Dr. Chukuka Enwemeka, Board Chair, called the 25th meeting of the National Advisory Board on Medical Rehabilitation Research to order at 9:15 am. Current Board members and visitors introduced themselves. Minutes of the previous meeting were approved.
December 5-6, 2002
May 1-2, 2003
December 8-9, 2003
Members Present
| Chukuka S. Enwemeka, Chair Marjorie Anderson Lawrence Becker Allan Bergman Melanie C. Brown |
Florence Clark Robert C. Dean Gerben DeJong (by phone) Gloria D. Eng Gary W. Goldstein |
June I. Kailes Patrick Kochanek Samantha J. Scolamiero Lynn Underwood John Whyte |
Members Absent
Thomas E. Strax
Ex-Officio Members Present
| Mindy L. Aisen, VA Duane Alexander, NICHD Daofen Chen, NINDS Gil Devey, NSF |
Martin Gould, NCD Robert Jaeger, NIDRR Don Lollar, CDC Ann O'Mara, NCI |
Daniel Sklare, NIDCD Michael Weinrich, NICHD |
Ex-Officio Members Absent
| Chhanda Dutta, NIA | Steven J. Hausman, NIAMS | Claudette Varricchio, NINR |
Invited Speakers
| Juanita Anders | George T. Timberlake | Harry T. Whelan |
NICHD Staff
| Kristy Alston Beth Ansel Lisa Freund James Hanson |
Lisa Kaeser Lois Maiman Carol Nicholson Ralph Nitkin |
Louis Quatrano Carol Sheredos Robert Stretch Susan Streufert |
Susananne Strickland Viyada Tongprasri Al Wigmore |
Visitors
| Kurt Henry, DOD Weijia Ni, CSR |
Jo Pelham, CSR Nancy Shinowara, CSR |
Ron Waynart, FDA |
REPORT OF THE NICHD DIRECTOR
Dr. Michael Weinrich began with a review of NCMRR funding trends. The Center is currently receiving about two dozen R01 applications per round (three rounds per year), in addition to applications submitted in response to special research initiatives (e.g., Requests for Applications [RFAs]). The R01 is the traditional NIH investigator-initiated research mechanism, which makes up the bulk of NIH funding. Over the last few rounds, the funding rate of NCMRR applications has varied somewhat, but generally remains above that of the NICHD as a whole. This suggests that NCMRR applicants receive adequate support in the NIH grant process and are not disadvantaged in peer review.
Dr. Weinrich called on NCMRR staff to highlight current research initiatives, which include: dynamic health assessment; robotics for rehabilitation therapy; a traumatic brain injury (TBI) network (stressing the link between acute therapies and rehabilitative outcomes); rehabilitation for stroke or hip facture (timing, intensity, and duration); augmentative and alternative communication strategies; muscle contractures; and, pharmacological interventions to promote neuromodulation. A full listing of NCMRR Requests for Applications (RFAs) and Program Announcements (PAs) can be found on the Center website at http:// www.nichd.nih.gov/about/ncmrr/funding.htm. Staff also indicated that later in the week (May 3-4, 2002), the NCMRR would convene a working group to discuss research priorities for the new Pediatric Critical Care and Rehabilitation Program. October 10-11, 2002, the Center will sponsor a conference on Inflicted Neurotrauma in Childhood.
CONCEPT CLEARANCE
Because of its broad expertise, the Board is sometimes called on to provide an additional level of review for certain NCMRR research initiatives. Dr. Robert Stretch, Director, Division of Scientific Review, NICHD, led this part of the discussion. Brief background material on each of the proposals had been distributed prior to the meeting. Although the NCMRR currently has research initiatives that cross the domains of medical rehabilitation, the following three proposals fall in the new Pediatric Critical Care and Rehabilitation Program.
