Hilal Olla, Gupta Pratham, Luginaah Nasong Anthony, Moshref Leena, Askin Nicole, Epp Carla, Nassar Renee, Hirmiz Roaa, Paunic Milica, Hossami Mahmoud, Abdel-Nabi Rhonda, Touma Kayla, Sharma Depen, Fatima Rija, Akingbade Emmanuel, Hamm Caroline, Delisle Megan
Western University Faculty of Science, London, Ontario, Canada.
Western University Schulich School of Medicine & Dentistry, London, Ontario, Canada.
BMJ Open. 2025 Mar 29;15(3):e088828. doi: 10.1136/bmjopen-2024-088828.
Interventions are needed to increase participation in clinical trials through optimised trial design and enrolment workflows. Patient navigation is a promising intervention for increasing participation in clinical trials by optimising enrolment workflows. Patient navigation is defined as a personalised intervention aimed at overcoming barriers and ensuring timely access to healthcare services, diagnosis, treatment and care. This scoping review aims to fill a gap in current literature by summarising what is known about patient navigation, aiming to increase clinical trial participation.
A search was conducted for peer-reviewed literature published in English from inception through 21 December 2023, and the search was updated on 5 March 2025. Sources of literature included Cochrane CENTRAL (Ovid), MEDLINE (Ovid), EMBASE (Ovid), Cumulative Index of Nursing and Allied Health (CINAHL; on EBSCOhost; EBSCO Industries, Inc), Epistemonikos and PROSPERO databases. Searches were also conducted through the Turning Research into Practice and International Clinical Trials Registry Platform (WHO) databases, Google Scholar and the Agency for Health Research and Quality platform to ensure the retrieval of all relevant articles. Reference lists of eligible studies were also examined. The Google Scholar search was limited to the first 10 pages of results. The search strategy focused on the following key concepts: navigation (eg, navigator, care coordination, case management) and clinical trials. Searches were reviewed using the PRESS Peer Review of Electronic Search Strategies 2015. This review was guided based on the JBI methodology for scoping reviews using a five-step review process: identify the research questions; search and identify relevant studies; select studies based on a priori criterion; chart the data; and collate, summarise and report the results according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews.
This scoping review identifies and analyses existing research; therefore, ethics approval is not required. Findings will be disseminated through conference presentations and a publication in a scientific journal.
需要通过优化试验设计和入组流程来增加参与临床试验的人数。患者导航是一种很有前景的干预措施，可通过优化入组流程来提高参与临床试验的人数。患者导航被定义为一种个性化干预措施，旨在克服障碍并确保及时获得医疗服务、诊断、治疗和护理。本综述旨在通过总结关于患者导航的已知信息来填补当前文献中的空白，以提高临床试验的参与度。
检索了从创刊至2023年12月21日以英文发表的同行评审文献，并于2025年3月5日更新了检索。文献来源包括Cochrane CENTRAL（Ovid）、MEDLINE（Ovid）、EMBASE（Ovid）、护理及相关健康累积索引（CINAHL；在EBSCOhost上；EBSCO Industries, Inc）、Epistemonikos和PROSPERO数据库。还通过将研究转化为实践数据库和国际临床试验注册平台（世界卫生组织）、谷歌学术以及卫生研究与质量机构平台进行检索，以确保检索到所有相关文章。还检查了符合条件的研究的参考文献列表。谷歌学术搜索仅限于结果的前10页。搜索策略聚焦于以下关键概念：导航（如导航员、护理协调、病例管理）和临床试验。使用《2015年电子搜索策略同行评审》对搜索进行审查。本综述以JBI范围综述方法为指导，采用五步综述流程：确定研究问题；搜索并识别相关研究；根据预先设定的标准选择研究；绘制数据图表；并根据系统评价和Meta分析扩展版的首选报告项目对范围综述进行整理、总结和报告结果。
本范围综述识别并分析现有研究；因此，无需伦理批准。研究结果将通过会议报告和发表在科学期刊上进行传播。
