The Year in Veterans Affairs & Military Medicine 2015-2016

THE YEAR IN

VETERANS AFFAIRS

& Military Medicine

SPECIAL SECTION: VA Research INTERVIEWS VA Secretary Robert A. McDonald VA Under Secretary for Health David J. Shulkin VHA Chief Nursing Officer Donna Gage 2015-2016 Edition

help protect your patients’ abstinence

ViVitrol®

(naltrexone for extendedrelease injectable suspension)

has been added to the VA National Formulary

VIVITROL is1: Nonaddictive and nonnarcotic A competitive opioid blocker (ie, antagonist) One month of naltrexone therapy in a single shot Used in conjunction with psychosocial support

ViVitrol is a nonnarcotic, nonaddictive, once-monthly medication indicated for: The prevention of relapse to opioid dependence, following opioid detoxification.

VIVITROL is also indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. Patients should not be actively drinking at the time of initial VIVITROL administration. VIVITROL should be part of a comprehensive management program that includes psychosocial support.

important safety information ViVitrol is contraindicated for:

Patients receiving opioid analgesics, with current physiologic opioid dependence, in acute opioid withdrawal, who have failed the naloxone challenge test or have a positive urine screen for opioids and who have exhibited hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose, or any other components of the diluent.

Prior to the initiation of VIVITROL, patients should be opioid-free for a minimum of 7-10 days to avoid precipitation of opioid withdrawal that may be severe enough to require hospitalization.

from opioid and alcohol dependence

VIVITROL is NOT1: Pleasure-producing Associated with abuse A replacement or substitute for opioids Associated with withdrawal upon VIVITROL discontinuation A controlled substance

additional important safety information Warnings and precautions Vulnerability to opioid overdose:

Following VIVITROL treatment, opioid tolerance is reduced from pretreatment baseline, and patients are vulnerable to potentially fatal overdose at the end of a dosing interval, after missing a dose, or after discontinuing VIVITROL treatment.

Attempts to overcome blockade may also lead to fatal overdose.

injection site reactions: In some cases, injection site reactions may be very severe. Some cases of injection site reactions required surgical intervention.

For additional Important Safety Information, please see Brief Summary of Prescribing Information on adjacent pages. Please see Full Prescribing Information, including Medication Guide.

Visit www.vivitrol.com to learn more about how VIVITROL can help. reference: 1. VIVITROL [prescribing information]. Waltham, MA: Alkermes, Inc; 2013.

VIVITROL® (naltrexone for extended-release injectable suspension) Intramuscular BRIEF SUMMARY See package insert for full prescribing information (rev. July 2013).

INDICATIONS AND USAGE: VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. Patients should not be actively drinking at the time of initial VIVITROL administration. In addition, VIVITROL is indicated for the prevention of relapse to opioid dependence, following opioid detoxification. VIVITROL should be part of a comprehensive management program that includes psychosocial support.

CONTRAINDICATIONS: VIVITROL is contraindicated in: patients receiving opioid analgesics, patients with current physiologic opioid dependence, patients in acute opioid withdrawal, any individual who has failed the naloxone challenge test or has a positive urine screen for opioids, and patients who have previously exhibited hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose, or any other components of the diluent.

WARNINGS AND PRECAUTIONS: Vulnerability to Opioid Overdose: After opioid detoxification, patients are likely to have reduced tolerance to opioids. VIVITROL blocks the effects of exogenous opioids for approximately 28 days after administration.

However, as the blockade wanes and eventually dissipates completely, patients who have been treated with VIVITROL may respond to lower doses of opioids than previously used, just as they would have shortly after completing detoxification.

