Understanding the Use of Composite Endpoints in Clinical Trials.
Understanding the Use of Composite Endpoints in Clinical Trials.
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DOI：
10.5811/westjem.2018.4.38383
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发表时间：
2018-07
期刊：
影响因子：
--
通讯作者：
McCoy CE
中科院分区：
文献类型：
--
作者：
McCoy CE
临床医生、医疗机构、医疗网络和政策制定者在管理个体患者或人群时，将临床试验中报告的结果作为医疗决策的基础。因此，选择有效的主要终点对于随机对照试验（RCT）证明新疗法的疗效至关重要。然而，最近治疗的改进导致几种常见疾病的发病率和死亡率下降，从而导致可用作临床试验终点的相关结局减少。复合终点已被用作维持RCT可行性的解决方案，特别是在面临低事件发生率、高成本和长期随访时。然而，使用复合终点的益处必须与临床医生和政策制定者误解的风险进行权衡，因为不正确的解释可能对患者和人群产生不利影响。本文定义了复合终点，讨论了其使用的基本原理，并提供了一种实用的方法来解释结果，以帮助医疗决策。
Clinicians, institutions, healthcare networks, and policymakers use outcomes reported in clinical trials as the basis for medical decision-making when managing individual patients or populations. Therefore, the choice of a valid primary endpoint is crucial for randomized controlled trials (RCT) to demonstrate efficacy of new therapies. Recent improvements in treatment, however, have led to a decline in the morbidity and mortality of several common diseases, resulting in a reduction in relevant outcomes that can be used as clinical trial endpoints. Composite endpoints have been used as a solution to maintain the feasibility of RCTs, particularly when facing low event rates, high cost, and long follow-up. However, the benefits of using composite endpoints must be weighed against the risks of misinterpretation by clinicians and policymakers, as incorrect interpretation may have a detrimental effect on patients and populations. This paper defines a composite endpoint, discusses the rationale for its use, and provides a practical approach to interpreting results to aid in medical decision-making.
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