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