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 5-6, 2016
The 53nd meeting of the NABMRR was called to order at 9:03 a.m. Board members introduced themselves, followed by brief introductions from NIH staff and other visitors. Minutes from the previous meeting of May 2-3, 2016, were unanimously approved. Future Board meetings would be May 1–2, 2017; December 4–5, 2017; and May 7-8, 2018.
Ex-Officio Members Present:
Alison Cernich, NICHD
Daofen Chen, NINDS
Ralph Nitkin, NICHD
Karen Lohmann Segal, VA
Lois Tully, NINR
Ex-Officio Members Absent:
Lyndon Joseph, NIA
Cate Miller, NIDILR
Michael Swanson, CDC
NICHD Staff and Visitors:
Ahmed Calvo, HRSA
Scott Campbell, AOTF
Fred Cecere, Thought Leadership
Theresa Cruz, NICHD
Kathryn DeLaurentis, FDA
Robyn Ellerbe, APTA
Thomas Fise, AOPA
Lyn Jakeman, NINDS
Rusti Johnson, NICHD
Lisa Kaeser, NICHD
Naomi Kleitman, Neilsen Fn
Kimberly Kontson, FDA
Sue Marden, NICHD
Mary Ellen Michel, NICHD
Maria Nurminskaya, CSR
Vivek Pinto, FDA
Louis Quatrano, NICHD
Elizabeth Rasch, CC-RMD
Christine Rogers, NICHD
Brian Schulz, VA
Marilyn Spivack, Spaulding
Erik Wolf, DOD
NICHD Director's Report
Dr. Diana Bianchi noted that she appreciated the opportunity to address the Board in her new role as Director of NICHD. She discussed her lifelong commitment to NICHD as a neonatologist and medical geneticist. She was a member of the National Advisory Child Health and Human Development (NACHHD) Council from 2012 to 2016, participated in the Scientific Vision process in 2010, and was a participant in and moderator of the first Human Placenta Project meeting. She added that NICHD has funded 41 of her 43 project-years of her research grants.
Dr. Bianchi noted that the transition website of President Elect Donald J. Trump lists the advancement of research in health care as one of its goals. At the time of the Board meeting, NICHD was operating on a continuing resolution funded through December 9, but Congress was considering extending the continuing resolution through April or May. The continuing resolution maintains the previous year’s funding levels.
The 21st Century Cures Act passed in the House by a vote of 392 to 26. The bill reauthorized NIH funding through 2020 and added $4.8 billion of additional funding over 10 years for three initiatives: the All of Us Research Project of the Precision Medicine Initiative, the Cancer Moonshot, and the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative. The Act also authorized $1 billion in additional funding to the states for opioid treatment and $500 million to the Food and Drug Administration (FDA). The Act also called for improving medical rehabilitation research at the NIH. It required that the National Center for Medical Rehabilitation Research (NCMRR) director, when developing the current research plan, identify existing resources available to support rehabilitation research and include objectives, benchmarks, and guiding principles for rehabilitation research. The Act also required the NCMRR director to develop an annual report for the coordinating committee and advisory board and requires the coordinating committee to host a scientific conference or workshop at least every five years.
In recent years, the NICHD payline had been declining and the number of grant applications had increased. Moreover, the Institute was more heavily invested than other Institutes and Centers (ICs) in human studies, which carry higher budgets. In response, the NICHD would identify its priorities more clearly, bring greater flexibility for discretionary funding, and be more strategic about its investments. The NACHHD Council would continue to review any grantees of getting aggregate annual NIH funding of more than $1 million and the NICHD would be more selective in participation in broad NIH funding opportunity announcements (FOAs).
NICHD has worked to improve its paylines this fiscal year (FY), pushing the payline for R01s, R21s, and R03s from the 9th percentile to the 10th percentile by the end of the fiscal year and increasing the paylines for training and career development mechanisms as well. NICHD would also consider the use of new metrics, such as the relative citation ratio and the research commitment index when evaluating grant applications in an effort to support more researchers at an earlier stage in their careers.
The NACHHD Council reviewed the NICHD Office of Health Equity and recommended the Office produce a strategy for health disparities research, helping to create a diverse workforce, and serving as the point for communications on health disparities research and diversity in the workforce within and outside of the NIH. A new director of the office was expected to be hired soon.
Dr. Bianchi also discussed the Zika in Infants and Pregnancy (ZIP) Cohort Study, which plans to enroll 10,000 women in Puerto Rico and Central and South America. The goals include:
- Determining the risks of Zika infection during pregnancy
- Determining the maternal and fetal outcomes of symptomatic and asymptomatic Zika infection during pregnancy
- Assessing the effect of the timing of the infection and potential confounders, such a co-infection, on the outcomes
- Assessing outcomes of infants with congenital Zika infection versus postpartum infection
The study would also examine primary outcomes, including microcephaly, fetal demise, and ocular abnormalities such as glaucoma. Zika could be transmitted through sexual contact and, in a mouse model, reduced male fertility. An NICHD workshop on the effects of the virus on child development was held in September 2016. The meeting report had been submitted to JAMA Pediatrics.
As part of the Precision Medicine Initiative, the NIH was building the All of Us Research Program with the goal of enrolling at least 1 million participants within four years. Pregnant women and people with disabilities would be included among the enrollment for version 1, and children would be included in the second round of enrollment, expected to begin in the summer of 2017. Issues related to the enrollment of people with intellectual disabilities were being worked out. The Research Program’s infrastructure included a Data Research Center, a biobank, a participant technologies center, and connections to health care provider organizations.
The Environmental influences on Child Health Outcomes (ECHO) Program was investigating the longitudinal impact of prenatal, perinatal, and postnatal environmental exposures on pediatric health outcomes, including obesity, respiratory diseases such as asthma, and neurodevelopment. The study would use 78 existing cohorts and consider environmental exposure in the broad sense of the term, including the social environment and sleep patterns.
In redirecting the National Children’s Study funds, the NIH created an Institutional Development Award (IDeA) Program Opportunity to extend the National Pediatric Clinical Trials Network into more rural settings. The goals were to give children in rural areas a chance to participate in clinical trials, link IDeA state centers with clinical trial experts, and build capacity and improve access. Currently, 23 U.S. states plus Puerto Rico qualify for IDeA funding.
