Using Bayesian Adaptive Trial Designs for Comparative Effectiveness Research: A Virtual Trial Execution.

BACKGROUND: Bayesian and adaptive clinical trial designs offer the potential for more efficient processes that result in lower sample sizes and shorter trial durations than traditional designs. OBJECTIVE: To explore the use and potential benefits of Bayesian adaptive clinical trial designs in comparative effectiveness research. DESIGN: Virtual execution of ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) as if it had been done according to a Bayesian adaptive trial design. SETTING: Comparative effectiveness trial of antihypertensive medications. PATIENTS: Patient data sampled from the more than 42 000 patients enrolled in ALLHAT with publicly available data. MEASUREMENTS: Number of patients randomly assigned between groups, trial duration, observed numbers of events, and overall trial results and conclusions. RESULTS: The Bayesian adaptive approach and original design yielded similar overall trial conclusions. The Bayesian adaptive trial randomly assigned more patients to the better-performing group and would probably have ended slightly earlier. LIMITATIONS: This virtual trial execution required limited resampling of ALLHAT patients for inclusion in RE-ADAPT (REsearch in ADAptive methods for Pragmatic Trials). Involvement of a data monitoring committee and other trial logistics were not considered. CONCLUSION: In a comparative effectiveness research trial, Bayesian adaptive trial designs are a feasible approach and potentially generate earlier results and allocate more patients to better-performing groups. PRIMARY FUNDING SOURCE: National Heart, Lung, and Blood Institute.

Diabetes control through an educational intervention.

OBJECTIVE: We evaluated the effect of an educational intervention administered to patients or/and physicians on the reduction in HbA(1c) and achieving diabetic control in a high-risk primarily Black inner-city population. METHODS: The study was designed as a four-arm randomized clinical trial where an educational program on diabetes was offered to physicians only, patients only, and both physicians and their patients, while the fourth arm did not receive any instruction. We built regression models at 24 months of follow-up to assess the likelihood of reaching glycemic goal as well as to measure the absolute reduction in HbA(1c) controlling for arm assignment, insulin use, race, age, sex, smoking, insulin use, and having achieved blood pressure control. RESULTS: Between April 2005 and July 2007, there were 823 patients randomized into the study. In multivariate analyses, the intervention group in which only patients received education showed a trend toward achieving a significant mean reduction in HbA(1c) with 49% (P = .06) higher odds of reaching glycemic control and .12 (P = .06) greater absolute percentage point drop in HbA(1c) compared to the no education group. CONCLUSION: Although our study reports positive results, it warrants a special emphasis on the behavior of the patient. Study results bring attention to disease management programs such as peer support networks that empower the patients that shift some of the responsibility to them.

Do Bayesian adaptive trials offer advantages for comparative effectiveness research? Protocol for the RE-ADAPT study.

BACKGROUND: Randomized clinical trials, particularly for comparative effectiveness research (CER), are frequently criticized for being overly restrictive or untimely for health-care decision making. PURPOSE: Our prospectively designed REsearch in ADAptive methods for Pragmatic Trials (RE-ADAPT) study is a 'proof of concept' to stimulate investment in Bayesian adaptive designs for future CER trials. METHODS: We will assess whether Bayesian adaptive designs offer potential efficiencies in CER by simulating a re-execution of the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) study using actual data from ALLHAT. RESULTS: We prospectively define seven alternate designs consisting of various combinations of arm dropping, adaptive randomization, and early stopping and describe how these designs will be compared to the original ALLHAT design. We identify the one particular design that would have been executed, which incorporates early stopping and information-based adaptive randomization. LIMITATIONS: While the simulation realistically emulates patient enrollment, interim analyses, and adaptive changes to design, it cannot incorporate key features like the involvement of data monitoring committee in making decisions about adaptive changes. CONCLUSION: This article describes our analytic approach for RE-ADAPT. The next stage of the project is to conduct the re-execution analyses using the seven prespecified designs and the original ALLHAT data.

A qualitative evaluation of a citywide Community Health Partnership program.

