Military Medicine International Journal of amsus raising the bar: extremity trauma care guest editors
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support, and INBRE-funded studies for launching scienti fic careers in research focus areas. The BADER Consortium used this unique model to enhance the capacity at MTFs and VA sites, making it possible for more innovative, high-impact research to be conducted. Research Capacity-Building Infrastructures General principles of the INBRE Program were implemented by the BADER Consortium to construct a broad, nationwide orthopaedic rehabilitation clinical research network across FIGURE 1. BADER Consortium Framework as indicated by the light blue region with coordination and oversight components above. MILITARY MEDICINE, Vol. 181, November/December Supplement 2016 15 BADER Consortium: Partnering for Optimal Orthopaedic Rehabilitation Outcomes government, academic, and industrial partners. The Consor- tium
’s research capacity-building components consist of three Scienti
fic and Technical Cores; a Clinical Research Core (CRC); a Research Advisory Committee (RAC) —groups of scientific experts providing research reviews, advice, and expertise; and access to graduate training in Biomechanics and Move- ment Science. Three Scienti fic and Technical Cores provide strategic support to orthopaedic rehabilitation scientists and partnering clinicians at the MTFs and VA sites. The Biomechanics Core provides the Consortium expertise and support in biomechan- ics and human movement analysis methodologies. The services of the Core include assistance with solving on-site problems with hardware and software, expert advice for research proposals and the development of new strategies and methods in support of clinical research areas. The Biostatistics Core at Christiana Care Health System provides episodic biostatistics support under a fee-for-service mechanism — where BADER pays the costs of incurred fees in order to be cost-effective. The Core provides pre- and postaward support to BADER-supported investigators, including but not limited to power analysis, statistical modeling, and specialized data analyses. Located at UD, the Rehabilitation Outcomes Measurement Core works directly with Principal Investigators to ensure that adequate outcomes measurement techniques are introduced and followed in the research process. The speci
fic aim of the Rehabilitation Outcomes Measurement Core is to assist investigators in the selection, use, implemen- tation, analysis, and interpretation of relevant outcomes vari- ables for studies that are proposed and implemented within the BADER Consortium. The CRC provides on-site staf fing support necessary to develop, conduct, and monitor clinical studies under the direc- tion of MTF administrative directors and clinical research leaders in support of MTF, the EACE, and/or CRSR scienti fic staff. The CRC is central, offering “boots on the ground” support staff to assist with research efforts at MTFs and VA sites. It is the Consortium ’s central body of study execution and provides MTF-led research teams with resources to develop, conduct, and monitor clinical studies, as well as day-to-day support, education, and training. Two full-time, on-site CRC staff members are dedicated to each of the MTFs. The highly skilled individuals provide MTF staff with on-site technical assistance, protocol management, and human subject recruitment support. The CRC research support infrastructures are further organized to develop and support a research-intensive culture by assisting MTF investigators with establishing a uniform and sustainable research capability that facilitates ongoing and new clinical research protocols across all participating study sites. Research expertise and mentorship are provided through the RAC, comprising experts specializing in DoD research and priority clinical gap areas. The overall purpose of the RAC is to assure the quality and impact of BADER Consor- tium research. The team conducts scienti fic reviews of pro- posed projects and performs reviews of research project progress reports. Efforts of the RAC are bolstered by an extensive group of BADER Consortium af filiates from which MTF and VA research partnerships are formed. Access to a graduate training program in Biomechanics and Movement Science has been made available to MTF and VA center staff. Under an agreement with the College of Health Sciences at UD, the BADER Consortium provides graduate stipends for select MTF and VA research staff to enhance their skills and research expertise through the pur- suit of graduate education degrees. Research Support Infrastructures The Consortium ’s research support components are designed to ease the burden of administrative overhead, ensure data safety, and facilitate the forming of research partnerships. They consist of a single, Consortium-wide master Cooperative Research and Development Agreement (Consortium CRADA), a centralized protocol and data management system (PDMS), and administrative support for forming and sustaining DoD and VA research partnerships with academia and industry. To accelerate the establishment of clinical