In a process involving hundreds of scientists in 2002, the National Institutes of Health (NIH) identified high-priority scientific opportunities and needs the agency should pursue. Criteria used to identify the most important initiatives included: goals that could not be accomplished by a single institute, but were the responsibility of the NIH as a whole; initiatives that the NIH could not afford not to do; initiatives that no other entity could or would do; and initiatives that would transform biomedical research. This “Roadmap for Medical Research” included, as 1 of 3 major theme areas, the goal of “re-engineering the clinical research enterprise.” Initiatives developed under this roadmap theme are intended to facilitate and enhance clinical research in numerous ways, including promoting integration of clinical research networks, harmonizing regulatory processes, revolutionizing clinical research training, and developing technologies to improve clinical outcomes assessment. This supplemental issue of Medical Care describes the last of these initiatives, the Patient-Reported Outcomes Measurement Information System (PROMIS)—its rationale, the funded network, and the network’s conceptual, analytic, empirical work, and goals. One clinical research issue highlighted by the roadmap process was the need for more valid, reliable, and generalizable measures of clinical outcomes that are important to patients. Conventional measures of disease status do not fully capture the ways that chronic diseases and their treatment affect individuals. Many aspects of patients’ subjective experience, such as symptom severity and frequency, emotional and social wellbeing, and perceived level of health and functional ability, are important targets for disease intervention. Measurement of patient-reported outcomes (PROs) is particularly important in clinical trials, where laboratory or imaging results may not translate into important benefit to patients, or in trials where 2 treatments may be comparably effective, but have different adverse-effect profiles that differentially affect symptoms, functioning, or other aspects of patients’ quality of life. The identified need for improved PRO measurement engendered an NIH request for applications to develop a validated, dynamic system to measure PROs efficiently in study participants with a wide range of chronic diseases and demographic characteristics. The intent was to create a collaborative group of funded investigators that would take advantage of computer technologies and advances in modern measurement theory to develop an improved tool for measuring PROs. The broad objectives outlined in the request for applications were to: (1) develop and test a large bank of items measuring PROs; (2) create a computerized adaptive testing system that will allow for efficient, psychometrically robust assessment of PROs in clinical research on a wide range of chronic diseases; and (3) create a publicly-available system that can be added to and modified periodically, and that will allow researchers to access a common item repository and a computerized adaptive test (CAT).
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