While there have been numerous community-based programs in Baltimore, Maryland, aimed at helping patients access medical treatments and services, they historically were underutilized and did not operate synergistically. For that reason, sanofi-aventis, along with key stakeholders in Baltimore, developed the Community Health Partnership (CHP) to educate, empower, and connect patients to community health resources to enable patients to be more proactive about their health. The CHP utilizes a community health liaison (CHL) and a community health action team (CHAT) consisting of community health leaders who are hands-on activists and health care workers who coordinate activities and provide guidance for the CHP. The goal of the program is to foster community collaboration to raise awareness of the need to improve health in the community and to identify and connect patients to existing resources and services that can help. A qualitative evaluation of the Baltimore CHP was conducted through focus group and key informant interviews with members of the CHAT and CHP. Results suggest that the CHP program has enhanced patient-provider relationships, brought together a wealth of resources, and made people more aware of health information. The CHP facilitated providers' ability to help patients find resources and empowered patients in the community to better manage their health conditions. In parallel, physicians requested additional culturally sensitive resources on medical conditions that addressed the health literacy of their diverse patients. Through stakeholder engagement, many more communities beyond Baltimore can become better networked to help patients navigate the health care system and improve their health.

Readmissions after unauthorized discharges in the cardiovascular setting.

BACKGROUND: Patients who left against medical advice (AMA) may be at higher risk for a hospital readmission if the unauthorized discharge was premature. The objective of this study is to examine the relationship between discharges AMA from nonfederal acute care hospitals and cardiovascular disease (CVD) hospital readmissions while addressing bias due to potential confounding, selection, and hospital-level clustering. METHODS: This cross-sectional study used hospital discharge data covering the period between 2000 and 2005. The outcome variables captured readmissions for a CVD-related condition following an index CVD-related discharge. The covariate of interest was an indicator for a discharge AMA in the index hospitalization. The relationship between discharges AMA and 7-day, 31-day, and 180-day readmissions was examined using multivariate models with adjustment for clustering and selection bias. RESULTS: The sample included 348,572 patients, of which 7001 (2%), 19,779 (6%), and 48,855 (14%) were readmitted within 7, 31, and 180 days, respectively. The percentage of patients who were readmitted (7 days; 31 days; 180 days) was higher among the AMA group versus the non-AMA group (2.2% vs. 1%, P < 0.002; 1.3% vs. 1%, P < 0.001; 1.2% vs. 1%, P = 0.02). The adjusted odds of a CVD-related readmission to the same hospital within 7 days, 31 days, and 180 days were 154% (P < 0.001), 51% (P < 0.001), and 19% (P = 0.004) higher, respectively, for patients who left AMA. Results were robust in examining readmissions to any hospital as well as corrections for observable selection bias through propensity score analysis. CONCLUSIONS: A discharge AMA among patients with a discharge diagnosis for CVD during the index hospitalization was predictive of CVD-related readmissions. The strength of the association between a discharge AMA and readmission was greatest within the first week after discharge.

Diabetes knowledge in a high risk urban population.

This study explored the impact of an intensive educational intervention to patients on their knowledge and understanding of diabetes. This study was a hypothesis-testing, prospective study, with an experimental two-by-two factorial design. The educational programs were offered to physicians only, patients only, or both patients and their physicians. In the fourth arm, neither patients nor their physicians received any education. Patients with uncontrolled diabetes were enrolled in the study. The outcome was the changes in the score of patients on the diabetes knowledge test. The knowledge test was administered at the time of enrollment and every six months thereafter. The study showed that a total of 622 (75%) patients took the diabetes knowledge test. The mean diabetes knowledge test score increased over time for both insulin and non-insulin users. The mean diabetes knowledge score in patients with patient education only was 11 points higher compared to those in the group of patients and their physicians without education (P=.0104). The study indicated that patients who are exposed to the educational program end up with better knowledge on all counts, than patients who just go through the health care system in the course of usual care for diabetes.

Barriers to self-management of diabetes: a qualitative study among low-income minority diabetics.

OBJECTIVES: Diabetes self-management is a key element in the overall management of diabetes. Identifying barriers to disease self-management is a critical step in achieving optimal health outcomes. Our goal was to explore patients' perceptions about barriers to self-management of diabetes that could possibly help explain poor health outcomes among minority patients. STUDY DESIGN: Four focus groups were conducted among 31 predominately African American patients with diabetes who were enrolled in the Baltimore Cardiovascular Partnership Study, a NIH-funded multiyear prospective partnership study. The topic guide consisted of a series of open-ended questions about knowledge of current health status, medication use, continuity of care, blood glucose level and nutrition. RESULTS: The focus groups confirmed that previously reported barriers to self-management persisted and identified new concerns that could be associated with poor health outcomes among minority patients with diabetes. Attitudes, perceptions and behaviors surrounding diabetes and self-management of the condition did vary across individuals, however, the variation appeared to reflect the individual's knowledge and opinions rather than patient's age, sex, or culture. The primary barrier to diabetes self-management resulted from lack of knowledge of target blood glucose and blood pressure. Several participants found some of the health information to be quite confusing. CONCLUSIONS: Diabetes is a major public health concern and the lack of awareness of target blood glucose and blood pressure further complicates the problem. The limited health literacy seen in this study could help explain several of the barriers to self-management. The barriers to self-management identified in this qualitative study are amenable to intervention that could improve health outcomes.

