Military Medicine International Journal of amsus raising the bar: extremity trauma care guest editors
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fixation of in-bone implanted prosthesis. J Rehabil Res Dev 2008; 45(4): vii –xiv. MILITARY MEDICINE, Vol. 181, November/December Supplement 2016 12 EACE: Overview of the Research and Surveillance Division MILITARY MEDICINE, 181, 11/12:13, 2016 The Bridging Advanced Developments for Exceptional Rehabilitation (BADER) Consortium: Reaching in Partnership for Optimal Orthopaedic Rehabilitation Outcomes Steven J. Stanhope, PhD*; Jason M. Wilken, PhD, MPT†‡; Alison L. Pruziner, PT, DPT, ATC‡§; Christopher L. Dearth, PhD‡§; Marilynn Wyatt, MA, PT∥; CAPT Gregg W. Ziemke, MSC USN (Ret.)¶; Rachel Strickland, MBA*; Suzanne A. Milbourne, PhD, OTR/L**; Kenton R. Kaufman, PhD†† ABSTRACT The Bridging Advanced Developments for Exceptional Rehabilitation (BADER) Consortium began in September 2011 as a cooperative agreement with the Department of Defense (DoD) Congressionally Directed Medical Research Programs Peer Reviewed Orthopaedic Research Program. A partnership was formed with DoD Military Treatment Facilities (MTFs), U.S. Department of Veterans Affairs (VA) Centers, the National Institutes of Health (NIH), academia, and industry to rapidly conduct innovative, high-impact, and sustainable clinically relevant research. The BADER Consortium has a unique research capacity-building focus that creates infrastructures and strategically connects and supports research teams to conduct multiteam research initiatives primarily led by MTF and VA investigators. BADER relies on strong partnerships with these agencies to strengthen and support orthopaedic rehabilitation research. Its focus is on the rapid forming and execution of projects focused on obtaining optimal functional outcomes for patients with limb loss and limb injuries. The Consortium is based on an NIH research capacity-building model that comprises essential research support components that are anchored by a set of BADER-funded and initiative-launching studies. Through a partnership with the DoD/VA Extremity Trauma and Amputation Center of Excellence, the BADER Consortium ’s research initiative-launching program has directly supported the identification and establishment of eight BADER-funded clinical studies. BADER ’s Clinical Research Core (CRC) staff, who are embedded within each of the MTFs, have supported an additional 37 non-BADER Consortium-funded projects. Additional key research support infra- structures that expedite the process for conducting multisite clinical trials include an omnibus Cooperative Research and Development Agreement and the NIH Clinical Trials Database. A 2015 Defense Health Board report highlighted the Consortium ’s vital role, stating the research capabilities of the DoD Advanced Rehabilitation Centers are significantly enhanced and facilitated by the BADER Consortium. INTRODUCTION The signi ficant traumatic injuries to limbs sustained by service members during combat deployments in Operations Enduring Freedom, Iraqi Freedom, and New Dawn posed new chal- lenges to Department of Defense (DoD) Military Treatment Facilities (MTFs) and U.S. Department of Veterans Affairs (VA) sites. 1 During active periods of con flict, the number and complexity of injuries resulting in limb loss and limb salvage grew substantially relative to past con flicts.
