Economic Burden Associated with the Treatment with a Cardiovascular Polypill in Secondary Prevention in Spain: Cost-Effectiveness Results of the NEPTUNO Study.

Purpose: The aim of this study was to estimate health-care resources utilization, costs and cost-effectiveness associated with the treatment with CNIC-Polypill as secondary prevention of atherosclerotic cardiovascular disease (ASCVD) compared to other treatments, in clinical practice in Spain. Patients and Methods: An observational, retrospective study was performed using medical records (economic results [healthcare perspective], NEPTUNO-study; BIG-PAC-database) of patients who initiated secondary prevention between 2015 and 2018. Patients were followed up to 2 years (maximum). Four cohorts were balanced with a propensity-score-matching (PSM): 1) CNIC-Polypill (aspirin+atorvastatin+ramipril), 2) Monocomponents (same separate drugs), 3) Equipotent (equipotent drugs) and 4) Other therapies ([OT], other cardiovascular drugs). Incidence of cardiovascular events, health-care resources utilization and healthcare and non-healthcare costs (2020 Euros) were compared. Incremental cost-effectiveness ratios per cardiovascular event avoided were estimated. Results: After PSM, 1614 patients were recruited in each study cohort. The accumulated incidence of cardiovascular events during the 24-month follow-up was lower in the CNIC-Polypill cohort vs the other cohorts (19.8% vs Monocomponents: 23.3%, Equipotent: 25.5% and OT: 26.8%; p<0.01). During the follow-up period, the CNIC-Polypill cohort also reduced the health-care resources utilization per patient compared to the other cohorts, particularly primary care visits (16.6 vs Monocomponents: 18.7, Equipotent: 18.9 and OT: 21.0; p<0.001) and hospitalization days (2.3 vs Monocomponents: 3.4, Equipotent: 3.7 and OT: 4.0; p<0.001). The treatment cost in the CNIC-Polypill cohort was lower than that in the other cohorts (€4668 vs Monocomponents: €5587; Equipotent: €5682 and OT: €6016; p<0.001) (Difference: -€919, -€1014 and -€1348, respectively). Due to the reduction of cardiovascular events and costs, the CNIC-Polypill is a dominant alternative compared to the other treatments. Conclusion: CNIC-Polypill reduces recurrent major cardiovascular events and costs, being a cost-saving strategy as secondary prevention of ASCVD.

Cost-Effectiveness of the CNIC-Polypill Strategy Compared With Separate Monocomponents in Secondary Prevention of Cardiovascular and Cerebrovascular Disease in Portugal: The MERCURY Study.

Background: Cardiovascular (CV) diseases remain a leading and costly cause of death globally. Patients with previous CV events are at high risk of recurrence. Secondary prevention therapies improve CV risk factor control and reduce disease costs. Objectives: To assess the cost-effectiveness of a CV polypill strategy (CNIC-Polypill) compared with the loose combination of monocomponents to improve the control of CV risk factors in patients with previous coronary heart disease or stroke. Methods: A Markov model cost-utility analysis was developed using 4 health states, SMART risk equation, and 3-month cycles for year 1 and annual cycles thereafter, over a lifetime horizon from the perspective of the National Health System in Portugal (base case). The NEPTUNO study, Portuguese registries, mortality tables, official reports, and the literature were consulted to define effectiveness, epidemiological costs, and utility data. Outcomes were costs (estimated in 2020 euros) per life-year (LY) and quality-adjusted LY (QALY) gained. A 4% discount rate was applied. Alternative scenarios and one-way and probabilistic sensitivity analyses tested the consistency and robustness of results. Results: The CNIC-Polypill strategy in secondary prevention provides more LY and QALY, at a higher cost, than monocomponents. The incremental cost-utility ratio is €1557/QALY gained. Assuming a willingness-to-pay threshold of €30 000/QALY gained, there is a 79.7% and a 44.4% probability of the CNIC-Polypill being cost-effective and cost-saving, respectively, compared with the loose combination of monocomponents. Results remain consistent in the alternative scenarios and robust in the sensitivity analyses. Discussion: The model reflects increments in the number of years patients would live and in quality of life with the CNIC-Polypill. The clinical effectiveness of the CNIC-Polypill strategy initially demonstrated in the NEPTUNO study has been recently corroborated in the SECURE trial. The incremental cost of the CNIC-Polypill strategy emerges slightly above the comparator, but willingness-to-pay estimates and sensitivity analyses indicate that the CNIC-Polypill strategy is consistently cost-effective compared with monocomponents and remains within acceptable affordability margins. Conclusion: The CNIC-Polypill is a cost-effective secondary prevention strategy. In patients with histories of coronary heart disease or stroke, the CNIC-Polypill more effectively controls CV risk factors compared with monocomponents.

