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STATISTICS AND MEDICINE

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Volume 356:1705-1707 April 26, 2007 Number 17
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Challenges in Using Observational Studies to Evaluate Adverse Effects of Treatment
Michael D. Hughes, Ph.D., and Paige L. Williams, Ph.D.

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In this issue of the Journal, Friis-Møller and colleagues (pages 1723–1735) report on results from a prospective observational study involving more than 23,000 patients infected with HIV. The study, called the Data Collection on Adverse Effects of Anti-HIV Drugs (DAD) trial, identified a possible increased risk of myocardial infarction associated with exposure to protease inhibitors but not to nonnucleoside reverse-transcriptase inhibitors. Because randomized studies are rarely well powered for evaluating adverse effects of treatment, well-designed observational studies are important.1 However, such studies raise complex questions concerning both the potential confounding of risk associations and the mechanisms by which treatment might . . . [Full Text of this Article]


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Dr. Hughes is a professor and Dr. Williams a senior lecturer in the Center for Biostatistics in AIDS Research at the Harvard School of Public Health, Boston.


Related Letters:

Antiretroviral Drugs and the Risk of Myocardial Infarction
Kaplan R. C., Tien P. C., Lazar J., Zangerle R., Sarcletti M., Pollack T. M., Rind D. M., Sabin C., Friis-Møller N., Lundgren J. D., the Writing Committee of the DAD Study Group , Stein J. H.
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N Engl J Med 2007; 357:715-717, Aug 16, 2007. Correspondence

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