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1.
Chest ; 165(3): 653-668, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37977263

ABSTRACT

BACKGROUND: Nebulizers are used commonly for inhaled drug delivery. Because they deliver medication through aerosol generation, clarification is needed on what constitutes safe aerosol delivery in infectious respiratory disease settings. The COVID-19 pandemic highlighted the importance of understanding the safety and potential risks of aerosol-generating procedures. However, evidence supporting the increased risk of disease transmission with nebulized treatments is inconclusive, and inconsistent guidelines and differing opinions have left uncertainty regarding their use. Many clinicians opt for alternative devices, but this practice could impact outcomes negatively, especially for patients who may not derive full treatment benefit from handheld inhalers. Therefore, it is prudent to develop strategies that can be used during nebulized treatment to minimize the emission of fugitive aerosols, these comprising bioaerosols exhaled by infected individuals and medical aerosols generated by the device that also may be contaminated. This is particularly relevant for patient care in the context of a highly transmissible virus. RESEARCH QUESTION: How can potential risks of infections during nebulization be mitigated? STUDY DESIGN AND METHODS: The COPD Foundation Nebulizer Consortium (CNC) was formed in 2020 to address uncertainties surrounding administration of nebulized medication. The CNC is an international, multidisciplinary collaboration of patient advocates, pulmonary physicians, critical care physicians, respiratory therapists, clinical scientists, and pharmacists from research centers, medical centers, professional societies, industry, and government agencies. The CNC developed this expert guidance to inform the safe use of nebulized therapies for patients and providers and to answer key questions surrounding medication delivery with nebulizers during pandemics or when exposure to common respiratory pathogens is anticipated. RESULTS: CNC members reviewed literature and guidelines regarding nebulization and developed two sets of guidance statements: one for the health care setting and one for the home environment. INTERPRETATION: Future studies need to explore the risk of disease transmission with fugitive aerosols associated with different nebulizer types in real patient care situations and to evaluate the effectiveness of mitigation strategies.


Subject(s)
COVID-19 , Pulmonary Disease, Chronic Obstructive , Humans , Administration, Inhalation , Pandemics/prevention & control , Respiratory Aerosols and Droplets , Nebulizers and Vaporizers , Pulmonary Disease, Chronic Obstructive/drug therapy , Bronchodilator Agents
2.
Semin Respir Crit Care Med ; 44(3): 396-404, 2023 06.
Article in English | MEDLINE | ID: mdl-37015287

ABSTRACT

Occupational respiratory diseases are caused by exposure to respiratory hazards at work. It is important to document those exposures and whether they are causing or exacerbating disease because these determinations can have important impacts on diagnosis, treatment, job restrictions, and eligibility for benefits. Without investigation, it is easy to miss clinically relevant exposures, especially in those with chronic diseases that can have work and nonwork causes. The first and most important step in identifying exposures to respiratory hazards at work is to take an appropriate history. For efficiency, this is a two-step process. An initial quick screening history is done by asking only a few questions. Follow-up questions are asked if there are positive responses to the screening questions or if an occupational etiology is suspected based on the clinical presentation. Electronic health records have promise for facilitating this process. Follow-up to the screening history may include additional questions, evaluating additional sources of information about workplace exposures, and medical testing. Radiographic findings or tests conducted on noninvasive samples or lung tissue can be used as biomarkers. Online resources can be used to learn more about exposures associated with occupations and industries and to see if investigations evaluating exposures were performed in the patient's own workplace. It is important to adhere to the patient's wishes about contacting the employer. With patient consent, the employer can be an important source of information about exposures and, if a problem exists, has an important role in taking corrective action. Consultation for challenging cases is available from a variety of professional and governmental entities. If a clinician identifies a significant public health issue, such as an occupational disease outbreak, it is important to notify relevant public health authorities so that steps can be taken to prevent additional exposures and appropriately care for those already exposed.