Lessons Learned From 10 Years of Preschool Intervention for Health Promotion: JACC State-of-the-Art Review.

Implementing a health promotion program for children is a complex endeavor. In this review, we outline the key lessons learned over 10 years of experience in implementing the SI! Program (Salud Integral-Comprehensive Health) for cardiovascular health promotion in preschool settings in 3 countries: Colombia (Bogotá), Spain (Madrid), and the United States (Harlem, New York). By matching rigorous efficacy studies with implementation science, we can help bridge the divide between science and educational practice. Achieving sustained lifestyle changes in preschool children through health promotion programs is likely to require the integration of several factors: 1) multidisciplinary teams; 2) multidimensional educational programs; 3) multilevel interventions; 4) local program coordination and community engagement; and 5) scientific evaluation through randomized controlled trials. Implementation of effective health promotion interventions early in life may induce long-lasting healthy behaviors that could help to curb the cardiovascular disease epidemic.

Myocardial Bridging: Diagnosis, Functional Assessment, and Management: JACC State-of-the-Art Review.

Myocardial bridging (MB) is a congenital coronary anomaly in which a segment of the epicardial coronary artery traverses through the myocardium for a portion of its length. The muscle overlying the artery is termed a myocardial bridge, and the intramyocardial segment is referred to as a tunneled artery. MB can occur in any coronary artery, although is most commonly seen in the left anterior descending artery. Although traditionally considered benign in nature, increasing attention is being given to specific subsets of MB associated with ischemic symptomatology. The advent of contemporary functional and anatomic imaging modalities, both invasive and noninvasive, have dramatically improved our understanding of dynamic pathophysiology associated with MBs. This review provides a contemporary overview of epidemiology, pathobiology, diagnosis, functional assessment, and management of MBs.

Chronic disease stigma, skepticism of the health system, and socio-economic fragility: Qualitative assessment of factors impacting receptiveness to group medical visits and microfinance for non-communicable disease care in rural Kenya.

BACKGROUND: Non-communicable diseases (NCDs) are the leading cause of mortality in the world, and innovative approaches to NCD care delivery are being actively developed and evaluated. Combining the group-based experience of microfinance and group medical visits is a novel approach to NCD care delivery. However, the contextual factors, facilitators, and barriers impacting wide-scale implementation of these approaches within a low- and middle-income country setting are not well known. METHODS: Two types of qualitative group discussion were conducted: 1) mabaraza (singular, baraza), a traditional East African community gathering used to discuss and exchange information in large group settings; and 2) focus group discussions (FGDs) among rural clinicians, community health workers, microfinance group members, and patients with NCDs. Trained research staff members led the discussions using structured question guides. Content analysis was performed with NVivo using deductive and inductive codes that were then grouped into themes. RESULTS: We conducted 5 mabaraza and 16 FGDs. A total of 205 individuals (113 men and 92 women) participated in the mabaraza, while 162 individuals (57 men and 105 women) participated in the FGDs. In the context of poverty and previous experiences with the health system, participants described challenges to NCD care across three themes: 1) stigma of chronic disease, 2) earned skepticism of the health system, and 3) socio-economic fragility. However, they also outlined windows of opportunity and facilitators of group medical visits and microfinance to address those challenges. DISCUSSION: Our qualitative study revealed actionable factors that could impact the success of implementation of group medical visits and microfinance initiatives for NCD care. While several challenges were highlighted, participants also described opportunities to address and mitigate the impact of these factors. We anticipate that our approach and analysis provides new insights and methodological techniques that will be relevant to other low-resource settings worldwide.

Sex differences in health status, healthcare utilization, and costs among individuals with elevated blood pressure: the LARK study from Western Kenya.

BACKGROUND: Elevated blood pressure is the leading risk factor for global mortality. While it is known that there exist differences between men and women with respect to socioeconomic status, self-reported health, and healthcare utilization, there are few published studies from Africa. This study therefore aims to characterize differences in self-reported health status, healthcare utilization, and costs between men and women with elevated blood pressure in Kenya. METHODS: Data from 1447 participants enrolled in the LARK Hypertension study in western Kenya were analyzed. Latent class analysis based on five dependent variables was performed to describe patterns of healthcare utilization and costs in the study population. Regression analysis was then performed to describe the relationship between different demographics and each outcome. RESULTS: Women in our study had higher rates of unemployment (28% vs 12%), were more likely to report lower monthly earnings (72% vs 51%), and had more outpatient visits (39% vs 28%) and pharmacy prescriptions (42% vs 30%). Women were also more likely to report lower quality-of-life and functional health status, including pain, mobility, self-care, and ability to perform usual activities. Three patterns of healthcare utilization were described: (1) individuals with low healthcare utilization, (2) individuals who utilized care and paid high out-of-pocket costs, and (3) individuals who utilized care but had lower out-of-pocket costs. Women and those with health insurance were more likely to be in the high-cost utilizer group. CONCLUSIONS: Men and women with elevated blood pressure in Kenya have different health care utilization behaviors, cost and economic burdens, and self-perceived health status. Awareness of these sex differences can help inform targeted interventions in these populations.

