Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards

Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards
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DOI:
10.1016/s1470-2045(16)30510-1
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发表时间:
2016-11-01
期刊:
影响因子:
51.1
通讯作者:
Coens, Corneel
Coens, Corneel
中科院分区:
医学1区
文献类型:
--
作者:
Bottomley, Andrew;Pe, Madeline;Coens, Corneel

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健康相关生活质量(HRQOL)和其他患者报告的结果的测量在癌症随机试验中产生重要数据,以帮助评估癌症治疗的风险和好处,并促进以患者为中心的癌症护理。然而,分析和解释这些措施的方式多种多样,使得很难在试验中比较结果,并阻碍了将研究结果应用于为出版物、产品标签、临床指南和卫生政策提供信息。为了解决这些问题,已经建立了制定分析患者报告结果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和治疗组织(EORTC)领导,旨在就如何在癌症随机试验中标准化HRQOL和其他患者报告的结果数据的分析提供建议。这一个人观点讨论了这个项目启动的原因,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好处。
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.