Division of Rheumatology, University of Chicago, Chicago, IL, United States.
Division of Rheumatology and Clinical Immunology, University of Pittsburgh Medical Center, BST S 727, 3500 Terrace Street Pittsburgh, PA 15261, United States.
Semin Arthritis Rheum. 2021 Jun;51(3):539-546. doi: 10.1016/j.semarthrit.2021.03.018. Epub 2021 Apr 15.
Idiopathic inflammatory myopathies (IIM) are a group of diseases characterized by muscle weakness, which limit activities of daily living. Patient Reported Outcomes Measurement Information System (PROMIS) is a set of outcome measures developed using NIH funding, but has not yet been studied in adult IIM. Currently, the most commonly used PROs in IIM are Health Assessment Questionnaire (HAQ-DI) and SF-36 physical function-10 (PF10), both of which have several limitations. In this study, we investigated psychometric properties of PROMIS physical function-20 (PF-20) and compared to HAQ-DI and SF-36 PF10.
Patients with IIM completed PROMIS PF-20 and six myositis core set measures [manual muscle testing (MMT), physician (MD-GDA), patient (PT-GDA) and extra-muscular global disease activity, HAQ-DI and creatine kinase], SF-36 PF10 and functional tests [six-minute walk, timed up-and-go and sit-to-stand tests] at monthly visits over 6-months. Total improvement score (TIS) using 2016 ACR/EULAR myositis response criteria was obtained as measures of change.
Fifty patients [mean age, 51.6; 60% females] were enrolled; 6 PM, 24 DM, 9 NM and 11 with AS. PROMIS PF-20 showed strong test-retest reliability when repeated in 1-month. PROMIS PF-20 had moderate-strong correlations with MD-GDA, PT-GDA, MMT, HAQ-DI, SF-36 PF10, and functional tests indicating good convergent validity. Change in PROMIS PF-20 strongly correlated with TIS demonstrating good responsiveness. HAQ-DI and SF-36 PF10 exhibited similar validity and responsiveness; HAQ-DI was found to have a ceiling effect.
PROMIS PF-20 demonstrates favorable psychometric properties in a large cohort of myositis patients and offers distinct advantages.
特发性炎性肌病（IIM）是一组以肌肉无力为特征的疾病，这些肌肉无力限制了日常生活活动。患者报告结局测量信息系统（PROMIS）是一组使用 NIH 资金开发的结果测量工具，但尚未在成人 IIM 中进行研究。目前，IIM 中最常用的 PRO 是健康评估问卷（HAQ-DI）和 SF-36 生理功能-10（PF10），两者都有几个局限性。在这项研究中，我们研究了 PROMIS 生理功能-20（PF-20）的心理测量特性，并与 HAQ-DI 和 SF-36 PF10 进行了比较。
IIM 患者在 6 个月的时间内每月接受一次 PROMIS PF-20 和六项肌炎核心组测量（手动肌肉测试（MMT）、医生（MD-GDA）、患者（PT-GDA）和肌肉外整体疾病活动、HAQ-DI 和肌酸激酶）、SF-36 PF10 和功能测试（六分钟步行、计时上下和坐立起身测试）。使用 2016 年 ACR/EULAR 肌炎反应标准获得总改善评分（TIS）作为变化的测量值。
共纳入 50 名患者[平均年龄 51.6 岁；60%为女性]；6 名皮肌炎、24 名多发性肌炎、9 名无肌病性皮肌炎和 11 名包涵体肌炎。PROMIS PF-20 在一个月内重复时表现出良好的重测信度。PROMIS PF-20 与 MD-GDA、PT-GDA、MMT、HAQ-DI、SF-36 PF10 和功能测试均具有中度至强相关性，表明具有良好的聚合效度。PROMIS PF-20 的变化与 TIS 呈强相关，表明具有良好的反应性。HAQ-DI 和 SF-36 PF10 具有相似的有效性和反应性；HAQ-DI 存在天花板效应。
PROMIS PF-20 在肌炎患者的大样本中表现出良好的心理测量特性，并具有明显的优势。
