Dr. Rebecca Craik, Board Chair, called the 21th meeting of the National Advisory Board on Medical Rehabilitation Research to order at 9:00 am. Members of the Board, Ex-officio members, and visitors were invited to introduce themselves.
Dr. Duane Alexander, Chairman, National Advisory Child Health and Human Development Council, and Director, National Institute of Child Health and Human Development, presided.
Dec. 4-5, 2000May 7-8, 2001Dec. 3-4, 2001
Dr. Duane Alexander indicated that the National Institute of Child Health and Human Development (NICHD) budget increased by 14.6 percent which was similar to the overall National Institutes of Health (NIH) increase. While total NICHD funds increased from $750 million to $860 million, the National Center for Medical Rehabilitation Research (NCMRR's) share increased from $26.9 million to $31.5 million. In the current round of budget negotiations, the president is proposing a 5 percent increase for NIH, while Congress is suggesting increases of 15%. NIH is currently wrestling with guidelines for stem cell research and gene therapy. The NICHD has just completed a comprehensive plan to address the issues of health disparities among certain populations.
Dr. Harold Varmus has resigned from NIH to become President and Chief Executive Officer of the Memorial Sloan Kettering Cancer NCMRR. Dr. Ruth Kirschstein, Deputy Director of NIH and former Director of the National Institute of General Medical ScienceNIGMS, was named Acting Director of NIH. She immediately recruited NICHD's own Dr. Maddox to a temporary detail as Acting Deputy Director, NIH; during this time, Dr. Maddox's NICHD responsibilities will be delegated to other senior staff at the Institute. NICHD recently named Mr. Thomas Hooven to serve as Associate Director for Administration, NICHD, and Dr. Laurence Stanford was recruited from the National Institute of Mental Health to lead the Division of Scientific Review at NICHD. The position of Scientific Director for NICHD remains open.
Dr. Alexander was pleased to introduce Dr. Michael Weinrich as the Director of the NCMRR. Dr. Weinrich was a professor of neurology at the University of Maryland Medical School and acting chief of physical medicine and rehabilitation at the Baltimore Veterans Administration Hospital. He also served as medical director of Montebello Rehabilitation Hospital and medical director for rehabilitation at Kernan Hospital, both in Baltimore. He is a leading researcher in the area of computer-assisted rehabilitation strategies for stroke and brain-injured patients, with a particular emphasis on aphasia (acquired language problems). Recently, he spent a year working with congressional staff on Medicare legislation.
Dr. Weinrich began by introducing Dr. Beth Ansel, who had just joined NCMRR as the Director, Clinical Practices (CP) Program, after several years' experience at the National Institute on Deafness and Other Communication Disorders, NIH. Dr. Ansel has clinical experience in the evaluation and treatment of communication disorders and will assist the NCMRR in both pediatric and clinical initiatives.
Because of his recent experiences on Capitol Hill, Dr. Weinrich provided some background on the support of rehabilitative treatments through Social Security and Medicaid. In 1997, caps were imposed to limit the reimbursement of outpatient medical rehabilitation. This highlights the need to demonstrate and document the efficacy of rehabilitation treatments. Research must discard practices that are not helping and improve those that work. This is a time of new opportunities and approaches in research, including collaborations with other federal funding agencies.
Dr. Weinrich highlighted upcoming NCMRR initiatives in traumatic brain injury (TBI), regional research networks, and pediatric rehabilitation. In the ensuing discussion, Board members urged NCMRR not to restrict the TBI initiative to external insults on the brain, but to also include acquired brain disorders such as anoxia (lack of oxygen) and cancer. In the area of outcomes research, NCMRR should stress the potential cost benefits of effective rehabilitative therapies. For example, there is good data on the economic benefits of interventions for heart disease and pediatric disorders such as phenylketonuria and hypothyroidism. NMCRR must also promote clinical trials to optimize the timing, intensity, and duration of rehabilitative therapies. Currently, the NCMRR supports funding for pilot clinical studies and clinical-trial planning grants, and recently applications were received for medium-scale clinical trials in such areas as pain management, treadmill-assisted walking for spinal cord injury, pharmacological treatments for depression in brain injury, and enhancing bladder function in spinal cord-injury. While controlled, double-blind clinical trials have become the gold standard for documenting efficacy, the ethics of withdrawing rehabilitative care from affected individuals in the "control" group needs to be carefully considered.