The Gabriella Miller Kids First Research Program used genomic sequencing to determine the etiology of structural birth defects and childhood cancers. DNA sequence data, along with clinical phenotype data from the fiscal year 2015 cohorts, would be deposited in the forthcoming Kids First Data Resource. Data would be made publicly available for all researchers to identify genetic pathways and to explore whether there were shared genetic pathways between childhood cancer and structural birth defects. The NIH issued an FOA to analyze childhood cancer and structural birth defects genomic datasets.
Dr. Bianchi then invited further discussion from the Board. One member asked what variables are being studied in the ZIP study. Dr. Bianchi indicated that it was a clinical study that collected biospecimens, does imaging, and had a standard physical exam. Some centers were also looking at sight and hearing.
Another Board member asked whether the All of Us Research Program would include subpopulations, such as people with disabilities. Dr. Bianchi said that the Research Program was open to everyone. The Program would collect its own data and was also interested in populations for which data sets have already been collected. She noted that this was a good time to pose questions about specific subpopulations that the Research Program might be able to answer. Dr. Cernich added that NICHD had cohorts and data on traumatic brain injury (TBI), spinal cord injuries (SCIs), and cerebral palsy. Dr. Bianchi added that it was important to ensure that the leader of the Research Program, Eric Dishman, knew about those cohorts and data. One question was whether the Research Program data could help meet some of the Rehabilitation Research Plan’s goals.
NCMRR Director's Report
Dr. Alison Cernich updated the Board on the NIH rehabilitation research conference that the NCMRR organized in May. The conference was an opportunity for advocates and people in different areas of rehabilitation to meet, energize the field, encourage collaboration, and give input for the final NIH Research Plan on Rehabilitation. The meeting was live tweeted and hit a trend point on Twitter. The second day of the conference included a town hall meeting at which attendees were able to raise questions and issues and provide suggestions, such as how to measure the impact of the plan.
The NCMRR launched the research plan in September. The Trans-NIH Medical Rehabilitation Coordinating Committee (MRCC) was instrumental in producing the plan, which must be incorporated into the NIH Director’s report every three years, but did not need to be presented to Congress. The plan included six areas:
- Rehabilitation across the lifespan
- Community and family
- Technology use and development
- Research design and methodology
- Translational science
- Building research capacity and infrastructure
Dr. Cernich indicated that the NIH launched the research plan in September 2016 at a White House event, the Design for All showcase. The event, which highlighted clothing designs that could accommodate people with disabilities, generated attention for investigators working in fabrics and wearables.
Dr. Cernich noted that she would provide some initial outcomes on the research plan during her presentation to the NABMRR in May, 2017. She would report the number of grants; the types of projects (basic, clinical, translational); the investigators, including those new to a rehabilitation category; and the impact of the work on the field including changes in practice guidelines. Investigators were just beginning to apply for funding related to the plan, so there would be a lag before it is possible to see the effect of the plan; data from fiscal year 2015 would serve as the baseline.
The NCMRR was involved in sponsoring two other workshops, Technology in Pediatric Rehabilitation, which was cosponsored with the National Science Foundation (NSF), and Clinical Trials in Rehabilitation, which was sponsored by the NCMRR in collaboration with theRehabilitation Research Resource to Enhance Clinical Trials (REACT) Center.
The NIH had five active FOAs that relate to rehabilitation:
- Rehabilitation Research Career Development
- NIH Health Care Systems Research Collaboratory
- BRAIN Initiative
- Promoting Caregiver Health Using Self-Management
- Global Noncommunicable Diseases and Injury Across the Lifespan
Dr. Cernich noted the Medical Rehabilitation Research Resource (MR3) Network, which had six centers and a coordinating center, had been very active at national research meetings. Within each of their respective research domains, the centers provided research expertise and resources, collaborative opportunities, and even support pilot studies. The Network was a great resource for rehabilitation researchers, and Dr. Cernich urged Board members to look at those opportunities and encourage their students to do the same. The Centers could be accessed through the coordinating center at http://www.ncmrr.org and further background would be presented later in the meeting.
Mary Ellen Michel, Ph.D., was retiring from the NCMRR at the end of 2016, but Jennifer Jackson, Ph.D., recently joined as an analyst. At that point, the Center had four health science administrators, one health specialist, one program support specialist, and an administrative assistant. The NCMRR linked to its federal partners on its website and also sent out a listserv newsletter that has 846 subscribers.
The NCMRR received $70 million in funding for FY 2016, a slight increase over the prior year. Congress had not yet passed the budget for FY 2017. Distribution of the budget included 56% for research projects, with the next biggest categories of training and career development, small business projects, and multicomponent projects. Most of the training and career development was funded through K12s, T32s, and K01s grants, while the majority of research funding was through R01s. Small business projects were funded largely through R43s and the larger phase-two R44s along with some R42 technology transfer grants. The six research infrastructure grants supported through the P2C mechanism represented NCMRR funding in multi-component projects.
In terms of specific research categories, the largest investments were in the areas of and prosthetics/robotics and pediatrics (up to age 21 years), followed by research on pain, wheelchairs, behavioral issues, and gait. Grouping by patient populations, NCMRR research focused on conditions such as stroke, SCI, TBI, cerebral palsy, and amputation.
Dr. Cernich then invited discussion from the Board and visitors. One member asked whether the Board could get information about NCMRR investments as they relate to the objectives of the research plan. Dr. Cernich said that she would certainly provide that information. The NCMRR was developing analyses strategies to categorize the grants, many of which could fit into two or more categories.
A member asked what the NCMRR could do to help smaller companies mass market their rehabilitation products. Dr. Cernich said that she was always willing to meet with companies and individuals who have ideas for rehabilitation products. The Small Business Innovation Research (SBIR) and the Small Business Technology Transfer (STTR) programs helped small companies to commercialize their products and develop a niche market. The NCMRR had been meeting with federal partners to determine how to do this better and was talking to other relevant groups. The Department of Defense (DoD) and the Department of Energy (DoE) were investing in advanced manufacturing, including wearables and fabrics, and the NCMRR was helping to identify opportunities in this field. Some athletic companies were also interested in developing wearables to measure body temperature, something that would be particularly useful for people with multiple sclerosis. However, the bottom line for the NCMRR was getting products to the people who need them.
