[用于蛇咬临床试验的全球核心结果测量]
Michael Abouyannis1,2, Hanif Esmail3,4, Mainga Hamaluba2,5
1Centre for Snakebite Research and Interventions, Liverpool School of Tropical Medicine, Liverpool, Royaume-Uni.
Medecine tropicale et sante internationale
|December 14, 2023
概括
标准化蛇的临床试验至关重要. 建议全球使用包括死亡率和残疾在内的五个核心结果指标,以提高研究的一致性和患者护理.
科学领域:
- 全球健康 全球健康
- 临床试验 临床试验
- 毒蛇咬伤后,毒蛇的毒液也开始发出.
背景情况:
- 蛇咬临床试验经常采用多种结果测量方法,突出了对标准化的关键需求.
- 缺乏标准化的结果阻碍了对蛇咬研究的比较分析和元分析.
研究的目的:
- 建立一套与全球相关的蛇临床试验的核心结果措施.
- 确保蛇研究的标准化,使全世界的患者和临床医生受益.
主要方法:
- 一个系统的文献审查和蛇咬临床试验的元分析确定了相关的结果领域和工具.
- 一个包括患者在内的全球利益相关者小组通过促进讨论和投票,就核心成果措施达成共识.
主要成果:
- 提出了五种普遍的核心结果指标:死亡率,世卫组织残疾评估量表,患者特异性功能量表,急性过敏反应 (布朗标准) 和血清疾病 (正式标准).
- 综合症特异性的核心结果措施应根据毒害物种进行纳入.
结论:
- 拟议的核心结果测量集为蛇临床试验提供了全球标准化.
- 这种标准化的方法支持患者和临床医生的优先事项,促进元分析,适用于低收入和中等收入环境.
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