{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,12]],"date-time":"2026-11-12T20:23:29Z","timestamp":1794515009575,"version":"4.9.1"},"reference-count":9,"publisher":"SAGE Publications","issue":"13","license":[{"start":{"date-parts":[[2026,8,22]],"date-time":"2026-08-22T00:00:00Z","timestamp":1787356800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,8,22]],"date-time":"2026-08-22T00:00:00Z","timestamp":1787356800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100000090","name":"Congressionally Directed Medical Research Programs","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000090","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100010434","name":"\u2018la Caixa\u2019 Foundation","doi-asserted-by":"publisher","award":["ID100010434"],"award-info":[{"award-number":["ID100010434"]}],"id":[{"id":"10.13039\/100010434","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100017147","name":"nternational Progressive MS Alliance","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100017147","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Italian Ministry of University and Research","award":["PE0000006"],"award-info":[{"award-number":["PE0000006"]}]},{"DOI":"10.13039\/100000890","name":"National Multiple Sclerosis Society","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000890","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Ministerio de Ciencia e Innovacion de Espana","award":["CP23\/00117"],"award-info":[{"award-number":["CP23\/00117"]}],"id":[{"id":"https:\/\/ror.org\/05r0vyz12","id-type":"ROR","asserted-by":"crossref"}]},{"name":"Ministerio de Ciencia e Innovacion de Espana","award":["FORT23\/00034"],"award-info":[{"award-number":["FORT23\/00034"]}],"id":[{"id":"https:\/\/ror.org\/05r0vyz12","id-type":"ROR","asserted-by":"crossref"}]},{"name":"Fundacion Merck Salud","award":["PI21\/01860"],"award-info":[{"award-number":["PI21\/01860"]}],"id":[{"id":"https:\/\/ror.org\/03hzthr30","id-type":"ROR","asserted-by":"crossref"}]},{"name":"Fundacion Merck Salud","award":["PI24\/01277"],"award-info":[{"award-number":["PI24\/01277"]}],"id":[{"id":"https:\/\/ror.org\/03hzthr30","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Mult Scler"],"published-print":{"date-parts":[[2026,11]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Reproducibility and comparability of disability outcomes remain major challenges in multiple sclerosis (MS) research. Definitions of disability progression vary widely across studies, and calculation criteria are often insufficiently documented to enable replication.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Framework:<\/jats:title>\n                    <jats:p>To address these issues, a consensus process endorsed by the International Advisory Committee on Clinical Trials in MS was conducted to develop practical guidelines for outcome calculation across a range of study designs and research questions. Instead of proposing a single universal endpoint definition, we establish specific recommendations for each use case, within a fixed parameter space derived from extraction and systematisation of common practices for baseline selection, event confirmation, relapse handling, and event categorisation. These criteria are implemented in a shared computational framework, \u201cmsprog,\u201d available as open-source R and Python software and as a web application. The tool supports different disability scales, facilitates full reporting of parameters, and adapts to both clinical trial and real-world settings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>The integration of consensus-based guidelines with a standardised, extensible implementation provides a practical basis for consistent and reproducible specification of disability outcomes in MS.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/13524585261478492","type":"journal-article","created":{"date-parts":[[2026,8,22]],"date-time":"2026-08-22T11:34:31Z","timestamp":1787398471000},"page":"1347-1352","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["A community-validated tool for clinical outcome calculation in multiple sclerosis: Consensus development and scenario-specific recommendations"],"prefix":"10.1177","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0302-393X","authenticated-orcid":false,"given":"Noemi","family":"Montobbio","sequence":"first","affiliation":[{"name":"Department of Health Sciences, University of Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3823-4000","authenticated-orcid":false,"given":"Francesca","family":"Bovis","sequence":"additional","affiliation":[{"name":"Department of Health Sciences, University of Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9312-2522","authenticated-orcid":false,"given":"Lisa","family":"Hofer","sequence":"additional","affiliation":[{"name":"Departments