Summary Minutes - May 4-5, 2015

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)
May 4-5, 2015

Dr. Nicholas LaRocca, Acting Board Chair, called the 50th meeting of the NABMRR to order at 9:00 am. Future Board meetings will be: December 7- 8, 2015; May 2-3, 2016; and December 5-6, 2016.

Members Present:

Amy Bastian
Michelle Camicia
Sureyya Dikman
Gerard Franciso
Carmen Green
Joseph Hidler
Fay Horak
Todd Kuiken
Nicholas LaRocca
Dennis Matthews
Kevin Means
Randy Nudo
Roger Smith
Marilyn Spivack
Jonathan Wolpaw

Members Absent:

Anthony Delitto
Richard Shields

Ex-Officio Members Present:

Alison Cernich, NICHD
Daofen Chen, NINDS
Patricia Dorn, VA
Alan Guttmacher, NICHD
Lyndon Joseph, NIA
Cate Miller, NIDILR
Ralph Nitkin, NICHD
Lynne Padgett, NCI
James Panagis, NIAMS
Lana Shekim, NIDCD
Lois Tully, NINR

Ex-Officio Members Absent:

Ted A. Conway, NSF
Martin Gould, NCD
Michael Swanson, CDC

NICHD Staff and Visitors:

Tim Brindle, VA
Leighton Chan, NIHCC
Theresa Cruz, NICHD
Robyn Ellerbe, APTA
Abby Ershow, NIHODS
Rosemary Filart, Penn State
Craig Fisher, APA
Sarah Glavin, NICHD
Jennifer Guimond, NICHD
Lyn Jakeman, NINDS
Adnan Jalil, APTA
Rusti Johnson, NICHD
Lisa Kaeser, NICHD
Naomi Kleitman, CHNFdn
Tiffany Knowlton, AAP
Audrey Kusiak, VA
Susan Lin, APTA
Martha Matocha, NINR
Mary Ellen Michael, NICHD
Maria Nurminskaya, CSR
Grace Peng, NIBIB
Louis Quatrano, NICHD
Mary Rogers, NIBIB
Carol Sheredos, NICHD
Karen Siegel, VA
Paul Smedberg, AAPMR
Cathy Spong, NICHD
Katie Stout, MRMC
Peter Thomas, DRRC
Tracy Wheeler, CHNFdn


The new Director of the NCMRR, Dr. Alison Cernich, was introduced, followed by brief introductions from the rest of the Board, NIH staff, and other visitors. Minutes from the previous meeting of December 1- 2, 2014, were approved. Dr. LaRocca stated that this meeting would focus on informing the strategic planning for NCMRR by having Board members identify the priorities of the future.

Remembrance: Dr. David Gray (1944-2015)

Dr. Ralph Nitkin presented a remembrance of Dr. David Gray, who died earlier in 2015. Dr. Gray, whose training was in genetics and behavior, experienced a severe spinal cord injury (SCI) at the age of 32 as the result of a fall. He came to the NICHD in 1981 and was a great mentor and inspiration. He had a distinguished career advocating for people with disabilities. In 1986, Dr. Gray was appointed by President Ronald Reagan to head the National Institute on Handicap Research (now the National Institute on Disability and Independent Living Research [NIDILR]) and immediately lobbied against the use of the word "handicapped." He played a pivotal role in the Americans with Disabilities Act (ADA) and was present when President George H.W. Bush signed the ADA into law. Dr. Gray was instrumental in forming the NCMRR in 1991 and served as its first Deputy Director. In 1995, he returned to academia as a professor of occupational therapy at Washington University in St. Louis, where he taught and conducted research on promoting participation and employment for people with disabilities. Dr. Gray believed that for those with disabilities, "employment is even more important than exercise." He served on the National Advisory Child Health and Human Development (NACHHD) Council from 2003 to 2006, established the Enabling Mobility Center at Paraquad, and helped found the Research and Training Center on Independent Living. A pioneer in the field of disability research and a tireless advocate for those with disabilities, he will be greatly missed.

Advisory Board members recalled Dr. Gray as an enthusiastic mentor and a compassionate man with a wonderful sense of humor. He had passion and great insight about priority research items. He brought to the field the perspective of one living with a disability and was an effective advocate for making rehabilitation a standard part of dealing with disabilities. This June, Dr. Gray will be posthumously designated an Honorary Fellow by the Rehabilitation Engineering and Assistive Technology Society of North America.

NICHD Director's Report

Dr. Alan Guttmacher welcomed Dr. Cernich to the NIH, saying that she brings important skill sets, including a broad administrative and regulatory background. He commended the search committee for identifying such an excellent group of candidates and thanked the NCMRR staff under Dr. Nitkin's steady leadership for keeping the Center on track during the transition.

In news from around the NIH, Dr. Harold Varmus has stepped down as Director of the National Cancer Institute (NCI), and Dr. Douglas Lowry will serve as Acting Director. The President of the United States appoints the NCI Director, so would be no search committee. Dr. Varmus, who also formerly served as Director of the NIH, returned to New York, where he will conduct research.

Dr. Elisel J. Pérez-Stable, professor of medicine, chief of the Division of General Internal Medicine, and Director of the Center for Aging in Diverse Communities at the University of California, San Francisco, was named Director of the National Institute on Minority Health and Health Disparities. He will start in September 2015.

Don Lindberg has retired as Director of the National Library of Medicine (NLM), and Betsy Humphreys was named as Acting Director. There will not be an active search until the Advisory Council to the Director (ACD) Working Group, chaired by National Human Genome Research Institute (NHGRI) Director Dr. Eric Green and Yale University's Dr. Harlan Krumholz, would present its report on the formulation of a vision for the NLM over the next decade.

The search for the National Institute of Neurological Disorders and Stroke (NINDS) Director is currently underway.

