Lipscomb Joseph, Snyder Claire F, Gotay Carolyn C
Department of Health Policy and Management, Rollins School of Public Health, Emory University, Rm 642, 1518 Clifton Road, NE, Atlanta, GA 30322, USA.
Qual Life Res. 2007 Feb;16(1):143-64. doi: 10.1007/s11136-006-9116-x. Epub 2006 Nov 8.
In 2001, the U.S. National Cancer Institute established the Cancer Outcomes Measurement Working Group (COMWG) to evaluate and advance the state of the science in patient-reported outcome (PRO) measurement, with a focus on health-related quality of life (HRQOL). To guide its work, the COMWG adopted the revised Medical Outcomes Trust (MOT) attributes and review criteria for evaluating health status and quality-of-life instruments.
With the MOT attributes providing the organizing principle, this paper summarizes and draws inferences from key COMWG findings about the methodological soundness of HRQOL assessment in cancer and steps required to move the field forward.
Across a range of cancer research applications, especially clinical trials, a variety of generic, general cancer, and cancer site-specific measures of HRQOL have demonstrated adequate reliability, validity, responsiveness, feasibility, and cultural and language adaptation. Methodological challenges remain in the interpretability of HRQOL measures, though substantial progress has been made in defining a "minimum important difference" in scale scores. Much work remains in forging a stronger link between the conceptual model and measurement model in HRQOL instrumentation. Progress along all MOT attributes will likely accelerate with the growing application of modern psychometrics, particularly item response theory modeling, which provides the underpinnings for item banking and computer-adaptive assessment of HRQOL. Future research should emphasize prospectively designed studies to evaluate PRO measures within the MOT framework and in-depth investigations of the role of PRO measures in cancer decision making at all levels.
2001年，美国国立癌症研究所成立了癌症结局测量工作组（COMWG），以评估和推进患者报告结局（PRO）测量领域的科学现状，重点关注健康相关生活质量（HRQOL）。为指导其工作，COMWG采用了修订后的医学结局信托（MOT）属性以及评估健康状况和生活质量工具的评审标准。
以MOT属性为组织原则，本文总结了COMWG关于癌症患者HRQOL评估方法学合理性的关键发现，并从中得出推论，同时阐述了推动该领域发展所需的步骤。
在一系列癌症研究应用中，尤其是临床试验中，各种通用、一般癌症及特定癌症部位的HRQOL测量工具已证明具有足够的信度、效度、反应度、可行性以及文化和语言适应性。尽管在定义量表分数的“最小重要差异”方面已取得重大进展，但HRQOL测量工具的可解释性方面仍存在方法学挑战。在HRQOL测量工具中，概念模型与测量模型之间建立更紧密联系的工作仍任重道远。随着现代心理测量学，特别是项目反应理论模型的日益应用，所有MOT属性方面的进展可能会加速，项目反应理论模型为HRQOL的题库建设和计算机自适应评估提供了基础。未来的研究应强调前瞻性设计的研究，以在MOT框架内评估PRO测量工具，并深入研究PRO测量工具在各级癌症决策中的作用。
