Standardized Interoperable Data Collection for Myositis Research: Developing Common Data Elements for Myositis Disease Activity Core Set Measures

Didem Saygin¹, Matthew Diller², Varsha Surampudi³, Mark Bodkin³, Payam Farhadi⁴, Adam Schiffenbauer⁵, Audrey Kessel³, Chris Mecoli⁶, Rohit Aggarwal⁷, Helene Alexanderson⁸, Michelle Best⁹, Olivier Benveniste¹⁰, Hector Chinoy¹¹, Brian Feldman¹², Linda Kobert¹³, Manuel Lubinus¹⁴, Liza McCann¹⁵, Chester V. Oddis¹⁶, Nicolino Ruperto¹⁷, Jens Schmidt¹⁸, Victoria Werth¹⁹, Christie Bartels²⁰, Hanna Kim²¹, Andrew Mammen²², Julie Paik²³, Ellen M. Werner¹³, Ingrid de Groot²⁴, Pedro Machado²⁵, Susan Kim²⁶, Tahseen Mozaffar²⁷, Adam M Huber²⁸, Angelo Ravelli²⁹, Richard Scheuermann² and Lisa Rider³⁰, ¹Rush University Medical Center, Chicago, IL, ²National Library of Medicine, National institutes of Health, Bethesda, MD, ³Social Scientific System Inc, a DLH holding company, Baltimore, MD, ⁴National Institutes of Health/National Institute of Environmental Health Sciences, Bethesda, MD, ⁵National Institute of Health/National Institute of Dental and Craniofacial Research, Bethesda, MD, ⁶Johns Hopkins University School of Medicine, Baltimore, MD, ⁷University of Pittsburgh, Rheumatology and Clinical Immunology, Pittsburgh, United States of America, Pittsburgh, PA, ⁸Karolinska University Hospital, Stockholm, Sweden, ⁹Cure JM Foundation, Lessburg, VA, ¹⁰Sorbonne Uniersite, Hopital de la Pitie-Salpetriere, Paris, France, ¹¹The University of Manchester, Manchester, United Kingdom, ¹²The Hospital for Sick Children, Toronto, ON, Canada, ¹³The Myositis Association, Columbia, MD, ¹⁴Myositis Support and Understanding, Lincoln, DE, ¹⁵Alder Hey Children's NHS Foundation Trust, Liverpool, United Kingdom, ¹⁶University of Pittsburgh, Pittsburgh, PA, ¹⁷Université Milano Bicocca and Fondazione IRCSS S. Gerardo dei Tintori, Monza, Monza and Brianza, Italy, ¹⁸Immanuel University Hospital Ruedersdorf, Brandenburg Medical School, Rudersdorf, Germany, ¹⁹University of Pennsylvania, Philadelphia, PA, ²⁰University of Wisconsin School of Medicine and Public Health, Madison, WI, ²¹NIAMS, NIH, Bethesda, MD, ²²NIH, Bethesda, MD, ²³Johns Hopkins Rheumatology, Baltimore, MD, ²⁴The Myositis Association, Rotterdam, Netherlands, ²⁵University College London, London, United Kingdom, ²⁶UCSF Benioff Children's Hospital, San Francisco, CA, ²⁷University of California, Irvine, Orange, CA, ²⁸IWK Grace Health Centre, Halifax, NS, Canada, ²⁹IRCCS Istituto Giannina Gaslini, Genoa, Italy, Genoa, Genoa, Italy, ³⁰National Institute of Environmental Health Sciences/National Institutes of Health, Environmental Autoimmunity Group, Bethesda, MD

Meeting: ACR Convergence 2025

Keywords: Data Management, Myositis, Outcome measures

Session Information

Date: Sunday, October 26, 2025

Title: (0280–0305) Muscle Biology, Myositis & Myopathies – Basic & Clinical Science Poster I

Session Type: Poster Session A

Session Time: 10:30AM-12:30PM

Background/Purpose: Recent progress has been made in developing myositis outcome assessments, response and classification criteria, and consensus in the design and conduct of clinical trials through the International Myositis Assessment and Clinical Studies Group (IMACS). However, critical deficiencies remain for data standardization across myositis registries. While the National Institute of Health (NIH) Common Data Elements (CDEs) Repository has been developed to facilitate consistent data collection and data sharing, few myositis-specific or autoimmune disease CDEs currently exist. Here, we developed CDEs for myositis core set activity measures (CSMs) using novel data science strategies to support myositis research interoperability.