A member asked how the NCMRR would measure the impact of the projects that it funds. Dr. Cernich said that one approach was to examine the number of citations for research practice guidelines. The NCMRR would also consider metrics related to product commercialization and success, including whether a product made it to market, was still on the market, and realized a profit. Dr. Cernich encouraged Board members to send their ideas about other metrics of success to the NCMRR. A Board member suggested that Dr. Cernich include graphs of emerging trends in the presentations at future Board meetings.
Clinical Trials Workshop and Clinical Trials Policy
Dr. Mary Ellen Michel, Program Director at the NCMRR, provided a review of workshop on clinical trials jointly sponsored by the NCMRR and the REACT infrastructure network in September, 2016. A videocast of the workshop and an executive summary were posted on the NCMRR website. In addition, a summary of the workshop, entitled “Medical Rehabilitation: Recommendations to Advance the Field with High-Impact Clinical Trials,” would be published in the Archives of Physical Medicine and Rehabilitation.
Some of the discussion centered on the definition of a clinical trial and prompting investigators to state the purpose of the trial (e.g., getting a product out to the community, understanding a therapeutic mechanism, or optimizing a dose and delivery). It was agreed that feasibility studies were needed, but that they could be difficult to fund. Other discussion focused on appropriate trial design, fidelity of treatments, appropriate comparison groups and add-on studies, sustainability of effect, and patient heterogeneity. Members also agreed that investigators should be encouraged to seek advice on trial design at the earliest planning stages and that proposed treatments should be designed with an eye toward translation to real-world usage. Another consideration was how to accommodate heterogeneity of patient populations and their environmental supports when designing a trial, for this would impact optimizing outcomes versus generalizability of the results.
Dr. Susan Marden, another NCMRR Program Director, provided some background on the NIH’s enhanced stewardship of clinical trials. Dr. Marden indicated that the NIH spent $3.2 billion a year on clinical trials but had limited ability to assess and monitor the clinical trials portfolio. The NIH was implementing new clinical trial activities to enhance the quality and transparency of clinical trials across ICs. This effort began in 2010 when the Institute of Medicine (IOM) was invited by the National Cancer Institute (NCI) Director to evaluate the NCI’s Cooperative Clinical Trials Groups and found that it took more than two years to launch a cancer clinical trial. In addition, results of some trials were never reported. The IOM made 12 recommendations for improving NCI clinical trials. In 2012, Congress directed that the IOM recommendations be reviewed to determine implementation across all ICs.
The NIH Clinical Trials Working Group was formed in 2012 to address the Congressional mandate to enhance the quality and transparency of clinical trials. It concluded that seven of the IOM recommendations were applicable, but only for some ICs; and, that there were particular weaknesses in investigator-initiated clinical trials versus large network clinical trials. In 2013, the NIH developed its own set of recommendations to enhance clinical trial stewardship. These included:
- Improve the application, acceptance, and award processes for clinical trials.
- Improve peer review and advisory council review.
- Incorporate trial-specific language into notices of grant awards.
- Improve monitoring systems, tools, and processes for oversight of clinical trials.
- Train and empower program officers to take remedial action to move stalled studies forward.
- Require good clinical practice training for investigators, research personnel, and program staff.
- Streamline institutional review board (IRB) review of multisite studies, including the use of a single IRB.
- Require the dissemination of clinical trial results.
In 2014, the committee revised the definition of clinical trial to make a distinction between clinical trials and other clinical research. The current NIH definition for a clinical trial is, “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” In 2015, an NIH task force reviewed the implementation of the proposed recommendations, as well as drafting policy and identifying proposed standard data elements for each IC to collect for clinical trials.
The Government Accounting Office (GAO) reviewed how the NIH had addressed the 2013 recommendations. While generally favorable, the GAO report said the NIH had not finalized the data that all ICs should be collecting and did not have a plan for how the data would be used. One of the changes to enhance clinical trials was that, as of January 2017, all NIH-funded investigators and staff involved in clinical trials should be trained in clinical practice. In addition, each IC must develop specific FOAs exclusively for clinical trial research applications. Therefore, the ICs would do an inventory of their respective clinical trials, decide on priorities, and determine which FOAs should be reissued and which should be allowed to expire. NICHD had a clinical trials working group to develop FOAs the Institute would use to solicit clinical trials.
Another policy change was that, as of May 2017, multisite trials would use a single institutional review board (IRB), a change that is expected to facilitate development and oversight of clinical trials. In addition, the NIH and the FDA have developed a clinical trial protocol template that would go into effect in the fall of 2017. It was meant to clarify the information that the respective agencies require and to reduce delays when investigators do not supply the necessary information. This template could also help produce standardized data sets.
Clinical trials must share their results so that the information gets out to the community and that data could potentially be used by other investigators. The result of the clinical trial must be reported within one year after the trial’s primary endpoint.
The NIH Office of the Director appointed a trans-NIH Clinical Trial Operations Working Group to oversee implementation of the new policies. The enhanced stewardship of clinical trials was expected to bring more trust and transparency to clinical research.
In the discussion that followed, a Board member asked whether these changes applied to proof-of-concept or pilot studies. Dr. Marden said that those studies would have to come in through a clinical trial FOA. However, the protocol template did not apply to this earlier phase 0. Someone else asked whether the dissemination-of-data requirement would affect informed consent. Dr. Marden indicated that the informed consent should address the sharing of data, including genetic data, but that patient data should not be individually identifiable because the “sharing” refers to the results of the clinical trial. Study section reviewers and funding agency representative would also consider privacy issues. Dr. Nitkin added that improved clinical trials stewardship would increase the validity of studies and would lead to more efficient spending of research dollars.
Dr. Bianchi indicated that one of her priorities was to revamp the NICHD website to make it easy to find clinical trial results. The NICHD would list recent clinical trials and their conclusions. Dr. Michel also noted that the NICHD has the Data and Specimen Hub (DASH), which NICHD investigators could use as part of their data-sharing plan. Dr. Cernich said that there was funding available to help investigators to get their data into DASH.
Concept review and clearance of all proposed Requests for Applications (RFAs) was required by the NIH. Though this review may be carried out in a number of different ways, for many Institutes concept review was a function of their national advisory councils or boards.
Dr. Louis A. Quatrano presented a proposal for a Limb Loss Registry. (Board member Ken Kaufman was in conflict with this particular proposal and was absent from the discussion.) The proposed registry would collect data related to the incidence and prevalence of limb loss in the United States and include information related to surgical techniques and outcomes, physiological changes, and assistive technologies. NICHD had a similar registry for Down syndrome. The proposed funding would support the construction of the registry and initial collection of data. There is no other database that tracks this information.