of Biomedicine and Clinical Research, Neurology, Multiple Sclerosis Centre and Research Center for Clinical Neuroimmunology and Neuroscience (RC2NB), University Hospital Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dieter A.","family":"H\u00e4ring","sequence":"additional","affiliation":[{"name":"Biostatistics, Novartis Pharma AG, Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6525-8174","authenticated-orcid":false,"given":"Pascal","family":"Benkert","sequence":"additional","affiliation":[{"name":"Departments of Biomedicine and Clinical Research, Neurology, Multiple Sclerosis Centre and Research Center for Clinical Neuroimmunology and Neuroscience (RC2NB), University Hospital Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1849-3184","authenticated-orcid":false,"given":"Carmen","family":"Tur","sequence":"additional","affiliation":[{"name":"Department of Neurology, Multiple Sclerosis Center of Catalonia (Cemcat), Hospital Universitari Vall d\u2019Hebron, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3778-1376","authenticated-orcid":false,"given":"Tomas","family":"Kalincik","sequence":"additional","affiliation":[{"name":"Neuroimmunology Centre, The Royal Melbourne Hospital, VIC, Australia"},{"name":"Department of Medicine, CORe, The University of Melbourne, VIC, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7294-9723","authenticated-orcid":false,"given":"Sifat","family":"Sharmin","sequence":"additional","affiliation":[{"name":"Neuroimmunology Centre, The Royal Melbourne Hospital, VIC, Australia"},{"name":"Department of Medicine, CORe, The University of Melbourne, VIC, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ariadna","family":"Masot Llima","sequence":"additional","affiliation":[{"name":"Department of Neurology, Multiple Sclerosis Center of Catalonia (Cemcat), Hospital Universitari Vall d\u2019Hebron, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Hern\u00e1ndez Soria","sequence":"additional","affiliation":[{"name":"Department of Neurology, Multiple Sclerosis Center of Catalonia (Cemcat), Hospital Universitari Vall d\u2019Hebron, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1088-110X","authenticated-orcid":false,"given":"Amber","family":"Salter","sequence":"additional","affiliation":[{"name":"Department of Neurology, Section on Biostatistics and Clinical Informatics, UT Southwestern Medical Center, Dallas, TX, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Istvan","family":"Morocz","sequence":"additional","affiliation":[{"name":"The Neuro, Brain Imaging Centre, McGill University, Montr\u00e9al, QC, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qing","family":"Wang","sequence":"additional","affiliation":[{"name":"Neuroscience, F. Hoffmann-La Roche Ltd, Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6963-8892","authenticated-orcid":false,"given":"Jens","family":"Kuhle","sequence":"additional","affiliation":[{"name":"Departments of Biomedicine and Clinical Research, Neurology, Multiple Sclerosis Centre and Research Center for Clinical Neuroimmunology and Neuroscience (RC2NB), University Hospital Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven","family":"Chappell","sequence":"additional","affiliation":[{"name":"Neuroscience, F. Hoffmann-La Roche Ltd, Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruggero","family":"Capra","sequence":"additional","affiliation":[{"name":"Multiple Sclerosis Center, Montichiari Hospital, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cinzia","family":"Cordioli","sequence":"additional","affiliation":[{"name":"Multiple Sclerosis Center, Montichiari Hospital, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5175-9541","authenticated-orcid":false,"given":"Marcus","family":"D\u2019Souza","sequence":"additional","affiliation":[{"name":"Departments of Biomedicine and Clinical Research, Neurology, Multiple Sclerosis Centre and Research Center for Clinical Neuroimmunology and Neuroscience (RC2NB), University Hospital Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3031-7549","authenticated-orcid":false,"given":"Timothy","family":"Coetzee","sequence":"additional","affiliation":[{"name":"National Multiple Sclerosis Society, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xavier","family":"Montalban","sequence":"additional","affiliation":[{"name":"Department of Neurology, Multiple Sclerosis Center of Catalonia (Cemcat), Hospital Universitari Vall d\u2019Hebron, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4266-0106","authenticated-orcid":false,"given":"Douglas L.","family":"Arnold","sequence":"additional","affiliation":[{"name":"The Neuro, Brain Imaging Centre, McGill