Summary Minutes – May 2-3, 2022

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)

Board Members Present:

Ex-Officio Members Present:

Ex-Officio Members Absent:

National Institutes of Health (NIH) Staff and Visitors Present on Videocast:

Day 1: May 2, 2022

The videocast recording of the first day of the May 2022 NABMRR meeting is available online. Time stamps (in parentheses) direct readers to each section of the meeting recording.

Welcome, Approval of Minutes, and Future Meetings (0:04)

NCMRR Deputy Director Ralph Nitkin, Ph.D., opened the virtual meeting at 10:02 a.m. Chair Eric Perreault, Ph.D., took roll call and announced that Albert C. Lo, M.D., Ph.D., had resigned from the Board because of an increased workload. A motion to approve the minutes of NABMRR’s December 2021 meeting carried. Future NABMRR meeting dates are as follows:

• December 5–6, 2022
• May 1–2, 2023
• December 4–5, 2023

NICHD Update from the Director (7:18)

Diana W. Bianchi, M.D., Director, NICHD
Dr. Bianchi’s presentation included updates on NICHD 60th anniversary events, the NIH budget, COVID-19 research, pediatric medical devices, and NIH and NICHD staffing.

NICHD 60th Anniversary (8:25)

The NICHD 60th anniversary webpage highlights key advances and milestones in NICHD’s history, the people who help NICHD achieve its mission, the institute’s future research directions, and anniversary activities and events. On October 17, 2022, NIHCD will hold a 60th Anniversary Scientific Symposium with the theme “Healthy Pregnancies, Healthy Children, and Healthy and Optimal Lives.”

NIH Budget (9:55)

In March 2022, Congress belatedly passed a resolution to fund the federal government for fiscal year (FY) 2022. The budget provided $45 billion for NIH, including $1.68 billion for NICHD. Targeted appropriations specified $7.5 million to study the impact of COVID-19 on children and an increase of $30 million for the Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE) initiative. The Gabriella Miller Kids First Pediatric Research Program, which is administered through the NIH Common Fund, received $12.6 million. The Advanced Research Projects Agency for Health (ARPA-H) program received $1 billion.

President Biden’s proposed FY 2023 budget currently designates $62.5 billion for NIH and $1.68 billion for NICHD. NICHD’s Congressional Justification (PDF 1.33 MB) includes a fact sheet and selected program highlights, including several items of interest to NABMRR members.

On April 13, 2022, NICHD staff members participated in a Maternal Health Action Plan Cabinet meeting at the White House (with opening remarks from Vice President Harris ). On April 25, 2022, Dr. Bianchi briefed the Senate Appropriations Committee staff on the IMPROVE initiative. Funding to study pregnancy in people with disabilities has been announced. On May 3, 2022, Dr. Bianchi plans to brief a few members of Congress on implementation of the 15 recommendations from the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC).

COVID-19 Research (17:28)

Dr. Bianchi highlighted two recent NICHD-funded studies and recent developments in the NIH Researching COVID to Enhance Recovery (RECOVER) program . RECOVER is a billion-dollar effort to understand, prevent, and treat long COVID. The program is supporting adult, pregnant, pediatric, and autopsy clinical cohorts, including children with multisystem inflammatory syndrome. Thousands of adult and pediatric research participants will be enrolled from new and existing cohorts using a common protocol across research sites. Full pediatric enrollment has now begun at all sites.

A recent study by Shuffrey et al. in JAMA Pediatrics described possible neurodevelopmental effects from the COVID-19 pandemic. Researchers analyzed data from 255 children born to mothers with and without SARS-CoV-2 infection between March and December 2020. At 6 months, infants in both groups showed a slight decrease in gross motor, fine motor, and social skills compared with infants born pre-pandemic. The researchers linked maternal stress during pregnancy to potentially negative neurodevelopmental effects in offspring, concluding that children born during the pandemic may experience slight neurodevelopmental delays.

A 2022 study by Boutzoukas et al. in Pediatrics investigated the effect of school masking policies on more than 1.1 million students and 157,000 staff attending in-person school across North Carolina, Wisconsin, Missouri, California, Washington, Georgia, Tennessee, Kansas, and Texas. Schools with mandatory masking during the Delta surge had approximately 72% fewer cases of in-school transmission of SARS-CoV-2 than schools with optional or partial masking policies did. In the overall cohort, only about 10% of cases were school-acquired; most cases were community-acquired. Masking was highly effective in preventing infection.

Because of the pandemic, Dr. Bianchi said that all official NIH meetings, including remote study section and advisory meetings, were effective when being conducted virtually for the past 2 years, so NIH will likely continue to use hybrid options moving forward. NICHD is now offering flexible work schedules, up to 80% telework, and remote work options. She asked the Board members to comment on their remote work experiences during the discussion period.

Pediatric Medical Devices (25:33)

The NIH Pediatric Research Consortium (N-PeRC) is an NIH-wide initiative that was launched in June 2018 to capitalize on pediatric research expertise and resources across NIH’s 27 institutes and centers (ICs). NIH support for pediatric research currently totals more than $4 billion, and nearly every IC supports this area. A pediatric medical device subgroup was convened in 2021 to coordinate NIH efforts in this space and address the problem of the stagnant number of devices being developed or evaluated for pediatric indications in the United States. The N-PeRC pediatric medical device subgroup has recommended the following:

• Transdisciplinary, multi-stakeholder collaborative platforms to advance the development of reasonable solutions
• Coordination of national multi-stakeholder efforts through a public–private partnership to drive a transformative positive shift in pediatric medical device development

NIH and NICHD Staffing (28:15)

NIH

• After 12 years of service, Francis Collins, M.D., Ph.D., stepped down as NIH director on December 20, 2021. Although he is now a tenured senior investigator at the National Human Genome Research Institute, he was named science advisor to the President and co-chair of the President’s Council of Advisors on Science and Technology (a Cabinet position).
• Larry Tabak, Ph.D., D.D.S., is now the NIH acting director while the White House searches for the next NIH director. The position is a political appointment that requires Senate confirmation.
• Director positions for the National Cancer Institute (NCI) and National Center for Advancing Translational Sciences are also now open. The NCI position requires Senate confirmation.