One Board member asked whether the registry would include data from the Department of Veterans Affairs (VA). Dr. Cernich indicated that the NCMRR had contacted VA and the DoD about combining efforts on this. There were restrictions on how VA could share its data, but the NCMRR wanted to make the registry as interoperable as possible. The registry would focus on amputees, but it would also be possible to explore more generalized questions, including limb loss and opioid abuse. Dr. Cernich added that the registry would include children, to help understand the effects of the surgery and device use, and that the NCMRR was working out partnerships on this project. The proposed concept was approved unanimously.
Nomination for Chair-Elect
The current Board chair, Dr. Amy Bastian, would finish her term with the May, 2017 meeting. So nominations were sought for the chair-elect, who would assume that role at the conclusion of that meeting. Dr. Gregory E. Hicks was nominated and he accepted. No other nominations or self-nominations were made and Dr. Hicks was approved unanimously.
Medical Rehabilitation Research Resource (MR3) Network
The MR3 was a program to support and enhance medical rehabilitation research to optimize patient care and quality-of-life for persons with disabilities. The network included six centers, funded through the NIH P2C mechanism; most of these programs also partnered with secondary institutions to provide access to a broad array of research opportunities and collaborations. The principal investigators (PIs) from each center programs presented a short summary of their programs and the particular research that they facilitate.
Dr. Marcas M. Bamman provided some background on the REACT center based at the University of Alabama at Birmingham (UAB) in partnership with Baylor University. The REACT center funded a handful of pilot studies each year and provided vouchers to facilitate the collection of preliminary data. The UAB center supported four pilot projects in the first year and would fund five in the second year. Its mobile technology laboratory provided expertise in wearable technology and mobile health apps. The center’s activities also included developing educational materials, training investigators on clinical trial design, supporting visiting scholars, conducting training workshops, and providing access to core laboratories, clinical resources, and databases.
The MR3 offered complementary resources, including to the National Exercise Clinical Trials Network and the North American Research Committee on Multiple Sclerosis. The Center also had core facilities that those who use the MR3 Centers could draw on, including cellular imaging and microscopy, DNA sequencing and genotyping, and human tissue phenotyping.
Dr. Michael L. Boninger provided some background on the Alliance for Regenerative Rehabilitation Research and Training (AR3T) based at the University of Pittsburgh with connections to Stanford University, the Mayo Clinic, and the University of California, San Francisco. The goal of AR3T was to expand scientific knowledge, expertise, and methodologies across the domains of regenerative medicine and rehabilitation. This would be accomplished through education, collaboration, pilot funding, technology development, and quality monitoring. AR3T provided free telephone consultations to investigators who needed expert advice. It also reviewed the aims and methodology sections of a grant application or may pay an expert to do that review. The center also offered short-term sabbaticals.
AR3T had three research cores available for collaborative opportunities: one on cellular therapeutics and tissue regeneration, another on mechanotransductive methods, and a third on mechanosensitive biomarkers. The cores also provided opportunities to explore stem cell function and tissue regeneration.
The center held quarterly webinars and would offer a large open, online course through Coursera. AR3T provided travel awards to the annual Symposium on Regenerative Rehabilitation, which has been growing every year. AR3T had also successfully used social media and has an active website with nearly 5,000 page views per month. The center hosted an advanced training course designed to attract a diverse audience; 46% of the attendees were from underrepresented groups.
Dr. Boninger showed the inputs, outputs, and long-term outcomes, including human capital (skills, training, and knowledge), information capital (educational modules, networking forums, and technical training) and development capital (leadership, alignment, and teamwork). AR3T funded regenerative rehabilitation pilot projects conducted by basic scientists who had not previously done rehabilitation research and clinicians who had their first experience doing basic science. Those were the types of projects the center aimed to stimulate.
A Board member asked whether most of the research is with animals, but Dr. Boninger indicated that the center had many studies involving humans, including work on exercise and massage. VA researchers and PIs funded by other ICs had shown interest in the AR3T’s work and in receiving funding for pilot projects.
Dr. Scott L. Delp provided some background on the National Center for Simulation in Rehabilitation Research (NCSRR) based at Stanford University. The mission of NCSRR was to equip the rehabilitation research community with access to state-of-the-art simulation tools to facilitate an understanding of human movement and to design treatment programs. It developed OpenSim software that has been used by 26,000 people, provided support and training, held workshops and webinars, hosted visiting scholars, and funded pilot projects. The software has applications for cerebral palsy, TBI, stroke, prosthetics, assistive robotics, and other patient populations.
NCSRR software was being used around the world as a simulation tool in research. For example, the simulation software helped determine why an assistive device required an unexpected amount of the user’s energy by interfering with the dynamics of the muscles and tendons involved in the motion. OpenSim software had been used for a variety of other projects, including estimating muscle and joint forces and doing forward dynamics simulation. It was a platform for sharing models, data, and tools.
NCSRR had 26,000 OpenSim users, trained 110 researchers, awarded 24 Outstanding Research Awards, funded 11 pilot projects, and hosted 14 million page views. Dr. Delp said that the P2C funding for the center was equivalent to funding two R01s, but because the P2C focuses on building capacity across institutions, it had an even greater effect than two R01s. A Board member asked the youngest age that OpenSim could simulate. Dr. Delp said they could customize the model for a child as young as nine years old.
Dr. Richard M. Greenwald discussed the Center for Translation of Rehabilitation Engineering Advances and Technology (TREAT), which was associated with Simbex and Dartmouth College in New Hampshire. TREAT was formed six years ago with NCMRR funding to provide education, expert consultation, and assistance to accelerate commercialization of rehabilitation and assistive technologies. Many researchers lacked the resources to get their ideas to market. Challenges included the lack of market opportunity, insufficient return on investment, the existence of a similar device that makes it to the market first, product not being adopted, and technology not working.
TREAT was a consortium that included entrepreneurs, engineers, scientists, clinicians, and regulatory experts. It provided education, fellowships and sabbaticals, commercialization services, and pilot project grants. It helped people think through the commercialization process, including whether there was a market and how much the market would pay. TREAT also provided modest stipends. TREAT mentored 180 innovators, funded 13 sabbaticals and fellowships, awarded $550,000 in pilot grant funding, and helped secure $4.5 million in follow-on funding. TREAT was helped support the creation of 55 jobs and helped bring eight products to market.
