National Advisory Board on Medical Rehabilitation Research (NABMRR)
National Center for Medical Rehabilitation Research (NCMRR)
National Institute of Child Health and Human Development (NICHD)
December 3-4, 2007
Dr. Diana Cardenas, Board Chair, called the 36th meeting of the NABMRR to order at 9:00 a.m. Minutes from the previous meeting were approved.
Future Board Meetings
May 1-2, 2008
December 1-2, 2008
May 7-8, 2009
Members Present
| Kimberly Anderson Martha Banks Diana Cardenas Leticia Castillo Lynn Gerber Ken Giacin |
Murray Goldstein Richard Greenwald Joy Hammel Lisa Iezzoni Alan Jette Linda Robinson |
Marcia Scherer Marca Sipski Margaret Turk Gale Whiteneck Carolee Winstein Steven Wolf |
Members Absent
None
Ex-Officio Members Present
| Duane Alexander, NICHD Robert Jaeger, NSF Naomi Kleitman, NINDS |
Amy Donahue, NIDCD Patricia Dorn, VA Art Sherwood, NIDRR |
Mark Swanson, CDC Michael Weinrich, NICHD Rosemary Yancik, NIA |
Ex-Officio Members Absent
| Martin Gould, NCD Kathy Mann Koepke, NINR |
Anne O'Mara, NCI James Panagis, NIAMS |
NICHD Staff and Visitors
| Beth Ansel Karen Casey Alberto Esquenazi (MossRehab) Rosemary Filart (NCRR) Marc Goldstein (APTA) JoAnne Goodnight (OER) Tammara Jenkins Lisa Kaeser Danuta Krotoski |
Sheila Lambowitz (CMS) Johnalyn Lyles Carol Nicholson Ralph Nitkin Josephine Pelham (CSR) Berengère Poletti (France) Louis Quatrano Al Wigmore Michelle Rodrigues (SRI) Mona Rowe |
W. Scott Selbie (C-Motion) Carol Sheredos Nancy Shinowara Peter Thomas (PPSV) Biao Tian (CSR) Janice Wahlmann |
INTRODUCTIONS AND UPDATE ON MEMBER ACTIVITIES
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:
Steven Wolf served on the faculty for the annual NCMRR-sponsored Enhanced Rehabilitation Research in the South (ERRIS) grantwriting workshop and helped in the biennial NCMRR training workshop, which took place at the annual meeting of the American Congress for Rehabilitation Medicine (ACRM) and American Society for Neurorehabilitation (ASNR) in Washington, D.C in October 2007. He also worked with Marc Goldstein to increase research awareness and resources in the American Physical Therapy Association (APTA).
Marcia Scherer made presentations at international meetings on disability and assistive technologies. She continues her work with the Assistive Technologies Section of the World Health Organization.
Rick Greenwald has continued his studies on head injury, collecting data on 430,000 head impacts among football players as well as focusing on gender differences in sports injuries. He is also starting collaborations with the military to assess the impact of head injuries in combat. His company is also developing a device to help as assess falls among the elderly.
Lynn Gerber is directing the Center for Study of Chronic Illness in Virginia. She is setting up a new Ph.D. program in rehabilitation sciences that focuses on the relationship between chronic illness and disability. She is collaborating with NIH intramural programs and Inova Hospital to study the role of exercise in pulmonary hypertension. She was also cited her role as former Chief of Rehabilitation Medicine at the NIH Clinical Center.
Murray Goldstein remains active in his "retirement". He discussed his past efforts to work with the Traumatic Brain Injury Association to address injuries in school sports. He continues his efforts to promote a Middle East cerebral palsy study, which brings together Jordanians and Palestinians to contrast effectiveness of high-tech and village-based treatment strategies. The U.S. Department of State is interested in expanding the study to include Morocco.
Joy Hammel is working with the American Occupational Therapy Association on basic competencies for delivering assistive technologies and rehabilitation as well as promoting an evidence-based review of disability research. She is also involved in a National Institute for Disability and Rehabilitation Research (NIDRR)-funded center in Chicago and has participated in various meetings, including a summit on disabilities and the State of the Science on Aging with Cognitive Disabilities. She is the Executive Director of the Society for Disability Studies and continues her work to increase the accessibility of research findings.
