved hand
hygiene and environmental disinfection
1 container of disinfecting wipes (Clorox Disinfecting Wipes (The Clorox
Company, Oakland, CA, USA); active ingredient, 0.29% quaternary ammonium
chloride compound)
Pre‐labeled 1.7‐ounce containers of alcohol‐based hand sanitiser (AeroFirst
non‐aerosol alcohol‐based foaming hand sanitiser (DEB SBS Inc, Stanley, NC, USA,
for The Clorox Company); active ingredient, 70% ethyl alcohol)
Receptacle in classrooms for empty containers
Sanitiser and wipes provided to classroom/teacher with instructions for use.
Teachers disinfected desks once daily.
Hand sanitiser to be used:
before and after lunch, after use of the restroom (on return to the classroom;
hand hygiene with soap and water occurred in the restroom, because sanitisers
were not placed there), after any contact with potentially infectious secretions
(e.g. after exposure to other ill children or shared toys that had been mouthed)
Research team arranged supply of materials and instructed teachers on use.
Teachers instructed in use of materials and in collecting empty containers and
distributing new product.
Products provided to schools.
Instruction provided face‐to‐face to teachers and children.
Elementary schools and their classrooms in the USA
8‐week period
Desks disinfected once a day.
Products replenished as needed.
None described.
Individually labelled containers collected every 3 weeks from the classroom to
assess adherence.
Product usage: average wipes used/week: 897 (128 wipes/classroom/week)
Average bottles of hand sanitiser used per week: 8.75 (1.25
bottles/classroom/week)
Quarantine
Miyaki 2011
Quarantine from work (stay‐at‐home order)
Employees
Prevent spread of influenza in workplaces by quarantining workers who had a
co‐habitating family member with an ILI
Full wages to employee
Non‐compulsory asking of workers whose family members developed an ILI to stay
at home voluntarily on full wages.
Daily measuring of temperature before leaving work.
Where symptoms were doubtful, industrial physician made judgement.
Company doctors provided input on cancelling of stay‐at‐home orders as required.
Health management department oversaw the procedures and decisions.
Mode of advice to employees not described.
Car industries in Japan
Stay‐at‐home order for 5 days after resolution of ILI symptoms or 2 days after
alleviation of fever over 7.5 months
Strict standard for cancelling of stay‐at‐home orders described.
None described.
Recording of compliance with stay‐at‐home request
100% compliance to stay at home reported.
Other (miscellaneous) interventions
Farr 1988a
trial 1
2 active interventions in addition to control of no tissues:
A. Virucidal nasal tissues
B. Placebo tissues
Families
Reduce transmission of viruses from hand contamination via hand‐to‐hand contact
or large‐particle aerosol through tissues for nose blowing and coughs and
sneezes
3‐ply tissues with:
A. 5.1 mg/inch2 (2.54 cm2) of the virucidal mixture (58.8% citric acid, 29.4%
malic acid, 11.8% sodium lauryl sulphate)
B. 3 mg/inch2 (2.54 cm2) of saccharin
applied uniformly to all 3 plies of the tissue
Tissues prepared by Kimberly‐Clark Corporation, Neenah, WI, USA.
Family visits to distribute tissues
Weekly contact of mother
Families instructed to only use supplied tissues.
Nurse epidemiologist visited families.
Face‐to‐face visits to families and individuals in families (especially mothers)
Communities in the USA
6 months overall
Monthly family visits
Weekly contact with mother
Not described
Not described
Family visits and weekly contact with mother to encourage compliance
Not described
Farr 1988b
trial 2
2 active interventions (no control):
A. Virucidal nasal tissues
B. Placebo tissues
Families
Reduce transmission of viruses from hand contamination via hand‐to‐hand contact
or large‐particle aerosol through tissues for nose blowing and coughs and
sneezes
2‐ply tissues containing:
A. 4.0 mg/inch2 (2.54 cm2) of antiviral mixture (53.3% citric acid, 26.7% malic
acid, 20% sodium lauryl sulphate)
B. 3 mg/inch2 (2.54
cm2) of succinic acid, malic acid, sodium hydroxide, and polyethylene glycol
Tissues prepared by Kimberly‐Clark Corporation, Neenah, WI, USA.
Family visits to distribute tissues and encourage compliance
Weekly contact of mother
Families instructed to only use supplied tissues.
Nurse epidemiologist visited families monthly.
Study monitor visited bimonthly.
Face‐to‐face visits to families and individuals in families (especially mothers)
Communities in the USA
6 months overall
Monthly family visits
Weekly contact with mother
Bimonthly study monitor visit
None described.
None described.
Bimonthly study monitor visits to encourage compliance as well as monthly and
weekly contact by nurse
In 124/222 families, 1 or more family members reported not using the tissues
regularly and/or reported having side effects from the tissues.
Longini 1988
2 active interventions (no control):
A. Virucidal nasal tissues
B. Placebo tissues
Households and their families
Prevent intrafamilial transmission of viral agents in a community setting
Treated tissues of 3‐ply material identified with no specific identifiers
(Kimberly‐Clark Corporation)
with inside layer containing:
A. citric and malic acid plus sodium lauryl sulphate;
B. succinic acid.
Tissues delivered to households with specific instructions on use (all purposes,
when blowing nose, coughing or sneezing) and to discard after use and to help
young children use tissues if develop a cold.
Tissues assigned by study sponsor (Kimberly‐Clark Corporation).
Supply of tissues throughout 5‐month trial period
Households in the USA
5 months' overall supply
Resupply of tissues as required
None described.
Reported use of tissues “not at all, some of the time, most of the time, or all
of the time”
Reported use “all of the time”:
A. vs B.
82% vs 71%
Chard 2019
(additional details from Chard 2018)
Water, Sanitation, and Hygiene for Health and Education in Laotian Primary
Schools (WASH HELPS)
Primary schools and their students
Prevent the spread of pathogens within schools through improved water supply and
hygiene facilities and improved WASH
habits in children at home and throughout the life course
For each school:
Water supply for school compound:
(borehole, protected dug well with pump, or gravity‐fed system)
Water tank to supply toilet and hand‐washing station
School sanitation facilities (3 toilet compartments)
Hand‐washing facilities:
2 sinks with tapped water and supply of soap available (1 bar of soap/pupil)
3 group hand‐washing tables with soap and water
At least 1 drinking water filter per classroom
Schedules of daily group hand‐washing, compound and toilet cleaning
Cost per school: USD 13,000 to 17,500
Provision of school:
Water supply, sanitation facilities, hand‐washing facilities (individual and
group), drinking water filters
Behaviour change education and promotion including daily group hygiene
activities
Daily hand‐washing and cleaning schedules
UNICEF paid for materials.
School and teachers conducted daily hand‐washing activities with children.
Students participated in daily group cleaning activities.
Facilities provided within schools.
Children participated in group hand‐washing and cleaning.
Primary schools and their classrooms (in Laos)
One‐off provision of water and hygiene facilities
Daily hand‐washing activities and cleaning for 1 school year
Cleaning schedules posted in at least 1 classroom near toilet.
Water supply tailored to the school requirements/environment.
Sanitation facilities provided as needed and designated for boys, girls, and
students with disabilities.
Rain water tank provision affected by rain water supply, so changed to tanks
with motorised hand pumps or gravity‐fed water supply systems.
Theft and animal consumption of supplied soap reduced supply.
Unannounced visits every 6 to 8 weeks for structured observations to measure
fidelity and adherence
Fidelity Index score (0 to 20): for hardware provided see Table 1 in paper and
protocol
Adherence index: student report of behavioural outcomes index score (0 to 4)
Fidelity: 30.9% across all schools and visits
Adherence: 29.4%
Hardware provision: 87.8% of schools
School‐level adherence: 61.4%
Group compound cleaning: 94.8%, toilet use: 75.5%, group toilet cleaning: 68.3%,
group hand‐washing: 48.7%, individual hand‐washing with soap after toilet use:
23.9%. Further details (Chard 2018)
Hartinger 2016
Integrated environmental home‐based intervention package (IHIP)
Households and their householders including children
Reduce infections and improve child growth in households in rural communities
with limited facilities through a multicomponent, low‐cost environmental
intervention to improve drinking water, sanitation, personal hygiene, and
household air quality developed in pilot (Hartinger 2011; Hartinger 2012) using
a participatory approach that addressed local beliefs and cultural views
Per household:
"OPTIMA‐improved stove": improved ventilated solid‐fuel stove
Kitchen sink with in‐kitchen water connection providing piped water
Point‐of‐use water quality intervention applying solar disinfection to drinking
water
Community engagement with local and regional stakeholders in design and
development
Provision of stoves, kitchen sinks, and plastic bottles for solar water
treatment, and hygiene education
Training of mothers/caretakers in:
‐ solar drinking‐water disinfection (SODIS)[20] according to standard procedures
‐ hand hygiene (washing own and children’s hands with soap at critical
times[21])
‐ advice to separate animals and their excreta from the kitchen environment
Project‐initiated repairs
Health promoters hired local elementary school teachers and implemented and
promoted the interventions.
4 teams of field staff conducted spot‐check observations.
Face‐to‐face and to individual households; mode of delivery of training as
individual or group not described
Households in rural communities in Peru
Stoves and sinks installed over initial 3 months.
Monthly reinforcement over 12 months of SODIS, child and kitchen hygiene
Weekly spot checks of compliance
Repairs after 9 months
Environmental samples test middle and end of 12‐month surveillance.
Tailored to particular household facilities and environments as needed and to
local beliefs and cultural customs
Repairs to stoves as needed and checked at 9 months
Not described
Weekly spot‐check observations of household hygiene and environmental health
conditions (e.g. presence of SODIS bottles on the roof or kitchen) using a
checklist
Monthly self‐report by mothers of stove and sink use
SODIS use:
60% initially and 10% at end of study
Self‐reported use by mothers: 90% with slight decrease at end
Self‐reported stove use: 90% daily
Sink use: 66% daily
35% of stoves needed minor repairs,
1% needed major repairs.
Best‐functioning stoves achieved mean 45% and 27% reduction of PM2.5 and CO,
respectively, in mothers’ personal exposure.
Huda 2012
Sanitation Hygiene Education and Water Supply in Bangladesh (SHEWA‐B)
Villages and their households with a child < 5 years old
Reduce illness in children < 5 years by improving hygiene practices, sanitation
and water supply and treatment in their household
Materials for training of community hygiene promoters and promotion activities
including flip charts and flash cards with messages alerting participants to
presence of unobservable “germs” and practices to minimise germs
See Box 1 in paper for 11 key messages.[22]
Engaging local residents under guidance of local NGOs to develop community
action plans addressing:
Latrine coverage and usage
Access to and use of arsenic‐free water
Improved hygiene practices, especially hand‐washing with soap
Recruitment and appointment of community hygiene promoters
Household visits, courtyard meetings, and social mobilisation activities (e.g.
water, sanitation and hygiene fairs, village theatre, group discussions in tea
stalls (the social meeting point for village men)) by community promoters
Structured observation in households
Community hygiene promoters (local residents with at least 10 years' schooling
trained for 10 days on behaviour change communication in water, sanitation, and
hygiene)
Face‐to‐face delivery to groups (villages and households) and individuals
Villages and households in districts of Bangladesh
Community activities held in villages.
Meetings held in courtyards of groups of households.
Household visits
18 months overall
Expected household visit and courtyard meeting every 2 months
Hand‐washing opportunities: after own or child’s defecation,
prior to preparing and serving food, prior to eating and feeding
a child
Community action plans developed for and by local residents.
Not described
Structured observation of hand‐washing and child faeces disposal behaviour in
households and spot checks of type of household water and sanitation facilities
HW:
Food‐related:
No significant difference from baseline to 18 months;
IG versus CG
After anus cleaning: 36% versus 27%
Defecation: 30% versus 23%
No access to latrine decreased from 10.3% to 6.8%.
No significant improvement in access to improved latrines, solid waste disposal,
drainage systems, and covered containers for water storage
Ibfelt 2015
Disinfection of toys
Daycare nurseries
Reduce transmission of pathogens via shared toys in daycare environment through
regular disinfection treatment
Disinfectants:
Turbo Oxysan (Ecolab, Valby, Denmark) for washing machines
Sirafan M, Ecolab (1% to 3% benzalkonium chloride, 1% to 3%
didecyldimethylammonium chloride, and 5% to 7% alcohol ethoxylates) for
immersion or wiping
Collection and commercial cleaning of toys from nurseries:
‐ linen and toys suitable for washing machines were washed at 46 °C and
subsequently disinfected
‐ toys not suitable for washing machines immersed in disinfectant or wiped with
microfibre cloth
Commercial cleaning company: Berendsen A/S, Søborg, Denmark
Cleaning companies collected the toys and linen and cleaned them offsite, then
returned them.
Daycare nurseries in Denmark
Commercial industrial cleaning facility
2 to 3 months overall
Cleaning every 2 weeks
Staggered cleaning to ensure children had toys to play with whilst others were
being cleaned
None described.
None described.
None described.
Najnin 2019 (see also Qadri 2015 for further details)
2 active interventions:
A. Combined cholera vaccine and 'behaviour change communication' intervention
B. Cholera vaccine‐alone group
Low‐income households and compounds
Prevent or reduce transmission of respiratory illness based on the Integrated
Behavioural Model for Water Sanitation and Hygiene (IBM‐WASH) theoretical
framework (Dreibelbis 2013; Hulland 2013)
A. and B.
Cholera vaccine
ShanChol™ (Shantha Biotechnics‐Sanofi, India)
A. Following hardware per compound:
a. Hand‐washing hardware:
(i) Bucket with a tap (provided free of charge)
(ii) Soapy water bottle (mixture of a commercially available sachet of powdered
detergent
(∼USD 0.03) with 1.5 L of water in a plastic bottle with a hole punched in the
cap) supplied by participating compounds
(iii) Bowl to collect rinse water after
washing hands (see photo in text or in Najnin 2017doi.org/10.1093/ije/dyx187)
b. Water treatment hardware:
Dispenser containing liquid sodium hypochlorite
See Figure 2 in Najnin 2017 for photos of both doi.org/10.1093/ije/dyx187
and more details.
Participants own water vessels for water treatment
Print materials for behaviour change to compounds and households
A. and B.
Provision of cholera vaccine (2 doses at least 14 days apart)
Provision of hand‐washing hardware and behaviour change communication activities
Encouragement of hand‐washing after defecation, after cleaning child’s anus, and
before preparing food
Encouragement to add chlorine to own water vessels
Benefits were again explained.
Follow‐up visits by health promoters
Dushtha Shasthya Kendra (DSK), an NGO, delivered the hardware and behavioural
intervention (through community health promoters).
Separate data collectors observed soap availability.
Hand‐washing and water treatment hardware mostly delivered at the compound level
in person.
Behaviour change communication messages were delivered both at compound and
household levels.
Households and compounds (where several
households share a common water source, kitchen,
and toilets) in Bangladesh
Behaviour change communication messages delivered first (within 3 months of
cholera vaccination).
Point‐of‐use water hardware provided 3 months later.
Follow‐up health promoter visits 3 times in 2 months after hardware
installation, then 2 times/month (over nearly 2 years).
Hardware‐related problems (breakage/leakage) were addressed on health promoter
follow‐up visits.
None described.
Unannounced home visits by data collectors who observed presence of soap/soapy
water and water in most convenient place for hand‐washing (either reserved in a
container or available at the tap)
Residual chlorine was measured indicating uptake of chlorine dispenser.
Presence of soap / soapy water and water:
A. Handwashing group compounds: 45% (1,729 / 3,886);
B. Vaccine‐only group compound: 22% (438 / 1,965);
C. Control: 28% (556 / 1991)
Residual chlorine present in stored drinking water of 4% (160/3886) of
households in the vaccine‐plus‐behaviour‐ change compound and none in the other
2 compounds.
Gargling
Goodall 2014
2 active interventions:
A. Vitamin D3 supplementation
B. Gargling water
University students
Decrease the incidence of URTI through increased vitamin D levels (associated
with greater frequency and severity of URTI) and gargling (as preventative
measure against URTI)
A. Vitamin D3: container of 8 capsules of 10,000 IU (purchased from Euro‐Pharm
International Canada Inc.)
Weekly email reminder
B. Gargling: 30 mL of tap water 2/day
A. Vitamin D: instructed to take 1 pill weekly
B. Gargling: instructed to gargle twice daily for 30 seconds
All participants received general
lifestyle and health advice on sleep, nutrition, hand hygiene, and exercise.
Not specified, presumably the researchers, including a study pharmacist
Vitamin D3 supplied individually, but no further details.
Method of lifestyle and health advice provision also not described.
In university student housing (in residences or off‐campus) in Canada
2 months overall
Vitamin D3: weekly supplementation and email reminder
Gargling: 30 mL of water for 30 seconds twice daily
None described.
None described.
None described.
None described.
Ide 2014
2 active interventions (no control):
A. Green tea gargling
B. Water gargling
High school students
Prevent influenza spread and infection in high school students who are at
increased risk from close interaction through gargling as a non‐pharmaceutical
intervention, specifically green tea containing highly bioactive catechin
(‐)‐epigallocatechin gallate, with possible anti‐influenza virus properties
A. Bottled green tea (500 mL)
containing a catechin concentration of 37 ± 0.2 mg/dL, including approximately
18% (‐)‐epigallocatechin gallate (manufactured by the Kakegawa Tea Merchants
Association).
Concentration measured by high‐performance liquid chromatography based on the
average concentration in 10 bottles from the same production
lot (September 2011) used for gargling in the study.
B. Tap water
A. Provision of green tea
B. Advice to gargle with tap water and not to gargle green tea during study
A. and B.
Advice to gargle at least 3 times/day (after arriving at school, after lunch,
and after school)
Consumption of green tea and other tea was not restricted for
either group.
Safety monitoring carried out throughout the study (not further described).
Materials supplied by researchers.
High schools’ vice principals and head teachers assisted with safety monitoring.
Green tea supplied individually to students.
Mode of gargling advice not described.
High schools in Japan
Gargling 3 times/day for 90 days
None described.
None described.
Daily questionnaire included questions about daily
adherence to gargling regimen.
Adherence rate of gargling at
or above 75%, and absence of green tea gargling when in the
water gargling group.
Gargling adherence rate: green tea group: 73.7%; water group: 67.2%
Satomura 2005
2 active interventions:
A. Water gargling
B. Povidone‐iodine gargling
Healthy adults
Prevent URTIs through gargling water alone, which may wash out pathogens from
the pharynx and oral cavity through whirling water or through chlorine, or
povidone‐iodine for its perceived virucidal properties
A. Water
B. 15 to 30 times diluted 7% povidone‐iodine (as indicated by manufacturer)
Local administrators instructed participants to:
‐ gargle dose of water or povidone‐iodine 3 times/day;
‐ maintain hand‐washing routine;
‐ not change other hygiene habits;
‐ not take any cold remedies;
‐ complete gargling diary.
Weekly monitoring of
hygienic actions and encouragement to keep up assigned intervention every week
Local project administrators (18 healthcare professionals) provided instructions
and monitoring and encouragement.
Not specified, but likely to have been face‐to‐face and individually, at least
initially for instructions
18 healthcare sites in Japan (4 in northern region, 9 in central region, 5 in
western region)
60 days overall
1. Water gargling:
20 mL for 15 s at least 3 times/day
2. Povidone‐iodine gargling:
20 mL of dilution 3 times/day
If diluted povidone‐iodine caused serious discomfort
or was not available, participants were allowed
to gargle with water instead.
3 participants assigned to povidone‐iodine gargled with water instead as the
povidone‐iodine “did not agree with them”.
Completion of gargling diary: frequency of gargling and hand‐washing
Weekly monitoring and encouragement by local administrators
9 participants did not complete diary.
Average frequency of gargling / person / day:
With water:
A: 3.6
B: 0.8
Control: 0.9
With povidone‐iodine:
A.: <0.1
B: 2.9
Control: 0.2
ABH: alcohol‐based rub
ARI: acute respiratory infection
CDC: Centers for Disease Control and Prevention
CG: control group
CHG: chlorhexidine gluconate
CO: carbon monoxide
DCCs: daycare centres
FM: face masks
HCP: healthcare personnel
HCW: healthcare worker
HH: hand hygiene
HSG: hand sanitiser group
HSW: hand‐washing with soap and water
HWWS: hand‐washing with soap
IG: intervention group
IHIP: integrated environmental home‐based intervention package
ILI: influenza‐like illness
IU: international units
LTCFs: long‐term care facilities
NGOs: non‐governmental organisations
NH: nursing home
no.: number
NPIs: non‐pharmaceutical interventions
PM2.5: particulate matter of less than 2.5 microns
RAs: research assistants
RIs: respiratory infections
RTIs: respiratory tract infections
SD: standard deviation
SSTI: skin and soft‐tissue infection
SWG: soap‐and‐water group
TCID: tissue‐culture infectious dose
URTI: upper respiratory tract infection
WHO: World Health Organization
wk: week
w/w: weight for weight
[1]: Occupational Safety and Health Administration (OSHA). OSHA technical
manual: section VIII: chapter 2: respiratory protection. US Department of Labor.
www.osha.gov/dts/osta/otm/otm_viii/otm_viii_2.html (accessed 21 April 2020).
[2]: Ministry of Health and Long‐Term Care, Public Health Division, Provincial
Infectious Diseases Advisory Committee. Preventing respiratory illnesses:
protecting patient and staff: infection control and surveillance standards for
febrile respiratory illness (FRI) in non‐outbreak conditions in acute care
hospitals [September 2005]
http://www.health.gov.on.ca/english/providers/program/infectious/diseases/best_prac/bp_fri_080406.pdf
(accessed September 11 2009). [URL inactive]
[3]: Before eating, after sneezing, coughing, handling money, using restroom,
returning to desk and interacting with others who may be sick
[4]: after coming into classroom, before and after lunch, after break, after
physical education, when they went home and after coughing, sneezing or blowing
their noses
[5]: after toileting and when visibly dirty plus a protocol for particular
circumstances: after coming into the classroom; before and after lunch; after
playing outside; when they went home; after coughing, sneezing, or blowing their
noses; and after diapering
[6]: 1) when entering into the classroom; 2) after sneezing, coughing, or
blowing their nose; 3) after using the toilet/washroom; 4) before eating any
food; and 5) when leaving the school at the end of the day
[7]: what to do if hands were dirty, why students should wash their hands,
benefits of washing hands and using hand sanitizer, procedure for washing hands
using hand sanitizer, to cover mouth and nose with upper part of sleeve while
coughing and/or sneezing
[8]: Boyce JM, Pittet D, Healthcare Infection Control Practices Advisory
Committee, HICPAC/ SHEA/APIC/IDSA Hand Hygiene Task Force. Guideline for hand
hygiene in healthcare settings. Recommendations of the Healthcare Infection
Control Practices Advisory Committee and the HICPAC/SHEA/APIC/ IDSA Hand Hygiene
Task Force. MMWR Recommendations and Reports 2002;51(RR‐16):1–45.
www.cdc.gov/mmwr/preview/mmwrhtml/rr5116a1.htm (accessed 21 April 2020).
International Bank for Reconstruction and Development/ World Bank,
Bank‐Netherlands Water Partnership, Water and Sanitation Program. Hand washing
manual: a guide for developing a hygiene promotion program to increase
handwashing with soap. http://go.worldbank.org/PJTS4A53C0 (Accessed 16 May
2007). [URL inactive] California State Department of Education. Techniques for
Preventing the Spread of Infectious Diseases. Sacramento (CA): California State
Department of Education, 1983. Geiger BF, Artz L, Petri CJ, Winnail SD, Mason
JW. Fun with Handwashing Education. Birmingham (AL): University of Alabama,
2000. Roberts A, Pareja R, Shaw W, Boyd B, Booth E, Mata JI. A tool box for
building health communication capacity.
www.globalhealthcommunication.org/tools/29 (Accessed 10 October 2007). [URL
inactive] Stark P. Handwashing Technique. Instructor’s Packet. Learning Activity
Package. Sacramento (CA): California State Department of Education, 1982.
[9]: DIN EN 1500: Chemische Desinfektionsmittel und Antiseptika, Hygienische
Händedesinfektion, Prüfverfahren und Anforderungen (Phase 2/Stufe 2). Brüssel
(Belgium): CEN, European Comittee for Standardization 1997;1‐20.
[10]: DIN EN 12791: Chemische Desinfektionsmittel und Antiseptika, Chirugische
Händedesinfektionsmittel ‐ Prüfverfahren und Anforderungen (Phase 2/Stufe 2).
Brüssel (Belgium): CEN, European Comittee for Standardization 2005;1‐31.
[11]: after defaecation, after cleaning an infant who had defaecated, before
preparing food, before eating, and before feeding infants
[12]: non‐governmental organisation that supports community‐based health and
development initiatives
[13]: “Healthy Hands” Rules (from Figure 3 in paper): Do use “special soap” when
arrive to school, before lunch, after go to bathroom (only if soap and water not
available), if rub nose or eyes or if fingers in mouth, if teacher asks. Do not:
use “special soap” if hand dirt on them, put “special soap” on another student,
play with ‘special soap”, put hands near eyes after using “special soap”.
[14]: Calculated by subtracting each day’s soap weight from the previous day’s
weight. Maximum number of grams of soap consumed for each compound was
identified and the day on which the maximum soap consumption was recorded. A per
capita estimate of daily soap consumption was calculated
[15]: National Health and Medical Research Council. Staying Healthy in Child
Care. Canberra (Australia): Australian Government Publishing Service, 1994
[16]: upon arrival, before and after lunch, and prior to departure
[17]: knowledge and awareness of HH guidelines, perceived importance of
performing HH, perceived behavioural control (i.e. perceived ease or difficulty
of performing the behaviour), and habit
[18]: “According to the Dutch national guidelines, HH is mandatory for
caregivers before touching/preparing food, before caregivers themselves ate or
assisted children with eating, and before wound care; and after diapering, after
toilet use/wiping buttocks, after caregivers themselves coughed/sneezed/wiped
their own nose, after contact with body fluids (e.g. saliva, vomit, urine,
blood, or mucus when wiping children’s noses), after wound care, and after hands
were visibly soiled.” (p. 2495)
[19]: having touched household items being used by the index patients and/or
other symptomatic household contacts, and after coughing/sneezing, before meals,
before preparing meals and when returning home
[20]: SODIS: www.sodis.ch/index_EN.html
[21]: after defecation, after changing diapers, before food preparation and
before eating
[22]: 1. Wash both hands with water and soap before eating/ handling food 2.
Wash both hands with water and soap/ash after defecation 3. Wash both hands with
water and soap/ash after cleaning baby’s bottom 4. Use hygienic latrine by all
family members including Children 5. Dispose of children’s faeces into hygienic
latrines 6. Clean and maintain latrine 7. Construct a new latrine if the
existing one is full and fill the pit with soil/ash. 8. Safe collection and
storage of drinking water 9. Draw drinking water from arsenic safe water point
10. Wash raw fruits and vegetables with safe water before eating and cover food
properly 11. Manage menstruation period safely (p.605)
ASSESSMENT OF RISK OF BIAS IN INCLUDED STUDIES
Three pairs of review authors (TOJ/EB, LA/GB, MJ/EF) independently assessed risk
of bias for the method of random sequence generation and allocation concealment
(selection bias), blinding of participants and personnel (performance bias),
blinding of outcome assessment (detection bias), outcome reporting (attrition
bias), and selective reporting (reporting bias). We used the Cochrane 'Risk of
bias' tool to assess risk of bias, classifying each 'Risk of bias' domain as
'low', ‘high’, or ‘unclear’. The following were indications for low risk of
bias:
1. method of random sequence generation: the method was well‐described and is
likely to produce balanced and truly random groups;
2. allocation concealment: the next treatment allocation was not known to
participant/cluster or treating staff until after consent to join the study;
3. blinding of participants and personnel: the method is likely to maintain
blinding throughout the study;
4. blinding of outcome assessors: all outcome assessors were unaware of
treatment allocation;
5. outcome reporting: participant attrition throughout the study is reported,
and reasons for loss are appropriately described; and
6. selective reporting: all likely planned and collected outcomes have been
reported.
MEASURES OF TREATMENT EFFECT
When possible, we performed meta‐analysis and summarised effectiveness as risk
ratio (RR) using 95% confidence intervals (CIs). For studies that could not be
pooled, we used the effect measures reported by the trial authors (such as RR or
incidence rate ratio (IRR) with 95% CI or, when these were not available,
relevant P values).
UNIT OF ANALYSIS ISSUES
Many of the included studies were cluster‐RCTs. To avoid any unit of analysis
issues, we only included treatment effect estimates that were based on methods
that were appropriate for the analysis of cluster trials, such as mixed models
and generalised estimating equations. Given this restriction, we used the
generalised inverse‐variance method of meta‐analysis. Some cluster‐RCTs that did
not report cluster‐adjusted treatment effects provided sufficient data (number
of events and participants by treatment group and intraclass correlations) for
us to calculate appropriate treatment effect estimates and standard errors.
For studies with multiple treatment groups but only one control group, where
appropriate, we adjusted standard errors upwards to avoid unit of analysis
errors in the meta‐analyses.
DEALING WITH MISSING DATA
Given the urgency of this update, we did not contact authors of studies with
significant missing data. Previously, whenever details of studies were unclear,
or studies were only known to us by abstracts or communications at meetings, we
corresponded with first or corresponding authors.
ASSESSMENT OF HETEROGENEITY
Aggregation of data was dependent on types of comparisons, sensitivity and
homogeneity of definitions of exposure, populations and outcomes used. We
calculated the I2 statistic and Chi2 test for each pooled estimate to assess the
presence of statistical heterogeneity (Higgins 2002; Higgins 2003).
ASSESSMENT OF REPORTING BIASES
Given the widely disparate nature of our evidence base, we limited our
assessment of possible reporting biases to funnel plot visual inspection if we
had > 10 included studies.
DATA SYNTHESIS
If possible and appropriate, we combined studies in a meta‐analysis. We used the
generalised inverse‐variance random‐effects model. We chose the random‐effects
model because we expected clinical heterogeneity due to differences in pooled
interventions and outcome definitions, and methodological heterogeneity due to
pooling of RCTs and cluster‐RCTs.
SUBGROUP ANALYSIS AND INVESTIGATION OF HETEROGENEITY
We conducted two post hoc subgroup analyses:
1. healthcare workers for the comparison of masks versus control; and
2. children for the comparison of hand hygiene versus control.
We did not conduct further investigation of heterogeneity due to insufficient
numbers of studies included in the comparisons.
SENSITIVITY ANALYSIS
We conducted a sensitivity analysis for hand hygiene versus control where we
included the most precise and unequivocal measure of viral illness reported for
each included study.
SUMMARY OF FINDINGS AND ASSESSMENT OF THE CERTAINTY OF THE EVIDENCE
We created three 'Summary of findings' tables using the following outcomes:
numbers of cases of viral illness (including ARIs, ILI, and laboratory‐confirmed
influenza) and adverse events related to the intervention (summary of findings
Table 1; summary of findings Table 2; summary of findings Table 3). We planned
to include the secondary outcomes of deaths; severity of viral illness as
reported in the studies; absenteeism; hospital admissions; and complications
related to the illness (e.g. pneumonia). However, this data were poorly reported
in the included studies. We used the five GRADE considerations (study
limitations, consistency of effect, imprecision, indirectness, and publication
bias) to assess the certainty of evidence as it related to the studies which
contributed data to the meta‐analyses for the prespecified outcomes (Atkins
2004). We used the methods and recommendations described in Section 8.5 and
Chapter 12 of the Cochrane Handbook for Systematic Reviews of Interventions
(Higgins 2011), employing GRADEpro GDT software (GRADEpro GDT 2015). We
justified all decisions to down‐ or upgrade the certainty of the evidence in
footnotes, and made comments to aid the reader's understanding of the review
where necessary.
RESULTS
DESCRIPTION OF STUDIES
See Characteristics of included studies and Characteristics of excluded
studies tables.
RESULTS OF THE SEARCH
We identified a total of 3180 titles in this 2020 update. We excluded
3092 titles and retrieved the full papers of 88 studies, to include 44 new
studies. See Figure 1.
Open in figure viewer
Figure 1
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Study flow diagram.
INCLUDED STUDIES
The 44 newly included studies were all RCTs (n = 11) or cluster‐RCTs (n = 33)
published between 2010 and 2019. We included 23 RCTs in the 2011 version of the
review. For detailed descriptions of the interventions of the included studies,
see Table 1.
Fifteen trials focused on using masks (Aiello 2010; Aiello 2012; Barasheed 2014;
Canini 2010; Cowling 2008; Ide 2016; Jacobs 2009; Loeb 2009; MacIntyre 2009;
MacIntyre 2011; MacIntyre 2013; MacIntyre 2015; MacIntyre 2016; Radonovich 2019;
Suess 2012). Ten of the 15 trials compared medical/surgical masks to no mask
(control) (Aiello 2010; Aiello 2012; Barasheed 2014; Canini 2010; Cowling 2008;
Jacobs 2009; MacIntyre 2009; MacIntyre 2015; MacIntyre 2016; Suess 2012). One
study compared catechin‐treated masks to no mask (Ide 2016), and one study
included cloth masks versus control (third arm in MacIntyre 2015). Three of the
15 trials were in healthcare workers (Ide 2016; Jacobs 2009; MacIntyre 2015),
whilst the remaining trials were in non‐healthcare workers (students,
households, families, or pilgrims). Only one trial was conducted during H1N1
pandemic season (Suess 2012).
Five of the 15 trials compared N95 masks or P2 masks to medical/surgical masks
(Loeb 2009; MacIntyre 2009; MacIntyre 2011; MacIntyre 2013; Radonovich 2019).
All of these trials, except for one study that was conducted on household
individuals (MacIntyre 2009), included healthcare workers either in a hospital
setting, Loeb 2009; MacIntyre 2011; MacIntyre 2013, or an outpatient setting
(MacIntyre 2009; Radonovich 2019).
One trial evaluated the effectiveness of quarantining workers of one of two
sibling companies in Japan whose family members had developed an ILI during the
2009 to 2010 H1N1 influenza pandemic (Miyaki 2011).
Fifteen trials compared hand hygiene interventions with no hand hygiene
(control) and provided data suitable for meta‐analysis. The populations in these
trials included adults, children, and families, in settings such as schools
(Biswas 2019; Stebbins 2011), childcare centres (Azor‐Martinez 2018; Correa
2012; Roberts 2000; Zomer 2015), homes/households (Cowling 2009; Larson 2010;
Little 2015; Nicholson 2014; Ram 2015; Sandora 2005; Simmerman 2011), offices
(Hubner 2010), and military trainees (Millar 2016). None of the trials was
conducted during a pandemic, although some of the studies were conducted during
peak influenza seasons.
A further 10 trials that compared a variety of hand hygiene modalities to
control provided insufficient information to include in meta‐analyses. Three
trials were in children: one was conducted in daycare centres in Denmark
examining a multimodal hygiene programme (Ladegaard 1999), and two trials
compared a hand hygiene campaign or workshop in an elementary school environment
in Saudi Arabia, Alzaher 2018, and Egypt, Talaat 2011. Three trials tested
virucidal hand treatment in an experimental setting, Gwaltney 1980; Turner
2004a, and in a community, Turner 2012, in the USA. Feldman 2016 compared
hand‐washing with chlorhexidine gluconate amongst Israeli sailors. One trial
compared hand sanitiser packaged in a multimodal hygiene programme amongst
office employees in the USA (Arbogast 2016). Two trials were conducted in a
long‐term facility setting: one trial examined the effect of a bundle hand
hygiene programme on infectious risk in nursing home residents in France (Temime
2018), and the other trial compared the effect of using hand sanitisers in
healthcare workers on the rate of infections (including respiratory infections)
in nursing home residents in Hong Kong (Yeung 2011).
Five trials compared different hand hygiene interventions in a variety of
settings such as schools (Morton 2004 in kindergartens and elementary schools in
the USA; Priest 2014 in primary schools in New Zealand; and Pandejpong 2012 in
kindergartens in Thailand). One study was conducted in low‐income neighbourhoods
in Karachi, Pakistan (Luby 2005), and one was conducted in a workplace
environment in Finland (Savolainen‐Kopra 2012). A variety of interventions were
used across these trials such as soap and water (Luby 2005; Savolainen‐Kopra
2012), hand sanitiser (Morton 2004; Pandejpong 2012; Priest 2014;
Savolainen‐Kopra 2012), body wash (Luby 2005), and alcohol‐based hand wipes
(Morton 2004), with or without additional hygiene education. There was
considerable variation in interventions, and the information in the trial
reports was insufficient to permit meta‐analysis.
Seven trials compared a combined intervention of hand hygiene and face masks
with control. Four of these trials were carried out in households in Germany
(Suess 2012), Thailand (Simmerman 2011), Hispanic immigrant communities in the
USA (Larson 2010), and households in Hong Kong (Cowling 2009). Two trials were
conducted amongst university student residences (Aiello 2010; Aiello 2012), and
one trial in a group of pilgrims at the annual Hajj (Aelami 2015). Moreover, six
trials evaluated the incremental benefit of combining surgical mask in addition
to hand hygiene with soap, Simmerman 2011, hand sanitiser, Aiello 2010; Aiello
2012; Larson 2010; Suess 2012, or both, Cowling 2009, versus mask or hand
hygiene alone on the outcomes of ILI and influenza. Aelami 2015 investigated a
hygienic package (alcohol‐based handrub (gel or spray), surgical masks, soap,
and paper handkerchiefs) with a control group.
Seven trials compared a multimodal combination of hand hygiene and disinfection
of surfaces, toys, linen, or other components of the environment with a control
(Ban 2015; Carabin 1999; Ibfelt 2015; Kotch 1994; McConeghy 2017; Sandora 2008;
White 2001). Variation in scope and type of interventions and insufficient data
in trial reports precluded meta‐analysis. All studies except for one were in
children (McConeghy 2017 was in nursing population).
Three trials included in two papers investigated the role of virucidal
tissues in interrupting transmission of naturally occurring respiratory
infections in households (Farr 1988a; Farr 1988b; Longini 1988). Four
cluster‐RCTs implemented complex, multimodal sanitation, education, cooking, and
hygiene interventions (Chard 2019; Hartinger 2016; Huda 2012; Najnin 2019). All
four of these trials were conducted in low‐income countries in settings with
minimal to no access to basic sanitation.
Three trials assessed the effect of gargling on the incidence of upper
respiratory tract infections (URTIs) or influenza: gargling with povidone‐iodine
(Satomura 2005), green tea (Ide 2014), and tap water (Goodall 2014).
ONGOING STUDIES
We identified six ongoing studies. Two assess hand hygiene measures
(NCT03454009; NCT04267952), and four assess face
masks (NCT04471766; NCT04296643; NCT04337541; Wang 2015) one of which –
NCT04337541 ‐ published as this review update was going to press.
EXCLUDED STUDIES
We excluded a total of 160 studies. We identified 12 new studies for exclusion
at the data extraction stage of this 2020 update, all of which appeared to be
eligible at screening. Six of the 12 studies were ineligible due to only
reporting composite outcomes that included other infections besides those caused
by respiratory viruses (Azor‐Martinez 2014; Bowen 2007; Chami 2012; Denbak 2018;
Stedman‐Smith 2015; Vessey 2007); two trials measured absenteeism due to
non‐specific infection (Lennell 2008; Rosen 2006); one trial only had two
clusters (Nandrup‐Bus 2009); one study was not an RCT (Patel 2012); one study
evaluated a hand hygiene intervention that was antibacterial rather than
antiviral (Slayton 2016); and one study had no respiratory illness data for
extraction (Uhari 1999).
RISK OF BIAS IN INCLUDED STUDIES
The overall risk of bias is presented graphically in Figure 2 and summarised in
Figure 3. Details on risk of bias for the included studies are provided below.
Open in figure viewer
Figure 2
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'Risk of bias' graph: review authors' judgements about each risk of bias item
presented as percentages across all included trials.
Open in figure viewer
Figure 3
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'Risk of bias' summary: review authors' judgements about each risk of bias item
for each included trial.
ALLOCATION
For this 2020 review, information on sequence generation was overall poorly
reported in most of the newly included studies. Twenty‐one newly included
studies provided adequate information on randomisation scheme and were judged as
at low risk of bias (Aiello 2012; Azor‐Martinez 2016; Azor‐Martinez 2018; Biswas
2019; Canini 2010; Correa 2012; Goodall 2014; Ide 2014; MacIntyre 2015;
MacIntyre 2016; Millar 2016; Najnin 2019; Priest 2014; Radonovich 2019; Ram
2015; Simmerman 2011; Stebbins 2011; Suess 2012; Talaat 2011; Turner 2012; Zomer
2015). Nine studies described the use of computerised sequence generation
program/software (Aiello 2012; Azor‐Martinez 2018; Biswas 2019; Canini 2010;
Millar 2016; Najnin 2019; Radonovich 2019; Talaat 2011; Turner 2012). One study
used random number tables for sequence generation (Azor‐Martinez 2016). Three
studies described using the random function in Microsoft Excel (Correa 2012;
MacIntyre 2016; Suess 2012). Two studies used statistical software to generate a
randomisation allocation (MacIntyre 2015; Priest 2014). Two studies reported
using block randomisation: Ram 2015 used block randomisation, and an independent
investigator generated the list of random assignments, whilst Simmerman
2011 performed block randomisation. Stebbins 2011 used constrained
randomisation, and Zomer 2015 reported using stratified randomisation by means
of computer generation with a 1:1 ratio in each of the strata.
Fourteen studies reported insufficient information to permit a judgement on the
adequacy of the process to minimise selection bias (Aelami 2015; Alzaher 2018;
Arbogast 2016; Barasheed 2014; Chard 2019; DiVita 2011; Feldman 2016; Hubner
2010; Ibfelt 2015; McConeghy 2017; Miyaki 2011; Pandejpong 2012;
Savolainen‐Kopra 2012; Yeung 2011). Six studies provided some description about
sequence generation, but it was still unclear (Hartinger 2016; Huda 2012; Ide
2016; Little 2015; MacIntyre 2011; MacIntyre 2013). Huda 2012 mentioned random
number tables, but it was unclear if this was for random selection or
randomisation. Ide 2016 used computer‐generated randomisation, but the method
was not stated. Hartinger 2016 used covariate‐constrained randomisation, but the
method was not described. In Little 2015, participants were automatically
randomly assigned by the intervention software, but the sequence generation was
not described. Two studies used a secure computerised randomisation program
(MacIntyre 2011; MacIntyre 2013), but the sequence generation was not described.
Three of the newly included studies were poorly randomised (Ban 2015; Nicholson
2014; Temime 2018). Ban 2015 included only two clusters, and the randomisation
scheme was not reported. Nicholson 2014 used coin tossing, which can lead to a
large imbalance. Temime 2018 used “simple randomisation” with no further
description.
For the RCTs included in previous versions of the review, three were poorly
reported with no description of randomisation sequence or concealment
of allocation (Gwaltney 1980; Turner 2004a; Turner 2004b). The quality of the
cluster‐RCTs varied, with four studies not providing a description of the
randomisation procedure (Carabin 1999; Kotch 1994; Morton 2004; White 2001). We
rated seven studies as at low risk of bias for sequence generation (Cowling
2008; Cowling 2009; Luby 2005; Roberts 2000; Sandora 2005; Sandora
2008; Satomura 2005), and a further six studies as at unclear risk of bias (Farr
1988a; Farr 1988b; Ladegaard 1999; Loeb 2009; Longini 1988; MacIntyre 2009).
Many of the newly included cluster‐RCTs did not report adequately on allocation
concealment. Twenty‐one of these studies reported adequate allocation and were
judged as at low risk of bias (Aiello 2012; Alzaher 2018; Azor‐Martinez 2016;
Azor‐Martinez 2018; Biswas 2019; Canini 2010; Chard 2019; Goodall 2014; Ide
2014; Ide 2016; Little 2015; MacIntyre 2011; MacIntyre 2015; Nicholson 2014;
Priest 2014; Radonovich 2019; Ram 2015; Savolainen‐Kopra 2012; Stebbins 2011;
Suess 2012; Turner 2012). Aiello 2012 randomised all residence houses in each of
the residence halls prior to the intervention implementation. Alzaher
2018 allocated schools prior to all schoolgirls attending selected schools being
invited to participate. Azor‐Martinez 2016 allocated schools/classes prior to
children's recruitment. Azor‐Martinez 2018 assigned clusters prior to
recruitment. Biswas 2019 completed the allocation prior to individuals being
recruited. Chard 2019 allocated schools prior to individuals being
recruited. Goodall 2014 used opaque, sealed, serially numbered envelopes that
were only accessed when two study personnel were present. Ide 2014 also reported
using individual drawing of sealed, opaque envelopes to randomly assign
participants to the study groups. MacIntyre 2011 randomised hospitals prior to
inclusion of participants. In MacIntyre 2015, hospital wards were randomised
prior to recruitment of individuals. Nicholson 2014 used coin tossing to assign
communities to intervention or control arms. Radonovich 2019 used constrained
randomisation to resolve any potential imbalance between covariates between the
trial arms. Four studies reported the use of central randomisation: Canini
2010 used central randomisation employing an interactive voice response system;
Ide 2016 used central randomisation services; in Little 2015 participants were
automatically randomly assigned by the intervention software; and Ram
2015 described a central allocation through data collectors notifying the field
research officer, who consulted the block randomisation list to make the
assignment of the household compound to intervention or
control. Savolainen‐Kopra 2012 randomised clusters by matching prior to the
onset of the interventions. Four studies reported that allocation was assigned
by personnel (investigator, physician, or statistician) unaware of the
randomisation sequence (Priest 2014; Stebbins 2011; Suess 2012; Turner
2012). Twenty‐two studies reported insufficient information to permit a
judgement on the adequacy of the process to minimise selection bias (Aelami
2015; Arbogast 2016; Ban 2015; Barasheed 2014; Correa 2012; DiVita 2011; Feldman
2016; Hartinger 2016; Hubner 2010; Huda 2012; Ibfelt 2015; MacIntyre 2013;
McConeghy 2017; Millar 2016; Miyaki 2011; Najnin 2019; Pandejpong 2012;
Simmerman 2011; Talaat 2011; Temime 2018; Yeung 2011; Zomer 2015). Two studies
provided some information about allocation, but it was not enough to permit a
judgement on risk of bias (Barasheed 2014; Simmerman 2011). Barasheed
2014 randomised pilgrim tents using an independent study co‐ordinator who was
not an investigator, but did not describe how this was done. Simmerman
2011 described using a study co‐ordinator to assign households to study arm
(after consent was obtained). Only one of the newly added studies was judged as
at high risk of bias, where random assignment was allocated by doctors enrolling
the participants (MacIntyre 2016). Of the previously included RCTs, 14 provided
no or an insufficient description of concealment of allocation (Carabin
1999; Farr 1988a; Farr 1988b; Gwaltney 1980; Kotch 1994; Ladegaard 1999; Larson
2010; MacIntyre 2009; Morton 2004; Roberts 2000; Sandora 2008; Turner 2004a;
Turner 2004b; White 2001). We assessed all of the remaining studies as at low
risk of bias (Canini 2010; Cowling 2008; Cowling 2009; Loeb 2009; Longini 1988;
Luby 2005; Sandora 2005; Satomura 2005). Aiello 2010 used the drawing of a
uniform ticket with the name of each hall out of a container and was rated as at
high risk of bias.