The NICHD Associate Director for Extramural Research and Director of the Division of Extramural Research would be announced soon.

Dr. Guttmacher reported on the Precision Medicine Initiative (PMI) , which aims to build a broad research program to encourage creative approaches to precision medicine, test the approaches rigorously, and ultimately use them to build the evidence base needed to build clinical practice. The initiative will involve a longitudinal study of at least a million Americans. An ACD Working Group chaired by Drs. Rick Lifton (Yale University), Bray Patrick-Lake (Duke University), and Kathy Hudson (NIH) was charged with articulating the vision and study design for the PMI. This report will be presented to ACD in September. NIH is seeking public input on the characteristics, purpose, and overall aspect of the development and implementation of the national research cohort and information about other research entities that might be combined to form the national cohort. Dr. Guttmacher noted that a number of the million participants might require rehabilitation services and urged Board members to offer their input at this early stage of the planning. Comments would be accepted online until May 7, or Board members could email Dr. Guttmacher with their thoughts.

A new schedule was developed for Small Business Innovative Research (SBIR)/Small Business Technology Transfer (STTR) solicitations to reduce the period between the close of a solicitation and the issuance of the phase I and II awards. This change will help small businesses avoid a loss of research momentum due to a protracted NIH review process. The new schedule is as follows: submission September 5, estimated award date in March; submission January 5, estimated award date in July; and submission April 5, estimated award date in September or December.

NICHD is undertaking a global review of the Institute's extramural training programs. A task force led by Dennis Twombly, Deputy Director of Extramural Policy at NICHD, will examine whether the right proportion of the budget is being spent on training and recommend best practices. The final report will be presented at the NICHD September 2015 NACHHD Council meeting.

He also reported that the NICHD is creating a centralized resource for researchers to store and access de-identified data and biosamples from studies that the NICHD has supported over the years. This centralized hub, called NICHD Data and Specimen Hub (N-DASH), will help grantees comply with the NIH Data Sharing Policy and make data available for replication studies. It is expected to launch in June 2015.

The 2nd Human Placenta Project (HPP) Meeting was held last week with more than 300 people in attendance. The goal was to foster thinking about placental research and monitoring placental function in real time. A better understanding about the way the placenta develops and heals itself might inform the basic biology of healing in ways that could be used in rehabilitation.

The fiscal year 2015 budget funding the government through September 30, 2015, provides $30.1 billion to the NIH. The NICHD budget is $1,286,571,000, which includes about $67 million set aside for the NCMRR. The conference report includes the following language on rehabilitation research: "The agreement expects the NIH Rehabilitation Coordinating Committee (NIH RCC) to host a trans-NIH State-of-the-Science Conference on Medical Rehabilitation Research, develop and regularly update a trans-NIH plan for medical rehabilitation science, and better coordinate the grants to adhere to the definition of rehabilitation research recommended by the Blue Ribbon Panel on Medical Rehabilitation Research. The NIH is urged to establish certain benchmarks to assess whether the coordination proposals being implemented are having a positive impact on rehabilitation science at NIH. Finally, the agreement requests the NICHD and the NIH Directors receive an annual briefing to discuss progress in rehabilitation research and the level of trans-NIH activity in this area of research."

The 21st Century Cures draft legislation would increase NIH funding in dramatic fashion ($31.811 billion, fiscal year 2016; $33.331 billion, fiscal year 2017; $34.851 billion, fiscal year 2018). As authorizing legislation, it does not actually appropriate money even if it passes. The NIH Director must develop a 5-year NIH Research Strategic Plan to increase "efficient and effective focus of biomedical research" and identify "strategic focus areas" with measureable objectives. Institute and Center (IC) directors (except NCI's) are to be appointed by the NIH Director for 5-year terms but can be removed earlier or reappointed with no limit.

Q&A with the NICHD Director

A Board member noted that the 21st Century Cure legislation includes a request for Congress to provide 5 years of funding to set up a surveillance system of neurological disorders, starting with multiple sclerosis and Parkinson's disease, to help get a better scope of these conditions, especially for underserved populations.

A Board member asked whether the $67 million for the NCMMR represented a decrease in funding. Dr. Guttmacher stated that NCMRR funding is a fixed percentage of the extramural budget, which goes up or down in relation to the NICHD budget.

A Board member asked whether Board input was desired about the review of training programs. Dr. Guttmacher stated that it would be very welcome. There is no money to increase the training budget so the review was focused on whether the money is being invested the right way and what kinds of careers need the most support. He added that a significant issue is how to train for the next 20 years. If the future of research is trans-disciplinary, training must adapt accordingly. The focus is on training for the future, not the past. A Board member suggested that co-funding should be explored, observing that not-for-profit organizations might be interested in such a model.

A Board member asked about the process for research grants for rehabilitation and how they are prioritized. Dr. Guttmacher stated that with dedicated funding, the NCMRR is currently able to fund or co-fund a few applications farther down the payline than the rest of the Institute. If that should flip, it would make a difference. When the data are analyzed, it might be the NCMRR is getting more good grants, not better grants. Dr. Cernich added that the NCMRR is not the only funding source for rehabilitation grants at the NIH. She noted that members should not look at just the NCMRR but rather at a collaborative way of funding rehabilitation research across the NIH, which includes a significant number of studies with primary assignment at other NIH ICs.

NCMRR Director's Report

Dr. Cernich had served as Deputy Director for the Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury at the U.S. Department of Defense (DOD) and before that the Director of Neuropsychology and Director of the Polytrauma Support Clinical Team at the U.S. Department of Veterans Affairs (VA) Maryland Health Care System. She noted that while she enjoyed working with those programs, she wanted to get back into research and the opportunity to use science to better the lives of individuals. Dr. Cernich is a neuropsychologist by training with a focus on traumatic brain injury (TBI), stroke, and Parkinson's disease. She stated that she was honored to come to the NCMRR and very grateful for the warm welcome that she received.

