Building Research Capacity in Rehabilitation Science

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					BUILDING RESEARCH CAPACITY IN REHABILITATION SCIENCE


                         July 9-10, 2001
                       Bethesda, Maryland

                       Meeting Highlights


                      Institutional Sponsors

                         Clinical Center
                   National Institutes on Health

                 Neuroscience Research Center
                 National Rehabilitation Hospital


               Professional Association Sponsors

     American Academy of Physical Medicine & Rehabilitation

          American Congress of Rehabilitation Medicine

               Association of Academic Physiatrists


                    Federal Agency Sponsors

        National Center for Medical Rehabilitation Research

     National Institute on Disability & Rehabilitation Research


           Conference Planning Committee Co-chairs

                     Lynn Gerber, MD
           Department of Rehabilitation Medicine
                    NIH Clinical Center
    AAPM&R Research Advisory & Advocacy Committee (chair)

                    Gerben DeJong, PhD
              Neuroscience Research Center &
           Center for Health & Disability Research
               National Rehabilitation Hospital
      ACRM Research Policy & Legislation Committee (chair)
BUILDING RESEARCH CAPACITY IN REHABILITATION SCIENCE

                                        July 9-10, 2001
                                      Bethesda, Maryland

                                       Meeting Highlights


WELCOME

Dr. John Gallin
NIH Clinical Center

     In the future, we may see national virtual clinical research centers, in which rural clinics
      can interact via the Internet with the NIH-sponsored General Clinical Research Centers
      around the country.

     Obstacles to clinical research include medical school debt, reluctance of managed care
      organizations, mistrust by patients, an inadequately informed public, and a lack of
      research training for health professionals.

     In the near future, national research policy is likely to require formal training in clinical
      research and certification of investigators and sites. The NIH intramural research
      program already adopted a set of standards for clinical research [see
      http://www.cc.nih.gov/ccc/clinicalresearch/index.html] in January 2000 and is mobilizing
      resources to implement them. The Clinical Center offers a required 4-hour training
      course for principal investigatorsnow web-based and available to the public [see
      http://www.cc.nih.gov/ccc/cr/index.html]. Among other clinical research course
      offerings is a required course for lay and professional members of the NIH institutional
      review boards [see http://ohsr.od.nih.gov/irb_cbt/].

Dr. Gail Gamble
Mayo Clinic
American Academy of Physical Medicine and Rehabilitation (President)

     This conference is an opportunity to make a statement both to individuals in our field and
      to basic researchers on the importance of facilitating collaborations.

     The depth of the AAPMR commitment is demonstrated by its establishment of a
      foundation that will help fund such researcher-clinician links.

FRAMING THE ISSUE

Dr. Lynn Gerber
Department of Rehabilitation Medicine


                                                                July 9-10-rehab conf—Page 1 of 18
NIH Clinical Center

A conference entitled “Building Research Capacity in Rehabilitation Science” was held July 9-
10, 2001 on the campus of the National Institutes of Health. Conference sponsors included the
American Academy of Physical Medicine and Rehabilitation, the American Congress of
Rehabilitation Medicine, the National Center for Medical Rehabilitation Research, the
Association of Academic Physiatrists, the National Institute on Disability and Rehabilitation
Research, The National Institute of Health’s Warren Grant Magnuson Clinical Center, and the
National Rehabilitation Hospital’s Neurosciences Research Program.

The conference was designed to bring together professionals actively engaged in rehabilitation
science who perform investigations at the physiological/impairment end of the disability model
and those who conduct research more clinically based research at the functional/disability end of
the disability model. Conference themes included:

1.     The barriers and opportunities to expand collaborative research opportunities for basic
       and clinical researchers;

2.     The infrastructure and capacity-building tools needed to advance rehabilitation research
       including opportunities for broadening collaboration through the creation of database
       generation and access; and

3.     New methods to improve transfer of information from bench to clinic and health policy.

BACKGROUND

Dr. Gerber cont.

In 1997, at the request of Senator Robert Dole, The Institute of Medicine (IOM) published a
report entitled “Enabling America.” This landmark report assessed “the current knowledge
base in Rehabilitation Science and Engineering” and whether there was, “effective transfer
and clinical translation of scientific findings that will promote health and health care for
people with disabling conditions.”

