N95 Respirators vs Medical Masks for Preventing Influenza Among Health Care PersonnelA Randomized Clinical Trial

Corresponding Author: Lewis J. Radonovich Jr, MD, National Personal Protective Technology Laboratory, Centers for Disease Control and Prevention, 626 Cochrans Mill Rd, B141, R108, Pittsburgh, PA 15236 (mto5@cdc.gov).

Accepted for Publication: July 25, 2019.

Author Contributions: Drs Perl and Radonovich had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Radonovich, Simberkoff, Cummings, Gaydos, Gorse, Reich, Perl.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Radonovich, Simberkoff, Cummings, Gaydos, Nyquist, Reich, Perl.

Critical revision of the manuscript for important intellectual content: Radonovich, Bessesen, Brown, Cummings, Gaydos, Los, Krosche, Gibert, Gorse, Nyquist, Reich, Rodriguez-Barradas, Price, Perl.

Statistical analysis: Brown, Cummings, Reich.

Obtained funding: Cummings, Perl.

Administrative, technical, or material support: Radonovich, Simberkoff, Bessesen, Cummings, Gaydos, Los, Krosche, Gorse, Nyquist, Rodriguez-Barradas, Price, Perl.

Supervision: Radonovich, Simberkoff, Cummings, Los, Nyquist, Reich, Price, Perl.

Other - execution of study design; data management and monitoring: Los.

Other - Site principal investigator for conduct of study and also contributed ongoing input on conduct and analysis of study: Gibert.

Other - laboratory testing support: Gaydos.

Other - recruiting patients: Price.

Conflict of Interest Disclosures: Dr Bessesen reported receiving grants from the Department of Veterans Affairs during the conduct of the study. Dr Brown reported receiving grants from the US Department of Veterans Affairs during the conduct of the study. Dr Cummings reported receiving grants from the Centers for Disease Control and Prevention, the National Institutes of Health, and MedImmune outside the submitted work and the Biomedical Advanced Research and Development Authority during the conduct of the study. Ms Los reported receiving grants from Centers for Disease Control and Prevention, the Veterans Health Administration, and the Biodefense Advanced Research and Development Agency during the conduct of the study. Dr Gibert reported receiving financial support for the conduct of the study, including research personnel, from the Veterans Health Administration during the conduct of the study. Dr Gorse reported receiving grants from the US Department of Veterans Affairs during the conduct of the study. Dr Nyquist reported receiving grants from the Centers for Disease Control and Prevention/Division of Healthcare Quality Promotion, the National Institute for Occupational Safety and Health, and the Veterans Health Administration during the conduct of the study; personal fees and nonfinancial support from Sequirus outside the submitted work; and serving on a policy making committee regarding infectious disease for the American Academy of Pediatrics Committee on Infectious Diseases. Dr Reich reported receiving grants from Veterans Health Administration during the conduct of the study. Dr Rodriguez-Barradas reported receiving grants from Veterans Affairs Central Office during the conduct of the study. Dr Perl reported receiving grants from the Centers for Disease Control and Prevention and Biomedical Advanced Research and Development Authority during the conduct of the study and grants from Medimmune outside the submitted work. No other disclosures were reported.

Funding/Support: This trial was funded by the US Centers for Disease Control and Prevention, Veterans Health Administration, and the Biodefense Advanced Research and Development Agency.

Role of the Funder/Sponsor: The sponsors were not involved in data collection, analysis, or interpretation; writing of the manuscript; or the decision to submit the manuscript. The sponsors reviewed and made technical comments about the study protocol prior to enrollment and the final manuscript prior to submission for publication.

