Dataset Information

Medical Masks Versus N95 Respirators for Preventing COVID-19 Among Health Care Workers : A Randomized Trial.

ABSTRACT:

Background

It is uncertain if medical masks offer similar protection against COVID-19 compared with N95 respirators.

Objective

To determine whether medical masks are noninferior to N95 respirators to prevent COVID-19 in health care workers providing routine care.

Design

Multicenter, randomized, noninferiority trial. (ClinicalTrials.gov: NCT04296643).

Setting

29 health care facilities in Canada, Israel, Pakistan, and Egypt from 4 May 2020 to 29 March 2022.

Participants

1009 health care workers who provided direct care to patients with suspected or confirmed COVID-19.

Intervention

Use of medical masks versus fit-tested N95 respirators for 10 weeks, plus universal masking, which was the policy implemented at each site.

Measurements

The primary outcome was confirmed COVID-19 on reverse transcriptase polymerase chain reaction (RT-PCR) test.

Results

In the intention-to-treat analysis, RT-PCR-confirmed COVID-19 occurred in 52 of 497 (10.46%) participants in the medical mask group versus 47 of 507 (9.27%) in the N95 respirator group (hazard ratio [HR], 1.14 [95% CI, 0.77 to 1.69]). An unplanned subgroup analysis by country found that in the medical mask group versus the N95 respirator group RT-PCR-confirmed COVID-19 occurred in 8 of 131 (6.11%) versus 3 of 135 (2.22%) in Canada (HR, 2.83 [CI, 0.75 to 10.72]), 6 of 17 (35.29%) versus 4 of 17 (23.53%) in Israel (HR, 1.54 [CI, 0.43 to 5.49]), 3 of 92 (3.26%) versus 2 of 94 (2.13%) in Pakistan (HR, 1.50 [CI, 0.25 to 8.98]), and 35 of 257 (13.62%) versus 38 of 261 (14.56%) in Egypt (HR, 0.95 [CI, 0.60 to 1.50]). There were 47 (10.8%) adverse events related to the intervention reported in the medical mask group and 59 (13.6%) in the N95 respirator group.

Limitation

Potential acquisition of SARS-CoV-2 through household and community exposure, heterogeneity between countries, uncertainty in the estimates of effect, differences in self-reported adherence, differences in baseline antibodies, and between-country differences in circulating variants and vaccination.

Conclusion

Among health care workers who provided routine care to patients with COVID-19, the overall estimates rule out a doubling in hazard of RT-PCR-confirmed COVID-19 for medical masks when compared with HRs of RT-PCR-confirmed COVID-19 for N95 respirators. The subgroup results varied by country, and the overall estimates may not be applicable to individual countries because of treatment effect heterogeneity.

Primary funding source

Canadian Institutes of Health Research, World Health Organization, and Juravinski Research Institute.

SUBMITTER: Loeb M

PROVIDER: S-EPMC9707441 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Medical Masks Versus N95 Respirators for Preventing COVID-19 Among Health Care Workers : A Randomized Trial.

Loeb Mark M Bartholomew Amy A Hashmi Madiha M Tarhuni Wadea W Hassany Mohamed M Youngster Ilan I Somayaji Ranjani R Larios Oscar O Kim Joseph J Missaghi Bayan B Vayalumkal Joseph V JV Mertz Dominik D Chagla Zain Z Cividino Maureen M Ali Karim K Mansour Sarah S Castellucci Lana A LA Frenette Charles C Parkes Leighanne L Downing Mark M Muller Matthew M Glavin Verne V Newton Jennifer J Hookoom Ravi R Leis Jerome A JA Kinross James J Smith Stephanie S Borhan Sayem S Singh Pardeep P Pullenayegum Eleanor E Conly John J

Annals of internal medicine 20221129 12

<h4>Background</h4>It is uncertain if medical masks offer similar protection against COVID-19 compared with N95 respirators.<h4>Objective</h4>To determine whether medical masks are noninferior to N95 respirators to prevent COVID-19 in health care workers providing routine care.<h4>Design</h4>Multicenter, randomized, noninferiority trial. (ClinicalTrials.gov: NCT04296643).<h4>Setting</h4>29 health care facilities in Canada, Israel, Pakistan, and Egypt from 4 May 2020 to 29 March 2022.<h4>Particip ...[more]

PMID: 36442064

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Project description:ImportanceClinical 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.ObjectiveTo compare the effect of N95 respirators vs medical masks for prevention of influenza and other viral respiratory infections among HCP.Design, setting, and participantsA 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.InterventionsOverall, 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 measuresThe 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.ResultsAmong 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 relevanceAmong 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 registrationClinicalTrials.gov Identifier: NCT01249625.

Project description:BackgroundRecently, several randomized controlled trials (RCTs) have evaluated the effect of N95 respirators compared with medical masks to protect against acute respiratory infections. However, these studies are limited by modest sample sizes and inconclusive results. Therefore, the goal of the present study was to review the relevant and available published RCTs with the aid of the increased power of meta-analytic methods in order to assess the effectiveness of medical masks and N95 respirators in reducing the risk of respiratory infections.MethodsThis meta-analysis follows the recommendations of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement for conducting and reporting results. We searched PubMed, Web of Science, Embase, and Cochrane databases from inception through April 1, 2020 to identify potentially relevant studies. Two authors (LS and JS) independently searched the titles and abstracts of the potentially eligible articles. They independently retrieved required data from the eligible trials; the data were initially tabulated for statistical analysis. Two authors (JRL and LS) independently assessed the methodological quality of the included RCTs using the Cochrane Collaboration's tool for assessing risk of bias.ResultsSix articles met the inclusion criteria. The pooled analysis showed that N95 respirators did not reduce the risk of infection with respiratory viruses compared with medical/surgical masks (5.7% vs. 7.9%; RR = 1.12; 95% CI: 0.88-1.41; p = 0.36); however, there was no statistically significant difference in laboratory-confirmed influenza between N95 and medical masks (RR = 0.91; 95% CI: 0.77-1.07; p = 0.26). Medical masks provided similar protection against other viruses, including coronavirus (RR = 0.74; 95% CI: 0.32-1.73; p = 0.49). Respiratory illness, as well as influenza-like illness were less frequently observed with N95 respirators.ConclusionsOur meta-analysis suggests that there are insufficient data to definitively determine whether N95 respirators are superior to medical masks in protection against transmissible acute respiratory infections. Further randomized trials are necessary to compare the above methods of respiratory protection in the context of COVID-19 incidence.

Dataset Information

Medical Masks Versus N95 Respirators for Preventing COVID-19 Among Health Care Workers : A Randomized Trial.

Background

Objective

Design

Setting

Participants

Intervention

Measurements

Results

Limitation

Conclusion

Primary funding source

Publications

Medical Masks Versus N95 Respirators for Preventing COVID-19 Among Health Care Workers : A Randomized Trial.

Similar Datasets

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