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Division of Prevention and Population Sciences Strategic Plan
On March 29, 2007, the National Heart, Lung, and Blood Institute released its Strategic Plan to provide a guide for its research and training programs over the next decade. The plan consists of a set of goals that reflect the successive movement of scientific discovery from "form to function" (Goal 1), "function to causes" (Goal 2), and "causes to cures" (Goal 3). Within each goal, specific-research Challenges are provided that address the overarching Goal. The Division of Prevention and Population Sciences (DPPS) supports research in all three goal areas, though most efforts are concentrated in Goal 3, which includes studies in populations.
The DPPS Strategic Plan uses the NHLBI Strategic Plan as its framework. Specific programs "either ongoing or planned" and possible future research areas are provided within each Goal and under specific Challenges. In addition, the Division works in close collaboration with other Divisions at the NHLBI, most notably the Division of Cardiovascular Diseases, which directly shares research objectives in prevention, diagnosis, and treatment of cardiovascular diseases, and with other Federal agencies, such as the National Center for Health Statistics, the Agency for Healthcare Research and Quality, the Food and Drug Administration, and the Centers for Disease Control and Prevention.
The Division of Prevention and Population Sciences
The Division of Prevention and Population Sciences supports and provides leadership for population- and clinic-based research on the causes, prevention, and clinical care of cardiovascular, lung, and blood diseases . Research includes a broad array of epidemiological studies to describe disease and risk factor patterns in populations and to identify risk factors for disease; clinical trials of interventions to prevent disease; studies of genetic, behavioral, sociocultural, and environmental influences on disease risk and outcomes; and studies of the application of prevention and treatment strategies to determine how to improve clinical care and public health. The Division also supports training and career development for these areas of research. The Division is organized into four major components: the Epidemiology Branch, the Clinical Applications and Prevention Branch, the Women's Health Initiative Branch, and the Office of Biostatistics Research.
NHLBI Strategic Plan Goals and Strategies and DPPS Programs and Plans
Goal 1: To Improve Understanding of the Molecular and Physiological Basis of Health and Disease, and To Use That Understanding To Develop Improved Approaches to Disease Diagnosis, Treatment, and Prevention.
Challenge 1.1: To delineate mechanisms that relate molecular events to health and disease
1.1.b. Identify intracellular targets of key signaling and transcriptional pathways in normal and pathological states.
The Division supports observational interventional studies, such as the PROGENI studies that expose individuals to either putatively efficacious or proven therapies to change risk factor levels and that include collection of DNA for genome-wide association studies (GWAS). Investigators are able to determine how environmental perturbations and genetic variants interact to affect risk factor responses. These studies may be used to investigate the efficacy of therapeutic and life style interventions to promote the advancement of personalized medicine.
The Division recognizes the value of adding provocative tests of known effective interventions and additional "omics" measures to existing and new studies to better understand gene by environment interactions on risk factors and disease, constituting a "to bench and back" approach.
1.1.c. Determine key genetic variants that are associated with specific diseases and delineate the molecular mechanism that account for susceptibility or resistance to disease.
The Division supports family studies, candidate gene studies, and GWA studies on multiple cohorts and case-control studies through the SHARe and STAMPEED programs. It also supports one of the largest GWA studies of African American cohorts through the CARe program. Fine-mapping and sequencing studies occur through the NHLBI-sponsored Resequencing and Genotyping Centers. All of these programs include worldwide data sharing to maximize interrogation of huge data sets. Additional population-based research and basic science may elucidate novel molecular mechanisms that account for disease susceptibility. Proteomic and metabolomic (as well as other "-omics" measures) overlaying these initial GWAS cohorts allow systems approaches to explore biological pathways.
The Division is embarking upon expansion of the GWAS to other cohorts including additional minority populations from the Women's Health Initiative. Minority populations reflect different gene pools, different clinical profiles and different environmental conditions.
1.1.d. Define molecular, cellular, and organ-specific responses to environmental challenges and the mechanisms by which heritable and non-genetic factors interact in disease initiation and progression and in therapeutic response.
