PMID- 38315514 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20240222 IS - 1929-0748 (Print) IS - 1929-0748 (Electronic) IS - 1929-0748 (Linking) VI - 13 DP - 2024 Feb 5 TI - Blockchain-Based Dynamic Consent and its Applications for Patient-Centric Research and Health Information Sharing: Protocol for an Integrative Review. PG - e50339 LID - 10.2196/50339 [doi] LID - e50339 AB - BACKGROUND: Blockchain has been proposed as a critical technology to facilitate more patient-centric research and health information sharing. For instance, it can be applied to coordinate and document dynamic informed consent, a procedure that allows individuals to continuously review and renew their consent to the collection, use, or sharing of their private health information. Such has been suggested to facilitate ethical, compliant longitudinal research, and patient engagement. However, blockchain-based dynamic consent is a relatively new concept, and it is not yet clear how well the suggested implementations will work in practice. Efforts to critically evaluate implementations in health research contexts are limited. OBJECTIVE: The objective of this protocol is to guide the identification and critical appraisal of implementations of blockchain-based dynamic consent in health research contexts, thereby facilitating the development of best practices for future research, innovation, and implementation. METHODS: The protocol describes methods for an integrative review to allow evaluation of a broad range of quantitative and qualitative research designs. The PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) framework guided the review's structure and nature of reporting findings. We developed search strategies and syntax with the help of an academic librarian. Multiple databases were selected to identify pertinent academic literature (CINAHL, Embase, Ovid MEDLINE, PubMed, Scopus, and Web of Science) and gray literature (Electronic Theses Online Service, ProQuest Dissertations and Theses, Open Access Theses and Dissertations, and Google Scholar) for a comprehensive picture of the field's progress. Eligibility criteria were defined based on PROSPERO (International Prospective Register of Systematic Reviews) requirements and a criteria framework for technology readiness. A total of 2 reviewers will independently review and extract data, while a third reviewer will adjudicate discrepancies. Quality appraisal of articles and discussed implementations will proceed based on the validated Mixed Method Appraisal Tool, and themes will be identified through thematic data synthesis. RESULTS: Literature searches were conducted, and after duplicates were removed, 492 articles were eligible for screening. Title and abstract screening allowed the removal of 312 articles, leaving 180 eligible articles for full-text review against inclusion criteria and confirming a sufficient body of literature for project feasibility. Results will synthesize the quality of evidence on blockchain-based dynamic consent for patient-centric research and health information sharing, covering effectiveness, efficiency, satisfaction, regulatory compliance, and methods of managing identity. CONCLUSIONS: The review will provide a comprehensive picture of the progress of emerging blockchain-based dynamic consent technologies and the rigor with which implementations are approached. Resulting insights are expected to inform best practices for future research, innovation, and implementation to benefit patient-centric research and health information sharing. TRIAL REGISTRATION: PROSPERO CRD42023396983; http://tinyurl.com/cn8a5x7t. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/50339. CI - (c)Wendy M Charles, Mark B van der Waal, Joost Flach, Arno Bisschop, Raymond X van der Waal, Hadil Es-Sbai, Christopher J McLeod. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 05.02.2024. FAU - Charles, Wendy M AU - Charles WM AUID- ORCID: 0000-0003-1627-6899 AD - Health Administration Program, Business School, University of Colorado, Denver, Denver, CO, United States. AD - Healthcare Informatics Program, University of Denver, Denver, CO, United States. FAU - van der Waal, Mark B AU - van der Waal MB AUID- ORCID: 0000-0001-7575-1309 AD - Triall, Maarssen, Netherlands. AD - Athena Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands. FAU - Flach, Joost AU - Flach J AUID- ORCID: 0000-0002-4431-6096 AD - Triall, Maarssen, Netherlands. FAU - Bisschop, Arno AU - Bisschop A AUID- ORCID: 0000-0002-9814-6459 AD - Triall, Maarssen, Netherlands. FAU - van der Waal, Raymond X AU - van der Waal RX AUID- ORCID: 0000-0002-9795-9773 AD - Triall, Maarssen, Netherlands. FAU - Es-Sbai, Hadil AU - Es-Sbai H AUID- ORCID: 0009-0003-1463-1532 AD - Triall, Maarssen, Netherlands. FAU - McLeod, Christopher J AU - McLeod CJ AUID- ORCID: 0000-0001-6851-0152 AD - Department of Cardiovascular Medicine, Mayo Clinic, Jacksonville, FL, United States. LA - eng PT - Journal Article DEP - 20240205 PL - Canada TA - JMIR Res Protoc JT - JMIR research protocols JID - 101599504 PMC - PMC10877491 OTO - NOTNLM OT - best practices OT - blockchain OT - clinical trial OT - data reuse OT - data sharing OT - dynamic consent OT - health care data OT - integrative research review OT - scientific rigor OT - technology implementation COIS- Conflicts of Interest: None declared. EDAT- 2024/02/05 14:43 MHDA- 2024/02/05 14:44 PMCR- 2024/02/05 CRDT- 2024/02/05 11:53 PHST- 2023/06/27 00:00 [received] PHST- 2023/12/07 00:00 [accepted] PHST- 2023/12/01 00:00 [revised] PHST- 2024/02/05 14:44 [medline] PHST- 2024/02/05 14:43 [pubmed] PHST- 2024/02/05 11:53 [entrez] PHST- 2024/02/05 00:00 [pmc-release] AID - v13i1e50339 [pii] AID - 10.2196/50339 [doi] PST - epublish SO - JMIR Res Protoc. 2024 Feb 5;13:e50339. doi: 10.2196/50339.