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Abstract Background The escalating prevalence of type 2 diabetes (T2DM) poses an unparalleled economic catastrophe to developing countries. Cardiovascular diseases remain the primary source of costs among individuals with T2DM, incurring expenses for medications, hospitalizations, and surgical interventions. Compelling evidence suggests that the risk of cardiovascular outcomes can be reduced by three classes of glucose-lowering therapies (GLT), including SGLT2i, GLP-1A, and pioglitazone. However, an evidence-based and cost-effective protocol is still unavailable for many countries. The objective of the current study is to compare the effectiveness and cost-effectiveness of GLT in individuals with T2DM in Brazil. Methods We employed Bayesian Networks to calculate the incremental cost-effectiveness ratios (ICER), expressed in international dollars (Int$) per disease-adjusted life years [DALYs] averted. To determine the effectiveness of GLT, we conducted a systematic review with network meta-analysis (NMA) to provide insights for our model. Additionally, we obtained cardiovascular outcome incidence data from two real-world cohorts comprising 851 and 1337 patients in primary and secondary prevention, respectively. Our cost analysis took into account the perspective of the Brazilian public health system, and all values were converted to Int$. Results In the NMA, SGLT2i [HR: 0.81 (95% CI 0.69–0.96)], GLP-1A [HR: 0.79 (95% CI 0.67–0.94)], and pioglitazone [HR: 0.73 (95% CI 0.59–0.91)] demonstrated reduced relative risks of non-fatal cardiovascular events. In the context of primary prevention, pioglitazone yielded 0.2339 DALYs averted, with an ICER of Int$7,082 (95% CI 4,521–10,770) per DALY averted when compared to standard care. SGLT2i and GLP-1A also increased effectiveness, resulting in 0.261 and 0.259 DALYs averted, respectively, but with higher ICERs of Int$12,061 (95% CI: 7,227–18,121) and Int$29,119 (95% CI: 23,811–35,367) per DALY averted. In the secondary prevention scenario, all three classes of treatments were deemed cost-effective at a maximum willingness-to-pay threshold of Int$26,700. Notably, pioglitazone consistently exhibited the highest probability of being cost-effective in both scenarios. Conclusions In Brazil, pioglitazone presented a higher probability of being cost-effective both in primary and secondary prevention, followed by SGLT2i and GLP-1A. Our findings support the use of cost-effectiveness models to build optimized and hierarchical therapeutic strategy in the management of T2DM. Trial registration CRD42020194415.

HEARTS en las Américas es la adaptación regional de la iniciativa Global HEARTS de la Organización Mundial de la Salud, que será el modelo para el manejo del riesgo de las enfermedades cardiovasculares (ECV) en la atención primaria de salud en la Región de las Américas para el año 2025. Ya se ha implementado en 21 países y 1045 centros de atención primaria de salud en toda América Latina y el Caribe. Se ha adoptado un enfoque de salud pública y de sistemas de salud para introducir sistemáticamente intervenciones simplificadas en el nivel de la atención primaria de salud que se centran en el control de la hipertensión como punto de entrada clínico. En este artículo se presenta una aplicación nueva y mejorada cuyo componente principal es la calculadora de riesgo de ECV y de manejo de la hipertensión. Se resume el enfoque de evaluación del riesgo y la metodología utilizada por la Organización Mundial de la Salud para actualizar sus tablas de riesgo cardiovascular del 2019; se describe la aplicación, su uso, su funcionalidad y su proceso de validación; y se presenta un conjunto de recomendaciones prácticas para optimizar el manejo del riesgo de ECV y de la hipertensión, mediante el uso de la aplicación en la práctica clínica. La aplicación HEARTS es una herramienta sólida para mejorar la calidad de la atención prestada en los centros de atención primaria. La creación y difusión de la aplicación HEARTS es un paso esencial en el camino hacia la eliminación de las ECV prevenibles en la Región de las Américas.