NICHD

• Rohan Hazra, M.D., who was previously chief of the Maternal and Pediatric Infectious Disease Branch (MPIDB) in the Division of Extramural Research (DER), has now been named the DER director after serving as the acting director since February 2020. He will oversee 12 extramural scientific research branches.
• As the director of the new Division of Extramural Activities, Rebekah Rasooly, Ph.D., will oversee NICHD’s Scientific Review and Grants Management branches as well as its Extramural Policy and Training offices. She was previously chief of the Office of Wellness, Technology, and Training at the National Institute of Nursing Research.
• Nahida Chakhtoura, M.D., who was previously a medical officer and physician with DER’s MPIDB, has been named chief of DER’s Pregnancy and Perinatology Branch.
• Una Grewal, Ph.D., M.P.H., has been named director of the Division of Population Health Research (DiPHR). She joined the DiPHR Epidemiology Branch as a staff scientist in September 2007. Her research focuses on fetal growth and pregnancy outcomes, especially in relation to maternal nutrition. She previously served as the DiPHR deputy director and the division’s acting director since February 2020.
• The NICHD scientific director and NICHD clinical director positions are currently vacant, and search committees are working to make both appointments.

Discussion (35:12)

Dr. Perreault asked how much the NICHD budget increased for FY 2022 and how the increase affected NCMRR’s budget. Dr. Bianchi said that the increase was 3.6% across all ICs and NCMRR’s budget was a fixed percentage of the NICHD budget.

A Board member said that although they enjoy working in their office, having a hybrid approach improves accessibility and inclusivity for many people, so it is the best model. Dr. Bianchi said that remote access has allowed NICHD workshop attendance to accommodate as many as 1,500 people from around the world at a single event and has improved transparency and information equity because the recordings are available afterward. In-person meetings have also had positive effects, especially for trainees in Dr. Bianchi’s research laboratory. There are downsides to both being fully remote and being fully in person. Technology has become state-of-art for hybrid meetings.

Theresa Cruz, Ph.D., said that the RECOVER program published a research opportunity announcement on April 28, 2022, for research on the prevention and treatment of long COVID in children. Its due date is May 29, 2022, and it falls under the Other Transaction Authority (OTA).

Dr. Cruz said that she will be participating in a pediatric device forum later in the month. She plans to ensure that rehabilitation is well represented for pediatric devices.

NCMRR Director’s Report (42:35)

Theresa Cruz, Ph.D., Director, NCMRR

Staff Updates (42:59)

NCMRR has no new staff arrivals or departures to report since the last NABMRR meeting. NCMRR is transitioning back to the physical workplace, and NIH is hiring program officers and scientific review officers.

Activities and Collaborations (44:31)

In February, the Mayo Clinic launched the Limb Loss and Preservation Registry , a quality data registry and part of a collaboration with the U.S. Department of Defense (DoD). Data have already been collected on 35,000 patients from 1.4 million patient encounters at 4 large hospital centers and 4 community-based medical centers. The registry is seeking to add hospital and clinical sites, and there is no participation cost for medical centers. The goal is to understand the incidence and prevalence of limb loss and interventions to preserve limbs.

Reviews are underway for two NCMRR and NICHD research funding opportunity announcements (FOAs):

• Home and Community-Based Physical Activity Interventions to Improve the Health of Wheelchair Users (HD-22-017). The due date for applications was March 30, 2022. This initiative resulted from a workshop, Pathways to Prevention: Can Physical Activity Improve the Health of Wheelchair Users?
• Promoting Reproductive Health for Adolescents and Adults with Disabilities (HD-23-005). The due date for applications was March 30, 2022. This resulted from a workshop, Reproductive Health for Persons with Disabilities in the Transition from Adolescence to Adulthood.

Awards are expected to be made by the end of the calendar year. Dr. Cruz thanked NCMRR’s federal partners, the U.S. Department of Veterans Affairs, DoD, and the National Institute on Disability, Independent Living, and Rehabilitation Research, for helping to incorporate lived experience requirements into these FOAs.

NCMRR is sponsoring a $15,000 prize in the Design by Biomedical Undergraduate Teams (DEBUT) Challenge. The prize will be awarded to the best rehabilitative and assistive technology for the functional and healthcare needs of people with physical disabilities. Team applications are due May 31, 2022. DEBUT is led by the National Institute of Biomedical Imaging and Bioengineering (NIBIB).

NCMRR continues to support the development of common data elements (CDEs) for neurorehabilitation. Twelve working groups with more than 130 members spent approximately a year developing the CDEs. The first version (V1.0) of the CDEs was published on the National Institute of Neurological Disorders and Stroke (NINDS) CDE website in January 2022, and NCMRR will discuss how to further address gap areas and move forward. NCMRR is also working with the National Library of Medicine on research standards around lower limb loss and COVID-19 CDEs.

Recent NIH-sponsored workshops and meetings (available via NIH VideoCast) include the following:

• The Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Initiative hosted “Brain Behavior Quantification and Synchronization” on March 1–2, 2022.
  • Day 1: https://videocast.nih.gov/watch=44549
  • Day 2: https://videocast.nih.gov/watch=44551
•  
• NICHD and the Bill and Melinda Gates Foundation hosted “The Brain Across the Lifespan: Tools and Methodologies for Measuring the Changing Brain” on April 18–19, 2022.
  • Day 1: https://videocast.nih.gov/watch=45039
  • Day 2: https://videocast.nih.gov/watch=45041

Upcoming NIH-sponsored workshops and meetings include:

• The BRAIN Initiative’s BRAIN Neuroethics Working Group Workshop on Continuing Trial Responsibilities on May 24–25, 2022
• The Annual BRAIN Initiative^® Meeting with a theme of “Open Science, New Tools” on June 21–22, 2022

The next session in the NIH Rehabilitation Research Speaker Series will take place on May 20, 2022 at 12 p.m. ET. Martina Mancini, Ph.D., from Oregon Health & Science University, and Lynn Worobey, Ph.D., D.P.T., ATP, from the University of Pittsburgh, will speak on assistive and rehabilitation technology.

The World Health Organization (WHO) should release its Rehabilitation 2030 updates before NABMRR’s December meeting.

