ABSTRACT

Cardiovascular diseases are the leading cause of mortality and morbidity in the Region of the Americas, and hypertension represents its main risk factor. However, population hypertension control rates in the Region are poor. Global Hearts is the World Health Organization's flagship initiative to reduce the burden of cardiovascular diseases. HEARTS in the Americas Initiative is its regional adaptation that seeks to be the cardiovascular disease risk management model, including hypertension and diabetes, in primary health care throughout the Americas by 2025.

HEARTS in the Americas is being implemented in 22 countries and over 2 095 primary care centers. All implementing countries have defined their treatment protocols, and HEARTS in the Americas has supported continuous improvement. Because WHO recently released the 2021 Guideline for the Pharmacological Treatment of Hypertension in Adults and HEARTS in the Americas introduced the key drivers for hypertension control, the initiative generated a methodology to help countries update and strengthen their treatment protocols.

This article describes the process of developing the treatment protocol appraisal checklist and defines the resulting clinical pathway. This tool can help countries and primary care centers to improve their protocols by identifying the improvement points and upgrading clinical pathways.

Keywords
Cardiovascular diseases; hypertension; practice guideline; clinical protocols; critical pathways; public health; Americas

RESUMEN

Las enfermedades cardiovasculares son la principal causa de mortalidad y morbilidad en la Región de las Américas, y la hipertensión representa su principal factor de riesgo. Sin embargo, las tasas de control de la hipertensión arterial en la Región son desalentadoras. Global Hearts es la iniciativa insignia de la Organización Mundial de la Salud para reducir la carga de las enfermedades cardiovasculares. La iniciativa HEARTS en las Américas es su adaptación regional, y tiene como objetivo ser el modelo de manejo del riesgo de enfermedades cardiovasculares, incluida la hipertensión y la diabetes, en la atención primaria de salud en la Región para el año 2025.

HEARTS en las Américas se está aplicando en 22 países y más de 2 095 centros de atención primaria. Todos los países que están aplicando esta iniciativa han definido sus protocolos de tratamiento, y HEARTS en las Américas ha brindado apoyo para la mejora continua. Debido a que la OMS publicó recientemente la guía para el tratamiento farmacológico de la hipertensión en adultos (2021) y HEARTS en las Américas determinó cuáles son los impulsores clave para el control de la hipertensión, la iniciativa elaboró una metodología para ayudar a los países a actualizar y fortalecer sus protocolos de tratamiento.

En este artículo se describe el proceso de elaboración de la lista de verificación para la evaluación del protocolo de tratamiento y se define la vía clínica resultante. Esta herramienta puede ayudar a los países y los centros de atención primaria a mejorar sus protocolos para que determinen cuáles son los puntos que se deben mejorar y elaboren las vías clínicas.

Palabras clave
Enfermedades cardiovasculares; hipertensión; guía de práctica clínica; protocolos clínicos; vías clínicas; salud pública; Américas

RESUMO

A iniciativa HEARTS nas Américas está sendo implementada em 22 países e mais de 2 095 centros de atenção primária à saúde. Todos os países que estão implementando a iniciativa definiram seus protocolos de tratamento, e a HEARTS nas Américas contribuiu para a melhoria contínua. Como a OMS lançou recentemente as Diretrizes de 2021 para o tratamento medicamentoso da hipertensão arterial em adultos e a HEARTS nas Américas desenvolveu os elementos essenciais para o controle da hipertensão, a iniciativa criou uma metodologia para auxiliar os países na atualização e no fortalecimento de seus protocolos de tratamento.

Este artigo descreve o processo de elaboração da lista de verificação para avaliação do protocolo de tratamento e define o caminho clínico resultante. Esta ferramenta pode ajudar os países e os centros de atenção primária à saúde a aprimorarem seus protocolos mediante a identificação dos pontos para melhoria e o desenvolvimento de caminhos clínicos.

As doenças cardiovasculares são a principal causa de morbimortalidade na Região das Américas, e a hipertensão é seu principal fator de risco. Entretanto, as taxas de controle da hipertensão na população da Região são baixas. Global Hearts é a principal iniciativa da Organização Mundial da Saúde para reduzir a carga de doenças cardiovasculares. A iniciativa HEARTS nas Américas é sua adaptação regional, que almeja ser o modelo para o gerenciamento de risco de doenças cardiovasculares, incluindo a hipertensão e o diabetes, na atenção primária à saúde em toda a Região das Américas até 2025.

