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ResPECT (Respiratory Protection Effectiveness Clinical Trial)

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Cluster randomised controlled trial to examine medical mask use as source control for people with respiratory illness

Authors » MacIntyre CR , Zhang Y , Chughtai AA , Seale H , Zhang D , Chu Y , Zhang H , Rahman B , Wang Q

Journal » BMJ open

Year » 2016

Links » Pubmed DOI PubMed Central

This article is included in 10 Systematic reviews Systematic reviews (10 references) 3 Broad syntheses Broad syntheses (3 references)

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Rationale: Medical masks are commonly used by sick individuals with influenza-like illness (ILI) to prevent spread of infections to others, but clinical efficacy data are absent. Objective: Determine whether medical mask use by sick individuals with ILI protects well contacts from related respiratory infections. Setting: 6 major hospitals in 2 districts of Beijing, China. Design: Cluster randomised controlled trial. Participants: 245 index cases with ILI. Intervention: Index cases with ILI were randomly allocated to medical mask (n=123) and control arms (n=122). Since 43 index cases in the control arm also used a mask during the study period, an as-treated post hoc analysis was performed by comparing outcomes among household members of index cases who used a mask (mask group) with household members of index cases who did not use a mask (no-mask group). Main outcome measure: Primary outcomes measured in household members were clinical respiratory illness, ILI and laboratory-confirmed viral respiratory infection. Results: In an intention-to-treat analysis, rates of clinical respiratory illness (relative risk (RR) 0.61, 95% CI 0.18 to 2.13), ILI (RR 0.32, 95% CI 0.03 to 3.13) and laboratory-confirmed viral infections (RR 0.97, 95% CI 0.06 to 15.54) were consistently lower in the mask arm compared with control, although not statistically significant. A post hoc comparison between the mask versus no-mask groups showed a protective effect against clinical respiratory illness, but not against ILI and laboratory-confirmed viral respiratory infections. Conclusions: The study indicates a potential benefit of medical masks for source control, but is limited by small sample size and low secondary attack rates. Larger trials are needed to confirm efficacy of medical masks as source control. © Published by the BMJ Publishing Group Limited.

Chughtai AA, MacIntyre CR et al

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Pilot Randomised Controlled Trial to Test Effectiveness of Facemasks in Preventing Influenza-like Illness Transmission among Australian Hajj Pilgrims in 2011.

Authors » Barasheed O , Almasri N , Badahdah AM , Heron L , Taylor J , McPhee K , Ridda I , Haworth E , Dwyer DE , Rashid H , Booy R , Hajj Research Team

Journal » Infectious disorders drug targets

Year » 2014

Links » Pubmed DOI

This article is included in 16 Systematic reviews Systematic reviews (16 references) 1 Broad synthesis Broad syntheses (1 reference)

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Studies to determine the effectiveness of facemasks in preventing influenza have been inconclusive, largely due to small sample size. The Hajj pilgrimage, where the incidence of influenza and other respiratory infections is high, provides an excellent opportunity to test the effectiveness of facemasks against syndromic and laboratory-confirmed infections. Hence, a pilot study was conducted among Australian pilgrims to assess the feasibility of such a large-scale trial in the coming years. At the 2011 Hajj, tents were randomised to 'supervised mask use' versus 'no supervised mask use'. Pilgrims with ILI symptoms for ≤3 days were recruited as 'cases' and those who slept within 2 meters of them as 'contacts'. Surgical facemasks were provided to cases and contacts in the 'mask' tents, but not in the 'control' tents. Pilgrims in both groups were given diaries to record their respiratory symptoms. Nasal or pharyngeal swabs were collected from the cases and contacts with ILI for point-of-care and nucleic acid tests. A total of 22 tents were randomised to 'mask' (n=12) or 'control' (n=10). There were 164 pilgrims recruited; 75 in 'mask' and 89 in 'control' group. Mask use compliance was 76% in the 'mask' group and 12% in the 'control' group. Based on developing syndromic ILI, less contacts became symptomatic in the 'mask' tents compared to the 'control' tents (31% versus 53%, p= 0.04). However, laboratory results did not show any difference between the two groups. This pilot study shows that a large trial to assess the effectiveness of facemasks use at Hajj is feasible.

