Downsides of face masks and possible mitigation strategies: a systematic review protocol
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Description: Objective To identify, appraise, and synthesise studies evaluating the downsides of wearing facemasks in any setting. We also discuss potential strategies to mitigate these downsides. Methods PubMed, Embase, CENTRAL, EuropePMC were searched (inception-18/5/2020), and clinical registries were searched via CENTRAL. We also did forward-backward citation search of the included studies. We included randomised controlled trials and observational studies comparing facemask use to any active intervention or to control. Two author pairs independently screened articles for inclusion, extracted data and assessed the quality of included studies. The primary outcomes were compliance, discomforts, harms, and adverse events of wearing facemasks. Findings We screened 5471 articles, including 37 (40 references); 11 were meta-analysed. For mask wear adherence, 47% more people wore facemasks in the facemask group compared to control; adherence was significantly higher (26%) in the surgical/medical mask group than in N95/P2 group. The largest number of studies reported on the discomfort and irritation outcome (20-studies); fewest reported on the misuse of masks, and none reported on mask contamination or risk compensation behaviour. Risk of bias was generally high for blinding of participants and personnel and low for attrition and reporting biases. Conclusion There are insufficient data to quantify all of the adverse effects that might reduce the acceptability, adherence, and effectiveness of face masks. New research on facemasks should assess and report the harms and downsides. Urgent research is also needed on methods and designs to mitigate the downsides of facemask wearing, particularly the assessment of alternatives such as face shields.