Dr. Cernich explained that, based on the Blue Ribbon Panel recommendations, she is focusing on identifying the opportunities that exist for the NCMRR to coordinate with other NIH Institutes and federal agencies. The RCC has begun meeting to determine how to work together on strategic planning and cross-cutting initiatives and how to evaluate the current portfolio of rehabilitation research across Institutes in a way that complements the NCMRR portfolio. The research plan is being developed as a rewrite, not an update. There is a need to capture the progress that has been made and determine the goals for the future that will make an impact in rehabilitation medicine. This will be accomplished through a wide outreach effort to the scientific and advocacy communities, and, importantly, to individuals living with disabilities. Career development networks will continue to be funded through the next planning cycle and the infrastructure networks will be recompeted shortly and are now in the review process.

Current NCMRR staff consists of three Health Science Administrators (HSAs), one Health Specialist, one Program Support Specialist, and one Administrative Assistant. Recruitment is ongoing for a new HSA, and opportunities are being explored to augment staff with fellowships and internships.

Dr. Cernich reviewed the funding for NCMRR since 2010, noting that funding was highest in fiscal year 2010 ($70 million), dropped in the ensuing years into the $50 million range, and then rose to $66 million in fiscal year 2014. The bulk of the NCMRR budget (62% or about $40 million) went to research projects including about $29 million to R01s. Small business projects and training and career development projects accounted for 18% and 16% of NCMRR funding, respectively and multi-component projects (4%) round out the funding.

Current NCMRR initiatives include the Medical Rehabilitation Research Infrastructure Network (MRRIN), which is co-funded by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and the NINDS, and specialized Career development programs for physiatrists, physical and occupational therapists, and rehabilitation engineers, respectively, and specific research initiatives that may include other NIH ICs.

Dr. Cernich provided a snapshot of the NCMRR investment portfolio by category (pain, gait, prosthetics and robotics, pediatrics, wheelchair, and behavioral) to help identify where the NCMRR is invested and how it fits into the NIH overall. In the coming months, NCMRR will do a lifespan analysis to determine whether there is sufficient investment in pediatric populations. There is a sense that this population should be studied further, in particular following these patients as they age from childhood into adulthood. Most trauma patients are between 18 and 21 years of age. The NCMRR has also analyzed its investment portfolio by contributing conditions (e.g., cerebral palsy, TBI, SCI, stroke, and amputation).

The NCMRR is currently looking at the way that the NIH codes rehabilitation research. There is a sense that a more appropriate code for the NCMRR should focus on the concept of physical rehabilitation, to exclude, for example, research on drug and alcohol rehabilitation. The current physical medicine code suggests that the bulk of the NIH rehabilitation investment (about 74%) is in research projects, with the NICHD (39%) and the NINDS (18%) combining for the largest investment (57%). There is a good distribution across the Institutes, but there is a need to better define and operationalize "physical rehabilitation" in order to better coordinate research priorities, not just within the NCMRR but also across the entire NIH.

Dr. Cernich elaborated on the rehabilitation research plan, which will encompass the entire NIH, noting that significant partnership is required from other ICs to best manage the portfolio. She observed that it is important to understand the challenges before setting goals, and to this end, every effort will be made to ensure that input is obtained from all interested parties. Dr. Cernich emphasized the need to get the insights from this Advisory Board and expects that by the next Board meeting in December, she will have met with other federal agencies to ensure that all priorities are in sync. She offered a proposed timeline for input, which includes a Request for Information in August 2015 and culminates in drafting the plan for public comment by March 2016 and publishing the plan by June 2016.

Two major initiatives that will impact the planning process are the increased role of the RCC and the State-of-the-Science meeting that the NCMRR will host at the request of Congress in the spring of 2016. The RCC will revisit the charge, purpose, activities, and business rules of the NCMRR, both scientifically and administratively. Other Institutes are very interested in how to work efficiently and collaboratively to drive the rehabilitation research agenda. The RCC will look at current projects and determine what areas are not being covered. This will give a much clearer picture of what is being funded and what is not being represented. The State-of-the-Science meeting will be a trans-NIH event, and the NCMRR is exploring other co-sponsorship opportunities that will bring the community together. A planning committee will be established following the Advisory Board meeting. Dr. Cernich again emphasized that she will be very active in coming months in soliciting feedback from both internal and external parties.

Q&A with the NCMRR Director

A Board member asked whether there would be collaboration with the Patient-Centered Outcomes Research Institute (PCORI) and whether the planning process would involve looking at global perspectives. Dr. Cernich said that collaboration with PCORI is actively being explored and she will be meeting with PCORI in the weeks ahead. She has also reached out to the Health Resource and Services Administration (HRSA) and will be actively engaging other federal entities. Dr. Cernich added that she has met with the NICHD Office of Global Health to gain insight about partnerships with international bodies, but the initial focus will be closer to home. The Board member suggested that because pediatric research is complicated, the NCMRR should consider setting up a pediatric research network.

A Board member asked whether there are metrics for determining the success of the training programs. The member questioned whether the nine different training mechanisms (F31, K01, K08, K12, K23, K24, K99, T15, and T32) were equally effective and wondered whether, at a time of tight funding lines, too many people are being trained for too small a pool. Dr. Cernich stated that she is looking at a strategic analysis for the measure of success, but it appears that previous NCMRR awardees have remained committed to academic research. The NICHD training review will examine the question of the balance of funds spent on training and career development versus research. The NCMRR is currently in a renewal phase and will be looking at the training investment, specifically whether it is being done in the smartest way possible and whether the support that the NCMRR is providing is appropriate for the field.

