Patient-Reported Physical Function Measures in Cancer Clinical Trials.

IF 5.2 2区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Epidemiologic Reviews Pub Date : 2017-01-01 DOI:10.1093/epirev/mxx008
Thomas M Atkinson, Angela M Stover, Daniel F Storfer, Rebecca M Saracino, Thomas A D'Agostino, Denise Pergolizzi, Konstantina Matsoukas, Yuelin Li, Ethan Basch
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Abstract

Patient-reported outcomes (PROs) are increasingly used to monitor treatment-related symptoms and physical function decrements in cancer clinical trials. As more patients enter survivorship, it is important to capture PRO physical function throughout trials to help restore pretreatment levels of function. We completed a systematic review of PRO physical function measures used in cancer clinical trials and evaluated their psychometric properties on the basis of guidelines from the US Food and Drug Administration. Five databases were searched through October 2015: PubMed/MEDLINE, EMBASE, CINAHL (Cumulative Index of Nursing and Allied Health Literature), Health and Psychosocial Instruments, and Cochrane. From an initial total of 10,233 articles, we identified 108 trials that captured PRO physical function. Within these trials, approximately 67% used the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and 25% used the Medical Outcomes Study Short Form 36. Both the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and Medical Outcomes Study Short Form 36 instruments generically satisfy most Food and Drug Administration requirements, although neither sought direct patient input as part of item development. The newer Patient-Reported Outcomes Measurement Information System physical function short form may be a brief, viable alternative. Clinicians should carefully consider the psychometric properties of these measures when incorporating PRO instrumentation into clinical trial design to provide a more comprehensive understanding of patient function.

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癌症临床试验中患者报告的身体功能测量方法。
在癌症临床试验中,越来越多地使用患者报告结果(PROs)来监测与治疗相关的症状和身体功能下降情况。随着越来越多的患者进入存活期,在整个试验过程中捕捉患者报告的身体功能以帮助恢复治疗前的功能水平非常重要。我们对癌症临床试验中使用的PRO身体功能测量方法进行了系统性回顾,并根据美国食品药品管理局的指南对其心理测量特性进行了评估。截至 2015 年 10 月,我们检索了五个数据库:PubMed/MEDLINE、EMBASE、CINAHL(护理和联合健康文献累积索引)、健康和社会心理工具以及 Cochrane。在最初总共 10,233 篇文章中,我们确定了 108 项采集 PRO 身体功能的试验。在这些试验中,约 67% 使用了欧洲癌症研究与治疗组织的生活质量问卷,25% 使用了医学结果研究简表 36。欧洲癌症研究与治疗组织的生活质量调查表和医学结果研究简表 36 都能满足食品与药物管理局的大部分要求,但在项目开发过程中都没有直接征求患者的意见。较新的患者报告结果测量信息系统(Patient-Reported Outcomes Measurement Information System)身体功能简表可能是一种简短可行的替代方法。临床医生在将患者报告结果测量工具纳入临床试验设计时,应仔细考虑这些测量工具的心理测量特性,以便更全面地了解患者的功能。
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来源期刊
Epidemiologic Reviews
Epidemiologic Reviews 医学-公共卫生、环境卫生与职业卫生
CiteScore
8.10
自引率
0.00%
发文量
10
期刊介绍: Epidemiologic Reviews is a leading review journal in public health. Published once a year, issues collect review articles on a particular subject. Recent issues have focused on The Obesity Epidemic, Epidemiologic Research on Health Disparities, and Epidemiologic Approaches to Global Health.
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