{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,13]],"date-time":"2026-03-13T07:22:09Z","timestamp":1773386529116,"version":"3.50.1"},"reference-count":36,"publisher":"Public Library of Science (PLoS)","issue":"10","license":[{"start":{"date-parts":[[2025,10,7]],"date-time":"2025-10-07T00:00:00Z","timestamp":1759795200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100007366","name":"Fondazione Italiana Sclerosi Multipla","doi-asserted-by":"publisher","award":["2020\/R-Multi\/024"],"award-info":[{"award-number":["2020\/R-Multi\/024"]}],"id":[{"id":"10.13039\/100007366","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100003196","name":"Ministero della Salute","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003196","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Background<\/jats:title>\n<jats:p>Advance care planning (ACP) practice in people with progressive multiple sclerosis (PwPMS) remains limited. ConCure-SM project aims to assess the effectiveness of a structured ACP intervention (clinician\u2019s training programme and use of a booklet during ACP conversations) using a multi-phased design.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Methods<\/jats:title>\n<jats:p>Single-arm pilot\/feasibility trial involving PwPMS, their significant others (SOs), and clinicians from six Italian centers. Primary study outcome was completion of an advance care plan document (ACP-Doc). Other outcomes included safety, feasibility of enrollment and assessment, and (analyzed using mixed-methods approach) Hospital Anxiety and Depression Scale (HADS), quality of communication, quality of life (MSQOL-29), and caregiver burden. Participants were interviewed to identify factors influencing the ACP implementation process.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Results<\/jats:title>\n<jats:p>Seventy-five PwPMS were eligible out of 164 screened; 56\/75 (75%) refused participation and 19 were included. Of these, 11 (58% vs 30% hypothesized) completed the ACP-Doc. A total of 25 adverse events (increase in anxiety) occurred, three possibly related to the intervention, and we found a worsening of HADS-Anxiety score (<jats:italic><jats:italic>p<\/jats:italic><\/jats:italic>\u2009=\u20090.02) and MSQOL-29 mental health composite score (<jats:italic><jats:italic>p<\/jats:italic><\/jats:italic>\u2009=\u20090.04) during follow-up. PwPMS\/SO interviews revealed four themes: significance of the ACP process (on the individual, on relation with clinicians), its impact (on emotions, on family relations), preparedness as key, and challenges (practicability, SO commitment). Barriers and facilitators for ACP were identified in two clinician focus groups.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Conclusions<\/jats:title>\n<jats:p>The intervention supported neurologists in guiding PwPMS in their ACP. However, trial findings and the high proportion of refusals point to the need to enrich the intervention with a new component targeting PwPMS and SOs.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec005\">\n<jats:title>Trial registration<\/jats:title>\n<jats:p>ISRCTN48527663.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0331220","type":"journal-article","created":{"date-parts":[[2025,10,7]],"date-time":"2025-10-07T17:23:36Z","timestamp":1759857816000},"page":"e0331220","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":1,"title":["Advance care planning in multiple sclerosis (ConCure-SM): A multicenter single-arm pilot and feasibility study"],"prefix":"10.1371","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9930-7579","authenticated-orcid":true,"given":"Alessandra","family":"Solari","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ludovica","family":"De Panfilis","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8012-2451","authenticated-orcid":true,"given":"Roberta Martina","family":"Zagarella","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luca","family":"Ghirotto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mariangela","family":"Farinotti","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alberto","family":"Gajofatto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria Grazia","family":"Grasso","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paola","family":"Kruger","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2902-5589","authenticated-orcid":true,"given":"Alessandra","family":"Lugaresi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katia","family":"Mattarozzi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sara","family":"Montepietra","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francesco","family":"Patti","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eugenio","family":"Pucci","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michela","family":"Rimondini","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claudio","family":"Solaro","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marta","family":"Perin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrea","family":"Giordano","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9555-7252","authenticated-orcid":true,"given":"Simone","family":"Veronese","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"on behalf of the ConCure-SM project","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2025,10,7]]},"reference":[{"issue":"14","key":"pone.0331220.ref001","doi-asserted-by":"crossref","first-page":"1816","DOI":"10.1177\/1352458520970841","article-title":"Rising prevalence of multiple sclerosis