Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Medical Rehabilitation Research (NCMRR)
National Advisory Board on Medical Rehabilitation Research (NABMRR)
May 3, 2021 (Virtual Meeting Format)
Cheri A. Blauwet
Stephanie C. DeLuca
Robyn Watson Ellerbe
Arthur W. English
Thubi H.A. Kolobe
Albert C. Lo
Craig M. McDonald
Eric Jon Perreault
Michael Wade Shrader
Elizabeth R. Skidmore
Ex-Officio Members Present:
Daofen Chen, NINDS
Theresa Cruz, NCMRR
Lyndon Joseph, NIA
Mary F. Lovley, OSERS
Lana Shekim, NIDCD
Chuck Washabaugh, NIAMS
Ex-Officio Members Absent:
Jerome L. Fleg, NHLBI
Kristi Hill, NIDILRR
Christopher Steele, DoD
NICHD Staff and Visitors:
Liz Ramos Cook
Welcome, Approval of Minutes, and Future Meetings
Ralph Nitkin, Ph.D., Deputy Director, NCMRR and Edelle C. Field-Fote, P.T., Ph.D., FAPTA, NABMRR Chair
Dr. Nitkin opened the virtual meeting at 10:00 a.m. and welcomed the participants, as well as those watching the live or archived webcast. Dr. Field-Fote, Advisory Board chair, called the roll of Advisory Board members and ex officio members.
Dr. Field-Fote asked for approval of the minutes from the December 2020 meeting, which are available on the NCMRR website. The motion to approve the minutes passed unanimously by voice acclamation with no abstentions.
Dr. Field-Fote announced that future NABMRR meetings are planned for December 6–7, 2021; May 2–3, 2022; and December 5–6, 2022. The 2022 meetings will be held in person, and the December 2021 meeting is likely to be a hybrid meeting.
NICHD Update from the Director
Diana Bianchi, M.D., Director, NICHD
Dr. Bianchi updated the Advisory Board on the Institute’s budget, as well as NICHD research on coronavirus disease (COVID-19) in children and other Institute research activities and initiatives. She concluded with an update on the progress of NICHD’s strategic plan.
Although the full budget will not be released until mid-May and budget hearings will not take place until the week of May 24, President Biden has requested a “skinny budget” for fiscal year (FY) 2022. His proposed NIH budget is $51 billion, which is a $9 billion (20 percent) increase. The proposed budget also includes $6.5 billion to create and launch an Advanced Research Projects Agency for Health (ARPA-H) and $110 million (a $100 million increase) to support research to understand the disparate health effects of climate change through increased funding of NIH’s Climate Change and Human Health program. NICHD is one of six Institutes and Centers (ICs) participating in the trans-NIH Executive Committee for Climate Change and Human Health. Vice President Harris is continuing her interest in health disparities research as it affects maternal morbidity and mortality. On April 23, Alison Cernich, Ph.D., NICHD Deputy Director, briefed the Deputy Chief of Staff of the Department of Health and Human Services (HHS) on NIH activities in maternal health.
NICHD Research on Coronavirus Disease (COVID-19) in Children
CARING for Children with COVID. Beginning in May 2020, it became apparent that COVID-19 was associated with a multisystem inflammatory syndrome in children (MIS-C). A new trans-NIH program, Collaboration to Assess Risk and Identify loNG-term outcomes (CARING) for Children with COVID, seeks to understand COVID-19 in children and MIS-C by designing and supporting studies to investigate specific research questions.
Rapid Testing Programs. NIH’s Rapid Acceleration of Diagnostics (RADx℠) initiative has made progress in several of its components. Since the last NABMRR meeting, the RADx Advanced Technology Platforms (RADx-ATP) program has successfully scaled to 2 million COVID-19 tests per day. The RADx Underserved Populations (RADx-UP) initiative has been enabling and enhancing rapid testing for COVID-19 in underserved and vulnerable communities.
- For phase I, Washington University in St. Louis, an NICHD Intellectual and Developmental Disability Research Center, received a supplemental award from RADx-UP for a trial to offer weekly COVID-19 saliva tests to students, teachers, and staff in six special education schools in the greater St. Louis area. The study objectives are to determine the best implementation strategies using a U.S. Food and Drug Administration (FDA)–approved diagnostic test; evaluate the best testing approaches and mitigation strategies to guide the safe return to school for vulnerable children with disabilities; and develop a one-pager and website of best practices to help other school districts bring kids with disabilities back to school safely.
- For phase II, RADx-UP has issued a notice of intent to publish a research opportunity announcement to fund the development of return-to-school diagnostic testing approaches (NOT-OD-21-097). The goal of this award is to develop and test COVID-19 diagnostic testing approaches to safely return children and staff to the in-person school setting in underserved and vulnerable communities. The focus will be on children and adolescents below age 16 and all school personnel. Researchers will advance methods to integrate routine testing into return to or maintenance of in-person instruction and to identify effective, scalable, and sustainable testing implementation strategies, including in-school testing, in community pediatric primary care clinics, childcare centers, preschool, and school settings serving primarily underserved or disadvantaged children and their families. Other Transaction Authority (OTA) is being used to provide flexibility for changing circumstances and for funding non-traditional partners. The budget is $50 million from the Office of the Director (OD) congressional appropriation, and an initial $33 million will go to eight projects in FY2021. The application process for the remainder of the funding is ongoing.
Treating Long COVID in Adults and Children. The NIH Post-Acute Sequelae of COVID-19 (PASC) Initiative is a new NIH initiative to identify the causes and, ultimately, the means of prevention and treatment of individuals who have been sickened by COVID-19 but who do not fully recover within a few weeks. In the FY2021 COVID relief bill, $1.15 billion was appropriated to support NIH research and clinical trials related to the long-term effects of COVID-19. This trans-NIH effort seeks to improve the understanding of and develop strategies to prevent and treat post-acute manifestations of COVID-19 infection across the lifespan. Specific language in the Research Opportunity Announcement (ROA) included children, and applications are currently under review.
