Personal protective effect of wearing surgical face masks in public spaces on self-reported respiratory symptoms in adults: pragmatic randomised superiority trial.

Autor: Solberg RB; Centre for Epidemic Interventions Research (CEIR), Norwegian Institute of Public Health, Oslo, Norway runar.solberg@fhi.no., Fretheim A; Centre for Epidemic Interventions Research (CEIR), Norwegian Institute of Public Health, Oslo, Norway.; Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway., Elgersma IH; Centre for Epidemic Interventions Research (CEIR), Norwegian Institute of Public Health, Oslo, Norway., Fagernes M; Division of Infection Control, Norwegian Institute of Public Health, Oslo, Norway., Iversen BG; Division of Infection Control, Norwegian Institute of Public Health, Oslo, Norway., Hemkens LG; Pragmatic Evidence Lab, Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Basel, Switzerland.; Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.; Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, CA, USA., Rose CJ; Centre for Epidemic Interventions Research (CEIR), Norwegian Institute of Public Health, Oslo, Norway.; Cluster for Reviews and Health Technology Assessments, Division for Health Services, Norwegian Institute of Public Health, Oslo, Norway., Elstrøm P; Centre for Epidemic Interventions Research (CEIR), Norwegian Institute of Public Health, Oslo, Norway.
Jazyk: angličtina
Zdroj: BMJ (Clinical research ed.) [BMJ] 2024 Jul 24; Vol. 386, pp. e078918. Date of Electronic Publication: 2024 Jul 24.
DOI: 10.1136/bmj-2023-078918
Abstrakt: Objective: To evaluate the personal protective effects of wearing versus not wearing surgical face masks in public spaces on self-reported respiratory symptoms over a 14 day period.
Design: Pragmatic randomised superiority trial.
Setting: Norway.
Participants: 4647 adults aged ≥18 years: 2371 were assigned to the intervention arm and 2276 to the control arm.
Interventions: Participants in the intervention arm were assigned to wear a surgical face mask in public spaces (eg, shopping centres, streets, public transport) over a 14 day period (mask wearing at home or work was not mentioned). Participants in the control arm were assigned to not wear a surgical face mask in public places.
Main Outcome Measures: The primary outcome was self-reported respiratory symptoms consistent with a respiratory infection. Secondary outcomes included self-reported and registered covid-19 infection.
Results: Between 10 February 2023 and 27 April 2023, 4647 participants were randomised of whom 4575 (2788 women (60.9%); mean age 51.0 (standard deviation 15.0) years) were included in the intention-to-treat analysis: 2313 (50.6%) in the intervention arm and 2262 (49.4%) in the control arm. 163 events (8.9%) of self-reported symptoms consistent with respiratory infection were reported in the intervention arm and 239 (12.2%) in the control arm. The marginal odds ratio was 0.71 (95% confidence interval (CI) 0.58 to 0.87; P=0.001) favouring the face mask intervention. The absolute risk difference was -3.2% (95% CI -5.2% to -1.3%; P<0.001). No statistically significant effect was found on self- reported (marginal odds ratio 1.07, 95% CI 0.58 to 1.98; P=0.82) or registered covid-19 infection (effect estimate and 95% CI not estimable owing to lack of events in the intervention arm).
Conclusion: Wearing a surgical face mask in public spaces over 14 days reduces the risk of self-reported symptoms consistent with a respiratory infection, compared with not wearing a surgical face mask.
Trial Registration: ClinicalTrials.gov NCT05690516.
Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure at www.icmj.org/disclosure-of-interest/ and declare: support from the Centre for Epidemic Interventions Research, Norwegian Institute of Public Health; no financial relationship with any organisation that might have an interest in the submitted work in previous three years; AF has received financial support from the World Health Organization (WHO) to attend meetings it has hosted; CR is named inventor on a patent application related to vaccine development. LGH’s institution (RC2NB) was contracted by WHO for the development of study protocol templates to evaluate public health and social measures; LGH received travel support from WHO; no other relationships or activities that could appear to have influenced the submitted work.
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Databáze: MEDLINE