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随机对照试验——设计问题

Randomized controlled trials - a matter of design.

作者信息

Spieth Peter Markus, Kubasch Anne Sophie, Penzlin Ana Isabel, Illigens Ben Min-Woo, Barlinn Kristian, Siepmann Timo

机构信息

Department of Anesthesiology and Critical Care Medicine, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Saxony, Germany; Center for Clinical Research and Management Education, Division of Health Care Sciences, Dresden International University, Dresden, Saxony, Germany.

Pediatric Rheumatology and Immunology, Children's Hospital, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Saxony, Germany.

出版信息

Neuropsychiatr Dis Treat. 2016 Jun 10;12:1341-9. doi: 10.2147/NDT.S101938. eCollection 2016.

Abstract

Randomized controlled trials (RCTs) are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials.gov. The most relevant recommendations regarding design, conduction, and reporting of RCTs may include the following: 1) clinically relevant end points should be defined a priori, and an unbiased analysis and report of the study results should be warranted, 2) both significant and nonsignificant results should be objectively reported and published, 3) structured study design and performance as indicated in the Consolidated Standards of Reporting Trials statement should be employed as well as registration in a public trial database, 4) potential conflicts of interest and funding sources should be disclaimed in study report or publication, and 5) in the comparison of experimental treatment with standard care, preplanned interim analyses during an ongoing RCT can aid in maintaining clinical equipoise by assessing benefit, harm, or futility, thus allowing decision on continuation or termination of the trial.

摘要

随机对照试验(RCTs)是循证医学的标志,也是将研究数据转化为临床实践的基础。本综述总结了RCTs常用的设计和质量指标,为解释和批判性评估临床研究数据提供指导。它还反思了均衡原则及其在临床科学中的实际适用性,重点关注重症监护和神经学研究。我们使用MEDLINE、PubMed和ClinicalTrials.gov数据库对教育材料、综述文章、方法学研究和已发表的临床试验进行了综述。关于RCTs设计、实施和报告的最相关建议可能包括以下几点:1)应事先定义临床相关终点,并保证对研究结果进行无偏分析和报告;2)应客观报告和发表显著和不显著的结果;3)应采用《报告试验的统一标准》声明中指出的结构化研究设计和实施方法,并在公共试验数据库中进行注册;4)应在研究报告或发表中声明潜在的利益冲突和资金来源;5)在将实验性治疗与标准治疗进行比较时,正在进行的RCT中的预先计划的中期分析可通过评估益处、危害或无效性来帮助维持临床均衡,从而允许决定试验的继续或终止。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f6c5/4910682/68504c606483/ndt-12-1341Fig1.jpg

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