Strategies to Enrich Inclusion and Achieve Equity (STRIVE) Initiative
Because it must do more to address the underlying causes of health disparities, including tackling structural racism and diversifying the scientific workforce internally and in the broader extramural community, NICHD is participating in the NIH UNITE initiative. NICHD’s specific effort, Strategies to Enrich Inclusion and Achieve Equity (STRIVE), is being led by Charisee Lamar, Ph.D., M.P.H., R.R.T., and the NICHD Office of Health Equity (OHE). OHE has established three committees to address the different aspects of these issues:
- The Equity, Diversity, and Inclusion in NICHD’s Workforce Committee will recruit and retain the best talent across all career paths to more fully accomplish the OHE mission.
- The Scientific Workforce Committee will train and support the scientific careers of diverse scientists in the extramural community.
- The Health Disparities Research Committee will encompass research across intramural and extramural divisions.
These committees include more than 50 NICHD staff members from various career paths, both scientific and administrative, with diverse skill sets and viewpoints. There will be extensive coordination with UNITE and other NIH groups and consultation with external stakeholders. The committees will evaluate baseline data and collect new data to develop three 5-year comprehensive action plans. The action plans will be integrated into NICHD’s 2020 Strategic Plan.
NICHD Strategic Plan Progress
Progress made on the NICHD Strategic Plan (PDF 2.3 MB) is now being documented on a new “Check Our Progress” website. Staff developed metrics, which are shown on the website, to track progress toward several of the plan’s scientific themes and strategic objectives. For each scientific research theme, the website includes highlighted programs and activities and current funding opportunities, collaborations, or other programs that are responsive to the Strategic Plan’s goals. The website also features selected Research Advances and published NICHD-supported research that is responsive to the Strategic Plan goal. The website will be updated regularly throughout the year.
Dr. Bianchi ended her report with the following summary points:
- COVID-19 has disproportionately affected people with disabilities.
- NICHD is focused on ensuring that people with disabilities are included in COVID-19 research, particularly to enable children to attend school in person to receive necessary support services.
- NICHD will make every effort to ensure that children, pregnant women, and individuals with disabilities are included in PASC research.
- NIH and NICHD are committed to a diverse and inclusive workforce and to increasing research on health disparities.
- Dr. Field-Fote asked Dr. Bianchi how MIS-C differed between children and adults. Dr. Bianchi said that several immunology studies have shown that MIS-C is more of an acute immune reaction in children than in adults; in children, MIS-C has a quick onset but resolves quickly. Children also have a higher risk for MIS-C than adults do, and there is no exact equivalent in adults. Further work is being done to differentiate MIS-C from acute COVID-19 and Kawasaki syndrome. Although the long-term effects vary between children and adults, both groups can experience long-term effects from COVID-19.
- Dr. Stevens-Lapsley asked for an update on providing COVID-19 vaccines for children ages 12 to 16. Dr. Bianchi said that the initial clinical trials for children ages 12 to 16 look promising, with 100 percent efficacy. During the April 29 director’s call, Anthony S. Fauci, M.D., said that he did not yet have any information on when emergency use authorization might be granted for this age group. Dr. Bianchi wondered whether the approval process had been slowed by the investigation of recent reports of blood clotting after administration of the Johnson & Johnson vaccine but had no further information on the approval process. There are ongoing clinical trials that continue to test the vaccine efficacy and dosages in younger age groups.
- Dr. DeLuca asked how the STRIVE initiative might address populations—in the workforce and in clinical trial recruitment—that intersect more than one underserved group (e.g., a person from a racial minority group who also has a disability). Dr. Bianchi said that NICHD was interested in this intersection and cited the phrase, “No research about me without me,” because people of color who have a disability have a different perspective from others. She added that she recently learned from a presentation by NIH Center for Scientific Review Director Noni Byrnes, Ph.D., that there is unintentional bias in how NIH builds its study sections. This demonstrated how building equity, diversity, and inclusion is a deep and complex problem. Dr. Cruz responded that she was on the STRIVE Health Disparities Research Committee to address intersectionalism.
- Dr. McDonald asked whether there were requirements or preferences for NIH study section members to be funded by NIH grants, because such a requirement could create a cycle of disparity. Dr. Bianchi responded that the main qualification was scientific expertise in a focus area. She added that current grant funding is not a requirement for study section members.
- Dr. Perreault asked Dr. Bianchi to comment on how the STRIVE goals for workforce equity and scientific workforce development could be achieved and to specify how achieving these goals might affect current NCMRR programs, such as F, K, and T awards. Dr. Bianchi said that the details were still being worked out, but it would begin with developing an understanding of the current workforce population, capturing baseline information, and developing targeted goals.
- Dr. Kolobe asked when the STRIVE 5-year comprehensive action plan would begin. Dr. Bianchi responded that the program was launched in the past 2 weeks with a series of listening sessions, so it was too early to say when the action plan would be ready, but she plans to provide an update at the next NABMRR meeting.
- Dr. Ellerbe commented that she was excited to hear about the STRIVE goal to tackle the structural racism that causes health disparities. She asked about the focus of and participants in the listening sessions. She also asked whether addressing structural racism as an underlying cause of health disparities was discussed in the listening sessions. Dr. Bianchi responded that the initial listening sessions allowed NICHD workforce members to share personal perspectives and ideas for goals to address internally. STRIVE is addressing structural racism as an underlying cause of health disparities in the Division of Extramural Research. A new initiative called IMPROVE (Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone) is specifically addressing health disparities in maternal morbidity and mortality but will also be addressing health disparities in other areas.
NCMRR Director’s Report
Theresa Cruz, Ph.D., Director, NCMRR
Dr. Cruz updated the Advisory Board on NCMRR staff changes, NCMRR’s Rehabilitation Research Plan, and the center’s activities over the past few months.
NCMRR Staff Updates
- Lou Quatrano, Ph.D., retired after 42 years of federal service. He was a member of NCMRR since its founding in 1991 and was NICHD’s small business programs lead.
