Goal 3: Advance Translational Research

The Investigator's Catch-22: How Can NHLBI Help?

The Critical Challenge is to determine how NHLBI can continue to foster the translational research necessary to allow our researchers to further develop their NHLBI-funded basic science discoveries. Researchers can't readily get a "typical" grant to perform the preclinical and early clinical translational IND-enabling research, and also can't yet attract private sector support without having done the work to "de-risk" ...more »

Submitted by (@nhlbiforumadministrator1)

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

Details on the impact of addressing this CQ or CC :

Ensuring that NHLBI-funded researchers have the means to further develop promising research discoveries will ensure that NHLBI continues to fulfill its Mission. Providing funding or resources to move basic science discoveries from the lab towards the clinic can expand the research environments, opportunities, and collaborations available to NHLBI investigators and lead to potential new therapies for heart, lung, and blood diseases.

Feasibility and challenges of addressing this CQ or CC :

Just as research project itself can take years, if not decades, to accomplish, so too can a cultural shift in our extramural research community. While one may have a different understanding of what constitutes "translational" research depending upon his or her vantage point, in reality it is bi-directional (from bench to bedside and back to bench) and offers possibilities for a wide range of researchers. Engaging established basic scientists in translational research can open new opportunities to them, and younger researchers are likely more familiar and well-poised for new research paradigms and collaborative efforts such as those afforded by the translational development process.

Basic discovery science is appropriately the backbone of the NHLBI extramural research program. But, for any basic science discovery to have a meaningful impact on human health, it must be "translated from the bench to the bedside." These next steps in translation involve a tremendous amount of research that is not amenable to hypothesis-driven grant mechanisms like an R01 or P01. Without access to funding support for early-stage translational work, investigators can be stymied and NHLBI-funded basic science discoveries can languish.

Name of idea submitter and other team members who worked on this idea : NHLBI Staff

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Goal 4: Develop Workforce and Resources

Suipport new research using the R21 mechanism

The decision by NHLBI to not support the R21 mechanism may be stifling new and innovative research, partcularly by young investigators who do not have a track record of R01 funding. The critical challenge is to keep funding new ideas from younger investigators to keep their careers viable while they obtain the data and publications necessary for further R01-level funding.

Submitted by (@georgeporter)

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 state of NHLBI funding rates for R01s are so low that we are undoubtedly loosing many young researchers as the fail to obtain adequate support for their research. Funding R21 grants will allow new, innovative, and perhps risky projects to proceed, while keeping less established researchers in the field. Re-establishing R21 funding may prevent the impression that NHLBI is more interested in supporting established labs and not advocating for and supporting new investigators.

Feasibility and challenges of addressing this CQ or CC :

Given the limited budget of R21s, they will not have as large an impact on the overall budget of NHLBI as the equivalent number of funded R01 grants. Therefore, this change is feasible from a financial standpoint. Obviously, funding R21s will decrease funding for other mechanisms. Finally, it is possible that many of these grants will not lead to advances in the field, but it is my understanding that studies show the same thing about R01s.

Name of idea submitter and other team members who worked on this idea : George Porter

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Goal 2: Reduce Human Disease

Treatment Options for Diabetics and Impact on Cardiovascular Health

As a clinician, over the years I have noted major differences in adverse cardiovascular outcomes in diabetics who are treated with insulin +/- oral agents compared to those only treated with oral agents. Cardiovascular events occur much less often and at a much later timeframe in diabetics ("Type 2/adult onset") treated with insulin as the primary method. Even with newer agents, there may be slight improvement, but ...more »

Submitted by (@patty.gladowski)

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

Details on the impact of addressing this CQ or CC :

Delaying the onset of injury to vasculature in Type 2 diabetics would have a major impact on quality of life for the diabetic and costs to the healthcare system. Dialysis and related costs are around $200,000/yr and interfere with life and ability to work, leg ulcers are often chronic and in many cases result in amputation.

Feasibility and challenges of addressing this CQ or CC :

This study could be performed in the clinical setting or could be completed with chart review to determine diabetics on insulin on insulin and review outcomes. If access to charts for patients continuously treated for five years or longer were available, this study could be done in a shorter timeframe and at less cost. A long term and costly alternative would be to begin a clinical trial. Medical claims data may be an alternative, but it would be important to identify onset of diabetes and treatment for a minimum of five years.

Name of idea submitter and other team members who worked on this idea : Patricia Gladowski

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7 up votes
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Goal 2: Reduce Human Disease

Can one integrate cardiac imaging studies with genetic,clinical, "omics", and historical data to predict disease and personalize

There are many novel imaging modalities, including radiographic, scintigraphic, sonographic, MR-based, and molecular for the heart and vessels. Patients have unique medical "signatures"- genetic risk factor profiles, epigenetic markings, "omics" profiles, and personal clinical and family history as well as symptom constellation and physical exam findings. Can these all be integrated into a single personalized profile ...more »

Submitted by (@dpinsky)

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

Feasibility and challenges of addressing this CQ or CC :

This will require a combination of informatics, state of the art imaging, and state of the art genetics and omics profiling with integration with the electronic health record.

