Summary Minutes - December 2-3, 2013

National Advisory Board on Medical Rehabilitation Research (NABMRR)
National Center for Medical Rehabilitation Research (NCMRR)
Eunice Kennedy Shriver National Institute of Child Health
and Human Development (NICHD)
December 2-3, 2013

Dr. Nicholas LaRocca, Board Chair, called the 47th meeting of the NABMRR to order at 8:45 am. Future Board meetings will be: May 5-6, 2014; December 1-2, 2014; May 4-5, 2015.

Members Present:
Anthony Delitto
Sureyya Dikman                    
Gerard Francisco
Edgar Garcia-Rill
David Good
Carmen Green
Marilyn Hamilton
Fay Horak
Todd Kuiken
Nicholas LaRocca
Dennis Matthews
Richard Shields
Gary Smith
Roger O. Smith
Marilyn Price Spivack
Jonathan Wolpaw
 
Members Absent:
Carol Espy-Wilson
 
Ex-Officio Members Present:
Tim Brindle, VA
Daofen Chen, NINDS
Amy Donahue, NIDCD
Alan Guttmacher, NICHD
Lyndon Joseph, NIA
Yvonne Maddox, NICHD
Ralph Nitkin, NICHD
Lynn Padgett, NCI
Lois Tully, NINR
 
Ex-Officio Members Absent:
Ted A. Conway, NSF
Abby Ershow, NHLBI
Martin Gould, NCD
James Panagis, NIAMS
Michael Swanson, CDC
Cate Miller, NIDRR
 
NICHD Staff and Visitors:
David Annett, IMS
Cindy Caughman, NCCAM
Theresa Cruz, NICHD
Diane Damiano, NIH CC
FL Dammann, NICHD
Donald DeNucci, NIDCR
Craig Fisher, APA
Tinera Fobbs, NICHD
Sarah Glavin, NICHD
Shirley Groer, VA
Andrew Guccione, GMU
Audrey Hill, NICHD
Adnan Jalil, APTA
Rusti Johnson, NICHD
Teresa Jones, NIDDK
Lisa Kaeser, NICHD
Partap Khalsa, NCCAM
Naomi Kleitman, CHNF
Susan Lin, AOTA
Michael Marge, NICHD
Peter Mayberry, SBP
Mary Ellen Michel, NICHD
Jo Pelham, CSR
Grace Peng, NIBIB
Lou Quatrano, NICHD
Mary Rodgers, NIBIB
Christine Rogers, NICHD
Mona Rowe, NICHD
Brian Schultz, VA
Carol Sheredos, NICHD
Nancy Shinowara, NICHD
David Shurtleff, NCCAM
Cathy Spong, NICHD
Katie Stout, MRMC
Manana Sukhareva, NIBIB
Peter Thomas, DRRC
Nancy White, APTA  
Bill Winfrey, DCRF   
Cheri Wiggs, NEI   

Call to Order and Introductions

The agenda for the meeting was highlighted by Dr. Ralph Nitkin, and was followed by introductions from the Board members and visitors, including new Board members, Drs. Francisco, Horak, Dikman, Delitto, and Matthews. Minutes from the previous meeting were approved.

Report of the Acting NCMRR Director

Dr. Ralph Nitkin, as Acting Director, reported on NCMRR’s budget, initiatives, staff changes, and ongoing transition in response to the Blue Ribbon Panel (BRP) report about the Center’s role in facilitating rehabilitation research. Both sequestration and the government shutdown affected NIH’s budget in 2013. Dr. Nitkin discussed these funding changes and their effect on the NCMRR.

Dr. Nitkin discussed the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative. The BRAIN Initiative will have an operating budget of about $40 million in 2014, representing less than 1% of the NIH budget. This Initiative will target the development of technology that aims to yield wide-ranging benefits. The development of these technological advances is intended to provide “fundamental insight about how the nervous system functions in health and disease.” The BRAIN Initiative is designed to promote collaboration across labs and organizations. One focus of the BRAIN Initiative is circuits of interacting neurons, Dr. Nitkin explained; neuroscience working groups identified this area as holding great promise in accelerating brain research. Dr. Nitkin noted that a deep understanding of circuits requires:

  • Identifying and characterizing a circuit’s component cells
  • Defining cells’ synaptic connections with one another
  • Observing dynamic patterns of cellular activity in vivo during behavior
  • Perturbing these patterns to test their significance
  • Defining information processing algorithms within a circuit
  • Understanding the interaction among circuits in the brain as a whole

Dr. Nitkin reviewed the Medical Rehabilitation Research Infrastructure Network (MRRIN) program and the current seven research domains covered. As this program comes up for recompetition, the NCMRR would like to explore expanding into additional domains and seeks Board advice on key research opportunities.  

Dr. Nitkin provided an overview of the NIH BRP report, including its charge, roster of members, activities, and recommendations. Empanelled in 2011 by the Director of the NICHD and the Director of the NIH, the BRP reported to the NICHD Director.

Dr. Nitkin described the main takeaways from the report, released in December 2012, by stating that the Panel believed the NCMRR needed a stronger role for coordination, more independence, and a dedicated budget. Also, the Panel believed that the NCMRR and its Board should take a greater leadership role and set a vision for rehabilitation research at the NIH. The report also identified a “critical need to substantially increase all aspects of rehabilitation research across the continuum of translational research in order to meet the growing rehabilitation needs of Americans.”

In response to these recommendations, the NCMRR was going to adopt a new funding model in an effort to enhance coordination among the NIH Institutes and Centers (ICs). Under the proposed model, the NCMRR would transfer primary assignment of rehabilitation research applications to other NIH Institutes, when possible, and instead use NCMRR funds to focus more on co-funding rehabilitation research grants managed by other NIH Institutes, especially those applications that formerly had primary assignment within the NCMRR. The NICHD feels that the proposed model would address many of the BRP’s recommendations and the concerns of the rehabilitation community. However, the NCMRR will still be housed within the NICHD, contrary to the BRP’s recommendation that it become an independent entity. The NCMRR would maintain primary assignment and directly fund research infrastructure, training and career development, conferences, and small business grants.