The report acknowledged that we have made progress in enabling America through legislation,
health care policy, health care delivery and technological advances. We have also made some
progress in rehabilitation research and to some extent, in translating this into practice. However,
much remains to be done.

We have not been successful in fully integrating those with disability into full-life activities. We
have made improvements in removing transportation and other environmental barriers and in
increasing the awareness of the needs of individuals with disabilities. These improvements will
require continued vigilance.

Research on cure, reduction of disability, and restoration of function remains undersupported.
Fundamentally, rehabilitation science suffers from a lack of critical mass of people doing it, and



                                                                  July 9-10-rehab conf—Page 2 of 18
a relatively small body of ongoing research that is relevant to rehabilitation practice. Without
more basic and clinical research, disability will remain a much larger societal and personal
burden than it needs to be.

QUESTIONS ADDRESSED BY THE CONFERENCE

Dr. Gerber cont.

1.     What are some of the barriers that hinder bench/bedside communication and successful
       collaboration between bench researchers, clinical researchers, and rehabilitation
       practitioners?

       a.      Which of these barriers can be addressed by improving infrastructure such as the
               creation of research networks and new information technology?

       b.      Which of these can be solved with more funding?

       c.      Which of these require new research methods or new conceptual approaches?

2.     Where are significant scientific opportunities for collaborative work?

3.     Do we need new models for rehabilitation research? How closely does therapeutic
       efficacy in rehabilitation follow the medical model? How dependent is this research on
       traditional clinical trial methodology?

The disabling - enabling process is influenced by physiological, anatomical, environmental,
cultural and other factors. We need knowledge from disparate disciplines to understand and
influence the disability continuum. We also need to advance both the science and therapeutic
interventions related to disability.

The conference was designed to ask how we can increase capacity in rehabilitation science in
part to meet the need for stimulating more “translational research” and ultimately clinical
research and practice. We need two steps in the process. First is to bring basic research findings
into the clinical arena and influence practice. Second is to convert findings and improved
clinical practice into health policies that will assure that these benefits will accrue to individuals
with disabilities. The intent of this conference was to begin a dialog that will help develop a
model for increasing communication, support and quality in rehabilitation research, by
establishing linkages between bench scientists, clinical researchers, rehabilitation practitioners,
and health policy makers. This is needed to help clinically responsible professionals to connect
with scientists at the bench to advance science, clinical practice, and health policy.

PROMISING OPPORTUNITIES

Opening speakers were basic science researchers who are addressing the underlying pathological
or disease-related processes that are known to result in one or more disabling conditions. Their
investigations serve as examples of how basic and clinical scientists could collaborate and thus


                                                                   July 9-10-rehab conf—Page 3 of 18
influence future investigations that address the needs of individuals with disabilities. Opening
speakers included Drs. Steven Stanhope, Sudha Agarwal, Ronenn Roubenoff and Ronald Hayes.

Dr. Stanhope
Physical Disabilities Branch
Department of Rehabilitation Medicine
NIH Clinical Center

Dr. Stanhope presented a model for disability-related research, which he coined, the “trans-
rehabilitation-research-domain” (TRRD) model. The model builds on the IOM-NCMRR model
of disability, which describes the domains relevant to medical rehabilitation. The IOM-NCMRR
model defines rehabilitation relevant areas of research as those that are related to the underlying
pathophysiological processes, to impairments, to functional limitations, to disability, and to
societal limitations. Research in the traditional medical model addresses disease processes or
impairments and seeks better a understanding of how these occur, how they can be controlled,
how they can be cured or how they can prevented from occurring in the first place. Research of
this type is heavily weighted toward pathophysiology and impairment end of the IOM-NCMRR
model of disability. The TRRD model goes beyond the medical model to understand how
disease processes and impairments result in functional limitations and disability. Thus, reducing
disability may be achieved through a variety of techniques including reducing impairments,
providing replacement/assistive technologies to substitute for loss or to use alternative strategies
to achieve maximum function. The TRRD model opens up opportunities to explore linkages
between pathophysiological or anatomical impairments and functional limitations or physical
disabilities.

Using motion analysis as an example, Dr Stanhope applied the TRRD model to elaborate his
views. Initially the model requires that there be a comprehensive assessment of impairments and
capabilities to help understand the inter-domain relationships prior to the instigation of motion
control strategies. Second, the model requires that there be a complete set of plausible
movement control strategies that can be evaluated for their relative success in compensating for
the underlying impairments. And third, the model suggests that the physical demands required in
activities of daily living be explored to determine how these demands relate to both to the
impairment and overall task performance.

