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Crowther and colleagues measured the effect of oral vitamin K or placebo on prevention of bleeding in 724 patients with international normalized ratios (INRs) of 4.5 to 10.0 who were receiving warfarin. They found that 15.8% of vitamin K recipients and 16.3% of placebo recipients had at least 1 bleeding complication; 2.5% and 1.1%, respectively, had major bleeding events; and 1.1% and 0.8% experienced thromboembolism. Low-dose oral vitamin K lowered the INR but did not reduce bleeding in overanticoagulated patients.
Silverberg and colleagues compared the effectiveness and safety of lipid-lowering therapy in 829 HIV-infected patients receiving antiretroviral therapy and 6941 patients without HIV infection. Reductions in low-density lipoprotein cholesterol and triglyceride levels were smaller in HIV-infected patients than in uninfected patients. The effect was larger for the triglyceride response to gemfibrazole than for the low-density lipoprotein cholesterol response to statins. Dyslipidemia is more difficult to treat in patients with HIV infection than in the general population.
Among 1849 U.S. patients who had myocardial infarction, the 28% who were black had higher unadjusted mortality and rehospitalization rates, more angina, and worse quality of life. However, many of these differences did not persist after statistical adjustment to make patient risk factors and site of care comparable in black and white patients. The results suggest that differences in baseline cardiac risk and hospital factors are more important determinants of outcome than are differences in treatments received for myocardial infarction.
The effect of “connectedness” (whether a patient goes to a particular physician or practice) on measures of clinical performance is unknown. Using a recently validated measure, the authors found that patients who were more connected to a primary care physician were more likely to receive recommended prevention services. This measure of patient–physician connectedness may be a good indicator of adherence to the patient-centered medical home model of primary care.
The Centers for Medicare & Medicaid Services (CMS) limit coverage of cancer drugs for off-label indications to those indications listed in specified drug compendia. This systematic review of 14 off-label indications assessed whether 6 drug compendia provide comprehensive, research-based, and timely information for off-label prescribing in oncology. The authors conclude that current compendia lack transparency, do not seem to follow systematic methods to review or update evidence, and fail to cite many studies.
Off-label prescribing is essential but raises concerns about toxicity, cost, and effectiveness. A possible means of controlling the use of off-label drugs is to focus on those that are both expensive and potentially risky—principally, biotechnology drugs. This article suggests a 2-step process for controlling use of such drugs.
In 2007, CMS established a publicly transparent process to revise the list of acceptable drug compendia. Because conflicts of interest may lead to biased judgments, the 2008 Medicare Improvements for Patients and Providers Act includes a provision that prohibits CMS from using compendia that lack a publicly transparent process for evaluating therapies and for identifying editors' and advisors' potential conflicts of interest.
In this issue, Atlas and colleagues report that patients who were more connected to a personal physician were more likely to receive recommended prevention services in primary care settings and that patient–physician connectedness varies among practice organizations. The authors have taken an important step by proposing and validating a way to measure a central feature of primary care and the patient-centered medical home. This measure, which requires only administrative data, deserves wider testing.
The articles in this issue by Abernethy and colleagues, Gillick, and Tillman and associates shine a bright light on a weak point in our efforts to inform clinical practice by the best possible evidence. Tillman and associates provide a background for considering Abernethy and colleagues' review, which questions the reliability of compendia methods. Gillick thinks that a strengthened decision-making process should focus attention on the most expensive and toxic cancer drugs. I conclude that we should adopt something like Gillick's proposal to use the CMS national coverage procedures, of which the salient feature is a systematic review of the evidence.
This issue provides a clinical overview of alcohol use, focusing on prevention, diagnosis, treatment, practice improvement, and patient information. Readers can complete the accompanying CME quiz for 1.5 credits.
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