worldwide: Insights from the Atlas of MS, third edition","volume":"26","author":"C Walton","year":"2020","journal-title":"Mult Scler"},{"issue":"1","key":"pone.0331220.ref002","doi-asserted-by":"crossref","first-page":"43","DOI":"10.1038\/s41572-018-0041-4","article-title":"Multiple sclerosis","volume":"4","author":"M Filippi","year":"2018","journal-title":"Nat Rev Dis Primers"},{"issue":"8","key":"pone.0331220.ref003","doi-asserted-by":"crossref","DOI":"10.1212\/WNL.0000000000008907","article-title":"Multiple cause of death analysis in multiple sclerosis: A population-based study","volume":"94","author":"K Harding","year":"2020","journal-title":"Neurology"},{"issue":"8","key":"pone.0331220.ref004","doi-asserted-by":"crossref","first-page":"621","DOI":"10.1136\/jnnp-2016-315238","article-title":"Survival and cause of death in multiple sclerosis: a 60-year longitudinal population study","volume":"88","author":"HMB Lunde","year":"2017","journal-title":"J Neurol Neurosurg Psychiatry"},{"issue":"9","key":"pone.0331220.ref005","article-title":"Definition and recommendations for advance care planning: an international consensus supported by the European Association for Palliative Care","volume":"18","author":"JAC Rietjens","year":"2017","journal-title":"Lancet Oncol"},{"key":"pone.0331220.ref006","author":"A Coulter","year":"2011"},{"key":"pone.0331220.ref007","article-title":"A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance","volume":"374","author":"K Skivington","year":"2021","journal-title":"BMJ"},{"issue":"3","key":"pone.0331220.ref008","doi-asserted-by":"crossref","first-page":"1145","DOI":"10.1007\/s10072-023-07087-y","article-title":"User appraisal of a booklet for advance care planning in multiple sclerosis: a multicenter, qualitative Italian study","volume":"45","author":"A Giordano","year":"2024","journal-title":"Neurol Sci"},{"issue":"8","key":"pone.0331220.ref009","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2021-052012","article-title":"Study protocol on advance care planning in multiple sclerosis (ConCure-SM): intervention construction and multicentre feasibility trial","volume":"11","author":"L De Panfilis","year":"2021","journal-title":"BMJ Open"},{"issue":"1","key":"pone.0331220.ref010","doi-asserted-by":"crossref","first-page":"406","DOI":"10.1186\/s13063-018-2735-z","article-title":"CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials","volume":"19","author":"S Grant","year":"2018","journal-title":"Trials"},{"key":"pone.0331220.ref011","article-title":"CONSORT 2010 statement: extension to randomised pilot and feasibility trials","volume":"355","author":"SM Eldridge","year":"2016","journal-title":"BMJ"},{"key":"pone.0331220.ref012","first-page":"21","article-title":"The Control Preferences Scale","volume":"29","author":"LF Degner","year":"1997","journal-title":"Can J Nurs Res"},{"issue":"6","key":"pone.0331220.ref013","article-title":"Role Preferences of People with Multiple Sclerosis: Image-Revised, Computerized Self-Administered Version of the Control Preference Scale","volume":"8","author":"AutoMS project","year":"2013","journal-title":"PLoS One"},{"issue":"6","key":"pone.0331220.ref014","doi-asserted-by":"crossref","first-page":"361","DOI":"10.1111\/j.1600-0447.1983.tb09716.x","article-title":"The hospital anxiety and depression scale","volume":"67","author":"AS Zigmond","year":"1983","journal-title":"Acta Psychiatr Scand"},{"issue":"3","key":"pone.0331220.ref015","first-page":"121","article-title":"Detecting psychological distress in cancer patients: validity of the Italian version of the Hospital Anxiety and Depression Scale","volume":"7","author":"M Costantini","year":"1999","journal-title":"Support Care Cancer"},{"issue":"1","key":"pone.0331220.ref016","doi-asserted-by":"crossref","first-page":"34","DOI":"10.1111\/j.1369-7625.2004.00311.x","article-title":"The OPTION scale: measuring the extent that clinicians involve patients in decision\u2010making tasks","volume":"8","author":"G Elwyn","year":"2005","journal-title":"Health Expect"},{"issue":"4","key":"pone.0331220.ref017","doi-asserted-by":"crossref","first-page":"339","DOI":"10.1017\/S1121189X00002529","article-title":"The assessment of patient involvement across consultation. The Italian version of the OPTION scale","volume":"16","author":"C Goss","year":"2007","journal-title":"Epidemiol Psichiatr Soc"},{"issue":"6","key":"pone.0331220.ref018","doi-asserted-by":"crossref","first-page":"856","DOI":"10.1177\/1352458518774935","article-title":"eMSQOL-29: Prospective validation of the abbreviated, electronic version of MSQOL-54","volume":"25","author":"R Rosato","year":"2019","journal-title":"Mult Scler"},{"issue":"4","key":"pone.0331220.ref019","doi-asserted-by":"crossref","first-page":"494","DOI":"10.1017\/S0714980800012484","article-title":"Reliability, Validity and Reference Values of the Zarit Burden Interview for Assessing Informal Caregivers of Community-Dwelling Older Persons with Dementia","volume":"19","author":"R H\u00e9bert","year":"2000","journal-title":"Can J Aging"},{"issue":"5","key":"pone.0331220.ref020","doi-asserted-by":"crossref","first-page":"797","DOI":"10.1017\/S1041610210002218","article-title":"The Italian version of the Zarit Burden interview: a validation study","volume":"23","author":"R Chattat","year":"2011","journal-title":"Int Psychogeriatr"},{"issue":"5","key":"pone.0331220.ref021","doi-asserted-by":"crossref","first-page":"1086","DOI":"10.1089\/jpm.2006.9.1086","article-title":"Psychometric characteristics of a quality of communication