Martha Banks conducted a workshop on neuropsychological batteries that focused on the practical interview. She is co-editing a three-volume set on international perspectives on disability (including the perspective of indigenous women). She is active in the American Psychological Association, particularly in the area of anti-violence planning and disability perspectives. She was recently elected president of the Society for Psychology of Women.
Linda Robinson is involved in the rehabilitative care of children at Inova Hospital, especially protocols for the care of children with traumatic brain injury (TBI). She is also involved with the impact of injuries and rehabilitation for soldier returning from deployment.
Kim Anderson is doing research at the Reeve-Irvine Research Center with a particular focus on the molecular and cellular neuroscience of spinal cord injuries (SCI) in animal models. She is also doing studies on arm and hand assessments and outcome measures and is interested in defining rehabilitation priorities for people with SCI. She is also on the board of directors for the World Spinal Society.
Marca Sipski is finishing her term as president of the American Spinal Cord Injury Association. She is promoting efforts to partner with other professional SCI organizations and government groups. She is reviewing outcome measures for SCI and should be publishing an article on autonomic standards for SCI in 2008. Her own research is on sexual function in multiple sclerosis and SCI and she also has a NIDRR project on bladder sensation. In addition, she is involved in efforts to promote patient participation in clinical trials.
Gale Whiteneck is director of research at Craig Hospital. His research focuses on outcome measures for "participation". He is putting together a large study to examine what elements of the rehabilitation process have the most impact on the lives of people with disabilities.
Through his company, Ken Giacin is working to promote the use of umbilical cord stem-cell transplants to treat hematopoietic disorders. This work includes international collaborations with India and Taiwan as well as a contract to build a national inventory of stem cells in the United States. His company is also exploring the potential of stem cells for improved wound healing (e.g., ulcers).
Alan Jette is developing a functional outcome tool for SCI using computer-adapted testing strategies. He has an NIH grant for a randomized control trial of post hip fracture outcomes, which relates to a recent NCMRR workshop to develop A Research Agenda for Getting beyond the Plateau: Promoting Recovery through the Chronic Phase, in which he participated. He has been very active in promoting the recent Institute of Medicine report on the Future of Disabilities in America. He is also collaborating with the Karolinska Institute in an effort for support non-medical scientists in doing research on disability. He gives adaptive ski lessons to people with disabilities.
Carolee Winstein has attempted to promote rehabilitation research interests during the academic reorganization at the University of Southern California. She is developing a research proposal on post-traumatic stress disorder and TBI in returning veterans; the effort will involve collaborations across several institutions and specialties. She is also involved in the use of innovative therapeutics (e.g., robotics and virtual reality) in rehabilitation and organized a recent research meeting in Israel. She will be serving as the facilitator for an APTA research summit on cerebral palsy and she is collaborating on a phase three clinical trial on stroke rehabilitation.
Peggy Turk is active in the NCMRR-sponsored K12 program that supports career development of physiatrist researchers and is particularly involved in the effort to expand the program into pediatric rehabilitation. She is co-editing the journal Disability and Health.
Lisa Iezzoni deferred her comments because she was scheduled to lead a discussion later in the meeting. (However, her presentation had to be postponed until the May 2008 meeting.)
Leticia Castillo is an advisor for the NCMRR Pediatric Critical Care and Rehabilitation Program. Her own research is focused on nutritional requirements for children with disabilities, particular with respect to proper weight management, energy requirements, and unique caloric needs. She is working with clinical colleagues to improve nutritional standards.
Diana Cardenas is working as chair of her academic department to continue support for clinical residents. She is co-editing a textbook on SCI, which should be published in 2008. She is serving on the Research and Residency Committee of the Accreditation Council for Graduate Medical Education and is working to increase research on musculoskeletal issues. Her own research continues to focus on SCI and TBI, particularly in the area of pain perception, upper extremity function, and urinary tract infection. She is also working on the NCMRR-sponsored K12 program that supports physiatrist researchers.
NICHD DIRECTOR'S REPORT
Dr. Duane Alexander indicated that the NIH budget will be slightly more than $29 billion, a very slight increase over the previous year. The budget for the NICHD will be $1.254 billion, likewise slightly above the level of previous years. With a relatively large cohort of on-going grants coming to a close, the NICHD may be able to support more than 500 new and competing grants and could maintain a percentile payline in the mid-teens. The President proposed a small increase in the NIH budget that was also supported by Congress; however this increase will not quite match the three-percent inflationary rate. The NIH appropriation included $69 million for the National Children's Study (NCS), but commitments for future years are still under negotiation. Until the overall NIH budget is actually approved, the NIH will continue operating under a continuing resolution.
