Mozetic de Barros Valéria, Pacheco Rafael Leite, Cabrera Martimbianco Ana Luiza, Mozetic Vânia, Junior Sebastião Castilho, Riera Rachel
Cardiologist at Escola Paulista de Medicina, Universidade Federal de São Paulo (Unifesp), São Paulo, São Paulo, Brazil.
Researcher at Núcleo de Avaliação de Tecnologias em Saúde, Hospital Sírio-Libanês (HSL), São Paulo, São Paulo, Brazil; Professor at Department of Medicine, Centro Universitário São Camilo (CUSC), São Paulo, São Paulo, Brazil; Pesquisador, Disciplina de Economia e Gestão em Saúde, Universidade Federal de São Paulo (Unifesp), São Paulo, São Paulo, Brazil.
J Clin Epidemiol. 2024 Jan;165:111212. doi: 10.1016/j.jclinepi.2023.11.002. Epub 2023 Nov 7.
To estimate the frequency and critically appraise the use and reporting of composite outcomes in randomized clinical trials on pharmacological interventions for coronary artery disease.
A metaresearch study. A search strategy was developed to retrieve references from MEDLINE. We considered articles, published from 1st January 2020, to December 31, 2021, reporting results of clinical primary outcomes from randomized clinical trials which assessed pharmacological interventions, used alone or in combination, for the treatment or secondary prevention (previous coronary event) of coronary artery disease.
From the 34 included studies, 28 (82.35%) had a primary composite outcome. Thirteen unique composite primary outcomes were used with the most frequent being "cardiovascular death, myocardial infarction, stroke" (12/28, 42.86%). The term major adverse cardiac events was used for five distinct composite primary outcomes. A combination of 12 different components resulted in the 28 primary composite outcomes, with stroke being the most frequent component present in 96.43% (27/28) of the primary composite outcomes. From the included studies, 60.71% (17/28) reported the estimates for each individual component and the direction of the effect was consistent between all components and the composite outcomes in 58.82% (10/17) of them. Additionally, no included study discussed potential limitations and/or related advantages of the composite outcomes.
In randomized clinical trials on pharmacological interventions for coronary artery disease, composite outcomes are frequently used, but the definition of their components is very heterogeneous. The estimate for individual components within the composite outcome is often not fully reported, which prevents a complete analysis of their adequacy for clinical practice. The term major adverse cardiac events was used inconsistently and to refer to different set of components, which can also be misleading and confusing.
评估在冠心病药物干预随机临床试验中复合结局的使用频率，并对其应用和报告进行严格评价。
一项元研究。制定了检索策略以从MEDLINE中检索参考文献。我们纳入了2020年1月1日至2021年12月31日发表的文章，这些文章报告了评估单独或联合使用药物干预治疗或二级预防（既往冠心病事件）冠心病的随机临床试验的临床主要结局结果。
在纳入的34项研究中，28项（82.35%）有主要复合结局。使用了13种独特的复合主要结局，最常见的是“心血管死亡、心肌梗死、卒中”（12/28，42.86%）。“主要不良心脏事件”一词用于5种不同的复合主要结局。12种不同成分的组合产生了28种主要复合结局，卒中是最常见的成分，存在于96.43%（27/28）的主要复合结局中。在纳入的研究中，60.71%（17/28）报告了每个单独成分的估计值，其中58.82%（10/17）的所有成分与复合结局之间的效应方向一致。此外，没有纳入的研究讨论复合结局的潜在局限性和/或相关优势。
在冠心病药物干预随机临床试验中，复合结局被频繁使用，但其成分的定义非常不一致。复合结局中各个成分的估计值往往没有得到充分报告，这妨碍了对其在临床实践中的适用性进行全面分析。“主要不良心脏事件”一词的使用不一致，且指代不同的成分组合，这也可能会产生误导和混淆。