questionnaire assessing communication about end-of-life care","volume":"9","author":"R Engelberg","year":"2006","journal-title":"J Palliat Med"},{"issue":"4","key":"pone.0331220.ref022","doi-asserted-by":"crossref","first-page":"669","DOI":"10.1016\/j.jpainsymman.2016.10.367","article-title":"Measuring Advance Care Planning: Optimizing the Advance Care Planning Engagement Survey","volume":"53","author":"RL Sudore","year":"2017","journal-title":"J Pain Symptom Manage"},{"issue":"3","key":"pone.0331220.ref023","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0282960","article-title":"Italian cross-cultural adaptation of the Quality of Communication questionnaire and the 4-item advance care planning engagement questionnaire","volume":"18","author":"L De Panfilis","year":"2023","journal-title":"PLoS One"},{"issue":"6","key":"pone.0331220.ref024","doi-asserted-by":"crossref","first-page":"349","DOI":"10.1093\/intqhc\/mzm042","article-title":"Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups","volume":"19","author":"A Tong","year":"2007","journal-title":"Int J Qual Health Care"},{"issue":"2","key":"pone.0331220.ref025","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1191\/1478088706qp063oa","article-title":"Using thematic analysis in psychology","volume":"3","author":"V Braun","year":"2006","journal-title":"Qualitat Res Psychol"},{"issue":"1","key":"pone.0331220.ref026","doi-asserted-by":"crossref","first-page":"80","DOI":"10.1186\/s13012-018-0758-1","article-title":"Using Normalization Process Theory in feasibility studies and process evaluations of complex healthcare interventions: a systematic review","volume":"13","author":"CR May","year":"2018","journal-title":"Implement Sci"},{"key":"pone.0331220.ref027","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.h1258","article-title":"Process evaluation of complex interventions: Medical Research Council guidance","volume":"350","author":"GF Moore","year":"2015","journal-title":"BMJ"},{"issue":"1","key":"pone.0331220.ref028","doi-asserted-by":"crossref","first-page":"135","DOI":"10.1186\/s12874-018-0591-x","article-title":"Improving the normalization of complex interventions: part 2 - validation of the NoMAD instrument for assessing implementation work based on normalization process theory (NPT)","volume":"18","author":"TL Finch","year":"2018","journal-title":"BMC Med Res Methodol"},{"issue":"17","key":"pone.0331220.ref029","doi-asserted-by":"crossref","first-page":"1316","DOI":"10.1136\/heartjnl-2019-314758","article-title":"Clinician-targeted interventions to improve advance care planning in heart failure: a systematic review and meta-analysis","volume":"105","author":"M Schichtel","year":"2019","journal-title":"Heart"},{"issue":"1","key":"pone.0331220.ref030","doi-asserted-by":"crossref","first-page":"78","DOI":"10.1186\/s12889-024-21209-x","article-title":"Factors related to patients\u2019 readiness for advance care planning: a systematic review","volume":"25","author":"MA Rezaei","year":"2025","journal-title":"BMC Public Health"},{"issue":"7","key":"pone.0331220.ref031","article-title":"Interventions for interpersonal communication about end of life care between health practitioners and affected people","volume":"7","author":"RE Ryan","year":"2022","journal-title":"Cochrane Database Syst Rev"},{"issue":"6","key":"pone.0331220.ref032","doi-asserted-by":"crossref","first-page":"751","DOI":"10.1001\/jamainternmed.2019.0077","article-title":"Effect of the Serious Illness Care Program in Outpatient Oncology: A Cluster Randomized Clinical Trial","volume":"179","author":"R Bernacki","year":"2019","journal-title":"JAMA Intern Med"},{"issue":"6","key":"pone.0331220.ref033","doi-asserted-by":"crossref","first-page":"715","DOI":"10.1200\/JCO.2006.06.7827","article-title":"Randomized Controlled Trial of a Prompt List to Help Advanced Cancer Patients and Their Caregivers to Ask Questions About Prognosis and End-of-Life Care","volume":"25","author":"JM Clayton","year":"2007","journal-title":"J Clin Oncol"},{"issue":"10","key":"pone.0331220.ref034","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0240815","article-title":"A realist review of advance care planning for people with multiple sclerosis and their families","volume":"15","author":"L Cottrell","year":"2020","journal-title":"PLoS One"},{"key":"pone.0331220.ref035","doi-asserted-by":"crossref","first-page":"111","DOI":"10.1186\/1741-7015-11-111","article-title":"Evaluating complex interventions in end of life care: the MORECare statement on good practice generated by a synthesis of transparent expert consultations and systematic reviews","volume":"11","author":"IJ Higginson","year":"2013","journal-title":"BMC Med"},{"key":"pone.0331220.ref036","article-title":"Education needs in palliative care and advance care planning of Italian residents in neurology: An online survey","author":"A Bombaci","year":"2024","journal-title":"Eur J Neurol"}],"container-title":["PLOS One"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0331220","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,7]],"date-time":"2025-10-07T17:23:45Z","timestamp":1759857825000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0331220"}},"subtitle":[],"editor":[{"given":"Nayanatara Arun","family":"Kumar","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2025,10,7]]},"references-count":36,"journal-issue":{"issue":"10","published-online":{"date-parts":[[2025,10,7]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0331220","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10,7]]}}}