{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T10:06:38Z","timestamp":1788948398434,"version":"build-2803163510"},"reference-count":48,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2026,5,26]],"date-time":"2026-05-26T00:00:00Z","timestamp":1779753600000},"content-version":"unspecified","delay-in-days":25,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J Scleroderma Relat Disord"],"accepted":{"date-parts":[[2025,9,14]]},"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:p>The Scleroderma Clinical Trials Consortium (SCTC) is committed to advancing the understanding and treatment of systemic sclerosis (SSc). This review focuses on the development and validation of various outcome instruments by the SCTC, which are crucial for evaluating the effectiveness of interventions in clinical trials and observational studies. Key instruments discussed include the Assessment of Systemic Sclerosis-Associated RAynaud\u2019s Phenomenon Questionnaire, the SCTC Radiologic Scoring System for calcinosis, the Mawdsley Questionnaire for calcinosis, the University of California Los Angeles SCTC Gastrointestinal Tract Instrument (GIT) 2.0, the SCTC Activity Index and the SCTC Damage Index. Additionally, the SCTC and World Scleroderma Foundation (WSF) Skin Scoring Certification is highlighted as an important resource for researchers. Each instrument\u2019s purpose, description and validation process are examined, underscoring their pivotal role in advancing SSc research and improving patient outcomes.<\/jats:p>","DOI":"10.1136\/jsrd-2026-000009","type":"journal-article","created":{"date-parts":[[2026,5,26]],"date-time":"2026-05-26T13:50:13Z","timestamp":1779803413000},"page":"e000009","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Scleroderma Clinical Trials Consortium (SCTC) outcome instruments for evaluation of systemic sclerosis"],"prefix":"10.1136","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3357-9402","authenticated-orcid":false,"given":"Antonia","family":"Valenzuela","sequence":"first","affiliation":[{"name":"Rheumatology and Clinical Immunology, Pontificia Universidad Catolica de Chile, Santiago de Chile, Santiago Metropolitan Region, Chile"},{"name":"Red de Salud UC Christus, Santiago, Santiago Metropolitan Region, Chile"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lorinda","family":"Chung","sequence":"additional","affiliation":[{"name":"Stanford University School of Medicine, Stanford, California, USA"},{"name":"VA Palo Alto Health Care System, Palo Alto, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2793-2364","authenticated-orcid":false,"given":"John D","family":"Pauling","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, NHS North Bristol NHS Trust, Bristol, UK"},{"name":"Musculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robyn","family":"Domsic","sequence":"additional","affiliation":[{"name":"Division of Rheumatology and Clinical Immunology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1878-8591","authenticated-orcid":false,"given":"Lesley","family":"Saketkoo","sequence":"additional","affiliation":[{"name":"Medicine, New Orleans Scleroderma and Sarcoidosis Patient Care and Research Center, New Orleans, Louisiana, USA"},{"name":"University Medical Center\u2014Comprehensive Pulmonary Hypertension Center and Interstitiatial Lung Disease Clinic Programs, New Orleans, Louisiana, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kim","family":"Fligelstone","sequence":"additional","affiliation":[{"name":"Patient Research Partner, London, UK"},{"name":"Scleroderma & Raynaud UK (SRUK), London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne-Marie","family":"Russell","sequence":"additional","affiliation":[{"name":"Birmingham City University School of Health Sciences, Birmingham, UK"},{"name":"University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6822-3401","authenticated-orcid":false,"given":"Dinesh","family":"Khanna","sequence":"additional","affiliation":[{"name":"University of Michigan, Ann