5
Reducing the Burden of Cardiovascular Disease: Intervention Approaches

The preceding chapters have described the many interrelated risk factors that influence cardiovascular health, which involve aspects of economies and societies that extend far beyond public health and health systems. This underscores the complexity of any undertaking to promote cardiovascular health and to prevent and manage cardiovascular disease (CVD). In addition to being complex, CVD is also a long-term problem. It cannot be addressed through a singular, time-limited commitment but rather requires long-term interventions and sustainable solutions.

This chapter first outlines the ideal vision of a comprehensive approach to promote cardiovascular health and reduce the burden of cardiovascular disease. The chapter then turns to a more pragmatic and focused discussion, starting first with a description of the committee’s approach to the evidence. This is followed by a more thorough consideration of the rationale and evidence for components of the ideal approach, which include population-based approaches such as policies and communications campaigns; delivery of health care; and community-based programs. Recognizing the complexity of the disease and the local realities and practical constraints that exist in developing countries, the goal of this final section of the chapter is to identify, based on the totality of the available evidence, what is most advisable and feasible in the short term and what might hold promise as part of longer-term strategies.



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5 Reducing the Burden of Cardiovascular Disease: Intervention Approaches T he preceding chapters have described the many interrelated risk factors that influence cardiovascular health, which involve aspects of economies and societies that extend far beyond public health and health systems. This underscores the complexity of any undertaking to promote cardiovascular health and to prevent and manage cardiovas- cular disease (CVD). In addition to being complex, CVD is also a long- term problem. It cannot be addressed through a singular, time-limited commitment but rather requires long-term interventions and sustainable solutions. This chapter first outlines the ideal vision of a comprehensive approach to promote cardiovascular health and reduce the burden of cardiovascular disease. The chapter then turns to a more pragmatic and focused discussion, starting first with a description of the committee’s approach to the evidence. This is followed by a more thorough consideration of the rationale and evidence for components of the ideal approach, which include population- based approaches such as policies and communications campaigns; delivery of health care; and community-based programs. Recognizing the complex- ity of the disease and the local realities and practical constraints that exist in developing countries, the goal of this final section of the chapter is to identify, based on the totality of the available evidence, what is most advis- able and feasible in the short term and what might hold promise as part of longer-term strategies. 

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 PROMOTING CARDIOVASCULAR HEALTH IN THE DEVELOPING WORLD IDEAL STRATEGY TO ADDRESS GLOBAL CVD IN THE DEVELOPING WORLD The factors described in Chapters 2 and 3 that contribute to the burden of CVD and related chronic diseases are the targets for change in the quest to promote global cardiovascular health. These can be divided into behav- ioral factors (such as tobacco use, diet, and physical activity); biological factors (such as blood pressure, cholesterol, and blood glucose); psycho- social factors (such as depression, anxiety, acute and chronic life stressors, and lack of social support); health systems factors (such as access to care, screening, diagnosis, and quality of care); and intersectoral factors (such as tobacco control policies and agricultural policies). The evidence describing the interrelated determinants of CVD provides a strong conceptual basis for a strategy that coordinates across multiple sectors and integrates health promotion, prevention, and disease management as part of a long-term, comprehensive approach. This approach would employ multiple interven- tion strategies in a mix of programs and policies that accomodate variations in need according to context and locale. The ideal approach would take advantage of opportunities for interven- tion at all stages of the life course in order to promote cardiovascular health by preventing acquisition and augmentation of risk, detecting and reducing risk, managing CVD events, and preventing the progression of disease and recurrence of CVD events. Policies and programs to change the factors that contribute to CVD would be designed to work through population- wide approaches; through interventions within health systems; and through community-based programs with components in schools, worksites, and other community settings. A comprehensive strategy of this kind that takes into account the full range of complex determinants of CVD, illustrated in Figure 5.1, would have the theoretical potential to produce a synergistic interaction among approaches at individual and population levels. Concur- rent modalities could include policy and regulatory changes, health promo- tion campaigns, innovative applications of communications technologies, efficient use of medical therapies and technologies, and integrated clinical programs. For individuals already at high risk or with existing disease, this approach would combine education, support, and incentives to both address behavioral risk factors and improve adherence to clinical interven- tions. Participation in this approach extends beyond clinical providers and public health approaches to also include public media outlets, community leaders, and related sectors, especially food and agriculture policy, trans- portation and urban planning, and private-sector entities such as the food and pharmaceutical industries. All these players are potential partners both in assessing needs and capacity and in developing and implementing solutions.