The Physical Disabilities Branch in the Rehabilitation Medicine Department of the NIH Clinical
Center has developed movement capture and analysis techniques in keeping with the TRRD
model. These techniques include three-dimensional, six-degrees-of-freedom motion capture and
modeling capabilities, generalized data analysis techniques, induced acceleration analysis
models, and computer-based simulation capabilities. This work serves as an example of how
research can bridge the gaps between impairment, functional limitation, and disability domains.

Stanhope indicated that future work in this area is needed to:

1.     Develop new measures in the impairment domain (such as muscular strength) that will
       directly relate to the demands of functional tasks. One goal of this work would be to
       express the functional muscular loads as a percent of the muscles maximum capability.
       These measurement capabilities are important for the identification of overuse


                                                                 July 9-10-rehab conf—Page 4 of 18
       syndromes, evaluating the process of movement strategy selection, and determining the
       minimum level of muscle force generation and movement control required prior to the
       onset of functional limitations and physical disabilities.

2.     Continue to develop methods for exploring the realm of plausible movement control
       strategies. These methods must be capable of identifying or incorporating subject-specific
       impairment/capability characteristics.

3.     Continue to develop IAA techniques that will relate muscle effort to the global aspects of
       movement performance. For example, determine the contribution of each net muscular
       moment to the maintenance of upright posture and production of forward velocity during
       gait for a number of compensatory strategies used to generate upright walking. This
       information is vital to the ultimate understanding of the relationship between impairment
       and functional limitation/strategy selection.

4.     Promote a rehabilitation-focused center of excellence model in major metropolitan areas
       that would effectively provide sufficient access to these capabilities. In addition, these
       centers should also promote additional awareness through various educational strategies.
       The cost and space requirements of human motion capture and analysis systems greatly
       exceed the resources available to most acute and chronic care facilities.

Dr. Sudha Agarwal
University of Pittsburgh

Dr. Agarwal presented her work on the molecular basis for the reparative actions of physical
therapies in joint diseases.

      Treatment (e.g., medications, rest, splinting, and surgery) provides only temporary relief
       of joint diseases, such as rheumatoid and osteoarthritis. Turning to rehabilitative
       therapies, prolonged bed rest causes atrophy of muscles, bone, and tendon while
       continuous passive motion improves joint healing, and exercise is even better. The
       questions that arise are whether motion-based therapies work for inflamed joints, and, if
       so, why?

      To examine the cellular basis of motion-based healing and cartilage regeneration, Dr.
       Agarwal developed a model using chondrocytes on a flexible and stretchable membrane.
       Applying various levels of mechanicalthat is, dynamic tensilestrain and/or
       introducing known inflammatory agents, her laboratory measures various markers of
       inflammation and of cartilage synthesis.

      Interleukin-1beta and tumor necrosis factor-alpha were used as proinflammatory agents.
       Some of the inflammatory markers were the mRNA for several proinflammatory
       proteins, the proteins themselves or their enzymatic products or byproducts,
       inflammatory cytokines, and nuclear translocation of NF-kappaB (responsible for
       transcriptional activation of proinflammatory genes).




                                                                July 9-10-rehab conf—Page 5 of 18
      Reparative markers included proteoglycans, collagen type-II, and STAT-1, a signal
       transducer and activator of transcription.

      Initial observations were that low-magnitude tensile strength suppressed inflammation
       and induced cartilage repair, and that higher-magnitude tensile strength was
       proinflammatory and contributed to cartilage degradation.

      Studies to identify how low-magnitude tensile strength inhibits the signal cascade
       initiated by interleukin-1beta have shown that NF-kappaB no longer migrates to the
       nucleus and that this may be related to the behavior of the cytoskeletal protein vimentin,
       which appears to bind to NF-kappaB and take it to the cell periphery.

      When subjected to stress over a longer period, the cartilage cells produce interleukin-10
       mRNA.

      Future plans include extending the in vitro studies and looking for correlates in animal
       models. The lab is interested in developing a mechanism for measuring the amount of
       stress during human movement and in evaluating existing physical therapy devices for
       efficacy by measuring the expression of some of the in vitro markers. Some day it might
       be possible to accelerate tissue repair by applying optimal motion therapy based on these
       measures and to use inhibitors of proinflammatory proteins or genes to promote healing.