Palavras-chave
Doenças cardiovasculares; hipertensão; guia de prática clínica; protocolos clínicos; procedimentos clínicos; saúde pública; América

Cardiovascular diseases (CVD) are the leading cause of premature mortality and morbidity in the Americas, accounting for 2 million deaths annually and a substantial negative socioeconomic impact (¹1. Martinez R, Soliz P, Mujica OJ, Reveiz L, Campbell NRC, Ordunez P. The slowdown in the reduction rate of premature mortality from cardiovascular diseases puts the Americas at risk of achieving SDG 3.4: a population trend analysis of 37 countries from 1990 to 2017. J Clin Hypertens (Greenwich). 2020 Aug;22(8):1296-1309. doi: 10.1111/jch.13922.
https://doi.org/10.1111/jch.13922... ). In terms of their risk factors high blood pressure is the most relevant one (²2. Campbell NRC, Schutte AE, Varghese CV, Ordunez P, Zhang XH, Khan T, et al. São Paulo call to action for the prevention and control of high blood pressure: 2020. J Clin Hypertens (Greenwich). 2019 Dec;21(12):1744-1752. doi: 10.1111/jch.13741.
https://doi.org/10.1111/jch.13741... ). In Latin America and the Caribbean, more than one-third of adults live with hypertension. However, even though the treatment of hypertension is very cost-effective, relatively easy, and safe, only 23% of men and 35% of women are controlled (blood pressure < 140/90 mmHg) (³3. NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in hypertension prevalence and progress in treatment and control from 1990 to 2019: a pooled analysis of 1201 population-representative studies with 104 million participants. Lancet. 2021 Sep 11;398(10304):957-980. doi: 10.1016/S0140-6736(21)01330-1.
https://doi.org/10.1016/S0140-6736(21)01... ).

The Global HEARTS Initiative is a broad strategy launched in 2016 by the World Health Organization (WHO) to reduce premature CVD morbidity and mortality through the implementation of health policies at the population level and strengthening CVD management in primary health care settings (⁴4. World Health Organization. HEARTS Technical Package. Geneva: WHO; 2016. Available at: https://www.who.int/news/item/15-09-2016-global-hearts-initiative Access date: June 9th, 2022.
https://www.who.int/news/item/15-09-2016... ). The Pan American Health Organization (PAHO), the regional office of the WHO, initiated HEARTS in the Americas, a comprehensive CVD risk reduction program, which is poised to become the Americas' CVD care management model by 2025 (⁵5. Campbell NRC, Ordunez P, Giraldo G, Rodriguez Morales YA, Lombardi C, Khan T, et al. WHO HEARTS: A Global Program to Reduce Cardiovascular Disease Burden: Experience Implementing in the Americas and Opportunities in Canada. Can J Cardiol. 2021 May;37(5):744-755. doi: 10.1016/j.cjca.2020.12.004.
https://doi.org/10.1016/j.cjca.2020.12.0... ). It is currently being implemented and expanded in 22 countries and more than 2 095 primary health care (PHC) facilities. Its fundamental goals are improved coverage and control of hypertension and CVD risk reduction in the population served.

