{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T14:27:33Z","timestamp":1793543253569,"version":"4.5.0"},"reference-count":31,"publisher":"The Journal of Rheumatology","issue":"11","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Rheumatol"],"accepted":{"date-parts":[[2026,7,22]]},"published-print":{"date-parts":[[2026,11]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>This study aimed to evaluate the clinical meaningfulness and improvement thresholds of the myositis core set measures (CSMs) of disease activity in idiopathic inflammatory myopathies (IIMs), emphasizing associations with patient-reported outcome measures (PROMs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Adults with IIM were enrolled in a 6-month prospective observational study. PROMs were collected monthly, including patient global assessment (PtGA), Health Assessment Questionnaire\u2013Disability Index (HAQ-DI), pain and fatigue (visual analog scale [VAS]), 36-item Short Form Health Survey (SF-36), and Patient-Reported Outcomes Measurement Information System Physical Function Short Form 20. Physician-reported outcomes (physician global assessment [PGA], extramuscular global disease activity [ExGLB], manual muscle testing 9 [MMT9]) and Total Improvement Score (TIS) of the 2016 American College of Rheumatology\/European Alliance of Associations for Rheumatology (ACR\/EULAR) Myositis Response Criteria were collected every 3 months. Associations were evaluated using Spearman correlation and linear mixed models to assess construct validity. Responsiveness, effect sizes, and clinically important differences (CIDs) were assessed using the anchors patient-reported and physician-reported global impression of change (PGIC and PhGIC, respectively) at 6 months.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Fifty patients (mean age, 51.6 [SD 14.9] years; 60% female) were enrolled. Most CSMs showed strong baseline and longitudinal associations with PROMs, including pain, fatigue, physical function, and quality of life (QOL). Significant improvements were observed in most CSMs with moderate to large effect sizes, using PGIC and PhGIC as anchors. The CIDs according to PGIC were 2.1 for PGA, 1.4 for ExGLB, 1.7 for PtGA, 4.2 for MMT9, 0.5 for HAQ-DI, 1475 IU\/L for creatine kinase, and 28.0 for TIS. PhGIC demonstrated similar results.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>CSMs demonstrate robust validity and responsiveness, closely aligning with patients\u2019 symptoms, function, and QOL and supporting their utility in IIM trials. We established CIDs for CSMs and TIS.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3899\/jrheum.2025-1331","type":"journal-article","created":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T12:25:14Z","timestamp":1785587114000},"page":"1253-1261","source":"Crossref","is-referenced-by-count":0,"title":["Clinical Meaningfulness and Improvement Thresholds of Myositis Core Set Measures: Association With Patient-Reported Outcomes"],"prefix":"10.3899","volume":"53","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8680-4661","authenticated-orcid":false,"given":"Shiri","family":"Keret","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2830-7675","authenticated-orcid":false,"given":"Raisa Lomanto","family":"Silva","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irada","family":"Choudhuri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eugenia","family":"Gkiaouraki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-7088-0507","authenticated-orcid":false,"given":"Tanya","family":"Chandra","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1384-9834","authenticated-orcid":false,"given":"Nantakarn","family":"Pongtarakulpanit","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shreya","family":"Sriram","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-1451-7947","authenticated-orcid":false,"given":"Vaidehi","family":"Kothari","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaushik