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评估预防 COVID-19 的真实世界干预措施的研究设计。

Study Designs to Assess Real-World Interventions to Prevent COVID-19.

机构信息

Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, United States.

Department of Health Behavior & Health Education, School of Public Health, University of Michigan, Ann Arbor, MI, United States.

出版信息

Front Public Health. 2021 Jul 27;9:657976. doi: 10.3389/fpubh.2021.657976. eCollection 2021.


DOI:10.3389/fpubh.2021.657976
PMID:34386470
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8353119/
Abstract

In the face of the novel virus SARS-CoV-2, scientists and the public are eager for evidence about what measures are effective at slowing its spread and preventing morbidity and mortality. Other than mathematical modeling, studies thus far evaluating public health and behavioral interventions at scale have largely been observational and ecologic, focusing on aggregate summaries. Conclusions from these studies are susceptible to bias from threats to validity such as unmeasured confounding, concurrent policy changes, and trends over time. We offer recommendations on how to strengthen frequently applied study designs which have been used to understand the impact of interventions to reduce the spread of COVID-19, and suggest implementation-focused, pragmatic designs that, moving forward, could be used to build a robust evidence base for public health practice. We conducted a literature search of studies that evaluated the effectiveness of non-pharmaceutical interventions and policies to reduce spread, morbidity, and mortality of COVID-19. Our targeted review of the literature aimed to explore strengths and weaknesses of implemented studies, provide recommendations for improvement, and explore alternative real-world study design methods to enhance evidence-based decision-making. Study designs such as pre/post, interrupted time series, and difference-in-differences have been used to evaluate policy effects at the state or country level of a range of interventions, such as shelter-in-place, face mask mandates, and school closures. Key challenges with these designs include the difficulty of disentangling the effects of contemporaneous changes in policy and correctly modeling infectious disease dynamics. Pragmatic study designs such as the SMART (Sequential, Multiple-Assignment Randomized Trial), stepped wedge, and preference designs could be used to evaluate community re-openings such as schools, and other policy changes. As the epidemic progresses, we need to move from analyses of available data (appropriate for the beginning of the pandemic) to proactive evaluation to ensure the most rigorous approaches possible to evaluate the impact of COVID-19 prevention interventions. Pragmatic study designs, while requiring initial planning and community buy-in, could offer more robust evidence on what is effective and for whom to combat the global pandemic we face and future policy decisions.

摘要

面对新型冠状病毒 SARS-CoV-2,科学家和公众都渴望获得有关哪些措施可以有效减缓其传播速度并预防发病率和死亡率的证据。除了数学建模外,迄今为止评估大规模公共卫生和行为干预措施的研究主要是观察性和生态学研究,重点是汇总摘要。这些研究的结论容易受到有效性威胁的影响,例如未测量的混杂、同时发生的政策变化以及随时间的趋势。我们提供了有关如何加强常用于了解减少 COVID-19 传播的干预措施影响的研究设计的建议,并提出了以实施为重点的实用设计,这些设计可以在将来用于为公共卫生实践建立强大的证据基础。

我们对评估非药物干预措施和减少 COVID-19 传播、发病率和死亡率的政策有效性的研究进行了文献检索。我们对文献的有针对性审查旨在探讨实施研究的优缺点,提出改进建议,并探讨替代现实世界的研究设计方法,以增强基于证据的决策。

预/后、中断时间序列和差异差异等研究设计已用于评估州或国家一级的一系列干预措施(如就地避难、口罩强制令和学校关闭)的政策效果。这些设计的关键挑战包括难以理清政策同时变化的影响以及正确建模传染病动态。实用研究设计,如 SMART(顺序、多次分配随机试验)、逐步楔形和偏好设计,可用于评估学校等社区重新开放和其他政策变化。

随着疫情的发展,我们需要从对现有数据的分析(适用于疫情初期)转变为主动评估,以确保尽可能采用最严格的方法来评估 COVID-19 预防干预措施的影响。实用研究设计虽然需要初始规划和社区支持,但可以提供更有力的证据,说明哪些措施有效以及针对谁,以应对我们面临的全球大流行和未来的政策决策。

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本文引用的文献

[1]
Within study comparisons and risk of bias in international development: Systematic review and critical appraisal.

Campbell Syst Rev. 2019-7-26

[2]
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Am J Epidemiol. 2021-11-2

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Lancet Infect Dis. 2021-4

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Nucleic Acids Res. 2021-1-8

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Health Equity. 2020-10-20

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BMJ. 2020-9-7

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