HEARTS in the Americas is based on six technical pillars; one of the most relevant includes standardized treatment protocols and medications (⁵5. Campbell NRC, Ordunez P, Giraldo G, Rodriguez Morales YA, Lombardi C, Khan T, et al. WHO HEARTS: A Global Program to Reduce Cardiovascular Disease Burden: Experience Implementing in the Americas and Opportunities in Canada. Can J Cardiol. 2021 May;37(5):744-755. doi: 10.1016/j.cjca.2020.12.004.
https://doi.org/10.1016/j.cjca.2020.12.0... ). Accordingly, the initiative created a pragmatic methodology to advance standardized and effective hypertension treatment protocols (⁶6. DiPette DJ, Skeete J, Ridley E, Campbell NRC, Lopez-Jaramillo P, Kishore SP, et al. Fixed-dose combination pharmacologic therapy to improve hypertension control worldwide: Clinical perspective and policy implications. J Clin Hypertens (Greenwich). 2019 Jan;21(1):4-15. doi: 10.1111/jch.13426.
https://doi.org/10.1111/jch.13426... ) based on a defined shortlist of ideal antihypertensive medications (⁷7. Pan American Health Organization. HEARTS in the Americas: Protocols and Medications. Available at: https://www.paho.org/en/hearts-americas/hearts-americas-protocols-and-medications. Access date: June 9th, 2022.
https://www.paho.org/en/hearts-americas/... ). As a result, most HEARTS countries are progressively moving from their current (immediately implementable) protocols—based on the best available pharmacologic options for each country— to acceptable protocols emphasizing the use of two-drug combination medications in the initial management of the newly diagnosed individual with hypertension, and are taking steps to develop and implement preferred protocols, stressing the inclusion of fixed-dose combination medications in a single pill which includes molecules with ideal characteristics (⁸8. DiPette DJ, Goughnour K, Zuniga E, Skeete J, Ridley E, Angell S, et al. Standardized treatment to improve hypertension control in primary health care: The HEARTS in the Americas Initiative. J Clin Hypertens (Greenwich). 2020 Dec;22(12):2285-2295. doi: 10.1111/jch.14072.
https://doi.org/10.1111/jch.14072... ).

At the end of 2021, WHO launched the Guideline for the Pharmacological Treatment of Hypertension in Adults (⁹9. World Health Organization. Guideline for the pharmacological treatment of hypertension in adults. Geneva: WHO; 2021. Available at: https://apps.who.int/iris/bitstream/handle/10665/344424/9789240033986-eng.pdf. Access date: June 9th, 2022.
https://apps.who.int/iris/bitstream/hand... ). In parallel, HEARTS in the Americas Innovation Group (IG) agreed on the key drivers to improve hypertension control, a set of evidence-based recommendations to make specific clinical and managerial process improvements at the PHC setting (¹⁰10. Brettler J, Giraldo G, Aumala T, Best A, Campbell N, Cyr S, et al. Drivers and scorecards to improve hypertension control in primary care practice: Recommendations from the HEARTS in the Americas Innovation Group. Lancet Reg Health Am. 2022. May; 01:100223. doi: 10.1016/j.lana.2022.100223
https://doi.org/10.1016/j.lana.2022.1002... ).

Based on these two developments (⁹9. World Health Organization. Guideline for the pharmacological treatment of hypertension in adults. Geneva: WHO; 2021. Available at: https://apps.who.int/iris/bitstream/handle/10665/344424/9789240033986-eng.pdf. Access date: June 9th, 2022.
https://apps.who.int/iris/bitstream/hand... ,¹⁰10. Brettler J, Giraldo G, Aumala T, Best A, Campbell N, Cyr S, et al. Drivers and scorecards to improve hypertension control in primary care practice: Recommendations from the HEARTS in the Americas Innovation Group. Lancet Reg Health Am. 2022. May; 01:100223. doi: 10.1016/j.lana.2022.100223
https://doi.org/10.1016/j.lana.2022.1002... ) supported by extensive systematic reviews, HEARTS in the Americas developed a methodology to help countries update and strengthen their treatment protocols. As a result, an appraisal checklist was created to identify potential points of improvement in the current treatment protocols. This checklist directly led to the development of the HEARTS Clinical Pathway for Hypertension and CVD Risk Management. The clinical pathway concept comprises a multifactorial intervention for the mutual decision-making and organization of care processes for a well-defined group of patients during a well-defined period (¹¹11. Schrijvers G, van Hoorn A, Huiskes N. The care pathway: concepts and theories: an introduction. Int J Integr Care. 2012 Sep 18;12(Spec Ed Integrated Care Pathways):e192. doi: 10.5334/ijic.812.
https://doi.org/10.5334/ijic.812... ). The HEARTS clinical pathway meets these requirements, and its core remains a practical and effective treatment protocol.

This article aims to describe the process of developing the treatment protocol appraisal checklist and define the resulting clinical pathway. These tools can help countries and PHC centers enhance their protocols by identifying the improvement points and developing clinical pathways.

