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American Journal of Epidemiology Advance Access originally published online on February 16, 2006
American Journal of Epidemiology 2006 163(7):589-599; doi:10.1093/aje/kwj079
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American Journal of Epidemiology Copyright © 2006 by the Johns Hopkins Bloomberg School of Public Health All rights reserved; printed in U.S.A.

Special Article

Combined Analysis of Women's Health Initiative Observational and Clinical Trial Data on Postmenopausal Hormone Treatment and Cardiovascular Disease

Ross L. Prentice1, Robert D. Langer2, Marcia L. Stefanick3, Barbara V. Howard4, Mary Pettinger1, Garnet L. Anderson1, David Barad5, J. David Curb6, Jane Kotchen7, Lewis Kuller8, Marian Limacher9, Jean Wactawski-Wende10,11 for the Women's Health Initiative Investigators

1 Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA
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
11 Department of Gynecology-Obstetrics, University at Buffalo, Buffalo, NY

Reprint requests to Dr. Ross L. Prentice, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue North, M3-A410, P.O. Box 19024, Seattle, WA 98109-1024 (e-mail: rprentic{at}whi.org).

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.

cardiovascular diseases; clinical trials; cohort studies; estrogens; hormone replacement therapy; postmenopause; progestins

Abbreviations: CHD, coronary heart disease; CI, confidence interval; E-alone, estrogen alone; E+P, estrogen plus progestin; WHI, Women's Health Initiative


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