This could result in potentially life threatening opioid intoxication (respiratory compromise or arrest, circulatory collapse, etc.) if the patient uses previously tolerated doses of opioids. Cases of opioid overdose with fatal outcomes have been reported in patients who used opioids at the end of a dosing interval, after missing a scheduled dose, or after discontinuing treatment. Patients should be alerted that they may be more sensitive to opioids, even at lower doses, after VIVITROL treatment is discontinued, especially at the end of a dosing interval (i.e., near the end of the month that VIVITROL was administered), or after a dose of VIVITROL is missed. It is important that patients inform family members and the people closest to the patient of this increased sensitivity to opioids and the risk of overdose. There is also the possibility that a patient who is treated with VIVITROL could overcome the opioid blockade effect of VIVITROL. Although VIVITROL is a potent antagonist with a prolonged pharmacological effect, the blockade produced by VIVITROL is surmountable. The plasma concentration of exogenous opioids attained immediately following their acute administration may be sufficient to overcome the competitive receptor blockade. This poses a potential risk to individuals who attempt, on their own, to overcome the blockade by administering large amounts of exogenous opioids. Any attempt by a patient to overcome the antagonism by taking opioids is especially dangerous and may lead to life-threatening opioid intoxication or fatal overdose. Patients should be told of the serious consequences of trying to overcome the opioid blockade. Injection Site Reactions: VIVITROL injections may be followed by pain, tenderness, induration, swelling, erythema, bruising, or pruritus; however, in some cases injection site reactions may be very severe. In the clinical trials, one patient developed an area of induration that continued to enlarge after 4 weeks, with subsequent development of necrotic tissue that required surgical excision. In the post marketing period, additional cases of injection site reaction with features including induration, cellulitis, hematoma, abscess, sterile abscess, and necrosis, have been reported. Some cases required surgical intervention, including debridement of necrotic tissue. Some cases resulted in significant scarring. The reported cases occurred primarily in female patients. VIVITROL is administered as an intramuscular gluteal injection, and inadvertent subcutaneous injection of VIVITROL may increase the likelihood of severe injection site reactions. The needles provided in the carton are customized needles. VIVITROL must not be injected using any other needle. The needle lengths (either 1.5 inches or 2 inches) may not be adequate in every patient because of body habitus. Body habitus should be assessed prior to each injection for each patient to assure that the proper needle is selected and that the needle length is adequate for intramuscular administration. Healthcare professionals should ensure that the VIVITROL injection is given correctly, and should consider alternate treatment for those patients whose body habitus precludes an intramuscular gluteal injection with one of the provided needles. Patients should be informed that any concerning injection site reactions should be brought to the attention of the healthcare professional. Patients exhibiting signs of abscess, cellulitis, necrosis, or extensive swelling should be evaluated by a physician to determine if referral to a surgeon is warranted.

Precipitation of Opioid Withdrawal: The symptoms of spontaneous opioid withdrawal (which are associated with the discontinuation of opioid in a dependent individual) are uncomfortable, but they are not generally believed to be severe or necessitate hospitalization. However, when withdrawal is precipitated abruptly by the administration of an opioid antagonist to an opioid-dependent patient, the resulting withdrawal syndrome can be severe enough to require hospitalization. Review of postmarketing cases of precipitated opioid withdrawal in association with naltrexone treatment has identified cases with symptoms of withdrawal severe enough to require hospital admission, and in some cases, management in the intensive care unit. To prevent occurrence of precipitated withdrawal in patients dependent on opioids, or exacerbation of a pre-existing subclinical withdrawal syndrome, opioiddependent patients, including those being treated for alcohol dependence, should be opioid-free (including tramadol) before starting VIVITROL treatment. An opioidfree interval of a minimum of 7–10 days is recommended for patients previously dependent on short-acting opioids. Patients transitioning from buprenorphine or methadone may be vulnerable to precipitation of withdrawal symptoms for as long as two weeks. If a more rapid transition from agonist to antagonist therapy is deemed necessary and appropriate by the healthcare provider, monitor the patient closely in an appropriate medical setting where precipitated withdrawal can be managed. In every case, healthcare providers should always be prepared to manage withdrawal symptomatically with non-opioid medications because there is no completely reliable method for determining whether a patient has had an adequate opioid-free period. A naloxone challenge test may be helpful; however, a few case reports have indicated that patients may experience precipitated withdrawal despite having a negative urine toxicology screen or tolerating a naloxone challenge test (usually in the setting of transitioning from buprenorphine treatment). Patients should be made aware of the risks associated with precipitated withdrawal and encouraged to give an accurate account of last opioid use. Patients treated for alcohol dependence with VIVITROL should also be assessed for underlying opioid dependence and for any recent use of opioids prior to initiation of treatment with VIVITROL. Precipitated opioid withdrawal has been observed in alcohol-dependent patients in circumstances where the prescriber had been unaware of the additional use of opioids or co-dependence on opioids. Hepatotoxicity: Cases of hepatitis and clinically significant liver dysfunction were observed in association with VIVITROL exposure during the clinical development program and in the postmarketing period.

Transient, asymptomatic hepatic transaminase elevations were also observed in the clinical trials and postmarketing period. Although patients with clinically significant liver disease were not systematically studied, clinical trials did include patients with asymptomatic viral hepatitis infections. When patients presented with elevated transaminases, there were often other potential causative or contributory etiologies identified, including pre-existing alcoholic liver disease, hepatitis B and/or C infection, and concomitant usage of other potentially hepatotoxic drugs. Although clinically significant liver dysfunction is not typically recognized as a manifestation of opioid withdrawal, opioid withdrawal that is precipitated abruptly may lead to systemic sequelae including acute liver injury. Patients should be warned of the risk of hepatic injury and advised to seek medical attention if they experience symptoms of acute hepatitis. Use of VIVITROL should be discontinued in the event of symptoms and/or signs of acute hepatitis. Depression and Suicidality: Alcohol- and opioiddependent patients, including those taking VIVITROL, should be monitored for the development of depression or suicidal thinking. Families and caregivers of patients being treated with VIVITROL should be alerted to the need to monitor patients for the emergence of symptoms of depression or suicidality, and to report such symptoms to the patient’s healthcare provider. Alcohol Dependence: In controlled clinical trials of VIVITROL administered to adults with alcohol dependence, adverse events of a suicidal nature (suicidal ideation, suicide attempts, completed suicides) were infrequent overall, but were more common in patients treated with VIVITROL than in patients treated with placebo (1% vs 0). In some cases, the suicidal thoughts or behavior occurred after study discontinuation, but were in the context of an episode of depression that began while the patient was on study drug. Two completed suicides occurred, both involving patients treated with VIVITROL. Depression-related events associated with premature discontinuation of study drug were also more common in patients treated with VIVITROL (~1%) than in placebo-treated patients (0). In the 24-week, placebo-controlled pivotal trial in 624 alcohol-dependent patients, adverse events involving depressed mood were reported by 10% of patients treated with VIVITROL 380 mg, as compared to 5% of patients treated with placebo injections. Opioid Dependence: In an open-label, long-term safety study conducted in the US, adverse events of a suicidal nature (depressed mood, suicidal ideation, suicide attempt) were reported by 5% of opioid-dependent patients treated