2 This is
attributed to advancements in the effectiveness of body armor, rapid evacuation, and early medical attention programs. 3 To address the new clinical challenges associated with combat-related limb injuries and loss, DoD and VA of ficials
established specialized clinical programs for extremity trauma care and research, technology development initiatives in orthotics and prosthetics, and the development of consortia to conduct and support clinically focused research programs related to orthopaedics and rehabilitation. The Bridging Advanced Developments for Exceptional Rehabilitation (BADER) Consortium, started in September 2011, is part of that collaborative effort. Its overall goal is to strengthen evidence-based orthopaedic rehabilitation care to achieve optimal functional outcomes for wounded warriors and civilians with traumatic limb loss and limb differences. The purpose of this article is three-fold. First, we highlight the BADER Consortium ’s model system and methods for supporting the establishment of impactful and sustainable research capabilities. This includes research capacity-building components, research support infrastructures, and initiative- launching studies. Second, we demonstrate results indicating *University of Delaware, 540 S. College Ave, Newark, DE 19713. †Center for the Intrepid, Department of Rehabilitation Medicine, Brooke Army Medical Center, 3551 Roger Brooke Drive, Joint Base San Antonio, Fort Sam Houston, TX 78234. ‡Extremity Trauma and Amputation Center of Excellence, 2748 Worth Road, Suite 29 Fort Sam Houston, TX 78234. §Research and Development Section, Department of Rehabilitation, Walter Reed National Military Medical Center, 8901 Rockville Pike, Bethesda, MD 20889. ∥Naval Medical Center San Diego, 34800 Bob Wilson Drive, San Diego, CA 92134. ¶Naval Medical Center Portsmouth, 620 John Paul Jones Circle, Portsmouth, VA 23708. **Center for Disabilities Studies, University of Delaware, 540 Wyoming Road, Newark, DE 19716. ††Biomedical Engineering, Mayo Clinic, 200 First St. SW, Rochester, MN 55905. This article was presented at the Extremity War Injuries Meeting, Washington, DC, January 26 –28, 2015, and the Defense Health Board Brie fing, Washington, DC, May 21, 2014. The views expressed herein are those of the authors and do not re flect
the of ficial policy or position of Brooke Army Medical Center, U.S. Army Medical Department, U.S. Army Of fice of the Surgeon General, Department of the Army, Department of Defense, or the U.S. Government. doi: 10.7205/MILMED-D-15-00501 MILITARY MEDICINE, Vol. 181, November/December Supplement 2016 13
the effectiveness of BADER Consortium activities. Finally, we present a discussion containing insights gained to date. Orthopaedic Rehabilitation Research Efforts A review of related research programs is needed to provide context for best understanding the BADER Consortium ’s central role in developing these critical research infrastruc- tures. In 2001, following an assessment of the Army Medical Department ’s ability to care for large populations of combat amputees, Walter Reed Army Medical Center, now Walter Reed National Military Medical Center, was established as the
first specialized amputee care center. In 2007, three DoD Advanced Rehabilitation Centers (ARCs) were established for military amputees with special- ized clinical programs in orthopaedics and orthopaedic reha- bilitation. These centers are the Military Advanced Training Center at Walter Reed National Military Medical Center; the Center for the Intrepid and the San Antonio Military Medi- cal Center at the Brook Army Medical Center; and the Com- prehensive Combat and Complex Casualty Care (C5) Program at Naval Medical Center San Diego. In concert with DoD efforts, the VA established an Amputee System of Care across the United States with regional amputation centers and polytrauma amputation network sites. 1,4
The ARCs implemented advanced motivational and thera- peutic rehabilitation care models that utilized intensive rehabili- tation, peer dynamics, and advanced rehabilitation technologies with the goal of obtaining unprecedented outcomes and quality of life (QoL) following rehabilitation. As a result, service members with salvaged and amputated limbs began returning to active duty, including redeployment to combat zones. 5 Efforts of the ARCs to obtain high functional and QoL outcomes have led to a series of orthopaedic technology devel- opment initiatives. The Telemedicine and Advanced Technol- ogy Research Center, a component of the U.S. Army Medical Research and Materiel Command (USAMRMC), expanded their Advanced Prosthetics and Neural Engineering Program to include a Lower Extremity Gait Systems –integrated research team. In addition, the Defense Advanced Research Projects Agency (DARPA) established the Revolutionizing Prosthetics Program in 2006. The Revolutionizing Prosthetics Program developed “two anthropomorphic advanced modular prototype prosthetic arm systems, including sockets, which offer increased range of motion, dexterity and control options. ” 6
ernment agencies, the Armed Forces Institute of Regenera- tive Medicine (AFIRM) was launched in 2007 to accelerate research and the delivery of regenerative medicine therapies to treat the most severely injured service members. The pri- mary focus of AFIRM research has been seeking fundamen- tal breakthroughs in basic scienti fic domains at the cellular and tissue levels. 7 As a natural extension of the AFIRM Consortium, the Major Extremity Trauma Research Consortium (METRC) was established in September 2009. METRC consists of a national network of clinical centers and one data-coordinating center that work together with the DoD to conduct multicenter clin- ical research studies relevant to the treatment and outcomes of orthopaedic trauma sustained in the military. The overall goal of the METRC is to “produce the evidence needed to establish treatment guidelines for the optimal care of the wounded warrior and ultimately improve the clinical, func- tional, and QoL outcomes of both service members and civil- ians who sustain high-energy trauma to their extremities. ” 8