HEARTS in the Americas is the regional adaptation of the World Health Organizations Global Hearts Initiative, which will be the model for risk management for cardiovascular disease (CVD) in primary health care in the Region of the Americas by 2025. It has already been implemented in 21 countries and 1045 primary health care centers throughout Latin America and the Caribbean. It takes a public health and health systems approach to systematically introduce simplified interventions at the primary health care level and focuses on hypertension as a clinical entry point. This paper introduces a new, improved application (app), the main component of which is the calculator for CVD risk and hypertension management. The paper summarizes the risk assessment approach and the methodology used by the World Health Organization to update its cardiovascular risk charts in 2019; describes the app, its use, functionality and validation process; and provides a set of practical recommendations for optimizing CVD risk and hypertension management by using the app in clinical practice. The HEARTS app is a powerful tool to improve the quality of care provided in primary health settings. The creation and dissemination of the HEARTS app is an essential step in the journey towards eliminating preventable CVD in the Americas.

Abstract Background Evidence on cognitive function in older South Africans is limited, with few population-based studies. We aimed to estimate baseline associations between cognitive function and cardiometabolic disease risk factors in rural South Africa. Methods We use baseline data from “Health and Aging in Africa: A Longitudinal Study of an INDEPTH Community in South Africa” (HAALSI), a population-based study of adults aged 40 and above in rural South Africa in 2015. Cognitive function was measured using measures of time orientation, immediate and delayed recall, and numeracy adapted from the Health and Retirement Study cognitive battery (overall total cognitive score range 0–26). We used multiple linear regression to estimate associations between cardiometabolic risk factors (including BMI, hypertension, dyslipidemia, diabetes, history of stroke, alcohol frequency, and smoking status) and the overall cognitive function score, adjusted for potential confounders. Results In multivariable-adjusted analyses (n = 3018; male = 1520; female = 1498; median age 59 (interquartile range 50–67)), cardiometabolic risk factors associated with lower cognitive function scores included: diabetes (b = − 1.11 [95% confidence interval: − 2.01, − 0.20] for controlled diabetes vs. no diabetes); underweight BMI (b = − 0.87 [CI: − 1.48, − 0.26] vs. normal BMI); and current and past smoking history compared to never smokers. Factors associated with higher cognitive function scores included: obese BMI (b = 0.74 [CI: 0.39, 1.10] vs. normal BMI); and controlled hypertension (b = 0.53 [CI: 0.11, 0.96] vs. normotensive). Conclusions We provide an important baseline from rural South Africa on the associations between cardiometabolic disease risk factors and cognitive function in an older, rural South African population using standardized clinical measurements and cut-offs and widely used cognitive assessments. Future studies are needed to clarify temporal associations as well as patterns between the onset and duration of cardiometabolic conditions and cognitive function. As the South African population ages, effective management of cardiometabolic risk factors may be key to lasting cognitive health.

Abstract Background The high co-morbidity of mental disorders, particularly depression, with non-communicable diseases (NCDs) such as cardiovascular disease (CVD), is concerning given the rising burden of NCDs globally, and the role depression plays in confounding prevention and treatment of NCDs. The objective of this randomised control trial (RCT) is to determine the real-world effectiveness of strengthened depression identification and management on depression outcomes in hypertensive patients attending primary health care (PHC) facilities in South Africa (SA). Methods/design The study design is a pragmatic, two-arm, parallel-cluster RCT, the unit of randomisation being the clinics, with outcomes being measured for individual participants. The 20 largest eligible clinics from one district in the North West Province are enrolled in the trial. Equal numbers of hypertensive patients (n = 50) identified as having depression using the Patient Health Questionnaire (PHQ-9) are enrolled from each clinic, making up a total of 1000 participants with 500 in each arm. The nurse clinicians in the control facilities receive the standard training in Primary Care 101 (PC101), a clinical decision support tool for integrated chronic care that includes guidelines for hypertension and depression care. Referral pathways available include referrals to PHC physicians, clinical or counselling psychologists and outpatient psychiatric and psychological services. In the intervention clinics, this training is supplemented with strengthened training in the depression components of PC101 as well as training in clinical communication skills for nurse-led chronic care. Referral pathways are strengthened through the introduction of a facility-based behavioural health counsellor, trained to provide structured manualised counselling for depression and adherence counselling for all chronic conditions. The primary outcome is defined as at least 50% reduction in PHQ-9 score measured at 6 months. Discussion This trial should provide evidence of the real world effectiveness of strengtheneddepression identification and collaborative management on health outcomes of hypertensive patients withcomorbid depression attending PHC facilities in South Africa. Trial registration South African National Clinical Trial Register: SANCTR (http://www.sanctr.gov.za/SAClinicalTrials) (DOH-27-0916-5051). Registered on 9 April 2015. ClinicalTrials.gov: ID: NCT02425124. Registered on 22 April 2015.