A proposed RFA to promote clinical trials of Therapeutic Interventions in Childhood Cardiopulmonary Arrest engendered significant discussion. While the Board appreciated the urgent need to promote research on acute treatments for children, they questioned how these studies would connect to rehabilitative outcomes. Clearly, there is a need to enhance collaboration between clinicians in the acute setting (e.g., intensive care units) and those who support rehabilitative and more long-range outcomes. The Board also discussed the broader issue of the NCMRR's expansion into pediatric critical care. While pediatric critical care is central to the NICHD mission, the connection to NCMRR priorities needs to be better articulated. Ultimately, the Board supported this initiative, but encouraged Staff to strengthen the connection between acute and rehabilitative outcomes, and to promote collaboration among the relevant clinical specialties.
The second proposed RFA focused on Pilot Clinical Trials in the Epidemiology, Prevention and Treatment of Respiratory Failure in Children. This will focus on the complications of mechanical ventilation in young children. The Board felt that this proposal has merit, especially because of the connection to long-range outcomes and issues of resiliency in children. The Board encouraged Staff to include linkage to chronic rehabilitation issues, build on international experiences with mechanical ventilation, and consider quality-of-life issues (for the children as well as their families).
The third proposal sought to support a National Training Program for Pediatric Critical Care Clinicians, using the NIH Institutional Research Career Development Award mechanism (K12). This training program would be complementary to the current NCMRR program that supports Physical Medicine and Rehabilitation doctors. A key aspect of this program would be getting clinical departments to commit salary and resources to clinicians seeking research training. The Board pointed out that critical care nurses could also contribute to the training effort. The Board questioned the commitment of these trainees to rehabilitation versus strictly pediatric issues (e.g., pulmonology or anesthesia), and whether their career focus would be on acute survival versus longer-term outcomes. The Board voted unanimously not to accept this proposal, and encouraged Staff to come back with a modified version that better addresses potential connections to rehabilitative research and more long-term outcomes.
PHOTOMEDICINE AND TISSUE ENGINEERING
Dr. Chukuka Enwemeka help arrange a special informational session to update the Board on exciting new research opportunities in photomedicine and tissue engineering, which may have particular relevance to medical rehabilitation. Dr. Enwemeka began with a historical introduction to the biophysics of light interaction with tissues and early applications in medicine. Current thinking is that at the cellular level, radiant energy can interact with mitochondria and cell membranes to alter ATP synthesis, calcium flows, and reactive oxygen species, which ultimately leads to changes in RNA, DNA and/or protein synthesis.
Dr. George T. Timberlake discussed the use of photo-activated, collagen-cross linking compounds for surgical wound closure. This could provide faster and stronger wound closure, possibly eliminating the need for sutures or surgical clips. This would have particular appeal for corneal transplantation where photo-activated approaches would reduce the risk of inflammation and infection, and complications associated with suture breakage. Current research is focusing on optimizing the binding properties of the cross-linking compounds and tensile strength of the repair.
Dr. Harry T. Whelan reviewed applications of near-infrared irradiation to tissue engineering. Infrared (IR) or near-IR penetrates much further into tissues than visible light, raising the possibility of improved imaging of tissues, even in a dynamic setting. IR even penetrates the human skull raising the possibility of non-invasive methods of brain imaging. Light in the IR range also has the potential to accelerate repair and healing in acute trauma settings (such as the battlefield). IR and near-IR radiation could also be used to treat mucosal lesions and to enhance chemotherapy, and may even have a role in promoting neuronal recovery and bone repair.
Dr. Juanita J. Anders discussed applications of light therapy to injured central and peripheral nervous tissues. Studies in the rat facial nerve injury model demonstrate that IR treatment facilitates nerve regeneration. In the injured cortical spinal tract, IR treatment delays the invasion of macrophage and microglia as well as the blocking the proliferation of fibroblasts and astrocytes; this would give nerve axons more of a chance to regenerate and reestablish connections.
Dr. Enwemeka concluded by reviewing the use of IR to promote tendon repair. It appears to stimulate collagen synthesis, and may have particular application to treating diabetic ulcers.
