Goal 3: Advance Translational Research

Pathways for Developing Pediatric Medical Devices

There is a need to develop innovative means to attract appropriate medical device industries to develop devices for the treatment and/or diagnosis of cardiovascular, pulmonary, or blood diseases in young children.

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 :

A greater number of needed medical devices for pediatric would be developed and made clinically available for children with cardiovascular, pulmonary, or blood diseases.

Feasibility and challenges of addressing this CQ or CC :

This will involve developing innovative ways of using NIH funds (e.g. RFA requiring public-private partnerships or other cost-sharing methods) to incentivize industry. These (and others) should certainly be feasible over a 5-10 year span to implement. However, this leads to the question of how NIH might facilitate such public-private partnerships and cost-sharing methods. Partnering with NICHD on this work would be appropriate.

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

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13 net votes
23 up votes
10 down votes
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Goal 2: Reduce Human Disease

US-based Clinical Development of Innovative Medical Devices

Though innovative medical devices are often conceived of and developed in the US, US consumers are frequently the last to benefit. Innovators frequently go to market first in Europe and are now moving toward emerging countries, delaying the medical benefits available to the US population. Can the NHLBI and FDA’s CDRH, working together as sister agencies, develop strategies such as funding opportunities or collaborative ...more »

Submitted by (@nhlbiforumadministrator1)

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

Details on the impact of addressing this CQ or CC :

Addressing this CC may empower the development of new regulatory paradigms within CDRH, enable the streamlined development of several NHLBI medical devices in the US, lead to a minimized delay in US availability for truly innovative technologies, and grow the pool of US clinicians experienced in working with device developers at the earliest stages of human/device interaction.

Feasibility and challenges of addressing this CQ or CC :

In the past 18 months

• NHLBI and CDRH have executed a structured working relationship, within the NIH Centers for Accelerated Innovations, where CDRH provides high-level feedback to early stage NHLBI medical device developers.

• CDRH has developed two new programs –one to enable US conduct of early feasibility studies/first-in-human (EFS/FIH) studies and a second to provide expanded access to senior agency reviewers for innovators developing high risk technologies.

Additionally, CDRH is focused on exploring and evaluating additional pilot programs to expand first-in-human trials within the US. NHLBI’s portfolio of awardees includes a number of medical device development projects that could qualify for the EFS/FIH program. Development of new collaboration or funding opportunities focused on this segment of device developers could attract additional innovators to the NHLBI family and encourage the US-based clinical development of their innovative technologies. The relationship that has been built between NHLBI and CDRH, in conjunction with CDRH’s more open approach to working with innovators, makes this the perfect time to expand NHLBI/CDRH innovator support beyond the NCAI program and into the overall NHLBI portfolio.

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

Voting

4 net votes
19 up votes
15 down votes
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Goal 2: Reduce Human Disease

Non-Adherence of Patients with Chronic Respiratory Diseases

There are various reasons responsible for patients’ non-adherence. One of them is insufficient or lack of education about medications and equipment required for their treatment.

Submitted by (@vlady.rozenbaum)

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 a critical need to develop uniform guidelines and handouts addressing the confusion over the proper use of medications (particularly inhalers) and equipment (i.e. oxygen). Improper use leads to diminished or no benefit, frustration, and, ultimately, even to a patient's decision to stop the treatment.

Feasibility and challenges of addressing this CQ or CC :

This is an issue that has been universally acknowledged for a number of years. With the help of patient focus groups, convened at the NHLBI, national pulmonological conferences, or at local venues around the country, appropriate materials can be created to benefit patients and reduce a huge burden on nation's economy due to decreased productivity and increase in hospital admissions.

Name of idea submitter and other team members who worked on this idea : COPD-ALERT

Voting

0 net votes
20 up votes
20 down votes
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Goal 2: Reduce Human Disease

Transforming Clinical Practice through Patient-Centered Medical Nutrition and Lifestyle Education

The fact that diet contributes significantly to prevention and treatment of disease is now a foregone conclusion. National and international guidelines offer evidence based recommendations advocating nutrients, foods and eating patterns that are most closely associated with reduced risk. Patients assume that physicians are knowledgeable regarding the role of diet in health and that they are trained to counsel patients ...more »

Submitted by (@lvanhorn)

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

Details on the impact of addressing this CQ or CC :

AHA/ACC guidelines subsequent to the NHLBI ATPIII all provide diet-related recommendations for improving public health that, if followed, could offer tremendous benefits in reduced disability, death and health care costs. However, imperative to the implementation of these life-saving recommendations, is an informed and educated provider base that is skilled in: assessment of patients’ diets and eating behaviors, evaluation of possible risk factor contributors and initiation of diet counseling or referral to a qualified nutritionist.