Dr. Ralph Nitkin provided some data on the number and success of NCMRR research applications. From fiscal year 1992 through 1999, annual NICHD expenditures on NCMRR projects have increased from $7,269,763 to $26,847,352. Although, this may seem like a small percentage of the Institute's extramural budget, NICHD has several diverse interests, and NCMRR's share has been increasing steadily from 1.7 percent in fiscal year 1992 to 4.4 percent in fiscal year 1999.
From the start, the NCMRR has made a strong investment in training and career development, and currently supports about 15 institutional training grants (T32s) and a number of individual career awards (K01, K08) to support clinically-trained researchers in the area of medical rehabilitation. Therefore, the special role of bioengineering and product development in the rehabilitation community, NCMRR has done particularly well with the Small Business Innovation Research Grant mechanism.
Although, the total number of R01 applications to NCMRR has leveled off, there has been a shift from those responding to the special initiatives of the earlier years to more investigator-initiated applications. The success rate for NCMRR applicants is similar to that of other parts of NIH (around 25 percent). Dr. Nitkin discussed some of the NIH peer-review groups that typically evaluate applications for NCMRR in order to show that they have the appropriate neurobiological, behavioral, bioengineering, and/or social science expertise and would be sympathetic to the programmatic interests of the Center. Nonetheless, more NCMRR applications would justify a larger medical rehabilitation presence among the peer-review panels of NIH.
It should also be noted that NICHD has an Institute-wide payline for investigator-initiated applications; therefore, the Institute's commitment to NCMRR research is partly driven by the number of good applications that NCMRR receives. The NCMRR needs to continue promoting research opportunities and encourage the development of quality applications. NCMRR staff remains ready to work with new investigators to develop focused research proposals and better the NIH system.
Dr. Louis Quatrano discussed a trans-NIH meeting on mobility, which stemmed from NCMRR's role in highlighting medical rehabilitation research across the NIH Institutes. He also described an upcoming forum on measurement issues in children with disabilities. This forum, jointly sponsored with Exceptional Parent Magazine, will be part of the World Congress & Exposition on Disabilities, November 10-12, 2000.
Dr. Weinrich discussed a workshop on home ventilation as a model for the financing of medical rehabilitation therapies. He also presented some upcoming meeting topics: rehabilitation for stroke and hip fracture; rehabilitation in school-based settings for children with traumatic brain injury(TBI); and, issues in pediatric trauma and rehabilitation.
Dr. Nitkin presented a workshop on rehabilitation engineering solutions to develop a web-based resource for consumers, engineers, and entrepreneurs. The Board was very enthusiastic about this proposal, and urged him to involve appropriate professional societies and federal agencies. Dr. Nitkin also presented a conference on exercise physiology (underlying physiology, therapeutic exercise, clinical outcomes, and recommendations); the Board added such issues as sustainability, habit, support, compliance, and adaptation and felt that NCMRR should follow it up with a research initiative. Finally, Dr. Nitkin discussed a conference on pain as a secondary condition in persons with physical disabilities. The Board suggested additional syndromes and conditions that should be included.