BLINDING
Although blinding is less of a concern in cluster‐RCTs, the risk of bias is
substantial when the outcomes are subjective and the outcome assessor is not
blinded. We judged 26 studies to have a high risk of bias (Aiello 2012; Alzaher
2018; Arbogast 2016; Azor‐Martinez 2016; Azor‐Martinez 2018; Ban 2015; Biswas
2019; Carabin 1999; Chard 2019; Correa 2012; Cowling 2008; Ide 2014; Kotch 1994;
Ladegaard 1999; Little 2015; MacIntyre 2011; MacIntyre 2015; MacIntyre 2016;
McConeghy 2017; Najnin 2019; Nicholson 2014; Ram 2015; Sandora 2008;
Savolainen‐Kopra 2012; Temime 2018; Zomer 2015). We assessed five cluster‐RCTs
as at low risk of bias. Farr 1988a and Farr 1988b were double‐blinded studies
and were judged as at low risk of bias. MacIntyre 2013 and Simmerman
2011 reported laboratory‐confirmed influenza, and blinding would not have
affected the result. In Miyaki 2011 the self‐reported respiratory symptoms were
confirmed by a physician. We judged three cluster‐RCTs to have a low risk of
detection bias because the outcome was laboratory‐confirmed influenza, Barasheed
2014; Suess 2012, or physician‐confirmed ILI, Pandejpong 2012. Two cluster‐RCTs
provided insufficient data to judge the effect of non‐blinding. Talaat
2011 included outcomes that were both self‐reported ILI and laboratory‐confirmed
influenza. In Yeung 2011 the detection of cases was based on record for
hospitalisation related to infection (including pneumonia). Eleven cluster‐RCTs
were not blinded, but we judged the primary outcome to be unaffected by
non‐blinding. Seven trials reported laboratory‐confirmed influenza (Aiello
2012; Cowling 2009; Larson 2010; Loeb 2009; MacIntyre 2009; Millar 2016;
Stebbins 2011). Four studies reported self‐reported outcome (Canini 2010; Priest
2014; Roberts 2000; Sandora 2008), but outcome assessors were not aware of the
intervention assignment. Five RCTs were double‐blinded and were judged as at low
risk of bias (Goodall 2014; Ide 2016; Longini 1988; Luby 2005; White 2001),
whilst two studies were single‐blinded where investigators, Radonovich 2019, or
laboratory personnel, Turner 2012, were blinded. Four RCTs were not blinded and
were judged as at high risk of bias given the subjective nature of the outcome
assessed (Hubner 2010; Ibfelt 2015; Jacobs 2009; Satomura 2005). Turner
2004a and Turner 2004b were double‐blind studies, but insufficient information
was provided to assess risk of bias.
INCOMPLETE OUTCOME DATA
In this 2020 review, we assessed 26 newly included trials as having a low risk
of attrition bias, with sufficient evidence from the participant flow chart, and
explanation of loss to follow‐up (which was minimal) similar between groups
(Aiello 2012; Alzaher 2018; Arbogast 2016; Azor‐Martinez 2018; Barasheed 2014;
Canini 2010; Chard 2019; Correa 2012; Goodall 2014; Hartinger 2016; Hubner 2010;
Ide 2014; Ide 2016; MacIntyre 2011; MacIntyre 2013; MacIntyre 2015; MacIntyre
2016; Miyaki 2011; Pandejpong 2012; Radonovich 2019; Ram 2015; Simmerman 2011;
Suess 2012; Turner 2012; Yeung 2011; Zomer 2015). Seven studies did not report
sufficient information on incomplete data (attrition bias) (Aelami 2015; DiVita
2011; Feldman 2016; Hartinger 2016; Ibfelt 2015; McConeghy 2017; Priest 2014).
Twelve studies had a high risk of attrition bias (Azor‐Martinez 2016; Ban 2015;
Biswas 2019; Huda 2012; Little 2015; Millar 2016; Najnin 2019; Nicholson 2014;
Savolainen‐Kopra 2012; Stebbins 2011; Talaat 2011; Temime 2018). In
Azor‐Martinez 2016, attrition levels were high and differed between the two
groups. Ban 2015 did not report on reasons for loss to follow‐up. Biswas 2019
did not provide information on missing participants (28 children in the control
schools and two children in the intervention schools). Huda 2012 did not provide
a flow diagram of study participants. Little 2015 had high attrition that
differed between the two groups. Attrition in Millar 2016 differed amongst the
three groups. In addition, ARI cases were captured utilising clinic‐based
medical records for those participants who sought hospital care only. In Najnin
2019, there was high migration movement during the study, which could have
distorted the baseline characteristics even more. There was no description of
how such migration and changes in the intervention group were dealt with. In
Nicholson 2014, households were removed from the study if they provided no data
for five consecutive weeks. Although attrition was reported in Savolainen‐Kopra
2012, and 76% of volunteers who were recruited at the beginning of the reporting
period completed the study, new recruits were added during the study to replace
volunteers lost in most clusters. The total number of reporting participants at
the end of the trial was 626 (91.7%) compared to the beginning, meaning that
15.7% of participants were replaced during the study. In Stebbins 2011 reasons
for episodes of absence in 66% of the study participants were not reported.
Talaat 2011 did not provide a flow chart of clusters flow during the study
period and provided no information on withdrawal. Temime 2018 was greatly biased
due to underreporting of outcomes in the control groups. Furthermore, no study
flow chart was provided, and there was no reporting on any exclusions.
SELECTIVE REPORTING
In this 2020 review, 22 newly included studies reported all specified outcomes
and were judged as at low risk of reporting bias (Aiello 2012; Barasheed 2014;
Canini 2010; Chard 2019; Goodall 2014; Hartinger 2016; Ibfelt 2015; Ide 2016;
Little 2015; MacIntyre 2011; MacIntyre 2013; MacIntyre 2015; MacIntyre 2016;
Pandejpong 2012; Priest 2014; Radonovich 2019; Savolainen‐Kopra 2012; Simmerman
2011; Suess 2012; Temime 2018; Turner 2012; Zomer 2015). For 18 studies, it is
unlikely that other outcomes were measured and not reported, although no
protocol was available to assess reporting bias (Aelami 2015; Alzaher 2018;
Arbogast 2016; Azor‐Martinez 2016; Azor‐Martinez 2018; Ban 2015; Biswas 2019;
Correa 2012; DiVita 2011; Feldman 2016; Hubner 2010; Huda 2012; Ide 2014; Miyaki
2011; Nicholson 2014; Stebbins 2011; Talaat 2011; Yeung 2011). Three studies
were at high risk of reporting bias (McConeghy 2017; Millar 2016; Najnin 2019).
In McConeghy 2017, URTI was mentioned in the methods (the intervention
presumably would have targeted these), but only lower respiratory tract
infection (LRTI) and overall infection were reported. Millar 2016 was originally
conducted for another purpose; we could not find the respiratory outcomes
reported in the study as part of the original study protocol. In Najnin 2019,
the published study protocol did not include respiratory illness as an outcome.
OTHER POTENTIAL SOURCES OF BIAS
An additional consideration for cluster‐RCTs is identification/recruitment bias,
where individuals are recruited in the trial after clusters are randomised. Such
bias can introduce an imbalance amongst groups. Of the cluster‐RCTs included in
our 2020 review, we judged 13 to have a low risk of identification/recruitment
bias (Arbogast 2016; Biswas 2019; Canini 2010; Cowling 2008; Longini 1988; Luby
2005; MacIntyre 2015; MacIntyre 2016; Roberts 2000; Sandora 2005; Suess 2012;
Temime 2018; White 2001). In Arbogast 2016, all identified individuals (office
workers) were included in the assigned cluster. Schools were identified and then
randomised to the clusters; students were then randomly selected from each
classroom and school. Nine studies described identification of participants,
consenting/enrolling, and then randomising to the clusters (Canini 2010; Cowling
2008; Longini 1988; Luby 2005; MacIntyre 2015; MacIntyre 2016; Roberts 2000;
Sandora 2005; White 2001). Suess 2012 identified and consented patients, then
recruitment was performed by physicians unaware of cluster assignment. In Temime
2018, directors of the included nursing homes agreed to participate in the study
before randomisation, and written consent was not required from the
residents. We judged 11 cluster‐RCTs as at high risk of
identification/recruitment bias (Aiello 2010; Aiello 2012; Azor‐Martinez 2018;
Chard 2019; Correa 2012; Cowling 2009; Larson 2010; McConeghy 2017; Nicholson
2014; Priest 2014; Savolainen‐Kopra 2012). In Aiello 2010 and Aiello 2012,
recruitment continued for two weeks after start of the study, which could have
introduced bias. Six trials identified and recruited participants after cluster
randomisation (Azor‐Martinez 2018; Chard 2019; Cowling 2009; Larson 2010;
McConeghy 2017; Nicholson 2014). Three trials recruited new participants after
the start of the study to replace those lost to follow‐up (Correa 2012; Priest
2014; Savolainen‐Kopra 2012). We judged five cluster‐RCTs to have probable
identification/recruitment bias (Alzaher 2018; Barasheed 2014; MacIntyre 2011;
Najnin 2019; Radonovich 2019), whereas in 19 studies there were insufficient
details to permit a judgement of risk of bias (Carabin 1999; DiVita 2011;
Feldman 2016; Hartinger 2016; Huda 2012; Ibfelt 2015; Kotch 1994; Ladegaard
1999; MacIntyre 2009; MacIntyre 2013; Millar 2016; Miyaki 2011; Pandejpong 2012;
Radonovich 2019; Sandora 2008; Stebbins 2011; Talaat 2011; Yeung 2011; Zomer
2015).
Twenty‐six cluster‐RCTs reported intracluster correlation coefficient (ICC) to
adjust sample size, taking into consideration clustering effects, and described
adjusting outcomes for clustering effect using different statistical methods, or
provided justification for not performing adjusted analysis for clustering
(Aiello 2010; Aiello 2012; Arbogast 2016; Canini 2010; Carabin 1999; Correa
2012; Cowling 2008; Cowling 2009; Hartinger 2016; Huda 2012; Little 2015; Luby
2005; MacIntyre 2009; MacIntyre 2011; MacIntyre 2013; MacIntyre 2015; MacIntyre
2016; McConeghy 2017; Priest 2014; Radonovich 2019; Ram 2015; Roberts 2000;
Stebbins 2011; Suess 2012; Talaat 2011; Temime 2018). Five cluster‐RCTs did not
report the ICC but described adjusting outcomes for clustering effect using
different statistical methods, or explained why adjusted analysis for clustering
was not performed (Biswas 2019; Chard 2019; McConeghy 2017; Simmerman 2011;
Zomer 2015). Thirteen cluster‐RCTs provided insufficient details on ICC and/or
did not perform adjusted analysis or justified the absence of it (Alzaher 2018;
Azor‐Martinez 2016; Azor‐Martinez 2018; Barasheed 2014; Feldman 2016; Larson
2010; Millar 2016; Miyaki 2011; Najnin 2019; Nicholson 2014; Pandejpong 2012;
Savolainen‐Kopra 2012; Yeung 2011). Two cluster‐RCTs reported the ICC but did
not perform adjusted analysis or justified the absence of it (Sandora 2005;
Sandora 2008).
EFFECTS OF INTERVENTIONS
See: Summary of findings 1 Medical/surgical masks compared to no masks for
preventing the spread of viral respiratory illness; Summary of findings 2 N95
respirators compared to medical/surgical masks for preventing the spread of
viral respiratory illness; Summary of findings 3 Hand hygiene compared to
control for preventing the spread of viral respiratory illness
COMPARISON 1: MEDICAL/SURGICAL MASKS COMPARED TO NO MASKS
We included nine trials (eight of which were cluster‐RCTs) comparing
medical/surgical masks versus no masks (Aiello 2012; Barasheed 2014; Canini
2010; Cowling 2008; Jacobs 2009; MacIntyre 2009; MacIntyre 2015; MacIntyre 2016;
Suess 2012). Two trials were conducted with healthcare workers (HCWs) (Jacobs
2009; MacIntyre 2015), whilst the other seven studies included people living in
the community. All trials were conducted in non‐pandemic settings.
PRIMARY OUTCOMES
1. NUMBERS OF CASES OF VIRAL ILLNESS (INCLUDING ARIS, ILI, AND
LABORATORY‐CONFIRMED INFLUENZA)
Pooling of all nine trials found an estimate of effect for the outcomes of ILI
cases (risk ratio (RR) 0.99, 95% confidence interval (CI) 0.82 to 1.18;
low‐certainty evidence; Analysis 1.1) suggesting that wearing a medical/surgical
mask may make little or no difference for this outcome. Similarly, the estimate
of effect for laboratory‐confirmed influenza cases (RR 0.91, 95% CI 0.66 to
1.26; 6 trials; moderate‐certainty evidence; Analysis 1.1) suggests that wearing
a medical/surgical mask probably makes little or no difference compared to not
wearing a mask for this outcome. We downgraded the certainty of the evidence two
levels for ILI due to inconsistency of the effect across studies and wide CI of
the pooled effect. Sixty‐five per cent of the weight of the ILI analysis was
carried by one study (Aiello 2012).
A separate analysis of the two trials in healthcare workers for the outcome ILI
(RR 0.37, 95% CI 0.05 to 2.50; low‐certainty evidence; Analysis 1.2) suggests
that there is considerable uncertainty as to whether there is any benefit
(Jacobs 2009; MacIntyre 2015). The effect estimate was downgraded due to very
wide CI interval of the pooled effect.
The design of most trials assessed whether masks protected the wearer. Four
trials were cluster‐RCTs, with all participants in the intervention clusters
required to wear masks, thus assessing both source control and personal
protection. In two trials the clusters were households with a member with new
influenza; neither of these studies found any protective effect (RR 1.03 in 105
households (Canini 2010); RR 1.21 in 145 households (MacIntyre 2009)). In two
trials the clusters were college dormitories during the influenza season;
neither study found any reduction (RR 1.10 in 37 dormitories (Aiello 2012); RR
0.90 in three dormitories (Aiello 2010)). We excluded Aiello 2010 from the
meta‐analysis since we did not consider 'randomisation' of three clusters to
three arms to be a proper randomised trial.
2. ADVERSE EVENTS RELATED TO THE INTERVENTION
Canini 2010 reported that 38 (75%) of participants in the intervention arm
experienced discomfort with the mask use due to warmth (45%), respiratory
difficulties (33%), and humidity (33%). Children reported feeling pain more
frequently (3/12) than other participants wearing adult face masks (1/39; P =
0.04). In MacIntyre 2015, adverse events associated with face mask use were
reported in 40.4% (227/562) of HCWs in the medical‐mask arm. General discomfort
(35.1%; 397/1130) and breathing problems (18.3%; 207/1130) were the most
frequently reported adverse events. Suess 2012 reported that the majority of
participants (107/172; 62%) did not report any problems with mask‐wearing. More
adults reported no problems (71%) compared to children (36/72; 50%; P = 0.005).
The main issues when wearing a face mask for adults as well as for children were
"heat/humidity" (18/34; 53% of children; 10/29; 35% of adults; P = 0.1),
followed by "pain" and "shortness of breath". Cowling 2008 mentioned that no
adverse events were reported. The other trials did not report measuring adverse
outcomes.
SECONDARY OUTCOMES
1. DEATHS
Not reported.
2. SEVERITY OF VIRAL ILLNESS AS REPORTED IN THE STUDIES
Jacobs 2009 reported that participants in the mask group were significantly more
likely to experience more days with headache and feeling bad. They found no
significant differences between the two groups for symptom severity scores. None
of the other trials reported this outcome.
3. ABSENTEEISM
Not reported.
4. HOSPITAL ADMISSIONS
Not reported.
5. COMPLICATIONS RELATED TO THE ILLNESS (E.G. PNEUMONIA)
Not reported.
COMPARISON 2: N95/P2 RESPIRATORS COMPARED TO MEDICAL/SURGICAL MASKS
We included five trials comparing medical/surgical masks with N95/P2 respirators
(Loeb 2009; MacIntyre 2009; MacIntyre 2011; MacIntyre 2013; Radonovich 2019).
All of these trials except MacIntyre 2009 included HCWs. MacIntyre 2009 included
carers and household members of children with a respiratory illness recruited
from a paediatric outpatient department and a paediatric primary care practice
in Sydney, Australia.
PRIMARY OUTCOMES
1. NUMBERS OF CASES OF VIRAL ILLNESS (INCLUDING ARIS, ILI, AND
LABORATORY‐CONFIRMED INFLUENZA)
Pooling of three trials found an estimate of effect suggesting considerable
uncertainty as to whether an N95/P2 respirator provides any benefit compared to
medical/surgical masks for the outcome of clinical respiratory illness (RR 0.70,
95% CI 0.45 to 1.10; very low‐certainty evidence; Analysis 2.1) (MacIntyre 2011;
MacIntyre 2013 (2 arms); Radonovich 2019). Based on five trials conducted in
four healthcare settings and one household (Loeb 2009; MacIntyre 2009; MacIntyre
2011; MacIntyre 2013; Radonovich 2019), the estimates of effect for the outcome
of ILI (RR 0.82, 95% CI 0.66 to 1.03; low‐certainty evidence; Analysis 2.1)
suggest that N95/P2 respirators may make little or no difference for this
outcome. The estimate of the effect for the outcome of laboratory‐confirmed
influenza infection (RR 1.10, 95% CI 0.90 to 1.34; moderate‐certainty evidence;
Analysis 2.1) suggests that the use of a N95/P2 respirator compared to a
medical/surgical mask probably makes little or no difference for this more
precise and objective outcome. The outcomes clinical respiratory illness and ILI
were reported separately. Considering how these outcomes were defined, it is
highly likely that there was considerable overlap between the two, therefore
these outcomes were not combined into a single clinical outcome (Analysis 2.1).
The laboratory‐confirmed viral respiratory infection outcome included influenza
primarily but multiple other common viral respiratory pathogens were also
included in several studies. The laboratory‐confirmed viral infection outcome
was considered more precise and objective in comparison to the clinical
outcomes, which were more subjective and considered to be less precise. The
findings did not change when we restricted the evidence to HCWs (Analysis 2.2).
2. ADVERSE EVENTS RELATED TO THE INTERVENTION
Harms were poorly reported, but generally discomfort wearing medical/surgical
masks and N95/P32 respirators was mentioned in several studies. Radonovich 2019
mentioned that participants wearing the N95 respirator reported skin irritation
and worsening of acne. MacIntyre 2011 reported that adverse events were more
common with N95 respirators; in particular, discomfort was reported in 41.9% of
N95 wearers versus 9.8% of medical‐mask wearers (P < 0.01); headaches were more
common with N95 (13.4% versus 3.9%; P < 0.01); difficulty breathing was reported
more often in the N95 group (19.4% versus 12.5%; P = 0.01); and N95 caused more
problems with pressure on the nose (52.2% versus 11.0%; P < 0.01). In MacIntyre
2013, fewer participants using the N95 respirator reported problems (38%
(195/512) versus 48% (274/571) of participants in the medical‐mask arm; P =
0.001). Loeb 2009 mentioned that no adverse events were reported.
The one trial conducted in the community mentioned that more than 50% of
participants reported concerns with both types of masks, mainly that wearing
them was uncomfortable, but there were no significant differences between the P2
(N95) and surgical‐mask groups (MacIntyre 2009).
SECONDARY OUTCOMES
1. DEATHS
Not reported.
2. SEVERITY OF VIRAL ILLNESS AS REPORTED IN THE STUDIES
Not reported.
3. ABSENTEEISM
Loeb 2009 reported that 42 participants (19.8%) in the surgical‐mask group
reported an episode of work‐related absenteeism compared with 39 (18.6%) of
participants in the N95 respiratory group (absolute risk difference −1.24%, 95%
CI −8.75% to 6.27%; P = 0.75).
4. HOSPITAL ADMISSIONS
Not reported.
5. COMPLICATIONS RELATED TO THE ILLNESS (E.G. PNEUMONIA)
Loeb 2009 reported that there were no episodes of LRTIs.
COMPARISON 3: HAND HYGIENE COMPARED TO CONTROL
Sixteen trials compared hand hygiene interventions with control and provided
sufficient data to include in meta‐analyses (Azor‐Martinez 2018; Biswas 2019;
Correa 2012; Cowling 2008; Cowling 2009; Hubner 2010; Larson 2010; Little 2015;
Millar 2016; Nicholson 2014; Ram 2015; Roberts 2000; Sandora 2005; Simmerman
2011; Stebbins 2011; Zomer 2015). The populations of these studies included
adults, children, and families, in settings such as schools, childcare centres,
homes, and offices. None of the studies was conducted during a pandemic,
although a few studies were conducted during peak influenza seasons. A further
16 trials comparing hand hygiene to a control had other outcomes or insufficient
information to include in meta‐analyses (Alzaher 2018; Arbogast 2016;
Azor‐Martinez 2016; DiVita 2011; Feldman 2016; Gwaltney 1980; Ladegaard 1999;
Luby 2005; Morton 2004; Priest 2014; Savolainen‐Kopra 2012; Talaat 2011; Temime
2018; Turner 2012; White 2001; Yeung 2011). The results of these trials were
consistent with the findings of our meta‐analyses. The results for all outcomes
from the 16 trials that were meta‐analysed and the 16 trials that were not
meta‐analysed are shown in Table 2.
Open in table viewer
Table 2. Results from trials of hand hygiene compared to control
Study
Comparison (see Table 1 for details of interventions)
Reported outcomes
Results
Alzaher 2018
cluster‐RCT
Saudi Arabia
Hand‐washing workshop and posters vs usual practice
% absence days due to URI
0.39% and 0.72% in intervention group schools; 0.86% and 1.39% in control
schools
Arbogast 2016
cluster‐RCT
USA
Hand sanitiser + wipes + hand foam vs none
Both groups received education + signage about hand‐washing
1. Health insurance claims for preventable illnesses per employee
2. Absences per employee
1. 0.30 claims in intervention; 0.37 in control (27% relative reduction; P =
0.03)
2. 1.45 in intervention; 1.53 in control (5.0% relative reduction in
intervention; P = 0.30)
Azor‐Martinez 2016
RCT
Spain
Hand‐washing with soap and water plus hand sanitiser vs usual hand‐washing
practices
% absence days due to URI
1.15% in intervention; 1.68% in control. Significantly lower in intervention (P
< 0.001)
Azor‐Martinez 2018
cluster‐RCT
Spain
Education and hand hygiene with soap and water vs hand hygiene with sanitiser vs
usual hand‐washing procedures
1. URI incidence rate ratio (primary)
2. Percentage difference in absenteeism days
1. HH soap vs control 0.94 (95% CI 0.82 to 1.08); HH sanitiser vs control 0.77
(95% CI 0.68 to 0.88); HH soap vs HH sanitiser 1.21 (95% CI 1.06 to 1.39)
2. HH soap 3.9% vs control 4.2% (P < 0.001); HH sanitiser 3.25% vs control 4.2%
(P = 0.026); HH soap 3.9% vs HH sanitiser 3.25% (P < 0.001)
Biswas 2019
cluster‐RCT
Bangladesh
Hand sanitiser and respiratory hygiene education and cough/sneeze hygiene vs no
intervention
1. ILI incidence rate (at least 1 episode)
2. Laboratory‐confirmed influenza
1. 22 per 1000 student‐weeks in intervention; 27 per 1000 student‐weeks in
control, not statistically significantly different
2. 3 per 1000 student‐weeks in intervention; 6 per 1000 student‐weeks in
control, P = 0.01
Correa 2012
cluster‐RCT
Colombia
Alcohol‐based hand sanitiser in addition to hand‐washing vs usual hand‐washing
practice
ARIs in 3rd trimester of follow‐up
Hazard ratio for intervention to control 0.69 (95% CI 0.57 to 0.83)
Cowling 2008
cluster‐RCT
Hong Kong
Hand hygiene (36 households) vs face mask (mask) vs education (control)
Secondary attack rate for:
1. laboratory‐confirmed influenza;
2. ILI definition 1;
3. ILI definition 2;
4. ILI definition 3.
1. HH 0.06; mask 0.07; control 0.06
2. HH 0.18; mask 0.18; control 0.18
3. HH 0.11; mask 0.10; control 0.11
4. HH 0.04; mask 0.08; control 0.04
Cowling 2009
cluster‐RCT
Hong Kong
Hand hygiene (HH) vs face mask + hand hygiene (HH + mask) vs education (control)
Secondary attack rate for:
1. laboratory‐confirmed influenza;
2. ILI definition 1;
3. ILI definition 2.
1. HH 5; HH + mask 7; control 10
2. HH 16; HH + mask 21; control 19
3. HH 4; HH + mask 7; control 5
DiVita 2011 (conference abstract)
RCT
Bangladesh
Hand‐washing stations with soap and motivation vs none
1. SAR for laboratory‐confirmed influenza
2. SAR for ILI
1. SAR higher in intervention group (11.0% vs 7.5%)
2. SAR higher in intervention group (14.2% vs 11.9%)
Feldman 2016
cluster‐RCT
Israel
Hand disinfection + soap and water installed vs none
1. Number of respiratory infections
2. Number of off‐duty days
1. 11 in each group
2. 112 in intervention; 104 in control
Gwaltney 1980
RCT
USA
Virucidal hand wash vs placebo
1. Number with illness after immediate exposure
2. Number with illness after 2‐hour delay in exposure
1. 0 of 8 in intervention; 7 of 7 in control
2. 1 of 10 in intervention; 6 of 10 in control
Hubner 2010
RCT
Germany
Hand disinfection provided vs none
Odds ratios (95% CI) (intervention:control)
1. Influenza
2. Common cold
3. Sinusitis
4. Sore throat
5. Fever
6. Cough
1. 1.02 (0.20 to 5.23)
2. 0.35 (0.17 to 0.71)
3. 1.87 (0.52 to 6.74)
4. 0.62 (0.31 to 1.25)
5. 0.38 (0.14 to 0.99)
6. 0.45 (0.22 to 0.91)
Ladegaard 1999
RCT
Denmark
Hand hygiene and education vs none
Sick days during the "effect period"
22 days/child in the intervention group vs 36 days/child in the control group
Larson 2010
cluster‐RCT
USA
Education vs education with alcohol‐based hand sanitiser vs education with hand
sanitiser and face masks
Incidence rate ratios (episodes per 1000 person‐weeks) for:
1. URI;
2. ILI;
3. influenza;
Secondary attack rates for:
4. URI/ILI/influenza;
5. ILI/influenza.
1. HS 29; HS + masks 39; control 35
2. HS 1.9; HS + masks 1.6; control 2.3
3. HS 0.6; HS + masks 0.5; control 2.3
4. HS 0.14; HS + masks 0.12; control 0.14
5. HS 0.02; HS + masks 0.02; control 0.02
Little 2015
RCT
England
Bespoke automated web‐based hand hygiene motivational intervention with tailored
feedback vs none
Number of participants with 1 or more episodes of URI
Risk ratio for intervention to control 0.86 (95% CI 0.83 to 0.89; P < 0.001)
Luby 2005
RCT
Pakistan
Antibacterial soap and education about hand‐washing vs plain soap and education
vs none
1. Cough or difficulty breathing in children < 15 yrs (episodes/100
person‐weeks)
2. Congestion or coryza in children < 15 yrs (episodes/100 person‐weeks)
3. Pneumonia in children < 5 yrs (episodes/100 person‐weeks)
All outcomes significantly lower than control
1. 4.21 in antibacterial soap group; 4.16 in plain soap group; 8.50 in control
group
2. 7.32 in antibacterial soap group; 6.87 in plain soap group; 14.78 in control
group
3. 2.42 in antibacterial soap group; 2.20 in plain soap group; 4.40 in control
group
Millar 2016
cluster‐RCT
USA
Standard educational promotion of hand‐washing vs enhanced promotion vs
promotion plus a once‐weekly application of chlorhexidine‐based body wash
Incidence rates of ARI over 20 months
37.7 enhanced + body wash; 29.3 enhanced; 35.3 standard; RR for enhanced + body
wash to standard 1.07 (95% CI 1.03 to 1.11); RR for enhanced to enhanced + body
wash 0.78 (95% CI 0.75 to 0.81)
Morton 2004
cluster‐RCT
Cross‐over study
USA
Alcohol gel plus education vs regular hand‐washing
Absence due to infectious illness
Results not stated numerically
Nicholson 2014
cluster‐RCT
India
Combination hand‐washing promotion with provision of free soap vs none
Target children:
1. Episodes of ARI (per 100 person‐weeks)
2. School absence episodes (per 100 person‐days)
Families:
3. Episodes of ARI
1. 16 in intervention; 19 in control
2. 1.2 in intervention; 1.7 in control
3. 10 in intervention; 11 in control
Priest 2014
cluster‐RCT
New Zealand
Hand hygiene education and hand sanitiser vs education alone
1. % absence days due to respiratory illness
2. % absence days due to any illness
1. 0.84% in intervention group; 0.80% in control (P = 0.44)
2. 1.21% in intervention group; 1.16% in control (P = 0.35)
Ram 2015
RCT
Bangladesh
Education to promote intensive hand‐washing in households plus soap provision vs
none
1. Secondary attack ratio for intervention to control for ILI
2. Laboratory‐confirmed influenza
1. 1.24 (95% CI 0.93 to 1.65)
2. 2.40 (95% CI 0.68 to 8.47)
Roberts 2000
cluster‐RCT
Australia
Hand‐washing programme with training for staff and children vs none
Incidence rate ratio for ARI
IRR 0.92 for intervention to control (95% CI 0.86 to 0.99)
Sandora 2008
cluster‐RCT
USA
Hand sanitiser and education vs none
Incidence rates for ARI (episodes per person‐month)
0.43 in intervention; 0.42 in control
Savolainen‐Kopra 2012
cluster‐RCT
Finland
Hand hygiene with soap and water (IR1 group) vs with alcohol‐based hand rub (IR2
group) vs control (none); intervention groups also received education
1. Number of respiratory infection episodes/week
2. Number of reported infection episodes/week
3. Number of reported sick leave episodes/week
1. 0.076 in IR1; 0.085 in IR2; 0.080 in control, NS
2. 0.097 in IR1; 0.107 in IR2; 0.104 in control, NS
3. 0.042 in IR1; 0.035 in IR2; 0.035 in control. Significantly higher in IR1
compared with control
Simmerman 2011
cluster‐RCT
Thailand
Hand‐washing (HW) vs handwashing plus paper surgical face masks (HW + FM) vs
control (none)
Odds ratios for secondary attack rates for influenza
OR for HW: control 1.20 (95% CI 0.76 to 1.88)
OR for HW + masks: control 1.16 (95% CI 0.74 to 1.82)
OR for HW + masks: HW 0.72 (95% CI 0.21 to 2.48)
Stebbins 2011
cluster‐RCT
USA
Training in hand and respiratory (cough) hygiene + hand sanitiser vs none
Incidence rate ratios for intervention to control for:
1. laboratory‐confirmed influenza (RT‐PCR);
2. influenza‐A;
3. absence.
1. IRR 0.81 (95% CI 0.54 to 1.23)
2. IRR 0.48 (95% CI 0.26 to 0.87)
3. IRR 0.74 (95% CI 0.56 to 0.97)
Talaat 2011
cluster‐RCT
Egypt
Mandatory hand‐washing intervention + education vs none
1. Number of absence days due to ILI
2. Number of absence days
1. 917 in intervention; 1671 in control (P < 0.001)
2. 13,247 in intervention; 19,094 in control (P < 0.001)
Temime 2018
cluster‐RCT
France
Hand hygiene with alcohol‐based hand rub, promotion, staff education, and local
work groups vs none
Incidence rate of ARI clusters (5 or more people in same nursing home)
2 ARI clusters in intervention; 1 in control
Turner 2012
RCT
USA
Antiviral hand treatment vs no treatment
1. Number of rhinovirus infections
2. Common cold infections
3. Rhinovirus‐associated illnesses
1. 49 in intervention; 49 in control, NS
2. 56 in intervention; 72 in control, NS
3. 26 in intervention; 24 in control, NS
White 2001
DB‐RCT
USA
Hand rub with benzalkonium chloride (hand sanitiser) vs placebo
ARI symptoms
Laboratory: testing of virucidal and bactericidal activity of the product
30% to 38% decrease of illness and absenteeism (RR for illness absence incidence
0.69; RR for absence duration 0.71)
Yeung 2011
cluster‐RCT
Hong Kong
Alcohol‐based hand gel + materials + education vs control (basic life support
workshop)
Difference between pre‐study period and poststudy in pneumonia infections
recorded in residents
0.63/1000 reduction in intervention group; 0.16/1000 increase in control
Zomer 2015
cluster‐RCT
Netherlands
4 components:
1. Hand hygiene products, paper towel dispensers, soap, alcohol‐based hand
sanitiser, and hand cream provided for 6 months
2. Training and booklet
3. 2 team training sessions aimed at hand hygiene improvement
4. Posters and stickers for caregivers and children as reminders
Combination vs usual practice
Incidence rate ratio for intervention to control for common cold
IRR 1.07 (95% CI 0.97 to 1.19)
8.2 episodes per child‐year in intervention; 7.4 episodes per child‐year in
control
ARI: acute respiratory infection
CI: confidence interval
cluster‐RCT: cluster‐randomised controlled trial
DB‐RCT: double‐blind randomised controlled trial
HH: hand hygiene
HS: hand sanitiser
HW: hand‐washing
ILI: influenza‐like illness
IRR: incidence rate ratio
NS: non‐significant
OR: odds ratio
RCT: randomised controlled trial
RR: risk ratio
RT‐PCR: reverse‐transcriptase polymerase chain reaction
SAR: secondary attack rate
URI: upper respiratory infection
yrs: years
PRIMARY OUTCOMES
1. NUMBERS OF CASES OF VIRAL ILLNESS (INCLUDING ARIS, ILI, AND
LABORATORY‐CONFIRMED INFLUENZA)
Pooling of seven trials for the broad outcome of ARI showed a 16% relative
reduction in the numbers of participants with ARI (RR 0.84, 95% CI 0.82 to 0.86;
moderate‐certainty evidence; Analysis 3.1.1) in the hand hygiene group (Analysis
3.1), suggesting a probable benefit (Azor‐Martinez 2018; Correa 2012; Larson
2010; Little 2015; Millar 2016; Nicholson 2014; Sandora 2005). When considering
the more strictly defined outcomes of ILI, Biswas 2019; Cowling 2008; Cowling
2009; Hubner 2010; Larson 2010; Little 2015; Ram 2015; Roberts 2000; Simmerman
2011; Zomer 2015, and laboratory‐confirmed influenza, Biswas 2019; Cowling 2008;
Cowling 2009; Hubner 2010; Larson 2010; Ram 2015; Simmerman 2011; Stebbins 2011,
the estimates of the effect were heterogeneous, suggesting that hand hygiene
made little or no difference (RR 0.98, 95% CI 0.85 to 1.13 for ILI;
low‐certainty evidence; Analysis 3.1.2) (RR 0.91, 95% CI 0.63 to 1.30 for
laboratory‐confirmed influenza; low‐certainty evidence; Analysis 3.1.3)
(Analysis 3.1). All 16 trials could be pooled for analysis of the composite
outcome ‘ARI or ILI or influenza’, with each study only contributing once with
the most comprehensive outcome (in terms of number of events) reported showing
an 11% relative reduction in participants with a respiratory illness, suggesting
that hand hygiene may offer a benefit (RR 0.89, 95% CI 0.84 to 0.95;
low‐certainty evidence; Analysis 3.2), but with high heterogeneity. In a
sensitivity analysis we used only the most precise and unequivocal (with
laboratory confirmed considered the most precise and an undefined ARI considered
the least precise) outcome reported in each of 11 studies identified by JMC, an
infectious disease physician, and found an estimate of effect in favour of hand
hygiene, but with wider CIs (RR 0.92, 95% CI 0.80 to 1.05; Analysis 3.3).
We considered that studies in children might have a different effect than
studies in adults, so we conducted subgroup analysis by age group. We found no
evidence of a difference in treatment effect by age group (P = 0.21; Analysis
3.4).
2. ADVERSE EVENTS RELATED TO THE INTERVENTION
Correa 2012 reported that no adverse events were observed; in the study by
Priest 2014, skin reaction was recorded for 10.4% of participants in the hand
sanitiser group versus 10.3% in the control group (RR 1.01, 95% CI 0.78 to
1.30).
SECONDARY OUTCOMES
1. DEATHS
Not reported.
2. SEVERITY OF VIRAL ILLNESS AS REPORTED IN THE STUDIES
Not reported.
3. ABSENTEEISM
Three trials measured absenteeism from school or work and demonstrated a 36%
relative reduction in the numbers of participants with absence in the hand
hygiene group (RR 0.64, 95% CI 0.58 to 0.71; Analysis 3.5) (Azor‐Martinez 2016;
Hubner 2010; Nicholson 2014).
4. HOSPITAL ADMISSIONS
Not reported.
5. COMPLICATIONS RELATED TO THE ILLNESS (E.G. PNEUMONIA)
Not reported.
COMPARISON 4: HAND HYGIENE + MEDICAL/SURGICAL MASKS COMPARED TO CONTROL
PRIMARY OUTCOMES
1. NUMBERS OF CASES OF VIRAL ILLNESS (INCLUDING ARIS, ILI, AND
LABORATORY‐CONFIRMED INFLUENZA)
Six trials (Aelami 2015; Aiello 2012; Cowling 2009; Larson 2010; Simmerman 2011;
Suess 2012) were able to be pooled to compare the use of the combination of hand
hygiene and medical/surgical masks with control. Four of these trials were in
households, two in university student residences, and one at the annual Hajj
pilgrimage. For both outcomes (ILI and influenza), pooling demonstrated an
estimate of effect suggesting little or no difference between the hand hygiene
and medical/surgical mask combination and control. The number of trials and
events was lower than for comparisons of hand hygiene alone, or medical/surgical
masks alone, and the confidence interval was wide. For ILI, the RR for
intervention compared to control was 1.03 (95% CI 0.77 to 1.37; Analysis 4.1.1),
and for influenza it was 0.97 (95% CI 0.69 to 1.36; Analysis 4.1.2) (Analysis
4.1). Full results of these trials are shown in Table 3
Open in table viewer
Table 3. Results from trials of hand hygiene + medical/surgical masks compared
to control
Study
Comparison (see Table 1 for details of interventions)
Reported outcomes
Results
Aelami 2015 (conference abstract)
RCT
Saudi Arabia
Hand hygiene education + alcohol‐based hand rub + soap + surgical masks vs none
Proportion with ILI (defined as presence of ≥ 2 of the following during their
stay: fever, cough, and sore throat)
52% in intervention; 55.3% in control (P < 0.001)
Aiello 2010
cluster‐RCT
USA
Face mask use (FM) vs face masks + hand hygiene (FM + HH) vs control
Note that this study is not included in meta‐analysis as each treatment group
included only 1 cluster.
1. ILI
2. Laboratory‐confirmed influenza A or B
Significant reduction in ILI cases in both intervention groups compared with
control over weeks 3 to 6
No significant differences between FM and FM + HH
Aiello 2012
cluster‐RCT
USA
Face mask use (FM) vs face masks + hand hygiene (FM + HH) vs control
1. Clinical ILI
2. Laboratory‐confirmed influenza A or B
1. Non‐significant reductions in FM group compared with control over all weeks.
Significant reduction in FM + HH group compared with control in weeks 3 to 6
2. Non‐significant reductions in both intervention groups compared with control
Cowling 2009
cluster‐RCT
Hong Kong
Hand hygiene (HH) vs hand hygiene plus face masks (HH + mask) vs control
Secondary attack ratio for:
1. laboratory‐confirmed influenza;
2. ILI definition 1;
3. ILI definition 2.
1. HH 5; HH + mask 7; control 10
2. HH 16; HH + mask 21; control 19
3. HH 4; HH + mask 7; control 5
Larson 2010
cluster‐RCT
USA
Education (control) vs education with alcohol‐based hand sanitiser (HS) vs
education + HS + face masks (HS + mask)
Incidence rate ratios (episodes per 1000 person‐weeks) for:
1. URI;
2. ILI;
3. influenza.
Secondary attack rates for:
4. URI/ILI/influenza;
5. ILI/influenza.
1. HS 29; HS + mask 39; control 35
2. HS 1.9; HS + mask 1.6; control 2.3
3. HS 0.6; HS + mask 0.5; control 2.3
4. HS 0.14; HS + mask 0.12; control 0.14
5. HS 0.02; HS + mask 0.02; control 0.02
Simmerman 2011
cluster‐RCT
Thailand
Control vs hand‐washing (HW) vs hand‐washing + paper surgical face masks (HW +
mask)
Odds ratio for secondary attack rates for influenza
OR for HW: control 1.20 (95% CI 0.76 to 1.88)
OR for HW + mask: control 1.16 (95% CI 0.74 to 1.82)
OR for HW + mask: HW 0.72 (95% CI 0.21 to 2.48)
Suess 2012
cluster‐RCT
Germany
Face mask + hand hygiene (mask + HH) vs face masks only (mask) vs none (control)
Secondary attack rates in household contacts:
1. Laboratory‐confirmed influenza
2. ILI
1. Mask 9; mask + HH 15; control 23
2. Mask 9; mask + HH 9; control 17
CI: confidence interval
cluster‐RCT: cluster‐randomised controlled trial
FM: face mask
HH: hand hygiene
HS: hand sanitiser
HW: hand‐washing
ILI: influenza‐like illness
OR: odds ratio
RCT: randomised controlled trial
URI: upper respiratory infection
2. ADVERSE EVENTS RELATED TO THE INTERVENTION
Adverse events related to mask wearing in the study by Suess 2012 are reported
under Comparison 1 (medical/surgical masks). There was no mention of adverse
events related to hand hygiene.
SECONDARY OUTCOMES
1. DEATHS
Not reported.
2. SEVERITY OF VIRAL ILLNESS AS REPORTED IN THE STUDIES
Not reported.
3. ABSENTEEISM
Not reported.
4. HOSPITAL ADMISSIONS
Not reported.
5. COMPLICATIONS RELATED TO THE ILLNESS, E.G. PNEUMONIA
Not reported.
COMPARISON 5: HAND HYGIENE + MEDICAL/SURGICAL MASKS COMPARED TO HAND HYGIENE
PRIMARY OUTCOMES
1. NUMBERS OF CASES OF VIRAL ILLNESS (INCLUDING ARIS, ILI AND
LABORATORY‐CONFIRMED INFLUENZA)
Three trials studied the addition of medical/surgical masks to hand hygiene
(Cowling 2009; Larson 2010; Simmerman 2011). All three trials had three arms,
and are also included in the comparison of hand hygiene plus medical/surgical
mask versus control (Comparison 4). All three studies showed no difference
between hand hygiene plus medical/surgical mask groups and hand hygiene alone,
for all outcomes. The estimates of effect suggested little or no difference when
adding masks to hand hygiene compared to hand hygiene alone: for the outcome ILI
(RR 1.03, 95% CI 0.69 to 1.53; 3 trials) and the outcome laboratory‐confirmed
influenza (RR 0.99, 95% CI 0.69 to 1.44), the estimates of effect were not
different and the CIs were relatively wide, suggesting little or no difference
(Analysis 5.1). However, the CIs around the estimates were wide and do not rule
out an important benefit.
2. ADVERSE EVENTS RELATED TO THE INTERVENTION
Not reported.
SECONDARY OUTCOMES
1. DEATHS
Not reported.
2. SEVERITY OF VIRAL ILLNESS AS REPORTED IN THE STUDIES
Not reported.
3. ABSENTEEISM
Not reported.
4. HOSPITAL ADMISSIONS
Not reported.
5. COMPLICATIONS RELATED TO THE ILLNESS (E.G. PNEUMONIA)
Not reported.
COMPARISON 6: MEDICAL/SURGICAL MASKS COMPARED TO OTHER (NON‐N95) MASKS
One trial compared medical/surgical masks with cloth masks in hospital
healthcare workers (MacIntyre 2015), and another trial compared catechin‐treated
masks versus control masks in healthcare workers and staff of hospitals,
rehabilitation centres, and nursing homes in Japan (Ide 2016).