Abstract Background The scale-up of antiretroviral treatment (ART) programmes has seen HIV/AIDS transition to a chronic condition characterised by high rates of comorbidity with tuberculosis, non-communicable diseases (NCDs) and mental health disorders. Depression is one such disorder that is associated with higher rates of non-adherence, progression to AIDS and greater mortality. Detection and treatment of comorbid depression is critical to achieve viral load suppression in more than 90% of those on ART and is in line with the recent 90-90-90 Joint United Nations Programme on HIV/AIDS (UNAIDS) targets. The CobALT trial aims to provide evidence on the effectiveness and cost-effectiveness of scalable interventions to reduce the treatment gap posed by the growing burden of depression among adults on lifelong ART. Methods The study design is a pragmatic, parallel group, stratified, cluster randomised trial in 40 clinics across two rural districts of the North West Province of South Africa. The unit of randomisation is the clinic, with outcomes measured among 2000 patients on ART who screen positive for depression using the Patient Health Questionnaire (PHQ-9). Control group clinics are implementing the South African Department of Health’s Integrated Clinical Services Management model, which aims to reduce fragmentation of care in the context of rising multimorbidity, and which includes training in the Primary Care 101 (PC101) guide covering communicable diseases, NCDs, women’s health and mental disorders. In intervention clinics, we supplemented this with training specifically in the mental health components of PC101 and clinical communications skills training to support nurse-led chronic care. We strengthened the referral pathways through the introduction of a clinic-based behavioural health counsellor equipped to provide manualised depression counselling (eight sessions, individual or group), as well as adherence counselling sessions (one session, individual). The co-primary patient outcomes are a reduction in PHQ-9 scores of at least 50% from baseline and viral load suppression rates measured at 6 and 12 months, respectively. Discussion The trial will provide real-world effectiveness of case detection and collaborative care for depression including facility-based counselling on the mental and physical outcomes for people on lifelong ART in resource-constrained settings. Trial registration ClinicalTrials.gov (NCT02407691) registered on 19 March 2015; Pan African Clinical Trials Registry (201504001078347) registered on 19/03/2015; South African National Clinical Trials Register (SANCTR) (DOH-27-0515-5048) NHREC number 4048 issued on 21/04/2015.

