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Abstract Number: 2913

A Draft Modified Core Domain Set for Patient-Reported Outcomes (PRO) in Patients with Idiopathic Inflammatory Myopathies (IIM): An Omeract Report

Malin Regardt1,2, Christopher A. Mecoli3,4,5, Jin Kyun Park6,7,8,9,10,11,12,13,14, Merrilee Needham15, Ingrid De Groot16, Catherine Sarver17, Ingrid E. Lundberg18, Beverly Shea19, Marianne De Visser20, Yeong Wook Song13, Clifton O. Bingham III21, Lisa Christopher-Stine22,23,24 and Helene Alexanderson25, 1Learning, Informatics,Management and Ethics, Karolinska institutet, Stockholm, Sweden, 2Function Area Occupational Therapy and Physical Therapy, Karolinska University Hospital, Stockholm, Sweden, 3Johns Hopkins University School of Medicine, Baltimore, MD, 4Internal Medicine/Rheumatology, Johns Hopkins University, Baltimore, MD, 5Rheumatology, Johns Hopkins University, Baltimore, MD, 6Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea, Republic of (South), 7Division of Rheumatology, Seoul National University Hospital, Seoul, Korea, Republic of (South), 8Department of Molecular medicine and biopharmaceutical science, Seoul National University, seoul, Korea, Republic of (South), 9Division of Rheumatology, Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea, Republic of (South), 10[email protected], Division of Rheumatology, Seoul National University Hospital, Seoul, Korea, Republic of (South), 11Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea, Republic of (South), 12Division of Rheumatology, Department of Internal Medicine, Seoul National University, Seoul, Korea, Republic of (South), 13Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, and College of Medicine, Seoul National University, Seoul, Korea, Republic of (South), 14Department of Molecular Medicine and Biopharmaceutical Sciences, BK21 plus Graduate School of Convergence Science and Technology, and College of Medicine or College of Pharmacy, Seoul National University, Seoul, Korea, Republic of (South), 15Murdoch University, Perth, Australia, 16patient research partner, Rotterdam, Netherlands, 17patient research partner, maryland, MD, 18Department of Medicine, Division of Rheumatology, Karolinska Institutet, Stockholm, Sweden, 19Bruyere Research Institute, Ottawa, ON, Canada, 20Department of Neurology, Academic Medical Centre, Amsterdam, Netherlands, 21Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, 22Ste 4100 Rm 409, Johns Hopkins University School of Medicine, Baltimore, MD, 23Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 24Medicine and Neurology, Johns Hopkins University, Baltimore, MD, 25Department of NVS, Division of Physical Therapy, Karolinska Institutet, Huddinge, Sweden

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Idiopathic Inflammatory Myopathies (IIM), outcome measures and patient outcomes

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Session Information

Date: Wednesday, October 24, 2018

Session Title: 6W007 ACR Abstract: Patient Outcomes, Preferences, & Attitudes II: PROs (2910–2915)

Session Type: ACR Concurrent Abstract Session

Session Time: 9:00AM-10:30AM

A Draft Modified Core Domain Set for Patient-Reported Outcomes (PRO) in Patients with Idiopathic Inflammatory Myopathies (IIM): An OMERACT Report

Background/Purpose: The OMERACT Myositis special interest group (SIG) represents clinicians, patients, and researchers from four continents. Focus groups were conducted including 61 patients on three countries resulting in a list of 26 domains (1). In collaboration with International Myositis Assessment Clinical Study Group (IMACS), our goal was to identify a set of core patient-reported outcomes (PRO) in regards to life impact important to assess in clinical trials and clinical practice in myositis.

Methods: Patients with adult polymyositis, dermatomyositis, antisynthetase syndrome, or immune-mediated necrotizing myopathy (IMNM) in South Korea, Sweden and USA (N=638) responded to the first online modified Delphi in 2016. The second modified Delphi included patients (N=563), health care providers (HCP) (N=101), care givers (N=27) and regulatory agencies (n=xx) from multiple countries in 2017. A third modified Delphi was administered in 2018 including 410 patients, 109 HCP, 22 caregivers.

Results: From this work, four domains were deemed mandatory to measure in all clinical trials for IIM: fatigue, pain, levels of physical activity, and muscle symptoms (Figure 1). Additional optional domains include skin symptoms, lung symptoms, and joint symptoms. Several other domains were deemed important to study with further research efforts including sleeping difficulty, cognitive distress, ability to work, and emotional distress.

Conclusion: A draft set of core PRO has been developed through validated methods based on OMERACT guidelines. Fatigue, pain, levels of physical activity and muscle symptoms were included in the inner circle and should always be used in clinical trials in IIM. We next seek to develop corresponding instruments with each of these domains with future efforts.

Reference: Regardt M et al. Patients’ experience of myositis and further validation of a patient-reported outcome measure – establishing core domains and expanding patient input on clinical assessment in myositis. Report from OMERACT 12. J Rheumatol 2015;42:2492-5.

Figure 1: Draft Modified Core Domain Set for PROs in IIM Patients


Disclosure: M. Regardt, None; C. A. Mecoli, None; J. K. Park, None; M. Needham, None; I. De Groot, None; C. Sarver, None; I. E. Lundberg, Bristol-Myers Squibb, 2,AstraZeneca, 2,AstraZeneca, 5,UCB, Inc., 5,Corbus Pharmaceuticals, 5,Novartis, 1,Roche, 1; B. Shea, None; M. De Visser, None; Y. W. Song, Astellas Pharma, Inc., 9; C. O. Bingham III, None; L. Christopher-Stine, Inova Diagnostics, 7; H. Alexanderson, None.

To cite this abstract in AMA style:

Regardt M, Mecoli CA, Park JK, Needham M, De Groot I, Sarver C, Lundberg IE, Shea B, De Visser M, Song YW, Bingham III CO, Christopher-Stine L, Alexanderson H. A Draft Modified Core Domain Set for Patient-Reported Outcomes (PRO) in Patients with Idiopathic Inflammatory Myopathies (IIM): An Omeract Report [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/a-draft-modified-core-domain-set-for-patient-reported-outcomes-pro-in-patients-with-idiopathic-inflammatory-myopathies-iim-an-omeract-report/. Accessed February 6, 2023.
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