Dr. Thomas Strax, Board Chair, called the 26th meeting of the National Advisory Board on Medical Rehabilitation Research to order at 9:15 a.m. Current Board members and visitors introduced themselves. Minutes of the previous meeting were approved.
May 1-2, 2003December 8-9, 2003May 6-7, 2004
Dr. Michael Weinrich, NCMRR Director, provided an update on the Center's activities. Dr. Nancy Shinowara joined the NCMRR from the Center for Scientific Review at the National Institutes of Health (NIH). She has several years' experience as a scientific review administrator with expertise in rehabilitative engineering and the Small Business research program. She will have two roles: to expand the Small Business Innovative Research program in the Center and to support clinical research.
In fiscal year (FY) 2002, the NCMRR supported 225 new and continuing grants, totaling more than $60 million. This steady growth has resulted primarily from an increase in number of quality investigator-initiated applications in the area of rehabilitation, as supported by NCMRR staff and peer-review feedback. In addition, the Center has been attracting experienced researchers from allied fields by promoting research opportunities in such areas as neuroplasticity, bioengineering, and outcomes research.
The NIH is still without a new budget, so Institutes have been functioning on continuing resolutions, which hold spending to FY 2002 levels. This does not allow support of new initiatives, but does permit funding of new and on-going investigator-initiated grants at more conservative levels (i.e., reduced paylines for the present). The President has proposed an increase of approximately 9 percent for the NIH funding in FY 2003, but it appears unlikely that the current commitment to double the NIH budget over a five-year cycle will continue beyond FY 2004. In future appropriations, less money may be targeted for specific initiatives, leaving more discretion to support investigator-initiated proposals from the field. However, bioterrorism and homeland security initiatives may impact NIH resources.
The NIH continues to support training activities. This is a particular priority within the NCMRR, which supports several departmental training grants and career development awards. In a continuing effort to encourage newly trained clinicians to go into research, the NIH will support another round in the loan repayment program. Although last year's competition was limited to clinical researchers supported by NIH grants, the current competition will include clinicians on any funded grant project. The application deadline has been extended to January 31, 2003. For more information on the loan repayment program, go to http://www.lrp.nih.gov/.
Dr. Weinrich highlighted some of the current NCMRR research activities. In October 2002, the NCMRR sponsored the Training Program for Leadership in Rehabilitation Research, held in conjunction with the American Congress of Rehabilitation Medicine. The conference was an interactive forum to assist department chairs and other leaders in rehabilitation in building successful research programs. The session attracted chairs from departments of physical therapy, speech, psychology, and physical medicine and rehabilitation. The NCMRR sponsored a meeting in October on Inflicted Neurotrauma in Children. This meeting attracted a large number of the leading investigators in the field, and a consensus-style report is forthcoming. In early November 2002, the NCMRR helped sponsor a meeting at the Kessler Medical Rehabilitation Research and Education Corporation entitled, Clinical Trials in Medical Rehabilitation: Enhancing Rigor and Relevance. July 21-22, 2003, the NCMRR will organize a major meeting on Physical Disability through the Lifespan at the Natcher Center on the NIH campus. This meeting will be a trans-governmental collaboration with a broad focus on lifespan issues (beyond just geriatrics). It will consist of platform sessions and breakouts, with the intent of shaping policy and developing a research agenda.
At its May 2002 meeting, the Advisory Board began the process of updating the Research Plan for the National Center for Medical Rehabilitation Research (for full text of the 1993 plan, go to http://www.nichd.nih.gov/publications/pubs/documents/plan.pdf (PDF - 223 KB)). However, strategic planning activities are currently on hold at the NIH, as the new director, Dr. Elias Zerhouni, is developing a more coordinated process that crosses institute boundaries. Dr. Zerhouni is emphasizing greater accountability, clinical and translational research, and identification of potential barriers to research progress.
