对复合终点的不实用性和决策值的实证估计
Bernardo Sousa-Pinto1, Antonio Bognanni2, Sara Gil-Mata1
1Faculty of Medicine, MEDCIDS - Department of Community Medicine, Information and Health Decision Sciences, University of Porto, Porto, Portugal; CINTESIS@RISE - Health Research Network, Faculty of Medicine, MEDCIDS, University of Porto, Porto, Portugal.
本研究引入了一种新方法,用于计算使用不实用性的复合终点的决策值 (DTs). 该方法发现,与安慰剂相比,鼻内鼻炎药物对不良事件的危害微不足道.
科学领域:
- 临床决策的过程
- 健康研究成果研究结果
- 基于证据的医学是基于证据的医学.
背景情况:
- GRADE决策证据 (EtD) 框架要求对健康干预措施的效果大小 (微不足道,小,中等,大) 进行判断.
- 确定事先的决策门 (DTs) 对于一致的判断至关重要,先前的工作重点是单一的结果.
- 复合终点,结合多个结果,为DT估计带来独特的挑战.
研究的目的:
- 提出一种方法论方法,用于估计基于聚合不实用性的复合终点的决策值 (DTs).
- 为医疗技术评估中复合终点推导DTs提供实用工具和示例.
- 通过复合终点,促进对健康干预措施的更强大,更一致的评估.
主要方法:
- 开发了一种方法,包括计算聚合的不实用性,根据其相对频率对个别结果不实用性进行加权.
- 采用使用概率分布的建模方法来解决不实用性估计中的不确定性.
- 通过实践示例说明了用于鼻炎的鼻内药物的不良事件.
主要成果:
- 介绍了基于建模的方法来计算聚合不实用性和为复合终点推导DTs的方法步骤.
- 引入了一个webtool (https://compositedt.med.up.pt/),以便轻松实施拟议的方法.
- 证明与安慰剂相比,鼻腔鼻炎药物与不良事件的微不足道伤害有关.
结论:
- 提出了一个有价值的方法来估计复合终点的DTs.
- 强调了这种方法对临床研究,临床实践和决策过程的有用性.
- 强调了DTs对于健康干预评估中的复合终点的重要性.
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