两十年来NICE技术评估提交的数据质量的评估
Leeza Osipenko1,2, Saba Ajwat Ul-Hasan3,2, Debra Winberg4
1The London School of Economics and Political Science, London, UK l.osipenko@lse.ac.uk.
BMJ open
|February 13, 2024
概括
为医疗技术评估向NICE提交的临床证据通常质量不佳. 这项研究发现20年来证据质量没有改善,影响了患者的福利决定.
科学领域:
- 卫生经济学 卫生经济学
- 制药政策 制药政策
- 临床证据评估临床证据评估
背景情况:
- 国家卫生和护理卓越研究所 (NICE) 开发了健康技术评估 (HTA) 流程.
- 技术评估 (TAs) 使用临床和经济数据评估制药产品.
- 数据的不确定性可能会对HTA结果产生负面影响.
研究的目的:
- 评估提交给NICE的TAs临床数据的质量.
- 具体检查比较器数据,生活质量 (QoL) 数据,随机对照试验 (RCT) 和整体证据质量.
主要方法:
- 从2000年到2019年 (直到TA600年) 的409个TAs的回顾性分析.
- 从评估组,证据审查组报告和最终评估决定中提取的数据.
- 分析使用了质量评分和描述性统计数据.
主要成果:
- 三分之二的旅行社的总体证据质量很差或无法接受.
- 很大一部分单一的旅行社 (STA) 在比较证据 (39%) 和QoL数据 (44%) 中显示质量差或不可接受.
- 在20年的研究期间,没有观察到证据质量的改善.
结论:
- 影响NICE决策的关键临床证据组成部分质量差.
- 为药物进入临床实践,生成可靠的临床数据至关重要.
- 确保高质量的证据对于实现患者利益至关重要.
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