Additionally, Dr. Nitkin noted, the new funding model for the NCMRR includes a dedicated budget equal to 6.5% of the NICHD extramural budget, an annual level (about $60 million) that reflects a modest increase from the last 5 years’ funding levels of the Center. NCMRR staff would largely switch their focus to coordinating and catalyzing rehabilitation research across the NIH, as opposed to grants administration per se. The Advisory Board would help provide strategic input to this funding strategy, reflecting stakeholder groups’ concerns. Dr. Nitkin outlined a timeline for these changes to the NCMRR. He added that the new model was in some sense “an experiment” and procedures would need to evolve over time.

Dr. Nitkin fielded a series of questions. One attendee requested clarification on the timeline. Dr. Nitkin said that this new model for the NCMRR cannot be completely operationalized immediately because it requires some work with the other ICs to lay the groundwork for the transition; the new model will need to be implemented over time. In response to whether a continuation of the sequester would further reduce the NIH budget, Dr. Nitkin noted that the NIH is not expecting impact to be as great as before; however, the legislative details are still being resolved.   

One attendee asked how the other ICs have worked with establishing specific rehabilitation review sections. Dr. Nitkin said that review expertise is recruited from the bottom up in response to the investigator-initiated applications that are submitted, rather than through a formal top-down directive. In fact, several study sections in the Center for Scientific Review (CSR) are good homes for rehabilitation research; within some of the other ICs, the in-house study sections are increasingly focusing on functional outcomes, which is also good for the rehabilitation field.

One attendee asked how much staff the NCMRR has compared with other organizations of the same funding size, and whether the Board would start thinking about emerging themes for rehabilitation infrastructure. Dr. Nitkin said that other NIH coordinating organizations like the Office of Research for Women’s Health (ORWH) have more staff. He said that the NICHD is having a “staffing crunch” in general, and although the NCMRR does need more support many NICHD components, need support as well. Dr. Yvonne Maddox added that there are also limitations on staff travel and conferences that may impact the NCMRR, and that the NICHD is facing difficulties in hiring new employees with a reduced Research Management and Support (RMS) budget.

Another attendee asked if the role of the NCMRR should serve as the “translational engine” for research that is done in other ICs, as opposed to doing the same thing that other ICs are doing and coordinating it better. Dr. Nitkin said this was an interesting concept and added that the Center could do a lot of good in that area. Dr. Nitkin added that clinical trial design is also an important issue in rehabilitation research.

One participant made a general comment that the ability to innovate is very important, and some of the things that need to be done could be done through public-private partnerships. For example, partners could help with conferences. The attendee suggested that members should be thinking about how others can help as the NCMRR moves forward.

Another attendee asked how funds will be allocated operationally by the NCMRR across the areas—i.e., infrastructure, conferences, co-funding, etc. Dr. Nitkin said that the NCMRR will need to work with colleagues from other ICs to determine the process.

Rehabilitation Research Portfolios of Other NIH Institutes

Dr. Theresa Cruz led a discussion of the types of rehabilitation research supported by other NIH Institutes. She explained that “rehabilitation” is a cross-cutting topic at the NIH and falls within the mission of several NIH Institutes; the NCMRR is only one source of rehabilitation funding at the NIH. Under the new funding plan, the NCMRR will co-fund studies with the other ICs to support rehabilitation research at the NIH. Rehabilitation research funded by NCMRR encompasses basic, applied, and clinical research and disease-specific and disease-agnostic research. Dr. Cruz detailed the type of rehabilitation research funded by each Institute from 2008 to 2013. 

Program officers from National Center for Complementary and Alternative Medicine (NCCAM), National Cancer Institute (NCI), National Eye Institute (NEI), National Institute on Aging (NIA), National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute of Dental and Craniofacial Research (NIDCR), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Nursing Research (NINR), and Department of Veterans Affairs (VA) attended. Dr. Cruz invited each program officer to add more information to the description involving their Institutes. 

NINDS: Central Nervous System (CNS) plasticity, motor control, and sensorimotor integration; stroke, spinal cord injury, traumatic brain injury (TBI), cerebral palsy, Parkinson’s disease, and pain; neural prosthetics, functional electrical stimulation, non-invasive brain stimulation, imaging, and motor training. The NINDS representative pointed out that rehabilitation is very important to the Institute’s strategic planning and that rehabilitation research is distributed across a number of portfolios throughout the NINDS. The representative also noted that the word “recovery” is often used instead of “rehabilitation” at the NINDS.

NIDCD: Hearing, speech, and language rehabilitation; deafness, aphasia, dysarthria, tinnitus; hearing aids, cochlear implants, augmentative and alternative communication; vestibular, balance, and postural instability. The NIDCD representative indicated that her IC funds speech language research resulting from a number of conditions and works with other ICs on those conditions.

NICHD: The NCMRR funds research on CNS and musculoskeletal plasticity, motor control, and sensorimotor integration; spinal cord injury, stroke, TBI, cerebral palsy, musculoskeletal disorders, and limb loss; mobility, prosthetics and orthotics, assistive devices, outcome measures, and behavioral interventions. The NICHD also has Branches that fund research on pediatric trauma and critical illness and on intellectual and developmental disabilities.

NIA: Understand aging and extend healthy life; balance/falls, gait, mobility, and environment; osteoporosis/fractures and frailty; stroke, Parkinson’s disease, and dementia. The NIA representative stated that when NIA looks at rehabilitation research, it is from the perspective of keeping people independent as they age and to prevent them from going into nursing homes or other care facilities.

NCI: Rehabilitation after surgery, radiation, and/or chemotherapy; exercise and weight loss; fatigue; survivorship, and psychosocial and cognitive outcomes; quality of life specific to cancer type (e.g., sexual health, urinary tract health). The NCI representative said that as cancer survivorship grows, rehabilitation research is a growing area for NCI, including cognitive rehabilitation.

NEI: Blindness and low vision; cortical plasticity; neural prosthetics and assistive devices. The NEI representative added that with assistive devices, NEI coordinates with other ICs such as NIBIB. She also emphasized NEI’s interest in low vision and technologies to help people who have reductions in sight later in life, who may have different needs from people who are blind all their life.