      Earlier pending studies include comparing continuous application of stress (as in the
       above experiments) with intermittent application, working with tissue from arthritic joints
       to compare with the healthy tissue used above, and pinpointing the prior steps leading to
       the change in vimentin.

Dr. Ronenn Rouben
Tufts University

Dr. Rouben presented his work in muscle research and sarcopenia.

      Sarcopenia refers to the muscle loss that occurs with aging. An old thigh muscle vs. a
       young one shows less muscle, less subcutaneous fat, and more dark intramuscular fat. A
       40% loss of lean mass can be fatal, but even a 5% loss causes demonstrable morbidity.
       Loss of muscle can mean loss of strength and independence.

      Signs of sarcopenia show up typically about age 75, and 50% of individuals in their 80s
       have sarcopenia. However, in a longitudinal study, Dr. Roubenoff’s lab showed a 1.5%
       loss in strength of knee extensors and flexors per year in men and women between ages
       60 and 70. Men, but not women, also lost strength in their elbow extensors and flexors
       during that period. Clumping of muscle fibers also increases with age.

      Cross-sectional studies show a decline in number and size of Type 2 muscle fiber, but not
       Type 1. Protein synthesis measurements show no change in whole body protein synthesis



                                                                July 9-10-rehab conf—Page 6 of 18
       but a decline in rate of myofibrillar synthesis with age. Resistance exercises target type 2
       fibers and improve muscle protein synthesis within 2 weeks in elderly men.

      In men, older fibers of both types 1 and 2 produce less force. The larger fibers of men
       produce more force than those of women, but their smaller fibers produce the same
       amount, which is one piece of evidence (there are others) that simplistic models are not
       applicable.

      Although growth hormone secretion decreases with age, among postmenopausal women,
       those with lowest muscle mass had the highest GH secretion over 24 hours. It is possible
       that fat mass was the confounding factor. Fat mass suppresses GH in animal studies and
       also secretes tumor necrosis factor, which has a catabolic effect on muscle.

      Changes in both catabolic and anabolic cytokines may be linked to changes in muscle
       mass in the elderly. For example, IL-6 production is 2x higher, and IL-1 receptor
       antagonist is 3x-5x higher. In women, IL-6 production is a predictor of loss of muscle
       mass, but in men, it is a low level of insulin-like growth factor-1 that correlates with
       muscle mass loss.

      A rat model involving induced weight loss has been useful for examining cytokine gene
       expression patterns, which differ in Types 1 and 2 muscle fibers. White blood cells were
       eliminated as a potential source of the muscle cytokines. For some cytokines, activity
       occurs when they are injected into rats but not in culture. This suggests that they are
       secondary mediators.

      Regarding exercise: Running downhill caused a larger increase in IL-6 in younger vs.
       older humans. Diabetics who undertook resistance training increased their muscle
       catabolic cytokinesTNF, transforming growth factor, and IGF-1but not circulating
       levels. They also were able to decrease their diabetes medications. Multivariate analysis
       linked the TNF and TGF changes with physical activity and IGF-1 with change in
       strength. A longitudinal exercise study in the elderly also showed reversal of the decline
       in muscle mass and strength within a few months.

      Regarding nutrition: There is a level of dietary intake so low that it prevents
       strengthening through exercise. In nursing home studies and in HIV patients receiving
       nutritional supplements, exercise improves strength 2x-3x more than better nutrition.

Dr. Ron Hayes
University of Florida

Dr. Hayes presented his views on the interface between CNS injury/disease and rehabilitation.

      No animal model of brain injury can fully represent the human situation. Nor can single
       gene or single protein studies suffice since multiple pathways are involved. Dr. Hayes
       anticipates that rehabilitation medicine will be a fruitful area for collaboration between



                                                                July 9-10-rehab conf—Page 7 of 18
    basic and clinical researchersand an area in which pharmaceutical companies are
    unlikely to wish to compete.

   Responses to injury, training, or even intentional modulation show thatdespite earlier
    conceptsthe adult brain is extremely plastic. Relevant rehabilitation medicine research
    could explore the behavioral and environmental determinants of this plasticity, the effects
    and timing of behavioral and environmental therapies, and application of new
    technologies.

