Showing 5 ideas for tag "testing"

Goal 2: Reduce Human Disease

Viscoelastic vs traditional coagulation tests as a guide to hemostatic treatments

Does the use of viscoelastic testing to guide plasma transfusion improve outcomes when compared to traditional coagulation testing?

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 PT/INR are frequently used to guide hemostatic interventions, particularly in the ICU where the risk for hemorrhage is increased. In part, this is the result of long standing misconceptions regarding the relationship between PT/INR values with in vivo coagulation factor concentrations and clinical coagulation or hemostasis. Indeed, this misinformation almost certainly contributes to the well-documented inappropriate use of plasma products. To this point, it has now been demonstrated in a variety of clinical settings that the PT/INR is often poorly predictive of clinical coagulopathy or peri-procedural bleeding complications.

The last decade has seen a resurgence of interest in viscoelastic tests as alternatives assessments of hemostasis and guides to blood component use. Indeed, a body of literature supports the potential value of these tests in specific clinical settings. However, the value of such testing strategies has not been well described in the setting of the intensive care unit. Ongoing equipoise regarding the optimal assessment of coagulation status in the ICU suggests that a well conducted trial in this domain would have the potential to be truly transformative.

Feasibility and challenges of addressing this CQ or CC

The assessment of coagulation status and decisions related to plasma transfusion occurs multiple times throughout the day in essentially every intensive care unit across the US. Therefore, an adequately sized study population is clearly present and therefore, a multicenter trial is feasible with NHLBI support.

A potential challenge with a study evaluating the optimal coagulation testing strategy is the incomplete penetration of viscoelastic testing in current clinical practice raising concerns related to the resource and educational requirements if such a trial were pursued. Additionally, viscoelastic testing can take several forms, each of which may impose specific confounders. Therefore, specific technologies and transfusion algorithms would likely need to be employed.

Importantly, innovative trial designs may also help us to address some of the feasibility concerns noted above. One such design that may prove valuable in this setting is the stepped-wedge cluster randomization design. Implementation of such a design might be expected to improve investigator/clinician cooperation/compliance and may help reduce treatment group contamination.

Name of idea submitter and other team members who worked on this idea Daryl J. Kor, MD and Walter H. Dzik, MD for the 2015 NHLBI State of the Science in Transfusion Medicine.

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Goal 2: Reduce Human Disease

Improving patient-centered outcome assessments in HLBS studies

What types of newer patient-centered quality of life assessment tools can be employed in heart, lung, blood and sleep studies so that they can be validated and refined to improve our measurement of quality of life outcomes in populations of interest to NHLBI?

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

Details on the impact of addressing this CQ or CC

Improving our ability to precisely measure heart, lung, blood, and sleep patients' quality of life can enable evaluation of a treatment's impact on patient-centered outcomes such as overall quality of life and its components -- pain, symptoms, and a patients' social, psychological, and physical functioning.

Feasibility and challenges of addressing this CQ or CC

New tools have been developed, notably through the PROMIS common fund project, that allow potentially more precise, reliable, valid and sensitive measurement of Q of L outcomes, with less patient burden. These tools are available but require validation in HLBS populations to allow widespread adoption and routine use in NHLBI-supported clinical trials and population studies.
Advances in biomedical science mean we are living longer with chronic diseases, and the goal of treatment increasingly focuses on disease management, maximizing function, and improving quality of life, not just lengthening life. In addition, patient-centered approaches to health care encourage a view of patients as “whole persons” with emphasis on function and capturing the "patient's voice," not just mortality/morbidity outcomes. Functional and quality of life outcomes, e.g., assessment of pain, symptoms, emotional distress, physical & social functioning, are critically important outcomes to many HLBS patients, but their measurement requires self-reports of patient experiences and thus pose challenges to precise, valid and reliable assessment.

Assessment tools using computerized adaptive testing (CAT), such as those developed in the Patient-Reported Outcomes Measurement Information System (PROMIS) project, have been shown to be precise, valid, sensitive to change and easier to administer than traditional Q of L measures in a limited number of studies, but they require validation in HLBS patient populations before they can be used more widely in NHLBI-funded studies.

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

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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 »

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 3: Advance Translational Research

Increased testing of new ideas

As indicated in two influential papers we have published, there are many potential contributing factors to obesity beyond those commonly discussed and studied and some of these are potentially modifiable. Increased research to understand whether these putative factors are really influential and whether they can be modified to produce benefits with respect to obesity are in order.

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

Feasibility and challenges of addressing this CQ or CC

The two papers we referenced in this Critical Challenge were: 1) Keith SW, Redden DT, Katzmarzyk PT, Boggiano MM, Hanlon EC, Benca RM, Ruden D, Pietrobelli A, Barger JL, Fontaine KR, Wang C, Aronne LJ, Wright SM, Baskin M, Dhurandhar NV, Lijoi MC, Grilo CM, DeLuca M, Westfall AO, Allison DB. Putative contributors to the secular increase in obesity: exploring the roads less traveled. Int J Obes (Lond). 2006;30(11):1585-94. doi: 10.1038/sj.ijo.0803326. PMID: 16801930; and 2) McAllister EJ, Dhurandhar NV, Keith SW, Aronne LJ, Barger J, Baskin M, Benca RM, Biggio J, Boggiano MM, Eisenmann JC, Elobeid M, Fontaine KR, Gluckman P, Hanlon EC, Katzmarzyk P, Pietrobelli A, Redden DT, Ruden DM, Wang C, Waterland RA, Wright SM, Allison DB. Ten putative contributors to the obesity epidemic. Crit Rev Food Sci Nutr. 2009;49(10):868-913. doi: 10.1080/10408390903372599. PMID: 19960394; PMCID: PMC2932668.

Name of idea submitter and other team members who worked on this idea David B. Allison, Ph.D.; Kevin Fontaine, Ph.D.; Kathryn A. Kaiser, Ph.D.; Andrew W. Brown, Ph.D.; Edward C. Archer, Ph.D.

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Goal 2: Reduce Human Disease

Determining the significance of variants of unknown significance

Variants of unknown significance (VUS) confound the value of genetic testing. We need to improve our understanding of the clinical significance of VUS so we can more definitively re-classify them as pathologic or benign variants.

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

Details on the impact of addressing this CQ or CC

Next gen sequencing and clinical genetic testing are becoming a more frequent component of clinical care. Not infrequently a VUS result is returned providing little clinical value to the patient. Determining the significance of these variants will be extremely valuable to patients undergoing genetic testing.

Feasibility and challenges of addressing this CQ or CC

Bioinformatics and big data infrastructure will mature over the next several years to allow us to record VUS results, follow patients longitudinally, aggregate data, and ultimately determine the significance of VUS.

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

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