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POLICY APPROACHES (Global, National, Local) Globalization Financial Legal Regulatory Trade Health Health Workforce Workforce Environment to Enable Individuals to Make Demographicn Globalizatio and Maintain Healthful Choices Change WIDER SOCIETY Social Drugs & Drugs and Determinants Technologies Technologies Biological Risk INDIVIDUAL Health FAMILY Inequities Quality o Care Quality off Care Therapeutic, Behavioral NEIGHBORHOOD, COMMUNITY Risk Rehabilitative Services Preventive, Diagnostic, Education DETERMINANTS Access to Care Access to Care Enhancement of Knowledge, Motivation, and Skills of Individuals Cultural and HEALTH CARE DELIVERY Social Norms Media Community Interventions Settings Based Systems Systems nfrastructure IInfrastructure HEALTH COMMUNICATION  FIGURE 5.1 Comprehensive strategy to address cardiovascular disease. Figure 5-1 R01642 editable vectors

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 PROMOTING CARDIOVASCULAR HEALTH IN THE DEVELOPING WORLD Such a comprehensive approach stands as an ideal for countries facing the burden of CVD and for global stakeholders in the fight against CVD and related chronic diseases. Reality, of course, complicates this ideal con- siderably. A comprehensive integrated approach of this kind has not been successfully implemented in a model that can be readily replicated in low and middle income country settings. Progress in high income countries points to models for many of the components that could make up such an ideal approach to CVD, but interventions that may be efficacious in certain settings cannot be assumed to be effective if they are implemented in settings that have significantly different available resources and differ significantly at the level of policy or population characteristics. Most of the intervention components described as part of the ideal approach do not have sufficient evidence to support scale-up for widespread implementation in low and middle income countries in the immediate term. Even with suf- ficient evidence to support implementation, many low and middle income country governments might not have adequate resources in place to under- take ambitious, comprehensive, full-scale approaches. Nevertheless, although the components are likely to work best in syn- ergy with each other, the lack of readiness and capacity to accomplish the comprehensive ideal is not reason to do nothing. An impact on the very high burden of CVD is possible even without doing everything that makes up the ideal. Indeed, developing countries will want to focus more pragmatically on efforts that promise to be economically feasible, have the highest likelihood of intervention success, and have the largest morbidity impact. The goal of this chapter is to provide an analysis to help determine (1) what policies, programs, and clinical interventions have sufficient evi- dence for priority implementation in developing countries in the near term and (2) what approaches have a solid conceptual basis but require greater knowledge based on specific policies and programs with demonstrated ef- fectiveness and implementability in developing-country settings in order to make progress toward implementation in the medium and long term. Chapter 7 will continue the discussion of feasibility and prioritizing the use of limited resources in low and middle income countries with a synthesis of the available economic evidence and future economic research needs for the intervention approaches described in this chapter. Building a Strategy to Address CVD The following briefly outlines the series of components needed for countries and supporting global stakeholders to build a strategy to promote cardiovascular health. As described above, these components would ideally be integrated to work toward a comprehensive intervention strategy. The intent is to develop a supportive policy environment and build the capac-

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 REDUCING THE BURDEN OF CARDIOVASCULAR DISEASE ity to develop, implement, and evaluate intervention programs, with the ultimate goal of reducing the burden of CVD through reduction of risk factors and management of disease. This includes “top-down” policies and complementary “bottom-up” approaches in health care delivery systems and in community-based education and health promotion programs. The specific components within each of these steps and examples of the avail- able evidence to support their implementation are described later in the chapter, along with more discussion of the limitations, taking into account gaps in the evidence and variations among countries in baseline capacity, economic status, and level of infrastructure. Needs and Capacity Assessment A crucial basis for developing policies and programs is for governments and communities to estimate and, where possible, measure the nature of the problem as it occurs in the local context where approaches will be imple- mented; to assess the needs of the population; to catalog current efforts; to assess the available capacity and infrastructure to address CVD and related chronic diseases; and to gauge the political will to support the available op- portunities for action. This assessment will inform priorities and determine choices about the implementation of evidence-based policies and programs as well as capacity-building efforts. This should lead to specific and realistic goals for intervention strategies that are adapted to local baseline capacity and burden of disease and that also aim to improve that baseline capacity. This critical underlying step was discussed in full in Chapter 4. Country-level measurement, assessment, and prioritization of this kind can occur at the level of national or local governments, such as provincial or city-level health authorities. In many low and middle income countries, this will require the development of sufficient capacity and infrastructure to carry out population-based approaches for measuring cause-specific mortality and behavioral and biological risk factors. In countries with very limited capacity at baseline, at first it may be nongovernmental organiza- tions, foreign assistance agencies, and other donors who need to carry out a needs assessment and prioritization before implementing programmatic efforts. Regardless of the driving force behind the initiated action, this strategic planning can, to the extent possible, involve local authorities, be harmonized with local efforts, and be designed as an opportunity to im- prove local baseline capacity over time. Policy Strategies When a baseline is established and priorities are determined based on country-level data, the starting place for developing intervention ap-

