Advances in Patient Reported Outcomes: The NIH PROMIS Measures

Abstract

Patient-reported outcomes (PRO) are questionnaire measures of patients’ symptoms, functioning, and health-related quality of life. They are designed to provide important clinical information that generally cannot be captured with objective medical testing. In 2004, the National Institutes of Health launched a research initiative to improve the clinical research enterprise by developing state-of-the-art PROs. The NIH Patient-Reported Outcomes Measurement System (PROMIS) and Assessment Center are the products of that initiative. Adult, pediatric, and parent-proxy item banks have been developed by using contemporary psychometric methods, yielding rapid, accurate measurements. PROMIS currently provides tools for assessing physical, mental, and social health using short-form and computer-adaptive testing methods. The PROMIS tools are being adopted for use in clinical trials and translational research. They are also being introduced in clinical medicine to assess a broad range of disease outcomes. Recent legislative developments in the United States support greater efforts to include patients’ reports of health experience in order to evaluate treatment outcomes, engage in shared decision-making, and prioritize the focus of treatment. PROs have garnered increased attention by the Food and Drug Administration (FDA) for evaluating drugs and medical devices. Recent calls for comparative effectiveness research favor inclusion of PROs. PROs could also potentially improve quality of care and disease outcomes, provide patient-centered assessment for comparative effectiveness research, and enable a common metric for tracking outcomes across providers and medical systems.

Feasibility and diagnostic accuracy of the Patient‐Reported Outcomes Measurement Information System (PROMIS) item banks for routine surveillance of sleep and fatigue problems in ambulatory cancer care

“…[15][16][17][18][19][20] minutes per patient to complete all measures, feasibility survey and demographic data. We did not have separate data on time to completion of PROMIS items alone but other studies suggest an average of two minutes for completion of PROMIS CAT item banks for an average of 4-8 items, 36 which aligns with our average number of items to complete PROMIS CATs. Figure 1 shows the various patient preferences regarding the burden, use, and acceptability of routine screening.…”

“…29 and routine cancer care in the Canadian cancer system. 33 The uptake of PROMIS measures for routine clinical care has been hampered by a number of logistical concerns including: computation of T-scores in "real time" as part of routine care, interpretation of the meaning of T-scores and change in these scores for clinical decision-making, and a lack of understanding and confidence in IRT methods and how they compare to legacy measures [34][35][36] .…”

Higher Frequency of Reoperation With a New Bicruciate-retaining Total Knee Arthroplasty

“…The PF-CAT is based on modern psychometric techniques using item response theory, which has been used in the educational field to optimize test administration for decades by reducing time constraints to the participant, test length, data entry errors, and organizational cost while preserving data efficacy [3,4]. The PF-CAT includes a total of 124 physical function items across five categories related to activities of daily living and the Global10 is a 10-item instrument representing five primary domains (physical functioning, pain, fatigue, emotional distress, social health) with cutoffs across domains [4,5,10].…”

Clinimetric Dilemmas in Outcome Scales for Mental Disorders

“…The items in the PROMIS have undergone a careful evaluation for unidimensionality. The items in the various domains are considered as item banks from which the user can select his or her scale [27]. …”