REPORT OF THE NICHD DIRECTOR
Dr. Duane Alexander was quite enthusiastic about the new nominee for the NIH Director, Dr. Dr. Elias Zerhouni [for more background on the new director, go to http://www.nih.gov/about/director/index.htm. The NIH is heading into the final year of the five-year drive to double research funding. Early projections for the NICHD suggest an increase of about 9 percent in Fiscal Year (FY) 2003. At present, there appears to be little controversy between House and Senate proposals for the NIH, although biomedical research is not the highest Congressional priority at the present time. Congress is working on the Bioterrorism initiative, which would direct significant resources to support research on vaccines, biowarfare and infectious agents, and would be directed by the National Institute for Allergy and Infectious Diseases (NIAID). In the years beyond FY2003, significantly small increases in NIH funding are being proposed. This would have a dramatic impact on the size and number of new grants in subsequent years.
Following Dr. Alexander's formal report, he took questions from the Board on other issues. Dr. Alexander indicated that the new National Institute for Biomedical Imaging and Bioengineering (NIBIB) would support general studies in imaging, bioengineering, and technique development, but would be less involved in research targeted to specific organs, systems, or disorders. The NICHD Longitudinal Study on Children is proceeding on schedule; the Institute has hired staff, initiated collaborations with other agencies, and began populating the steering committee and 22 working groups. The Board asked for more background on the Friends of the NICHD. This is an independent coalition of over 100 diverse organizations (e.g., professional societies, disease treatment and support, and other advocacy groups) that have interests related to the NICHD mission. The Board was concerned that there is not yet representation from the rehabilitative community in this coalition. The Board sought some clarification of the connection of the new Pediatric Critical Care and Rehabilitation program to the rest of the NCMRR mission. Dr. Alexander reiterated the need to blend acute care with rehabilitative outcomes. He pointed out that although other NIH Institutes support research on acute care (e.g., brain trauma, stroke, cardiovascular disease), trauma and acute care for kids raises special issues that are not being covered elsewhere in the NIH.
STRATEGIC PLANNING WITHIN NICHD
Dr. Weinrich provided background on the strategic planning process within the Institute. Strategic planning provides a road map for future initiatives, research opportunities, and public vision. It would not be appropriate to use "business models" to direct and evaluate biomedical research. Although the Center has responded to many of the goals of the 1993 Research Plan for the NCMRR, we are not looking to merely update that document. The Board does not have the time to take on the full task of strategic planning, but they can suggest areas of research opportunity and need as well representative constituencies (e.g., patients, advocates, clinicians, researchers). The NCMRR is a center within a larger Institute; there are overlapping interests within that Institute (see below) and with other NIH Institutes (e.g., National Institute of Arthritis and Musculoskeletal and Skin Diseases [NIAMS], National Institute of Neurological Disorders and Stroke [NINDS], and the National Institute on Aging [NIA]).
Dr. Lynne Haverkos gave a brief overview of the Child Development and Behavior (CHD) Branch of the NICHD and potential collaboration with the NCMRR. The branch has six program areas, all of which focus on the interaction of behavior and the environment: Cognitive, Social, and Affective Development; Child Maltreatment and Violence; Developmental Psychobiology and Cognitive Neuroscience; Behavioral Pediatrics and Health Promotion Research; Human Learning and Learning Disabilities; Language, Bilingual and Biliteracy Development and Disorders; and Early Learning and School Readiness.
Dr. James Hanson discussed the Mental Retardation and Developmental Disabilities Branch (MRDD) of the NICHD. The branch has diverse research interests in the area of neurobiology and behavior. It promotes translational research to improve the lives of children and adults with MRDD. Dr. Hanson reviewed the current NCMRR research priorities and indicated how they could also apply to people with MRDD. Approximately one-sixth of children are diagnosed with some form of MRDD by their teenage years, and both the MRDD branch and the NCMRR are interested in minimizing the progression of disabilities into handicaps.