- Jennifer Jackson, Ph.D., is transferring to the National Institute of Biomedical Imaging and Bioengineering (NIBIB) to work on the RADx initiative.
- NCMRR plans to onboard a new program officer in June 2021.
Rehabilitation Research Plan Update
The NIH Rehabilitation Research Plan continues to evolve. Beginning with the 2016 Rehabilitation Research Plan and following a Request for Information in the fall of 2019 that received few responses, an subcommittee of the advisory board was convened to work on the plan. They met throughout the spring and summer of 2020. A new Request for Information was released on September 18, 2020, to gather broad public input on the plan’s newly revised draft research objectives. The NIH Medical Rehabilitation Coordinating Committee (MRCC) took the comments and wrote a final set of recommendations for the Research Plan objectives in December 2020. Dr. Cruz has been circulating the final draft to IC directors for their endorsements. The response has been positive, and the final Rehabilitation Research Plan will be submitted to Congress sometime in 2021. Dr. Cruz thanked everyone who helped with this endeavor.
The updated Rehabilitation Research Plan now includes:
- Overall metrics from the rehabilitation research grant portfolio
- Specific activities that NIH has undertaken to support the research themes, such as funding opportunity announcements (FOAs), workshops, and programs
- Updated research objectives under the original themes that include:
- Calls to action rather than observations
- More inclusion of people with disabilities and their preferences
- A lifespan approach that begins at infancy and extends to advanced age
- Calls for open-source data sharing that align with the NIH Data Sharing Policy
- Individual training awards and self-sustaining research
- A new section on interagency collaborations that affect rehabilitation research
Dr. Cruz said that the plan is only as useful as the community makes it. She also noted that the COVID-19 pandemic was the “elephant in the room,” because the coordinating committee discussed how the pandemic could essentially affect every research objective. The final decision was to write a foreword that explained the pandemic’s impact on the development and finalization of the plan. The plan remains non–disease specific.
Virtual Meetings. NCMRR staff members have continued to stay connected with the community during the pandemic through attending or presenting at the following virtual meetings and outreach opportunities:
- American Medical Rehabilitation Providers Association
- Design of Medical Devices
- American Society of Neurorehabilitation
- HHS Small Business Program Conference
- American Academy of Orthotists and Prosthetists
- American College of Sports Medicine
- International Conference on Ambulatory Monitoring of Physical Activity and Movement
NIH-Sponsored Meetings. NCMRR staff members will be participating in the following NIH-sponsored workshops and meetings:
- The NCMRR Speaker Series begins on May 21, 2021, and will feature James Finley, Ph.D., from the University of Southern California, and Ela Plow, PT, Ph.D., from the Cleveland Clinic, presenting their advances in the field of stroke rehabilitation.
- The 16th Annual NIH Pain Consortium Symposium will be held on May 24, 2021, with the theme “Pain and Pandemics: Challenges and Opportunities in the Current Social and Healthcare Climate.” Julie M. Fritz, PT, Ph.D., FAPTA, from the University of Utah, will deliver a keynote address on “Pain Management in a Time of Dual Pandemics: Opportunities to Advance Health Equity.”
- The Medical Rehabilitation Research Resource (MR3) Network is hosting its first scientific retreat June 29–30, 2021. The topic is precision rehabilitation.
New FOAs. NICHD is now participating in the following NIH Parent Announcements (PAs):
- PA-20-183: Research Project Grant (Parent R01 Clinical Trial Required)
- PA-20-200: NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)
- PA-20-194: NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)
- PA-20-195: NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
Program Announcements, Policy Updates, and Resources. The following Program Announcements and Resources (PAs/PARs) and Notices (NOTs) apply to NABMRR:
- NOT-EB-21-008: National Robotics Initiative
- PAR-21-099: Music and Health: Understanding and Developing Music Medicine (R21 Clinical Trial Optional)
- PAR-21-100: Music and Health: Understanding and Developing Music Medicine (R01 Clinical Trial Optional)
- PAR-21-191: Firearm Injury and Mortality Prevention Research (R21/R33 Clinical Trial Optional)
- PAR-21-192: Firearm Injury and Mortality Prevention Research (R01 Clinical Trial Optional)
- NOT-HD-21-025: Reproductive Health, Pregnancy, and Parenting among Women with Disabilities
- NOT-OD-21-073: Upcoming Changes to the Biographical Sketch and Other Support Format Page for Due Dates on or after May 25, 2021
- PAR-21-151 and NOT-OD-21-053: NIH Support for Conferences and Scientific Meetings (Parent R13 Clinical Trial Not Allowed)
- NOT-OD-21-074: Announcement of Childcare Costs for Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellows
- NOT-HD-20-036: NICHD Data and Safety Monitoring Guidelines for Extramural Clinical Trials and Clinical Research
Updates to NIH RePORTER. NIH funding information has recently been updated on the NIH RePORTER website. The matchmaker feature is still a part of the website, and researchers should continue to use it when working with junior colleagues.
Pregnancy and Disability. Dr Cruz provided the following updates on several pregnancy and disability programs:
- NABMRR has a collaboration with the Centers for Disease Control and Prevention (CDC) to collect disability-related survey questions for the Pregnancy Risk Assessment Monitoring System (PRAMS). The purpose of the data collection is to understand birth experiences for women with disabilities. The questions ask about health-related difficulties in six core functional domains: seeing, hearing, walking, cognition, self-care, and communication. Data from 2019 are expected to be released to the public in April.
- NICHD is working with the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) on two trans-NIH projects. One is to study disability and pregnancy, and the other is the development of a National Research Center for Parents with Disabilities.
- As listed above, NICHD issued a Notice of Special Interest (NOSI) to increase the number of applications in this area (NOT-HD-21-025).