MacIntyre CR et al (ACTRN12609000778280)

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Suess T et al

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Aiello AE et al

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An effective quarantine measure reduced the total incidence of influenza A H1N1 in the workplace: another way to control the H1N1 flu pandemic.

Authors » Miyaki K , Sakurazawa H , Mikurube H , Nishizaka M , Ando H , Song Y , Shimbo T

Journal » Journal of occupational health

Year » 2011

Links » Pubmed DOI

This article is included in 2 Systematic reviews Systematic reviews (2 references)

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OBJECTIVES: To evaluate the effectiveness of a non-vaccine quarantine measure against pandemic influenza A H1N1 in workplaces. METHODS: Design was quasi-cluster randomized controlled trial in two sibling companies (Cohort 1 n=6,634, Cohort 2 n=8,500). The follow-up period was from July 1st, 2009 to February 19th, 2010 (233 days). Intervention was voluntary waiting at home on full pay if the family became Influenza like Illness (ILI). The incidences of influenza A H1N1 and those of the subgroups whose families got ILI in both cohorts were compared by a Cox regression model and log-rank test. RESULTS: There were 189 and 270 workers who got H1N1 infection during the follow-up period in each cohort. In this period 317 workers in Cohort 1 were asked to wait at home for several days (100% obeyed). The intervention group (Cohort 1) showed a statistically significant lower risk (p for log-rank test=0.033) compared with the control (Cohort 2), and the hazard ratio of the intervention was 0.799 [0.658-0.970] after adjusting for age, sex, BMI and smoking status. The workers who were asked to wait at home showed H1N1 infection more frequently (49 out of 317) compared with the workers whose family got ILI but were not asked to wait and work regularly (77 out of 990, RR=2.17 [1.48-3.18]). CONCLUSIONS: The waiting on full pay policy in the workplace reduced the overall risk of influenza A H1N1 by about 20% in one flu season in Japan. This kind of non-vaccine measure will be a promising option in workplaces to control the next flu pandemic.

MacIntyre CR, et al

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GRIPMASK

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Documents

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The role of facemasks and hand hygiene in the prevention of influenza transmission in households: Results from a cluster randomised trial; Berlin, Germany, 2009-2011

Authors » Suess T , Remschmidt C , Schink SB , Schweiger B , Nitsche A , Schroeder K , Doellinger J , Milde J , Haas W , Koehler I , Krause G , Buchholz U

Journal » BMC infectious diseases

Year » 2012

Links » Pubmed DOI PubMed Central

This article is included in 19 Systematic reviews Systematic reviews (19 references) 1 Broad synthesis Broad syntheses (1 reference)

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Background: Previous controlled studies on the effect of non-pharmaceutical interventions (NPI) - namely the use of facemasks and intensified hand hygiene - in preventing household transmission of influenza have not produced definitive results. We aimed to investigate efficacy, acceptability, and tolerability of NPI in households with influenza index patients.Methods: We conducted a cluster randomized controlled trial during the pandemic season 2009/10 and the ensuing influenza season 2010/11. We included households with an influenza positive index case in the absence of further respiratory illness within the preceding 14 days. Study arms were wearing a facemask and practicing intensified hand hygiene (MH group), wearing facemasks only (M group) and none of the two (control group). Main outcome measure was laboratory confirmed influenza infection in a household contact. We used daily questionnaires to examine adherence and tolerability of the interventions.Results: We recruited 84 households (30 control, 26 M and 28 MH households) with 82, 69 and 67 household contacts, respectively. In 2009/10 all 41 index cases had a influenza A (H1N1) pdm09 infection, in 2010/11 24 had an A (H1N1) pdm09 and 20 had a B infection. The total secondary attack rate was 16% (35/218). In intention-to-treat analysis there was no statistically significant effect of the M and MH interventions on secondary infections. When analysing only households where intervention was implemented within 36 h after symptom onset of the index case, secondary infection in the pooled M and MH groups was significantly lower compared to the control group (adjusted odds ratio 0.16, 95% CI, 0.03-0.92). In a per-protocol analysis odds ratios were significantly reduced among participants of the M group (adjusted odds ratio, 0.30, 95% CI, 0.10-0.94). With the exception of MH index cases in 2010/11 adherence was good for adults and children, contacts and index cases.Conclusions: Results suggest that household transmission of influenza can be reduced by the use of NPI, such as facemasks and intensified hand hygiene, when implemented early and used diligently. Concerns about acceptability and tolerability of the interventions should not be a reason against their recommendation.Trial registration: The study was registered with ClinicalTrials.gov (Identifier NCT00833885). © 2012 Suess et al; licensee BioMed Central Ltd.