Subject(s)
Occupational Diseases , Occupational Exposure , Humans , Occupational Exposure/adverse effects , Occupational Diseases/diagnosis , Occupational Diseases/epidemiology , Occupational Diseases/etiology
3.
Article in English | MEDLINE | ID: mdl-36865705

ABSTRACT

Objective: To understand healthcare worker (HCW) perceptions of infection risk associated with aerosol-generating procedures (AGPs) and their affective response to performing AGPs. Design: Systematic review. Methods: Systematic searches of PubMed, CINHAL Plus, and Scopus were conducted using combinations of selected keywords and synonyms. To reduce bias, titles and abstracts were screened for eligibility by 2 independent reviewers. Also, 2 independent reviewers extracted data from each eligible record. Discrepancies were discussed until consensus was reached. Results: In total, 16 reports from across the globe were included in this review. Findings suggest that AGPs are generally perceived to place HCWs at high risk of becoming infected with respiratory pathogens and that this perception stimulates a negative affective response and hesitancy to participate in the procedures. Conclusions: AGP risk perception are complex and context dependent but have important influences on HCW infection control practices, decision to participate in AGPs, emotional welfare, and workplace satisfaction. New and unfamiliar hazards paired with uncertainty lead to fear and anxiety about personal and others' safety. These fears may create a psychological burden conducive to burnout. Empirical research is needed to thoroughly understand the interplay between HCW risk perceptions of distinct AGPs, their affective responses to conducting these procedures under various conditions, and their resulting decision to participate in these procedures. Results from such studies are essential for advancing clinical practice; they point to methods for mitigating provider distress and better recommendations for when and how to conduct AGPs.

4.
Open Forum Infect Dis ; 10(2): ofad057, 2023 Feb.
Article in English | MEDLINE | ID: mdl-36824623

ABSTRACT

Background: Viral respiratory infections (VRIs) are common and are occupational risks for healthcare personnel (HCP). VRIs can also be acquired at home and other settings among HCPs. We sought to determine if preschool-aged household contacts are a risk factor for VRIs among HCPs working in outpatient settings. Methods: We conducted a secondary analysis of data from a cluster randomized trial at 7 medical centers in the United States over 4 influenza seasons from 2011-2012 to 2014-2015. Adult HCPs who routinely came within 6 feet of patients with respiratory infections were included. Participants were tested for respiratory viruses whenever symptomatic and at 2 random times each season when asymptomatic. The exposure of interest was the number of household contacts 0-5 years old (preschool-aged) at the beginning of each HCP-season. The primary outcome was the rate of polymerase chain reaction-detected VRIs, regardless of symptoms. The VRI incidence rate ratio (IRR) was calculated using a mixed-effects Poisson regression model that accounted for clustering at the clinic level. Results: Among the 4476 HCP-seasons, most HCPs were female (85.4%) and between 30 and 49 years of age (54.6%). The overall VRI rate was 2.04 per 100 person-weeks. In the adjusted analysis, HCPs having 1 (IRR, 1.22 [95% confidence interval {CI}, 1.05-1.43]) and ≥2 (IRR, 1.35 [95% CI, 1.09-1.67]) preschool-aged household contacts had higher VRI rates than those with zero preschool-aged household contacts. Conclusions: Preschool-aged household contacts are a risk factor for developing VRIs among HCPs working in outpatient settings.

5.
J Infect Dis ; 225(5): 891-902, 2022 03 02.
Article in English | MEDLINE | ID: mdl-34534319

ABSTRACT

BACKGROUND: The association of hemagglutination inhibition (HAI) antibodies with protection from influenza among healthcare personnel (HCP) with occupational exposure to influenza viruses has not been well-described. METHODS: The Respiratory Protection Effectiveness Clinical Trial was a cluster-randomized, multisite study that compared medical masks to N95 respirators in preventing viral respiratory infections among HCP in outpatient healthcare settings for 5180 participant-seasons. Serum HAI antibody titers before each influenza season and influenza virus infection confirmed by polymerase chain reaction were studied over 4 study years. RESULTS: In univariate models, the risk of influenza A(H3N2) and B virus infections was associated with HAI titers to each virus, study year, and site. HAI titers were strongly associated with vaccination. Within multivariate models, each log base 2 increase in titer was associated with 15%, 26% and 33%-35% reductions in the hazard of influenza A(H3N2), A(H1N1), and B infections, respectively. Best models included preseason antibody titers and study year, but not other variables. CONCLUSIONS: HAI titers were associated with protection from influenza among HCP with routine exposure to patients with respiratory illness and influenza season contributed to risk. HCP can be reassured about receiving influenza vaccination to stimulate immunity.


