BUILDING RESEARCH CAPACITY IN REHABILITATION SCIENCE

Institutional Sponsors
Neuroscience Research Center
National Rehabilitation Hospital

Clinical Center
National Institutes on Health

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
Gerben DeJong, PhD
     Neuroscience Research Center
     National Rehabilitation Hospital
Lynn Gerber, MD
     Department of Rehabilitation Medicine
     NIH Clinical Center

This conference proceedings was made possible in part by the U.S. Army & Materiel Command (Cooperative Agreement Award # DAMD17-02-2-0032, Cheryl R. Miles, project officer) establishing the NRH Neuroscience Research Center at the National Rehabilitation Hospital and the MedStar Research Institute in Washington, DC. The views, opinions, and/or findings contained in this paper are those of the author(s) and should not be construed as an official Department of the Army position, policy or decision unless so designated by other documentation.

BUILDING RESEARCH CAPACITY IN REHABILITATION SCIENCE

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
NIH Clinical Center

The conference entitled “Building Research Capacity in Rehabilitation Science” was held 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 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 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 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). 

* 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 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 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. 

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
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. 

* 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 was $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. 

* 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]

      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. 

      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. 

* 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;

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. 

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