Sreerama","family":"Reddy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eaman","family":"Alhassan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3094-0215","authenticated-orcid":false,"given":"Anushka","family":"Aggarwal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1940-3064","authenticated-orcid":false,"given":"Maha","family":"Almackenzie","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-0444-1406","authenticated-orcid":false,"given":"Niladri","family":"Bhowmick","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0994-1590","authenticated-orcid":false,"given":"Siamak","family":"Moghadam-Kia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9529-3111","authenticated-orcid":false,"given":"Chester V.","family":"Oddis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7531-8038","authenticated-orcid":false,"given":"Rohit","family":"Aggarwal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2262","published-online":{"date-parts":[[2026,8,1]]},"reference":[{"key":"2026110105301030000_53.11.1253.1","doi-asserted-by":"crossref","first-page":"e115","DOI":"10.1016\/S2665-9913(23)00322-3","article-title":"Idiopathic inflammatory myopathies: current insights and future frontiers","volume":"6","author":"Connolly","year":"2024","journal-title":"Lancet Rheumatol"},{"key":"2026110105301030000_53.11.1253.2","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/40.11.1262"},{"key":"2026110105301030000_53.11.1253.3","doi-asserted-by":"publisher","DOI":"10.1038\/nrrheum.2018.33"},{"key":"2026110105301030000_53.11.1253.4","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2017-211400"},{"key":"2026110105301030000_53.11.1253.5","doi-asserted-by":"publisher","DOI":"10.1186\/1477-7525-4-79"},{"key":"2026110105301030000_53.11.1253.6","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-4733.2007.00275.x"},{"key":"2026110105301030000_53.11.1253.7","doi-asserted-by":"crossref","first-page":"3672","DOI":"10.1093\/rheumatology\/kead110","article-title":"Performance of the 2016 ACR-EULAR Myositis Response Criteria in adult dermatomyositis\/polymyositis therapeutic trials and consensus profiles","volume":"62","author":"Saygin","year":"2023","journal-title":"Rheumatology"},{"key":"2026110105301030000_53.11.1253.8","doi-asserted-by":"publisher","DOI":"10.1002\/acr.20532"},{"key":"2026110105301030000_53.11.1253.9","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2117912"},{"key":"2026110105301030000_53.11.1253.10","doi-asserted-by":"crossref","first-page":"1355","DOI":"10.1093\/rheumatology\/keae143","article-title":"A patient-centred assessment of the 2016 ACR-EULAR Myositis Response Criteria: evaluating the meaningfulness of response","volume":"64","author":"Saygin","year":"2025","journal-title":"Rheumatology"},{"key":"2026110105301030000_53.11.1253.11","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2017-211468"},{"key":"2026110105301030000_53.11.1253.12","doi-asserted-by":"publisher","DOI":"10.1016\/j.nmd.2017.09.016"},{"key":"2026110105301030000_53.11.1253.13","doi-asserted-by":"publisher","DOI":"10.4236\/jwarp.2015.77047"},{"key":"2026110105301030000_53.11.1253.14","doi-asserted-by":"crossref","first-page":"3043","DOI":"10.1007\/s10067-023-06719-0","article-title":"Association between self-reported race and ethnicity and myositis-specific autoantibodies in a diverse cohort of patients with inflammatory myopathy","volume":"42","author":"Beam","year":"2023","journal-title":"Clin Rheumatol"},{"key":"2026110105301030000_53.11.1253.15","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/kes167"},{"key":"2026110105301030000_53.11.1253.16","doi-asserted-by":"crossref","first-page":"756","DOI":"10.1093\/mr\/road094","article-title":"Gender differences in patient experience in idiopathic inflammatory myopathies: subanalysis from the COVAD dataset","volume":"34","author":"Yoshida","year":"2024","journal-title":"Mod Rheumatol"},{"key":"2026110105301030000_53.11.1253.17","doi-asserted-by":"publisher","DOI":"10.1037\/0033-2909.112.1.155"},{"key":"2026110105301030000_53.11.1253.18","doi-asserted-by":"publisher","DOI":"10.1016\/S0895-4356(03)00044-1"},{"key":"2026110105301030000_53.11.1253.19","doi-asserted-by":"publisher","DOI":"10.1016\/S0889-857X(02)00032-7"},{"key":"2026110105301030000_53.11.1253.20","doi-asserted-by":"crossref","unstructured":"Keret