Godolphin Peter J, Bath Philip M, Algra Ale, Berge Eivind, Brown Martin M, Chalmers John, Duley Lelia, Eliasziw Misha, Gregson John, Greving Jacoba P, Hankey Graeme J, Hosomi Naohisa, Johnston S Claiborne, Patsko Emily, Ranta Annamarei, Sandset Per Morten, Serena Joaquín, Weimar Christian, Montgomery Alan A
From the Nottingham Clinical Trials Unit (P.J.G., L.D., A.A.M.), University of Nottingham, United Kingdom.
Stroke Trials Unit, Division of Clinical Neuroscience (P.J.G., P.M.B.), University of Nottingham, United Kingdom.
Stroke. 2019 Aug;50(8):2187-2196. doi: 10.1161/STROKEAHA.119.025019. Epub 2019 Jun 10.
Background and Purpose- In randomized stroke trials, central adjudication of a trial's primary outcome is regularly implemented. However, recent evidence questions the importance of central adjudication in randomized trials. The aim of this review was to compare outcomes assessed by central adjudicators with outcomes assessed by site investigators. Methods- We included randomized stroke trials where the primary outcome had undergone an assessment by site investigators and central adjudicators. We searched MEDLINE, EMBASE, CENTRAL (Cochrane Central Register of Controlled Trials), Web of Science, PsycINFO, and Google Scholar for eligible studies. We extracted information about the adjudication process as well as the treatment effect for the primary outcome, assessed both by central adjudicators and by site investigators. We calculated the ratio of these treatment effects so that a ratio of these treatment effects >1 indicated that central adjudication resulted in a more beneficial treatment effect than assessment by the site investigator. A random-effects meta-analysis model was fitted to estimate a pooled effect. Results- Fifteen trials, comprising 69 560 participants, were included. The primary outcomes included were stroke (8/15, 53%), a composite event including stroke (6/15, 40%) and functional outcome after stroke measured on the modified Rankin Scale (1/15, 7%). The majority of site investigators were blind to treatment allocation (9/15, 60%). On average, there was no difference in treatment effect estimates based on data from central adjudicators and site investigators (pooled ratio of these treatment effects=1.02; 95% CI, [0.95-1.09]). Conclusions- We found no evidence that central adjudication of the primary outcome in stroke trials had any impact on trial conclusions. This suggests that potential advantages of central adjudication may not outweigh cost and time disadvantages in stroke studies if the primary purpose of adjudication is to ensure validity of trial findings.
背景与目的——在随机化卒中试验中，通常会对试验的主要结局进行中心裁决。然而，近期证据对中心裁决在随机化试验中的重要性提出了质疑。本综述的目的是比较中心裁决者评估的结局与现场研究者评估的结局。方法——我们纳入了主要结局已由现场研究者和中心裁决者进行评估的随机化卒中试验。我们检索了MEDLINE、EMBASE、CENTRAL（Cochrane对照试验中心注册库）、科学网、PsycINFO和谷歌学术以查找符合条件的研究。我们提取了关于裁决过程以及主要结局的治疗效果的信息，这些信息由中心裁决者和现场研究者进行评估。我们计算了这些治疗效果的比值，使得这些治疗效果的比值>1表明中心裁决导致的治疗效果比现场研究者的评估更有益。采用随机效应荟萃分析模型来估计合并效应。结果——纳入了15项试验，共69560名参与者。纳入的主要结局包括卒中（8/15，53%）、包括卒中的复合事件（6/15，40%）以及采用改良Rankin量表测量的卒中后功能结局（1/15，7%）。大多数现场研究者对治疗分配不知情（9/15，60%）。平均而言，基于中心裁决者和现场研究者的数据得出的治疗效果估计没有差异（这些治疗效果的合并比值=1.02；95%CI，[0.95 - 1.09]）。结论——我们没有发现证据表明卒中试验中主要结局的中心裁决对试验结论有任何影响。这表明，如果裁决的主要目的是确保试验结果的有效性，那么在卒中研究中，中心裁决的潜在优势可能并不超过成本和时间方面的劣势。