In many low-income countries, care for patients with non-communicable diseases (NCDs) and mental health conditions is provided by nurses. The benefits of nurse substitution and supplementation in NCD care in high-income settings are well recognised, but evidence from low- and middle-income countries is limited. Primary Care 101 (PC101) is a programme designed to support and expand nurses' role in NCD care, comprising educational outreach to nurses and a clinical management tool with enhanced prescribing provisions. We evaluated the effect of the programme on primary care nurses' capacity to manage NCDs.In a cluster randomised controlled trial design, 38 public sector primary care clinics in the Western Cape Province, South Africa, were randomised. Nurses in the intervention clinics were trained to use the PC101 management tool during educational outreach sessions delivered by health department trainers and were authorised to prescribe an expanded range of drugs for several NCDs. Control clinics continued use of the Practical Approach to Lung Health and HIV/AIDS in South Africa (PALSA PLUS) management tool and usual training. Patients attending these clinics with one or more of hypertension (3,227), diabetes (1,842), chronic respiratory disease (1,157) or who screened positive for depression (2,466), totalling 4,393 patients, were enrolled between 28 March 2011 and 10 November 2011. Primary outcomes were treatment intensification in the hypertension, diabetes, and chronic respiratory disease cohorts, defined as the proportion of patients in whom treatment was escalated during follow-up over 14 mo, and case detection in the depression cohort. Primary outcome data were analysed for 2,110 (97%) intervention and 2,170 (97%) control group patients. Treatment intensification rates in intervention clinics were not superior to those in the control clinics (hypertension: 44% in the intervention group versus 40% in the control group, risk ratio [RR] 1.08 [95% CI 0.94 to 1.24; p = 0.252]; diabetes: 57% versus 50%, RR 1.10 [0.97 to 1.24; p = 0.126]; chronic respiratory disease: 14% versus 12%, RR 1.08 [0.75 to 1.55; p = 0.674]), nor was case detection of depression (18% versus 24%, RR 0.76 [0.53 to 1.10; p = 0.142]). No adverse effects of the nurses' expanded scope of practice were observed. Limitations of the study include dependence on self-reported diagnoses for inclusion in the patient cohorts, limited data on uptake of PC101 by users, reliance on process outcomes, and insufficient resources to measure important health outcomes, such as HbA1c, at follow-up.Educational outreach to primary care nurses to train them in the use of a management tool involving an expanded role in managing NCDs was feasible and safe but was not associated with treatment intensification or improved case detection for index diseases. This notwithstanding, the intervention, with adjustments to improve its effectiveness, has been adopted for implementation in primary care clinics throughout South Africa.The trial is registered with Current Controlled Trials (ISRCTN20283604).

The reality of finite resources has a real-world impact on a patient's ability to receive life-saving care in resource-poor settings. Blood for transfusion is an example of a scarce resource. Very few studies have looked at predictors of survival in patients requiring massive transfusion. We used data from a rural hospital in Kenya to develop a prediction model of survival among patients receiving massive transfusion.Patients who received five or more units of whole blood within 48 hours between 2004 and 2010 were identified from a blood registry in a rural hospital in Kenya. Presenting characteristics and in-hospital survival were collected from charts. Using stepwise selection, a logistic model was developed to predict who would survive with massive transfusion versus those who would die despite transfusion. An ROC curve was created from this model to quantify its predictive power.Ninety-five patients with data available met inclusion criteria, and 74% survived to discharge. The number of units transfused was not a predictor of mortality, and no threshold for futility could be identified. Preliminary results suggest that initial blood pressure, lack of comorbidities, and indication for transfusion are the most important predictors of survival. The ROC curve derived from our model demonstrates an area under the curve (AUC) equal to 0.757, with optimism of 0.023 based on a bootstrap validation.This study provides a framework for making prioritization decisions for the use of whole blood in the setting of massive bleeding. Our analysis demonstrated an overall survival rate for patients receiving massive transfusion that was higher than clinical perception. Our analysis also produced a preliminary model to predict survival in patients with massive bleeding. Prediction analyses can contribute to more efficient prioritization decisions; these decisions must also include other considerations such as equity, acceptability, affordability and sustainability.