Dr. Steven A. Kautz discussed the National Center of Neuromodulation for Rehabilitation (NM4R), located at the Medical University of South Carolina (MUSC). The mission of NM4R was to develop and support a community of rehabilitation researchers who apply brain stimulation and operant conditioning technologies to both mechanistic and intervention studies, and to develop technology and theory for the field of rehabilitation. MUSC had extensive expertise in the use of neuromodulation approaches to treat psychiatric conditions coupled with expertise in operant conditioning. The goals of the Center were to train researchers, provide scientific programming, build the research community, and advance the field. NM4R provided two levels of workshops and trained 59 people so far. The advanced workshops offered training in transcranial magnetic stimulation (TMS) and operant conditioning techniques.
NM4R also offered hands-on trainings for visiting scholars, as well as consultations to help develop protocols and to provide feedback and mentorship on grant applications. NM4R sponsored scientific programming, including at a Society for Neuroscience meeting and at the American Congress of Rehabilitation Medicine. The center had also been building a research community that now includes 203 members. In its first year, NM4R funded six pilot studies at a cost of $225,000. One of the center’s accomplishments was development of a transcranial electrical stimulation that was much less painful. In tests on healthy adults, researchers were able to use this method to elicit movement in an individual’s hand.
Dr. Kenneth Ottenbacher provided background on the Center for Large Data Research and Data Sharing in Rehabilitation (CLDR) at the University of Texas Medical Branch. The CLDR was a consortium that includes Cornell University, the Interuniversity Consortium for Political and Social Research (ICPSR) at the University of Michigan, and the University of Michigan Health System. Advances in bioinformatics, statistical computing, and the Internet have resulted in access to large amounts of data, including data related to rehabilitation. But large datasets would be overwhelming and the rehabilitation field had not been taking advantage of the opportunities offered by large datasets. The CLDR worked with large data sets associated with health outcomes such as data from the Centers for Medicare & Medicaid Services, the All of Us Research Program of the Precision Medicine Initiative, and the National Patient-Centered Clinical Research Network of the Patient-Centered Outcomes Research Institute (PCORnet).
One of the biggest challenges of large data was learning how to keep track of it, manage it, define and aggregate it, and create analytical files. One example of large data research was a project that Dr. Ottenbacher conducted using 1.7 million Medicare files to determine the rates of hospital readmission for six impairment groups receiving inpatient rehabilitation. Those within the debility impairment group were readmitted at the highest rate, followed by those with neurologic conditions and brain dysfunction. Debility was a category involving hospital-induced disability such as atrophy. The average cost of readmission was $36,000, and many cases could be prevented.
The CLDR offered education and training, including presentations at conferences, many of which are videotaped and available on the Internet. It also had a monthly lecture program. The center partnered with Cornell University to input rehabilitation-related data into a data directory, DisabilityStatistics.org, which receives 250,000 visits per year. The data sets had been screened; many were from public sources, and some were from private sources and may require a data use agreement. The directory allowed users to filter the data by criteria to obtain the specific data they need.
The CLDR had funded pilot projects that offer practical experience in managing, analyzing, and interpreting findings using large data analytics. The grants of up to $25,000 were designed to build research capacity within the field. The CLDR also funded visiting scholars. One of the CLDR’s projects aimed to help with data sharing and archiving for secondary research use, which is becoming a requirement for researchers. The data sharing aspect of the program were conducted in partnership with the Inter-university Consortium for Political and Social Research (ICPSR), which helped archive the data, run workshops, and make the data available to investigators. The CLDR could help a site set up licensing and data use agreements.
In the discussion that followed, a Board member asked about the quality of the pilot studies that come to the centers. Dr. Bamman said that the proposed pilot studies ranged in quality, but some were very high-quality proposals. The proposals came from people at different career stages, from early-career investigators to more established professors. The pilot program provided applicants the opportunity to consult with any of the Center’s experts. The significant interaction between applicants and the staff of the centers could bolster an applicant’s chances of receiving a grant. Dr. Nitkin said that the idea was to provide a more nimble source of funding to help researchers in the early stages of a project and to develop enough preliminary data to apply for a larger grant. Dr. Delp added that the 35 proposals NCSRR received this year were stronger than those received in the first year. Of the proposals this year, half were fundable once they were given a little coaching; and six were very good after coaching was provided.
A Board member asked how the availability of funding for pilot studies is publicized. Dr. Delp said that NCSRR had a mailing list. Dr. Bamman added that REACT was increasing its user base through its network website. The NCSRR also sent announcements of their pilot awards to listservs, including listservs distributed by the NIH and the NCMRR.
A member asked how the Board should measure the value of the centers; that is, what were the key measures for impact: number of grants, patients, or papers? Dr. Bamman suggested that it was all of those. Another measure of success was the centers’ ability to reach researchers and get information out to the community, including end users, health care providers, and patients. His center had been developing a large network. Dr. Kautz said that one measure of success was how NM4R affected the next generation of studies and papers on neuromodulation and rehabilitation. Dr. Greenwald indicated that TREAT submitted a development plan and should be judged based upon their plan. TREAT’s aim was to get rehabilitation products to people and to spread the word about the impact of rehabilitation research, so another measure of success was whether the research community is familiar with TREAT. Dr. Boninger said that AR3T could create a meaningful dashboard with variables such as pilot funding, R01s, product submission, products to market, and utilization of data sets that had not been largely used in the past. The dashboard could be a good metric to show progress. Dr. Ottenbacher said that CLDR would have achieved its mission when the existence of these large data sets and understanding of how they could be used was widely known among researchers.
A Board member asked whether the centers were actively soliciting grant applications from diverse populations and from the less pedigreed institutions. Dr. Delp said that the centers had a subcontract with San Francisco State, which has a diverse student body. NCSRR recruited heavily for a diverse population for its advanced training; 46 percent were from underrepresented populations. Dr. Boninger added that all of the centers had a diversity plan and that this metric could be part of the dashboard. Dr. Bamman said that the UAB panel included the university’s dean of diversity and inclusion, who worked with them on this issue. REACT used the dean’s database to help disseminate information about the MR3 Network.
A Board member asked whether the MR3 Network had adequate funding to accomplish the mission. Dr. Delp said that he believed the MR3Network had a good number of centers and that their budgets were big enough to make an impact.
