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Research Support of Mission Readiness

Research Support of Mission Readiness. Serving Navy and Marine Corps Needs in Joint Operations. 1. Research Support Of Mission Readiness. Wayman Wendell Cheatham, MD, FACE Special Assistant to the Surgeon General for Clinical Research. Translational Resource. Experience gained from:

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Research Support of Mission Readiness

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  1. Research Support of Mission Readiness Serving Navy and Marine Corps Needs in Joint Operations 1

  2. Research SupportOf Mission Readiness Wayman Wendell Cheatham, MD, FACE Special Assistant to the Surgeon General for Clinical Research

  3. Translational Resource • Experience gained from: • Observation • Basic science • Medical research • Surgical research • Invaluable benefit to the Force • Fight against disease • Repair and rehabilitation from trauma

  4. Translational Resource • Grecian Wars • Roman Military Campaigns • US Revolutionary War • Crimean War • US Civil War • Spanish - American War • World War I • World War II • Korean War • Vietnam War • Operation Iraqi Freedom / Enduring Freedom

  5. Grecian Wars (4th Century BCE) • Hippocrates (4th Century BCE) • “ He who would become a surgeon, let him join an army [navy] and follow it” • Wrote about wound care and antiseptics

  6. Roman Military (1st Century BCE – CE) • Caesar Augustus (63 BCE – 14 CE) • Gave titles, land grants and retirement benefits to military physicians • Roman military physicians boiled their medical implements before using them and washed wounds in acetum (made from wine) • Used sedative herbs that contained scopolamine and analgesics made from poppies (morphine)

  7. Revolutionary War (1775 – 1783) • No knowledge of antiseptics or aseptic practices • No sedatives other than alcohol • No analgesics of note • (essentially, compared to Grecian and Roman times, medical practice had “dumbed down” to a level of idiocy!)

  8. Crimean War (1853 – 1856) • Gave legitimacy to Nursing – Florence Nightingale and her 38 nurses at the British War Hospital in Turkey • Civilian Translation: • Medical care delivery not possible or even thinkable without the expertise of the Nursing Profession!

  9. Civil War (1861 – 1865)

  10. Civil War (1861 – 1865) • 14,000 military physicians entered the War • but only 527 had previously performed surgery • Instituted ligation of long arteries following amputation to prevent death from re-exacerbation of hemorrhage • Anesthesia first used routinely during amputation, with better outcomes

  11. Civil War (1861 – 1865) • Translation: • Surgical training programs with requirement for maintenance of surgical logs and minimal number of procedures on a recurrent basis required to maintain accreditation • Amputation became more common since it could be shown that it really could save lives with reduction of morbidity and mortality related to the amputation itself

  12. Spanish-American War (1898) • War Wound Mortality = 385 • But 2,565 die from disease • Major Walter Reed determines the vector for Yellow Fever • Established measures to reduce the risk • Mosquito netting • No camps near swamps or standing water

  13. Spanish-American War (1898) • Translation: • Concept of “Vectors” of disease transmission became a scientific investigation and line of discovery • Measures for eradication of pestilence became an industry

  14. World War I (1914 – 1918) • First credible recognition of psychological trauma • “shell shock” • Transfusion of blood reduces death • Pavilion style General Hospitals • copied by the civilian community for the next 75 years

  15. World War I (1914 – 1918) • Translation: • The entire science and theory of psychological trauma develops • “What”, transfuse blood!!!? – Never more a question • Scattered “cottage style” hospitals with varying capabilities and competence gave way to multi-disciplinary centers of care with multiple specialties close at hand

  16. World War II (1939 – 1945) • Dr. Charles Drew develops method of separating plasma from blood cells to “expand” the use of collected blood • Sulfanilamide demonstrated wide spread utility in infections • Penicillin (discovered in 1929) became widely recognized and used after Pfizer mass produced it to support treatment of battle injuries • Aid stations set up close to the line of battle

