Registration Rates, Adequacy of Registration, and a Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials Published in Surgery Journals
Registration Rates, Adequacy of Registration, and a Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials Published in Surgery Journals
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DOI：
10.1097/sla.0b013e318299d00b
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发表时间：
2014-01-01
影响因子：
9
通讯作者：
Grady, Helen L. O.
中科院分区：
文献类型：
--
作者：
Killeen, Shane;Sourallous, Panos;Grady, Helen L. O.
目的：为了确定在外科文献中发表的注册试验的比例，比较，在注册的试验中，主要结果登记与那些出版，并确定是否结果报告偏倚有利于显着的主要outcomes.Background：试验方案注册前患者随机对照试验（RCT）是一个先决条件，许多期刊，试图减少出版和选择性报告偏倚。医学文献分析表明，登记率低，报告和登记的主要结局之间存在差异。这还没有在当代surgical journals.Methods：随机对照试验，确定了2009年和2010年从10个高影响因子的外科杂志。一名研究者确定了所有RCT，并提取了主要和次要结局、研究开始和完成日期、资金来源和试验注册号。使用试验注册号检索试验注册，以获得主要和次要结局、研究开始和完成日期以及注册日期。记录试验登记率和登记充分性。结果：共分析246篇文献，其中未注册86篇（34.9%），注册不充分52篇（21%）。在108项充分注册的试验中，32项（29%）在已发表的主要结局与试验注册中注册的结局之间存在差异。在24项已发表的研究中，有22项研究的主要结局具有统计学显著性，（91.7%），而在2（8.3%）的差异产生了统计学上不显著的结果。在普通外科杂志上发表的所有随机对照试验中，只有不到一半得到了充分注册，大约30%的患者在登记和发表的主要结果中存在差异，其中90%的可评估结果支持统计学阳性结果。
Objective: To determine the proportion of registered trials published in the surgical literature, to compare, in registered trials, the primary outcomes registered with those published and to determine whether outcome-reporting bias favored significant primary outcomes.Background: Trial protocol registration before patient enrolment for randomized controlled trials (RCTs) is a perquisite for many journals in attempt to decrease publication and selective reporting bias. Analysis of the medical literature demonstrates poor registration rates with discrepancies between reported and registered primary outcomes. This has not been evaluated in contemporary surgical journals.Methods: RCTs were identified for 2009 and 2010 from 10 high-impact factor surgical journals. One investigator identified all RCTs and extracted primary and secondary outcomes, dates of commencement and completion of study, funding source, and trial registration number. Trial registers were searched using the trial registration number for primary and secondary outcomes, dates of commencement and completion of study, and date of registration. Trial registration rates and registration adequacy were recorded. Register and published primary outcomes were then compared.Results: A total of 246 papers were analyzed, among which 86 (34.9%) were not registered and 52 (21%) were inadequately registered. Of the 108 adequately registered trials, 32 (29%) had a discrepancy between the published primary outcome and that registered in trial register. In the 24 published studies where it was possible to assess, the discrepancy favored a statistically significant primary outcome in 22 (91.7%) whereas in 2 (8.3%) the discrepancy produced a statistically insignificant result.Conclusions: Less than half of all RCTs published in general surgical journals were adequately registered, and approximately 30% had discrepancies in the registered and published primary outcome with 90% of those assessable favoring a statistically positive result.