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0 PROMOTING CARDIOVASCULAR HEALTH IN THE DEVELOPING WORLD proaches is policy strategies for population-based prevention. The pri- mary population approach can be based on setting or changing policies, incentives, and regulations, especially those related to food, agriculture, and tobacco. There is evidence to support the implementation of some of these policies in the immediate term. For those developing countries where there exist democratic means to develop policies, where regulatory and enforcement capacity is sufficient, these policy changes may include, for example, taxation and regulations on tobacco production and sales; regulations on tobacco and food marketing and labeling; alterations in subsidies for foods and other food and agricultural policies; and strategies to make rapid urbanization more conducive to health. Regulatory change usually needs to be incremental and should be proportional to the possible impact and cost. Health Communications Both in coordination with policy changes and as a separate strategy for affecting crucial CVD-related behaviors, there is substantial promise in implementing health communications and education efforts. Public com- munication interventions that are coordinated with select policy changes can enhance the effectiveness of both approaches, which together can help create an environment in which more targeted programs in health systems and communities can succeed. Even in the absence of an ideal policy envi- ronment, well-constructed stand-alone population-level health communi- cation efforts have the potential to be effective in encouraging population behavior change, for example, in areas such as smoking initiation and salt and fat consumption. Depending on the governmental infrastructure within a country, policies with coordinated communication and health education efforts can occur at the level of national or local authorities. Delivery of Quality Health Care Along with select population-based approaches, a key step in address- ing CVD is to strengthen health systems to deliver high-quality, responsive care for the prevention and management of CVD. Improving health care de- livery includes, for example, provider-level strategies, financing, integration of care, workforce development, and access to essential medical products. The need to strengthen health systems in low and middle income countries is not specific to CVD, and it is important that ongoing efforts in this area take into account not only traditional focus areas such as infectious disease and maternal and child health but also CVD and related chronic diseases as well as chronic care needs that are shared among chronic non-infectious diseases and chronic infections such as HIV/AIDS and tuberculosis (TB).

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 REDUCING THE BURDEN OF CARDIOVASCULAR DISEASE Community-Based Programs Along with efforts to implement population-based approaches and to strengthen health systems, an ideal comprehensive integrated approach would also include community-based programs that offer opportunities to access individuals where they already gather, such as schools, worksites, and other community organizations. Depending on local priorities, there is po- tential for synergism in both effectiveness and economic feasibility through coordinated interventions that target multiple risk factors, are conducted in multiple settings in communities, and coordinate the health systems and population-based strategies described above with related, community- specific strategies. Because of the lack of community-based models that have been successfully implemented, evaluated, and sustained in low and middle income country settings, the critical next step in these settings is to support research to develop and evaluate demonstration projects through implementation trials. In many cases, the focus can be on adapting and evaluating programs with demonstrated success in developed countries. The design of demonstration programs will need to take into account local in- frastructure and capacity to develop and maintain such programs over time, particularly if they are ultimately intended to affect a large portion of the population and operate on a large scale. Scale-Up and Dissemination The ultimate goal when intervention approaches in all these domains are demonstrated to be effective and feasible is scale-up, maintenance, and dissemination. In addition to implementing best practices and evidence- based policies and programs on a larger scale, this includes disseminating in a broader global context, by sharing knowledge among similar coun- tries with analogous epidemiological characteristics, capacity, and cultural norms and expectations. Ongoing Monitoring, Evaluation, and Assessment As described in Chapter 4, ongoing surveillance and evaluation of implemented strategies will allow policy makers and other stakeholders to determine if implemented actions are having the intended effect and meet- ing the defined goals, and to reassess needs, capacity, and priorities over time. This will be critical to alter policies and programs as priorities change, as new lessons are learned, and as a country goes through inevitable transi- tions in its economy and its health or social environments.