Subject(s)
Influenza A Virus, H1N1 Subtype , Influenza Vaccines , Influenza, Human , Orthomyxoviridae Infections , Antibodies, Viral , Delivery of Health Care , Hemagglutination Inhibition Tests , Humans , Influenza A Virus, H3N2 Subtype , Influenza, Human/epidemiology , Influenza, Human/prevention & control
6.
Infect Control Hosp Epidemiol ; 43(9): 1216-1220, 2022 09.
Article in English | MEDLINE | ID: mdl-34350820

ABSTRACT

OBJECTIVE: The implementation of mandatory influenza vaccination policies among healthcare personnel (HCP) is controversial. Thus, we examined the affect of mandatory influenza vaccination policies among HCP working in outpatient settings. SETTING: Four Veterans' Affairs (VA) health systems and three non-VA medical centers. METHODS: We analyzed rates of influenza and other viral causes of respiratory infections among HCP working in outpatient sites at 4 VA health systems without mandatory influenza vaccination policies and 3 non-VA health systems with mandatory influenza vaccination policies. RESULTS: Influenza vaccination was associated with a decreased risk of influenza (odds ratio, 0.17; 95% confidence interval [CI], 0.13-0.22) but an increased risk of other respiratory viral infections (incidence rate ratio, 1.26; 95% CI, 1.02-1.57). CONCLUSIONS: Our fitted regression models suggest that if influenza vaccination rates in clinics where vaccination was not mandated had equalled those where vaccine was mandated, HCP influenza infections would have been reduced by 52.1% (95% CI, 51.3%-53.0%). These observations, their possible causes, and additional strategies to reduce influenza and other viral respiratory illnesses among HCP working in ambulatory clinics warrant further investigation.


Subject(s)
Influenza Vaccines , Influenza, Human , Delivery of Health Care , Health Personnel , Humans , Influenza Vaccines/therapeutic use , Influenza, Human/epidemiology , Influenza, Human/prevention & control , Vaccination
7.
Occup Environ Med ; 79(2): 94-101, 2022 02.
Article in English | MEDLINE | ID: mdl-34321351

ABSTRACT

OBJECTIVES: Recent evidence suggests that occupational physical activity (OPA) is associated with adverse cardiovascular health, whereas leisure time physical activity is protective. This study explored explanatory physiological mechanisms. METHODS: Nineteen males (68% white, age=46.6±7.9 years, body mass index=27.9±5.1 kg/m2) with high self-reported OPA wore activity (ActiGraph and activPAL) and heart rate (HR) monitors for 7 days and an ambulatory blood pressure (BP) monitor on one workday and one non-workday. Mixed effects models compared cardiovascular variables (24-hour, nocturnal, waking and non-work time HR and BP) and nocturnal HR variability (HRV) on workdays versus non-workdays. Additional models examined associations of daily activity (steps, light physical activity (LPA) and moderate-to-vigorous physical activity (MVPA)) with cardiovascular variables. Workday by daily activity interactions were examined. RESULTS: 24-hour and waking HR and diastolic BP as well as non-work diastolic BP were significantly higher on workdays versus non-workdays (p<0.05 for all). However, no difference in systolic BP or nocturnal HR or BP was observed between work and non-workdays (p>0.05 for all). Low-frequency and high-frequency power indices of nocturnal HRV were lower on workdays (p<0.05 for both). Daily steps and LPA were positively associated with 24-hour and waking HR on work and non-workdays. Significant interactions suggested MVPA increases HR and lowers nocturnal HRV during workdays, with the opposite effect on non-workdays. CONCLUSIONS: Cardiovascular load was higher on workdays versus non-workdays with no compensatory hypotensive response following workdays. Daily MVPA may differentially affect ambulatory cardiovascular load and nocturnal HRV on workdays versus non-workdays, supporting the physical activity health paradox hypothesis.


