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心血管试验中可公开获取的方案报告及其与阳性研究结果的关联(来自随机试验流行病学研究[ESORT])

Reporting of a Publicly Accessible Protocol and Its Association With Positive Study Findings in Cardiovascular Trials (from the Epidemiological Study of Randomized Trials [ESORT]).

作者信息

Odutayo Ayodele, Altman Douglas G, Hopewell Sally, Shakir Mubeen, Hsiao Allan J, Emdin Connor A

机构信息

Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom; Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.

Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.

出版信息

Am J Cardiol. 2015 Oct 15;116(8):1280-3. doi: 10.1016/j.amjcard.2015.07.046. Epub 2015 Jul 29.

Abstract

Selective outcome reporting is common among published randomized trials and is often associated with the reporting of positive study findings. We investigated whether publication of study protocols in publicly accessible formats is associated with the reporting of positive findings. An extended version of the Cochrane highly sensitive search strategy was used to identify reports of randomized trials on cardiovascular disease that were published in December 2012 and indexed in PubMed by November 2013. Study characteristics and methodologic characteristics were extracted in duplicate. The Fisher's exact test and multivariable logistic regression were used to compare characteristics between trials that reported a publicly accessible protocol and those that did not. One hundred ninety-one reports of cardiovascular randomized trials were identified, 23 (12%) of which reported an accessible protocol. Trials reporting an accessible protocol were significantly larger and more likely to report strong trial methods, including reporting a power calculation, attrition, and the use of an intention-to-treat analysis. Despite greater statistical power, trials reporting an accessible protocol were less likely to report positive findings after controlling for known confounders (odds ratio 0.35, 95% confidence interval 0.13 to 0.94). Reporting of an accessible protocol is associated with a reduced likelihood of reporting positive findings. Further investigation is needed to determine if this association is causal.

摘要

在已发表的随机试验中,选择性结果报告很常见,且常与阳性研究结果的报告相关。我们调查了以可公开获取的格式发表研究方案是否与阳性结果的报告相关。采用Cochrane高灵敏度检索策略的扩展版本,以识别2012年12月发表且截至2013年11月在PubMed中编目的心血管疾病随机试验报告。研究特征和方法学特征由两人独立提取。采用Fisher精确检验和多变量逻辑回归比较报告了可公开获取方案的试验与未报告的试验之间的特征。共识别出191篇心血管随机试验报告,其中23篇(12%)报告了可获取的方案。报告了可获取方案的试验规模显著更大,且更有可能报告强有力的试验方法,包括报告功效计算、失访情况以及采用意向性分析。尽管有更大的统计功效,但在控制已知混杂因素后,报告了可获取方案的试验报告阳性结果的可能性较小(优势比0.35,95%置信区间0.13至0.94)。报告可获取的方案与报告阳性结果的可能性降低相关。需要进一步调查以确定这种关联是否具有因果关系。

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