Arbor, Michigan, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5472-3840","authenticated-orcid":false,"given":"Tracy","family":"Frech","sequence":"additional","affiliation":[{"name":"Division of Rheumatology and Immunology, Vanderbilt University, Nashville, Tennessee, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Ross","sequence":"additional","affiliation":[{"name":"University of Melbourne VCCC, Parkville, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mandana","family":"Nikpour","sequence":"additional","affiliation":[{"name":"The University of Sydney School of Public Health, Sydney, New South Wales, Australia"},{"name":"Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3975-8938","authenticated-orcid":false,"given":"Christopher","family":"Denton","sequence":"additional","affiliation":[{"name":"Division of Medicine, University College London Medical School, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Murray","family":"Baron","sequence":"additional","affiliation":[{"name":"Sir Mortimer B Davis Jewish General Hospital, Montreal, Quebec, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,5,26]]},"reference":[{"key":"2026090902100808000_11.1.e000009.1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keq310"},{"key":"2026090902100808000_11.1.e000009.2","doi-asserted-by":"publisher","DOI":"10.1080\/1744666X.2018.1464390"},{"key":"2026090902100808000_11.1.e000009.3","doi-asserted-by":"crossref","first-page":"952","DOI":"10.1093\/rheumatology\/37.9.952","article-title":"Oral iloprost in Raynaud\u2019s phenomenon secondary to systemic sclerosis: a multicentre, placebo-controlled, dose-comparison study","volume":"37","author":"Black","year":"1998","journal-title":"Rheumatology (Sunnyvale)"},{"key":"2026090902100808000_11.1.e000009.4","doi-asserted-by":"publisher","DOI":"10.1002\/1529-0131(199804)41:4<670::AID-ART14>3.0.CO;2-I"},{"key":"2026090902100808000_11.1.e000009.5","doi-asserted-by":"publisher","DOI":"10.1002\/art.10486"},{"key":"2026090902100808000_11.1.e000009.6","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2012-202836"},{"key":"2026090902100808000_11.1.e000009.7","doi-asserted-by":"crossref","first-page":"e237","DOI":"10.1016\/S2665-9913(19)30079-7","article-title":"Comparative efficacy and safety of treatments for secondary Raynaud\u2019s phenomenon: a systematic review and network meta-analysis of randomised trials","volume":"1","author":"Khouri","year":"2019","journal-title":"Lancet Rheumatol"},{"key":"2026090902100808000_11.1.e000009.8","doi-asserted-by":"publisher","DOI":"10.1177\/2397198318774307"},{"key":"2026090902100808000_11.1.e000009.9","unstructured":"Administration, U.S.D.o.H.a.H.S.F.a.D . Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.. 2009. Available: http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM193282.pdf"},{"key":"2026090902100808000_11.1.e000009.10","first-page":"184","article-title":"Patient participation in patient-reported outcome instrument development in systemic sclerosis","volume":"35 Suppl 106","author":"Pauling","year":"2017","journal-title":"Clin Exp Rheumatol"},{"key":"2026090902100808000_11.1.e000009.11","doi-asserted-by":"crossref","first-page":"1373","DOI":"10.1002\/acr.23475","article-title":"Multinational Qualitative Research Study Exploring the Patient Experience of Raynaud\u2019s Phenomenon in Systemic Sclerosis","volume":"70","author":"Pauling","year":"2018","journal-title":"Arthritis Care Res"},{"key":"2026090902100808000_11.1.e000009.12","doi-asserted-by":"crossref","first-page":"18","DOI":"10.1093\/rheumatology\/key026","article-title":"The patient experience of Raynaud\u2019s phenomenon in systemic sclerosis","volume":"58","author":"Pauling","year":"2019","journal-title":"Rheumatology (Oxford)"},{"key":"2026090902100808000_11.1.e000009.13","doi-asserted-by":"crossref","first-page":"1725","DOI":"10.1002\/acr.25038","article-title":"Assessment of the Systemic Sclerosis-Associated Raynaud\u2019s Phenomenon Questionnaire: Item Bank and Short-Form