Reporting and Interpretation of Randomized Controlled Trials With Statistically Nonsignificant Results for Primary Outcomes
Reporting and Interpretation of Randomized Controlled Trials With Statistically Nonsignificant Results for Primary Outcomes
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DOI：
10.1001/jama.2010.651
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发表时间：
2010-05-26
影响因子：
120.7
通讯作者：
Altman, Douglas G.
中科院分区：
文献类型：
--
作者：
Boutron, Isabelle;Dutton, Susan;Altman, Douglas G.
背景以往的研究表明，临床试验结果的解释可能会被已发表报告的作者扭曲。目的识别扭曲陈述或“旋转”的性质和频率（即，具体的报告策略，无论其动机如何，以强调实验性治疗是有益的，尽管主要结局的统计学差异不显著，或分散读者对无统计学意义结果的注意力）数据来源2007年3月通过PubMed检索MEDLINE，使用科克伦高灵敏度检索策略，2006年12月发表的随机对照试验报告。如果是平行组随机对照试验，且明确的主要结局显示统计学上无显著性结果，则纳入研究选择文章（即，P >= .05）.数据提取两名读者使用预测试的标准化数据提取表对每篇选定的文章进行评价。72人符合资格并接受评估。13篇文章报告了标题与旋转（18.0%; 95%置信区间[CI]，10.0%-28.9%）。分别在27份（37.5%; 95% CI，26.4%-49.7%）和42份（58.3%; 95% CI，46.1%-69.8%）报告摘要的结果和结论章节中确定了自旋，17份（23.6%; 95% CI，14.4%-35.1%）报告的结论仅关注治疗有效性。分别在21份（29.2%; 95% CI，19.0%-41.1%）、31份（43.1%; 95% CI，31.4%-55.3%）和36份（50.0%; 95% CI，38.0%-62.0%）报告的正文结果、讨论和结论章节中识别出自旋。超过40%的报告旋转在至少2个这些部分的主要text.Conclusion在2006年发表的随机对照试验的统计不显着的主要成果，报告和解释的结果往往是不一致的结果。JAMA. 2010;303（20）：2058-2064 www.jama.com
Context Previous studies indicate that the interpretation of trial results can be distorted by authors of published reports.Objective To identify the nature and frequency of distorted presentation or "spin" (ie, specific reporting strategies, whatever their motive, to highlight that the experimental treatment is beneficial, despite a statistically nonsignificant difference for the primary outcome, or to distract the reader from statistically nonsignificant results) in published reports of randomized controlled trials (RCTs) with statistically nonsignificant results for primary outcomes.Data Sources March 2007 search of MEDLINE via PubMed using the Cochrane Highly Sensitive Search Strategy to identify reports of RCTs published in December 2006.Study Selection Articles were included if they were parallel-group RCTs with a clearly identified primary outcome showing statistically nonsignificant results (ie, P >= .05).Data Extraction Two readers appraised each selected article using a pretested, standardized data abstraction form developed in a pilot test.Results From the 616 published reports of RCTs examined, 72 were eligible and appraised. The title was reported with spin in 13 articles (18.0%; 95% confidence interval [CI], 10.0%-28.9%). Spin was identified in the Results and Conclusions sections of the abstracts of 27 (37.5%; 95% CI, 26.4%-49.7%) and 42 (58.3%; 95% CI, 46.1%-69.8%) reports, respectively, with the conclusions of 17 (23.6%; 95% CI, 14.4%-35.1%) focusing only on treatment effectiveness. Spin was identified in the main-text Results, Discussion, and Conclusions sections of 21 (29.2%; 95% CI, 19.0%-41.1%), 31 (43.1%; 95% CI, 31.4%-55.3%), and 36 (50.0%; 95% CI, 38.0%-62.0%) reports, respectively. More than 40% of the reports had spin in at least 2 of these sections in the main text.Conclusion In this representative sample of RCTs published in 2006 with statistically nonsignificant primary outcomes, the reporting and interpretation of findings was frequently inconsistent with the results. JAMA. 2010;303(20):2058-2064 www.jama.com