News from the NIH: Person-centered outcomes measurement: NIH-supported measurement systems to evaluate self-assessed health, functional performance, and symptomatic toxicity

Excerpt

There is rapidly growing interest in the capture of person-centered outcomes in clinical and population-based research and in healthcare delivery settings. Stakeholders (e.g., patients, clinicians, payers, regulators, researchers) increasingly agree that person-centered outcome measurement can accelerate the development of new knowledge, improve the efficiency and quality of care, and may also contribute to clinician or health system performance metrics and regulatory review of new therapies [1‐3]. These outcomes may be incorporated into both observational studies and clinical trials, and provide salient endpoints in trials of preventive or disease-modifying treatments, as well as behavioral or psychosocial interventions. Over the past decade, the National Institutes of Health (NIH) has invested in the development and evaluation of several measurement systems that are now available for research and clinical use. These include the Patient Reported Outcomes Measurement Information System^® (PROMIS^®) [4], the NIH Toolbox for Assessment of Neurological and Behavioral Function (NIH Toolbox^®) [5], the Quality of Life Outcomes in Neurological Disorders (Neuro-QoL) [6], Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) [7], and the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [8]. In this paper, we (i) describe each system; (ii) highlight considerations in the design and interpretation of studies that employ one or more of these systems; and (iii) summarize future directions for continued implementation of these systems in clinical practice, population-based research, observational studies, and clinical trials. …