• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法,用中文像聊天一样搜索,搜遍4000万医学文献。AI智能推荐,让科研检索更轻松。

立即免费搜索

文件翻译

保留排版,准确专业,支持PDF/Word/PPT等文件格式,支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述,25分钟生成高质量综述,智能提取关键信息,辅助科研写作。

立即免费体验

揭示临床研究护理的专业领域:采用数据挖掘方法的范围综述

Uncovering the Professional Landscape of Clinical Research Nursing: A Scoping Review with Data Mining Approach.

作者信息

Bozzetti Mattia, Guberti Monica, Lo Cascio Alessio, Privitera Daniele, Genna Catia, Rodelli Silvia, Turchini Laura, Amatucci Valeria, Giordano Luciana Nicola, Mora Vincenzina, Napolitano Daniele, Caruso Rosario

机构信息

Department of Biomedicine and Prevention, University of Rome Tor Vergata, 00133 Rome, Italy.

Allied Health Professions Directorate, Orthopedic Research Institute, 40136 Bologna, Italy.

出版信息

Nurs Rep. 2025 Jul 24;15(8):266. doi: 10.3390/nursrep15080266.

DOI:10.3390/nursrep15080266
PMID:40863653
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12388699/
Abstract

: Clinical Research Nurses (CRNs) have emerged as pivotal actors in the conduct, coordination, and oversight of clinical trials globally. Over the past three decades, the role of the CRN has evolved in response to the increasing complexity of research protocols, ethical standards, and regulatory frameworks. Originating as task-oriented support figures, CRNs have progressively assumed broader responsibilities that include patient advocacy, protocol integrity, ethical vigilance, and interprofessional coordination. By mapping the global literature on CRNs, this review will examine how their role has been defined, implemented, and evaluated over the past three decades. : A scoping review was conducted using JBI methodology and PRISMA-ScR guidelines. The search covered the peer-reviewed and gray literature from 1990 to 2024 across major databases. Data analysis combined traditional extraction with topic modeling, Multiple Correspondence Analysis, and k-means clustering to identify key themes. : From the 128 included studies, four major themes emerged: clinical trial management, role perception and team integration, professional competencies and development, and systemic barriers. Despite formal competency frameworks, CRNs face inconsistencies in role recognition, unstable contracts, and limited career pathways. Emotional strain and professional isolation are recurrent. Over time, their functions have evolved from task execution to broader responsibilities, including advocacy and ethical oversight. However, no studies reported patient-level outcomes, revealing a critical gap in the evidence base. : CRNs play a vital but undervalued role in clinical research. Persistent structural challenges hinder their development and visibility. Enhancing institutional support and generating outcome-based evidence are necessary steps toward fully integrating CRNs into research infrastructures.

摘要

临床研究护士(CRNs)已成为全球临床试验开展、协调和监督的关键角色。在过去三十年中,CRN的角色随着研究方案、伦理标准和监管框架日益复杂而不断演变。CRNs最初是面向任务的支持人员,逐渐承担了更广泛的职责,包括患者权益倡导、方案完整性维护、伦理警觉和跨专业协调。通过梳理关于CRNs的全球文献,本综述将考察其角色在过去三十年中是如何被定义、实施和评估的。

采用JBI方法和PRISMA-ScR指南进行了一项范围综述。检索涵盖了1990年至2024年各大数据库中的同行评审文献和灰色文献。数据分析将传统提取方法与主题建模、多重对应分析和k均值聚类相结合,以确定关键主题。

在纳入的128项研究中,出现了四个主要主题:临床试验管理、角色认知与团队整合、专业能力与发展以及系统性障碍。尽管有正式的能力框架,但CRNs在角色认可方面存在不一致、合同不稳定且职业发展路径有限。情绪压力和职业孤立屡见不鲜。随着时间的推移,他们的职能已从任务执行演变为更广泛的职责,包括倡导和伦理监督。然而,没有研究报告患者层面的结果,这揭示了证据基础中的一个关键差距。

CRNs在临床研究中发挥着至关重要但却被低估的作用。持续存在的结构性挑战阻碍了他们的发展和知名度。加强机构支持并生成基于结果的证据是将CRNs全面纳入研究基础设施的必要步骤。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d85/12388699/1750c8d53e73/nursrep-15-00266-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d85/12388699/a0178dc8730b/nursrep-15-00266-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d85/12388699/c331a687256f/nursrep-15-00266-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d85/12388699/8a25977d2d0e/nursrep-15-00266-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d85/12388699/1750c8d53e73/nursrep-15-00266-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d85/12388699/a0178dc8730b/nursrep-15-00266-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d85/12388699/c331a687256f/nursrep-15-00266-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d85/12388699/8a25977d2d0e/nursrep-15-00266-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d85/12388699/1750c8d53e73/nursrep-15-00266-g004.jpg

