Goal 2: Reduce Human Disease

Targeting Preclinical Diastolic Dysfunction to Prevent Heart Failure

Heart failure (HF) affects over 5 million American adults, and projected estimates show growth of this epidemic by 25% over the next 15 years as the population of the United States continues to age. Heart failure with preserved EF (HFpEF) encompasses 50% of all heart failure cases. Preclinical diastolic dysfunction (PDD) is defined as normal systolic function, moderate or severe diastolic dysfunction determined by Doppler ...more »

Submitted by (@chen.horng)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Details on the impact of addressing this CQ or CC :

There is currently no FDA approved therapy for HFpEF and yet HFpEF makes up 50% of all HF population. The prevalence of PDD (ACC/AHA Stage B HF) is abt 28% of the general population and these patients do not have symptoms of HF. Understanding the pathophysiology of PDD may leady to the development of therapeutic strategies to prevent the development of HFpEF. This would decrease the burden of HF impact public health and be cost-effective, similar to the use of vaccine to prevent infectious diseases.

Feasibility and challenges of addressing this CQ or CC :

With echocardiography, we are able to identify PDD patients before they develop symptomatic HF. Hence with research funding, we can better characterize preclinical diastolic dysfunction, and to discover further targets for this entity to prevent development of HFpEF

Name of idea submitter and other team members who worked on this idea : Horng H Chen

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Goal 4: Develop Workforce and Resources

Research training to support population-focused obesity research in ethnic minority populations

NIH is already facing a challenge in increasing the number and viability of researchers of color. Obesity research in black (or other high risk minority) populations can be used to explore how research training programs that focus on specific issues of importance to populations of color might contribute to the recruitment and success of ethnic minority researchers in the NIH system.

Submitted by (@skumanyi)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Details on the impact of addressing this CQ or CC :

To say the least, not all researchers of color study disparities related issues and not all disparities research is done by researchers of color. That is the way it should be. However, I suspect that research focusing on populations of color would attract a greater than average proportion of researchers of color (NIMHD might have data on this but NIMHD funding alone would be grossly insufficient as the only relevant funding stream. It would also be inappropriate and ineffective to silo the entire burden as an NIMHD responsibility).

Feasibility and challenges of addressing this CQ or CC :

The infrastructure for such training might not exist. Isolated minority researchers attached to various centers and programs would not necessarily work; some sort of networking would have to be done based on an infrastructure devoted to population-oriented obesity research and with a critical mass of obesity researchers focusing on the black (or other) population..

Name of idea submitter and other team members who worked on this idea : Shiriki Kumanyika, Melicia Whitt-Glover, Debra Haire-Joshu

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Goal 2: Reduce Human Disease

Prevent the Development of COPD

What can be done to prevent the development of COPD in individuals at increased risk. Quitting smoking before the development of COPD can prevent COPD development. What can be done to prevent COPD for individuals with other identified ris factors

Submitted by (@jsullivan)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Details on the impact of addressing this CQ or CC :

Several risk factors have been identified that identify individuals at risk for developing COPD including low birth weight, poor maximally attained lung function and the presence of asthma. Strategies to prevent COPD development in these individuals are needed.

Feasibility and challenges of addressing this CQ or CC :

The Lung Health Study demonstrated that smoking cessation prevents COPD progression. Studies of similar size and duration should be organized to address other risk factors.

Name of idea submitter and other team members who worked on this idea : COPD Foundation, COPDF MASAC

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Goal 3: Advance Translational Research

Impact research related to obesity interventions in black and and other high-risk populations?

How can we increase high-impact obesity and CVD-related intervention research with black and other high risk populations. Specifically, how can the NHLBI and NIH process ensure the generation of more research on solutions to weight issues that is goal-oriented and population-focused, e.g., sets of studies designed to align with a coherent, population-focused research agenda with prioritized questions based on potential ...more »

Submitted by (@skumanyi)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Compelling Question (CQ)

Details on the impact of addressing this CQ or CC :

The high and above-average prevalence of obesity and severe obesity among black children and adults persists, and obesity prevalence is still increasing in some age and gender subgroups in the black population. Current treatments don’t seem to work as well to reduce weight in blacks compared to whites (at least based on studies in adults), although some show promise for reduction of CVD risk factors even with modest weight loss. Preventive interventions are urgently needed but underdeveloped.