Outreach Efforts (53:51)

NCMRR representatives participated in the following national professional society meetings and meetings with stakeholder groups, some in person during the first few months of 2022:

• Training in Grantsmanship for Rehabilitation Research, January
• American Physical Therapy Association Combined Sections Meeting, February
• American Academy of Orthotists and Prosthetists Annual Meeting & Scientific Symposium, March
• American Society for Neurorehabilitation Annual Meeting, April
• American Speech-Language-Hearing Association Online Conference, April–May
• International Workshop on the Neural and Social Bases of Creative Movement, April
• American College of Sports Medicine Annual Meeting and World Congresses, May-June
• Association of Academic Physiatrists, May

COVID-19 (55:00)

The NIH Rapid Acceleration of Diagnostics (RADx^®) program, which is sponsored by NIBIB to improve access to at-home COVID-19 tests, partnered with the Consortia for Improving Medicine with Innovation & Technology to host a listening session on March 24, 2022.

The National Eye Institute issued a Notice of Special Interest, Addressing Accessibility Inequities with COVID Home-Based Testing for Individuals with Visual Impairment (NOT-EY-22-010), to support research addressing the urgent need to provide accessible home-based COVID-19 testing to people who are visually impaired.

Discussion (59:08)

Dr. Perreault asked whether future NCMRR meetings were likely to include an in-person component. Dr. Cruz said yes, the biannual meetings will either be one in-person meeting and one remote or both as hybrid meetings. It is important to make the meeting experience equal and accessible for everyone.

Activity-Dependent Therapies to Promote Peripheral Nerve Regeneration (1:00:42)

Arthur English, Ph.D., Professor of Cell Biology, Associate Professor of Rehabilitation Medicine, Affiliate Scientist, Yerkes Regional Primate Research Center, Emory University School of Medicine

Dr. English presented his research on activity-dependent therapies for promoting peripheral nerve regeneration. After describing how traumatic peripheral nerve injuries and the subsequent poor regeneration of axons in peripheral nerves represent a major public health problem, he provided evidence for combining surgical reconstruction of injured peripheral nerves with novel therapeutic strategies that enhance spontaneous recovery from nerve injury to restore adequate function. Novel therapeutic strategies include exercise, motor and sensory axon stimulation, and enhancement of the availability of brain-derived neurotrophic factor (BDNF). This includes the use of small molecule BDNF mimetics or prodrugs. The presence of the axonal microtubule–associated protein, tau, is also an important and necessary component for axon regeneration. The presentation was followed by Board discussion.

Concept Clearance (1:46:34)

Theresa Cruz, Ph.D., Director, NCMRR

Dr. Cruz asked NABMRR members for feedback on a proposed Request for Applications (RFA) for Ableism, Understanding and Mitigating Health Disparities Experienced by People with Disabilities. People with disabilities experience a wide range of health disparities, making them the largest group living with health disparities in the United States. But despite this designation, most biomedical research efforts to date have focused on correcting or curing the disabling condition rather than on addressing whole-person wellness and approaching the disabling condition as just one aspect of a person’s identity. The goal of the RFA is to encourage research to understand the impact of ableism (the assumption that people with disabilities are somehow inferior or inadequate, leading to discrimination and social prejudice).

Discussion (1:49:38)

A Board member said that they were pleased to see this RFA concept. Ableism affects a person’s ability to live well in a community. It is an interesting area to pursue, and doing so will help bring disability more squarely into the academic health disparities discussion.

Another Board member said that they supported the RFA because, as someone with high-level quadriplegia, they have not had one job where they have not experienced some form of discrimination or ableism that limited their ability to succeed and move forward. Identifying and addressing the contributing factors may help. Although rehabilitation research is incredibly important, ableism does affect the occupations and social and community lives of people with disabilities. Dr. Cruz said that rehabilitation research and optimizing function would always be the priority of NCMRR.

Another Board member said that the RFA addresses recent advocacy efforts to shift to a more social model of disability. They agreed withthe first Board member comment in the discussion that ableism research could help move disability into the academic health disparities discussion. Many people are facing disparities because of their different functional limitations, and that issue needs to be addressed.

A Board member asked about the RFA’s language on the overall health and wellness of individuals with disabilities, since health and wellness can involve a mixture of disability status, ableism, and failure to address existing health issues. Practitioners often disregard new medical issues in people with disabilities because of their overarching preexisting diagnoses. The Board member asked for clarification on whether overall health and wellness were as important in the RFA as health disparities. Dr. Cruz said that the nuances of identity and some words (e.g., “health”) could create problems with the proposed RFA. The RFA will need to be worded so that its intended outcome of reducing disparities is clear; a workshop may be needed to clarify the wording in the RFA. The Board member agreed that clarifying the language in the RFA would be important.

Another Board member said that the timing of the RFA was good, given the current dialogue and social movement around the importance of diversity, equity, and inclusion. Many people in society have not been properly included in communities and workplaces. This is an important topic.

A Board member agreed with the previous suggestions about clarifying the language and said that it would be good to ask researchers to demonstrate how disability does not stand in the way of societal participation. They pointed to Dr. Bianchi’s earlier comment that when the pandemic arrived, we were all unable to go to work; nevertheless, we all found a way to work. That is the silver lining from the past 2 years.

The first Board member to comment during this discussion said that this topic is critically important and has the power to make a significant impact. They agreed that a workshop would be helpful for developing the language in the RFA and suggested that a workshop could also be used to propose a framework modeled on the different levels of racism (i.e., systemic, institutional, interpersonal, and internalized) and specify the types of research (e.g., examples) that could address the various issues.

Dr. Perreault asked whether there were any parallel efforts in other parts of NIH. Dr. Cruz said that NICHD had several health disparities initiatives, but the disability community did not seem to be adequately represented in them. An Advisory Committee to the Director (ACD) group is seeking the experiences of people with disabilities for targeting principal investigators. Overall, NIH is addressing structural racism and other types of discrimination. Dr. Cruz said that other ICs are interested in this topic.

A Board member said that ableism was an important topic and suggested that other RFAs also include language to address ableism, especially for stakeholder engagement activities.

Another Board member said that they participated in a National Science Foundation Convergence Accelerator program to enhance opportunities for people with disabilities. Ableism was discussed, and the paper from that program may provide a good source of information.