A Board member suggested a greater emphasis on a pain strategy, particularly chronic pain as related to health disparities. There is a serious question whether a person of color receives the same assessment and treatment experience. Disparities must be better included as part of the conversation, and we must look for more opportunities to partner and leverage more dollars for the best health outcomes for all.

A Board member observed that it appears combining projects across Institutes gets more for our money. Dr. Cernich said that this was still to be determined. Dr. Nitkin noted that other NIH Institutes have contributed to NICHD's K12 networks and research infrastructure program (although coordinated funding does require additional administrative work). Moreover, there is certainly strong interest across the NIH in the brain research initiative, which would have implications for rehabilitation research.

A Board member suggested that with the growing awareness of the relationship between cognition and motor control, palliative issues should not be excluded. Dr. Cernich agreed, noting that rehabilitation is a team sport. Individuals are multifactorial and benefit from a team approach. There is a need to look at a multidisciplinary approach and target the whole person in innovative ways.

A Board member suggested that the NCMRR has an identity crisis. If the NCMRR were a company, it would go bankrupt, because it has so many interests. The member asked whether leadership was considering identifying a more narrow focus. Dr. Cernich stated that the planning process would focus on what the NCMRR should be doing. It will take into account the broad legislative definition but also look at what the NCMRR does in relation to others and what areas are already sufficiently covered. The NCMRR cannot be all things to all people. We must understand the landscape of rehabilitation research and work with our colleagues to determine what is covered, what is not covered, and where the NCMRR best fits.

A Board member encouraged the NCMRR to take a more active role in supporting research on caregivers for the rehabilitation population.

A Board member asked about the data used in prioritizing. Dr. Cernich stated that U.S. Census data could be used, but there are disparities depending on who has the disabilities. Centers for Medicare and Medicaid Services (CMS) data, which reflect billing rates, are also used, and may better reflect what percentage has disabilities and gets services. However, the NIH has a broad public health mission. Amputees, for example, are a low proportion, but this population still must be served. Therefore, we must take the data into account but not necessarily allow it to set all priorities. A Board member suggested that perhaps better data are needed.

A Board member asked whether, given budget issues and the broad definition of rehabilitation, there would be a shift in funding priorities away from established groups, such as physiatrists. Dr. Cernich said there would be no change in this cycle, but training for the future might have to change if it becomes more collaborative and multidisciplinary. Everything will be reviewed, and we might have to look at how to incentivize collaboration as a funding source.

A Board member voiced concern about fewer people choosing to enter the field of rehabilitation. The member suggested more focus on the barriers in training programs, as well as on how the NCMRR will address the challenges that the external world, particularly insurers, has put on rehabilitation. Many people with disabilities, especially chronic disabilities that worsen as they age, will be dependent on state Medicaid, which is extremely limiting. Dr. Cernich agreed that there has indeed been more emphasis on sports medicine than rehabilitation medicine. She noted that for those struggling with disability issues over the course of 15 years or longer, it is usually the family that has to offer or fight for financial support. The challenges are clearly different in the private sector as opposed to the VA or DOD. We need to look more at what the secondary conditions are and how they affect or cause other chronic health conditions.

A Board member observed that some of the training that the NCMRR provides must support the next generation of researchers, but it is not clear what science will look like in the future. The trans-NIH approach is part of training the next generation. The question was posed whether there had been any shift in trans-NIH funding, and whether there was a strategy going forward. Dr. Nitkin stated that ICs have their own issues and mandates, but that the NIH is largely driven by investigator-initiated and peer-reviewed research proposals. Thus, it often comes down to the payline and which proposals are appear to be the most impactful. Dr. Cernich added that as the NIH-strategic plan develops, the role of the NCMRR will be clearer, and this will shape co-funding opportunities. The merger to a prospective plan with other Institutes will clarify who our partners are.

A Board member asked how much of the NIH rehabilitation-related research outside of the NCMRR is based on coding versus collaboration with the NCMRR. Dr. Cernich explained that the analysis was not yet at the point to make the distinction between rehabilitation and physical rehabilitation and then determine collaboration versus code. The analysis will certainly look at how effectively trans-NIH initiatives move NCMRR initiatives forward.

A Board member wondered whether we are missing something that helps define rehabilitation. There was nothing mentioned about what makes the NCMRR and rehabilitation unique. Rehabilitation understands outcomes, but this was not reflected in the data that were presented. Dr. Cernich stated that any plan must be directed at an outcome (i.e., a goal that has measurable impact). The NCMRR plan should define what success looks like, both for the NCMRR and for individuals with disabilities in terms of how their lives are improved. The impact of research should be to improve health. Today's breakout session questions focus on what success looks like and how we involve the community to make that happen. These discussions could change NCMRR priority areas.

A Board member suggested that a new clinical-trial model to address rehabilitation therapies might be needed, because this area is complex, is hard to test, and requires more effort and investment from the researchers. Dr. Cernich pointed out the hurdle of educating the scientific community and review boards about unique aspects of rehabilitation clinical trials. It would entail a cultural change. To be effective, the strategic plan must address both the science and the culture.

A Board member commented that the culture also must change at the U.S. Food and Drug Administration (FDA). The whole approval pathway must be looked at in an overarching way. Dr. Cernich agreed with the importance of collaborating across agencies but cautioned that while big thinking is good, it must not detract from the focus of what can be accomplished as a practical matter.

A Board member stated that NIH does a good job of leading, but the member emphasized that lack of diversity remains a challenge. As populations become more diverse, grant administrators must keep underserved populations, including children, in mind.

