评价一家肿瘤学研究医院临床伦理委员会（CEC）实施过程：使用规范进程理论（EvaCEC）的过程评估研究方案。

Evaluating a clinical ethics committee (CEC) implementation process in an oncological research hospital: protocol for a process evaluation study using normalisation process theory (EvaCEC).

机构信息

Bioethics Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy

PhD Program in Clinical and Experimental Medicine, University of Modena and Reggio Emilia, Modena, Italy.

出版信息

BMJ Open. 2023 Mar 9;13(3):e067335. doi: 10.1136/bmjopen-2022-067335.

DOI:10.1136/bmjopen-2022-067335

PMID:36894200

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10008162/

Abstract

INTRODUCTION

A Clinical Ethics Committee (CEC) is a multi-professional service whose aim is to support healthcare professionals (HPs) and healthcare organisations to deal with the ethical issues of clinical practice.Although CEC are quite common worldwide, their successful implementation in a hospital setting presents many challenges.EVAluating a Clinical Ethics Committee implementation process (EvaCEC) will evaluate the implementation of a CEC in a comprehensive cancer centre in Northern Italy 16 months after its establishment.

METHODS AND ANALYSIS

EvaCEC is a mixed-method study with a retrospective quantitative analysis and a prospective qualitative evaluation by a range of data collection tools to enable the triangulation of data sources and analysis. Quantitative data related to the amount of CEC activities will be collected using the CEC's internal databases. Data on the level of knowledge, use and perception of the CEC will be collected through a survey with closed-ended questions disseminated among all the HPs employed at the healthcare centre. Data will be analysed with descriptive statistics.The Normalisation Process Theory (NPT) will be used for the qualitative evaluation to determine whether and how the CEC can be successfully integrated into clinical practice. We will perform one-to-one semistructured interviews and a second online survey with different groups of stakeholders who had different roles in the implementation process of the CEC. Based on NPT concepts, the interviews and the survey will assess the acceptability of the CEC within the local context and needs and expectations to further develop the service.

ETHICS AND DISSEMINATION

The protocol has been approved by the local ethics committee. The project is co-chaired by a PhD candidate and by a healthcare researcher with a doctorate in bioethics and expertise in research. Findings will be disseminated widely through peer-reviewed publications, conferences and workshops.

TRIAL REGISTRATION NUMBER

NCT05466292.

摘要

简介

临床伦理委员会（CEC）是一种多专业服务，旨在为医疗保健专业人员（HPs）和医疗保健组织提供支持，以解决临床实践中的伦理问题。虽然 CEC 在全球范围内相当普遍，但在医院环境中成功实施 CEC 会带来许多挑战。评估临床伦理委员会实施过程（EvaCEC）将在意大利北部的一家综合癌症中心成立 16 个月后评估 CEC 的实施情况。

方法和分析

EvaCEC 是一项混合方法研究，采用回顾性定量分析和一系列数据收集工具进行前瞻性定性评估，以实现数据源和分析的三角交叉。使用 CEC 的内部数据库收集与 CEC 活动数量相关的定量数据。通过一项封闭式问题调查收集有关 CEC 的知识、使用和认知水平的数据，该调查将在医疗中心的所有 HPs 中传播。将使用描述性统计方法对数据进行分析。规范过程理论（NPT）将用于定性评估，以确定 CEC 是否以及如何成功融入临床实践。我们将对不同利益相关者群体进行一对一的半结构化访谈和第二次在线调查，这些群体在 CEC 的实施过程中扮演了不同的角色。基于 NPT 概念，访谈和调查将评估 CEC 在当地背景下的可接受性以及进一步发展服务的需求和期望。