COVID-19 Research. NICHD issued NOT-HD-20-031: Research on Rehabilitation Needs Associated with the COVID-19 Pandemic. The purpose of this NOSI is to encourage applications in three areas related to the intersection of COVID-19, the associated mitigation actions, and rehabilitation:
- Research to address the rehabilitation needs of survivors of COVID-19
- Research to understand the impact of disruptions to rehabilitation services caused by the COVID-19 pandemic and associated mitigation actions
- Research to understand the social, behavioral, economic, and health impact of the COVID-19 pandemic and the associated mitigation actions on people with physical disabilities
NIH also launched a database to track neurological symptoms associated with COVID-19, including headaches, fatigue, cognitive difficulties, stroke, pain, and sleep disorders. Finally, as described by Dr. Bianchi, NIH has launched the PASC initiative to study “Long COVID,” which will have a focus on developing phenotypes. Additional awards will be made for digital platforms to support this work and provide a data repository.
December 2021 NABMRR Meeting. The next Advisory Board meeting will include the addition of new Advisory Board members, the introduction of a new NCMRR program officer, output of the common data elements (CDEs) on the neurorehabilitation project with the National Institute of Neurological Disorders and Stroke (NINDS), and output of the lower limb loss research standards. The format (virtual, in-person, or hybrid) remains to be determined.
- Dr. Cruz shared her personal frustration with the level of accessibility for virtual meetings. For example, at a virtual meeting that included a presentation on making research more accessible and inclusive, she was told that closed captioning was too expensive to use. At another meeting, when she asked about accessibility, Dr. Cruz was told that each individual speaker was responsible for entering their own captions. Dr. Cruz was a speaker for the meeting but had received no instructions about entering captions. She started asking, “How are you doing your accessibility?” before meetings. Although the organizers would say that accessibility was important to them, when the meeting started, it was not accessible. Other organizers say, “You’re the only person who has asked about accessibility.” Dr. Cruz asked Advisory Board members to insist that the meetings in which they plan or participate in the rehabilitation community have accessibility options for attendees, especially attendees with sensory deficits. Dr. Blauwet thanked Dr. Cruz for raising this important issue and said that it is critical to ensure that the increased use of virtual platforms does not exacerbate disparities in access. Ms. Lovley also thanked Dr. Cruz for raising this issue. Dr. Field-Fote added that NABMRR is the right group to help spread this message.
- Dr. Nitkin said that prevention is an important part of the discussion and that NCMRR was particularly interested in secondary prevention.
- Dr. McDonald said that he appreciated why the Rehabilitation Research Plan was disease agnostic but wondered how the effect of the COVID-19 pandemic on the rehabilitation population and rehabilitation portfolio could be measured or tracked with metrics and analytics. Dr. Cruz said that COVID-related applications could be tagged or referenced with the NOSI information, but so far there have not been as many COVID-19 applications as she had expected. Dr. Nitkin added that NCMRR plans to work with the National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID) on applications that address those areas. He noted that COVID-19 is also revealing the needs of people with disabilities and health disparities, so those types of applications are starting to come in.
NCMRR Budget Priorities
Theresa Cruz, Ph.D., Director, NCMRR
Dr. Cruz asked for feedback on whether the NCMRR budget reflects the center’s priorities. She showed slides using unofficial data estimates for discussion purposes, noted that all official NIH data comes from the NIH RePORTER, and made the following points:
- The NCMRR budget increased approximately $30 million from 2013 to 2020, with small incremental increases each year. The 2020 budget was about $80 million.
- The number of NCMRR award applications generally remained steady from 2013 to 2020. There was a slight increase in 2016.
- Dividing the NCMRR budget by funding mechanism shows a shift in priorities from 2015 to 2020. Research projects increased from 59 percent to 73 percent. SBIR funding decreased from 18 percent to 7 percent.
- Comparing NCMRR with the overall NICHD budget distribution in 2020 shows similar percentages across funding mechanisms, with the NCMRR percentages slightly higher for Small Business Innovation Research (SBIR) and Training and Career Development.
- Dividing the 2020 funding data by disease or condition shows that stroke is the highest-funded disease area, but the Center also funds research for a wide variety of conditions. Dividing all NIH funding data by Research Plan theme shows areas where more applications could be encouraged (e.g., community and family).
Dr. Cruz asked Advisory Board members to comment on whether NCMRR was prioritizing the right grant mechanisms and how it could better align funding with its Research Plan. She also asked them to identify any missed opportunities and comment on whether NCMRR is being responsive to the needs of the rehab research community. Advisory Board members made the following comments:
- Dr. McDonald said that the funding percentage for Training and Career Development would drop with the elimination of the K12 award. He asked what proportion of the $10 million in that category was for K12 awards and suggested issuing a call for individual K awards for that amount. Dr. Cruz said that K12 awards represented $3 million and agreed that the Center would need to incentivize training awards to keep the funding percentages at previous levels. Dr. Nitkin added that NCMRR has made more awards in this area than other NICHD Branches have, but funding the infrastructure networks, although highly successful, limits what the Center can do in other areas. The Center would like to move to more limber and diverse funding mechanisms while maintaining the funding theme. Dr. Perreault said that he understood the rationale for moving from institutional to individual K12 awards but would like to continue the benefits of the networks that have been established. He asked whether the Center had considered a hybrid approach as another solution. Such an approach might involve individual awards that also include a network component or similar programs that benefit trainees. Dr. Cruz said that she agreed and that there are similar NICHD examples that might provide solutions with community cohort effects. Dr. Nitkin asked Advisory Board members to continue to think about what might be missing within the funding mechanisms.
- Regarding prioritizing innovation versus implementation, Dr. Field-Fote said that the two areas go hand in hand, because it is inadvisable to fund innovations that cannot be implemented. For example, some high-tech approaches are too expensive and inaccessible for implementation in the real world. Mr. Wudlick agreed, adding that many technologies or innovations that have been developed are still waiting for implementation. He added that more work is needed to develop dissemination and education tools for clinicians. Mr. Wudlick expressed frustration with the pace of implementation, especially in adaptive fitness, the area that he is most passionate about.