PRIMARY OUTCOMES
1. NUMBERS OF CASES OF VIRAL ILLNESS (INCLUDING ARIS, ILI, AND
LABORATORY‐CONFIRMED INFLUENZA)
MacIntyre 2015 found that the rate of ILI was higher in the cloth mask arm
compared to the medical/surgical masks arm (RR 13.25, 95% CI 1.74 to 100.97).
Ide 2016 did not find a benefit from the catechin‐treated masks over untreated
masks on influenza infection rates (adjusted odds ratio (OR) 2.35, 95% CI 0.40
to 13.72; P = 0.34).
2. ADVERSE EVENTS RELATED TO THE INTERVENTION
In MacIntyre 2015 adverse events associated with face mask use were reported in
40.4% (227/562) of HCWs in the medical/surgical mask arm and 42.6% (242/568) in
the cloth mask arm (P = 0.45). The most frequently reported adverse events were
general discomfort (35.1%; 397/1130) and breathing problems (18.3%; 207/1130).
Laboratory tests showed the penetration of particles through the cloth masks to
be very high (97%) compared with medical/surgical masks (44%). Ide 2016 reported
that there were no serious adverse events associated with the intervention.
SECONDARY OUTCOMES
1. DEATHS
Not reported.
2. SEVERITY OF VIRAL ILLNESS AS REPORTED IN THE STUDIES
Not reported.
3. ABSENTEEISM
Not reported.
4. HOSPITAL ADMISSIONS
Not reported.
5. COMPLICATIONS RELATED TO THE ILLNESS (E.G. PNEUMONIA)
Not reported.
COMPARISON 7: SOAP + WATER COMPARED TO SANITISER, AND COMPARISONS OF DIFFERENT
TYPES OF SANITISER
Two trials compared soap and water with sanitiser (Azor‐Martinez 2018;
Savolainen‐Kopra 2012). Another trial compared different types of hand sanitiser
in a virus challenge study (Turner 2004a; Turner 2004b), and one trial studied
the frequency of use of hand sanitiser (Pandejpong 2012). The full results of
these four trials are shown in Table 4.
Open in table viewer
Table 4. Results from trials of soap + water compared to hand sanitisers
Study
Comparison (see Table 1 for details of interventions)
Reported outcomes
Results
Azor‐Martinez 2018
cluster‐RCT
Spain
Education and hand hygiene with soap and water (HH soap) vs hand hygiene with
sanitiser (HH sanitiser) vs usual hand‐washing procedures
1. URI incidence rate ratio (primary)
2. Percentage difference in absenteeism days
1: HH soap vs control 0.94 (95% CI 0.82 to 1.08); HH sanitiser vs control 0.77
(95% CI 0.68 to 0.88); HH soap vs HH sanitiser 1.21 (95% CI 1.06 to 1.39)
2: HH soap 3.9% vs control 4.2% (P < 0.001); HH sanitiser 3.25% vs control 4.2%
(P = 0.026); HH soap 3.9% vs HH sanitiser 3.25% (P < 0.001)
Pandejpong 2012
cluster‐RCT
Thailand
Alcohol hand gel applied every 60 minutes vs every 120 minutes vs once before
lunch (3 groups).
Absent days due to confirmed ILI/present days
0.017 in every hour group; 0.025 in every 2 hours group; 0.026 in before lunch
group. Statistically significant difference between every hour group and before
lunch group, and between every hour and every 2 hours groups
Savolainen‐Kopra 2012
cluster‐RCT
Finland
Hand hygiene with soap and water (IR1 group) vs with alcohol‐based hand rub (IR2
group) vs control (none); intervention groups also received education
1. Number of respiratory infection episodes/week
2. Number of reported infection episodes/week
3. Number of reported sick leave episodes/week
1. 0.076 in IR1; 0.085 in IR2; 0.080 in control, NS
2: 0.097 in IR1; 0.107 in IR2; 0.104 in control, NS
3: 0.042 in IR1; 0.035 in IR2; 0.035 in control. Significantly higher in IR1
compared with control
Turner 2004a and Turner 2004b
RCT
Canada
Study 1. Ethanol vs salicylic acid 3.5% vs salicylic acid 1% and pyroglutamic
acid 3.5%
Study 2. Skin cleanser wipe vs ethanol (control)
% of volunteers infected with rhinovirus
7% in each intervention group; 32% in control (study 1)
22% in intervention, 30% in control (study 2)
CI: confidence interval
cluster‐RCT: cluster‐randomised controlled trial
HH: hand hygiene
ILI: influenza‐like illness
NS: non‐significant
RCT: randomised controlled trial
URI: upper respiratory infection
PRIMARY OUTCOMES
1. NUMBERS OF CASES OF VIRAL ILLNESS (INCLUDING ARIS, ILI, AND
LABORATORY‐CONFIRMED INFLUENZA)
In the trial by Azor‐Martinez 2018, ARI incidence was significantly higher in
the soap‐and‐water group compared with the hand sanitiser group (rate ratio
1.21, 95% CI 1.06 to 1.39). In contrast, there was no significant difference
between interventions in Savolainen‐Kopra 2012. In the rhinovirus challenge
study (Turner 2004a; Turner 2004b), all hand sanitisers tested led to a
significant lowering of infection rates, but no differences between sanitisers
were observed. The study sample size was small.
2. ADVERSE EVENTS RELATED TO THE INTERVENTION
Two trials stated that no adverse events were observed (Pandejpong 2012;
Savolainen‐Kopra 2012).
SECONDARY OUTCOMES
1. DEATHS
Not reported.
2. SEVERITY OF VIRAL ILLNESS AS REPORTED IN THE STUDIES
Not reported.
3. ABSENTEEISM
The authors of Azor‐Martinez 2018 also observed a significant benefit for hand
sanitiser in reduction in days absent, whereas there was no difference between
intervention groups in the Savolainen‐Kopra 2012 trial. The study on frequency
of use of sanitiser found that use of sanitiser every hour significantly reduced
days absent compared with use every two hours or with use only before the lunch
break (Pandejpong 2012).
4. HOSPITAL ADMISSIONS
Not reported.
5. COMPLICATIONS RELATED TO THE ILLNESS (E.G. PNEUMONIA)
Not reported.
COMPARISON 8: SURFACE/OBJECT DISINFECTION (WITH OR WITHOUT HAND HYGIENE)
COMPARED TO CONTROL
PRIMARY OUTCOMES
1. NUMBERS OF CASES OF VIRAL ILLNESS (INCLUDING ARIS, ILI, AND
LABORATORY‐CONFIRMED INFLUENZA)
Six trials contributed data to this comparison (Ban 2015; Carabin 1999; Ibfelt
2015; Kotch 1994; McConeghy 2017; Sandora 2008). Full results of these trials
are shown in Table 5. Five of the six trials combined disinfection with other
interventions such as hand hygiene education, provision of hand hygiene
products, and audits. Ban 2015 utilised a combination of provision of hand
hygiene products, and cleaning and disinfection of surfaces, and demonstrated a
significant reduction in ARI in the intervention group (OR 0.47, 95% CI 0.48 to
0.65). A similar result was seen in Carabin 1999, with a significant reduction
in episodes of ARI. Two studies tested multicomponent interventions and observed
no significant difference in ARI outcomes (Kotch 1994; McConeghy 2017).
Open in table viewer
Table 5. Results from trials of surface/object disinfection (with or without
hand hygiene) compared to control
Study
Comparison (see Table 1 for details of interventions)
Reported outcomes
Results
Ban 2015
cluster‐RCT
China
Hand hygiene products, surface cleaning and disinfection provided to families
and kindergartens vs none
1. Respiratory illness
2. Cough and expectoration
1. OR 0.47 for intervention to control (95% CI 0.38 to 0.59)
2. OR 0.56 (95% CI 0.48 to 0.65)
Carabin 1999
cluster‐RCT
Canada
One‐off hygiene education and disinfection of toys with bleach vs none
Difference in incidence rate for URTI (cluster‐level result)
0.28 episodes per 100 child‐days lower in intervention group (95% CI 1.65 lower
to 1.08 higher); URTI incidence rate IRR 0.80 (95% CI 0.68 to 0.93)
Ibfelt 2015
cluster‐RCT
Denmark
Disinfectant washing of linen and toys by commercial company every 2 weeks vs
usual care
Presence of respiratory viruses on surfaces
Statistically significant reduction in intervention group in adenovirus,
rhinovirus, RSV, metapneumovirus, but not other viruses including coronavirus
Kotch 1994
RCT
USA
Training in hand‐washing and diapering and disinfection of surfaces vs none
Respiratory illness incidence rate in:
1. children < 24 months;
2. children >= 24 months.
1. 14.78 episodes per child‐year in intervention; 15.66 in control
2. 12.87 in intervention; 11.77 in control
McConeghy 2017
RCT
USA
Staff education, cleaning products, and audit of compliance and feedback vs none
Infection rates
Upper respiratory infections not reliably recorded or reported.
Sandora 2008
cluster‐RCT
USA
Hand sanitiser and disinfection of classroom surfaces vs materials about good
nutrition (control)
Absence due to respiratory illness (multivariable analysis)
Rate ratio 1.10 for intervention to control (95% CI 0.97 to 1.24)
CI: confidence interval
cluster‐RCT: cluster‐randomised controlled trial
IRR: incident rate ratio
OR: odds ratio
RCT: randomised controlled trial
RSV: respiratory syncytial virus
URTI: upper respiratory tract infection
One trial compared disinfection alone to usual care (Ibfelt 2015). This study
demonstrated a significant reduction in some viruses detected on surfaces in the
childcare centres (adenovirus, rhinovirus, respiratory syncytial virus (RSV),
and metapneumovirus), but not in other viruses, including coronavirus.
2. ADVERSE EVENTS RELATED TO THE INTERVENTION
Not reported.
SECONDARY OUTCOMES
1. DEATHS
Not reported.
2. SEVERITY OF VIRAL ILLNESS AS REPORTED IN THE STUDIES
Not reported.
3. ABSENTEEISM
Only one study measured this outcome (Sandora 2008), observing no significant
difference between groups for the outcome of absence due to respiratory illness
(rate ratio for intervention to control 1.10, 95% CI 0.97 to 1.24).
4. HOSPITAL ADMISSIONS
Not reported.
5. COMPLICATIONS RELATED TO THE ILLNESS (E.G. PNEUMONIA)
Not reported.
COMPARISON 9: COMPLEX INTERVENTIONS COMPARED TO CONTROL
Complex interventions are either multifaceted environmental programmes (such as
those in low‐income countries) or combined interventions including hygiene
measures and gloves, gowns, and masks.
Four trials studied complex hygiene and sanitation interventions in low‐income
country settings (Chard 2019; Hartinger 2016; Huda 2012; Najnin 2019). Full
results from these studies are given in Table 6.
Open in table viewer
Table 6. Results from trials of complex interventions compared to control
Study
Comparison (see Table 1 for details of interventions)
Reported outcomes
Results
Complex hygiene and sanitation interventions compared to control
Chard 2019
cluster‐RCT
Laos
Complex sanitation intervention and education vs none
Pupil‐reported symptoms of respiratory infection over 1 week
NS difference between groups. 29% of intervention group; 32% control
group; adjusted risk ratio 1.08 (95% CI 0.95 to 1.23)
Hartinger 2016
cluster‐RCT
Peru
Cooking and sanitation provision and education vs none
Number of ARI episodes per child‐year
NS difference between groups. Risk ratio for intervention to control 0.95 (95%
CI 0.82 to 1.10)
Huda 2012
cluster‐RCT
Bangladesh
Sanitation provision and education vs none
Respiratory illness
12.6% in intervention group; 13.0% in control group. Not adjusted for multiple
outcome measurements. No CIs reported.
Najnin 2019
cluster‐RCT
Bangladesh
Sanitation and behaviour change intervention (plus cholera vaccine) vs none
Respiratory illness in past 2 days
2.8% in intervention group; 2.9% in control group
ARI: acute respiratory infection
CI: confidence interval
cluster‐RCT: cluster‐randomised controlled trial
NS: non‐significant
RCT: randomised controlled trial
PRIMARY OUTCOMES
1. NUMBERS OF CASES OF VIRAL ILLNESS (INCLUDING ARIS, ILI, AND
LABORATORY‐CONFIRMED INFLUENZA)
All four trials of complex interventions observed no significant differences
between groups in rates of viral respiratory illness.
2. ADVERSE EVENTS RELATED TO THE INTERVENTION
Not reported
SECONDARY OUTCOMES
1. DEATHS
Not reported.
2. SEVERITY OF VIRAL ILLNESS AS REPORTED IN THE STUDIES
Not reported.
3. ABSENTEEISM
Not reported.
4. HOSPITAL ADMISSIONS
Not reported.
5. COMPLICATIONS RELATED TO THE ILLNESS (E.G. PNEUMONIA)
Not reported.
COMPARISON 10: PHYSICAL DISTANCING/QUARANTINE COMPARED TO CONTROL
We found one quasi‐cluster‐RCT assessing the effectiveness of quarantining
workers of one of two sibling companies in Japan whose family members developed
an ILI during the 2009 to 2010 H1N1 influenza pandemic (Miyaki 2011). Workers in
the intervention group were asked to stay home on full pay until five days after
the household member(s) showed resolution of symptoms or two days after
alleviation of fever.
PRIMARY OUTCOMES
1. NUMBERS OF CASES OF VIRAL ILLNESS (INCLUDING ARIS, ILI, AND
LABORATORY‐CONFIRMED INFLUENZA)
Compliance with the intervention was 100%. In the intervention group 2.75% of
workers contracted influenza, compared with 3.18% in the control group (Cox
hazard ratio 0.799, 95% CI 0.66 to 0.97; P = 0.02), indicating that the rate
of infection was reduced by 20% in the intervention group. However, the risk of
a worker being infected was 2.17‐fold higher in the intervention group where
workers stayed at home with their infected family members. The authors concluded
that quarantining workers who have infected household members could be a useful
additional measure to control the spread of respiratory viruses in an epidemic
setting.
2. ADVERSE EVENTS RELATED TO THE INTERVENTION
Not reported.
SECONDARY OUTCOMES
1. DEATHS
Not reported.
2. SEVERITY OF VIRAL ILLNESS AS REPORTED IN THE STUDIES
Not reported.
3. ABSENTEEISM
Not reported.
4. HOSPITAL ADMISSIONS
Not reported.
5. COMPLICATIONS RELATED TO THE ILLNESS (E.G. PNEUMONIA)
Not reported.
COMPARISON 11: EYE PROTECTION COMPARED TO CONTROL
We did not find any randomised studies investigating the effect of eye
protection compared to control.
COMPARISON 12: GARGLING COMPARED TO CONTROL
Three trials investigated the effect of gargling. Satomura 2005 compared throat
gargling with povidone‐iodine versus tap water in healthy adults. Ide 2014
compared gargling with green tea versus tap water in high school students, and
Goodall 2014 compared gargling with tap water with no gargling in university
students.
PRIMARY OUTCOMES
1. NUMBERS OF CASES OF VIRAL ILLNESS (INCLUDING ARIS, ILI, AND
LABORATORY‐CONFIRMED INFLUENZA)
Satomura 2005 reported that gargling with tap water reduced the incidence of
URTIs compared to the control group (usual care) (hazard ratio (HR) 0.60, 95% CI
0.39 to 0.95). Gargling with povidone‐iodine did not reduce the incidence of
URTIs compared to the control group (HR 0.88, 95% CI 0.58 to 1.34).
Goodall 2014 found no difference in laboratory‐confirmed URTIs between the
gargling (tap water) and no‐gargling groups (RR for gargling versus no gargling
0.82, 95% CI 0.53 to 1.26; P = 0.36).
In a meta‐analysis of gargling versus control based on two trials (Goodall 2014;
Satomura 2005), the pooled estimate of effect suggested little or no difference
for the outcome of clinical URTI due to gargling (RR 0.91, 95% CI 0.63 to 1.31;
Analysis 6.1).
There was no difference in the incidence of laboratory‐confirmed influenza
between high school students gargling with green tea compared with those using
tap water (adjusted OR 0.69, 95% CI 0.37 to 1.28; P = 0.24) (Ide 2014). There
was also no difference in the incidence of clinically defined influenza
(adjusted OR 0.75, 95% CI 0.50 to 1.13; P = 0.17). However, the authors reported
that adherence to the interventions amongst students was low.
2. ADVERSE EVENTS RELATED TO THE INTERVENTION
Satomura 2005 reported no adverse events during the 60‐day intervention period.
Ide 2014 also did not observe any adverse events during the study. Goodall 2014
did not report on adverse effects.
SECONDARY OUTCOMES
1. DEATHS
Not reported.
2. SEVERITY OF VIRAL ILLNESS AS REPORTED IN THE STUDIES
Satomura 2005 reported that the mean peak score in bronchial symptoms was lower
in the water gargling group (0.97) than in the povidone‐iodine gargling group
(1.41) and the control group (1.40), P = 0.055. Other symptoms were not
significantly different between groups. Goodall 2014 reported that symptom
severity was greater in the gargling group for clinical and laboratory‐confirmed
URTI, but this was not statistically significant (225.3 versus 191.8, and 210.5
versus 191.8, respectively). Ide 2014 did not report symptom or illness
severity.
3. ABSENTEEISM
Not reported.
4. HOSPITAL ADMISSIONS
Not reported.
5. COMPLICATIONS RELATED TO THE ILLNESS (E.G. PNEUMONIA)
Not reported.
COMPARISON 13: VIRUCIDAL TISSUES COMPARED TO CONTROL
Two reports (three trials) conducted in the USA studied the effect of virucidal
tissues (Farr 1988a; Farr 1988b; Longini 1988). Full results from these studies
are given in Table 7.
Open in table viewer
Table 7. Results from trials of virucidal tissues compared to control
Study
Comparison
Reported outcomes
Results
Virucidal tissues compared with placebo or no tissues
Farr 1988a and Farr 1988b
cluster‐RCT
USA Trial 1 and Trial 2
Trial 1. Virucidal nasal tissues vs placebo vs none
Trial 2. Virucidal nasal tissues vs placebo
Respiratory illnesses per person over 24 weeks
Trial 1
Trial 2
Trial 1: 3.4 in tissues group; 3.9 in placebo group; 3.6 in no‐tissues group
Trial 2: 3.4 in tissues group; 3.6 in placebo group
NS
Longini 1988
DB‐PC RCT
USA
Virucidal nasal tissues vs placebo
Secondary attack rate of viral infections (number of infections in household
members of index case)
10.0 in intervention; 14.3 in placebo; NS
cluster‐RCT: cluster‐randomised controlled trial
DB‐PC: double‐blind, placebo‐controlled
NS: non‐significant
RCT: randomised controlled trial
vs: versus
PRIMARY OUTCOMES
1. NUMBERS OF CASES OF VIRAL ILLNESS (INCLUDING ARIS, ILI, AND
LABORATORY‐CONFIRMED INFLUENZA)
The three trials of virucidal tissues reported no differences in infection rates
between tissues and placebo, and between tissues and no tissues (Farr 1988a;
Farr 1988b; Longini 1988).
2. ADVERSE EVENTS RELATED TO THE INTERVENTION
Farr 1988b reported cough in 4% of participants using virucidal tissues versus
57% in the placebo group, but 24% reported nasal burning in the virucidal tissue
group versus 8% in the placebo group. Longini 1988 did not report on adverse
effects.
SECONDARY OUTCOMES
1. DEATHS
Not reported.
2. SEVERITY OF VIRAL ILLNESS AS REPORTED IN THE STUDIES
Not reported.
3. ABSENTEEISM
Not reported.
4. HOSPITAL ADMISSIONS
Not reported.
5. COMPLICATIONS RELATED TO THE ILLNESS (E.G. PNEUMONIA)
Not reported.
DISCUSSION
SUMMARY OF MAIN RESULTS
See Table 8.
Open in table viewer
Table 8. Summary of main results of the review for the primary outcomes
Interventions
RCT/cluster‐RCT (N = 67)
Medical/surgical masks
Masks (medical/surgical) compared to no masks
9 trials no effect on ILI (RR 0.99, 0.82 to 1.18) (Aiello 2010; Barasheed 2014;
Canini 2010; Cowling 2008; Jacobs 2009; MacIntyre 2009; MacIntyre 2015;
MacIntyre 2016; Suess 2012); 6 trials no effect on laboratory‐confirmed
influenza 95% CI RR 0.84 (0.61 to 1.17) (Aiello 2012; Cowling 2008; MacIntyre
2009; MacIntyre 2015; MacIntyre 2016; Suess 2012); 2 trials in HCWs no effect on
ILI (RR 0.37, 0.05 to 2.50) (Jacobs 2009; MacIntyre 2015).
Medical/surgical masks vs other (non‐N95) masks: 1 trial more ILI with cloth
mask (RR 13.25, 1.74 to 100.97) (MacIntyre 2015); 1 trial no effect of
catechin‐treated masks on influenza (adjusted OR 2.35, 0.40 to 13.72) (Ide
2016).
N95 respirator
N95 respirators compared to medical/surgical masks
3 trials no difference for clinical respiratory illness (RR 0.70, 0.45 to 1.10)
(MacIntyre 2011; MacIntyre 2013; Radonovich 2019);
4 trials no difference for ILI (95% CI RR 0.81, 0.62 to 1.05) (Loeb 2009;
MacIntyre 2009; MacIntyre 2011; Radonovich 2019); 4 trials no difference for
laboratory‐confirmed influenza (95% CI RR 1.06, 0.81 to 1.38) (Loeb 2009;
MacIntyre 2009; MacIntyre 2011; Radonovich 2019).
4 studies conducted in HCWs, 3 trials no difference for clinical respiratory
illness (RR 0.70, 0.45 to 1.10) (MacIntyre 2011; MacIntyre 2013; Radonovich
2019); 3 trials no difference for ILI (RR 0.64, 0.32 to 1.31) (Loeb 2009;
MacIntyre 2011; Radonovich 2019); 3 trials no difference for
laboratory‐confirmed ILI (RR 1.02, 0.73 to 1.43) (Loeb 2009; MacIntyre 2011;
Radonovich 2019).
Hand hygiene
Hand hygiene compared to control
16 trials found effect on combined outcome (ARI or ILI or influenza) (RR 0.89,
0.84 to 0.95) (Azor‐Martinez 2018; Biswas 2019; Correa 2012; Cowling 2008;
Cowling 2009; Hubner 2010; Larson 2010; Little 2015; Millar 2016; Nicholson
2014; Ram 2015; Roberts 2000; Sandora 2005; Simmerman 2011; Stebbins 2011; Zomer
2015); 7 trials effect on ARI (RR 0.84, 0.82 to 0.86) (Azor‐Martinez 2018;
Correa 2012; Larson 2010; Little 2015; Millar 2016; Nicholson 2014; Sandora
2005); 10 trials no effect on ILI (RR 0.98, 0.85 to 1.13) (Biswas 2019; Cowling
2008; Cowling 2009; Hubner 2010; Larson 2010; Little 2015; Ram 2015; Roberts
2000; Simmerman 2011; Zomer 2015); 8 trials no effect on laboratory‐confirmed
influenza (RR 0.91, 95% CI 0.63 to 1.30) (Biswas 2019; Cowling 2008; Cowling
2009; Hubner 2010; Larson 2010; Ram 2015; Simmerman 2011; Stebbins 2011)
Hand hygiene + medical/surgical masks
Hand hygiene + medical/surgical masks compared to control
7 trials no effect on ILI (95% CI RR 0.97, 0.80 to 1.19) (Aelami 2015; Aiello
2010; Aiello 2012; Cowling 2009; Larson 2010; Simmerman 2011; Suess 2012); 4
trials no effect on laboratory‐confirmed influenza (RR 0.97, 0.69 to 1.36)
(Cowling 2009; Larson 2010; Simmerman 2011; Suess 2012).
Hand hygiene + medical/surgical masks compared to hand hygiene
3 trials no effect on ILI (RR 1.03, 0.69 to 1.53) or laboratory‐confirmed
influenza (RR 0.99, 0.69 to 1.44) (Cowling 2009; Larson 2010; Simmerman 2011).
Soap + water compared to sanitiser, and comparisons of different types of
sanitiser
Soap + water compared to sanitiser, and comparisons of different types of
sanitiser
1 trial hand sanitiser was more effective than soap and water (Azor‐Martinez
2018); 1 trial there was no difference (Savolainen‐Kopra 2012).
2 trials in children antiseptic was more effective (Morton 2004; White 2001); 1
trial in children antiseptic = soap (Luby 2005).
1 trial hand sanitisers were better than placebo, but no difference between
sanitisers (Turner 2004a); 1 trial no difference between different wipes (Turner
2004b).
Surface/object disinfection (with or without hand hygiene) compared to control
Surface/object disinfection compared to control
2 trials were effective on ARI (Ban 2015; Carabin 1999); 1 trial was effective
for viruses detected on surface (Ibfelt 2015); 2 trials showed no difference in
ARIs (Kotch 1994; McConeghy 2017).
Disinfection of living quarters
‐
Complex interventions
Complex interventions compared to control
4 trials in low‐income countries found no effect on respiratory viral illness
(Chard 2019; Hartinger 2016; Huda 2012; Najnin 2019).
Physical interventions (masks, gloves, gowns combined)
‐
Gloves
‐
Gowns
‐
Physical distancing
‐
Quarantine in the community
Quarantine compared to control
1 trial effective for influenza (Cox hazard ratio 0.799, 95% CI 0.66 to 0.97)
(Miyaki 2011).
Eye protection
‐
Gargling
Gargling compared to control
1 trial gargling with tap water was effective, povidone‐iodine was not effective
(Satomura 2005); 1 trial gargling with green tea was not more effective than tap
water (Ide 2014); 1 trial gargling with water was not effective (Goodall 2014);
pooling of 2 trials no effect of gargling (RR 0.91, 95% CI 0.63 to 1.31)
(Goodall 2014; Satomura 2005).
Virucidal tissues
Virucidal tissues compared to control
1 trial had a small effect (Farr 1988a) ("The study authors conclude that
virucidal tissues have only a small impact upon the overall rate of natural
acute respiratory illnesses"); 2 trials non‐significant difference (Farr 1988b;
Longini 1988).
Nose wash
‐
ARI: acute respiratory infection
CI: confidence interval
HCW: healthcare worker
ILI: influenza‐like illness
OR: odds ratio
RCT: randomised controlled trial
RR: risk ratio
1. MEDICAL/SURGICAL MASKS COMPARED TO NO MASKS
The pooled estimates of effect from RCTs and cluster‐RCTs for wearing
medical/surgical masks compared to no masks suggests little or no difference in
interrupting the spread of ILI (RR 0.99, 95% CI 0.82 to 1.18; low‐certainty
evidence) or laboratory‐confirmed influenza (RR 0.91, 95% CI 0.66 to 1.26;
moderate‐certainty evidence) in the combined analysis of all populations from
the included trials. We found similar results for ILI in HCWs (RR 0.37, 95% CI
0.05 to 2.50; very low‐certainty evidence). Four trials were cluster‐RCTs, with
all participants in the intervention clusters required to wear masks, thus
assessing both source control and personal protection. In two trials the
clusters were households with a member with new influenza; neither trial found
any protective effect (RR 1.03 in 105 households (Canini 2010); RR 1.21 in 145
households (MacIntyre 2009)). In two trials the clusters were college
dormitories during the influenza season; neither trial found any reduction (RR
1.10 in 37 dormitories (Aiello 2012); RR 0.90 in three dormitories (Aiello
2010)). We excluded Aiello 2010 from meta‐analysis since we did not consider
'randomisation' of three clusters to three arms was a proper randomised trial.
Less than half of the trials comparing masks with no masks addressed harms of
mask wearing (Canini 2010; Cowling 2008; MacIntyre 2015; Suess 2012). Warmth,
respiratory difficulties, humidity, and general discomfort were the most
frequently reported adverse events. More adults reported no harms compared to
children.
In one trial (MacIntyre 2015), cloth masks were associated with a significantly
higher risk of both ILI and laboratory‐confirmed respiratory virus infection in
HCWs. In addition, filtration capacity of the two‐ply cotton cloth masks was
found to be only 3% and markedly less than with surgical masks based on
standardised particle testing. The authors suggested moisture retention, poor
filtration, and penetration of the virus through the mask as plausible
explanations for the increased risk of infection.
We did not find any randomised trials assessing the effectiveness of barrier
interventions using a combination of masks, gloves, and gowns.
2. N95 RESPIRATORS COMPARED TO MEDICAL/SURGICAL MASKS
Comparisons between N95 respirators and surgical masks for the outcomes of
clinical respiratory illness and the outcome of laboratory‐confirmed influenza
showed estimates of effect suggesting considerable uncertainty for any benefit
for the former outcome and probably little or no difference for the latter
outcome. Five trials (four in healthcare settings and one in a household
setting) compared N95/P2 respirators with surgical masks. Pooling of three of
these trials showed an estimate of effect suggesting considerable uncertainty as
to whether there was any benefit comparing N95 respirators and medical/surgical
face masks for the outcome of clinical respiratory illness (RR 0.70, 95% CI
0.45 to 1.10; very low‐certainty evidence), and that N95 respirators may make
little or no difference for the outcome ILI (RR 0.82, 95% CI 0.66 to 1.03;
low‐certainty evidence) and probably little or no difference for the outcome
laboratory‐confirmed influenza (RR 1.10, 95% CI 0.90 to 1.34; moderate‐certainty
evidence). The presence of imprecision (wide confidence intervals) and
heterogeneity, particularly for the more subjective and less precise outcomes of
clinical respiratory illness and ILI compared to laboratory‐confirmed influenza
infection, makes it difficult to assess whether there may be a benefit of either
medical/surgical masks or N95/P2 respirators. Restricting the pooling to HCWs
made no difference to the overall findings. The two trials with the largest
event rates were quite consistent in their findings of no significant
differences between N95 and surgical masks for the outcomes laboratory‐confirmed
influenza and all laboratory‐confirmed viral infections (Loeb 2009; Radonovich
2019). Three of the trials contributing to this analysis were carried out by
members of the same group (MacIntyre 2009; MacIntyre 2011; MacIntyre 2013).
In general, harms were poorly reported or not reported at all in trials
comparing N95 respirators with surgical masks. General discomfort resulting in
reduced wear compliance was the most frequently reported harm.
3. HAND HYGIENE COMPARED TO CONTROL
We found that the estimate of effect may offer a benefit for hand hygiene for
the composite outcome 'ARI or ILI or influenza' (RR 0.89, 95% CI 0.84 to 0.95;
low‐certainty evidence), and probably offers a benefit for the outcomes ARI
alone (RR 0.84, 95% CI 0.82 to 0.86; moderate‐certainty evidence) and
absenteeism (RR 0.64, 95% CI 0.58 to 0.71). An observed estimate of effect in
favour of hand hygiene for laboratory‐confirmed influenza but with wider CIs may
be a consequence of smaller sample sizes in conjunction with a more rigorous
outcome measure.
4. HAND HYGIENE + MEDICAL/SURGICAL MASKS COMPARED TO CONTROL
The estimate of effect of combined hand hygiene and mask interventions compared
to control in six (mostly small) trials suggested that the intervention may make
little or no difference for the outcomes ILI (RR 1.03, 95% CI 0.77 to 1.37) and
laboratory‐confirmed influenza (four trials) (RR 0.97, 95% CI 0.69 to 1.36).
5. HAND HYGIENE + MEDICAL/SURGICAL MASKS COMPARED TO HAND HYGIENE
We also found an estimate of effect suggesting that adding masks to hand hygiene
compared to hand hygiene alone may make little or no difference for the outcomes
ILI (RR 1.03, 95% CI 0.69 to 1.53; 3 trials) and laboratory‐confirmed influenza
(RR 0.99, 95% CI 0.69 to 1.44).
6. MEDICAL/SURGICAL MASKS COMPARED TO OTHER (NON‐N95) MASKS
One trial found that medical/surgical masks were more effective than cloth masks
at reducing the rate of ILI (RR 13.25, 95% CI 1.74 to 100.97) (MacIntyre 2015),
but the extremely wide CIs make this finding difficult to interpret. One trial
did not find a benefit from catechin‐treated masks over untreated masks on
influenza infection rates (adjusted OR 2.35, 95% CI 0.40 to 13.72; P = 0.34)
(Ide 2016).
Harms of wearing masks were reported in 40.4% of HCWs using medical/surgical
masks, and in 42.6% of those wearing cloth masks (P = 0.45) (MacIntyre 2015).
The penetration of particles was higher in cloth masks (97%) compared to
medical/surgical masks (44%).
7. SOAP + WATER COMPARED TO SANITISER, AND COMPARISONS OF DIFFERENT TYPES OF
SANITISER
There were too few trials comparing different types of hand hygiene
interventions to be certain of any true differences between soap and water,
alcohol‐based hand sanitisers, or other types of interventions. Also, it is
uncertain whether the incremental effect of adding virucidals or antiseptics to
hand‐washing actually decreased the respiratory disease burden outside the
confines of the rather atypical studies. The extra benefit may have been, at
least in part, accrued by confounding additional routines.
8. SURFACE/OBJECT DISINFECTION (WITH OR WITHOUT HAND HYGIENE) COMPARED TO
CONTROL
We identified six trials on surface/object disinfection (with or without hand
hygiene), and although they were heterogeneous (and therefore could not be
pooled), three of them showed a clear benefit compared to controls (Ban 2015;
Carabin 1999; Ibfelt 2015).
We found no RCTs with nose disinfection, or disinfection of living quarters as
described in observational studies reported in Jefferson 2011.
9. COMPLEX INTERVENTIONS COMPARED TO CONTROL
Four trials studied complex hygiene and sanitation interventions, all in
low‐income country settings (Chard 2019; Hartinger 2016; Huda 2012; Najnin
2019). These trials could not be pooled due to the heterogeneity of the
interventions and settings. All four trials found no significant differences
between groups in the rates of viral respiratory illness.
10. PHYSICAL DISTANCING/QUARANTINE COMPARED TO CONTROL
A disappointing finding was the lack of proper evaluation of global and highly
resource‐intensive measures such as screening at entry ports and physical
distancing. We identified only one trial that evaluated the effect of quarantine
(Miyaki 2011), and found a reduction in influenza transmission to co‐workers
when those with infected household members stayed home from work. However,
staying home increased their risk of being infected two‐fold.
11. EYE PROTECTION COMPARED TO CONTROL
We did not find any trials assessing the effectiveness and safety of eye
protection.
12. GARGLING COMPARED TO CONTROL
Three trials addressed the use of gargling in preventing respiratory infections
(Goodall 2014; Ide 2014; Satomura 2005). Although the trials used a variety of
liquids and different outcomes, pooling the results of the two trials
that compared gargling with tap water versus control did not show a favourable
effect in reducing URTIs (RR 0.91, 95% CI 0.63 to 1.31) (Goodall 2014; Satomura
2005).
13. VIRUCIDAL TISSUES COMPARED TO CONTROL
Two reports (three trials) identified in Jefferson 2011 studied the effect of
virucidal tissues compared to placebo or no tissues (Farr 1988a; Farr 1988b;
Longini 1988). These trials found no differences in infection rates and could
not be pooled.
OVERALL COMPLETENESS AND APPLICABILITY OF EVIDENCE
Several features need consideration before making generalisations based on the
included studies.
The settings of the included studies, which were conducted over four decades,
were heterogeneous and ranged from suburban schools, Carabin 1999, to emergency
departments, intensive care units, and paediatric wards, Loeb 2009, in
high‐income countries; slums in low‐income countries (Luby 2005); and an upper
Manhattan immigrant Latino neighbourhood (Larson 2010). Few attempts were made
to obtain socio‐economic diversity by (for example) involving more schools in
the evaluations of the same programme. We identified only a few studies from
low‐income countries, where the vast majority of the burden of ARIs lies and
where inexpensive interventions are so critical. Additionally, limited
availability of over‐the‐counter medications and national universal
comprehensive health insurance provided with consequent physician prescription
of symptomatic treatment may further limit the generalisability of findings.
The included trials generally reported few events and were conducted mostly
during non‐epidemic periods. The large study by Radonovich 2019 is an exception
as it crossed over two of the highest reporting years for influenza in the USA
between 2010 and 2017 (Elflein 2019). None of the trials were conducted during a
pandemic such as SARS‐CoV‐1, SARS‐CoV‐2, or Middle East respiratory syndrome
(MERS).
Of the trials assessing the effect of masks, six were carried out in those at
greater exposure (i.e. HCWs) (Jacobs 2009; Loeb 2009; MacIntyre 2011; MacIntyre
2013; MacIntyre 2015; Radonovich 2019). None of these studies included HCWs
undertaking aerosol‐generating procedures, for which the World Health
Organization (WHO) currently recommends the N95 or equivalent mask. Three trials
on hand hygiene interventions were carried out in nursing homes, and included
HCWs (McConeghy 2017; Temime 2018; Yeung 2011). The scarcity of RCTs on HCWs
limits the generalisability of such results.
The variable quality of the methods of some studies is striking. Incomplete or
no reporting of randomisation (Turner 2004a), blinding (Farr 1988a; Farr 1988b),
numerators and denominators (Carabin 1999; Kotch 1994), interventions, and
cluster coefficients in the relevant trials (Carabin 1999), led to a
considerable loss of information. Potential biases were often not discussed.
Inappropriate placebos caused design problems. In some studies the placebo
probably carried sufficient effect to dilute the intervention effects (Longini
1988). Two valiant attempts with virucidal tissues probably failed because
placebo handkerchiefs were impregnated with a dummy compound that stung the
users' nostrils (Farr 1988a; Farr 1988b).
Some studies used impractical interventions. Volunteers subjected to the
intervention hand cleaner (organic acids) were not allowed to use their hands
between cleaning and virus challenge, so the effect of normal use of the hands
on the intervention remains unknown (Turner 2004a; Turner 2004b). Two per cent
aqueous iodine painted on the hands, although a successful antiviral
intervention, causes unacceptable cosmetic staining, which is impractical for
all but those at the highest risk of epidemic contagion (Gwaltney 1980).
Compliance with interventions, especially educational programmes, was a problem
for many studies despite the importance of many such low‐cost interventions.
Compliance with mask wearing varied; it was generally around 60% to 80%, but was
reported to be as low as 40% (see Table 1). Overall, the logistics of carrying
out trials that involve sustained behaviour change are demanding, particularly
in challenging settings such as immigrant neighbourhoods or students' halls of
residence.
The identified trials provided sparse and unsystematic data on adverse effects
of the intervention, and few of the RCTs measured or reported compliance with
the intervention, which is especially important for the use of medical/surgical
masks or N95 respirators. No studies investigated how the level of adherence may
have influenced the effect size.
We did not identify any studies assessing the effects of eye protection, and we
identified only one study on physical distancing, during the 2009 H1N1 influenza
pandemic. The dearth of evidence and predominant setting of seasonal viral
circulation limits generalisability of our findings to other contexts such as
the COVID‐19 pandemic and any future epidemics due to other respiratory viruses.
QUALITY OF THE EVIDENCE
We found the available evidence base identified through our search processes to
be of variable quality. Reporting of sequence generation and allocation
concealment were poor in 30% to 50% of studies across the categories of
intervention comparisons. Given the nature of the intervention comparison,
blinding of treatment allocation after randomisation was rarely achieved.
Although blinding of outcome assessment is highly feasible and desirable, most
outcomes were assessed by self‐reports. Outcomes in some studies were poorly
defined, with a lack of clarity as to the possible aetiologic agents (bacterial
versus viral). Some studies used laboratory‐confirmed outcomes, both adding
precision and lowering the risk of bias (see Table 9 for heterogeneity of trial
outcome definitions). We found no evidence of selective reporting of outcomes
within the included studies. We believe publication bias is unlikely, as the
included studies demonstrated a range of effects, both positive and negative,
over all study sizes. The variable quality of the studies hampers drawing any
firm conclusions.
Open in table viewer
Table 9. Trial authors’ outcome definitions
Study
Outcomes definitions
Masks (n = 13)
1.
Cowling 2008
cluster‐RCT
Hong Kong
Laboratory:
QuickVue Influenza A+B rapid test
Viral culture on MDCK (Madin‐Darby canine kidney cells)
Samples were harvested using NTS, but the text refers to a second procedure from
June 2007 onwards with testing for influenza viruses on index participants with
a negative QuickVue result but a fever ≥ 38 °C who were also randomised and
further followed up. Data on clinical signs and symptoms were collected for all
participants, and an additional NTS was collected for later confirmation of
influenza infection by viral culture. It is noteworthy that dropout was higher
in households of index participants who had a negative result on the rapid
influenza test (25/44, 57%) compared to those who had a positive result (45/154,
29%).
Effectiveness: secondary attack ratios (SAR): SAR is the proportion of household
contacts of an index case who subsequently were ill with influenza (symptomatic
contact individuals with at least 1 NTS positive for influenza by viral culture
or PCR)
3 clinical definitions were used for secondary analysis:
1. fever ≥ 38 °C or at least 2 of the following symptoms: headache, coryza,
sore throat, muscle aches and pains;
2. at least 2 of the following S/S: fever ≥ 37.8 °C, cough, headache, sore
throat and muscle aches and pains; and
3. fever of ≥ 37.8 °C plus cough or sore throat.
Safety: harms were not mentioned as an outcome in the methods, but it was
reported in the results that there were no adverse events.
2.
Jacobs 2009
RCT
Japan
Laboratory‐confirmation not reported.
Effectiveness: URTI is defined on the basis of a symptom score with a score > 14
being a URTI according to Jackson’s 1958 criteria ("Jackson score"). These are
not explained in text, although the symptoms are listed in Table 3 (any, sore
throat, runny nose, stuffy nose, sneeze, cough, headache, earache, feel bad)
together with their mean and scores (SD) by intervention arm.
Safety: the text does not mention or report harms. These appear to be
indistinguishable from URTI symptoms (e.g. headache, which is reported as of
significantly longer duration in the intervention arm). Compliance is
self‐reported as high (84.3% of participants).
3.
Loeb 2009
cluster‐RCT
HCW
Canada
Clinical respiratory illness, influenza‐like illness, and laboratory‐confirmed
respiratory virus infection.
1. Clinical respiratory illness, defined as 2 or more respiratory symptoms or 1
respiratory symptom and a systemic symptom.
2. Influenza‐like illness, defined as fever ≥ 38 °C plus 1 respiratory symptom.
3. Laboratory‐confirmed viral respiratory infection. Laboratory confirmation
was by nucleic acid detection using multiplex RT‐PCR for 17 respiratory
viruses.
Safety: harms were not mentioned as an outcome in the methods, but it is stated
in the results that no adverse events were reported by participants.
4.
MacIntyre 2009
cluster‐RCT
Australia
Eligibility criteria were stipulated as follows:
1. the household contained > 2 adults > 16 years of age and 1 child 0 to 15
years of age;
2. the index child had fever (temperature > 37.8 °C) and either a cough or sore
throat;
3. the child was the first and only person to become ill in the family in the
previous 2 weeks;
4. adult caregivers consented to participate in the study; and
5. the index child was not admitted to the hospital.
Definitions used for outcomes:
1. ILI defined by the presence of fever (temperature > 37.8 °C), feeling
feverish or a history of fever, > 2 symptoms (sore throat, cough, sneezing,
runny nose, nasal congestion, headache), or 1 of the symptoms listed plus
laboratory confirmation of respiratory viral infection.
2. Laboratory confirmation: multiplex RT‐PCR tests to detect influenza A and B
and RSV, PIV types 1–3, picornaviruses (enteroviruses or rhinoviruses),
adenoviruses, coronaviruses 229E and OC43, and hMPV plus > 1 sym
Effectiveness: presence of ILI or a laboratory diagnosis of respiratory virus
infection within 1 week of enrolment.
Safety: harms not mentioned as an outcome in the methods, but it is reported in
the results that more than 50% of participants reported concerns with mask
wearing, mainly that wearing a face mask was uncomfortable, but there were no
significant differences between the P2 (N95) and surgical mask groups. Other
concerns were that the child did not want the parent wearing a mask.
5.
Aiello 2010
cluster‐RCT
USA
Laboratory details are described in appendix.
Effectiveness: ILI, defined as cough and at least 1 constitutional symptom
(fever/feverishness, chills, headache, myalgia). ILI cases were given contact
nurses phone numbers to record the illness and paid USD 25 to provide a throat
swab. 368 participants had ILI, 94 of which had a throat swab analysed by PCR.
10 of these were positive for influenza (7 for A and 3 for B), respectively by
arm 2, 5 and 3 using PCR, 7 using cell culture.
Safety: no outcomes on harms planned or reported.
6.
Canini 2010
cluster‐RCT
USA
The primary endpoint was the proportion of household contacts who developed an
ILI during the 7 days following inclusion. Exploratory cluster‐level efficacy
outcome, the proportion of households with 1 or more secondary illness in
household contacts.
A temperature over 37.8 °C with cough or sore throat was used as primary
clinical case definition.
The authors also used a more sensitive case definition based on a temperature
over 37.8 °C or at least 2 of the following: sore throat, cough, runny nose, or
fatigue.
Safety: adverse reactions due to mask wearing were reported, with 38 (75%)
participants in the intervention arm experiencing discomfort with mask use due
to warmth (45%), respiratory difficulties (33%), and humidity (33%). Children
wearing children face masks reported feeling pain more frequently than other
participants wearing adult face masks (P = 0.036).
7.
Aiello 2012
cluster‐RCT in halls of residence in the USA
Clinically verified ILI ‐ case definition (presence of cough and at least 1 or
more of fever/feverishness, chills, or body aches)
Laboratory‐confirmed influenza A or B. Throat swab specimens were tested for
influenza A or B using real‐time PCR.
Safety: no outcomes on harms planned or reported.