A Board member asked the MR3 PIs whether they had a plan to sustain funding. Dr. Greenwald indicated that TREAT hoped to become fully sustainable by the end of the current funding cycle by raising money from outside sources. However, he noted that model may not be possible for other centers. Dr. Bamman said that REACT was making an effort to partner with their Clinical and Translational Science Award program, which could help them reach sustainability. He also said that there were opportunities with the 17 ICs who could help fund the MR3. Dr. Greenwald said that MR3 was a model system for the NIH; it could be adopted by all of the ICs.
A Board member asked how the MR3 could reach out to private industry. Gary Cutter, also from the REACT, said that three companies came to them in search of advice. The model was unusual because it was free: People could call and get free advice or $10,000 in training. Dr. Kautz added that companies asked the NM4R about the feasibility of breaking into the rehabilitation market, and the center assisted them. Dr. Boninger said that his center had corporations involved in its symposium.
Evaluation and Dissemination of MR3
Dr. Nitkin provided some additional perspectives for evaluating the MR3 Network, including coordination of efforts across networks, evolution of topics over across the funding cycles, and the attraction of new researchers into medical rehabilitation research field, and support for researchers who worked with MR3 networks and then obtained funding from other ICs. But, he added, the focus of the conversation should be on whether the NCMRR should continue to support a program of research networks. Did they continue to justify the research funds involved? What should be the appropriate evaluation metrics?
A Board member asked how the MR3 centers align with the overall NIH rehabilitation research plan. Dr. Cernich pointed out that the MR3 centers were directly responsive to the research plan’s goal of building the research infrastructure.
A member said that for a program like the MR3 to be successful, awareness of the program should be significantly increased, and asked how to generate that buzz. He also asked what the biggest accomplishments were from the previous grant cycles. Dr. Cernich said that there were data she could present to the Board at its next meeting on this topic. One of the unique aspects of the MR3 in the current funding cycle was the establishment of a coordinating center to do communications, marketing, and publicity, relieving the investigators of those duties and ensuring they were done.
A member expressed doubt that the MR3 centers had adequately reached out to under-resourced institutions, which could benefit from the resources the program offers. Nonetheless, the mechanism was a good one and covered the breadth of rehabilitation research. Another member added that if the centers focused on something that was not being formally taught and then brought it into the mainstream, it would make them worthwhile, and then asked if there examples of that occurring. An audience member said that a significant portion of the NCMRR budget was going to fund the MR3 program, but the MR3 expanded the scope of rehabilitation research and multiplied the NCMRR’s efforts in the field.
Dr. Cernich said that she understood the Board would like to know more about the history of the network program, how many people they have touched, the level of the NIH’s investment, the advances the networks have made, and whether those advances have been incorporated into clinical use. There also appeared to be a desire to receive data to help measure the success of the networks. She suggested that as an agenda item for the next meeting.
Dr. Nitkin added that the increasingly limited geographic diversity of research could be an issue. It appeared that NIH funding was going to fewer and fewer different institutions and this may support fewer perspectives. The networks could help even the playing field and provide a bit more diversity.
A Board member said that clinical research was not reaching the full diversity of the U.S. population, because it was restricted to the larger academic medical centers. Patients at academic medical centers were a non-representative group of patients. Dr. Cernich said that there were NIH infrastructure mechanisms to increase diversity, including the Institutional Development Award (IDeA) to broaden state diversity and programs with a special focus on Historically Black Colleges and Universities as well as places that are not major academic medical centers. But, she added, the NCMRR had not gotten the traction in those geographic areas and institutions. She asked how the NCMRR could diversify into those communities. One member suggested putting the onus on the people who get funding in dissemination and implementation to broaden beyond their immediate institutions.
Lyn Jakeman of the National Institute of Neurological Disorders and Stroke (NINDS) indicated that highlighting network support in study sections and publications would raise awareness of the value of this mechanism and of the centers. Dr. Nitkin said that a few years ago, the NCMRR did a search to track NIH applications arising from center interactions that went to other ICs. Those applications had an elevated success rate as well. Dr. Jakeman agreed but said that if peer reviewers realized research applications benefited from interactions with the centers, it would raise the understanding and awareness of the centers across the research communities.
Dr. Cernich said that the NCMRR was working with several research journals to produce a simultaneous publication of the NIH rehabilitation research plan. She was preparing to do a briefing at the Rayburn Office Building on December 8. This briefing offered an opportunity to highlight how important this research is and how it could change lives. She asked Board members to contact Lisa Kaeser to suggest other points to make. Dr. Cernich indicated that in addition to the briefing, she would monitor the Cures Act and update the Board. This first day of the Board meeting ended with adjournment at 5 p.m.
Challenges in Limb Loss Research
Dr. Kenton R. Kaufman provided some background on limb loss research. He indicated that the two major reasons for amputations are trauma and vascular disease. About 1,700 military personnel suffered amputations as a result of the wars in Iraq and Afghanistan. The estimated cost of care was $2.5 billion. Because of improvements in technology and rehabilitation, about 19% of soldiers who suffered amputations returned to duty. Among U.S. civilians, there were 185,000 amputations per year. Between 1 and 2 million amputees live in the United States. Hospital costs are about $8 billion per year. Most amputees were male. African Americans were four times more likely to have an amputation than the general population, and Hispanics nearly three times more likely.
Among veterans, the secondary health effects of amputation included higher rates of obesity (due to inactivity), hypertension, osteoarthritis, and osteoporosis. The mortality rate for veterans with an amputation was 1.6 times higher than for veterans with a limb salvage procedure, and 2.2 times higher than for civilian controls. The psychological impact was serious, including perceived loss of ability to participate in activities, negative body image, and dissatisfaction with their sex lives. About one-half of veterans with amputations had major depression.
About one-half of amputees suffered from a fall each year, a higher rate than among the elderly. Those with transfemoral amputations fell more than twice as often as older adults. Fear of falling led amputees to become inactive and to additional secondary health conditions. Any assistive technology provided had to be accompanied by good rehabilitation, or it would not be used to its full effect.
Dr. Kaufman’s group has found that only 25% of those who had an above-the-knee amputation received prostheses. At the VA, fewer than 20% of those who had a transfemoral amputation got prostheses. Dr. Kaufman’s group found that amputees who were using a mobility aid were 30 times less likely to get a prosthesis and that the probability decreased with age.
