背景:区块链已被提出作为促进更多以患者为中心的研究和健康信息共享的关键技术。例如,它可以应用于协调和记录动态知情同意,允许个人不断审查和续签对收集的同意的程序,使用,或分享他们的私人健康信息。有人建议这样做是为了促进道德,顺应纵向研究,和病人的参与。然而,基于区块链的动态同意是一个相对较新的概念,目前尚不清楚建议的实现在实践中的效果如何。在健康研究环境中批判性评估实施的努力是有限的。
目的:本协议的目的是指导在健康研究环境中识别和评估基于区块链的动态同意的实施。从而促进未来研究的最佳实践的发展,创新,和执行。
方法:该方案描述了综合审查的方法,以评估广泛的定量和定性研究设计。PRISMA-P(系统审查和荟萃分析方案的首选报告项目)框架指导了审查的结构和报告结果的性质。我们在学术图书馆员的帮助下开发了搜索策略和语法。选择了多个数据库来识别相关的学术文献(CINAHL,Embase,OvidMEDLINE,PubMed,Scopus,和WebofScience)和灰色文献(电子论文在线服务,ProQuest论文和论文,开放获取论文和论文,和谷歌学者)全面了解该领域的进展。资格标准是根据PROSPERO(国际前瞻性系统审查登记册)要求和技术准备标准框架定义的。共有2名评审员独立评审和提取数据,而第三位审稿人将裁定差异。文章的质量评估和讨论的实施将基于经过验证的混合方法评估工具进行,主题将通过专题数据综合来确定。
结果:进行了文献检索,在删除重复项之后,492篇文章符合筛选条件。标题和摘要筛选允许删除312篇文章,根据纳入标准,留下180篇符合条件的文章进行全文审查,并确认项目可行性的足够文献。结果将综合基于区块链的动态同意的证据质量,以患者为中心的研究和健康信息共享,涵盖有效性,效率,满意,法规遵从性,以及管理身份的方法。
结论:该审查将全面介绍新兴的基于区块链的动态同意技术的进展以及实施的严格性。由此产生的见解有望为未来的研究提供最佳实践,创新,和实施有利于以患者为中心的研究和健康信息共享。
背景:PROSPEROCRD42023396983;http://tinyurl.com/cn8a5x7t。
■DERR1-10.2196/50339。
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.
BACKGROUND: PROSPERO CRD42023396983; http://tinyurl.com/cn8a5x7t.
UNASSIGNED: DERR1-10.2196/50339.