European Organisation for Research and Treatment of Cancer (EORTC Headquarters), Brussels, Belgium.
European Organisation for Research and Treatment of Cancer (EORTC Headquarters), Brussels, Belgium.
Lancet Oncol. 2016 Nov;17(11):e510-e514. doi: 10.1016/S1470-2045(16)30510-1. Epub 2016 Oct 18.
Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established. This consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations on how to standardise the analysis of HRQOL and other patient-reported outcomes data in cancer randomised trials. This Personal View discusses the reasons why this project was initiated, the rationale for the planned work, and the expected benefits to cancer research, patient and provider decision making, care delivery, and policy making.
健康相关生活质量（HRQOL）和其他患者报告结局的衡量标准在癌症随机试验中产生了重要数据，有助于评估癌症治疗的风险和益处，并促进以患者为中心的癌症护理。然而，这些措施的各种分析和解释方法使得难以在试验之间比较结果，并阻碍了研究结果的应用，以告知出版物、产品标签、临床指南和卫生政策。为了解决这些问题，设立了设定分析患者报告结局和生活质量终点数据的国际标准（SISAQOL）倡议。该联盟由欧洲癌症研究与治疗组织（EORTC）领导，旨在就如何标准化癌症随机试验中 HRQOL 和其他患者报告结局数据的分析提供建议。本个人观点讨论了启动该项目的原因、计划工作的基本原理以及对癌症研究、患者和提供者决策、护理提供和政策制定的预期益处。
