Institute for Evidence-Based Healthcare, Bond University, Gold Coast, Queensland, Australia
Institute for Evidence-Based Healthcare, Bond University, Gold Coast, Queensland, Australia.
BMJ Open. 2021 Feb 22;11(2):e044364. doi: 10.1136/bmjopen-2020-044364.
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.
Systematic review and meta-analysis.
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.
We included randomised controlled trials and observational studies comparing face mask 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 face masks.
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.
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.
Open Science Framework website https://osf.io/sa6kf/ (timestamp 20-05-2020).
识别、评价并综合评估在任何环境下佩戴口罩的不利影响的研究。我们还讨论了减轻这些不利影响的潜在策略。
系统综述和荟萃分析。
通过 PubMed、Embase、CENTRAL 和 EuropePMC （从建库至 2020 年 5 月 18 日）进行检索，并通过 CENTRAL 对临床试验注册库进行检索。我们还对纳入研究进行了向前和向后的引文搜索。
我们纳入了比较口罩使用与任何积极干预或对照组的随机对照试验和观察性研究。
两对作者独立筛选纳入文章、提取数据并评估纳入研究的质量。主要结局指标为佩戴口罩的依从性、不适、危害和不良事件。
我们筛选了 5471 篇文章，其中包括 37 篇（40 篇参考文献）；11 篇进行了荟萃分析。对于口罩佩戴依从性，47%（95%CI 25%68%，p<0.0001），与对照组相比，更多的人在口罩组佩戴口罩；与 N95/P2 组相比，口罩组（26%，95%CI 8%46%，p<0.01）的佩戴率显著更高。大多数研究报告了不适和刺激的结果（20 项研究）；很少有研究报告口罩的误用情况，也没有研究报告口罩污染或风险补偿行为。参与者和人员的盲法偏倚风险通常较高，而失访和报告偏倚风险较低。
目前尚无足够的数据来量化所有可能降低口罩可接受性、依从性和有效性的不良影响。关于口罩的新研究应评估和报告危害和不利影响。还迫切需要关于减轻口罩佩戴不利影响的方法和设计的研究，特别是对面罩替代品的评估。
Open Science Framework 网站 https://osf.io/sa6kf/（时间戳 2020 年 5 月 20 日）。
