Shi Lan, Lindsell Christopher John, Liu Dandan
Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.
Department of Biostatistics & Bioinformatics, Duke University, Durham, NC, USA.
J Clin Transl Sci. 2024 Mar 8;8(1):e55. doi: 10.1017/cts.2024.492. eCollection 2024.
Composite endpoints can encode multiple pieces of information and are increasingly adopted in clinical trials. Advocacy for using composite endpoints began decades ago in cardiovascular trials, leading to incorporation of patient-oriented outcomes and consideration of a hierarchical ranking system. The use of composite endpoints in coronavirus disease (COVID-19) trials has evolved similarly. We conducted a literature review to investigate the use of composite endpoints in acute heart failure and COVID-19 clinical trials. The results showed more frequent use of patient-oriented outcomes and ordinal composite endpoints in COVID-19 trials, which might be driven by global consensus on a set of common outcome measures.
复合终点可以编码多条信息,并且在临床试验中越来越多地被采用。几十年前,在心血管试验中就开始倡导使用复合终点,这导致纳入了以患者为导向的结局,并考虑了分层排序系统。在冠状病毒病(COVID-19)试验中,复合终点的使用也有类似的发展。我们进行了一项文献综述,以调查复合终点在急性心力衰竭和COVID-19临床试验中的使用情况。结果显示,在COVID-19试验中,以患者为导向的结局和有序复合终点的使用更为频繁,这可能是由一套共同结局指标的全球共识所推动的。