The Division supports a number of well-known large-scale longitudinal cohort studies such as ARIC, MESA, CHS, WHI, CARDIA, and the Framingham Study that include clinical and imaging measures of manifest and subclinical disease, and that include environmental measures such as diet, physical activity, sleep, and psychological factors. The recent introduction of extensive genotyping in these cohorts will allow assessment of gene by environment interactions on disease initiation and progression.
In conjunction with other Institute initiatives, the Division recognizes the value in adding more refined environmental measures and measures of gene expression and proteomics to evaluate the effect of exposures on gene products and disease development. Other projects might include epigenetics, e.g. genome-wide methylation patterns, and their association with risk factors and disease.
1.1.e. Determine the role of systemic pathological processes, such as inflammation, immunity, and infection, in the development and evolution of disease.
The Division oversees a number of well-known cohort studies, including the Framingham Heart Study, ARIC, MESA, WHI, CARDIA, the Jackson Heart Study, the Strong Heart Study, and the GOCADAN Study that include systemic measures of inflammation, immunity and infection. These studies also include genotyping and environmental and lifestyle measures to better understand how multiple inflammatory factors contribute to disease initiation and progression.
Biomarkers are constantly being added and refined to provide more objective and integrated measures of environmental exposures in existing and new cohorts.
Challenge 1.2. To discover biomarkers that differentiate clinically relevant disease subtypes and that identify new molecular targets for application to prevention and diagnosis - including imaging and therapy
1.2.a. Identify molecular signatures that allow complex disease phenotypes to be stratified into clinically relevant categories.
The Division supports research initiatives to identify the value of putative biomarkers for disease diagnosis, progression, and treatment effectiveness. New biomarkers will be evaluated for predictive value and refined disease phenotyping taking advantage of accessible stored samples along with cumulative risk factor, environmental, genetic and clinical data.
The Division recognizes the value of assessing gene expression, proteomics, and metabolomics in existing cohorts to provide further opportunities for biomarker discovery for identification of subtypes of disease and for prediction of response to perturbations or interventions.
Challenge 2.1: To accelerate translation of basic research findings into clinical studies and trials and promote translation of clinical research findings back to the laboratory.
2.1.c. Integrate, analyze, and share extant and emerging genotypic and phenotypic data.
The Division supports multiple well-known large-scale cohort studies (e.g., Framingham Heart Study, MESA, ARIC, CARDIA, Jackson Heart Study, Hispanic Community Health Study, the Strong Heart Study, WHI observational component, and CHS) and clinical trials (e.g., Women's Health Initiative and ACCORD) that include detailed data on multiple clinical and subclinical phenotypes. Extensive genotypic data have been obtained for some cohorts (e.g., Framingham, ARIC, and Strong Heart Study), while progress is being made towards obtaining similar data for others (WHI and MESA). Working with the National Center for Bioinformatics (NCBI) at the National Library of Medicine, the Division has already made available for the general scientific community combined genotype-phenotype data on the Framingham Heart Study (Framingham SHARe). Additional data sets from PROGENI and STAMPEED will provide genotype- phenotype data for response to known efficacious interventions, and for case-control studies of heart, lung and blood clinical outcomes. BioLINCC, jointly managed with the Division of Blood Diseases and Resources will facilitate the scientific community's access to biospecimens and data from a wide variety of observational and clinical trial studies. The Division also supports a program to translate basic behavioral science into clinical and public health interventions aimed at preventing obesity.
The Division recognizes that the optimal value of these cohort and trial databases will depend on maximal integration of data across levels of function (e.g., genetic, molecular, organ-based, whole individual, community) and across cohorts (i.e., pooling data as much as possible), on developing robust analytical approaches to complex data structures, and on enabling widespread sharing of data with the scientific community while assuring protection of confidentiality for research subjects.
Challenge 2.2: To enable early and accurate risk stratification and diagnosis of cardiovascular, lung, and blood disorders.
