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In This Issue of Archives of Internal Medicine
Arch Intern Med. 2007;167(15):1570.
Institutional Review Boards Should Require Clinical Trial Registration
Public registration of most phase 2 and all phase 3 clinical research trials is required by many medical journals as a condition of publication. Levin and Palmer argue that enforcement of clinical trial registration by medical journals is insufficient because clinical trial investigators or their sponsors could avoid registration by planning to publish their positive results in journals that do not require registration and not publishing their negative results. They recommend that institutional review boards enforce clinical trial registration and that such enforcement is consistent with existing ethical principles and US regulations. No new regulation is required.
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Obesity, Waist Circumference, Weight Change, and the Risk of Psoriasis in Women
Psoriasis is a common chronic inflammatory disease of the skin that poses a lifelong burden on those affected. Higher adiposity may increase the risk of psoriasis, but no prospective data are available on this relation. Setty et al prospectively studied 78 626 women with no history of psoriasis at baseline over a 14-year period and found a strong, graded, positive association between body mass index measured at multiple prior time points (age 18 years, baseline, and updated biennially during follow-up) and the risk of incident psoriasis. The authors also report that other measures of increased adiposity such as weight gain from age 18 years, higher waist circumference, hip circumference, and waist-hip ratio are all associated with a higher risk of incident psoriasis.
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Cardiologists' Use of Percutaneous Coronary Interventions for Stable Coronary Artery Disease
Percutaneous coronary intervention (PCI) is commonly performed in patients with stable coronary artery disease, even in settings where current evidence does not suggest that patients would benefit from the procedure. Using case scenarios with focus groups of interventional and noninterventional cardiologists, Lin et al describe cardiologists' attitudes and beliefs about PCI and factors that influence their decision to recommend PCI in patients with stable coronary disease. Belief in the benefit of an open artery, physician perception of patient expectations, and defensive medicine all influence cardiologists' decision making. Non–evidence-based viewpoints appear to contribute to the widespread use of PCI for indications beyond the current evidence base.
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A Randomized Factorial Trial of Vitamins C and E and Beta Carotene in the Secondary Prevention of Cardiovascular Events in Women
Observational evidence suggests that diets rich in antioxidants may protect against risk of cardiovascular disease, but results from trials have generally been disappointing. The Women's Antioxidant Cardiovascular Study (WACS) examined the effects of vitamins C and E and beta carotene, as well as their combinations, in a randomized factorial trial among women at increased risk of vascular events. There were no significant effects on the primary end point of total cardiovascular disease, suggesting that widespread use of these agents for cardiovascular disease prevention does not appear warranted.
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Single-Site vs Multisite Bone Density Measurement for Fracture Prediction
Discordance between bone density measurement sites with dual-energy x-ray absorptiometry is common, but it is unclear how this affects fracture prediction. Using individual and combinations of bone density measurements, Leslie et al compared fracture rates in 16 505 women 50 years or older over 3.2 years. The minimum measurement did not provide any better fracture prediction than using a hip measurement alone. There was a significant improvement in fracture prediction when any hip measurement was added to a model that contained the spine measurement. The total hip measurement alone maximized overall osteoporotic fracture prediction, but the spine was the most useful site for the prediction of spine fractures alone.
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