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[ABSTRACT]. The World Health Organization Global Hearts initiative (HEARTS) and technical package aim to improve the primary health care management of hypertension and other risk factors for cardiovascular disease at the population level. This study describes the first HEARTS implementation pilot project in Guatemala’s Ministry of Health (MOH) primary health care system. This pilot began in April 2022 in six primary health care facilities in three rural indigenous municipalities. The project consisted of HEARTS-aligned strategies adapted to enhance program sustainability in Guatemala. Outcomes were defined using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. The primary reach outcome was treatment count, defined as the absolute number of patients per month receiving medication treatment for hypertension. The primary effectiveness outcomes were mean systolic blood pressure (BP), mean diastolic BP, and proportion of patients with BP control (<130/80 mmHg). In the first month of the post-implementation period, there was a statistically significant increase of 25 patients treated per month above the baseline of 20 to 25 patients (P = .002), followed by a significant increase of 2.4 additional patients treated each month (P = .005) thereafter. The mean change in systolic BP was −4.4 (95% CI, −8.2 to −0.5; P = 0.028) mmHg, and the mean change in diastolic BP was −0.9 (95% CI, −2.8 to 1.1; P = .376) mmHg. The proportion of the cohort with BP control increased from 33.4% at baseline to 47.1% at 6 months (adjusted change, 13.7%; 95% CI, 2.2% to 25.2%; P = .027). These findings support the feasibility of implementing the HEARTS model for BP control throughout the MOH primary health care system, which is where most Guatemalans with hypertension seek care.

[RESUMEN]. El paquete técnico de la Iniciativa Global Hearts ("HEARTS") de la Organización Mundial de la Salud tiene como objetivo mejorar el control de la hipertensión y de otros factores de riesgo de enfermedades cardiovasculares a nivel poblacional en el ámbito de la atención primaria de salud de salud. Este estudio describe el primer proyecto piloto de implementación de HEARTS en el sistema de atención primaria de salud del Ministerio de Salud de Guatemala. El proyecto, que comenzó en abril del 2022 en seis centros de atención primaria de salud pertenecientes a tres municipios rurales indígenas, consistió en estrategias alineadas con HEARTS y adaptadas para mejorar la sostenibilidad del programa en Guatemala. Los criterios de valoración de los resultados se definieron mediante el marco estandarizado de evaluación de cobertura, efectividad, adopción, implementación y mantenimiento (RE-AIM, por su sigla en inglés). El criterio principal de la cobertura fue la cantidad de tratamientos, definida como el número absoluto de pacientes por mes que recibían tratamiento farmacológico para la hipertensión. Los criterios principales de la efectividad fueron la media de presión arterial (PA) sistólica, la media de PA diastólica y la proporción de pacientes con un control de la PA (<130/80 mmHg). En el primer mes del período posterior a la implementación, se registró un aumento estadísticamente significativo de 25 pacientes tratados al mes por encima del valor inicial de 20 a 25 pacientes (n = 25; p = 0,002), seguido de un aumento significativo de 2,4 pacientes adicionales tratados al mes (p = 0,005) posteriormente. El cambio en la media de la PA sistólica fue de -4,4 (IC del 95%: -8,2 a -0,5); p = 0,028) mmHg, en tanto que el cambio en la media de la PA diastólica fue de -0,9 (IC del 95%, -2,8 a 1,1); p = 0,376) mmHg. La proporción de la cohorte con control de la PA aumentó del 33,4% al inicio al 47,1% a los seis meses (cambio ajustado, 13,7%; IC del 95%, 2,2% a 25,2%; p = 0,027). Estos resultados respaldan la viabilidad de la implementación del modelo HEARTS para el control de la PA en la totalidad del sistema de atención primaria de salud del Ministerio de Salud de Guatemala, al que acude en busca de atención la mayoría de las personas con hipertensión.