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): Rheumatic diseases, cartilage and connective tissue, muscle disease, bone biology and diseases, and skin diseases; musculoskeletal injury—tendon and ligament repair and rehabilitation, fracture repair; exercise physiology; osteoarthritis, scoliosis, and pain, including low back pain;

National Heart Lung and Blood Institute (NHLBI): Exercise associated with treatment for cardiovascular disease, Chronic Obstructive Pulmonary Disease, and claudication; sleep disorders; heart valve replacements, stents, and left ventricular assist device;

NIBIB: Disease and condition agnostic, technology-driven; rehabilitation engineering—brain computer interface, neural prosthetics, neurotechnology, modeling, and robotics; multiple imaging modalities (acquisition and processing), biomaterials, implantable medical devices and systems, biocompatibility, regenerative medicine and tissue engineering, sensors, and telehealth and point-of-care technologies; epidural and transcutaneous spinal stimulators, intelligent prosthetics, regenerative scaffolds, microECOG, and nanoelectrodes. The NIBIB representative said that NIBIB partners very frequently with the NCMRR on co-funding, and it works very well. She added that other programs in NIBIB also have implications for rehabilitation.

NINR: Disease and condition agnostic; prevent disease and disability; symptom management; end-of-life and palliative care; wellness and self-management; family and caregivers. The NINR representative said that NINR is focused on prevention and quality of life. She stated that NINR is a small IC but is interested in training as well as research support. There is no specific rehabilitation research portfolio at NINR, but rehabilitation-related research spans a number of NINR portfolios, including caregiving.

NCCAM: Thai chi, guided imagery, massage, acupuncture, and pain. The NCCAM representative said that pain management is a major area for the NCCAM and it has a strong mind-body program. NCCAM also has strong collaborations with Department of Defense (DoD) and VA. Dr. Nitkin said that there is overlap between the NCCAM and the NCMRR in terms of clinical trial design.

NIDCR: Oral care in people with disabilities and osseointegration. The NIDCR representative said that dental implants are of interest, as well as rehabilitation for oral cancer and craniofacial anomalies. He said NIDCR gets ideas from practitioners on rehabilitation needs

NIDDK: Physical activity for people with diabetes and/or kidney disease, bowel and bladder, and skin ulcers. The NIDDK representative said that she sees a lot of overlap with the NCMRR and looks forward to being a part of the working group. She said that NIDDK has a major interest in optimizing nutrition and secondary prevention of diabetic ulcers and improving quality of life.

National Institute of General Medical Sciences (NIGMS): Burns and tissue and regenerative medicine.

National Institute of Mental Health (NIMH): Cognitive/psychosocial remediation, and psychiatric and behavioral disorders secondary to chronic disabilities (e.g., depression, aggression).

National Institute on Drug Abuse (NIDA): Pain medication and other treatments.

National Center for Advancing Translational Sciences (NCATS): Clinical and Translational Science Award (CTSA)/infrastructure and bridge awards.

In addition, there are a number of other federal supporters of rehabilitation research:

  • National Institute on Disability and Rehabilitation Research (NIDRR), located in the Department of Education
  • The VA representative said that VA research is generally intramural research, but it also funds some collaborative work with DoD. One board member indicated that it is possible for some extramural researchers to apply to the VA intramural program; in response, a program officer reminded everyone that the program officers at the VA need to be contacted first. Dr. Nancy Shinowara mentioned that VA research has suffered from budget cuts.
  • DoD, include the Defense Advanced Research Projects Agency (DARPA) and the Telemedicine & Advanced Technology Research Center (TATRC). A DoD representative stated that DoD research has been affected by budget cuts.

One Board member said that the NIMH has gone away from the disease entity and moved to cross-cutting criteria and constructs. He advocated doing something similar for the NCMRR.

One Board member asked what the unique contribution was of the NCMRR. Dr. Cruz stated that some NCMRR niches include orthotics, wheelchairs, and other assistive devices and also most of the research on limb loss. She emphasized that all rehabilitation applications will have a home. An audience member stated that the NIH is not receiving applications in some areas. Dr. Cruz indicated that if some key areas are not represented in the analysis or there does not appear to be appropriate study section review groups, it might be because there are not enough applications to justify it. Moreover, she indicated that her analysis was based on funded applications only. Another board member said that there are more ICs in the room than he has ever seen before and that he appreciated that.

Concept Clearance

Because of its broad expertise, the Board is sometimes called on to provide the NCMRR with a first level of review for potential research initiatives. Board members received brief background material in the weeks prior to the meeting for two specific proposals described below. NICHD Deputy Director, Dr. Yvonne Maddox, presided over the concept clearance process. Dr. Maddox emphasized the need to keep the discussion at a broad level.

The Board was presented with an initiative on the use of biomarkers to assess TBI over time. Dr. Mary Ellen Michel, of the NCMRR, stated that biomarkers are needed that go beyond the acute phases of the injury. Although chronic traumatic encephalopathy can be diagnosed at the end of life, there are no dynamic measures of brain pathophysiology. Dr. Michel added that health professionals need to be able to follow the progress of TBI beyond the acute phase to help develop rehabilitation interventions. The biomarkers initiative uses the Small Business Innovative Research (SBIR) mechanism because there are some companies who are working in this area, and these companies would be motivated to get something on the market. Dr. Michel said this could be the incentive to get people working in the chronic as well as acute phase.

One Board member stated this is an opportunity whose time has come. She added that the Centers for Medicare and Medicaid Services (CMS) needs to be part of the discussion to work on rehabilitation, as well, because “buy-in” will be needed to get people access to rehabilitation therapies. Another Board member agreed. Another commenter stated that the Food and Drug Administration (FDA) also needs to be involved. One Board member said that biomarkers need to be defined carefully because secondary conditions may also influence biomarkers, and that the scope needs to be thought out carefully. An agency representative reported that the VA, DoD, and the NINDS are supporting projects that may have some relationship to this idea, and some collaboration with them would be helpful. Dr. Michel stated that these projects have been and will be looked at.

One Board member stated this biomarkers concept should go beyond the SBIR mechanism to develop R01 projects. Dr. Nitkin said that the NCMRR is receiving R01 type applications in this area, but that more business-based applications are needed. Another Board member stated that translational work will be needed in relation to the biomarkers concept. Another commenter indicated that it might be helpful to hone down on the most important complications of chronic TBI and then to see if biomarkers could be helpful. Dr. Michal responded that the heterogeneity of the chronic TBI population will pose challenges because many complications occur, and that long-term patient follow-up will be needed. One Board member stated said that it is easy to develop a biomarker and difficult to validate it. Another commenter added that DoD, National Football League (NFL), and others may want to co-fund this research. Concept concurrence was granted.