Treatment of heart failure in African Americans--a call to action.

Advances in heart failure treatment have not necessarily translated into equity in improved outcomes for African Americans. Heart failure in African Americans is characterized by a higher prevalence, especially at younger ages; more-adverse course with more frequent hospitalizations; and higher mortality rates compared to the general population. Despite this distinct disease profile, African Americans are remarkably underrepresented in large heart failure trials. This paper reviews the unique course of heart failure in African Americans and discusses treatment in the context of clinical trial evidence. African Americans with heart failure may respond differently to some standard therapies compared to whites, but low levels of enrollment of AAs in large clinical trials preclude valid conclusions in certain cases. An important exception is the African American Heart Failure Trial (AHeFT), a well-designed, prospective, randomized, placebo-controlled, double-blind study, that added a combination of fixed-dose isosorbide dinitrate/hydralazine (ISDN/ HYD) to standard therapy and showed a 43% improvement in survival and a 33% reduction in first hospitalizations. Despite compelling evidence from AHeFT, post hoc secondary analyses, and recommendations from current practice guidelines, ISDN/HYD remains underutilized in African Americans with heart failure. In this paper, we put forth a call to action for racial equity in clinical research and treatment in African Americans with heart failure.

Ethnic disparities, hospital quality, and discharges against medical advice among patients with cardiovascular disease.

BACKGROUND: Nationally, cardiovascular disease is the third-ranked disease category in terms of discharges against medical advice (AMA). Disparities in discharges AMA have not been examined among patients with cardiovascular disease, nor has the moderating role of hospital quality been studied. METHODS: We examined the dual effect of race/ethnicity and hospital quality on discharges AMA by retrospectively analyzing hospital discharge data of patients who were admitted with a primary diagnosis of cardiovascular disease from 2000 through 2005. RESULTS: A total of 2619 of the 312,183 hospitalizations for cardiovascular disease (.8%) resulted in a discharge AMA. The sample was 50% male, 32% non-White, and an average age of 68 years of age. Non-White race was associated with a higher probability of a discharge AMA in a high-quality hospital (adjusted odds ratio [AOR] 1.2, P < .001). Non-White race/ethnicity was associated with a lower probability of a discharge AMA in a low-quality hospital (AOR .8, P = .01). A discharge AMA was less likely at a high-quality hospital (AOR .7, P < .001), regardless of race/ethnicity. The modifying effect of hospital quality is more apparent at the highest levels of hospital quality. CONCLUSIONS: Hospital quality is negatively correlated with discharges AMA and moderates the relationship between race/ethnicity and discharges AMA.

Improved attainment of blood pressure and cholesterol goals using single-pill amlodipine/atorvastatin in African Americans: the CAPABLE trial.

OBJECTIVE: To investigate the efficacy and safety of single-pill amlodipine/atorvastatin therapy for the simultaneous treatment of hypertension (HTN) and dyslipidemia in African Americans. PATIENTS AND METHODS: Conducted between July 19, 2004, and August 9, 2005, the Clinical Utility of Caduet in Simultaneously Achieving Blood Pressure and Lipid End Points trial was a 20-week, open-label, noncomparative, multicenter trial of the efficacy and safety of single-pill amlodipine/atorvastatin in controlling elevated blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) in African Americans with concomitant HTN and dyslipidemia and either no additional risk factors, 1 or more cardiovascular risk factors, or coronary heart disease or a risk equivalent. Eight dosage strengths of single-pill amlodipine/atorvastatin were flexibly titrated. The primary efficacy assessment of the main trial was the percentage of patients who attained the LDL-C treatment goals of both the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure and the National Cholesterol Education Program Adult Treatment Panel III. RESULTS: Of the 1170 African American patients screened, 501 were enrolled in the study and 499 received drug therapy. At end point, 236 (48.3%) of 489 patients reached both their BP and LDLC goals (vs 4 [0.8%] of 484 at baseline); 280 (56.8%) of 493 reached BP goals (vs 7 [1.4%] of 494 at baseline); and 361 (73.7%) of 490 reached LDL-C goals (vs 138 [28.5%] of 484 at baseline). Among the 499 patients receiving drug therapy, common treatment-related adverse events were peripheral edema (17 patients [3.4%]), headache (11 [2.2%]), myalgia (11 [2.2%]), and constipation (10 [2.0%]). CONCLUSION: Single-pill amlodipine/atorvastatin therapy was well tolerated and effectively targeted HTN and dyslipidemia in this population of African Americans who were at risk of cardiovascular disease.