[RESUMO]. O pacote de medidas técnicas da iniciativa Global Hearts (“HEARTS”) da Organização Mundial da Saúde tem como objetivo melhorar o controle da hipertensão arterial e de outros fatores de risco para doenças cardiovasculares na atenção primária à saúde em nível populacional. Este estudo descreve o primeiro projeto-piloto de implementação da iniciativa HEARTS no sistema de atenção primária à saúde do Ministério da Saúde da Guatemala. O projeto-piloto começou em abril de 2022 em seis estabelecimentos de atenção primária à saúde em três municípios indígenas rurais. O projeto consistiu em estratégias alinhadas à iniciativa HEARTS e adaptadas para melhorar a sustentabilidade do programa na Guatemala. Os desfechos foram definidos usando a estrutura de avaliação RE-AIM (sigla em inglês para alcance, efetividade, adoção, implementação e manutenção). O desfecho primário de alcance foi a quantidade de tratamentos, definida como o número absoluto de pacientes por mês que receberam tratamento medicamentoso para hipertensão. Os desfechos primários de efetividade foram pressão arterial (PA) sistólica média, PA diastólica média e proporção de pacientes com controle da PA (<130/80 mmHg). No primeiro mês do período pós-implementação, houve um aumento estatisticamente significante de 25 pacientes tratados por mês acima da linha de base de 20 a 25 pacientes (n = 25; P = 0,002), seguido de um aumento significante de 2,4 pacientes adicionais tratados a cada mês (P = 0,005) depois disso. A mudança média na PA sistólica foi de −4,4 (intervalo de confiança [IC] de 95%: −8,2 a −0,5; P = 0,028) mmHg, e a mudança média na PA diastólica foi de −0,9 (IC de 95%: −2,8 a 1,1; P = 0,376) mmHg. A proporção da coorte com controle da PA aumentou de 33,4% na linha de base para 47,1% após 6 meses (mudança ajustada, 13,7%; IC de 95%: 2,2% a 25,2%; P = 0,027). Esses achados apoiam a viabilidade da implementação do modelo HEARTS para o controle da PA em todo o sistema de atenção primária à saúde do Ministério da Saúde da Guatemala, no qual a maioria dos indivíduos com hipertensão arterial procura atendimento.

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BACKGROUND: The HEARTS technical package was developed by the World Health Organization to address the implementation gap in cardiovascular disease prevention in low- and middle-income countries. Guatemala is a middle-income country that is currently implementing HEARTS. National authorities in Guatemala are interested in exploring how hypertension and diabetes management can be integrated in HEARTS implementation. The objective of this study is to conduct a feasibility and acceptability pilot trial of integrated hypertension and diabetes management based on HEARTS in the publicly funded primary care system in Guatemala. METHODS: A single-arm pilot trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in September 2023. A planned sample of 100 adult patients diagnosed with diabetes (n = 45), hypertension (n = 45), or both (n = 10) will be enrolled. The intervention will consist of HEARTS-aligned components: Training health workers on healthy-lifestyle counseling and evidence-based treatment protocols, strengthening access to medications and diagnostics, training on risk-based cardiovascular disease management, team-based care and task sharing, and systems monitoring and feedback, including implementation of a facility-based electronic monitoring tool at the individual level. Co-primary outcomes of feasibility and acceptability will be assessed using an explanatory sequential mixed-methods design. Secondary outcomes include clinical effectiveness (treatment with medication, glycemic control, and blood pressure control), key implementation outcomes (adoption, fidelity, usability, and sustainability), and patient-reported outcome measures (diabetes distress, disability, and treatment burden). Using an implementation mapping approach, a Technical Advisory Committee will develop implementation strategies for subsequent scale-up planning. DISCUSSION: This trial will produce evidence on implementing HEARTS-aligned hypertension and diabetes care in the MOH primary care system in Guatemala. Results also will inform future HEARTS projects in Guatemala and other low- and middle-income countries. TRIAL REGISTRATION: ClinicalTrials.gov ID NCT06080451. The trial was prospectively registered on October 12, 2023.

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Bothrops atrox envenomations are common in the Brazilian Amazon. The venom of B. atrox is highly inflammatory, which results in severe local complications, including the formation of blisters. Moreover, there is little information on the immune mechanisms associated with this condition. Thus, a longitudinal study was carried out to characterize the profile of the cell populations and soluble immunological mediators in the peripheral blood and blisters in B. atrox patients s according to their clinical manifestations (mild and severe). A similar response in both B. atrox patient groups (MILD and SEV) was observed, with an increase in inflammatory monocytes, NKT, and T and B cells, as well as CCL2, CCL5, CXCL9, CXCL10, IL-1ß and IL-10, when compared with the group of healthy blood donors. After the administration of antivenom, the participation of patrolling monocytes and IL-10 in the MILD group was observed. In the SEV group, the participation of B cells was observed, with high levels of CCL2 and IL-6. In the blister exudate, a hyperinflammatory profile was observed. In conclusion, we revealed the involvement of cell populations and soluble mediators in the immune response to B. atrox envenomation at the local and peripheral level, which is related to the onset and extent of the inflammation/clinical manifestation.