2.2.a. Exploit noninvasive imaging methods to detect and quantify subclinical disease.
The Division supports a number of observational and intervention studies that focus on noninvasive imaging tests, such as carotid ultrasonography, echocardiography, magnetic resonance imaging (MRI), and computerized tomography (CT), to identify subclinical disease and study their associations with cardiovascular events and risk factors. These imaging measures may be used to improve risk stratification, provide insights into pathophysiology and disease development, and identify viable targets for disease prevention.
The Division acknowledges the value of advances in noninvasive imaging to further understand mechanisms of initiation, progression, and reversal of disease and enable measurement of the clinical outcomes of interventions. The Division recognizes the need to advance research on noninvasive measures from a sole focus on diagnosis and prognosis to additional focus on outcomes and comparative value.
2.2.b. Apply new discoveries in biomarkers to improve risk assessment, diagnosis, prognosis, and prediction of response to therapy.
The Division supports multiple observational studies and clinical trials that systematically measure multiple novel biomarkers for possible risk stratification, diagnostic, and predictive tools. Biological samples are obtained during clinical examinations and stored for longitudinal analyses while also measuring initiation and progression of subclinical and clinical disease.
The Division supports improved risk prediction by supporting large population studies that include all population groups, including adequate numbers of women and minorities. The Division recognizes that improved ability to detect subclinical disease and monitor disease progression could potentially transform clinical decision-making and motivate lifestyle choices and behaviors that affect clinical outcomes. The Division is considering programs using -omics technologies to uncover new biomarkers that may become useful tools for evaluating risk and individual responsiveness to interventions in populations and, ultimately, for identifying new therapeutic targets.
Challenge 2.3: To develop personalized preventive and therapeutic regimens for cardiovascular, lung, and blood diseases.
2.3.a. Improve the understanding of interactions between genetic and environmental factors that influence disease development and progression and response to therapy.
The Division conducts observational studies that evaluate genetic associations with phenotypic response to known efficacious environmental effects (e.g., PROGENI), and genetic studies in conjunction with clinical trials to evaluate genetic determinants of drug effects on major cardiovascular clinical outcomes (e.g., ALLHAT and GenHAT). Efforts are underway (e.g., through CARe, SHARe and STAMPEED) to make combined phenotype and genotype data from the large observational studies (e.g., Jackson Heart Study, ARIC, CHS, CARDIA) available for scientific communities to better understand how genetic and environmental factors interact to contribute to disease initiation and progression. These studies identify subgroups based on genotype that may be most likely to benefit from targeted environmental changes designed to reduce the development or progression of cardiovascular diseases.
The Division recognizes that identification and evaluation of such associations may enhance understanding of complex traits and permit investigators to explore the relationship between genetic variants, gene expression, and gene-environmental interactions, and move clinical medicine and public health practice towards genetically-guided preventative and therapeutic approaches. The Division is considering programs that develop more precise measures of environmental exposures through integrated biomarkers, "-omics" measures, and more robust definitions of clinical phenotypes. There is considerable interest in validation and calibration of dietary and physical activity data from questionnaires and novel technologies. The Division is planning to develop shared databases with information from multiple studies to facilitate integration and analysis of results.
2.3.b. Identify and evaluate interventions to promote health and treat disease in genetically defined patient sub-groups by altering developmental or environmental exposures including drugs, diet and exercise, sleep duration and quality, and infectious agents and allergens.
The Division supports intervention studies and clinical trials that evaluate health promotion and disease treatment strategies in selected patients and populations by altering environmental exposures including drugs, diet and exercise. For example, the Division supports programs, such as PROGENI, that aim to identify novel genes that interact with specific environmental exposures to modify risk factors for cardiovascular disease.
The Division encourages novel approaches for modeling complex interactions between gene and environmental exposures. Large cohort studies often include measures of exposure to drugs, allergens, and infectious agents in addition to information about diet, exercise, and psychosocial factors. The generated results may provide a wealth of information for generating hypotheses and identifying potential interventions.
