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临床研究护士专业能力的理想画像:一项定性研究。

An ideal portrait of the professional competence of clinical research nurses: A qualitative study.

作者信息

Yang Heng, Chen Yipei, Peng Xin

机构信息

Nursing Department, Union Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.

School of Nursing, Huazhong University of Science and Technology, Wuhan, China.

出版信息

Asia Pac J Oncol Nurs. 2025 Mar 8;12:100682. doi: 10.1016/j.apjon.2025.100682. eCollection 2025 Dec.

DOI:10.1016/j.apjon.2025.100682
PMID:40201532
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11976228/
Abstract

OBJECTIVE

This study aims to identify and define the ideal professional competencies of Clinical Research Nurses (CRNs) in China, focusing on the essential knowledge, skills, and personal attributes required for effective practice in clinical trials.

METHODS

Interviews were conducted with CRNs, Nurse Managers (NMs), Principal Investigators (PIs), Sub-Investigators (SIs), Clinical Research Coordinators (CRCs), Clinical Research Associates (CRAs), and subjects. Thematic analysis was performed using Colaizzi's seven-step method to analyze interview data and identify key competencies.

RESULTS

The study identified four primary themes that characterize the ideal CRN profile: (1) theoretical knowledge ability, (2) practical technical ability, (3) professional quality and ability, and (4) personal traits. A total of 21 specific indicators were delineated, reflecting the diverse expectations of various stakeholders in clinical trials.

CONCLUSIONS

The findings highlight the multifaceted nature of CRN competencies, emphasizing the importance of comprehensive training programs tailored to the needs of CRNs. This study provides a foundational framework for enhancing CRN training and professional development in China.

摘要

目的

本研究旨在识别并界定中国临床研究护士(CRN)的理想专业能力,重点关注临床试验有效实践所需的基本知识、技能和个人特质。

方法

对临床研究护士、护士长(NM)、主要研究者(PI)、副研究者(SI)、临床研究协调员(CRC)、临床研究助理(CRA)以及受试者进行访谈。采用Colaizzi七步法进行主题分析,以分析访谈数据并确定关键能力。

结果

该研究确定了表征理想临床研究护士形象的四个主要主题:(1)理论知识能力,(2)实践技术能力,(3)专业素质与能力,(4)个人特质。共划定了21项具体指标,反映了临床试验中各利益相关方的不同期望。

结论

研究结果凸显了临床研究护士能力的多面性,强调了根据临床研究护士需求制定全面培训计划的重要性。本研究为加强中国临床研究护士培训和专业发展提供了一个基础框架。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/952e/11976228/4ccf15a67631/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/952e/11976228/4ccf15a67631/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/952e/11976228/4ccf15a67631/gr1.jpg

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本文引用的文献

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BMC Nurs. 2024 Sep 19;23(1):671. doi: 10.1186/s12912-024-02332-x.
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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.
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Family resilience and vulnerability of patients at diagnosis of lung cancer: A qualitative study.
肺癌诊断时患者的家庭韧性和脆弱性:一项定性研究。
J Clin Nurs. 2024 Aug;33(9):3669-3683. doi: 10.1111/jocn.17206. Epub 2024 May 19.
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Informed consent in clinical practice: Old problems, new challenges.临床实践中的知情同意:老问题,新挑战。
J R Coll Physicians Edinb. 2024 Jun;54(2):153-158. doi: 10.1177/14782715241247087. Epub 2024 Apr 14.
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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.
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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。
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