Subject(s)
Blood Pressure/physiology , Exercise/physiology , Leisure Activities , Workload , Adult , Cardiovascular Physiological Phenomena , Heart Rate/physiology , Humans , Male , Middle Aged , Monitoring, Ambulatory , Occupational Stress/physiopathology , Occupations
8.
Workplace Health Saf ; 70(2): 81-89, 2022 Feb.
Article in English | MEDLINE | ID: mdl-34927499

ABSTRACT

Background: The physical activity (PA) health paradox hypothesizes that occupational physical activity (OPA) and leisure time PA have differential cardiovascular health effects due to increased cardiovascular load without adequate recovery; however, research describing worker PA lacks high-quality objective OPA measurement. This study aimed to objectively describe PA profiles of men reporting high OPA and make comparisons to aerobic PA and OPA recommendations. Methods: Male food service, material moving, health care, or maintenance workers wore activity (ActiGraph® and activPAL®) and heart rate monitors for 7 days. Participants recorded work, non-work, and sleep times in a diary. PA was operationalized as time spent in sedentary behavior, upright time, light, moderate, vigorous, and moderate-to-vigorous PA during work and non-work hours. PA profiles were described and compared with Centers for Disease Control and Prevention aerobic PA guidelines (≥21.4 minute/day) and OPA recommendations (<30 minute/hour upright and intensity of <30% heart rate reserve). Findings: Nineteen male workers (68% White, age = 46.6±7.9 years) were more active on workdays than non-workdays (sedentary: 492.3 vs. 629.7 minute/day; upright: 462.4 vs. 325.2 minute/day; moderate-to-vigorous PA: 72.4 vs. 41.5 minute/day, respectively; all p < .05). Most participants (17/19) achieved aerobic PA guidelines across all days with more achieving on workdays (19/19) than non-workdays (13/19). OPA often exceeded recommended limits with participants accumulating 39.6±12.2 minutes/work hour upright and 30.3±25.9% of working time >30% heart rate reserve. Conclusions/Application to Practice: Male workers reporting high OPA typically met aerobic PA guidelines but exceeded recommended OPA limits. The long-term health implications of such activity profiles should be investigated.


Subject(s)
Exercise , Sedentary Behavior , Adult , Humans , Male , Middle Aged , Sleep , Workplace
10.
Am J Infect Control ; 49(11): 1369-1375, 2021 11.
Article in English | MEDLINE | ID: mdl-34182066

ABSTRACT

BACKGROUND: Healthcare personnel (HCP) knowledge and attitudes toward infection control measures are important determinants of practices that can protect them from transmission of infectious diseases. METHODS: Healthcare personnel were recruited from Emergency Departments and outpatient clinics at seven sites. They completed knowledge surveys at the beginning and attitude surveys at the beginning and end of each season of participation. Attitudes toward infection prevention and control measures, especially medical masks and N95 respirators, were compared. The proportion of participants who correctly identified all components of an infection control bundle for seven clinical scenarios was calculated. RESULTS: The proportion of participants in the medical mask group who reported at least one reason to avoid using medical masks fell from 88.5% on the pre-season survey to 39.6% on the post-season survey (odds ratio [OR] for preseason vs. postseason 0.11, 95% CI 0.10-0.14). Among those wearing N95 respirators, the proportion fell from 87.9% to 53.6% (OR 0.24, 95% CI 0.21-0.28). Participants correctly identified all components of the infection control bundle for 4.9% to 38.5% of scenarios. CONCLUSIONS: Attitudes toward medical masks and N95 respirators improved significantly between the beginning and end of each season. The proportion of HCP who correctly identified the infection control precautions needed for clinical scenarios was low, but it improved over successive years of participation in the study.


Subject(s)
Respiratory Protective Devices , Respiratory Tract Infections , Attitude , Delivery of Health Care , Health Personnel , Humans , Masks , Outpatients , Respiratory Tract Infections/prevention & control
11.
J Occup Environ Med ; 63(8): 646-656, 2021 08 01.
Article in English | MEDLINE | ID: mdl-34016912

ABSTRACT

OBJECTIVES: To propose a framework for considering SARS-CoV-2 antigen testing of unexposed asymptomatic workers in selected workplaces. METHODS: This is a commentary based on established occupational safety and health principles, published articles, and other pertinent literature, including non-peer-reviewed preprints in medrixiv.org prior to April 16, 2021. RESULTS: Not applicable to this commentary/viewpoint article. CONCLUSION: Antigen testing is a rapidly evolving and useful public health tool that can be used to guide measures to reduce spread of SARS-CoV-2 in the community and in selected workplaces. This commentary provides a proposed framework for occupational safety and health practitioners and employers for considering antigen testing as a method to screen asymptomatic workers in selected non-healthcare settings. When applied selectively, antigen testing can be a useful, effective part of a comprehensive workplace program for COVID-19 prevention and control.