- Regarding SBIR funding, Mr. Wudlick said that the funding amounts have not increased in recent years despite how costly it is to develop medical devices, so the cost of implementation of the devices is a difficult gap to bridge. Dr. Cruz said that NIH does not set the SBIR limits; that is done by the Small Business Administration.
- An Advisory Board member asked about funding more health disparities research. Dr. Cruz said that the STRIVE initiative will hopefully provide more data that can inform the Center. Health disparities research is currently lacking.
- Dr. Kolobe asked what percentage of the individual K awards were awarded to underrepresented and minority applicants and whether funds could be set aside to develop a pipeline for these researchers. Dr. Cruz said that she would need to make a special request to NIH to obtain demographic data on research awards, but that is something to consider. Dr. Nitkin added that NCMRR encourages researchers to develop connections to communities with underrepresented populations.
Joe Bonner, Ph.D., Health Scientist Administrator and Program Officer, NCMRR, NICHD
Dr. Bonner presented an update on the Pathways to Prevention (P2P) workshop and then asked for concept clearance on a funding proposal. He made the following points during the P2P workshop presentation:
- The NIH Office of Disease Prevention, along with other federal partners, convened the P2P virtual workshop held in early December 2020 to assess the available scientific evidence on the benefits of physical activity interventions for health and wellness among users of wheeled mobility devices.
- The information will be used to increase the scope and detail of the Physical Activity Guidelines’ recommendations for individuals with disability. As many as 3.6 million Americans use a wheeled mobility device.
- The P2P process includes a portfolio analysis, a systematic review of evidence, the virtual workshop mentioned above, an independent panel report, and a federal partners meeting.
- The portfolio analysis revealed that NICHD provides the highest number of funded projects for physical activity in wheelchair users, and research projects are the largest funding mechanism used for these projects. The overall funding amount was close to $20 million from 2016 through 2020.
- The systematic evidence review is a large document. Its main finding was that physical activity was associated with improvements in walking ability and general function, balance, fall risk, depression, sleep, activities of daily living, aerobic capacity, and female sexual function. The limitations of the review included the absence of studies that reported long-term cardiovascular or metabolic disease outcomes; evidence being limited by heterogenicity of interventions and control groups and small numbers of participants; a lack of evidence for many outcomes prioritized by NICHD, NCMRR, and NINDS (e.g., bladder function, decubitus ulcers, lipid panels); and inadequately reported adverse effects of interventions.
- The P2P workshop was attended by 292 people, and its recording has been viewed 347 times to date.
- The draft of the independent panel report contained 26 recommendations. The report underwent a public comment period, which is now closed, so the document is under review.
- The systematic evidence review underwent a public comment period, which is now closed, so the document is under review.
- The portfolio analysis was presented at the P2P workshop and will be used to inform the federal partners meeting.
- The federal partners meeting will take place on July 28–29, 2021.
The concept would solicit research project grant applications for research in promoting health through physical activity for individuals who use a wheelchair for mobility. Along with the P2P workshop discussed above, the NIH Research Plan for Rehabilitation, the NICHD Strategic Plan, and the missions of NIH federal partners will also inform this FOA. Special considerations will be taken to address recommendations of an independent panel report that was produced by the P2P workshop. NIH staff will promote examples of projects considered high priority in the RFA based on the state of the science and programmatic balance, but research areas with significant investment in ongoing activities would be considered low priorities. NCMRR is currently soliciting participation from other ICs, which will influence the scope. Previous research into the benefits of physical activity and the harms of sedentary behavior have left knowledge gaps in the field of physical activity for individuals who use wheelchairs. The objective of this RFA is to address some of those gaps and to improve our knowledge of the benefits and requirements of physical activity for people who use a wheelchair. In accordance with the 21st Century Cures Act, each awarded project will be highly encouraged to share data with the research community.
- Dr. McDonald suggested using the wording “benefits and potential risks of physical activity” instead of “harm of sedentary behavior.” He also suggested that the benefits of physical activity should be more of a priority than the harms of sedentary behavior.
- Dr. Reinkensmeyer asked whether the breakdown between manual and power wheelchair users in the U.S. population was a knowledge gap. He also wondered what percentage of people who use manual wheelchairs can propel themselves. Dr. Bonner said that those numbers are not well known and added that the types and frequency of use for assistive technologies are also unknown. Most of the studies that described exercise interventions did not describe the types of wheelchairs being used by the study participants.
- Dr. Perreault asked how this RFA would affect the budget. Dr. Cruz said that NCMRR does not often publish RFAs and does not provide budget information about RFAs. She added that the partner ICs were likely to share the budget for the proposed RFA.
- Dr. Perreault made a motion to approve the concept clearance. Mr. Wudlick seconded the motion, which passed with no abstentions.
New Chair Nomination
Edelle C. Field-Fote, PT, Ph.D., FAPTA, NABMRR Chair
Dr. Field-Fote said that her term as chair was ending and asked for nominations for the next NABMRR chair, a 2-year appointment. Dr. Lo and Dr. Reinkensmeyer nominated Dr. Perreault. No other nominations were received. A motion was made to elect Dr. Perreault to the position of NABMRR chair, seconded, and it passed with no abstentions.
Learning Health Systems Rehabilitation Research Network (LeaRRn) Workshop Reflections
Linda Resnik, PT, Ph.D., FAPTA, Professor of Health Services Policy and Practice, Center for Gerontology and Healthcare Research, Brown University
Dr. Resnik presented a comprehensive summary of the LeaRRn workshop, “Shaping the Future of Telerehabilitation through Research ,” which took place on April 20 and 23, 2021, and focused on the shift to telemedicine during the COVID-19 pandemic. She made the following points:
- LeaRRn is a collaboration between Brown University, Boston University, and the University of Pittsburgh and nine health system partners. It is funded by NCMRR and the National Institute of Nursing Research (NINR). LeaRRn is a part of the MR3 network.