 

The context and process of intervening on weight issues differs by cultural and socioeconomic contexts. Yet, research that specifically focuses on approaches that can be effective in black population subgroups in communities at large is sparse; many studies are small, with methodological limitations. Within the overall research effort to address obesity, more studies, better studies, and coordinated studies on black Americans as a high risk sub-population could move the needle. This could be a general need related to high-risk populations who will never be the mainstream research focus and may have different contexts and needs.

Feasibility and challenges of addressing this CQ or CC :

It is feasible to do this if the challenges can be overcome and appropriate funding mechanisms are provided. The typical funding mechanisms focus on investigators rather than on populations and on disconnected R01s. The likelihood that these will add up to tell a coherent story is low. More mechanisms are needed to support coordinated studies planned to have collective impact for the black (or other) population. Other challenges are to improve methodological quality (including design, measurements, and duration), phase studies so that they can build on each other, and standardize process and outcome assessments to improve the ability to synthesize study results.

Name of idea submitter and other team members who worked on this idea : Shiriki Kumanyika and members/colleagues who are authors of a journal supplement to Obesity Reviews, October 2014

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Goal 1: Promote Human Health

Prevention of Obesity

What are the behavioral factors that predispose to excessive weight gain and development of obesity? And, which intervention strategies can effectively prevent excessive weight gain and obesity? NHLBI, other NIH institutes and the society at-large have invested heavily in research and clinical practice aimed at treatment of obesity (i.e, weight loss in those who are already overweight). However, much less research ...more »

Submitted by (@rpate0)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Details on the impact of addressing this CQ or CC :

Reducing the prevalence of obesity is one of the great public health challenges of the 21st century. Research should be focused, first and foremost, on prevention, not treatment, of this problem. It seems highly likely that improving the behaviors that can prevent obesity would produce a wide range of important public health benefits.

Feasibility and challenges of addressing this CQ or CC :

Two generations ago the prevalence of obesity was much lower than it is today. The prevalence was lower then, not because overweight people were better at losing weight; rather rates were lower because far fewer people became overweight in the first place. It is high time that the scientific community, clinicians, and public health practitioners invested their efforts in prevention first, where there is every reason to believe we could be successful. These efforts should be informed by a robust body of knowledge, and it is recommended that NHLBI lead the effort to expand the body of knowledge on primary prevention of obesity.

Name of idea submitter and other team members who worked on this idea : Russell Pate

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Goal 3: Advance Translational Research

Early prediction of cardiovascular disease by primary-care assessment

Tools for early assessment of cardiovascular disease have become available but not adopted in primary-care settings. Increased arterial stiffness is a well-known marker for advanced cardiovascular disease (CVD) and has been shown to be an independent predictor of cardiovascular mortality. In addition, arterial pulse wave velocity (PWV) has been readily accepted as a measure of arterial stiffness. Despite significant ...more »

Submitted by (@roy.wallen)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Details on the impact of addressing this CQ or CC :

In the US, 84 million adults will see their primary care physician for treatment of cardiovascular disease (CVD). CVD is responsible for an average of one death every 40 seconds. The direct and indirect costs of cardiovascular disease and stroke are approximately $315 billion, including the cost of health care services, medications to treat high blood pressure, and missed days of work. The World Health Organization states that 80% of premature heart disease and stroke is preventable. Focusing on assessing risk factors for cardiovascular disease, screening for individuals at risk, and then providing effective and affordable treatment to those who require it can prevent disability and death and improve quality of life.

 

In Europe, the European Society of Cardiology (ESC) has issued guidelines based on the weight of evidence in favor of the usefulness of screening for CVD by assessing arterial stiffness. These guidelines are supported by nonrandomized trials and suggest the development of randomized trials or meta-analyses. However, no guidelines exist in the US for screening for arterial stiffness from such organizations as the American Heart Association (AHA) and the American College of Cardiology (ACC). Existing guidelines to include assessment of cholesterol, lifestyle, obesity, and factors for risk are important. However, a simple, low-cost, objective measurement could be implemented at the point of primary care to improve early detection and treatment of CVD.

Feasibility and challenges of addressing this CQ or CC :

Screening capabilities and some level of clinical evidence exist for early detection of CVD. Therefore, implementation of a practice guideline in the US is very feasible. Studies and assessment from existing data such as have been completed by ESC can be replicated in the US and promulgated by AHA and ACC. This effort will require support from public and private entities, including universities, in order to see practice standards implemented.

