医疗技术评估的利益风险评估的方法指南和出版物:一个范围审查
Erica Aranha Suzumura1,2, Bruna de Oliveira Ascef3, Fernando Henrique de Albuquerque Maia3
1Departamento de Medicina Preventiva, Faculdade de Medicina - FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, Brazil esuzumura@yahoo.com.br.
BMJ open
|June 8, 2024
概括
本范围审查对医疗技术的益处风险评估 (BRA) 方法进行了映射. 调查结果将为巴西提供信息.
科学领域:
- 医疗技术评估 (HTA) 是指对医疗技术进行评估.
- 监管科学 监管科学
- 决策科学 决策科学
背景情况:
- 利益风险评估 (BRA) 在整个健康技术生命周期中至关重要.
- 目前BRA的方法指南多样化,涵盖了监管和HTA背景.
- 需要在卫生技术评估中对BRA方法进行标准化.
研究的目的:
- 绘制现有的方法指南和文件,用于进行和报告利益风险评估 (BRA).
- 确定适合的BRA指南,以便在巴西制定国家HTA指南.
- 为巴西关于BRA对HTA的方法指南的制定提供信息.
主要方法:
- 进行了全面的范围审查.
- 搜索包括电子数据库,48个组织的灰色文献和专家咨询.
- 选择了符合条件的文件,并通过叙事合成合成数据.
主要成果:
- 包括83份文件,涵盖BRA在技术生命周期,监管和HTA环境中的指导.
- 确定了BRA的129种不同的方法方法.
- 通常引用的框架包括问题,目标,替代方案,后果,权衡,不确定性,风险和相关决策 (PORC-UT) 和利益风险行动小组 (BRAT);多标准决策分析 (MCDA) 是最常引用的定量框架.
结论:
- 与监管环境相比,BRA在卫生技术评估 (HTA) 中的方法不那么成熟.
- 确定的BRA方法为在巴西制定标准化指南提供了基础.
- 这一审查直接支持制定巴西关于BRA的HTA的方法指南.
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