WHO HYPERTENSION GUIDELINE AND HEARTS IN THE AMERICAS KEY DRIVERS FOR HYPERTENSION CONTROL

The new WHO hypertension guideline (⁹9. World Health Organization. Guideline for the pharmacological treatment of hypertension in adults. Geneva: WHO; 2021. Available at: https://apps.who.int/iris/bitstream/handle/10665/344424/9789240033986-eng.pdf. Access date: June 9th, 2022.
https://apps.who.int/iris/bitstream/hand... ) has a remarkable implementation profile. For instance, it emphasizes a lower blood pressure threshold for initiating pharmacological treatment, increased use of CVD risk assessment in treatment decisions such as lower blood pressure treatment targets in high CVD-risk patients, the importance of using standardized and simple treatment algorithms/protocols, more substantial consideration for the use of two medications (two-pills or, preferably, a single-pill, fixed-dose combination) in the initial treatment, and the relevance of timely patient follow-up and implementation of team-based care, among others (¹²12. Al-Makki A, DiPette D, Whelton PK, Murad MH, Mustafa RA, Acharya S, et al. Hypertension Pharmacological Treatment in Adults: A World Health Organization Guideline Executive Summary. Hypertension. 2022 Jan;79(1):293-301. doi: 10.1161/HYPERTENSIONAHA.121.18192.
https://doi.org/10.1161/HYPERTENSIONAHA.... ).

Furthermore, based on the study of the most successful and innovative hypertension programs globally, the HEARTS in the Americas IG defined eight evidence-based hypertension control key drivers categorized into five domains:

1. Diagnosis (blood pressure measurement accuracy and CVD risk evaluation)

2. Treatment (standardized treatment protocol and treatment intensification)

3. Continuity of care and follow-up

4. Delivery system (team-based care, medication refill)

5. System for performance evaluation

Implementing the key drivers for hypertension control will allow PHC facilities to guide their program implementation, enhance their culture of quality improvement and ultimately improve hypertension control while serving as a model for other non-communicable diseases management at the PHC level in diverse settings (¹⁰10. Brettler J, Giraldo G, Aumala T, Best A, Campbell N, Cyr S, et al. Drivers and scorecards to improve hypertension control in primary care practice: Recommendations from the HEARTS in the Americas Innovation Group. Lancet Reg Health Am. 2022. May; 01:100223. doi: 10.1016/j.lana.2022.100223
https://doi.org/10.1016/j.lana.2022.1002... ).

HEARTS IN THE AMERICAS, TREATMENT PROTOCOL APPRAISAL CHECKLIST

HEARTS in the Americas established a core advisory group of physicians and university professors from high and middle-income countries with proven clinical experience in hypertension management (internal medicine, cardiology, nephrology, and public health experts) and in-depth knowledge of the HEARTS model (⁵5. Campbell NRC, Ordunez P, Giraldo G, Rodriguez Morales YA, Lombardi C, Khan T, et al. WHO HEARTS: A Global Program to Reduce Cardiovascular Disease Burden: Experience Implementing in the Americas and Opportunities in Canada. Can J Cardiol. 2021 May;37(5):744-755. doi: 10.1016/j.cjca.2020.12.004.
https://doi.org/10.1016/j.cjca.2020.12.0... ). The first goal was to design a standardized methodology to upgrade current treatment protocols by identifying specific improvement points. To this end, the advisory group defined the attributes and components of a preferred treatment protocol and then created an appraisal checklist. The preferred protocol was based on the recommendations derived from the treatment protocol model recommended by the WHO HEARTS technical package (¹³13. World Health Organization. HEARTS: technical package for cardiovascular disease management in primary health care. Tool for the development of a consensus protocol for treatment of hypertension. Geneva: WHO; 2018. Available at: heart-package-tool-for-the-development.pdf(who.int) Access date: June 9th, 2022.
heart-package-tool-for-the-development.p... ), the HEARTS in the Americas specific recommendations to improve treatment protocols (⁸8. DiPette DJ, Goughnour K, Zuniga E, Skeete J, Ridley E, Angell S, et al. Standardized treatment to improve hypertension control in primary health care: The HEARTS in the Americas Initiative. J Clin Hypertens (Greenwich). 2020 Dec;22(12):2285-2295. doi: 10.1111/jch.14072.
https://doi.org/10.1111/jch.14072... ), the 2021 WHO hypertension guideline (⁹9. World Health Organization. Guideline for the pharmacological treatment of hypertension in adults. Geneva: WHO; 2021. Available at: https://apps.who.int/iris/bitstream/handle/10665/344424/9789240033986-eng.pdf. Access date: June 9th, 2022.
https://apps.who.int/iris/bitstream/hand... ), and the HEARTS in the Americas key drivers for hypertension control (¹⁰10. Brettler J, Giraldo G, Aumala T, Best A, Campbell N, Cyr S, et al. Drivers and scorecards to improve hypertension control in primary care practice: Recommendations from the HEARTS in the Americas Innovation Group. Lancet Reg Health Am. 2022. May; 01:100223. doi: 10.1016/j.lana.2022.100223
https://doi.org/10.1016/j.lana.2022.1002... ).