research pro- jects and research partnerships, BADER Consortium leader- ship worked with the Medical Research Law Of fice of the Staff Judge Advocate, USAMRMC to develop the BADER Consortium CRADA. The goal of this initiative was to jetti- son the traditional project-speci fic CRADA format—where CRADAs are customized to each project —in favor of a sin- gle consortium CRADA model that outlined the breadth of policies and procedures encountered by the activities of a national consortium. To establish the Consortium CRADA, a selection of CRADAs from the Navy, Army, and the NIH were gathered. The content of each example CRADA was reviewed and categorized. Like categories were then combined and sys- tematically reduced to generalized guidelines in each CRADA activity category. Each category was then tested against applicable federal regulations and active policies. The resulting “master” Consortium CRADA was virtually exercised using an array of Consortium-related scenarios. The resulting policy and implementation procedures, such as on-boarding projects and the declaration and approval of amendments, were developed. Before full implementation, the Consortium CRADA was trialed at two government sites. Implemented via a collaborative agreement with the NIH Eunice Kennedy Shriver National Institute for Child Health and Human Development, the NIH ’s Clinical Trials Database serves as a rehabilitation outcomes data collection tool with patient self-report and a secure centralized web-based portal for the management of clinical study data and tissue repository information. This PDMS is a Federal Information Security Management Act –compliant tool that simplifies data sharing among member sites by standardizing research methods while simultaneously facilitating protocol tracking and compliance monitoring. While fully customizable, it uses standardized forms, common data elements, and a common vocabulary. MILITARY MEDICINE, Vol. 181, November/December Supplement 2016 16 BADER Consortium: Partnering for Optimal Orthopaedic Rehabilitation Outcomes The centralized administrative core provides valuable sup- port for the establishment and sustainment of research partner- ships. This includes support for grand rounds presentations, site visits by potential collaborators, and scienti fic planning meetings at MTF and VA sites. Initiative-Launching Studies The initiative-launching component contains a set of BADER Consortium-funded clinical research studies aimed at launching impactful clinical research initiatives in partnership with the MTFs and VA sites. BADER-funded projects are awarded via a peer-reviewed, limited competition award program open to the BADER Consortium Af filiates responding to a Consortium- generated call for proposals. The proposals are scienti fically
reviewed by the BADER RAC and ultimately selected by the Consortium ’s Government Steering Committee. The goal of these initiative-launching projects is to establish sustainable multiteam system partnerships and generate clinically focused results that advance patient care paradigms in critical patient care gap areas. Furthermore, this BADER-supported program is designed to provide necessary funding to propel new and early-career scientists into independent researchers leading sustainable research programs at MTF and VA sites. This funding mechanism is also ideally suited for establishing a technology translation pipeline, based on a multiteam system model, by taking emerging technologies from Telemedicine and Advanced Technology Research Center and DARPA programs and rapidly transitioning the technology across research activity category teams into clinical trials and patient care paradigms (Fig. 2). RESULTS
The BADER Consortium became operational in 2013 follow- ing an initial 12-month “discovery” phase. During that phase, a total of eight CRC on-site research support staff were identi- fied in collaboration with MTF staff, hired by UD, trained and on-boarded at the MTFs. Development and testing of the Consortium CRADA was completed on September 19, 2012. Within four months of its implementation, six partner institu- tions completed on-boarding to the Consortium CRADA. At the time of this report, the BADER Consortium contains nine industrial partners, eight government sites, 21 BADER- supported employees (10 are stationed full time at MTF sites), and 99 BADER-af filiated experts located at academic research sites across North America. Recently, a generic version of the Consortium CRADA was provided to CDMRP of ficials, upon request, for use by other CDMRP-funded consortia. By 2014, the BADER Consortium completed two rounds of BADER-funded calls for proposals and identi fied its eighth BADER-funded clinical study. The earliest studies received clearance from the USAMRMC Human Research Protection Of fice to begin study activities in June of 2013. The Adminis- trative Core provided critical support for these activities by coordinating efforts, in partnership with the EACE, to identify research gap areas used to solicit proposals for BADER- funded projects and assist with the scienti fic review process. Totaling $7.6 million in direct project funding, the eight BADER-funded studies have a net planned enrollment greater than 1,400 subjects. Topic areas covered by BADER-funded projects and their emerging team research initiatives include the following: assessing new, clinically relevant research areas in DoD- identi