Subject(s)
COVID-19 , Occupational Health , COVID-19 Serological Testing , Humans , SARS-CoV-2 , Workplace
12.
Am J Infect Control ; 49(7): 893-899, 2021 07.
Article in English | MEDLINE | ID: mdl-33581146

ABSTRACT

BACKGROUND: Health care personnel (HCP) working in outpatient settings routinely interact with patients with acute respiratory illnesses. Absenteeism following symptom development and lack of staff trained to obtain samples limit efforts to identify pathogens among infected HCP. METHODS: The Respiratory Protection Effectiveness Clinical Trial assessed respiratory infection incidence among HCP between 2011 and 2015. Research assistants obtained anterior nasal and oropharyngeal swabs from HCP in the workplace following development of respiratory illness symptoms and randomly while asymptomatic. Participants received take-home kits to self-collect swabs when absent from work. Samples mailed to a central laboratory were tested for respiratory viruses by reverse transcription polymerase chain reaction. RESULTS: Among 2,862 participants, 3,467 swabs were obtained from symptomatic participants. Among symptomatic HCP, respiratory virus was detected in 904 of 3,467 (26.1%) samples. Self-collected samples by symptomatic HCP at home had higher rates of viral detection (40.3%) compared to 24% obtained by trained research assistants in the workplace (P < .001). CONCLUSIONS: In this randomized clinical trial, take-home kits were an easily implemented, effective method to self-collect samples by HCP. Other studies have previously shown relative equivalence of self-collected samples to those obtained by trained healthcare workers. Take-home kit self-collection could diminish workforce exposures and decrease the demand for personnel protective equipment worn to protect workers who collect respiratory samples.


Subject(s)
Influenza, Human , Respiratory Tract Infections , Viruses , Delivery of Health Care , Health Personnel , Humans , Respiratory Tract Infections/diagnosis
13.
J Occup Environ Med ; 63(1): 1-9, 2021 01 01.
Article in English | MEDLINE | ID: mdl-33378322

ABSTRACT

OBJECTIVES: To identify important background information on pooled tested of employees that employers workers, and health authorities should consider. METHODS: This paper is a commentary based on the review by the authors of pertinent literature generally from preprints in medrixiv.org prior to August 2020. RESULTS/CONCLUSIONS: Pooled testing may be particularly useful to employers in communities with low prevalence of COVID-19. It can be used to reduce the number of tests and associated financial costs. For effective and efficient pooled testing employers should consider it as part of a broader, more comprehensive workplace COVID-19 prevention and control program. Pooled testing of asymptomatic employees can prevent transmission of SARS-CoV-2 and help assure employers and customers that employees are not infectious.


Subject(s)
COVID-19 Testing , COVID-19/diagnosis , Occupational Health Services , Occupational Health , SARS-CoV-2/isolation & purification , COVID-19/epidemiology , Humans , Sensitivity and Specificity
14.
J Occup Environ Hyg ; 18(1): 28-34, 2021 01.
Article in English | MEDLINE | ID: mdl-33284081

ABSTRACT

Powered air-purifying respirators (PAPRs) are worn to protect workers from hazardous respiratory exposures in a wide range of workplaces, including healthcare. However, PAPRs may diminish the ability of wearers to correctly hear words spoken by others, potentially interfering with safe performance of healthcare duties. Accordingly, the impact of PAPRs during healthcare use on speech intelligibility (SI) and consequently on user safety, usability, and patient care is not well studied. The objectives of this study were to (1) determine a listener's ability to comprehend single-syllable words spoken by a PAPR wearer; (2) determine a PAPR wearer's ability to intelligibly hear and identify single-syllable words spoken by a PAPR wearer; (3) to assess the variability between speakers, listeners, and PAPR models; (4) to investigate the effects of PAPR design features on SI; and (5) inform a SI requirement for certifying future PAPRs for use in healthcare. This study utilized a Modified Rhyme Test to assess SI for PAPRs. The current National Institute for Occupational Safety and Health (NIOSH) methods for assessing SI are limited to the recently introduced PAPR100 respirator class and the class of respirators claiming chemical, biological, radiological, and nuclear (CBRN) protections. Four NIOSH-approved PAPRs were evaluated using four human subjects. Four experimental conditions were examined:(1) Speaker and Listener with no PAPR; (2) Speaker and Listener both wearing PAPRs; (3) Speaker with a PAPR, Listener without a PAPR; and (4) Speaker without a PAPR, Listener with a PAPR resulted in a total of 144 experiments. Statistical analysis showed that the SI performance ratings were not significantly different among the PAPR models, but experimental conditions had significant impact on SI. The pattern of SI across the conditions of the experiment also showed a significant difference depending on PAPR model. The SI performance rating for all PAPRs could meet the current NIOSH CBRN certification requirement for speech intelligibility.