A motion carried to approve the RFA and hold a workshop on the topic.

Mini Symposium: Perspectives on the Different Roles of Assessment in Rehabilitation (2:05:45)

Three experts shared their perspectives on the different roles of assessment in rehabilitation. Each presentation lasted about 25 minutes, followed by a technical discussion.

Overview of Need for Integrated Assessments (2:10:53)

Carolee Winstein, Ph.D., P.T., University of Southern California

Dr. Winstein provided an overview of integrated rehabilitation assessments. She described the history of the functional independence measure (FIM) and how the FIM was used to rate the efficiency of inpatient rehabilitation units. The International Classification of Functioning, Disability and Health (ICF) framework is useful for thinking about the rehabilitation process. The assessment(s) to be used should depend on the hypothesized mechanism of action of the target of the treatment or intervention. Interventions are dynamic; they require collaboration and two-way communication. Some inherent bias exists, suggesting that objective assessments are superior to subjective or patient-reported outcome assessments; however, using both quantitative (objective) and patient-reported (subjective) outcomes assessments provides a more comprehensive understanding of the underlying biological, psychological, and socio-behavioral state of the individual. Looking forward, research assessment tools must align with the hypothesized mechanism of action, reflect the underlying psychological and biology or physiology (neuroscience), use mixed methods (i.e., quantitative and qualitative measures), and be patient-centered (i.e., use patient-reported outcomes), because patient perspectives matter.

Discussion (2:39:39)

A Board member said that as a rehabilitation expert, they also struggle with measurement devices and outcome tools, many of which were developed to assess something other than what they are being used for. The patient’s cognitive status is a critical component of the rehabilitation. Very few tools measure the patient’s comprehension of the instructions. The Board member asked Dr. Winstein for her opinion on incorporating a cognitive status evaluation into outcome measures. Dr. Winstein said that the rehabilitation community is beginning to tackle this problem, but there are many domains of cognitive function (e.g., executive function, memory, planning), and each area of cognition affects a different area of the brain.

Bridge Between Subjective Measures of Participation and Mechanisms (2:43:29)

Cathy Stinear, Ph.D., University of Auckland

Dr. Stinear began by describing the difference between recovery and outcome. Recovery is improvement over time; outcome is status at a single point in time. When measuring the effects of interventions after surgery, trauma, or other events requiring rehabilitation, it is important to clarify whether the goal is recovery or outcome. The ICF can help determine what makes a good measure. Activity is the execution of a task. Activity limitations are difficulties with everyday tasks, and the difficulties may be due to a combination of factors. Measuring activity involves both capacity (the tasks the person can do), which is evaluated in a structured setting with standardized measures and behavioral assessments, and performance (the tasks the person performs in the real world), which are measured with patient reports, observation, wearable technologies, and ecological momentary assessments. Various activity capacity measures exist for the upper and lower limbs, plus motor activity logs and walking and mobility tests. Questions to ask to determine which measures to use include the following:

• How would the intervention affect this measure?
• Is this measure in a sensible place on the impairment-capacity-performance-participation continuum?
• Are we measuring recovery or outcome?
• How can we use technologies to objectively measure activity performance and participation?

Discussion (2:59:39)

Dr. Nitkin asked how to use outcomes measurements to account for bringing a patient to a new level of function rather than as a continuous variable. Dr. Stinear said that this is why it is problematic to measure only outcomes. There can be many changes along a continuum. Measures need to capture change over time and the final outcome when the intervention ends while also acknowledging that further change is likely to occur going forward.

A Board member said that asking patients to perform qualitative tasks can create virtuous loops with practice on their own, so it is a good point to mention that all activities of daily life are not the same and are not the same to all people. Choosing the appropriate task is not always built into the assessment, so using measures that capture change over time is a good idea.

Mechanistic Assessments of Impairment (3:02:43)

Jules Dewald, Ph.D., Northwestern University

Dr. Dewald began by asking, “What drives the impairments that we see in our clients? How do the impairments affect function and, ultimately, participation?” Movement impairment and associated loss of function may be caused by weakness, hypertonia resulting in spasticity, or abnormal drive from the brain resulting in loss of independent joint control. Dr. Dewald’s work focuses primarily on studying abnormal drive from the brain and effectively measuring, understanding, and treating impairments that result in functional-activity deficits and lack of participation. His laboratory uses robotic systems to understand and quantify normal and pathologic movements and the brain activity that occurs during certain tasks. Mechatronic systems can treat loss of independent joint control during reaching, help train people to increase functional work area, and engage more efficient neural pathways in the brain. Dr. Dewald is also developing simpler carbon-fiber assistive devices for clinic and home use based on his robotic research, and clinical trials to test these devices are underway. In the future, wearable technologies (e.g., bracelets) will be used to track paretic arm motor deficits in the home setting.

Discussion (3:26:25)

Dr. Perreault asked whether any of Dr. Dewald’s activity assessment innovations had gone beyond the laboratory yet. Dr. Dewald said that the translational work was in progress.

Dr. Nitkin asked whether training stroke patients to use the opposite hemisphere of the brain came with a cost to freedom of movement or integration of activities. Dr. Dewald said it did and added that the patient’s position (sitting or standing) and level of effort can also be limiting factors. Using the ipsilateral cortex increases strength but reduces efficiency, because some co-activations are not functional. He said that more is not always better in functional rehabilitation.

A Board member said that their group and others had also noticed deficits in ipsilateral arm control because the contralateral arm is stealing resources from the ipsilateral limb. The Board member then led the group through a 30-minute technical discussion of the different roles of assessment in rehabilitation. Attendees asked the symposium presenters more specific questions about their research.

Day 2: May 3, 2022

Viewers can access the videocast recording of the second day. Time stamps (in parentheses) direct readers to each section of the recording.
Dr. Cruz provided the following Day 1 updates:

• A webinar providing technical assistance for the RECOVER clinical trials OTA opportunity will be held Friday, May 6, 2022, at 4 p.m. eastern time (ET). Anyone interested in applying should attend the webinar.
• Dr. Bianchi has been named a finalist for the Samuel J. Heyman Service to America Medal for her work on COVID-19 and the needs of underserved populations. Being nominated and named a finalist for this public service award is a huge honor.