of Excellence (EACE) was legislated by Congress as a collab- orative organization to enhance research partnerships between the DoD, VA, academia, and industry. One unique aspect of the EACE is a congressional mandate to “conduct research to develop scienti fic information aimed at saving injured extrem- ities, avoiding amputations, and preserving and restoring the function of injured extremities. ” 4 The primary mission of the EACE is to coordinate multidisciplinary teams to conduct sci- enti fic research at the ARCs and VA sites that improves clinical outcomes and returns patients to the highest possible level of physical, psychological, and emotional functions. The scope of the EACE mission includes treatment, research, education and training, and mitigation following traumatic extremity injury and/or amputation. 4 With the burgeoning increase in clinical research and advanced patient care activities, the need soon became appar- ent for specialized “infrastructures” that would enhance the capacity to conduct and sustain world-class orthopaedic reha- bilitation research. In 2010, the DoD Congressionally Directed Medical Research Programs (CDMRP) Peer Reviewed Ortho- paedic Research Program established the Orthopaedic Reha- bilitation Clinical Consortium Award (ORCCA). The goal of the ORCCA was to “establish a strong infrastructure for con- tinuing clinical studies on combat-relevant musculoskeletal injuries and products that result in changes to, or validation of, current clinical practices that lead to better outcomes for our injured warriors. ” 9
Research (CRSR) was established in 2011 to advance the rehabilitative care for service members with combat-related injuries through synergistic research projects that promote successful return to duty and community reintegration. Housed in the Uniformed Services University of the Health Sciences, CRSR is an academic arm of rehabilitation activities within the DoD and well positioned to expedite the translation of advancements into patient care settings via the education and training of future health care providers within the military healthcare system. 10 The BADER Consortium In September 2011, the BADER Consortium, based at the University of Delaware (UD), received the ORCCA award. 11 A partnership was formed with four MTFs (the three ARCs and the Naval Medical Center Portsmouth), the EACE, VA Centers, the National Institutes of Health (NIH), academia, MILITARY MEDICINE, Vol. 181, November/December Supplement 2016 14 BADER Consortium: Partnering for Optimal Orthopaedic Rehabilitation Outcomes and industry to rapidly conduct innovative, high-impact, clini- cally relevant orthopaedic rehabilitation research. Using an NIH capacity-building model approach that provides essen- tial infrastructures and project funding to conduct impactful research, the BADER Consortium has further strengthened MTF/VA efforts to establish and support a growing ortho- paedic rehabilitation research culture. The mission of the BADER Consortium is to help establish sustainable world-class programs in orthopaedic rehabilitation research at MTFs and VA sites that result in evidence-based orthopaedic rehabilitation care. Our vision is for wounded warriors and civilians with limb loss and limb difference to routinely bene fit from significant orthopaedic rehabilitation advancements, and as a result obtain optimal functional clini- cal outcomes and fully re-engage in life and work activities. These goals are being realized through three primary objectives: (1) Establish infrastructures to support the advancement of orthopaedic rehabilitation research capabilities at ARCs and VA sites that promote optimal functional outcomes and QoL; (2) Conduct a variety of innovative, high-impact, and clinically relevant BADER-funded initiative-launching studies that lead to sustainable externally funded research programs; and (3) Preserve advancements in orthopaedic rehabilitation research by establishing an externally funded, self- sustaining clinical research enterprise. METHODS
The BADER Consortium framework (Fig. 1) is modeled on the Institutional Development Award (IDeA) Network of Biomedical Research Excellence (INBRE) program —a com-
ponent of the research capacity-building IDeA program of the NIH.
12 Established in 1993 by congressional mandate, the IDeA program aims to increase research competitiveness and sustainment of select states. This is accomplished through support for two major programs: Centers of Biomedical Research Excellence and INBREs. The INBRE program cre- ates infrastructure to administratively support a broad research network
—typically multiple disparate research, academic, and patient care centers geographically dispersed across a state or region. The activities conducted by an INBRE Program — while broad in nature and containing policies and procedures to ensure full compliance with human subject protection, scienti fic integrity, and administrative federal regulations —generally reside in three categories: research capacity-building, research- Yüklə 2,47 Mb. Dostları ilə paylaş:
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