   Some examples:

    (1)    Cognitive strategies are synergistic with medications in Alzheimer’s patients.

    (2)    Conversely, the risk of Alzheimer’s increases even 10x in individuals who have
           undergone traumatic brain injury.

    (3)    Various motion-based therapies are more effective in the presence of adrenergic
           agents or amphetamines.

   The translation of research on how to improve survival in traumatic brain injuries to the
    clinic has been disappointing. One study shows that the guidelines of the American
    Association of Neurological Surgeons are not followed 75% of the time and that most
    trauma centers do not follow them.

   Technological areas offering opportunities for research with humans:

    (1)    Imagingfor a noninvasive look at brain function and brain chemistry;

    (2)    Neurally-based prostheticsdeveloping systems that predict movement and then
           superimpose movement processors to control motor movement;

    (3)    Stem cell biology in combination with gene and proteonomic expressionto
           obtain information on what determines differentiation and apply this to control the
           environment in a subject.

   No one therapy can cure a brain injury. However, while it is possible to design a
    randomized controlled trial to test multiple therapies, such a trial would be very large and
    would require multicenter participation and public funding.

   New paradigms and multidisciplinary approaches are needed to further rehabilitation
    research.




                                                             July 9-10-rehab conf—Page 8 of 18
INFRASTRUCTURE AND CAPACITY BUILDING

Dr. Gerben DeJong
Neuroscience Research Center
National Rehabilitation Hospital

Dr. DeJong framed the discussion on infrastructure and capacity building.

      With the benefit of the earlier presentations, we need to consider the preconditions for
       sound translational research—research that translates from basic science to clinical
       research/practice to health policy. In short, what kinds of infrastructure must be in place
       to facilitate transdomain or translational research?

      The discontinuities from basic science research to clinical research/practice to health
       policy are not unique to medical rehabilitation. These discontinuities transcend the health
       sciences. There is much that medical rehabilitation can learn from other fields and
       disciplines that also face these discontinuities. Looking at experiences in other health
       sciences may aid medical rehabilitation research in determining the capacities it needs to
       thrive.

      When we think about infrastructure and capacity building, we need to consider the
       following:

       A.     Physical capital

              1.      Facilities and laboratories
              2.      Information and communication systems
              3.      Databases
              4.      Adequate funding from both public and private sources

       B.     Human and intellectual capital

              1.      Institutional/organizational leadership
              2.      Research leadership
              3.      Institutional knowledge and history
              4.      Basic science/clinical science/health services research
                      a.       Content
                      b.       Methods
              5.      Training and mentoring
              6.      Peer networks

       C.     Social and political capital

              1.      Institutional support
              2.      Institutional research culture
              3.      Stakeholder buy-in and support


                                                                July 9-10-rehab conf—Page 9 of 18
              4.      Political support
              5.      Research partnerships
              6.      Professional and research associations
              7.      Alliances with industry

      Increasingly, large-scale research with enough statistical power requires multi-center
       trials and collaboration. We need to consider the preconditions for sound multi-center
       research—information and communication systems, databases, collaborator and
       institutional buy-in. Multi-center research requires a much more sophisticated research
       capacity in terms of leadership, obtaining buy-in, research methods, and databases.

      Infrastructure and capacity building in trans-domain or translational research raises more
       fundamental questions about overall medical rehabilitation research capacity. Trans-
       domain or translational research capacity assumes that medical rehabilitation already has
       some fundamental research capacities upon which to build. Thus, the capacity for
       translational research cannot be considered independently of the capacity for medical
       rehabilitation research in general.

Dr. Susan Horn
Institute for Clinical Outcomes Research

Dr. Horn presented her work on the “clinical practice improvement” (CPI) method as an
alternative or complement to randomized clinical trials (RCTs)

      Clinical practice improvement is a methodology that analyzes the contents and findings
       of individual steps of the healthcare process to determine how to achieve the best
       outcomesthat is, what to do and when for specific types of patients who may vary in
       the severity of their illness. [See www.isisicor.com for more information on CPI.]
       Learning precisely what to do for better outcomes can decrease the costs of patient care.

      CPI is distinct from (1) outcomes research, which is not connected to detailed process
       stages and does not adjust for different severity among patients; (2) guidelines, which
       provide a menu of steps, define patients too vaguely, and are not connected to outcomes;
       and (3) randomized clinical trials, which usually test only one treatment at a time, include
       only a minority of patients with the problem being studied, subject them to more than
       everyday treatment, and often are not generalizable.

