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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

Prentice RL
Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109-1024, USA. rprentic@whi.org
Langer RD
No affiliation info available
Stefanick ML
No affiliation info available
Howard BV
No affiliation info available
Pettinger M
No affiliation info available
Anderson GL
No affiliation info available
Barad D
No affiliation info available
Curb JD
No affiliation info available
Kotchen J
No affiliation info available
Kuller L
No affiliation info available
Limacher M
No affiliation info available
Wactawski-Wende J
No affiliation info available
Women's Health Initiative Investigators
No affiliation info available

MeSH

AgedBiasCardiovascular DiseasesConfounding Factors, EpidemiologicEstrogen Replacement TherapyEstrogens, Conjugated (USP)FemaleHumansIncidenceMedroxyprogesterone AcetateMiddle AgedObservationPostmenopauseProgestinsProportional Hazards ModelsRandomized Controlled Trials as TopicUnited StatesWomen's Health

Pub Type(s)

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

Language

eng

PubMed ID

16484450

Clinical Trial Links

Binge Eating & Birth Control
Characterizing the Neural Substrates of Irritability in Women: an Experimental Neuroendocrine Model

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 -