Dr. Weinrich provided an update on the NCMRR regional research networks. These networks were originally developed in response to an initiative developed by the Board to build research infrastructure in medical rehabilitation. The NICHD committed to support four, geographically distinct networks to enhance research capacity in respective regions. Currently in its third year, the program has been successful with each of the four networks developing innovative outreach and research support programs. However, the NCMRR must now consider what is appropriate for the next phase of research support. What is the best mechanism for support of new investigators: should networks support brief sabbatical training, intensive workshops, and/or other meeting formats? How can the networks attract experienced investigators from allied fields to focus on issues in rehabilitation research? Is there a continuing need for regional research networks versus national networks organized around specific research techniques and/or clinical specialties? The Board cautioned the NCMRR about falling prey to "constituency management" if they try to delineate networks organized around specific rehabilitation topics. A more detailed discussion of the NCMRR research networks and infrastructure support will occur at the next Board meeting.
Because of its broad expertise, the Board is sometimes called on to provide an additional level of review for certain NCMRR research initiatives. Brief background material on each proposal was distributed to Board members prior to the meeting. Dr. Weinrich introduced the following six initiatives.
A proposed request for applications (RFA) on the Genetic Basis of Recovery and Rehabilitation was presented. Current research considers genetic susceptibility and risk factors for disease, but this initiative would focus on potential genetic differences in the recovery process. There was brief discussion of research opportunities in this field and possible clinical implications of these findings. The Board agreed that the initiative had significant potential and could influence the specificity and timing of clinical interventions.
The second proposed RFA focused on Exercise and Health Promotion for Persons with Disabilities. This would solicit Small Business Innovative Research (SBIR) applications that propose modifications to existing exercise equipment as well as novel designs appropriate for use by persons with disabilities. The initiative would also have the potential to attract new inventors, engineers, and entrepreneurs to the disability field. The Board was enthusiastic about this initiative. They recommended that the initiative also support consideration of such issues as motivation, ecocultural acceptance, prevention of geriatric disabilities, and universal design so that the equipment would be appropriate for the broadest possible target audience.
The third RFA proposal would seek SBIR proposals to develop Training Materials on Surgical Amputations, Prosthetics and Orthotics. This would help clinical departments that did not have sufficient educational and clinical resources to adequately train clinical specialists in assistive technologies. The Board supported this initiative and its focus on practioners, especially surgeons. They suggested soliciting applications through the Small Business Technology Transfer Research (STTR) mechanism as well, and encouraged the NCMRR to seek collaboration with the Department of Defense.
The fourth RFA proposal would solicit Innovations in Design and Development of Powered Mobility Devices - Scooters. The Board endorsed this SBIR/STTR initiative. They encouraged consideration of multiple terrain accessibility, and pointed out that perhaps the NCMRR should use a broader term than "scooters" to denote a wider array of mobility aids.
The fifth RFA would solicit SBIR and STTR proposals to promote Innovative Technologies in Pediatric Critical Care and Rehabilitation. The Board supported this initiative, hoping that it would stimulate the pediatric device market. They encouraged the NCMRR consider issues such as caregiver burden, communication technologies, and environmental control by the individual.
The sixth proposal sought to support a National Training Program for Pediatric Critical Care and Rehabilitation Scientists, using the NIH Institutional Research Career Development Award mechanism (K12). This training program would complement the current NCMRR K12 program that supports graduates in Physical Medicine and Rehabilitation. A key aspect of the program would be getting clinical departments to commit salary and resources to support clinicians seeking research training. Based on feedback from the previous Board meeting, the proposal was modified to increase the link between critical care and rehabilitative outcomes, and to target junior faculty level trainees. The Board discussed the potential commitment of pediatric critical care trainees to rehabilitative versus strictly pediatric issues. After some debate, the Board concluded that it was not realistic for the training program to have a primary focus on both pediatric critical care and rehabilitation. Ultimately, it voted to unanimously support NCMRR staff in developing a training program for pediatric critical care clinicians, but encouraged the program to expose trainees to long-term outcome and other rehabilitative issues through the appropriate mentoring and training plans.
Exercise and health promotion is becoming an increasing important issue for persons with disabilities. With a greater understanding of exercise physiology, activity-mediated processes, psychosocial benefits of health interventions, and current barriers for people with disabilities, this is a particularly timely topic for the National Advisory Board on Medical Rehabilitation Research and provides important background for current NCMRR initiatives. To facilitate discussion, the NCMRR brought in four current grantees who represent diverse biomedical and sociobehavioral viewpoints and bring particular insight to the clinical and societal issues faced by persons with disabilities.
