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N95 Respirators vs Medical Masks for Preventing Influenza Among Health Care Personnel: A Randomized Clinical Trial.
JAMA. 2019 09 03; 322(9):824-833.JAMA

Abstract

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.

Authors+Show Affiliations

National Personal Protective Technology Laboratory, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Pittsburgh, Pennsylvania.Veterans Affairs New York Harbor Healthcare System, New York. New York University School of Medicine, New York.Veterans Affairs Eastern Colorado Healthcare System, Denver. University of Colorado School of Medicine, Aurora.University of Massachusetts, Amherst.University of Florida, Gainesville. Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.Johns Hopkins School of Medicine, Baltimore, Maryland.Johns Hopkins School of Medicine, Baltimore, Maryland.Johns Hopkins School of Medicine, Baltimore, Maryland. Weill Cornell Medicine, New York, New York.Veterans Affairs Medical Center, Washington, DC. George Washington University School of Medical and Health Sciences, Washington, DC.Veterans Affairs St Louis Healthcare System, St Louis, Missouri. St Louis University School of Medicine, St Louis, Missouri.University of Colorado School of Medicine, Aurora. Children's Hospital Colorado, Aurora.University of Massachusetts, Amherst.Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas. Baylor College of Medicine, Houston, Texas.University of Colorado School of Medicine, Aurora. Denver Health Medical Center, Denver, Colorado.Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland. University of Texas Southwestern Medical Center, Dallas.No affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Pragmatic Clinical Trial
Randomized Controlled Trial
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

31479137

Citation

Radonovich, Lewis J., et al. "N95 Respirators Vs Medical Masks for Preventing Influenza Among Health Care Personnel: a Randomized Clinical Trial." JAMA, vol. 322, no. 9, 2019, pp. 824-833.
Radonovich LJ, Simberkoff MS, Bessesen MT, et al. N95 Respirators vs Medical Masks for Preventing Influenza Among Health Care Personnel: A Randomized Clinical Trial. JAMA. 2019;322(9):824-833.
Radonovich, L. J., Simberkoff, M. S., Bessesen, M. T., Brown, A. C., Cummings, D. A. T., Gaydos, C. A., Los, J. G., Krosche, A. E., Gibert, C. L., Gorse, G. J., Nyquist, A. C., Reich, N. G., Rodriguez-Barradas, M. C., Price, C. S., & Perl, T. M. (2019). N95 Respirators vs Medical Masks for Preventing Influenza Among Health Care Personnel: A Randomized Clinical Trial. JAMA, 322(9), 824-833. https://doi.org/10.1001/jama.2019.11645
Radonovich LJ, et al. N95 Respirators Vs Medical Masks for Preventing Influenza Among Health Care Personnel: a Randomized Clinical Trial. JAMA. 2019 09 3;322(9):824-833. PubMed PMID: 31479137.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - N95 Respirators vs Medical Masks for Preventing Influenza Among Health Care Personnel: A Randomized Clinical Trial. AU - Radonovich,Lewis J,Jr AU - Simberkoff,Michael S, AU - Bessesen,Mary T, AU - Brown,Alexandria C, AU - Cummings,Derek A T, AU - Gaydos,Charlotte A, AU - Los,Jenna G, AU - Krosche,Amanda E, AU - Gibert,Cynthia L, AU - Gorse,Geoffrey J, AU - Nyquist,Ann-Christine, AU - Reich,Nicholas G, AU - Rodriguez-Barradas,Maria C, AU - Price,Connie Savor, AU - Perl,Trish M, AU - ,, PY - 2019/9/4/entrez PY - 2019/9/4/pubmed PY - 2019/9/27/medline SP - 824 EP - 833 JF - JAMA JO - JAMA VL - 322 IS - 9 N2 - 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. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/31479137/N95_Respirators_vs_Medical_Masks_for_Preventing_Influenza_Among_Health_Care_Personnel:_A_Randomized_Clinical_Trial_ L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2019.11645 DB - PRIME DP - Unbound Medicine ER -