8.
Barasheed 2014
cluster‐RCT
Saudi Arabia
Laboratory: 2 nasal swabs from all ILI cases and contacts. 1 for influenza POCT
using the QuickVue Influenza (A+B) assay (Quidel Corporation, San Diego, USA)
and 1 for later NAT for influenza and other respiratory viruses. However, there
was a problem with getting POCT on time during Hajj.
Effectiveness: to assess the effectiveness of face masks in the prevention of
transmission of ILI. ILI was defined as subjective (or proven) fever plus 1
respiratory symptom (e.g. dry or productive cough, runny nose, sore throat,
shortness of breath).
Safety: no outcomes on harms planned or reported.
9.
MacIntyre 2011
cluster‐RCT
China
Clinical respiratory illness
Influenza‐like illness
Laboratory‐confirmed viral respiratory infection
Laboratory‐confirmed influenza A or B
1. Clinical respiratory illness, defined as 2 or more respiratory or 1
respiratory symptom and a systemic symptom.
2. Influenza‐like illness, defined as fever ≥ 38 °C plus 1 respiratory symptom
(i.e. cough, runny nose, etc.).
3. Laboratory‐confirmed viral respiratory infection (detection of adenoviruses,
human metapneumovirus, coronavirus 229E ⁄ NL63, parainfluenza viruses 1, 2,
and 3, influenza viruses A and B, respiratory syncytial virus A and B,
rhinovirus A/B and coronavirus OC43/HKU1 by multiplex PCR).
4. Laboratory‐confirmed influenza A or B.
5. Adherence with mask/respirator use.
Safety: adherence and adverse effects of mask wearing were collected at exit
interviews 4 weeks' poststudy. Significantly higher adverse events with N95
respirator compared to medical mask for discomfort, headache, difficulty
breathing, nose pressure, trouble communicating, not wearing, and unspecified
“other” side effects. Over 50% of those wearing N95 respirators reported adverse
events. Of those wearing medical masks versus N95 respirators, 85.5% (420/491)
versus 47.4% (447/943) reported no adverse events (P < 0.001), respectively.
10.
MacIntyre 2013
cluster‐RCT
China
Laboratory:
1. Laboratory‐confirmed viral respiratory infection in symptomatic
participants, defined as detection of adenoviruses; human metapneumovirus;
coronaviruses 229E/NL63 and OC43/HKU1; parainfluenza viruses 1, 2, and 3;
influenza viruses A and B; respiratory syncytial viruses A and B; or
rhinoviruses A/B by NAT using a commercial multiplex PCR (Seegen, Inc.,
Seoul, Korea).
2. Laboratory‐confirmed influenza A or B in symptomatic participants.
3. Laboratory‐confirmed bacterial colonisation in symptomatic participants,
defined as detection of Streptococcus pneumoniae, Legionella, Bordetella
pertussis, Chlamydia, Mycoplasma pneumoniae, or Haemophilus influenzae type
B by multiplex PCR (Seegen, Inc.).
Effectiveness: clinical respiratory illness defined as 2 or more respiratory
symptoms or 1 respiratory symptom and a systemic symptom. ILI defined as fever
(38 °C) plus 1 respiratory symptom.
Safety: adverse effects measured using a semi‐structured questionnaire.
Investigators stated that there was higher reported adverse effects and
discomfort of N95 respirators compared with the other 2 arms. In terms of
comfort, 52% (297 of 571) of the medical mask arm reported no problems, compared
with 62% (317 of 512) of the targeted arm and 38% (217 of 574) of the N95 arm (P
< 0.001).
11.
MacIntyre 2015
cluster‐RCT
Vietnam
Clinical respiratory illness, influenza‐like illness, and laboratory‐confirmed
respiratory virus infection.
1. Clinical respiratory illness, defined as 2 or more respiratory symptoms or 1
respiratory symptom and a systemic symptom.
2. Influenza‐like illness, defined as fever ≥ 38 °C plus 1 respiratory symptom.
3. Laboratory‐confirmed viral respiratory infection. Laboratory confirmation
was by nucleic acid detection using multiplex RT‐PCR for 17 respiratory
viruses.
Safety: adverse events associated with face mask use were reported in 40.4%
(227/562) of HCWs in the medical/surgical mask arm and 42.6% (242/568) in the
cloth mask arm (P = 0.45). The most frequently reported adverse events were:
general discomfort (35.1%; 397/1130) and breathing problems (18.3%; 207/1130).
The rate of ILI was higher in the cloth mask arm compared to medical/surgical
masks (RR 13.25, 95% CI 1.74 to 100.97).
12.
MacIntyre 2016
cluster‐RCT
China
Clinical respiratory illness, influenza‐like illness, and laboratory‐confirmed
viral respiratory infection.
1. Clinical respiratory illness, defined as 2 or more respiratory symptoms
(cough, nasal congestion, runny nose, sore throat, or sneezes) or 1
respiratory symptom and a systemic symptom (chill, lethargy, loss of
appetite, abdominal pain, muscle or joint aches).
2. Influenza‐like illness, defined as fever ≥ 38 °C plus 1 respiratory symptom.
3. Laboratory‐confirmed viral respiratory infection, defined as detection of
adenoviruses, human metapneumovirus, coronaviruses 229E/NL63 and OC43/HKU1,
parainfluenza viruses 1, 2, and 3, influenza viruses A and B, respiratory
syncytial virus A and B, or rhinovirus A/B by NAT using a commercial
multiplex PCR.
Safety: no outcomes on harms planned or reported.
13.
Radonovich 2019
cluster‐RCT
USA
Laboratory. Primary outcome: incidence of laboratory‐confirmed influenza,
defined as:
1. detection of influenza A or B virus by RT‐PCR in an upper respiratory
specimen collected within 7 days of symptom onset;
2. detection of influenza from a randomly obtained swab from an asymptomatic
participant; and
3. influenza seroconversion (symptomatic or asymptomatic), defined as at least
a 4‐fold rise in haemagglutination inhibition antibody titres to influenza A
or B virus between pre‐season and postseason serological samples deemed not
attributable to vaccination.
Effectiveness. Secondary outcomes: incidence of 4 measures of viral respiratory
illness or infection as follows:
1. acute respiratory illness with or without laboratory confirmation;
2. laboratory‐detected respiratory infection, defined as detection of a
respiratory pathogen by PCR or serological evidence of infection with a
respiratory pathogen during the study surveillance period(s), which was
added to the protocol prior to data analysis; and
3. laboratory‐confirmed respiratory illness, identified as previously described
(defined as self‐reported acute respiratory illness plus the presence of at
least PCR–confirmed viral pathogen in a specimen collected from the upper
respiratory tract within 7 days of the reported symptoms and/or at least a
4‐fold rise from pre‐intervention to postintervention serum antibody titres
to influenza A or B virus).
Influenza‐like illness, defined as temperature of at least 100 °F (37.8 °C) plus
cough and/or a sore throat, with or without laboratory confirmation.
Safety: 19 participants reported skin irritation or worsening acne during years
3 and 4 at 1 site in the N95 respirator group.
Hand and hygiene (n = 32)
14.
Alzaher 2018
cluster‐RCT
Saudi Arabia
Episode of URI was defined as having 2 of the following symptoms for a day or 1
of the symptoms for 2 or more consecutive days: 1) a runny nose, 2) a stuffy or
blocked nose or noisy breathing, 3) sneezing, 4) a cough, 5) a sore throat, and
6) feeling hot, having a fever or a chill.
15.
Arbogast 2016
cluster‐RCT
USA
ICD‐9 used: 46611: acute bronchiolitis due to respiratory syncytial virus,
46619: acute bronchiolitis due to other infectious organisms, 4800: pneumonia
due to adenovirus, 4809: viral pneumonia, unspecified, 4870: influenza with
pneumonia, 07999: unspecified viral infection, 4658: acute upper respiratory
infections of other multiple sites, 4659: acute upper respiratory infections of
unspecified site, 4871: influenza with other respiratory manifestations.
16.
Azor‐Martinez 2016
RCT
Spain
Upper respiratory illness was defined as 2 of the following symptoms during 1
day, or 1 of the symptoms for 2 consecutive days: (1) runny nose; (2) stuffy or
blocked nose or noisy breathing; (3) cough; (4) feeling hot or feverish or
having chills; (5) sore throat; or (6) sneezing.
17.
Azor‐Martinez 2018
RCT
Spain
Respiratory illness (RI) was defined as the presence of 2 of the following
symptoms during 1 day or the presence of 1 of the symptoms for 2 consecutive
days: (1) runny nose, (2) stuffy or blocked nose or noisy breathing, (3) cough,
(4) feeling hot or feverish or having chills, (5) sore throat, or (6) sneezing.
ICD‐10 and ICD‐9 diagnosis codes used: nonspecific upper respiratory tract
infection (465.9), otitis media (382.9), pharyngotonsillitis (463), lower
respiratory tract infections (485 and 486), acute bronchitis (490), and
bronchiolitis (466.19). Study authors combined the bronchopneumonia code (485)
and pneumonia code (486) under the label “lower respiratory tract infections.”
If > 1 antibiotic was prescribed during an episode, they used the first
prescription for analysis. The final diagnosis was done by the medical
researchers on the basis of the symptoms described above and a review of the
medical history of children with RIs.
18.
Biswas 2019
cluster‐RCT
Bangladesh
Influenza‐like illness: an ILI episode was defined as measured fever > 38 °C or
subjective fever and cough.
Laboratory‐confirmed influenza
Nasal swabs for real‐time RT‐PCR.
19.
Correa 2012
cluster‐RCT
Colombia
Acute respiratory infection was defined as 2 or more of the following symptoms
for at least 24 hours, lasting at least 2 days: runny, stuffy, or blocked nose
or noisy breathing; cough; fever, hot sensation, or chills; and/or sore throat.
Ear pain alone was considered ARI alternately.
20.
Cowling 2009
cluster‐RCT
Hong Kong
Laboratory‐confirmed of influenza virus infection by RT‐PCR for influenza A and
B virus.
Clinical influenza‐like illness: used 2 clinical definitions of influenza based
on self‐reported data from the symptom diaries as secondary analyses. The first
definition of clinical influenza was at least 2 of the following signs and
symptoms: temperature 37.8 °C or greater, cough, headache, sore throat, and
myalgia; the second definition was temperature 37.8 °C or greater plus cough or
sore throat.
21.
DiVita 2011 (conference abstract)
RCT
Bangladesh
Influenza‐like illness was defined as fever in children < 5 years old and fever
with cough or sore throat in individuals > 5 years old.
22.
Feldman 2016
cluster‐RCT
Israel
Infectious diseases grouped into diarrhoeal, respiratory, and skin infection.
Based on ICD‐9, but no supplementary material was accessible for further
definition (Supplementary Material C lists all ICD‐9 diagnoses tallied in this
”outcome”).
23.
Gwaltney 1980
RCT
USA
Viral cultures and serology if rhinovirus in laboratory‐inoculation
24.
Hubner 2010
RCT
Germany
Assessing illness rates due to common cold and diarrhoea. Collecting data on
illness symptoms (common cold, sinusitis, sore throat, fever, cough, bronchitis,
pneumonia, influenza, diarrhoea) and associated absenteeism at the end of every
month.
Definitions of symptoms were given to the participants as part of the individual
information at the beginning of the study. Whilst most symptoms are quite
self‐explanatory, "influenza" and "pneumonia" are specific diagnoses that were
confirmed by professional diagnosis only. Similarly, (self‐) diagnosis of
"fever" required objective measurement with a thermometer.
25.
Ladegaard 1999
RCT
Denmark
Laboratory: serological evidence
Effectiveness: influenza‐like illness (described as fever, history of fever or
feeling feverish in the past week, myalgia, arthralgia, sore throat, cough,
sneezing, runny nose, nasal congestion, headache).
However, a positive laboratory finding for influenza converts the ILI definition
into one of influenza.
26.
Larson 2010
cluster‐RCT
USA
Study goals: rates of symptoms and secondary transmission of URIs, incidence of
virologically confirmed influenza, knowledge of prevention and treatment
strategies for influenza and URIs, and rates of influenza vaccination.
1. Laboratory‐confirmed influenza: nasal swabs to test for influenza types A
and B as well as other common respiratory viruses by rapid culture (R‐Mix,
Diagnostic Hybrids, Inc., Athens, OH, USA). PCR and subtyping of the samples
was done during the second half of the second year of the study.
2. Influenza‐like illness: CDC definition of ILI from the Sentinel Physicians'
Network was used to determine when masks should be worn: “temperature of
≥37.8°C and cough and/or sore throat in the absence of a known cause other
than influenza".
3. Episodes of URI = upper respiratory infection: not clear, no explicitly
stated definition, reported that the most commonly reported URI symptoms are
cough or rhinorrhoea.
27.
Little 2015
RCT
England
Respiratory tract infections defined as 2 symptoms of an RTI for at least 1 day
or 1 symptom for 2 consecutive days. For reported ILI, study authors did not use
WHO or CDC definitions because these definitions require measured temperature,
and thus were not appropriate (participants were not included after a clinical
examination), and they did not use the European Centre for Disease Prevention
and Control definition (1 systemic and 1 respiratory symptom) because, according
to the international influenza collaboration, this definition does not
necessarily differentiate ILI from a common cold. Influenzanet suggests making
high temperature a separate element. Their pragmatic definition of ILI therefore
required a high temperature (feeling very hot or very cold; or measured
temperature > 37.5 °C), a respiratory symptom (sore throat, cough, or runny
nose), and a systemic symptom (headache, severe fatigue, severe muscle aches, or
severe malaise).
28.
Luby 2005
RCT
Pakistan
Defined pneumonia in children according to the WHO clinical case definition:
cough or difficulty breathing with a raised respiratory rate (> 60 per minute in
individuals younger than 60 days old, > 50 per minute for those aged 60 to 364
days, and > 40 per minute for those aged 1 to 5 years)
29.
Millar 2016
cluster‐RCT
USA
Medically attended, outpatient cases of acute respiratory infection in the study
population. The case definition was any occurrence of the following
International Classification of Disease, 9 Revision, Clinical Modification
(ICD‐9) symptom or disease‐specific codes: 460‐466, 480‐488, and specifically
465.9, 482.9, 486, and 487.1.
Acute respiratory infections (460 to 466)
460 Acute nasopharyngitis (common cold)
461 Acute sinusitis
462 Acute pharyngitis
463 Acute tonsillitis
464 Acute laryngitis and tracheitis
465 Acute upper respiratory infections of multiple or unspecified sites
466 Acute bronchitis and bronchiolitis
Pneumonia and influenza (480 to 488)
480 Viral pneumonia
481 Pneumococcal pneumonia (Streptococcus pneumoniae pneumonia)
482 Other bacterial pneumonia
483 Pneumonia due to other specified organism
484 Pneumonia in infectious diseases classified elsewhere
485 Bronchopneumonia, organism unspecified
486 Pneumonia, organism unspecified
487 Influenza
488 Influenza due to identified avian influenza virus
465.9 Acute upper respiratory infections of unspecified site
482.9 Bacterial pneumonia NOS
487.1 Diagnosis of influenza with other respiratory manifestations
30.
Morton 2004
cluster‐RCT
Cross‐over study
USA
Respiratory illnesses defined by symptoms of upper respiratory infections such
as nasal congestion, cough, or sore throat, in any combination, with or without
fever
31.
Nicholson 2014
cluster‐RCT
India
Acute respiratory infections
Operational definitions for all the illnesses were taken from Black's Medical
Dictionary. ARIs defined as "Pneumonia, cough, fever, chest pain and shortness
of breath, cold, inflammation of any or all of the airways, that is, nose,
sinuses, throat, larynx, trachea and bronchi".
32.
Pandejpong 2012
cluster‐RCT
Thailand
Influenza‐like illness defined if 2 or more symptoms of stuffy nose, cough,
fever or chills, sore throat, headache, diarrhoea, presence of hand, foot, or
mouth ulcers.
33.
Priest 2014
cluster‐RCT
New Zealand
Respiratory illness was defined as an episode of illness that included at least
2 of the following caregiver‐reported symptoms for 1 day, or 1 of these symptoms
for 2 days (but not fever alone): runny nose, stuffy or blocked nose or noisy
breathing, cough, fever, sore throat, or sneezing.
34.
Ram 2015
RCT
Bangladesh
Influenza‐like illness
Age‐specific definitions of ILI. For individuals ≥ 5 years old, ILI was defined
as history of fever with cough or sore throat. For children < 5 years old, ILI
was defined as fever; study authors used this relatively liberal case definition
in order to include influenza cases with atypical presentations in children.
Laboratory‐confirmed influenza infection
Oropharyngeal swabs from index case patients for laboratory testing for
influenza. All swabs were tested by PCR for influenza A and B, with further
subtyping of influenza A isolates.
35.
Roberts 2000
cluster‐RCT
Australia
The symptoms of acute upper respiratory illness elicited from parents were: a
runny nose, a blocked nose, and cough. Study authors used a definition of colds
based on a community intervention trial of virucidal impregnated tissues.
A cold was defined as either 2 symptoms for 1 day or 1 of the respiratory
symptoms for at least 2 consecutive days, but not including 2 consecutive days
of cough alone. Study authors defined a new episode of a cold as the occurrence
of respiratory symptoms after a period of 3 symptom‐free days.
36.
Sandora 2005
cluster‐RCT
USA
The overall rates of secondary respiratory and GI illness.
Respiratory illness was defined as 2 of the following symptoms for 1 day or 1 of
the symptoms for 2 consecutive days: (1) runny nose; (2) stuffy or blocked nose
or noisy breathing; (3) cough; (4) fever, feels hot, or has chills; (5) sore
throat; and (6) sneezing. An illness was considered new or separate when a
period of at least 2 symptom‐free days had elapsed since the previous illness.
An illness was defined as a secondary case when it began 2 to 7 days after the
onset of the same illness type (respiratory or GI) in another household member.
37.
Savolainen‐Kopra 2012
cluster‐RCT
Finland
Nasal and pharyngeal stick samples from participants with respiratory symptoms
38.
Simmerman 2011
cluster‐RCT
Thailand
Influenza‐like illness defined by WHO as fever plus cough or sore throat, based
on self‐reported symptoms.
Laboratory‐confirmed secondary influenza virus infections amongst household
members described as the secondary attack rate. The secondary influenza virus
infection was defined as a positive rRT‐PCR result on days 3 or 7 or a four‐fold
rise in influenza HI antibody titres with the virus type and subtype matching
the index case.
39.
Stebbins 2011
cluster‐RCT
USA
The primary outcome was an absence episode associated with an influenza‐like
illness that was subsequently laboratory confirmed as influenza A or B. The
following CDC definition for ILI was used: fever ≥ 38 °C with sore throat or
cough.
40.
Talaat 2011
cluster‐RCT
Egypt
Nasal swab for QuickVue test for influenza A and B viruses.
Influenza‐like illness (defined as fever > 38 °C and either cough or sore
throat).
41.
Temime 2018
cluster‐RCT
France
ARIs were defined as the combination of at least 1 respiratory symptom and 1
symptom of systemic infection.
42.
Turner 2004b
RCT
Canada
Virologic assays
43.
Turner 2012
RCT
USA
Laboratory‐confirmed rhinovirus infection by PCR assay.
Common cold illness was defined as the presence of any of the symptoms of nasal
obstruction, rhinorrhoea, sore throat, or cough on at least 3 consecutive days.
Illnesses separated by at least 3 symptom‐free days were considered as separate
illnesses.
44.
Yeung 2011
cluster‐RCT
Hong Kong
Pneumonia
45.
Zomer 2015
cluster‐RCT
Netherlands
Incidence of gastrointestinal and respiratory infections in children monitored
by parents. The common cold was defined as a blocked or runny nose with at least
1 of the following symptoms: coughing, sneezing, fever, sore throat, or earache.
Hand hygiene and masks (n = 6)
46.
Aelami 2015 (conference abstract)
RCT
Saudi Arabia
Influenza‐like illness was defined as the presence of at least 2 of the
following during their stay: fever, cough, and sore throat.
Safety: no outcomes on harms planned or reported.
47.
Aiello 2010
cluster‐RCT
USA
Influenza‐like illness case definition (presence of cough and at least 1
constitutional symptom (fever/feverishness, chills, or body aches).
Safety: no outcomes on harms planned or reported.
48.
Cowling 2009
cluster‐RCT
Hong Kong
2 clinical definitions of influenza. First definition was at least 2 of the
following signs and symptoms: temperature 37.8 °C or greater, cough, headache,
sore throat, and myalgia. The second was temperature 37.8 °C or greater plus
cough or sore throat.
Safety: no outcomes on harms planned or reported.
49.
Larson 2010
cluster‐RCT
USA
Study goals: rates of symptoms and secondary transmission of URIs, incidence of
virologically confirmed influenza, knowledge of prevention and treatment
strategies for influenza and URIs, and rates of influenza vaccination.
1. Laboratory‐confirmed influenza: nasal swabs to test for influenza types A
and B as well as other common respiratory viruses by rapid culture (R‐Mix,
Diagnostic Hybrids, Inc., Athens, OH, USA). PCR and subtyping of the samples
was done during the second half of the second year of the study.
2. Influenza‐like illness: CDC definition of ILI from the Sentinel Physicians'
Network was used to determine when masks should be worn: “temperature of
≥37.8°C and cough and/or sore throat in the absence of a known cause other
than influenza".
3. Episodes of URI = upper respiratory infection: not clear, no explicitly
stated definition, reported that the most commonly reported URI symptoms are
cough or rhinorrhoea.
Safety: no outcomes on harms planned or reported.
50.
Simmerman 2011
cluster‐RCT
Thailand
Laboratory‐confirmed secondary influenza virus infections amongst household
members described as the secondary attack rate. The secondary influenza virus
infection was defined as a positive rRT‐PCR result on days 3 or 7 or a four‐fold
rise in influenza HI antibody titres with the virus type and subtype matching
the index case.
Influenza‐like illness defined by WHO as fever plus cough or sore throat, based
on self‐reported symptoms.
Safety: no outcomes on harms planned or reported.
51.
Suess 2012
cluster‐RCT
Germany
Quantitative RT‐PCR for samples of nasal wash.
Influenza virus infection as a laboratory‐confirmed influenza infection in a
household member who developed fever (> 38.0 °C), cough, or sore throat during
the observation period. Also secondary outcome measure of the occurrence of ILI
as defined by WHO as fever plus cough or sore throat.
Safety: the study reported that the majority of participants (107/172, 62%) did
not report any problems with mask wearing. This proportion was significantly
higher in the group of adults (71/100, 71%) compared to the group of children
(36/72, 50%) (P = 0.005). The main problem stated by participants (adults and
children) was "heat/humidity" (18/34, 53% of children; 10/29, 35% of adults) (P
= 0.1), followed by "pain" and "shortness of breath" when wearing a
face mask.
Surface/object disinfection (with or without hand hygiene)(n = 8)
52.
Ban 2015
cluster‐RCT
China
Acute respiratory illness classified as the appearance of 2 or more of the
following symptoms: fever, cough and expectoration, runny nose and nasal
congestion.
53.
Carabin 1999
cluster‐RCT
Canada
The presence of nasal discharge (runny nose) accompanied by 1 or several of the
following symptoms: fever, sneezing, cough, sore throat, ear pain, malaise,
irritability. A URTI was defined as a cold for 2 consecutive days.
54.
Chard 2019
cluster‐RCT
Laos
Pupils were considered to have symptoms of respiratory infection if they
reported cough, runny nose, stuffy nose, or sore throat.
55.
Ibfelt 2015
cluster‐RCT
Denmark
Laboratory confirmation of 16 respiratory viruses: influenza A; influenza B;
coronavirus NL63229E, OC43 and HKU1; parainfluenza virus 1, 2, 3, and 4;
rhinovirus; RSV A/B; adenovirus; enterovirus; parechovirus; and bocavirus using
quantitative PCR
56.
Kotch 1994
RCT
USA
Respiratory symptoms include coughing, runny nose, wheezing or rattling in the
chest, sore throat, or earache.
57.
McConeghy 2017
RCT
USA
Classified infections as lower respiratory tract infections (i.e. pneumonia,
bronchitis, or chronic obstructive pulmonary disease exacerbation) or other.
58.
Sandora 2008
cluster‐RCT
USA
RI was defined as an acute illness that included > 1 of the following symptoms:
runny nose, stuffy or blocked nose, cough, fever or chills, sore throat, or
sneezing.
59.
White 2001
DB‐RCT
USA
RI was defined as: cough, sneezing, sinus trouble, bronchitis, fever alone,
pink‐eye, headache, mononucleosis, and acute exacerbation of asthma.
Other (miscellaneous) interventions (n = 4)
60.
Hartinger 2016
cluster‐RCT
Peru
ARI was defined as a child presenting cough or difficulty breathing, or both.
ALRI was defined as a child presenting cough or difficulty breathing, with a
raised respiratory rate > 50 per minute in children aged 6 to 11 months and > 40
per minute in children aged > 12 months on 2 consecutive measurements. An
episode was defined as beginning on the first day of cough or difficulty
breathing and ending with the last day of the same combination, followed by at
least 7 days without those symptoms.
61.
Huda 2012
cluster‐RCT
Bangladesh
Study authors classified acute respiratory illness as having cough and fever or
difficulty breathing and fever within 48 h prior to interview.
62.
Najnin 2019
cluster‐RCT
Bangladesh
Classified participants as having respiratory illness if they reported having
fever plus either cough or nasal congestion or fever plus breathing difficult.
63.
Satomura 2005
RCT
Japan
Upper respiratory tract infection defined as all of the following conditions:
1. both nasal and pharyngeal symptoms;
2. severity of at least 1 symptom increased by 2 grades or more; and
3. worsening of a symptom of 1 increment or more for > 3 days.
Because of the difference in the mode of transmission, study authors excluded
influenza‐like diseases featured by moderate or severe fever; anti‐influenza
vaccination in the preseason and arthralgia, and treated them separately. The
incidence was determined by 1 study physician who was blinded to group
assignment.
Virucidal tissues (n = 2)
64.
Farr 1988a
cluster‐RCT
USA trial 1 and trial 2
RI defined as: occurrence of at least 2 respiratory symptoms on the same day or
the occurrence of a single respiratory symptom on 2 consecutive days (except for
sneezing). The respiratory symptoms were as follows: sneezing, nasal congestion,
nasal discharge, sore throat, scratchy throat, hoarseness, coughing, malaise,
headache, feverishness, chilliness and myalgia.
65.
Longini 1988
DB‐PC RCT
USA
Respiratory illness defined as 1 or more of the following symptoms occurring
during the course of acute episode: coryza, sore throat or hoarseness, earache,
cough, pain on respiration, wheezy breathing or phlegm from the chest.
ALRI: acute lower respiratory infection
ARIs: acute respiratory infections
CDC: Centers for Disease Control and Prevention
CI: confidence interval
cluster‐RCT: cluster‐randomised controlled trial
CRI: clinical respiratory illness
DB‐PC: double‐blind, placebo‐controlled
DB‐RCT: double‐blind randomised controlled trial
GI: gastrointestinal
HCW: healthcare workers
HI: haemagglutinin
hMPV: human metapneumo virus
ICD‐9: International Classification of Disease, 9th Revision, Clinical
Modification
ICD‐10: International Classification of Disease, 10th Revision, Clinical
Modification
ILI: influenza‐like illness
NAT: nucleic acid testing
NOS: not otherwise specified
NTS: nasal and throat swab
PCR: polymerase chain reaction
PIV: parainfluenza virus
POCT: point‐of‐care testing
RCT: randomised controlled trial
RI: respiratory infection
RR: risk ratio
rRT‐PCR: real‐time reverse transcriptase polymerase chain reaction
RSV: respiratory syncytial virus
RTI: respiratory tract infection
RT‐PCR: reverse transcriptase polymerase chain reaction
SAR: secondary attack ratios
SD: standard deviation
S/S: signs and symptoms
URI: upper respiratory infection
URTI: upper respiratory tract infection
WHO: World Health Organization
POTENTIAL BIASES IN THE REVIEW PROCESS
The non‐drug (and often locally manufactured) nature of most of the
interventions in this review, the lack of effective regulation in some settings,
and the possible endless number of manufacturers make it difficult to gauge the
existence of unpublished data. Non‐drug interventions typically have no or very
poor regulation.
In this 2020 update, we focused on RCTs and cluster‐RCTs, providing a higher
level of evidence compared with the previous version of the review, which also
meta‐analysed observational studies when appropriate (Jefferson 2011). However,
many of the trials were small and hence underpowered, and at high or unclear
risk of bias due to poor reporting of methods and lack of blinding. The
populations, outcomes, comparators, and interventions tested were heterogeneous.
Due to the urgency of this update in the context of the COVID‐19 pandemic, we
did not contact trial authors to request missing data. This means that we have
not considered studies that included other non‐respiratory infections and did
not provide stratified data by type of infection.
AGREEMENTS AND DISAGREEMENTS WITH OTHER STUDIES OR REVIEWS
Several reviews of RCTs have found broadly similar results to this review for
face masks. In a meta‐analysis comparing surgical masks with N95 respirators,
Smith 2016 pooled three trials (Loeb 2009; MacIntyre 2011; MacIntyre 2013), and
found an estimate of effect suggesting no difference for laboratory‐confirmed
respiratory infections (OR 0.89, 95% CI 0.64 to 1.24) or ILI (OR 0.51, 95% CI
0.19 to 1.41). A similar meta‐analysis, Offeddu 2017, based on two trials,
MacIntyre 2011; MacIntyre 2015, concluded that masks (either N95/P2 respirators
or medical/surgical masks) were effective against clinical respiratory
infections (RR 0.59, 95% CI 0.46 to 0.77) and ILI (RR 0.34, 95% CI 0.14 to
0.82). Pooling of two studies, MacIntyre 2011; MacIntyre 2013, also found an
estimate of effect that favoured N95 respirators to medical/surgical masks for
clinical respiratory infections (RR 0.47, 95% CI 0.36 to 0.62), but not for ILI
based on three studies, Loeb 2009: MacIntyre 2011; MacIntyre 2013 (RR 0.59, 95%
CI 0.27 to 1.28) (Offeddu 2017). The outcome of clinical respiratory infection
is considered to be the most subjective and least precise outcome.
A recent meta‐analysis included five trials comparing N95/P2 respirators with
medical/surgical masks and found no difference between groups for either
influenza (RR 1.09, 95% CI 0.92 to 1.28) or respiratory viral infections (RR
0.89, 95% CI 0.70 to 1.11) (Long 2020). By excluding Loeb 2009 (an open,
non‐inferiority RCT that compared surgical masks with N95 respirators in
protecting HCWs against influenza), the authors reported a significant
protective effect against viral infections (RR 0.61, 95% CI 0.39 to 0.98). The
authors do not report a rationale for the exclusion in the sensitivity analysis
and do not report on exclusion of the studies with low weighting, which arguably
would be more relevant in a sensitivity analysis. The two trials that make up
96% of the weighting, Loeb 2009; Radonovich 2019, demonstrated no significant
differences in the outcome events. A recent meta‐analysis of four RCTs
(Bartoszko 2020), adjusting for clustering, which compared N95 respirators
with the use of medical masks, found pooled estimates of effect that did not
demonstrate any difference in any laboratory‐confirmed viral respiratory
infection (OR 1.06, 95% CI 0.90 to 1.25), laboratory‐confirmed influenza (OR
0.94, 95% CI 0.73 to 1.20), or clinical respiratory illness (OR 1.49, 95% CI
0.98 to 2.28), with the evidence profile suggesting that there was greater
imprecision and inconsistency in the outcome of clinical respiratory
illness. Moreover, in another recent systematic review that assessed the
effectiveness of personal protective and environmental measures in
non‐healthcare settings (funded by the WHO), 10 RCTs reporting estimates of the
effectiveness of face masks in reducing laboratory‐confirmed influenza virus
infections in the community were identified (Xiao 2020). The evidence from these
RCTs suggested that the use of face masks either by infected persons or by
uninfected persons does not have a substantial effect on influenza
transmission.
The findings from several systematic reviews and meta‐analyses over the last
decade have not demonstrated any difference in the clinical effectiveness of N95
respirators or equivalent compared to the use of surgical masks when used by
HCWs in multiple healthcare settings for the prevention of respiratory virus
infections, including influenza.
Reviews based on observational studies have usually found a stronger protective
effect for face masks, but have important biases. The review by Chu 2020 did not
consider RCTs of influenza transmission, but only the observational studies
examining impact on SARS, MERS, or SARS‐CoV‐2. For N95 masks versus no mask in
HCWs, there was a large protective effective with an OR of 0.04 (95% CI 0.004 to
0.30); for surgical masks versus no masks, there was an OR of 0.33 (0.17 to
0.61) overall, but four of these studies were in healthcare settings. Chu 2020
has been criticised for several reasons: use of an outdated 'Risk of bias' tool;
inaccuracy of distance measures; and not adequately addressing multiple sources
of bias, including recall and classification bias and in particular confounding.
Confounding is very likely, as preventive behaviours such as mask use, social
distancing, and hand hygiene are correlated behaviours, and hence any effect
estimates are likely to be overly optimistic.
Also based on observational studies, Jefferson 2011 found a protective effect of
wearing surgical masks with hygienic measures compared to not wearing masks in
the SARS 2003 outbreak (OR 0.32, 95% CI 0.26 to 0.39). However, the evidence was
based on case‐control studies carried out during the outbreak. There was some
additional but very limited supportive evidence from the cohort studies in
Jefferson 2011.
Although the use of eye protection and physical distancing measures are
widely believed to be effective in reducing transmission of respiratory viruses
and mitigating the impact of an influenza pandemic, we found only one trial
investigating the role of self‐quarantine in reducing the incidence of H1N1
influenza events in the workplace, and no trials examining the effect of eye
protection. The evidence for these measures was derived largely from
observational studies and simulation studies, and the overall quality of
supporting evidence is relatively low. The finding of limited evidence
evaluating these interventions was also consistent with a recent review funded
by the WHO for the preparation of its guidelines on the use
of non‐pharmaceutical interventions for pandemic influenza in non‐medical
settings (Fong 2020).
There are several previous systematic reviews on hand hygiene and respiratory
infections. Five of them reviewed the evidence in a community setting (Moncion
2019; Rabie 2006; Saunders‐Hastings 2017; Warren‐Gash 2013: Wong 2014), and
three focused on children (Mbakaya 2017; Willmott 2016; Zivich 2018). The
earliest review in 2006 included eight studies (Rabie 2006), three of which were
RCTs. The pooled estimate of seven studies was described as “indicative” of the
effect of hand hygiene, but the studies were of poor quality. The Warren‐Gash
2013 review included 16 studies (10 of which were RCTs) and reported mixed and
inconclusive results. A 2014 review identified 10 RCTs and reported that the
combination of hand hygiene with face masks in high‐income countries (five
trials) significantly reduced the incidence of laboratory‐confirmed influenza
and ILI, whilst hand hygiene alone did not (Wong 2014). This significant
reduction in laboratory‐confirmed influenza and ILI for hand hygiene and face
masks may have been based on the raw numbers without adjusting for any
clustering effects in the included cluster trials, which produced
inappropriately narrow CIs, and possibly biased treatment effect estimates.
Moreover, trials from the low‐income countries were not included in the review,
and this significant effect was not demonstrated when all the trials identified
in the review were combined. The Saunders‐Hastings 2017 review of studies
evaluating the effectiveness of personal protective measures in interrupting
pandemic influenza transmission only identified two RCTs (Azor‐Martinez 2014;
Suess 2012), which reported a significant effect of hand hygiene. The Moncion
2019 review identified seven RCTs of hand hygiene compared to control, with
mixed results for preventing the transmission of laboratory‐confirmed or
possible influenza. Systematic reviews of RCTs of hand hygiene interventions
amongst children, Mbakaya 2017; Willmott 2016, or at a non‐clinical workplace,
Zivich 2018, identified heterogeneous trials with quality problems including
small numbers of clusters and participants, inadequate randomisation, and
self‐reported outcomes. Evidence of impact on respiratory infections was
equivocal.
Figures and Tables -
Figure 1
Study flow diagram.
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Figures and Tables -
Figure 2
'Risk of bias' graph: review authors' judgements about each risk of bias item
presented as percentages across all included trials.
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Figures and Tables -
Figure 3
'Risk of bias' summary: review authors' judgements about each risk of bias item
for each included trial.
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Figures and Tables -
Analysis 1.1
Comparison 1: Randomised trials: medical/surgical masks versus no masks, Outcome
1: Viral illness
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Figures and Tables -
Analysis 1.2
Comparison 1: Randomised trials: medical/surgical masks versus no masks, Outcome
2: Influenza‐like illness in healthcare workers
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Figures and Tables -
Analysis 2.1
Comparison 2: Randomised trials: N95 respirators compared to medical/surgical
masks, Outcome 1: Viral illness
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Figures and Tables -
Analysis 2.2
Comparison 2: Randomised trials: N95 respirators compared to medical/surgical
masks, Outcome 2: Viral illness in healthcare workers
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Figures and Tables -
Analysis 3.1
Comparison 3: Randomised trials: hand hygiene compared to control, Outcome 1:
Viral illness
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Figures and Tables -
Analysis 3.2
Comparison 3: Randomised trials: hand hygiene compared to control, Outcome 2:
ARI or ILI or influenza (including outcome with most events from each study)
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Analysis 3.3
Comparison 3: Randomised trials: hand hygiene compared to control, Outcome 3:
Influenza or ILI: sensitivity analysis including outcomes with the most precise
and unequivocal definitions
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Figures and Tables -
Analysis 3.4
Comparison 3: Randomised trials: hand hygiene compared to control, Outcome 4:
ARI or ILI or influenza: subgroup analysis
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Analysis 3.5
Comparison 3: Randomised trials: hand hygiene compared to control, Outcome 5:
Absenteeism
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Analysis 4.1
Comparison 4: Randomised trials: hand hygiene + medical/surgical masks compared
to control, Outcome 1: Viral illness
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Analysis 5.1
Comparison 5: Randomised trials: hand hygiene + medical/surgical masks compared
to hand hygiene, Outcome 1: Viral illness
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Analysis 6.1
Comparison 6: Randomised trials: gargling compared to control, Outcome 1: Viral
illness
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Summary of findings 1. Medical/surgical masks compared to no masks for
preventing the spread of viral respiratory illness
Randomised studies: medical/surgical masks compared to no masks for preventing
the spread of viral respiratory illness
Patient or population: general population and healthcare workers
Setting: community and hospitals
Intervention: medical/surgical masks
Comparison: no masks
Outcomes
Anticipated absolute effects* (95% CI)
Relative effect
(95% CI)
№ of participants
(studies)
Certainty of the evidence
(GRADE)
Comments
Risk with no masks
Risk with randomised studies: masks
Viral illness ‐ influenza‐like illness
Study population
RR 0.99
(0.82 to 1.18)
3507 (9 RCTs)
⊕⊕⊝⊝
LOWa,b
160 per 1000
158 per 1000
(131 to 189)
Viral illness ‐ laboratory‐confirmed influenza
Study population
RR 0.91
(0.66 to 1.26)
3005 (6 RCTs)
⊕⊕⊕⊝
MODERATEb
40 per 1000
36 per 1000
(26 to 50)
Influenza‐like illness in healthcare workers
Study population
RR 0.37
(0.05 to 2.50)
1070 (2 RCTs)
⊕⊕⊝⊝
LOWa,b
Studies in healthcare workers only
40 per 1000
15 per 1000
(2 to 100)
Adverse events
‐
‐
(3 RCTs)
⊕⊝⊝⊝
VERY LOWa,c
Adverse events were not reported consistently and could not be meta‐analysed.
Adverse events reported for masks included warmth, discomfort, respiratory
difficulties, humidity, pain, and shortness of breath, in up to 45% of
participants.
*The risk in the intervention group (and its 95% confidence interval) is based
on the median observed risk in the comparison group of included studies and the
relative effect of the intervention (and its 95% CI).
CI: confidence interval; RCT: randomised controlled trial; RR: risk ratio
GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of
the estimate of the effect.
Moderate certainty: We are moderately confident in the effect estimate: the true
effect is likely to be close to the estimate of the effect, but there is a
possibility that it is substantially different.
Low certainty: Our confidence in the effect estimate is limited: the true effect
may be substantially different from the estimate of the effect.
Very low certainty: We have very little confidence in the effect estimate: the
true effect is likely to be substantially different from the estimate of effect.
aStudy limitations (lack of blinding).
bImprecision (wide confidence intervals).
cImprecision: 2 steps (only 3 studies enumerated adverse events; another study
mentioned no adverse events).
Figures and Tables -
Summary of findings 1. Medical/surgical masks compared to no masks for
preventing the spread of viral respiratory illness
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Summary of findings 2. N95 respirators compared to medical/surgical masks for
preventing the spread of viral respiratory illness
Randomised studies: N95 respirators compared to medical/surgical masks for
preventing the spread of viral respiratory illness
Patient or population: healthcare workers and general population
Setting: hospitals and households
Intervention: N95 masks
Comparison: medical/surgical masks
Outcomes
Anticipated absolute effects* (95% CI)
Relative effect
(95% CI)
№ of participants
(studies)
Certainty of the evidence
(GRADE)
Comments
Risk with medical masks
Risk with randomised studies: N95
Viral illness ‐ clinical respiratory illness
Study population
RR 0.70
(0.45 to 1.10)
7799 (3 RCTs)
⊕⊝⊝⊝
VERY LOWa,b,c
All studies were conducted in hospital settings with healthcare workers.
120 per 1000
84 per 1000
(54 to 132)
Viral illness ‐ influenza‐like illness
Study population
RR 0.82
(0.66 to 1.03)
8407 (5 RCTs)
⊕⊕⊝⊝
LOWa,b
1 study was conducted in households (MacIntyre 2009).
50 per 1000
41 per 1000
(33 to 52)
Viral illness ‐ laboratory‐confirmed influenza
Study population
RR 1.10
(0.90 to 1.34)
8407 (5 RCTs)
⊕⊕⊕⊝
MODERATEb
1 study was conducted in households (MacIntyre 2009).
70 per 1000
77 per 1000
(63 to 94)
Adverse events
‐
‐
(5 RCTs)
⊕⊝⊝⊝ VERY LOWa,b,c
There was insufficient consistent reporting of adverse events to enable
meta‐analysis.
Only 1 study reported detailed adverse events: discomfort was reported in 41.9%
of N95 wearers versus 9.8% of medical mask wearers (P < 0.001); headaches were
more common with N95 (13.4% versus 3.9%; P < 0.001); difficulty breathing was
reported more often in the N95 group (19.4% versus 12.5%; P = 0.01); and N95
caused more problems with pressure on the nose (52.2% versus 11.0%; P < 0.001).
4 RCTs either reported no adverse events or only reported on comfort wearing
masks.
*The risk in the intervention group (and its 95% confidence interval) is based
on the median risk in the comparison group and the observed relative effect of
the intervention (and its 95% CI).
CI: confidence interval; RCT: randomised controlled trial; RR: risk ratio
GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of
the estimate of the effect.
Moderate certainty: We are moderately confident in the effect estimate: the true
effect is likely to be close to the estimate of the effect, but there is a
possibility that it is substantially different.
Low certainty: Our confidence in the effect estimate is limited: the true effect
may be substantially different from the estimate of the effect.
Very low certainty: We have very little confidence in the effect estimate: the
true effect is likely to be substantially different from the estimate of effect.
aStudy limitations (lack of blinding).
bImprecision (wide confidence interval or no meta‐analysis conducted).
cInconsistency of results (heterogeneity).
Figures and Tables -
Summary of findings 2. N95 respirators compared to medical/surgical masks for
preventing the spread of viral respiratory illness
Navigate to table in Review
Summary of findings 3. Hand hygiene compared to control for preventing the
spread of viral respiratory illness
Hand hygiene compared to control for preventing the spread of viral respiratory
illness
Patient or population: prevention of spread of viral respiratory illness
Setting: schools, childcare centres, homes, offices
Intervention: hand hygiene
Comparison: control
Outcomes
Anticipated absolute effects* (95% CI)
Relative effect
(95% CI)
№ of participants
(studies)
Certainty of the evidence
(GRADE)
Comments
Risk with control
Risk with hand hygiene
Acute respiratory illness
Study population
RR 0.84
(0.82 to 0.86)
44,129 (7 RCTs)
⊕⊕⊕⊝
MODERATEa
380 per 1000
319 per 1000
(312 to 327)
Influenza‐like illness
Study population
RR 0.98
(0.85 to 1.13)
32,641 (10 RCTs)
⊕⊕⊝⊝
LOWa,b
90 per 1000
88 per 1000
(77 to 102)
Laboratory‐confirmed influenza
Study population
RR 0.91
(0.63 to 1.30)
8332 (8 RCTs)
⊕⊕⊝⊝
LOWb,c
80 per 1000
73 per 1000
(50 to 104)
Composite of acute respiratory illness, influenza‐like illness, influenza
Study population
RR 0.89
(0.84 to 0.95)
61,372 (16 RCTs)
⊕⊕⊝⊝
LOWa,b
200 per 1000
178 per 1000
(168 to 190)
Adverse events
‐
‐
(2 RCTs)
⊕⊝⊝⊝
VERY LOWa,b,c
Data were insufficient to conduct meta‐analysis.
1 study reported that no adverse events were observed, and another study
reported that skin reaction was recorded for 10.4% of participants in the hand
sanitiser group versus 10.3% in the control group.
*The risk in the intervention group (and its 95% confidence interval) is based
on the median observed risk in the comparison groups of included studies and the
relative effect of the intervention (and its 95% CI).
CI: confidence interval; RCT: randomised controlled trial; RR: risk ratio
GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of
the estimate of the effect.