Surgical mask to prevent influenza transmission in households: A cluster randomized trial

Authors » Canini L , Andréoletti L , Ferrari P , D'Angelo R , Blanchon T , Lemaitre M , Filleul L , Ferry JP , Desmaizieres M , Smadja S , Valleron AJ , Carrat F

Journal » PloS one

Year » 2010

Links » Pubmed DOI PubMed Central

This article is included in 14 Systematic reviews Systematic reviews (14 references) 1 Broad synthesis Broad syntheses (1 reference)

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Background: Facemasks and respirators have been stockpiled during pandemic preparedness. However, data on their effectiveness for limiting transmission are scarce. We evaluated the effectiveness of facemask use by index cases for limiting influenza transmission by large droplets produced during coughing in households. Methodology and Principal Findings: A cluster randomized intervention trial was conducted in France during the 2008- 2009 influenza season. Households were recruited during a medical visit of a household member with a positive rapid influenza A test and symptoms lasting less than 48 hours. Households were randomized either to the mask or control group for 7 days. In the intervention arm, the index case had to wear a surgical mask from the medical visit and for a period of 5 days. The trial was initially intended to include 372 households but was prematurely interrupted after the inclusion of 105 households (306 contacts) following the advice of an independent steering committee. We used generalized estimating equations to test the association between the intervention and the proportion of household contacts who developed an influenza-like illness during the 7 days following the inclusion. Influenza-like illness was reported in 24/148 (16.2%) of the contacts in the intervention arm and in 25/158 (15.8%) of the contacts in the control arm and the difference between arms was 0.40% (95%CI: 210% to 11%, P = 1.00). We observed a good adherence to the intervention. In various sensitivity analyses, we did not identify any trend in the results suggesting effectiveness of facemasks. Conclusion: This study should be interpreted with caution since the lack of statistical power prevents us to draw formal conclusion regarding effectiveness of facemasks in the context of a seasonal epidemic. © 2010 Canini et al.

A randomized clinical trial of three options for N95 respirators and medical masks in health workers.

Authors » MacIntyre CR , Wang Q , Seale H , Yang P , Shi W , Gao Z , Rahman B , Zhang Y , Wang X , Newall AT , Heywood A , Dwyer DE

Journal » American journal of respiratory and critical care medicine

Year » 2013

Links » Pubmed DOI

This article is included in 19 Systematic reviews Systematic reviews (19 references)

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RATIONALE: We compared three policy options for the use of medical masks and N95 respirators in healthcare workers (HCWs). OBJECTIVES: A cluster randomized clinical trial of 1,669 hospital-based HCWs in Beijing, China in the winter of 2009-2010. METHODS: Participants were randomized to medical masks, N95 respirators, or targeted use of N95 respirators while doing high-risk procedures or barrier nursing. Outcomes included clinical respiratory illness (CRI) and laboratory-confirmed respiratory pathogens in symptomatic subjects. MEASUREMENTS AND MAIN RESULTS: The rate of CRI was highest in the medical mask arm (98 of 572; 17%), followed by the targeted N95 arm (61 of 516; 11.8%), and the N95 arm (42 of 581; 7.2%) (P < 0.05). Bacterial respiratory tract colonization in subjects with CRI was highest in the medical mask arm (14.7%; 84 of 572), followed by the targeted N95 arm (10.1%; 52 of 516), and lowest in the N95 arm (6.2%; 36 of 581) (P = 0.02). After adjusting for confounders, only continuous use of N95 remained significant against CRI and bacterial colonization, and for just CRI compared with targeted N95 use. Targeted N95 use was not superior to medical masks. CONCLUSIONS: Continuous use of N95 respirators was more efficacious against CRI than intermittent use of N95 or medical masks. Most policies for HCWs recommend use of medical masks alone or targeted N95 respirator use. Continuous use of N95s resulted in significantly lower rates of bacterial colonization, a novel finding that points to more research on the clinical significance of bacterial infection in symptomatic HCWs. This study provides further data to inform occupational policy options for HCWs. Clinical trial registered with Australian New Zealand Clinical Trials Registry http://www.anzctr.org.au (ACTRN 12609000778280).