Challenge 2.4: To enhance the evidence available to guide the practice of medicine, and improve public health.
The Division has a long and distinguished tradition of excellence in the conduct of observational cohorts that characterize disease risk and provide insights for viable treatment targets. It further supports randomized clinical trials (e.g. hypertension treatment trials: HDFP, SHEP, ALLHAT; dietary and other lifestyle interventions: DASH, PREMIER, ACT, WMT); multiple risk factors: MRFIT; hormone replacement therapy: WHI) that provide the highest level of evidence to guide the practice of medicine and public health. Many of the current rigorous standards of evidence upon which practice guidelines, especially JNC-7 and obesity, are based on the Division- supported studies. Division-sponsored community- and clinic-based studies provide guidance on the best ways to prevent risk factors and to help clinicians effectively treat diseases and risk factors.
The Division remains committed to ongoing generation of evidence that will inform disease prevention, diagnosis, and treatment. The ongoing ACCORD trial has reported its first results on target glucose levels while the hypertension and lipid components continue. Trials such as ALLHAT and TOHP continue to yield new information about practice. Other trials, such as SPRINT, a trial that could have a major impact on hypertension management, are in planning.
Goal 3: To Generate an Improved Understanding of the Processes Involved in Translating Research into Practice and Use That Understanding To Enable Improvements in Public Health and To Stimulate Further Scientific Discovery.
Challenge 3.1: Complement bench discoveries and clinical trial results with focused behavioral and social science research
The Division supports behavioral and social science research to investigate the relationship among psychosocial risk factors (e.g., depression, social support, hostility, stress), health- damaging and health-promoting behaviors, and cardiovascular risk factors and outcomes and delineate the physiologic, neural, and behavioral mechanisms that mediate these associations. Other work seeks to identify psychological, social and behavioral factors (e.g. motivational, emotional and cognitive processes) that are involved in the formation, change, or maintenance of cardiac risk factor behaviors and develop and test innovative interventions to ameliorate psychosocial and behavioral risk factors (e.g., nutrition, physical activity and tobacco smoking) and improve cardiovascular health.
Ongoing projects aim to identify high-risk subgroups of depressed patients and develop better treatments for depressed CHD patients. Other projects are evaluating the effects of stress management interventions, using innovative strategies, based on basic behavioral and social sciences research, to promote healthy behaviors. The Division is particularly interested in elucidating the psychosocial, behavioral and sociocultural factors responsible for health disparities with the aim to develop and test cost-effective interventions that may both reduce disparities while improving overall public health. Special projects are focusing on American Indians and Alaska Natives, as well as other groups at high CVD risk such as Hispanic/Latino populations, African Americans, rural and low-income groups and immigrants. Studies of gene/environment interactions supported by DPPS include the influence of genes on behavior as well as the neurohormonal pathways through which psychosocial factors influence gene expression.
Future research directions include investigating the use of new technologies and novel intervention methods (such as adaptive designs and systems science approaches) to develop and test interventions; studies investigating the influence of genes and neurohormonal pathways on behavior; studies that address the importance of psychological, cognitive and social sequellae of heart disease; and the need for user-friendly and reliable tools to measure quality of life and outcomes of heart diseases and treatments.
3.1.a. Develop and evaluate new approaches to implement proven preventive and lifestyle interventions
The Division supports research on behavioral, clinical, community and healthcare approaches to reduce cardiovascular diseases. Projects range from observational analyses to clinical and community trials. The Division supports research in nontraditional families, low SES, rural and immigrant populations, as well as research to prevent health disparities (such as a program testing implementation of programs to control high blood pressure in African Americans); interventions at individual and group levels including those in schools, worksites, neighborhood and community, health care settings, family and community-based approaches; and studies that examine the extent to which risk stratification and application of personalized medicine can improve effectiveness in cardiovascular disease prevention and treatment. The Division supports studies to prevent and treat obesity in childhood and in young and older adults; studies on weight loss maintenance in adults; novel dietary strategies; complementary or alternative medicine for cardiovascular disease prevention; trials in physical activity; hypertension prevention and treatment interventions in diverse population; and health disparities research.
