Department of Critical Care Medicine, University of Calgary, 3134 Hospital Drive NW, Calgary, AB, T2N 2T9, Canada.
Department of Anesthesiology and Pain Medicine, University of Ottawa, 1053 Carling Avenue, B302, Ottawa, ON, K1Y 4E9, Canada.
BMC Med. 2018 Feb 21;16(1):26. doi: 10.1186/s12916-018-1018-6.
The ability to reproduce experiments is a defining principle of science. Reproducibility of clinical research has received relatively little scientific attention. However, it is important as it may inform clinical practice, research agendas, and the design of future studies.
We used scoping review methods to examine reproducibility within a cohort of randomized trials examining clinical critical care research and published in the top general medical and critical care journals. To identify relevant clinical practices, we searched the New England Journal of Medicine, The Lancet, and JAMA for randomized trials published up to April 2016. To identify a comprehensive set of studies for these practices, included articles informed secondary searches within other high-impact medical and specialty journals. We included late-phase randomized controlled trials examining therapeutic clinical practices in adults admitted to general medical-surgical or specialty intensive care units (ICUs). Included articles were classified using a reproducibility framework. An original study was the first to evaluate a clinical practice. A reproduction attempt re-evaluated that practice in a new set of participants.
Overall, 158 practices were examined in 275 included articles. A reproduction attempt was identified for 66 practices (42%, 95% CI 33-50%). Original studies reported larger effects than reproduction attempts (primary endpoint, risk difference 16.0%, 95% CI 11.6-20.5% vs. 8.4%, 95% CI 6.0-10.8%, P = 0.003). More than half of clinical practices with a reproduction attempt demonstrated effects that were inconsistent with the original study (56%, 95% CI 42-68%), among which a large number were reported to be efficacious in the original study and to lack efficacy in the reproduction attempt (34%, 95% CI 19-52%). Two practices reported to be efficacious in the original study were found to be harmful in the reproduction attempt.
A minority of critical care practices with research published in high-profile journals were evaluated for reproducibility; less than half had reproducible effects.
重现实验是科学的基本原则之一。临床研究的可重复性受到的科学关注相对较少。然而，它很重要，因为它可能为临床实践、研究议程以及未来研究的设计提供信息。
我们使用范围综述方法，在发表于顶级一般医学和重症监护期刊的一组检查临床重症监护研究的随机试验中检查可重复性。为了确定相关的临床实践，我们在《新英格兰医学杂志》、《柳叶刀》和《美国医学会杂志》中搜索了截至 2016 年 4 月发表的随机试验。为了确定这些实践的一套全面研究，包括文章在内的信息在其他高影响力的医学和专业期刊中进行了二次搜索。我们纳入了晚期随机对照试验，研究了普通内科-外科或专科重症监护病房（ICU）住院成人的治疗性临床实践。纳入的文章使用可重复性框架进行分类。原始研究首次评估了一种临床实践。复制尝试在新的一组参与者中重新评估该实践。
总体而言，在 275 篇纳入文章中，有 158 种实践得到了检验。确定了 66 种实践的复制尝试（42%，95%CI 33-50%）。原始研究报告的效果大于复制尝试（主要终点，风险差异 16.0%，95%CI 11.6-20.5%与 8.4%，95%CI 6.0-10.8%，P = 0.003）。在有复制尝试的临床实践中，超过一半的实践效果与原始研究不一致（56%，95%CI 42-68%），其中大量实践在原始研究中被报道有效，而在复制尝试中无效（34%，95%CI 19-52%）。有两个在原始研究中被报道有效的实践在复制尝试中被发现是有害的。
在发表于高知名度期刊的重症监护研究中，只有少数临床实践被评估了可重复性；不到一半的实践有可重复的效果。