S , Chandra T , Kaly L , . Normal creatine kinase in idiopathic inflammatory myopathies- patient characteristics and disease activity [abstract]. Arthritis Rheumatol 2024;76 (suppl 9).","DOI":"10.1136\/annrheumdis-2024-eular.4803"},{"key":"2026110105301030000_53.11.1253.21","first-page":"603","article-title":"Defining clinical improvement in adult and juvenile myositis","volume":"30","author":"Rider","year":"2003","journal-title":"J Rheumatol"},{"key":"2026110105301030000_53.11.1253.22","unstructured":"Almackenzie M , Aggarwal A , Keret S , . Validity and responsiveness of core set measures in idiopathic inflammatory myositis based on 36-item Short Form Health Survey (SF-36). Arthritis Rheumatol 2024;76 (suppl 9)."},{"key":"2026110105301030000_53.11.1253.23","doi-asserted-by":"crossref","first-page":"51","DOI":"10.1186\/s41927-019-0095-2","article-title":"Use of a \u201ccritical difference\u201d statistical criterion improves the predictive utility of the Health Assessment Questionnaire-Disability Index score in patients with rheumatoid arthritis","volume":"3","author":"Behrens","year":"2019","journal-title":"BMC Rheumatol"},{"key":"2026110105301030000_53.11.1253.24","first-page":"557","article-title":"Minimum important difference between patients with rheumatoid arthritis: the patient\u2019s perspective","volume":"20","author":"Wells","year":"1993","journal-title":"J Rheumatol"},{"key":"2026110105301030000_53.11.1253.25","unstructured":"U.S. Food and Drug Administration . Patient-focused drug development: methods to identify what is important to patients. February 2022. [Internet. Accessed August 4, 2026.] Available from: https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/patient-focused-drug-development-methods-identify-what-important-patients"},{"key":"2026110105301030000_53.11.1253.26","doi-asserted-by":"publisher","DOI":"10.1097\/MLR.0000000000000273"},{"key":"2026110105301030000_53.11.1253.27","doi-asserted-by":"crossref","first-page":"10","DOI":"10.1186\/s40900-018-0093-3","article-title":"Enhancing the incorporation of the patient\u2019s voice in drug development and evaluation","volume":"4","author":"Chalasani","year":"2018","journal-title":"Res Involv Engagem"},{"key":"2026110105301030000_53.11.1253.28","doi-asserted-by":"crossref","first-page":"780","DOI":"10.1093\/rheumatology\/keae126","article-title":"Pain is common in myositis and associated with disease activity","volume":"64","author":"Chandrasekhara Pillai","year":"2025","journal-title":"Rheumatology"},{"key":"2026110105301030000_53.11.1253.29","doi-asserted-by":"crossref","first-page":"763","DOI":"10.1093\/rheumatology\/keae091","article-title":"Patient-reported outcome for physical function in idiopathic inflammatory myopathy","volume":"64","author":"Keret","year":"2025","journal-title":"Rheumatology"},{"key":"2026110105301030000_53.11.1253.30","doi-asserted-by":"crossref","first-page":"1783","DOI":"10.1002\/acr.22392","article-title":"Clinically important changes in Short Form 36 Health Survey scales for use in rheumatoid arthritis clinical trials: the impact of low responsiveness","volume":"66","author":"Ward","year":"2014","journal-title":"Arthritis Care Res"},{"key":"2026110105301030000_53.11.1253.31","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/kead316"}],"container-title":["The Journal of Rheumatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.3899\/jrheum.2025-1331","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T13:30:30Z","timestamp":1793539830000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.jrheum.org\/lookup\/doi\/10.3899\/jrheum.2025-1331"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,1]]},"references-count":31,"journal-issue":{"issue":"11","published-online":{"date-parts":[[2026,11,1]]},"published-print":{"date-parts":[[2026,11]]}},"alternative-id":["10.3899\/jrheum.2025-1331"],"URL":"https:\/\/doi.org\/10.3899\/jrheum.2025-1331","relation":{},"ISSN":["0315-162X","1499-2752"],"issn-type":[{"value":"0315-162X","type":"print"},{"value":"1499-2752","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,1]]}}}