Introduction to Afternoon Breakout Groups

Dr. Nitkin gave an overview of the purpose of the three breakout group discussions that were to be held later in the afternoon. The objectives of breakout group discussions included the following:

  • To help start a strategic planning process
  • To help identify unmet needs, relationships the NCMRR needs to build, and infrastructure that needs to be made available
  • To prioritize; some topics are mature and may not need additional facilitation, while topics may need specific support or to be incentivized
  • To consider how the NCMRR can facilitate research that is really helping people with disabilities
  • To discuss career development needs

Dr. Nitkin provided the groups with a list of research themes for discussion, ranging from plasticity to secondary conditions to chronic pain. Dr. Maddox reminded the groups to think about not just what the NCMRR and the Institutes can do, but about what would this provide to the field of medical rehabilitation research.

Once given their objectives, each group held discussions about the NCMRR and its role in rehabilitation research. Then, each breakout group reported its initial findings to the whole group on day one of the conference, followed by more finely honed reports on day two of the conference.

Discussion by Breakout Group 1

The breakout group first addressed the staffing and logistical issues that the new funding paradigm presents to NCMRR staff. The group expressed a desire for a permanent NCMRR director to be hired as soon as possible. NCMRR staff was encouraged to have frequent, regular interactions (formal and informal) with other NIH program staff to help increase rehabilitation research at the NIH.

The group discussed the difficulty of performing rehabilitation clinical trials and suggested that, in the next round, an R24 rehabilitation research infrastructure site be dedicated to educating the field regarding clinical trial design and methodology. They also suggested R24 sites related to pediatric rehabilitation and secondary injury following disability. The group members indicated that both of these areas could present opportunities for collaboration with the new pediatric trauma branch at the NICHD. The group proposed that the NCMRR support the R34 clinical trials planning grant as a funding mechanism to help the field submit stronger applications for clinical trial grants to institutes across the NIH.

The group discussed the need for long-term follow-up for intervention studies, talking specifically about the need for these types of data to justify costs to third-party payers. Several group members discussed the possibility of using telemedicine technologies to collect the follow-up data. Health services research, particularly use of services with respect to health insurance reform, and clinical effectiveness studies were also cited as two areas ripe for attention.

Other avenues of research that the group felt the NCMRR should consider include genomics with respect to response to treatment, autonomic dysfunction, biofeedback via brain–computer interface, plasticity with emphasis on the connection to functional outcomes (perhaps using common data elements from the NINDS), gender and women’s health issues, psychosocial factors to rehabilitation, and the role of caregivers.

For a future Advisory Board meeting, the group indicated that it would like a report on the R24 rehabilitation research infrastructure program, including assessment of the program’s success through varying metrics and the desired outcomes for the next iteration of the program.

Finally, the group renewed the NCMRR’s commitment to training and dissemination. The NCMRR was encouraged to interact with the new NICHD Communications Director to revitalize the NCMRR newsletter and social media presence. 

Discussion by Breakout Group 2

A variety of points were made regarding infrastructure needs. One participant expressed concern about how the process of transition is going to play out for the NCMRR, saying that the process is not well elucidated and that it is not clear how this will happen operationally. Another person asked whether there will there be a single point of contact for ICs or whether different part of ICs will be involved. One attendee asserted that collaboration depends on relationship building and trust. This relationship building requires staff time and focus to deal with personality issues, and it is unclear whether there is enough staff or the right skill set for this effort. Taking grants that are assigned to one IC, with its own set of paylines and ideas, and giving them to another IC will be difficult. Larger ICs have their own priorities and will not like being handed grants and told that they will get only partial co-funding. The other general organizational issue confronting this NCMRR shift is that there has yet to be any announced plan to open a search for a new NCMRR director. Although the NCMRR has a strong Acting Director, this search needs to be completed.

The discussion then turned to clinical trials design, described as a “knotty” issue confronting rehabilitation research. Several group members stated that the operating paradigm for clinical trial design is the drug trial, which generally entails a straightforward comparison between intervention and control groups. However, rehabilitation research involves more complex interventions, dedicated people who deeply believe in the intervention and become involved with participants, and long periods of time. This combination of factors creates problems for clinical trial design. Even a crossover design, which may address some of these issues, can be problematic. One group member posed the question: “Given two interventions that both work to some extent, how can researchers determine which intervention works best for each person?”

Additional questions were also raised regarding clinical trial design for rehabilitation research. Does the rehabilitation research sphere need different criteria for review panels to assess research proposals for clinical trials, or is the need for different people on the review panels? Is there a need for R34 clinical trial planning grants or similar mechanisms? One of the MRRIN centers could provide assistance in this regard. One participant questioned the assertion that there is a problem with the review committees and said the issue should be framed as a field issue rather than a review issue. How should patients be monitored in clinical trials in non-acute environments? Can NCATS be the appropriate partner on this issue?

One participant said there was a need to increase understanding of clinical trial design issues in the field as a whole, rather than designing one individual trial, and that researchers should bring issue of trials to the field. This could be done via an MRRIN center. There may be a need to emphasize specific research topics with more advanced science, where the field is ready for such a trial. Partnering with an IC that is running an acute trial to add a rehabilitation component might be easier than starting a rehabilitation trial from the ground up.

The discussion then turned to telemedicine and rehabilitation research. Participants asked whether the NCMRR should be concerned with telemedicine issues and how to develop mechanisms to promote telemedicine follow-up and interventions. Without long-term follow-up, researchers would not know about the outcomes, and this is essential for rehabilitation. Another possibility could be to develop or adapt an instrument to measure state of rehab/quality of life (QOL) over a long distance.

Because chronic diseases do not go away, long-term environmental support is important. However, participants questioned how well developed telemedicine is with regard to rehabilitation. There are different components to telemedicine — not just having a device, but knowing how to use the device in a home, for example. There are technology issues, privacy issues, and human factors issues in telemedicine. The issue is really how to create home-based rehabilitation, especially in the long term. Are there research opportunities related to that goal and, if so, what are they? Research to show these interventions’ effectiveness is needed to ensure that such interventions can be covered by insurers even without a clinical facility or visit.

Breakout group participants then discussed possibilities for interventions to improve plasticity. Plasticity is widely recognized as a key concept, but participants stated that it is unclear what should the NCMRR do related to plasticity. Moreover, they pointed out that plasticity is a matter of timing, which is key to providing whatever benefit can be delivered from rehabilitation interventions. Participants discussed whether different types of brain imaging could reveal the effects of TBI, stroke, or other injury on the brain before and after rehabilitation interventions. Plasticity applies not just to the brain but also to the rest of the neurological system and the musculoskeletal system. However, rehabilitation patients need not just plasticity but functionally relevant plasticity, with a view toward how it contributes to recovery. There is a lot of work going on in this area, but more research is needed.