 

Nowhere is the opportunity greater to assess, evaluate and offer guidance towards improvement of key diet behaviors than in primary care. Patients perceive physicians as credible, respected sources of nutrition counseling. Physician endorsement of diet and lifestyle change favorably influences patient adherence. Research to evaluate patient-centered medical education and training programs is needed to evaluate and compare patient perception, health impact and health outcomes of these translational nutrition efforts. Ultimately, the goal is to further calculate and quantify the economic and personal benefits that accompany these strategies in order to implement transformed medical education aimed at preventive strategies.

Feasibility and challenges of addressing this CQ or CC :

This is a major challenge due to current medical training focused on diagnosis and treatment rather than prevention. Research is needed to demonstrate cost/benefit of transformative education and training that shifts the focus from treatment to prevention. Successful outcomes can provide preliminary evidence needed to promote a paradigm shift across -medical schools and allied health professions with the ultimate goal of - improving medical practice and quality of life. Evidence is needed that documents patient-centered impact resulting from this training and actual practice. Proposed is a comprehensive, team science approach to testing the results of nutrition and lifestyle medicine in primary care and the biomedical, behavioral and economic impact derived from it.

This represents an ambitious task requiring an academic medical center environment that not only has the educational aspect in place but also the capacity to provide the translational effort at the bedside and in outpatient settings to allow measurement of results. It requires leadership in multiple arenas and coordination between education and clinical application that are crucial to successful implementation. It further requires leadership and expertise in big data, economics, biostatistics and the accompanying technology required to

assess, analyze and report all of the aspects and components inherent in a project of this magnitude.

Name of idea submitter and other team members who worked on this idea : Linda Van Horn, PhD, RD

Voting

3 net votes
7 up votes
4 down votes
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Goal 4: Develop Workforce and Resources

Enhancing Medical Professional Education, Training and Research

Would using multi-disciplinary teams (nutritionists, exercise physiologists, social workers, nurses, etc.) be an effective approach to applying lifestyle medicine to improve patient care?

Submitted by (@nhlbiforumadministrator1)

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

Details on the impact of addressing this CQ or CC :

It would have a global impact on the health of the public, should patients CV and pulmonary health improve as a result of training and application of skills.

Feasibility and challenges of addressing this CQ or CC :

Previous NHLBI initiatives dovetail with the proposed and have demonstrated feasibility. NHLBI supported the Nutrition Academic Award program.

There is a movement to implement novel approaches to enhance training in and application of lifestyle medicine (e.g., smoking, nutrition and physical activity) for physicians (e.g., resident physicians and fellows) to improve patient care and cardiovascular and pulmonary health outcomes. The Affordable Care Act (ACA) recognizes the role of nutrition and physical activity and recommends that health professionals (e.g., practicing physicians, residents, fellows, physician assistants, nurse practitioners) counsel patients on lifestyle behavior changes. To capitalize on ACA, medical professionals must be trained and obtain the necessary practice skills to deliver needed services. Research to evaluate the approach must be an integral part of the process.

 

Collaborative resource needs in public-private partnerships have the potential to address this CQ. Research to evaluate this approach is equally needed.

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

Voting

15 net votes
31 up votes
16 down votes
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Goal 1: Promote Human Health

Qigong and Tai Chi for Chronic Disease Prevention

Non-pharmacological interventions for pain and stress have gained tremendous momentum. Mind-Body Practice -- Qigong and Tai Chi -- are group based and inexpensive to implement. The evidence base suggests that these practices are safe and effective for a multitude of preventable chronic disorders.. THE QUESTION: Given safety and efficacy, should there be vigorous research on implementation of Qigong and Tai Chi and ...more »

Submitted by (@rogerjahnke)

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

Details on the impact of addressing this CQ or CC :

What can we do to assure that safe, effective, inexpensive non-parmacological approaches like Qigong and Tai Chi become widely diffused into communities, agencies, organizations, schools, health systems and businesses.

Feasibility and challenges of addressing this CQ or CC :

We have participated in a number of studies that have contributed to the evidence base for Mind-Body Practice as a safe and effective non-pharmacological programming.

 

The key -- group based. For the financing, group based is inexpensive. For the efficacy group based supports compliance.

