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National Institute of Mental Health Multisite Eban HIV/STD Prevention Intervention for African American HIV Serodiscordant Couples: A Cluster Randomized Trial [Original Investigation]
Background Human immunodeficiency virus (HIV) has disproportionately affected African Americans. Couple-level interventions may be a promising intervention strategy.
Methods To determine if a behavioral intervention can reduce HIV/sexually transmitted disease (STD) risk behaviors among African American HIV serodiscordant couples, a cluster randomized controlled trial (Eban) was conducted in Atlanta, Georgia; Los Angeles, California; New York, New York; and Philadelphia, Pennsylvania; with African American HIV serodiscordant heterosexual couples who were eligible if both partners were at least 18 years old and reported unprotected intercourse in the previous 90 days and awareness of each other's serostatus. One thousand seventy participants were enrolled (mean age, 43 years; 40% of male participants were HIV positive). Couples were randomized to 1 of 2 interventions: couple-focused Eban HIV/STD risk-reduction intervention or attention-matched individual-focused health promotion comparison. The primary outcomes were the proportion of condom-protected intercourse acts and cumulative incidence of STDs (chlamydia, gonorrhea, or trichomonas). Data were collected preintervention and postintervention, and at 6- and 12-month follow-ups.
Results Data were analyzed for 535 randomized couples: 260 in the intervention group and 275 in the comparison group; 81.9% were retained at the 12-month follow-up. Generalized estimating equation analyses revealed that the proportion of condom-protected intercourse acts was larger among couples in the intervention group (0.77) than in the comparison group (0.47; risk ratio, 1.24; 95% confidence interval [CI], 1.09 to 1.41; P = .006) when adjusted for the baseline criterion measure. The adjusted percentage of couples using condoms consistently was higher in the intervention group (63%) than in the comparison group (48%; risk ratio, 1.45; 95% CI, 1.24 to 1.70; P < .001). The adjusted mean number of (log)unprotected intercourse acts was lower in the intervention group than in the comparison group (mean difference, –1.52; 95% CI, –2.07 to –0.98; P < .001). The cumulative STD incidence over the 12-month follow-up did not differ between couples in the intervention and comparison groups. The overall HIV seroconversion at the 12-month follow-up was 5 (2 in the intervention group, 3 in the comparison group) of 535 individuals, which translates to 935 per 100 000 population.
Conclusion To our knowledge, this is the first randomized controlled intervention trial to report significant reductions in HIV/STD risk behaviors among African American HIV serodiscordant couples.
Trial Registration clinicaltrials.gov Identifier: NCT00644163
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Rosiglitazone Revisited: An Updated Meta-analysis of Risk for Myocardial Infarction and Cardiovascular Mortality [Review Article]
Context Controversy regarding the effects of rosiglitazone therapy on myocardial infarction (MI) and cardiovascular (CV) mortality persists 3 years after a meta-analysis initially raised concerns about the use of this drug.
Objective To systematically review the effects of rosiglitazone therapy on MI and mortality (CV and all-cause).
Data Sources We searched MEDLINE, the Web site of the Food and Drug Administration, and the GlaxoSmithKline clinical trials registry for trials published through February 2010.
Study Selection The study included all randomized controlled trials of rosiglitazone at least 24 weeks in duration that reported CV adverse events.
Data Extraction Odds ratios (ORs) for MI and mortality were estimated using a fixed-effects meta-analysis of 56 trials, which included 35 531 patients: 19 509 who received rosiglitazone and 16 022 who received control therapy.
Results Rosiglitazone therapy significantly increased the risk of MI (OR, 1.28; 95% confidence interval [CI], 1.02-1.63; P = .04) but not CV mortality (OR, 1.03; 95% CI, 0.78-1.36; P = .86). Exclusion of the RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes) trial yielded similar results but with more elevated estimates of the OR for MI (OR, 1.39; 95% CI, 1.02-1.89; P = .04) and CV mortality (OR, 1.46; 95% CI, 0.92-2.33; P = .11). An alternative analysis pooling trials according to allocation ratios allowed inclusion of studies with no events, yielding similar results for MI (OR, 1.28; 95% CI, 1.01-1.62; P = .04) and CV mortality (OR 0.99; 95% CI, 0.75-1.32; P = .96).
