Samuel Robert, Knight Stephen R, Adams Richard, Das Prajnan, Dorth Jennifer, Finch David, Guren Marianne G, Hawkins Maria A, Moug Susan, Rajdev Lakshmi, Sebag-Montefiore David, Renehan Andrew G, Fish Rebecca
NIHR Manchester Biomedical Research Centre, Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, UK.
University of Leeds, Leeds Institute for Medical Research, St. James's University Hospital, Leeds, UK.
EClinicalMedicine. 2024 Dec 5;78:102939. doi: 10.1016/j.eclinm.2024.102939. eCollection 2024 Dec.
Variation in outcomes definitions and reporting limit the utility of clinical trial results. The Core Outcome Research Measures in Anal Cancer (CORMAC) project developed a core outcome set (COS) for chemoradiotherapy trials for anal squamous cell carcinoma (ASCC) through an international healthcare professional and patient consensus process. The CORMAC-COS comprises 19 outcomes across 4 domains (disease activity, survival, toxicity, life impact). In CORMAC-2 we have established standardised definitions for the 11 disease activity and survival outcomes in the CORMAC COS. Definitions were agreed through a 3 step process, initially identifying existing definitions through systematic review (registered with PROSPERO, CRD42016036540), using these to populate a two-round Delphi questionnaire completed by 51 experts from 13 countries, and finally ratification through an online consensus meeting. Standardising the definitions for these core outcomes facilitates real world utilisation of the CORMAC-COS, thereby increasing the quality of data available for clinical decision-making and ultimately enhancing patient care.
结局定义和报告的差异限制了临床试验结果的效用。肛管癌核心结局研究指标（CORMAC）项目通过国际医疗专业人员和患者达成共识的过程，为肛管鳞状细胞癌（ASCC）的放化疗试验制定了核心结局集（COS）。CORMAC-COS包括4个领域（疾病活动、生存、毒性、生活影响）的19个结局。在CORMAC-2中，我们为CORMAC COS中的11个疾病活动和生存结局建立了标准化定义。定义通过三个步骤达成一致，首先通过系统评价（在PROSPERO注册，CRD42016036540）确定现有定义，利用这些定义填充由来自13个国家的51名专家完成的两轮德尔菲问卷，最后通过在线共识会议批准。对这些核心结局进行标准化定义有助于CORMAC-COS在现实世界中的应用，从而提高可用于临床决策的数据质量，并最终改善患者护理。
