National Advisory Board on Medical Rehabilitation Research (NABMRR)National Center for Medical Rehabilitation Research (NCMRR)National Institute of Child Health and Human Development (NICHD)May 3-4, 2007
Dr. Diana Cardenas, Board Chair-elect, called the 35th meeting of the NABMRR to order at 8:30 a.m. Minutes from the previous meeting were approved.
December 3-4, 2007May 1-2, 2008December 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:
Steven Wolf participated in an NCMRR-sponsored workshop, Getting Beyond the Plateau. As the Catherine Worthington fellow, he gave a keynote talk at the American Physical Therapy Association (APTA) on interventions in neurorehabilitation, in which he made a special effort to highlight some NCMRR-sponsored research activities.
Alan Jette has been traveling around the country providing briefings on the Institute of Medicine (IOM) Report, The Future of Disability in America (discussed in more detail later in the meeting). He has also been organizing a new Masters program at Boston University focusing on disability in public health.
Zev Rymer was actively forging links between the health sciences and engineering researchers. He also took part in a major initiative to develop new upper-limb prosthetics that was sponsored by the Defense Advanced Research Projects Agency (DARPA) in the U.S. Department of Defense.
Murray Goldstein continues to participate in an international effort to update the definition and classification of cerebral palsy. The initial consensus was published in the journal Developmental Medicine and Childhood Neurology. He also highlighted a special effort to support cerebral palsy clinical trials across the Middle East, with a focus on approaches appropriate for home therapy and desert environments.
Martha Banks gave a workshop on victim services and domestic violence, which was sponsored by the Brain Injury Association of Wyoming. She has collaborated on similar projects in the Boston region.
Joy Hammel was working with occupational therapists on the role of therapists in promoting participation and with Rehabilitation Engineering and Assistive Technology Society of North America (RESNA) to develop national competency requirements in the area of technology and environmental support. Her work is exploring rehabilitation outcomes in post-acute settings and she recently participated in an Agency for Healthcare Research and Quality (AHRQ) summit, Health Homes for People with Disabilities.
Carolee Winstein has been involved in the reorganization of departments involving rehabilitation research and allied health departments at the University of Southern California (USC). She participated in an APTA initiative to support junior researchers and is working with junior colleagues at USC to address rehabilitation issues in cancer (a topic that was discussed at a previous Board meeting).
Marcia Scherer reported that the University of Rochester is developing an NIH-funded center for translational research. She is also participating in a rehabilitation technology training program at Cornell University. She contributed data to the World Health Organization (WHO) International Classification of Function (ICF) and is continuing her research on the outcomes of assistive technology. She is active in an American Congress of Rehabilitation Medicine (ACRM) effort to push for independent institute status at the NIH for medical rehabilitation. She is also collaborating with fellow Board member, Martha Banks, on activities at the American Psychology Academy and edits the Journal for Rehabilitation Technology.
Richard Greenwald is working on an NIH biomedical research proposal (BRP) on the biochemical basis of traumatic brain injury (TBI) with a particular focus on sports injuries. The project has received significant public attention especially from the National Football League. He is working with the American Academy of Orthotics and Prosthetics to foster the development of young investigators.
Ken Giacin continues to work though his company StemCyte® to promote access to stem cells derived from umbilical cord blood (as highlighted later in the Board meeting). Collaborations now extend into 25 countries. He is also working with the Health Resources and Services Administration within the U.S. Department of Health and Human Services (DHHS) to build a national inventory of stem cells, especially cell lines that would be antigenically appropriate for minority populations. He is also developing collaborations with the National Children’s Medical Center in Washington, D.C.
Linda Robinson continues her work in trauma research, especially in the area of acute support. She is developing a program to promote self-management for trauma patients. She worked with the Brain Trauma Foundation to develop recommendations for pre-hospital intubation in the treatment of TBI. She is also involved in studies to explore TBI outcomes in automotive accidents involving pedestrian injury.
Leticia Castillo has been doing research on metabolic and energy requirements in critical illness. She indicated that there is a need to re-evaluate WHO standards for the nutritional requirements of critically ill children. She is also involved in the planning of state programs to prevent child abuse.