with VIVITROL 380 mg (n=101) and 10% of opioid-dependent patients treated with oral naltrexone (n=20). In the 24-week, placebo-controlled pivotal trial that was conducted in Russia in 250 opioid-dependent patients, adverse events involving depressed mood or suicidal thinking were not reported by any patient in either treatment group (VIVITROL 380 mg or placebo).

When Reversal of VIVITROL Blockade Is Required for Pain Management: In an emergency situation in patients receiving VIVITROL, suggestions for pain management include regional analgesia or use of non-opioid analgesics. If opioid therapy is required as part of anesthesia or analgesia, patients should be continuously monitored in an anesthesia care setting by persons not involved in the conduct of the surgical or diagnostic procedure. The opioid therapy must be provided by individuals specifically trained in the use of anesthetic drugs and the management of the respiratory effects of potent opioids, specifically the establishment and maintenance of a patent airway and assisted ventilation. Irrespective of the drug chosen to reverse VIVITROL blockade, the patient should be monitored closely by appropriately trained personnel in a setting equipped and staffed for cardiopulmonary resuscitation.

Eosinophilic Pneumonia: In clinical trials with VIVITROL, there was one diagnosed case and one suspected case of eosinophilic pneumonia. Both cases required hospitalization, and resolved after treatment with antibiotics and corticosteroids.

Similar cases have been reported in postmarketing use. Should a person receiving VIVITROL develop progressive dyspnea and hypoxemia, the diagnosis of eosinophilic pneumonia should be considered. Patients should be warned of the risk of eosinophilic pneumonia, and advised to seek medical attention should they develop symptoms of pneumonia. Clinicians should consider the possibility of eosinophilic pneumonia in patients who do not respond to antibiotics. Hypersensitivity Reactions Including Anaphylaxis: Cases of urticaria, angioedema, and anaphylaxis have been observed with use of VIVITROL in the clinical trial setting and in postmarketing use. Patients should be warned of the risk of hypersensitivity reactions, including anaphylaxis. In the event of a hypersensitivity reaction, patients should be advised to seek immediate medical attention in a healthcare setting prepared to treat anaphylaxis. The patient should not receive any further treatment with VIVITROL. Intramuscular Injections: As with any intramuscular injection, VIVITROL should be administered with caution to patients with thrombocytopenia or any coagulation disorder (eg, hemophilia and severe hepatic failure). Alcohol Withdrawal: Use of VIVITROL does not eliminate nor diminish alcohol withdrawal symptoms. Interference with Laboratory Tests: VIVITROL may be cross-reactive with certain immunoassay methods for the detection of drugs of abuse (specifically opioids) in urine. For further information, reference to the specific immunoassay instructions is recommended.

ADVERSE REACTIONS: Serious adverse reactions that may be associated with VIVITROL therapy in clinical use include: severe injection site reactions, eosinophilic pneumonia, serious allergic reactions, unintended precipitation of opioid withdrawal, accidental opioid overdose and depression and suicidality. The adverse events seen most frequently in association with VIVITROL therapy for alcohol dependence (ie, those occurring in ≥5% and at least twice as frequently with VIVITROL than placebo) include nausea, vomiting, injection site reactions (including induration, pruritus, nodules and swelling), muscle cramps, dizziness or syncope, somnolence or sedation, anorexia, decreased appetite or other appetite disorders. The adverse events seen most frequently in association with VIVITROL therapy in opioid dependent patients (ie, those occurring in ≥ 2% and at least twice as frequently with VIVITROL than placebo) were hepatic enzyme abnormalities, injection site pain, nasopharyngitis, insomnia, and toothache. Clinical Studies Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In all controlled and uncontrolled trials during the premarketing development of VIVITROL, more than 1100 patients with alcohol and/or opioid dependence have been treated with VIVITROL. Approximately 700 patients have been treated for 6 months or more, and more than 400 for 1 year or longer. Adverse Events Leading to Discontinuation of Treatment: Alcohol Dependence: In controlled trials of 6 months or less in alcoholdependent patients, 9% of alcohol-dependent patients treated with VIVITROL discontinued treatment due to an adverse event, as compared to 7% of the alcoholdependent patients treated with placebo. Adverse events in the VIVITROL 380-mg group that led to more dropouts than in the placebo-treated group were injection site reactions (3%), nausea (2%), pregnancy (1%), headache (1%), and suicide-related events (0.3%). In the placebo group, 1% of patients withdrew due to injection site reactions, and 0% of patients withdrew due to the other adverse events. Opioid Dependence: In a controlled trial of 6 months, 2% of opioid-dependent patients treated with VIVITROL discontinued treatment due to an adverse event, as compared to 2% of the opioid-dependent patients treated with placebo.

