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Topic collections Viral Infections; Occupational and Environmental Medicine; Randomized Controlled
Trial; H1N1 Influenza; Infectious Diseases
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Related Articles published in Surgical Mask vs N95 Respirator for Preventing Influenza Among Health Care
the same issue Workers: A Randomized Trial
Mark Loeb et al. JAMA. 2009;0(2009):20091466.
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T
HE 2009 INFLUENZA A(H1N1) PANDEMIC HAS RE-
domly assigned to wear either a medical mask or a fit-tested
vived debate about the role of respiratory protection
N95 respirator when caring for patients with febrile respira-
in preventing the transmission of influenza to health
tory illness. Randomization of individual HCP permitted
care personnel (HCP). The Centers for Disease Con-
analysis at the individual level—a key strength of the study
trol and Prevention (CDC) guidelines for preventing trans-
design. Participants were evaluated for clinical and laboratory-
mission of seasonal influenza are intended to limit exposure
confirmed respiratory illness using influenza serology and a
to large respiratory droplets and recommend the use of a medi-
multiplex polymerase chain reaction (PCR) to detect a vari-
cal (surgical) mask during the care of a patient with influ-
ety of viral respiratory pathogens. Influenza infection, diag-
enza as part of a comprehensive infection control strategy.1,2
nosed by a positive PCR or a 4-fold or greater rise in titers,
However, data suggest that under certain conditions, influ-
was the primary outcome. The study was sufficiently pow-
enza viruses can be transmitted via smaller particles that evade
ered to show noninferiority of the surgical masks given a 20%
filtration by such masks.3 Unlike medical masks, N95 par-
event rate. The 2 randomized study groups were well bal-
ticulate respirators protect wearers from small particles when
anced with similar risk factors for influenza infection, in-
appropriately designed and worn.4 Recommendations to pre-
cluding vaccination and febrile respiratory illness among
vent influenza transmission take on special importance dur-
household members, and participants were evenly distrib-
ing pandemics, when there is little, if any, native immunity
uted across study hospital wards. Only 30% of nurses in each
and vaccine is not available immediately.5
study group had been vaccinated against influenza.
During the current pandemic, public health organizations
During the trial, influenza infection occurred in 23.6% of
and professional societies have reviewed information on influ-
nurses wearing medical masks and 22.9% of nurses wearing
enza transmission and severity of the pandemic H1N1 virus
N95 respirators (P=.86 for the comparison of the absolute risk
and developed differing recommendations for respiratory pro-
difference). Although the study was not powered to detect other
tection. Some groups, including the World Health Organiza-
differences, rates of noninfluenza respiratory viral infections,
tion and Society for Healthcare Epidemiology of America, rec-
physician visits for respiratory illness, and work-related ab-
ommend the use of medical masks for most patient care
senteeism were virtually identical between groups.
activities, and others, most notably the CDC, recommend N95
Some strengths and limitations of this study offer impor-
respirators. Deliberations have been influenced by animal stud-
tant lessons. Ensuring similar exposures to influenza among
ies indicating that 2009 influenza A(H1N1) virus was trans-
HCP is critical in studies of respiratory protection. Loeb et al8
mitted via inhaled particles and replicated in the lower respi-
addressed this challenge by randomizing individual HCP so
ratory tract.3,6 In September 2009, the Institute of Medicine
any given ward had HCP wearing a mixture of masks and res-
(IOM) supported the use of N95 respirators during the care
pirators. Loeb and colleagues also assessed nonoccupational
of patients infected with H1N1 influenza, although this group
exposures by questioning HCP about ill household contacts.
was instructed not to consider the available supply or com-
Because approximately 40% of influenza infections are asymp-
fort of N95 respirators in their decision.7
tomatic, the investigators also assessed influenza infection by
The debate on the type of mask has been hampered by a
serology and PCR, which improved sensitivity and power.9
lack of clinical trials examining the efficacy of medical masks
However, the authors did not directly assess exposure risks
and N95 respirators and by limited understanding of the rela-
by collecting data on the number of nurse contacts with pa-
tive contributions of different transmission modes of influ-
enza. In this issue of JAMA, Loeb et al8 report the results of a Author Affiliations: Division of Healthcare Quality Promotion, Centers for Dis-
multicenter randomized trial comparing N95 respirators with ease Control and Prevention, Atlanta, Georgia (Dr Srinivasan); School of Medi-
surgical masks in preventing the transmission of influenza cine and Bloomberg School of Public Health, Johns Hopkins University, Baltimore,
Maryland (Dr Perl).
Corresponding Author: Arjun Srinivasan, MD, Division of Healthcare Quality Pro-
See also related article. motion, Centers for Disease Control and Prevention, 1600 Clifton Rd, MS A35,
Atlanta, GA 30333 (beu8@cdc.gov).
©2009 American Medical Association. All rights reserved. (Reprinted) JAMA, Published online October 1, 2009 E1
tients exhibiting febrile respiratory illness. Further, although area. Uncovering the truth and identifying the most appro-
limited observations on adherence with mask and respirator priate way to protect HCP will require that other investiga-
use were performed—and adherence was 87.5% for N95 res- tors build on this study, replicating methodological strengths
pirators and 100% for masks—the study did not evaluate hand and addressing limitations. Ultimately, accumulating a body
hygiene adherence, triage procedures, and the implementa- of evidence on this topic will provide much-needed answers.
tion of respiratory hygiene/cough etiquette strategies. As dem- The recent IOM report calls on both federal agencies and pri-
onstrated during the severe acute respiratory syndrome (SARS) vate institutions to “fund and undertake additional research”
outbreaks, these other factors are also important determi- on respiratory protection for HCP.7 However, while the de-
nants of exposure risk.10 bate over the role of respiratory protection in preventing in-
What are the implications of these findings? A single study fluenza transmission will continue, neither the ongoing dis-
will not end the debate over influenza respiratory protec- cussion nor the need for more research should excuse anyone
tion for HCP. Unfortunately, this intense discussion over from failing to implement other measures that are known to
respiratory protection has distracted attention from the criti- protect patients and HCP from influenza.
cal importance of implementing other strategies known to Published Online: October 1, 2009 (doi:10.1001/jama.2009.1494).
prevent the transmission of influenza in health care set- Financial Disclosures: None reported.
Disclaimer: The opinions in this editorial are those of the authors and do not nec-
tings. Indeed, the use of personal protective equipment such essarily represent the views of the Centers for Disease Control and Prevention.
as masks and respirators should be considered the “last line Additional Information: Dr Perl was a member of the IOM committee “Respiratory
protection for healthcare workers in the workplace against novel H1N1 influenza A.”
of defense” in a hierarchy of infection control measures. Additional Contributions: Justin Lessler, PhD, Bloomberg School of Public Health
Chief among these is the annual vaccination of HCP against at the Johns Hopkins University, provided careful review of this document, for which
influenza, which has been shown to protect both patients and he was not compensated.
E2 JAMA, Published online October 1, 2009 (Reprinted) ©2009 American Medical Association. All rights reserved.