Evaluating and improving methods for measuring cancer outcomes is critically important for NCI's initiatives to enhance the quality of cancer care, reduce
cancer-related health disparities, and better understand the burden of disease on individuals and populations. To assess the current state of the science
and to identify priorities for future research and practice, the Applied Research Program (ARP)'s Outcomes Research Branch (ORB) created the Cancer Outcomes Measurement Working Group (COMWG) to evaluate existing endpoint
measures and formulate alternative strategies for valid, reliable, sensitive, and feasible clinical and patient-centered endpoint measures. These measures
include health-related quality of life, satisfaction with patient care and health system performance, and the economic burden of cancer. COMWG focuses on
the four major disease sites (breast, prostate, colorectal, and lung) across the entire continuum of care.
Another focus of COMWG is improving outcomes measurement through the use of improved statistical methods for identifying clinically meaningful differences and accounting for missing data, and through the tools provided by the field of psychometrics. The Applied Research Program has created tutorials and provided references for researchers to learn about psychometric tools and other tools to aid in assessing and developing outcomes measures. Questionnaire Design and Testing provides more information on psychometric tools.
Another key ORB-supported initiative is the trans-NIH Patient-Reported Outcomes Measurement Information System (PROMIS), a publicly available Web-based resource that can be used to measure key health symptoms and health-related quality of life domains such as pain, fatigue, depression, and physical function. These domains are relevant to a variety of chronic diseases, including cancer. ORB staff are actively involved on the PROMIS project with representation on the PROMIS Network Steering Committee and scientific contributions to the development of cancer-specific HRQOL domains and development of the analytic plan.
The Patient-Reported Outcomes version of the Common Terminology Criteria (PRO-CTCAE) is an ORB-supported project that is developing an electronic-based system for patient self-reporting of symptom adverse events (AEs) listed in th CTCAE, with the goal of improving the grading accuracy and precision of this class of AEs. The accurate reporting of AEs that occur to patients on clinical trials is a federal requirement that facilitates evaluation of new therapies.