Department of Biomedicine and Prevention, University of Rome Tor Vergata, Rome, Italy.
Azienda USL-IRCCS di Reggio Emilia, EBP & Research Unit of Health Profession, Reggio Emilia, Italy.
Semin Oncol Nurs. 2024 Oct;40(5):151711. doi: 10.1016/j.soncn.2024.151711. Epub 2024 Aug 17.
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.
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，但它们越来越复杂，需要大量资源。本范围综述旨在探讨当前评估肿瘤学 CT 工作负荷（WL）的方法，并确定用于测量临床研究护士 WL 的工具。
通过 MEDLINE、Scopus、CINAHL 和 COCHRANE 数据库进行搜索，并采用由 Arksey 和 O'Malley 制定并经 Joanna Briggs 研究所修订的框架进行。进行数据提取和综合分析，以分析用于 WL 评估的工具及其维度。
在确定的 1005 条记录中，有 12 条符合纳入标准。CT 相关的复杂性和 WL 可归因于五个主要领域：（1）方案，（2）单个病例，（3）数据管理，（4）监管和（5）与工作人员相关。这些工具在方法、评分系统和评估的领域上存在差异。值得注意的是，方案相关领域在大多数工具中普遍存在，突出了其在 WL 评估中的重要性。此外，研究结果显示，不同研究之间的 WL 评分差异很大，强调了 CT 中 WL 管理的复杂性和可变性。
本范围综述强调了评估 CT 中 WL 的重要性，并提供了对现有工具和方法的深入了解。护士作为临床研究团队不可或缺的成员，在试验管理中承担着重大责任，需要对 WL 分配采取平衡的方法。未来的研究应侧重于验证和标准化评估工具，以优化资源分配并提高 CT 中心的研究效率。
了解 CT 中的 WL 动态对参与研究交付的护士至关重要。通过使用经过验证的 WL 评估工具，护士可以为适当的人员配备水平辩护，并促进有效的试验管理，最终改善 CT 环境中的患者结局和研究质量。