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Goal 1: Promote Human Health

The coupling of mechanical stress to biochemistry, molecular biology and electrophysiology

Cells aren’t beakers holding soluble reactants waiting to be mixed. Cells are structured objects where life forms as a flow of free energy between three pools: chemical, electrical and mechanical. Most papers in the literature ignore structure (except of Xray or EM of specific proteins) and almost all ignore the coupling of mechanics to the other pools. Cells cannot be studied with in vitro experiments. We can study single ...more »

Submitted by (@nhlbiforumadministrator1)

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

Details on the impact of addressing this CQ or CC :

If we learn how a third of all cellular energy is used we have a better chance of understanding the other 2/3.

Feasibility and challenges of addressing this CQ or CC :

See more at: http://grants.nih.gov/grants/guide/notice-files/NOT-HL-15-252.html#sthash.7xHiSbcd.dpuf

Name of idea submitter and other team members who worked on this idea : Dr. Frederick Sachs

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Goal 3: Advance Translational Research

Clinical Tools for Pediatric CVD Risk Reduction and Asthma Treat

What are effective strategies and clinical decision support tools that can maximize pediatric care providers’ adoption of evidence-based recommendations for assessment and treatment of cardiovascular risk factors and/or asthma? • Clinical recommendations and associated implementation tools are often incorporated into electronic medical records (EMRs). Currently there is no standard EMR format and therefore it is difficult ...more »

Submitted by (@nhlbiforumadministrator)

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

Details on the impact of addressing this CQ or CC :

• Cardiovascular disease (CVD) remains the leading cause of death and disability in North America. There is extensive evidence documenting the initiation of the atherosclerotic process, the pathologic basis for clinical heart disease, in childhood. Additionally, asthma a chronic condition that affects more than 7 million children in the U.S. and leading to numerous emergency visits.

• Among the major factors that are associated with increased clinical recommendation use are ease of access and feasibility. A common obstacle that providers face is the availability of proper information at the point of care.

• The Community Preventive Services Task Force recommends clinical decision-support systems for prevention of cardiovascular disease based on sufficient evidence of effectiveness in improving screening for CVD risk factors and practices for CVD-related preventive care services, clinical tests, and treatments. Mobile solutions may help to further facilitate this process.

• Successful implementation of clinical recommendations for prevention and treatment of CVD pediatric risk factors and asthma could greatly reduce the number of youth moving into adulthood at increased risk for CVD and could improve health outcomes for children with asthma.

Feasibility and challenges of addressing this CQ or CC :

• Most care providers have mobile devices or computers for use in the clinical setting. There is good evidence that clinical decision support tools (and other implementation tools) can help facilitate adoption of clinical recommendation.

• It is important to test strategies in a large scale intervention that will measure clinical CVD outcomes.

Name of idea submitter and other team members who worked on this idea : NHLBI Staff

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Goal 3: Advance Translational Research

Improve patient compliance through community health workers

What are effective strategies for community-based participatory dissemination and implementation research initiatives in rural settings? • Limited number of studies that adapt evidence- or practice-based interventions to rural settings • Needs innovative approaches to engaging the rural community • New intervention approaches needs testing in rural communities • Building a team would have to involve of local community ...more »

Submitted by (@nhlbiforumadministrator)

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

Details on the impact of addressing this CQ or CC :

• Nearly 60 million Americans living in rural communities face additional barriers to receiving effective prevention and treatment services.

• Rural residents often enter care later in the course of their illness than their urban peers, enter care with more serious symptoms, and require more intensive and expensive treatment.

• The rural communities in the US are closely connected and can be leveraged to disseminate heart, lung, blood, and sleep relevant preventive and/or treatment options within those communities.

• Enhance understanding of community resilience factors, cultural, and individual factors that may enhance the provision and utilization of prevention and treatment services in these communities.

• Generate knowledge to improve the organization, efficiency, effectiveness, quality, and services for rural and frontier populations.

• Support movement of evidence-based effective health care and prevention and the public health knowledge base in rural communities in the US.

• Stimulate implementation science in rural and frontier communities

• High return on investment.

Feasibility and challenges of addressing this CQ or CC :

• NHLBI investigators could initiate controlled trials that would maximize the opportunities available in rural communities.

• Documented sustainable interventions and scientific research could serve to reduce morbidity and mortality in high-risk rural populations.

Name of idea submitter and other team members who worked on this idea : NHLBI Staff

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Goal 3: Advance Translational Research

Addressing Health Inequities through Nontraditional Partnerships

What non-traditional partnerships can be leveraged to address health inequities?