NIH Research Plan on Rehabilitation (3:24)

Theresa Cruz, Ph.D., Director, NCMRR
Alicia Ross, M.P.A., Program Analyst, Health Program Specialist, NCMRR

The NIH Research Plan on Rehabilitation (RPR) (PDF 1.51 MB) report-out is usually done at the December Board meeting, but there were delays in closing out data because of the NIH continuing resolutions and the COVID-19 pandemic. This mini-update was designed to complement the December 2021 report.

Ms. Ross said that all data presented are considered a draft until the NIH Office of Financial Management (OFM) concurs. The following information contains confirmed FY 2020 figures. NABMRR feedback is needed to determine whether these are the types of data required to track progress on the research plan. Challenges and caveats were also presented for consideration.

Overarching Strategy (6:00)

Baseline data were taken from the 2015 portfolio, before the first RPR was published. Data are collected only from the NIH Rehabilitation Research, Condition, and Disease Category (RCDC), and the lists of projects are available to the public in the NIH Research Portfolio Online Reporting Tools Expenditures and Results. Each official category is verified by the ICs, and official dollars are verified by OFM. Intramural projects are removed, and then each project is categorized in two “tiers.” Tier I is based on a keyword approach for the six themes within the RPR, and primary and secondary codes are based on the primary and additional aims of each project. The six themes in Tier I are:

A: Rehabilitation Across the Lifespan
B: Community and Family
C: Technology Use and Development
D: Research Design and Methodology
E: Translational Science
F: Building Research Capacity and Infrastructure

Tier II includes the phase of research for each project (i.e., basic, disease-related basic, applied [translational or clinical], infrastructure, or unable to categorize).

Automatic/Manual Coding Process (7:27)

The automatic grant coding process employs an algorithm that was initially developed using FY 2015 through FY 2018 data and then used to classify new data from FY 2019. NCMRR then used the coding rules to check the coding for new grants. There were 533 new awards in FY 2020. Each project was separately checked by two coders and the codes reconciled for agreement. Each IC received the reconciled portfolio and confirmed or revised the proposed coding. All ICs were integrated for the final analysis.

FY 2020 Data (8:31)

A total of 1,963 grants for $847 million were identified across 27 ICs. Approximately 25% of the grants ($82.2 million) are designated as clinical trials. About 40% of the new 533 FY 2020 grants fall into the category theme of research design and methodology. The largest Tier II category for FY 2020 is applied clinical (58%).

Year-to-Year Trends (12:42)

Graphical data showing data trends from FY 2015 through FY 2020 for the number of grants and funded dollars across each theme were presented. The numbers of grants and dollars spent are increasing over time.

NCMRR Funding and Investigators (23:52)

Graphical data showing NCMRR funding trends (number of projects and dollars spent) from FY 2012 through FY 2021 were presented. In FY 2021, 241 grants were funded with $84.2 million. Approximately 39% of the funded projects were for training. The number of new NCMRR awards decreased in FY 2020.

NCMRR investigators apply for all of the types of grant mechanisms, but most applications are R01s. The average cost of grants for NCMRR investigators from FY 2012 through FY 2021 was presented in graphical form, and the average amount is trending about 10% lower than that of other NIH R01 grants. The number of R01 principal investigators (PIs) that NCMRR funds each given FY was presented (e.g., 67 in FY 2020). An analysis that cross-referenced rehabilitation PIs (2012–2020) across all NIH ICs found an extremely low occurrence of R01 PIs having grants that exceeded $1 million in any given fiscal year. A future analysis will look at the training and career development pathways.

Discussion (14:32 and 34:22)

A Board member asked for clarification on how clinical trials grants were classified into more than one category. Dr. Cruz said that some of the grants existed before the classifications were changed, and some infrastructure is undesignated; there are some gaps in the data.

Dr. Perreault asked why only 25% of the projects were categorized as clinical trials but more than 50% were considered to be applied clinical or translational studies. Dr. Cruz said that the slides were divided into new awards and previously awarded projects.

A Board member said that Theme B continued to lag behind the other themes. They asked whether it was too complicated a theme and whether NCMRR had analyzed the barriers for researchers to submit community and family grants. Dr. Cruz suggested creating targeted FOAs in this area and analyzing all grant applications, rather than only the 20% of applications that were funded. She added that Theme B continues to be a glaring deficit in the research portfolio. Dr. Nitkin added that this topic would also be part of the infrastructure discussion later in the day. Dr. Perreault suggested including data on all applications, rather than reporting data only from funded applications. Ms. Ross said that RCDC does not compile data on grant applications, so analyzing those data would require a different type of effort.

A Board member asked whether data were collected on how many of the funded applications went to new investigators. Dr. Cruz said they were and provided information on NCMRR investigators.

Another Board member asked whether PI (i.e., single or multiple) and composition data on successfully funded grants could be shared. Dr. Cruz said that this would be an interesting analysis.

A Board member asked whether the average costs of the R01 grants were on a cost-per-year basis and how the amount exceeds the $250,000 maximum for modular budgets. Dr. Cruz said that the costs were for each year and that they included both direct and indirect costs (i.e., total costs). The Board member encouraged NIH to reconsider the constraints of the modular budget, which have been in place for more than 20 years and have become outdated.

A Board member asked how the new early career R03 grants were trending with respect to topic areas and whether those projects were translating into R01 grants. Dr. Cruz said that she was pleased with the R03 process, the trend for more applications, and the progression of the PIs into other grant mechanisms.

Another Board member noted that rehabilitation research may be more expensive than other types of research because of multiple intervention components, multimodal assessments, and multiple site participation. Dr. Cruz added that NCMRR does not want to support underpowered trials.

A Board member asked why there were so few K99/R00 applications and whether NCMRR was tracking the career development of the awardees. Dr. Cruz said that NIH broadly tracked the K99 PIs, and they have been successful in gaining faculty positions. The career window for qualifying for a K99 grant is fairly small, which may explain the low numbers of awardees. Dr. Nitkin added that NCMRR also has special access to use the K01 and K12 career development mechanisms.