As a result, the advisory group developed a treatment protocol evaluation checklist proposal. This proposal underwent a broad consultative process involving the treatment protocol groups from each HEARTS implementing country. After several rounds of iterations, the tool was agreed upon by a broad consensus. The resulting appraisal checklist comprises 34 questions in three domains: 1) requirements to optimize protocol implementation, 2) hypertension treatment, and 3) CVD risk management. (Table 1) Each of the questions selected was accompanied by operational definitions, the evidence´s certainty, recommendation type, and background source.

HEARTS IN THE AMERICAS, A COMPREHENSIVE CLINICAL PATHWAY

A standardized, simple, directive, and algorithmic protocol represents a significant step forward in improving hypertension's clinical management (¹⁴14. Jaffe MG, Frieden TR, Campbell NRC, Matsushita K, Appel LJ, Lackland DT, et al. Recommended treatment protocols to improve management of hypertension globally: A statement by Resolve to Save Lives and the World Hypertension League (WHL). J Clin Hypertens (Greenwich). 2018 May;20(5):829-836. doi: 10.1111/jch.13280.
https://doi.org/10.1111/jch.13280... ). However, a recurring concern from HEARTS implementing countries is that HEARTS treatment protocol seems too top-down and is focused primarily on hypertension. Indeed, implementing countries called for a more comprehensive and inclusive clinical and management tool. In this context, the new WHO hypertension guideline and the HEARTS in the Americas key drivers for hypertension control represented timely incentives to move towards a comprehensive standardized clinical pathway.

Thus, although the clinical pathway maintained the HEARTS' standardized hypertension treatment protocol as its core, it expanded its scope to innovatively incorporate and harmonize other relevant elements to improve hypertension and the CVD secondary prevention management, the main goals of HEARTS in the Americas. (Figure 1)

The resulting standardized clinical pathway reflects “the ABCs” of CVD prevention and treatment. Indeed, it has been designed to cover most of the population, be team-driven rather than physician-centered, and actively involve patients and caregivers, all essential tenets of the chronic care model (¹⁵15. Pan American Health Organization. Innovative Care for Chronic Disease. Organizing and Delivering High Quality Care for Chronic Noncommunicable Disease in the Americas. Washington, DC: PAHO; 2013. Available at: https://www.paho.org/hq/dmdocuments/2013/PAHO-Innovate-Care-2013-Eng.pdf. Access date: June 9th, 2022.
https://www.paho.org/hq/dmdocuments/2013... ).

Step A advises a standardized technique for blood pressure measurement, includes a broad screening strategy, and recommends using automated and clinically validated blood pressure measuring devices for accurate blood pressure measurement (¹⁶16. Sharman JE, O'Brien E, Alpert B, Schutte AE, Delles C, Hecht Olsen M, et al. Lancet Commission on Hypertension Group. Lancet Commission on Hypertension group position statement on the global improvement of accuracy standards for devices that measure blood pressure. J Hypertens. 2020 Jan;38(1):21-29. doi:10.1097/HJH.0000000000002246.
https://doi.org/10.1097/HJH.000000000000... ,¹⁷17. Campbell NRC, Khalsa T, Ordunez P, Rodriguez Morales YA, Zhang XH, Parati G, et al. Brief online certification course for measuring blood pressure with an automated blood pressure device. A free new resource to support World Hypertension Day Oct 17, 2020. J Clin Hypertens (Greenwich). 2020 Oct;22(10):1754-1756. doi: 10.1111/jch.14017
https://doi.org/10.1111/jch.14017... ). Step B encourages the healthcare team to use the HEARTS app to estimate CVD risk in all patients, but not delay the initiation of treatment if needed, and stratify them according to their CVD risk level to select the best clinical approach (¹⁸18. Ordunez P, Tajer C, Gaziano T, Rodriguez YA, Rosende A, Jaffe MG. The HEARTS app: a clinical tool for cardiovascular risk and hypertension management in primary health care. Rev Panam Salud Publica. 2022 Mar 28;46:e12. doi: https://doi.org/10.26633/RPSP.2022.12.
https://doi.org/10.26633/RPSP.2022.12... ). Finally, step C is the heart of the clinical pathway. This outlines a standardized treatment protocol, including pharmacological and non-pharmacological recommendations for hypertension and a comprehensive and pragmatic approach to CVD secondary prevention in PHC.

