Department of Anesthesiology, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.
Department of Anesthesiology, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.
J Clin Epidemiol. 2021 Sep;137:236-240. doi: 10.1016/j.jclinepi.2021.05.003. Epub 2021 May 15.
To determine the incidence of outcome switching in follow-up publications of randomized controlled trials. Outcome switching leads to bias where treatment benefits are more likely to be overestimated or based on chance.
Meta-research study including all follow-up publications 2014-2018 in the New England Journal of Medicine, The Lancet, the Journal of the American Medical Association, and the British Medical Journal. Two independent reviewers compared the primary outcomes of follow-up publications with the original RCT publication and the trial protocol.
Seventy-eight follow-up publications were identified. Thirty-one (40%) used different primary outcomes in the follow-up publication compared with the original RCT. In seventeen (55%) of these the outcome switch was neither pre-specified nor explained in the journal publication. The incidence of outcome switching in follow-up studies rose to 70% when preceded by outcome switching in the corresponding initial RCT (P< 0.001).
In this study, outcome switching occurred in 40% of follow-up publications of previously published RCTs. The majority is neither pre-specified nor explained.
确定随机对照试验随访出版物中结局转换的发生率。结局转换会导致偏倚，使治疗效果更有可能被高估或基于偶然。
元研究包括 2014 年至 2018 年在《新英格兰医学杂志》、《柳叶刀》、《美国医学会杂志》和《英国医学杂志》上发表的所有随访出版物。两名独立审查员比较了随访出版物的主要结局与原始 RCT 出版物和试验方案。
共确定了 78 篇随访出版物。31 篇（40%）在随访出版物中使用了与原始 RCT 不同的主要结局。在这 17 篇（55%）中，结局转换既没有预先指定，也没有在期刊出版物中解释。当相应的初始 RCT 中存在结局转换时，随访研究中的结局转换发生率上升至 70%（P<0.001）。
在这项研究中，先前发表的 RCT 的随访出版物中有 40%出现了结局转换。大多数既没有预先指定，也没有解释。
