Dr. Alberto Esquenazi, Board Chair, called the 34th meeting of the NABMRR to order at 9:00 a.m. Minutes from the previous meeting were approved.
May 3-4, 2007December 3-4, 2007May 1-2, 2008
As in previous meetings, Board members provided updates on their outside efforts to promote medical rehabilitation research and the activities of the NCMRR. Highlights include the following:
Lisa Iezzoni has been involved in a study of conditions requiring rehabilitation in order to characterize access to health care services.
Margaret Turk has been working to increase inclusion of evidence-based practice in clinical licensure. She has also been working with National Institute on Disability and Rehabilitation Research (NIDRR) on reviewing of their research programs.
Ken Giacin discussed his company, which provides access to umbilical cord blood samples for stem cell transplants. About 60 percent of the samples are used for bone marrow transplants in children and 40 percent are used for transplants in adults. He promotes these applications through building national and international collaborations.
Rick Greenwald discussed his small company, which seeks to commercialize technologies for rehabilitation and prevention. His current efforts focus on the design of specially engineered helmets to collect data on the impact of traumatic brain injury (TBI) in children in an effort to improve the prognosis, as well as research on prevention of falls in the elderly.
Linda Robinson is a trauma researcher who was formerly director of research and education of the Brain Injury Association. She also brings the perspective of a parent of a brain-injured child to the Board. She is interested in pre-hospital intubation and the SIREN study of pedestrians involved in car crashes.
Diana Cardenas has recently moved to the Miami Project to continue her research in spinal cord injury (SCI). She indicated that SCI treatments had not advanced significantly since World War II, but noted that now was the time to develop new treatment approaches.
Zev Rymer has been serving as the liaison to the National Advisory Child Health and human Development Council, the advisory council for the NICHD. He explained that recent Council discussions have highlighted the current financial constraints of the National Institutes of Health (NIH) and the less-than-optimal prospects for research support. He also noted the increased pressure on junior investigators and a paucity of new research initiatives.
Carolee Winstein was involved in organizational changes at her institution to increase focus on health promotion and disease prevention. Her own research and mentoring activities focuses on stroke rehabilitation, motor control and learning, and improved outcome measures.
Steven Wolf discussed his research on feed-back and feed-forward motor control to predict which patients would most benefit from rehabilitation therapy. He is leading a major clinical trial to explore the application of forced-use constraint-induced therapy to improve hand function in stroke patients. The EXCITE trial is engaging patients and families to improve outcomes.
Joy Hammel is an occupational therapist interested in the role of environment and societal factors in rehabilitation and knowledge translation. Her current research focuses on environmental supports and the measurement of participation.
Murray Goldstein discussed a February 2007 meeting to develop a new definition and classification scheme for cerebral palsy. He indicated that the outcomes of the meeting would be published in the journal Cerebral Palsy and Child Neurology. He provided an update on a study of the impact on cerebral palsy on the quality of life of children. This international collaboration involves the U.S. State Department and a unique cohort of clinicians in the Middle East.
Leticia Castillo briefly mentioned her research on the nutritional requirements of critically ill children, which will be discussed in more detail during the afternoon session on pediatric critical care and rehabilitation.
Martha Banks discussed her research company that supports neurological assessment and function. She added that she is also involved in research on underserved populations and partner violence.
Marcia Scherer is participating in a regional consortium funded by the NIH to promote clinical and translational research. She explained that she is particularly interested in psychosocial evaluation of individual strengths and weaknesses for matching individuals to appropriate assistive technologies.
Alberto Esquenazi has been involved in clinical administration, specially in the area of behavioral and communication support. He recently received the Distinguished Clinician Award from the Academy of Physical Medicine and Rehabilitation (PM&R) and is interested in building a neurorehabilitation training program for physical therapists.
Dr. Duane Alexander thanked the Board for their continued service to the NIH. The NCMRR is now 15 years old and its annual budget has grown from $500,000 to more than $70 million in FY2006. In fact, the Center has grown faster than other programs within the NICHD and has significantly impacted the field of medical rehabilitation.
