Showing 6 ideas for tag "study"

Goal 2: Reduce Human Disease

What causes the structural abnormalities that cause sleep apnea, and how can they be prevented?

It is estimated that up to 28% of the population suffer from sleep apnea, which impairs functioning and reduces quality of life, while increasing risk of accidents and a variety of cardiovascular, metabolic, and neuropsychiatric diseases. A large portion of sleep apnea cases are caused by abnormal oro-nasal-maxillo-mandibular features that result in crowding of the upper airway, making it vulnerable to collapsing or... more »

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

Details on the impact of addressing this CQ or CC

Obstructive sleep apnea (OSA) is a common condition, which causes chronic fatigue and daytime sleepiness, as well as cognitive impairments affecting learning, concentration, and memory. Over the long term, it increases many health risks, including accidents, cardiovascular disease, and depression. OSA is characterized by partial, or complete, blockage of the airway during sleep, so that breathing repeatedly pauses or airflow is limited, causing repeated arousals from sleep. It is usually secondary to a narrow, or collapsible, airway due to either 1) obesity or overweight, or 2) abnormal morphology of the mandible or maxilla bones, which crowds facial structures, such as the tongue and nose, narrowing the pharynx. The causes of obesity are already being well studied, but there is relatively little research on the etiology of the structural abnormalities involved in OSA. Abnormalities of facial structure are widespread in the population causing, not only OSA, but also orthodontic problems that require many to get braces or have wisdom teeth extracted, and widespread temporomandibular joint (TMJ) problems. However, multiple studies have documented that these abnormalities are almost completely absent from populations living a preindustrial, agrarian or forager, lifestyle, making them a “disease of civilization”. In particular, the abnormalities are associated with consumption of a modern diet of processed foods during prenatal, infant, and early childhood development.

Feasibility and challenges of addressing this CQ or CC

Current evidence implicates three factors in the development of these structural abnormalities: prenatal maternal nutrition (especially vitamin K2 status), breastfeeding vs. bottle-feeding, and frequency of consumption of tough foods after weaning (which provides exercise to the jaw). We need to form a large cohort and study orthodontic development prospectively from fetal development through mid-childhood, with data on diet, feeding practices, and physiological measures of nutrient status. Measurement methods are available using existing technologies to collect the necessary data on each of these measures. Determining the causes responsible for these structural abnormalities will enable further research to demonstrate effective methods of preventing them. Given that many patients with OSA are rendered so miserable by it that they undergo maxillomandibular advancement surgery to correct it, an expensive procedure with a lengthy recovery period, prevention would be a far better solution. This research will move us a big step closer to a future without sleep apnea and its formidable collection of negative effects on health and functioning.

Name of idea submitter and other team members who worked on this idea Bonnie Dixon

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6 net votes
44 up votes
38 down votes
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Goal 2: Reduce Human Disease

Optimal Use of mechanical circulatory support devices to Minimize Pump Thrombosis & AEs

There is a need for the development of a collaborative observational study that leverages off of existing registries, such as INTERMACS and STS, that will follow mechanical circulatory support devices (mechanical circulatory support device) patients prospectively and collect process-of-care data to identify 1) optimal approaches for the management of patients and 2) pumps to minimize the occurrence of adverse hemodynamic... more »

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

Details on the impact of addressing this CQ or CC

Completion of the proposed observational study would optimize mechanical circulatory support device/left ventricular assist device use and minimize serious adverse events such as pump thrombosis.

Feasibility and challenges of addressing this CQ or CC

Use of mechanical circulatory support is expanding to less sick populations, so optimal and safe use of these devices is critical.
Mechanical circulatory support devices (mechanical circulatory support device) have become important therapeutic options for patients with advanced heart failure. Considerable efforts are underway to develop newer generations of devices that are smaller, more durable and reliable, with fewer adverse events. However, mechanical circulatory support devices that are currently being used continue to have considerable risks and hemodynamic complications associated with them including bleeding, stroke, and intra-pump thrombus formation. Many factors influence the occurrence of these adverse events in patients receiving mechanical circulatory support devices, including patient selection, patient management such as the anticoagulation regimen used, pump selection, surgical placement and implantation of the pump, and mechanical aspects of the pump including pump speed and pulsatility, among other factors. The existence of multiple factors and complexities influencing and contributing to these adverse event outcomes preclude a standard clinical trial approach.