Peter Axelson is the chief executive officer of a small business (Beneficial Designs, Inc.) that promotes accessibility for people with disabilities to vocational, recreational, and leisure opportunities, as well as activities of daily living. He bases his projects on a personal as well as professional need to achieve a balance between the physical, emotional, and spiritual. Assistive technologies may function at several levels: personal (e.g., wheelchairs, glasses, specialized clothing), activity-specific (the mono-ski, hand-cranked bicycles, hiking wheelchairs, modified canoes), or environmental (promoting universal design). The current guidelines of the Americans with Disabilities Act focus on indoor environments rather than accessibility to the outdoors (e.g., sidewalks, trails, shared-use paths). Dr. Axelson reviewed some current projects, which have received NCMRR support through the SBIR program. His company has developed recreational trail standards, which incorporate specific measurements of trail width, surface composition, grade, and resting sites in order to communicate the level of accessibility for persons with disabilities. It has also developed software (available at http://www.trailexplorer.org ) to help people with disabilities plan recreational activities. Another project documents the accessibility of amusement parks and playgrounds. His company has also helped develop objective measures of wheelchair performance to assist consumers, while also improving on pushrim design, braking, and metabolic demands on the user.
Dr. James Rimmer (University of Illinois at Chicago) discussed the benefits of exercise in terms of cardiovascular fitness, secondary effects, and overall psychosocial health. Physical activity - whether formal exercise, leisure activities, household chores, or occupational responsibilities - promotes cardiovascular endurance, muscular strength, flexibility, improved body composition, and pulmonary function. Cardiovascular fitness (typically measured as maximal oxygen consumption) improves insulin sensitivity preventing the onset of diabetes, reduces blood pressure, and promotes independence.
On the other hand, physical inactivity contributes to 250,000 deaths per year, making it the second most preventable cause of death. People with disabilities tend to fall in the lowest decile of the population with respect to cardiovascular fitness. They lack the ability to do certain activities of daily living and miss out on opportunities for daily aerobic exercise. Barriers to exercise include inability to walk, difficulty with balance, painful movements, hostile environments, and even transportation problems. Lack of exercise leads to secondary complications, such as pressure sores, isolation, and depression. Dr. Rimmer cited the need for research to define optimal exercise parameters, cross-sectional and prospective studies of people with disabilities (to compare to data on the able-bodied population), and longitudinal studies of health interventions. He also discussed the need for supervised transitional settings to promote integration into the community and the identification of local exercise programs and trainers especially suited for people with disabilities.
Dr. Craig McDonald (University of California at Davis) focused on rehabilitative issues most relevant to children. Case studies of children with spina bifida reveal a high incidence of obesity, especially among females. Although there are prescribed programs for weight management in children, they are not appropriate for those with cerebral palsy. Moreover, many of these children lack the health coverage and physical access to participate in exercise programs. Even among able-bodied children, there has been a remarkable increase in obesity over the last two decades. This increase has been blamed on changes in diet, more sedentary activities, elimination of physical education classes in schools, decreased physical labor, and more television watching. There is a viscous cycle between inactivity and increased obesity. Promoting research on children with disabilities is particularly problematic. Standard measurements of body mass and energy consumption cannot be performed on children in wheelchairs, although Dual Energy X-ray Absorptiometry (DEXA) scans may provide a reasonable measure of regional tissue composition. Children with spinal cord injury have reduced metabolism, so standard developmental tables are not appropriate.
In order to study children in more natural settings, Dr. McDonald and his colleagues developed portable metabolic monitoring devices and step activity counters. They found significant gender differences in activity patterns even among able-bodied children, with girls being much more sedentary outside of the school environment. This trend would lead to metabolic syndrome obesity, which is associated with hyperlipidemia, hypertension, and increased insulin resistance (diabetes). Moreover, inactivity in childhood leads to significant health and weight-management problems in adulthood. Dr. McDonald has explored the strategies for weight management in children, which would be especially applicable to those with disabilities. They found that to be successful, first and foremost, the activities must be fun. It is important to balance aerobic exercise with strength training, while attending to issues of behavioral compliance, nutritional education and general fitness promotion. Dr. McDonald echoed Dr. Rimmer's call for longitudinal studies, especially those that focus on children with disabilities, school environments and access to recreational activities. Very little data exists on the risk of exercise for children with musculoskeletal disorders, such as muscular dystrophy, but initial studies suggest that these children also benefit from aerobic training. In fact, within the dystrophic muscles there appears to be a shift of muscle fiber type to those with improved repair capacity. In addition to issues of neurological and functional improvement, research on children needs to address overall fitness, longevity, psychological benefits, and social integration.