At the time of this meeting, the NIH was still under a continuing resolution, as was the whole Department of Health and Human Services and most other parts of the government. In January 2007, the new Congress was scheduled to take final action on the FY2007 budget. It was likely that the NIH would be funded at FY2006 levels, but there could also be slight increases or slight decreases. For now, the NIH was taking a cautious approach to budget by making new awards at 80 percent levels with additional funds to be provided when the new appropriation is approved. The NICHD had to reduce funding to new and competing grants by 17-22 percent (depending on the approved funding levels) in order to maintain funding for the uppermost ten percentiles of peer-reviewed applications. The NICHD would be able to maintain this level of funding throughout the fiscal year, although there would be some uncertainty for applicants who fell right around the projected payline.
The new Congress would have new committee membership and chairs. Congressman Joe Barton, Chairman of the House Energy and Commerce Committee, had shown significant interest in the NIH reauthorization bill, including possible changes to restrictions, requirements, and reporting activities for the NIH, as well as increasing the size of the NIH Director’s fund to support more trans-NIH activities. The Autism bill, which had recently cleared both the Senate and the House, would increase annual NIH funding for autism research from $102 million to $975 million over five years, but the bill was an authorization not an appropriation. The NIH reauthorization bill also capped the number of NIH institutes with outside review every seven years.
The Board asked Dr. Alexander about the potential for collaborations with other governmental agencies in the current climate. He indicated that there was willingness to collaborate, but that resources to share and initiate programs were more limited than in past years. The Board also discussed the potential impact of the autism bill on the NICHD research priorities.
Dr. Michael Weinrich asked Dr. Bill Riley, of the National Institute of Mental Health (NIMH), to update the Board on an important new NIH initiative for improving patient outcomes, the Patient-Reported Outcomes Measurement Information System (PROMIS). Dr. Riley has been working with Dr. Louis Quatrano of the NCMRR to include disability measures among the outcome variables. PROMIS is part of the NIH Roadmap and dovetails with a similar initiative in the Center for Medicare and Medicaid Services (CMS). PROMIS would provide researchers with access to patients in an effort to develop a large item bank of relevant outcome measures. Computer-adaptive technology and item-response theory would be used to reduce patient burden, improve precision and reliability, and facilitate integration with other outcome measures. The initiative provided $25 million to seven sites to collect data on thousands of diseases and conditions, including health-related quality of life (HRQL) measures to assess physical, mental, and social health. The HRQL currently targeted adults, but would soon be extended to children. CMS would use PROMIS in the post-acute setting, where judgments currently rely almost exclusively on clinician-reported data. More information on the PROMIS initiative is available at http://www.nihpromis.org .
Dr. Weinrich also highlighted NCMRR-supported activities in the news. Drs. Wolf, Winstein, and colleagues completed a major randomized-control study of stroke rehabilitation, the EXCITE trial, which was published in the Journal of the American Medical Association. EXCITE, along with a similar trial on body weight-supported treadmill therapy, demonstrated that good randomized controlled trials could be done in rehabilitation. NCMRR researcher Br. Todd Kuiken published landmark studies on biomechanical approaches to enhance control of artificial limbs, which the popular media described as the onset of the bionic man and woman. Dr. Kuiken developed novel strategies for improving neural control in amputees by redirecting peripheral nerves into other tissues in residual limbs, where they could more appropriately interact with implanted electrodes and thus direct more complex movements in prosthetic controller devices. Braingate TM, another project, which was jointly supported by the NCMRR, the National Institute for Neurological Disorders and Stroke (NINDS), and the National Institute for Bioimaging and Bioengineering (NIBIB), developed improved cortical arrays to pick up residual signals in the brain motor cortex of severely paralyzed individuals in order to more effectively drive prosthetics and other assistive devices. Dr. Weinrich also noted that NCMRR’s own Louis Quatrano received the Tibbetts award from the Small Business Community for his continued effort to support innovative research.