Participants also stated that rehabilitation professionals such as physiatrists and physical therapists need new measurement tools to allow them to look more closely at function and recovery. The participants agreed that there are a lot of outcome measures available but no consensus about these measures—every grant has its own outcome measure, and researchers cannot combine or compare analysis of different outcome measures.

Participants then turned to an examination of the effect of the infrastructure program and assessing its success. This included a question of how should the NCMRR measure success for an infrastructure program, as well as what the NCMRR should be asking from the Centers in the next funding round. One participant replied that an evaluation should look at the networks’ specific aims and how the networks advanced their aims. Another person indicated that another measure of success is how many pilot projects turned into grants, as well as how the commercialization process worked. Another participant commented that turnover in the program has been high and asked who decides on the topics. NIH staff indicated that the review process has done a good job of ensuring that the best projects are selected and that it is somewhat up to the field (applicants) to decide on topics.

One participant said that researchers should look at the mechanisms of secondary injury, which are overlooked and under-researched. Participants also want to see more work on aging with disability and comorbid conditions. As they age, people with disabilities are more likely to develop comorbidity, and many do not have access to specialty care. Breakout group members identified accessibility for people with disabilities to medical and allied services—not just access to insurance but also accessible facilities and expertise in dealing with people with disabilities—as another area of interest. Many people are unaware of what is available in rehabilitation, and this gap in information contributes to lack of access. Some participants noted that accessibility is a large social issue that the NCMRR may not be in a position to address this, but there may be research questions related to this issue.

Two participants emphasized the need to prove that rehabilitation services are worth compensation by insurers. They advocated for comparative-effectiveness research on common rehabilitation therapies.

Another need in the rehabilitation world is for pediatric studies to be included within rehabilitation research. In particular, research studies that focus on long-term impacts of injury/condition and intervention in children are needed. Participants posited that a network site that focuses on children could be helpful.

Participants then examined the use of technology in rehabilitation. Brain-computer interface is a hot topic; interventions are not generalizable or practical yet, but they could be useful in the future. The initial emphasis in the field has been on communication and control, but those technologies are a long way from practical use, and many are for limited populations only. Can these technologies be used to measure effects of brain or muscle stimulation? There are many variables to investigate with stimulation (frequencies, intensities, mechanical, timing, etc.). The NCMRR might focus on stimulation as a clinical trials issue or component that is compared to a well-defined standard of care.

Another participant asked about investigating interventions that are used in other countries and how the NCMRR utilizes international research. The NCMRR does look to international research, one participant responded, but much of it is of questionable quality.

The breakout group also discussed the need to look at disability’s effects on the lives of women and girls in the long term. The effects of disability on sexuality are also an area of research interest. 

Genomics’ influence in rehabilitation, where different genotypes are associated with different rehabilitation results, was another topic for research that was identified by participants. There is currently an infrastructure center focused in this area. Participants said genomics could be used to look at the nexus between psychiatry and rehabilitation outcomes, especially how people cope with their condition/injury and the rehabilitation process. Beyond genomics, psychosocial research related to rehabilitation was identified as important by multiple participants.

Finally, the group discussed the importance of the autonomic nervous system—particularly the bladder and bowel—as an area that needs more research, and one that patients consider more important that walking. Pressure ulcers, which are studied across the NIH outside of the rehabilitation context, should also be considered in the context of rehabilitation. Discussion participants stated that it is important to get research results in these areas directly to consumers as quickly as possible, because practitioners may not know what to do with these results. NCMRR staff indicated that there are plans to improve dissemination activities to better provide information to people who are not researchers. That said, they cautioned that the NIH cannot tell people what to do; the NCMRR needs to disseminate research findings without making specific clinical recommendations.

Discussion by Breakout Group 3

The group discussed the difficulty in designing clinical trials for rehabilitation. One participant noted that many rehabilitation research studies have been small in size. Moreover, the patients in rehabilitation research studies are often heterogeneous in many ways, posing difficulties for clinical trial design. According to one participant, although several NIH ICs have taken on some rehabilitation research studies, there is still a lack of preliminary data that is rigorous enough to pass muster with a traditional clinical trials review panel. This individual suggested that one possible role for the NCMRR could be to develop standards for preliminary clinical studies. Another attendee commented that rehabilitation researchers have often developed innovative research designs, but no one has taken stock of what has already been done. This individual suggested a detailed portfolio analysis of rehabilitation research with an emphasis on clinical studies. 

Participants then discussed outcome measures for rehabilitation. Attendees questioned which outcome measures are most important for rehabilitation clients and for rehabilitation researchers. For example, one participant asked whether being able to walk or being able to use the bathroom unassisted is most meaningful in terms of QOL. One participant responded that QOL is probably the most important, but that first there needs to be a handle on what constitutes rehabilitation research itself. Another attendee commented that if the primary outcome measure is health, the outcome measures will all contribute to health (e.g., activity, plasticity, cognitive health, etc.). One participant responded that before developing a master list of rehabilitation outcomes, the group must pose the question of what improves a person’s life, which would revolve around disablement and ability. Another attendee commented that measuring rehabilitation outcomes cannot be solely about health, because good rehabilitation occurs even when people’s health is in decline; health is instead an essential ingredient in the mix.
One participant focused on the term “activity,” as this term encompasses a broad range of topics related to rehabilitation research. One attendee proposed that, in essence, rehabilitation research should be about disability and function.

Returning to clinical design specifically, attendees discussed the problem of dose-response in rehabilitation research. Without knowing dose-response relationships, one participant said, rehabilitation researchers cannot even identify the active ingredient, much less form a rigorous clinical trial. 

Another person reminded the group of the importance of CMS as the primary payer for many rehabilitation interventions. Participants suggested that health services research and cost-effectiveness studies were needed. Several participants said that evaluation of rehabilitation interventions lacks objective outcomes. These participants expressed the opinion that it would be better to have objective—rather than self-reported—measures on how well someone is walking or moving, for example. One person commented that the best measures tend to be those of capacity, but that there is limited understanding of how capacity translates into activity in the real world. For instance, in measuring gait speed, researchers can look at whether a person can cross a street before the light turns red, but researchers often struggle to find other scenarios where time length measures translate into activities outside of the laboratory.