Methods: Dictionaries of several myositis registries were examined to understand how myositis CSMs are captured across databases. We used the Linked data Modeling Language (LinkML), an open-source data modeling framework for creating schemas for structured, linked data to develop computable CDEs. Information and metadata of CDEs were captured in a machine-readable format that leverages existing standards for data standardization and reuse. The Observational Health Data Science and Informatics (OHDSI) application Athena-OHDSI Vocabularies Repository (Odysseus Data Services, Inc.) was utilized to map CDEs to the Observational Medical Outcomes Partnership (OMOP) vocabulary. After development of draft CDEs for myositis CSMs, a hybrid conference was held to discuss results, reach consensus on the coding of myositis CSM CDEs, and to prioritize additional forms for development of CDEs. An international panel of 13 myositis experts and 11 discussants, including adult/pediatric rheumatologists, neurologists, dermatologists, physical therapists, and patients/patient advocates, attended the consensus conference. The Delphi method and modified nominal group technique were used in tandem as consensus methods for each CDE. Comments from participants were received via an open survey on REDCap and discussed, followed by electronic voting to reach consensus. Participants also ranked additional myositis measures for future CDE development.

Results: A standardized workflow has been established for creation of CDEs in myositis and other autoimmune diseases (Figure). CDEs for all myositis CSMs were drafted, except CHQ-P50 due to its restrictive licensing. After receiving several comments on each CDE and holding discussions to improve the coding of the CSM CDEs, 100% agreement among participants was reached for all CDEs (Table 1). The prioritized measures for future CDEs included IIM Response, Classification and Flare Criteria, damage measures, task-oriented physical function measures, and patient-reported outcome measures via PROMIS instruments among others (Table 2).

Conclusion: Leveraging broad multispecialty expertise in myositis and patient communities through IMACS and data science expertise of the National Library of Medicine (NLM), the first myositis-specific CDEs have been developed to accelerate the ability to conduct interoperable myositis clinical studies and therapeutic trials.

Figure 1. Flow diagram of the project steps.

