title: The Respiratory Protection Effectiveness Clinical Trial (ResPECT): a cluster-randomized comparison of respirator and medical mask effectiveness against respiratory infections in healthcare personnel.
abstract: Although N95 filtering facepiece respirators and medical masks are commonly used for protection against respiratory infections in healthcare settings, more clinical evidence is needed to understand the optimal settings and exposure circumstances for healthcare personnel to use these devices. A lack of clinically germane research has led to equivocal, and occasionally conflicting, healthcare respiratory protection recommendations from public health organizations, professional societies, and experts.
  
  
  
  The Respiratory Protection Effectiveness Clinical Trial (ResPECT) is a prospective comparison of respiratory protective equipment to be conducted at multiple U.S. study sites. Healthcare personnel who work in outpatient settings will be cluster-randomized to wear N95 respirators or medical masks for protection against infections during respiratory virus season. Outcome measures will include laboratory-confirmed viral respiratory infections, acute respiratory illness, and influenza-like illness. Participant exposures to patients, coworkers, and others with symptoms and signs of respiratory infection, both within and beyond the workplace, will be recorded in daily diaries. Adherence to study protocols will be monitored by the study team.
  
  
  
  ResPECT is designed to better understand the extent to which N95s and MMs reduce clinical illness among healthcare personnel. A fully successful study would produce clinically relevant results that help clinician-leaders make reasoned decisions about protection of healthcare personnel against occupationally acquired respiratory infections and prevention of spread within healthcare systems.
  
  
  
  The trial is registered at clinicaltrials.gov, number NCT01249625 (11/29/2010).
authors.affiliation: U.S. Department of Veterans Affairs, National Center for Occupational Health and Infection Control, 1601 SW Archer Road, Mailstop 151E, Gainesville, FL, 32608, USA. lewis.radonovich@va.gov.
authors.forename: Lewis J
authors.initials: LJ
authors.lastname: Radonovich
authors.affiliation: Veterans Affairs Eastern Colorado Healthcare System, Denver, CO, USA.|University of Colorado School of Medicine, Denver, CO, USA.
authors.forename: Mary T
authors.initials: MT
authors.lastname: Bessesen
authors.affiliation: Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.|University of Florida, Gainesville, Florida, USA.
authors.forename: Derek A
authors.initials: DA
authors.lastname: Cummings
authors.affiliation: U.S. Department of Veterans Affairs, National Center for Occupational Health and Infection Control, 1601 SW Archer Road, Mailstop 151E, Gainesville, FL, 32608, USA.
authors.forename: Aaron
authors.initials: A
authors.lastname: Eagan
authors.affiliation: Johns Hopkins School of Medicine, Baltimore, MD, USA.
authors.forename: Charlotte
authors.initials: C
authors.lastname: Gaydos
authors.affiliation: Veterans Affairs Medical Center and George Washington University School of Medical and Health Sciences, Washington, DC, USA.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Gibert
authors.affiliation: Veterans Affairs St. Louis Healthcare System and Saint Louis University School of Medicine, St. Louis, MO, USA.
authors.forename: Geoffrey J
authors.initials: GJ
authors.lastname: Gorse
authors.affiliation: Children's Hospital Colorado, Aurora, CO, USA.|University of Colorado School of Medicine, Denver, CO, USA.
authors.forename: Ann-Christine
authors.initials: AC
authors.lastname: Nyquist
authors.affiliation: Department of Biostatistics and Epidemiology, University of Massachusetts, Amherst, MA, USA.
authors.forename: Nicholas G
authors.initials: NG
authors.lastname: Reich
authors.affiliation: Michael E. DeBakey VAMC and Baylor College of Medicine, Houston, Texas, USA.
authors.forename: Maria
authors.initials: M
authors.lastname: Rodrigues-Barradas
authors.affiliation: Denver Health, Denver, CO, USA.|University of Colorado School of Medicine, Denver, CO, USA.
authors.forename: Connie
authors.initials: C
authors.lastname: Savor-Price
authors.affiliation: National Personal Protective Technology Laboratory, National Institute for Occupational Safety and Health, Pittsburgh, PA, USA.
authors.forename: Ronald E
authors.initials: RE
authors.lastname: Shaffer
authors.affiliation: Veterans Affairs New York Harbor Healthcare System, New York, NY, USA.
authors.forename: Michael S
authors.initials: MS
authors.lastname: Simberkoff
authors.affiliation: Johns Hopkins School of Medicine, Baltimore, MD, USA.
authors.forename: Trish M
authors.initials: TM
authors.lastname: Perl
mesh_terms: D000553:Ambulatory Care; D005260:Female; D006282:Health Personnel; D006801:Humans; D008397:Masks; D009784:Occupational Diseases / Q000517:prevention & control*; D011446:Prospective Studies; D012134:Respiratory Protective Devices; D012141:Respiratory Tract Infections / Q000517:prevention & control*; D014777:Virus Diseases / Q000517:prevention & control*; D017132:Workplace
keywords: Healthcare personnel; Influenza; Masks; Respirators; Respiratory infections