{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T13:56:58Z","timestamp":1791381418701,"version":"4.3.3"},"reference-count":17,"publisher":"BMJ","issue":"10","license":[{"start":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T00:00:00Z","timestamp":1791331200000},"content-version":"unspecified","delay-in-days":6,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"European Commissions\u2019","award":["101057263"],"award-info":[{"award-number":["101057263"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,9,15]]},"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Reperfusion therapies improve outcomes in acute ischaemic stroke, but hyperacute treatment decisions remain complex and are rarely informed by individualised outcome predictions. Artificial intelligence (AI)-based clinical decision support systems (CDSS) could provide real-time prognostic estimates, yet prospective evidence of their feasibility and performance within routine workflows is scarce. We aim to prospectively evaluate the real-time feasibility, usability and predictive performance of an AI-based CDSS (VALIDATE-CDSS) for individualised outcome prediction in acute stroke care.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>Prospective, multicentre observational study enrolling consecutive patients with acute ischaemic stroke at three tertiary stroke centres. Clinical management will follow standard practice at the discretion of treating physicians. In parallel, a dedicated researcher will collect patient data in real time and enter them into VALIDATE-CDSS via a mobile application, operating in shadow mode without influencing clinical decisions. The system will generate individualised predictions of 3-month functional outcome (modified Rankin Scale) for four treatment strategies (intravenous thrombolysis, endovascular thrombectomy, combined therapy or no reperfusion) at three sequential time points: baseline clinical data, non-contrast CT and CT angiography. The primary outcome is the real-world feasibility and usability of VALIDATE-CDSS within the hyperacute stroke workflow. Secondary outcomes include predictive performance, agreement between model-suggested and actual treatments, incremental value with increasing data availability and potential bias across predefined subgroups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Enrolment began after approval by the ethics committees of all participating centres (Vall d'Hebron Institut de Recerca, PR(AG)432-2023; Ethikkommission der Medizinischen Fakult\u00e4t Heidelberg, S-687\/2023; Helsinki Committee, Hadassah Medical Center-Ein Kerem, HMO-0529-22). Results will be disseminated through peer-reviewed open-access journals and conference presentations. Following open science principles, anonymised data and metadata will be deposited in the Zenodo repository on study completion.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05622539\">NCT05622539<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2026-120511","type":"journal-article","created":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T13:25:30Z","timestamp":1791379530000},"page":"e120511","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Real-time prospective (shadow mode) validation of an AI-based clinical decision support system for predicting 3-month functional outcome in acute stroke: the VALIDATE study protocol"],"prefix":"10.1136","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct05622539","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05622539","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8100-9477","authenticated-orcid":false,"given":"Marta","family":"Rubiera","sequence":"first","affiliation":[{"name":"Stroke Unit, Hospital Universitari Vall d\u2019Hebron, Barcelona, Spain"},{"name":"Stroke Research Group, Vall d\u2019Hebron Institut de Recerca, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Bendszus","sequence":"additional","affiliation":[{"name":"Department of Neuroradiology, University of Heidelberg, Heidelberg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronen R","family":"Leker","sequence":"additional","affiliation":[{"name":"Department of Neurology, Hebrew University Hadassah Medical School, Yerushalayim, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3447-5453","authenticated-orcid":false,"given":"Adam","family":"Hilbert","sequence":"additional","affiliation":[{"name":"Charit\u00e9 Lab for Artificial Intelligence in Medicine (CLAIM), Charit\u00e9 - Universit\u00e4tsmedizin Berlin, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ingo","family":"Werren","sequence":"additional","affiliation":[{"name":"Digital Health Department, IBM iX GmbH, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8072-3994","authenticated-orcid":false,"given":"Luis Miguel","family":"Lopez-Ramos","sequence":"additional","affiliation":[{"name":"Simula Metropolitan Center for Digital Engineering AS, Oslo, Norway"},{"name":"Fuenlabrada School of Engineering, Rey Juan Carlos University, Fuenlabrada, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mercedes","family":"Ayesta","sequence":"additional","affiliation":[{"name":"NORA Health, Sant Cugat, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Que","family":"Nguyen","sequence":"additional","affiliation":[{"name":"Technological University Dublin, Dublin, Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9681-5973","authenticated-orcid":false,"given":"Sussane","family":"Bonekamp","sequence":"additional","affiliation":[{"name":"Department of Neuroradiology, University of Heidelberg, Heidelberg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victoria","family":"Sala","sequence":"additional","affiliation":[{"name":"Stroke Research Group, Vall d\u2019Hebron Institut de Recerca, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hamza","family":"Jubran","sequence":"additional","affiliation":[{"name":"Department of Neurology, Hebrew University Hadassah Medical School, Yerushalayim, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia","family":"Meza","sequence":"additional","affiliation":[{"name":"Stroke Research Group, Vall d\u2019Hebron Institut de Recerca, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fatma","family":"Shalabi","sequence":"additional","affiliation":[{"name":"Department of Neurology, Hebrew University Hadassah Medical School, Yerushalayim, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoel","family":"Schwartzmann","sequence":"additional","affiliation":[{"name":"Department of Neurology, Hebrew University Hadassah Medical School, Yerushalayim, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Cano","sequence":"additional","affiliation":[{"name":"NORA Health, Sant Cugat, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Malte","family":"von Tottleben","sequence":"additional","affiliation":[{"name":"Digital Health, Empirica Gesellschaft f\u00fcr Kommunikations- und Technologieforschung mbH, Bonn, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Kelleher","sequence":"additional","affiliation":[{"name":"ADAPT Research Centre, School of Computer Science and Statistics, Trinity College, Dublin, Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dietmar","family":"Frey","sequence":"additional","affiliation":[{"name":"Charit\u00e9 Lab for Artificial Intelligence in Medicine (CLAIM), Charit\u00e9 - Universit\u00e4tsmedizin Berlin, Berlin, Germany"},{"name":"Corporate Member of Freie Universit\u00e4t Berlin and Humboldt-Universit\u00e4t zu Berlin, Department of Neurosurgery, Charit\u00e9 - Universit\u00e4tsmedizin Berlin, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,10,7]]},"reference":[{"key":"2026100706251635000_16.10.e120511.1","doi-asserted-by":"crossref","unstructured":"Gonzalez-Smith J , Shen H , Singletary E , et al . 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