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Snakebites are considered a major public health problem worldwide. In the Amazon region of Brazil, the snake Bothrops atrox (B. atrox) is responsible for 90% of the bites. These bites may cause local and systemic signs from acute inflammatory reaction and hemostatic changes, and present common hemorrhagic disorders. These alterations occur due the action of hemostatically active and immunogenic toxins which are capable of triggering a wide range of hemostatic and inflammatory events. However, the crosstalk between coagulation disorders and inflammatory reaction still has gaps in snakebites. Thus, the goal of this study was to describe the relationship between the consumption of fibrinogen and the profile of inflammatory molecules (chemokines and cytokines) in evenomations by B. atrox snakebites. A prospective study was carried out with individuals who had suffered B. atrox snakebites and presented different levels of fibrinogen consumption (normal fibrinogen [NF] and hypofibrinogenemia [HF]). Seventeen patients with NF and 55 patients with HF were eligible for the study, in addition to 50 healthy controls (CG). The molecules CXCL-8, CCL-5, CXCL-9, CCL-2, CXCL-10, IL-6, TNF, IL-2, IL-10, IFN-γ, IL-4, and IL-17A were quantified in plasma using the CBA technique at three different times (pre-antivenom therapy [T0], 24 h [T1], and 48 h [T2] after antivenom therapy). The profile of the circulating inflammatory response is different between the groups studied, with HF patients having higher concentrations of CCL-5 and lower IFN-γ. In addition, antivenom therapy seems to have a positive effect, leading to a profile of circulating inflammatory response similar in quantification of T1 and T2 on both groups. Furthermore, these results suggest that a number of interactions of CXCL-8, CXCL-9, CCL-2, IL-6, and IFN-γ in HF patients are directly affected by fibrinogen levels, which may be related to the inflammatory response and coagulation mutual relationship induced by B. atrox venom. The present study is the first report on inflammation-coagulation crosstalk involving snakebite patients and supports the better understanding of envenomation's pathophysiology mechanisms and guides in the search for novel biomarkers and prospective therapies.

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Infection by Helicobacter pylori is a major risk factor for gastric cancer (GC), the second leading cause of cancer-related death worldwide. Although biomarkers such as pepsinogens (PGs) and soluble urokinase plasminogen activator receptor (suPAR) may have diagnostic and/or prognostic value in patients with GC, their levels may be affected by H. pylori infection. The aim of this study was to investigate the association of the presence of antibodies to H. pylori and cytotoxin-associated gene A (CagA) with plasma levels of PGs and suPAR in a cohort of Guatemalan GC patients and controls. To this end, levels of suPAR, Pepsinogens I and II (PGI and PGII), and antibodies to H. pylori and CagA toxin were determined by ELISA in plasma samples from 67 GC patients and 136 matched healthy controls. Seropositivity for CagA was significantly higher in patients with GC than in controls. Pepsinogens II and suPAR levels were higher and PGI/PGII ratios were lower in GC patients than in controls. There was a significant association of H. pylori seropositivity status with increased levels of PGII and lower PGI/PGII ratios, particularly in the control (non-GC) population. The levels of suPAR were not significantly affected by H. pylori or CagA seropositivity status. These results suggest that the seropositivity status for H. pylori and CagA need to be taken into account during the GC diagnostic process.

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Snakebites are considered a major public health problem worldwide. In the Amazon region of Brazil, the snake Bothrops atrox (B. atrox) is responsible for 90% of the bites. These bites may cause local and systemic signs from acute inflammatory reaction and hemostatic changes, and present common hemorrhagic disorders. These alterations occur due the action of hemostatically active and immunogenic toxins which are capable of triggering a wide range of hemostatic and inflammatory events. However, the crosstalk between coagulation disorders and inflammatory reaction still has gaps in snakebites. Thus, the goal of this study was to describe the relationship between the consumption of fibrinogen and the profile of inflammatory molecules (chemokines and cytokines) in evenomations by B. atrox snakebites. A prospective study was carried out with individuals who had suffered B. atrox snakebites and presented different levels of fibrinogen consumption (normal fibrinogen [NF] and hypofibrinogenemia [HF]). Seventeen patients with NF and 55 patients with HF were eligible for the study, in addition to 50 healthy controls (CG). The molecules CXCL-8, CCL-5, CXCL-9, CCL-2, CXCL-10, IL-6, TNF, IL-2, IL-10, IFN-γ, IL-4, and IL-17A were quantified in plasma using the CBA technique at three different times (pre-antivenom therapy [T0], 24 h [T1], and 48 h [T2] after antivenom therapy). The profile of the circulating inflammatory response is different between the groups studied, with HF patients having higher concentrations of CCL-5 and lower IFN-γ. In addition, antivenom therapy seems to have a positive effect, leading to a profile of circulating inflammatory response similar in quantification of T1 and T2 on both groups. Furthermore, these results suggest that a number of interactions of CXCL-8, CXCL-9, CCL-2, IL-6, and IFN-γ in HF patients are directly affected by fibrinogen levels, which may be related to the inflammatory response and coagulation mutual relationship induced by B. atrox venom. The present study is the first report on inflammation-coagulation crosstalk involving snakebite patients and supports the better understanding of envenomation's pathophysiology mechanisms and guides in the search for novel biomarkers and prospective therapies.