Innovative Technologies for Improved Medical Diagnoses, Rehabilitation and Warfighter Readiness
Abstract
The “Innovative Technologies for Improved Medical Diagnoses, Rehabilitation and Warfighter Readiness” program at USUHS is designed to answer fundamental questions of importance to the military medical mission of the Department of Defense in the three portfolio areas: Transforming Technology for the Warfighter (TTW), Surgical Critical Care, and the Rehabilitation Sciences Research. Portfolio 1: The Transforming Technology for the Warfighter (TTW) program supports USUHS partnerships with other DoD biomedical labs, civilian universities and medical centers (including minority serving institutions), and the National Institutes of Health to advance and deliver new technologies to improve warfighter health and readiness. Research projects, which focus primarily on the Combat Casualty Care, Military Operational Medicine, and Clinical and Rehabilitative Medicine defense medical R&D areas of interest, are selected based on scientific peer review and programmatic review with an emphasis on direct relevance to identified military needs, translational potential, and clear strategy for product commercialization. Specifically, the program aims to advance Technology Readiness Level (TRL) 3 projects to TRL 4/5/6 within a maximum of three (3) to five (5) year performance period. Although the program is built around the needs of the warfighter, it also advances civilian care by supporting projects that benefit both the warfighter and the general public. The TTW program fully supports the DoD’s Joint Capabilities Integration and Development System (JCIDS) and continually works to link projects to DoD requirements documents, including the 2008 Initial Capability Documents (ICD) for Military Operational Medicine, the 2014 ICD for Combat Casualty Care (CCC) Devices and Products, the 2015 ICD for CCC Training Technologies, the 2015 ICD for CCC Medical R&D, and the 2017 ICD for Clinical and Rehabilitative Medicine. Portfolio 2: The Surgical Critical Care Initiative (SC2i), a consortium of 7 institutions (USU, Henry M. Jackson Foundation for the Advancement of Military Medicine, NMRC, Duke, Emory, DecisionQ), enrolls critically ill patients (as well as healthy controls), leveraging medical and multi–omics data to develop Clinical Decision Support Tools (CDSTs) that will improve clinical outcomes and lower resource utilization across military and civilian healthcare systems. The CDSTs will further assist readiness by either accelerating return to duty (abridged length-of-stay across the ICU, general ward, and rehabilitation continuum of care) and curbing medical resource burdens. The SC2i also collaborates with the Lawrence Livermore National Laboratory, University of Pittsburgh, University of South Florida, Brooke Army Medical Center, University of Vermont, among others. Through collecting patient specimens, laboratory testing, microbial analytics, and data modeling, our CDSTs will augment individual precision medicine, decrease the Warfighter’s healing time, and accelerate their return to readiness. The SC2i is transforming patient data into actionable information, improving diagnosis in healthcare, and reducing the cost of care through early detection of surgical complications. Our current focus is on 3 CDSTs to aid in advanced Sepsis prediction, timing of wound closure, and early detections of pneumonia, bacteremia, and venous thromboembolism. The AIDEx (Sepsis and other Decompensation) tool will be launched into the BAMC in FY23, with use in nine other military medical facilities within the year following. Additionally, the SC2i is working with the Office of Regulated activities to develop a regulatory strategy for the AIDEx tool for the FDA using a predicate 510(k) pathway. This tool aims to predict sepsis 6-12 hours prior to onset. The WounDx CDST should be in place prior to FY27 in multiple MHS and civilian facilities. WounDx addresses an unmet clinical need of uncertainty in the timing of wound closure; additionally, it will lessen the number of dehisced wounds, which occur in an approximately 15-30% of wounded warriors. Other CSDTs include diagnosis of acute kidney injury, severe traumatic brain injury, acute respiratory distress syndrome, open abdomen infections, appendicitis, heterotopic ossification, and snakebite recovery. We have 2 CDSTs currently in use in the MHS or civilian hospitals: Invasive Fungal Infection, which is used to detect patients at increased risk of fungal infections, as well as the Massive Transfusion Protocol app to identify when such is needed in trauma patients. The MTP app has been further adapted for use in Role 1 / 2 care settings and is undergoing external validations in partnership with ARA and MTEC. Potential cost savings (2018 internal business case analysis) through the use of seven of our CDSTs is estimated at $10B annually for the US healthcare system, and $110M annually for the US military health system. Other SC2i work includes USUHS Department of Surgery student engagement and the generation and dissemination of knowledge products throughout the civilian and medical communities. Recruitment to date is approximately 3,300 patients; 7,600 laboratory samples, and 62 million data points. Portfolio 3: The Center