The NCMRR budget was at about $70 million and was largely driven by continued success of investigator-initiated rehabilitation proposals in peer review. Dr. Weinrich explained that this situation demonstrated that NCMRR applicants were competing well even in these current tough times. In the area of research support, about 75 percent of NCMRR funds were committed to on-going research projects leaving about 25 percent for new and competing proposals.
Dr. Weinrich highlighted a joint announcement (NOT-HD-07-005) with CMS to support participation of Medicare subjects in approved NIH research studies in order to develop the necessary evidence-base to improve rehabilitation practice (see http://grants.nih.gov/grants/guide/notice-files/NOT-HD-07-005.html). Currently, local carriers were denying support for subjects who participate in clinical trials.
Dr. Weinrich pointed out that the NCMRR administrative budget was shrinking, making it difficult to co-fund conferences and adequately support staff travel to professional meetings. The Board felt that it was essential for NCMRR staff to maintain visibility at national meetings, especially in support of the emerging cadre of rehabilitation researchers and collaborators. The Board urged the NCMRR to seek ways to increase administrative support for travel and collaborations.
Dr. Weinrich also discussed a new model for supporting the biennial medical rehabilitation training workshop through collaboration with appropriate professional societies on a rotating basis. For example, the NCMRR was currently working with the American Congress of Rehabilitation Medicine and the American Society for Neurorehabilitation to have the workshop at their joint meeting, which would take place in Washington, D.C., October 3-7, 2007.
The NCMRR was also initiating three new national networks to support career development in allied health, neuro-rehabilitation, and bioengineering, respectively. Applications using the K12 mechanism would be reviewed early in the spring of 2007 and would complement current NCMRR programs that support the career development of physiatrists and pediatric critical care researchers.
Dr. Naomi Kleitman was invited to provide some background on NINDS support of rehabilitation research. With an annual budget of about $1.5 billion, the NINDS supports research on basic neuroscience and 600 specific diseases. The institute generally tried to direct 80 percent of its extramural funds to support investigator-initiated research and 20 percent for contracts, initiatives, training and special projects. For each of the three funding rounds, a portion of the 80 percent is set aside to support applications of “high program priority” and a number of new investigators whose applications were slightly above payline. The NINDS shares common interests with the NCMRR with respect to assistive technologies and rehabilitation research, particularly in the areas of stroke, traumatic brain injury (TBI), spinal cord injury (SCI), paralysis, and other aspects of motor outcome. The NINDS supports translational research through a series of preclinical-translation program announcements (PARs), an extensive clinical trial program, the neurological emergencies treatment trials network, and specific portfolios in neural engineering, TBI, stroke, and SCI. Dr. Kleitman also highlighted aspects of the NIH Blueprint for Neuroscience Research (see http://neuroscienceblueprint.nih.gov/ for more details). Three unifying themes include: neurodegeneration from disease and aging (FY2007 initiative), development of the nervous system throughout the life span (FY2008), and plasticity of the nervous system (FY2009).
Ms. Sandy Delcore, Information Resources Management Branch, NICHD, provided an update on the NIH-wide transition from paper grant applications ( SF424 format) to electronic submissions ( PHS398 format) to improve efficiency and reduced paperwork. This required change would standardize the application process across several government agencies using Grants.gov as the single common portal. Once submitted, NIH applications and reviews could be tracked through ERA commons. In the short term, the transition requires coordinated efforts across the NIH, which was converting to electronic submission mechanism by mechanism according to published timelines. All applicants were required to register on Grants.gov and ERA.commons; applications were to be submitted in PDF format. Moreover, all applications must refer to some funding opportunities announcement (FOA); however, generic FOAs were being developed for investigator-initiated proposals that were not responding to specific program announcement (PAs/PARs) or requests for application (RFAs). More information on the transition process is available at http://grants.nih.gov/grants/ElectronicReceipt/
Dr. Fernando Stein, Baylor College of Medicine and Medical Director of Texas Children's Hospital International of the Texas Children’s Hospital Progressive Care Unit, discussed some of the challenges of pediatric critical care. Research was needed to track long-term outcomes rather than mortality per se. Danger signs and other triggers to intervention needed to be formalized to eliminate observer-controlled thresholds and standardize clinical care. There were currently 410 pediatric intensive care units (PICUs) in the United States that care for critically-ill and at-risk infants. In the past three decades, mortality in these units dropped markedly from 35 percent in 1970 to only 4 percent in 2000, but the absolute number of impaired survivors has increased. The severity of impairment and the need for services were not well characterized. Further research was also needed to understand the trajectories of recovery and improve integration of physiological and psychological services. Treatment in PICUs was costly and there were wide variations in efficiency.
