评估化学疗法诱导的外周神经病的干预措施的忠实性:决策,以提高协议质量遵守
Kirin Saint1, Tina Paul2, Clare Patterson2
1University of Michigan Medical School, Ann Arbor, MI, USA.
Integrative cancer therapies
|July 27, 2024
概括
这项研究强调了在化疗诱导的外周神经病变的试验中需要强有力的忠实度测量. 一种新的监测方法确保了癌症幸存者研究的遵守.
科学领域:
- 在瘤学瘤学.
- 综合医学是一个整体的医学.
- 临床试验 临床试验
背景情况:
- 干预需要忠实监测标准化试验流程和坚持.
- 目前针对化疗诱导的外围神经病变的试验往往缺乏具体的干预忠实度指标.
- 开发有效的忠实性保证对于可靠的研究结果至关重要.
研究的目的:
- 检查化学疗法诱导的周围神经病变现有的试验中的忠实度.
- 在III期随机临床试验中开发和实施忠实性保证过程.
- 改善癌症幸存者的干预措施的标准化和坚持.
主要方法:
- 对化学疗法诱导的外周神经病变发表的疗法试验中的忠实性监测的定性分析 (PubMed搜索到2023年2月).
- 基于现有指导方针,开发一个以教练/参与者为导向的忠实性检查方法.
- 在正在进行的第三阶段试验中,独立评估教练培训课程 (视频录制) 和参与者家庭练习日志,使用忠实性检查表.
主要成果:
- 没有一项符合条件的试验具有特定的干预忠实度措施.
- 第三阶段试验纳入了前性策略:教练培训,虚拟交付和参与者参与.
- 在教练主导的虚拟会议中观察到高干预忠实度 (100%对结构的坚持,对技能的高度坚持).
- 参与者对家庭方案的坚持率为63%.
结论:
- 针对化疗诱导的外周神经病变的试验需要适当的忠实度措施来获得准确的结果.
- 该研究提出了一种可行的忠实性监测方法,以确保在瘤学环境中进行干预和遵守协议.
- 这种方法支持教练和参与者在临床试验中保持忠诚.
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