The Board asked what the NICHD would do if the specific funds for the NCS were not included in the new NIH budget. Dr. Alexander indicated that one-third of the research sites have already been activated but that the budget may curtail these efforts. He noted that there has been congressional support for the NCS that led to appropriation of additional NIH funds in past years. In response to another question, Dr. Alexander indicated that the NCS cohort would include children with disabilities, but added that this will be strictly an observational not interventional study, although it would have the possibility of referrals into specific trials.
Dr. Alexander also discussed the Pediatric Medical Device Act, which was bundled together with drug research initiatives and passed by Congress. According to this legislation, drug companies will have to do research to demonstrate the relevance of their product for pediatric populations, but oversight would mainly be the responsibility of the Food and Drug Administration (FDA). Within the NIH, it is unclear which Institute will take the lead on device research, but likely choices include the NICHD, National Institute of Biomedical Imaging and Bioengineering and the National Heart, Lung, and Blood Institute.
The Board asked if the NIH would be tracking the effect of funding reductions on research careers. Dr. Alexander indicated that Congress is supporting changes in reporting requirements to better follow the impact on individual careers. The Board also asked how the NIH tracks rehabilitation research and how it fits in NIH director Elias Zerhouni's current initiatives. Dr. Alexander responded that rehabilitation was included among the list of more than 340 categories routinely reported to Congress and that Dr. Zerhouni is especially interested in promoting interdisciplinary research. Dr. Alexander also highlighted NICHD support for a new K12 career development program in applied health, new T32 departmental training grants, and multidisciplinary project initiatives.
NCMRR DIRECTOR'S REPORT
Dr. Michael Weinrich indicated that NCMRR funding in the past year was $75 million, similar that of the last two years. For the past year, the Institute payline for R01 grants was at the 15th percentile, but smaller R03 and R21 grants were supported to the 20th percentile. In order to maintain reasonable support for investigator-initiated proposals, the Institute has reduced the number of set-aside research initiatives (e.g., Requests for Applications). With NICHD paylines improving relative to those of other NIH institutes, the NCMRR has been able to reclaim a few projects that had been shifted to other institutes during leaner budgetary times.
Dr. Weinrich introduced two new national career development programs, which are being supported through the K12 mechanism. The new programs support mentored research for allied health professionals who are committed to research careers.
Restrictions on the NIH research management and support budget continues to limit staff travel and the number of NCMRR-sponsored meetings. During the past year, the NCMRR was only able to support three meetings: Medical Home Model for Life-threatening Illness; A Research Agenda for Getting Beyond the Plateau: Promoting Recovery through the Chronic Phase; and the biennial NCMRR training workshop (held at the ACRM-ASNR meetings). Despite administrative restrictions, NCMRR staff continues in their efforts to brainstorm with applicants, collaborate with other agencies, meet with professional and advocacy groups, and advance medical rehabilitation research.
In response to a question about the TBI clinical trials network, Dr. Weinrich indicated that NCMRR was not going to re-compete the network in the current form but was talking with the National Institute for Neurological Disorders and Stroke (NINDS) about other approaches to support TBI research. The Board asked about rehabilitation research efforts on the intramural side. Dr. Weinrich responded that in the past, the NICHD had collaborated with the NIH Clinical Center to support a clinical disability center, but the Clinical Center had decided to explore other ways to support rehabilitation services in the intramural program.
Dr. Weinrich concluded by reminding the Board that the NCMRR is developing a new slate of nominees for the Board and welcomes suggestions for scientific and public people with a commitment to medical rehabilitation research.
ANALYSIS OF THE NCMRR RESEARCH PORTFOLIO
Tammara Jenkins and Johnalyn Lyles provided an update on their attempts to define the proportion of "intervention" research supported by the NCMRR. To define clinical trials, they deferred to the NIH definition, which refers to research in which human subjects are assigned to receive specific interventions. Using this definition, they analyzed the NCMRR research portfolio. They found that "interventional" proposals had roughly the same success rates as other proposals research proposals submitted to the Center. They noted some studies in animal models that sought to refine clinical practice and perhaps those studies should also be considered part of the NCMRR interventional research portfolio. Although the Board was satisfied with the proportion of interventional research supported by the NCMRR, they wondered if there was a need to further analyze the types of interventional research proposals coming into the Center. They also considered the possibility of stratifying interventional research by the level of analysis (e.g., pathophysiology, impairment, function, or disability).
