Jennifer L Beaumont1, Elizabeth S Davis1, Jeffrey R Curtis1, David Cella1, Huifeng Yun1. 1. J.L. Beaumont, MS, Clinical Outcomes Solutions, Tucson, Arizona; E.S. Davis, MS, Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama; J.R. Curtis, MD, MS, MPH, Division of Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama; D. Cella, PhD, Northwestern University Feinberg School of Medicine, Chicago, Illinois; H. Yun, PhD, Department of Epidemiology, and Division of Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA. The authors declare no conflicts of interest relevant to this article. Address correspondence to Dr. H. Yun, Department of Epidemiology, 230H Ryals Public Health Building, University Blvd, University of Alabama at Birmingham, AL 35294, USA. Email: yunn@uab.edu. Accepted for publication February 24, 2021.
Abstract
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 patients with RA 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]) and 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 underestimation of 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 an MCT of 2 points for PROMIS Physical Functioning.
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 patients with RA 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]) and 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 underestimation of 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 an MCT of 2 points for PROMIS Physical Functioning.
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