Moderate certainty: We are moderately confident in the effect estimate: the true
effect is likely to be close to the estimate of the effect, but there is a
possibility that it is substantially different.
Low certainty: Our confidence in the effect estimate is limited: the true effect
may be substantially different from the estimate of the effect.
Very low certainty: We have very little confidence in the effect estimate: the
true effect is likely to be substantially different from the estimate of effect.
aStudy limitation (majority of studies were unblinded, with participant‐assessed
outcome).
bInconsistent results across studies.
cImprecision (wide confidence interval or no meta‐analysis conducted).
Figures and Tables -
Summary of findings 3. Hand hygiene compared to control for preventing the
spread of viral respiratory illness
Navigate to table in Review
Table 1. Description of interventions in included studies, using the items from
the Template for Intervention Description and Replication (TIDieR) checklist
Author, year
Brief name
Recipient
Why
What (materials)
What (procedures)
Who provided
How
Where
When and how much
Tailoring
Modification of intervention throughout trial
Strategies to improve or maintain intervention fidelity
Extent of intervention fidelity
Masks compared to either no masks or different mask types
Barasheed 2014
Supervised mask use
Religious pilgrims ≥ 15 years
Prevent respiratory virus infections at mass gatherings through mask use
Plain surgical face masks (3M Standard Tie‐On Surgical Mask, Cat No: 1816)
manufactured by 3M company, USA; 5 masks per day
Written instructions on face mask use
Special polythene bags for disposal
Masks provided to index case and their contacts with advice on mask use (before
prayers, in seminars, and after meals).
Written instructions provided on face mask use, need to change them, and
disposal.
Not described, presumably the medical researchers
Face‐to‐face provision of masks, instructions, and reminders
Tents of pilgrimage site (Mina Valley, Saudi Arabia)
Advice on mask use given throughout pilgrimage stay (5 days)
None reported.
None reported.
The medical researchers followed pilgrims each day to remind participants about
recording their mask usage in health diary.
Face mask use: mask group: 56/75 (76%), control group: 11/89 (12%)
(P < 0.001)
76% of intervention tents wore masks.
10 of 75 (13%) pilgrims in ‘mask’ tents wore face masks during sleep.
Canini 2010
Surgical face masks
Householders (over 5 years)
Limit transmission of influenza transmission by large droplets produced during
coughing in households
Initial supply of 30 masks:
for adults and children > 10: surgery masks with earloops, 3 plys, anti fog
(AEROKYN, LCH medical products, Paris, France)
Children 5 to 10: face mask KC47127, (Kimberly‐Clark, Dallas, TX, USA)
Closed plastic bags for disposal
Masks given immediately on home visit by attending general practitioner with
demonstration of proper use and instruction to be worn for 5 days in presence of
another household member or in confined space (e.g. car) and to change every 3
hours or if damaged.
General practitioners
Face‐to‐face individually
Households in France
One‐off provision of masks worn for 5 days
None described.
None described.
Not described, but reported mask usage was measured
34/51 (66%)
wore masks > 80% of the duration.
Reported mask‐wearing: 11 ± 7.2 masks during 4.0 ± 1.6 days with an average use
of
2.5 ± 1.3 masks per day and duration of use of 3.7 ± 2.7 hours/day
Jacobs 2009
Face masks
Hospital healthcare providers (nurses, doctors, and co‐medical personnel)
Decrease risk of infection through limiting droplet spread through masks
Hospital‐standard disposable surgical
Mask MA‐3 (Ozu Sangyo, Tokyo, Japan); quantity not specified
Provision of masks and instructions for use
Not described, presumably research team
Face‐to‐face
Tertiary care hospital in Tokyo, Japan
Face masks worn whilst on hospital property.
77 days
None described.
None described.
Self‐reported compliance
Self‐reported compliance for both groups reported as good, with full compliance
by 84.3% and remainder complying 79.2% to 98.7%.
Loeb 2009
2 active interventions
A. surgical masks
B. N95 respirators
Healthcare workers (nurses)
Reduce transmission of influenza in healthcare settings through coughing or
sneezing with protective masks
A. Surgical masks
B. N95 respirators
Provision of masks or N95 respirators
Instruction in use and proper placement of devices
Fit‐testing and demonstration of positioning of N95 using standard protocol and
procedure (details provided)
Qualitative fit‐testing using saccharin or Bitrex protocol[1]
Provided by research team (not further described)
Fit‐testing by technician for N95
In‐person face‐to‐face
Tertiary hospitals in Ontario, Canada
1 influenza season (12 weeks)
Use of mask as required[2] when providing care to or within 1 m of patient with
febrile respiratory illness, ≥ 38 °C, and new or worsening cough or shortness of
breath
Nurses to wear N95 when caring for patients with “febrile respiratory illness”
Fit‐testing of nurses not already fit‐tested
Ceased before end of season
Compliance audits during peak of season by trained auditor who stood short
distance from patient isolation room
18 episodes:
N95: 6/7 participants (85.7%) wearing assigned device versus 100% for masks
MacIntyre 2009
2 active interventions in addition to infection control guidelines
A. Surgical masks (SM)
B. P2 masks (P2)
Householders with a child with fever and respiratory symptoms
Prevent or reduce respiratory virus transmission in the community through
non‐pharmaceutical interventions
A. 3M surgical mask, catalogue no. 1820;
St Paul, MN, USA for adults
B. P2 masks (3M flat‐fold P2 mask, catalogue no. 9320; Bracknell, Berkshire, UK)
A and B: health guidelines and pamphlets about infection control
Provision of masks and pamphlets and education about infection prevention and
mask use
Telephone calls and exit interviews to record adherence to mask use
All groups: health guidelines, pamphlets about infection control were provided
Not described, presumably research team
Face‐to‐face and by telephone
Households in Sydney, Australia
2 winter seasons (3 months and 6 months)
2 weeks of follow‐up
Masks to be worn at all times
when in same room as index child, regardless of
distance from child
None described.
None described.
Daily telephone calls to record mask use throughout day
Exit interviews about adherence
Reported mask use:
Day 1
SM: 36/94 (38%)
P2: 42/92 (46%) stated wearing “most or all” of the time. Other participants
were wearing face masks rarely or never.
Day 5:
SM: 29/94 (31%)
P2: 23/92 (25%)
MacIntyre 2011
3 active interventions
A. Medical masks
B. N95 respirators fit‐tested
C. N95 respirators non‐fit‐tested
Healthcare workers
Protect HCWs by preventing transmission of influenza and other respiratory
viruses from patients through mask wearing
Daily supply of
A. 3 medical masks (3M medical mask, catalogue number 1820, St Paul, MN, USA)
2 respirators:
B. N95 fit‐tested mask (3M flat‐fold N95 respirator, catalogue number 9132)
fit‐tested with 3M FT‐30 Bitrex Fit Test kit according to manufacturer's
instructions (3M, St Paul, MN, USA)
C. N95 non‐fit‐tested mask (3M flat‐fold N95 respirator, catalogue number 9132)
Diary cards for usage recording
Supply of masks or respirators.
Instruction in when to wear it, correct fitting, and storage (in paper bag in
personal locker)
Instruction in importance of hand hygiene before and after removal
For fit‐tested group: fit‐testing procedure
Masks provided to hospitals.
Training of staff provided by 1 member of research team.
Masks and training provided face‐to‐face, not described if training was
individually or in groups.
Emergency departments and respiratory wards in hospitals in Beijing, China
Entire work shift for 4 weeks
Taken off for toilet and meal breaks and at end of shift
None described.
Mask ⁄ respirator use monitored by:
(i) observed compliance by head ward nurse recorded daily;
(ii) self‐report diary cards carried during day recording;
(i) no. hours;
(ii) usage.
Exit interviews
Adherence for usage was high for all and not significantly
different amongst arms.
Medical mask: 76%, 5 hours
N95 fit‐tested: 74%, 5.2 hours
N95 non‐fit‐tested: 68%, 4.9 hours
MacIntyre 2013
3 active interventions
A. N95 respirators at all times
B. N95 respirators targeted use
C. Medical masks
Healthcare workers (nurses and doctors)
Protect HCWs from respiratory infections from patients through mask use
Daily supply of:
A. and B.
2 respirators
(3M Health Care
N95 Particulate Respirator; catalogue number 1860)
3M FT‐30 Bitrex Fit Test Kit
C. 3 masks
3 masks
(3M Standard Tie‐On Surgical Mask catalogue number mask 1817; 3M, St Paul, MN,
USA)
Pocket‐sized diary card with tick boxes for mask use
Supply of respirators
Instructions in use including times and fit
Fit‐testing procedure according to the manufacturer’s instructions (3M)
For targeted N95:
checklist of defined high‐risk procedures, including common aerosol‐generating
procedures
3M supplied respirators and masks.
Provider of instructions not specified.
Masks and training provided face‐to‐face, not described if training was
individually or in groups.
Emergency departments and respiratory wards of tertiary hospitals in Beijing,
China
For 4 weeks,
A and B worn at all times on shift;
B. targeted (intermittent) use of N95 respirators only whilst performing
high‐risk procedures or barrier.
None described.
None described.
Self‐reported daily record of number of hours worked, mask or respirator use,
number of high‐risk procedures undertaken collected by study staff.
Compliance highest for targeted
N95 (82%; 422/516) versus N95 (57%; 333/581)
versus medical mask (66%; 380/572).
MacIntyre 2015
2 active interventions
A. Cloth masks
B. Medical masks
Hospital
healthcare workers
Prevent respiratory infections in HCWs from patients through mask‐wearing
A. 5 cloth masks for study duration (2‐ layer, cotton)
B. 2 medical masks daily for each 8‐hour shift for study duration (3 layers,
non‐woven material)
All masks locally manufactured.
Written instructions on cleaning cloth masks
Cloth or medical masks to be worn at all times on shift.
Cloth masks to be washed with soap and water daily after shifts, and the process
of cleaning to be documented.
Provision of written instructions for cloth mask cleaning
Researchers arranged supply of masks and instructions and any training of staff
assisting the delivery.
Masks and written instructions provided face‐to‐face.
Hospital wards in Vietnam
4 weeks (25 days) of face mask use
Masks not worn while in the toilet or during tea or lunch breaks.
None described.
Monitored compliance with mask use by
self‐report diary card and exit survey and interviews with a sub‐sample
(ACTRN12610000887077)
Mask‐wearing compliance:
cloth mask: 56.8%; medical mask: 56.6%;
Reported cloth mask washing: 23/25 days (92%)
MacIntyre 2016
Medical mask use
Sick householders with ILI (index cases) and their well contacts of the same
household
Protect well people in the community from transmission of respiratory pathogens
by contacts with ILI through mask use
21 medical masks (3M 1817 surgical mask)
Diary cards for mask use
Supply of masks
Instructions for mask wearing and hand‐washing protocol
Provision of diary cards
Study staff member provided masks and instructions in use.
Masks and instructions provided face‐to‐face and individually.
Fever clinics of major hospitals in Beijing, China
3 masks/day for 21 days
Mask wearing: whenever in the same room as a household member or a visitor to
the household
Hand‐washing: before putting on and after taking off
Allowed to remove their masks during mealtimes and whilst asleep and to cease
wearing once symptoms resolved
None reported.
Self‐reported daily record of mask use using diary card
Mask use: mask group: 4.4 hours; control group: 1.4 hours
Radonovich 2019
2 active interventions
A. N95 respirators (N95)
B. Medical masks (MM)
Healthcare personnel of outpatient sites within medical centres
Prevent HCP from acquiring
workplace viral respiratory infections and transmitting them to others by
effective respiratory protection by N95 respirators which reduce aerosol
exposure and inhalation of small airborne particles, meet filtration
requirements, and fit tightly
A. N95 respirators:
3M Corporation 1860, 1860S, and 1870 (St Paul, MN, USA) or Kimberly Clark
Technol Fluidshield
PFR95‐270, PFR95‐274 (Dallas, TX, USA)
B. Medical mask Precept 15320 (Arden, NC, USA) or
Kimberly Clark Technol Fluidshield 47107 (Dallas, TX, USA).
Reminder signs posted at each site
A portable computer equipped with data recording software (HandyAudit; Toronto,
Canada) to document adherence (Radonovich 2016)
Participants instructed to wear assigned protective devices whenever they were
positioned within
6 feet (1.83 m) of patients with suspected or confirmed
respiratory illness and to don a new N95/MM with each patient interaction.
Hand hygiene recommended
to all participants in accordance with Centers for Disease Control
and Prevention guidelines.
Infection prevention policies
were followed at each study site.
Reminder signs posted at sites and emails sent.
Annual fit‐testing conducted for all participants.
Filtration testing performed on the device models in the study. Further details
in protocol (Radonovich 2016).
Centres provided device supplied by study to HCP.
Study personnel posted reminder signs and emails and conducted adherence
observations.
Face‐to‐face individual provision of devices and adherence observations
Onsite posting of signs
Other reminders by email
Outpatient sites within medical centres in USA
As instructed, for each new patient interaction during 12‐week period of peak
viral respiratory illness each year for 4 years (total of 48 weeks)
Fitting of N95 masks
None described.
Reminder signage posted at study sites, and emails sent by study personnel.
Self‐reported daily device wearing of “always”, “sometimes”, “never”, or “did
not recall"
Observation of device‐wearing behaviours as participants entered and exited care
rooms conducted during unannounced, inconspicuous visits to randomly selected
sites documented on portable computer
Device wearing:
N95: 89.4% reported “always” or “sometimes” versus MM: 90.2%
“Never”
N95: 10.2%
MM: 9.5%
Hand hygiene
Alzaher 2018
Hand hygiene workshop
Primary school girls
Targeted school children to improve hand hygiene to reduce school absences due
to upper respiratory infection and spread of infection in schools and to
families
6‐minute video‐clip of 2 siblings that attended school‐based health education
about hand hygiene
Short interactive lecture about:
common infections in schools,
methods of transmission, hand‐washing procedure using soap and water including
when to wash hands
Puzzle games related to hand hygiene
Posters with cartoon princesses’ picture promoting hand‐washing
Delivery of workshop and distribution of supporting materials (games and
posters) to school and students
Study investigator delivered workshop.
Delivered face‐to‐face in group format for the workshop
2 primary girls’ schools in Saudi Arabia
1‐hour once‐off workshop; posters and games provided to school
Not described
Not described
Posters in restrooms as reminders of hand‐washing hygiene during 5‐week
follow‐up period after workshop
Not reported
Arbogast 2016
Multimodal hand hygiene intervention programme in addition to control of brief
video
Office buildings and the employees of health insurance company
Reduce hand‐to‐mouth germ transmission from shared workspaces and workplace
facilities and thereby healthcare claims and absenteeism through improved
workplace hand hygiene
Alcohol‐based hand sanitiser (PURELL Advanced, GOJO Industries Inc, Akron, OH,
USA) installed as wall‐mounted dispensers, stands, or free‐standing bottles
One 8‐ounce bottle of hand sanitiser (PURELL Advanced) per cubicle
One 100‐count canister of hand wipes (PURELL Wipes) per cubicle
Replenishment products stored in supply room
(in addition to existing foam hand wash (GOJO Green Certified Foam Handwash) and
an alcohol‐based hand sanitiser foam wall‐mounted dispenser (PURELL, GOJO
Industries) already provided near the restroom exits prior to intervention)
Identical soap in all restrooms
Intervention and control group:
brief (< 1‐minute educational video) about proper hand hygiene technique, for
both washing and sanitising hands
‘‘Wash Your Hands’’, signage promoting hand hygiene compliance, was already
posted next to restroom exits at both the control and intervention sites.
Hand hygiene supplies installed in offices.
Replenishment product was made easily available to individual employees upon
request via a simple process.
Monitoring of product shipments into sites
Physical collection and full replacement of soap, sanitiser, and wipes
Intervention and control group:
educational video embedded at end of baseline online knowledge survey
Not described, presumably study investigators arranged installations
Hand hygiene supplies provided in office environments and individually at staff
cubicles/offices.
Video provided individually via email.
High‐traffic common areas of 2 US health insurance company offices (e.g. near
elevators, at entrances) and appropriate public spaces (e.g. coffee area, break
rooms, conference rooms, training rooms, lobbies, reception areas); individual
staff cubicles of mostly open plan offices (average 309 square feet).
Office restrooms
13.5 months overall
One‐off email video
11 days before study hand hygiene supplies installed.
13 months of provision of supplies
2 times evening collection and full replacement of products
Sanitiser installed in high‐use areas of the offices.
Not described
Employee survey at 4 months included questions about hand hygiene practice
compliance.
Monitoring of product
shipments into the sites and physical collection of the soap, sanitiser, and
wipes products 2 times in the study; collected samples were measured and usage
rates were
estimated
Intervention group employees: reported 40% more cleaning of work area regularly;
significantly more likely to keep the hand sanitiser with them and use it
throughout the day; significant increases in hand sanitiser use for at‐risk
activities[3]
Estimated use by average employee from sample collection:
sanitiser 1.8 to 3.0 times/day,
soap
2.1 to 4.4 times/day,
wipes at their desk 1.4 to 1.5 times/week
Azor‐Martinez 2016
Hand‐washing programme
Primary school children and their parents and teachers
Prevent transmission of upper respiratory infections in schools and to families
through non‐pharmaceutical
intervention of hand‐washing programme in schools
Brochure about hand‐washing awareness and habits
Workshop content materials
Stories, songs, and classroom posters about hand hygiene and infection
transmission
Hand sanitiser (ALCO ALOE GEL hand sanitiser by Americo Govantes Burguete, S.L.
Madrid, Spain containing 0.2% chlorhexidine digluconate, 1% phenoxyethanol, 0.1%
benzalkonium chloride, 5% aloe barbadensis, 70% denat ethyl alcohol, excipients
quantity sufficient for 100 mL alcohol 70%, pH 7.0 to 7.5)
Informational poster about when and how to wash hands
Written and verbal guidance to teachers, parents, and students on properties,
possible side effects, and precautionary measures for gel use and storage
Brochure sent to parents by mail with study information sheet.
Workshop provided for pupils and teachers:
frequent infections in schools, transmission and prevention, instructions on
correct hand‐washing (water and soap, soaping > 20 s, drying hands),
use of hand sanitisers and possible side effects
Classroom activities linked to hand hygiene and infection transmission
Reinforcement of hand hygiene by teachers
Hand sanitiser dispensers fixed to walls with an informational poster about
hand‐washing
Supervision of younger children when using hand sanitiser and administration of
sanitiser if needed
Instruction of children in hand‐washing procedures after toilet and when dirty
and correct hand sanitiser use[4]
Brochure sent by school administration.
Workshop and verbal and written information presumably provided by the study
research assistant.
Classroom activities provided by research assistant and teachers.
Supervision and administration of hand sanitiser for younger children by
teachers
Brochure sent by mail to individual parents.
Workshops and classroom activities delivered in groups face‐to‐face.
Teacher reinforcement of hand hygiene provided to class face‐to‐face.
Hand sanitiser use supervision was provided individually and face‐to‐face.
Primary school classes in Spain (details not provided)
8 months overall
One‐off brochure and installation of hand sanitiser dispensers
2‐hour workshop held 1 month before study commencement
Fortnightly classroom activities
As required, teacher supervision and administration of hand sanitiser
Daily reinforcement of hand hygiene by teachers
Supervision and administration of hand sanitiser as needed by teachers,
especially for younger children
Not described
Daily reinforcement by teachers of hand hygiene
Fortnightly support by research assistant promoting hand‐washing
Self‐reported correct hand‐washing procedure (water and soap, soaping > than 20
s, drying hands)
Self‐reported correct hand‐washing included in analysis but not separately
reported.
Azor‐Martinez 2018
Educational and hand hygiene programme
2 active interventions:
A. soap and water
B. hand sanitiser
Day care centres and their attending children, their parents, and DCC staff
Prevent transmission of respiratory infections by improved hand hygiene of
children, parents, and staff through hand‐washing practices and use of hand
sanitiser due to its bactericide and virucide properties
A. Liquid soap (no specific antibacterial components (pH = 5.5))
OR
B. Hand sanitiser (70% ethyl alcohol (pH = 7.0 to 7.5)) for home use and in
dispensers for school classroom
Workshop content handout
Stories, songs, and posters about hand hygiene and infection transmission
Installation of liquid soap or hand sanitiser dispensers in classrooms
Supervision and administration of hand sanitiser if required
3 hand hygiene workshops for parents and DCC staff:
1. Hand‐washing practices, hand sanitiser use, possible side effects and
precautionary measures (HSG only)
2. RIs and their treatments
3. Fever
Instructions to children, parents, and DCC staff on usual hand‐washing practices
and protocol [5]
Classroom activities (stories and songs) about hand hygiene and infection
transmission
Workshop delivered by researchers.
Research assistant provided hand hygiene materials to DCCs and parents.
Parents and staff supervised and administered sanitiser where indicated.
Workshops delivered face‐to‐face in groups to parents and staff.
Workshop content emailed to attendees individually.
Individual face‐to‐face supervision of hand sanitiser use, as indicated
Classroom of DCCs (in Spain) for child interventions
Workshops provided at DCCs.
8 months overall
Initial 1‐hour workshop 1 month before study commencement
3 further identical sessions/DCC provided again 1 month apart
Fortnightly classrooms and DCC activities
One‐off installation of dispensers
As‐needed supervision of hand sanitiser use
Dose of sanitiser: 1 to 2 mL/disinfection
Administration of hand sanitiser in the case of young children
DCC staff could attend training at other DCC if unable to attend at own DCC.
Not described
Not described
Reported that no monitoring of compliance
through continuous observation of hand hygiene
behaviours was done, but amount of hand sanitiser was measured
Families or DCC staff, or both, used 1660 L of hand sanitiser, estimated use by
each child of dose 6 to 8 times/day.
Biswas 2019
Hand sanitiser and respiratory hygiene education
Primary schools and their students and staff
Reduce community‐wide influenza virus transmission by improving hand‐washing and
respiratory hygiene and use of sanitiser in schoolchildren as contributors to
community‐wide virus transmission
Hand sanitiser
(63% ethyl alcohol) in colourless, transparent 1.5‐litre local plastic bottles
(manufactured by a local pharmaceutical company and was available commercially
in Bangladesh (price: USD 5.75/L))
Video clip on respiratory hygiene practices
Behavioural change materials – 3 colour posters (see Appendix of paper)
Curriculum materials for hygiene classes
Installation of hand sanitiser in wall dispensers in all classrooms and outside
all toilets, refilled by field staff as needed
Encouragement of use of sanitiser at 5 key times during the day[6]
Hand and respiratory hygiene education provided.[7]
Integration of hygiene messages into school’s hygiene curriculum
Delivery of video clip on respiratory hygiene practice
Behaviour change materials distributed and placed around schools.
Use of sanitiser by classroom teachers after training
Training of selected teachers in consultation with head of school and management
committee in key messages
Communication of key messages by the selected teachers to other teachers
Selected teachers responsible for dissemination of intervention messages
throughout were trained over 2 days in these messages, behaviour change
communication, sanitiser use, and practices for preventing spread of respiratory
secretions.
Classroom teachers conveyed intervention messages during regular hygiene
classes.
Field staff replaced supplies as needed.
Hand sanitiser and education materials provided to schools.
Education provided in classrooms in groups and face‐to‐face.
Primary schools (in Bangladesh)
Sanitiser in each classroom and outside toilets
Education in classroom
10 weeks
Intervention messages conveyed in classrooms 3 times/week.
Refills provided as needed.
Not described
Structured field observation by 2 field staff of 5 hours/school observing
hand‐washing and respiratory hygiene behaviours of children at 2 different
locations in a classroom or outside
Every other day, field staff measured the level of hand sanitiser in the morning
and in the afternoon to calculate amount of hand sanitiser used/day/school and
enrolled children.
Hand‐washing observed opportunities:
IG 604/921 (66%) vs CG 171/802 (21%)
Hand sanitiser used in 91% of observed hand‐washing events in intervention
schools.
Average
consumption of hand sanitiser/child/day: 4.3 mL
Observation of proper cough or sneeze etiquette: IG: 33% vs CG: 2%
Correa 2012
Alcohol‐based hand rubs
Childcare centres and their staff and children
Reduce incidence and transmission of infection in children by improved hand
hygiene where water is scarce including provision of ABH and training in hand
hygiene teaching techniques
Dispensers of alcohol‐based hand rubs with ethanol 62.0% (PURELL, GOJO
Industries, Akron, OH, USA)
Workshop materials[8]
Visual reminders on ABH techniques in bathrooms and next to dispensers
ABH and training
on proper use to staff and children
Pre‐trial ABH use workshop to teachers that followed recommended HH teaching
techniques and instructed teachers to add ABH to routine HH and give preference
to hand‐washing with soap and water if hands visibly soiled
Continuous refilling of ABH
ABH technique refresher workshops (8/centre)
Monitoring of safety, proper use of ABH, amount of ABH used
Local representative
of GOJO Industries Inc.
provided dispensers and dispenser
installations free of charge.
Fieldwork team delivered other components.
Face‐to‐face training and provision of materials; group training
Childcare centres in Colombia (centres or community homes)
ABH in centres, classrooms, and common areas depending on size
Visual reminders
in bathrooms
and next to dispensers
Workshops and training presumably provided in centres.
8 months overall
1 ABH dispenser per centre with < 14 children;
1 per classroom in larger centres; 1 per classroom +
1 for common areas in centres with > 28 children
1 workshop pre‐trial to staff
Monthly 30‐minute ABH technique refresher training (8 per centre)
Biweekly monitoring
Refilled ABH as needed
Not described
Visual reminders and monthly refresher training
Monitoring of safety, proper use of ABH, amount of ABH used
Semi‐structured survey on completion of teachers' perceptions
about changes in HH practices and use of HSW and ABH.
Measurement of consumption
of resources and costs related to ABH use and HSW
Teachers at 7
intervention centres reported almost
complete substitution of HSW with ABH, and HSW decreased from 3 times per day to
1 per day, and ABH rose to 6 per day. Teachers at remaining 14 centres reported
partial substitution of HSW with ABH.
Controls reported HSW 3 times per day.
Median number of ABH applications per child
rose from 3.5 to 4.5 in preschools and 3.5 to 5.5 in community centres.
DiVita 2011
Household hand‐washing promotion
Householders with index patient with ILI
Prevent influenza transmission in households in resource‐poor settings through
provision of hand‐washing facilities and use of them at critical times for
pathogen transmission
Hand‐washing stations with soap
Provision of hand‐washing stations
Hand‐washing motivation to wash at critical times for pathogen transmission
(e.g. after coughing or sneezing)
Not specifically described, presumably the researchers
Face‐to‐face provision of facilities in households
"Motivation" not described
Household in Bangladesh
Over 2 influenza seasons
One‐off provision of hand‐washing facilities
Frequency of “motivation” not described
Not described
Not described
Not described
Not described
Feldman 2016
2 active interventions
A. Hand disinfection with chlorhexidine gluconate + hygiene education
B. Hygiene education
Naval ships and their sailors
Reduced infection transmission and improved hand hygiene in sailors who are at
increased risk due to closed environments, contact with shared surfaces, and
poor HH culture
Septadine solution (Floris, Misgav, Israel) 70% alcohol and 0.5% CHG; inactive
materials: purified water, glycerin, propylene glycol, and methylene blue
Installation of CHG disinfection devices on ships alongside regular soap and
water
Supply and replenishment of CHG (sent to ships regardless of replenishment
demands)
Hygiene instruction by a naval physician (to both intervention groups and study
control group)
Provision of CHG presumably by study team and funds
Hygiene instruction by naval physician
CHG sent to ships directly.
Mode of hygiene instruction not described.
Navy fast missile boats and patrol boats of naval base in Israel
Dispensers installed in key locations onboard (adjacent to heads (toilets), mess
decks
(dining rooms), common areas).
4 months
Unlimited supply of CHG replenished on demand for 4 to 5 months.
Automatic amount dispensed: 3 mL
CHG replenished on demand.
Not described
Total amount of CHG dispensed was tallied.
Mean volume CHG:
8.2 mL per sailor per day (projected yearly cost USD 45 per sailor)
Gwaltney 1980
A. Virucidal hand preparation
B. Placebo (no control)
Healthy young adults
Reduce infection rates by interrupting viral spread by hand or self‐inoculation
route
A. Virucidal hand preparation:
aqueous iodine (2% iodine and 4% potassium iodide)
B. Placebo: aqueous solution
of food colours (Kroger; Kroger Co., Cincinnati, OH, USA) mixed to resemble the
colour of iodine with 0.01% iodine and 0.02% potassium iodide to give an odour
of iodine
Masks
Immersion of each finger and thumb of both hands to proximal interphalangeal
joint (interphalangeal joint of thumb) into designated preparation for 5 seconds
then air‐dried for 5 to 6 min
Exposure of recipients to donors either immediately after treatment or after
2‐hour delay by hand contact with donor stroking fingers for 10 s
Masks worn by donors and recipients during procedure.
Recipients placed in single isolation rooms after second exposure till end of
experiment.
Researchers
Face‐to‐face and individually
US university
Exposure to donors on 3 consecutive days (days 2, 3, and 4) after initial
exposure
Not described
Not described
Reported knowledge of hand preparation use as active, placebo, or don't know
Active (n = 24):
6 active
2 placebo
16 don't know
Placebo (n = 22):
6 active
7 placebo
9 don't know
Hubner 2010
Alcoholic hand disinfection
Employees (administrative officers)
Reduce absenteeism and spread of infection in administration employees with
frequent customer contact and work with paper documents through improved hand
hygiene
2 alcohol‐based hand rubs (500 mL bottles) for desktop use to ensure minimal
effort for use:
1. Amphisept E (Bode Chemie, Hamburg, Germany) ethanol (80% w/w) based formula
with antibacterial, antifungal, and limited virus inactivating activity.
2. For participants with skin problems:
Sterillium (Bode Chemie, Hamburg, Germany) 2‐propanol (45% w/w), 1‐propanol (30%
w/w), and mecetronium etilsulfate (0.2% w/w), with a refatting effect and has
activity against bacteria, fungi and enveloped viruses.
Hand cream: Baktolan balm, water‐in‐oil emulsion with no non‐antibacterial
properties (Bode Chemie, Hamburg, Germany)
Provision of hand rub and instruction on use as needed at work only and in
accordance with prevailing standard[7]: at least 5 times per day, especially
after toileting, blowing nose, before eating, and after contact with ill
colleagues, customers, and archive material
Presumably provided or arranged by study team
In person to staff
Administration offices in Germany
Hand rubs used at desk or work (not outside of work).
12 months overall
Hand rub used as much needed for complete wetting of the hands (at least 3 mL or
a palmful)[8] at least 5 times per day.
Hand rub use especially after toileting, blowing nose, before eating, and after
contact with ill colleagues, customers, and archive material
Not described
Self‐reported compliance with hand hygiene measures
Reported mean hand disinfection frequency times per day:
> 5: 19%
3 to 5: 59.8%
1 to 2: 20.5%
< 1: 0.7%
Ladegaard 1999
(translated from Danish)
Hand hygiene programme
Daycare centres and their staff, children, and parents of children
Reduce risk of infection in child care through increased hygienic education of
daycare professionals, motivation of daycare facilities for regular hand
hygiene, and informing parents about hand hygiene
Personnel guide on recommendations for: hygiene, ventilation, out‐of‐stay care,
stricter hygienic regulations in cases with selected diseases
Fairy tale and poster “The Princess Who Won't Wash Hands”
Colouring in drawings
“Wash hands” song and rhymes
T‐shirt for children with the inscription “Clean hands ‐ yes thank you”
Diploma for children and book “The Princess Who Won't Wash Hands” to also be
used by parents with their child
Informational leaflet for parents in envelope
Staff meeting in each DCC and training in microbiological cause of infection
spread guided by National Board of Health and Hygiene
Education of children in hand‐washing (about bacteria and why and when to wash
hands)
Practical hand‐washing classes with 4 to 5 children at a time
Provision of t‐shirt, book, and diploma to children
Provision of leaflet for parents
Research team presumably provided training.
Face‐to‐face with training and activities by group with staff and children
Information sent home to parents via children.
Onsite in DCCs
2‐month intervention period
1‐hour training of children
None described.
None described.
None described.
None reported.
Little 2015
Web‐based hand‐washing intervention
Householders (over 18) who were general practice patients
Prevent transmission of respiratory tract infections through improved hand
hygiene to reduce spread via close contact (via droplets) and hand‐to‐face
contact
Website‐based programme: provided information about the importance of influenza
and role of hand‐washing;
developed a plan to maximise intention formation for hand‐washing;
reinforced helpful attitudes and norms;
addressed negative beliefs
(URL provided for demonstration version no longer active; see
www.lifeguideonline.org)
Provision of link to website for direct log in
Automated emails prompted participants to use sessions and complete monthly
questionnaires and maintain hand‐washing.
Researchers delivered web‐based programme and emails.
Online individually
Households in England
4 months overall
4 weekly web‐based sessions
Monthly email questions to maintain hand‐washing over 4 months
Tailored feedback provided within web programme
None described.
Emailed questions monthly to maintain hand‐washing
None reported.
Luby 2005
Hand‐washing promotion at neighbourhood level with 2 interventions at household
level
A. Antibacterial soap
B. Plain soap
Neighbourhoods and their households
Improve hand‐washing and bathing with soap in settings where communicable
diseases are leading causes of childhood morbidity and mortality
Slide shows, videotapes, and pamphlets illustrating health problems from
contaminated hands and specific hand‐washing instructions
Soaps: 90‐gram white bars without brand names or symbols, same smell with
identical generic white wrappers with serial numbers matched to households
A. Households: 2 to 4 white bars of 90‐gram antibacterial soap containing 1.2%
triclocarban (Safeguard Bar Soap: Procter & Gamble Company (Cincinnati, OH, USA)
B. Households: plain soap (no triclocarban)
Soap packets
Hand‐washing promotion to neighbourhoods:
Neighbourhood meetings of 10 to 15 householders (mothers) from nearby homes and
monthly meetings for men
Soap to households
Fieldworker home visits: discussed importance of and correct hand‐washing (wet
hands, lather them completely with soap, rub them together for 45 seconds, and
rinse off completely) technique and promote regular hand‐washing habits[11]
Encouragement of daily bathing with soap and water
Research team in collaboration with Health Oriented Preventive Education
(HOPE)[12]
Fieldworkers were trained in interviewing and hand‐washing promotion.
Face‐to‐face in small groups and individually
Neighbourhoods and homes in Karachi, Pakistan
1‐year weekly household visits
30‐ to 45‐minute neighbourhood meetings 2 to 3 times/week first 2 months then
weekly for months 2 to 9, then monthly
Monthly men’s meetings first 3 months
Weekly household visits
Soap replaced regularly.
None described.
None described, though soap use measured.
Households' mean use of study soap per week: 3.3 bars
Average use per resident per day: 4.4 g
Millar 2016 additional details from Ellis 2010
Skin and soft‐tissue infection prevention intervention in addition to SSTI brief
on entry also provided to control
A. Enhanced standard
B. Chlorhexidine
Military trainees
Improve personal hygiene practices to prevent infection, especially acute
respiratory
infection in military trainees who are at increased risk
A. Enhanced standard: supplemental materials (a pocket card and posters in the
barracks)
B. CHG: CHG‐based body wash (Hibiclens, Mölnlycke Heath Care, Norcross, GA, USA)
Provision of education and hygiene‐based measures in addition to standard SSTI
prevention brief
upon entry:
Enhanced standard:
supplemental
materials
CHG: as for enhanced standard group, plus a CHG‐based body wash and instructions
for use
Not described, presumably the researchers
Face‐to‐face and individually for body wash and pocket card
Mode of education not described.
US military training base
One‐off education on entry to training
CHG: use of wash 1 per week for entire training period (14 weeks)
None described.
None described.
None described.
None described.
Morton 2004
Healthy hands (alcohol gel as hand‐washing adjunct)
Elementary schools and their children and staff
Prevent infections in elementary school‐age children who are particularly
vulnerable through adjunct use of alcohol gel and education based on Health
Belief Model (HBM) (Kirscht 1974)
Alcohol gel and dispensers:
AlcoSCRUB (60% ethyl alcohol) supplied by Erie Scientific Company, Portsmouth,
NH, USA
‘‘Healthy Hands Rules’’ protocol[13]
(Figure 3 in paper)
Healthy Hand Resource Manual for school nurse, available for parents
Monthly newsletters to parents
‘‘Healthy Hands’’ refrigerator magnet for families (see Figure 2 in paper)
Informational letter to local primary care providers, paediatricians, family
practitioners, and advanced practice nurses
“Germ Unit” curriculum and materials including Germ models and Glo Germ
Healthy hands protocol introduced after "Germ unit" education in classes
Daily reminders to children on public address system (in first week) then weekly
reminders
Review of protocol in each classroom after vacation by school nurse
2 classroom visits from school nurse
“Healthy Hands” magnet provided to parents and guardians.
“Hand Checks on Wednesdays” to identify adverse effects of gel
Gel provided by suppliers.
Research team provided educational aspects.
Classroom teachers responsible for encouraging use of gel and reinforcing
protocol
School nurse assisted in monitoring and hand checks for adverse effects.
Face‐to‐face training in classes and individual information giving and
monitoring
Elementary schools in USA
Wall‐mounted near door entrance of each classroom at age‐appropriate height
46 days
0.5 mL dispensed per application.
Use of “special soap” according to “Healthy Hands Protocol” (Figure 3 in paper)
Reinforcement teaching provided if gel usage indicated that it was needed.
Germ unit education tailored for each grade level.
1 student was concerned gel was making her sick, so school nurse provided
additional classroom visit to allay concerns.
Usage of gel calculated.
5 gel applications per day
1 dispenser lasted 1 month.
Nicholson 2014
Hand‐washing with
soap
Households with 5‐year‐olds and their mothers
Targeted 5‐year‐old children and their mothers as change agents to reduce
incidence of respiratory infections (and diarrhoeal disease) through
hand‐washing using behaviour change principles (Claessen 2008), including social
norms for child and mother (Perkins 2003), using fear of contamination and
disgust (Curtis 2001), peer pressure (Sidibe 2003), morale boosting, and
networking support
Initial supply of 5 bars of free soap (90‐gram Lifebuoy bars) replenished on
submission of empty wrappers.
Environmental cue reminders (wall hangers, danglers)
Rewards (e.g. stickers, coins, toy animals)
Provision of soap and social marketing programme (Sidibe 2009) (Lifebuoy
branding) to educate, motivate, and reward children for HWWS at key times
Weeks 1 to 17: hand‐washing occasions, germ education, soap’s importance in germ
removal
Week 18 onward: encouragement of HWWS on 5 key occasions supported by
environmental cues
"Classrooms" for children
Home visits for mothers
Parents’ evenings to boost morale, build networks, and run competition for
compliance, assignment completion, and folder decoration
Establishment of a "Good Mums" club for sharing HWWS tips
Rewards provided by mothers.
Children encouraged to advocate HWWS within families before meals.
Establishment of social norms for child and mother with pledges in front of
peers
Dedicated team of "promoters" delivered education and home visits.
Mothers provided supplied rewards.
Face‐to‐face in groups
Individually by mother to child
"Classrooms" held in community buildings
Home visits of households in Mumbai, India
41 weeks
Weekly "classrooms" after school and home visits
HWWS encouraged 5 key occasions: after defecation, before each of 3 meals, and
during bathing.
Week 18 onward: hand‐washing on 5 occasions for 10 consecutive days
6 weekly parents’ meetings
Mothers were asked to provide and share hand‐washing tips with other mothers,
competitions held for mothers.
Technical difficulties with "soap acceleration sensors" to measure HWWS
behaviours prevented successful use.
Registers for "classrooms" and home visits where 3‐week gaps in attendance
triggered supervisors to ask participants to resume or be withdrawn
Monitoring of soap resale on open market by use of unique identifiers on soap
wrappers and twice weekly checks in local shops
Collection of used soap wrappers as soap consumption measure
Soap consumption:
IG vs CG:
235 g vs 45 g
Pandejpong 2012
3 active interventions (no control) different time‐interval applications of
alcohol hand gel
A. Every 60 min
B. Every 120 min
C. Once before lunch
Preschool classes (students and teachers) and their parents
Targeted preschool children who can have high infection rates in ILI; have close
interaction so at risk of airborne, droplet, and contact transmission; and are
of increasingly younger ages through hand gel as a single strategy of convenient
and effective disinfection
1 container of alcohol hand gel per classroom (active ingredients: ethyl
alcohol, 70%; chlorhexidine gluconate,1%; Irgasan (triclosan), 0.3%)
Cost of hand gel every 60
minutes was USD 6.39 per child per 12‐week period
Leaflet describing risk factors for ILI for each family
Teachers instructed to:
assist each child with dispensing hand gel at required
time interval,
store hand gel properly, and refill gel as needed.
Monitoring of hand gel use at specified times
Teachers supervised, stored, and refilled hand gel.
Instructions to teachers presumably provided by researchers.
Leaflets distributed through school.
Monitoring of use by 2 research assistants
Face‐to‐face to schools, teachers and children
Individual assistance to children with hand gel
Leaflets given to each family.
Kindergarten school in Bangkok, Thailand
12 weeks overall
1 pump of gel per child per disinfection round at 1 of 3 time intervals of
school day:
A. every 60 min
B. every 120 min
C. once only before lunch, the school standard for hand hygiene
None described.
Students whose families declined to participate were not asked
to use alcohol hand gel.
These students remained in their classrooms
and continued to follow the school standard for hand
hygiene.
2 research
assistants monitored hand gel use every 60 or 120 minutes for the duration of
study.
Classroom teachers were required to co‐sign after each disinfection
round.
Reported that compliance was ensured for each intervention
group
Cost of hand gel every 60
minutes was USD 6.39 per child per 12‐week period.
Priest 2014
Hand sanitiser provision (in addition to hand hygiene education session also
provided to control group)
Primary schools and their students, teachers, and administrative staff
Reduce person‐to‐person community transmission of infectious disease by
targeting improved and additional hand hygiene of school children through
supervised hand sanitiser provision as an alternative to improving and
maintaining bathroom facilities
‘‘No touch’’ dispensers
(> 60% ethanol) for each classroom that dispensed dose when hands were placed
under an infrared sensor
Supply of top‐up sanitiser as needed
Dispensers installed into each classroom.
Teachers asked to ensure that the children
used sanitiser at particular times and to oversee general use (McKenzie 2010).
Weekly classroom visits to top‐up of sanitiser and measure quantity used
30‐minute in‐class hand hygiene education session provided (also to control
group) plus instruction in hand sanitiser use.
School liaison research assistants topped‐up sanitiser.
Teachers
Installation of dispensers to classrooms
Supervision of children by teachers delivered face‐to‐face individually and as a
class.
City schools in New Zealand
20 weeks (2 school terms)
Sanitiser to be used by students at least after coughing/sneezing, blowing their
nose, and as they leave for morning break and for
lunch break.
Approximately 0.45 mL of sanitiser dispensed per wash.
Weekly top‐up of sanitiser
Children were able to use the sanitiser at any time they wished as well as at
key times (McKenzie 2010).
Change of sanitiser after week 10 to flavourless type of the same % ethanol in
41 of 396
classrooms (10%) (in 9 of 34 schools)
due to children tasting it when eating, affecting use.
Weekly classroom visits by school liaison research assistants who recorded
quantity of sanitiser used
Total amount of sanitiser per classroom was measured.
Compliance defined as dispensing a volume equivalent to at least
45 mL per child of hand sanitiser solution over the trial period.
100% dispensing 45 mL per child
Average hand sanitiser dispensed/child for 34
schools: 94 mL
Median classroom difference in sanitiser usage between first 10 weeks and second
10 weeks amongst classes that
switched products was 220 mL.
Ram 2015
Soap and intensive hand‐washing promotion
Household compounds and its householders (adults and children) that had a
householder with ILI
Reduce household transmission of ILI and influenza by promoting hand‐washing in
households with householder with ILI as other householders who are well are at
highest risk of exposure due to crowded and poorly ventilated homes.
Followed constructs of Social Cognitive Theory and the Health Belief Model
(Glanz 2008) and behaviour change communication using social marketing concepts
Hand‐washing station in central location of each compound using:
large water container with a tap;
plastic case for soap;
bar of soap.
Cue cards depicting critical times for hand‐washing:
after coughing or sneezing;
after cleaning one’s nose or child’s nose,
after defecation;
after clearing a child who has defecated;
before food preparation or serving;
before eating.
Hand‐washing station in each compound
Didactic and interactive group‐level education and skills training describing
influenza symptoms, transmission, and prevention, promoting health and
non‐health benefits of hand‐washing with soap and identification of barriers and
proposed solutions to hand‐washing with soap
Daily surveillance including weighing of soap and replacing if ≥ 20 g and
resupply of water in container if needed
Posting of cue cards
Asking householders to demonstrate hand‐washing with soap technique
Intervention staff arranged provision of hand‐washing station and presumably
provided education.
Intervention staff conducted daily surveillance and reinforcement visits.
All elements delivered face‐to‐face but at compound (facilities), group
(education), and individual levels (reinforcement).
Household compounds in a rural area of Bangladesh consisting of several
households with common courtyard, shared latrine, water source, and cooking
facilities
Initiation of intervention within 18 hours of study enrolment, then daily visits
until 10 days following resolution of index case patient’s symptoms
Day 1 set up of hand‐washing station
Daily surveillance included observation of individual hand‐washing reinforcement
and modelling as needed.
None described.
Daily surveillance of facilities and reinforcement and modelling of hand‐washing
behaviours including observed hand‐washing
Cue cards in common areas of courtyard
Presence or absence of soap during each of first 10 days of surveillance from
180 household compounds
Patterns and amount of soap use measured.[14]
Soap present for at least 7 days in all compounds and on all 10 days in 133
compounds (74%).