Margaret Turk has been active in the NCMRR-sponsored Rehabilitation Medicine Scientist Training Program, which supports emerging clinical researchers in rehabilitation medicine and noted that she has been quite impressed with the young residents supported by this program. She participated in a DHHS meeting on Health Care for People with Disabilities and is working with two new rehabilitation journals to provide special support for pediatric issues.
Lisa Iezzoni participated in a DHHS meeting on Barriers to Women with Disabilities. She has been active in advocacy for people with disabilities within the Boston area and cited recent efforts to improve access to mammography; unfortunately, she added, the newer digital mammography machines are actually less accessible for people with disabilities.
Diana Cardenas continues her research on urinary tract infections among people with spinal cord injury. In Miami, she became chair of a new department, which provides opportunities to support new faculty and promote rehabilitation research. Like Dr. Turk, Dr. Cardenas has been active in the NCMRR Rehabilitation Medicine Scientist Training Program and is particularly impressed with the quality of the candidates and the commitment of their mentors. She also discussed an initiative to support rehabilitation for military personnel.
Dr. Michael Weinrich, NCMRR Director, began by introducing Johnalyn Lyles who recently joined the NCMRR as a program analyst. He explained that the NIH is undergoing a comprehensive review of the way that it classifies grants with respect to diseases and conditions. Currently, each NIH Institute and Center has its own way of classifying grants, making it difficult standardize information across the entire NIH. The new system being developed has a more objective classification strategy, based on the use of knowledge-management approaches and key-word strategies.
He added that paylines across the NIH are generally improving. Within the NICHD, paylines for R01 grants have increased about 5 percentile points from about 10 to about 15. In an effort to support especially innovative approaches and newer investigators, paylines for R21 exploratory research grants in the NICHD increased to the 20 th percentile to match that of R03 pilot grants (these are both shorter-term grant mechanisms). The NICHD worked to maintain support for career development grants (K awards), but funding for departmental training grants (T32 awards) is especially tight.
In the past, the Advisory Board has recommended support of national career development programs in medical rehabilitation, a suggestion that led to successful programs for physiatrists and later for pediatric critical care researchers using the K12 mechanism. The NCMRR recently developed a special initiative to support career-development programs in the domains of allied health, rehabilitation engineering, and neurorehabilitation. Unfortunately, the Institute did not receive successful applications in the latter two domains and decided to use the funds to support two outstanding programs in the area of allied health.
Dr. Weinrich briefly discussed an effort to support rehabilitation research activities on the NIH intramural campus. In 2000, the NICHD began collaborating with the Clinical Center to build infrastructure and support rehabilitation researchers. However, unilateral changes by the Clinical Center in recent years have led to the cessation of these activities.
Dr. Weinrich also explained that the NCMRR has been trying to respond to an IOM recommendation for improved collaboration among federal agencies. For example, the Center continues to participate in the Interagency Committee on Disability Research. Another positive step is that Dr. Michael Selzer, a rehabilitation researcher who currently directs one of the NCMRR infrastructure networks, took over as the Director of Research and Development in the Veterans Administration. A Department of Defense initiative on blast injuries led to an NIH workshop on head injury with follow-up workshops at national meetings.
Dr. Weinrich also described the NCMRR’s continued support of a TBI clinical trials network. The network is developing its first trial, which will focus on the use of CDP-choline to promote functional recovery. Although the NCMRR remains committed to supporting TBI research, it decided not to renew the clinical trials network beyond the current five-year funding period because of difficulties managing network activities and integrating them with other NIH research efforts.
The NCMRR biennial training and career development workshop will be coming up this fall, and the Center is trying a new model in order to reduce costs and leverage resources. The workshop will be held as an adjunct to a national rehabilitation meeting that happens to be meeting in the Washington D.C. area. This year the NCMRR is working with the American Congress of Rehabilitation Medicine (ACRM) and the American Society for Neurorehabilitation (ASNR) to hold the training workshop at their annual meeting in early October.