Development","volume":"75","author":"Yu","year":"2023","journal-title":"Arthritis Care Res (Hoboken)"},{"key":"2026090902100808000_11.1.e000009.14","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2011.06.013"},{"key":"2026090902100808000_11.1.e000009.15","doi-asserted-by":"crossref","first-page":"1281","DOI":"10.1093\/rheumatology\/kead371","article-title":"Construct validity and reliability of the Assessment of Systemic Sclerosis-Associated Raynaud\u2019s Phenomenon (ASRAP) questionnaire","volume":"63","author":"Pauling","year":"2024","journal-title":"Rheumatology (Oxford)"},{"key":"2026090902100808000_11.1.e000009.16","doi-asserted-by":"crossref","first-page":"704","DOI":"10.1093\/rheumatology\/keae049","article-title":"A phase 2 trial investigating the efficacy and safety of the mPGES-1 inhibitor vipoglanstat in systemic sclerosis-related Raynaud\u2019s","volume":"64","author":"Tornling","year":"2025","journal-title":"Rheumatology (Oxford)"},{"key":"2026090902100808000_11.1.e000009.17","doi-asserted-by":"crossref","first-page":"554","DOI":"10.1097\/BOR.0000000000000539","article-title":"Calcinosis in scleroderma","volume":"30","author":"Valenzuela","year":"2018","journal-title":"Curr Opin Rheumatol"},{"key":"2026090902100808000_11.1.e000009.18","doi-asserted-by":"publisher","DOI":"10.1177\/2397198318783926"},{"key":"2026090902100808000_11.1.e000009.19","doi-asserted-by":"crossref","first-page":"425","DOI":"10.1002\/acr.22434","article-title":"Validation of a novel radiographic scoring system for calcinosis affecting the hands of patients with systemic sclerosis","volume":"67","author":"Chung","year":"2015","journal-title":"Arthritis Care Res (Hoboken)"},{"key":"2026090902100808000_11.1.e000009.20","doi-asserted-by":"crossref","first-page":"151980","DOI":"10.1016\/j.semarthrit.2022.151980","article-title":"Change in calcinosis over 1 year using the scleroderma clinical trials consortium radiologic scoring system for calcinosis of the hands in patients with systemic sclerosis","volume":"53","author":"Valenzuela","year":"2022","journal-title":"Semin Arthritis Rheum"},{"key":"2026090902100808000_11.1.e000009.21","doi-asserted-by":"crossref","first-page":"2441","DOI":"10.1093\/rheumatology\/keab810","article-title":"A pilot study to evaluate the safety and efficacy of treprostinil in the treatment of calcinosis in systemic sclerosis","volume":"61","author":"Chung","year":"2022","journal-title":"Rheumatology (Oxford)"},{"key":"2026090902100808000_11.1.e000009.22","doi-asserted-by":"publisher","DOI":"10.1016\/j.autrev.2018.10.006."},{"key":"2026090902100808000_11.1.e000009.23","doi-asserted-by":"crossref","first-page":"463","DOI":"10.1016\/j.rdc.2023.01.017","article-title":"Patient Experience of Systemic Sclerosis-Related Calcinosis: An International Study Informing Clinical Trials, Practice, and the Development of the Mawdsley Calcinosis Questionnaire","volume":"49","author":"Saketkoo","year":"2023","journal-title":"Rheum Dis Clin North Am"},{"key":"2026090902100808000_11.1.e000009.24","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2013-204424"},{"key":"2026090902100808000_11.1.e000009.25","doi-asserted-by":"publisher","DOI":"10.1191\/1478088706qp063oa"},{"key":"2026090902100808000_11.1.e000009.26","doi-asserted-by":"publisher","DOI":"10.1177\/1525822X05279903"},{"key":"2026090902100808000_11.1.e000009.27","unstructured":"Krueger RCM . Focus Groups: A Practical Guide for Applied Research. 3rd edn. Thousand Oaks, CA: Sage, 2000."},{"key":"2026090902100808000_11.1.e000009.28","unstructured":"MQ P . Qualitative Research and Evaluation Methods. 3rd edn. Thousand Oaks, CA: Sage, 2002."