Department of Operating Rooms, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.
Ann Surg. 2013 May;257(5):818-23. doi: 10.1097/SLA.0b013e3182864fa3.
To assess the proportion of registered surgical trials with results published in journals with high-impact factors; compare the primary outcomes specified in trial registries with those reported in the published papers; and determine whether primary outcome-reporting bias favored significant outcomes.
Outcome-reporting bias, that is, the selective reporting of a subset of the original registered outcome measures based on their results, has not yet been studied specifically for surgical trials.
We searched PubMed for reports of surgical randomized controlled trials (RCTs) indexed between 2007 and 2012 in 10 general medical journals and 10 surgical journals with the highest impact factors. For each article included, we obtained the trial registration information using a standardized data extraction form.
Of the 327 evaluated surgical trials, registration was lacking for 109 (33%) published papers. Two (2%) of these papers were published in general medical journals and 107 (98%) in surgical journals. Twelve (6%) of the trials were still recruiting patients, and 48 (22%) were registered after completion of the study. A total of 152 trials were registered before the end of the trial with the primary outcome clearly specified. Among these papers, 49% (75 of 152) showed some evidence of discrepancies between outcomes registered and the outcomes published, most often related to omitting or introducing a primary outcome. These discrepancies favored statistically significant results in 28% of the papers.
The quality of registration of surgical trials published in surgical journals was inferior to those published in general medical journals. Comparison of the primary outcomes of surgical RCTs registered with their subsequent publication indicated that selective outcome reporting is prevalent and appears to be higher than in general medical trials.
评估已注册的外科试验中结果发表在高影响因子期刊的比例；比较试验注册中规定的主要结局与已发表论文中的报告结果；并确定主要结局报告是否存在偏向有利的显著性结局。
结局报告偏倚，即根据结果选择性报告原始注册结局指标的一个子集，尚未专门针对外科试验进行研究。
我们在 PubMed 中检索了 2007 年至 2012 年期间索引的 10 种普通医学期刊和 10 种影响因子最高的外科期刊中报告的外科随机对照试验（RCT）。对于每一篇纳入的文章，我们使用标准化的数据提取表获取试验注册信息。
在 327 项评估的外科试验中，有 109 项（33%）已发表的论文缺乏注册信息。其中有 2 篇（2%）发表在普通医学期刊上，107 篇（98%）发表在外科期刊上。12 项（6%）试验仍在招募患者，48 项（22%）在研究完成后进行了注册。共有 152 项试验在试验结束前进行了注册，明确规定了主要结局。在这些论文中，有 49%（75/152）显示出注册结局与发表结局之间存在差异的一些证据，最常见的是省略或引入主要结局。这些差异在 28%的论文中导致了统计学上显著的结果。
发表在外科期刊上的外科试验的注册质量低于发表在普通医学期刊上的试验。比较注册的外科 RCT 的主要结局与其后续发表的结果表明，选择性结局报告普遍存在，且似乎高于普通医学试验。
