Comparison of Registered and Reported Outcomes in Randomized Clinical Trials Published in Anesthesiology Journals
Comparison of Registered and Reported Outcomes in Randomized Clinical Trials Published in Anesthesiology Journals
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麻醉学期刊上发表的随机临床试验的注册和报告结果比较
作者：
P. Jones;J. Chow;M. Arango;Jason A. Fridfinnson;Nan Gai;K. Lam;T. Turkstra
背景：随机临床试验为临床决策提供了高质量的证据。试验注册是通过减少发表偏倚和选择性结局报告偏倚来改善RCT报告的众多工具之一。我们研究的目的是检查在前6名全身麻醉学期刊上发表的RCT是否充分注册，以及报告的主要和次要结局是否与最初注册的结局一致。方法：根据预先规定的方案，使用电子数据库系统筛选和提取2007年、2010年、2013年和2015年期间按影响因子（麻醉、麻醉与镇痛、麻醉学、英国麻醉学杂志、加拿大麻醉学杂志和欧洲麻醉学杂志）发表在6种顶级全身麻醉学期刊上的RCT数据。对每种期刊的目录进行人工检索（一式两份），以确定符合条件的RCT。充分注册的试验定义为在第一例患者入组前已在公开可用的试验注册中心注册，并具有明确定义的主要结局。对于充分注册的试验，将试验注册中注册的结局与文章中报告的结局进行比较，记录结局差异并按差异类型进行分析。结果：在研究的4年中，确定了860项随机对照试验，其中102项随机对照试验被确定已充分注册（12%）。充分注册的试验比例随着时间的推移而增加，2015年有38%的RCT得到充分注册。2015年注册不足的最常见原因是在第一例患者已经入组后注册RCT。在充分注册的试验中，92%至少有1项主要或次要结局差异。2015年，42%的RCT至少有1个主要结局差异，而90%的RCT至少有1个次要结局差异。结论：尽管试验注册是公认的最佳实践，但麻醉学期刊上发表的RCT注册不足率很高。虽然强制试验注册随着时间的推移增加了充分注册试验的比例，但仍有不可接受的高比例未充分注册的RCT。在充分注册的试验中，注册和报告结果之间的差异率很高，这表明需要将已发表的RCT与其试验注册条目进行比较，以便能够全面评估研究的质量。如果临床医生根据主要结果转换扭曲的证据做出决定，患者护理可能会受到负面影响。
BACKGROUND: Randomized clinical trials (RCTs) provide high-quality evidence for clinical decision-making. Trial registration is one of the many tools used to improve the reporting of RCTs by reducing publication bias and selective outcome reporting bias. The purpose of our study is to examine whether RCTs published in the top 6 general anesthesiology journals were adequately registered and whether the reported primary and secondary outcomes corresponded to the originally registered outcomes. METHODS: Following a prespecified protocol, an electronic database was used to systematically screen and extract data from RCTs published in the top 6 general anesthesiology journals by impact factor (Anaesthesia, Anesthesia & Analgesia, Anesthesiology, British Journal of Anaesthesia, Canadian Journal of Anesthesia, and European Journal of Anaesthesiology) during the years 2007, 2010, 2013, and 2015. A manual search of each journal’s Table of Contents was performed (in duplicate) to identify eligible RCTs. An adequately registered trial was defined as being registered in a publicly available trials registry before the first patient being enrolled with an unambiguously defined primary outcome. For adequately registered trials, the outcomes registered in the trial registry were compared with the outcomes reported in the article, with outcome discrepancies documented and analyzed by the type of discrepancy. RESULTS: During the 4 years studied, there were 860 RCTs identified, with 102 RCTs determined to be adequately registered (12%). The proportion of adequately registered trials increased over time, with 38% of RCTs being adequately registered in 2015. The most common reason in 2015 for inadequate registration was registering the RCT after the first patient had already been enrolled. Among adequately registered trials, 92% had at least 1 primary or secondary outcome discrepancy. In 2015, 42% of RCTs had at least 1 primary outcome discrepancy, while 90% of RCTs had at least 1 secondary outcome discrepancy. CONCLUSIONS: Despite trial registration being an accepted best practice, RCTs published in anesthesiology journals have a high rate of inadequate registration. While mandating trial registration has increased the proportion of adequately registered trials over time, there is still an unacceptably high proportion of inadequately registered RCTs. Among adequately registered trials, there are high rates of discrepancies between registered and reported outcomes, suggesting a need to compare a published RCT with its trial registry entry to be able to fully assess the quality of the study. If clinicians base their decisions on evidence distorted by primary outcome switching, patient care could be negatively affected.