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临床研究中的发表偏倚。

Publication bias in clinical research.

作者信息

Easterbrook P J, Berlin J A, Gopalan R, Matthews D R

机构信息

Division of Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21205.

出版信息

Lancet. 1991 Apr 13;337(8746):867-72. doi: 10.1016/0140-6736(91)90201-y.

Abstract

In a retrospective survey, 487 research projects approved by the Central Oxford Research Ethics Committee between 1984 and 1987, were studied for evidence of publication bias. As of May, 1990, 285 of the studies had been analysed by the investigators, and 52% of these had been published. Studies with statistically significant results were more likely to be published than those finding no difference between the study groups (adjusted odds ratio [OR] 2.32; 95% confidence interval [Cl] 1.25-4.28). Studies with significant results were also more likely to lead to a greater number of publications and presentations and to be published in journals with a high citation impact factor. An increased likelihood of publication was also associated with a high rating by the investigator of the importance of the study results, and with increasing sample size. The tendency towards publication bias was greater with observational and laboratory-based experimental studies (OR = 3.79; 95% Cl = 1.47-9.76) than with randomised clinical trials (OR = 0.84; 95% Cl = 0.34-2.09). We have confirmed the presence of publication bias in a cohort of clinical research studies. These findings suggest that conclusions based only on a review of published data should be interpreted cautiously, especially for observational studies. Improved strategies are needed to identify the results of unpublished as well as published studies.

摘要

在一项回顾性调查中,对1984年至1987年间经牛津中央研究伦理委员会批准的487个研究项目进行了研究,以寻找发表偏倚的证据。截至1990年5月,研究人员已对其中285项研究进行了分析,其中52%已经发表。与那些未发现研究组之间存在差异的研究相比,具有统计学显著结果的研究更有可能发表(校正比值比[OR]为2.32;95%置信区间[Cl]为1.25 - 4.28)。具有显著结果的研究也更有可能带来更多的发表物和报告,并发表在具有高引用影响因子的期刊上。发表可能性的增加还与研究人员对研究结果重要性的高评价以及样本量的增加有关。与随机临床试验相比,观察性研究和基于实验室的实验性研究中发表偏倚的倾向更大(OR = 3.79;95% Cl = 1.47 - 9.76)(随机临床试验的OR = 0.84;95% Cl = 0.34 - 2.09)。我们已经证实在一组临床研究中存在发表偏倚。这些发现表明,仅基于已发表数据的综述得出的结论应谨慎解释,尤其是对于观察性研究。需要改进策略以识别未发表研究以及已发表研究的结果。

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