Group Information: For the ResPECT Team (Contributors): The Johns Hopkins University and Health System (Baltimore, MD): Trish M. Perl, MD, MSc; Justin Getka, BA; Tina Hoang, MS; Rose Kajih, PharmD; Amanda Krosche, BS; Meghan Kubala, MS, MD: Jenna Los, MLA; Liandra Presser, MD; Kathleen Pulice, MS; Margaret Spach, DDS. VA New York Harbor Healthcare System (New York, NY): Michael S. Simberkoff, MD; Cynthia Akagbosu, BA, MA; Madeline Dansky, BA; Benedict J. Frederick, BA; Marilyn Last, RN; Scott Laverie, RN; Courtney Pike, BA; Shefali Rikhi, BS; Nicole Spector, RN; Christine A. Reel-Brander, RN. Denver Health & Hospital Authority (Denver, CO): Connie Price, MD; Katie Gorman, BS; Amy Irwin, DNP, RN; Sean O’Malley; Kevin Silva, BS. UT Southwestern Medical Center (Dallas, TX) Trish M. Perl, MD, MSc; Deepa Raj, MPH; VA Eastern Colorado Healthcare System (Aurora, CO): Mary Bessesen, MD; Jill C. Adams BSN, BA; Shannon Kingery, BS; Stefanie Tuder, BS; Erron Fritchman-Palmer, MPH. Children’s Hospital Colorado (Denver, CO): Ann-Christine Nyquist, MD, MSPH; Megan Gorski, BA. VA Washington DC Medical Center (Washington, DC): Cynthia Gibert, MD, MSc; Laura Chopko, BA; Kathy Haines, MSW, MPH; Caitlin Langhorne, MPH; Dana Silver, BA; Courtney Southard, MPH. VA Michael C. DeBakey Medical Center (Houston, TX): Maria C. Rodriguez-Barradas MD; Barbara Kertz, MS; Mahwish Mushtaq, MD, MPH; Blanca Vargas, MD. Centers for Disease Control and Prevention, National Institute for Occupational Safety & Health (Pittsburgh, PA): Edward Fisher, MS; Ronald Shaffer, PhD; Lewis J. Radonovich, MD. Veteran’s Health Administration Office of Public Health (Gainesville, FL): Aaron Eagan, MPH, RN; Lewis J. Radonovich, MD. HandyMetrics Corporation (Toronto, Ontario, Canada): Melanie Lipka, BS; Michael Tsang, PhD. Laboratory Core at Johns Hopkins University (Baltimore, MD): Charlotte Gaydos, DrPH, Jeffrey Holden, MA; Alexandra Valsamakis, MD, PhD. Laboratory Core at VA St Louis Healthcare System and St Louis University School of Medicine (St Louis, MO): Geoffrey J. Gorse, MD; Michelle Mitchell, BS; Gira B. Patel, MS; Yinyi Yu, BS. REDCap Core at Johns Hopkins University (Baltimore, MD): Andre Hackman, BA, Michael Sherman, BS. Statistical and Epidemiologic Core (University of Florida, Gainesville): Brooke A. Borgert MS., Derek A.T. Cummings, PhD, MPH, MSc.; Susan Rattigan (University of Massachusetts, Amherst): Alexandria C. Brown, PhD; Nicholas G. Reich, PhD (Johns Hopkins University, Baltimore, MD); Justin Lessler, PhD, MHS, MS.

Disclaimer: The findings and conclusions in this article are the authors’ own and do not necessarily represent the views of the National Institute for Occupational Safety and Health, the Centers for Disease Control and Prevention, the Department of Veterans Affairs, or other affiliates. Mention of product names does not imply endorsement. All information and materials in this article are original.

Data Sharing Statement: See Supplement 4.

Additional Contributions: We thank the members of the data and safety monitoring board, Daniel Morgan, MD (University of Maryland, Baltimore), Elizabeth Colantuoni, PhD (Johns Hopkins Bloomberg School of Public Health, Baltimore), and Tia Powell, MD (Albert Einstein College of Medicine, Bronx). We also thank David Weissman, MD (National Institute for Occupational Safety and Health) and Michael Hodgson, MD (Occupational Safety and Health Administration). None of our consults were financially compensated for their expertise, support, and guidance throughout the study. We are immensely grateful to the study personnel and coordinators, the supporting clinical staff, and, most importantly, the participants.