Subject(s)
Respiratory Protective Devices/standards , Speech Intelligibility , Equipment Design , Health Personnel , Humans
15.
Clin Infect Dis ; 73(11): e4428-e4432, 2021 12 06.
Article in English | MEDLINE | ID: mdl-32645144

ABSTRACT

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) presents a large risk to healthcare personnel (HCP). Quantifying the risk of coronavirus infection associated with workplace activities is an urgent need. METHODS: We assessed the association of worker characteristics, occupational roles and behaviors, and participation in procedures with the risk of endemic coronavirus infection among HCP who participated in the Respiratory Protection Effectiveness Clinical Trial (ResPECT), a cluster randomized trial to assess personal protective equipment to prevent respiratory infections and illness conducted from 2011 to 2016. RESULTS: Among 4689 HCP seasons, we detected coronavirus infection in 387 (8%). HCP who participated in an aerosol-generating procedure (AGP) at least once during the viral respiratory season were 105% (95% confidence interval, 21%-240%) more likely to be diagnosed with a laboratory-confirmed coronavirus infection. Younger individuals, those who saw pediatric patients, and those with household members <5 years of age were at increased risk of coronavirus infection. CONCLUSIONS: Our analysis suggests that the risk of HCP becoming infected with an endemic coronavirus increases approximately 2-fold with exposures to AGPs. Our findings may be relevant to the coronavirus disease 2019 (COVID-19) pandemic; however, SARS-CoV-2, the virus that causes COVID-19, may differ from endemic coronaviruses in important ways. CLINICAL TRIALS REGISTRATION: NCT01249625.


Subject(s)
COVID-19 , Coronavirus OC43, Human , Child , Delivery of Health Care , Humans , Risk Factors , SARS-CoV-2
16.
Disaster Med Public Health Prep ; 14(5): 658-669, 2020 10.
Article in English | MEDLINE | ID: mdl-32423515

ABSTRACT

N95 respirators are personal protective equipment most often used to control exposures to infections transmitted via the airborne route. Supplies of N95 respirators can become depleted during pandemics or when otherwise in high demand. In this paper, we offer strategies for optimizing supplies of N95 respirators in health care settings while maximizing the level of protection offered to health care personnel when there is limited supply in the United States during the 2019 coronavirus disease pandemic. The strategies are intended for use by professionals who manage respiratory protection programs, occupational health services, and infection prevention programs in health care facilities to protect health care personnel from job-related risks of exposure to infectious respiratory illnesses. Consultation with federal, state, and local public health officials is also important. We use the framework of surge capacity and the occupational health and safety hierarchy of controls approach to discuss specific engineering control, administrative control, and personal protective equipment measures that may help in optimizing N95 respirator supplies.


Subject(s)
COVID-19/prevention & control , N95 Respirators/supply & distribution , Pandemics/prevention & control , Resource Allocation/methods , COVID-19/transmission , Humans , N95 Respirators/statistics & numerical data , Occupational Exposure/prevention & control , Pandemics/statistics & numerical data , Personal Protective Equipment/statistics & numerical data , Personal Protective Equipment/supply & distribution , Resource Allocation/statistics & numerical data , United States
20.
JAMA ; 322(9): 824-833, 2019 09 03.
Article in English | MEDLINE | ID: mdl-31479137

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.


Subject(s)
Health Personnel , Infectious Disease Transmission, Patient-to-Professional/prevention & control , Influenza, Human/prevention & control , Influenza, Human/transmission , Masks , Respiratory Protective Devices , Adult , Ambulatory Care , Female , Humans , Incidence , Infection Control/methods , Influenza, Human/diagnosis , Influenza, Human/epidemiology , Male , Middle Aged , Occupational Exposure , Respiratory Tract Infections/prevention & control , Respiratory Tract Infections/transmission
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