Dr. Duane Alexander discussed the NIH budget. He described a particular emphasis on providing support for new investigators as well as bridge funding for investigators who have a single grant, which they are in the process of renewing. The NIH had support from both the House and Senate in the 2008 appropriation hearing. Congress provided $69 million for the National Children’s Study (NCS) allotted to the NIH director’s budget in order to emphasize the trans-NIH, trans-governmental nature of this effort. The NCS supports a data center and 107 data-gathering sites. NCS awards in 2007 will provide continued support for seven Vanguard sites along with funding for 30 new sites. Families will be recruited to the NCS before pregnancy in order to gather relevant data on environment, community, family, and other factors; a special effort will be made to include children with developmental and acquired disabilities.
Dr. Alexander also explained that the NIH Reform Act directs the NIH to centralize activities (e.g., Roadmap) to overcome obstacles to the integration of basic, clinical, and translational research. The NIH will create new internal committees and workshops to facilitate the convergence of planning activities. Medical rehabilitation was highlighted in the public hearings, with a particular mention of prosthetic devices. The NICHD will be working with the Food and Drug Administration on such issues as pediatric medical devices, user fees, Best Pharmaceuticals for Children Act, and the Pediatric Medical Device Safety and Improvement Act.
The Advisory Board had a lively discussion with Dr. Alexander on some additional issues. He indicated that current initiatives involving pediatric medical devises are intended to provide support for non-profit companies and to encourage activities in areas without immediate commercial incentives. He added that the NICHD remains interested in promoting basic and applied research in instrument development and is already supporting projects on heart valves, ambulation, and diabetes control, as well as collaborations with other NIH Institutes. Congress is increasingly focused results-oriented outcomes, pushing the NIH for evidence of progress in research advances, treatments, and potential cures. However, Congress also remains supportive of investigator-initiated projects, research on disease mechanisms, and centralized resources.
In response to a question about the NCMRR budget, Dr. Alexander indicated that the Institute does not have a rehabilitation budget per se, but rather NCMRR allotments are largely driven by the success of rehabilitation applications in the NIH peer-review system. Because the overall NICHD budget remains relatively flat, he does not expect a lot of change in rehabilitation support in the near future, although the Christopher and Dana Reeve Paralysis Act could have some influence on NICHD priorities. As far as IOM recommendations for increased coordination of rehabilitation support, Dr. Alexander felt that the field still needs more nurturing and continued emphasis on training and career development. In response to a particular question about when the rehabilitation field might be able to achieve institute status at the NIH, Dr. Alexander suggested that it would require at least a doubling or tripling of research capacity in order to justify consideration. Furthermore, there needed to be a greater emphasis on research within the relevant clinical fields, especially physical medicine and rehabilitation (PM&R) where the academic research track is not adequately supported.
Because of its broad expertise, the Advisory Board is sometimes called on to provide an additional level of review for NCMRR research initiatives. Background material for this process was distributed to Board members prior to the meeting. As head of the NICHD Division of Scientific Review, Dr. Robert Stretch presided over the concept clearance process, and Dr. Weinrich introduced the following three research initiatives.
The first proposal would solicit supplements to NIH Clinical and Translational Science Awards (CTSA) to stimulate the involvement of General Clinical Research Centers in rehabilitation research and aspects of enhanced community involvement. Other NIH institutes may also be interested in contributing to this initiative. This effort will encourage a change of focus from diseases to conditions and disease management. The Board endorsed this initiative, but stressed the need to be explicit in promoting links with the community. Dr. Rosemary Filart of the National Center for Research Resources (NCRR) provided some additional background on the CTSAs, which were launched on behalf of the NIH Roadmap for Medical Research. The program provides a definable academic home for basic, clinical, and translational research that facilitates the translation of discoveries into improved health care. The NCRR welcomes discussions with their colleagues at the NICHD and the National Institute on Disability and Rehabilitation Research (NIDRR) on access to resources and other ways to improve collaborations.