Another important topic for rehabilitation is pain, which was identified as a crosscutting issue relevant for all NIH Institutes. Pain limits activity and is related to health disparities and diversity issues, several participants agreed.

Discussion participants talked about using common data elements and electronic health records as a basis for studying rehabilitation. One participant asserted that researchers should think about what type of evidence can be aggregated, especially as the move to electronic medical records continues. A group member commented that combining data enables researchers to examine disparities, pain, and diversity issues among patients. For instance, if a person had been injured by a gunshot in a certain part of the spine, researchers could track how the patient was prepared, what the outcome was, and what the differences were relative to other similar patients. This approach would require embracing the challenges of big data, but the outcomes would be specific to the rehabilitation community in terms of what interventions would be best. However, one participant cautioned that studying rehabilitation through electronic health records could be tricky if key factors were not tracked consistently across patients. Suggestions floated to overcome this barrier ranged from public-private partnerships for conducting this data collection, to having several different centers compete to collect the data centrally.

Based on the discussion, the group identified several priorities for rehabilitation research that the NCMRR might play some role in catalyzing:

  • Focus on common data elements
  • Use lessons from other NIH-funded clinical trials that used databases, and collect data on certain rehabilitation-related measures that could be embedded in funded clinical trials.
  • Encourage other Institutes to include more rehabilitation-related variables in clinical trials.
  • Define NIH-validated outcome measures that should be included in any funded study on rehabilitation.
  • Consider utilizing the R21, R34 or UH2 mechanisms to fund smaller studies looking at dosing, feasibility, and other issues as needed to prepare for the design of rehabilitation clinical trials:
  • Set very specific targets for these grants to cover specific gaps in rehabilitation research.
  • Consider a Funding Opportunity Announcement (FOA) on translational tools that would permit more validation of these clinical measures and identify how these measures relate to “real world” functionality outside the lab.

Breakout Group Reports Back to the Entire Board

Group 1

Initial discussion focused on how the NCMRR could best serve the rehabilitation research community through coordination. The group emphasized that the NCMRR needs to develop a model for coordination that is more intensive and strategic than the NCMRR had in the past. The group emphasized the importance of providing incentives for other ICs to partner with the NCMRR on funding. For the co-funding model to work, the details that have yet to work out will be crucial. The group stressed that a collaborative approach to the development of the rehabilitation research plan is important. 

In regard to coordination, Group 1 suggested that the NCMRR:

  • Develop a Rehabilitation Research Plan in partnership with NIH Institutes
  • Meet frequently with NIH Institutes to coordinate and implement the research plan
  • Review the research plan annually
  • Conduct an annual portfolio and applications analysis
  • Co-fund awards with other NIH Institutes
  • Support basic, clinical, and translational research, and foster the connections across the continuum
  • Involve the advocacy community

Group 1 then discussed the primary role the NCMRR could play in training and capacity building. The group members suggested that NCMRR staff could play a valuable role as mentors and liaisons for applicants in rehabilitation research. NCMRR staff could help young investigators understand how the funding process works and how to frame and prepare an application. Within grantee institutions, tight funding makes mentoring more challenging, participants stated. Participants suggested reviewing the impact of current training programs, both K12 and T32. One participant stated that a major problem occurred when young investigators get to the end of their first grant and are unable to secure additional funding. Another participant cautioned that the group needed to be careful about what it was building capacity for: if there will be no research funding available, it does not help to train too many new researchers. 

The group identified these gaps and umbrellas in rehabilitation research:

  • Addressing comorbidities among people with disabilities
  • Studying therapeutic mechanisms and how best to measure them
  • Focusing on some specific areas: cognition, assistive devices, service delivery, home interventions, community interventions, measurement, plasticity, and motor learning

The group identified the following needs and ideas regarding infrastructure centers:

  • Evaluate impact of current centers
  • Co-fund centers in collaboration with ICs
  • New centers could examine: clinical trial design, objective measurement, personalized medicine, basic/translational research cycle, diversity

Research and networking opportunities identified included the following:

  • Comorbidities that affect rehabilitation; comorbidities is a challenging topic for separate ICs to address and the NCMRR can make a contribution here; portfolio analysis is needed. 
  • Translational research is also important to have a feedback loop between basic translational and clinical research
  • Better ways to measure outcomes
  • Understanding the underlying conditions that lead to the need for rehab
  • Why do some treatments work for some people and not others? Need to understand the population to understand the underlying mechanisms of how rehabilitation works.
  • Portfolio analysis needed—need to analyze unfunded as well as funded applications and see why they don’t make the cut

Group 2

Group 2 identified the following recommendations for NCMRR’s role in the rehabilitation research arena, as well as gaps in the research literature and unique issues facing rehabilitation researchers:

  • Build staff interactions across the NIH—formal and informal. This would require regular, frequent meetings
  • Address clinical trial design challenge in rehabilitation research:
    • Complex, unique, not-well-understood design issues
    • Infrastructure center or planning mechanism could facilitate this study
  • Assess long-term follow-up needs—telemedicine for functional assessment and for intervention delivery
  • Educate, train, and disseminate information to professionals to address health disparities
  • Ensure plasticity research includes a focus on functional benefits of plasticity
  • Create new measurement tools to deal with the need for outcome measures and to exploit large bodies of data
  • Evaluate infrastructure centers and their programs
  • Encourage prevention of secondary injuries as a research area and as a potential area for infrastructure center, and include: aging for people with disabilities, accessibility
  • Fund specific pediatric-focused rehabilitation
  • Investigate technology, specifically brain computer interfaces and their possible impact on rehabilitation
  • Study gender issues related to disability—conference possible on girls’ and women’s issues
  • Provide attention to autonomic disabilities, such as bowel and bladder control, because this is an under-researched area that is really important to people with disabilities

Group 3

This breakout group took a broad perspective in evaluating rehabilitation research needs and NCMRR’s role, and created a graphic to illustrate the “person centered” nature of the group’s discussion (see below). 