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 PROMOTING CARDIOVASCULAR HEALTH IN THE DEVELOPING WORLD Global Support As described in more detail in Chapter 8, international agencies can play an important role in working toward comprehensive country-level approaches. These agencies can help initiate and enrich any country’s CVD prevention and management process through direct financial and techni- cal assistance. In addition, external aid and coordination can facilitate the transfer of lessons learned among countries, allowing each country to actively contribute to the international repertoire of prevention strategies. APPROACH TO THE EVIDENCE This chapter is concerned with what works. The challenge is to define what qualifies as an intervention that works, to martial these findings together to establish a coherent evidence base, and then to use this as the basis to necessarily prioritize approaches. This section of the chapter briefly discusses the committee’s approach to considering evidence for evaluat- ing intervention approaches for CVD at all levels. This includes how the methodology for evaluating large-scale programs and population-based and policy interventions differs from clinical interventions and small-scale projects as well as a special emphasis on the importance of effectiveness and implementation evidence in relevant contexts. The attempt to define a broad-based set of effective approaches avail- able for CVD promotion and prevention rests on data standards—notably data standards that continue to evolve. The aspirational standard is evi- dence that describes causal linkages between intervention and better health status (i.e., outcomes). These data should meet the additional standards of contextual generalizability so that the reported findings are feasible based on implementation evidence and economic evaluation and adaptable in a variety of settings. The intent is that good epidemiologic observational data on the role of risk factors and the preventive effects of reductions in those risk factors will lead to hypotheses about causal pathways that interventions are designed to influence. Ideally, these hypotheses will be confirmed by prospective inter- ventional studies that are repeated and reaffirmed in a variety of settings. Evidence from randomized trials can be highly valuable to infer causality. As a rigid evidence standard, however, this is not always available, feasible, necessary, or even optimal. For many intervention approaches, the best available evidence can also come from, for example, cohort evaluations and qualitative assessments as well as other research methodologies that support plausible causal linkages. For policy and public health approaches in particular, traditionally defined rigorous evaluation standards are often unrealistic, and it is instead a comprehensive perspective on the totality of

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 REDUCING THE BURDEN OF CARDIOVASCULAR DISEASE the available evidence that is weighed alongside other policy pressures to drive implementation decisions. Therefore, the committee did not apply randomization as a standard of evidence for consideration of the illustrative examples included in this chapter. However, the committee did restrict its review of the evidence to published studies that included some comparison condition, either through a control group or a comparison to before and after an intervention was implemented. The second standard for evidence set out by the committee is one of relevancy, an issue of particular importance here, although it is by no means exclusive to low and middle income countries. Conceptually, the ideal is not narrowly defined evaluations focused on internal validity but instead evalu- ations that look beyond efficacy—the estimation of what is possible—to effectiveness—the determination of what actually was accomplished by an intervention in a real-world setting. This refers to what is often a tension between confident findings of causal influence and confident findings of the relevance of evidence. Studies imposing enough controls on the context to support strong causal statements often in the process have to create a con- text that is distant from the messy environment and constraints in which programs at scale will be implemented, particularly in low and middle income countries. This review of evidence by the committee respects that tension, and then puts substantial emphasis on relevance. Beyond effectiveness and relevance, the ultimate ideal standard to in- form large investments in programs and intervention approaches is evidence from implementation research, operations research, and health services research. In addition, evidence on economic feasibility is a critical factor in determining implementation readiness and prioritizing intervention ap- proaches. The available evidence from economic evaluations of intervention approaches is the subject of Chapter 7. Applying the standards described here to the available evidence for CVD in developing countries revealed significant gaps in the evidence base, especially given the desire to have a concrete basis for advocating policy change, system change, or program implementation. The committee, how- ever, does not intend that the message about higher data mandates with a responsible exposure of these data gaps be equated with a suggestion of inaction. A principle throughout the report is one of being action-oriented based on available findings. The committee’s review of the available evi- dence according to these standards informed an analysis of which potential components of the ideal comprehensive approach warrant priority for implementation or, if near-term implementation is not supported, which components warrant other intermediate steps to develop the evidence base in support of implementation in the longer-term. Given the broad and global scope of this study, a comprehensive sys- tematic review of all available evidence related to every aspect of CVD and

