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如何在肿瘤研究医院设立临床伦理委员会:基于常态化过程理论(EVACEC)的过程评估研究的定性结果

How to implement a clinical ethics committee in an oncological research hospital: Qualitative results from a process evaluation study using normalization process theory (EVACEC).

作者信息

Perin Marta, Magelssen Morten, Crico Chiara, Ghirotto Luca, Annoni Marco, Gualandri Giorgio, De Panfilis Ludovica

机构信息

Legal Medicine and Bioethics, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.

Centre for Medical Ethics, Institute of Health and Society, University of Oslo, Oslo, Norway.

出版信息

PLoS One. 2025 May 6;20(5):e0318870. doi: 10.1371/journal.pone.0318870. eCollection 2025.

DOI:10.1371/journal.pone.0318870
PMID:40327687
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12054913/
Abstract

INTRODUCTION

The Clinical Ethics Committee (CEC) of the Local Health Authority (LHA) of Reggio Emilia, Italy, is a multi-professional service established in 2020 to support healthcare professionals (HPs) in dealing with ethical issues in clinical practice. We evaluated the integration of the CEC into routine practice, 24 months after its implementation.

METHODS

We conducted semi-structured interviews with CEC members and LHA stakeholders involved in the service implementation. The interview scripts were outlined and transcript analysis was carried out following the four concepts of Normalization Process Theory (NPT): coherence, cognitive participation, collective action, reflexive monitoring.

RESULTS

Between June 2022 and January 2023, 15 participants were interviewed (12 CEC members and 3 LHA directors). All participants consider the service an important opportunity for HPs to be supported in complex situations (coherence). The CEC's President, a bioethicist working at the LHA, played a key role ensuring the CEC's participation and activation (cognitive participation). The main barriers to the CEC implementation were: financial sustainability, CEC members' lack of training, absence of in-person relationships (collective action). Overall, participants reported a positive experience with the CEC, however recommended several modifications (reflexive monitoring).

CONCLUSIONS

We identified key components to support the normalization of CECs and enable their activation within a clinical setting. An active and sustainable CEC must be visible, accessible, understood and trusted, clear in purpose, sufficiently integrated into the life of the organisation, adequately resourced, appropriately constituted and competent, accountable and independent. These findings can inform the development of practical strategies for CECs implementation and of appropriate outcomes for further evaluation.

摘要

引言

意大利雷焦艾米利亚地方卫生局(LHA)的临床伦理委员会(CEC)是一个多专业服务机构,成立于2020年,旨在支持医疗保健专业人员(HPs)处理临床实践中的伦理问题。我们在CEC实施24个月后评估了其融入常规实践的情况。

方法

我们对参与服务实施的CEC成员和LHA利益相关者进行了半结构化访谈。访谈脚本进行了概述,并根据规范化过程理论(NPT)的四个概念进行了转录分析:连贯性、认知参与、集体行动、反思性监测。

结果

在2022年6月至2023年1月期间,对15名参与者进行了访谈(12名CEC成员和3名LHA主任)。所有参与者都认为该服务是医疗保健专业人员在复杂情况下获得支持的重要机会(连贯性)。CEC主席是一名在LHA工作的生物伦理学家,在确保CEC的参与和启动方面发挥了关键作用(认知参与)。CEC实施的主要障碍包括:财务可持续性、CEC成员缺乏培训、缺乏面对面的关系(集体行动)。总体而言,参与者对CEC的体验是积极的,但建议进行一些改进(反思性监测)。

结论

我们确定了支持CEC规范化并使其在临床环境中得以启动的关键要素。一个活跃且可持续的CEC必须是可见的、可及的、被理解和信任的,目标明确,充分融入组织生活,资源充足,组成合理且具备能力,有问责制且独立。这些发现可为CEC实施的实用策略制定以及进一步评估的适当结果提供参考。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c27b/12054913/a6041b6e3b8f/pone.0318870.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c27b/12054913/a6041b6e3b8f/pone.0318870.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c27b/12054913/a6041b6e3b8f/pone.0318870.g001.jpg

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