Soap and water together were present 7 or more of first 10 days in 99% of
compounds, with water and soap observed together on all 10 days in 99 compounds
(55%)
Soap consumption per capita:
median: 2.3 g
maximal: 5 g (on Day 7)
Roberts 2000
Education about infection control measures, hand‐washing, and aseptic nose
wiping
Childcare centres and their staff and children
Reduce transmission of respiratory infections in childcare centres through
improved infection control procedures
GloGerm (GloGerm, Moab, UT, USA)
Newsletters to staff
Songs and rhymes on hand‐washing
Plastic bags (sandwich bags available at supermarkets) to cover hand for nose
wiping
Staff training in good health (developed by Kendrick 1994) and practical
exercise of hand‐washing with GloGerm
Fortnightly visits and newsletter to reinforce training and to communicate
techniques
Recommended hand‐washing technique as per guidelines of the time[15] and after
toileting, before eating, after changing diaper (staff and child), and after
wiping nose unless barrier used
Teaching of technique to children and wash hands for infants
Training and reinforcement activities provided by 1 of the researchers.
Teachers delivered training to children based on their training.
Face‐to‐face in groups for training and classes and individually as needed to
children or staff
Childcare centres in Canberra, Australia
8 months overall
3‐hour training in evening or 1‐hour during lunch for new staff after study
start
Duration of hand‐washing: “count to 10” to wash and “count to 10” to rinse
Training for new staff provided as needed.
None described.
6‐weekly compliance measured by recorded observation of recommended practice for
3 hours in morning in each centre, graded by quantiles of frequency of
recommended hand‐washing by children.
Compliance was reported only in relation to analysis of outcomes.
High compliance reported for nose wiping and child hand‐washing.
Sandora 2005
Healthy Hands Healthy Families
Families with an index child in out‐of‐home childcare
Reduce illness transmission in the home through multifactorial campaign centred
on hand hygiene education and hand sanitiser
Alcohol‐based hand sanitiser: active ingredient: 62% ethyl alcohol (PURELL
Instant Hand Sanitizer; GOJO Industries, Inc, Akron, OH, USA)
Hand hygiene educational materials at home (fact sheets, toys, games)
Supply of hand sanitiser and hand hygiene materials
Biweekly telephone calls
Biweekly educational materials
Study investigator
Not stated whether materials mailed or delivered in person
Homes in USA
Sanitiser use in home
5 months overall
Biweekly educational materials
Sanitiser dispensed 1 mL each pump.
None described.
None described.
Recorded amount of hand sanitiser used (as reported by the primary caregiver)
Median frequency of reported times of hand sanitiser use: 5.2 per day
38% used > 2 ounces of hand sanitiser per fortnight = 4 to 5 uses per day
Savolainen‐Kopra 2012
further details from Savolainen‐Kopra 2010
STOPFLU
Enhanced hygiene
2 active interventions
IR1. Soap and water wash
IR2. Alcohol‐based hand rub
Office workers of office work units
Prevent transmission of respiratory infections in workplaces through enhanced
hand hygiene with behavioural recommendations to reduce transmission by droplets
during coughing or sneezing
IR1: Liquid hand soap (“Erisan Nonsid” by Farmos Inc., Turku,
Finland)
IR2: in addition:
Alcohol‐based hand rub, 80% ethanol (“LV” by Berner Inc., Helsinki, Finland)
Bottles of hand hygiene product (free of charge) to be used at home and in the
office (IR2).
Written instructions on hygiene for further reference
Toilets equipped with liquid hand soap (all groups) or alcohol‐based hand rub
(IR2).
Guidance on other ways to limit transmission of infections, e.g. frequent
hand‐washing in office and at home, coughing, sneezing into disposable
handkerchief or sleeve, avoiding hand‐shaking
Visits to work clusters and monitoring of materials availability
Monthly electronic “information spot” about viral diseases for motivation to
maintain hygiene habits
Adherence activities
In collaboration with occupational health clinics servicing the corporation
Specially trained research nurse provided guidance and visited worker clusters
throughout intervention period.
In‐person provision of soap or hand rub
Guidance and written instructions given personally.
Face‐to‐face visits by study nurse
Office work units in corporations in Helsinki, Finland
15 to 16 months overall
Monthly visits by nurse throughout
Nurses assisted with any practical problems with intervention as they arose.
New employees received guidance on hand hygiene and habits.
None described.
Adherence assessed by
an electronic self‐report survey of transmission‐limiting habits 3 times (more
details in protocol).
Use of soap (IR1) and alcohol‐based disinfectant
(IR2) for
personal use was recorded.
Study nurse checked availability of soap and alcohol rub.
Avoiding hand‐shaking became more common and remained high in both groups.
Recorded use for personal use smaller than predicted use based on hand hygiene
instructions.
Soap or disinfectant usage per participant:
IR1: 6.1
IR2: 6.9
Stebbins 2011
“WHACK the Flu”
(hand sanitiser and training in hand and respiratory hygiene)
Elementary schools and their students and homeroom teachers
Targeted school‐aged children as important sources of influenza transmission
through improved cough etiquette and hand hygiene in schools including sanitiser
as potential inexpensive non‐pharmaceutical
interventions
Hand sanitiser dispensers
with 62% alcohol‐based hand sanitiser from PURELL (GOJO Industries, Inc, Akron,
OH, USA) automatically dispensing 1 dose
Delivery of grade‐specific presentations on “WHACK the Flu” concepts and proper
hand‐washing technique and sanitiser use:
(W)ash or sanitise your hands often; (H)ome is where you stay when you are sick;
(A)void touching your eyes, nose and mouth; (C)over your coughs and sneezes; and
(K)eep your distance from sick people
(provided URL no longer active)
Desired frequency of hand wash use taught to student (see When and how much)
Installation of hand sanitiser dispensers
Refresher training at each school
Reinforcement of message and monitoring of sanitiser
Project staff provided education.
Home room teachers reinforced message and monitored proper use of sanitiser.
Face‐to‐face at schools, presumably as a group in classes
Elementary schools (Pittsburgh, USA)
Dispensers installed in each classroom and all major common areas.
Whole intervention over 1 influenza season
One‐off installation of hand sanitiser dispensers
One‐off 45‐minute education presentation and one‐off refresher training at onset
of influenza season
Goal of use of 1 dose (0.6 mL) of sanitiser 4 times per day[16]
Encouraged to wash hands or use additional doses of hand sanitiser, or both, as
needed
None reported.
Monthly teacher surveys of observed NPI‐related behaviour in their students
before, during, and after influenza season
Measurement of hand sanitiser use at 2‐week intervals throughout the
intervention period
Teacher surveys of observed classroom NPI behaviour indicated successful
adoption and maintenance of behaviours throughout influenza season.
Average sanitiser use: 2.4 times per day
Talaat 2011
Intensive hand hygiene campaign
Schools and their students, teachers, and parents
Reduce or prevent transmission of influenza viruses amongst children through
intensive hand hygiene intervention campaign
Soap supplied as needed.
Grade‐specific student booklets each including a set of 12 games and fun
activities that promoted hand‐washing
Hand hygiene activities materials including:
games (e.g. how to escape from the germs);
puzzles;
soap activities (e.g. soap drawing);
song specially developed to promote hand hygiene
Teachers’ guidebook including detailed description of the students’ activities
and methods to encourage students to practice these activities.
Posters with messages to wash hands with soap and water upon arriving at school,
before and after meals, after using the bathroom, and after coughing or
sneezing.
Informational flyers for parents reinforcing the messages delivered at the
schools.
Establishment of a hand hygiene team in each school
Provision of hand hygiene activities:
weekly exercises (e.g. games, aerobics, songs, experiments); school activities,
(e.g. obligatory hand‐washing under supervision, morning broadcast, parent
meetings, students‐parents information transfer);
specific school initiatives: (e.g. competitions and awards, hand‐washing
committee, school trips to soap factory and water purification plant)
More details in Table 1 of paper
Song played regularly.
Social worker weekly visits
Distribution of flyers to parents
Hand hygiene team (3 teachers from social studies, arts, and sports and the
school nurse) ensured that all pre‐designed activities for the hand hygiene
campaign were implemented.
6 independent social workers visited the schools.
Delivered face‐to‐face in groups and individually
Elementary schools (grades 1 to 3) in Cairo, Egypt
In school environment and classrooms
Poster near sinks in classrooms and on playground
12 weeks overall
Weekly hand hygiene campaign activities
Weekly visits by social workers
Twice‐daily obligatory supervised hand‐washing required by students for about 45
seconds, followed by proper rinsing and drying with a clean cloth towel.
Soap and hand‐drying material provided by school administration if children did
not bring their own as was the custom or families could not afford it.
Schools could create own motivating activities such as selecting a weekly hand
hygiene champion, developing theatre plays, and launching school contests for
drawings and songs.
None described.
Observation by social workers of hand hygiene activities, availability of soap
and drying material, and students’ hand‐washing during the day
Schools created own activities to improve compliance.
About 93% of the students had soap and drying material available.
All but 2 intervention schools “had a rigorous system of ensuring that
schoolchildren were washing their hands at least twice daily”.
Temime 2018
Multifaceted hand hygiene programme (including alcohol‐based hand rub)
Nursing home staff, residents, visitors, and outside care providers
Nursing homes and their residents, staff, and visitors and external providers
have an increased risk of person‐to‐person transmission of pathogens, and HH is
a simple and cost‐effective tool for infection control; however, compliance with
HH is poor in nursing homes.
Dispensers and pocket‐sized containers of hand rub solution
Posters promoting hand hygiene
Developed local HH guidelines
eLearning module on infection control and HH training with online quizzes
requiring sufficient performance
Facilitated access to hand rub solution
Campaign to promote HH with posters and event organisation
Formation of local work groups in each NH
Development of local HH guidelines
Staff education using eLearning
Monitoring of quantity of hand rub solution used
Same nurse provided HH training for all NHs.
Provision of hand rub by NH
Local work group developed guideline.
eLearning module and posters presumably developed by research team.
Provision of materials face‐to‐face
Education and quizzes via eLearning
Nursing homes in France
1 year overall
One‐off provision of hand rub
One‐off eLearning repeated if unsatisfactory performance.
If staff did not score sufficiently on online quiz, they were invited to repeat
the eLearning.
None described.
Estimated mean amount of hand rub solution used per resident per day assessed as
proxy for HH frequency, based on quantity of hand rub solution bought by NH
(which was routinely monitored in all the NHs).
Hand rub solution used:
baseline quantity of consumed hand rub solution was 4.5 mL per resident per day.
Over the 1 year, mean quantity consumed was significantly higher in intervention
NH (7.9 mL per resident per day) than control (5.7 per resident per day).
Turner 2004a
Clinical trial 1
3 active interventions (no control)
Product:
A. Ethanol
B. Salicylic acid
C. Salicylic acid with pyroglutamic acid
Healthy volunteers
Assess the residual virucidal activity of organic acids used in currently
available over‐the‐counter skin products for the prevention of experimental
rhinovirus colds
1.7 mL of hand products:
A. 62% ethanol, 1% ammonium lauryl sulphate, and 1% Klucel)
B. 3.5% salicylic acid, or vehicle containing
C. 1% salicylic acid and
3.5% pyroglutamic acid
Disinfection of hands then application of test product then allowed to dry.
15 min later, fingertips of each hand contaminated with 155 TCID50
of rhinovirus type 39 in a volume of 100 μL.
Hands air‐dried for 10 min.
Intentional attempted inoculation with virus by contact with fingers,
conjunctiva, and nasal mucosa with fingers of right hand.
Left hand eluted in 2 mL of virus‐collecting broth.
Researchers
Face‐to‐face individually
Communities in Manitoba, Canada
1.7 mL of product applied.
See What for timing
Not described
Not described
Not described
Not described
Turner 2004b
Clinical trial 2
2 active interventions (no control)
Skin cleaner wipe product:
A. Pyroglutamic acid
B. Ethanol
Healthy volunteers
Assess the residual virucidal activity of organic acids used in currently
available over‐the‐counter skin products for the prevention of experimental
rhinovirus colds
Skin cleanser wipe containing:
A. 4% pyroglutamic acid formulated with 0.1% benzalkonium chloride
B. 62% ethanol
Application of product to hands with towelette then allowed to dry.
15 min later, fingertips of each hand contaminated with 106 TCID50
of rhinovirus type 39 in a volume of 100 μL.
Intentional attempted inoculation with virus by contact with fingers,
conjunctiva, and nasal mucosa with fingers of right hand.
Left hand eluted in 2 mL of virus‐collecting broth.
Researchers
Face‐to‐face individually
Communities in Manitoba, Canada
Dose not reported; see What for timing
Additional group challenged 1 h after application; final group challenged 3 h
after application (remained at study site and not allowed to use or wash hands
between).
Not described
Not described
Not described
Not described
Turner 2012
Antiviral hand lotion
Healthy adults
Reduce rhinovirus infection and illness through hand disinfection with ethanol
and organic acid sanitiser
Lotion containing 62% ethanol, 2% citric acid, and 2% malic acid
Daily diary
Provision of lotion and instructions for use
Meetings with participants to check compliance
Staff of study site presumably supplied lotion.
Study site staff met with participants.
Face‐to‐face and presumably individually, but not specified
Study site at university community in the USA
9 weeks
Every 3 hours whilst awake
and after hand‐washing for 9 weeks
Compliance meetings twice weekly for first 5 weeks then weekly meetings with
participants
None reported.
None reported.
Self‐reported daily diary of time of each product application
Twice weekly for 5 weeks then weekly meetings with participants to reinforce
compliance with treatment
“All subjects … applied at least 90% of the expected amount of hand treatment”
(p.1424)
Yeung 2011
Multifaceted hand hygiene programme (including alcohol‐based hand rub)
Long‐term care facilities and their healthcare workers
Promote use of alcohol‐based hand rub by staff in LTCFs as an effective, timely,
and low‐irritant method of hand hygiene in a high‐risk environment
Free supply of pocket‐sized containers of alcohol‐based antiseptic hand rub
(either WHO formulation I (80% ethanol) or II (80% propanol) carried by each HCW
(supplier: Vickmans Laboratories)
Replacement hand rub as required
Hand hygiene seminar content
Reminder materials (3 to 5 posters and specially designed ballpoint pens)
Provision of materials
Provision of hand hygiene seminars to HCWs covering:
indications, proper method, and importance of antiseptic hand rubbing and
washing according to WHO 2006a) guidelines
Provision of feedback session
Direct, unobtrusive observation of hand hygiene adherence
Training of observation staff
Study team delivered the materials, seminars, and observer training.
Administrative staff of LTCF provided replacement hand rub and communicated with
HCWs.
6 registered nurses conducted direct observation of adherence after 2‐hour
training (100% interrater reliability).
Delivered face‐to‐face and individually for hand rub and pens; not described if
education was individually or by group, but seminar implies as a group
LTCFs in Hong Kong
Posters posted in common areas.
Adherence observations occurred in common rooms and resident rooms but not
bathing or toilet areas.
7 months overall
Initial 2‐week intervention period, then 7 months of hand rub provision and
reminders
3 identical seminars at start of intervention; each staff member to attend once
Feedback session 3 months after start of intervention
2‐hour training of observers
Adherence observations either 9 am to 12 pm or 3 pm to 6 pm, 1 LTCF at a time
Replacement of hand rub as required
As adherence dropped off in the middle months, the feedback session was
delivered.
Direct observation of HCW adherence to hand‐washing and antiseptic hand rubbing
(recorded separately and anonymously) during bedside procedures or physical
contact with residents
3300 hand hygiene opportunities during 248.5 hours of observation on 92 days
90% attendance of seminars
Hand rubbing with gel increased significantly from 1.5% to 15.9%.
Hand‐washing decreased significantly from 24.3% to 17.4%.
Control: 30%
Overall hand‐washing adherence increased from 25.8% to 33.3%.
Zomer 2015
Hand hygiene products and training
Daycare centres and their caregivers (staff)
Reduce infections in children attending DCCs through improved access to HH
materials (Zomer 2013a) and compliance of their DCC caregivers to hand hygiene
guidelines based on socio‐cognitive and environmental determinants of
caregivers’ HH behaviour[17] (Zomer 2013b)
HH products:
dispensers for paper towels, soap, alcohol‐based hand sanitiser, and hand cream,
with refills for 6 months
Reminder posters and stickers for children and DCC caregivers
Training materials including booklet
Provision of free HH products sponsored by SCA Hygiene Products, Sweden.
Provision of posters and stickers for children and staff
Provision of training about RIVM 2011 for mandatory HH[18]
Distribution of training booklet
Team training sessions aimed at goal‐setting and formulating HH improvement
activities (Erasmus 2011; Huis 2013)
Study team arranged supply of HH products and presumably provided training.
Products provided to DCCs in person for staff use.
Mode of training not specified.
DCCs in regions of the Netherlands
6 months overall
Initial one‐off supply of products
3 training sessions with 1‐month interval
2 team training sessions
Replacement hand hygiene provided as required.
None described.
6‐month follow‐up observation of whether intervention dispensers and
posters/stickers in use
Survey of DCC caregivers
HH guidelines compliance observed at 1, 3, and 6 months' follow‐up:
no. of HH actions/no. of opportunities
2 DCCs did not use any HH products.
Sanitiser products used in at least 1 of 2 groups in 94%, 89%, 86%, and 45% of
intervention DCCs.
Posters used in 86%, stickers in 74%.
DCC survey results:
79% attended at least 1 training session; 77% received HH guidelines booklet.
HH compliance at 6 months:
IG: 59% vs CG: 44% (Zomer TP, et al, unpublished data)
All intervention DCCs received guidelines training; all but 2 received at least
1 team training.
Hang hygiene and masks
Aelami 2015
Hygienic education and package
Religious pilgrims
Prevent influenza‐like illness by reduced infection transmission through
personal hygiene measures
Hygiene package of:
alcohol‐based hand rub (gel or spray)
surgical masks
soap
paper handkerchiefs
user instructions
Not clearly described, but it appears that packages may have been distributed by
trained physicians before departure to or on site of country of pilgrimage
Not specifically described
Not described, but it appears that packages were distributed face‐to‐face and
individually
Not described if before departure (from Iran) or on site (in Saudi Arabia)
One‐off during Hajj season
Not described
Not described
Not described
None described
Aiello 2010
2 active interventions:
A. Face mask (FM)
B. Face mask and hand hygiene (FM + HH)
Students living in university residences
Reduce the incidence of and mitigate ILI by use of non‐pharmaceutical
interventions of personal protection measures
7 face masks (standard medical procedure masks with ear loops TECNOL procedure
masks; Kimberly‐Clark)
7 resealable plastic bags for mask storage when not in use (e.g. eating) and for
disposal
Alcohol‐based hand sanitiser
(62% ethyl alcohol in a gel base, portable 2‐ounce squeeze bottle, 8‐ounce pump)
Hand hygiene education (proper hand hygiene practices and cough etiquette) via
emailed video, study website, written materials detailing appropriate hand
sanitiser and mask use
Weekly supply of masks through student mailboxes
Provision of basic hand hygiene education through an email video link, the study
website, and written materials; instruction to wear mask as much as possible;
education in correct mask use, change of masks daily, use of provided resealable
bags for mask storage and disposal
Provision of replacement supplies which students signed for upon receipt
Not described, except education provided via study website (URL not provided)
“Trained staff” for compliance monitoring
Study‐affiliated residence hall staff provided replacement supplies.
Education via email and study website; provision of masks and sanitiser in
person to residences
University residence halls in the USA
One‐off education, 6 weeks (excluding spring break) of face mask and/or hand
hygiene measures which commenced at “the beginning of the influenza season just
after identification of the first case of influenza on campus” (p.496).
Replacement supplies provided as needed.
Mask wearing during sleep optional and encouraged outside of residence.
University spring break occurred during weeks 4 and 5 of the study, with most
students leaving campus and travelling; they were not required to continue
protective measures at that time.
Weekly web‐based student survey included: self‐reported average number of times
hands washed/day and average duration of hand‐washing to obtain composite
"optimal handwashing” score (at least 20 s ≥ 5/day);
average no. of mask hours/day/week; average hand sanitiser use/day/week and
amount used.
Trained staff in residence hall common areas observed silently and anonymously
improper mask use, instances of hand sanitiser use.
Average mask use hours/day:
FM + HH 2.99 vs FM 3.92
Average hand‐washing times/day:
FM + HH 6.11 vs FM 8.18 vs control group 8.75
Daily washing seconds/day:
FM + HH 20.65 vs FM 23.15 vs control 22.35
Hand sanitiser use times/day:
FM + HH: 5.2 vs FM 2.31 vs control 2.02
No. of proper mask wearing participants/hour of observation:
FM + HH 2.26 vs
FM 1.94
Aiello 2012
2 interventions:
A. Face mask (FM)
B. Face mask and hand sanitiser (FM + HH)
Students living in university residences
Prevent ILI and laboratory‐confirmed influenza by use of non‐pharmaceutical
interventions of personal protection measures (e.g. face masks and hand hygiene)
Packets of 7 standard medical procedure masks with ear loops (TECNOL procedure
masks, Kimberly‐Clark, Roswell, GA, USA) and plastic bags for storage during
interruptions in mask use (e.g. whilst eating, sleeping) and for daily disposal
Hand sanitiser (2‐ounce squeeze bottle, 8‐ounce pump bottle with 62% ethyl
alcohol in a gel base)
Replacement face masks and hand sanitiser
Educational video: proper hand hygiene and use of standard medical procedure
face masks
Intervention materials and educational video provided.
Supply of masks and instructions on wearing
Provision of replacement masks or sanitisers as needed on site
Trained study staff available at tables in each residence hall for surplus masks
and sanitiser and for observing compliance
Hygiene packs delivered to student mailboxes; face‐to‐face supply also available
University residence halls in the USA
One‐off educational video at start
Weekly supply of hygiene packs
Masks to be worn at least 6 hours/day
Study staff available onsite with replacement supplies as needed for duration of
intervention (6 weeks, excluding spring break)
Students encouraged but not obliged to wear masks outside of residence hall.
1‐week university spring break during the study when majority of students left
campus
Weekly student survey including compliance (e.g. masks hours/day, frequency and
amount of sanitiser use, number of hand washes/day, duration of hand‐washing
(seconds)
Observed compliance completed by trained study staff who daily and anonymously
observed mask wearing in public areas of residences.
Self‐reported mask wearing: no significant difference
Sanitiser use:
significantly more in FM + HH than FM or control groups
More results in S1 of paper.
Staff observed an average of 0.0007 participants properly wearing a mask for
each hour of observation.
Cowling 2009
2 active interventions in addition to control of lifestyle education:
A. Enhanced hand hygiene (HH)
B. Face masks and enhanced hygiene (FM + HH)
Householders with index patient with influenza
Reduce transmission of influenza in households through personal protective
measures
A. and B.
Liquid soap for each kitchen and bathroom: 221 mL Ivory liquid hand soap
(Proctor & Gamble, Cincinnati, OH, USA)
Alcohol hand rub in individual small bottles (100 mL) WHO recommended
formulation I, 80% ethanol, 1.45% glycerol, and 0.125% hydrogen peroxide
(Vickmans Laboratories, Hong Kong, China)
B. Adults: box of 50 surgical face masks (Tecnol–The Lite One (Kimberly‐Clark,
Roswell, GA, USA) to each household member or C. Children 3 to 7: box of 75
paediatric masks
Home visits
Provision of soap, hand rub, and masks as applicable and when to use them
HH: education about efficacy of hand hygiene
Demonstration of proper hand‐washing and antisepsis techniques
+ FM: education about efficacy of surgical face masks in reducing disease spread
to household contacts if all parties wear masks
Demonstration of proper wearing and hygienic disposal
All groups: provision of education about the importance of a healthy diet and
lifestyle, both in terms of illness prevention (for household contacts) and
symptom alleviation (for the index case)
Trained study nurse provided interventions.
Face‐to‐face to householders
Households in Hong Kong
Initial home visit scheduled within 2 days (ideally 12 h) of index case
identification.
Further home visits day 3 and 6, 7‐day follow‐up
HH: use of liquid soap after every washroom visit, sneezing or coughing, when
their hands were soiled. Use rub when first returning home and immediately after
touching any potentially contaminated surfaces
FM: masks worn as often as possible at home (except eating or sleeping) and when
the index patient was with the household members outside of the household
Not described
Not described
Monitoring of adherence during home visits
Evaluation of adherence on final visit by interview or self‐reported practices
and counting of amount of soap and rub left in bottles and remaining masks for
FM group
Most initial visits completed within 12 h.
Intervention groups “reported
higher adherence … than the
control group. Self‐reported data were consistent with measurements of amount of
soap, alcohol hand rub,
and face masks used” (p.443) (see Table 6 in paper).
“Adherence to the hand hygiene intervention was
slightly higher in the hand hygiene group than the face mask
plus hand hygiene group.”
Median masks used:
Index: 9
Contact: 4
More details in paper and Appendices
Larson 2010
2 active interventions in addition to control of URI education:
A. Alcohol‐based hand sanitiser (HS)
B. Face masks and hand sanitiser (FM + HS)
Hispanic householders with at least 1 preschool or elementary school child
Reduce incidence and secondary transmission of URIs and influenza through
non‐pharmaceutical household level interventions
A. and B.
2‐month supply of hand sanitiser in 8‐, 4‐, and 1‐ounce containers:
PURELL (Johnson & Johnson, Morris
Plains, NJ, USA)
B. 2‐month supply of masks:
Procedure
Face Masks for adults and children (Kimberly‐Clark, Roswell, GA, USA)
Replacement supplies at least once every 2 months
Disposable thermometers
Educational materials about URI prevention, treatment, and vaccination (written
in Spanish or English language)
Provision of materials and instructions for when to use including demonstration
of use and observation of return demonstration by householder
A. Mask worn when householder had: “temperature of ≥37.8°C and cough and/or sore
throat in the absence of a known cause other than influenza” (CDC definition of
influenza‐like illness at the time).
Home visits to reinforce adherence, replenish supplies and record use, answer
questions
B. Telephone calls to reinforce mask use
All groups received URI educational materials.
4 trained bilingual research assistants (RAs) with minimum baccalaureate degree
and experience in community‐based research; procedures were practised with each
other until demonstrated proficiency
Face‐to‐face to householders
Households in New York, USA
19‐month follow‐up
Initial home visit, then at least every 2 months
Sanitiser for use at home, work, and school
B. Telephone calls days 1, 3, 6
Masks worn for 7 days when within 3 feet of person with ILL or no symptoms.
Change masks between interactions with person with ILL
Householders' questions and misconceptions addressed on home visits.
None described.
RA home visits for adherence with random accompaniment by project manager, who
also made random calls to householders
Telephone calls to reinforce mask use
Used bottles or face masks, or both, monitored for usage.
Sanitiser use (mean ounces/month)
HH: 12.1
FM + HH: 11.6
Mask compliance was “poor”: 22/44 (50%) used within 48 hours of onset.
Mask users reported mean mask use of 2.
Simmerman 2011
2 active interventions:
A. Hand‐washing education and hand‐washing kit (HW)
B. Hand‐washing education, hand‐washing kit, and face masks (HW + FM)
Households with a febrile, influenza‐positive child
Decrease influenza virus transmission in household with a febrile
influenza‐positive child through promoted use of hand‐washing or hand‐washing
with face mask use
A. and B.
Hand‐washing kit per household including graduated dispenser with standard
unscented liquid hand soap (Teepol brand. Active ingredients: linear alkyl
benzene sulfonate, potassium salt, and sodium lauryl ether sulphate)
Replacement soap as needed
Written materials from education including pamphlets and posters attached near
sinks in household.
B. Box of 50 standard paper surgical face masks and 20 paediatric
face masks (Med‐con company, Thailand #14IN‐20AMB‐30IN)
A. and B.
Provision of intensive hand‐washing education on initial home visit to household
members with 5 approaches: discussion, individual hand‐washing training,
self‐monitoring diary, provision of soap, and provision of written materials
(Kaewchana 2012)
Individual hand‐washing training ("why to wash", "when to wash", and "how to
wash" in 7 hand‐washing steps described in Thailand Ministry of Public Health
guidelines)
B. Provision of education of benefits of and appropriate face mask wearing
Soap replaced as needed.
More details (Kaewchana 2012)
Study nurse conducted home visits, provided education and monitoring activities.
Education provided face‐to‐face as a group to household member and individually
for hand‐washing training.
In homes (in Bangkok, Thailand)
One‐off provision of kits at initial home visit conducted within 24 hours of
enrolment
Subsequent home visits on days 3, 7, and 21
90‐day supply of hand‐washing supplies
30‐minute education provided at initial home visit
B. No face masks whilst eating or sleeping as impractical and could hinder
breathing in ill child
Impromptu education and training provided by nurses as questions arose.
None described.
Self‐monitoring diary recording hand‐washing frequency > 20 s and face mask use
for that group
Reinforcement of messages by nurses on subsequent home visits
Amount of household liquid soap and number of face masks used
Reported average hand‐washing episodes/day:
HW: 4.7
HW + FM: 4.9
Parents had highest frequency (5.7), others (4.8), siblings (4.3), index cases
(4.1).
Average soap used/week:
HW: 54 mL/person
HW + FM: 58.1 mL/person
B. Mask use:
12/person/week
Mask wearing median minutes/day: 211
Parents 153,
other relations
59, index patients 35, siblings 17
Suess 2012
2 active interventions in addition to written information:
A. Mask/hygiene (MH)
B. Mask (M)
Households with an influenza‐positive index case in the absence of
further respiratory illness within the preceding 14 days
Prevent influenza transmission in
households through easily applicable and accessible non‐pharmaceutical
interventions
such as face masks or hand hygiene measures
A. Alcohol‐based hand rub (Sterilium, Bode Chemie, Germany)
A. and B.
Surgical face masks in 2 different sizes:
children < 14 years (Child’s Face Mask, Kimberly‐Clark, USA) and adults (Aérokyn
Masques, LCH Medical Products, France)
Written information provided on correct use of intervention and on infection
prevention (Seuss 2011) (Tips and information on the new flu A/H1N1)
(URL provided is no longer active)
Digital tympanic thermometer
General written information on infection prevention
A. Provision of hand rub and masks
A. and B. Provision of masks only
Provision of thermometer and how to use it
Mask fit assessed (at first household visit)
Information provided by telephone and written instructions at home visit on
proper use of interventions and recommendations to sleep in a different room
than the index patient, not to take meals with the index patient, etc. (Seuss
2011)
In‐person demonstration of interventions at first home visit
All participating households received general written information on infection
prevention.
Study personnel arranged provision of materials, rang the participants, visited
the homes, demonstrated and assessed fit of masks.
Provision of materials in person to households
Initial telephone delivery of information
Face‐to‐face home visits
Households in Berlin, Germany
Over 2 consecutive flu seasons
Day 1 households received all necessary material instructions.
Household visits no later than 2 days after symptom onset of the index case,
then days 2, 3, 4, 6, 8 (5 times) or on days 3, 4, 6, 8 (4 times) depending on
the day of recruitment
Hand rub use: after direct contact
with the index patient (or other symptomatic household
members), after at‐risk activities or contact[19]
Mask use: at all times when index patient and/or any other household member with
respiratory symptoms were together in 1 room
Regular change of face masks, not worn during the night or outside the household
Adult masks worn if
masks for under 14‐year‐olds
did not fit properly.
If other household members developed fever (> 38.0 °C), cough, or sore throat,
they were asked to adopt the same preventive behaviour as the index patient.
In the season 2010/11 participants also recorded number of masks used per day.
Self‐reported daily adherence with face masks, i.e. if they wore masks “always”,
“mostly”, “sometimes”, or “never” as instructed.
Participants of the MH households additionally noted the number of hand
disinfections per day.
Exit questionnaire about (preventive) behaviour during the past 8 days, general
attitudes towards NPI, the actual amount of used intervention materials, and, if
applicable, problems with wearing
face masks.
Used intervention material per household member was calculated by dividing the
amount used per household by the number of household members.
See paper and Suess 2011 for more details.
Face mask use (median/individual):
MH: 12.6
M: 12.9
Daily adherence was good, reaching a plateau of over 50% in nearly all groups
from the third day on.
MH hand rub use (median):
87 mL (Seuss 2011)
MH mean frequency of daily hand disinfection: 7.6 (SD 6.4) times per day
See paper and Suess 2011 for more results.
Hand hygiene and surface/object disinfection
Ban 2015
Hand hygiene and surface cleaning or disinfection
Kindergartens and the families of their students
Reduce transmission of infection in young children from contaminated surfaces or
hands through hand hygiene and surface cleaning or disinfection
Antibacterial products for hand hygiene and surface cleaning or disinfection:
liquid antimicrobial soap for hand‐washing (0.2% to 0.3% parachlorometaxylenol).
Instant hand sanitiser for hand disinfecting (72% to 75% ethanol), antiseptic
germicide (4.5% to 5.5% parachlorometaxylenol, diluting before use).
Bleach (4.5% to 5.0% sodium hypochlorite, diluting before use) for surface
disinfecting.
Produced by Whealthfields Lohmann (Guangzhou) Company Ltd.
Provision of products to kindergartens and families
Instruction of parents or guardians and teachers in hand hygiene techniques and
use of antibacterial products
Daily cleaning of kindergartens with products
At least twice/week cleaning of homes and weekly cleaning or disinfecting of
items such as children’s toys, house furnishings, frequently touched objects
(doorknobs, tables or desks), kitchen surfaces (utensils, cutlery, countertops,
chopping boards, sinks, floors, etc.), bathroom surfaces (toilet, sink, floor,
etc.)
Monitoring activities
Research team provided products and instructions and monitoring.
Materials provided to kindergartens and families in person and presumably
instructions in person to families and staff.
In kindergartens (hard surfaces) and families’ homes (Xiantao, China)
1 year overall
Daily hand‐washing with soap before eating, after using bathroom, nose blowing,
and outdoor activities
Hand sanitiser carried daily.
Kindergarten cleaning daily
Home cleaning at least twice/week
Families and teachers could contact study management at any time as needed.
Exchange of empty bottles for new ones at any time
Not described
Close contact with teachers and families for monitoring, e.g. unscheduled
parents’ meetings, quarterly home visits, phone interviews, and monthly cell
phone messages
Monthly survey of consumption of products by volume, total usage, person usage
Consumption of products by person (mL/person/day).
Liquid soap: 7.7
Sanitiser: 1.4
Bleach: 25.0
Antiseptic‐germicide: 12.5
Carabin 1999
Hygiene programme
Daycare centres and their staff and children
Reduce infections in at‐risk children (under 3 years old) in DCCs with
inexpensive, easily implementable and practical interventions
Hygiene materials and documents, e.g. colouring books, hand‐washing posters,
hygiene videotapes
Materials for training
Reimbursement of equivalent of 1 full‐time educator’s salary
Bleach (diluted 1:10) for toy and play area cleaning
Provision of comprehensive hygiene training session to entire DCC staff,
especially the educators of participating classrooms
Training in recommendations for hygiene practices:
i. toy cleaning
ii. hand‐washing technique and schedule
iii. use of creative reminder cues for hand‐washing
iv. open window for daily period
v. sandbox and play area cleaning
Payment of salary of educator for the day to encourage participation
DCC meetings to discuss training session with all staff
Training appears to have been provided by study team.
Appears staff trained as a group, i.e. “entire DCC staff”
Daycare centres in Canada
Location of training not described, except may have been off‐site from DCCs
since 1 DCC did not “send” staff to training.
15‐month trial
One‐off 1‐day training
Toy cleaning at least every 2 days
Hand‐washing at least after DCC arrival, after outside play, after bathroom,
before lunch
Open windows at least 30 min/day
Biweekly cleaning of sandbox/play area
Teachers to use creative reminder cues for hand‐washing with children
Not described
Follow‐up telephone questionnaire for DCC directors about following training
recommendations
Use of materials: colouring book: 22/24
poster: 23/24
videotapes: 18/24
staff meetings: 19/24
Increased frequency of toy cleaning: 6/24
Use of rake and shovel for sandpit: 17/24
Frequency of cleaning sandbox: 14/24
Kotch 1994
Hygiene
Caregivers at child daycare centres (CDCCs)
Develop feasible, multicomponent hygienic intervention to reduce infections in
children at CDCCs who are at increased risk
Hygiene curriculum for caregivers
Availability of soap, running water, and disposable towels
Waterless disinfectant scrub (Cal Stat) used only if alternative was not washing
at all.
Handouts posted in CDCC.
Delivery of hygiene curriculum to caregivers through initial training session
which required demonstration of participants’ hand‐washing and diapering skills
Local procedures:
Hand‐washing of children and staff
Disinfection of toilet and diapering areas
Physical separation of diapering areas from food preparation and serving areas
Hygienic diaper disposal
Daily washing and disinfection of toys, sinks, kitchen and bathroom floors
Daily laundering of blankets, sheets, dress‐up clothes
Hygienic preparation, serving, and clean up of food
Separate training of food handlers
As‐required induction training for new staff
Onsite follow‐up training reinforcing adaptations, demonstrations and discussion
of hygiene techniques, responding to questions, and review of handouts
Monthly meeting with centre directors to encourage leadership and support
Research team delivered training.
Scrub donated by Calgon Vetal Laboratories.
Face‐to‐face training and follow‐up group and individually
Classrooms of child daycare centres in the USA
8 months overall
3‐hour initial training session
Cleaning schedules as described in column What (procedures)
Onsite follow‐up training 1 week and 5 weeks later
Follow‐up sessions addressed questions and local adaptations to procedures.
As‐required induction training
During intervention, research team encouraged directors to address physical
barrier to hygiene practice, such as distance between sink and diapering areas
and sink access in rooms.
Follow‐up sessions reinforced training.
Meeting with directors
5 weekly unobtrusive recorded observation by training staff
Rate of compliance to barrier modification was better in younger centres, which
were more likely to have written guidelines.
McConeghy 2017
Multifaceted hand‐washing and surface‐cleaning intervention
Nursing homes and their staff
Reduce exposure to pathogens
and person‐person transmission in high‐risk facility of close environment and
potentially contaminated surfaces through multifaceted intervention equipping
staff to protect residents from infection within the “culture” of care
Education and launch materials
Online module for certified nursing assistants about: infection prevention,
product, and monitoring
"Essential bundle" of hygiene products supplied at no cost:
‐ hand sanitiser gel and foam
‐ antiviral facial tissues
‐ disinfecting spray
‐ hand and face wipes
Plus additional:
‐ 4 skin cream and wipe products
iPads for compliance audits
Newsletters for support during intervention
Pre‐intervention:
NH administrators required to:
‐ identify a "Heroes In Prevention" champion and team
‐ allow all staff participation in education
‐ iPad use for staff in each floor or community
‐ ask staff to incorporate intervention into workflow
Delivery of 3 components:
‐ education
‐ cleaning products
‐ compliance audit and feedback
Education:
Launch event for all staff to publicise programme and explain roles
Intensive training of "hygiene monitors" for data collection and compliance
audit and feedback tool
Training of site champion
Training of select group of certified nursing assistants (online module)
Audit and feedback activities
Ongoing support during intervention:
‐ newsletter with best practices
‐ teleconferences with each NH
‐ "onboarding" education of new staff
Study personnel equipped staff with knowledge and tools and support.
NH staff (e.g. champion, hygiene monitors, nursing assistants) delivered aspects
of interventions after specific training.
Face‐to‐face interaction with staff for planning and some aspects and delivery
of products
Some aspects delivered online (e.g. nursing modules, compliance auditing)
Nursing homes in the USA
Onsite and at unit/team levels
Online training
6 months overall: training period: 3 months
1‐hour launch event
1 or 2 hygiene monitors/site
1 champion/site
1‐hour online module for selected nursing assistants
iPads for each community or floor
Weekly teleconferences
initially decreased in frequency over time.
Weekly measurement of product consumption
Sites could use existing comparable products from another vendor and fill in any
gaps with study products.
New staff provided with education, as needed and came onboard.
Retraining of sites with low training participation rates
2 sites retrained due to low training participation rate.
Cloud‐based audit and feedback system via secure login to web browsers on NHs’
existing computers or via iPads included weekly product consumption to get
measure:
weekly count of product units consumed x no. of hand hygiene occasions
Online training participation rates:
> 90% for 3/5 sites,
13% and 23% for 2/5
Administrators demonstrated high fidelity in reporting measures of
hand‐washing (> 80% of time).
Hand‐washing rates in Figure 1B in paper reported as “relatively constant” and
“not ideal in the first few months”, but improved significantly over time.
Sandora 2008
Multifactorial intervention, including alcohol‐based hand sanitiser and surface
disinfection
Elementary school and its students
Reduce transmission of infections in schoolchildren through improved hand
hygiene and environmental disinfection
1 container of disinfecting wipes (Clorox Disinfecting Wipes (The Clorox
Company, Oakland, CA, USA); active ingredient, 0.29% quaternary ammonium
chloride compound)
Pre‐labeled 1.7‐ounce containers of alcohol‐based hand sanitiser (AeroFirst
non‐aerosol alcohol‐based foaming hand sanitiser (DEB SBS Inc, Stanley, NC, USA,
for The Clorox Company); active ingredient, 70% ethyl alcohol)
Receptacle in classrooms for empty containers
Sanitiser and wipes provided to classroom/teacher with instructions for use.
Teachers disinfected desks once daily.
Hand sanitiser to be used:
before and after lunch, after use of the restroom (on return to the classroom;
hand hygiene with soap and water occurred in the restroom, because sanitisers
were not placed there), after any contact with potentially infectious secretions
(e.g. after exposure to other ill children or shared toys that had been mouthed)
Research team arranged supply of materials and instructed teachers on use.
Teachers instructed in use of materials and in collecting empty containers and
distributing new product.
Products provided to schools.
Instruction provided face‐to‐face to teachers and children.
Elementary schools and their classrooms in the USA
8‐week period
Desks disinfected once a day.
Products replenished as needed.
None described.
Individually labelled containers collected every 3 weeks from the classroom to
assess adherence.
Product usage: average wipes used/week: 897 (128 wipes/classroom/week)
Average bottles of hand sanitiser used per week: 8.75 (1.25
bottles/classroom/week)
Quarantine
Miyaki 2011
Quarantine from work (stay‐at‐home order)
Employees
Prevent spread of influenza in workplaces by quarantining workers who had a
co‐habitating family member with an ILI
Full wages to employee
Non‐compulsory asking of workers whose family members developed an ILI to stay
at home voluntarily on full wages.
Daily measuring of temperature before leaving work.
Where symptoms were doubtful, industrial physician made judgement.
Company doctors provided input on cancelling of stay‐at‐home orders as required.
Health management department oversaw the procedures and decisions.
Mode of advice to employees not described.
Car industries in Japan
Stay‐at‐home order for 5 days after resolution of ILI symptoms or 2 days after
alleviation of fever over 7.5 months
Strict standard for cancelling of stay‐at‐home orders described.
None described.
Recording of compliance with stay‐at‐home request
100% compliance to stay at home reported.
Other (miscellaneous) interventions
Farr 1988a
trial 1
2 active interventions in addition to control of no tissues:
A. Virucidal nasal tissues
B. Placebo tissues
Families
Reduce transmission of viruses from hand contamination via hand‐to‐hand contact
or large‐particle aerosol through tissues for nose blowing and coughs and
sneezes
3‐ply tissues with:
A. 5.1 mg/inch2 (2.54 cm2) of the virucidal mixture (58.8% citric acid, 29.4%
malic acid, 11.8% sodium lauryl sulphate)
B. 3 mg/inch2 (2.54 cm2) of saccharin
applied uniformly to all 3 plies of the tissue
Tissues prepared by Kimberly‐Clark Corporation, Neenah, WI, USA.
Family visits to distribute tissues
Weekly contact of mother
Families instructed to only use supplied tissues.
Nurse epidemiologist visited families.
Face‐to‐face visits to families and individuals in families (especially mothers)
Communities in the USA
6 months overall
Monthly family visits
Weekly contact with mother
Not described
Not described
Family visits and weekly contact with mother to encourage compliance
Not described
Farr 1988b
trial 2
2 active interventions (no control):
A. Virucidal nasal tissues
B. Placebo tissues
Families
Reduce transmission of viruses from hand contamination via hand‐to‐hand contact
or large‐particle aerosol through tissues for nose blowing and coughs and
sneezes
2‐ply tissues containing:
A. 4.0 mg/inch2 (2.54 cm2) of antiviral mixture (53.3% citric acid, 26.7% malic
acid, 20% sodium lauryl sulphate)
B. 3 mg/inch2 (2.54
cm2) of succinic acid, malic acid, sodium hydroxide, and polyethylene glycol
Tissues prepared by Kimberly‐Clark Corporation, Neenah, WI, USA.
Family visits to distribute tissues and encourage compliance
Weekly contact of mother
Families instructed to only use supplied tissues.
Nurse epidemiologist visited families monthly.
Study monitor visited bimonthly.
Face‐to‐face visits to families and individuals in families (especially mothers)
Communities in the USA
6 months overall
Monthly family visits
Weekly contact with mother
Bimonthly study monitor visit
None described.
None described.
Bimonthly study monitor visits to encourage compliance as well as monthly and
weekly contact by nurse
In 124/222 families, 1 or more family members reported not using the tissues
regularly and/or reported having side effects from the tissues.
Longini 1988
2 active interventions (no control):
A. Virucidal nasal tissues
B. Placebo tissues
Households and their families
Prevent intrafamilial transmission of viral agents in a community setting
Treated tissues of 3‐ply material identified with no specific identifiers
(Kimberly‐Clark Corporation)
with inside layer containing:
A. citric and malic acid plus sodium lauryl sulphate;
B. succinic acid.
Tissues delivered to households with specific instructions on use (all purposes,
when blowing nose, coughing or sneezing) and to discard after use and to help
young children use tissues if develop a cold.