for Rehabilitation Sciences Research (CRSR) supports clinical and translational research efforts dedicated to enhancing the rehabilitative care of the wounded warrior, particularly those with orthopedic trauma, amputation and neurological injury. Research focus areas include: 1) Identifying and mitigating barriers to successful rehabilitation, return to duty and community reintegration; 2) Improved pain management to support active participation in rehabilitation; 3) Applying Advanced Technologies to augment rehabilitation methods and outcomes assessments; 4) Developing and testing advanced technologies to restore individual functional independence; 5) Regenerative Rehabilitation translational products for war-related trauma. Musculoskeletal injuries (MSKI) are the largest source of disability in the military and affect 800,000 Service Members annually, accounting for 25 million days of limited duty. Most concerning, the disability discharge rate for MSKI has increased 13x between 1981 and 2005 (70 vs. 950 per 100,000 persons), and these trends have continued to increase in the Department of Defense (DoD) and Veterans Affairs Administration in the most recent decade. The Defense Health Agency recognized this unmet clinical/operational gap and funded the formation of the Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR) organization in 2019. In the past three years since our inception, MIRROR has established a world-class infrastructure (data, regulatory, governance) that is compliant with the DoD for conducting research, expanded the number of studies from 14 to 40, formed partnerships with 24 military and academic centers, received $65 million in grant funding, hosted 5 educational symposiums, generated 19 Post-Operative Rehabilitation Protocols to standardized care across the Tri-Service, and published 82 abstracts and peer-reviewed publications. Since then, our enrollment across all studies is approximately 5,100 subjects. Moving forward, we plan to execute on our current projects and continue to provide value through: (1) research and operational support to new military treatment facilities, (2) closing critical care injury/pain gaps (e.g., spine, knee, ankle, shoulder), (3) evaluating novel imaging modalities (e.g., elastography), (4) performing sub analyses to understand gender disparities, predisposition to injury, response to treatments, etc. MIRROR was also selected to host a 3-hour session at MHSRS 2022. The Photomedicine to Enhance Military Readiness program is a four-year, $22 million initiative with the Wellman Institute, The Geneva Foundation, HJF, and Spaulding Rehabilitation that supports JPCs 5, 6 and 8. These teams are executing 15 clinical and translational research projects to deliver optimal dosimetry of photobiological therapy to enhance performance, reduce the potential for MSKI, assist with nerve graft healing, enhance audiology function, etc. Projects are progressing and in various stages of device development, benchtop research, and regulatory review [Institutional Review Board (IRB) approval for clinical trials and Institutional Care and Use Committee (IACUC) approval for animal research]. In addition to these clinical and translational research projects, CRSR continues to provide leadership and coordination of the Military Treatment Facility Engagement Committee (MTFEC) within the Pain Management Collaboratory (PMC) Coordinating Center (PMC3), which is an $81 million inter-agency initiative to support a multi-component research effort focused on non-pharmacological approaches for pain management supporting JPCs 6 and 8. Four ongoing pragmatic trials studying non-pharmacological approaches to pain for military service members and veterans continue, expanding to one additional performance site. A one-hour session at MHSRS 2022 titled, ‘Novel Interventions for Non-pharmacological Pain Management,’ was moderated by DoD representative and MTFEC member, Dr. Henry Nothnagel. To continue conversations among VA, DoD, and DHA members, a cross-collaboration working group has been established to discuss policies and procedures to enhance clinical research execution within the DoD. CRSR has been a leader in the 30-institution NCAA-DoD Concussion Assessment, Research and Education (CARE) Consortium, which includes the Service Academy Longitudinal TBI Outcomes Study (SALTOS). To date, recruitment totals over 53,000 participants, including more than 23,000 Service Academy cadets and midshipmen, with just over 6,700 recorded concussions, making this the largest study of its kind on the natural history and neurobiology of concussion. Thus far in FY22, 15 manuscripts have been published and 23 presentations have been completed to disseminate important findings from this cohort. Additional funding has been secured, totaling $42.65 million for the longitudinal continuation study, CARE-SALTOS Integrated (CSI). Stand-up of CSI, which will follow cadets, midshipmen, and NCAA athletes post-graduation to determine intermediate and long-term impacts of concussion on health and military service, is currently underway at five military sites, and over 500 military participants have completed Tier 1 of CSI.
Document Details
- Document Type
- Accomplishment
- Publication Date
- Oct 01, 2024
- Source ID
- 42e4cdc6be83576956b4b45c15141e89