Conclusions Eleven years after the introduction of rosiglitazone, the totality of randomized clinical trials continue to demonstrate increased risk for MI although not for CV or all-cause mortality. The current findings suggest an unfavorable benefit to risk ratio for rosiglitazone.
Published online June 28, 2010 (doi:10.1001/archinternmed.2010.207).
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About This Journal [About This Journal]
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In This Issue of Archives of Internal Medicine [In This Issue of Archives of Internal Medicine]
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Measuring Outcomes of Coronary Artery Bypass Surgery: What Is Important and to Whom? [Editorial]
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Rosiglitazone Revisited: An Updated Meta-analysis of Risk for Myocardial Infarction and Cardiovascular Mortality [Review Article]
Context Controversy regarding the effects of rosiglitazone therapy on myocardial infarction (MI) and cardiovascular (CV) mortality persists 3 years after a meta-analysis initially raised concerns about the use of this drug.
Objective To systematically review the effects of rosiglitazone therapy on MI and mortality (CV and all-cause).
Data Sources We searched MEDLINE, the Web site of the Food and Drug Administration, and the GlaxoSmithKline clinical trials registry for trials published through February 2010.
Study Selection The study included all randomized controlled trials of rosiglitazone at least 24 weeks in duration that reported CV adverse events.
Data Extraction Odds ratios (ORs) for MI and mortality were estimated using a fixed-effects meta-analysis of 56 trials, which included 35 531 patients: 19 509 who received rosiglitazone and 16 022 who received control therapy.
Results Rosiglitazone therapy significantly increased the risk of MI (OR, 1.28; 95% confidence interval [CI], 1.02-1.63; P = .04) but not CV mortality (OR, 1.03; 95% CI, 0.78-1.36; P = .86). Exclusion of the RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes) trial yielded similar results but with more elevated estimates of the OR for MI (OR, 1.39; 95% CI, 1.02-1.89; P = .04) and CV mortality (OR, 1.46; 95% CI, 0.92-2.33; P = .11). An alternative analysis pooling trials according to allocation ratios allowed inclusion of studies with no events, yielding similar results for MI (OR, 1.28; 95% CI, 1.01-1.62; P = .04) and CV mortality (OR 0.99; 95% CI, 0.75-1.32; P = .96).
Conclusions Eleven years after the introduction of rosiglitazone, the totality of randomized clinical trials continue to demonstrate increased risk for MI although not for CV or all-cause mortality. The current findings suggest an unfavorable benefit to risk ratio for rosiglitazone.
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Case Volume, Quality of Care, and Care Efficiency in Coronary Artery Bypass Surgery [Original Investigation]
Background How case volume and quality of care relate to hospital costs or length of stay (LOS) are important questions as we seek to improve the value of health care.
Methods We conducted an observational study of patients 18 years or older who underwent coronary artery bypass grafting surgery in a network of US hospitals. Case volumes were estimated using our data set. Quality was assessed by whether recommended medications and services were not received in ideal patients, as well as the overall number of measures missed. We used multivariable hierarchical models to estimate the effects of case volume and quality on hospital cost and LOS.
Results The majority of hospitals (51%) and physicians (78%) were lowest-volume providers, and only 18% of patients received all quality of care measures. Median LOS was 7 days (interquartile range [IQR], 6-11 days), and median costs were $25 140 (IQR, $19 677-$33 121). In analyses adjusted for patient and site characteristics, lowest-volume hospitals had 19.8% higher costs (95% CI, 3.9%-38.0% higher); adjusting for care quality did not eliminate differences in costs. Low surgeon volume was also associated with higher costs, though less strongly (3.1% higher costs [95% CI, 0.6%-5.6% higher]). Individual quality measures had inconsistent associations with costs or LOS, but patients who had no quality measures missed had much shorter LOS and lower costs than those who missed even one.