Tissues assigned by study sponsor (Kimberly‐Clark Corporation).
Supply of tissues throughout 5‐month trial period
Households in the USA
5 months' overall supply
Resupply of tissues as required
None described.
Reported use of tissues “not at all, some of the time, most of the time, or all
of the time”
Reported use “all of the time”:
A. vs B.
82% vs 71%
Chard 2019
(additional details from Chard 2018)
Water, Sanitation, and Hygiene for Health and Education in Laotian Primary
Schools (WASH HELPS)
Primary schools and their students
Prevent the spread of pathogens within schools through improved water supply and
hygiene facilities and improved WASH
habits in children at home and throughout the life course
For each school:
Water supply for school compound:
(borehole, protected dug well with pump, or gravity‐fed system)
Water tank to supply toilet and hand‐washing station
School sanitation facilities (3 toilet compartments)
Hand‐washing facilities:
2 sinks with tapped water and supply of soap available (1 bar of soap/pupil)
3 group hand‐washing tables with soap and water
At least 1 drinking water filter per classroom
Schedules of daily group hand‐washing, compound and toilet cleaning
Cost per school: USD 13,000 to 17,500
Provision of school:
Water supply, sanitation facilities, hand‐washing facilities (individual and
group), drinking water filters
Behaviour change education and promotion including daily group hygiene
activities
Daily hand‐washing and cleaning schedules
UNICEF paid for materials.
School and teachers conducted daily hand‐washing activities with children.
Students participated in daily group cleaning activities.
Facilities provided within schools.
Children participated in group hand‐washing and cleaning.
Primary schools and their classrooms (in Laos)
One‐off provision of water and hygiene facilities
Daily hand‐washing activities and cleaning for 1 school year
Cleaning schedules posted in at least 1 classroom near toilet.
Water supply tailored to the school requirements/environment.
Sanitation facilities provided as needed and designated for boys, girls, and
students with disabilities.
Rain water tank provision affected by rain water supply, so changed to tanks
with motorised hand pumps or gravity‐fed water supply systems.
Theft and animal consumption of supplied soap reduced supply.
Unannounced visits every 6 to 8 weeks for structured observations to measure
fidelity and adherence
Fidelity Index score (0 to 20): for hardware provided see Table 1 in paper and
protocol
Adherence index: student report of behavioural outcomes index score (0 to 4)
Fidelity: 30.9% across all schools and visits
Adherence: 29.4%
Hardware provision: 87.8% of schools
School‐level adherence: 61.4%
Group compound cleaning: 94.8%, toilet use: 75.5%, group toilet cleaning: 68.3%,
group hand‐washing: 48.7%, individual hand‐washing with soap after toilet use:
23.9%. Further details (Chard 2018)
Hartinger 2016
Integrated environmental home‐based intervention package (IHIP)
Households and their householders including children
Reduce infections and improve child growth in households in rural communities
with limited facilities through a multicomponent, low‐cost environmental
intervention to improve drinking water, sanitation, personal hygiene, and
household air quality developed in pilot (Hartinger 2011; Hartinger 2012) using
a participatory approach that addressed local beliefs and cultural views
Per household:
"OPTIMA‐improved stove": improved ventilated solid‐fuel stove
Kitchen sink with in‐kitchen water connection providing piped water
Point‐of‐use water quality intervention applying solar disinfection to drinking
water
Community engagement with local and regional stakeholders in design and
development
Provision of stoves, kitchen sinks, and plastic bottles for solar water
treatment, and hygiene education
Training of mothers/caretakers in:
‐ solar drinking‐water disinfection (SODIS)[20] according to standard procedures
‐ hand hygiene (washing own and children’s hands with soap at critical
times[21])
‐ advice to separate animals and their excreta from the kitchen environment
Project‐initiated repairs
Health promoters hired local elementary school teachers and implemented and
promoted the interventions.
4 teams of field staff conducted spot‐check observations.
Face‐to‐face and to individual households; mode of delivery of training as
individual or group not described
Households in rural communities in Peru
Stoves and sinks installed over initial 3 months.
Monthly reinforcement over 12 months of SODIS, child and kitchen hygiene
Weekly spot checks of compliance
Repairs after 9 months
Environmental samples test middle and end of 12‐month surveillance.
Tailored to particular household facilities and environments as needed and to
local beliefs and cultural customs
Repairs to stoves as needed and checked at 9 months
Not described
Weekly spot‐check observations of household hygiene and environmental health
conditions (e.g. presence of SODIS bottles on the roof or kitchen) using a
checklist
Monthly self‐report by mothers of stove and sink use
SODIS use:
60% initially and 10% at end of study
Self‐reported use by mothers: 90% with slight decrease at end
Self‐reported stove use: 90% daily
Sink use: 66% daily
35% of stoves needed minor repairs,
1% needed major repairs.
Best‐functioning stoves achieved mean 45% and 27% reduction of PM2.5 and CO,
respectively, in mothers’ personal exposure.
Huda 2012
Sanitation Hygiene Education and Water Supply in Bangladesh (SHEWA‐B)
Villages and their households with a child < 5 years old
Reduce illness in children < 5 years by improving hygiene practices, sanitation
and water supply and treatment in their household
Materials for training of community hygiene promoters and promotion activities
including flip charts and flash cards with messages alerting participants to
presence of unobservable “germs” and practices to minimise germs
See Box 1 in paper for 11 key messages.[22]
Engaging local residents under guidance of local NGOs to develop community
action plans addressing:
Latrine coverage and usage
Access to and use of arsenic‐free water
Improved hygiene practices, especially hand‐washing with soap
Recruitment and appointment of community hygiene promoters
Household visits, courtyard meetings, and social mobilisation activities (e.g.
water, sanitation and hygiene fairs, village theatre, group discussions in tea
stalls (the social meeting point for village men)) by community promoters
Structured observation in households
Community hygiene promoters (local residents with at least 10 years' schooling
trained for 10 days on behaviour change communication in water, sanitation, and
hygiene)
Face‐to‐face delivery to groups (villages and households) and individuals
Villages and households in districts of Bangladesh
Community activities held in villages.
Meetings held in courtyards of groups of households.
Household visits
18 months overall
Expected household visit and courtyard meeting every 2 months
Hand‐washing opportunities: after own or child’s defecation,
prior to preparing and serving food, prior to eating and feeding
a child
Community action plans developed for and by local residents.
Not described
Structured observation of hand‐washing and child faeces disposal behaviour in
households and spot checks of type of household water and sanitation facilities
HW:
Food‐related:
No significant difference from baseline to 18 months;
IG versus CG
After anus cleaning: 36% versus 27%
Defecation: 30% versus 23%
No access to latrine decreased from 10.3% to 6.8%.
No significant improvement in access to improved latrines, solid waste disposal,
drainage systems, and covered containers for water storage
Ibfelt 2015
Disinfection of toys
Daycare nurseries
Reduce transmission of pathogens via shared toys in daycare environment through
regular disinfection treatment
Disinfectants:
Turbo Oxysan (Ecolab, Valby, Denmark) for washing machines
Sirafan M, Ecolab (1% to 3% benzalkonium chloride, 1% to 3%
didecyldimethylammonium chloride, and 5% to 7% alcohol ethoxylates) for
immersion or wiping
Collection and commercial cleaning of toys from nurseries:
‐ linen and toys suitable for washing machines were washed at 46 °C and
subsequently disinfected
‐ toys not suitable for washing machines immersed in disinfectant or wiped with
microfibre cloth
Commercial cleaning company: Berendsen A/S, Søborg, Denmark
Cleaning companies collected the toys and linen and cleaned them offsite, then
returned them.
Daycare nurseries in Denmark
Commercial industrial cleaning facility
2 to 3 months overall
Cleaning every 2 weeks
Staggered cleaning to ensure children had toys to play with whilst others were
being cleaned
None described.
None described.
None described.
Najnin 2019 (see also Qadri 2015 for further details)
2 active interventions:
A. Combined cholera vaccine and 'behaviour change communication' intervention
B. Cholera vaccine‐alone group
Low‐income households and compounds
Prevent or reduce transmission of respiratory illness based on the Integrated
Behavioural Model for Water Sanitation and Hygiene (IBM‐WASH) theoretical
framework (Dreibelbis 2013; Hulland 2013)
A. and B.
Cholera vaccine
ShanChol™ (Shantha Biotechnics‐Sanofi, India)
A. Following hardware per compound:
a. Hand‐washing hardware:
(i) Bucket with a tap (provided free of charge)
(ii) Soapy water bottle (mixture of a commercially available sachet of powdered
detergent
(∼USD 0.03) with 1.5 L of water in a plastic bottle with a hole punched in the
cap) supplied by participating compounds
(iii) Bowl to collect rinse water after
washing hands (see photo in text or in Najnin 2017doi.org/10.1093/ije/dyx187)
b. Water treatment hardware:
Dispenser containing liquid sodium hypochlorite
See Figure 2 in Najnin 2017 for photos of both doi.org/10.1093/ije/dyx187
and more details.
Participants own water vessels for water treatment
Print materials for behaviour change to compounds and households
A. and B.
Provision of cholera vaccine (2 doses at least 14 days apart)
Provision of hand‐washing hardware and behaviour change communication activities
Encouragement of hand‐washing after defecation, after cleaning child’s anus, and
before preparing food
Encouragement to add chlorine to own water vessels
Benefits were again explained.
Follow‐up visits by health promoters
Dushtha Shasthya Kendra (DSK), an NGO, delivered the hardware and behavioural
intervention (through community health promoters).
Separate data collectors observed soap availability.
Hand‐washing and water treatment hardware mostly delivered at the compound level
in person.
Behaviour change communication messages were delivered both at compound and
household levels.
Households and compounds (where several
households share a common water source, kitchen,
and toilets) in Bangladesh
Behaviour change communication messages delivered first (within 3 months of
cholera vaccination).
Point‐of‐use water hardware provided 3 months later.
Follow‐up health promoter visits 3 times in 2 months after hardware
installation, then 2 times/month (over nearly 2 years).
Hardware‐related problems (breakage/leakage) were addressed on health promoter
follow‐up visits.
None described.
Unannounced home visits by data collectors who observed presence of soap/soapy
water and water in most convenient place for hand‐washing (either reserved in a
container or available at the tap)
Residual chlorine was measured indicating uptake of chlorine dispenser.
Presence of soap / soapy water and water:
A. Handwashing group compounds: 45% (1,729 / 3,886);
B. Vaccine‐only group compound: 22% (438 / 1,965);
C. Control: 28% (556 / 1991)
Residual chlorine present in stored drinking water of 4% (160/3886) of
households in the vaccine‐plus‐behaviour‐ change compound and none in the other
2 compounds.
Gargling
Goodall 2014
2 active interventions:
A. Vitamin D3 supplementation
B. Gargling water
University students
Decrease the incidence of URTI through increased vitamin D levels (associated
with greater frequency and severity of URTI) and gargling (as preventative
measure against URTI)
A. Vitamin D3: container of 8 capsules of 10,000 IU (purchased from Euro‐Pharm
International Canada Inc.)
Weekly email reminder
B. Gargling: 30 mL of tap water 2/day
A. Vitamin D: instructed to take 1 pill weekly
B. Gargling: instructed to gargle twice daily for 30 seconds
All participants received general
lifestyle and health advice on sleep, nutrition, hand hygiene, and exercise.
Not specified, presumably the researchers, including a study pharmacist
Vitamin D3 supplied individually, but no further details.
Method of lifestyle and health advice provision also not described.
In university student housing (in residences or off‐campus) in Canada
2 months overall
Vitamin D3: weekly supplementation and email reminder
Gargling: 30 mL of water for 30 seconds twice daily
None described.
None described.
None described.
None described.
Ide 2014
2 active interventions (no control):
A. Green tea gargling
B. Water gargling
High school students
Prevent influenza spread and infection in high school students who are at
increased risk from close interaction through gargling as a non‐pharmaceutical
intervention, specifically green tea containing highly bioactive catechin
(‐)‐epigallocatechin gallate, with possible anti‐influenza virus properties
A. Bottled green tea (500 mL)
containing a catechin concentration of 37 ± 0.2 mg/dL, including approximately
18% (‐)‐epigallocatechin gallate (manufactured by the Kakegawa Tea Merchants
Association).
Concentration measured by high‐performance liquid chromatography based on the
average concentration in 10 bottles from the same production
lot (September 2011) used for gargling in the study.
B. Tap water
A. Provision of green tea
B. Advice to gargle with tap water and not to gargle green tea during study
A. and B.
Advice to gargle at least 3 times/day (after arriving at school, after lunch,
and after school)
Consumption of green tea and other tea was not restricted for
either group.
Safety monitoring carried out throughout the study (not further described).
Materials supplied by researchers.
High schools’ vice principals and head teachers assisted with safety monitoring.
Green tea supplied individually to students.
Mode of gargling advice not described.
High schools in Japan
Gargling 3 times/day for 90 days
None described.
None described.
Daily questionnaire included questions about daily
adherence to gargling regimen.
Adherence rate of gargling at
or above 75%, and absence of green tea gargling when in the
water gargling group.
Gargling adherence rate: green tea group: 73.7%; water group: 67.2%
Satomura 2005
2 active interventions:
A. Water gargling
B. Povidone‐iodine gargling
Healthy adults
Prevent URTIs through gargling water alone, which may wash out pathogens from
the pharynx and oral cavity through whirling water or through chlorine, or
povidone‐iodine for its perceived virucidal properties
A. Water
B. 15 to 30 times diluted 7% povidone‐iodine (as indicated by manufacturer)
Local administrators instructed participants to:
‐ gargle dose of water or povidone‐iodine 3 times/day;
‐ maintain hand‐washing routine;
‐ not change other hygiene habits;
‐ not take any cold remedies;
‐ complete gargling diary.
Weekly monitoring of
hygienic actions and encouragement to keep up assigned intervention every week
Local project administrators (18 healthcare professionals) provided instructions
and monitoring and encouragement.
Not specified, but likely to have been face‐to‐face and individually, at least
initially for instructions
18 healthcare sites in Japan (4 in northern region, 9 in central region, 5 in
western region)
60 days overall
1. Water gargling:
20 mL for 15 s at least 3 times/day
2. Povidone‐iodine gargling:
20 mL of dilution 3 times/day
If diluted povidone‐iodine caused serious discomfort
or was not available, participants were allowed
to gargle with water instead.
3 participants assigned to povidone‐iodine gargled with water instead as the
povidone‐iodine “did not agree with them”.
Completion of gargling diary: frequency of gargling and hand‐washing
Weekly monitoring and encouragement by local administrators
9 participants did not complete diary.
Average frequency of gargling / person / day:
With water:
A: 3.6
B: 0.8
Control: 0.9
With povidone‐iodine:
A.: <0.1
B: 2.9
Control: 0.2
ABH: alcohol‐based rub
ARI: acute respiratory infection
CDC: Centers for Disease Control and Prevention
CG: control group
CHG: chlorhexidine gluconate
CO: carbon monoxide
DCCs: daycare centres
FM: face masks
HCP: healthcare personnel
HCW: healthcare worker
HH: hand hygiene
HSG: hand sanitiser group
HSW: hand‐washing with soap and water
HWWS: hand‐washing with soap
IG: intervention group
IHIP: integrated environmental home‐based intervention package
ILI: influenza‐like illness
IU: international units
LTCFs: long‐term care facilities
NGOs: non‐governmental organisations
NH: nursing home
no.: number
NPIs: non‐pharmaceutical interventions
PM2.5: particulate matter of less than 2.5 microns
RAs: research assistants
RIs: respiratory infections
RTIs: respiratory tract infections
SD: standard deviation
SSTI: skin and soft‐tissue infection
SWG: soap‐and‐water group
TCID: tissue‐culture infectious dose
URTI: upper respiratory tract infection
WHO: World Health Organization
wk: week
w/w: weight for weight
[1]: Occupational Safety and Health Administration (OSHA). OSHA technical
manual: section VIII: chapter 2: respiratory protection. US Department of Labor.
www.osha.gov/dts/osta/otm/otm_viii/otm_viii_2.html (accessed 21 April 2020).
[2]: Ministry of Health and Long‐Term Care, Public Health Division, Provincial
Infectious Diseases Advisory Committee. Preventing respiratory illnesses:
protecting patient and staff: infection control and surveillance standards for
febrile respiratory illness (FRI) in non‐outbreak conditions in acute care
hospitals [September 2005]
http://www.health.gov.on.ca/english/providers/program/infectious/diseases/best_prac/bp_fri_080406.pdf
(accessed September 11 2009). [URL inactive]
[3]: Before eating, after sneezing, coughing, handling money, using restroom,
returning to desk and interacting with others who may be sick
[4]: after coming into classroom, before and after lunch, after break, after
physical education, when they went home and after coughing, sneezing or blowing
their noses
[5]: after toileting and when visibly dirty plus a protocol for particular
circumstances: after coming into the classroom; before and after lunch; after
playing outside; when they went home; after coughing, sneezing, or blowing their
noses; and after diapering
[6]: 1) when entering into the classroom; 2) after sneezing, coughing, or
blowing their nose; 3) after using the toilet/washroom; 4) before eating any
food; and 5) when leaving the school at the end of the day
[7]: what to do if hands were dirty, why students should wash their hands,
benefits of washing hands and using hand sanitizer, procedure for washing hands
using hand sanitizer, to cover mouth and nose with upper part of sleeve while
coughing and/or sneezing
[8]: Boyce JM, Pittet D, Healthcare Infection Control Practices Advisory
Committee, HICPAC/ SHEA/APIC/IDSA Hand Hygiene Task Force. Guideline for hand
hygiene in healthcare settings. Recommendations of the Healthcare Infection
Control Practices Advisory Committee and the HICPAC/SHEA/APIC/ IDSA Hand Hygiene
Task Force. MMWR Recommendations and Reports 2002;51(RR‐16):1–45.
www.cdc.gov/mmwr/preview/mmwrhtml/rr5116a1.htm (accessed 21 April 2020).
International Bank for Reconstruction and Development/ World Bank,
Bank‐Netherlands Water Partnership, Water and Sanitation Program. Hand washing
manual: a guide for developing a hygiene promotion program to increase
handwashing with soap. http://go.worldbank.org/PJTS4A53C0 (Accessed 16 May
2007). [URL inactive] California State Department of Education. Techniques for
Preventing the Spread of Infectious Diseases. Sacramento (CA): California State
Department of Education, 1983. Geiger BF, Artz L, Petri CJ, Winnail SD, Mason
JW. Fun with Handwashing Education. Birmingham (AL): University of Alabama,
2000. Roberts A, Pareja R, Shaw W, Boyd B, Booth E, Mata JI. A tool box for
building health communication capacity.
www.globalhealthcommunication.org/tools/29 (Accessed 10 October 2007). [URL
inactive] Stark P. Handwashing Technique. Instructor’s Packet. Learning Activity
Package. Sacramento (CA): California State Department of Education, 1982.
[9]: DIN EN 1500: Chemische Desinfektionsmittel und Antiseptika, Hygienische
Händedesinfektion, Prüfverfahren und Anforderungen (Phase 2/Stufe 2). Brüssel
(Belgium): CEN, European Comittee for Standardization 1997;1‐20.
[10]: DIN EN 12791: Chemische Desinfektionsmittel und Antiseptika, Chirugische
Händedesinfektionsmittel ‐ Prüfverfahren und Anforderungen (Phase 2/Stufe 2).
Brüssel (Belgium): CEN, European Comittee for Standardization 2005;1‐31.
[11]: after defaecation, after cleaning an infant who had defaecated, before
preparing food, before eating, and before feeding infants
[12]: non‐governmental organisation that supports community‐based health and
development initiatives
[13]: “Healthy Hands” Rules (from Figure 3 in paper): Do use “special soap” when
arrive to school, before lunch, after go to bathroom (only if soap and water not
available), if rub nose or eyes or if fingers in mouth, if teacher asks. Do not:
use “special soap” if hand dirt on them, put “special soap” on another student,
play with ‘special soap”, put hands near eyes after using “special soap”.
[14]: Calculated by subtracting each day’s soap weight from the previous day’s
weight. Maximum number of grams of soap consumed for each compound was
identified and the day on which the maximum soap consumption was recorded. A per
capita estimate of daily soap consumption was calculated
[15]: National Health and Medical Research Council. Staying Healthy in Child
Care. Canberra (Australia): Australian Government Publishing Service, 1994
[16]: upon arrival, before and after lunch, and prior to departure
[17]: knowledge and awareness of HH guidelines, perceived importance of
performing HH, perceived behavioural control (i.e. perceived ease or difficulty
of performing the behaviour), and habit
[18]: “According to the Dutch national guidelines, HH is mandatory for
caregivers before touching/preparing food, before caregivers themselves ate or
assisted children with eating, and before wound care; and after diapering, after
toilet use/wiping buttocks, after caregivers themselves coughed/sneezed/wiped
their own nose, after contact with body fluids (e.g. saliva, vomit, urine,
blood, or mucus when wiping children’s noses), after wound care, and after hands
were visibly soiled.” (p. 2495)
[19]: having touched household items being used by the index patients and/or
other symptomatic household contacts, and after coughing/sneezing, before meals,
before preparing meals and when returning home
[20]: SODIS: www.sodis.ch/index_EN.html
[21]: after defecation, after changing diapers, before food preparation and
before eating
[22]: 1. Wash both hands with water and soap before eating/ handling food 2.
Wash both hands with water and soap/ash after defecation 3. Wash both hands with
water and soap/ash after cleaning baby’s bottom 4. Use hygienic latrine by all
family members including Children 5. Dispose of children’s faeces into hygienic
latrines 6. Clean and maintain latrine 7. Construct a new latrine if the
existing one is full and fill the pit with soil/ash. 8. Safe collection and
storage of drinking water 9. Draw drinking water from arsenic safe water point
10. Wash raw fruits and vegetables with safe water before eating and cover food
properly 11. Manage menstruation period safely (p.605)
Figures and Tables -
Table 1. Description of interventions in included studies, using the items from
the Template for Intervention Description and Replication (TIDieR) checklist
Navigate to table in Review
Table 2. Results from trials of hand hygiene compared to control
Study
Comparison (see Table 1 for details of interventions)
Reported outcomes
Results
Alzaher 2018
cluster‐RCT
Saudi Arabia
Hand‐washing workshop and posters vs usual practice
% absence days due to URI
0.39% and 0.72% in intervention group schools; 0.86% and 1.39% in control
schools
Arbogast 2016
cluster‐RCT
USA
Hand sanitiser + wipes + hand foam vs none
Both groups received education + signage about hand‐washing
1. Health insurance claims for preventable illnesses per employee
2. Absences per employee
1. 0.30 claims in intervention; 0.37 in control (27% relative reduction; P =
0.03)
2. 1.45 in intervention; 1.53 in control (5.0% relative reduction in
intervention; P = 0.30)
Azor‐Martinez 2016
RCT
Spain
Hand‐washing with soap and water plus hand sanitiser vs usual hand‐washing
practices
% absence days due to URI
1.15% in intervention; 1.68% in control. Significantly lower in intervention (P
< 0.001)
Azor‐Martinez 2018
cluster‐RCT
Spain
Education and hand hygiene with soap and water vs hand hygiene with sanitiser vs
usual hand‐washing procedures
1. URI incidence rate ratio (primary)
2. Percentage difference in absenteeism days
1. HH soap vs control 0.94 (95% CI 0.82 to 1.08); HH sanitiser vs control 0.77
(95% CI 0.68 to 0.88); HH soap vs HH sanitiser 1.21 (95% CI 1.06 to 1.39)
2. HH soap 3.9% vs control 4.2% (P < 0.001); HH sanitiser 3.25% vs control 4.2%
(P = 0.026); HH soap 3.9% vs HH sanitiser 3.25% (P < 0.001)
Biswas 2019
cluster‐RCT
Bangladesh
Hand sanitiser and respiratory hygiene education and cough/sneeze hygiene vs no
intervention
1. ILI incidence rate (at least 1 episode)
2. Laboratory‐confirmed influenza
1. 22 per 1000 student‐weeks in intervention; 27 per 1000 student‐weeks in
control, not statistically significantly different
2. 3 per 1000 student‐weeks in intervention; 6 per 1000 student‐weeks in
control, P = 0.01
Correa 2012
cluster‐RCT
Colombia
Alcohol‐based hand sanitiser in addition to hand‐washing vs usual hand‐washing
practice
ARIs in 3rd trimester of follow‐up
Hazard ratio for intervention to control 0.69 (95% CI 0.57 to 0.83)
Cowling 2008
cluster‐RCT
Hong Kong
Hand hygiene (36 households) vs face mask (mask) vs education (control)
Secondary attack rate for:
1. laboratory‐confirmed influenza;
2. ILI definition 1;
3. ILI definition 2;
4. ILI definition 3.
1. HH 0.06; mask 0.07; control 0.06
2. HH 0.18; mask 0.18; control 0.18
3. HH 0.11; mask 0.10; control 0.11
4. HH 0.04; mask 0.08; control 0.04
Cowling 2009
cluster‐RCT
Hong Kong
Hand hygiene (HH) vs face mask + hand hygiene (HH + mask) vs education (control)
Secondary attack rate for:
1. laboratory‐confirmed influenza;
2. ILI definition 1;
3. ILI definition 2.
1. HH 5; HH + mask 7; control 10
2. HH 16; HH + mask 21; control 19
3. HH 4; HH + mask 7; control 5
DiVita 2011 (conference abstract)
RCT
Bangladesh
Hand‐washing stations with soap and motivation vs none
1. SAR for laboratory‐confirmed influenza
2. SAR for ILI
1. SAR higher in intervention group (11.0% vs 7.5%)
2. SAR higher in intervention group (14.2% vs 11.9%)
Feldman 2016
cluster‐RCT
Israel
Hand disinfection + soap and water installed vs none
1. Number of respiratory infections
2. Number of off‐duty days
1. 11 in each group
2. 112 in intervention; 104 in control
Gwaltney 1980
RCT
USA
Virucidal hand wash vs placebo
1. Number with illness after immediate exposure
2. Number with illness after 2‐hour delay in exposure
1. 0 of 8 in intervention; 7 of 7 in control
2. 1 of 10 in intervention; 6 of 10 in control
Hubner 2010
RCT
Germany
Hand disinfection provided vs none
Odds ratios (95% CI) (intervention:control)
1. Influenza
2. Common cold
3. Sinusitis
4. Sore throat
5. Fever
6. Cough
1. 1.02 (0.20 to 5.23)
2. 0.35 (0.17 to 0.71)
3. 1.87 (0.52 to 6.74)
4. 0.62 (0.31 to 1.25)
5. 0.38 (0.14 to 0.99)
6. 0.45 (0.22 to 0.91)
Ladegaard 1999
RCT
Denmark
Hand hygiene and education vs none
Sick days during the "effect period"
22 days/child in the intervention group vs 36 days/child in the control group
Larson 2010
cluster‐RCT
USA
Education vs education with alcohol‐based hand sanitiser vs education with hand
sanitiser and face masks
Incidence rate ratios (episodes per 1000 person‐weeks) for:
1. URI;
2. ILI;
3. influenza;
Secondary attack rates for:
4. URI/ILI/influenza;
5. ILI/influenza.
1. HS 29; HS + masks 39; control 35
2. HS 1.9; HS + masks 1.6; control 2.3
3. HS 0.6; HS + masks 0.5; control 2.3
4. HS 0.14; HS + masks 0.12; control 0.14
5. HS 0.02; HS + masks 0.02; control 0.02
Little 2015
RCT
England
Bespoke automated web‐based hand hygiene motivational intervention with tailored
feedback vs none
Number of participants with 1 or more episodes of URI
Risk ratio for intervention to control 0.86 (95% CI 0.83 to 0.89; P < 0.001)
Luby 2005
RCT
Pakistan
Antibacterial soap and education about hand‐washing vs plain soap and education
vs none
1. Cough or difficulty breathing in children < 15 yrs (episodes/100
person‐weeks)
2. Congestion or coryza in children < 15 yrs (episodes/100 person‐weeks)
3. Pneumonia in children < 5 yrs (episodes/100 person‐weeks)
All outcomes significantly lower than control
1. 4.21 in antibacterial soap group; 4.16 in plain soap group; 8.50 in control
group
2. 7.32 in antibacterial soap group; 6.87 in plain soap group; 14.78 in control
group
3. 2.42 in antibacterial soap group; 2.20 in plain soap group; 4.40 in control
group
Millar 2016
cluster‐RCT
USA
Standard educational promotion of hand‐washing vs enhanced promotion vs
promotion plus a once‐weekly application of chlorhexidine‐based body wash
Incidence rates of ARI over 20 months
37.7 enhanced + body wash; 29.3 enhanced; 35.3 standard; RR for enhanced + body
wash to standard 1.07 (95% CI 1.03 to 1.11); RR for enhanced to enhanced + body
wash 0.78 (95% CI 0.75 to 0.81)
Morton 2004
cluster‐RCT
Cross‐over study
USA
Alcohol gel plus education vs regular hand‐washing
Absence due to infectious illness
Results not stated numerically
Nicholson 2014
cluster‐RCT
India
Combination hand‐washing promotion with provision of free soap vs none
Target children:
1. Episodes of ARI (per 100 person‐weeks)
2. School absence episodes (per 100 person‐days)
Families:
3. Episodes of ARI
1. 16 in intervention; 19 in control
2. 1.2 in intervention; 1.7 in control
3. 10 in intervention; 11 in control
Priest 2014
cluster‐RCT
New Zealand
Hand hygiene education and hand sanitiser vs education alone
1. % absence days due to respiratory illness
2. % absence days due to any illness
1. 0.84% in intervention group; 0.80% in control (P = 0.44)
2. 1.21% in intervention group; 1.16% in control (P = 0.35)
Ram 2015
RCT
Bangladesh
Education to promote intensive hand‐washing in households plus soap provision vs
none
1. Secondary attack ratio for intervention to control for ILI
2. Laboratory‐confirmed influenza
1. 1.24 (95% CI 0.93 to 1.65)
2. 2.40 (95% CI 0.68 to 8.47)
Roberts 2000
cluster‐RCT
Australia
Hand‐washing programme with training for staff and children vs none
Incidence rate ratio for ARI
IRR 0.92 for intervention to control (95% CI 0.86 to 0.99)
Sandora 2008
cluster‐RCT
USA
Hand sanitiser and education vs none
Incidence rates for ARI (episodes per person‐month)
0.43 in intervention; 0.42 in control
Savolainen‐Kopra 2012
cluster‐RCT
Finland
Hand hygiene with soap and water (IR1 group) vs with alcohol‐based hand rub (IR2
group) vs control (none); intervention groups also received education
1. Number of respiratory infection episodes/week
2. Number of reported infection episodes/week
3. Number of reported sick leave episodes/week
1. 0.076 in IR1; 0.085 in IR2; 0.080 in control, NS
2. 0.097 in IR1; 0.107 in IR2; 0.104 in control, NS
3. 0.042 in IR1; 0.035 in IR2; 0.035 in control. Significantly higher in IR1
compared with control
Simmerman 2011
cluster‐RCT
Thailand
Hand‐washing (HW) vs handwashing plus paper surgical face masks (HW + FM) vs
control (none)
Odds ratios for secondary attack rates for influenza
OR for HW: control 1.20 (95% CI 0.76 to 1.88)
OR for HW + masks: control 1.16 (95% CI 0.74 to 1.82)
OR for HW + masks: HW 0.72 (95% CI 0.21 to 2.48)
Stebbins 2011
cluster‐RCT
USA
Training in hand and respiratory (cough) hygiene + hand sanitiser vs none
Incidence rate ratios for intervention to control for:
1. laboratory‐confirmed influenza (RT‐PCR);
2. influenza‐A;
3. absence.
1. IRR 0.81 (95% CI 0.54 to 1.23)
2. IRR 0.48 (95% CI 0.26 to 0.87)
3. IRR 0.74 (95% CI 0.56 to 0.97)
Talaat 2011
cluster‐RCT
Egypt
Mandatory hand‐washing intervention + education vs none
1. Number of absence days due to ILI
2. Number of absence days
1. 917 in intervention; 1671 in control (P < 0.001)
2. 13,247 in intervention; 19,094 in control (P < 0.001)
Temime 2018
cluster‐RCT
France
Hand hygiene with alcohol‐based hand rub, promotion, staff education, and local
work groups vs none
Incidence rate of ARI clusters (5 or more people in same nursing home)
2 ARI clusters in intervention; 1 in control
Turner 2012
RCT
USA
Antiviral hand treatment vs no treatment
1. Number of rhinovirus infections
2. Common cold infections
3. Rhinovirus‐associated illnesses
1. 49 in intervention; 49 in control, NS
2. 56 in intervention; 72 in control, NS
3. 26 in intervention; 24 in control, NS
White 2001
DB‐RCT
USA
Hand rub with benzalkonium chloride (hand sanitiser) vs placebo
ARI symptoms
Laboratory: testing of virucidal and bactericidal activity of the product
30% to 38% decrease of illness and absenteeism (RR for illness absence incidence
0.69; RR for absence duration 0.71)
Yeung 2011
cluster‐RCT
Hong Kong
Alcohol‐based hand gel + materials + education vs control (basic life support
workshop)
Difference between pre‐study period and poststudy in pneumonia infections
recorded in residents
0.63/1000 reduction in intervention group; 0.16/1000 increase in control
Zomer 2015
cluster‐RCT
Netherlands
4 components:
1. Hand hygiene products, paper towel dispensers, soap, alcohol‐based hand
sanitiser, and hand cream provided for 6 months
2. Training and booklet
3. 2 team training sessions aimed at hand hygiene improvement
4. Posters and stickers for caregivers and children as reminders
Combination vs usual practice
Incidence rate ratio for intervention to control for common cold
IRR 1.07 (95% CI 0.97 to 1.19)
8.2 episodes per child‐year in intervention; 7.4 episodes per child‐year in
control
ARI: acute respiratory infection
CI: confidence interval
cluster‐RCT: cluster‐randomised controlled trial
DB‐RCT: double‐blind randomised controlled trial
HH: hand hygiene
HS: hand sanitiser
HW: hand‐washing
ILI: influenza‐like illness
IRR: incidence rate ratio
NS: non‐significant
OR: odds ratio
RCT: randomised controlled trial
RR: risk ratio
RT‐PCR: reverse‐transcriptase polymerase chain reaction
SAR: secondary attack rate
URI: upper respiratory infection
yrs: years
Figures and Tables -
Table 2. Results from trials of hand hygiene compared to control
Navigate to table in Review
Table 3. Results from trials of hand hygiene + medical/surgical masks compared
to control
Study
Comparison (see Table 1 for details of interventions)
Reported outcomes
Results
Aelami 2015 (conference abstract)
RCT
Saudi Arabia
Hand hygiene education + alcohol‐based hand rub + soap + surgical masks vs none
Proportion with ILI (defined as presence of ≥ 2 of the following during their
stay: fever, cough, and sore throat)
52% in intervention; 55.3% in control (P < 0.001)
Aiello 2010
cluster‐RCT
USA
Face mask use (FM) vs face masks + hand hygiene (FM + HH) vs control
Note that this study is not included in meta‐analysis as each treatment group
included only 1 cluster.
1. ILI
2. Laboratory‐confirmed influenza A or B
Significant reduction in ILI cases in both intervention groups compared with
control over weeks 3 to 6
No significant differences between FM and FM + HH
Aiello 2012
cluster‐RCT
USA
Face mask use (FM) vs face masks + hand hygiene (FM + HH) vs control
1. Clinical ILI
2. Laboratory‐confirmed influenza A or B
1. Non‐significant reductions in FM group compared with control over all weeks.
Significant reduction in FM + HH group compared with control in weeks 3 to 6
2. Non‐significant reductions in both intervention groups compared with control
Cowling 2009
cluster‐RCT
Hong Kong
Hand hygiene (HH) vs hand hygiene plus face masks (HH + mask) vs control
Secondary attack ratio for:
1. laboratory‐confirmed influenza;
2. ILI definition 1;
3. ILI definition 2.
1. HH 5; HH + mask 7; control 10
2. HH 16; HH + mask 21; control 19
3. HH 4; HH + mask 7; control 5
Larson 2010
cluster‐RCT
USA
Education (control) vs education with alcohol‐based hand sanitiser (HS) vs
education + HS + face masks (HS + mask)
Incidence rate ratios (episodes per 1000 person‐weeks) for:
1. URI;
2. ILI;
3. influenza.
Secondary attack rates for:
4. URI/ILI/influenza;
5. ILI/influenza.
1. HS 29; HS + mask 39; control 35
2. HS 1.9; HS + mask 1.6; control 2.3
3. HS 0.6; HS + mask 0.5; control 2.3
4. HS 0.14; HS + mask 0.12; control 0.14
5. HS 0.02; HS + mask 0.02; control 0.02
Simmerman 2011
cluster‐RCT
Thailand
Control vs hand‐washing (HW) vs hand‐washing + paper surgical face masks (HW +
mask)
Odds ratio for secondary attack rates for influenza
OR for HW: control 1.20 (95% CI 0.76 to 1.88)
OR for HW + mask: control 1.16 (95% CI 0.74 to 1.82)
OR for HW + mask: HW 0.72 (95% CI 0.21 to 2.48)
Suess 2012
cluster‐RCT
Germany
Face mask + hand hygiene (mask + HH) vs face masks only (mask) vs none (control)
Secondary attack rates in household contacts:
1. Laboratory‐confirmed influenza
2. ILI
1. Mask 9; mask + HH 15; control 23
2. Mask 9; mask + HH 9; control 17
CI: confidence interval
cluster‐RCT: cluster‐randomised controlled trial
FM: face mask
HH: hand hygiene
HS: hand sanitiser
HW: hand‐washing
ILI: influenza‐like illness
OR: odds ratio
RCT: randomised controlled trial
URI: upper respiratory infection
Figures and Tables -
Table 3. Results from trials of hand hygiene + medical/surgical masks compared
to control
Navigate to table in Review
Table 4. Results from trials of soap + water compared to hand sanitisers
Study
Comparison (see Table 1 for details of interventions)
Reported outcomes
Results
Azor‐Martinez 2018
cluster‐RCT
Spain
Education and hand hygiene with soap and water (HH soap) vs hand hygiene with
sanitiser (HH sanitiser) vs usual hand‐washing procedures
1. URI incidence rate ratio (primary)
2. Percentage difference in absenteeism days
1: HH soap vs control 0.94 (95% CI 0.82 to 1.08); HH sanitiser vs control 0.77
(95% CI 0.68 to 0.88); HH soap vs HH sanitiser 1.21 (95% CI 1.06 to 1.39)
2: HH soap 3.9% vs control 4.2% (P < 0.001); HH sanitiser 3.25% vs control 4.2%
(P = 0.026); HH soap 3.9% vs HH sanitiser 3.25% (P < 0.001)
Pandejpong 2012
cluster‐RCT
Thailand
Alcohol hand gel applied every 60 minutes vs every 120 minutes vs once before
lunch (3 groups).
Absent days due to confirmed ILI/present days
0.017 in every hour group; 0.025 in every 2 hours group; 0.026 in before lunch
group. Statistically significant difference between every hour group and before
lunch group, and between every hour and every 2 hours groups
Savolainen‐Kopra 2012
cluster‐RCT
Finland
Hand hygiene with soap and water (IR1 group) vs with alcohol‐based hand rub (IR2
group) vs control (none); intervention groups also received education
1. Number of respiratory infection episodes/week
2. Number of reported infection episodes/week
3. Number of reported sick leave episodes/week
1. 0.076 in IR1; 0.085 in IR2; 0.080 in control, NS
2: 0.097 in IR1; 0.107 in IR2; 0.104 in control, NS
3: 0.042 in IR1; 0.035 in IR2; 0.035 in control. Significantly higher in IR1
compared with control
Turner 2004a and Turner 2004b
RCT
Canada
Study 1. Ethanol vs salicylic acid 3.5% vs salicylic acid 1% and pyroglutamic
acid 3.5%
Study 2. Skin cleanser wipe vs ethanol (control)
% of volunteers infected with rhinovirus
7% in each intervention group; 32% in control (study 1)
22% in intervention, 30% in control (study 2)
CI: confidence interval
cluster‐RCT: cluster‐randomised controlled trial
HH: hand hygiene
ILI: influenza‐like illness
NS: non‐significant
RCT: randomised controlled trial
URI: upper respiratory infection
Figures and Tables -
Table 4. Results from trials of soap + water compared to hand sanitisers
Navigate to table in Review
Table 5. Results from trials of surface/object disinfection (with or without
hand hygiene) compared to control
Study
Comparison (see Table 1 for details of interventions)
Reported outcomes
Results
Ban 2015
cluster‐RCT
China
Hand hygiene products, surface cleaning and disinfection provided to families
and kindergartens vs none
1. Respiratory illness
2. Cough and expectoration
1. OR 0.47 for intervention to control (95% CI 0.38 to 0.59)
2. OR 0.56 (95% CI 0.48 to 0.65)
Carabin 1999
cluster‐RCT
Canada
One‐off hygiene education and disinfection of toys with bleach vs none
Difference in incidence rate for URTI (cluster‐level result)
0.28 episodes per 100 child‐days lower in intervention group (95% CI 1.65 lower
to 1.08 higher); URTI incidence rate IRR 0.80 (95% CI 0.68 to 0.93)
Ibfelt 2015
cluster‐RCT
Denmark
Disinfectant washing of linen and toys by commercial company every 2 weeks vs
usual care
Presence of respiratory viruses on surfaces
Statistically significant reduction in intervention group in adenovirus,
rhinovirus, RSV, metapneumovirus, but not other viruses including coronavirus
Kotch 1994
RCT
USA
Training in hand‐washing and diapering and disinfection of surfaces vs none
Respiratory illness incidence rate in:
1. children < 24 months;
2. children >= 24 months.
1. 14.78 episodes per child‐year in intervention; 15.66 in control
2. 12.87 in intervention; 11.77 in control
McConeghy 2017
RCT
USA
Staff education, cleaning products, and audit of compliance and feedback vs none
Infection rates
Upper respiratory infections not reliably recorded or reported.
Sandora 2008
cluster‐RCT
USA
Hand sanitiser and disinfection of classroom surfaces vs materials about good
nutrition (control)
Absence due to respiratory illness (multivariable analysis)
Rate ratio 1.10 for intervention to control (95% CI 0.97 to 1.24)
CI: confidence interval
cluster‐RCT: cluster‐randomised controlled trial
IRR: incident rate ratio
OR: odds ratio
RCT: randomised controlled trial
RSV: respiratory syncytial virus
URTI: upper respiratory tract infection
Figures and Tables -
Table 5. Results from trials of surface/object disinfection (with or without
hand hygiene) compared to control
Navigate to table in Review
Table 6. Results from trials of complex interventions compared to control
Study
Comparison (see Table 1 for details of interventions)
Reported outcomes
Results
Complex hygiene and sanitation interventions compared to control
Chard 2019
cluster‐RCT
Laos
Complex sanitation intervention and education vs none
Pupil‐reported symptoms of respiratory infection over 1 week
NS difference between groups. 29% of intervention group; 32% control
group; adjusted risk ratio 1.08 (95% CI 0.95 to 1.23)
Hartinger 2016
cluster‐RCT
Peru
Cooking and sanitation provision and education vs none
Number of ARI episodes per child‐year
NS difference between groups. Risk ratio for intervention to control 0.95 (95%
CI 0.82 to 1.10)
Huda 2012
cluster‐RCT
Bangladesh
Sanitation provision and education vs none
Respiratory illness
12.6% in intervention group; 13.0% in control group. Not adjusted for multiple
outcome measurements. No CIs reported.
Najnin 2019
cluster‐RCT
Bangladesh
Sanitation and behaviour change intervention (plus cholera vaccine) vs none
Respiratory illness in past 2 days
2.8% in intervention group; 2.9% in control group
ARI: acute respiratory infection
CI: confidence interval
cluster‐RCT: cluster‐randomised controlled trial
NS: non‐significant
RCT: randomised controlled trial
Figures and Tables -
Table 6. Results from trials of complex interventions compared to control
Navigate to table in Review
Table 7. Results from trials of virucidal tissues compared to control
Study
Comparison
Reported outcomes
Results
Virucidal tissues compared with placebo or no tissues
Farr 1988a and Farr 1988b
cluster‐RCT
USA Trial 1 and Trial 2
Trial 1. Virucidal nasal tissues vs placebo vs none
Trial 2. Virucidal nasal tissues vs placebo
Respiratory illnesses per person over 24 weeks
Trial 1
Trial 2
Trial 1: 3.4 in tissues group; 3.9 in placebo group; 3.6 in no‐tissues group
Trial 2: 3.4 in tissues group; 3.6 in placebo group
NS
Longini 1988
DB‐PC RCT
USA
Virucidal nasal tissues vs placebo
Secondary attack rate of viral infections (number of infections in household
members of index case)
10.0 in intervention; 14.3 in placebo; NS
cluster‐RCT: cluster‐randomised controlled trial
DB‐PC: double‐blind, placebo‐controlled
NS: non‐significant
RCT: randomised controlled trial
vs: versus
Figures and Tables -
Table 7. Results from trials of virucidal tissues compared to control
Navigate to table in Review
Table 8. Summary of main results of the review for the primary outcomes
Interventions
RCT/cluster‐RCT (N = 67)
Medical/surgical masks
Masks (medical/surgical) compared to no masks
9 trials no effect on ILI (RR 0.99, 0.82 to 1.18) (Aiello 2010; Barasheed 2014;
Canini 2010; Cowling 2008; Jacobs 2009; MacIntyre 2009; MacIntyre 2015;
MacIntyre 2016; Suess 2012); 6 trials no effect on laboratory‐confirmed
influenza 95% CI RR 0.84 (0.61 to 1.17) (Aiello 2012; Cowling 2008; MacIntyre
2009; MacIntyre 2015; MacIntyre 2016; Suess 2012); 2 trials in HCWs no effect on
ILI (RR 0.37, 0.05 to 2.50) (Jacobs 2009; MacIntyre 2015).