Cluster randomised controlled trial to examine medical mask use as source control for people with respiratory illness

Authors » MacIntyre CR , Zhang Y , Chughtai AA , Seale H , Zhang D , Chu Y , Zhang H , Rahman B , Wang Q

Journal » BMJ open

Year » 2016

Links » Pubmed DOI PubMed Central

This article is included in 10 Systematic reviews Systematic reviews (10 references) 3 Broad syntheses Broad syntheses (3 references)

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Use of surgical face masks to reduce the incidence of the common cold among health care workers in Japan: a randomized controlled trial.

Authors » Jacobs JL , Ohde S , Takahashi O , Tokuda Y , Omata F , Fukui T

Journal » American journal of infection control

Year » 2009

Links » Pubmed DOI

This article is included in 8 Systematic reviews Systematic reviews (8 references)

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BACKGROUND: Health care workers outside surgical suites in Asia use surgical-type face masks commonly. Prevention of upper respiratory infection is one reason given, although evidence of effectiveness is lacking. METHODS: Health care workers in a tertiary care hospital in Japan were randomized into 2 groups: 1 that wore face masks and 1 that did not. They provided information about demographics, health habits, and quality of life. Participants recorded symptoms daily for 77 consecutive days, starting in January 2008. Presence of a cold was determined based on a previously validated measure of self-reported symptoms. The number of colds between groups was compared, as were risk factors for experiencing cold symptoms. RESULTS: Thirty-two health care workers completed the study, resulting in 2464 subject days. There were 2 colds during this time period, 1 in each group. Of the 8 symptoms recorded daily, subjects in the mask group were significantly more likely to experience headache during the study period (P < .05). Subjects living with children were more likely to have high cold severity scores over the course of the study. CONCLUSION: Face mask use in health care workers has not been demonstrated to provide benefit in terms of cold symptoms or getting colds. A larger study is needed to definitively establish noninferiority of no mask use.

A randomized intervention trial of mask use and hand hygiene to reduce seasonal influenza-like illness and influenza infections among young adults in a university setting

Authors » Aiello AE , Coulborn RM , Perez V

Journal » International Journal of Infectious Diseases

Year » 2010

Links » DOI

This article is included in 1 Systematic review Systematic reviews (1 reference)

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BACKGROUND: Early efforts to decrease transmission of pandemic influenza will likely rely on nonpharmaceutical interventions (NPIs), because of delays in availability of suitable vaccines and limited stock of antiviral medications. We conducted a randomized trial to estimate reductions in influenza-like illness (ILI) and laboratory-confirmed influenza infection associated with use of face masks combined with hand hygiene measures and face masks alone in a university setting.

Surgical mask vs N95 respirator for preventing influenza among health care workers: a randomized trial.

Authors » Loeb M , Dafoe N , Mahony J , John M , Sarabia A , Glavin V , Webby R , Smieja M , Earn DJ , Chong S , Webb A , Walter SD

Journal » JAMA : the journal of the American Medical Association

Year » 2009

Links » Pubmed DOI

This article is included in 1 Structured summary of primary studies Structured summaries of primary studies (1 reference) 19 Systematic reviews Systematic reviews (19 references)

