Showing 5 ideas for tag "patients"

Goal 2: Reduce Human Disease

Evidence based approaches to Red Blood Cell transfusion

What are the optimal RBC transfusion thresholds for adult and pediatric cancer patients undergoing chemotherapy regimens that may improve functional status and quality of life?

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Cancer patients undergo intensive medical and surgical therapies to treat their underlying disease. Treatment commonly results in anemia requiring RBC and platelet transfusions to support the patient through the hypoproliferative phase of chemotherapy. This is particularly true for those patients requiring hematopoetic stem cell transplantation (HSCT). Following therapy, cancer outpatients commonly receive RBC transfusions for weeks to months to maintain their functional status.

Common causes of death in patients with hematological malignancies and other cancers are infections and bleeding. A meta-analysis of clinical trials suggested that liberal transfusion is associated with greater risk of infection. Conversely, restrictive transfusion could adversely affect quality of life and functional status in oncology populations. In addition, pre-clinical and clinical studies support that concomitant anemia and thrombocytopenia significantly compound bleeding risk, and that hemostasis can be optimized in thrombocytopenia by maintaining a higher hematocrit. Although bleeding risks in relation to platelet transfusion thresholds are well studied in patients with hematological malignancy, optimal hemoglobin levels in thrombocytopenic patients are not known. Despite the significant allocation of blood components to cancer patients as a whole, RBC transfusion practices are not well studied within this group.

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Randomized controlled clinical trials and other studies investigating optimal transfusion thresholds and other measures of practice are required to provide health care providers with evidence to guide one of the most common therapies administered in the setting of malignancy. The clinically important end points of well-designed studies could include: 1) quality of life and functional status for both inpatients and outpatients; 2) neurocognitive development in pediatric populations; 3) bleeding events / bleeding scores; 4) impact on immunity including immunomodulation and infection; 5) reconstitution of hematopoiesis; and 6) survival and/or recurrence of disease.. Besides a generalizable study population, certain target populations of interest are those with high risk disease, HSCT patients, patients undergoing radiation therapy, and pediatric patients.

There are >1.6 million new cases of cancer annually in the USA, including >50,000 with leukemia and >6,000 with HSCT. Cancer therapies are rapidly advancing in the era of genomics and immunotherapy. Capitalizing on the tradition of research in cancer, single and multicenter studies of RBC transfusion are feasible using randomized controlled designs in conjunction with clinical trials of chemotherapeutic regimens. The results of these studies will impact a large patient population’s quality of life, and may ultimately impact healthcare cost and blood demand.

Name of idea submitter and other team members who worked on this idea Nareg Roubinian, MD and Naomi Luban, MD for the 2015 NHLBI State of the Science in Transfusion Medicine

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Goal 2: Reduce Human Disease

RCT of stepped-care depression treatment on CV events & death

Does treating depression improve survival and reduce major adverse cardiac events in acute coronary syndrome patients?

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

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A substantial evidence base now exists showing that depression is associated with a two-fold increased risk of death and recurrent CV events in cardiac patients, leading to a recent AHA scientific statement recommending its elevation to the status of a risk factor for adverse medical outcomes in patients with acute coronary syndrome (Lichtman et al., 2014). Yet there is currently no clinical trial evidence that reducing depression improves cardiac morbidity and mortality. A clinical trial, using new, more effective depression treatment methods, such as collaborative care approaches that combine psychological counseling with medication in stepped-care fashion, is needed to determine whether effective treatment of depression can improve survival and reduce clinical cardiovascular events in cardiac patients.

Feasibility and challenges of addressing this CQ or CC

Newer stepped-care treatments for depression, combining medication and psychotherapy, have recently been developed and found to more effectively reduce depression than earlier treatments. By using these newer treatment methods to substantially lower depression, we can better answer the question as to whether treating the newly acknowledged risk factor of depression in ACS patients can improve clinical outcomes in these patients.

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

Similar changes to those in modern manufacdturing are required through our new technical society inlcuding medicine.