NIH Data Sharing Plan (45:34)

Rebecca F. Rosen, Ph.D., Director, Office of Data Science and Sharing (ODSS), NICHD

Dr. Rosen introduced NABMRR members to ODSS, described NIH’s new Data Management and Sharing (DMS) policy, and shared how NICHD plans to implement the new DMS policy.

ODSS was established in 2021 under the NICHD Strategic Plan’s 2020 scientific stewardship goal “Facilitating data sharing and access to biospecimens.” The ODSS vision is to create a culture of responsible and innovative use of data and biospecimens that accelerates research and improves health for NICHD populations. ODSS’s mission is to develop a diverse, secure, and interoperable research data ecosystem and to advise on best practices for data collection, standards, management, sharing, and use across the research and funding life cycles, to advance scientific discovery in support of NICHD’s mission to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all.

The NICHD Data and Specimen Hub (DASH), which is currently being updated, is a centralized resource for researchers to share deidentified data from studies funded by NICHD. It contains a portal for requesting biospecimens from selected studies.

NIH published the final DMS policy for data management and sharing (NOT-OD-21-013) on October 29, 2020. On January 25, 2023, it will go into effect for all applications and proposals submitted to NIH. Data sharing accelerates scientific progress by empowering new scientific questions and innovation, fostering transparency and validation of research results, increasing statistical power by combining multiple datasets, increasing opportunities for collaboration, facilitating the development and improvement of therapeutic and diagnostic strategies for patients, and promoting public trust in research.

The DMS policy requires researchers to prospectively plan for how scientific data and any accompanying metadata will be managed and shared. A DMS plan that considers any potential restrictions or limitations must be submitted with every application and proposal. Compliance with the DMS policy is monitored within the IC operations module. The DMS policy applies to all research funded or conducted in whole or in part by NIH (e.g., extramural grants, contracts, intramural research projects, funding agreements) that results in the generation of scientific data, regardless of NIH funding level or funding mechanism. The DMS policy does not apply to research and other activities that do not generate scientific data, including training, infrastructure development (repositories, data coordinating centers), and non-research activities.

Dr. Rosen discussed what scientific data are, how much data should be shared, when data must be shared, and who reviews, assesses, and enforces each DMS plan. Safeguarding participant privacy and confidentiality is paramount when sharing human data. The elements of a DMS plan are outlined in NOT-OD-21-014. Information on allowable costs (NOT-OD-21-015) and repository selection (NOT-OD-21-016) is also available. DMS plans may be publicly shared. A DMS plan template and sample plans are currently in development.

Among other awareness efforts, NICHD has formed a Data and Biospecimen Ecosystem Working Group to define the scope of the NICHD research data and specimen ecosystem and the expectations and timeline for the build-out of the system. The working group has intramural and extramural data-sharing subcommittees that are engaging with NICHD staff and the research community.

Trans-NIH coordination efforts and resources include a data sharing website as a one-stop shop for information on policies and related resources, an adjunct website that is specific to NICHD, FAQs, Requests for Information (RFIs) about genomic data sharing harmonization, an RFI about sharing data from participants from Tribal Nations, sample consent language, and investigator and program officer trainings.

Discussion (1:20:50)

Dr. Nitkin asked whether creating DMS plans could help scientists plan better studies. Dr. Rosen said that scientists should plan their data collection based on what data would be useful or interesting for sharing with their colleagues. A large number of research projects use existing data. Careful thought is required throughout the entire process.

A Board member asked Dr. Rosen to comment on the relationships between NIH’s data sharing policy, its CDE project, and the ClinicalTrials.gov website, because these are the places where data are standardized and shared. Dr. Rosen said that CDEs should be mentioned in a DMS plan if they are used. ClinicalTrials.gov has a data-sharing gap that creates reproducibility issues.

A Board member asked whether DMS plans would be shared on ClinicalTrials.gov. Dr. Rosen said that if individual-level data are stored in a data repository like DASH, their location should be cross-referenced on ClinicalTrials.gov, and digital object identifiers (DOIs) should be used for this process. Existing tools for tracking DOIs can be employed.

The Board member then asked how data quality would be assessed over time. Dr. Rosen said that data quality depends on whether the results of a study can be reproduced, so that is why data must be shared. The broad language around data quality for publication refers to the annotation of the data. The Board member said that data standards also come into play. Dr. Rosen said that the Data Quality and Standards Working Group would be addressing all of these issues, and many ICs have standards collaboratives for their research communities.

Another Board member asked how a DMS plan could account for data that are considered intellectual property (e.g., translational efforts). Dr. Rosen said that there are some exceptions to data sharing and that the timelines can often be adjusted based on this type of constraint (e.g., Small Business Innovation Research grants have data sharing timelines that differ from those of other funding opportunities).

A Board meber asked how approval of the DMS plan would fit into the overall grant application timeline and how data sharing costs would factor into the grant application’s budget. Dr. Rosen said that guidance is in development for both of these areas.

Diversity, Equity, Inclusion, and Accessibility (DEIA) (1:32:11)

Marie Bernard, M.D., Chief Officer for Scientific Workforce Diversity (COSWD), NIH

Dr. Bernard presented NIH’s DEIA Strategic Plan, described recent COSWD activities, and provided an update on NIH’s UNITE initiative. The COSWD motto is “Great minds think differently.”

After providing background on the development of the NIH DEIA Strategic Plan, Dr. Bernard said that the plan is part of a governmentwide strategic plan to advance DEIA in the federal workforce. The overarching principles are to communicate a vision and aspirations for all of NIH, have a broad scope, articulate NIH’s definitions for DEIA, report examples of accomplishments, convey priorities, provide accountable measures of progress, and collect input from internal and external stakeholders. The Strategic Plan’s scope includes articulating NIH’s vision for strengthening DEIA, capturing activities that the NIH workforce will undertake to meet the Strategic Plan’s vision, and harmonizing with the NIH-wide Strategic Plan. NIH’s DEIA priorities are organized around accomplishments, needs, opportunities, and challenges in the following three key areas:

• Objective 1: Implement organizational practices to center and prioritize DEIA in the workforce
• Objective 2: Grow and sustain DEIA through structural and cultural change
• Objective 3: Advance DEIA through research

COSWD’s vision is to enable NIH and NIH-funded institutions to benefit from the nation’s full range of talent and foster creativity and innovation in science. The mission is to be the NIH thought leader in the science of scientific workforce diversity, using evidence-based approaches to catalyze cultures of inclusive excellence. Individuals with disabilities are considered an underrepresented group (URG). Since the office’s inception in 2019 (NOT-OD-20-031), COSWD has created many successful initiatives, including the 21st Century Scholars Program, the Scientific Workforce Diversity Seminar Series, and DEIA Mentorship Supplements.