Group 3 discussed the following:

  • Need for development of a strategic plan with key players from other ICs
  • Staff and resource allocation needs attention—there are many uncertainties
  • Co-funding mechanism may be restricted by budget reality
  • Importance of patient-centered concepts
  • The NCMRR brings to the table certain strengths that other agencies may not:
    • Activity/plasticity emphasis
    • Understanding that psychosocial component is a challenging and integral
    • component of research
    • Expertise in dose-response and identifying the active ingredient in rehabilitation
    • interventions
    • Perspective to assess feasibility of interventions; can they really be implemented?
    • Clinical trial design for rehabilitation research is challenging
    • Health services research could be useful for developing /studying large data sets
    • Help create outcome measures
    • Help determine cost-effectiveness of interventions

Recommendations:

  • The NCMRR would develop prospective database with common data elements (CDEs)
  • Use R34 mechanism to plan for randomized clinical trials (RCTs)
    • 1 year of feasibility study could translate into a clinical trial
  • Develop translational tools to make sure interventions apply when patient gets home
  • Common themes across ICs—e.g., health disparities, activity levels, pain, psychosocial—would help bridge across Institutes

From attendees’ comments:

  • One infrastructure center could provide blinded outcome assessments to individual studies;
  • CDEs could have broad implications

Report of the NICHD Director

Dr. Alan Guttmacher began by providing some updates from the NIH. Dr. Jeremy Brown was appointed the first permanent director of the NIH Office of Emergency Care Research. Dr. George Koob was named a Director of the National Institute on Alcohol Abuse and Alcoholism. The annual report on America’s Children was released in July, which indicated a drop in exposure to secondhand smoke, a fifth straight year drop in preterm births, but a rise in binge drinking among 12th graders. The NIH brokered an historical agreement with the Lacks family concerning appropriate research access to HeLa cell derived from Henrietta Lacks. The NIH is developing a longer-term vision for intramural research programs. The NICHD has worked with the Down Syndrome Consortium to help connect individual and families with research and health care resources.

Dr. Guttmacher provided some updates on the BRAIN initiative, a major NIH commitment to key technologies that will further research on brain function, especially at the level of neuronal circuits. The principles of this initiative include experimental systems and models, boundary-crossing interdisciplinary collaborations, integration of spatial and temporal analyses, data-sharing platforms, validation and dissemination of technologies, and ethical implications of neuroscience research. Research priorities include a census of cell types in the brain, structural maps, large-scale recording capacity, tools for circuit manipulation, links to functional behavior, computational analyses, imaging technologies, collection of clinical data, and dissemination.

Within the NICHD, Dr. Guttmacher highlighted a 10-year coordinated commitment to the Human Placenta Project. He indicated the transition of NICHD staff including the appointment of new extramural Branch chiefs: Lisa Freund, Child Development and Behavior Branch, Valerie Maholmes, Pediatric Trauma and Critical Illness Branch, and Tonse Raju, Pregnancy and Perinatology Branch; recruitment continues for the Gynecological Health and Disease Branch. Dr. Michael Weinrich, former Director of NCMRR, took on a new role as the Senior Advisor the NICHD in the area of Device Development, Biotechnology, and Bioengineering. He explained that there is a national search for a new Director of NCMRR with Dr. Ralph Nitkin serving as Acting Director. In addition, NIH veteran Dr. Mary Ellen Michel joined the staff NCMRR. Kerri Childress was named as the new Communications Director for the NICHD, and Dr. Bruce Simons-Morton was named Associate Director for Prevention Research, taking over for Dr. Bill Martin. Dr. Guttmacher also indicated that Dr. Ralph Nitkin was selected as this year’s recipient of the American Congress of Rehabilitation Medicine (ACRM) Gold Key Award for his continued work with medical and allied professional and extraordinary service to the cause of rehabilitation. New NICHD Advisory Child Health and Human Development Council members included rehabilitation colleagues Drs. Walter Frontera and Patricia Dorn. Recent Congressional briefings included women’s health, newborn screening, the National Children’s Study, rehabilitation, and muscular dystrophy.

Fiscal year (FY) 2014 began with a 16-day shutdown and significant budget uncertainties. In fact, the NIH was operating under a continuing resolution through January 15. The NICHD’s FY2013 appropriation was $1.245 billion, which represents a 5.68% reduction compared to FY2012. Dr. Guttmacher indicated that (at the time of the December meeting) the FY2014 appropriation is still in progress.

Day 2: Wrap-Up Discussion of the Breakout Groups

On Day 2 of the conference, each breakout group gave a succinct summary of its recommendations and discussions, in some cases presenting slides. Dr. Nitkin asked presenters to focus on: What is the research question? What is the real need? What can be used within the NCMRR?

Group 1

The group recommended additional portfolio analysis in rehabilitation, especially of unfunded applications. It also recommended a review of the impact of the current rehabilitation training programs and the rehabilitation infrastructure program. The group discussed different ICs evaluation processes and how they vary in their assessment methodologies. Translational research should not be considered as an endpoint but rather part of a cycle that involves basic and clinical research studies. Research evaluation should also include the advocacy community.

The group agreed with Group 2 on that the R34 was a good idea but suggested that it might need its own study section. Several members stated, with much conviction, that planning grants can be a positive influence to force investigators to really consider what a definitive large-scale trial would look like, and to structure their research accordingly. The group also agreed on the focus on comorbidities in persons with disabilities and due consideration for research on cognitive deficits, assistive devices, service delivery, personalized medicine, and home/community interventions.

Group 2

The group emphasized the importance of building cross-IC staff interaction through interpersonal relationships, stating that frequent contacts, formal and informal, will be needed. This relationship-building will demand considerable staff time. 

The group stated that the “simple” model used for pharmaceutical drug trials is not appropriate for rehabilitation research. It suggested that the R34 clinical trials planning mechanisms should be made available through the NCMRR. The group proposed that MRRIN could provide services that would include outcome measure development and/or blinded assessment for trials, which would increase the quality and decrease the cost of trials. Many participants agreed that too many clinical trials are too small and underpowered. Additionally, clinical trials should focus on a functional benefit as an endpoint, not simply on imaging results. 

The group stated that the MRRIN program should be evaluated as a whole and by center. 

More creative, efficient and cost-effective research designs, beyond clinical trials, are needed. The group also stated that study sections are too hostile to methods outside of clinical trials. An FOA that explicitly rules out clinical trials may be needed to even the playing field for observational research, which can narrow the focus for clinical trials and provide valuable information in itself. Participants also asserted that more creative and modern thinking needs to be infused into “dinosaur” study sections, especially to get them to appreciate the need for observational trials in key areas. 

A suggestion was made to piggyback on standardized outcome datasets available elsewhere—such as datasets developed to analyze spinal cord injury, multiple sclerosis, etc.—and to disseminate the availability of these datasets to the rehabilitation community. 