PROSTHETICS AND ORTHOTICS: FROM ENGINEERING TO REHABILITATION MEDICINE
Dr. Alberto Esquenazi, former Board member, provided some personal perspectives from his work as a clinician and researcher. Patients in his gait clinic place a high priority on walking. Improved mobility has obvious implications for reducing financial burden, institutionalization, and dependency on external resources. The gait lab is equipped with multiple cameras to provide serial images of the gait pattern, which provide additional and more relevant information than could be obtained from clinical observation alone. The lab provides accurate and repeatable measures of several key aspects of natural gait performance, including joint motion, forces, walking speed, all of which can be combined with electromyographic measurements of specific muscles. By looking for discoordination problems or abnormal muscle activation patterns, the clinician can determine the root cause of gait abnormalities and design therapeutic strategies to improve mobility. Treatments might include some mixture of exoskeletal devices, Botox® injections, stretching, casting, or even tendon surgery.
Research has demonstrated that clinical observation alone does not lead to an accurate or reliable diagnosis. A study of rehabilitation surgeons revealed significant variation among the treatments recommended for given gait abnormalities based on clinical observation alone. Dr. Esquenazi also pointed out that sometimes it is better to work with abnormal gait dynamics rather than recommending major surgical interventions based on visual assessment alone, especially if the gait provides functional mobility for that individual.
FRENCH PERSPECTIVES ON THE CONTRIBUTION OF SCIENCE AND TECHNOLOGY TO THE FIELD OF DISABILITIES
Ms. Berengere Poletti, a member of the French Parliament with a particular interest in disabilities, met with the Board as part of her visit to the NIH. Speaking through a translator, she indicated that she is particularly interested in what science and technology offer to improve the lives of people with disabilities. She is also interested in the political pressures that shape choices and opportunities for these people. France provides "human aid" but does not provide support for technological assistance. Because France lacks the appropriate expertise, Ms. Poletti is looking outside the country to develop the necessary collaborations to promote assistive technologies.
Currently, each French worker annually provides the equivalent of one day's pay to a national disabilities fund. However, the government is only now realizing the complexity of the problem with respect to the types of disabilities and levels of disability in the French population. During her recent travels, Ms. Polletti was very impressed with the Defense Advanced Research Projects Agency research on brain-controlled movements of prosthetic limbs and with attempts in Holland to develop a special village supporting people with disabilities.
The Board indicated to Ms. Poletti that in the U.S. rehabilitation research is often driven by support for war victims. They also highlighted the concept of "universal design", which is an attempt to make the environment more friendly to people with disabilities. Individualized adaptations are also needed and often involve low-cost modifications to overcome every-day barriers. The Board also stressed the need to focus on children with disabilities. Overall, investments to support people with disabilities enable them to get back to work, and provide reductions in health burdens, and have much broader economic and political benefits. The Board encouraged Mr. Polletti to include people with disabilities in the decision-making process.
MAKING ASSISTIVE TECHNOLOGIES MORE APPROPRIATE FOR PERSONS WITH DISABILITIES
The Board had a group discussion to advise the NCMRR on better ways to support assistive technologies. Given that the NIH is involved in research and not in health policy, the discussion centered on improving the design of assistive technologies, improving access, and providing useful, relevant solutions that do not end up in the closet.
Dr. W. Scott Selbie, a rehabilitation researcher and small business operator, provided some background on an NCMRR initiative that he took on to develop a web-site that would provide feedback on assistive devices, off-market products, and home-grown solutions for people with disabilities. The site was supposed to promote interaction among consumers and their families, rehabilitation engineers, and marketers. Although there are grass-roots organizations that already work in this area for specific audiences, they were reluctant to cooperate with the NCMRR project. Dr. Selbie also pointed out that there are potential liability issues with providing information on unsupported products. Most assistive devices are promoted commercially, so the web-site would also have to deal with manufactures.
The Board discussed the need for a universal dataset to better understand the needs of people with disabilities and current application of assistive technologies. Some efforts are already underway, including the European Physiome Project. The Board also discussed the need for uniform evaluation and functional criteria. For example, WheelchairNet is a virtual community and organization built by people with disabilities to evaluate wheelchair products and Rehabilitation Engineering and Assistive Technology Society of North America (RESNA) and American National Standards Institute (ANSI) have collaborated to develop wheelchair standards. The Board felt that perhaps it was more appropriate for public organizations rather than governmental agencies to take on the role of creating consensus rather than governmental agencies. However, it would be more complex to evaluate technologies for cognitive rehabilitation. The Board also mentioned NIDRR's efforts to support rehabilitation engineering centers.