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CONTEXT: Data about the effectiveness of the surgical mask compared with the N95 respirator for protecting health care workers against influenza are sparse. Given the likelihood that N95 respirators will be in short supply during a pandemic and not available in many countries, knowing the effectiveness of the surgical mask is of public health importance. OBJECTIVE: To compare the surgical mask with the N95 respirator in protecting health care workers against influenza. DESIGN, SETTING, AND PARTICIPANTS: Noninferiority randomized controlled trial of 446 nurses in emergency departments, medical units, and pediatric units in 8 tertiary care Ontario hospitals. INTERVENTION: Assignment to either a fit-tested N95 respirator or a surgical mask when providing care to patients with febrile respiratory illness during the 2008-2009 influenza season. MAIN OUTCOME MEASURES: The primary outcome was laboratory-confirmed influenza measured by polymerase chain reaction or a 4-fold rise in hemagglutinin titers. Effectiveness of the surgical mask was assessed as noninferiority of the surgical mask compared with the N95 respirator. The criterion for noninferiority was met if the lower limit of the 95% confidence interval (CI) for the reduction in incidence (N95 respirator minus surgical group) was greater than -9%. RESULTS: Between September 23, 2008, and December 8, 2008, 478 nurses were assessed for eligibility and 446 nurses were enrolled and randomly assigned the intervention; 225 were allocated to receive surgical masks and 221 to N95 respirators. Influenza infection occurred in 50 nurses (23.6%) in the surgical mask group and in 48 (22.9%) in the N95 respirator group (absolute risk difference, -0.73%; 95% CI, -8.8% to 7.3%; P = .86), the lower confidence limit being inside the noninferiority limit of -9%. CONCLUSION: Among nurses in Ontario tertiary care hospitals, use of a surgical mask compared with an N95 respirator resulted in noninferior rates of laboratory-confirmed influenza. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00756574

N95 Respirators vs Medical Masks for Preventing Influenza Among Health Care Personnel: A Randomized Clinical Trial.

Authors » Radonovich, Lewis J. , Simberkoff, Michael S. , Bessesen, Mary T. , Brown, Alexandria C. , Cummings, Derek A. T. , Gaydos, Charlotte A. , Los, Jenna G. , Krosche, Amanda E. , Gibert, Cynthia L. , Gorse, Geoffrey J. , Nyquist, Ann-Christine , Reich, Nicholas G. , Rodriguez-Barradas, Maria C. , Price, Connie Savor , Perl, Trish M.

Journal » JAMA

Year » 2019

Links » Pubmed DOI PubMed Central

This article is included in 14 Systematic reviews Systematic reviews (14 references)

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IMPORTANCE: Clinical studies have been inconclusive about the effectiveness of N95 respirators and medical masks in preventing health care personnel (HCP) from acquiring workplace viral respiratory infections. OBJECTIVE: To compare the effect of N95 respirators vs medical masks for prevention of influenza and other viral respiratory infections among HCP. DESIGN, SETTING, AND PARTICIPANTS: A cluster randomized pragmatic effectiveness study conducted at 137 outpatient study sites at 7 US medical centers between September 2011 and May 2015, with final follow-up in June 2016. Each year for 4 years, during the 12-week period of peak viral respiratory illness, pairs of outpatient sites (clusters) within each center were matched and randomly assigned to the N95 respirator or medical mask groups. INTERVENTIONS: Overall, 1993 participants in 189 clusters were randomly assigned to wear N95 respirators (2512 HCP-seasons of observation) and 2058 in 191 clusters were randomly assigned to wear medical masks (2668 HCP-seasons) when near patients with respiratory illness. MAIN OUTCOMES AND MEASURES: The primary outcome was the incidence of laboratory-confirmed influenza. Secondary outcomes included incidence of acute respiratory illness, laboratory-detected respiratory infections, laboratory-confirmed respiratory illness, and influenzalike illness. Adherence to interventions was assessed. RESULTS: Among 2862 randomized participants (mean [SD] age, 43 [11.5] years; 2369 [82.8%]) women), 2371 completed the study and accounted for 5180 HCP-seasons. There were 207 laboratory-confirmed influenza infection events (8.2% of HCP-seasons) in the N95 respirator group and 193 (7.2% of HCP-seasons) in the medical mask group (difference, 1.0%, [95% CI, -0.5% to 2.5%]; P = .18) (adjusted odds ratio [OR], 1.18 [95% CI, 0.95-1.45]). There were 1556 acute respiratory illness events in the respirator group vs 1711 in the mask group (difference, -21.9 per 1000 HCP-seasons [95% CI, -48.2 to 4.4]; P = .10); 679 laboratory-detected respiratory infections in the respirator group vs 745 in the mask group (difference, -8.9 per 1000 HCP-seasons, [95% CI, -33.3 to 15.4]; P = .47); 371 laboratory-confirmed respiratory illness events in the respirator group vs 417 in the mask group (difference, -8.6 per 1000 HCP-seasons [95% CI, -28.2 to 10.9]; P = .39); and 128 influenzalike illness events in the respirator group vs 166 in the mask group (difference, -11.3 per 1000 HCP-seasons [95% CI, -23.8 to 1.3]; P = .08). In the respirator group, 89.4% of participants reported "always" or "sometimes" wearing their assigned devices vs 90.2% in the mask group. CONCLUSIONS AND RELEVANCE: Among outpatient health care personnel, N95 respirators vs medical masks as worn by participants in this trial resulted in no significant difference in the incidence of laboratory-confirmed influenza. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01249625.