Mortality in PICUs had declined for several reasons. Physicians were more tuned into key physiological variables with better tools for monitoring function and infant health. The limits of technology and potential complications were better understood, especially in the use of ventilators. Steroid treatments had improved neurodevelopmental sequalae. Overall management of childhood illness was more integrated with more attention being paid to documenting best practices. Improved hygiene in clinical and home settings decreased the spread of cholera-promoting bacteria and reduced the incidence of diarrhea. Increased awareness of potential warning signs had decreased the incidence of respiratory complications.
Human factors still played a large role in the delivery of pediatric critical care. Protracted care for infants involved handing-off of responsibilities across clinical shifts and sleep deprivation among staff, which could increase the potential for medical errors. The increased time needed to document complex treatments also detracted from delivery of optimal patient care. The field of pediatric critical care field needed to push beyond considerations of mortality alone to more long-term functional outcomes.
Advisory Board member Leticia Castillo discussed the support of pediatric critical care research in the NCMRR. Many diseases treated in the PICU resulted in conditions that require long-term rehabilitation. A significant number of patients came to the PICU as a result of various chronic disabilities (40-60 percent of PICU admissions). Pediatric patients were unique, with distinct developmental, physiological, and psychosocial needs. The PICU dealt with a heterogeneous population without the appropriate research base to understand trajectories of recovery, develop practice standards, and apply treatments to this unique population.
The pediatric critical care program in the NCMRR is focused on developing appropriate research links to rehabilitation, epidemiology, prevention, and treatment of childhood disabilities. The program was currently sponsoring research on a wide range of diseases and disorders. It also supported the Collaborative Pediatric Critical Care Research Network (CPCCRN) to evaluate innovative research approaches in the care of critically ill children across six clinical centers (with a data-coordinating center). Training of physician-scientists was supported through individual career development awards (K23 and K08 awards) as well as through a national network of mentors using the K12 mechanism.
Dr. Zev Rymer provided some background on the neurological basis of spasticity and potential treatment strategies. He explained that spasticity is a disorder of muscle tone that increases resistance to externally controlled movements and is often accompanied with increased tendon jerks and clonus. Spasticity may be due to abnormal reflex responses in which spinal motorneurons were more excitable. Clinically, spasticity may be associated with abnormal cutaneous reflexes (such as the Babinski response), spasms, pain, and muscle contractures, but was distinct from weakness or impaired coordination. These aspects may result from abnormalities in interneuronal processing due to loss of monaminergic input from the reticulospinal system.
Treatment for spasticity had improved because of a better understanding of motorneuron and interneuron circuitry and biophysics as well as better measures of physiological and biomechanical variables in humans. In brain injury and stroke, alterations in motorneuron excitability were important, but in spinal cord injury alterations in the electrophysiological properties of interneurons were more prominent. Early studies in anesthetized animals incorrectly focused attention on treatments involving barbiturates but missed the potential role of serotonergic factors and brain-stem pathways. Although monoaminergic drugs were available, there had been relatively little focus on their potential to treat spasticity and weakness.