fied critical gap areas to reduce the incidence of falls; retraining to improve walking and running after amputation; prescribing prosthetics for work and carrying heavy loads; and determining the impact of robotic prosthetics on functional outcome levels and QoL. Additional projects focus on improving measures of functional outcomes and determining the effectiveness of current rehabilitation care trajectories. In addition to their assignments on BADER-funded research projects, members of the CRC on-site staff have provided support for 37 non-BADER-funded studies at MTF sites. The nature of CRC staff contributions has been broad. Their responsibilities have included completing literature reviews in preparation of project presentations and publications; recruiting human subjects; assisting with the preparation of grant proposals; monitoring regulatory documents and pro- cesses; engagement with clinical staff to promote systematic outcomes assessment; loading research data into the PDMS; and contributing to the evaluation and acquisition of labora- tory equipment. The Scienti fic and Technical Cores demonstrated the capac- ity to provide support for orthopaedic rehabilitation research. The cores have supported BADER-funded research projects and provided valuable support and expertise for research ideas that become new research proposals and research areas. The Biomechanics Core supported a multicenter CRSR project to enhance data sharing. The Biostatistics Core provided statisti- cal modeling support for seven external grant applications in the fall of 2014. The Outcomes Core spearheaded two clinical research initiatives and provided assistance to nearly all pro- jects and grant proposals. FIGURE 2. Multiteam System Model indicating five research activity levels. Research initiative partnerships emerge from one or more collaborating organizations at each level joining to form a multiteam research system to address an identi fied gap in patient care. MILITARY MEDICINE, Vol. 181, November/December Supplement 2016 17 BADER Consortium: Partnering for Optimal Orthopaedic Rehabilitation Outcomes At the time of this report, one BADER-funded study has been completed. BADER research efforts have led to five published manuscripts, six pending publications, and 44 pub- lished abstracts. Thirteen grant proposals have been submitted to various agencies for external funding. These submissions have resulted in six externally funded projects having a net value of $3.5 million and an additional $7.9 million in pend- ing grant submissions. In 2013, the Defense Health Board (DHB) was tasked with reviewing the full spectrum of amputee care and de fining
a strategy for preserving and continuing the advancements. 1 BADER Consortium leadership provided one of many DHB briefs and support materials leading to the April 8, 2015, DHB report titled, “Sustainment and Advancement of Ampu- tee Care. ” Following an extensive review, the DHB described BADER Consortium as “central to the ARCs’ research capabilities and current efforts. ” The DHB also found that the Consortium “significantly enhanced and facilitated” the research capabilities of the ARCs. 1 DISCUSSION The BADER Consortium is uniquely positioned among its partner programs to advance the orthopaedic rehabilitation research agenda. It uses a clinical research capacity-building component that supports research team building and the suc- cessful identi fication and establishment of impactful and sustainable research initiatives. Key research infrastruc- tures have been established in support of BADER-funded, externally funded, and MTF-supported clinical research pro- jects. However, not all partner organizations have uniformly embraced Consortium-centric components. The Consortium CRADA is a Consortium-centric mecha- nism that is used to rapidly onboard study sites and research projects. It provides a uniform standard operating procedure that addresses the broad range of policies related to research partnerships. Adoption of the Consortium-centric CRADA has been mixed across branches of the military, although readily embraced by academic, industrial, and select govern- ment partners. As a result, natural separations have begun to form between Consortium CRADA partners and nonpartners. Such divisions are disadvantageous and Consortium activities would be enhanced by the broad acceptance of a uni fied CRADA mechanism. While BADER Consortium ’s research infrastructures and project activities are seen as “central” to the ARCs’ mission, they should not be viewed as complete. BADER ’s opera- tional model was originally designed to focus primarily in three component areas —capacity-building, research-support, FIGURE 3. Primary (beige shaded) and emerging (gray shaded) components of the BADER Consortium operations model. Green-shaded elements indicate primary collaboration sites (acronym de finitions in