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Third, the research efforts in critical care are vast. Certain key areas should be pursued with increased interest. Critical care medicine is a multidisciplinary specialty, and research efforts should be cognizant of the fact that surgeons, pediatricians, anesthesiologists, and basic scientists interested in critical care work together to solve the common problems encountered in the critically ill.
Many of the most important questions facing critical care medicine have not been investigated. Each year 100,000 patients suffer severe overwhelming sepsis or infection, and the resulting shock and multiple organ failure remain as the underlying core problems causing death, severe complications, and prolonged stay in the ICU.
As a result, costs continue to climb, and bed availability can be severely curtailed. Multicenter trials will increase not only the size of the studies but can insure more rapid completion as well as less biased and more powerful results.
Each year in this country over 50,000 individuals die as a result of complications from severe brain injury following trauma or ruptured blood vessels in the brain. Another 50,000 are permanently disabled. The vast majority are young and active members of the work force. Multicenter trials can be carried out to evaluate very common, critical illnesses. In fact, in 1983, NIH Consensus Conference in Critical Care Medicine recommended that such randomized studies can and should be conducted.
Not only must mortality be reduced, but the length of hospital stay and complications all impact on bed availability as well as overall cost. By the nature of their illness, critically ill patients draw heavily on hospital resources far out of proportion to the size of their population.
The society believes that only through an increase in appropriations substantially above the President's request can the Heart, Lung, and Blood Institute meet its stated goals for advances in research and training. The society recommends that the subcommittee provide the NHLBI with the financial means to fully fund the greater percentage of research grants. We also hope that the committee will encourage the Heart, Lung, and Blood Institute to support increased research in the critical care injury and illness both at the intra- and extra-mural levels.
Mr. Chairman, on behalf of the Society of Critical Care Medicine, we appreciate the opportunity to present our views and stand ready to answer any questions you might have.
[The statement follows:]
STATEMENT OF DR. T. JAMES GALLAGHER
Mr. Chairman and Members of the Subcommittee, I am T. James Gallagher, M.D., Professor and Chief, Division of Critical Care Medicine, University of Florida College of Medicine. I appear today as President of the Society of Critical Care Medicine to present our views on funding for the National Heart, Lung and Blood Institute. The Society is particularly concerned with the current rate of awards for approved grants, the lack of full funding of awards selected for federal funding, and the lack of research generally in the emerging field of critical care medicine.
Critical care medicine involves life threatening or severe illnesses which often include interaction and
involvement of more than one organ system. Care often requires
a combination of high technology support in the form of respirators, drugs to support blood pressure and heart function, specialized monitoring, the use of newer biologic agents and other medications, as well as around-the-clock nursing care.
The Society of Critical Care Medicine is a 20-year old, multidisciplinary organization formed by specialists from Anesthesiology, Internal Medicine, Pediatrics and Surgery. These specialists represent 90 percent of the Society's membership. It is the only professional organization devoted exclusively to critical care. The more than 5,000 members of the Society blend the knowledge, skill and technology from the four medical specialities, as well as nursing and the allied health professions, into a coordinated effort to achieve an optimal outcome for critically ill or injured patients. The goals of the Society include improving effective and efficient humane care for patients with acute life-threatening illnesses
and injuries, promoting and developing optimal facilities in which critical care medicine may be practiced, and assuring high educational standards in critical care medicine.
Increased Award Rate for Approved Grants
The Society recommends appropriations sufficient to allow awards of research grants up to the 35th percentile of approved research grant applications, with full funding of the awards, thereby eliminating the so-called "downward
negotiation" of 7 to 10 percent typical after grants win
funding approval. The funding of additional competing investigator-initiated research projects will allow the NHLBI to pursue several initiatives in both basic and clinical research. Under the proposed budget for the NHLBI, grants would be funded only to the 23rd percentile an inadequate level to sustain progress made thus far. More disturbing to the Society is the fact that new grants, often applied for by young scientists who represent the future of our field, would be hard pressed for federal funding. Critical care research is still a comparatively new field and would suffer greatly under this budget.
The Society is also concerned about the proposal to reduce the duration of grants to four years, and instead supports the NHLBI proposal to stabilize the proportion of five year grant awards at a fixed level. This will create a balance of stabilization of funding especially for clinical studies, and an opportunity for new investigators in terms of the competing pool of grants.
Expanded Research in Critical Care
Research efforts in critical care are vast, yet certain key areas should be pursued with increased interest. Critical care medicine is a multidisciplinary subspecialty, and
research efforts should be more cognizant of this
characteristic. The Society recommends that increased interest should be paid to multidisciplinary teams of internists, surgeons, pediatricians, anesthesiologists and basic scientists interested in critical care who work together to solve the common problems encountered in the intensive care unit.
Many of the most important questions facing critical care medicine have not been investigated. Each year 100,000 patients suffer severe overwhelming sepis or infection, and resulting shock and multiple organ failure remain as the underlying core problems causing death, severe complications and prolonged stay in the ICU. As a result, costs continue to climb and bed availability can be severely curtailed. In order to evaluate various therapeutic modalities, randomized, prospective clinical studies must be performed. These studies may be difficult to carry out within a single unit or institution beause of the ethics and logistics of patient consent, as well as the need to act quickly. Multicenter trials increase not only the size of the study, but can ensure more rapid completion, as well as less biased and more powerful
Each year in the United States over 50,000 individuals die as a result of complications from severe brain injury following trauma or rupture of blood vessels in the brain; another 50,000 are permanently disabled. The vast majority are young and active members of the work force. The complex interaction of the brain with other vital organs after such injury underlines the need for multidisciplinary, multicenter investigations of these critical illnesses which have such a devastating impact on so many productive members of society. If multicenter trials can be performed evaluating thrombolytic therapy in acute myocardial infarction, then they
can be carried out to evaluate very common critical illnesses. In fact, the 1983 NIH Consensus Conference on Critical Care Medicine recommended that such randomized studies can be conducted by enrolling more than one ICU or institution to participate by randomizing units or institutions, not patients. Such multicenter studies would have the ability to answer some of the most pressing issues in critical care
The Society also wishes to emphasize that more clinical investigation is needed in this field. Clinical investigation must be carried out by physicians who are trained in the care of critically ill patients and know how to perform investigations on these same patients. More emphasis needs to be placed on the training and subsequent support of such academic critical care physicians.
Many previous studies in critical care medicine used improvements in physiological perimeters as the primary outcome variable. More emphasis needs to be placed on the most important outcomes, i.e. decreased severe morbidity and/or mortality. Not only must mortality be reduced, but length of hospital stay and complications all impact on bed availability, as well as overall cost. By the nature of their illnesses, critically ill patients draw heavily on hospital resources far out of proportion to the size of their population.
The Society of Critical Care Medicine believes that only through an increase in appropriations substantially above the President's request can the NHLBI meets its stated goals for advances in research and training for cardiac and respiratory research. The Society recommends that the Subcommittee provide the NHLBI with the financial means to