由于并发症而改变治疗效果:对120项随机对照试验的个人参与者数据进行元分析
Peter Hanlon1, Elaine W Butterly1, Anoop Sv Shah2
1School for Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.
临床试验往往不包括患有并发病的人. 这项研究没有发现证据表明并发症会影响治疗疗效,这表明试验结果具有广泛的适用性. 这支持对患有多种健康状况的患者使用标准疗效研究结果.
科学领域:
- 临床试验方法论 临床试验方法论
- 证据综合研究
- 药物监督 药物监督 药物监督
背景情况:
- 同病症在患者中很常见,但在临床试验中代表性不足,导致治疗建议的不确定性.
- 关于并发症如何改变治疗效果的经验数据很少.
- 这项研究旨在通过使用个人参与者数据 (IPD) 来量化治疗效果因共发病性而发生的改变.
结论:
- 对于具有适度并发症水平的患者来说,在各个子组中保持治疗疗效的假设是合理的.
- 结果表明,试验疗效数据可以与自然史和竞争性风险数据相结合,以评估伴随疾病人群的治疗益处.
- 这项研究支持将临床试验结果推广到现实世界患者群体的共同疾病.
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