Furthermore, the HEARTS clinical pathway highlights the approach to patients with established CVD, diabetes, and chronic kidney disease. CVD risk stratification sets different blood pressure thresholds to initiate antihypertensive pharmacologic treatment, control goals, and specific recommendations for aspirin and statins. This pharmacological treatment protocol uses only four steps for medication titration at maximum, systematically repeats blood pressure measurement in each visit among patients over the target, establishes a monthly interval visit until blood pressure control is achieved, and indicates minimum follow-up intervals according to CVD risk level. Finally, it includes recommendations for COVID, influenza, and pneumococcus immunizations.

The overall goal of the clinical pathway is to enhance the quality of care, reduce the unjustified clinical performance variability, improve risk-adjusted patient outcomes, promote patient safety, increase patient participation and satisfaction, and optimize the use of resources.

PRACTICAL IMPLICATIONS

PHC teams must support their clinical and management activities on evidence-based best practices to improve hypertension and CVD risk management. In addition, recommendations must be clear, directive, and operationalized through a standardized implementation tool to be effective. Therefore, the treatment protocol appraisal checklist and the clinical pathway adopted by HEARTS in the Americas meet all these requirements, keeping the simplicity and pragmatism necessary to facilitate its implementation.

The treatment protocol appraisal checklist allows each HEARTS implementing country to initiate a process to identify areas for improvement and then plan the changes needed to enable new treatment protocols.

Moreover, adopting a standardized clinical pathway allows the more comprehensive operationalization of the WHO hypertension guideline (⁹9. World Health Organization. Guideline for the pharmacological treatment of hypertension in adults. Geneva: WHO; 2021. Available at: https://apps.who.int/iris/bitstream/handle/10665/344424/9789240033986-eng.pdf. Access date: June 9th, 2022.
https://apps.who.int/iris/bitstream/hand... ) and the implementation of HEARTS in the Americas key drivers for hypertension control in PHC (¹⁰10. Brettler J, Giraldo G, Aumala T, Best A, Campbell N, Cyr S, et al. Drivers and scorecards to improve hypertension control in primary care practice: Recommendations from the HEARTS in the Americas Innovation Group. Lancet Reg Health Am. 2022. May; 01:100223. doi: 10.1016/j.lana.2022.100223
https://doi.org/10.1016/j.lana.2022.1002... ). In addition, this clinical pathway is aligned with the HEARTS System for Monitoring Evaluation indicators, a tool designed by HEARTS in the Americas (¹⁹19. Prado P, Gamarra A, Rodriguez L, Brettler JW, Farrell M, Girola ME et al. Monitoring and Evaluation Platform for HEARTS in the Americas to improve hypertension management in primary health care facilities. Rev Panam Salud Publica. 2022 (in press).) to guide and catalyze health system changes.

This process is expected to lead to changes in care management organization and positively impact the selection and upgrade of medication formularies and the education and training of care teams. This work is expected to be completed by the end of 2022, resulting in more effective and practical treatment protocols and a robust and comprehensive clinical pathway.

In conclusion, the ultimate goal of the HEARTS clinical pathway is to facilitate the successful implementation of a new model of care, increase hypertension control, improve CVD risk management, and optimize the use of resources through more active and informed engagement of health teams and patients.

Disclaimer.

PO, AR, DD, JB, GR, EZ and KC are staff members or consultants of the Pan American Health Organization. Authors hold sole responsibility for the views expressed in this manuscript, which may not necessarily reflect the opinion or policy of the Revista Panamericana de Salud Pública/Pan American Journal of Public Health and/or those of the Pan American Health Organization.

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