Recent findings from clinical trials examining the relationbetween postmenopausal hormone therapy and coronary heart disease1,2have appeared to be widely divergent from the results of earlierobservational studies. In randomized clinical trials, subjectsare randomly assigned to treatments, thereby minimizing possibledifferences between the groups in lifestyle or health-relatedfactors. In observational studies, by contrast, subjects whochoose to take a given agent may be very different from thosewho do not. Although apparent discrepancies in results haveraised questions about the validity of observational data, itis useful to explore both the methodologic and the biologicissues that . . . [Full Text of this Article]
Methodologic Issues
Confounding Bias, or "Healthy User" Effect
Compliance Bias
Incomplete Capture of Early Clinical Events
Biologic Differences
Hormone Regimen
Characteristics of the Populations
Conclusions
Source Information
From the Channing Laboratory (F.G., J.E.M.) and the Division of Preventive Medicine (J.E.M.), Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, and the Department of Epidemiology, Harvard School of Public Health (F.G., J.E.M.) both in Boston; and the Comparative Medicine Research Center, Wake Forest University School of Medicine, Winston-Salem, N.C. (T.B.C.).
Address reprint requests to Dr. Grodstein at the Channing Laboratory, 181 Longwood Ave., Boston, MA 02115.
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