DRUG INTERACTIONS: Patients taking VIVITROL may not benefit from opioidcontaining medicines. Naltrexone antagonizes the effects of opioid-containing medicines, such as cough and cold remedies, antidiarrheal preparations and opioid analgesics.

USE IN SPECIFIC POPULATIONS: Pregnancy: There are no adequate and wellcontrolled studies of either naltrexone or VIVITROL in pregnant women. VIVITROL should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Pregnancy Category C: Reproduction and developmental studies have not been conducted for VIVITROL. Studies with naltrexone administered via the oral route have been conducted in pregnant rats and rabbits. Teratogenic Effects: Naltrexone has been shown to increase the incidence of early fetal loss when given to rats at doses ≥30 mg/kg/day (11 times the human exposure based on an AUC(0-28d) comparison) and to rabbits at oral doses ≥60 mg/kg/day (2 times the human exposure based on an AUC(0-28d) comparison). There was no evidence of teratogenicity when naltrexone was administered orally to rats and rabbits during the period of major organogenesis at doses up to 200 mg/kg/day (175- and 14-times the human exposure based on an AUC(0-28d) comparison, respectively). Labor and Delivery: The potential effect of VIVITROL on duration of labor and delivery in humans is unknown. Nursing Mothers: Transfer of naltrexone and 6-naltrexol into human milk has been reported with oral naltrexone. Because of the potential for tumorigenicity shown for naltrexone in animal studies, and because of the potential for serious adverse reactions in nursing infants from VIVITROL, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use: The safety and efficacy of VIVITROL have not been established in the pediatric population. The pharmacokinetics of VIVITROL have not been evaluated in a pediatric population. Geriatric Use: In trials of alcohol-dependent subjects, 2.6% (n=26) of subjects were >65 years of age, and one patient was >75 years of age. Clinical studies of VIVITROL did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects. No subjects over age 65 were included in studies of opioid-dependent subjects. The pharmacokinetics of VIVITROL have not been evaluated in the geriatric population.

Renal Impairment: Pharmacokinetics of VIVITROL are not altered in subjects with mild renal insufficiency (creatinine clearance of 50-80 mL/min). Dose adjustment is not required in patients with mild renal impairment. VIVITROL pharmacokinetics have not been evaluated in subjects with moderate and severe renal insufficiency.

Because naltrexone and its primary metabolite are excreted primarily in the urine, caution is recommended in administering VIVITROL to patients with moderate to severe renal impairment. Hepatic Impairment: The pharmacokinetics of VIVITROL are not altered in subjects with mild to moderate hepatic impairment (Groups A and B of the Child-Pugh classification). Dose adjustment is not required in subjects with mild or moderate hepatic impairment. VIVITROL pharmacokinetics were not evaluated in subjects with severe hepatic impairment.

OVERDOSAGE: There is limited experience with overdose of VIVITROL. Single doses up to 784 mg were administered to 5 healthy subjects. There were no serious or severe adverse events. The most common effects were injection site reactions, nausea, abdominal pain, somnolence, and dizziness. There were no significant increases in hepatic enzymes. In the event of an overdose, appropriate supportive treatment should be initiated.

This brief summary is based on VIVITROL Full Prescribing Information.

Information (rev. July 2013)

Information (rev.VIVITROL July 2013)are registered trademarks of Alkermes, Inc. ALKERMES and Manufactured marketed Alkermes, Inc. ALKERMES andand VIVITROL are by registered trademarks of Alkermes, Inc. ©2015 Alkermes, Manufactured andInc. marketed by Alkermes, Inc. All rightsAlkermes, reserved.Inc. VIV-002154 Printed in U.S.A. ©2015 All rights reserved VIV-002104 Printed in U.S.A. www.vivitrol.com

A Lifetime of Service Must be Appreciated.

Powerful chemotherapy medications and other hazardous drugs are used to treat many of our veterans. Studies have shown that long-term exposure to these drugs can seriously impact those preparing and administering them.* Closed System Transfer Devices (CSTDs) shield those on the outside from harmful exposure.

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Safe. Simple. Closed. *www.cdc.gov/niosh **Evaluation of syringes used for compounding hazardous drugs and the contamination risks to healthcare personnel, Nebraska Methodist Hospital, Department of Pharmacy Services

Taking Noninvasive Monitoring to New Sites and Applications ™

EMMA™ Portable, fully self-contained mainstream capnograph that requires no routine calibration and minimal warm-up time.1 EMMA provides end-tidal carbon dioxide (EtCO2) and respiration rate, and can be used in emergency field medicine applications.