  17. World War II (1939 – 1945) • Translation: • For almost 75 years, component blood product therapy became more and more widespread – for economy sake • The profound benefit of use of antibiotics was vigorously and widely translated to civilian medicine (had been delayed for 2 decades until WW II started) • “Emergency Care Centers” strategically placed at health care facilities around metropolitan areas and geographically in rural areas

  18. Korean War (1950 – 1953) • Triage strategy shown to increase survival rates overall • Field hospitals established • Helicopter evacuation first used and shown to reduce death rate from wounds

  19. Korean War (1950 – 1953) • Translation: • “Maybe having only one or two major Genaral Hospitals in a metropolitan area was not such a good idea – especially as suburban sprawl became a reality • Community Hospitals became more “valuable” again as the “first stop” for care and assessment in areas distant from Urban Centers

  20. Vietnam War (“1965 – 1973”) • Strategy of rapid evacuation of wounded from battlefield to field hospitals confirmed to significantly increase survival

  21. Vietnam War (“1965 – 1973”) • Translation: • MedEvac Systems are crucial to every military conflict (“would not leave home without one!)” • MedEvac Systems set up in regional distribution, supported by: • State Police Helicopter Stand-by • Trauma Center Helicopter Stand-by • Coast Guard and Military (for civilian assistance when requested) Helicopter Stand-by

  22. Operation Iraqi Freedom (2003 - ) • Operations Iraqi Freedom / Enduring Freedom

  23. Navy Medicine Strategic Goals – Directed to Support: • Total Force • Agile Capabilities • Deployment Readiness • Patient and Family Centered Care • R&D and Clinical Investigation Programs • Quality of Care • Performance Based Budget

  24. Total Force • Maintain the right work force • ACCESSION • RETENTION • EDUCATION • TRAINING • INCENTIVES

  25. Agile Capabilities • Ensure healthy forces • Medically prepared to meet the mission • Through delivery of consistent, timely and appropriate health care- ACROSS THE ENTIRE RANGE OF JOINT MILITARY OPERATIONS

  26. Deployment Readiness • Warfighters and medical support personnel fully deployable • Achievement of all training, administrative and medical readiness requirements

  27. Patient & Family Centered Care • The “Core” concept of care delivery • Each warfighter and family member as a critical participant in their own health care • Recognizing the vital importance of the military culture, family, and chain-of-command in “centered care”

  28. R&D and Clinical Investigation Programs Tier I Goal Navy Medicine will conduct relevant research, development, testing, evaluation and clinical investigations which protect and improve the health of those in our care

  29. R&D and Clinical Investigation Programs • Conduct relevant research • Transition bench-top concepts and discovery to further development • Efficiently carry out scientifically legitimate and unbiased testing of the developed product concepts • Evaluate the mature research product in competently managed clinical investigations which translate clinical science to deployable products: • To protect and improve the health of all in our care • To ensure that products of “poor research” or that are not needed DO NOT GET TRANSLATED • To clear the way for directed development of viable assets

  30. Navy Medicine Priority Research Topics • 1)Traumatic brain injury and psychological health treatment and support for both operational forces and home based families. • 2) Medical systems support for maritime and expeditionary operations: • Limitation of injury, disease and medical risk • Body armor, head/neck stability support, hearing protection* • Optimal screening protocols and interventions for debilitative and oncologic disorders • Cervical, prostate and bowel cancer • Viral infection identification and immunization (malaria & H1N1 vaccines) • Risk to, and protection of, active duty expectant mother and fetus

  31. Navy Medicine Priority Research Topics(continued) • 2) Medical systems support for maritime and expeditionary operations (continued): • Means for survival of injury • Hemorrhage intervention and resuscitation fluids • Surgical innovations • Wound management* • Plastic and regenerative medicine • Patient medical support • Forward resuscitative support – optimal corpsman training procedures • Movement through care levels I, II and beyond with emphasis on USMC CASEVAC and EN ROUTE Care (modeling and simulation), DNBI • Astounding record of survival of casualties in transit from OCONUS to CONUS facilities • Digitized medical informatics and intervention guidance

