{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T11:31:31Z","timestamp":1792063891508,"version":"4.4.0"},"reference-count":53,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2020,9,29]],"date-time":"2020-09-29T00:00:00Z","timestamp":1601337600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis Care &amp;amp; Research"],"published-print":{"date-parts":[[2020,10]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>The core outcome set for trials in systemic sclerosis (SSc) was developed in 2008 and comprises 11 domains and 31 measures, leading to the development of the Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS). We aimed to assess the scope and consistency of outcomes reported in trials of SSc and the uptake of this core set and the CRISS.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Medline, the Cochrane Central Register of Controlled Trials, Embase, and ClinicalTrials.gov were searched to identify randomized trials published from January 1, 2000 to April 29, 2018 in adults with limited or diffuse SSc. Outcomes and measures were recorded for each trial, classified into domains and the frequency of outcomes before after publication of the publication of the core set calculated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>From 152 trials, 4,193 outcomes were classified into 84 domains. The 3 most common domains were health\u2010related quality of life (HRQoL) and function (59%, 130 measures), skin (47%, 59 measures), and pulmonary (45%, 168 measures). After the publication of the core outcome set, no trial reported the complete core set with adherence to each of the 11 domains, ranging from 6.1% to 54.4% and adherence to each of the 31 measures ranging from 0% to 48.1%. The 5 measures required for the CRISS were reported completely in 11% of trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Despite recognition that uniform acquisition and reporting of outcomes would enable a better evaluation of proposed SSc therapeutics, the outcome domains and measures reported in randomized trials in SSc remain very inconsistent, with little impact of the core outcome set.<\/jats:p><\/jats:sec>","DOI":"10.1002\/acr.24027","type":"journal-article","created":{"date-parts":[[2019,7,16]],"date-time":"2019-07-16T01:43:26Z","timestamp":1563241406000},"page":"1449-1458","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Scope and Consistency of Outcomes Reported in Trials of Patients With Systemic Sclerosis"],"prefix":"10.1002","volume":"72","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2590-5426","authenticated-orcid":false,"given":"Daniel","family":"Sumpton","sequence":"first","affiliation":[{"name":"University of Sydney Children\u2019s Hospital at Westmead, and Concord Hospital  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adrien","family":"Bigot","sequence":"additional","affiliation":[{"name":"Service de M\u00e9decine Interne, H\u00f4pital Bretonneau, CHRU Tours  Tours France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benedicte","family":"Sautenet","sequence":"additional","affiliation":[{"name":"Service de N\u00e9phrologie, H\u00f4pital Bretonneau CHRU Tours and Universit\u00e9 de Tours et Nantes SPHERE\u2013INSERM 1246  Tours France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan C.","family":"Craig","sequence":"additional","affiliation":[{"name":"Flinders University  Adelaide South Australia Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Geraldine","family":"Hassett","sequence":"additional","affiliation":[{"name":"Liverpool Hospital  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vivek","family":"Thakkar","sequence":"additional","affiliation":[{"name":"Liverpool Hospital and Macquarie University  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Tugwell","sequence":"additional","affiliation":[{"name":"University of Ottawa and Ottawa Hospital Research Institute  Ottawa Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allison","family":"Tong","sequence":"additional","affiliation":[{"name":"University of Sydney and Children\u2019s Hospital at Westmead  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,9,29]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(17)30933-9"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1097\/BOR.0000000000000551"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2006.066068"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/ker269"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/BOR.0000000000000172"},{"key":"e_1_2_6_7_1","doi-asserted-by":"crossref","first-page":"496","DOI":"10.1016\/B978-0-323-31696-5.00033-4","volume-title":"Kelley\u2019s Textbook of Rheumatology","author":"Beaton DE","year":"2017"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1136\/rmdopen-2015-000217"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-14-324"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10067-014-2728-6"},{"key":"e_1_2_6_11_1","first-page":"1194","article-title":"Systemic sclerosis: continuing progress in developing clinical measures of response","volume":"34","author":"Furst D","year":"2007","journal-title":"J Rheumatol"},{"key":"e_1_2_6_12_1","first-page":"2477","article-title":"Scleroderma: developing measures of response","volume":"32","author":"Furst DE","year":"2005","journal-title":"J