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Masimo Patient SafetyNet™* Patient SafetyNet is a remote monitoring and clinician notification system which displays near real-time information from any connected Masimo device at a central station and allows for alarms and alerts from the bedside devices to be sent directly to clinicians via pager or 3rd party gateway to IP phones.

Important Information for Federal Medical Practitioners National Stock Numbers

Distribution and Pricing Agreement (DAPA)(SP00200-03-H-0008)

Federal Supply Schedule Contract (V797D-30127)

DoD MMESO/DMMPO Handheld Pulse Oximeter Joint Product of Choice (IA-MP-1104-23)

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, and precautions. * The use of the trademarks PATIENT SAFETYNET and PSN is under license from University Health System Consortium.

1

For complete specifications, including measurements, see Operator’s Manual.

© 2015 Masimo. All rights reserved.

STG-0123A/CO-023644

For more information, visit www.masimo.com or call 800-257-3810

A PROUD PARTNER SINCE 1996 For nearly 20 years, US Foods has been a partner with the U.S. Department of Veterans Affairs and military medical facilities across the United States.

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n Contents

An understanding of the military community’s needs is at the heart of United Concordia Dental. Our commitment is evidenced through the company’s: •

Experience serving the military community’s dental needs for more than 19 years

•

Dedicated Government Business Unit with functions managed by military veterans

•

Extensive network of more than 107,000 dentists at more than 331,000 locations

•

Innovative technological solutions to meet any need

■■ Interviews • INTERVIEW: Robert A. McDonald Secretary of Veterans Affairs ............................................................ 10

By John D. Gresham • I NTERVIEW: David J. Shulkin, M.D. VA Under Secretary for Health ......................................................... 54

By John D. Gresham • I NTERVIEW: Donna Gage, Ph.D., R.N. Chief Nursing Officer, Veterans Health Administration ....................... 112

By Chuck Oldham

■■ Special Section: VHA OFFICE OF RESEARCH AND DEVELOPMENT • INTERVIEW: Dr. Timothy O’Leary Chief Research and Development Officer, Veterans Health Administration, U.S. Department of Veterans Affairs ........................... 24

By Craig Collins

• V A RESEARCH: Mental Health and Suicide Prevention........ 32

By Craig Collins

•V A RESEARCH: Vision Loss ........................................................ 38

By Craig Collins

•V A RESEARCH: Heart Health..................................................... 43

By Craig Collins

Experienced Dedicated Committed

•V A RESEARCH: Alzheimer’s Disease ........................................ 48

By Craig Collins

For more information, visit www.unitedconcordia.com

Full Spectrum Infection Control Solutions The world’s fastest autoclave from Start to Sterile.

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Uses fresh steam distilled water with every cycle.

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BRAVO™ The BRAVO is a fractionated vacuum sterilizer that incorporates both pre-vac (to remove air) and post-vac (to ensure a dry load every time) cycles to ensure the perfect steam penetration for any load.

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The BRAVO 17V, with a 17 liter chamber, has a large vacuum pump and employs total cycle times, including drying, starting at just 19 minutes.

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The BRAVO 17V comes standard with 5 sterilization trays, increasing load capacity and office efficiency.

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The BRAVO 21V, with a 21 liter chamber, is a larger chamber autoclave allowing the sterilization of a 14” cassette. The BRAVO 21V has a top filling port as well as a front mounted master drain port, and an integrated USB port for data logging. The BRAVO 21V continues to employ total cycle times, including drying, starting at just 23 minutes.

SANAO™ Easy on the hand, SciCan’s SANAO handpieces are ergonomic wonders.

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HPS (Hygiene Protection System) - SciCan is known as “your infection control specialist” in the dental industry, and the SANAO line incorporates its Hygiene Protection System, an internal resin to help prevent material and debris from collecting inside the handpiece.

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HYDRIM® G4 Instrument cleaning has never been faster or smarter.

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The HYDRIM C61w G4 has a 6 full size cassette capacity, the largest of its kind, allowing offices to turnover 120 instruments in 35 minutes. Start to dry.

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The time saved by automated washing compared to ultrasonic cleaning is approximately 1 hour of labor for every nine procedural set-ups.

Power - With a motor that produces up to 3.5 Ncm of torque, procedures will take less time, the preparations will be more precise, making the dentist more efficient overall.