Update on the Medical Rehabilitation Research Infrastructure Network (MRRIN)

Dr. Nitkin reported that the NICHD is currently analyzing the productivity of MRRIN. He gave a brief overview of the networks, which was originally developed in response to the Advisory Board's recognition of the need to build research infrastructure in medical rehabilitation through some combination of scientific cores, information technology, and networking activities. In the first phase (2000 to 2005), the NICHD committed almost $4 million per year to support the four geographically distinct networks that focused predominantly on research mentoring. In the second phase (2005 to 2010), the regional constraints were abandoned in favor of program that could provide specific scientific expertise in domains that were particularly relevant to rehabilitation research, not readily available elsewhere, and teachable. Of the 13 applications received in that open competition, the NCMRR was able to support six networks, thanks to additional support from the NINDS and the NIBIB. In addition, that configuration of centers resulted in trans-center cooperation, productive collaborations with accessing researchers, pilot funding and research grants, and the sharing of common resources and best practices across centers. The third phase of funding (2010 to 2015) encouraged applications that more fully covered the full range of the International Classification of Functioning, Disability, and Health (ICF). Of the 23 applications received in open competition, funding was available to support seven centers with the continued support of the NINDS and the NIBIB and there was a 50% turnover in centers from the previous phase. The seven funded centers range across the ICF spectrum and include: (1) genomics, gene expression, and proteomics; (2) muscle physiology, imaging, and function; (3) bioengineering and robotics; (4) modeling and simulation of movement; (5) assessment and outcomes; (6) analysis of large datasets; and (7) technology assessment and product development, commercialization, and regulations.

In the current 2015 renewal, the NCMRR was encouraging collaborations that expand into the following four domains (but would accept centers in any other research domains that meet the network criteria):

  • Clinical trial design: alternative trial designs, confounds, combinational therapies, sustainable outcomes, appropriate outcome measures, and targeting of the right patient populations
  • Engineering and the environment: sensors and motion analysis to document outcomes, collaborative platforms among providers, global solutions (telemedicine), and commercialization
  • Individualized medical rehabilitation and dynamic reassessment: diagnostic and prognostic strategies, genomic and biomarker factors, and unique comorbidities and secondary conditions
  • Applied behavioral supports for rehabilitation research and health outcomes: children, aging with disability, caregiver support, understanding of patient goals, sociodemographics, racial and ethnic factors, and gender

Dr. Nitkin introduced Dr. Sarah Glavin from the NICHD Office of Science Policy, Planning, and Communications Branch to report on the ongoing MRRIN evaluation project. Dr. Glavin stated that the evaluation, which is designed to provide formative information about what the program is providing and where it goes in the future, is halfway completed. She noted that MRRIN is central to the NCMRR mission and that the evaluation is focusing on the following issues:

  • How are MRRIN services selected, publicized, and prioritized?
  • What services do MRRIN centers provide, and what investigators do they help support?
  • Do MIRRIN centers promote collaboration in rehabilitation research, and if so, how?
  • What outputs from the MRRIN centers can be observed at this stage?

The current MIRRIN centers are: (1) Washington, DC—genetics and genomics; (2) University of California, San Diego—muscle physiology; (3) Stanford University—simulations; (4) Chicago—robotics; (5) Boston—outcome measures; (6) Texas—databases; and (7) the Center for Translation of Rehabilitative Engineering Advances and Technology and Simbex—commercialization.

Dr. Glavin cautioned that the programs are so different in scope and goals that in some ways, the process is more like evaluating seven distinct programs. As an example, it made more sense to talk about publications for centers doing more basic research than for the one working on commercialization. The most common services that the centers provide include training courses, conferences, and pilot projects. Eighty-seven percent of pilot funding went to candidates external to the home institution. There were a number of common areas of research, but the majority of the pilots focused on issues such as muscle function and/or stroke research. However, there was good overlap with more than one center supporting each disease focus. Publications by center were looked at as a measure of productivity, but the key evaluative issue was what type of research collaborations resulted from the center projects and how substantive was the center contribution. It is too soon to draw conclusions until more data are collected, but Dr. Glavin invited Board input into how the centers should be further evaluated and other interesting ways of analyzing their data.

Q&A with Dr. Glavin

A Board member asked whether the papers and publications from this program have had an impact. Dr. Glavin stated that the journal impact is not especially high but reasonable in the context of quality rehabilitation journals. In looking at actual and predictive citations through 2012 (i.e., which articles had more or fewer citations than would have been predicted), most were within the predicted range. The Board member asked whether, assuming that citations essentially mean how many people are reading the paper, the authors are reaching a wide enough audience. Should they disseminate their work in a different manner, through the press or social media? Dr. Glavin noted that these are not R01 grants and most of the pilots are rather small scale. Another Board member suggested that publications outside of scientific journals could reach many more people. Dr. Glavin said that they do collect this information for the programs as a whole, but it is unclear how closely an infrastructure program would be published this way. She added that they also track the degree to which advances are reported out to other agencies. In addition, there is considerable new social media outreach through the NICHD communications office and Dr. Glavin urged Board members to subscribe and "like" NICHD and share frequently.

A Board member asked whether there was a sense of where the program is going in the future in terms of what works and what should be done differently. Dr. Glavin stated that it is too soon to tell and more data are needed. One area to be considered is more consistent documentation. Some centers have much more extensive information than others, which affects tracking ability. This evaluation process is helping identify what we do not know.

A Board member asked whether any other outcome measures were being considered. Dr. Glavin enumerated a number of additional outcomes measures, including: (1) looking at whether the programs are serving young investigators versus established ones; (2) determining what publications used databases and other center resources; (3) determining the actual use of outcome measures  and other research tools developed by certain centers ; (4) looking at the use of the software and other research products provided by the centers; (5) following commercialization and product development resulting from center interactions; and (6) for the pilot projects, determining how the pilot investigators perceived the role of the centers in enhancing their research.

