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.Objective
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.Results and Conclusions
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 ldquo;minimum important differencerdquo; 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.