Dr. Rosemary Hughes (Baylor College of Medicine) discussed some issues unique to women with disabilities. The Center for Research on Women with Disabilities (CROWD) has focuses on life situations, health disparities, barriers, and overall health promotion. Through joint support of the NCMRR and Center for Disease Control and Prevention, CROWD surveyed 386 women with disabilities in a large research study. Overall in the United States, 20 percent of women have workplace limitations and the percentage rises with age reaching 40 percent by age 65. Disability is negatively associated with marital status, educational level, employment status, and socioeconomic status, leading to increased depression, stress, and reduced access to health care. Women with disabilities have greater barriers to exercise and maintenance of healthy behaviors. To address these disparities, Dr. Hughes and her colleagues proposed an intervention based on the chronic disease self-management model. The intervention stresses self-efficacy through self-report, action plans, and a buddy system; it has a positive impact on the health and lives of women with disabilities.
Dr. Stephen Haley (Boston University) discussed improved outcome measurement through the use of computer adaptive testing (dynamic assessment). Current outcome measures include such tests as the Functional Independence Measure (FIM™), Outcome and Assessment Information Set (OASIS), Minimal Data Set (MDS), Craig Handicap Assessment and Reporting Technique (CHART), Community Integration Questionnaire (CIQ), and the Health Status Survey Short Form (SF36). All these measures rely on fix-length forms, and are not necessarily valid across multiple acute settings and age ranges (e.g., the FIM™ has ceiling effects that limit applicability, while the SF36 is a broad measure that lacks sufficient sensitivity).
Borrowing technology from the educational testing field, a collaborative group of clinical, academic, and small business researchers explored the use of computer-adaptive testing to develop a rapid, precise measure that would have broadly applicability. The test begins with an initial outcome score estimate, then asks a question to refine the score. The multiple-choice response is scored and the outcome score is re-estimated. Based on this new estimate an optimal question is presented to further refine the score. The reiterative process continues until the estimated score achieves the desired level of confidence or a preset number of questions is reached. The conceptual framework addresses function, disability, participation, and environment; it appears to have excellent predictive value across multiple clinical domains and cultural settings.
Current research is focused on validating this new outcomes approach by refining the base of questions and comparing scores to established measures such as the FIM™ and SF36. Ultimately, computer-adaptive testing will eliminate ceiling and floor effects, provide rapid measures with minimal loss of accuracy and precision, reduce respondent burden, and provide valuable information tailored to the individual. Current challenges include refining the conceptual model, demonstrating the validity of a unidimensional outcome measure, showing that the test is measuring important outcomes (as defined by the consumer), validating the test over large and diverse samples, and addressing certain psychometric issues.
Drs. Grace Peng and John Haller provided some background on the newest NIH institute and its research agenda. The NIBIB was mandated by Congress in December 2002, beginning with a budget of $112 million. Its initial research base, developed through grants transferred from other NIH institutes, included over 300 imaging and bioengineering grants totaling $60 million. According to its mission statement, the NIBIB provides funding to enable technologies and methods and encourage multi-disciplinary approaches not currently supported by other NIH institutes. Unlike the majority of the NIH, NIBIB grants are not necessarily hypothesis-driven and tend to be more engineering than biomedical. Within the context of bioengineering, current research interests include biomedical imaging, biomaterials, nanoscience, sensors, surgery, bioinfomatics, and platform technologies. Biomaterial research, which has particular relevance to medical rehabilitation, includes tissue engineering, drug/protein/gene delivery, and host-material interactions. Within the area of bioimaging, the NIBIB is particularly interested in image-guided interventions, biosensors, molecular imaging, computer tomography (CT) imaging of tissues, and brain imaging using functional magnetic resonance imaging (fMRI) and positron emission tomography (PET). The NIBIB has assumed leadership on several trans-NIH initiatives including the Bioengineering Consortium (BECON) and the Biomedical Information Science and Technology Initiative (BISTI). Currently the NIBIB has a staff of about 40, which is expected to double in the next year or so. For more information on the new institute, go to www.nibib.nih.gov.
