Combined analysis of Women's Health Initiative Observational and Clinical Trial data on postmenopausal hormone treatment and cardiovascular disease
Combined analysis of Women's Health Initiative Observational and Clinical Trial data on postmenopausal hormone treatment and cardiovascular disease
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DOI：
10.1093/aje/kwj079
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发表时间：
2006-04-01
影响因子：
5
通讯作者：
Wactawski-Wende, J
中科院分区：
文献类型：
--
作者：
Prentice, RL;Langer, RD;Wactawski-Wende, J
随机对照试验和观察性研究数据均可用的情况为识别偏倚和改进研究设计和分析程序提供了重要机会。此外，对两个来源的数据进行联合分析可以扩展临床试验结果。美国妇女健康倡议包括对子宫切除术后妇女使用雌激素和对子宫妇女使用雌激素加前列腺素的随机对照试验，沿着相应的观察性研究。在本文中，冠心病，中风，静脉血栓栓塞症，结果首次从雌激素的临床试验和观察性研究数据的联合分析，显示剩余的偏差模式是类似的，以前报道的雌激素加炔雌醇。这些发现支持对雌激素和雌激素加炔雌醇临床试验的观察性数据和观察性研究数据进行某些联合分析，以提供雌激素治疗效果的调整观察性研究估计值。将由此产生的治疗效果估计值与相应的临床试验估计值进行比较，并对雌激素加孕酮进行平行分析。还提供了在年轻女性中绝经后激素治疗对冠心病的影响的应用。
Circumstances in which both randomized controlled trial and observational study data are available provide an important opportunity to identify biases and improve study design and analysis procedures. In addition, joint analyses of data from the two sources can extend clinical trial findings. The US Women's Health Initiative includes randomized controlled trials of use of estrogen by posthysterectomy women and of estrogen plus progestin by women with a uterus, along with corresponding observational study components. In this paper, for coronary heart disease, stroke, and venous thromboembolism, results are first presented from joint analysis of estrogen clinical trial and observational study data to show that residual bias patterns are similar to those previously reported for estrogen plus progestin. These findings support certain combined analyses of the observational data on estrogen and the estrogen plus progestin clinical trial and observational study data to give adjusted observational study estimates of estrogen treatment effects. The resulting treatment effect estimates are compared with corresponding clinical trial estimates, and parallel analyses are also presented for estrogen plus progestin. An application to postmenopausal hormone treatment effects on coronary heart disease among younger women is also provided.