Prentice Ross L, Langer Robert D, Stefanick Marcia L, Howard Barbara V, Pettinger Mary, Anderson Garnet L, Barad David, Curb J David, Kotchen Jane, Kuller Lewis, Limacher Marian, Wactawski-Wende Jean
Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109-1024, USA.
Am J Epidemiol. 2006 Apr 1;163(7):589-99. doi: 10.1093/aje/kwj079. Epub 2006 Feb 16.
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.
随机对照试验和观察性研究数据均可得的情况为识别偏倚以及改进研究设计和分析程序提供了重要契机。此外，对来自这两种来源的数据进行联合分析能够拓展临床试验结果。美国妇女健康倡议包括对子宫切除术后女性使用雌激素以及有子宫女性使用雌激素加孕激素的随机对照试验，以及相应的观察性研究部分。在本文中，针对冠心病、中风和静脉血栓栓塞，首先呈现雌激素临床试验和观察性研究数据联合分析的结果，以表明残留偏倚模式与先前报道的雌激素加孕激素的偏倚模式相似。这些发现支持对雌激素观察性数据以及雌激素加孕激素临床试验和观察性研究数据进行某些联合分析，以得出雌激素治疗效果的经调整观察性研究估计值。将所得的治疗效果估计值与相应的临床试验估计值进行比较，同时也对雌激素加孕激素进行平行分析。还提供了绝经后激素治疗对年轻女性冠心病影响的应用情况。