      While the RCT is generally viewed as the highest quality approach, two recent studies in
       the New England Journal of Medicine (June 22, 2000) concluded that the results of
       observational studies and RCTs were quite similar. Dr. Horn views CPIs and RCTs as
       complementary.

      When CPI was applied to severity of symptoms and types of treatment in long-term care
       (111 facilities, 2,490 residents), one result was that pressure ulcers clearly linked to
       incontinence and occurred less frequently with use of disposable briefs (vs. catheters) and
       with better nutrition and the G3 type of pressure-relieving bed.


                                                               July 9-10-rehab conf—Page 10 of 18
      Dr. Horn’s research group also foundbased on three different measuresthat long-
       term care residents with dementia were best managed with combination therapy. This is
       in direct contrast to the recommendations of previous guidelines.

      To deal with the comprehensiveness of CPI, such as the tracking of multiple factors for
       both patient condition and treatment across multiple sites, an internet-based informatics
       infrastructure is useful. It improves the accuracy of documentation, eliminates redundant
       data entry, and permits sharing and easier analysis of data. The investment is recouped
       by the reduction in resources needed to achieve improved patient outcomes.

      Because individuals who have had strokes are the patients most in need of rehabilitation,
       Dr. Horn illustrated how to plan for a CPI protocol using post-stroke rehabilitation as the
       subject and setting forth the goal, data collection instruments for the multiple disciplines
       involved, and possible process, patient, and outcome variables. This study is currently
       planned for 8 sites and 1,600 subjects.

      During discussion, it was pointed out that a CPI study costs much less than an RCT (e.g.,
       $1 million for the complex long-term care study vs. $35 million if it had been an RCT),
       and that the results of a CPI study can be used to better focus the design of a confirmatory
       RCT.

Dr. Joel Myklebust
National Institute on Disability and Rehabilitation Research

Dr. Myklebust presented his views on the infrastructure and capacity needed at the interface
between basic and applied research.

      NIDRR “conducts comprehensive and coordinated programs of research and related
       activities to maximize the full inclusion, social integration, employment, and independent
       living of disabled individuals of all ages” [see
       http://www.ed.gov/offices/OSERS/NIDRR/], For FY 2001, NIDRR’s budget is $100
       million. Currently, NIDRR spends 60% of its small business innovation research budget
       on research and development and supports 35 rehabilitation research and training centers
       and 14 rehabilitation engineering research centers. [See funding opportunities at
       http://www.ed.gov/offices/OSERS/NIDRR/#INFORMATION.]

      NIH spends about $164 million on rehabilitation-related research (broadly defined). The
       entire federal government spends about $350 million in disability and rehabilitation-
       related research.

      Alternate ways to bridge the gap between basic and clinical science include cross-training
       of basic and clinical researchers, use of a facilitator, increased collaborations, a feedback
       loop from the customer using the product, and efforts to counteract the devaluation of
       research. Cross-disciplinary topics and broad collaborations that go beyond biology to,
       for example, electronic and informatics should be encouraged.


                                                               July 9-10-rehab conf—Page 11 of 18
      Several kinds of infrastructure could assist translational research, such as the research
       networks that the National Center for Medical Rehabilitation Research [see
       http://www.nichd.nih.gov/about/ncmrr/networks.htm] is sponsoring, the NIDRR model
       systems program, and the GCRCs if the latter could add support for physical and
       occupational therapy to their other research resources.

      Clinicians need both more training in clinical research and more time to conduct research.
       To accomplish these requires institutional support.

Dr. Michael Weinrich
National Center for Medical Rehabilitation Research
National Institute for Child Health & Human Development

Dr. Weinrich presented his views on how to promote infrastructure and capacity building.

      To develop new clinical tools requires educating clinicians, extending basic science,
       using evidence-based science to determine practice, and conducting RCTs of adequate
       poweror, alternatively, CPIs. Only an RCT can test an intervention that does not yet
       exist (e.g., 6 hours of physical therapy for stroke instead of 3 hours). Patients are unique,
       but the study process is not.

      The field of rehabilitation medicine needs definitions of therapeutic interventions;
       convenient, meaningful outcome measures; a supportive research culture; collaborative
       teams; a new curriculum; and recruitment and retention of researchers.

