Manderlier Bénédicte, von Kemp Berlinde, Beeckman Katrien, Cosyns Bernard, Van den Bussche Karen
Universitair Ziekenhuis Brussel (UZ Brussel), Centre for Cardiovascular Diseases/Cardiology, Laarbeeklaan 101, 1090 Brussels, Belgium.
Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Department of Public Health/Nursing and Midwifery Research Group (NUMID), Laarbeeklaan 101, 1090 Brussels, Belgium.
Eur Heart J Qual Care Clin Outcomes. 2025 Jun 23;11(4):367-377. doi: 10.1093/ehjqcco/qcae038.
AIMS: There is an increasing awareness of the evidence-based selection of outcomes to be measured in clinical trials and clinical practice. Currently, there is no core outcome set (COS) for cardio-oncology, which may hinder the (inter)national comparison of the effectiveness of research and the quality of cardio-oncology care. The aim of this study is to develop a standard and pragmatic patient-centred outcome set to assess and monitor cancer patients and survivors at risk of or with cardiovascular diseases. METHODS AND RESULTS: A list of outcome domains was generated through a review of registries and guidelines, and six patient interviews. The project team reviewed and refined the outcome domains prior to starting a two-round Delphi procedure conducted between January and June 2022. The panellists, including healthcare providers and researchers, were invited to rate the importance of the outcomes. Twenty-six experts from 11 countries rated a list of 93 outcomes (round 1) and 63 outcomes (round 2) to gain consensus on a list of outcome measures, and of demographic factors, health status, and treatment variables. The final COS includes 15 outcome measures, reflecting four core areas: life impact (n = 2), pathophysiological manifestations (n = 9), resource use/economic impact (n = 1), and mortality/survival (n = 3). Next, 6 demographic factors, 21 health status, 3 cardiovascular, and 9 cancer variables were included. CONCLUSIONS: This is the first international development of a COS for cardio-oncology. This set aims to facilitate (inter)national comparison in cardio-oncology care, using standardized parameters and meaningful patient-centred outcomes for research and quality of care assessments.
目的:在临床试验和临床实践中,基于证据选择要测量的结局的意识日益增强。目前,心脏肿瘤学尚无核心结局集(COS),这可能会阻碍研究有效性的(跨)国比较以及心脏肿瘤学护理质量的比较。本研究的目的是制定一个标准且实用的以患者为中心的结局集,以评估和监测有心血管疾病风险或患有心血管疾病的癌症患者及幸存者。 方法与结果:通过审查登记处和指南以及进行六次患者访谈,生成了一份结局领域清单。在2022年1月至6月期间启动两轮德尔菲程序之前,项目团队对结局领域进行了审查和完善。邀请了包括医疗保健提供者和研究人员在内的小组成员对结局的重要性进行评分。来自11个国家的26位专家对93项结局(第一轮)和63项结局(第二轮)进行了评分,以就一系列结局指标以及人口统计学因素、健康状况和治疗变量达成共识。最终的核心结局集包括15项结局指标,反映四个核心领域:生活影响(n = 2)、病理生理表现(n = 9)、资源使用/经济影响(n = 1)和死亡率/生存率(n = 3)。接下来,纳入了6项人口统计学因素、21项健康状况、3项心血管和9项癌症变量。 结论:这是心脏肿瘤学核心结局集的首次国际制定。该核心结局集旨在通过使用标准化参数和有意义的以患者为中心的结局,促进心脏肿瘤学护理的(跨)国比较,以用于研究和护理质量评估。
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