  32. Navy Medicine Priority Research Topics(continued) • 3) Wound management throughout the continuum of care: • Chemical, molecular and cellular indicators of optimum time for wound closure • Wound-Vac • Comprehensive rehabilitation • Reset of personnel to operational fitness • 4) Hearing restoration and protection for maritime, surface and air support personnel • Sound energy abatement • Pharmacological intervention to protect and restore • 5) Undersea medicine, diving & submarine • physical endurance enhancement • catastrophe intervention

  33. This wound dehisced This wound healed Clinical Translational Research: Predicting Wound Closure & Healing Products from the Bedside Predictive Biomarkers Of Wound Healing • A component of a multi-pronged approach to develop wound therapies: • Biomarker Panel of Readiness for Wound Closure • Extracorporeal Shockwave Therapy (ESWT) with ONR, NNMC, & WRAMC Predictive biomarkers of wounds may reduce the number of required surgical procedures Co-sponsored by Navy Medical Development Program & ONR “Bench to Bedside” Medical Research: Product Development Stemming from the Surgical Suite

  34. Emergent Issues from OIF/OEF Heterotopic Ossification • More prevalent in OIF/OEF casualties than in similar civilian trauma (60% vs. 20%) • Can present a problem for rehabilitation/prosthetics • Risk factors: • Blast exposure • TBI Collaborators: NMRC, NNMC and WRAMC • Orthopedic surgeons from WRAMC/ NNMC working with researchers at NMRC to identify factors influencing bone growth/preventative treatments Wound effluent promotes bone growth in culture Sponsored by Navy Medical Development Program “Bench to Bedside” Medical Research - The close proximity of clinical medicine and basic research yields opportunity

  35. Injury Mapping XXXX XXXX XXXX M2 DEERS CHCS-2T DCIPS JTTR Navy-Marine Corps CTR Data Warehouse The Hard Part: Patient Data from Forward MTFs. (BASs, STPs, FRSSs Surg Co, Hospital Ships) Level 1-3 Theater Patient Records Level-0 DOW (Time of Death/ Cause of Death) DOW Data Level 1-3 Theater Laydown The Day-by-Day Medical Theater Laydown VA Data (Ultimate Outcome/ Quality of Life) Level-5+ Level-4 Disability Ratings Level 4 Landstuhl Patient Records Navy-Marine Corps Combat Trauma Registry Landstuhl Patient Records Level-5 CONUS Clinical Data (Complications of Care) CONUS Patient Records Navy-MC CTR Psychiatric Database A Critical Capability GuidingIntervention & Research Navy/Marine Corps Combat Trauma Registry • Informs Navy and Marine Corps combat developers, medical planners, research and development • Level I & II collection • Linked to Joint Trauma Registry Naval Health Research Center Co-sponsored by Navy Medical Development Program, MARCORSYSCOM (FFMP) , ONR, HQ USMC (HS), Army components, DoD BTA Critical Information Resource DoD-wide for Medical Planners, Combat Developers, Materiel Developers & Researchers

  36. Joint Service Cooperation • Products of DoD Enterprise-Wide Benefit • Results of cooperative effort • Transferable between Service platforms • Synergistic operational support • Evidenced by joint research and development cooperation between Army, Navy, Air Force, USUHS, VA • Applied research development/outcomes support: • Astounding record of survival from trauma for soldiers, marines and air personnel within theater • Profound record of successful evacuation from Southwest Asia to Level 4 in Central Europe and from Central Europe to CONUS • Unprecedented return to duty of wounded operational personnel

  37. Translational Research Clinical Practice in the Field, Clinic & MTF Medical R&D Laboratories • Examples of ongoing programs where Army and Navy surgeons have developed innovative clinical approaches (there are, and should be, more) • Wound management/healing • Heterotopic Ossification • Diagnostic Imaging of wound/organ perfusion Enhanced spectral imaging of perfusion in organs/wounds Navy and Army Surgeons working collaboratively to bridge clinical medicine with cutting edge research from the Medical R&D Laboratories Wound biomarkers Heterotopic Ossification A critical ingredient to success: from “Bench to Bedside” (and back again)

