Patron members sought for project engagement
Research Funding Advocacy
Within the mission of the North American SCI Consortium is to bring unified achievements in both research and policy. A key funding agency of SCI research is the National Institute of Neurological Disorders and Stroke (NINDS), which is an institute within the National Institutes of Health in the United States. NINDS spends approximately $80M per year on research dedicated toward spinal cord injury. Within each institute is a national advisory council consisting of established research scientists and academics. The National Advisory Neurological Disorders and Stroke (NANDS) Council has two general functions: (1) to advise the NINDS on policy and procedures affecting the extramural research programs and (2) to provide a second level of review for all grant and cooperative agreement applications considered by the Institute for funding. They meet 3 times per year. More about the NANDS Council may be viewed here (https://www.ninds.nih.gov/About-NINDS/Who-We-Are/Advisory-Council)
NASCIC members have decided there is a need to advocate for a redistribution of the research funding to have more emphasis on 1) chronic injury, 2) translational and clinical research to improve care and quality of life, and 3) incorporating the input and voice of those living with SCI and their caregivers in the entire process.
- The first step of this advocacy effort was to submit a letter to the NANDS Council regarding these three issues with the listing of the NASCIC members that support this effort at the time of submission. The letter was submitted prior to the September 13, 2018 council meeting. A copy may be viewed here - NASCIC Letter to NINDS_Advisory Council
- The second step of this advocacy effort was to query our community about their research priorities and present this information during the SCI 2020 'Decade of Disruption' meeting hosted by NINDS on February 12-13, 2019. A copy of the final report may be viewed here - SCI 2020 Panel and Survey Results
- A third step was to provide feedback on the state of rehabilitation research. In June 2019, the NIH National Center for Medical Rehabilitation Research was seeking public comment on the perceived progress on their 2015 Rehabilitation Research Strategic Plan (NIH_ResearchPlan_Rehabilitation). The NASCIC Executive Council (EC) reviewed the plan and rehabilitation research that had been funded. The EC submitted a response pointing out areas of the strategic plan in which less progress had been made. View the response here - NASCIC Response to NCMRR RFI
- A fourth step was to provide feedback on the research priorities resulting from the SCI 2020 meeting in February 2019. In July 2019, the NIH National Institute of Neurologic Disorders and Stroke was seeking public comment on the research priorities they identified during the NIH hosted conference February 12-13, 2019 titled “SCI 2020: Launching a Decade of Disruption in Spinal Cord Injury Research” (Day 1 video archive and Day 2 video archive). The NASCIC Executive Council (EC) reviewed the priorities and submitted a response pointing out areas that were missing or that should be revised. View the response here - SCI 2020 RFI response final web
Spinal Stimulation Survey
This project is seeking four people with lived experience of SCI (i.e. people with an SCI, their families, caregivers and supporters) to join the Project Team to co-create and conduct an online survey on spinal cord stimulation.
The purpose of the survey is to gather the perspectives and priorities of people with lived experience of SCI. Initiated by the Rick Hansen Institute, this project aims to ensure that spinal cord stimulation clinical research initiatives are meaningful and beneficial to people with lived experience of SCI. RHI and NASCIC will form a Project Team involving researchers and people with lived experience of SCI to finalize the objectives of the survey, develop the questions, and conduct the online survey.
The initial objectives identified by RHI for the survey are to: a) obtain information on the level of knowledge about spinal stimulation, b) identify and prioritize desired outcomes specific to spinal stimulation trials, c) determine what would be meaningful benefits, and d) understand the level of tolerance for risk, invasiveness of treatment procedure, time commitment, benefit to funders and overall demand.
The Project Team will also help encourage participation in the online survey to their networks, and assist in interpreting and sharing the results of the survey through a report, presentations and social media.
We also plan to make some of the de-identified data publicly available.
Survey on Info about Emerging Therapies
This project is intended to assess how people living with SCI access timely and reliable information about newer therapeutic interventions and clinical trials. It struck the authors that: a) many people with SCI may not be aware of emerging therapies and technologies; b) may be subject to “scam” information about therapies and interventions that aren’t proven to be effective; and c) may have unmet needs for unbiased information about treatments and trials.
The project will develop and distribute a survey directed toward the SCI community. The survey we are developing is meant to help our team understand how people living with SCI access and evaluate information about newer medical/therapeutic treatments and opportunities to participate in clinical trials. In a time of great hope for recovery from SCI, we are specifically interested in how people living with injuries determine which information they receive seems true and credible and which does not.
FDA Partnership in Patient & Caregiver Connection Program
The FDA division of the Center for Device and Radiological Health (CDRH) hosted their first Patient Engagement Town Hall meeting to kick-off the Patient & Caregiver Connection Program (PCC). NASCIC was one of fourteen organizations invited to be involved with the pilot program. During this test phase, we will work with the PCC program to help the program evolve to include more patient organizations.
The PCC was formed as an intentional and meaningful interaction with the patient population and the program is housed in the Office of Strategic Partnerships and Technology Innovation (OST). There are 3 goals to gain an understanding of:
- living with a specific disease or condition
- how medical devices are used for diagnosis, treatment, or management of a patient’s disease or condition, and
- current issues or trends related to medical devices.
The operation of the program is a simple feedback loop between PCC and the involved organizations. The OST contacts the PCC representatives with areas that need a greater understanding, then CDRH will issue key questions to the involved organization. These questions are disseminated to their constituents to gain feedback and the results and ancillary commentary is looped back to CDRH. This is a step in the right direction to have our voice heard within the FDA and to engage with them directly. The NASCIC liaison will be Jen French and will report periodically on updates from the FDA and active communications with the agency.