 

Challenges to date include funding and the application of clinical protocols to support randomized studies or meta-analyses that will provide evidence for benefits of early screening. Further, public policy and current funding are focused on treatment rather than prevention. Existing reimbursement established by the Centers for Medicare & Medicaid Services (CMS) is focused on treatment rather than prevention and private insurance carriers have followed this same policy. Broader clinical study will support both the adoption of screening tools in primary care and broader reimbursement policy.

Name of idea submitter and other team members who worked on this idea : Roy Wallen

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Goal 1: Promote Human Health

THE RELEVANCE OF PREVENTION TRIALS

Prevention trials, implemented to reduce or delay progression to overt disease in a population at risk to the disease, are an important approach to health promotion. Therapies shown to reduce disease severity in patients with a specific disease are obvious, but not the only, candidates for a prevention trial in populations at high risk for prevalent diseases (such as heart failure, diabetes, COPD, asthma in children). ...more »

Submitted by (@media0)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Details on the impact of addressing this CQ or CC :

The impact of implementing such trials is considerable. They will clearly address an important component of NHLBI’s mission with respect to effectiveness of therapies and behavioral interventions, and it has minimal and clearly definable overlap with commercial trials of specific therapeutic products. It will also provide an important public health focus – preventing disease or reducing the impact of disease processes, thus potentially reducing chronic care costs and increasing years of useful life.

Feasibility and challenges of addressing this CQ or CC :

The biggest challenge in designing and implementing prevention trials is identifying the target, “at risk” population most likely to develop the clinical disease from known biomarkers or early signs/symptoms. Increasing availability of large, population-based registries or databases maintained for other purposes provides a very cost-efficient mechanism to electronically screen and identify “at risk” individuals. The same mechanism may also facilitate implementation of pragmatic, electronically managed, cost efficient trials.

Name of idea submitter and other team members who worked on this idea : Sonja McKinlay other Team Members: Susan Assmann and Paul Stark

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Goal 2: Reduce Human Disease

How can we implement what we already know for ASCVD prevention?

We have a number of highly effective evidence-based interventions that have been shown to reduce ASCVD events - statins, BP drugs, aspirin, acute care. Yet large proportions of high risk population groups are not taking evidence-based treatment. Numerous interventions have been tried at multiple levels from the individual patient to the federal government payors. What are the best practices? How can we systematically ...more »

Submitted by (@jennifergrobinson)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Details on the impact of addressing this CQ or CC :

A starting point would be to complete the work of the Implementation Working Group convened as part of the NHLBI Cardiovascular Prevention Guidelines in 2008. Needs: (1) Collaboration of consortia involved in multilevel prevention efforts (HMOs, pharma plan managers, health systems, etc) (2) An information warehouse of best practices from consortium members. (3) Collaborate with learning healthcare systems groups to test & evaluate implementation/interventions (40 Disseminate best practices & support to broader range of groups

Feasibility and challenges of addressing this CQ or CC :

Much work has been done in this area & should be collated & assessed for efficacy and cost-benefit. Collaborative framework needed, will require infrastructure funding.

Name of idea submitter and other team members who worked on this idea : Jennifer G Robinson MD MPH

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Goal 2: Reduce Human Disease

Addressing the population-level determinants of CVD

Atherosclerotic CVD is an epidemic disease that is determined primarily by the social and physical environments acting in part through risk factor distributions. To date most preventive efforts have been in the clinical setting, using medications for risk factors. As useful as this is, a much better solution is to deal with the behavioral contributors to risk and their social determinants, including strong destructive ...more »

Submitted by (@stephen.fortmann)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Details on the impact of addressing this CQ or CC :

Atherosclerotic disease is largely preventable through behavior: physical activity, nutrition, absence of tobacco use. Achieving ideal risk factor levels would virtually eliminate ischemic CVD, even in genetically-susceptible individuals. The decline in CVD mortality has been in large part due to declines in risk factor levels. The current epidemic of obesity threatens to reverse these gains. It is a critical challenge to develop ways to counter the negative social and economic forces that prevent improvements in risk behaviors

Feasibility and challenges of addressing this CQ or CC :

The short-term nature of NHLBI research has limited its ability to address this overwhelming part of the CVD problem. This is the challenge. NHLBI needs new mechanisms and perhaps partnerships to discover ways to address these population-level issues. Research on how to build community coalitions to address public health policy and educational approaches to CVD prevention will require new funding mechanisms perhaps analogous to funding individual investigators rather than individual grants.