Name of idea submitter and other team members who worked on this idea : Dr Roger Jahnke, http://IIQTC.org

Voting

2 net votes
33 up votes
31 down votes
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Goal 2: Reduce Human Disease

Moonshot: Turning the BMT EMR into a Research Record

The critical challenge is to develop a standards-based BMT electronic medical record (EMR) and integrate research capacity into the architecture of EMR systems. The ultimate goal would be to build de-identified complete data-sets which can be used to support observational studies and clinical trials, improve transplant outcomes and inform public policy.

Submitted by (@rakeshgoyal)

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

Details on the impact of addressing this CQ or CC :

Clinical research is constrained by a clumsy method of acquiring biomedical data, generally relying on manual capture of information from EMR back-to-paper which is then transcribed into registry or specific clinical trial databases. This method is labor intensive, fraught with opportunities for error, and increasingly difficult to defend in light of the high costs associated with clinical trials. Adoption of standards-based clinical documentation and creating access to source clinical data would reduce or do-away with resource-intensive, very expensive and time-consuming data abstraction, enhance data quality and depth, and accelerate translational research.

Feasibility and challenges of addressing this CQ or CC :

As BMT centers increasingly adopt EMR systems in the United States, a vast and potentially very useful data resource is being created. However, most EMR systems offer very generic formats for clinical documentation and the medical information is inconsistently expressed in vocabulary, structure, and format. One challenge is the development of common standards-based clinical documentation format and its adoption by EMR system vendors and BMT institutions to support structured data sharing.

 

Large transplant centers can build their own integration engines to link EMR with stem cell lab, HLA, donor care, workflow etc. However, a broad implementation of integration IT solutions would be needed amongst centers conducting BMT clinical trials.

 

While CIBMTR's FormsNet application and Clinical Trials Network allow electronic data submission, data professionals still need to manually enter the data. Another challenge in creating a centralized data resource would be to build interoperability between transplant centers and research entities. An alternative to a large centralized database could be a distributed research network which allows data holders to maintain logical and physical control over their data and mitigate security, proprietary, legal, and privacy concerns.

Name of idea submitter and other team members who worked on this idea : Rakesh Goyal

Voting

57 net votes
71 up votes
14 down votes
Active

Goal 4: Develop Workforce and Resources

Medical student research training in LMIC settings

What are the strategies for heart, lung, blood, sleep workforce to gain first-hand international experience in clinical research/implementation research training in low- and middle-income country (LMIC) settings?

Submitted by (@nhlbiforumadministrator1)

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

Details on the impact of addressing this CQ or CC :

• Among the students who earn medical degrees in the United States, very few of them have been sufficiently trained to address the health needs of the most vulnerable populations.

• An international exposure in an LMIC setting would have enormous impact on clinical practice and research

• Any medical student interested in broadening their training may have opportunities for clinical and non-clinical hands-on experience and in turn this would increase number of physicians and researchers in global health.

Feasibility and challenges of addressing this CQ or CC :

Feasibility: • The NHLBI has a wealth of experience in training and career development programs in general and has supported and worked with global centers of excellence in this area.

• This experience can be used to leverage international experience in clinical practice and research outcomes in LMIC settings.

 

Challenges: • NHLBI would have to develop additional training mechanism(s) to foster clinical practice and research in an LMIC area.

 

• Resources for this unique training may be a challenge.

 

• Helping patients from vulnerable populations would involve confronting cultural differences and language barriers.

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

Voting

-30 net votes
5 up votes
35 down votes
Active

Goal 1: Promote Human Health

Establishing A Mobil Health Apps Monitoring Program

The recent Manhattan Research survey noted the increasing proliferation of health monitoring apps, which are accessible on mobile devices. Some experts believe that there are more than 40,000 of them already available. They mostly deal with wellness and fitness. The quality is very uneven and there is uncertainty among physicians which ones should be recommended to their patients.

Submitted by (@vlady.rozenbaum)

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

Details on the impact of addressing this CQ or CC :

A recent commentary in JAMA indicated a need for an independent or a government body to review and certify apps. That would be helpful to patients, particularly those suffering from chronic diseases. Very interesting discussion of this topic was published last October in Medical Economics.

Feasibility and challenges of addressing this CQ or CC :

Considering the fact that the number of physicians using apps continually increases, soliciting information on their experiences should not add an undue burden. Physicians will report their experiences and a quarterly assessment of the collected data will provide the expected reassurances to physicians and patients.