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 PROMOTING CARDIOVASCULAR HEALTH IN THE DEVELOPING WORLD related chronic diseases was not within the scope of this project. Nor was it feasible for this report to catalog every intervention approach that has been attempted and documented across all countries. Instead, to present the rationale put forth by the committee, the following sections include illustrative examples that represent the best available evidence to support the committee’s findings on the implementation potential for component strategies. In order to limit the length of this document and to avoid replica- tion of existing work, the committee sought existing relevant, high-quality, systematic and narrative reviews. In content areas where these were avail- able, this chapter includes summaries of key findings, but otherwise refers the reader to the available resources for more detailed information. The focus is on intervention approaches for CVD with evidence for effectiveness and implementation in developing countries. Where this evi- dence is limited, generalizable examples are offered with evidence for ef- fectiveness and implementation from both CVD-specific approaches in developed countries and developing-country evidence for non-CVD health outcomes. An assessment of the transferability of the evidence for these ap- proaches is included. For components where there is limited or no effective- ness or implementation data, the logical basis for intervention approaches is discussed as being derived from knowledge about the determinants of CVD, modifiable risk factors, and characteristics of ideal intervention design and implementation. Conclusion 5.1: Context matters for the planning and implementation of approaches to prevent and manage CVD, and it also influences the effectiveness of these approaches. While there are common needs and priorities across various settings, each site has its own specific needs that require evaluation. Additional knowledge needs to be generated not only about effective interventions but also about how to imple- ment these interventions in settings where resources of all types are scarce; where priorities remain fixed on other health and development agendas; and where there might be cultural and other variations that affect the effectiveness of intervention approaches. Translational and implementation research will be particularly critical to develop and evaluate interventions in the settings in which they are intended to be implemented. COMPONENTS OF A STRATEGY TO REDUCE THE BURDEN OF CVD This section presents in more detail the rationale for the ideal ap- proach described previously and the evidence for the main components, which include population-based approaches such as policies and health

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 REDUCING THE BURDEN OF CARDIOVASCULAR DISEASE communications campaigns; delivery of health care; and community-based programs. Recognizing the complexity of the disease and the local reali- ties and practical constraints that exist in developing countries, the goal of this final section of the chapter is to identify, based on the totality of the available evidence, policies, programs, and strategies to improve clinical care that have sufficient evidence for advisable and feasible implementation in developing countries in the near term as well as approaches that have a solid conceptual basis but need more evidence for specific policies and programs with demonstrated effectiveness and implementability in devel- oping country settings to progress toward implementation in the medium and long term. Intersectoral Policy Approaches1 Chapter 2 described the complexity of the determinants of CVD, which are drawn from a range of broad social and environmental influences. As a result, many of the crucial actions that are needed to support the reduction of CVD burden are not under the direct control of health ministries, but rather include other governmental agencies as well as private-sector entities. For example, they rely on tax rates on tobacco set by economic agencies, food subsidy policies set at agricultural agencies, access rules for public service advertising set by communication agencies, curricular choices by education agencies, and commitments to product reformulation by multi- national corporations. Thus, success in achieving the specific priority goals for CVD programs will rely heavily on decisions made outside of health agencies, and that success will only come if there is substantial intersectoral collaboration. The specifics of how that collaboration will come about will vary with the particular political arrangements in a country, but there will be a com- mon theme: success will depend on building a shared commitment across sectors in the whole of government. This will require engaging not only those already motivated by health-related goals but also those who have very different pressures and considerations driving their decision making. Therefore, it is important to acknowledge the different forces that drive policy decisions in different sectors in order to seek out shared objectives, including economic objectives. To this end, there will be a need not only to make a case that the population as a whole will benefit from addressing CVD, but also to make the specific case that work to target CVD-related behaviors and outcomes will be in the interest of each collaborating agency or stakeholder in the private sector. For example, it may not be enough to 1 This section is based in part on a paper written for the committee by Marie-Claude Jean and Louise St-Pierre.

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