Responsiveness and meaningful thresholds of PROMIS pain interference, fatigue, and physical function forms in adults with idiopathic inflammatory myopathies: Report from the OMERACT Myositis Working Group.

Myopathy Myositis OMERACT Outcome measures PROMIS Psychometrics

Journal

Seminars in arthritis and rheumatism
ISSN: 1532-866X
Titre abrégé: Semin Arthritis Rheum
Pays: United States
ID NLM: 1306053

Informations de publication

Date de publication:
09 Dec 2023
Historique:
received: 27 08 2023
revised: 18 11 2023
accepted: 28 11 2023
medline: 24 12 2023
pubmed: 24 12 2023
entrez: 23 12 2023
Statut: aheadofprint

Résumé

A series of qualitative studies conducted by the OMERACT Myositis Working Group identified pain interference, fatigue, and physical function as highly important life impact domains for adults with idiopathic inflammatory myositis (IIM). In this study, our goal was to assess the responsiveness and minimal important difference of PROMIS pain interference (6a), fatigue (7a), and physical function (8b). Adults with IIM from USA, Netherlands, Korea, Sweden, and Australia with two "clinical" visits were enrolled in this prospective study. Anchor questions on a Likert scale were collected at baseline, and manual muscle testing (MMT), physician and patient reported global disease activity, and PROMIS instruments were collected at both visits. Responsiveness was assessed with i) ANOVA, ii) paired t-test, effect size and standardized response mean, and iii) Pearson correlation. Minimal important difference (MID), minimal important change (MIC) and minimal detectable change (MDC) values were calculated. 114 patients with IIM (median age 60, 60 % female) completed both visits. Changes in PROMIS instruments were significantly different among anchor categories. Patients who reported improvement had a significant improvement in their PROMIS scores with at least medium effect size, while patients who reported worsening and stability did not show a significant change with weak effect size. PROMIS instruments had weak to moderate correlations with MMT, patient and physician global disease activity. MID was approximately 2-3 points for Pain Interference and 3-4 points for Fatigue and Physical Function forms based on the method used. MIC was approximately 4-5 for improvement of all the instruments, while MDC was 1.7-2 points for Pain Interference and Physical Function and 3.2-3.9 for Fatigue. This study provides evidence towards the responsiveness of the PROMIS instruments in a large international prospective cohort of adults with IIM supporting their use as PROMs in adult myositis.

Sections du résumé

BACKGROUND BACKGROUND
A series of qualitative studies conducted by the OMERACT Myositis Working Group identified pain interference, fatigue, and physical function as highly important life impact domains for adults with idiopathic inflammatory myositis (IIM). In this study, our goal was to assess the responsiveness and minimal important difference of PROMIS pain interference (6a), fatigue (7a), and physical function (8b).
METHODS METHODS
Adults with IIM from USA, Netherlands, Korea, Sweden, and Australia with two "clinical" visits were enrolled in this prospective study. Anchor questions on a Likert scale were collected at baseline, and manual muscle testing (MMT), physician and patient reported global disease activity, and PROMIS instruments were collected at both visits. Responsiveness was assessed with i) ANOVA, ii) paired t-test, effect size and standardized response mean, and iii) Pearson correlation. Minimal important difference (MID), minimal important change (MIC) and minimal detectable change (MDC) values were calculated.
RESULTS RESULTS
114 patients with IIM (median age 60, 60 % female) completed both visits. Changes in PROMIS instruments were significantly different among anchor categories. Patients who reported improvement had a significant improvement in their PROMIS scores with at least medium effect size, while patients who reported worsening and stability did not show a significant change with weak effect size. PROMIS instruments had weak to moderate correlations with MMT, patient and physician global disease activity. MID was approximately 2-3 points for Pain Interference and 3-4 points for Fatigue and Physical Function forms based on the method used. MIC was approximately 4-5 for improvement of all the instruments, while MDC was 1.7-2 points for Pain Interference and Physical Function and 3.2-3.9 for Fatigue.
CONCLUSION CONCLUSIONS
This study provides evidence towards the responsiveness of the PROMIS instruments in a large international prospective cohort of adults with IIM supporting their use as PROMs in adult myositis.

Identifiants

DOI: 10.1016/j.semarthrit.2023.152339 PMID: 38141522
pubmed: 38141522
pii: S0049-0172(23)00181-6
doi: 10.1016/j.semarthrit.2023.152339
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

152339

Informations de copyright

Copyright © 2023. Published by Elsevier Inc.

Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: The authors declare no relevant competing interests except that L.J.M. and D.B. are paid staff members of OMERACT.

Auteurs

D Saygin (D)

Division of Rheumatology, Department of Medicine, University of Pittsburgh, Pittsburgh, USA.

D DiRenzo (D)

Division of Rheumatology, Department of Medicine, University of Pennsylvania, Philadelphia, USA.

J Raaphorst (J)

Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Netherlands.

I de Groot (I)

Patient Research Partner, Netherlands.

C O Bingham (CO)

Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, USA.

I E Lundberg (IE)

Division of Rheumatology, Department of Medicine, Solna, Karolinska Institutet, Karolinska University, Stockholm, Sweden.

M Regardt (M)

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.

C Sarver (C)

Patient Research Partner, USA.

M de Visser (M)

Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, the Netherlands.

L J Maxwell (LJ)

Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.

D Beaton (D)

Institute for Work & Health and Institute for Health Policy Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.

J Y Kim (JY)

Division of Rheumatology, Department of Internal Medicine, Seoul National University Hospital and College of Medicine, Seoul, Korea.

M Needham (M)

Department of Neurology, Fiona Stanley Hospital, IIID Murdoch University and University of Notre Dame, Perth, Australia.

H Alexanderson (H)

Medical Unit Occupational Therapy and Physical Therapy, Karolinska University Hospital and Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.

L Christopher-Stine (L)

Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, USA.

C A Mecoli (CA)

Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, USA.

J K Park (JK)

Division of Rheumatology, Department of Internal Medicine, Seoul National University Hospital and College of Medicine, Seoul, Korea. Electronic address: jinkyunpark@snu.ac.kr.

Classifications MeSH