INSERM U1153, Université Paris Descartes, Sorbonne Paris Cité, Hôpital Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Cochrane France, and Sorbonne Université, Institut Pierre Louis de Santé Publique, Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix, Assistance Publique-Hôpitaux de Paris, Paris, France (A.D.).
INSERM U1153 and Cochrane France, Paris, France (I.A.).
Ann Intern Med. 2018 Sep 18;169(6):385-393. doi: 10.7326/M18-1517. Epub 2018 Aug 21.
Evidence about the effect on meta-analysis results of including unpublished trials or those published in languages other than English is unclear or discordant.
To compare treatment effects between published and unpublished randomized controlled trials (RCTs) and between trials published in English and other languages using a meta-epidemiologic approach.
Cochrane reviews published between March 2011 and January 2017 and trial references cited in the reviews.
RCTs included in meta-analyses of 3 or more trials with a binary efficacy outcome.
Trial characteristics were extracted by original review authors. A single reviewer assessed publication status and language, with quality assurance by another investigator.
Among 5659 RCTs included in 698 meta-analyses, 5303 (93.7%) were published in journal articles and 356 (6.3%) were unpublished. Of journal articles, 92.6% (4910 of 5303) were published in English and 7.4% (393 of 5303) in another language. Treatment effects were larger in published than unpublished trials (combined ratio of odds ratios [ROR] for 174 meta-analyses, 0.90 [95% CI, 0.82 to 0.98]; I2 = 19.3%; τ2 = 0.0492). Treatment effects were also larger for trials published in a language other than English than in English (combined ROR for 147 meta-analyses, 0.86 [CI, 0.78 to 0.95]; I2 = 0%; τ2 = 0.0000).
Reliance on the primary reference cited by review authors as the record of interest.
In meta-analyses, treatment effects were larger in published than unpublished trials and, for published trials, in those published in a language other than English than in English.
Cochrane France.
关于纳入未发表试验或用英文以外其他语言发表的试验对荟萃分析结果的影响的证据尚不清楚或存在矛盾。
采用荟萃流行病学方法比较已发表和未发表的随机对照试验（RCT）以及用英文和其他语言发表的试验的治疗效果。
2011 年 3 月至 2017 年 1 月发表的 Cochrane 综述以及综述中引用的试验参考文献。
纳入 3 项及以上 RCT 进行的荟萃分析，且这些 RCT 的结局指标为二分类数据。
原始综述作者提取试验特征。一名评审员评估发表状态和语言，另一名评审员进行质量保证。
在纳入 698 项荟萃分析的 5659 项 RCT 中，5303 项（93.7%）发表于期刊文章，356 项（6.3%）为未发表。在期刊文章中，92.6%（4910/5303）用英文发表，7.4%（393/5303）用其他语言发表。与未发表的 RCT 相比，发表的 RCT 的治疗效果更大（174 项荟萃分析的合并比值比[ROR]，0.90[95%CI，0.82 至 0.98]；I2=19.3%；τ2=0.0492）。用英文以外其他语言发表的 RCT 与用英文发表的 RCT 相比，治疗效果更大（147 项荟萃分析的合并 ROR，0.86[CI，0.78 至 0.95]；I2=0%；τ2=0.0000）。
依赖综述作者作为目标记录引用的主要参考文献。
在荟萃分析中，与未发表的 RCT 相比，发表的 RCT 的治疗效果更大，与用英文发表的 RCT 相比，用英文以外其他语言发表的 RCT 的治疗效果更大。
Cochrane 法国。