- The first day of the meeting featured sessions on the state of the science: utilization evidence, outcomes and implementation across settings, and gaps in knowledge. The second day focused on planning for the future, with policies, impacts, and current research. A virtual poster hall included 10 research posters. The meeting was closed-captioned and has been archived on the website.
- The two subcategories of telerehabilitation discussed at the workshop were the development of novel telerehabilitation interventions and telerehabilitation to replace some or all in-patient care. New nomenclature was discussed, as were the many modalities used to deliver telehealth appointments.
- The COVID-19 pandemic created a huge number of federal and state policy changes. Many of these changes will expire after the pandemic ends, so the future of telehealth is in question.
- Conference speakers presented a large amount of quantified data on the rapid expansion in outpatient telerehabilitation during the pandemic. Data showed slower adoption in other settings, such as home care.
- Research protocols were forced to pivot to allow telehealth visits. Some studies may provide new effectiveness data on the comparison between telehealth and usual care through standard delivery mechanisms.
- In various settings and for various patient populations, telerehabilitation has been offered for physical therapy, speech therapy, cardiac rehab, acupressure, yoga, tai chi, wheeled mobility, COVID-19 recovery, and physical activity.
- Telerehabilitation showed clear benefits for infection control, convenience, time savings, transportation access issues, access to expertise, and care in a home environment. Additional potential benefits included patient preference, access, dosage, accountability, decreased caregiver burden, and social connectiveness. There are mixed data on cost control.
- The barriers and challenges for patients included the digital divide (no cellular or Internet service, audio/video quality, and a lack of technology), physical interaction, training in technology, lack of equipment, and safety issues in the home. For providers, the challenges included work environment changes, including technology access, protocols, safety, and performing remote patient assessment. Organizational challenges included providing technology and equipment, protocols, and start-up costs and inefficiencies.
- The U.S. Department of Veterans Affairs (VA) developed several innovative solutions for enhancing access to technology, including a loaned tablet program.
- Several speakers shared algorithms for determining which patients could undergo initial evaluation via telehealth. Others shared novel evaluation and assessment techniques and strategies for special tests and measures that can be performed via telehealth. Several organizations developed safety checklists and methods for activating emergency services if necessary. Many organizations developed hybrid approaches that included a mix of in-person and telerehabilitation visits.
- Multiple systems and platforms exist for delivering telehealth, assessments, home exercise, medical notes, and more. Much of the time spent using these systems is unbillable.
- The outcomes of telerehabilitation are important to consider. These include functional outcomes and access. Some studies focused on telerehabilitation outcomes for specific conditions, such as chronic stroke.
- For future directions, conference attendees identified several broad areas for research and resource development, including training and resource development across disciplines, efficacy studies of novel telerehabilitation interventions, effectiveness and cost-effectiveness studies, implementation studies, and methods for biometric data collection to replicate in-person assessment. Many specific research questions were suggested.
- Most conference speakers and attendees agreed that telerehabilitation is here to stay.
- Dr. Field-Fote asked whether the proceedings of the conference would be published. Dr. Resnik said that the planning committee had been discussing that possibility.
- Dr. McDonald asked whether the conference addressed any pediatric issues, including telerehabilitation for children with cerebral palsy or other specific diagnoses or the impact on parents with children who need rehabilitation. Dr. Resnik said that one speaker addressed pediatric issues and one or two of the posters also included the pediatric population.
- Dr. Blauwet asked whether any of the presenters discussed strategies or best practices (e.g., digital health navigators) for mitigating health disparities in telerehabilitation. Dr. Resnik said that the presentations from the VA included several of these strategies, because the VA already has several advanced programs in place.
- Dr. Reinkensmeyer asked about the reimbursement levels for telerehabilitation. Dr. Resnik said that the Centers for Medicare & Medicaid Services (CMS) are currently reimbursing services at parity, but inefficiencies of the system create questions of whether that reimbursement is truly covering all time spent on a visit. New laws and cost comparison studies will be needed going forward. Dr. Reinkensmeyer asked a follow-up question about reimbursement for monitoring devices. Dr. Resnik said that there are billing codes for remote patient monitoring.
- Dr. Akinwuntan asked whether LeaRRn might develop a “telerehabilitation 101” workshop to help the rehabilitation community learn about the environment, equipment, security, and cognitive requirements for this type of telehealth. Dr. Resnik said that meeting attendees had identified the need for an interdisciplinary telehealth resource center. Developing these resources is not within the scope of funding for LeaRRn, but all of these resources were identified as a currently unmet need.
- Dr. Shrader asked about licensure across state lines and the use of wearable devices. Dr. Resnik said that one of the reasons that the VA is ahead on telerehabilitation is that the agency is not restricted by state lines. CMS and some states waived the licensure requirements during the pandemic, but regulatory changes will be needed going forward, and each state varies. Professional associations are beginning to advocate for these changes. There is some reimbursement for wearable devices, and the potential is still being discovered. Equipment and visits are variably reimbursed.
- Dr. Stevens-Lapsley asked for more information on the data about the length of episode of care in telerehabilitation. Dr. Resnik said that Intermountain Healthcare provided an interesting presentation not only on the length of episode, but also on the number of billing codes used for an episode. The pattern of care remains to be studied.
- Dr. Akinwuntan asked about better preparing the future workforce for delivering telehealth. Dr. Resnik said that training is needed at every level to better prepare practitioners.
- Dr. Nitkin said that it would be good to determine whether telehealth could also be used to improve rehabilitation compliance. Dr. Resnik agreed and said that one poster described a successful telehealth group physical therapy intervention for people with autism.
- Mr. Wudlick said that telehealth might provide access for reaching tribal members and people in rural areas. Dr. Resnik said that it especially offers access to specialty care that is not available in all areas of the country.