Board members and attendees suggested other ways to look at program evaluation:

  • Consider negotiating a milestone or benchmark to be met at the outset with the funded entity. Dr. Glavin noted that there are programs at NIH that do this and it can work very well in a situation with a well-established goal. However, it might be less applicable to a rapidly changing field, but it is something to consider going forward.
  • Canvass the center directors for their views on what changes are needed, and ask them for a bigger picture of what the next center should be focused on. Dr. Glavin noted that this question was asked in the interview, but the results have not been fully analyzed.
  • Consider an independent evaluation, such as by the Institute of Medicine.

Dr. Nitkin concluded that continued support from the NINDS, the NIBIB, and other NIH Institutes is desired. The response to the current Request for Applications (RFA) has been robust, especially for developing centers in clinical trial design and engineering and the environment. Applications will be peer-reviewed in early July, and the NCMRR hopes to work with other ICs to support between five and seven centers. A Board member asked what the funding decisions are based on. Dr. Nitkin stated that, among those that receive the most meritorious scores from peer-reviewers, the NCMRR would look to fund centers that support research in important and unique domains especially in some of the four domain areas highlighted. Depending on the array of scores it may even be possible to support a collaboration among applicants on a certain key research domain, but these are investigator-initiated proposals.

Research Plan Advisory Board Review and Performance Measurement

At this point in the afternoon, the Advisory Board and visitors were divided into four breakout groups to consider the following issues:

  • Review the previously proposed areas of focus, and consider new ones to help identify the structure of the research plan and prioritized areas of focus.
  • How do we measure progress or success in the areas that were identified?
  • How should NIH document and demonstrate the internal partnership that exists to support rehabilitation research?
  • How do we promote partnerships or collaboration in the field and support research capacity?
  • What would be the most effective method to seek input from the NABMRR through the research planning process (e.g., working groups, input to draft documents, identification of experts or stakeholders)? How should the NIH seek input from various groups who are stakeholders in this area?

Some resource material from previous Board discussions of research priorities and strategic planning was provided to the group. Each of the four groups reported back to the Board as a whole at the start of the second day.

Summary and Review of Group Discussions From Day 1

Group 1

The top priorities were as follows:

  • Participatory research: Includes how research can be quickly transferred to clinicians to increase acceptance and adherence
  • Pediatric research: Includes both congenital and injury as well as environmental exposures
  • Role of caregivers: Includes the relationship with the person with a disability and the impact on quality of life

The group also recognized the importance of exercise on biological systems, the use of precision medicine to understand subpopulations with disabilities, and adherence to therapy. Telemedicine was specifically identified as a way to monitor adherence, particularly in rural areas.

How do we measure progress or success in the areas that were identified?
The group identified good measures via the World Health Organization (WHO) classification and suggested that better measurements are needed for monitoring impairment in the field, fatigue, and post-acute care for spinal cord injury. A measurement repository is needed to organize this information. Better interview techniques are needed to clarify the needs and priorities of individuals with specific disabilities in terms of how they are personally affected. Develop a toolbox of measures and outcomes to fit individual needs.

How should the NIH document and demonstrate the internal partnership that exists to support rehabilitation research?
Employ more information-sharing with Board about what grants, workshops, and conferences are being co-funded. Use the Board as a sounding board on research needs and for serving on planning committees, which would facilitate Board members dissemination of information. Center grantees should be utilized to publicize meetings.

How do we promote partnerships/collaboration in the field and support research capacity?
Engage small businesses in discussions about research and use a business model to promote grantee accountability. Reach out to organizations (the Board could recommend some) for their input, and explore public-private partnerships and partnerships with foundations that support rehabilitation activities.

What would be the most effective method to seek input from the NABMRR through the research planning process (e.g., working groups, input to draft documents, identification of experts/stakeholders)? How should the NIH seek input from various groups who are stakeholders in this area?
Use the Board to identify what is on the cutting edge of research and offer advice on the science. Board members attend numerous conferences and meetings and could bring back valuable information. Utilize a business perspective, as if the Board were the owners of a company. Have the Board work on projects outside of Board meetings, such as validation measures. Set aside a feedback period during Board meetings to discuss priority areas.

A Board member asked for more information about a toolbox to gather measures, noting that the FDA is looking at something like this, and perhaps efforts could be coordinated. Group members stated that the idea is to see what is available and fill in the gaps. It is more a sense of gathering measures rather than developing new measures. A Board member suggested looking at the ICF classifications to make outcomes in each of the classification stages reflect real-world implications and encouraged the use of multidimensional measures. Dr. Cernich noted that there are many ways to look at outcomes and there is an effort to bring people together from different entities (e.g., FDA, hospitals) to develop a common language. There is a need for organization of other conditions rather than just for the rehabilitation community.

Group 2

The top priorities were as follows:

  • Clinical trial design: Includes validation of outcomes, comorbidities as confounders, and the relationship to interventions
  • Personalized holistic approach: Includes patient-oriented outcomes, psychosocial engagement, genomics, and aging with disabilities
  • Tele-rehabilitation: Includes addressing population disparities, delivery, technology, proof of efficacy, and partnership opportunities with the VA

The group also recognized the importance of more pediatric research, gaining a better understanding of mechanisms through imaging, and looking at approaches to pain.

How do we measure progress or success in the areas that were identified?
Conceptualize interim measures in addition to final measures. Have measures that are clinically meaningful. Determine who actually contributes to the grant to help develop collaboration with other ICs or agencies. Challenges include: (1) professional inertia, not always open to cutting-edge information; (2) a need for better reimbursed care models; (3) lack of adherence to rehabilitation schedules; (4) lack of coordination of care with cross-disciplinary teams; (5) a need for investigator expertise, especially in psychosocial qualitative outcomes; and (6) a need for common electronic medical records.

How should the NIH document and demonstrate the internal partnership that exists to support rehabilitation research?
Make available documentation of new grants and co-funding initiatives with other ICs, specifying how much money they put in. Work with private foundations as well as federal partners (e.g., VA, PCORI) and ICs beyond the NINDS and NIBIB that have not been traditional partners. Set and meet a goal for a trans-NIH rehabilitation committee. Institute joint workshops.