The second initiative focused on interventions for cognitive deficits. Dr. Weinrich pointed out that the TBI clinical trials rarely addressed interventions extending into the rehabilitation phase and especially not interventions to improve cognitive functioning. The Board discussed potential links to assistive technologies, outcomes and measurement issues, treatment of military blast injuries, and cognitive support, and heartily approved this initiative.
The third initiative would attempt to support mixed pharmacological approaches for improving cognitive and behavioral outcomes in brain injury. Dr. Weinrich indicated that despite more than 50 pharmacological trials in traumatic brain injury or stroke, there have been no real improvements in the treatment of these conditions. This situation may be due in part to the complex pathophysiology of these conditions. However advances in other clinical fields (e.g., cancer chemotherapy and AIDS) have come through the use of mixed pharmacological approaches. Moreover, there are already several drugs in the public domains that may be worth exploring in this context. The Board was mildly concerned that the focus was more on acute therapy, but recommended approval if the initiative was clearly anchored in rehabilitation outcomes.
With the conclusion of this meeting, Dr. Alberto Esquenazi will finish his one-year term as Chair, and Dr. Diana Cardenas will advance from the position of Chair-elect to Chair. Thus, nominations were sought for the next Chair-elect. Three excellent nominations were received for the position of chair-elect, but after brief discussions among the three, they agreed to unify behind Dr. Margaret Turk, who was accepted by the Board without dissent.
Ken Giacin provided some background on his company, StemCyte®, which was started about four years ago to provide access to stem cells from umbilical-cord blood to treat childhood disorders such as blood diseases, cancer, and more than 70 other conditions. Using venture capital, he sought to set up the largest, most racially diverse resource for cord blood stem cells. This is now an international effort that is growing at the rate of 50-55 percent per year.
Dr. Wise Young, a former NABMRR member and collaborator on the stem-cell project, provided additional background on the use of umbilical cord stem cells to treat human disease. At present, stem cells may be derived from a variety of sources including embryonic tissues, peripheral blood, bone marrow, and umbilical-cord blood. The first successful application of stem cells was in 1988, and it was used to treat Krabbe A disease. Apparently, exogenously supplied stem cells have unique homing properties that greatly enhanced their clinical utility.
Stem cells derived from umbilical-cord blood have some unique advantages over those derived from bone marrow: cord cells require less stringent matching of histological markers between the host and recipient; they can be stored for extended periods; they can be collected non-invasively; and they have a greater than 90 percent efficiency of engraftment in certain conditions. StemCyte® is building a significant body of evidence on treatments and outcomes and is continuing to support educational symposia and training opportunities for transplant researchers in other countries. However, as with fetal stem cells, the need for improved methods of expanding these precious cell lines to meet the growing clinical demand remains a key issue.
Tammara Jenkins provided some background on the concept of the medical home and support for children with disabilities. As mortality critical illness and illness in childhood has decreased, the morbidity of surviving children and access to specialized medical care have become increasingly significant issues. Approximately 23 percent of admissions to pediatric intensive care units (PICU) represent children with congenital neurodevelopmental disabilities who are especially technology dependent. Children with special health-care needs are at increased risk for physical, mental, and behavioral problems; multiple unmet health-care needs; increased hospital readmissions; and over-burdened families. The concept of the medical home, first introduced in 1967 and most recently redefined in 2002, provides for a comprehensive, family-centered approach to high-quality, cost-effective, and accessible health care. The goal is to be comprehensive, continuous, coordinated, compassionate, and culturally effective. Key outcomes include improved healthy status, reduced hospital visits, increased family satisfaction, and lower overall costs. The NCMRR recently hosted a workshop to evaluate the concept of the medical home and develop a research agenda.
Dr. Carol Nicholson provided more general background on the growth of the Pediatric Critical Care and Rehabilitation (PCCR) program in the NCMRR. During its first five years, the PCCR program supported 256 research applications. Roughly one-quarter of these could be classified as pediatric rehabilitation with the remainder more focused on pediatric critical care. Dr. Nicholson presented some examples of PCCR-supported research projects as well as the collaborative clinical trials network in critical care research. The network coordinates activities across six sites and is currently supporting trials on preventing nosocomial sepsis, reducing pertussis infections in very young infants, and dealing with bereavement.