Ongoing racial and ethnic injustice in the United States motivated NIH to establish the UNITE initiative, which aims to address structural racism and promote racial equity and inclusion at NIH and within the larger biomedical research enterprise. UNITE has five committees with specific aims to advance health disparities research and diversify both the internal and external workforce.

The NIH Common Fund has committed up to $58 million to fund transformative research to address health disparities and advance health equity. The NIH Community Partnerships to Advance Science for Society (ComPASS) initiative will be launched in 2023. ComPASS will listen to URG community needs and then commit $23 million to $52 million per year for 10 years to fund health equity research hubs for scientific support and partnership. UNITE is also addressing the lack of internal and external workforce diversity with recognition projects and Faculty Institutional Recruitment for Sustainable Transformation (FIRST) awards, respectively. New UNITE initiatives are also underway to enhance NIH career opportunities for URGs, incorporate more diverse perspectives when scoring grant applications, and recognize institutional DEIA excellence. All UNITE milestones and progress updates are available online.

Discussion (1:56:48)

A Board member thanked Dr. Bernard for her leadership and asked how disability could be included more in COSWD and UNITE research initiatives. Dr. Bernard said that she was in the process of forming a disability subgroup of the ACD and that Dr. Cruz was involved in these efforts. “Accessibility” was recently added to the group’s name.

Another Board member asked whether any COSWD pipeline initiatives help provide funding for minority students who want to transition into doctoral programs and postdoctoral research positions. Dr. Bernard said that students experience different financial challenges during each step in the process (e.g., high school, junior college, undergraduate) of becoming an NIH-funded investigator. Resources outside of NIH are available to provide mentorship and financial support, especially at the initial levels of education. NIH resources (e.g., diversity supplements) focus on the graduate level and beyond, and this is an area of focus for the UNITE committees.

A Board member said that the recommended postdoctoral salaries do not vary with cost of living, and most highly ranked research universities are in high-cost cities, so students without familial wealth are filtered away from the top institutions. They asked whether NIH had considered this structural barrier. Dr. Bernard said that this point was well taken. Recent increases in postdoctoral salaries have not matched the needs of people who live in high-cost areas. This weakness is being examined.

Impact of COVID-19 on People with Disabilities: Pathophysiology, Impairments, Access, and Support (2:09:28)

Lindsey Wooliscroft, M.D., M.S., Assistant Professor of Neurology, Oregon Health & Science University

Dr. Wooliscroft’s presentation described how COVID-19 and the governmental response to the pandemic affected people with disabilities. She also shared proposed actions to address the needs of people with disabilities during the pandemic.

WHO disability model framework conceptualizes a person’s level of functioning as a dynamic interplay between the person’s health condition, environment, and personal factors. The COVID-19 pandemic affected all of the framework’s components for disabilities. Acute SARS-CoV-2 infection can affect all major organ systems and create long-term health consequences (e.g., long COVID). When studying patients with underlying health conditions, scientists reached the following conclusions:

• Intellectual disability is one of the top risk factors for contracting SARS-CoV-2.
• People with physical disabilities are two to three times more likely to die from COVID-19 than people without such disabilities are.
• COVID-19 can directly cause a disabling condition (e.g., neuromuscular disease, stroke, acute limb ischemia leading to limb loss).
• COVID-19 can indirectly cause an increase in symptoms or affect the treatment of disabling conditions (e.g., by affecting drug absorption in patients with Parkinson’s disease).

The pandemic has disproportionately affected activity and participation for people with disabilities. Activity levels for people with disabilities were low before 2020 and decreased further after the pandemic. People with disabilities were more likely to report fear of leaving their homes, difficulty accessing healthcare, and a decrease inquality of life.

When assessing environmental and personal health factors associated with the pandemic, researchers concluded that people with disabilities were almost twice as likely to report food insecurity, delays in care, or unreceived needed care. The Internet is increasingly necessary to access care, but people with disabilities were less likely to have broadband access and had lower digital skills. People with disabilities reported more loneliness and reduced quality of life compared with people who did not have disabilities.

There are many potential and current actions to address the needs of people with disabilities during the COVID-19 pandemic (e.g., improve access to resources, information, prevention, testing, social care services, and health services). The White House also recommended expanding the U.S. Department of Health and Human Services (HHS) Administration for Community Living’s Disability Information and Access Line to support people with disabilities who face difficulty using or who cannot use a self-test; modifying or developing accessible at-home test design, packaging, and instruction; incentivizing manufacturers to prioritize at-home tests; asking states to directly distribute high-quality masks through community-based organizations serving individuals with disabilities; and equipping schools with guidance and support to keep vulnerable students safe and learning in person.

Discussion (2:36:55)

Dr. Perreault asked whether long COVID affected people with disabilities differently from the way it affected people who did not have disabilities. Dr. Wooliscroft said that she did not find any published research on that topic, likely because long COVID is a relatively newly described phenomenon.

Dr. Nitkin asked whether any progress had been made on making home test kits more accessible. Dr. Wooliscroft said that most of the current efforts were in making the home test kit instructions easier to understand, especially for people with intellectual disabilities. More work is needed to improve the packaging’s accessibility.

A Board member asked whether any studies were underway to collect more data from U.S. patients. Dr. Wooliscroft said that some datasets (e.g., from Vizient) examined cross-sectional associations with diagnosis and mortality rates. Countries with industrialized healthcare models tend to collect better patient data, but several disease-specific societies in the United States are assessing risk factors and other data.

Dr. Nitkin asked Dr. Wooliscroft what she had been hearing from her patients with multiple sclerosis (MS) about the pandemic. Dr. Wooliscroft said that her experience in the Pacific Northwest resonated with many of the findings that she presented. Environmental risks, such as summer forest fires, created additional risks that caused patients to be unable to leave their homes. Caregivers also had additional risks when caring for patients with disabilities who had contracted COVID-19. Multiple imperfections in the healthcare system were amplified in many ways during the pandemic.

