研究动态
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与肿瘤学临床试验相关的护理工作量和复杂性评估:范围界定审查。

Assessment of Nursing Workload and Complexity Associated with Oncology Clinical Trials: A Scoping Review.

发表日期:2024 Aug 17
作者: Mattia Bozzetti, Silvia Soncini, Maria Chiara Bassi, Monica Guberti
来源: BIOMEDICINE & PHARMACOTHERAPY

摘要:

临床试验 (CT) 在推进医学知识和患者护理方面发挥着至关重要的作用,但也日益复杂且资源密集。本次范围界定审查旨在探索当前评估肿瘤 CT 工作量 (WL) 的方法,并确定测量临床研究护士 WL 的工具。搜索是通过 MEDLINE、Scopus、CINAHL 和 COCHRANE 数据库进行的,并通过开发的框架进行由 Arksey 和 O'Malley 编写,并由 Joanna Briggs Institute 修订。进行数据提取和综合,以分析用于 WL 评估的仪器及其维度。在已识别的 1,005 条记录中,有 12 条符合纳入标准。与 CT 相关的复杂性和 WL 可归因于五个主要领域:(1) 协议、(2) 单例、(3) 数据管理、(4) 监管和 (5) 与工人相关。这些工具的方法、评分系统和评估领域各不相同。值得注意的是,与协议相关的领域在大多数仪器中都很普遍,凸显了它在 WL 评估中的重要性。此外,研究结果揭示了不同研究中的 WL 分数,强调了 CT 内 WL 管理的复杂性和可变性。本次范围界定审查强调了评估 CT 中 WL 的重要性,并提供了对现有工具和方法的见解。护士作为临床研究团队的重要成员,在试验管理中承担着重要责任,因此需要采取平衡的 WL 分配方法。未来的研究应侧重于验证和标准化评估工具,以优化 CT 中心的资源分配并提高研究效率。了解 CT 中的 WL 动态对于参与研究交付的护士至关重要。通过利用经过验证的 WL 评估工具,护士可以倡导适当的人员配备水平并促进高效的试验管理,最终改善 CT 环境中的患者治疗结果和研究质量。版权所有 © 2024 作者。由爱思唯尔公司出版。保留所有权利。
Clinical trials (CTs) play a crucial role in advancing medical knowledge and patient care but are increasingly complex and resource-intensive. This scoping review aims to explore the current approaches for evaluating workload (WL) in oncology CTs and identify tools for measuring clinical research nurses' WL.The search was conducted through MEDLINE, Scopus, CINAHL, and COCHRANE databases and carried out through the framework developed by Arksey and O'Malley and revised by the Joanna Briggs Institute. Data extraction and synthesis were performed to analyze instruments used for WL assessment and their dimensions.Of the 1,005 records identified, 12 meet the inclusion criteria. The complexity and WL associated with CTs can be attributed to five main domains: (1) protocol, (2) single case, (3) data management, (4) regulatory, and (5) worker-related. These instruments varied in their approaches, scoring systems, and domains assessed. Notably, the protocol-related domain was prevalent across most instruments, highlighting its importance in WL evaluation. Furthermore, findings revealed a wide range of WL scores across different studies, emphasizing the complexity and variability in WL management within CTs.This scoping review underscores the importance of evaluating WL in CTs and provides insights into existing tools and approaches. Nurses, as integral members of clinical research teams, bear significant responsibilities in trial management, necessitating a balanced approach to WL allocation. Future research should focus on validating and standardizing assessment tools to optimize resource allocation and enhance research efficiency in CT centers.Understanding WL dynamics in CTs is essential for nurses involved in research delivery. By utilizing validated WL assessment tools, nurses can advocate for appropriate staffing levels and promote efficient trial management, ultimately improving patient outcomes and research quality in CT settings.Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.