Bruner Deborah Watkins, Bryan Charlene J, Aaronson Neil, Blackmore C Craig, Brundage Michael, Cella David, Ganz Patricia A, Gotay Carolyn, Hinds Pamela S, Kornblith Alice B, Movsas Benjamin, Sloan Jeff, Wenzel Lari, Whalen Giles
Radiation Therapy Oncology Group, University of Pennsylvania, School of Nursing; American College of Radiology Imaging Network, Philadelphia, PA 19104-6096, USA. wbruner@nursing .upenn.edu
J Clin Oncol. 2007 Nov 10;25(32):5051-7. doi: 10.1200/JCO.2007.11.3324.
The objective of this report is to provide a historical overview of and the issues and challenges inherent in the incorporation of patient-reported outcomes (PROs) into multinational cancer clinical trials in the cancer cooperative groups.
An online survey of 12 cancer cooperative groups from the United States, Canada, and Europe was conducted between June and August of 2006. Each of the cooperative groups designated one respondent, who was a member of one of the PRO committees within the cooperative group.
There was a 100% response rate, and all of the cancer clinical trial cooperative groups reported conducting PRO research. PRO research has been conducted in the cancer cooperative groups for an average of 15 years (range, 6 to 30 years), and all groups had multidisciplinary committees focused on the design of PRO end points and the choice of appropriate PRO measures for cancer clinical trials. The cooperative groups reported that 5% to 50% of cancer treatment trials and an estimated 50% to 75% of cancer control trials contained PRO primary and secondary end points. There was considerable heterogeneity among the cooperative groups with respect to the formal and informal policies and procedures or cooperative group culture towards PROs, investigator training/mentorship, and resource availability for the measurement and conduct of PRO research within the individual cooperatives.
The challenges faced by the cooperative groups to the incorporation of PROs into cancer clinical trials are varied. Some common opportunities for improvement include the adoption of standardized training/mentorship mechanisms for investigators for the conduct of PRO assessments and data collection and the development of minimal criteria for PRO measure acceptability. A positive cultural shift has occurred in most of the cooperative groups related to the incorporation of PROs in clinical trials; however, financial and other resource barriers remain and need to be addressed.
本报告的目的是对患者报告结局（PROs）纳入癌症协作组的多国癌症临床试验的历史进行概述，并阐述其中固有的问题和挑战。
2006年6月至8月期间，对来自美国、加拿大和欧洲的12个癌症协作组进行了在线调查。每个协作组指定一名受访者，该受访者是协作组内PRO委员会的成员之一。
回复率为100%，所有癌症临床试验协作组均报告开展了PRO研究。PRO研究在癌症协作组中平均开展了15年（范围为6至30年），所有组都有多学科委员会，专注于PRO终点的设计以及为癌症临床试验选择合适的PRO测量方法。协作组报告称，5%至50%的癌症治疗试验以及估计50%至75%的癌症对照试验包含PRO主要和次要终点。在PRO的正式和非正式政策与程序、协作组文化、研究者培训/指导以及各协作组内PRO研究测量和开展的资源可用性方面，协作组之间存在相当大的异质性。
协作组在将PRO纳入癌症临床试验方面面临的挑战多种多样。一些常见的改进机会包括为研究者采用标准化的培训/指导机制以进行PRO评估和数据收集，以及制定PRO测量可接受性的最低标准。在大多数协作组中，与将PRO纳入临床试验相关的文化已发生积极转变；然而，财务和其他资源障碍仍然存在，需要加以解决。
