Objective To present an overview of a series of studies in which the clinical validity of the National Institutes of Health’s Patient Reported Outcome Measurement Information System (NIH; PROMIS) measures was evaluated, by domain, across six clinical populations. Study Design and Setting Approximately 1,500 individuals at baseline and 1,300 at follow-up completed PROMIS measures. The analyses reported in this issue were conducted post hoc, pooling data across six previous studies, and accommodating the different designs of the six, within-condition, parent studies. Changes in T-scores, standardized response means, and effect sizes were calculated in each study. When a parent study design allowed, known groups validity was calculated using a linear mixed model. Results The results provide substantial support for the clinical validity of nine PROMIS measures in a range of chronic conditions. Conclusion The cross-condition focus of the analyses provided a unique and multifaceted perspective on how PROMIS measures function in “real-world” clinical settings and provides external anchors that can support comparative effectiveness research. The current body of clinical validity evidence for the nine PROMIS measures indicates the success of NIH PROMIS in developing measures that are effective across a range of chronic conditions.

The National Quality Forum (NQF), a national organization that has been deeply involved in moving the quality-improvement agenda forward for many years (http://www.qualityforum.org), endorses and promulgates quality-ofcare and performance measures that various provider groups, regulatory agencies, payers and insurers, and others can use for accountability and quality improvement activities. In 2012 and 2013, the organization began an initiative to find PROs that might be added to its extensive collection of performance measures. Its National Voluntary Consensus Standards for Patient Outcomes: A Consensus Report defined outcomes as being important because they "reflect the reason that an individual seeks healthcare services. " 1 The individual patient's voice in many performance measures, however, has largely been missing. Few ways to assess performance are available at the organizational level, even though patients are often the best able to report on the experiences and results of their individual care.To fill that gap, NQF convened an expert panel at two public meetings and, as background for its deliberations, commissioned two authoritative background papers. This monograph is a revised and updated version of the first of these two papers, which provided the background on issues about selecting PROs for use in a variety of applications pertinent to the NQF mission and activities. The second paper, Patient-Reported Outcomes in Performance Measurement, 9 dealt with issues relating to processes for endorsing performance measures that reflect the end results (ultimate outcomes) of health care. Its primary focus was on accountable health care organizations.This monograph applies the conceptual and organizational frameworks that NQF has pioneered in the past decade or so. NQF distinguishes PROs, patientreported outcome measures (or PROMs), and patient-reported outcome performance measures (or PRO-PMs). NQF endorses PRO-PMs through transparent and consensus-based procedures. This monograph addresses the PROs that are likely to be used to inform PRO measures (PROMs) that would underpin scientifically acceptable and feasible performance measures. We do not address issues with identifying, evaluating, or endorsing PRO-PMs for health care organizations or clinicians. Key Concept DefinitionPatient A person who is receiving health care services or using long-term health care support services. Patientreported outcome (PRO)Any information on the outcomes of health care obtained directly from patients without modification by clinicians or other health care professionals. For purposes of this monograph, we use this term broadly to include any patient input, whether or not it is standardized or gathered with a structured questionnaire. Patientreported outcome measure (PROM)Any standardized or structured questionnaire regarding the status of a patient's health condition, health behavior, or experience with health care that comes directly from the patient (i.e., a PRO). The use of a structured, standardized tool such as a PROM wi...

Objective To evaluate the validity of the PROMIS® Physical Function measures using longitudinal data collected in six chronic health conditions. Study Design and Setting Individuals with rheumatoid arthritis (RA), major depressive disorder (MDD), back pain, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF), and cancer completed the PROMIS Physical Function computerized adaptive test (CAT) or fixed-length short form (SF) at baseline and at the end of clinically-relevant follow-up intervals. Anchor items were also administered to assess change in physical function and general health. Linear mixed effects models and standardized response means were estimated at baseline and follow-up. Results 1415 individuals participated (COPD n = 121; CHF n = 57; back pain n = 218; MDD n = 196, RA n = 521; cancer n = 302). The PROMIS Physical Function scores improved significantly for treatment of CHF and back pain patients, but not for patients with MDD or COPD. Most of the patient subsamples that reported improvement or worsening on the anchors showed a corresponding positive or negative change in PROMIS Physical Function. Conclusion This study provides evidence that the PROMIS Physical Function measures are sensitive to change in intervention studies where physical function is expected to change and able to distinguish among different clinical samples. The results inform the estimation of meaningful change, enabling comparative effectiveness research.

Objective To evaluate the comparability and responsiveness of PROMIS Fatigue Item Bank across six chronic conditions. Study Design and Setting Individuals (n=1,430) with chronic obstructive pulmonary disease (COPD; n=125), chronic heart failure (CHF; n=60), chronic back pain (n=218), major depressive disorder (MDD; n=196), rheumatoid arthritis (RA; n=521), and cancer(n=310) completed assessments from the PROMIS fatigue item bank at baseline and a clinically-relevant follow-up. The cancer and arthritis samples were followed in observational studies; the other four groups were enrolled immediately prior to a planned clinical intervention. All participants completed global ratings of change at follow-up. Linear mixed effects models and standardized response means were estimated to examine clinical validity and responsiveness to change. Results All patient groups reported more fatigue than the general population (range = 0.2 – 1.29 SD worse). The four clinical groups with pre-treatment baseline data experienced significant improvement in fatigue at follow-up (effect size range= 0.25 to 0.91). Individuals reporting better overall health usually experienced larger fatigue changes than those reporting worse overall health. Conclusion The results support the PROMIS fatigue measures’s responsiveness to change in six different chronic conditions. In addition, these results support the ability of the PROMIS fatigue measures to compare differences in fatigue across a range of chronic conditions, thereby enabling comparative effectiveness research.

The FACT-Leu scale is a valid, reliable, and efficient measure of leukemia-specific health-related quality of life for acute and chronic disease.