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群组随机对照试验报告完整性与夸大影响风险的系统评价。

Completeness of reporting and risks of overstating impact in cluster randomised trials: a systematic review.

机构信息

Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA; Duke Global Health Institute, Duke University, Durham, NC, USA.

Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA; Duke Global Health Institute, Duke University, Durham, NC, USA.

出版信息

Lancet Glob Health. 2021 Aug;9(8):e1163-e1168. doi: 10.1016/S2214-109X(21)00200-X.

Abstract

Overstating the impact of interventions through incomplete or inaccurate reporting can lead to inappropriate scale-up of interventions with low impact. Accurate reporting of the impact of interventions is of great importance in global health research to protect scarce resources. In global health, the cluster randomised trial design is commonly used to evaluate complex, multicomponent interventions, and outcomes are often binary. Complete reporting of impact for binary outcomes means reporting both relative and absolute measures. We did a systematic review to assess reporting practices and potential to overstate impact in contemporary cluster randomised trials with binary primary outcome. We included all reports registered in the Cochrane Central Register of Controlled Trials of two-arm parallel cluster randomised trials with at least one binary primary outcome that were published in 2017. Of 73 cluster randomised trials, most (60 [82%]) showed incomplete reporting. Of 64 cluster randomised trials for which it was possible to evaluate, most (40 [63%]) reported results in such a way that impact could be overstated. Care is needed to report complete evidence of impact for the many interventions evaluated using the cluster randomised trial design worldwide.

摘要

通过不完整或不准确的报告夸大干预措施的影响,可能导致影响低的干预措施不恰当地扩大规模。准确报告干预措施的影响对于全球卫生研究非常重要,可保护稀缺资源。在全球卫生领域,群组随机试验设计常用于评估复杂的多组分干预措施,其结果通常为二分类。二分类结局的影响的完整报告意味着报告相对和绝对措施。我们进行了一项系统评价,以评估在具有二分类主要结局的当代群组随机试验中报告做法和夸大影响的潜在风险。我们纳入了在 2017 年发表的所有在 Cochrane 对照试验中心注册的、至少有一个二分类主要结局的双臂平行群组随机试验的报告。在 73 项群组随机试验中,大多数(60 [82%])报告存在不完整。在可进行评估的 64 项群组随机试验中,大多数(40 [63%])以可能夸大影响的方式报告了结果。需要注意的是,对于使用群组随机试验设计在全球范围内评估的众多干预措施,需要报告完整的影响证据。

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