In order to begin a discussion of clinical opportunities in medical rehabilitation, Dr. Ralph Nitkin provided some background on clinical trials, research opportunities, and current activities sponsored by the NCMRR. He discussed the purpose of clinical trials, necessary background data, design issues, appropriate outcome measures, and other logistical and administrative topics.
Dr. Nitkin pointed out that medical rehabilitation may not be that different from other clinical disciplines when it comes to the support of clinical trials. Although medical rehabilitation is relatively new as a research field, it has a long history of treatment strategies and builds on allied fields that have solid research traditions (e.g., physiology, neuroscience, biomechanics, and behavior). There are conflicting demands on young clinicians who seek research training in rehabilitation, but this is true of other clinical disciplines as well. Because medical rehabilitation deals with post-acute care and more long-term outcomes, it may be more pressured to justify clinical treatments - especially in the current managed care environment. However, it should be noted that many accepted procedures in other clinical fields also lack true evidence-based research support. Another complication is that medical rehabilitation focuses on the treatment of function and disability, which are further removed from the primary biological mechanisms that drive current biomedical research. Moreover, the ideology of individualized approaches in rehabilitation must be modified in order to conduct randomized clinical trials, the current gold standard of evidence-based medicine. Medical rehabilitation is also unique in that it focuses on the whole person and interaction with environmental factors.
Nonetheless, medical rehabilitation offers several exciting opportunities for clinical trials (e.g., neuroplasticity and activity-mediated processes, bioengineering and assistive devices, and behavioral sociocultural support). But this research agenda requires increased support from clinical departments, professional organizations, and funding agencies. The NCMRR supports clinical trials through the funding of investigator-initiated clinical proposals; workshops, courses, and career development in clinical methodology; clinical trial planning grants; support of clinical networks to recruit patients and standardize protocols; and a limited number of requests for applications (RFA) targeted to certain conditions or approaches.
Dr. Nitkin provided a sampling of clinical trials supported by the NCMRR over its first decade, many of which were relatively small-scale studies involving relatively few patients. NMCRR trials have focused on chronic pain, cognitive and behavioral abnormalities, urinary tract and bladder dysfunction, neuroimaging for prognosis and monitoring recovery, reducing skin breakdown and ulceration, improving health care access and prioritization, tendon surgery and botulinum toxin treatments for cerebral palsy, pharmacological treatments to improve respiratory function, functional electrical stimulation to augment and promote muscle function, body-weight supported locomotor training for spinal cord injury, "constrained use" therapy for stroke, and patient-support and health-promotion programs. The major research themes of these studies include: optimizing timing/intensity/specificity of therapeutic interventions, promoting neuroplasticity and recovery through activity-driven processes, exercise to prevent deconditioning/atrophy, electrophysiological and neuroprosthetic approaches to supplement function, reducing occurrence of secondary complications, behavioral modifications and adaptations, enhancing social and psychological support, overall health promotion, and minimizing the effects of social and environmental barriers.
In Dr. Nitkin's opinion, future opportunities for clinical studies in medical rehabilitation include: molecular, cellular and bioengineering approaches to promote regeneration and restore function; optimizing therapies for patient conditions and goals; improved techniques to monitor progress and outcomes; adapting adult therapies to children; promoting telemedicine and home-based therapies; developing appropriate support for rehabilitation in rural environments; understanding gender and ethnic/racial differences in biomedical processes, health access, and support; alternative and complementary medicine; and, ecologically appropriate interventions for home and community to enhance compliance. A broader discussion of clinical trial research, clinical opportunities, and NCMRR priorities will take place at a future Board meeting.
The Board discussed potential topics for future meetings. Major topics include follow-up discussions of the clinical trials and the regional research networks. Other topics include: research approaches to define the "active ingredient" in physical therapy, how rehabilitation engineering and assistive technologies fit into the NCMRR research plan, a broad discussion of pediatric rehabilitation and its connection to critical care, and how to promote sustainable outcomes in rehabilitation especially through family and community support.
The meeting was adjourned at 12:05 p.m.