Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.
University Rennes, CHU Rennes, Inserm, CIC 1414 (Centre d'Investigation Clinique de Rennes), F-35000, Rennes, France.
Epidemiol Psychiatr Sci. 2020 Oct 28;29:e184. doi: 10.1017/S2045796020000992.
In the coronavirus disease 2019 (COVID-19) pandemic, a large number of non-pharmaceutical measures that pertain to the wider group of social distancing interventions (e.g. public gathering bans, closures of schools, workplaces and all but essential business, mandatory stay-at-home policies, travel restrictions, border closures and others) have been deployed. Their urgent deployment was defended with modelling and observational data of spurious credibility. There is major debate on whether these measures are effective and there is also uncertainty about the magnitude of the harms that these measures might induce. Given that there is equipoise for how, when and if specific social distancing interventions for COVID-19 should be applied and removed/modified during reopening, we argue that informative randomised-controlled trials are needed. Only a few such randomised trials have already been conducted, but the ones done to-date demonstrate that a randomised trials agenda is feasible. We discuss here issues of study design choice, selection of comparators (intervention and controls), choice of outcomes and additional considerations for the conduct of such trials. We also discuss and refute common counter-arguments against the conduct of such trials.
在 2019 冠状病毒病(COVID-19)大流行期间,广泛的社会隔离干预措施(例如,禁止公众集会、关闭学校、工作场所和除基本业务以外的所有场所、强制居家政策、旅行限制、边境关闭等)大量被采用。这些措施的紧急部署是以虚假可信度的建模和观察数据为依据的。对于这些措施是否有效存在重大争议,对于这些措施可能带来的危害程度也存在不确定性。鉴于如何、何时以及是否应该在重新开放期间应用和(或)取消/修改特定的 COVID-19 社会隔离干预措施存在平衡,我们认为需要进行信息性随机对照试验。虽然已经进行了少数这样的随机试验,但迄今为止所做的试验表明,随机试验方案是可行的。在这里,我们讨论了研究设计选择、对照(干预和对照组)选择、结果选择以及进行此类试验的其他考虑因素。我们还讨论并驳斥了反对进行此类试验的常见反对意见。