Abstract

BackgroundFatigue is prevalent and impactful in rheumatoid arthritis (RA). There is no standardized measure for its assessment nor data concerning the performance of PROMIS-Fatigue short forms (SFs) in people with RA. We evaluated the construct validity of 4-, 7-, and 8-item PROMIS-Fatigue SFs in RA patients across the range of disease activity.MethodsAdult RA patients were recruited from an online patient community and an observational cohort from three academic medical centers. Measures included PROMIS-Fatigue SFs, other PROMIS measures, and other patient reported outcomes including RAND-36 Vitality, Fatigue NRS, and patient global assessment of disease activity. Other measures from the observational cohort included 28-joint swollen and tender joints, physician global assessment, and the composite RA clinical disease activity index (CDAI).ResultsTwo-hundred online participants and 348 participants from the observational cohort were included. PROMIS Fatigue SF scores spanned the measurement continuum and correlated highly with each other (r’s ≥ 0.91) and other fatigue measures (r’s ≥ 0.85). PROMIS-Fatigue SF scores were highly and inversely associated with Physical Function and Participation (r’s − 0.77 to − 0.78), and moderately-highly and positively correlated with pain, sleep disturbance, anxiety, and depression (r’s 0.60 to 0.75). PROMIS-Fatigue SF scores showed dose-response relationships across fatigue severity descriptors and CDAI categories.ConclusionsThese results provide robust evidence supporting the construct validity of the 4, 7, and 8-item PROMIS-Fatigue SFs. They capture fatigue across the spectrum of RA disease activity in diverse groups of individuals and should be considered for use as patient-centered assessments of disease control and treatment efficacy.

Highlights

  • Fatigue is prevalent and impactful in rheumatoid arthritis (RA)

  • We have previously shown that PROMIS Fatigue short forms (SFs) items are understood and meaningful to people with RA [13]

  • Scores on the three PROMIS SFs showed evidence of adequate reliability at the group level and correlated highly with each other, with legacy fatigue measures, and with other PROMs that reflect disease activity supporting construct validity. These results are consistent with our earlier work where we evaluated the performance of PROMIS-Fatigue Computer-adaptive testing (CAT) in relation to legacy fatigue scales and other PROMS, and our debriefing studies that showed the Fatigue items were easy to understand and relevant to people with RA [13]

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Summary

Introduction

Fatigue is prevalent and impactful in rheumatoid arthritis (RA). We evaluated the construct validity of 4-, 7-, and 8-item PROMIS-Fatigue SFs in RA patients across the range of disease activity. Fatigue in rheumatoid arthritis (RA) is a prevalent symptom that greatly impacts day-to-day function and quality of life [1, 2]. Fatigue experienced by patients with RA encompasses a broad spectrum, ranging from mild tiredness to an overwhelming, pervasive state of exhaustion that greatly impacts physical, emotional, and social function and quality of life. Existing patient-reported outcome measures (PROMs) range from single item rating scales to multidimensional assessments, with no consensus on the optimal approach to fatigue assessment [6,7,8]. The NIH-developed Patient Reported Outcomes Measurement Information System (PROMIS®) fatigue measures have been shown to have robust psychometric properties across multiple chronic conditions minimally studied in RA [9,10,11,12]

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