BREAK OUT DISCUSSION GROUPS
Board members and other interested parties broke out into the following groups for discussion of research opportunities and needs: Biological and Behavioral Sciences; Clinical Trials and Applied Research; and Outcomes and Assessment.
The Biological and Behavioral Sciences group encouraged the NCMRR to pursue the following fields:
- Research at the interface of basic sciences and function
- Advances in gene therapy and genetic profiling Factors affecting neuroplasticity and regeneration (progesterone, enriched environment, photomedicine, aging)
- Plasticity of other tissues (going beyond neurological systems) (e.g., angiogenesis, muscle, bone, skin, connective tissue)
- Brain imaging to study abnormal brains, brain during movement tasks
- Mechanisms of reducing pain (esp. myofascial pain, back pain)
- Behavioral studies at the interface between biology and learning/re-learning
- Optimizing compensatory learning mechanisms and adaptations
- Trade-offs in neuroplasticity - recovery at the expense of other abilities?
- Selective attention and re-learning activities
- Executive function
- Training a cadre of rehabilitation researchers
- Protected time
- Security of salary (Canadian model: salary separate from grant support),
- Supplements to allow junior researchers to join established labs.
The Clinical Trials and Applied Research group highlighted the following opportunities:
- Translational research and how it diffuses into practice
- Websites to promote latest methodology and clinical recommendations
- Involve more people with disabilities in research, peer review, needs assessment
- Connecting to students at earlier levels (K-12 and college level), such as:
- Undergraduate Research Opportunities Program (UROP) at the Massachusetts Institute of Technology
- Research Experience for Undergraduates (REU) and Grant Opportunities for Academic Liaison with Industry (GOALI) sponsored by the National Science Foundation
- Student competitions (especially in the area of bioengineering)
- Include more rehabilitation expertise on clinical treatment teams
- Treatment plans should integrate traumatic/acute care, rehabilitation, and long-term quality of life
- Periodically re-evaluate persons with disabilities for adjustments and fitting of newer assistive devices (e.g., prosthetics)
- Improved follow-up of outcomes, especially long-term
- Longitudinal studies to better describe persons with disabilities and their needs
- Unique issues with children (different from adults)
- Bioengineering opportunities in
- Neurorehabilitation and neuroprosthetics
- Improved protection gear for sports
- Fall injury prevention in geriatric populations
- Lower-limb circulation assistance (prevention of amputation)
- Better mobility aids (especially scooters)
- Service delivery issues
- Clinical trials research
- Going beyond randomized trials (for some conditions, other approaches may be more appropriate)
- Training in methodology and conducting clinical trials
- Consider prevention research (but no need to duplicate mission of other agencies)
- Prevention of secondary complications is especially relevant to NCMRR
- Barriers to proper diagnosis and treatment of health conditions in persons with disabilities (e.g., cancer, reproductive health)
Strategic planning in these areas could involve professional societies and engineering organizations, including: Association of Academic Physiatrists, Neurorehabilitation, Cognitive Neuroscience Society, American College of Sports Medicine, Orthopedic Research Society, American Society of Biomechanics, Developmental Psychology, American Physical Therapy Association, American Occupational Therapy Association, American Congress of Cerebral Palsy, American Congress of Rehabilitative Medicine, and the American Heart Association (Stroke Division).
The Outcomes and Assessment group came up with the following recommendations:
- Integrate functional and clinical benchmarks, broader indicators of quality of life
- Include social, psychological, and spiritual factors; attitudes to disability
- Go beyond the "economic model"
- Highlight reintegration and participation
- Use the International Classification of Health (ICH-2) as a framework
- Using dynamic assessment approaches
- One-size-fits-all versus specificity
- Self-report plus clinical and family observations; include ecological domains
- Models to accommodation individual differences and change over time
- What counts as positive or negative outcomes? What is "success"?
