Combined analysis of Women's Health Initiative observational and clinical trial data on postmenopausal hormone treatment and cardiovascular disease.

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 Epidemiol

authors

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/kwj079

subject

Has Abstract

pub_date

2006-04-01 00:00:00

pages

589-99

issue

7

eissn

0002-9262

issn

1476-6256

pii

kwj079

journal_volume

163

pub_type

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