},{"key":"2026090902100808000_11.1.e000009.29","doi-asserted-by":"crossref","first-page":"23743735221075556","DOI":"10.1177\/23743735221075556","article-title":"Sarcoidosis Illuminations on Living During COVID-19: Patient Experiences of Diagnosis, Management, and Survival Before and During the Pandemic","volume":"9","author":"Saketkoo","year":"2022","journal-title":"J Patient Exp"},{"key":"2026090902100808000_11.1.e000009.30","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780401110"},{"key":"2026090902100808000_11.1.e000009.31","doi-asserted-by":"crossref","first-page":"e185","DOI":"10.1016\/S2665-9913(20)30010-2","article-title":"The future of treatment in systemic sclerosis: can we design better trials?","volume":"2","author":"Pope","year":"2020","journal-title":"Lancet Rheumatol"},{"key":"2026090902100808000_11.1.e000009.32","article-title":"Test-retest Reliability for the Mawdsley Calcinosis Questionnaire for the Measurement of Calcinosis Burden in Patients with Systemic Sclerosis [abstract]","volume":"74","author":"Chung","year":"2022","journal-title":"Arthritis Rheumatol"},{"key":"2026090902100808000_11.1.e000009.33","unstructured":"Fuller J , Kim H , Do V , et al . n.d. Validity of the Mawdsley Calcinosis Questionnaire in Adult and Juvenile Dermatomyositis."},{"key":"2026090902100808000_11.1.e000009.34","doi-asserted-by":"publisher","DOI":"10.1002\/art.22987"},{"key":"2026090902100808000_11.1.e000009.35","doi-asserted-by":"publisher","DOI":"10.1002\/art.24730"},{"key":"2026090902100808000_11.1.e000009.36","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2008.092353"},{"key":"2026090902100808000_11.1.e000009.37","doi-asserted-by":"crossref","first-page":"e528","DOI":"10.1016\/S2665-9913(24)00121-8","article-title":"Association of sustained lupus low disease activity state with improved outcomes in systemic lupus erythematosus: a multinational prospective cohort study","volume":"6","author":"Golder","year":"2024","journal-title":"Lancet Rheumatol"},{"key":"2026090902100808000_11.1.e000009.38","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keaa030"},{"key":"2026090902100808000_11.1.e000009.39","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-209768"},{"key":"2026090902100808000_11.1.e000009.40","doi-asserted-by":"publisher","DOI":"10.1136\/ard.60.6.592"},{"key":"2026090902100808000_11.1.e000009.41","doi-asserted-by":"crossref","first-page":"39","DOI":"10.2174\/1573397117666210913102759","article-title":"Do We Have Good Activity Indices in Systemic Sclerosis?","volume":"18","author":"Groseanu","year":"2022","journal-title":"Curr Rheumatol Rev"},{"key":"2026090902100808000_11.1.e000009.42","doi-asserted-by":"publisher","DOI":"10.1097\/00002281-199511000-00009"},{"key":"2026090902100808000_11.1.e000009.43","doi-asserted-by":"publisher","DOI":"10.1177\/2397198318765061"},{"key":"2026090902100808000_11.1.e000009.44","doi-asserted-by":"crossref","first-page":"1635","DOI":"10.1002\/art.42939","article-title":"Development and Initial Validation of the Novel Scleroderma Clinical Trials Consortium Activity Index","volume":"76","author":"Ross","year":"2024","journal-title":"Arthritis Rheumatol"},{"key":"2026090902100808000_11.1.e000009.45","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2018-214764"},{"key":"2026090902100808000_11.1.e000009.46","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780220205"},{"key":"2026090902100808000_11.1.e000009.47","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.160654"},{"key":"2026090902100808000_11.1.e000009.48","doi-asserted-by":"publisher","DOI":"10.5301\/jsrd.5000231"}],"container-title":["Journal of Scleroderma and Related Disorders"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/jsrd-2026-000009","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T09:10:14Z","timestamp":1788945014000},"score":1,"resource":{"primary":{"URL":"https:\/\/jsrd.bmj.com\/lookup\/doi\/10.1136\/jsrd-2026-000009"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5]]},"references-count":48,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,5,26]]},"published-print":{"date-parts":[[2026,5]]}},"alternative-id":["10.1136\/jsrd-2026-000009"],"URL":"https:\/\/doi.org\/10.1136\/jsrd-2026-000009","relation":{},"ISSN":["2397-1983","2397-1991"],"issn-type":[{"value":"2397-1983","type":"print"},{"value":"2397-1991","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5]]}}}