How do we promote partnerships/collaboration in the field and support research capacity?
Address the disparity between clinical and research salaries by supplementing research salaries with funds from private foundations, and build in protected time for clinician researchers. Build a training program around talented people in other fields, such as engineering, to apply their skills to rehabilitation. Explore what motivates people to enter the rehabilitation field. Consider revising the time limit for post-doctorates to longer than 5 years. Address collaborative efforts such as a team grant opportunity with multiple Principal Investigators (PIs).

What would be the most effective method to seek input from the Board through the research planning process (e.g., working groups, input to draft documents, identification of experts/stakeholders)? How should the NIH seek input from various groups who are stakeholders in this area?
The Board would benefit from having working groups with regular schedules to provide continuity and keep up energy. Ask societies for feedback, but also challenge them because sometimes societies advance ideas that sound logical at the time but do not fully stand up to scrutiny.

A Board member noted that cross-disciplinary training is important, but there are workforce issues to be considered, such whether we are training more investigators than we have the resources to support and the lack of protected time for clinician researchers with grants. There are also competing priorities for scientists as they consider taking out loans versus the ability to make money in the rehabilitation field.

Dr. Cernich asked how Board members viewed the role of the NCMRR in balancing training and competitive employment and addressing the capacity of departments to conduct research with protected time. Group 3 members stated that this issue was not specifically addressed, but they suggested that if there is an investment in standard outcome measures, it is important to consider who will use them, because physician scientists do not necessarily have the time to implement them. Dr. Cernich suggested that there might be a role for the NCMRR in education and implementation, noting that modifying the common data elements for the TBI repository created an administrative burden that made things more complicated and harder for researchers to implement. A Board member stated that standardized outcome data would be used so long as the measurements are integrated into electronic medical records.

A Board member raised a concern about CMS making demands on the treatment of the patient, putting emphasis on reimbursement for service, not the collection of data. Another Board member stated that clinician researchers should be supported and research should be seen as part of their job. A third Board member suggested that collection of data could be built into routine care, but it takes oversight to ensure quality.

Group 3

The top priorities were as follows:

  • Clinical trial (CT) design and methodology: Rehabilitation CTs should not be based on drug CTs, because many rehabilitation approaches involve training and commitment on the part of the therapists who must master the therapy and engage the patients. It is not realistic to assume that the same people will do the same thing for two or three alternative therapies. It might be better for one research site to do one therapy and another to do a different therapy to maintain consistency in the team.
  • Plasticity: Consider the process of rehabilitation as the interaction of two adaptors: the nervous system and the treatment being administered. There is a need to target plasticity-inducing mechanisms to determine whether the processes of this system lead to wider beneficial effects. Plasticity offers opportunities to improve functional outcomes.
  • Underserved populations: This includes children, women, minorities, and those with severe conditions for whom access is a problem. Better marketing is needed to increase the understanding of rehabilitation and tell the success stories that create the inspiration.
  • Telemedicine: Important in global health and reaching rural populations. Address the gap in determining how feasible this is in the rehabilitation setting in terms of customer access. Address how this is to be used for diagnostic and treatment applications and issues about reimbursement. Technology is increasingly important, but we must address how many can afford access to it.

The group considered the definition of "long-term outcome" and suggested that the desired outcome is one that is sustainable, so "long-term" will vary by this factor. The group also considered how to engage new people in research and suggested managing this at the program level by expanding the mechanism currently attached to R01s for minorities/persons with disabilities to medical/graduate students to draw them into programs for rehabilitation research.

How do we measure progress/success in the areas that were identified?
Markers of success could include a sustainable outcome and demonstrating a positive impact on patients, the impact of rehabilitation on functional outcomes, longitudinal data, and cost-effectiveness data. Challenges include the lack of applicable data, which affects CMS reimbursement.

How should the NIH document and demonstrate the internal partnership that exists to support rehabilitation research?
Designate individual staff members as NCMRR liaisons to various Institutes. Market NCMRR's activities to stakeholders and revise NIH travel policy that curtails going to meetings.

How do we promote partnerships/collaboration in the field and support research capacity?
More travel to meetings and more coverage in the lay press about what makes rehabilitation exciting and inspiring. Need for better advocating for rehabilitation on the part of NIH, especially to overcome poor pay and high emotional stress for professionals in this field. Students need to be targeted earlier, and undergraduate internships should be considered.

What would be the most effective method to seek input from the Board through the research planning process (e.g., working groups, input to draft documents, identification of experts or stakeholders)? How should the NIH seek input from various groups who are stakeholders in this area?
Working groups are useful, and it would be helpful to get more constructive input on draft documents from people outside of the usual group.

Group 3 participants noted that they also talked about using mentors who are researchers with a record of success to get new researchers involved. This is critical and must be done early in the career, when students are identifying their interests.

Group 4

The top priorities were as follows:

  • Research design and methodology: What is the best way to test hypotheses? Consider alternative methods to clinical trials. Use more sophisticated analytical and design techniques to account for confounders. Consider how to determine treatment effects in individual patients
  • Clinical decision-making: Related to the NIH PMI, includes the "omics" effect on treatment and prevention, environment, and societal and psychosocial components.
  • Special populations: Includes pediatric rehabilitation and the transition to adulthood, gender-specific health issues, the life course of aging with disability, health disparities, and caregivers as a target for intervention
  • Technologies: Includes sensors, mHealth, assistive technologies, and telemedicine approaches

The group recommended considering which areas are being addressed by other agencies; which areas are important for collaboration between or among agencies; and the importance of commercialization, because that is how important developments get to patients.

