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Combined analysis of Women's Health Initiative observational and clinical trial data on postmenopausal hormone treatment and cardiovascular disease.
Am J Epidemiol. 2006 Apr 01; 163(7):589-99.AJ

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.

Authors+Show Affiliations

Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109-1024, USA. rprentic@whi.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

16484450

Citation

Prentice, Ross L., et al. "Combined Analysis of Women's Health Initiative Observational and Clinical Trial Data On Postmenopausal Hormone Treatment and Cardiovascular Disease." American Journal of Epidemiology, vol. 163, no. 7, 2006, pp. 589-99.
Prentice RL, Langer RD, Stefanick ML, et al. Combined analysis of Women's Health Initiative observational and clinical trial data on postmenopausal hormone treatment and cardiovascular disease. Am J Epidemiol. 2006;163(7):589-99.
Prentice, R. L., Langer, R. D., Stefanick, M. L., Howard, B. V., Pettinger, M., Anderson, G. L., Barad, D., Curb, J. D., Kotchen, J., Kuller, L., Limacher, M., & Wactawski-Wende, J. (2006). Combined analysis of Women's Health Initiative observational and clinical trial data on postmenopausal hormone treatment and cardiovascular disease. American Journal of Epidemiology, 163(7), 589-99.
Prentice RL, et al. Combined Analysis of Women's Health Initiative Observational and Clinical Trial Data On Postmenopausal Hormone Treatment and Cardiovascular Disease. Am J Epidemiol. 2006 Apr 1;163(7):589-99. PubMed PMID: 16484450.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Combined analysis of Women's Health Initiative observational and clinical trial data on postmenopausal hormone treatment and cardiovascular disease. AU - Prentice,Ross L, AU - Langer,Robert D, AU - Stefanick,Marcia L, AU - Howard,Barbara V, AU - Pettinger,Mary, AU - Anderson,Garnet L, AU - Barad,David, AU - Curb,J David, AU - Kotchen,Jane, AU - Kuller,Lewis, AU - Limacher,Marian, AU - Wactawski-Wende,Jean, AU - ,, Y1 - 2006/02/16/ PY - 2006/2/18/pubmed PY - 2006/5/5/medline PY - 2006/2/18/entrez SP - 589 EP - 99 JF - American journal of epidemiology JO - Am J Epidemiol VL - 163 IS - 7 N2 - 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. SN - 0002-9262 UR - https://www.unboundmedicine.com/medline/citation/16484450/Combined_analysis_of_Women's_Health_Initiative_observational_and_clinical_trial_data_on_postmenopausal_hormone_treatment_and_cardiovascular_disease_ DB - PRIME DP - Unbound Medicine ER -