A Board member asked how the pandemic had affected Dr. Wooliscroft’s research, specifically with regard to possibly increasing telehealth visits. Dr. Wooliscroft said that her current NIH-funded clinical trial was designed to be conducted in person but had to be modified to allow virtual participation. Some participants would not have been able to join the study if it had only been in person. Private donors provided mobile devices for some participants to allow them to join the study. The lack of mobile devices is a huge barrier for many people.

Dr. Nitkin asked how increased anxiety from the pandemic affected patients with MS. Dr. Wooliscroft said that many medication guidelines and best practices changed during the pandemic. The National MS Society was helpful in making recommendations, updating information, and providing access to topic experts in the field.

Review of NCMRR Infrastructure Support (2:51:06)

Theresa Cruz, Ph.D., Director, NCMRR

In the 1990s, NABMRR identified research infrastructure support as a key need for the growing field. Research infrastructure support provides access to key expertise and state-of-the-art resources in specific research domains, as well as offering mentoring, collaborations, and key pilot funding. The goal is to improve the number and quality of rehabilitation research applications across NIH ICs. Because NCMRR remains committed to research infrastructure support, it is forming a new working group made up of NABMRR members to review the NCMRR research infrastructure program and make recommendations for future directions. The working group will meet monthly for 6 months with the goal of reporting its recommendations at the December 2022 NABMRR meeting. During this process, NCMRR will issue a parallel public RFI.

Discussion (3:04:01)

Dr. Perreault asked whether the research infrastructure support program goals could be addressed by the working group. Dr. Cruz said they could. Dr. Nitkin added that the NIH’s overall Research Plan contains goals that could be well aligned and addressed with this program. It also ties into broader training and development goals.

Dr. Perreault said that NABMRR members who would like to volunteer for the working group should email Dr. Cruz.

A Board member said that the funded centers must be highly productive in a short period of time (5 years). They asked whether center grants could be extended to allow time to generate new funding sources. Dr. Cruz said that the 5-year period could be a topic for working group evaluation. Dr. Nitkin said that the maximum funded time had been extended to 10 years to allow for submission of a recompeting application. But beyond that point, existing PIs could consider changing the focus of a center in order to apply for new funding.

A Board member asked whether public–private partnerships and diverse center collaborations were considered important factors for center grants. Dr. Cruz said that funded centers meet once a month to facilitate communication and share findings through webinars and workshops. She added that a past center that focused on translation was incredibly successful.

Another Board member said that the definition of “infrastructure” seemed to be one-sided or limited, especially with regard to training. They asked whether the working group could work to broaden its definition. Dr. Cruz said that it could.

Comments from Parting Members (3:15:12)

Arthur English, Ph.D., said that he has loved learning about issues that are relevant to the future of rehabilitation medicine and contributing to the field with his basic research. He spent much of his time on the Board listening to others and learning about the breadth of clinical rehabilitation. He was privileged to serve on the NICHD Advisory Council and advocate for rehabilitation-related issues and scientists. Half of his meetings were in person, and half were virtual. The virtual option allowed for give-and-take in the presentations and less travel, but he misses the in-person social interactions and friendships. Hybrid meetings should be a part of the future of NABMRR.

Thubi Kolobe, Ph.D., P.T., FAPTA,   said that she has gained a broad overview of the grant funding process and learned to appreciate the NCMRR staff’s hard work, immense behind-the-scenes efforts, and patient responses to questions and suggestions. The experience allowed her to share important information between NABMRR and another board on which she serves for the American Physical Therapy Association. She has particular concerns about issues facing minority researchers. Sometimes she felt that her concerns were heard, but not always. Some progress was made over the past 4 years, especially since the events of 2020 (the murder of George Floyd and other injustices). Dr. Kolobe shared a South African expression: “One has to listen in order to be heard.” She encouraged NABMRR members to continue to listen, especially to the group’s minority voices. Friendships and connections made through NABMRR have become part of Dr. Kolobe’s academic journey. She advocated for hybrid meetings in the future.

Barbara J. Lutz, Ph.D., R.N., CRRN, PHNA-BC, FAHA, FAAN, said that she appreciated the leadership from NCMRR and NICHD staff. She has missed the in-person meetings and felt close with the other members of her cohort. She advocated for hybrid meetings in the future. Dr. Lutz said that she learned so much about basic and translational research through her participation on the Board. The meeting presentations have contained valuable information, and she was pleased to participate in forming the strategic plan, which allowed her to advocate for the community and family issues that are important to nurses and social workers (e.g., patient-reported outcomes and qualitative data). Nurses are a crucial part of the rehabilitation team, and Dr. Lutz was honored to be the only nurse on the Board for 4 years. She asked NCMRR to continue to have a nurse on the NABMRR.

Mr. Rob Wudlick said that he has been honored to serve on the Board and that it has been a positive experience. Continuing to have Board members with spinal cord injuries participate is important to him, because they represent community members who are affected by NCMRR’s work. He advocated for hybrid meetings in the future and said that he enjoyed the brainstorming sessions during in-person meetings. He encouraged the remaining Board members to keep the end result of their work (i.e., pushing the science forward as fast as possible) top of mind and to continue to work with a sense of urgency. As someone with high-level quadriplegia, Mr. Wudlick has found that his physical health has deteriorated over the past 4 years. His caregiving support team has crumbled under the pressure of the economy. Home care is experiencing a crisis, and many patients are being institutionalized. He hopes the Board’s work can address these issues. All stakeholder perspectives and community involvement activities are important. He said he appreciated having an equal seat at the table.

Planning for Next Meeting (3:42:38)

Dr. Perreault asked for topics to address at future NABMRR meetings. Board members provided the following topics:

• Continued discussion of ableism in science, including invited speakers and a workshop
• Telehealth and teletherapy research (e.g., efficacy, cost-effectiveness, overall service delivery)
• Caregiving issues and crises in the service-delivery model
• Incorporation of stakeholder engagement and the lived-experience in research
• Diversity of opinions as part of the standard grant review criteria

Adjournment

Dr. Perreault adjourned the meeting at 2:40 p.m. ET.