PDF(Pubmed)
Abstract：
UNASSIGNED: Yoga interventions need fidelity monitoring to standardize the trial process and ensure adherence. We examined fidelity measures of current yoga trials and developed a fidelity assurance process in a phase III randomized clinical trial addressing chemotherapy-induced peripheral neuropathy among cancer survivors.
UNASSIGNED: We qualitatively analyzed the fidelity monitoring components in published clinical trials on yoga therapy for chemotherapy-induced peripheral neuropathy through a literature search in PubMed from inception to February 2023. Leveraging fidelity measures for community-based, complex interventions and yoga therapy reporting guidelines, we developed an instructor/participant-oriented fidelity checking approach in an ongoing phase III trial evaluating yoga for improving chemotherapy-induced peripheral neuropathy in cancer survivors. Two researchers independently assessed 4 of 8 video recordings of yoga instructor-led training sessions (50%) and participant-kept home practice logs using a developed fidelity checklist.
UNASSIGNED: None of the 4 eligible yoga trials specifically have intervention fidelity measures. We prospectively incorporated yoga instructor training, virtual delivery, and participant engagement strategies in the phase III trial protocol following guidelines. All trial yoga instructors were trained under study protocol to ensure compliance and participant engagement. There was high intervention fidelity in all instructor-led virtual sessions: an average of 100% adherence to class structure and three-thirds on specific skills. Assessment of participant adherence to the established home yoga protocol was 63%.
UNASSIGNED: Yoga trials for chemotherapy-induced peripheral neuropathy need adequate fidelity measures. Our study provides a feasible fidelity-monitoring approach to ensure trial intervention delivery and protocol adherence by instructors and participants in oncological settings.
UNASSIGNED: We qualitatively analyzed the fidelity monitoring components in published clinical trials on yoga therapy for chemotherapy-induced peripheral neuropathy through a literature search in PubMed from inception to February 2023. Leveraging fidelity measures for community-based, complex interventions and yoga therapy reporting guidelines, we developed an instructor/participant-oriented fidelity checking approach in an ongoing phase III trial evaluating yoga for improving chemotherapy-induced peripheral neuropathy in cancer survivors. Two researchers independently assessed 4 of 8 video recordings of yoga instructor-led training sessions (50%) and participant-kept home practice logs using a developed fidelity checklist.
UNASSIGNED: None of the 4 eligible yoga trials specifically have intervention fidelity measures. We prospectively incorporated yoga instructor training, virtual delivery, and participant engagement strategies in the phase III trial protocol following guidelines. All trial yoga instructors were trained under study protocol to ensure compliance and participant engagement. There was high intervention fidelity in all instructor-led virtual sessions: an average of 100% adherence to class structure and three-thirds on specific skills. Assessment of participant adherence to the established home yoga protocol was 63%.
UNASSIGNED: Yoga trials for chemotherapy-induced peripheral neuropathy need adequate fidelity measures. Our study provides a feasible fidelity-monitoring approach to ensure trial intervention delivery and protocol adherence by instructors and participants in oncological settings.
摘要：
■瑜伽干预需要保真度监测，以规范试验过程并确保依从性。我们检查了当前瑜伽试验的保真度测量，并在III期随机临床试验中开发了保真度保证过程，以解决癌症幸存者中化疗引起的周围神经病变。
■我们通过在PubMed中进行的文献检索，对已发表的瑜伽疗法治疗化疗引起的周围神经病变的临床试验中的保真度监测成分进行了定性分析。利用基于社区的保真度措施，复杂的干预措施和瑜伽治疗报告指南，我们在一项正在进行的III期试验中开发了一种以指导员/参与者为导向的保真度检查方法,该试验评估了瑜伽对改善癌症幸存者化疗诱导的周围神经病变的作用.两名研究人员使用开发的保真度清单独立评估了瑜伽教练主导的培训课程（50％）和参与者保存的家庭练习日志中的8个视频记录中的4个。
■4个合格的瑜伽试验中没有一个特别具有干预保真度措施。我们前瞻性地纳入瑜伽教练培训，虚拟交付，以及遵循指南的III期试验方案中的参与者参与策略.所有试验瑜伽教练都接受了研究方案的培训，以确保依从性和参与者参与。在所有由教师指导的虚拟课程中，干预保真度很高：平均100％坚持班级结构，三分之一的特定技能。参与者对已建立的家庭瑜伽协议的依从性评估为63％。
■针对化疗引起的周围神经病变的瑜伽试验需要足够的保真度措施。我们的研究提供了一种可行的保真度监测方法，以确保肿瘤环境中的讲师和参与者的试验干预交付和协议依从性。
■我们通过在PubMed中进行的文献检索，对已发表的瑜伽疗法治疗化疗引起的周围神经病变的临床试验中的保真度监测成分进行了定性分析。利用基于社区的保真度措施，复杂的干预措施和瑜伽治疗报告指南，我们在一项正在进行的III期试验中开发了一种以指导员/参与者为导向的保真度检查方法,该试验评估了瑜伽对改善癌症幸存者化疗诱导的周围神经病变的作用.两名研究人员使用开发的保真度清单独立评估了瑜伽教练主导的培训课程（50％）和参与者保存的家庭练习日志中的8个视频记录中的4个。
■4个合格的瑜伽试验中没有一个特别具有干预保真度措施。我们前瞻性地纳入瑜伽教练培训，虚拟交付，以及遵循指南的III期试验方案中的参与者参与策略.所有试验瑜伽教练都接受了研究方案的培训，以确保依从性和参与者参与。在所有由教师指导的虚拟课程中，干预保真度很高：平均100％坚持班级结构，三分之一的特定技能。参与者对已建立的家庭瑜伽协议的依从性评估为63％。
■针对化疗引起的周围神经病变的瑜伽试验需要足够的保真度措施。我们的研究提供了一种可行的保真度监测方法，以确保肿瘤环境中的讲师和参与者的试验干预交付和协议依从性。
