临床研究护士在开展去中心化临床试验中的利用情况与角色：一项文献综述
Clinical research nurse utilisation and role in the conduct of decentralised clinical trials: a literature review.
作者信息
Johnson Elizabeth, Marsh Lisa
机构信息
Assistant Professor, Mark & Robyn Jones College of Nursing, Montana State University, Bozeman, MT, USA.
Adjunct Faculty, Buntain College of Nursing, Northwest University, Kirkland, WA, USA.
出版信息
J Res Nurs. 2023 May;28(3):214-226. doi: 10.1177/17449871231162497. Epub 2023 Jun 13.
BACKGROUND
The decentralised clinical trial (DCT) model has been popularised given its remote or virtual design, permitting expanded participant enrolment into community settings. Clinical research nurses (CRNs) are specially trained in the management of clinical trials; however, the utilisation of the research nurse role relating to decentralised trial conduct is not well-established.
AIMS
A literature review was conducted to describe the role of the research nurse in the conduct of DCTs and the current utilisation of this nurse specialty for decentralised trial management.
METHODS
Use of keywords 'DCT' or 'virtual trial' and 'nursing' were used to identify full-text, peer-reviewed literature in the English language and published within the last 10 years that described the clinical research nursing role.
RESULTS
Of the 102 pre-screened articles identified across five databases, 11 articles were eligible for full-text analysis. Thematic groupings of common discussion elements included , and and .
CONCLUSIONS
Implications of this literature review include expanded trial sponsor awareness of the support requirements to facilitate research nurse utilisation and optimal decentralised trial conduct.
背景
分散式临床试验（DCT）模式因其远程或虚拟设计而受到推广，允许在社区环境中扩大参与者招募。临床研究护士（CRN）在临床试验管理方面接受过专门培训；然而，与分散式试验开展相关的研究护士角色的利用尚未得到充分确立。
目的
进行一项文献综述，以描述研究护士在分散式临床试验开展中的作用以及该护士专业在分散式试验管理中的当前利用情况。
方法
使用关键词“DCT”或“虚拟试验”以及“护理”来识别过去10年内发表的、以英文撰写的、经过同行评审的全文文献，这些文献描述了临床研究护理角色。
结果
在五个数据库中确定的102篇预筛选文章中，有11篇文章符合全文分析的条件。常见讨论元素的主题分组包括 、 以及 和 。
结论
该文献综述的意义包括扩大试验申办者对支持需求的认识，以促进研究护士的利用和优化分散式试验的开展。
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