- Expectations/goals may differ among patient, professional, family
- Adapt current measures (e.g., SF36, quality of life) and develop new measures
- Train clinicians in the use of these outcome measures
- Interface with clinical settings and managed care (HMO, insurance, Medicare)
- Support qualitative research
- Consider longer term outcomes (including sustained employment)
- Mix cross-sectional and retrospectively designs (could reduce costs of study)
- Including multiple outcome measures in NCMRR initiatives (RFAs and PAs)
- Support a working group on assessment
- Involve patients in NCMRR planning activities
- Include disability measures in NICHD longitudinal studies
- Risk adjustment and case-mix adjustment for outcome studies
- Analogue for outcome: consider the input (the intervention)
- Examine the sustainability of the rehabilitation result
- Promote research that crosses NCMRR domains
- Cohort studies for people with disabilities
- Framingham model (start with cohort)
- National Cancer Institute model (accumulate cohort as study progresses)
Strategic planning in this area should involve: caregivers and families (both as individual and organizations), health professionals, service providers, policy makers, managed care, foundation funders, disability researchers, social psychologists, policy researchers, and media.
HEALTHY PEOPLE 2010: DISABILITY AND SECONDARY CONDITIONS
Dr. Donald Lollar provided an overview of the special chapter on Disability and Secondary Conditions from the 2010 version of Healthy People (full text at: http:// www.health.gov/healthypeople/document/HTML/Volume1/06Disability.htm). Healthy People 2010 has an increased focus on disabilities, compared to the earlier Healthy People 2000. However, it has been difficult to capture the relevant data because current surveys are more focused on diagnosis than functional limitations or disability. In the current report, an attempt was made to promote health and well being, while also being sensitive to secondary conditions associated with chronic disabilities.
The newer version of Healthy People makes it clear that disability does not equal illness, health does not equate with medicine, and that rehabilitation is a process and disability is a descriptor. This is reflected in the change from International Classification of Disease (ICD) to the newer International Classification of Function (ICF). In this new format, diagnosis does not serve as a proxy for function. An attempt was also made to factor in the role of the environment, accommodations, and concurrent medical conditions. These advances in categorization will impact on clinical treatment, research, social policy, and disability statistics. The issue of health disparities has not been fully integrated into the report, and it is unclear which federal agency(ies) should coordinate this effort. Finally, a stakeholders forum is scheduled for September 20-21, 2002 in Atlanta, Georgia to focus on care giving and long-term care, emotional support, social participation, environment and technology, children and health.
NOMINATIONS FOR NEXT CHAIR ELECT
With the conclusion of this meeting, Chukuka Enwemeka finished his one-year term as Chair, and Tom Strax will advanced from the position of Chair-elect to Chair. Therefore, nominations were sought for the next Chair-elect. Generally, such nominations come from the sophomore class (i.e., those who have two more years left on their terms) and two nominations were received. After brief discussion and private ballot, John Whyte was elected by majority vote.
NEW BUSINESS AND AGENDA FOR NEXT MEETING
Among the topics for consideration at the next meeting are: health promotion for people with disabilities (especially women), dynamic assessment as a new tool for assessing disability and outcomes, training and capacity in the rehabilitation field, and methodology and research support. Dr. Weinrich suggested that the Board reach closure on the current wave of strategic planning. NCMRR may also provide some information on the new NIH Institute of Biomedical Imaging and Bioengineering.
ACKNOWLEDGEMENT OF RETIRING MEMBERS
The NCMRR appreciates the efforts of the following Board members who have completed their terms: Florence Clark, Gary Goldstein, June Kailes, Samantha Scolamiero, and especially Chukuka Enwemeka who served as Chair in his final year. The retiring members were presented with special certificates signed by the Director of the NIH. Each shared personal remarks on their experiences with the NCMRR over the last four years and encouraged the Center to continue to support research to improve the lives of people with disabilities.
The meeting was adjourned at 12:15 pm.
Respectfully submitted,
| ________________________ | ________________________ |
| Ralph M. Nitkin, Ph.D. Date | Chukuka Enwemeka, Ph.D. Date |
| Executive Secretary, NABMRR | Chairperson, NABMRR |
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