Predictors of blood pressure response to angiotensin receptor blocker/diuretic combination therapy: a secondary analysis of the irbesartan/hydrochlorothiazide blood pressure reductions in diverse patient populations (INCLUSIVE) study.

The secondary analysis of the Irbesartan/Hydrochlorothiazide Blood Pressure Reductions in Diverse Patient Populations (INCLUSIVE) clinical trial investigated whether baseline demographic and clinical variables are predictive of different degrees of blood pressure reduction following an angiotensin II receptor blocker/diuretic treatment regimen. Irbesartan/hydrochlorothiazide and other angiotensin receptor blocker combinations with a diuretic have been shown to be effective in reducing systolic blood pressure in a diverse patient population previously uncontrolled on monotherapy. Ordinary least squares regression analysis was performed on the intent-to-treat population of the INCLUSIVE study to identify variables predictive of variations in blood pressure changes in response to irbesartan/hydrochlorothiazide combination therapy. Higher baseline systolic blood pressure, female sex, type 2 diabetes, and statin therapy were found to be predictive of additional blood pressure lowering with this combination. The impact of higher baseline systolic blood pressure and diabetic state on changes in systolic blood pressure were diminished in female patients compared with male patients. In conclusion, a significant correlation may exist between certain clinical/demographic characteristics and the extent of the therapeutic response with irbesartan/hydrochlorothiazide treatment.

Efficacy and safety of fixed combinations of irbesartan/hydrochlorothiazide in older vs younger patients with hypertension uncontrolled with monotherapy.

Subgroup analysis of the Irbesartan/Hydrochlorothiazide Blood Pressure Reductions in Diverse Patient Populations (INCLUSIVE) trial evaluated the efficacy and safety of irbesartan/hydrochlorothiazide (HCTZ) fixed combinations in patients aged 65 years or older with uncontrolled systolic blood pressure (SBP) after >or= 4 weeks of antihypertensive monotherapy. The INCLUSIVE trial was a prospective, open-label, single-arm trial carried out in 119 sites. Of 844 patients completing placebo treatment, 212 were aged 65 years or older. Participants received treatment with placebo (4-5 weeks), HCTZ 12.5 mg (2 weeks), irbesartan/HCTZ 150/12.5 mg (8 weeks), and then irbesartan/HCTZ 300/25 mg (8 weeks). From baseline to week 18 (n=184, intent-to-treat population), mean change in SBP was -23.0+/-13.3 mm Hg (P<.001) and diastolic BP (DBP) was -10.9+/-7.7 mm Hg (P<.001). Mean SBP/DBP at study end was 134.0+/-14.7/75.1+/-8.4 mm Hg, and SBP, DBP, and SBP/DBP goal was achieved in 73%, 96%, and 72% of patients, respectively. Irbesartan/HCTZ combination therapy allowed SBP goal attainment in 73% of patients aged 65 years or older whose hypertension was previously uncontrolled with antihypertensive monotherapy.

A perspective on African American participation in clinical trials.

The relatively low participation of African Americans in phase III clinical trials has raised concerns about the appropriateness of generalizing study results to African American populations. If African American enrollment in clinical trials continues to be low, the society may continue to see disparities in the treatment of diseases as well as unanswered questions as to why the population fares less than others when diagnosed with certain diseases such as cancer and diabetes. Additionally, more clinical trials are needed to explicitly monitor the difference in outcomes across different populations. This article discusses the various reasons why African American patient recruitment and participation is sub-optimal; the critical role of clinical trials in therapies; recommendations by important authorities; and a new practice model (Collaborative Care Model) as an innovative strategy to augment participation rates of African Americans [and other minorities] in clinical trials.