Rheumatol"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2007.078923"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/acr.22804"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2017.03.003"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-015-0738-6"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-125-7-199610010-00011"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.f167"},{"key":"e_1_2_6_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780230202"},{"key":"e_1_2_6_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780401110"},{"key":"e_1_2_6_21_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10067-004-0942-3"},{"key":"e_1_2_6_22_1","doi-asserted-by":"publisher","DOI":"10.1097\/00005650-199206000-00002"},{"key":"e_1_2_6_23_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-97-5-652"},{"key":"e_1_2_6_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(16)00232-4"},{"key":"e_1_2_6_25_1","unstructured":"Inventiva Pharma sponsor.Proof\u2010of\u2010concept trial of IVA337 in diffuse cutaneous systemic sclerosis (FASST). ClinicalTrials.gov identifier: NCT02503644;2015. URL:https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02503644."},{"issue":"106","key":"e_1_2_6_26_1","first-page":"75","article-title":"Design of a randomised, placebo\u2010controlled clinical trial of nintedanib in patients with systemic sclerosis\u2010associated interstitial lung disease (SENSCIS)","volume":"35","author":"Distler O","year":"2017","journal-title":"Clin Exp Rheumatol"},{"key":"e_1_2_6_27_1","doi-asserted-by":"publisher","DOI":"10.5301\/jsrd.5000231"},{"key":"e_1_2_6_28_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/kex203"},{"key":"e_1_2_6_29_1","doi-asserted-by":"publisher","DOI":"10.1002\/acr.23207"},{"key":"e_1_2_6_30_1","doi-asserted-by":"publisher","DOI":"10.1177\/2397198318774307"},{"key":"e_1_2_6_31_1","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-13-132"},{"key":"e_1_2_6_32_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2013.11.013"},{"key":"e_1_2_6_33_1","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.090372"},{"key":"e_1_2_6_34_1","doi-asserted-by":"publisher","DOI":"10.1136\/thoraxjnl-2013-204202"},{"key":"e_1_2_6_35_1","author":"Khanna D","year":"2018","journal-title":"Arthritis Rheumatol"},{"key":"e_1_2_6_36_1","article-title":"Efficacy and safety of tocilizumab for the treatment of systemic sclerosis: results from a phase 3 randomized controlled trial [abstract]","volume":"70","author":"Khanna D","year":"2018","journal-title":"Arthritis Rheumatol"},{"key":"e_1_2_6_37_1","article-title":"Riociguat in patients with early diffuse cutaneous systemic sclerosis: a randomized, double\u2010blind, placebo\u2010controlled phase IIb study (RISE\u2010SSc) [abstract]","volume":"70","author":"Distler O","year":"2018","journal-title":"Arthritis Rheumatol"},{"key":"e_1_2_6_38_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-017-1978-4"},{"key":"e_1_2_6_39_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2016.5258"},{"key":"e_1_2_6_40_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/kex396"},{"key":"e_1_2_6_41_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.semarthrit.2018.03.013"},{"key":"e_1_2_6_42_1","doi-asserted-by":"publisher","DOI":"10.1002\/acr.23098"},{"key":"e_1_2_6_43_1","doi-asserted-by":"crossref","first-page":"45","DOI":"10.1186\/s13075-017-1252-x","article-title":"Multiplex serum protein analysis reveals potential mechanisms and markers of response to hyperimmune caprine serum in systemic sclerosis","volume":"19","author":"Quillinan N","year":"2017","journal-title":"Arthritis Res Ther"},{"key":"e_1_2_6_44_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2013-203674"},{"key":"e_1_2_6_45_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.chest.2016.11.052"},{"key":"e_1_2_6_46_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13075-016-1203-y"},{"key":"e_1_2_6_47_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2213-2600(16)30152-7"},{"key":"e_1_2_6_48_1","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.200702-326OC"},{"key":"e_1_2_6_49_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.22580"},{"key":"e_1_2_6_50_1","doi-asserted-by":"publisher","DOI":"10.1378\/chest.09-0108"},{"key":"e_1_2_6_51_1","doi-asserted-by":"publisher","DOI":"10.1002\/acr.20320"},{"key":"e_1_2_6_52_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjmed.2010.12.009"},{"key":"e_1_2_6_53_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00330-011-2223-2"},{"key":"e_1_2_6_54_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa055120"}],"container-title":["Arthritis Care &amp; Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/acr.24027","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/acr.24027","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/acrjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/acr.24027","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,2]],"date-time":"2025-10-02T16:24:58Z","timestamp":1759422298000},"score":1,"resource":{"primary":{"URL":"https:\/\/acrjournals.onlinelibrary.wiley.com\/doi\/10.1002\/acr.24027"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,9,29]]},"references-count":53,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2020,10]]}},"alternative-id":["10.1002\/acr.24027"],"URL":"https:\/\/doi.org\/10.1002\/acr.24027","archive":["Portico"],"relation":{},"ISSN":["2151-464X","2151-4658"],"issn-type":[{"value":"2151-464X","type":"print"},{"value":"2151-4658","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,9,29]]},"assertion":[{"value":"2019-03-22","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-07-09","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-09-29","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}