Reliability and validity of PROMIS physical function, pain interference, and fatigue as patient reported outcome measures in adult idiopathic inflammatory myopathies: International study from the OMERACT myositis working group

• Published in: Seminars in arthritis and rheumatism Vol. 58; p. 152111
• Main Authors: DiRenzo, Dana, Saygin, Didem, de Groot, Ingrid, Bingham III, Clifton O., Lundberg, Ingrid E., Needham, Merrilee, Park, Jin Kyun, Regardt, Malin, Sarver, Catherine, Song, Yeong Wook, Maxwell, Lara, Beaton, Dorcas, de Visser, Marianne, Christopher-Stine, Lisa, Mecoli, Christopher A., Alexanderson, Helene
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.02.2023
• Subjects: Adult; Fatigue - etiology; Humans; Myositis - complications; Pain - etiology; Patient Reported Outcome Measures; Quality of Life; Reproducibility of Results; Surveys and Questionnaires
• ISSN: 0049-0172; 1532-866X; 1532-866X
• DOI: 10.1016/j.semarthrit.2022.152111

Pain interference, fatigue, and impaired physical function are common features of idiopathic inflammatory myopathies (IIM). The objective of this study was to evaluate the construct validity and test-retest reliability of the Patient Reported Outcome Information System (PROMIS) Pain Interference 6av1.0, Fatigue 7av1.0, and Physical Function 8bv2.0 instruments. Patient-Reported Outcome Measures (PROMs) were deployed to adult IIM patients from OMERACT Myositis Working Group (MWG) international clinic sites via two online surveys (2019, 2021). Internal consistency of each PROM was analyzed by Cronbach's α. Construct validity was determined by a priori hypotheses generated by the MWG with >75% agreement for each hypothesis and calculated with Pearson correlations. Test-retest reliability was assessed using intraclass correlation coefficient with PROMIS instruments administered at time zero and 7 days. Surveys were sent to 368 participants in total; participants who completed each questionnaire varied (n=65 to 263). For construct validity, 10 out of 13 a priori hypotheses were met supporting construct validity of PROMIS instruments (Pain Interference 3/4, fatigue 4/4, and Physical Function 3/5). Test-retest reliability was strong for all PROMIS instruments. All PROMIS instruments demonstrated excellent internal consistency. None of the measures demonstrated any ceiling or floor effects except for a ceiling effect in the Pain Interference instrument. This study presents test-retest reliability and construct validity evidence supporting PROMIS Pain Interference (6a v1.0), Fatigue (7a v1.0), and Physical Function (8b v2.0) using a large international cohort of patients with IIM. Internal consistency of these instruments was excellent. A ceiling effect was noted in the Pain Interference instrument.