At the last board meeting, a subcommittee of Drs. Florence Clark, Chukuka Enwemeka, and Ralph Nitkin were charged with developing a policy for future Board elections. The following recommendations were approved:
The Executive Secretary received the name of Dr. Stineman in nomination for Chair prior to the meeting; no other nominations were put forward at the meeting. Also, the name of Dr. Enwemeka in nomination for Chair-elect (although Dr. Enwemeka could not attend the meeting, the Secretary did confirm his interest in the position prior to the meeting). In addition, the names of Dr. Clark and Ms. June Kailes were put in nomination. Each of the candidates was allowed to make a brief statement prior to lunch, and the Secretary read a brief greeting from Dr. Enwemeka. Votes were taken after lunch; Dr. Stineman was elected Chair by acclaim, while Dr. Enwemeka was elected Chair-Elect by getting a majority on the first ballot.
Dr. Nitkin reviewed last winter's successful training workshop and thanked Board members for remaining in town to meet with the trainees and participate in the workshop. It was resolved to make the session on NIH grantsmanship a higher priority, and to have more of a focus on developing research projects and career trajectories. Moreover, the session should avoid conflicts with the students' finals week, if possible.
Dr. Weinrich introduced the discussion of the future of medical rehabilitation. This topic was the beginning of a broader discussion of re-evaluating the goals and research plans of NCMRR to determine whether they need updating. Particular scenarios (Visions of Rehabilitation 25 Years in the Future) that had been prepared by Board members were distributed, and the meeting moved out into breakout groups along the following lines: Research, Clinical Practice, and Rehabilitative Therapies and Reintegration. At the end of the afternoon, the entire Board reconvened so that each group could report on their discussions.
The Research group discussed potential cellular/molecular advances in gene therapy and cell replacement, as well as bioengineering advances in implantable and external devices. Rehabilitation's role will focus on maximizing function. Research will focus on coordinating multiple systems, both within the body and in the context of how we interact with the external environment. Related issues include maximizing desired plasticity, increasing geriatric demographics, and creating more personalized quality-of-life outcome measures. Because of the increasing population that will need rehabilitation, a much larger percentage of the NIH budget must be spent on research in this area. In an analogy to the automotive industry, while research cannot provide new bodies, it will be providing replacement parts.
The Clinical group discussed manpower and training issues, as well as the demands of new technologies. Reimbursement issues will still dominate, as acute care is shortened and rehabilitative settings become almost non-existent. There will be new alliances between the researchers and consumers. Clinicians will be treating a new cohort of older, sicker patients, who will need more rehabilitative care then ever. This will involve new environments, including assisted-living group homes with pooled resources to provide access to the best equipment. Methods will need to shift to a community-based model for the delivery of care. Policy advocacy will connect people, functions, physiology, and financial resources. Technology will not replace the need to dialogue with the patient, but virtual reality may be an interesting way to enrich the lives of certain individuals. Research will have to generate more evidence-based interventions.
The Rehabilitative Therapies and Reintegration group started with advances in transportation. Smart cars will allow persons with disabilities more mobility, and also greatly reduce auto accidents. Mobility aids will be replaced by hovercrafts. The smart toilet will provide nutrient analysis of urine and feces and will make adjustments to meal planning. There will be a confluence of basic science and ecological issues, to enhance a person's interaction with the environment. NIH will provide important policy input to enhance participation. Fitness centers will be rehab-sensitive; pressure ulcers will be eliminated. Behavioral approaches to enhance efficacy will become more prominent.
Therapies will be more focused on the individual, with concern shifted from the diagnosis to potential integration and enhanced participation. Information technology will move from disease to rehabilitation orientation. An Institute for Rehabilitation is needed to bring together fragmented groups (this was also highlighted in the Institute of Medicine report).
