开发Menière病试验的核心结果集,COSMED研究:对现有试验中使用的结果进行范围审查
Maud M E Boreel1,2, Babette F van Esch1, Maartje A van Beers1
1Department of Otorhinolaryngology-Head and Neck Surgery, Leiden University Medical Center, Leiden, Netherlands.
Frontiers in neurology
|April 1, 2025
概括
这次对梅尼耶尔病治疗方法的审查发现临床试验中的结果措施不一致. 标准化结果对于开发核心成果集至关重要,以提高研究可靠性.
科学领域:
- 耳鼻喉科 耳鼻喉科 耳鼻喉科
- 临床试验方法论 临床试验方法论
背景情况:
- 梅尼尔病 (Meniere's disease,简称MD) 是一种内耳疾病,病因不明,导致临床试验中的治疗方法和结果测量变化.
- 缺乏标准化的结果领域和工具阻碍了MD的基于证据的治疗开发.
研究的目的:
- 审查到2024年为Meniere病的随机对照试验 (RCT) 中使用的结果领域,结果和结果测量仪器 (OMI).
- 为建立MD研究的核心成果集 (COS) 奠定基础.
主要方法:
- 我们对PubMed,Embase和Cochrane数据库进行了全面的文献搜索.
- 包括所有评估MD患者治疗效果的RCT.
- 从76个RCT中提取和分析了结果领域,结果和OMI.
主要成果:
- 在76个纳入的RCT中确定了各种各样的结果领域和OMI.
- 常见的结果包括头发作的严重程度/频率,前庭功能,听力损失和生活质量 (QoL).
- 在OMI使用中观察到显著的异质性,许多结果显著缺乏经过验证的工具.
结论:
- 在MD临床试验当前的做法表明需要标准化的结果选择.
- 这次范围审查确定了正在进行的"梅尼尔氏病核心结果集" (COSMED) 研究的潜在结果.
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