Medicare provided a classification system to help determine whether the individual should receive a prosthesis. The classification runs from K0 (bedridden) through K4 (athletic). Analysis of Medicare data indicated that about 30% of patients received a prosthesis that was one or two levels higher than the Medicare classification suggested they should receive. Further, analysis by Dobson and DaVanzo showed that those who received a higher level of prosthetic device actually cost Medicare less money in the long run.
Dr. Kaufman did a study with transfemoral amputees using a mechanical knee. On average, they fell four times a month. But when they were given a microprocessor knee and trained to use it, they became more active and fell much less often, about once a month. The microprocessor knee was so much better that about 30% of patients in the study refused to return the knee, even though they were supposed to do so under the terms of the study. An interesting outcome to the study was that when patients got the mechanical knee back, their falls increased, although not significantly.
Dr. Bianchi asked why only 20% of patients got prostheses. Dr. Kaufman said that the physician makes the decision. Dr. Cernich added that sometimes a patient has comorbid conditions that make a prosthesis inappropriate or that some patients do not want a prosthesis.
Dr. Kaufman indicated that Medicare classified prosthetic devices as durable medical equipment. Medicare’s concern about fraud in the provision of durable medical equipment had a significant effect on the provision of prosthetic care. There was a 42% decrease in spending on advanced technology and a 32% increase in spending on cheaper technology after Medicare began focusing more attention on durable medical equipment. Prosthetists were afraid of getting audited, because they cannot receive payments until the audit is done. There was a need for outcomes research in prosthetics so that clinicians could support their decisions using evidence-based practice. Dr. Kaufman said that he believed more advanced prosthetics save money, because the recipient becomes more active, falls less, is more likely to lose (or not gain) weight, and achieves the health that comes with being more active.
A Board member indicated if the microprocessor knee would reduce cardiovascular disease, there was a possibility that could be used to justify giving the knees to patients. Dr. Kaufman agreed but said that a limb-loss registry was needed to collect outcomes data. Data for people who had an amputation because of trauma and those who had an amputation because of a chronic condition should be tracked separately.
A Board member asked whether a claims analysis had been done on prostheses. Dr. Kaufman said that the analysis so far indicated that the more advanced prosthesis had higher upfront costs, but reduced health care costs over time. Dr. Cernich added that the Medicare data had limitations. For example, it was not possible to tell whether the patient actually uses the prosthetic.
A member said that he was struck by the fact that people were not even getting a prosthesis. Dr. Cernich said that the biggest challenge was the lack of outcome data. Prosthetists and orthotists did not enter medical records, so these were lumped in with other durable medical equipment in the payment codes. If the data showed the better prostheses worked better and saved money, that finding would change treatments for the acute trauma patients.
Dr. Kaufman said that there was a need for much more collaboration in the field of prosthetics. Also, the civilian and military trauma and prosthetic care systems needed to be integrated; each system could benefit the other. He summed up his talk by making the following points:
- Encourage greater transdisciplinary study of prosthetics.
- Treat the body, mind, and spirit of amputees.
- Train amputees to use the technology they receive.
- Provide the appropriate technology to patients.
- Develop outcomes data.
- Promote device development.
- Promote interagency collaboration.
- Ensure reimbursement.
Proposal to Videocast Future Meetings
Dr. Cernich proposed that the Board videocast and archive future meetings to open its work to a wider audience. After a short discussion, the motion to videocast future meetings was made and seconded. The Board voted unanimously to approve the motion.
Opening the Training Pipeline for People with Disabilities
Dr. Nitkin said that the NCMRR wanted to promote discussion about the training pipeline (high school through beginning faculty) for people with disabilities. As individuals progressed through the academic pipeline, they receive different and more targeted messages and career supports. But they still need to know who was dropping out of traditional academic careers and why; what the NIH’s responsibilities to ensure non-traditional researchers remained in the pipeline were; where along the pipeline the NIH should intervene; and what were the mentoring opportunities.
Dr. Nitkin indicated there was a need to identify diverse mentors and opportunities to collaborate with other federal/state agencies, academic institutions, professional organizations, and advocacy groups and community organizations in support of this effort. The NIH had a role in highlighting relevant research opportunities and in supporting and promoting role models. Promoting diversity improved the validity of research, supported subject recruitment, and helped ensure that it was targeted to the true needs and goals of the people involved.
The NIH offered diversity supplements to add qualified but under-represented individuals to on-going NIH research projects, but this program tended to support a much higher percentage of racial/ethnic minorities and few people with disabilities, who often face physical and attitudinal barriers in building careers in biomedical research field. He asked how the NIH could highlight opportunities for diversity supplements, especially focusing on people with disabilities. And he asked what the NCMRR’s role should be in promoting these programs to the research community.
In research protocols, the NIH mandated the appropriate recruitment of women, racial and ethnic minorities, and children, but there was no requirement to include people with disabilities. If people with disabilities were not adequately included in research, was the clinical finding valid for them? Including people with disabilities in research studies may require accommodations and modifications to protocols, but it would broaden the validity of the research and open up additional hypotheses.
Dr. Nitkin concluded by discussing opportunities to collaborate with academic Institutions (although it was unclear whether disability offices at these institutions were good at identifying/tracking people with disabilities), professional organizations (especially if they track clinicians and therapists with disabilities and could help Identify mentors/collaborators for trainees with disabilities), advocacy organizations (in support of broader educational opportunities and especially channeling into research careers as well as promoting relevant research opportunities), and finally other federal agencies (that support academic advancement).
Dr. Kathleen Friel described her own journey as a person with cerebral palsy who is now an assistant professor of neurology and neuroscience at Weill Cornell Medical Center. She said that she had science teachers who encouraged her in her early education. She did research internships along the way, which gave both her and her teachers more confidence that she could become a researcher. This also helped students who came after her.
When she was in graduate school, Dr. Friel received accommodations and assistance with surgical procedures used in the laboratory. She received diversity supplements from the NINDS and an NIH fellowship. During her postdoctoral work researching motor deficits in a cat model of cerebral palsy, she received help with tasks requiring fine motor skills. Dr. Friel received career-development awards to study the use of noninvasive brain stimulation to map changes in the brain’s motor cortex after hand therapy in children with cerebral palsy. Her research examines the efficacy of upper limb therapy in children and adults with cerebral palsy.
