Jongebloed Hannah, Chapman Anna, Marshall Skye, Orellana Liliana, White Victoria, Livingston Patricia, Ugalde Anna
Institute for Health Transformation, Centre for Quality and Patient Safety, School of Nursing and Midwifery, Faculty of Health, Deakin University, Geelong, Australia.
Institute for Health Transformation, Centre for Quality and Patient Safety, School of Nursing and Midwifery, Faculty of Health, Deakin University, Geelong, Australia.
Crit Rev Oncol Hematol. 2025 Jan;205:104547. doi: 10.1016/j.critrevonc.2024.104547. Epub 2024 Nov 1.
Stepped-wedge cluster-randomized trials (SW-CRTs) offer advantages for implementation research in healthcare and have been increasingly utilised in the oncology setting. Cancer-related SW-CRTs need to be robust to deliver impactful trial outcomes and support effective translation into practice. This review aimed to examine the application of the SW-CRT design in oncology settings including the trial design features and protocol deviations, the interventions tested, and the implementation aspects of those interventions. Five databases were searched from database inception to July 2023 for SW-CRTs which evaluated interventions in adults with cancer. Intervention characteristics, design features, protocol deviations, statistical approach, implementation strategies, and outcomes were described and evaluated narratively. The search yielded 3395 unique records with representing 15 trials which are reported over 49 publications. The 15 trials (n = 8 efficacy trials and n = 7 implementation trials) described diverse interventions in healthcare settings. Trials supported implementation of the intervention via educating and training healthcare professionals (n = 12; 80 %), met or exceeded recruitment targets (n = 10, 67 %) and evaluated a new model of care (n = 7; 47 %). Despite implementation outcomes being reported in 14 (93 %) trials, 12 (86 %) did not use an established evaluation framework to guide the selection and reporting of implementation outcomes. SW-CRTs were a utilised design for implementing diverse and complex healthcare interventions in the oncology setting. Trialists should consider the need to incorporate implementation frameworks, strategies and outcomes into their trial planning and resource allocation. This strategic approach can enhance the design and impact of SW-CRTs, leading to improved patient outcomes and advancements in cancer care.
阶梯楔形整群随机试验（SW-CRTs）在医疗保健实施研究中具有优势，并且在肿瘤学领域的应用越来越广泛。与癌症相关的SW-CRTs需要具备稳健性，以产生有影响力的试验结果，并支持有效地转化为实际应用。本综述旨在研究SW-CRT设计在肿瘤学环境中的应用，包括试验设计特征和方案偏差、所测试的干预措施以及这些干预措施的实施方面。从数据库建立到2023年7月，对五个数据库进行了检索，以查找评估成年癌症患者干预措施的SW-CRTs。对干预特征、设计特征、方案偏差、统计方法、实施策略和结果进行了描述，并进行了叙述性评估。检索产生了3395条独特记录，代表15项试验，这些试验发表在49篇以上的出版物中。这15项试验（n = 8项疗效试验和n = 7项实施试验）描述了医疗保健环境中的各种干预措施。试验通过对医疗保健专业人员进行教育和培训来支持干预措施的实施（n = 12；80%），达到或超过了招募目标（n = 10，67%），并评估了一种新的护理模式（n = 7；47%）。尽管14项（93%）试验报告了实施结果，但12项（86%）试验没有使用既定的评估框架来指导实施结果的选择和报告。SW-CRTs是一种用于在肿瘤学环境中实施多样化和复杂医疗保健干预措施的设计。试验者应考虑在试验规划和资源分配中纳入实施框架、策略和结果的必要性。这种战略方法可以增强SW-CRTs的设计和影响力，从而改善患者结局并推动癌症护理的进步。
