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


ABSTRACT:

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.

SUBMITTER: Solberg RB 

PROVIDER: S-EPMC11267995 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature

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Publications

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

Solberg Runar Barstad RB   Fretheim Atle A   Elgersma Ingeborg Hess IH   Fagernes Mette M   Iversen Bjørn Gunnar BG   Hemkens Lars G LG   Rose Christopher James CJ   Elstrøm Petter P  

BMJ (Clinical research ed.) 20240724


<h4>Objective</h4>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.<h4>Design</h4>Pragmatic randomised superiority trial.<h4>Setting</h4>Norway.<h4>Participants</h4>4647 adults aged ≥18 years: 2371 were assigned to the intervention arm and 2276 to the control arm.<h4>Interventions</h4>Participants in the intervention arm were assigned to wear a surgical face mask in public spa  ...[more]

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