How do we measure progress/success in the areas that were identified?
We focus on long-term outcomes, positive changes in patients' lives, adoption of new evidence-based clinical care protocols, translations from bench to bedside, and commercially reproducible technologies.

How should the NIH document and demonstrate the internal partnership that exists to support rehabilitation research?
Look at incoming and outgoing funds, the number of projects in terms of type, who was assigned, and who paid. Describe working group and interagency group activities in terms of products developed and the degree of involvement in the collaboration.

How do we promote partnerships/collaboration in the field and support research capacity?
Consider with whom to collaborate with. Offer resources to share with collaborators. Align with industry. Consider a mechanism for academic or industry collaboration grants. Co-fund with other ICs. Assign points in a review based on the level of collaboration. Improve outreach to stakeholders through social media, town hall meetings, and professional societies.

What would be the most effective method to seek input from the Board through the research planning process (e.g., working groups, input to draft documents, identification of experts/stakeholders)? How should the NIH seek input from various groups who are stakeholders in this area?
Consider virtual meetings with written input from members. Bring in outside expertise. Send materials in advance of meetings. Streamline meetings with more breaks built in. Provide more structure and efficiency at the meetings, and optimize the resources of the Board members.

A Board member suggested that NCMRR staff develop a presentation that Board members could use when addressing organizations or young researchers to help market the future of rehabilitation research.

A Board member suggested setting up subcommittees within the Board to develop plans for the future.

A Board member suggested reviewing the Board charter to ensure that the Board is doing what was originally intended. An NICHD staff member indicated that the charter that was passed in 1990 was very broad and the Board's activities fall within the mandate. However, there is a new authorization bill before Congress that would continue the NCMRR but formally require use of WHO classifications. This bill will be sent to Board members for their information.

State-of-the-Science Workshop Planning

Dr. Cernich discussed the involvement of the Board, noting that she understands that the level of engagement is limited by Board members' own extensive professional responsibilities. She stated that she would use the ideas generated at this meeting to inform the strategic goals of the NCMRR. The State-of-the-Science workshop closely encompasses those same goals and guidelines. Dr. Cernich suggested that the Board form two working groups: one focused on the goals and objectives of the scientific meeting, and one focused on the NCMRR research plan. She noted that today's discussion revealed recurring themes such as how to structure outcomes, partnerships with professional organizations, and the capabilities in industry for rehabilitation.

Board members offered the following suggestions:

  • Have specific working groups, but copy all Board members on the progress.
  • Present the timeline for the plan (with specified dates) to the community so stakeholders are aware of what is coming and could offer input into the decision-making. This fosters buy-in to the ultimate plan. Dr. Cernich noted that she envisions this as a very inclusive process and intends to meet with all professional and advocacy organizations and ensure that people with disabilities are represented.
  • Outline the ideas that are the shell of the strategic plan so that the Board can review it and provide input from the beginning.
  • Include the Association of Rehabilitation Nurses in the outreach.
  • Considering narrowing the interval between strategic plan updates. Needs and the way in which information is processed tend to change quickly.
  • Initiate more regular contact with the Board to present more organized and focused questions in advance of Board meetings so that the meeting time can be used most efficiently.
  • Provide the board with detailed grant information: the total number of applications, the number that get funded, the outliers, and a list of what the NCMRR considers to be obstacles and opportunities. Ask unsuccessful applicants for their feedback, not just successful applicants.
  • Consider having a closed session to ensure that there are no conflicts.
  • Do not present things to the Board if the decision is already made and the Board is just getting information after the fact. Use the Board for its strengths, not just for "show and tell."

Dr. Cernich assured the Board that she intends the meetings to be substantive and that she values their input as leaders in the field. She stated that the NCMRR would be surveying the federal landscape to determine what the needs are, what the roles are, and how best to communicate and collaborate. The research plan must focus on what the NIH should do to address the gaps in rehabilitation research. It will not solve every problem but will enhance the NCMRR's collaboration in both the public and private sectors. It is critical to remain focused on the mission to drive the research agenda. Dr. Cernich said that she will be communicating with the Board to ensure the goals and objectives are realistic.

Comments from Retiring Board Members

Dr. Nitkin presented each of the retiring Board members, Drs. Green, Kuiken, LaRocca, and Wolpaw with a certificate of service and thanked them for their service. The retiring Board members each made remarks about what they learned from their service on the Board including suggestions of what gaps and opportunities remain. They thanked NCMRR staff for their support and continued work on medical rehabilitation research. Dr. Nitkin announced the incoming slate of nominations, which include Indira Lanig, M.D., Allen Heinimann Ph.D., Kathleen Friel, Ph.D., Greg Hicks, PT, Ph.D., and Ken Kaufman, Ph.D.

Closing Comments and Solicitation of Topics for December Meeting

Board members made the following suggestions for meeting topics:

  • The strategic plan, including the frequency at which the plan should be updated
  • An in-depth review of grants, including project reports, specific funding data, and a snapshot of where the grants reside from a coding standpoint
  • Better identifying how the Board can help the NCMRR and sending more materials to the Board before meetings
  • An update on the State-of-the-Science meeting
  • Pain; HHS is getting involved in this, and it presents an opportunity to see where the NCMRR fits in
  • Some of the issues of the breakout sessions
  • An update on the NCMRR authorizing bill and a summary of the upcoming cancer rehabilitation workshop to see whether it might lead to initiatives.
  • A presentation that Board members could present to their constituencies so that members can be educators, advocates, and lobbyists.
  • A plan for rehabilitation clinical trials that substantively considers new models and new standards; could result in a publication.
  • Discussion of health policy, because it is not divisible from the ability to practice rehabilitation. (Dr. Cernich noted that the NCMRR could play a role in policy where a scientific role would help bridge the gap. She noted that the NCMRR is not a policy-making entity, but that it can provide the research to help inform the policy)


The meeting was adjourned at 11:30 am.

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