Attitudes to Mistakes. Changing prescription and protocol philosophy.
As an older patient, I am 89, I have one thing many others do not have, experience. As an engineer with much experience in manufacturing industry I have seen great recent changes in manufacturing sociology. Now, even top management comes to listen to “the Gemba” (the shop floor) and what could be regarded as mistakes are seen as opportunities to improve... more »

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As an engineer with considerable experience in manufacturing industry I have seen great changes in manufacturing sociology. We have come to listen to the Gemba (the shop floor) and inappropriate procedures are now regarded as opportunities to improve not something to be punished. Perhaps I can mention that my writing has been praised on this subject, for example for the book, "The Puritan Gift” by Kenneth and Will Hopper. “This is one of the best books I have ever read in my long life, and I don’t just mean books on business” Foreword: by Russ Ackoff, Wharton Business School. “late in their lives (the Hoppers) have given us an extraordinary gift” (translated from Chinese) Promise Hsu, Vista Magazine

Feasibility and challenges of addressing this CQ or CC

I suggest as a subject for discussion, that a change to a more aggressive use of antibiotics could save antibiotics. There is an old saying that the best time to hit a man is when he is down. The same surely applies to harmful bacteria.

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

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Goal 2: Reduce Human Disease

Reducing CV events in breast cancer survivors -knowledge gaps

Identifying breast cancer survivors at high risk for CV morbidity and mortality to allow targeting of management strategies to reduce CV events and thereby improve overall cancer-related survival.

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Chemotherapy for breast cancer stages I-III is known to be associated with or induce cardiotoxicity. Over 35% of these women develop progressive fatigue and exercise intolerance, and heart failure limiting their daily activities and frequently interfering with their ability to return to work. CV disease are the leading cause of morbidity and mortality for those surviving beyond 5 to 8 years from their breast cancer diagnosis. The excess of CV morbidity and mortality in these patients threatens to offset reductions in cancer-related survival. Identifying breast cancer survivors at high risk for CV morbidity and mortality could allow targeting of cardiovascular disease reducing therapeutic interventions.

Feasibility and challenges of addressing this CQ or CC

creating a multisite registry of women with Stage 1-3 breast cancer scheduled to receive chemotherapy and a control population women of similar demographic and CV risk profile without neoplasia, would allow to collect data at baseline and during/after cancer treatment related modern therapy, pre/post treatment functional status, including fatigue, behavioral and psychosocial risk factors and quality of life, and serum biomarkers indicative of myocardial injury, fibrosis, and heart failure.

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

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Goal 2: Reduce Human Disease

Cardiovascular dysfunction in geriatric trauma patients

There is too little research funding addressing cardiovascular dysfunction in geriatric trauma patients. There have been little interest in funding this work. Yet, the geriatric population is growing.



Geriatric trauma patients are predominantly women.



Historically, the trauma societies provide guidance for diagnosis and treatment of severe trauma. However, "trauma guidance" historically was the same for children,... more »

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

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Document and understand the role of cardiac dysfunction in contributing to morbidity and mortality of geriatric trauma patients.

Reduce mortality rates in geriatric trauma patients.

Feasibility and challenges of addressing this CQ or CC

Little research has been conducted to understand the role of cardiac dysfunction in elderly trauma patients. These patients may be intubated and treated with pain meds, so the normal symptoms of cardiac ischemia are silenced. Because 12 lead ECGs or cardiac enzymes are not routinely collected in these patients after admission, the question is what types of cardiac dysfunction occur and can they be prevented?

While evidence is scant, we conducted a structured chart review of WMD Shock Trauma patients' medical records in fiscal year 1999 data. Mean age was 76 and mean ISS of 24. In reviewing charts we found 71% of patients had one or more risk factors for ischemic heart disease (beyond age) and 30% had a history of ischemic heart disease. On admission 29% had ECG changes consistent with acute cardiac ischemia, but ischemic changes were noted equally between patients with and without a history of IHD. Cardiac enzymes were ordered for 45% of patients and 19% were positive. We found that patients with acute cardiac ischemia on admission (ECG or enzymes) had more adverse in-hospital cardiac events than those without ischemia on admission. Patients experiencing adverse events were significantly more likely to die.

We believe these findings suggest a substantial role of cardiac dysfunction in this population, but we were unable to generate interest in the topic.

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

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