The Division will continue to pursue and implement research approaches that are novel including those that integrate genetic, basic and social sciences, lifestyle behavioral changes and personalized medicine for cardiovascular disease prevention and treatment.
3.1.b. Develop and evaluate policy, environmental, and other approaches for use in community settings to encourage and support lifestyle changes
The Division supports and conducts research on policy and environmental approaches including those in worksites, schools, health-care and other community settings (e.g., churches) to improve health and prevent cardiovascular diseases. The Division also supports studies that use novel methods to assess environmental and policy changes. Intervention approaches to prevent cardiovascular diseases are conceptualized on a population basis. Studies include those that focus on obesity prevention, physical activity or community cardiovascular disease prevention. Environmental strategies include, for example, those that influence the social environment (e.g., social network, family), physical environment (e.g., providing sidewalks, safe neighborhoods, access to fitness clubs), and community environments (e.g., smaller portion sizes at restaurants or fresh fruits in supermarkets). Policy strategies include those that focus on health outcomes as a result of implementation of clinical guidelines (e.g., dietary, physical activity, and blood pressure guidelines), and enactment of laws and regulations (e.g., smoking bans, tax modifications, point-of-purchase nutrition labeling, and "smart growth" strategies, such as walkable neighborhoods).
The Division recognizes the value of research that uses multi-level intervention approaches focusing not only on the individual but on social environment-, physical environment-, community-, and systems-level influences.
3.1.c: Develop and evaluate interventions to improve patient, provider, and health care system behavior and performance in order to enhance quality of care and health outcomes.
The Division supports research that evaluates patient-, clinician-, system-, and multi-level interventions to improve clinical care delivery for prevention and treatment of cardiovascular diseases and to eliminate health disparities. A substantial proportion of these projects are individual- or cluster-randomized clinical trials. Programs include initiatives on improving heart failure disease management, a cardiovascular research network in community-based care, studies on weight loss in obese adults with cardiovascular risk factors, trials assessing innovative strategies to improve clinical practice through guidelines in heart, lung, and blood diseases, and studies to improve hypertensive care for inner city minorities.
The Division seeks to enhance quality of life and cardiovascular outcomes by supporting and conducting research that generates new knowledge, as well as knowledge that facilitates implementation of effective patient, clinician and/or health system interventions.
Challenge 3.2. To identify cost-effective approaches for prevention, diagnosis, and treatment
3.2.a. Evaluate the risks, benefits, and costs of diagnostic tests and treatments in representative populations and settings
The Division supports health services and outcomes research that evaluates the most effective and efficient ways to deliver health care in real-world settings, translating scientific discovery into communities. One such example is the evaluation of implantable cardioverter defibrillators for primary prevention in the HMO-based Cardiovascular Research Network, evaluating both clinical and cost outcomes. The Division also supports large-scale trials that rigorously evaluate the comparative clinical effectiveness of treatment options on health outcomes as well as the relative cost-effectiveness of these options. Such studies include ALLHAT, ACCORD, and SPRINT.
The Division acknowledges the importance of research on health services, cost-effectiveness, and outcomes that evaluates clinically feasible diagnostic tests and interventions in real-world settings, investigates interventions to eliminate disparities in health care delivery, and pursues the development and evaluation of improved metrics of health care quality and outcomes focusing on value-based diagnostics and treatments. It has funded linking cohort study data to CMS data, which provides information on medical care utilization, costs, and outcomes.
3.2.b. Develop research designs, outcome measures, and analytical methods to assess prevention and treatment programs in community and health care settings across populations and lifespan.
The Division supports various research designs including individual and group randomized designs, quasi-experimental designs, "natural experiments" (or opportunist evaluations), and traditional longitudinal (including long-term) cohort studies. The Division supports the analysis of data systems that characterize various population groups, access to health care, patterns of health care use, family structure, work roles, quality of life, clinical health status, and data analyses from clinical trials to examine, for example, cost-effectiveness, return on investment and other economic and health outcomes. Through the improved measures of diet and physical activity for genes and environment initiative (GEI), research is being conducted to develop novel, reliable and valid technologies that have low subject burden, and are economically feasible for use in studies of free-living and diverse populations to improve assessment of diet and physical activity.