text). Also shown are the four BADER-supported stages that DoD and VA research sites undergo to obtain research independence and clinical impact. MILITARY MEDICINE, Vol. 181, November/December Supplement 2016 18 BADER Consortium: Partnering for Optimal Orthopaedic Rehabilitation Outcomes and initiative-launching studies. As the result of our observa- tions and direct requests for assistance, BADER support has transitioned limited resources to assist with technology translation, research subject recruitment, and research part- nership activities (Fig. 3). Clearly, the development and sustainment of large-scale research subject recruitment capa- bilities focused on military personnel and civilians is an additional desired infrastructure, considering the goal of sus- taining world-class research and patient care efforts during periods of reduced con flict. 1
research and patient care is facilitated by an understanding and implementation of the science behind team science. 13 As the breadth of orthopaedic rehabilitation gap areas grows to encompass critical outcomes determinants in clinical acute care and early intervention focus areas, infrastructures for the rapid establishment and sustainment of dynamic research partnerships are also warranted. CONCLUSION The BADER Consortium is a highly effective network for enhancing orthopaedic rehabilitation research capacities at MTF and VA sites, establishing research areas in key gap areas and supporting an array of clinical studies in partner- ship with government, academia, and industry. Through its partnership with the EACE and cooperative agreement with CDMRP, the BADER Consortium is addressing important gaps in clinical orthopaedic rehabilitation research and patient care. Structures and activities of the BADER Consortium have become “central” to the ARCs’ research capabilities and cur- rent efforts to strengthen and sustain evidence-based ortho- paedic rehabilitation care that results in optimal functional outcomes for wounded warriors. 1 ACKNOWLEDGMENTS Support for the BADER Consortium was provided by the Congressionally Directed Medical Research Program (CDMRP), Peer Reviewed Orthopaedic Research Program (PRORP) via award number W81XWH-11-2-0222; the NIH-NIGMS (P20 GM103446); the NIH-NICHD through a collaboration agreement; and the University of Delaware, College of Health Sciences. Finally, none of this work would be possible without the courage and drive of wounded warriors whose desire to continue serving and actively engage life is beyond inspirational. REFERENCES 1. Defense Health Board Reports —Sustainment and Advancement of Amputee Care. April 8, 2015. Available at http://www.health.mil/About- MHS/Other-MHS-Organizations/Defense-Health-Board/Reports; accessed August 3, 2015. 2. Reznick JS, Gambel JM, Hawk AJ: Historical perspectives on the care of service members with limb amputations. In: Care of the Combat Amputee, pp 19 –40. Edited by Pasquina P, Cooper RA. Washington, Of fice of the Surgeon General at TMM Publications, Borden Institute, Walter Reed Army Medical Center, 2009. 3. Pasquina PF: Optimizing care for combat amputees: experiences at Walter Reed Army Medical Center. JRRD 2004; 41(Suppl 3a): vii –xii.
4. Extremity Trauma and Amputation Center of Excellence —EACE. Available at http://www.health.mil/About-MHS/Other-MHS-Organizations/Extremity- Trauma-and-Amputation-Center-of-Excellence; accessed August 3, 2015. 5. Clifton M: Amputee Achieves Goal: Returns to Iraq. DoD News. Avail- able at http://www.defense.gov/news/newsarticle; accessed July 17, 2015. 6. Sanchez J: Revolutionizing prosthetics. Defense Advanced Research projects Agency —Program Information—Revolutionizing Prosthetics. Available at http://www.darpa.mil/program/revolutionizing-prosthetics; accessed August 3, 2015. 7. Pottol KS: Armed Forces Institute of Regenerative Medicine —Annual Report 2013. Available at http://www.a firm.mil/assets/documents/annual_ report_2013.pdf; accessed July 15, 2015. 8. Bosse MJ, MacKenzie EJ: METRC Major Extremity Trauma Research Consortium —2013 Annual Report. Available at http://www.prioriti-mtf .org/pdfs/2013_METRC_Annual_Report.pdf; accessed July 15, 2015. 9. Program Announcement, Department of Defense Congressionally Directed Medical Research Programs, Peer Reviewed Orthopaedic Research Program, Orthopaedic Rehabilitation Clinical Consortium Award. Available at http://cdmrp.mil/funding/pa/10prorporcca_pa.pdf; accessed August 3, 2015. 10. Advancing Rehabilitative Care: Center for Rehabilitation Sciences Research —CRSR. Available at: http://crsr.org/?page_id=35; accessed August 3, 2015. 11. BADER Consortium: Bridging Advanced Developments for Exceptional Rehabilitation. Available at http://bader-c.org/; accessed August 3, 2015. 12. Groospe R: Introducing the Institutional Development Award (IDeA) Program. NIGMS Feedback Loop Blog. Available at http://loop.nigms .nih.gov/2012/05/introducing-the-institutional-development-award-idea- program-2/; accessed August 3, 2015. 13. Falk-Krzesinkski HJ, Borner K, Contractor N, et al. Advancing the science of team science. Clin Trans Sci 2010; 263 –66.
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