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n Contents ■■ Creating High-reliability Health Care

for Veterans ............................................................................ 67

By Robin R. Hemphill, MD, MPH and Gary L. Sculli, MSN, ATP

■■ VA & Military Health Benefits ........................................... 74

By J.R. Wilson

■■ 3-D Bioprinting

Many challenges remain for game-changing technology .................. 82

By J.R. Wilson

■■ PTSD Progress ...................................................................... 88

By Scott R. Gourley

■■ Prosthetic Advances.............................................................. 94

By J.R. Wilson

■■ Paralyzed Veterans of America........................................... 100

By J.R. Wilson

■■ New Hope for Patients with Spinal Cord Injury............. 106

By Gail Gourley

■■ The Ebola Epidemic and DOD’s Global

Health Engagement

How the 2014 West African Ebola response showcased the U.S. military’s infectious disease expertise.................................. 122

By Craig Collins

■■ Strategies to Fight Viruses and Multidrug-resistant

A university with Veteran roots

Doctor of Nursing Practice Eligible for VA benefits Primarily online • Post-Bachelors FNP • Post-Masters DNP

Find out more! va.rmuohp.edu

We also offer the following programs: • FNP Certificate

Post-Professional Doctorate in: • Speech-Language Pathology

Bacteria ................................................................................... 126

• Pediatric Physical Therapy

By Gail Gourley

• Health Sciences

■■ E mbracing Medical Simulation.......................................... 132

By Scott R. Gourley

■■ Military Exposures:

A New Era in Post-deployment Health.............................. 136

By Craig Collins

• Occupational Therapy

Online Masters in: • Health Sciences

va.rmuohp.edu

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1. Zelen CM, et al. Int Wound J. 2013 Oct;10(5):502-7.

2. Zelen CM. J Wound Care. 2013 Jul;22(7):347-8,350-1.

3. Zelen CM, et al. Wound Medicine. 2014 Feb;4:1-4.

4. Zelen CM, et al. Int Wound J. 2014 Apr;11(2):122-8.

5. Zelen CM, et al. Int Wound J. 2014 Nov 26. doi: 10.1111/iwj.12395.

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THE YEAR IN

2015-2016 Edition

VETERANS AFFAIRS

& Military Medicine Published by Faircount Media Group 701 North West Shore Blvd.

Tampa, FL 33609 Tel: 813.639.1900 www.defensemedianetwork.com www.faircount.com EDITORIAL Editor in Chief: Chuck Oldham Managing Editor: Ana E. Lopez Editor: Rhonda Carpenter Contributing Writers: Craig Collins, Gail Gourley, Scott R. Gourley, John D. Gresham, Dr. Robin Hemphill, Gary L. Sculli, J.R. Wilson DESIGN AND PRODUCTION Art Director: Robin K. McDowall Designers: Daniel Mrgan, Kenia Y. Perez-Ayala Ad Traffic Manager: Rebecca Laborde ADVERTISING Ad Sales Manager: Ken Meyer Account Executives: Bonnie Schneider, Jim Pidcock, Geoffrey Weiss, Kevin McTernan OPERATIONS AND ADMINISTRATION Chief Operating Officer: Lawrence Roberts VP, Business Development: Robin Jobson Business Development: Damion Harte Financial Controller: Robert John Thorne Chief Information Officer: John Madden Business Analytics Manager: Colin Davidson FAIRCOUNT MEDIA GROUP Publisher: Ross Jobson

©Copyright Faircount LLC. All rights reserved. Reproduction of editorial content in whole or in part without written permission is prohibited. Faircount LLC does not assume responsibility for the advertisements, nor any representation made therein, nor the quality or deliverability of the products themselves. Reproduction of articles and photographs, in whole or in part, contained herein is prohibited without expressed written consent of the publisher, with the exception of reprinting for news media use. Printed in the United States of America.

THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

INTERVIEW

Robert A. McDonald Secretary of Veterans Affairs

By John D. Gresham

Robert A. McDonald was nominated

by President Barack Obama to serve as the eighth secretary of Veterans Affairs, and was confirmed by the U.S. Senate on July 29, 2014.

Prior to joining the Department of Veterans Affairs (VA), McDonald was chairman, president, and chief executive officer of Procter & Gamble (P&G). Under his leadership, P&G significantly recalibrated its product portfolio; expanded its marketing footprint, adding nearly 1 billion people to its global customer base; and grew the firm’s organic sales by an average of 3 percent per year. This growth was reflected in P&G’s stock price, which rose from $51.10 the day he became CEO to $81.64 on the day his last quarterly results were announced – a 60 percent increase from 2009 to 2013.

During his tenure, P&G was widely recognized for its leader development prowess. In 2012, Chief Executive magazine named it the best company for developing leader talent. The Hay Group, a global management consulting firm, consistently cited P&G in its top-tier listing of the “Best Companies for Leadership” study. The company received recognition for its environmental and social sustainability initiatives, including receipt of the Secretary of State’s Award for Corporate Excellence for P&G’s operations in

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Pakistan and Nigeria. In addition, using the company’s innovative water purification packets, P&G committed itself to the 2020 goal of “saving one life every hour” by annually providing 2 billion liters of clean drinking water to people in the world’s developing countries.

An Army veteran, McDonald served with the 82nd Airborne Division; completed jungle, arctic, and desert warfare training; and earned the Ranger tab, the Expert Infantryman Badge, and Senior Parachutist wings. Upon leaving military service as a captain, McDonald was awarded the Meritorious Service Medal.

