American Journal of Epidemiology Advance Access published online on February 16, 2006
American Journal of Epidemiology, doi:10.1093/aje/kwj079
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1 Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA
* To whom correspondence should be addressed. 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.
Received June 13, 2005
Accepted October 27, 2005
SPECIAL ARTICLE
Combined Analysis of Women's Health Initiative Observational and Clinical Trial Data on Postmenopausal Hormone Treatment and Cardiovascular Disease
Ross L. Prentice 1 *,
Robert D. Langer 2,
Marcia L. Stefanick 3,
Barbara V. Howard 4,
Mary Pettinger 1,
Garnet L. Anderson 1,
David Barad 5,
J. David Curb 6,
Jane Kotchen 7,
Lewis Kuller 8,
Marian Limacher 9,
Jean Wactawski-Wende 10,
and
for the Women's Health Initiative Investigators
2 Outcomes Research Institute, Geisinger Health System, Danville, PA
3 Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA
4 Medstar Research Institute, Hyattsville, MD
5 Department of Obstetrics and Gynecology, Albert Einstein School of Medicine, Bronx, NY
6 Department of Geriatric Medicine, John A. Burns School of Medicine, University of Hawaii, Honolulu, HI
7 Division of Epidemiology, Health Policy Institute, Medical College of Wisconsin, Milwaukee, WI
8 Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA
9 Division of Cardiovascular Medicine, University of Florida College of Medicine, Gainesville, FL
10 Department of Social and Preventive Medicine, University at Buffalo, Buffalo, NY; Department of Gynecology-Obstetrics, University at Buffalo, Buffalo, NY
Ross L. Prentice, E-mail: rprentic{at}whi.org
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