针对肝硬化患者的以症状为中心的试验的目标和研究设计:专家共识
Arpan A Patel1,2, Elliot B Tapper3, Fasiha Kanwal4
1Tamar and Vatche Manoukian Division of Digestive Diseases, University of California, Los Angeles, Los Angeles, California, USA.
Hepatology communications
|June 2, 2023
概括
标准化对肝硬化症状的临床试验至关重要. 这个专家小组确定了未来对肝硬化患者的症状研究的关键设计,报告和测量元素.
科学领域:
- 肝病学 肝病学是一种肝病学.
- 临床试验设计 临床试验设计
- 症状管理 症状管理
背景情况:
- 对肝硬化患者来说,以症状为重点的临床试验至关重要.
- 需要标准化的流程和验证的措施来提高试验质量.
研究的目的:
- 定义设计和报告肝硬化中以症状为重点的临床试验的关键组件.
- 建立关于症状目标,测量工具和结果的共识.
- 在肝硬化患者的未来研究中运行定义.
主要方法:
- 形成了一个由肝病学家,护士,息护理提供者,药剂师和临床试验专家组成的专家写作小组.
- 专家小组成员从2022年7月到2023年1月进行了一次反复的共识形成过程.
- 定义了试验设计的关键要素,症状目标,测量和结果.
主要成果:
- 在临床试验的关键报告特征和研究设计考虑方面达成了共识.
- 确定了九个关键的症状目标:肌肉,,疼痛,疲劳,性功能障碍,睡眠障碍,抑郁/焦虑,恶心/吐,呼吸不良/喘息.
- 选择了已验证的仪器,并确定了未来研究的需求 (例如仪器验证,非药物干预).
结论:
- 一个专家小组为肝硬化中以症状为重点的临床试验制定了关键设计,报告和测量标准.
- 这些标准化元素旨在提高未来研究的质量和一致性.
- 这些发现为实施肝硬化症状管理的临床试验提供了框架.
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