Health Disparities and Diversity in Rehabilitation Research
Gregory Hicks, PT, Ph.D., FAPTA, Professor, Division of Physical Therapy, Associate Vice President for Clinical and Translational Research, University of Delaware
Dr. Hicks, who is a former member and chair of NABMRR, presented a comprehensive overview of the current state of health disparities and diversity in rehabilitation research. He gave his personal background and motivation for speaking about diversity, equity, and inclusion (DEI) and made the following points during the presentation:
- The physical therapy profession—and rehabilitation research in general—is long overdue in acting on DEI issues. The current political, racial, and healthcare crisis environment presents an opportunity to create change now. Rehabilitation researchers can take this time to reevaluate and make changes within the field to prioritize the creation of a scientific community that fosters the development of translational research that enhances the health and quality of life for people with physical disabilities from all races, ethnicities, faith backgrounds, and socioeconomic backgrounds.
- The COVID-19 pandemic is like the influenza pandemic of 1918–1919, 100 years ago, in the way that it has revealed systemic and structural racism and privilege. Age-adjusted data show that White and Asian Americans are much less likely than members of other racial groups to have died of COVID-19. These inequities in mortality rates are due to environmental factors and other social determinants of health. The pandemic magnified the impact of these issues.
- Rehabilitation professionals must now focus on post–COVID-19 morbidity. Data are emerging on symptom presentation in patients with “Long COVID.” As described in several recent publications, the recovery and care of these patients is likely to magnify health disparities.
- To answer the question of how the rehabilitation research community should address health inequities in society, the community can look to the Institute of Medicine Committee on Understanding and Eliminating Racial and Ethnic Disparities in Health Care and its 2003 book, Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care. The authors’ first recommendation is to promote consistency and equity of care through evidence‐based guidelines, followed by increasing the proportion of underrepresented U.S. racial and ethnic minorities in health professions. The third recommendation is to integrate cross‐cultural education into the training of current and future health professionals. The published data show that the rehabilitation community has been ineffective in following these recommendations.
- The ideal care process is affected by multiple external influences, including patient input; social, economic, and cultural influences; stereotyping; prejudice; and racially disparate clinical decisions.
- Local census data should be used to enroll students at every level, hire staff, and set recruitment goals for scientific studies and clinical trials. In scientific studies, data collected through these methods become applicable to the entire population, providing broad rather than selective inclusion for set interventions.
- The lack of research on disparities in rehabilitation can be shown by searching PubMed for “healthcare disparities AND rehabilitation.” Rehabilitation falls significantly behind other disciplines, such as nursing. The following steps are needed to meet the recommendations described in the Unequal Treatment report:
- Conduct research on dissemination and implementation.
- Understand how new rehabilitation discoveries perform in disparate groups.
- Diversify research samples.
- Identify DEI deficits in rehabilitation research.
- Locate health services researchers who will study health disparities and health equity within rehabilitation.
- Workforce diversification is needed to increase the proportion of underrepresented U.S. racial and ethnic minorities in the health professions. The literature supports the benefits of increasing all types of diversity, including racial diversity.
- Black, Latino, Asian, and Native Americans are significantly underrepresented in the physical therapy profession, including the American Physical Therapy Association (APTA) and among students and faculty nationally. Other rehabilitation disciplines have similar issues.
- There are viable pathways for change. For example, a few years ago, the Liaison Committee on Medical Education (LCME), which sets the standards for medical schools in North America, issued new accreditation standards on diversity that stated, “Each medical school must develop programs or partnerships aimed at broadening diversity among qualified applicants for medical school admission.” Published data show a trend toward increased diversity after the implementation of the new standards. Another example is the Advancing Diversity in Physical Therapy program at the University of Delaware, where the data also show a trend toward improved diversity and higher overall academic performance.
- Scientific training data also show negative trends in the career choices of underrepresented and female postdoctoral researchers. Published data reveal the factors associated with pursuing a research career in academia. The type and level of unbiased and genuine social support is a critical factor. Cohort programs can provide this type of support.
- To integrate cross‐cultural education into the training of current and future health professionals, it is important to recognize that unaddressed patient–provider sociocultural differences negatively influence communication and clinical decision‐making. For example, published data reveal racial bias in pain assessment and treatment recommendations and false beliefs about biological differences between Blacks and Whites. Cross‐cultural education offers promise as a tool to improve the provision of quality care to diverse patient populations and, ultimately, reduce healthcare inequities.
- Following these three recommendations will improve health equity in the rehabilitation community:
- Promote consistency and equity of rehabilitation care through evidence‐based guidelines that were developed through a lens of health equity.
- Increase the proportion of underrepresented U.S. racial and ethnic minorities among rehabilitation health professionals and researchers.
- Integrate cross‐cultural education into the training of current and future rehabilitation professionals and rehabilitation scientists.
- Dr. Akinwuntan asked how to create a pipeline for identifying diverse students to apply to physical therapy programs. Dr. Hicks said that the University of Delaware program identified undergraduate students in exercise science or who had undeclared majors. The program initially targeted and engaged juniors and seniors but quickly switched to targeting freshmen. Many of the students in the program end up attending doctoral programs at other institutions.
- Dr. Akinwuntan asked whether the demographic distribution of the region for each school played a major role in creating a diverse student pipeline. Dr. Hicks said that undergraduate students come to the university from all over the country. He added that there are different types of diversity in almost every region of the country, including indigenous populations. Regardless of student body diversity, following the recommendations for improving diversity in the field is still valuable. Dr. Akinwuntan suggested recruiting athletes or others engaged in sports to increase awareness of the physical therapy profession.
- Dr. Ellerbe asked whether the University of Delaware was doing anything to improve the number of students who go into physical therapy research as scientists. Dr. Hicks said that the program is taking it one step at a time, first increasing the number of physical therapists with plans to expand into scientific research in the future. An NCMRR training grant has contributed to this effort, and graduate students and faculty have begun to do more mentoring work.
- Dr. McDonald asked whether the increase of for-profit inpatient rehabilitation companies was having an impact on diversity. Dr. Hicks said that it would be part of the equation, but many factors are tied to finances. Data on healthcare inequities show that the lack of diversity is costing the country billions of dollars each year. Monetizing these factors may create funding opportunities for addressing these issues. Altruism is nice, but money influences people greatly.