The following morning, Dr. Weinrich led a discussion of the future of medical rehabilitation. Technological and biomedical advances will allow more people to survive serious injuries and disorders, with the need for very specialized equipment. Demographics will be shifting our focus to older populations. The cost of not providing support will be greater than the cost of maintaining and maximizing function. Rehabilitation will need a new cohort of people with care-taking skills. Health care professionals will need to improve their communication skills to understand patient needs. The NCMRR will need to support more research, training of caretakers, and health care networking. For example, HCFA must discuss the needs and cost issues and the Department of Defense supports technologies that could also be applied to those with disabilities. Computers and other assistive technologies would facilitate participation. Clinicians should appreciate potential overlap in the research and treatment of geriatrics and pediatrics. Further, researchers must emphasize translational research and technology transfer, including adapting older technologies to rehabilitative applications.
The Board suggested various approaches for highlighting medical rehabilitation research, including a five-pointed star of self-care, locomotion, communication, social integration, and vocation; maximizing participation (linking people to their muscles, limbs, and community); technology for living; living with disability successfully; a "virtual" center for medical rehabilitation; technology development with defense contractors (they have the technology, NCMRR could supply the applications); and riding the wave of biotechnology and bioengineering. The NCMRR research portfolio should include both investments in reasonable risks and gambling money. Taking a lesson from the field of gerontology, medical rehabilitation research should not neglect behavioral approaches (e.g., impulse control, desire to participate, pharmacological and cognitive therapies).
Dr. Weinrich urged Board members to review the Research Plan for the National Center for Medical Rehabilitation Research; he posed the question: does it need to be updated? Perhaps the Board could consider a conference with the NIH's, Office of Medical Applications Research or a Technology Assessment Conference. NCMRR could present to the Board the current research portfolio: success and obstacles.
Carey O'Connor (phone: 202-690-7865 or Email: email@example.com) of HCFA made a presentation on the Ticket to Work Incentives Improvement Act of 1999 (HR1180), which was signed into law December 1998. The purpose is to demonstrate that people with disabilities can be productive members of the workforce if they have adequate supports including health benefits and services. The legislation supports five new Medicare/Medicaid programs: 1) 24 month extension of Medicare benefits when the individual first returns to work; 2) Medigap consumer protection; 3) special Medicaid eligibility categories; 4) continued coverage for those who medically improve; and 5) state input into income ceilings.
The legislation encourages state participation by encouraging them to submit applications for projects to improve Medicaid infrastructure (e.g., personal assistance, transportation, and vocational rehabilitation). Medicaid demonstration projects (new for HCFA) include both physical and mental impairment eligibility categories, with the states being allowed to choose the impairments and maximum number of patients covered. The first-year-budget it $42 million, with the states providing 50-70 percent matching funds. Researchers could apply for grants and demonstration projects 60 days after the initial announcement, which should be in mid-May 2000. States may also need help in developing their applications. The particular needs of children should be covered by similar solicitations through the Family Opportunity Act of 2000.
The following suggestions were made for the future agenda items (Dr. Stineman, presiding): research presentations by NCMRR investigators (perhaps drawing on expertise within the Board); roundtable discussion of how NICHD funding legislation and research priorities are developed (e.g., working dinner with legislative representatives and the Friends of NICHD advocates); update on the newly funded regional rehabilitation research networks; presentation from the NIH NCMRR for Complementary and Alternative Medicine; and development of a conference on outcomes measurement. Although, this is an ambitious agenda, the Board expressed its willingness to have the second day extend to 3:00 pm rather than end at noon.
As usual, there will be a special Sunday evening orientation for newly appointed members as well as curious older members. The Board suggested that the new appointees buddy-up with more experienced members. The Board looks forward to getting the chat room up and running, and encourages NCMRR staff to send out materials by both regular mail and e-mail.
NCMRR appreciates the efforts of the following Board members who have completed their terms: Mr. Buoniconti, Ms. Novotny, Dr. Perry, Dr. Salcido, Dr. Whitney, and especially Dr. Craik, who served as both Chair and special liaison to the NICHD Advisory Council. The Board heard parting comments from Drs. Craik, Perry, Salcido, and Whitney, and presented them with special certificates signed by the Director of NIH.
The meeting was adjourned at 12:00 pm.