Dr. Friel listed some of the challenges of being a researcher who has a disability. She was often mistaken for a patient. People doubted her abilities. There were few role models. It was hard to find a job in an organization that valued diversity. She faced physical issues, such as fatigue and pain. Her employer worked to accommodate her challenges.
Dr. Friel said that she worked with children with cerebral palsy, all of whom were impressed that another person with the condition was a researcher. She made the following suggestions:
- Hire people with disabilities into research positions.
- Start early with outreach to engage young people with disabilities.
- Include scientists with disabilities as conference and seminar speakers. Make it normal to see scientists with disabilities at events.
- Have meetings for trainees with disabilities. (This is still unusual even in the diversity field.)
Dr. Joseph Hidler presented his experiences as a person with SCI who used a wheelchair. He majored in mechanical engineering in college and worked in laboratories during the summer. He applied to study biomedical engineering in graduate school after an orthopedist told him about the field. In his graduate school laboratory, he was treated like “one of the guys,” which made him feel comfortable. Dr. Hidler spent eight years in academia before starting his own company, Aretech, LLC, which develops rehabilitation technologies.
Dr. Hidler said that Dr. Nitkin touched on some of the challenges in bringing in more people with disability into research, including how to identify and track students with disabilities and get them interested in academia. Internships could help students become interested in a research or academic career. Supplemental funding was also an important start. Peer mentoring and role models were very important to recruiting and keeping students in academic research.
A Board member indicated that sometimes researchers wanted to bring in people with disabilities but were hesitant to ask whether the individual would want special assistance. Dr. Hidler agreed that people with disabilities do not want special treatment.
Another Board member said that she had students who were eligible for a diversity supplement but did not want to write the application because they did not want special privileges. Dr. Friel said that she would tell such a student that the supplement was there to increase the overall diversity in the field. Dr. Cernich said that if a student did not want to apply for the supplement, they should still be encouraged to stay in research. She also suggested that the NCMRR talk to the Department of Education and the NSF about what they have done to achieve diversity.
A Board member indicated that, as an African American in science, he had experienced some of the same things that Dr. Friel did: Others assumed that he received his scholarship because he was African American, although that was not the case.
A Board member asked whether there were enough opportunities for people with disabilities. Both Dr. Friel and Dr. Hidler indicated that there could be more opportunities and suggested that the NIH could do more to create and promote them. A member said that one approach was to collaborate with professional organizations, all of which have career development activities, including some for people with disabilities. It was important to disseminate information about those opportunities and to refer students with disabilities to those organizations.
Dr. Cernich asked how to get people with disabilities interested in science and how to get scientists interested in working with people with disabilities. How early did they need to get people in the pipeline? There were other federal entities that the NCMRR could work with to put science on their agenda.
An attendee said that the Craig H. Neilsen Foundation had set up a scholarship for students with SCI. The Foundation had funded 70 students but found that some college disability offices were unable to identify students at their institutions who used wheelchairs. She offered to have the foundation work with the NCMRR on the diversity effort.
Dr. Cernich asked the Board members to send additional thoughts on this topic to her.
Briefing from the Board's Working Lunch and Closing Comments
During the first day of the meeting, the Board members held a lunchtime discussion to make suggestions about how they could best fulfill their role as advisors to the NCMRR. Dr. Bastian summarized the results of the discussion. She referred back to the charter, which indicated that the Board advises the directors of the NIH, the NICHD, and the NCMRR on matters and policies relating to the Center's programs.
She indicated that the Board members were best used when they contribute intellectually and advocate for the NCMRR. The Board was pleased that they were able to contribute substantively to the research plan and the conference planning. However, the members agreed that they did not want to rubber-stamp initiatives that have already been worked out nor listen passively at meeting.
The Board recommended that they be given clear objectives in advance of each meeting with indication of the deliverables. More data on the NCMRR portfolio would help with more meaningful assessment. In order to assess a given proposal, they needed to understand the alternatives and the trade-offs involved. For example, when the Board considered and approved the limb loss registry, what other activities would not receive funding?
The Board would like to be involved in longer-range planning and perhaps the development of “moonshot” initiatives. This could include helping to define future opportunities and advocating for NCMRR activities and helping in the coordination with other ICs. The use of some sort of taxonomy for rehabilitation might help, especially in the context of what other NIH Institutes consider as “rehabilitation”. Given the upcoming agenda, the Board should be asked what data would be useful in the evaluating programs or defining a deliverable. And these materials should be sent out before the meeting; reading materials before the meeting would lead to better engagement.
The Board reiterated that the current format of one and a half day meetings was good. They also suggested instituting quarterly phone meetings to maintain momentum on special topics and projects. Board members would be willing to participate in subcommittees for any special topics or projects (e.g., training).
Dr. Cernich thanked the Board for their input. She said that the more feedback she hears, the easier it is to make the meetings more useful to the members. She said she would distribute slides and presentations before the meeting. A Board member said that this would allow him to think through the issues better, have a more informed opinion during discussions, and have more in-depth discussions.
Dr. Cernich said that part of the Board’s value was in getting advice from outside voices and in being connected to others in the field. Dr. Nitkin added that the Board also had the ability to bring issues raised at the meetings back out to their colleagues and constituents. A Board member said that she told her colleagues when she was about to attend a meeting and asked whether they had issues they wanted her to bring up. She also presented a summary to them after the meeting so they could feel more connected. Another member added that she disseminated materials she receives at the meeting to her institution.
Dr. Nitkin said he understood the Board members wanted to receive the slides in advance of the meeting. Dr. Cernich said that she would think more about what other steps were feasible, given the capacity of her office. She said she had tried to push out more information to the Board and would try to be clearer about deliverables and better define what the Board should work on. She said that she would consider having quarterly meetings, as long as there was a discussion to work on. She asked the Board whether they had suggestions about subcommittees they might want to form. For example, the Board may want to form a subcommittee to work on training, with deliverables clearly defined.
Topics for Future Meetings
Topics Board members suggested for future meetings included:
- The All of Us Research Program of the Precision Medicine Initiative
- The IMPACT (Improving Medicare Post-Acute Care Transformation) Act and the effect it would have on the rehabilitation industry
- Updates on items discussed at this meeting, including progress on the limb loss registry
- Analysis related to the research plan
Dr. Cernich thanked the Board for their work and adjourned the meeting at 12 noon.