Abstract:
: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.
journal_name
Am J Epidemioljournal_title
American journal of epidemiologyauthors
Prentice RL,Langer RD,Stefanick ML,Howard BV,Pettinger M,Anderson GL,Barad D,Curb JD,Kotchen J,Kuller L,Limacher M,Wactawski-Wende J,Women's Health Initiative Investigators.doi
10.1093/aje/kwj079subject
Has Abstractpub_date
2006-04-01 00:00:00pages
589-99issue
7eissn
0002-9262issn
1476-6256pii
kwj079journal_volume
163pub_type
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