      Relevant funding opportunities at NIH [see
       http://grants.nih.gov/grants/funding/funding_program.htm] include institutional training
       grants (the T series), career development grants (the K series), research awards (the R
       series), the SBIR and STTR (Small Business Technology Transfer) grants, and the
       multidisciplinary bioengineering research grants and partnerships.

      In response to Dr. Weinrich’s remarks, discussants highlighted both the importance and
       difficulty of identifying a mentor and the possibility that a mentor with a good track
       record on funding may need to come from outside the rehabilitation medicine
       department.

WORKSHOP REPORTS

Workshop 1: Promising opportunities

Moderator:    [Name]
              [Institutional affiliation]

Recorder:     [Name]
              [Institutional affiliation]


                                                                July 9-10-rehab conf—Page 12 of 18
    Early opportunities:

   Improving the quantity and quality of research: Use seminars and other aggressive
    mechanisms to attract bench scientists to rehabilitation research. Fund grants requiring
    multidisciplinary, problem-focused research groups. Teach grantsmanship and encourage
    mentors both locally and via distance learning. Fund research apprenticeships as well as
    career development. Fund fellowships and debt-forgiveness programs.

   Use funding to encourage translation of potentially fruitful basic science results in the
    following subjects:

    o      Pharmacologic agents that enhance cognitive performance in animal models;
    o      Pharmacologic agents combined with exercise to enhance bone density;
    o      Optimization of mechanical-stress-based therapies;
    o      Effect of oxidative stress and inflammation on exercise interventions;
    o      Imaging as an aid to muscle/motor control research and treatment;
    o      Applying CNS plasticity to recovery of function;
    o      Applying models, including CPI, to enhance clinical practice;
    o      Applying knowledge of swallowing to treatment of impairment and function;
    o      Applying theoretical and biomechanical models of neural control to CNS insult;
    o      Effect of memory on disability and societal adaptation to it; and
    o      Use of computerized dynamics to assess (a) complementary practices to treat pain
           and impairment and (b) social and psychological impact of disability on
           caregivers and family function.

   Investigate why successful clinical methods work.

    Longer-term opportunities:

   Create productive rehabilitation research environments by:

    o      Building a research culture in institutions and academia,

    o      Clearly defining the purpose and scope of rehabilitation research programs and
           defining the competencies and resources they require,

    o      Establishing research rotations for students and residents,

    o      Providing economic incentives for incorporating research into the curriculum,

    o      Training vertically (integratively), and

    o      Promoting vertical integration specialties.




                                                            July 9-10-rehab conf—Page 13 of 18
      Obstacles:

     Academic values that interfere with collaborations between basic and clinical scientists;
     Financial issues promoting care vs. research;
     Clinical faculty and practitioners uninterested in research;
     Limitations on tools, time, and funding for proposal writing;
     Lack of comprehensive, domain-crossing models and tools.

Existing approaches

     Focus on function (which encourages cross-disciplinary and integrative approaches);
     Develop training curricula that call for both clinical and research competencies;
     Offer physiatry and orthopedics residencies that provide research rotations;
     Encourage universities to fund release time and/or junior-senior partnerships for grant
      writing and pilot studies;
     Offer tutorial and retooling courses;
     Conduct research retreats;
     Create visiting faculty/scholars programs;
     Endow faculty positions/chairs;
     Create links to federal and corporate facilities.

Workshop 2: Infrastructure and capacity-building

Moderator:   [Name]
             [Institutional affiliation]

Recorder:    [Name]
             [Institutional affiliation]

     Standardization: Explore how to standardize measurement methods, terminology, and
      databases to facilitate data sharing for both retrospective and prospective studies.

     Research training: Attract research-oriented residents with a strategy and curriculum that
      stresses mentoring, researcher-clinician alliances, links from rehabilitation departments to
      academic centers (including through telecommunications), and workshops on obtaining
      grants.

     Alliances: Create alliances among professional societies both nationally and
      internationally. Explore opportunities for international research collaborations.

     Definition: Broaden the definition of rehabilitation to include any aspect that can
      contribute to restoration or improvement of function.




                                                              July 9-10-rehab conf—Page 14 of 18
      Public education: Promote an understanding of rehabilitation medicine research among
       legislators and the public, including the need for a rational research agenda (vs. being
       driven only by disease interest groups).