Dr. Rymer cautioned that even if the spasticity and muscle tone were treated, other functional problems might still remain. He went on to discuss current studies in animal models and motor-unit studies in affected humans. Stroke resulted in increased motorneuron excitability and changes in motor unit coordination, which suggested that serotonergic agonists would be effective in treating these symptoms. But in SCI, flexor spasms were a major source of spasticity, although extensor spasms were also present. Focus on the afferent pathways suggested that stretch sensors and/or force sensors may play a role in this dysfunction, but more precise measures of motion were needed to distinguish between these systems and determine the optimal pharmacological approaches.
Dr. Anne O'Mara of the Community Clinical Oncology Program of the National Cancer Institute (NCI) provided some background on rehabilitative issues in cancer treatment. Historically, the oncology community believed that “cure” trumped everything. However, with more effective treatments and improved survival rates, she explained cancer was now considered more as a chronic disease. There were still some racial/ethnic differences in the early detection and treatment of cancer, which could result from differences in detection rates and the access to care as well as inherent biological factors. Families of children with cancer aggressively pursued treatments and 97 percent of children were recruited into clinical trials versus only about 3 percent of adults diagnosed with cancer.
However, "cure" came with a cost for the nine million cancer survivors in the United States. Chemotherapy, radiation, and surgical treatments each had specific side effects and toxicities, including pain, peripheral neuropathy, fatigue, neurocognitive and psychosocial issues, and surgical disfigurement. In addition, cancer patients and their families had to cope with anxiety, depression, spiritual distress, and feelings of loss/grief. Pediatric cancer survivors were at increased risk for strokes, obesity, and cardiac problems. Increased attention was now being paid to treating and ameliorating the side effects of required cancer treatments. NCI research in this area includes studies of neurocognitive dysfunction, lymphedema, fatigue, pain, and peripheral neuropathy. Neurocognitive problems may be disease related (e.g., brain tumors) as well as treatment related (radiation of brain tissue and chemotherapeutic agents administered systemically that cross the blood-brain barrier). Neurocognitive treatments may involve cognitive rehabilitation, neuroprotective agents, and modification of cancer-dosing regimens. Lymphedema, resulting from obstruction of lymphatic function, was a particular problem in breast cancer surgery. Board members pointed out that this side effect could be a particular concern for women with disabilities who already have to rely more heavily on the use of their upper limbs for mobility. Dr. O’Mara concluded by discussing some NCI studies on the impact of cancer treatments on fatigue, functioning, and quality of life. She highlighted the need for rehabilitation researchers to collaborate with oncologists and surgeons to broaden the focus of cancer therapists.
Dr. Ralph Nitkin led a discussion on training and career development in the area of medical rehabilitation. He explained that rehabilitation research is a growing field due to the increasing patient demographics and chronic care needs, improved integration of clinical/basic/engineering/psychosocial research, and increased focus on real-world outcomes of function, participation and quality of life. Overall NIH support for training and career development had not increased significantly over the last few years and there were competing professional demands on clinicians, therapists, and researchers. Moreover, the number of permanent faculty positions available and the success rate of NIH grants was on the decline, making it even more difficult for new scientists to launch their independent researcher careers. NCMRR staff continues to provide support for new investigators through formal workshops, training meetings, and personal contacts by phone; the Board encouraged increased administrative support for NCMRR staff to attend diverse profession meetings to attract and support new medical rehabilitation researchers who deal with some of the unique issues in this field. The Board discussed potential limits to growth and the need to maintain appropriate diversity and perspective in the research community, including the balance between support for training and career-development mechanisms and smaller research grants versus larger clinical trials and basic research studies. The Board also noted that the NIH should also support training and mentorship in non-traditional environments such as small businesses engaged in innovative research and product development and in appropriate clinical and university settings that may not necessarily have a large base of NIH research grants. Participants also indicated that the NIH should also support candidates who were seeking to work in non-traditional research environments and in alternative career tracks.
Topics for future Board meetings included a discussion of staff availability at meetings, assessing NCMRR impact in both the short-term and long-term, NCMRR outreach and electronic publications, and publication of the Institute of Medicine report on Disability in America.
The meeting was adjourned at 12:05 a.m.