Medical/surgical masks vs other (non‐N95) masks: 1 trial more ILI with cloth
mask (RR 13.25, 1.74 to 100.97) (MacIntyre 2015); 1 trial no effect of
catechin‐treated masks on influenza (adjusted OR 2.35, 0.40 to 13.72) (Ide
2016).
N95 respirator
N95 respirators compared to medical/surgical masks
3 trials no difference for clinical respiratory illness (RR 0.70, 0.45 to 1.10)
(MacIntyre 2011; MacIntyre 2013; Radonovich 2019);
4 trials no difference for ILI (95% CI RR 0.81, 0.62 to 1.05) (Loeb 2009;
MacIntyre 2009; MacIntyre 2011; Radonovich 2019); 4 trials no difference for
laboratory‐confirmed influenza (95% CI RR 1.06, 0.81 to 1.38) (Loeb 2009;
MacIntyre 2009; MacIntyre 2011; Radonovich 2019).
4 studies conducted in HCWs, 3 trials no difference for clinical respiratory
illness (RR 0.70, 0.45 to 1.10) (MacIntyre 2011; MacIntyre 2013; Radonovich
2019); 3 trials no difference for ILI (RR 0.64, 0.32 to 1.31) (Loeb 2009;
MacIntyre 2011; Radonovich 2019); 3 trials no difference for
laboratory‐confirmed ILI (RR 1.02, 0.73 to 1.43) (Loeb 2009; MacIntyre 2011;
Radonovich 2019).
Hand hygiene
Hand hygiene compared to control
16 trials found effect on combined outcome (ARI or ILI or influenza) (RR 0.89,
0.84 to 0.95) (Azor‐Martinez 2018; Biswas 2019; Correa 2012; Cowling 2008;
Cowling 2009; Hubner 2010; Larson 2010; Little 2015; Millar 2016; Nicholson
2014; Ram 2015; Roberts 2000; Sandora 2005; Simmerman 2011; Stebbins 2011; Zomer
2015); 7 trials effect on ARI (RR 0.84, 0.82 to 0.86) (Azor‐Martinez 2018;
Correa 2012; Larson 2010; Little 2015; Millar 2016; Nicholson 2014; Sandora
2005); 10 trials no effect on ILI (RR 0.98, 0.85 to 1.13) (Biswas 2019; Cowling
2008; Cowling 2009; Hubner 2010; Larson 2010; Little 2015; Ram 2015; Roberts
2000; Simmerman 2011; Zomer 2015); 8 trials no effect on laboratory‐confirmed
influenza (RR 0.91, 95% CI 0.63 to 1.30) (Biswas 2019; Cowling 2008; Cowling
2009; Hubner 2010; Larson 2010; Ram 2015; Simmerman 2011; Stebbins 2011)
Hand hygiene + medical/surgical masks
Hand hygiene + medical/surgical masks compared to control
7 trials no effect on ILI (95% CI RR 0.97, 0.80 to 1.19) (Aelami 2015; Aiello
2010; Aiello 2012; Cowling 2009; Larson 2010; Simmerman 2011; Suess 2012); 4
trials no effect on laboratory‐confirmed influenza (RR 0.97, 0.69 to 1.36)
(Cowling 2009; Larson 2010; Simmerman 2011; Suess 2012).
Hand hygiene + medical/surgical masks compared to hand hygiene
3 trials no effect on ILI (RR 1.03, 0.69 to 1.53) or laboratory‐confirmed
influenza (RR 0.99, 0.69 to 1.44) (Cowling 2009; Larson 2010; Simmerman 2011).
Soap + water compared to sanitiser, and comparisons of different types of
sanitiser
Soap + water compared to sanitiser, and comparisons of different types of
sanitiser
1 trial hand sanitiser was more effective than soap and water (Azor‐Martinez
2018); 1 trial there was no difference (Savolainen‐Kopra 2012).
2 trials in children antiseptic was more effective (Morton 2004; White 2001); 1
trial in children antiseptic = soap (Luby 2005).
1 trial hand sanitisers were better than placebo, but no difference between
sanitisers (Turner 2004a); 1 trial no difference between different wipes (Turner
2004b).
Surface/object disinfection (with or without hand hygiene) compared to control
Surface/object disinfection compared to control
2 trials were effective on ARI (Ban 2015; Carabin 1999); 1 trial was effective
for viruses detected on surface (Ibfelt 2015); 2 trials showed no difference in
ARIs (Kotch 1994; McConeghy 2017).
Disinfection of living quarters
‐
Complex interventions
Complex interventions compared to control
4 trials in low‐income countries found no effect on respiratory viral illness
(Chard 2019; Hartinger 2016; Huda 2012; Najnin 2019).
Physical interventions (masks, gloves, gowns combined)
‐
Gloves
‐
Gowns
‐
Physical distancing
‐
Quarantine in the community
Quarantine compared to control
1 trial effective for influenza (Cox hazard ratio 0.799, 95% CI 0.66 to 0.97)
(Miyaki 2011).
Eye protection
‐
Gargling
Gargling compared to control
1 trial gargling with tap water was effective, povidone‐iodine was not effective
(Satomura 2005); 1 trial gargling with green tea was not more effective than tap
water (Ide 2014); 1 trial gargling with water was not effective (Goodall 2014);
pooling of 2 trials no effect of gargling (RR 0.91, 95% CI 0.63 to 1.31)
(Goodall 2014; Satomura 2005).
Virucidal tissues
Virucidal tissues compared to control
1 trial had a small effect (Farr 1988a) ("The study authors conclude that
virucidal tissues have only a small impact upon the overall rate of natural
acute respiratory illnesses"); 2 trials non‐significant difference (Farr 1988b;
Longini 1988).
Nose wash
‐
ARI: acute respiratory infection
CI: confidence interval
HCW: healthcare worker
ILI: influenza‐like illness
OR: odds ratio
RCT: randomised controlled trial
RR: risk ratio
Figures and Tables -
Table 8. Summary of main results of the review for the primary outcomes
Navigate to table in Review
Table 9. Trial authors’ outcome definitions
Study
Outcomes definitions
Masks (n = 13)
1.
Cowling 2008
cluster‐RCT
Hong Kong
Laboratory:
QuickVue Influenza A+B rapid test
Viral culture on MDCK (Madin‐Darby canine kidney cells)
Samples were harvested using NTS, but the text refers to a second procedure from
June 2007 onwards with testing for influenza viruses on index participants with
a negative QuickVue result but a fever ≥ 38 °C who were also randomised and
further followed up. Data on clinical signs and symptoms were collected for all
participants, and an additional NTS was collected for later confirmation of
influenza infection by viral culture. It is noteworthy that dropout was higher
in households of index participants who had a negative result on the rapid
influenza test (25/44, 57%) compared to those who had a positive result (45/154,
29%).
Effectiveness: secondary attack ratios (SAR): SAR is the proportion of household
contacts of an index case who subsequently were ill with influenza (symptomatic
contact individuals with at least 1 NTS positive for influenza by viral culture
or PCR)
3 clinical definitions were used for secondary analysis:
1. fever ≥ 38 °C or at least 2 of the following symptoms: headache, coryza,
sore throat, muscle aches and pains;
2. at least 2 of the following S/S: fever ≥ 37.8 °C, cough, headache, sore
throat and muscle aches and pains; and
3. fever of ≥ 37.8 °C plus cough or sore throat.
Safety: harms were not mentioned as an outcome in the methods, but it was
reported in the results that there were no adverse events.
2.
Jacobs 2009
RCT
Japan
Laboratory‐confirmation not reported.
Effectiveness: URTI is defined on the basis of a symptom score with a score > 14
being a URTI according to Jackson’s 1958 criteria ("Jackson score"). These are
not explained in text, although the symptoms are listed in Table 3 (any, sore
throat, runny nose, stuffy nose, sneeze, cough, headache, earache, feel bad)
together with their mean and scores (SD) by intervention arm.
Safety: the text does not mention or report harms. These appear to be
indistinguishable from URTI symptoms (e.g. headache, which is reported as of
significantly longer duration in the intervention arm). Compliance is
self‐reported as high (84.3% of participants).
3.
Loeb 2009
cluster‐RCT
HCW
Canada
Clinical respiratory illness, influenza‐like illness, and laboratory‐confirmed
respiratory virus infection.
1. Clinical respiratory illness, defined as 2 or more respiratory symptoms or 1
respiratory symptom and a systemic symptom.
2. Influenza‐like illness, defined as fever ≥ 38 °C plus 1 respiratory symptom.
3. Laboratory‐confirmed viral respiratory infection. Laboratory confirmation
was by nucleic acid detection using multiplex RT‐PCR for 17 respiratory
viruses.
Safety: harms were not mentioned as an outcome in the methods, but it is stated
in the results that no adverse events were reported by participants.
4.
MacIntyre 2009
cluster‐RCT
Australia
Eligibility criteria were stipulated as follows:
1. the household contained > 2 adults > 16 years of age and 1 child 0 to 15
years of age;
2. the index child had fever (temperature > 37.8 °C) and either a cough or sore
throat;
3. the child was the first and only person to become ill in the family in the
previous 2 weeks;
4. adult caregivers consented to participate in the study; and
5. the index child was not admitted to the hospital.
Definitions used for outcomes:
1. ILI defined by the presence of fever (temperature > 37.8 °C), feeling
feverish or a history of fever, > 2 symptoms (sore throat, cough, sneezing,
runny nose, nasal congestion, headache), or 1 of the symptoms listed plus
laboratory confirmation of respiratory viral infection.
2. Laboratory confirmation: multiplex RT‐PCR tests to detect influenza A and B
and RSV, PIV types 1–3, picornaviruses (enteroviruses or rhinoviruses),
adenoviruses, coronaviruses 229E and OC43, and hMPV plus > 1 sym
Effectiveness: presence of ILI or a laboratory diagnosis of respiratory virus
infection within 1 week of enrolment.
Safety: harms not mentioned as an outcome in the methods, but it is reported in
the results that more than 50% of participants reported concerns with mask
wearing, mainly that wearing a face mask was uncomfortable, but there were no
significant differences between the P2 (N95) and surgical mask groups. Other
concerns were that the child did not want the parent wearing a mask.
5.
Aiello 2010
cluster‐RCT
USA
Laboratory details are described in appendix.
Effectiveness: ILI, defined as cough and at least 1 constitutional symptom
(fever/feverishness, chills, headache, myalgia). ILI cases were given contact
nurses phone numbers to record the illness and paid USD 25 to provide a throat
swab. 368 participants had ILI, 94 of which had a throat swab analysed by PCR.
10 of these were positive for influenza (7 for A and 3 for B), respectively by
arm 2, 5 and 3 using PCR, 7 using cell culture.
Safety: no outcomes on harms planned or reported.
6.
Canini 2010
cluster‐RCT
USA
The primary endpoint was the proportion of household contacts who developed an
ILI during the 7 days following inclusion. Exploratory cluster‐level efficacy
outcome, the proportion of households with 1 or more secondary illness in
household contacts.
A temperature over 37.8 °C with cough or sore throat was used as primary
clinical case definition.
The authors also used a more sensitive case definition based on a temperature
over 37.8 °C or at least 2 of the following: sore throat, cough, runny nose, or
fatigue.
Safety: adverse reactions due to mask wearing were reported, with 38 (75%)
participants in the intervention arm experiencing discomfort with mask use due
to warmth (45%), respiratory difficulties (33%), and humidity (33%). Children
wearing children face masks reported feeling pain more frequently than other
participants wearing adult face masks (P = 0.036).
7.
Aiello 2012
cluster‐RCT in halls of residence in the USA
Clinically verified ILI ‐ case definition (presence of cough and at least 1 or
more of fever/feverishness, chills, or body aches)
Laboratory‐confirmed influenza A or B. Throat swab specimens were tested for
influenza A or B using real‐time PCR.
Safety: no outcomes on harms planned or reported.
8.
Barasheed 2014
cluster‐RCT
Saudi Arabia
Laboratory: 2 nasal swabs from all ILI cases and contacts. 1 for influenza POCT
using the QuickVue Influenza (A+B) assay (Quidel Corporation, San Diego, USA)
and 1 for later NAT for influenza and other respiratory viruses. However, there
was a problem with getting POCT on time during Hajj.
Effectiveness: to assess the effectiveness of face masks in the prevention of
transmission of ILI. ILI was defined as subjective (or proven) fever plus 1
respiratory symptom (e.g. dry or productive cough, runny nose, sore throat,
shortness of breath).
Safety: no outcomes on harms planned or reported.
9.
MacIntyre 2011
cluster‐RCT
China
Clinical respiratory illness
Influenza‐like illness
Laboratory‐confirmed viral respiratory infection
Laboratory‐confirmed influenza A or B
1. Clinical respiratory illness, defined as 2 or more respiratory or 1
respiratory symptom and a systemic symptom.
2. Influenza‐like illness, defined as fever ≥ 38 °C plus 1 respiratory symptom
(i.e. cough, runny nose, etc.).
3. Laboratory‐confirmed viral respiratory infection (detection of adenoviruses,
human metapneumovirus, coronavirus 229E ⁄ NL63, parainfluenza viruses 1, 2,
and 3, influenza viruses A and B, respiratory syncytial virus A and B,
rhinovirus A/B and coronavirus OC43/HKU1 by multiplex PCR).
4. Laboratory‐confirmed influenza A or B.
5. Adherence with mask/respirator use.
Safety: adherence and adverse effects of mask wearing were collected at exit
interviews 4 weeks' poststudy. Significantly higher adverse events with N95
respirator compared to medical mask for discomfort, headache, difficulty
breathing, nose pressure, trouble communicating, not wearing, and unspecified
“other” side effects. Over 50% of those wearing N95 respirators reported adverse
events. Of those wearing medical masks versus N95 respirators, 85.5% (420/491)
versus 47.4% (447/943) reported no adverse events (P < 0.001), respectively.
10.
MacIntyre 2013
cluster‐RCT
China
Laboratory:
1. Laboratory‐confirmed viral respiratory infection in symptomatic
participants, defined as detection of adenoviruses; human metapneumovirus;
coronaviruses 229E/NL63 and OC43/HKU1; parainfluenza viruses 1, 2, and 3;
influenza viruses A and B; respiratory syncytial viruses A and B; or
rhinoviruses A/B by NAT using a commercial multiplex PCR (Seegen, Inc.,
Seoul, Korea).
2. Laboratory‐confirmed influenza A or B in symptomatic participants.
3. Laboratory‐confirmed bacterial colonisation in symptomatic participants,
defined as detection of Streptococcus pneumoniae, Legionella, Bordetella
pertussis, Chlamydia, Mycoplasma pneumoniae, or Haemophilus influenzae type
B by multiplex PCR (Seegen, Inc.).
Effectiveness: clinical respiratory illness defined as 2 or more respiratory
symptoms or 1 respiratory symptom and a systemic symptom. ILI defined as fever
(38 °C) plus 1 respiratory symptom.
Safety: adverse effects measured using a semi‐structured questionnaire.
Investigators stated that there was higher reported adverse effects and
discomfort of N95 respirators compared with the other 2 arms. In terms of
comfort, 52% (297 of 571) of the medical mask arm reported no problems, compared
with 62% (317 of 512) of the targeted arm and 38% (217 of 574) of the N95 arm (P
< 0.001).
11.
MacIntyre 2015
cluster‐RCT
Vietnam
Clinical respiratory illness, influenza‐like illness, and laboratory‐confirmed
respiratory virus infection.
1. Clinical respiratory illness, defined as 2 or more respiratory symptoms or 1
respiratory symptom and a systemic symptom.
2. Influenza‐like illness, defined as fever ≥ 38 °C plus 1 respiratory symptom.
3. Laboratory‐confirmed viral respiratory infection. Laboratory confirmation
was by nucleic acid detection using multiplex RT‐PCR for 17 respiratory
viruses.
Safety: adverse events associated with face mask use were reported in 40.4%
(227/562) of HCWs in the medical/surgical mask arm and 42.6% (242/568) in the
cloth mask arm (P = 0.45). The most frequently reported adverse events were:
general discomfort (35.1%; 397/1130) and breathing problems (18.3%; 207/1130).
The rate of ILI was higher in the cloth mask arm compared to medical/surgical
masks (RR 13.25, 95% CI 1.74 to 100.97).
12.
MacIntyre 2016
cluster‐RCT
China
Clinical respiratory illness, influenza‐like illness, and laboratory‐confirmed
viral respiratory infection.
1. Clinical respiratory illness, defined as 2 or more respiratory symptoms
(cough, nasal congestion, runny nose, sore throat, or sneezes) or 1
respiratory symptom and a systemic symptom (chill, lethargy, loss of
appetite, abdominal pain, muscle or joint aches).
2. Influenza‐like illness, defined as fever ≥ 38 °C plus 1 respiratory symptom.
3. Laboratory‐confirmed viral respiratory infection, defined as detection of
adenoviruses, human metapneumovirus, coronaviruses 229E/NL63 and OC43/HKU1,
parainfluenza viruses 1, 2, and 3, influenza viruses A and B, respiratory
syncytial virus A and B, or rhinovirus A/B by NAT using a commercial
multiplex PCR.
Safety: no outcomes on harms planned or reported.
13.
Radonovich 2019
cluster‐RCT
USA
Laboratory. Primary outcome: incidence of laboratory‐confirmed influenza,
defined as:
1. detection of influenza A or B virus by RT‐PCR in an upper respiratory
specimen collected within 7 days of symptom onset;
2. detection of influenza from a randomly obtained swab from an asymptomatic
participant; and
3. influenza seroconversion (symptomatic or asymptomatic), defined as at least
a 4‐fold rise in haemagglutination inhibition antibody titres to influenza A
or B virus between pre‐season and postseason serological samples deemed not
attributable to vaccination.
Effectiveness. Secondary outcomes: incidence of 4 measures of viral respiratory
illness or infection as follows:
1. acute respiratory illness with or without laboratory confirmation;
2. laboratory‐detected respiratory infection, defined as detection of a
respiratory pathogen by PCR or serological evidence of infection with a
respiratory pathogen during the study surveillance period(s), which was
added to the protocol prior to data analysis; and
3. laboratory‐confirmed respiratory illness, identified as previously described
(defined as self‐reported acute respiratory illness plus the presence of at
least PCR–confirmed viral pathogen in a specimen collected from the upper
respiratory tract within 7 days of the reported symptoms and/or at least a
4‐fold rise from pre‐intervention to postintervention serum antibody titres
to influenza A or B virus).
Influenza‐like illness, defined as temperature of at least 100 °F (37.8 °C) plus
cough and/or a sore throat, with or without laboratory confirmation.
Safety: 19 participants reported skin irritation or worsening acne during years
3 and 4 at 1 site in the N95 respirator group.
Hand and hygiene (n = 32)
14.
Alzaher 2018
cluster‐RCT
Saudi Arabia
Episode of URI was defined as having 2 of the following symptoms for a day or 1
of the symptoms for 2 or more consecutive days: 1) a runny nose, 2) a stuffy or
blocked nose or noisy breathing, 3) sneezing, 4) a cough, 5) a sore throat, and
6) feeling hot, having a fever or a chill.
15.
Arbogast 2016
cluster‐RCT
USA
ICD‐9 used: 46611: acute bronchiolitis due to respiratory syncytial virus,
46619: acute bronchiolitis due to other infectious organisms, 4800: pneumonia
due to adenovirus, 4809: viral pneumonia, unspecified, 4870: influenza with
pneumonia, 07999: unspecified viral infection, 4658: acute upper respiratory
infections of other multiple sites, 4659: acute upper respiratory infections of
unspecified site, 4871: influenza with other respiratory manifestations.
16.
Azor‐Martinez 2016
RCT
Spain
Upper respiratory illness was defined as 2 of the following symptoms during 1
day, or 1 of the symptoms for 2 consecutive days: (1) runny nose; (2) stuffy or
blocked nose or noisy breathing; (3) cough; (4) feeling hot or feverish or
having chills; (5) sore throat; or (6) sneezing.
17.
Azor‐Martinez 2018
RCT
Spain
Respiratory illness (RI) was defined as the presence of 2 of the following
symptoms during 1 day or the presence of 1 of the symptoms for 2 consecutive
days: (1) runny nose, (2) stuffy or blocked nose or noisy breathing, (3) cough,
(4) feeling hot or feverish or having chills, (5) sore throat, or (6) sneezing.
ICD‐10 and ICD‐9 diagnosis codes used: nonspecific upper respiratory tract
infection (465.9), otitis media (382.9), pharyngotonsillitis (463), lower
respiratory tract infections (485 and 486), acute bronchitis (490), and
bronchiolitis (466.19). Study authors combined the bronchopneumonia code (485)
and pneumonia code (486) under the label “lower respiratory tract infections.”
If > 1 antibiotic was prescribed during an episode, they used the first
prescription for analysis. The final diagnosis was done by the medical
researchers on the basis of the symptoms described above and a review of the
medical history of children with RIs.
18.
Biswas 2019
cluster‐RCT
Bangladesh
Influenza‐like illness: an ILI episode was defined as measured fever > 38 °C or
subjective fever and cough.
Laboratory‐confirmed influenza
Nasal swabs for real‐time RT‐PCR.
19.
Correa 2012
cluster‐RCT
Colombia
Acute respiratory infection was defined as 2 or more of the following symptoms
for at least 24 hours, lasting at least 2 days: runny, stuffy, or blocked nose
or noisy breathing; cough; fever, hot sensation, or chills; and/or sore throat.
Ear pain alone was considered ARI alternately.
20.
Cowling 2009
cluster‐RCT
Hong Kong
Laboratory‐confirmed of influenza virus infection by RT‐PCR for influenza A and
B virus.
Clinical influenza‐like illness: used 2 clinical definitions of influenza based
on self‐reported data from the symptom diaries as secondary analyses. The first
definition of clinical influenza was at least 2 of the following signs and
symptoms: temperature 37.8 °C or greater, cough, headache, sore throat, and
myalgia; the second definition was temperature 37.8 °C or greater plus cough or
sore throat.
21.
DiVita 2011 (conference abstract)
RCT
Bangladesh
Influenza‐like illness was defined as fever in children < 5 years old and fever
with cough or sore throat in individuals > 5 years old.
22.
Feldman 2016
cluster‐RCT
Israel
Infectious diseases grouped into diarrhoeal, respiratory, and skin infection.
Based on ICD‐9, but no supplementary material was accessible for further
definition (Supplementary Material C lists all ICD‐9 diagnoses tallied in this
”outcome”).
23.
Gwaltney 1980
RCT
USA
Viral cultures and serology if rhinovirus in laboratory‐inoculation
24.
Hubner 2010
RCT
Germany
Assessing illness rates due to common cold and diarrhoea. Collecting data on
illness symptoms (common cold, sinusitis, sore throat, fever, cough, bronchitis,
pneumonia, influenza, diarrhoea) and associated absenteeism at the end of every
month.
Definitions of symptoms were given to the participants as part of the individual
information at the beginning of the study. Whilst most symptoms are quite
self‐explanatory, "influenza" and "pneumonia" are specific diagnoses that were
confirmed by professional diagnosis only. Similarly, (self‐) diagnosis of
"fever" required objective measurement with a thermometer.
25.
Ladegaard 1999
RCT
Denmark
Laboratory: serological evidence
Effectiveness: influenza‐like illness (described as fever, history of fever or
feeling feverish in the past week, myalgia, arthralgia, sore throat, cough,
sneezing, runny nose, nasal congestion, headache).
However, a positive laboratory finding for influenza converts the ILI definition
into one of influenza.
26.
Larson 2010
cluster‐RCT
USA
Study goals: rates of symptoms and secondary transmission of URIs, incidence of
virologically confirmed influenza, knowledge of prevention and treatment
strategies for influenza and URIs, and rates of influenza vaccination.
1. Laboratory‐confirmed influenza: nasal swabs to test for influenza types A
and B as well as other common respiratory viruses by rapid culture (R‐Mix,
Diagnostic Hybrids, Inc., Athens, OH, USA). PCR and subtyping of the samples
was done during the second half of the second year of the study.
2. Influenza‐like illness: CDC definition of ILI from the Sentinel Physicians'
Network was used to determine when masks should be worn: “temperature of
≥37.8°C and cough and/or sore throat in the absence of a known cause other
than influenza".
3. Episodes of URI = upper respiratory infection: not clear, no explicitly
stated definition, reported that the most commonly reported URI symptoms are
cough or rhinorrhoea.
27.
Little 2015
RCT
England
Respiratory tract infections defined as 2 symptoms of an RTI for at least 1 day
or 1 symptom for 2 consecutive days. For reported ILI, study authors did not use
WHO or CDC definitions because these definitions require measured temperature,
and thus were not appropriate (participants were not included after a clinical
examination), and they did not use the European Centre for Disease Prevention
and Control definition (1 systemic and 1 respiratory symptom) because, according
to the international influenza collaboration, this definition does not
necessarily differentiate ILI from a common cold. Influenzanet suggests making
high temperature a separate element. Their pragmatic definition of ILI therefore
required a high temperature (feeling very hot or very cold; or measured
temperature > 37.5 °C), a respiratory symptom (sore throat, cough, or runny
nose), and a systemic symptom (headache, severe fatigue, severe muscle aches, or
severe malaise).
28.
Luby 2005
RCT
Pakistan
Defined pneumonia in children according to the WHO clinical case definition:
cough or difficulty breathing with a raised respiratory rate (> 60 per minute in
individuals younger than 60 days old, > 50 per minute for those aged 60 to 364
days, and > 40 per minute for those aged 1 to 5 years)
29.
Millar 2016
cluster‐RCT
USA
Medically attended, outpatient cases of acute respiratory infection in the study
population. The case definition was any occurrence of the following
International Classification of Disease, 9 Revision, Clinical Modification
(ICD‐9) symptom or disease‐specific codes: 460‐466, 480‐488, and specifically
465.9, 482.9, 486, and 487.1.
Acute respiratory infections (460 to 466)
460 Acute nasopharyngitis (common cold)
461 Acute sinusitis
462 Acute pharyngitis
463 Acute tonsillitis
464 Acute laryngitis and tracheitis
465 Acute upper respiratory infections of multiple or unspecified sites
466 Acute bronchitis and bronchiolitis
Pneumonia and influenza (480 to 488)
480 Viral pneumonia
481 Pneumococcal pneumonia (Streptococcus pneumoniae pneumonia)
482 Other bacterial pneumonia
483 Pneumonia due to other specified organism
484 Pneumonia in infectious diseases classified elsewhere
485 Bronchopneumonia, organism unspecified
486 Pneumonia, organism unspecified
487 Influenza
488 Influenza due to identified avian influenza virus
465.9 Acute upper respiratory infections of unspecified site
482.9 Bacterial pneumonia NOS
487.1 Diagnosis of influenza with other respiratory manifestations
30.
Morton 2004
cluster‐RCT
Cross‐over study
USA
Respiratory illnesses defined by symptoms of upper respiratory infections such
as nasal congestion, cough, or sore throat, in any combination, with or without
fever
31.
Nicholson 2014
cluster‐RCT
India
Acute respiratory infections
Operational definitions for all the illnesses were taken from Black's Medical
Dictionary. ARIs defined as "Pneumonia, cough, fever, chest pain and shortness
of breath, cold, inflammation of any or all of the airways, that is, nose,
sinuses, throat, larynx, trachea and bronchi".
32.
Pandejpong 2012
cluster‐RCT
Thailand
Influenza‐like illness defined if 2 or more symptoms of stuffy nose, cough,
fever or chills, sore throat, headache, diarrhoea, presence of hand, foot, or
mouth ulcers.
33.
Priest 2014
cluster‐RCT
New Zealand
Respiratory illness was defined as an episode of illness that included at least
2 of the following caregiver‐reported symptoms for 1 day, or 1 of these symptoms
for 2 days (but not fever alone): runny nose, stuffy or blocked nose or noisy
breathing, cough, fever, sore throat, or sneezing.
34.
Ram 2015
RCT
Bangladesh
Influenza‐like illness
Age‐specific definitions of ILI. For individuals ≥ 5 years old, ILI was defined
as history of fever with cough or sore throat. For children < 5 years old, ILI
was defined as fever; study authors used this relatively liberal case definition
in order to include influenza cases with atypical presentations in children.
Laboratory‐confirmed influenza infection
Oropharyngeal swabs from index case patients for laboratory testing for
influenza. All swabs were tested by PCR for influenza A and B, with further
subtyping of influenza A isolates.
35.
Roberts 2000
cluster‐RCT
Australia
The symptoms of acute upper respiratory illness elicited from parents were: a
runny nose, a blocked nose, and cough. Study authors used a definition of colds
based on a community intervention trial of virucidal impregnated tissues.
A cold was defined as either 2 symptoms for 1 day or 1 of the respiratory
symptoms for at least 2 consecutive days, but not including 2 consecutive days
of cough alone. Study authors defined a new episode of a cold as the occurrence
of respiratory symptoms after a period of 3 symptom‐free days.
36.
Sandora 2005
cluster‐RCT
USA
The overall rates of secondary respiratory and GI illness.
Respiratory illness was defined as 2 of the following symptoms for 1 day or 1 of
the symptoms for 2 consecutive days: (1) runny nose; (2) stuffy or blocked nose
or noisy breathing; (3) cough; (4) fever, feels hot, or has chills; (5) sore
throat; and (6) sneezing. An illness was considered new or separate when a
period of at least 2 symptom‐free days had elapsed since the previous illness.
An illness was defined as a secondary case when it began 2 to 7 days after the
onset of the same illness type (respiratory or GI) in another household member.
37.
Savolainen‐Kopra 2012
cluster‐RCT
Finland
Nasal and pharyngeal stick samples from participants with respiratory symptoms
38.
Simmerman 2011
cluster‐RCT
Thailand
Influenza‐like illness defined by WHO as fever plus cough or sore throat, based
on self‐reported symptoms.
Laboratory‐confirmed secondary influenza virus infections amongst household
members described as the secondary attack rate. The secondary influenza virus
infection was defined as a positive rRT‐PCR result on days 3 or 7 or a four‐fold
rise in influenza HI antibody titres with the virus type and subtype matching
the index case.
39.
Stebbins 2011
cluster‐RCT
USA
The primary outcome was an absence episode associated with an influenza‐like
illness that was subsequently laboratory confirmed as influenza A or B. The
following CDC definition for ILI was used: fever ≥ 38 °C with sore throat or
cough.
40.
Talaat 2011
cluster‐RCT
Egypt
Nasal swab for QuickVue test for influenza A and B viruses.
Influenza‐like illness (defined as fever > 38 °C and either cough or sore
throat).
41.
Temime 2018
cluster‐RCT
France
ARIs were defined as the combination of at least 1 respiratory symptom and 1
symptom of systemic infection.
42.
Turner 2004b
RCT
Canada
Virologic assays
43.
Turner 2012
RCT
USA
Laboratory‐confirmed rhinovirus infection by PCR assay.
Common cold illness was defined as the presence of any of the symptoms of nasal
obstruction, rhinorrhoea, sore throat, or cough on at least 3 consecutive days.
Illnesses separated by at least 3 symptom‐free days were considered as separate
illnesses.
44.
Yeung 2011
cluster‐RCT
Hong Kong
Pneumonia
45.
Zomer 2015
cluster‐RCT
Netherlands
Incidence of gastrointestinal and respiratory infections in children monitored
by parents. The common cold was defined as a blocked or runny nose with at least
1 of the following symptoms: coughing, sneezing, fever, sore throat, or earache.
Hand hygiene and masks (n = 6)
46.
Aelami 2015 (conference abstract)
RCT
Saudi Arabia
Influenza‐like illness was defined as the presence of at least 2 of the
following during their stay: fever, cough, and sore throat.
Safety: no outcomes on harms planned or reported.
47.
Aiello 2010
cluster‐RCT
USA
Influenza‐like illness case definition (presence of cough and at least 1
constitutional symptom (fever/feverishness, chills, or body aches).
Safety: no outcomes on harms planned or reported.
48.
Cowling 2009
cluster‐RCT
Hong Kong
2 clinical definitions of influenza. First definition was at least 2 of the
following signs and symptoms: temperature 37.8 °C or greater, cough, headache,
sore throat, and myalgia. The second was temperature 37.8 °C or greater plus
cough or sore throat.
Safety: no outcomes on harms planned or reported.
49.
Larson 2010
cluster‐RCT
USA
Study goals: rates of symptoms and secondary transmission of URIs, incidence of
virologically confirmed influenza, knowledge of prevention and treatment
strategies for influenza and URIs, and rates of influenza vaccination.
1. Laboratory‐confirmed influenza: nasal swabs to test for influenza types A
and B as well as other common respiratory viruses by rapid culture (R‐Mix,
Diagnostic Hybrids, Inc., Athens, OH, USA). PCR and subtyping of the samples
was done during the second half of the second year of the study.
2. Influenza‐like illness: CDC definition of ILI from the Sentinel Physicians'
Network was used to determine when masks should be worn: “temperature of
≥37.8°C and cough and/or sore throat in the absence of a known cause other
than influenza".
3. Episodes of URI = upper respiratory infection: not clear, no explicitly
stated definition, reported that the most commonly reported URI symptoms are
cough or rhinorrhoea.
Safety: no outcomes on harms planned or reported.
50.
Simmerman 2011
cluster‐RCT
Thailand
Laboratory‐confirmed secondary influenza virus infections amongst household
members described as the secondary attack rate. The secondary influenza virus
infection was defined as a positive rRT‐PCR result on days 3 or 7 or a four‐fold
rise in influenza HI antibody titres with the virus type and subtype matching
the index case.
Influenza‐like illness defined by WHO as fever plus cough or sore throat, based
on self‐reported symptoms.
Safety: no outcomes on harms planned or reported.
51.
Suess 2012
cluster‐RCT
Germany
Quantitative RT‐PCR for samples of nasal wash.
Influenza virus infection as a laboratory‐confirmed influenza infection in a
household member who developed fever (> 38.0 °C), cough, or sore throat during
the observation period. Also secondary outcome measure of the occurrence of ILI
as defined by WHO as fever plus cough or sore throat.
Safety: the study reported that the majority of participants (107/172, 62%) did
not report any problems with mask wearing. This proportion was significantly
higher in the group of adults (71/100, 71%) compared to the group of children
(36/72, 50%) (P = 0.005). The main problem stated by participants (adults and
children) was "heat/humidity" (18/34, 53% of children; 10/29, 35% of adults) (P
= 0.1), followed by "pain" and "shortness of breath" when wearing a
face mask.
Surface/object disinfection (with or without hand hygiene)(n = 8)
52.
Ban 2015
cluster‐RCT
China
Acute respiratory illness classified as the appearance of 2 or more of the
following symptoms: fever, cough and expectoration, runny nose and nasal
congestion.
53.
Carabin 1999
cluster‐RCT
Canada
The presence of nasal discharge (runny nose) accompanied by 1 or several of the
following symptoms: fever, sneezing, cough, sore throat, ear pain, malaise,
irritability. A URTI was defined as a cold for 2 consecutive days.
54.
Chard 2019
cluster‐RCT
Laos
Pupils were considered to have symptoms of respiratory infection if they
reported cough, runny nose, stuffy nose, or sore throat.
55.
Ibfelt 2015
cluster‐RCT
Denmark
Laboratory confirmation of 16 respiratory viruses: influenza A; influenza B;
coronavirus NL63229E, OC43 and HKU1; parainfluenza virus 1, 2, 3, and 4;
rhinovirus; RSV A/B; adenovirus; enterovirus; parechovirus; and bocavirus using
quantitative PCR
56.
Kotch 1994
RCT
USA
Respiratory symptoms include coughing, runny nose, wheezing or rattling in the
chest, sore throat, or earache.
57.
McConeghy 2017
RCT
USA
Classified infections as lower respiratory tract infections (i.e. pneumonia,
bronchitis, or chronic obstructive pulmonary disease exacerbation) or other.
58.
Sandora 2008
cluster‐RCT
USA
RI was defined as an acute illness that included > 1 of the following symptoms:
runny nose, stuffy or blocked nose, cough, fever or chills, sore throat, or
sneezing.
59.
White 2001
DB‐RCT
USA
RI was defined as: cough, sneezing, sinus trouble, bronchitis, fever alone,
pink‐eye, headache, mononucleosis, and acute exacerbation of asthma.
Other (miscellaneous) interventions (n = 4)
60.
Hartinger 2016
cluster‐RCT
Peru
ARI was defined as a child presenting cough or difficulty breathing, or both.
ALRI was defined as a child presenting cough or difficulty breathing, with a
raised respiratory rate > 50 per minute in children aged 6 to 11 months and > 40
per minute in children aged > 12 months on 2 consecutive measurements. An
episode was defined as beginning on the first day of cough or difficulty
breathing and ending with the last day of the same combination, followed by at
least 7 days without those symptoms.
61.
Huda 2012
cluster‐RCT
Bangladesh
Study authors classified acute respiratory illness as having cough and fever or
difficulty breathing and fever within 48 h prior to interview.
62.
Najnin 2019
cluster‐RCT
Bangladesh
Classified participants as having respiratory illness if they reported having
fever plus either cough or nasal congestion or fever plus breathing difficult.
63.
Satomura 2005
RCT
Japan
Upper respiratory tract infection defined as all of the following conditions:
1. both nasal and pharyngeal symptoms;
2. severity of at least 1 symptom increased by 2 grades or more; and
3. worsening of a symptom of 1 increment or more for > 3 days.
Because of the difference in the mode of transmission, study authors excluded
influenza‐like diseases featured by moderate or severe fever; anti‐influenza
vaccination in the preseason and arthralgia, and treated them separately. The
incidence was determined by 1 study physician who was blinded to group
assignment.
Virucidal tissues (n = 2)
64.
Farr 1988a
cluster‐RCT
USA trial 1 and trial 2
RI defined as: occurrence of at least 2 respiratory symptoms on the same day or
the occurrence of a single respiratory symptom on 2 consecutive days (except for
sneezing). The respiratory symptoms were as follows: sneezing, nasal congestion,
nasal discharge, sore throat, scratchy throat, hoarseness, coughing, malaise,
headache, feverishness, chilliness and myalgia.
65.
Longini 1988
DB‐PC RCT
USA
Respiratory illness defined as 1 or more of the following symptoms occurring
during the course of acute episode: coryza, sore throat or hoarseness, earache,
cough, pain on respiration, wheezy breathing or phlegm from the chest.
ALRI: acute lower respiratory infection
ARIs: acute respiratory infections
CDC: Centers for Disease Control and Prevention
CI: confidence interval
cluster‐RCT: cluster‐randomised controlled trial
CRI: clinical respiratory illness
DB‐PC: double‐blind, placebo‐controlled
DB‐RCT: double‐blind randomised controlled trial
GI: gastrointestinal
HCW: healthcare workers
HI: haemagglutinin
hMPV: human metapneumo virus
ICD‐9: International Classification of Disease, 9th Revision, Clinical
Modification
ICD‐10: International Classification of Disease, 10th Revision, Clinical
Modification
ILI: influenza‐like illness
NAT: nucleic acid testing
NOS: not otherwise specified
NTS: nasal and throat swab
PCR: polymerase chain reaction
PIV: parainfluenza virus
POCT: point‐of‐care testing
RCT: randomised controlled trial
RI: respiratory infection
RR: risk ratio
rRT‐PCR: real‐time reverse transcriptase polymerase chain reaction
RSV: respiratory syncytial virus
RTI: respiratory tract infection
RT‐PCR: reverse transcriptase polymerase chain reaction
SAR: secondary attack ratios
SD: standard deviation
S/S: signs and symptoms
URI: upper respiratory infection
URTI: upper respiratory tract infection
WHO: World Health Organization
Figures and Tables -
Table 9. Trial authors’ outcome definitions
Navigate to table in Review
Comparison 1. Randomised trials: medical/surgical masks versus no masks
Outcome or subgroup title
No. of studies
No. of participants
Statistical method
Effect size
1.1 Viral illness Show forest plot
9
Risk Ratio (IV, Random, 95% CI)
Subtotals only
1.1.1 Influenza‐like illness
9
3507
Risk Ratio (IV, Random, 95% CI)
0.99 [0.82, 1.18]
1.1.2 Laboratory‐confirmed influenza
6
3005
Risk Ratio (IV, Random, 95% CI)
0.91 [0.66, 1.26]
1.2 Influenza‐like illness in healthcare workers Show forest plot
2
1070
Risk Ratio (IV, Random, 95% CI)
0.37 [0.05, 2.50]
Figures and Tables -
Comparison 1. Randomised trials: medical/surgical masks versus no masks
Navigate to table in Review
Comparison 2. Randomised trials: N95 respirators compared to medical/surgical
masks
Outcome or subgroup title
No. of studies
No. of participants
Statistical method
Effect size
2.1 Viral illness Show forest plot
5
Risk Ratio (IV, Random, 95% CI)
Subtotals only
2.1.1 Clinical respiratory illness
3
7799
Risk Ratio (IV, Random, 95% CI)
0.70 [0.45, 1.10]
2.1.2 Influenza‐like illness
5
8407
Risk Ratio (IV, Random, 95% CI)
0.82 [0.66, 1.03]
2.1.3 Laboratory‐confirmed influenza
5
8407
Risk Ratio (IV, Random, 95% CI)
1.10 [0.90, 1.34]
2.2 Viral illness in healthcare workers Show forest plot
4
Risk Ratio (IV, Random, 95% CI)
Subtotals only
2.2.1 Clinical respiratory illness
3
7799
Risk Ratio (IV, Random, 95% CI)
0.70 [0.45, 1.10]
2.2.2 Influenza‐like illness
4
8221
Risk Ratio (IV, Random, 95% CI)
0.81 [0.59, 1.11]
2.2.3 Laboratory‐confirmed influenza
4
8221
Risk Ratio (IV, Random, 95% CI)
1.05 [0.79, 1.40]
Figures and Tables -
Comparison 2. Randomised trials: N95 respirators compared to medical/surgical
masks
Navigate to table in Review
Comparison 3. Randomised trials: hand hygiene compared to control
Outcome or subgroup title
No. of studies
No. of participants
Statistical method
Effect size
3.1 Viral illness Show forest plot
16
Risk Ratio (IV, Random, 95% CI)
Subtotals only
3.1.1 Acute respiratory illness
7
44129
Risk Ratio (IV, Random, 95% CI)
0.84 [0.82, 0.86]
3.1.2 Influenza‐like illness
10
32641
Risk Ratio (IV, Random, 95% CI)
0.98 [0.85, 1.13]
3.1.3 Laboratory‐confirmed influenza
8
8332
Risk Ratio (IV, Random, 95% CI)
0.91 [0.63, 1.30]
3.2 ARI or ILI or influenza (including outcome with most events from each study)
Show forest plot
16
61372
Risk Ratio (IV, Random, 95% CI)
0.89 [0.84, 0.95]
3.3 Influenza or ILI: sensitivity analysis including outcomes with the most
precise and unequivocal definitions Show forest plot
11
26343
Risk Ratio (IV, Random, 95% CI)
0.92 [0.80, 1.05]
3.4 ARI or ILI or influenza: subgroup analysis Show forest plot
16
61372
Risk Ratio (IV, Random, 95% CI)
0.89 [0.84, 0.95]
3.4.1 Children
9
21283
Risk Ratio (IV, Random, 95% CI)
0.92 [0.84, 1.01]
3.4.2 Adults
7
40089
Risk Ratio (IV, Random, 95% CI)
0.85 [0.79, 0.92]
3.5 Absenteeism Show forest plot
3
3150
Risk Ratio (IV, Random, 95% CI)
0.64 [0.58, 0.71]
Figures and Tables -
Comparison 3. Randomised trials: hand hygiene compared to control
Navigate to table in Review
Comparison 4. Randomised trials: hand hygiene + medical/surgical masks compared
to control
Outcome or subgroup title
No. of studies
No. of participants
Statistical method
Effect size
4.1 Viral illness Show forest plot
6
Risk Ratio (IV, Random, 95% CI)
Subtotals only
4.1.1 Influenza‐like illness
6
4504
Risk Ratio (IV, Random, 95% CI)
1.03 [0.77, 1.37]
4.1.2 Laboratory‐confirmed Influenza
4
3121
Risk Ratio (IV, Random, 95% CI)
0.97 [0.69, 1.36]
Figures and Tables -
Comparison 4. Randomised trials: hand hygiene + medical/surgical masks compared
to control
Navigate to table in Review
Comparison 5. Randomised trials: hand hygiene + medical/surgical masks compared
to hand hygiene
Outcome or subgroup title
No. of studies
No. of participants
Statistical method
Effect size
5.1 Viral illness Show forest plot
3
Risk Ratio (IV, Random, 95% CI)
Subtotals only
5.1.1 Influenza‐like illness
3
2982
Risk Ratio (IV, Random, 95% CI)
1.03 [0.69, 1.53]
5.1.2 Laboratory‐confirmed influenza
3
2982
Risk Ratio (IV, Random, 95% CI)
0.99 [0.69, 1.44]
Figures and Tables -
Comparison 5. Randomised trials: hand hygiene + medical/surgical masks compared
to hand hygiene
Navigate to table in Review
Comparison 6. Randomised trials: gargling compared to control
Outcome or subgroup title
No. of studies
No. of participants
Statistical method
Effect size
6.1 Viral illness Show forest plot
2
830
Risk Ratio (IV, Random, 95% CI)
0.91 [0.63, 1.31]
Figures and Tables -
Comparison 6. Randomised trials: gargling compared to control
Navigate to table in Review
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