The role of genomic medicine in rehabilitation, the group asserted, should be expanded. Because genetics and molecular medicine are mechanisms under the general heading of plasticity, research results should be stratified by genetic variation. Epigenetic factors delivered over a lifetime can show the power of rehabilitation interventions, something that is urgently needed to prove to payers that they should support rehabilitation treatments. 

The group advocated for investigations of secondary injuries occurring in people who already have disabilities. This could include collaborations with the Centers for Disease Control and Prevention.

The NCMRR could facilitate training and education of professionals to address health services accessibility and disparity issues. Additionally, the group said the NCMRR could encourage an examination of gender issues in disability, possibly through conferences with the NIH ORWH on women’s and girls’ issues surrounding disability, especially as women are disproportionately the caregivers of people with disabilities. The group also asserted a need in pediatrics rehabilitation research for assessment of effectiveness of intervention and development of long-term tools, which could include collaborations with the FDA. Another priority was research on resiliency.

Another research area the group raised was brain-computer interfacing to supplement rehabilitation. This use of technology, the group said, needs to enhance rehabilitation; researchers could, in principle, come up with systems that could evaluate people in coma or other altered states.

Again, the discussion emphasized the importance of patient needs in prioritizing research. The importance of autonomic disabilities for spinal cord disabilities, the group said, gets less attention than mobility, but bladder, bowel, sexual, and skin issues are actually very important to patients.

Finally, the group recommended that the NCMRR help disseminate information to the rehabilitation community via websites, newsletters, and other communication channels.

Group 3

Group 3 mostly agreed with the other two groups but emphasized the importance of patient-centered research and patient-oriented outcomes for rehabilitation research, including due consideration of motor, cognitive, and psychosocial factors. This group emphasized the importance of feasibility in devising outcomes from the outset and a particular focus on non-responders as well. It suggested more infrastructure was necessary to develop and measure these patient-oriented and functional outcomes, which could include the use of clinical databases. The role of genomics in determining patient outcome was also identified as an underexplored niche for rehabilitation research. The group reiterated the need to consider socioeconomic and diversity factors in research outcomes and the impact of chronic pain.

NCMRR Strategies for Coordinating Rehabilitation Research Across the NIH

Dr. Ralph Nitkin gave a presentation on some potential strategies for working with other NIH groups. He began by reminding the Board that under the propose NICHD funding model, the NCMRR would still directly fund:

  • Training and career development (e.g., K awards, networks, department training grants, and fellowships)
  • Infrastructure networks
  • Conference grants
  • Small business and technology transfer grants

For research grants (e.g., R01s, R03s, R21s) that the NCMRR currently supports, Dr. Nitkin said, the NCMRR would complete the out-year commitments. However, researchers applying for new or renewal research applications should seek primary assignment to other ICs or other branches within the NICHD when appropriate. He added that, in some cases, the NCMRR could still be a home of last resort. Therefore, the NCMRR will likely be a lot more active in co-funding rehabilitation research applications that have primary assignment to other ICs.

Dr. Nitkin then discussed what NCMRR co-funding might look like. The applications that are funded are dependent on the range of investigator-initiated applications submitted and their relative ranking by the peer-review process. Dr. Nitkin explained the selection processes would include considerations for grant applications within and beyond the payline of the ICs. The range of research that falls within the IC paylines is dependent on what research applications receive the highest scores in the NIH peer-review process. Under this funding strategy, the NCMRR may offer partial funding to important rehabilitation applications that would have previously been fully funded by the participating IC. Another question for the NCMRR to consider, Dr. Nitkin explained, is how to negotiate support for the initial year of funding as well as support for the out-years.

Dr. Nitkin then discussed the NCMRR’s role in co-funding applications that fall beyond an IC’s payline. The NCMRR, in this circumstance, would have to work with the primary IC to incentivize support, as these would not normally be applications the IC would be able to support. He floated the idea of NCMRR funding 50% or even 75% of the application may be adequate incentive for the IC to support rehabilitation research projects just outside their traditional paylines. But even getting into this range would depend on the availability of investigator-initiated applications in these research domains with relatively meritorious scores from the peer review process. Dr. Nitkin noted that one downside to this new funding process is that the NCMRR is further removed from discussion with potential applicants and actual grantees.

One attendee commented that each IC’s payline is different, as is its grant application evaluation process. With the new co-funding model, NCMRR staff will need to stay apprised of the funding priorities and grants procedures across a variety of ICs.

Dr. Nitkin turned to the use of program announcements (PAs) and requests for applications (RFAs) to stimulating rehabilitation research in collaboration with other ICs. He advocated for targeted research topics that would attract appropriate rehabilitation applicants as well as researchers from allied fields. Dr. Nitkin noted that the NCMRR would have to work through the planning process of other ICs and get them to commit resources, especially for RFAs. The NCMRR and the IC would need to define topics of mutual interest. Another benefit is that RFAs and PARs often have dedicated peer-review panels. Finally, the NICHD may offer to help with the application review process for rehab-related grant applications to ease the burden for ICs.

Finally, Dr. Nitkin discussed supplemental funding strategies. The NCMRR could work with the Trans-NIH Rehabilitation Research Coordinating Committee to establish procedures. The Committee could target research priorities on an annual or semiannual basis. He also said that the NCMRR would work with program staff in other ICs to identify rehabilitation research opportunities in current grants—possibly through discussion with grantees—although the proposed supplement would have to be within the scope of original peer-reviewed application. Thus, for supplemental funding, the NCMRR would need to establish internal administrative review criteria, negotiate funding levels for specific supplements, require additional administrative oversight, and track outcomes of supplemental projects. Several commenters raised the issue of the additional administrative burden on ICs that would accompany supplemental funding grants. The group discussed timing and budgeting related to supplemental grant funding through the NCMRR.

New Business and Agenda for Future Meetings

Board chair Dr. Nicholas LaRocca solicited potential topics for the next meeting. This included discussions with the CMS, the Agency for Healthcare Research and Quality, and the Patient-Centered Outcomes Research Institute. The Board also requested an update on the search for a Director of NCMRR, the development of a research plan, and NCMRR co-funding strategies. There was also discussion of the NIH CSR and key peer-review issues as well as the fate of applications in key rehabilitation research domains. The Board also invited other NIH Institutes to briefly highlight their rehabilitation research priorities and grant successes. There was also consideration of a discussion on clinical design issues.

The meeting was adjourned at noon by Chair Dr. LaRocca.

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