The efficacy and tolerability of nebivolol in hypertensive African American patients.

Hypertensive African Americans often respond poorly to beta-blocker monotherapy, compared with whites. There is evidence, however, that suggests that this response may be different if beta-blockers with vasodilating effects are used. This 12-week, multi-center, double-blind, randomized placebo-controlled study assessed the antihypertensive efficacy and safety of nebivolol, a cardioselective, vasodilating beta1-blocker, at doses of 2.5, 5, 10, 20, or 40 mg once daily in 300 African American patients with stage I or II hypertension (mean sitting diastolic blood pressure [SiDBP] > or =95 mm Hg and < or =109 mm Hg). The primary efficacy end point was the baseline-adjusted change in trough mean SiDBP. After 12 weeks, nebivolol significantly reduced least squares mean SiDBP (P< or =.004) at all doses of 5 mg and higher and sitting systolic blood pressure (P< or =.044) at all doses 10 mg and higher, compared with placebo. The drug was safe and well-tolerated, with no significant difference in the incidence of adverse events compared with placebo. Nebivolol monotherapy provides antihypertensive efficacy, with few significant adverse effects, in hypertensive African Americans.

Evaluation of the angiotensin II receptor blocker azilsartan medoxomil in African-American patients with hypertension.

The efficacy and safety of azilsartan medoxomil (AZL-M) were evaluated in African-American patients with hypertension in a 6-week, double-blind, randomized, placebo-controlled trial, for which the primary end point was change from baseline in 24-hour mean systolic blood pressure (BP). There were 413 patients, with a mean age of 52 years, 57% women, and baseline 24-hour BP of 146/91 mm Hg. Treatment differences in 24-hour systolic BP between AZL-M 40 mg and placebo (-5.0 mm Hg; 95% confidence interval, -8.0 to -2.0) and AZL-M 80 mg and placebo (-7.8 mm Hg; 95% confidence interval, -10.7 to -4.9) were significant (P≤.001 vs placebo for both comparisons). Changes in the clinic BPs were similar to the ambulatory BP results. Incidence rates of adverse events were comparable among the treatment groups, including those of a serious nature. In African-American patients with hypertension, AZL-M significantly reduced ambulatory and clinic BPs in a dose-dependent manner and was well tolerated.

Building on the specialist's antihypertensive treatment recommendation: it's just the beginning.

Patients with established cardiovascular disease are a top priority for preventive medicine. Evidence from clinical trials supports the merits of aggressive risk reduction therapies in survivors of an acute event. Improving their cardiovascular risk factor profile prolongs survival, reduces the incidence of recurrent atherosclerotic events, and improves quality of life. Blood pressure (BP) control is an essential component of cardiovascular disease secondary prevention programs; however, many patients are not receiving adequate antihypertensive therapy to meet their BP goal. By building on the specialist's discharge antihypertensive prescription, primary care physicians are ideally positioned to assume responsibility for ensuring BP goals are achieved and maintained over the long term in patients who have survived an acute event. Current hypertension management guidelines define appropriate BP goals and incorporate clear advice on how these goals can be met. BP should be lowered slowly and carefully through lifestyle modifications and pharmacologic therapy. Antihypertensive treatment should be given according to guidelines for primary prevention, although specific antihypertensive classes are indicated for initial use in post-myocardial infarction and post-stroke patients. In many cases, BP goal attainment will require the use of combination therapy with two or more drugs from different classes. With the availability of effective and safe antihypertensive drug therapies, including fixed-dose combinations, a BP goal of <140/90 mm Hg should be achievable in most patients.

Hypertension-related morbidity and mortality in African Americans--why we need to do better.

Almost one third of adults in the United States have hypertension. Prevalence data among different racial or ethnic groups indicate that a disproportionate number of African Americans have hypertension compared with non-Hispanic whites and Mexican Americans. Earlier onset of high blood pressure and greater severity of hypertension contribute to a greater burden of hypertensive target organ damage in African Americans and may be a factor in the shorter life expectancy of this population compared with white Americans. There is a clear need for improved management of hypertension in African Americans via therapeutic lifestyle interventions and pharmacotherapy. While there is some evidence that particular antihypertensive agent classes provide blood pressure-lowering advantages over others, there is no support for withholding agents of any one class. When given as monotherapy, diuretics and calcium channel blockers may be relatively more effective in lowering blood pressure in African Americans than beta blockers, angiotensin-converting enzyme inhibitors, and angiotensin II receptor blockers. However, when combined with a diuretic, African Americans respond as well to these agents as other racial groups. Combination therapy using antihypertensive agents with differing modes of action provides additive antihypertensive efficacy and is well tolerated. Recent guidelines recommend combination therapy as the standard of care for patients with significant blood pressure elevation, especially those with diabetes mellitus and renal disease. These comorbidities are more common in African Americans and indicate the potential need for initial therapy with more than one agent or a combination of agents in one pill.