Name of idea submitter and other team members who worked on this idea : COPD-ALERT

Voting

27 net votes
40 up votes
13 down votes
Active

Goal 3: Advance Translational Research

Promoting Research on Translation of Evidence into Practice within Academic Medical Health Care Systems

Academic Medical Centers (AMCs) must become translational research leaders by conducting implementation research (IR) within their own health care systems. Doing so will require new paradigms, breaking down silos between research and operations, new incentives, and new funding streams. Steps include CTSA renewal requirements for significant IR and building on the QUERI (Quality Enhancement Research Initiatives) from ...more »

Submitted by (@kevinfiscella)

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

Details on the impact of addressing this CQ or CC :

AMCs are the engines of scientific research in the US. They possess the brain power, resources and reputation necessary to alter the trajectory of the translational continuum of research. Currently 62 AMCs are funded through CTSA in 31 states. Through their own health systems and their affiliates, AMCs provide health care to a sizable portion of the US population. Most AMCs now use the same EHR (EPIC). Nearly all are embarking on system change including establishing accountable care organizations, bundled payments, and medical centered homes. These assets provide fertile ground for research on how to best implement scientific evidence into health care to achieve the triple aim: improved care to patients, improved health to populations, and reduced costs. If AMCs take IR to heart, this could be a game changer. Success could establish a virtuous cycle whereby improved health and reduced costs convinces a skeptical Congress to authorize greater funding for NIH tagged to IR. This change requires moving AMC rhetoric into action and becoming leaders in IR in their own back yards.

Feasibility and challenges of addressing this CQ or CC :

The major challenges are new paradigms, incentives, infrastructure, and funding. Most AMCs regard health care systems operations and research as separate. Despite the mantra to become "learning health care systems" few AMCs conduct IR within their own health systems. Changing this paradigm will require incentive to change, new infrastructure including new types of teams, and funding streams. The CTSA renewal mechanism represents a starting place but this will need to be coupled with program announcements and center awards that establish a QUERI like infrastructure including teams of IR researchers, health care administrators and PBRNs. The challenge is great but a new paradigm is critical if scientific research is to guide the seismic changes that are occurring in within US health care.

Name of idea submitter and other team members who worked on this idea : Kevin Fiscella, MD, MPH

Voting

15 net votes
19 up votes
4 down votes
Active

Goal 3: Advance Translational Research

NHLBI Cardiovascular Engineering Strategy

Most impressive and impactful advances in CV diagnostics and therapies came in the last 50 years from CV engineering, including implantable devices and imaging technology. CV engineers are developing next breakthrough technology including tissue engineering and flexible electronics. However, organizational structure of NIH does not have an entity responsible for strategic development of CV engineering. NIBIB does not ...more »

Submitted by (@efimov)

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

Details on the impact of addressing this CQ or CC :

Cardiovascular Science produced numerous fundamental ideas, which frame our approaches to diagnostics and therapy of heart disease. However, translating these ideas to clinic very often requires engineering approaches. Examples of such breakthrough therapies are implantable pacemakers and defibrillators, stents, MRI, CT and many other imaging modalities. NIBIB supports many fields of biomedical engineering, except cardiovascular! NHLBI lacks a branch responsible for strategic development of cardiovascular engineering as a critical pathway to translation of basic science ideas. There is no study section or review group focusing on cardiovascular engineering. As a result, most of CV Engineering grants are reviewed by CV biologists, who lack engineering background and have quite different priorities and vision of the field. Next breakthrough developments will happen in tissue engineering, flexible/stretchable/biodegradable electronics, novel imaging modalities, computational physiology, and other classical biomedical engineering sub-fields. Unfortunately, they are less likely to happen in cardiovascular field, because NHLBI lacks corresponding organizational structure. A working group should be formed to frame NHLBI's vision for the future of cardiovascular engineering as an indispensable component for translation from CV biology to CV therapy.

Feasibility and challenges of addressing this CQ or CC :

Biomedical engineering has trained several generations of professionals in academia and industry, which pursue basic and translational research and development with great degree of success. CV Engineering is a standard component in numerous BME Departments. Large number of senior and junior CV engineers have been recognized for their significant contribution to CV health. There is enormous CV engineering expertise and experience, which should be leveraged by NHLBI, in order to broadly define institutional strategy not only for CV biology but also for CV engineering, which are equally important in development of future breakthrough therapies for CV disease. Currently, support for CV engineering is scattered across numerous mostly biology focused groups, lacking strategic vision and coherent policy. A number of talented CV engineers are forced to leave the field to pursue other areas of biomedical engineering, which enjoy better-organized professional group support.

Name of idea submitter and other team members who worked on this idea : Igor Efimov

Voting

8 net votes
17 up votes
9 down votes
Active