Preliminary findings of a randomized trial of non-pharmaceutical interventions to prevent influenza transmission in households.

Authors » Cowling BJ , Fung RO , Cheng CK , Fang VJ , Chan KH , Seto WH , Yung R , Chiu B , Lee P , Uyeki TM , Houck PM , Peiris JS , Leung GM

Journal » PloS one

Year » 2008

Links » Pubmed DOI PubMed Central

This article is included in 22 Systematic reviews Systematic reviews (22 references) 1 Broad synthesis Broad syntheses (1 reference)

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BACKGROUND: There are sparse data on whether non-pharmaceutical interventions can reduce the spread of influenza. We implemented a study of the feasibility and efficacy of face masks and hand hygiene to reduce influenza transmission among Hong Kong household members. METHODOLOGY/PRINCIPAL FINDINGS: We conducted a cluster randomized controlled trial of households (composed of at least 3 members) where an index subject presented with influenza-like-illness of <48 hours duration. After influenza was confirmed in an index case by the QuickVue Influenza A+B rapid test, the household of the index subject was randomized to 1) control or 2) surgical face masks or 3) hand hygiene. Households were visited within 36 hours, and 3, 6 and 9 days later. Nose and throat swabs were collected from index subjects and all household contacts at each home visit and tested by viral culture. The primary outcome measure was laboratory culture confirmed influenza in a household contact; the secondary outcome was clinically diagnosed influenza (by self-reported symptoms). We randomized 198 households and completed follow up home visits in 128; the index cases in 122 of those households had laboratory-confirmed influenza. There were 21 household contacts with laboratory confirmed influenza corresponding to a secondary attack ratio of 6%. Clinical secondary attack ratios varied from 5% to 18% depending on case definitions. The laboratory-based or clinical secondary attack ratios did not significantly differ across the intervention arms. Adherence to interventions was variable. CONCLUSIONS/SIGNIFICANCE: The secondary attack ratios were lower than anticipated, and lower than reported in other countries, perhaps due to differing patterns of susceptibility, lack of significant antigenic drift in circulating influenza virus strains recently, and/or issues related to the symptomatic recruitment design. Lessons learnt from this pilot have informed changes for the main study in 2008. TRIAL REGISTRATION: ClinicalTrials.gov NCT00425893 HKClinicalTrials.com HKCTR-365.

Face mask use and control of respiratory virus transmission in households

Authors » MacIntyre CR , Cauchemez S , Dwyer DE , Seale H , Cheung P , Browne G , Fasher M , Wood J , Gao Z , Booy R , Ferguson N

Journal » Emerging infectious diseases

Year » 2009

Links » Pubmed DOI PubMed Central

This article is included in 21 Systematic reviews Systematic reviews (21 references) 2 Broad syntheses Broad syntheses (2 references)

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Many countries are stockpiling face masks for use as a nonpharmaceutical intervention to control virus transmission during an influenza pandemic. We conducted a prospective cluster-randomized trial comparing surgical masks, non-fit- tested P2 masks, and no masks in prevention of influenzalike illness (ILI) in households. Mask use adherence was self-reported. During the 2006 and 2007 winter seasons, 286 exposed adults from 143 households who had been exposed to a child with clinical respiratory illness were recruited. We found that adherence to mask use significantly reduced the risk for ILI-associated infection, but <50% of participants wore masks most of the time. We concluded that household use of face masks is associated with low adherence and is ineffective for controlling seasonal respiratory disease. However, during a severe pandemic when use of face masks might be greater, pandemic transmission in households could be reduced.

Primary studies included in this broad synthesis

ResPECT (Respiratory Protection Effectiveness Clinical Trial)

MacIntyre CR et al (ACTRN12609000778280)

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