相似文献

1
Uncovering the Professional Landscape of Clinical Research Nursing: A Scoping Review with Data Mining Approach.揭示临床研究护理的专业领域:采用数据挖掘方法的范围综述
Nurs Rep. 2025 Jul 24;15(8):266. doi: 10.3390/nursrep15080266.
2
Prescription of Controlled Substances: Benefits and Risks管制药品的处方:益处与风险
3
Health professionals' experience of teamwork education in acute hospital settings: a systematic review of qualitative literature.医疗专业人员在急症医院环境中团队合作教育的经验:对定性文献的系统综述
JBI Database System Rev Implement Rep. 2016 Apr;14(4):96-137. doi: 10.11124/JBISRIR-2016-1843.
4
Experiences of registered nurses as managers and leaders in residential aged care facilities: a systematic review.注册护士在养老院的管理和领导经验:系统评价。
Int J Evid Based Healthc. 2011 Dec;9(4):388-402. doi: 10.1111/j.1744-1609.2011.00239.x.
5
Factors that impact on the use of mechanical ventilation weaning protocols in critically ill adults and children: a qualitative evidence-synthesis.影响重症成人和儿童机械通气撤机方案使用的因素:一项定性证据综合分析
Cochrane Database Syst Rev. 2016 Oct 4;10(10):CD011812. doi: 10.1002/14651858.CD011812.pub2.
6
Home treatment for mental health problems: a systematic review.心理健康问题的居家治疗:一项系统综述
Health Technol Assess. 2001;5(15):1-139. doi: 10.3310/hta5150.
7
The use of Open Dialogue in Trauma Informed Care services for mental health consumers and their family networks: A scoping review.创伤知情护理服务中使用开放对话模式为心理健康消费者及其家庭网络提供服务:范围综述。
J Psychiatr Ment Health Nurs. 2024 Aug;31(4):681-698. doi: 10.1111/jpm.13023. Epub 2024 Jan 17.
8
Digital credentials for environmental competencies: A scoping review of open recognition systems in climate education.环境能力的数字证书:气候教育中开放认可系统的范围审查
Open Res Eur. 2025 Aug 11;5:138. doi: 10.12688/openreseurope.20048.3. eCollection 2025.
9
An Integrative Review of Specialised Nursing Career Frameworks to Develop a Nursing Career Framework for Registered Nurses Working in Aged Care.一项关于专业护理职业框架的综合综述,旨在为从事老年护理工作的注册护士制定护理职业框架。
J Adv Nurs. 2024 Dec 18. doi: 10.1111/jan.16674.
10
[Entrustment: Innovation and Practice in Nursing Education].[委托:护理教育中的创新与实践]
Hu Li Za Zhi. 2025 Aug;72(4):4-6. doi: 10.6224/JN.202508_72(4).01.

本文引用的文献

1
Implementing research, improving practice: synergizing the clinical research nurse and the nurse researcher.
Minerva Gastroenterol (Torino). 2025 Jul 3. doi: 10.23736/S2724-5985.25.03976-2.
2
Shaping the future research agenda of Cancer Nursing in Italy: Insights and strategic directions.塑造意大利癌症护理的未来研究议程:见解与战略方向。
J Cancer Policy. 2024 Dec;42:100505. doi: 10.1016/j.jcpo.2024.100505. Epub 2024 Sep 8.
3
Assessment of Nursing Workload and Complexity Associated with Oncology Clinical Trials: A Scoping Review.评估与肿瘤学临床试验相关的护理工作量和复杂性:范围综述。
Semin Oncol Nurs. 2024 Oct;40(5):151711. doi: 10.1016/j.soncn.2024.151711. Epub 2024 Aug 17.
4
Clinical research nurses perceive their role as being like the hub of a wheel without real power: Empirical qualitative research.临床研究护士认为他们的角色就像没有实权的车轮轮毂:实证定性研究。
Nurs Open. 2024 May;11(5):e2183. doi: 10.1002/nop2.2183.
5
Operational complexities in international clinical trials: a systematic review of challenges and proposed solutions.国际临床试验中的操作复杂性:挑战与解决方案的系统评价。
BMJ Open. 2024 Apr 15;14(4):e077132. doi: 10.1136/bmjopen-2023-077132.
6
Enhancing competency of clinical research nurses: A comprehensive training and evaluation framework.提高临床研究护士的能力:一个全面的培训与评估框架。
World J Clin Cases. 2024 Mar 6;12(7):1378-1381. doi: 10.12998/wjcc.v12.i7.1378.
7
Enhancing the clinical research workforce: a collaborative approach with human resources.加强临床研究人员队伍:与人力资源部门的协作方法。
Front Pharmacol. 2024 Feb 7;15:1295155. doi: 10.3389/fphar.2024.1295155. eCollection 2024.
8
Challenges regarding informed consent in recruitment to clinical research: a qualitative study of clinical research nurses' experiences.知情同意在临床研究招募中的挑战:一项临床研究护士经验的定性研究。
Trials. 2023 Dec 11;24(1):801. doi: 10.1186/s13063-023-07844-6.
9
Construction of clinical research nurse training program based on position competence.基于岗位胜任力的临床研究护士培训方案构建
World J Clin Cases. 2023 Oct 26;11(30):7363-7371. doi: 10.12998/wjcc.v11.i30.7363.
10
Expert consensus on clinical research nurse management in China.中国临床研究护士管理专家共识
Asia Pac J Oncol Nurs. 2023 Jun 5;10(9):100254. doi: 10.1016/j.apjon.2023.100254. eCollection 2023 Sep.