PROMIS Fatigue short forms are reliable and valid in adults with rheumatoid arthritis

Abstract

Background Fatigue 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. Methods Adult 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). Results Two-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. Conclusions These 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.

Management of Fatigue in Rheumatoid Arthritis

“…A systematic review described 23 different fatigue tools which were published before Patient-Reported Outcomes Measurement Information System (PROMIS) was developed. 17 18 In their review, they concluded that ordinal (Likert) and VAS, the Short Form 36 vitality subscale, the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT), the RA-specific Multidimensional Assessment of Fatigue scale (MAF) and the Profile of Mood States were validated and seemed sensitive to change. 17 19 20 Some scales are generic, and others are disease specific.…”

“…Pain can lead to poor sleep, depressed mood and fatigue, all of which are connected. 6 18 28 31 32 Also, more than 10% of patients with RA have fibromyalgia 33 and 10% report depression in ERA. 26 Behavioural and psychological factors are more likely explanations of fatigue in RA and not disease activity.…”

Measures of Fatigue in Patients With Rheumatic Diseases: A Critical Review

“…In patients with RA, PROMIS Fatigue SF scores were strongly correlated with the RAND 36 Vitality and Fatigue NRS ( r ≥ 0.85). A range of strong correlations was also observed between the different PROMIS Fatigue SF scores ( r ≥ 0.91) .…”

“…On the seven‐item PROMIS SF, 1% had scores at the lowest level (29.4) and highest (83.2) level. On the eight‐item PROMIS SF, 6% were at the lowest level (33.1) and 7% at the highest level (77.7), whereas on the four‐item PROMIS SF, 7% scores were at the lowest level (33.7) and 10% were at the highest level (75.8), well below the threshold of 15% for evidence of floor and ceiling effects . On the 29‐item PROMIS SF in patients with RA, 5.5% were at the lowest (33.7) level and 9% were at the highest levels (75.8); in patients with OA, 1.9% were at the lowest level and 14.9% were at the highest level; in patients with FM, 17.5% were at the lowest level and 2.1% were at the highest level; and in patients with SLE, 7.7% were at the lowest level and 9.7% were at the highest level .…”

“…Cronbach's α showed evidence of adequate reliability at the individual level for the seven‐item PROMIS Fatigue SF (0.96) and eight‐item PROMIS Fatigue SF (0.95) and at the group level for the four‐item PROMIS Fatigue SF (0.84). ICCs between scales were 0.93 (95% CI 0.92‐0.95) for the seven‐item PROMIS Fatigue SF and the eight‐item PROMIS Fatigue SF, 0.91 (95% CI 0.90‐0.92) for the seven‐item PROMIS Fatigue SF and the 4‐item PROMIS Fatigue SF, and 0.98 (95% CI 0.98‐0.99) for the eight‐item PROMIS Fatigue SF and the four‐item PROMIS Fatigue SF .…”