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

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4 net votes
15 up votes
11 down votes
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Goal 4: Develop Workforce and Resources

Comparison Groups for Training Evaluation

Evaluating whether a particular training program is effective can be difficult if an appropriate comparison group is not available.

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 concerted effort is needed across the different institutes and other research-oriented training programs (e.g., RWJF) to collect and combine common data. A NIH Working Group may need to determine the best way to do this. Type of information needed is background (baseline) educational and career information about trainees, and educational and career information collected longitudinally. Specific metrics indicating success at different career stages (e.g. publications and grants at the post-doc and faculty level, or continued training at the graduate level for undergraduates, etc) would be developed and collected. In addition, specific information about the training programs themselves is needed, such as length and intensity of training, training content, mentoring components, research components, etc. Personality types of the trainees such as those obtained from the Myers-Briggs Test would be useful.

Feasibility and challenges of addressing this CQ or CC

This is NOT meant to be a competitive enterprise (e.g. which program is “best”) but rather a concerted effort to determine what works best for different segments of the population at different stages of career development, and an ability to draw relevant “comparison” groups from the mix. The study designs need to recognize the importance of not taking a cohort of students/trainees historically disadvantaged from succeeding in biomedical research and to offer them nothing to create a control setting that allows a greater chance of producing a positive effect size for a given intervention.

Name of idea submitter and other team members who worked on this idea Treva Rice for the PRIDE (Programs to increase diversity among individuals engaged in health-related research): Joe GN “Skip” Garcia, Francisco Moreno Girardin Jean-Louis, Gbenga Ogedegbe, DC Rao, Victor Davila-Roman, Mohamed Boutjdir, Betty Pace, Juan Gonzales, Bettina M Beech, Keith Norris, Marino Bruce, Alicia Fernandez, Kirsten Bibbins-Domingo, and Margaret Handley.

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2 net votes
7 up votes
5 down votes
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Goal 2: Reduce Human Disease

Data from regulatory studies a barrier to evidence-based medicine

Alignment of regulatory, healthcare, and research arms of the government is poor. There is a need to improve the design, quality and usefulness of data from regulatory studies to address major clinical questions and also to facilitate scientific inquiry. This is a barrier to evidence based medicine and improved treatments.

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

Name of idea submitter and other team members who worked on this idea Society for Vascular Surgery

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2 net votes
3 up votes
1 down votes
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Goal 3: Advance Translational Research

Translational research need not be mechanistic

Translation means laying the groundwork to advance an idea into the clinic. Late-stage translation means doing what FDA and IRBs require to obtain approval for an IND or an IDE and the associated protocol to test a new idea in humans. Mechanism is the mantra for investigator-initiated research in NIH study sections, but translation is often painstaking detailed work that follows mechanistic investigations, which typically... more »

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

Details on the impact of addressing this CQ or CC

Addressing this CC is vital in order to ensure that translation is not stymied at NHLBI.

Feasibility and challenges of addressing this CQ or CC

This is addressable. Study sections need to be charged with the mindset that new mechanistic insight is not an appropriate criterion for addressing the value of truly translational proposals. Staff involvement is desirable to monitor and enforce.

Name of idea submitter and other team members who worked on this idea audacious

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-14 net votes
9 up votes
23 down votes
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Goal 2: Reduce Human Disease

PUFA Toxicity

Our diets contain 20 times more omega-6 fatty acids than the diets of humans before agriculture, industrial solvent extraction of seed oils and hydrogenation. These acids including linoleic and arachidonic acids are precursors to eicosanoids that mediate inflammation and blood clotting and the amount in our diet has been shown to correlate with negative health outcomes. Should NHLBI fund more research into the effects... more »

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

Details on the impact of addressing this CQ or CC

Federal regulations could limit the amount of omega-6 fatty acids in foods and significantly reduce the incidence of atherosclerosis, strokes, heart attacks, asthma and autoimmune disease.

Feasibility and challenges of addressing this CQ or CC

Evidence already exists but should be confirmed in large scale studies

Name of idea submitter and other team members who worked on this idea James Shoemaker MD PhD

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-4 net votes
9 up votes
13 down votes
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