Submitted by (@nhlbiforumadministrator)

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

Details on the impact of addressing this CQ or CC :

- Broaden reach to underserved populations

- Increase ability to generate evidence based solutions to address health inequities

- Bring expertise and resources to core partner (NIH)

- Enhance ability to identify unanticipated problems and strengthen efforts across all phases of the implementation research agenda

Feasibility and challenges of addressing this CQ or CC :

Feasibility:

- Increased emphasis on health and health inequities by non-profit and particularly, for-profit organizations

- Affordable Care Act (ACA) includes both general and explicit provisions that could narrow the health disparities gaps through implementation research.

- Can leverage and build upon current research partnerships that exist between government agencies and health care delivery systems to address questions of major public health importance

- Opportune time to employ implementation research addressing health inequities through non-traditional research partnership with sectors such as education, state and local government, transportation (built environment), penal and re-entry systems (health risks and disparities), ministries of health, and for-profits, foundations, and non-profits with health care focus.

 

 

Challenges:

 

 

- Risk of disagreements and friction among partners and management with different priorities

 

- Synchronization of timing for decision making

 

- Achieving partners’ concurrence on decisions that provide the most cost effective solutions

 

- Time needed to establish trust among partners that do not routinely partner to address health inequities

 

- There are limited resources dedicated to fostering Public Private Partnerships

Name of idea submitter and other team members who worked on this idea : NHLBI Staff

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19 up votes
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Goal 2: Reduce Human Disease

Sleep Disorders and Brain Maturation

What is the effect of sleep disorders on child development? Specifically, how sleep apnea with intermittent hypoxia and or sleep deprivation alters the normal trajectory of maturation of brain regions controlling cognition, behavior and the cardiovascular system?

Submitted by (@raouf.amin)

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 significance of the behavioral and cardiovascular findings in children as they relate to health during adulthood is unknown. It remains to be defined whether the behavioral and cardiovascular abnormalities observed in children with sleep apnea are a reflection of structural and functional brain abnormalities, which might persist into adulthood and predispose to health problems at an older age.

A fundamental question that deserve investigation whether brain maturation in children with sleep apnea and sleep deprivation deviate from normal trajectory and whether brain plasticity can restore normal structure and function.

Such knowledge on brain maturation and plasticity in children with sleep disorders could lead to the identification of brain biomarkers that might signal risk for future mood and behavioral disorders and or cardiovascular diseases. The new knowledge will also identify sensitive period(s) during child development for interventions.

Feasibility and challenges of addressing this CQ or CC :

In the last decade, the application of new technologies of fMRI and diffusion MRI have permitted the study of the evolving brain connectome across all stages of development and created new potentials to inform our etiologic understanding of many pediatric and adult diseases.

We now can for the first time examine the brain developmental trajectories in children with chronic medical conditions including sleep disorders and compare the findings to normative data.

Name of idea submitter and other team members who worked on this idea : Raouf Amin, Mark DiFrancesco, Scott Holland

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4 up votes
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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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10 up votes
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Goal 1: Promote Human Health

Environmental Exposures and Atopic Disease

As the current chair of the Research and Training Division, I would like to convey that the AAAAI membership would like the NHLBI to consider the following in the development of its strategic plan:

 

What are the molecular and cellular responses in the lung that occur after environmental stimuli (including allergens) that predict homeostatic resilience or transition to atopic diseases?

Submitted by (@wheeze)

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

Name of idea submitter and other team members who worked on this idea : Mitchell Grayson on behalf of the American Academy of Allergy, Asthma, and Immunology

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Goal 3: Advance Translational Research

Direct thrombin inhibitors and anti-Xa (Ten A) inhibitors in trauma patients - physiologic effects and impact on outcomes

Direct thrombin inhibitors and anti-Xa (Ten A) inhibitors are new, undetectable and irreversible. We have no data on how well these drugs correlate with current measures of coagulopathy such as thromboelastography, or whether antifibrinolytics should be used in patients who are on these drugs. These drugs may increase incidence of traumatic brain injury after minor injury. They are also going to be used increasingly in ...more »

Submitted by (@nhlbiforumadministrator)

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

Details on the impact of addressing this CQ or CC :

Understanding pathophysiology of coagulopathy in trauma patients due to these drugs may lead to innovations in management of coagulopathy and help increase our ability to predict/prognostic poor clinical outcomes in patients on these new anticoagulants, detect these drugs in a timely manner and develop antidotes/reversal agents. 

Feasibility and challenges of addressing this CQ or CC :

These are eminently feasible with adequate support from the NHLBI. Challenges will be finding collaborations or institutions that have enough clinical volume and adequate basic science/translational research infrastructure to look at these questions seriously.

Name of idea submitter and other team members who worked on this idea : Sudha Jayaraman

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