Antihypertensive efficacy of Irbesartan/HCTZ in men and women with the metabolic syndrome and type 2 diabetes.

This subgroup analysis of the Irbesartan/Hydrochlorothiazide (HCTZ) Blood Pressure Reductions in Diverse Patient Populations (INCLUSIVE) trial evaluated the efficacy and safety of irbesartan/HCTZ fixed combinations in adults with uncontrolled systolic blood pressure (SBP) (140-159 mm Hg; 130-159 mm Hg for type 2 diabetes mellitus [T2DM]) after >or=4 weeks of antihypertensive monotherapy. Treatment was sequential: placebo (4-5 weeks), HCTZ 12.5 mg (2 weeks), irbesartan/HCTZ 150/12.5 mg (8 weeks), and irbesartan/HCTZ 300/25 mg (8 weeks). In the intent-to-treat analysis, mean change from baseline (end of placebo phase) off all previous therapy to Week 18 (study end) in T2DM patients (n=227) was -18.2+/-14.1 mm Hg for SBP (primary end point; p<0.001) and -8.7+/-8.2 mm Hg for diastolic blood pressure (p<0.001). Mean SBP/diastolic blood pressure changes in patients with the metabolic syndrome (n=345) were -21.0+/-14.3/-10.4+/-8.5 mm Hg (p<0.001). Overall, 56% (95% confidence interval, 49%-62%) of T2DM and 73% (95% confidence interval, 68%-77%) of metabolic syndrome patients achieved SBP goal (<140 mm Hg; <130 mm Hg for T2DM). Goal attainment rates were significantly higher among women with the metabolic syndrome than men. Treatments appeared to be well tolerated. Irbesartan/HCTZ fixed combinations achieved SBP goals in over half of the T2DM patients and nearly three quarters of patients with the metabolic syndrome, with SBP uncontrolled on antihypertensive monotherapy.

Racial disparities in hypertension prevalence, awareness, and management.

BACKGROUND: Effectively reducing cardiovascular disease disparities requires identifying and reducing disparities in risk factors. Improved understanding of hypertension disparities is critical. METHODS: Cross-sectional analysis of nationally representative samples of black and white adults 20 years and older who participated in the National Health and Nutrition Examination Survey (NHANES) 1999-2002 (white, n = 4624; black, n = 1837) and NHANES III conducted in 1988-1994 (white, n = 7121; black, n = 4709). We examined differences in hypertension prevalence, awareness, treatment, and blood pressure (BP) control among both treated and prevalent cases across the 2 periods. RESULTS: Hypertension prevalence increased significantly from 35.8% to 41.4% among blacks and from 24.3% to 28.1% among whites and remains significantly higher among blacks. Awareness is higher among blacks (77.7% vs 70.4%; P<.001), as is treatment (68.2% vs 60.4%; P<.001). These results are driven by higher rates in black women. Blood pressure control rates among those treated have increased in both races, primarily as a result of increased BP control in black and white men (27.3% and 44.7%, respectively; P

Addressing cardiovascular disparities through community interventions.

OBJECTIVES: To identify the components and impact of intervention programs aimed at reducing cardiovascular disparities. METHODS: A MEDLINE literature search with key words "cardiovascular" and "African American" was conducted, and all documented interventions targeted at reducing racial disparities were selected for review. We identified the type of intervention, the populations targeted, the length of intervention, and its impact. Articles that documented scientific evidence and some case reports were reviewed. RESULTS: Existing studies widely document cardiovascular disparities as they pertain to structure, process, and outcomes. Other factors affecting disparities pertain to patient, physician, system, or treatment factors. Documented programs tend to focus on lifestyle risk factors and attitudes toward those risk factors. The timelines in the studies are relatively short and do not allow for recording clinical endpoints. Most of the studies do not hinge on comprehensive community support, and they lack a sustainability component. CONCLUSIONS: The impact of programs has been short lived, which points to the need for sustainability programs possibly through community partnerships.