Conclusion Avoiding lowest-volume hospitals and maximizing quality are separate approaches to improving health care efficiency through reducing costs of coronary bypass surgery.
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Racial Differences in Admissions to High-Quality Hospitals for Coronary Heart Disease [Original Investigation]
Background Research increasingly shows that blacks with coronary heart disease (CHD) are treated at lower-quality hospitals. Little is known about racial differences in admission to high-quality hospitals.
Methods We identified all black and white Medicare patients with acute myocardial infarction and coronary artery bypass grafting (CABG) admitted during 2002 through 2005 to hospitals located in markets with top-ranked cardiac hospitals, as ascertained from the US News and World Report "America’s Best Hospitals" annual rankings. The relationship between race and admission to top-ranked hospitals was estimated using multinomial conditional logit models to account for distance from patient residence to all available hospitals.
Results In unadjusted analyses, blacks with AMI or undergoing CABG, compared with whites, were more likely to be admitted to top-ranked hospitals (18.3% vs 10.5% and 34.4% vs 22.7% [P < .001]) but also more likely to bypass top-ranked hospitals (25.8% vs 14.7% and 37.5% vs 26.3% [P < .001]). In models accounting for distance, blacks with acute myocardial infarction were more likely (odds ratio [OR], 1.12; 95% confidence interval [CI], 1.08-1.16 [P < .001]), whereas blacks undergoing CABG were equally likely (OR, 1.05; 95% CI, 0.97-1.13; P = .27) to be admitted to top-ranked hospitals compared with whites. However, within socially disadvantaged zip codes, blacks undergoing CABG were less likely to receive care at top-ranked hospitals (OR, 0.75; 95% CI, 0.64-0.86 [P < .001]) compared with whites and more likely to bypass top-ranked hospitals located closer to their residence (OR, 1.16; 95% CI, 1.02-1.30 [P = .03]).
Conclusion Black Medicare patients with acute myocardial infarction or undergoing CABG were equally or more likely to be admitted to top-ranked hospitals, except for socially disadvantaged black patients undergoing CABG.
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Receipt of High-Quality Coronary Heart Disease Care in the United States: All About Being Black or White: Comment on "Racial Differences in Admissions to High-Quality Hospitals for Coronary Heart Disease" [Invited Commentary]
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Geographic Variation in Carotid Revascularization Among Medicare Beneficiaries, 2003-2006 [Original Investigation]
Background Little is known about patterns in the use of carotid revascularization since a 2004 Medicare national coverage decision supporting carotid artery stenting. We examined geographic variation in and predictors of carotid endarterectomy and carotid stenting.
Methods Analysis of claims from the Centers for Medicare & Medicaid Services from January 1, 2003, through December 31, 2006. Patients were 65 years or older and had undergone carotid endarterectomy or carotid stenting. The main outcome measures were annual age-adjusted rates of carotid endarterectomy and carotid stenting, factors associated with the use of carotid revascularization, and mortality rate at 30 days and 1 year.
Results The rate of endarterectomy decreased from 3.2 per 1000 person-years in 2003 to 2.6 per 1000 person-years in 2006. After adjustment for demographic and clinical characteristics, there was significant geographic variation in the odds of carotid revascularization, with the East North Central region having the greatest odds of endarterectomy (odds ratio, 1.60; 95% confidence interval, 1.55-1.65) and stenting (1.61; 1.46-1.78) compared with New England. Prior endarterectomy (odds ratio, 3.06; 95% confidence interval, 2.65-3.53) and coronary artery disease (2.12; 2.03-2.21) were strong predictors of carotid stenting. In 2005, mortality was 1.2% at 30 days and 6.8% at 1 year for endarterectomy and 2.3% at 30 days and 10.3% at 1 year for stenting.
Conclusions Significant geographic variation exists for carotid endarterectomy and carotid stenting. Prior endarterectomy and coronary disease were associated with greater odds of carotid stenting.