The Division, through the Office of Biostatistics Research (OBR), supports the application of traditional statistical methods and the development of novel statistical methodologies for analyses of clinical trials and epidemiological studies. OBR statisticians collaborate widely with all divisions of NHLBI, including the Division of Intramural Research, as well as with other NIH Institutes and other national and international research organizations and universities. OBR's methodological interests include survival analysis, longitudinal data analysis, mid-trial corrections (trial extension and early stopping), and efficient study designs, including the monitoring of clinical studies for efficacy and safety while they are ongoing.
The Division will continue to identify and pursue statistical challenges within traditional clinical study frameworks and in the emerging areas of genetic and genomic research. Further areas of research include study design and analytic strategies for genetic-guided clinical trials and for clinical trials randomizing on genotypes. It is also anticipated that the areas of personalized medicine and personalized genomics will be the focus of further statistical developments.
Challenge 3.3: To promote the development and implementation of evidence-based guidelines in partnership with individuals, professional and patient communities, and health care systems and to communicate research advances effectively to the public.
3.3.a. Establish evidence-based guidelines for prevention, diagnosis, and treatment and identify gaps in knowledge.
The Division supports many well-known large-scale cohort studies and clinical trials that yield data critical for evidence-based clinical practice guidelines. The Framingham Risk Score has been integrated in cardiovascular guidelines such as the National Cholesterol Education Program. Recent findings from the ACCORD study will certainly impact the clinical guidelines on the management of diabetes in high-risk patients. In collaboration with the DPPS, the Division for the Application of Research Discoveries (DARD) leads the NHLBI effort in establishing integrated guidelines that holistically address the full range of cardiovascular risk factors.
The Division acknowledges the importance of pooled multiple cohorts and or clinical trial databases to help stratify risks for disorders other than coronary heart disease events, such as clinical heart failure. There is increasing interest in implementation research that seeks to identify optimal methods for incorporating guidelines in routine practice. Findings from these studies may impact the process of developing clinical guidelines.
3.3.b. Develop personalized and community- and health care system-oriented approaches to increase the use of evidence-based guidelines by individuals, communities, health care providers, public institutions, and, especially, by populations that experience a disproportionate disease burden.
The Division supports programs that speed the implementation of research findings into health care and community settings. The Division encourages research that enhances the understanding of contributions of individual health behaviors, community-based organizational and environmental polices, and health systems innovations to reduce health disparities.
The Division is supporting new, innovative evaluation projects on the outcomes of community programs that target the control of childhood obesity. Findings from these observations would help inform other communities on the usefulness of applying similar policies for the control of childhood obesity in their own communities. These programs may also provide novel ideas for generating personalized approaches to increase the use of evidence-based guidelines by populations that experience a disproportionate disease burden.
3.3.c. Communicate research advances effectively to the public.
The Division energetically works to communicate research advances to the public. It collaborates with the NHLBI press staff in the Division for the Application of Research Discoveries (DARD) to publicize major NHLBI funded prevention- and population-based research advances. The Division actively identifies potential newsworthy research results prior to the publication of articles or presentation of findings at major scientific conferences; the Division further works with the NHLBI press staff to prepare the news releases and respond to outside press inquiries. Aside from the general public, the Division supports communicating research advances to participants and communities of its longitudinal cohort studies.
The Division is committed to continuing support DARD as they lead NHLBI in speeding the application of scientific advances in the prevention, detection, and treatment of cardiovascular, long, and blood diseases and narrow the discovery-delivery gap. In addition, the Division will continue to highlight and communicate research findings to communities and participants of its large-scale longitudinal cohort studies.
AppendixList of NHLBI study abbreviations, names, and web sites: