{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T13:25:38Z","timestamp":1789046738486,"version":"build-2803163510"},"reference-count":61,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Med Internet Res"],"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n Medical real-world data (RWD) are often siloed across organizations, making them inaccessible for research. Unlocking these data could advance clinical research and patient care. The pan-European Data Nexus platform (DNP) links RWD, facilitating its use, for example by artificial intelligence (AI) tools, to support the generation of real-world evidence. In Europe, particularly Germany, the secondary use of health data is governed by stringent regulatory requirements, including informed consent.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n This study evaluated the informed broad consent form for the RWD (Data Nexus) platform, predicated on the principles of the Medical Informatics Initiative in Germany, and contextualized its implications for future data governance and regulatory use of RWD.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n The broad consent form was developed for the DNP and cross-sectionally distributed to consecutive rheumatology outpatients during routine follow-up at a tertiary center. Analyses included rates of agreement to the predefined broad consent items. A zero-inflated model (using R) was used to predict response rates.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n From July 2023 to May 2024, 74.9% (292\/390) of the patients signed the broad consent form and consented to DNP data donation. Median age was 56 (IQR 43.0-65.0) years, 72.5% (211\/291) were female, and median disease duration was 12 (IQR 4.0-22.0) years. Diagnoses included rheumatoid arthritis (96\/291, 33.3%), psoriatic arthritis (30\/291, 10.3%), spondyloarthritis (15\/291, 5.2%), systemic lupus erythematosus (90\/291, 30.9%), systemic sclerosis (14\/291, 4.8%), and other conditions (16\/291, 5.5%). Patients also answered 8 yes\/no broad consent items, with an average of \u201cyes\u201d and \u201cno\u201d responses of 7.5 (SD 1.5) and 0.2 (SD 0.5), respectively. Missing responses averaged 0.4 (SD 1.4). Of all participants, 78.4% (228\/291) agreed to all broad consent items. Approval rates for individual items exceeded 86%, indicating strong patient acceptance of secondary use of RWD under a structured governance framework, possibly reflecting trust, perceived benefit, low perceived risk, and governance confidence. Importantly, patients agreed to new techniques such as AI-based analysis of their donated RWD and, despite the social and ethical sensitivity, data distribution to third parties, including commercial industry. Consent rates were also high for the use of valuable omics and genomics data from biomaterial donations. Women showed higher consent rates, whereas educational attainment was not an indicator of response behavior.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n This is the first study assessing the willingness of patients with inflammatory rheumatic diseases to grant broad consent for secondary data use in an innovative RWD platform, implementing a modern framework in routine care and considering detailed patient preferences. Patients demonstrated high willingness to grant broad consent, providing key real-world evidence on patients\u2019 actual consent behavior for implementing RWD platform integration\u2014such as the European Health Data Space. The DNP supports scalable, General Data Protection Regulation\u2013compliant data sharing, enabling real-world and AI-driven research while preserving patient trust.<\/jats:p>\n <\/jats:sec>","DOI":"10.2196\/80347","type":"journal-article","created":{"date-parts":[[2026,5,13]],"date-time":"2026-05-13T05:25:06Z","timestamp":1778649906000},"page":"e80347-e80347","source":"Crossref","is-referenced-by-count":1,"title":["High Patient Willingness to Grant Broad Consent for Real-World Data Use in Rheumatology\u2014Implications for Real-World Data Platform Governance: Cross-Sectional Study"],"prefix":"10.2196","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8194-3243","authenticated-orcid":false,"given":"Jutta G","family":"Richter","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-8646-8505","authenticated-orcid":false,"given":"Antonia","family":"Becker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5628-8398","authenticated-orcid":false,"given":"Tim","family":"Filla","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1987-3931","authenticated-orcid":false,"given":"Hasan","family":"Acar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-2677-786X","authenticated-orcid":false,"given":"Waldemar","family":"Ockert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-8418-3143","authenticated-orcid":false,"given":"Dominykas","family":"Kriauciunas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-0605-2059","authenticated-orcid":false,"given":"Edith","family":"Aggarwal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-6572-0038","authenticated-orcid":false,"given":"Markus","family":"Schr\u00f6der","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-9069-3532","authenticated-orcid":false,"given":"Ralf","family":"Hansen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7408-9333","authenticated-orcid":false,"given":"J\u00f6rg HW","family":"Distler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-2106-9196","authenticated-orcid":false,"given":"Matthias","family":"Schneider","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2026,6,8]]},"reference":[{"issue":"14","key":"R1","doi-asserted-by":"publisher","DOI":"10.3390\/cancers16142516","article-title":"Real-world-time data and RCT synergy: advancing personalized medicine and sarcoma care through digital innovation","volume":"16","author":"Heesen","journal-title":"Cancers (Basel)"},{"issue":"3","key":"R2","doi-asserted-by":"publisher","DOI":"10.1136\/rmdopen-2020-001403","article-title":"Incidence of facial nerve palsies stratified by DMARD treatment in patients with rheumatoid arthritis: data from the RABBIT register","volume":"6","author":"Meissner","journal-title":"RMD Open"},{"key":"R3","unstructured":"FORWARD - The National Databank for Rheumatic Diseases. 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