Comprehensive Inclusion of SCI in CDC Neurologic Registry Development
Despite decades of discussions within the SCI community, efforts to form a comprehensive SCI national registry have been largely unsuccessful. Currently, several SCI datasets exist in the United States including the National Spinal Cord Injury Statistical Center database (utilizing data from SCI individuals admitted to rehabilitative programs within the SCI Model Systems of Care network), the VA SCI and Disorders Outcomes System, as well as a patchwork of individual state databases. There are variations in size, criteria for inclusion, purpose, data elements and collection platforms meaning data on the entire SCI population is not captured, nor is it captured uniformly.
The recently passed (2016) legislation “Advancing Research for Neurological Diseases Act of 2016 included in the 21st Century Cures Act of 2016’’ [page 1076] which was funded in 2018, gives NASCIC members the opportunity to inform the Centers for Disease Control & Prevention (CDC) of the strategic importance of a spinal cord injury (SCI) national registry. NASCIC will set appropriate SCI data fields to be collected using CDC’s lessons learned in phases one and two of the National Neurological Conditions Surveillance System to ensure that the resulting SCI database will serve policymakers, medical equipment and medical supplies providers and the overall SCI community as a whole.
53% of NASCIC members took part in voting to undertake the SCI Registry guidance project. Members unanimously approved acceptance of the SCI Registry guidance as an official project of NASCIC.
Open Data Sharing in SCI Research
How do you feel about people accessing your research data? Dr. John Kramer’s lab at ICORD and NASCIC have partnered to work on a research study examining how people with a spinal cord injury feel about their research data used by others. Data sharing is the idea of re-using anonymous, de-identified data from previous research in new ways, whether that be in new research done at a university, in policy creation in government, or even examining medication effects at pharmaceutical companies. This project involves several steps: First, a focus group will be formed to identify key areas of data sharing that should be examined. This information will lead to the creation of a data sharing survey, which will be disseminated across North America. The survey findings will then be analyzed, and results will be published as an academic paper and as a position statement that can guide data sharing policies. The key driving force behind this project is to hear from people living with spinal cord injury, their families, and their community, and to get their voices and beliefs about how their own research data should be treated.
Mid-Atlantic SCI Research Network
Consumer Advisory Team for Robotic Exoskeleton Working Group for Increased Mobility
This project aims to create an Advisory Team comprising 4-6 people living with SCI with diverse perspectives to collaborate with the Robotic Exoskeleton for Increased Mobility Working Group. This project is will be led by representatives from the Florida Institute for Human & Machine Cognition (IHMC) and Myolyn as part of their Discovery Award for the Toyota Mobility Unlimited Challenge. The high-level vision for this exoskeleton is a self-balancing, semi- autonomous, hands-free, highly mobile device that will increase mobility for people with lower limb paralysis.
The role of the Advisory Team will be to help identify and define the mobility goals of individuals with lower limb paralysis and provide a critical perspective for creating a road map that balances individuals’ needs, concerns, preferences, and goals with available and emerging approaches to address them.
Members of the Advisory Team will provide direct feedback to members of the Working Group through the attendance of at least one member of the Advisory Team at monthly Working Group teleconference meetings (1 hour/meeting) and through online communications with Working Group members (e.g. email, Slack, etc.). We will schedule one in-person Working Group meeting to be held this summer at IHMC (travel for Working Group members will be paid for using the Discovery Award). The project is expected to begin in June 2018.
Consumer Advisory Team for Neuromodulation Working Group for Bladder & Bowel
This project is seeking to create an Advisory Team comprising 5-6 people living with SCI to collaborate with the Neuromodulation for Bladder and Bowel Working Group.
Initiated by the Craig H. Neilsen Foundation Neurogenic Bladder and Bowel Workshop, this Neuromodulation Working Group was created out of a team of approximately 12 individuals from research, industry, clinical, and advocacy organizations to explore neuromodulation interventions for bladder and bowel function for individuals living with SCI. The goal of the Working Group is to promote adaptation and translation of neuromodulation technologies to meet the functional goals of individuals with neurogenic bladder and bowel dysfunctions within a 10-year timeframe. The purpose of the Neuromodulation Working Group is to (1) Identify existing or emerging neuromodulation technology that can be leveraged in our timeline to meet this goal; (2) Identify and describe the steps that the field should take to achieve this goal; (3) Identify the opportunities and barriers that exist in accomplishing this goal; and (4) Create a road map and manuscript to publish the working group’s recommendations.
The role of the Advisory Team will be to help identify and define the bladder and bowel goals of individuals with SCI, and provide a critical perspective for creating a road map that balances individuals’ needs, concerns, preferences, and goals with available and emerging neuromodulation approaches to address them. This will be accomplished by surveying NASCIC members and incorporating their feedback into a written document.
Enhancing Partnership: Guiding Principles for Conducting and Disseminating Research in Partnership with the SCI Community
Integrated KT (IKT) is an approach to doing research whereby research users as partners alongside researchers throughout the entire research process. The resulting research is more applicable, useful and translatable to end-users than research conducted by researchers alone. Despite the advantages of an IKT approach, only a small minority of KT activities have been planned and implemented in partnerships between researchers and the community. SCI researchers have often been accused of tokenism (i.e. people with SCI are asked to only endorse research to legitimize research programs over which they have little real control) and recent calls have highlighted the need for further support for SCI researchers and research users adopt IKT partnerships. While recommendations for adopting IKT approaches have been put forth, these recommendations are not informed by a process that uses a rigorous methodology (e.g. systematic review) and meaningful engagement of SCI stakeholders to develop IKT best practices. The objective is to develop and implement the first IKT guiding principles for conducting and disseminating research in partnership with the SCI community.
Several members of NASCIC are members of this consensus panel providing input as stakeholders, potential advocates, and adopters of the principles.