J.L. Beaumont, MS, Clinical Outcomes Solutions, Tucson, Arizona.
E.S. Davis, MS, Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama.
J Rheumatol. 2021 Aug;48(8):1239-1242. doi: 10.3899/jrheum.200990. Epub 2021 Mar 15.
We estimated meaningful change thresholds (MCTs) for Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue and Pain Interference in rheumatoid arthritis (RA).
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."
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.
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.
我们估计了患者报告的结局测量信息系统（PROMIS）疲劳和疼痛干扰在类风湿关节炎（RA）中的有意义变化阈值（MCT）。
在关节炎、风湿病和老龄化医学信息系统（ARAMIS）队列中，对 521 名 RA 患者的几种患者报告的结局（PRO）的反应性进行了评估。在基线、6 个月和 12 个月时，使用 PROMIS 疲劳（7 项）和疼痛干扰（6 项）短表进行测量。在 6 个月和 12 个月的随访中，获得了自我报告的过去 6 个月的回顾性变化（好很多/差很多、好一点/差一点、保持不变）。我们使用将变化评为“好一点”或“差一点”的患者的 PROMIS 评分的平均变化来估计 MCT。
基线疲劳和疼痛干扰评分接近正常（中位数分别为 54 和 56）。在 6 个月时，有 7.9%的患者报告他们的疲劳比基线时“好一点”（平均变化[标准差]：-2.6[4.8]），有 22.8%的患者“差一点”（1.7[5.6]）。有 11.5%的患者的疼痛“好一点”（-1.9[6.1]），有 24.2%的患者“差一点”（0.6[5.7]）。在 12 个月时，结果相似。因此，疲劳和疼痛干扰的 MCT 范围均为 1-2 分。变化得分与回顾性评分之间的相关性较低（0.13-0.29），表明 MCT 可能被低估。
PROMIS 疲劳和疼痛干扰的组级 MCT 约为 2-3 分，对应于较小的效应量，这与先前表明 PROMIS 身体功能的 MCT 为 2 分的工作一致。