McDonald graduated from the U.S. Military Academy at West Point

in the top 2 percent of the Class of 1975. He served as the brigade adjutant for the Corps of Cadets and was recognized by The Royal Society for the Encouragement of Arts, Manufacturing, and Commerce as the most distinguished graduate in academics, leadership, and physical education. He earned an MBA from the University of Utah in 1978.

The secretary is personally committed to values-based leadership and to improving the lives of others. He and his wife, Diane, are the founders of the McDonald Cadet Leadership Conference at West Point – a biennial gathering that brings together the best and brightest young minds from the best universities around the world and pairs them with senior business, nongovernmental organization, and government leaders in a multi-day, interactive learning experience.

The recipient of numerous leadership awards and honorary degrees, in 2014 McDonald was awarded the Public Service Star by the president of the Republic of Singapore for his work in helping to shape Singapore’s development as an international hub for connecting global companies with Asian firms and enterprises.

McDonald and his wife are the parents of two grown children, and the proud grandparents of two grandsons.

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

THE YEAR IN VETERANS AFFAIRS AND MILITARY MEDICINE: Just a few years ago, you were at the very top of the American corporate leadership ladder, acting as chairman, president, and CEO of Proctor & Gamble (P&G), one of the most ubiquitous and trusted names in U.S. business. Then you got a call from President Barack Obama asking you to take over as secretary of the Department of Veterans Affairs (VA), which was, at the time, a troubled agency. What made you leave P&G to take the position? Did you have a personal mission in mind when you accepted the offer? And how much did your own military experience influence you toward taking the job?

SECRETARY ROBERT A. McDONALD: I very much appreciate the confidence of President Obama in this nomination and I’m fully committed to fulfilling this charge to me.

That is to transform the Department of Veterans Affairs into an organization that delivers on its mission. That mission is to fulfill President Lincoln’s promise to care for those who have borne the battle, and their families and survivors.

And by serving and honoring the men and women who are America’s veterans, we are also creating an organization that lives by its core values. Those values are integrity, commitment, advocacy, respect, and excellence.

My life’s purpose has been to improve the lives of others.

My time at West Point and as an Airborne Ranger captain in the 82nd Airborne Division instilled in me a lifelong sense of duty to country.

My values are steeped in my experiences at West Point and in the military. Those values are what allowed me to be an effective leader at the Procter & Gamble Company. And those values are what I bring to the management of VA. I am still guided by that West Point cadet prayer, which encourages us to choose the harder right rather than the easier wrong. For me, taking care of veterans is very personal. I come from and care deeply for military families. My father served in the Army Air Forces after World War II. My wife’s father was shot down over Europe and survived harsh treatment as a POW. Her uncle was exposed to Agent Orange in Vietnam and still receives care from the VA. And my nephew right now is in the Air Force flying missions over the Middle East.

My 33 years with Procter & Gamble taught me the importance of effective management, strong leadership, and of being responsive to the needs of customers.

I’m a forward-looking leader who spent my business career expanding P&G to serve new, emerging, and underserved customers. That’s the experience needed to modernize the VA. The department’s problems with access, transparency, and accountability and integrity have been well documented.

There’s a lot of work being done to transform the department.

It isn’t easy, but it is essential, and it can be achieved.

We’re putting the veteran at the center of everything that we do, consistent with our mission.

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My charge is to provide veterans the care that they have earned in the most effective way possible, and VA employees have joined me in reconfirming our commitment to VA’s mission and core values.

When you arrived at VA in 2014, the department was clearly in crisis. Without listing what critics said was wrong at the time, can you tell us what your top priorities were to deal with during your initial months on the job?

In short, the overarching priority was to set a vision for change that is not only veteran-centric, but also veterandriven. We mean to put veterans, our customers, in control of the VA experience.

That patient-centric, veteran-centric solution is called “MyVA.” It’s called “MyVA” because veterans should view VA as their organization – an organization that belongs to them and provides quality care and benefits in the ways they need and want to be served.

When I got here, I found immediately that we had to rebuild trust with veterans and all of our stakeholders, focus completely on veterans’ outcomes to improve delivery of our services, and set a course for long-term excellence and reform.

Three things really stood out to me that led to my top five priorities: The veteran is the center of all we do; you can’t separate the veteran experience from the employee experience; and that the VA can’t do this by itself.

Informed by this, we came up with five initial priorities: provide veterans with predictable, consistent, and easy access to the care they have earned; improve the employee experience to unleash the power they have to positively affect veterans; establish a performance improvement culture (what we call a “lean” culture) to ensure safety, quality, and agility in the organization to meet veterans’ needs; identify the common support services across the VA and deliver those with efficiency and effectiveness; and leverage the community by establishing strong strategic partnerships.

These five initial priorities work together to create a new state of mind for VA. While today VA has many great employees and areas of excellence, we need to create an environment where we consistently implement best practices. VA systems and processes will support this improved veterancentric culture, and employees’ behaviors toward veterans and fellow employees will improve.

