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Priorities for clinical research in intracerebral hemorrhage: report from a National Institute of Neurological Disorders and Stroke workshop.

BACKGROUND AND PURPOSE: Spontaneous intracerebral hemorrhage (ICH) is one of the most lethal stroke types. In December 2003, a National Institute of Neurological Disorders and Stroke (NINDS) workshop was convened to develop a consensus for ICH research priorities. The focus was clinical research aimed at acute ICH in patients. METHODS: Workshop participants were divided into 6 groups: (1) current state of ICH research; (2) basic science; and (3) imaging, (4) medical, (5) surgical, and (6) clinical methodology. Each group formulated research priorities before the workshop. At the workshop, these were discussed and refined. RESULTS: Recent progress in management of hemorrhage growth, intraventricular hemorrhage, and limitations in the benefit of open craniotomy were noted. The workshop identified the importance of developing animal models to reflect human ICH, as well as the phenomena of rebleeding. More human ICH pathology is needed. Real-time, high-field magnets and 3-dimensional imaging, as well as high-resolution tissue probes, are ICH imaging priorities. Trials of acute blood pressure-lowering in ICH and coagulopathy reversal are medical priorities. The exact role of edema in human ICH pathology and its treatment requires intensive study. Trials of minimally invasive surgical techniques including mechanical and chemical surgical adjuncts are critically important. The methodologic challenges include establishing research networks and a multi-specialty approach. Waiver of consent issues and standardizing care in trials are important issues. Encouragement of young investigators from varied backgrounds to enter the ICH research field is critical. CONCLUSIONS: Increasing ICH research is crucial. A collaborative approach is likely to yield therapies for this devastating form of brain injury.

Animals↗

Recommendations of the National Heart, Lung, and Blood Institute working group on cerebrovascular biology and disease.

The National Heart, Lung, and Blood Institute (NHLBI) convened a conference call working group, consisting of experts in stroke and cerebrovascular biology on January 28, 2005. The purpose of this working group was to develop a prioritized set of recommendations for NHLBI to establish a focused and comprehensive set of research activities in cerebrovascular biology and disease. Three thematic areas of research emerged: (1) molecular and cellular neurobiology of cerebral blood vessels, focusing on genomics and proteomics, neurovascular signaling and cerebrovascular embryogenesis, development and plasticity; (2) resource development, involving the development of new methodological approaches for normal and altered function of the neurovascular unit, collaborative research, and training in cerebrovascular pathobiology; and (3) cerebrovascular diseases and translational approaches, addressing vascular mechanisms of disease, the role of risk factors, importance of biomarkers with the ultimate goal of developing new treatments.

Animals↗

Advancing the study of stroke in women: summary and recommendations for future research from an NINDS-Sponsored Multidisciplinary Working Group.

BACKGROUND AND PURPOSE: Women have poorer outcomes from stroke than men. Women also have risk factors that are unique, including pregnancy and hormone therapy. Hormone therapy for postmenopausal replacement increased the risk of ischemic stroke according to results of the Women's Health Initiative clinical trials. Based on the current understanding of the mechanisms of action of estrogen, the reasons for this increased risk are uncertain. One method to better understand the reasons for this increased risk is to re-evaluate estrogen's role in the neurovascular unit, simplistically comprised of the neurons, glia, and endothelial cells, as well as the processes of inflammation, and hemostasis/thrombosis. Besides the role of estrogen there are many gaps of knowledge about issues specific to women and stroke. SUMMARY OF REVIEW: A multidisciplinary workshop was held in August 2005 to summarize the current evidence for estrogen and, more generally, stroke in women, and to provide recommendations for future basic, preclinical, and clinical research studies. CONCLUSIONS: These studies may ultimately change the approach to stroke prevention and treatment in women.

Female↗

Report of the National Heart, Lung, and Blood Institute working group on outcomes research in cardiovascular disease.

The National Heart, Lung, and Blood Institute convened a working group on outcomes research in cardiovascular disease (CVD). The working group sought to provide guidance on research priorities in outcomes research related to CVD. For the purposes of this document, "outcomes research" is defined as investigative endeavors that generate knowledge to improve clinical decision making and healthcare delivery to optimize patient outcomes. The working group identified the following priority areas: (1) national surveillance projects for high-prevalence CV conditions; (2) patient-centered care; (3) translation of the best science into clinical practice; and (4) studies that place the cost of interventions in the context of their real-world effectiveness. Within each of these topics, the working group described examples of initiatives that could serve the Institute and the public. In addition, the group identified the following areas that are important to the field: (1) promotion of the use of existing data; (2) facilitation of collaborations with other federal agencies; (3) investigations into the basic science of outcomes research, with an emphasis on methodological advances; (4) strengthening of appropriate study sections with individuals who have expertise in outcomes research; and (5) expansion of opportunities to train new outcomes research investigators. The working group concluded that a dedicated investment in CV outcomes research could directly improve the care delivered in the United States.

Cardiovascular Diseases↗

Approaches to the treatment of pulmonary fibrosis.

There was a general consensus at the workshop that pulmonary fibrosis is a highly lethal lung disorder and that current therapies for this disease have little effect on the natural history of the disease. There was also broad consensus that much has been learned about the pathogenesis of this disease in recent years and this information can be used to direct new therapies for this disease. As a complement to the findings from studies on pulmonary fibrosis itself, there has also been significant development of new therapies for other disorders that might be useful in treating patients with pulmonary fibrosis. The following is a list of some of the issues and recommendations that were generated from this workshop.

Anti-Inflammatory Agents↗

Future research directions in asthma: an NHLBI Working Group report.

Over the last 20 years, the prevalence of asthma has nearly doubled and now affects 8-10% of the population in the United States. Asthma also remains a major illness in terms of morbidity and suffering, and is the leading cause of hospitalizations in children under 15 years of age. Because asthma poses a lifelong burden to patients and society, efforts to increase the understanding of its pathogenesis are a key factor leading to its control and cure. Consequently, the National Heart, Lung, and Blood Institute (NHLBI) convened a Working Group of extramural experts, entitled "Future Research Directions in Asthma," on April 9-10, 2003, to identify research areas of greatest promise and opportunity in the field of asthma. The priority areas identified for research in asthma include: (1) innate immunity, adaptive immunity, and tolerance; (2) mechanisms and consequences of persistent asthma and asthma exacerbations; (3) airway remodeling: clinical consequences and reversibility (clinical relevance and resolution); (4) genetics/gene-environment interactions, pharmacogenetics; (5) intervention/prevention/therapeutics; and (6) vascular basis of asthma.

Asthma↗