Disclosures: D. Saygin: None; M. Diller: None; V. Surampudi: None; M. Bodkin: None; P. Farhadi: None; A. Schiffenbauer: AstraZeneca, 11, Hope Pharmaceuticals, 5; A. Kessel: None; C. Mecoli: None; R. Aggarwal: Alexion, 2, ANI Pharmaceuticals, 2, Argenx, 2, Artasome, 2, AstraZeneca, 2, Boehringer-Ingelheim, 2, 5, Bristol-Myers Squibb(BMS), 2, 5, CabalettaBio, 2, Capella, 2, Capstanx, 2, CSL Behring, 2, EMD Serono, 2, 5, Galapagos, 2, Horizon Therapeutics, 2, I-Cell, 2, Immunovant, 2, Janssen, 2, 5, Kezar, 2, Kyverna, 2, Lilly, 2, Manta Medicines, 2, Nkarta, 2, Novartis, 2, Octapharma, 2, Pfizer, 2, 5, Priovant, 2, 5, Teva, 2, Tourmaline Bio, 2, UCB, 2, Verismo Therapeutics, 2; H. Alexanderson: None; M. Best: None; O. Benveniste: None; H. Chinoy: argenx, 2, AstraZeneca, 1, Pfizer, 2, 5; B. Feldman: Cabelleta, 1, Pfizer, 12, DSMB; L. Kobert: None; M. Lubinus: None; L. McCann: None; C. V. Oddis: None; N. Ruperto: Abbvie, 2, 6, AClaris, 2, 6, AlfaSigma, 2, 6, Amgen, 2, 6, AstraZeneca, 2, 6, Aurinia, 2, 6, Boehringer-Ingelheim, 2, 6, Bristol Myers and Squibb, 2, 6, Eli Lilly, 2, 6, Galapagos, 2, 6, Genentech, 2, 6, Guidepoint, 2, 6, Idorsia, 2, 6, Janssen, 2, 6, Novartis, 2, 6, Pfizer, 2, 6, Roche, 2, 6, Sanofi, 2, 6, Takeda, 2, 6; J. Schmidt: None; V. Werth: AbbVie/Abbott, 2, Alpine Immune Sciences, 2, Amgen, 2, 5, AnaptysBio, 2, argenx, 2, AstraZeneca, 2, 5, Biogen, 2, 5, Bristol-Myers Squibb(BMS), 2, 5, Cabaletta Bio, 2, Calyx, 2, Caribou, 2, CESAS Medical, 6, Corbus Pharmaceuticals, 5, Crisalis, 2, CSL Behring, 2, 5, Cugene, 2, Eli Lilly, 2, EMD Serono, 2, Evommune, 2, Gilead, 2, 5, GlaxoSmithKlein(GSK), 2, Horizon, 2, 5, Immunovant, 2, Innovaderm, 2, Janssen, 2, Kyowa Kirin, 2, MAPI Trust, 9, Merck KGaA, Darmstadt, Germany, 2, N/A, 12, The University of Pennsylvania owns the copyright for the CLASI., Nektar, 2, Nuvig Pharmaceuticals, 2, Pfizer, 2, 5, Priovant, 5, Regeneron, 2, 5, Rome Therapeutics, 2, 5, Sanofi, 2, Takeda, 2, UCB, 2, Ventus, 2, 5, Viela Bio, 2, 5, Xencor, 2; C. Bartels: None; H. Kim: Bristol-Myers Squibb(BMS), 12, CRADA, providing drug for clinical study, Cabaletta Bio, 1, 12, Cellular Therapy Product and Research Support, Eli Lilly, 12, CRADA, providing drug and research support; A. Mammen: None; J. Paik: ArgenX, 12,, Priovant, 12,; E. Werner: None; I. de Groot: None; P. Machado: AbbVie/Abbott, 2, 6, Eli Lilly, 2, 6, Novartis, 2, 6, Pfizer, 2, 6, UCB, 2, 6; S. Kim: Cabaletta, 1; T. Mozaffar: None; A. Huber: None; A. Ravelli: AbbVie, 2, 5, 6, Alexion, 2, 5, 6, Bristol-Myers Squibb(BMS), 2, 5, 6, Galapagos, 2, 5, 6, Johnson & Johnson, 2, 5, 6, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, Roche, 2, 5, 6, SOBI, 2, 5, 6; R. Scheuermann: None; L. Rider: None.

To cite this abstract in AMA style:

Saygin D, Diller M, Surampudi V, Bodkin M, Farhadi P, Schiffenbauer A, Kessel A, Mecoli C, Aggarwal R, Alexanderson H, Best M, Benveniste O, Chinoy H, Feldman B, Kobert L, Lubinus M, McCann L, V. Oddis C, Ruperto N, Schmidt J, Werth V, Bartels C, Kim H, Mammen A, Paik J, Werner E, de Groot I, Machado P, Kim S, Mozaffar T, Huber A, Ravelli A, Scheuermann R, Rider L. Standardized Interoperable Data Collection for Myositis Research: Developing Common Data Elements for Myositis Disease Activity Core Set Measures [abstract]. Arthritis Rheumatol. 2025; 77 (suppl 9). https://acrabstracts.org/abstract/standardized-interoperable-data-collection-for-myositis-research-developing-common-data-elements-for-myositis-disease-activity-core-set-measures/. Accessed .

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