The Board concluded that there is a need for more research on understanding consumer needs. Priorities include the development of simple, durable devices with adequate consideration of safety and liability issues. Quality, relevance, and impact should be determined by the users. Research should consider not just the needs of the consumer but also the environment in which the device would be used. Continued technological advances provide new opportunities to support people with disabilities but may push other devices into obsolescence.
FROM BENCH TO MARKETPLACE: NIH SUPPORT OF SMALL BUSINESS RESEARCH
Jo Anne Goodnight, NIH Office of Extramural Research, provided some background on the Small Business Innovative Research (SBIR) program and its special relevance for supporting medical rehabilitation research. Currently 11 different federal agencies participate in the SBIR program. The program was developed 25 years ago through a government partnership with small businesses to develop solutions to real problems that affect real people. The program stimulates technological innovation, uses small businesses to meet federal research and development (R&D) needs, fosters participation of minorities and disadvantaged persons, and increases private-sector commercialization of innovations derived from federal research.
Ms. Goodnight indicated that SBIR studies are divided into three phases. Phase one supports feasibility or proof-of-concept studies. For this phase, the NIH typically offers six-month grants of $100,000 or one-year grants within the Small Business Technology Transfer Research (STTR) program. Phase two supports the full R&D endeavor and a commercialization plan is required. For this phase, two-year grants for $750,000 are offered. Phase three is the commercialization, but SBIR/STTR funds are not provided for this phase.
SBIR/STTR eligibility rules specify that the business must have 500 or fewer employees and be majority US owned. The NIH appropriation directs 2.5 percent of the funds to SBIR programs and 0.3 percent to STTR programs. While SBIR grants are centered at small businesses, STTR grants support collaborations between a small business and a U.S. research institution. Intellectual property agreements are required for STTRs, but not for SBIRs, even though the majority of SBIRs also involve academic collaborations. At the NIH, success rates for phase-one SBIR and STTR applications in fiscal year 2006 were both about 20 percent, while successful phase-one applicants who went on to phase-two projects had success rates of 41 percent and 26 percent, for SBIRs and STTRs, respectively.
In recent years, the number of SBIR and STTR applications has been dropping. The reasons for the decline are not fully understood. Some factors may relate to firms no longer being eligible, firms not seeing incentive opportunities, or firms not taking advantage of the opportunity to revise and resubmit twice. Some NIH Institutes have incorporated the SBIR mechanism into specific research initiatives to be more in line with the contract mentality familiar to the small business community.
Ms. Goodnight concluded with an assessment of the impact of the SBIR program. From 1992 to 2001, the number of SBIR awards resulting in FDA-approved products increased by 51 percent and the cumulative sales of SBIR products increased by more than 200 percent reaching a total of almost $2 billion. The NIH created the Performance Outcomes and Data System, a special database to track outcomes of SBIR and STTR grants. The NIH also offers technical assistance with manufacturing and commercialization. In addition, a Pipeline to Partnerships was created to showcase technologies, promote collaborations, and enhance connections to venture capitalists. Ms. Goodnight concluded by highlighting some SBIR products specifically in the area of medical rehabilitation.
CONCLUDING BUSINESS AND AGENDA FOR NEXT MEETING
Dr. Liza Iezzoni's presentation on Disparities in Health Care for Persons with Disabilities got moved from this meeting and would be a priority for the May 2008 meeting. Future topics include a presentation on the intramural rehabilitation program on the NIH campus; developing a lexicon for "rehabilitation" and what it means to the research community as well as the public; and additional follow-up on the Institute for Medicine report Future of Disability in America. The Board suggested the formation of a couple of subcommittees to discuss the meaning of rehabilitation and to help the NCMRR evaluate its research portfolio and impact. It was also suggested that it may be more useful to have the NICHD Institute director, Dr. Alexander, meet with the Board on the second morning rather than on the first day.
The meeting was adjourned at 11:45 am.
| ________________________ | ________________________ |
| Ralph M. Nitkin, Ph.D. Date | Diana Cardenas, M.D. Date |
| Executive Secretary, NABMRR | Chair, NABMRR |
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