Different Lifestyle Interventions in Adults From Underserved Communities: The FAMILIA Trial.

BACKGROUND: The current trends of unhealthy lifestyle behaviors in underserved communities are disturbing. Thus, effective health promotion strategies constitute an unmet need. OBJECTIVES: The purpose of this study was to assess the impact of 2 different lifestyle interventions on parents/caregivers of children attending preschools in a socioeconomically disadvantaged community. METHODS: The FAMILIA (Family-Based Approach in a Minority Community Integrating Systems-Biology for Promotion of Health) study is a cluster-randomized trial involving 15 Head Start preschools in Harlem, New York. Schools, and their children's parents/caregivers, were randomized to receive either an "individual-focused" or "peer-to-peer-based" lifestyle intervention program for 12 months or control. The primary outcome was the change from baseline to 12 months in a composite health score related to blood pressure, exercise, weight, alimentation, and tobacco (Fuster-BEWAT Score [FBS]), ranging from 0 to 15 (ideal health = 15). To assess the sustainability of the intervention, this study evaluated the change of FBS at 24 months. Main pre-specified secondary outcomes included changes in FBS subcomponents and the effect of the knowledge of presence of atherosclerosis as assessed by bilateral carotid/femoral vascular ultrasound. Mixed-effects models were used to test for intervention effects. RESULTS: A total of 635 parents/caregivers were enrolled: mean age 38 ± 11 years, 83% women, 57% Hispanic/Latino, 31% African American, and a baseline FBS of 9.3 ± 2.4 points. The mean within-group change in FBS from baseline to 12 months was ∼0.20 points in all groups, with no overall between-group differences. However, high-adherence participants to the intervention exhibited a greater change in FBS than their low-adherence counterparts: 0.30 points (95% confidence interval: 0.03 to 0.57; p = 0.027) versus 0.00 points (95% confidence interval: -0.43 to 0.43; p = 1.0), respectively. Furthermore, the knowledge by the participant of the presence of atherosclerosis significantly boosted the intervention effects. Similar results were sustained at 24 months. CONCLUSIONS: Although overall significant differences were not observed between intervention and control groups, the FAMILIA trial highlights that high adherence rates to lifestyle interventions may improve health outcomes. It also suggests a potential contributory role of the presentation of atherosclerosis pictures, providing helpful information to improve future lifestyle interventions in adults.

Hypertension management in rural western Kenya: a needs-based health workforce estimation model.

BACKGROUND: Elevated blood pressure is the leading risk for mortality in the world. Task redistribution has been shown to be efficacious for hypertension management in low- and middle-income countries. However, the workforce requirements for such a task redistribution strategy are largely unknown. Therefore, we developed a needs-based workforce estimation model for hypertension management in western Kenya, using need and capacity as inputs. METHODS: Key informant interviews, focus group discussions, a Delphi exercise, and time-motion studies were conducted among administrative leadership, clinicians, patients, community leaders, and experts in hypertension management. These results were triangulated to generate the best estimates for the inputs into the health workforce model. The local hypertension clinical protocol was used to derive a schedule of encounters with different levels of clinician and health facility staff. A Microsoft Excel-based spreadsheet was developed to enter the inputs and generate the full-time equivalent workforce requirement estimates over 3 years. RESULTS: Two different scenarios were modeled: (1) "ramp-up" (increasing growth of patients each year) and (2) "steady state" (constant rate of patient enrollment each month). The ramp-up scenario estimated cumulative enrollment of 7000 patients by year 3, and an average clinical encounter time of 8.9 min, yielding nurse full-time equivalent requirements of 4.8, 13.5, and 30.2 in years 1, 2, and 3, respectively. In contrast, the steady-state scenario assumed a constant monthly enrollment of 100 patients and yielded nurse full-time equivalent requirements of 5.8, 10.5, and 14.3 over the same time period. CONCLUSIONS: A needs-based workforce estimation model yielded health worker full-time equivalent estimates required for hypertension management in western Kenya. The model is able to provide workforce projections that are useful for program planning, human resource allocation, and policy formulation. This approach can serve as a benchmark for chronic disease management programs in low-resource settings worldwide.