Search

Purpose: Fatigue is frequent and often severe and disabling in RA, and there is no consensus on how to measure it. We used online surveys and in-person interviews to evaluate PROMIS Fatigue 7a and 8a short forms (SFs) in people with RA.Methods: We recruited people with RA from an online patient community (n = 200) and three academic medical centers (n = 84) in the US. Participants completed both SFs then rated the comprehensiveness and comprehensibility of the items to their fatigue experience. Cognitive debriefing of items was conducted in a subset of 32 clinic patients. Descriptive statistics were calculated, and associations were evaluated using Pearson and Spearman correlation coefficients.Results: Mean SF scores were similar (p ≥ .61) among clinic patients reflecting mild fatigue (i.e., 54.5-55.9), but were significantly higher (p < .001) in online participants. SF Fatigue scores correlated highly (r ≥ 0.82; p < .000) and moderately with patient assessments of disease activity (r ≥ 0.62; p = .000). Most (70-92%) reported that the items "completely" or "mostly" reflected their experience. Almost all (≥ 94%) could distinguish general fatigue from RA fatigue. Most (≥ 85%) rated individual items questions as "somewhat" or "very relevant" to their fatigue experience, averaged their fatigue over the past 7 days (58%), and rated fatigue impact versus severity (72 vs. 19%). 99% rated fatigue as an important symptom they considered when deciding how well their current treatment was controlling their RA.Conclusions: Results suggest that items in the single-score PROMIS Fatigue SFs demonstrate content validity and can adequately capture the wide range of fatigue experiences of people with RA. [ABSTRACT FROM AUTHOR]

While the use of PROs in research is well established, many challenges lie ahead as their use is extended to other applications. There is consensus that health outcome evaluations that include PROs along with clinician-reported outcomes and administrative data are necessary to inform clinical and policy decisions. The initiatives presented in this paper underline evolving recognition that PROs play a unique role in adding the patient perspective alongside clinical (e.g., blood pressure) and organizational (e.g., admission rates) indicators for evaluating the effects of new products, selecting treatments, evaluating quality of care, and monitoring the health of the population. In this paper, we first explore the use of PRO measures to support drug approval and labeling claims. We critically evaluate the evidence and challenges associated with using PRO measures to improve healthcare delivery at individual and population levels. We further discuss the challenges associated with selecting from the abundance of measures available, opportunities afforded by agreeing on common metrics for constructs of interest, and the importance of establishing an evidence base that supports integrating PRO measures across the healthcare system to improve outcomes. We conclude that the integration of PROs as a key end point within individual patient care, healthcare organization and program performance evaluations, and population surveillance will be essential for evaluating whether increased healthcare expenditure is translating into better health outcomes. [ABSTRACT FROM AUTHOR]

To examine the effect of treatment-induced weight loss on Health-Related Quality of Life (HRQL), 38 mildly-to-moderately overweight persons recruited to participate in a study to examine the efficacy of a lifestyle modification treatment program completed a sociodemographic questionnaire, the Beck Depression Inventory (BDI), the Medical Outcomes Study Short-Form Health Survey (SF-36, as an assessment of HRQL), and underwent a series of clinical evaluations prior to treatment. After baseline evaluations, participants were randomly assigned to either a program of lifestyle physical activity or a program of traditional aerobic activity. Participants again completed the SF-36 and BDI after the 13-week treatment program had ended. Weight loss averaged 8.6 +/- 2.8 kg over the 13-week study. We found that weight loss was associated with significantly higher scores (enhanced HRQL), relative to baseline, on the physical functioning, role-physical, general health, vitality and mental health domains of the SF-36. The largest improvements were with respect to the vitality, general health perception and role-physical domains. There were no significant differences between the lifestyle and aerobic activity groups on any of the study measures. These data indicate that, at least in the short-term, weight loss appears to profoundly enhance HRQL. [ABSTRACT FROM AUTHOR]