Name of idea submitter and other team members who worked on this idea : Stephen P. Fortmann

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Goal 2: Reduce Human Disease

Restoring Balance to Stroke Prevention in Older AFib Patients

Improving Tools for Anticoagulation Decision-Making

Submitted by (@cbens0)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Details on the impact of addressing this CQ or CC :

AFib increases stroke risk by five-fold and doubles the risk that a stroke will result in permanent disability. While oral anticoagulation (OAC) is highly effective at reducing stroke risk, elderly patients are often under-anticoagulated. This is in part due to an under-appreciation of the stroke risk associated with AFib and the tendency of some health care professionals to prioritize perceived bleeding risk over stroke prophylaxis. Because current bleeding risk assessment tools are imperfect and largely unable to predict patients who are likely to have bleeding complications, they are often not utilized—or if used, do not truly predict which patients are at risk of a bleed. An improved bleeding risk tool is critical to improved risk assessment in the elderly. That bleeding risk tool should then be combined with the stroke risk tool for single risk stratification to streamline anticoagulation decision-making.

Feasibility and challenges of addressing this CQ or CC :

Developing effective integrated risk assessment tools is feasible only if there is consensus on the validity of the clinical information being provided. The approach to this critical challenge is two-fold. First, needed research that improves the reliability of bleeding risk assessment in the elderly should be pursued. Second, stroke and bleeding risk tools should be combined into a single risk stratification tool. This will require significant investment and focus, but the resulting bleeding risk assessment combined with the accepted CHA2DS2-VASc score, would significantly impact the 40 - 60% of patients who are currently not on an anticoagulant and are at increased risk of stroke and death.

Name of idea submitter and other team members who worked on this idea : AFib Optimal Treatment Task Force

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Goal 2: Reduce Human Disease

Optimizing Cardiovasular (CV) Prevention Medicine Use

Heart attacks and strokes cause substantial morbidity and mortality, while implementation of cholesterol and other CV prevention guidelines remain low. Proposed NCQA on-statin in the last year among those with DM was 46% in national field testing, and about 75% in Kaiser Permanente (KP). KP has had some success overcoming barriers to statin, aspirin, and blood pressure medicine adherence. If the nation as a whole is ...more »

Submitted by (@ronald.d.scott)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Details on the impact of addressing this CQ or CC :

Improving treatment rates to CV guidleines improves the population health and can be cost saving to the system. Currently statin use among DM and in those with ASCVD Risk >= 7.5% is about 40%. If treatment improved to 60 or 80% many CV avents would be averted and downstream cost savings.

Feasibility and challenges of addressing this CQ or CC :

KP has achieved blood pressure control rates of about 90% demonstrating possibility of high control / treatment rates. Improving treatment rates where there is a treatment gap in cost saving CV prevention should be a priority.

Name of idea submitter and other team members who worked on this idea : Ronald D Scott, MD. Kaiser Permanente Integrated Cardiovascular Health Team

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Goal 2: Reduce Human Disease

Cardiovascular risk and adverse event prediction & estimating net benefit in statin-treated individuals

Compelling Question: There is insufficient data to personalize the use of nonstatin or other preventive therapies in statin-treated patients. Equations could then be developed to predict CVD risk and to predict the risk of adverse events in statin-treated patients to guide intensification of therapy.

Submitted by (@jennifergrobinson)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Compelling Question (CQ)

Details on the impact of addressing this CQ or CC :

The 2013 ACC/AHA cholesterol guideline recommends statin therapy for the prevention of CVD events in moderate-high risk individuals. Many patients are still at increased CVD risk on statin therapy.

 

The potential for net benefit from CVD risk reduction therapies added to statin therapy depends on the absolute CVD risk in the statin-treated patient, the relative reduction in CVD risk from the added therapy, and the potential for net benefit.

Feasibility and challenges of addressing this CQ or CC :

This could be a pooling project of existing data from observational databases and clinical trials. Sophisticated pharmacoepidemiologic methods would be needed (and likely need to be developed) to draw appropriate inferences for application to clinical practice.

Name of idea submitter and other team members who worked on this idea : Jennifer Robinson MD MPH

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