Meaningful change thresholds for Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue and pain interference scores in patients with rheumatoid arthritis

Objective We estimated meaningful change thresholds (MCTs) for Patient-Reported Outcomes Measurement Information System (PROMIS®) Fatigue and Pain Interference in rheumatoid arthritis (RA).

Methods The responsiveness of several patient-reported outcomes (PROs) was assessed among 521 RA patients in the Arthritis, Rheumatism, and Aging Medical Information Systems (ARAMIS) cohort. PROMIS Fatigue (7 item) and Pain Interference (6 item) short form instruments were administered at baseline, 6 months, and 12 months. Self-reported retrospective changes over the previous 6 months (a lot better/worse, a little better/worse, stayed the same) were obtained at 6 and 12 months follow-up. We estimated MCTs using the mean change in PROMIS scores for patients who rated their change ‘a little better’ or ‘a little worse.’

Results Baseline fatigue and pain interference scores were near normal (median 54 and 56, respectively). At 6 months, 7.9% of patients reported their fatigue was a little better compared to baseline (mean change [SD]: -2.6 [4.8]), 22.8% a little worse (1.7 [5.6]). Pain was a little better for 11.5% of patients (-1.9 [6.1]) and a little worse for 24.2% of patients (0.6 [5.7]). At 12 months, results were similar. Thus, the MCT range was 1-2 points for both Fatigue and Pain Interference. Correlations between change scores and retrospective ratings were low (0.13-0.29), indicating possible underestimate for MCT.

Conclusion The group-level MCT for PROMIS Fatigue and Pain Interference is roughly 2-3 points and corresponds to a small effect size, which is consistent with earlier work demonstrating a MCT of 2 points for PROMIS Physical Functioning.