样本大小报告质量差,实用试验与实践试验并发的经济评估样本大小不足:一个跨部门调查
Changjin Wu1, Jun Hao2, Yu Xin3
1School of Public Health, Chongqing Medical University, Chongqing, China.
Journal of clinical epidemiology
|September 22, 2024
概括
实用试验中的经济评估很少考虑经济结果的样本大小,这可能会影响可靠性. 未来的试验应报告经济结果的样本大小计算,以提高透明度和证据质量.
科学领域:
- 卫生经济学 卫生经济学
- 临床试验设计 临床试验设计
- 医疗保健服务研究 医疗服务研究
背景情况:
- 实用随机对照试验 (pRCT) 对于产生有关干预成本效益的真实世界证据至关重要.
- 经济评估与PRCT相结合,提高了研究结果在医疗保健决策中的适用性.
- 然而,对于pRCT中经济结果的样本大小计算经常被忽视.
研究的目的:
- 在pRCTs中评估经济评估的样本大小计算报告质量.
- 在pRCTs中估计经济结果的统计力.
- 在实用试验中发现经济评估的方法和报告中的差距.
主要方法:
- 对2010年1月至2022年4月期间发表的pRCT进行了横截面调查.
- 数据是由独立审稿人从PubMed和OVID.中识别的研究中提取的.
- 在数据充足的情况下,对临床和经济结果进行了统计功率分析.
主要成果:
- 在包含的试验中,只有5.9%的试验 (共152个中9个) 在样本大小估计中考虑了经济结果,只有一个研究调整了样本大小.
- 经济评估的功率值往往低于初级临床终点,特别是质量调整后生命年 (QALY).
- 在某些情况下,非QALY经济结果的权力可能高于临床终点.
结论:
- 对pRCT中经济结果的样本大小计算的考虑和报告不足,可能会损害研究结果的可靠性和通用性.
- 在与实用试验并行进行的经济评估中,需要提高透明度和方法的严格性.
- 未来的pRCT协议应详细确定样本大小或根据经济结果进行调整,以提高证据质量.
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