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

Dana DiRenzo; Didem Saygin; Ingrid de Groot; Clifton O Bingham Iii; Ingrid E Lundberg; Merrilee Needham; Jin Kyun Park; Malin Regardt; Catherine Sarver; Yeong Wook Song; Lara Maxwell; Dorcas Beaton; Marianne de Visser; Lisa Christopher-Stine; Christopher A Mecoli; Helene Alexanderson

doi:10.1016/j.semarthrit.2022.152111

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

Semin Arthritis Rheum. 2023 Feb:58:152111. doi: 10.1016/j.semarthrit.2022.152111. Epub 2022 Nov 3.

Authors

Dana DiRenzo¹, Didem Saygin², Ingrid de Groot³, Clifton O Bingham Iii⁴, Ingrid E Lundberg⁵, Merrilee Needham⁶, Jin Kyun Park⁷, Malin Regardt⁸, Catherine Sarver⁹, Yeong Wook Song¹⁰, Lara Maxwell¹¹, Dorcas Beaton¹², Marianne de Visser¹³, Lisa Christopher-Stine⁴, Christopher A Mecoli¹⁴, Helene Alexanderson¹⁵

Affiliations

¹ Division of Rheumatology, Department of Medicine, University of Pennsylvania, USA.
² Division of Rheumatology, Department of Medicine, University of Chicago, USA.
³ Patient Research Partner, the Netherlands.
⁴ Division of Rheumatology, Department of Medicine, Johns Hopkins University, USA.
⁵ Division of Rheumatology, Department of Medicine, Karolinska Institutet, Karolinska University, Solna, Stockholm, Sweden.
⁶ Dept Neurology, Fiona Stanley Hospital, IIID Murdoch University and University of Notre Dame, Perth, Australia.
⁷ Division of Rheumatology, Department of Internal Medicine, Seoul National University Hospital and College of Medicine, Seoul, Korea.
⁸ Occupational Therapist, Department of Neurobiology, Care Sciences and Society, Division of Occupational Therapy, Karolinska Institutet and Medical Unit Occupational Therapy and Physical Therapy, Karolinska University Hospital, Stockholm, Sweden.
⁹ Patient Research Partner, USA.
¹⁰ Division of Rheumatology, Department of Internal Medicine, Medical Research Center, College of Medicine, Department of Molecular Medicine and Biopharmaceutical Sciences, Seoul National University.
¹¹ Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.
¹² Institute for Work & Health and Institute for Health Policy Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.
¹³ Department of Neurology, Amsterdam University Medical Centers, location Academic Medical Center, University of Amsterdam, the Netherlands.
¹⁴ Division of Rheumatology, Department of Medicine, Johns Hopkins University, USA. Electronic address: cmecoli1@jhmi.edu.
¹⁵ Physiotherapist, Medical Unit Occupational Therapy and Physical Therapy, Karolinska University Hospital and Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.

Abstract

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.

Publication types

Research Support, Non-U.S. Gov't
Research Support, N.I.H., Extramural

MeSH terms

Adult
Fatigue / etiology
Humans
Myositis* / complications
Pain / etiology
Patient Reported Outcome Measures*
Quality of Life
Reproducibility of Results
Surveys and Questionnaires

Abstract

Publication types

MeSH terms

Grants and funding