- Dr. Stevens-Lapsley asked for input on addressing the limitations on creating diversity in research studies where language barriers create challenges. Dr. Hicks said that this was a major issue for core services. Strategies might include language department partnerships and the use of translation services. Dr. Stevens-Lapsley suggested using administrative supplements for language services. Mr. Wudlick said that the University of Minnesota was also experiencing budget constraints that affected attempts to create translated materials and consent forms. He agreed that additional funding was necessary to improve reach and encouraged Advisory Board members to continue to work together to develop creative approaches.
Remarks from Parting Members
Dr. Ellerbe thanked NICHD, NCMRR, and her fellow Advisory Board members for the opportunity to serve on NABMRR and help shape its research portfolio. With her background in public health, she feels honored to have contributed to the development of the NIH Research Plan on Rehabilitation. Dr. Ellerbe has tried to provide input on the need to improve access to services for minority groups and increase opportunities for women and ethnic minorities on both sides of research—as investigators and as participants. She was excited to hear Dr. Hicks’s presentation and more about the STRIVE initiative and was proud to represent APTA and the physical therapy profession on this Advisory Board. She asked NCMRR to continue to include physical therapy representation on NABMRR.
Dr. Field-Fote said that it was her pleasure to work with everyone on the Rehabilitation 2020 Conference and the NIH Research Plan on Rehabilitation. She has missed spending time with Advisory Board members in person over the past year. Dr. Field-Fote thanked everyone for their many contributions to the Advisory Board and thanked NIH staff for their work and dedication to improving health and wellness for others in the United States and beyond.
Dr. Stevens-Lapsley said that the one consistent factor over the past year was realizing that change is real and will continue. Although she prefers to meet in person, change has allowed the Advisory Board to explore new ways to meet and accomplish its mission. Dr. Stevens-Lapsley is grateful to be part of a multidisciplinary group of individuals working toward the collective goal of optimizing rehabilitation. She thanked Dr. Cernich, Dr. Nitkin, and Dr. Cruz for their leadership in developing engaging and insightful meetings that cover a range of important topics. Dr. Stevens-Lapsley said that one of her most memorable experiences was working with Mr. Ludwick on their stakeholder engagement presentation. She expressed appreciation for the opportunity to serve on the Advisory Board.
Dr. McDonald thanked the group and said that it was an honor and privilege to serve on NABMRR. He said that he had learned a lot from the Advisory Board members and meeting presenters, adding that he had received much more than he had contributed over the years. Dr. McDonald has been impressed by the passion, leadership, and vision of Dr. Cernich, Dr. Cruz, and Dr. Nitkin and by Dr. Bianchi’s commitment to rehabilitation research. Dr. McDonald has been pleased to see the growth and diversification of the NCMRR portfolio and research community, as reflected by Advisory Board membership. He enjoyed planning the 2020 virtual conference and presenting information on precision medicine for children. He has tried to be a voice for children with disabilities and for pediatric rehabilitation research. Dr. McDonald looks forward to the contributions and advocacy efforts of the new Advisory Board members with pediatric expertise. He fondly remembers the days of meeting in person to share meals and take a group photograph. He thanked everyone for a wonderful 4 years.
Dr. Reinkensmeyer thanked the group for the honor of serving on NABMRR and recalled a funny story from the first time that he met Dr. Cernich but did not recognize her. He knew from that moment that the group would be down to earth and have a sense of humor. He acknowledged the importance of the Advisory Board’s work and said that he had learned a lot and greatly benefitted from the experience. Dr. Reinkensmeyer said that the group allowed him to learn about many disciplines and helped him navigate the care that his parents needed at the end of their lives. He concluded by saying that there are so many unmet needs and so much work to be done.
Dr. Skidmore said that the last 4 years had been a period of immense growth for NCMRR in terms of its budget and breadth of research. This is an exciting time to be a rehabilitation scientist. The challenges that lie ahead, including new ways of delivering, implementing, and disseminating care and ensuring that everyone has access to high-quality care, are challenges that the group needs to approach with the same passion, know-how, and collective wisdom that it has always demonstrated. Dr. Skidmore said that it was a pleasure to serve on NABMRR and that she would be watching its work in the future.
Final Summary and Planning for the Next Meeting
Eric Jon Perreault, Ph.D., Professor and Chair, Departments of Biomedical Engineering and Physical Medicine and Rehabilitation, Northwestern University
When Dr. Perreault asked for ideas for the agenda for the December 2021 NABMRR meeting, the following were suggested:
- Burnout and resilience prevention education, training, and resources for junior trainees
- More information about the STRIVE initiative (a topic raised by several Board members)
- A presentation on the COVID-19 pandemic’s impact on pregnant women
- A presentation on the role of technology and wearables in telehealth (a topic raised by two Board members)
- A presentation on telehealth from the patient and other stakeholders’ perspective
- More presentations, metrics, and analyses on DEI in rehabilitation, possibly as a standing item on the agenda
- A presentation on adaptive fitness and physical activity for wheelchair users
- A presentation how to increase diversity in recruitment of research participants, possibly from someone like Mona Fouad, M.D., M.P.H., at the University of Alabama, Birmingham.
- A presentation on how to expand DEI by hiring people with disabilities and information on how to collect institutional data in this area (a topic raised by two Board members)
- A presentation on the FDA approval process for rehabilitation devices
- A presentation on how to design research to improve reimbursement after implementation
- More information about how Post-Acute Sequelae of COVID-19 (PASC) is affecting the rehabilitation community
Dr. Cruz gauged the Advisory Board members’ interest in having a 2-day virtual meeting in December if there was not an option to hold the meeting in person. Dr. Cruz, Dr. Nitkin, and Dr. Perreault thanked the Advisory Board members for participating in the meeting and adjourned at 3:00 p.m.