PUBLICATION BIAS AND CLINICAL-TRIALS
PUBLICATION BIAS AND CLINICAL-TRIALS
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DOI：
10.1016/0197-2456(87)90155-3
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发表时间：
1987-12-01
期刊：
影响因子：
--
通讯作者：
SMITH, H
中科院分区：
文献类型：
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作者：
DICKERSIN, K;CHAN, S;SMITH, H
进行了一项研究，以评估由于选择性发表随机临床试验（RCT）而导致的医学文献可能产生误导的程度，其结果显示具有统计学意义的治疗效果。已发表试验的 318 位作者被问及是否参加过任何未发表的随机对照试验。 156 名受访者报告了 271 项未发表的试验和 1041 项已发表的试验。在 178 项已完成的未发表的具有指定趋势的随机对照试验中，26 项 (14%) 赞成新疗法，而 767 项已发表报告中有 423 项 (55%) (p < 0.001)。对于已完成但未发表的试验，未发表的主要原因是“负面”结果和缺乏兴趣。从提供的数据来看，未发表主要是由于未能撰写和提交试验结果，而不是拒绝提交的手稿。这项研究的结果意味着存在发表偏倚，这对于荟萃分析和统计上显着的阳性试验的解释都很重要。
A study was performed to evaluate the extent to which the medical literature may be misleading as a result of selective publication of randomized clinical trials (RCTs) with results showing a statistically significant treatment effect. Three hundred eighteen authors of published trials were asked whether they had participated in any unpublished RCTs. The 156 respondents reported 271 unpublished and 1041 published trials. Of the 178 completed unpublished RCTs with a trend specified, 26 (14%) favored the new therapy compared to 423 of 767 (55%) published reports (p < 0.001). For trials that were completed but not published, the major reasons for nonpublication were "negative" results and lack of interest. From the data provided, it appears that nonpublication was primarily a result of failure to write up and submit the trial results rather than rejection of submitted manuscripts. The results of this study imply the existence of a publication bias of importance both to meta-analysis and the interpretation of statistically significant positive trials.