Workshop 3: Bringing research into the clinical arena

Moderator:    [Name]
              [Institutional affiliation]

Recorder:     [Name]
              [Institutional affiliation]

      Bringing research into clinical practice: This includes:

       o      Interdepartmental and interdisciplinary collaborations;

       o      Clinical systems like the NIDRR model traumatic brain injury projects;

       o      State-of-the-art conferences that identify efficacy of care, strength of the evidence
              (possibly leading to clinical practice guidelines), and scientific opportunities; and

       o      An expanded, multifaceted view of care that includes the person, community, and
              populations as well as the disease, and adjustment and adaptation if there is no
              cure.

      Bringing research into policy: Stakeholder alliances and consumer buy-in are important
       in helping to translate clinical efficacy into health policy, e.g., making a good or service a
       part of a health plan’s benefit package. Stakeholders include agencies, consumer groups,
       healthcare providers, payers, and researchers.

      Establishing efficacy: Tools can include RCTs, CPI studies, long-term outcome studies,
       disability data from a large national health survey, and data on cost and function.

      Establishing health policy: Payers should fund studies to translate clinical efficacy into
       health policies. Proof is needed of fiscal as well as medical efficacy (quality =
       outcome/cost). Funding agencies should be proactive, using RFPs to guide the field (e.g.,
       in imaging, functional neurostimulation, joint replacement, xenotransplantation, ablative
       techniques, pain control, virtual reality systems, telehealth, rational drug design, and
       home care technology).

      Assigning responsibilities:

       o      Governmentfunding (including of infrastructure), dissemination, coordination;

       o      Academiamentoring, interdepartmental and interdisciplinary efforts,
              collaborations with industry;


                                                                  July 9-10-rehab conf—Page 15 of 18
       o       Private sectorclinical trials of pharmaceuticals and devices;

       o       Professional societiescirculate list of interested foundations and create
               foundations as well, network and communicate, improve conference agendas;

       o       Consumersadvocate on policy; philanthropic organizationsfund rehabilitation
               medicine, including endowed chairs;

       o       Allconsider whether there should be a separate national institute focused on
               rehabilitation research.

PLENARY SESSION: DISCUSSION OF WORKSHOP REPORTS

What the meeting accomplished vs what was envisioned for the meetings. The meeting
discussion went well beyond translational research, the original focus of the meeting, to a
discussion about the needs of medical rehabilitation research in general.

Other comments:

      The four regional network grants funded by NCMRR could be an effective model by
       which to facilitate research. [See http://www.nichd.nih.gov/about/ncmrr/networks.htm.]

      The common topics addressed in more than one workshop should be identified as
       potential priorities.

      The upcoming interdisciplinary conference of AAPMR should be able to further develop
       key areas for focus. The new Institute of Medicine report on chronic diseases can also
       offer guidance.

      Relevant professional societies should be encouraged to include at their meetings a
       section or day focusing on bridging the gapthat is, translational research.

      While it would be useful to have available a list of research subjects and the physiatrists
       who are principal investigators on those grants, current federal and association research
       rosters are incomplete.

       o The AAPMR Research Advisory and Advocacy Committee might address this topic.

       o An example was given of a professional organization that is able to centralize
         information because it conducts accreditationas well as setting curricula, standards,
         and scope of practice.

       o Establishing research retreatssimilar to the Gordon conferencesis a mechanism
         that could be used to help move the field forward faster.



                                                               July 9-10-rehab conf—Page 16 of 18
GLOSSARY


AAP        Association of Academic Physiatrists

AAPMR      American Academy of Physical Medicine and Rehabilitation

ACRM       American Congress of Rehabilitation Medicine

CPI        Clinical practice Initiative

GCRC       General Clinical Research Center

GH         Growth hormone

IGF-1      Insulin-like growth factor-1

IL         Interleukin

NCMRR      National Center for Medical Rehabilitation Research/ in the National Institute of
           Child Health and Human Development at NIH

NIDRR      National Institute on Disability and Rehabilitation Research/in the Office of
           Special Education and Rehabilitative Services in the Federal Department of
           Education

RCT        Randomized clinical trial

RFP        Request for proposals

SBIR       Small Business Innovation Research (program)

STTR       Small Business Technology Transfer (program)

TGF        Transforming growth factor

TNF        Tumor necrosis factor




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