Downsides of face masks and possible mitigation strategies: a systematic review and meta-analysis
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Abstract
To identify, appraise and synthesise studies evaluating the downsides of wearing face masks in any setting. We also discuss potential strategies to mitigate these downsides.
Design
Systematic review and meta-analysis.
Data sources
PubMed, Embase, CENTRAL and EuropePMC were searched (inception–18 May 2020), and clinical registries were searched via CENTRAL. We also did a forward–backward citation search of the included studies.
Inclusion criteria
We included randomised controlled trials and observational studies comparing face mask use to any active intervention or to control.
Data extraction and analysis
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 face masks.
Results
We screened 5471 articles, including 37 (40 references); 11 were meta-analysed. For mask wear adherence, 47% (95% CI 25% to 68%, p<0.0001), more people wore face masks in the face mask group compared with control; adherence was significantly higher (26%, 95% CI 8% to 46%, p<0.01) 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.
Conclusions
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 face masks should assess and report the harms and downsides. Urgent research is also needed on methods and designs to mitigate the downsides of face mask wearing, particularly the assessment of possible alternatives.
Systematic review registration
Open Science Framework website https://osf.io/sa6kf/ (timestamp 20-05-2020).
Article activity feed
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SciScore for 10.1101/2020.06.16.20133207: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Search strategies: We searched PubMed, Embase, PubMedsuggested: (PubMed, RRID:SCR_004846)Embasesuggested: (EMBASE, RRID:SCR_001650)7 Clinical trial registries were searched via Cochrane CENTRAL, which includes the WHO ICTRP and clinicaltrials.gov. Cochrane CENTRALsuggested: (Cochrane Central Register of Controlled Trials, RRID:SCR_006576)When meta-analysis is not possible or appropriate, we followed the guidance of the Cochrane Collaboration (Cochrane Handbook Section 12.2). Cochr…SciScore for 10.1101/2020.06.16.20133207: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Search strategies: We searched PubMed, Embase, PubMedsuggested: (PubMed, RRID:SCR_004846)Embasesuggested: (EMBASE, RRID:SCR_001650)7 Clinical trial registries were searched via Cochrane CENTRAL, which includes the WHO ICTRP and clinicaltrials.gov. Cochrane CENTRALsuggested: (Cochrane Central Register of Controlled Trials, RRID:SCR_006576)When meta-analysis is not possible or appropriate, we followed the guidance of the Cochrane Collaboration (Cochrane Handbook Section 12.2). Cochrane Collaborationsuggested: NoneResults from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:The key limitation includes the hospital-setting of most of the included studies: as hospital workers are accustomed to wearing masks, the conclusions may not be fully generalisable to the community. Although this varies among the studies that reported mask use in hospital setting, as there are different confounding factors that may contribute to increased reporting of irrigation (e.g. length of shift, air-conditioning on the wards and whether the staff were wearing the full PPE which adds to the full discomfort). We report two differences between the protocol and the review: first, the comparison of facemask to control in the adherence outcome was reported using risk difference (rather than pre-planned odds ratio) to more clearly convey the differences between the two groups (odds ratio for compliance with facemask wear was reported for the facemask versus facemask comparison, however). Second, not having anticipated data availability, we did not prespecify a subgroup analysis of the intervention (facemask wearing) by studies which evaluated facemask wear alone, and studies evaluating facemask with handwashing. Several recent systematic reviews have focused on the effectiveness of masks in preventing or reducing viral transmission; some of these reviews reported on harms in the included studies.5,15,39,50 However, none specifically focused on the wider set of studies examining the physiological, psychological and other adverse effects addressed in this review. The Cochrane r...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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SciScore for 10.1101/2020.06.16.20133207: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding Risk of bias was generally high for blinding of participants and personnel and low for attrition and reporting biases. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Methods PubMed, Embase, CENTRAL, EuropePMC were searched (inception-18/5/2020), and clinical registries were searched via CENTRAL. Embasesuggested: (EMBASE, SCR_001650)The search string was designed for PubMed and translated for use in other databases using the Polyglot Search Translator ( Appendix 2). SciScore for 10.1101/2020.06.16.20133207: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding Risk of bias was generally high for blinding of participants and personnel and low for attrition and reporting biases. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Methods PubMed, Embase, CENTRAL, EuropePMC were searched (inception-18/5/2020), and clinical registries were searched via CENTRAL. Embasesuggested: (EMBASE, SCR_001650)The search string was designed for PubMed and translated for use in other databases using the Polyglot Search Translator ( Appendix 2). PubMedsuggested: (PubMed, SCR_004846)7 Clinical trial registries were searched via Cochrane CENTRAL , which includes the WHO ICTRP and clinicaltrials . gov . Cochrane CENTRALsuggested: (Cochrane Central Register of Controlled Trials, SCR_006576)When meta-analysis is not possible or appropriate , we followed the guidance of the Cochrane Collaboration ( Cochrane Handbook Section 12.2). Cochrane Collaborationsuggested: NoneResults from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.
Results from OddPub: We did not find a statement about open data. We also did not find a statement about open code. Researchers are encouraged to share open data when possible (see Nature blog).
About SciScore
SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore is not a substitute for expert review. SciScore checks for the presence and correctness of RRIDs (research resource identifiers) in the manuscript, and detects sentences that appear to be missing RRIDs. SciScore also checks to make sure that rigor criteria are addressed by authors. It does this by detecting sentences that discuss criteria such as blinding or power analysis. SciScore does not guarantee that the rigor criteria that it detects are appropriate for the particular study. Instead it assists authors, editors, and reviewers by drawing attention to sections of the manuscript that contain or should contain various rigor criteria and key resources. For details on the results shown here, including references cited, please follow this link.
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