Dr. Alan Jette gave some background on the IOM report, The Future of Disability in America. In addition to Dr. Jette, who chaired the IOM panel, other current (Lisa Iezzoni, Margaret Turk) and past (June Isaacson Kailes, P. Hunter Peckham, and John Whyte) Board members were included on the panel, which released its report at the end of April 2007. The panel conducted a national workshop supported by the Center for Disease Control and Prevention (CDC). The panel's work and eventual consensus report was funded by the CDC, the NIDRR, and the NCMRR. The charge to the IOM panel was to evaluate progress and developments since earlier IOM reports on Disability in America released in 1991 and 1997. The panel focused on the following issues: definition, measurement, and monitoring of disability; trends in the amount, types and causes of disability; aging with disabilities and secondary health issues; transitions; role of assistive technologies and physical environments; and certain health-care financing issues.
Disability was defined as impairments in body structure or function, activity limitations, or participation restrictions. Current estimates for disability in the United States range from 40 to 50 million, but there is no single data source that yields estimates across all disability groups. Disabilities among children are increasing due primarily to asthma, obesity, and autism. Rates among working-age adults have leveled off, but obesity and diabetes remain significant health problems that place people at risk for future disability. Among the elderly, there are modest declines in the prevalence of limitations in activities of daily living. However, the panel concluded that there has been little progress in removing barriers to people with disabilities, and that it appears previous IOM recommendations in this area have received little or no serious consideration.
The panel recommended the creation of a comprehensive national disability monitoring system using the International Classification of Function (ICF) as a common language. The panel suggested that the National Center for Health Statistics (within the CDC) should take the lead in working with other agencies to create this system. The panel also identified a need for improving the ICF and developing core disability survey measures, which would be included in other national surveys.
As far as coordinating federal research activities, the panel noted no government-wide agreement on what constitutes disability research and there is little incentive for cross-agency collaborations. The panel indicated a need to increase public funding of disability research commensurate with the need and to improve coordination of federal activities in this area. The panel also made extensive recommendations with respect to access to health care and support services. The full report on The Future of Disability in America is available from the IOM at http://www.iom.edu/CMS/3740/25335/42494.aspx
The NCMRR sponsored a special workshop on March 6-7, 2007, entitled, A Research Agenda for Getting Beyond the Plateau: Promoting Recovery through the Chronic Phase. The workshop was also supported by the Interagency Committee on Disability Research (ICDR) Subcommittee on Medical Rehabilitation. Invited speakers, who included some members of the NABMRR, focused on opportunities for plasticity, adaptation, and non-traditional rehabilitation approaches extending into the chronic phase. Chronic disabilities rarely present themselves as an isolated incident followed by a period of acute recovery and function plateau. In fact, the chronic phase is often a dynamic battle to maintain function, prevent recurrence and other secondary conditions, make necessary psychosocial adjustments, and deal with dwindling resources. Unfortunately for people with disabilities, access to health services is often based on cost-containment strategies rather than the potential for functional improvement and rehabilitative progress. It was encouraging to have representatives from the Center for Medicare and Medicaid Service participate in the workshop and join the Advisory Board meetings.
The NCMRR noted its appreciation for the efforts of the following Board members who are completing their terms with this meeting: Alberto Esquenazi, Regino Perez-Polo, and William Zev Rymer. Retiring members were presented with special certificates signed by the NIH Director. Unfortunately, Drs. Perez-Polo and Esquenazi were not able to attend the meeting, but Dr. Rymer shared some personal comments on his term on the Board and his continued collaborations with NCMRR staff.
The scheduled talk on prosthetics and orthotics by NABMRR member Alberto Esquenazi will be rescheduled for the December 2007 meeting. Topics for future meetings include: aging with disabilities; developing databases and research cohorts of people with disabilities; developing unifying themes for NCMRR research activities; improved communications among NCMRR, the research community, advocates and consumers; a discussion of mild TBI and blast injuries; and the role of environmental factors in supporting or presenting barriers to people with disabilities.
The meeting was adjourned at 11:30 a.m.