University, Montr\u00e9al, QC, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7776-6472","authenticated-orcid":false,"given":"Peter A.","family":"Calabresi","sequence":"additional","affiliation":[{"name":"Department of Neurological Sciences, Larner College of Medicine, University of Vermont, Burlington, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6892-104X","authenticated-orcid":false,"given":"Maria P.","family":"Sormani","sequence":"additional","affiliation":[{"name":"Department of Health Sciences, University of Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,8,22]]},"reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"crossref","unstructured":"Samjoo IA Worthington E Drudge C et al. Comparison of ofatumumab and other disease-modifying therapies for relapsing multiple sclerosis: a network meta-analysis. J Comp Eff Res 2020; 9(18): 1255\u20131274. https:\/\/doi.org\/10.2217\/cer-2020-0122","DOI":"10.2217\/cer-2020-0122"},{"key":"e_1_3_4_3_2","doi-asserted-by":"crossref","unstructured":"Kalincik T Cutter G Spelman T et al. Defining reliable disability outcomes in multiple sclerosis. Brain 2015; 138(Pt. 11): 3287\u20133298. https:\/\/doi.org\/10.1093\/brain\/awv258","DOI":"10.1093\/brain\/awv258"},{"key":"e_1_3_4_4_2","doi-asserted-by":"crossref","unstructured":"Montobbio N Carmisciano L Signori A et al. Creating an automated tool for a consistent and repeatable evaluation of disability progression in clinical studies for multiple sclerosis. Mult Scler 2024; 30(9): 1185\u20131192. https:\/\/doi.org\/10.1177\/13524585241243157","DOI":"10.1177\/13524585241243157"},{"key":"e_1_3_4_5_2","doi-asserted-by":"crossref","unstructured":"Sharmin S Lorscheider J Lizak N et al. MSoutcomes: CORe multiple sclerosis outcomes toolkit. R package version 0.2.1 2024 https:\/\/CRAN.R-project.org\/package=MSoutcomes","DOI":"10.32614\/CRAN.package.MSoutcomes"},{"key":"e_1_3_4_6_2","volume-title":"Guideline on clinical investigation of medicinal products for the treatment of Multiple Sclerosis","author":"European Medicines Agency","year":"2015","unstructured":"European Medicines Agency. Guideline on clinical investigation of medicinal products for the treatment of Multiple Sclerosis (EMA\/CHMP\/771815\/2011 Rev. 2). European Medicines Agency, 2015."},{"key":"e_1_3_4_7_2","doi-asserted-by":"crossref","unstructured":"D\u2019Souza M Heikkil\u00e4 A Lorscheider J et al. Electronic neurostatus-EDSS increases the quality of expanded disability status scale assessments: experience from two phase 3 clinical trials. Mult Scler 2020; 26(8): 993\u2013996. https:\/\/doi.org\/10.1177\/1352458519845108","DOI":"10.1177\/1352458519845108"},{"key":"e_1_3_4_8_2","doi-asserted-by":"crossref","unstructured":"Kappos L Wolinsky JS Giovannoni G et al. Contribution of relapse-independent progression vs relapse-associated worsening to overall confirmed disability accumulation in typical relapsing multiple sclerosis in a pooled analysis of 2 randomized clinical trials. JAMA Neurol 2020; 77(9): 1132\u20131140. https:\/\/doi.org\/10.1001\/jamaneurol.2020.1568","DOI":"10.1001\/jamaneurol.2020.1568"},{"key":"e_1_3_4_9_2","doi-asserted-by":"crossref","unstructured":"Lublin FD H\u00e4ring DA Ganjgahi H et al. How patients with multiple sclerosis acquire disability. Brain 2022; 145(9): 3147\u20133161. https:\/\/doi.org\/10.1093\/brain\/awac016","DOI":"10.1093\/brain\/awac016"},{"key":"e_1_3_4_10_2","doi-asserted-by":"crossref","unstructured":"Kappos L Butzkueven H Wiendl H et al. Greater sensitivity to multiple sclerosis disability worsening and progression events using a roving versus a fixed reference value in a prospective cohort study. Mult Scler 2018; 24(7): 963\u2013973. https:\/\/doi.org\/10.1177\/1352458517709619","DOI":"10.1177\/1352458517709619"}],"container-title":["Multiple Sclerosis Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/13524585261478492","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/13524585261478492","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/13524585261478492","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/13524585261478492","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,11,12]],"date-time":"2026-11-12T19:50:32Z","timestamp":1794513032000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/13524585261478492"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,22]]},"references-count":9,"journal-issue":{"issue":"13","published-print":{"date-parts":[[2026,11]]}},"alternative-id":["10.1177\/13524585261478492"],"URL":"https:\/\/doi.org\/10.1177\/13524585261478492","relation":{},"ISSN":["1352-4585","1477-0970"],"issn-type":[{"value":"1352-4585","type":"print"},{"value":"1477-0970","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,22]]}}}