  38. Products Delivered Hemostatic Agents for Hemorrhage Then Now • Studies performed at The Naval Medical Research Center & The Institute of Surgical Research separately assessed multiple (10+) hemostatic preparations in pre-clinical swine hemorrhage models. • In 2008 the Committee for TCCC brokered a review of the data and recommended Combat Gauze. Navy: QuikClot Combat Gauze Army: Hemcon ATACCC circa 2000 ATACCC Circa 2008 Sponsored by MARCORSYSCOM(FFME) Sometimes medical product development provides a consensus solution, sometimes not. Competition is healthy, coordination essential.

  39. Products in the Pipeline Infusible Hemostatic for Internal Hemorrhage • Studies at the Naval Medical Research Center to compare two platelet-derived formulations in a laproscopically-induced (closed) liver injury hemorrhage model. • Platelet-derived Hemostatic Agent (PDHA) Control PDHA Co-sponsored by Navy Medical Development Program & US Army Combat Casualty Care Coordination of Navy and Army Advanced Development Programs, the Army Combat Casualty Care Program, DARPA, USU & Industry

  40. Current ERCS Products in the Pipeline • MOVES (Monitoring, Oxygen, Ventilation, & External Suction) Current ERCS • Lightweight, portable device targeted to provide capability for “transport of opportunity” • USMC Procurement CY09 • Adding anesthesia connection in FY10 • MOVES Anesthesia module scheduled for FY13/14 as P3I. Functions in Stand-alone as well Joint Program – MARCORSYSCOM (FFME) & Navy Medical Development MOVES II to include Army & USAF Requirements 40

  41. Products in the Pipeline Cybertech Cricothyrotomy Kit • Everything needed in one small, integrated package • One-handed operation device • Retractable scalpel that provides automatic, full retraction when the integrated tissue spreader is advanced into the incision. • Incorporates IR & Visible LEDs for illumination Co-sponsored by Navy Medical Development Program Joint USMC - Navy - Army Investment Partnering with Industry Dual-use with Civilian EMS

  42. The Navy Clinical Investigation Program(preparing the clinicians and researchers of the future) TOTAL # OF RESEARCH PROJECTS

  43. The Navy Clinical Investigation Program(preparing the clinicians and researchers of the future) TOTAL RESEARCH PUBLICATIONS

  44. The Navy Clinical Investigation Program(preparing the clinicians and researchers of the future) # OF RESEARCH FUNDING PARTNERS

  45. Quality of Care • Quality: • Outcomes carefully and systematically measured • Meet or exceed patient and third-party quality expectations • Evaluated/ investigated via maintenance of support platforms such as tissue and trauma registries • Development of real-time results - available in the field • Monitoring of evacuation care • Follow-up of results by “medical partners” (IOM, AFIP, “Joint Commission”) • Morbidity and Mortality reviews as “teaching moments”

  46. Quality of Care • Ready and convenient access to health care resources on the battlefield and at home • Assisted by upgraded IT systems, available in the field/in theater/at home • Consistent provision of lasting results: • Comprehensive preventive medicine • Entomology, malaria abatement, monitoring of endemic diseases, fresh water/food • New and advanced methods to mitigate health and physical risk • Assisting providers in delivery of the best and most current practice

  47. Quality of Care - The Outcome Achievement and Maintenance of: • Operational effectiveness • Reputation as a high-quality, high performance military medical enterprise • Provision of innovative, outcomes based, highly effective medical care to our Wounded Warriors as well as military families and health care beneficiaries • Reflecting great credit upon Military Medicine and our Nation’s image and capabilities

  48. Research Support of Mission Readiness Serving Navy and Marine Corps Needs in Joint Operations 48

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