Relatively few data exist on the burden of end-stage renal disease (ESRD) and use of renal replacement therapy (RRT)-a life-saving therapy-in developing regions. No study has quantified the proportion of patients who develop ESRD but are unable to access RRT.We performed a comprehensive literature search to estimate use and annual initiation of RRT worldwide, and present these estimates according to World Bank regions. We also present estimates of survival and of etiology of diseases in patients undergoing RRT. Using data on prevalence of diabetes and hypertension, we modeled the incidence of ESRD related to these risk factors in order to quantify the gap between ESRD and use of RRT in developing regions.We find that 1.9 million patients are undergoing RRT worldwide, with continued use and annual initiation at 316 and 73 per million population respectively. RRT use correlates directly (Pearson's r = 0.94) with regional income. Hemodialysis remains the dominant form of RRT but there is wide regional variation in its use. With the exception of the Latin American and Caribbean region, it appears that initiation of RRT in developing regions is restricted to fewer than a quarter of patients projected to develop ESRD. This results in at least 1.2 million premature deaths each year due to lack of access to RRT as a result of diabetes and elevated blood pressure and as many as 3.2 million premature deaths due to all causes of ESRD.Thus, the majority of patients projected to reach ESRD due to diabetes or hypertension in developing regions are unable to access RRT; this gap will increase with rising prevalence of these risk factors worldwide.

Objectives: To estimate the health impact and cost-effectiveness of a national penny-per-ounce sugar-sweetened beverage (SSB) tax, overall and with stratified costs and benefits for 9 distinct stakeholder groups., Methods: We used a validated microsimulation model (CVD PREDICT) to estimate cardiovascular disease reductions, quality-adjusted life years gained, and cost-effectiveness for US adults aged 35 to 85 years, evaluating full and partial consumer price pass-through., Results: From health care and societal perspectives, the SSB tax was highly cost-saving. When we evaluated health gains, taxes paid, and out-of-pocket health care savings for 6 distinct consumer categories, incremental cost-effectiveness ratios ranged from $20 247 to $42 662 per quality-adjusted life year for 100% price pass-through (incremental cost-effectiveness ratios similar with 50% pass-through). For the beverage industry, net costs were $0.92 billion with 100% pass-through (largely tax-implementation costs) and $49.75 billion with 50% pass-through (largely because of partial industry coverage of the tax). For government, the SSB tax positively affected both tax revenues and health care cost savings., Conclusions: This stratified analysis improves on unitary approaches, illuminating distinct costs and benefits for stakeholders with political influence over SSB tax decisions.

South Africa's rates of statin use are among the world's lowest, despite statins' demonstrated effectiveness for people with a high blood cholesterol level or history of cardiovascular disease. Almost 5 percent of the country's total mortality has been attributed to high cholesterol levels, fueled in part by low levels of statin adherence. Drawing upon experience elsewhere, we used a microsimulation model of cardiovascular disease to investigate the health and economic impacts of increasing prescription length from the standard thirty days to either sixty or ninety days, for South African adults on a stable statin regimen. Increasing prescription length to sixty or ninety days could save 1,694 or 2,553 lives per million adults, respectively. In addition, annual per patient costs related to cardiovascular disease would decrease by $152.41 and $210.29, respectively. Savings would largely accrue to patients in the form of time savings and reduced transportation costs, as a result of less frequent trips to the pharmacy. Increasing statin prescription length would both save resources and improve health outcomes in South Africa., (Project HOPE—The People-to-People Health Foundation, Inc.)

In low-resource settings, a physician is not always available. We recently demonstrated that community health workers-instead of physicians or nurses-can efficiently screen adults for cardiovascular disease in South Africa, Mexico, and Guatemala. In this analysis we sought to determine the health and economic impacts of shifting this screening to community health workers equipped with either a paper-based or a mobile phone-based screening tool. We found that screening by community health workers was very cost-effective or even cost-saving in all three countries, compared to the usual clinic-based screening. The mobile application emerged as the most cost-effective strategy because it could save more lives than the paper tool at minimal extra cost. Our modeling indicated that screening by community health workers, combined with improved treatment rates, would increase the number of deaths averted from 15,000 to 110,000, compared to standard care. Policy makers should promote greater acceptance of community health workers by both national populations and health professionals and should increase their commitment to treating cardiovascular disease and making medications available., (Project HOPE—The People-to-People Health Foundation, Inc.)