TY - JOUR
T1 - Reliability and validity of PROMIS physical function, pain interference, and fatigue as patient reported outcome measures in adult idiopathic inflammatory myopathies
T2 - International study from the OMERACT myositis working group
AU - DiRenzo, Dana
AU - Saygin, Didem
AU - de Groot, Ingrid
AU - Bingham III, Clifton O.
AU - Lundberg, Ingrid E.
AU - Needham, Merrilee
AU - Park, Jin Kyun
AU - Regardt, Malin
AU - Sarver, Catherine
AU - Song, Yeong Wook
AU - Maxwell, Lara
AU - Beaton, Dorcas
AU - de Visser, Marianne
AU - Christopher-Stine, Lisa
AU - Mecoli, Christopher A.
AU - Alexanderson, Helene
N1 - Funding Information: Portions of the work have been supported by the Rheumatic Diseases Research Core Center (P30-AR053503/AR070254) Core B from the National Institutes of Arthritis Musculoskeletal and Skin Diseases (NIAMS) of the National Institutes of Health (NIH). D.D. was supported through T32-AR048522. C.M. is supported by The Johns Hopkins Clinician Scientist Award, the Jerome L. Greene Foundation, and K23 AR075898-01. Dr. Christopher-Stine's work has been supported in part through the Huayi and Siuling Zhang Discovery Fund. Portions of the work have been supported by NuFactor, OptionCare, BioRx, Soleo Health, Walgreens, and US Bioservices. Dr. Alexanderson, Dr. Regardt and Dr Lundberg are supported by the Swedish Rheumatism Association. Funding from OMERACT which receives unrestricted funds from over 23 clinical research and pharmaceutical companies. Publisher Copyright: © 2022 Elsevier Inc.
PY - 2023/2/1
Y1 - 2023/2/1
N2 - Objective: 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. Methods: 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. Results: 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. Conclusions: 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.
AB - Objective: 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. Methods: 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. Results: 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. Conclusions: 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.
UR - http://www.scopus.com/inward/record.url?scp=85142148602&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.semarthrit.2022.152111
DO - https://doi.org/10.1016/j.semarthrit.2022.152111
M3 - Article
C2 - 36410180
SN - 0049-0172
VL - 58
JO - Seminars in Arthritis and Rheumatism
JF - Seminars in Arthritis and Rheumatism
M1 - 152111
ER -