You have often spoken, both during your time in industry and at VA, about having a “values-based” leadership style as your approach to dealing with challenges. What, in your opinion, does values-based leadership mean in real-world terms, and how are you promoting that at VA?

No organization can succeed without values to match its mission. Our mission at VA is to care for those “who shall 11

THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

have borne the battle,” their families, and survivors. When I arrived here, I found that VA had strong core values, but had lost sight of the veteran as the center of all it did, and didn’t realize it could not decouple the veteran’s experience from the employee experience. So, the first thing we did together was reaffirm those values – Integrity, Commitment, Advocacy, Respect, and Excellence – I CARE. On day one, I told our team that it was critical that all of us at VA reaffirm our commitment to our mission and our values. Veterans must know we are “all in” when it comes to accomplishing our mission and living by our values.

Since you arrived at the VA, clearly the “800-pound gorilla in the room” has been the backlog situation you inherited from your predecessor. As we sit here today, how is the department doing at reducing that backlog; how far have you come since you started; and do you think that the department will have eliminated it by the end of the present administration in January 2017?

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You know, the disability claims backlog dropped under 100,000 recently. The claims backlog has been reduced from a peak of 611,000 in March 2013 to 81,881 this week [Sept. 15, 2015], an 87 percent reduction – the lowest since we started measuring the backlog in 2007.

The disability claims inventory (total claims) also reduced from a peak of 884,000 in July 2012 to 369,352, a 58 percent reduction.

Average days pending for all claims is 103 days. Remember, disability backlog claims are those over 125 days.

How’d VBA [Veterans Benefits Administration] do it?

First, it’s thanks to our strong partnerships with veterans service organizations [VSOs].

They helped VBA complete a record-breaking 1.17 million claims in 2013. In 2014, [they] helped them beat that with another record year – 1.32 million claims.

And, thanks again to them and to dedicated VA employees, we’re on track to complete nearly 1.4 million claims by the end of this fiscal year.

I want anyone to tell me of another major part of the federal government that has transformed more in the last three years than VBA.

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U.S. DEPARTMENT OF VETERANS AFFAIRS PHOTO BY ROBERT TURTIL

■■ VA Secretary Robert A. McDonald addressed the 97th American Legion National Convention in Baltimore, Maryland, in September 2015. Here he meets informally with veterans at the convention.

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

This is real progress. But we still have veterans waiting too long, so we have more work to do.

The problems with VA’s mid- and senior-level were documented publicly before you arrived. After your first year on the job, do you feel that the administration and Congress have given you the legal authority and tools that you need to hire, fire, and move personnel throughout the department? And what else do you need to fully recruit, hire, and maintain oversight on the kind of management team that you want within the department?

A key principle of my management philosophy is what I call “sustainable accountability,” which means several things. [First], making sure your people understand the organization’s mission, values, and strategy. And as I talked about previously, the first thing we did is we had every employee recommit themselves to our mission and our values and we just redid that. And we’re going to do that every single year.

Second, setting realistic performance goals and providing our employees the resources to meet them.

Third, listening to employees’ concerns and helping them solve problems. That’s why in the over 200 visits I’ve done to different VA facilities, I hold a town hall meeting, talk to union leaders, listen to employees, [and] listen to veteran stakeholders, rewarding employees for good work and when all else fails, calling them to account for their misdeeds.

Now, I will tell you, VA has not operated that way in the past. It’s been managing to a budget instead of managing to requirements. And that’s put many people in positions of having to do more with less. Some responded by doing things that they shouldn’t have done, and we’re dealing with that.

We’ve proposed disciplinary action against some employees for access-related misdeeds.

We’ve repeatedly said that where wrongdoing is confirmed by our partner agencies such as DEA [Drug Enforcement Administration], FBI [the Federal Bureau of Investigation], and DOJ [Department of Justice], as well as local law enforcement, disciplinary actions will be pursued. One former VA employee was indicted by the Department of Justice. VA immediately terminated the Georgia VA employee’s access to all of VA’s systems and placed the employee on administrative leave. This employee now faces punishment that could be five years in jail and $250,000 for every [one] of [the] 50 charges that he’s under.

We’ve also proposed the removal of several senior executives. Some have been removed, fired. And two chose to retire before we took action on their firing.

Like the rest of the federal government, VA is facing severe financial restrictions, and possibly another round of sequestration, as a result of the

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Budget Control Act. As it stands right now, does the department have sufficient funds authorized from Congress to accomplish its mission? Or do you need to ask for additional funding to be able to fulfill this country’s obligations to its veterans?

Of course, to meet the challenges of the 21st century, VA will need adequate funding. The president’s 2016 budget request will provide the funding we need: $168.8 billion – $73.5 billion in discretionary funds and $95.3 billion in mandatory funds for benefits programs.

Some people in Washington are questioning the need for VA. Others have attempted to squeeze the needs of veterans within a “sequester” budget that artificially constrains the budget regardless of what it means to the programs we are trying to operate with VA and across the government.

The key to improving the veterans’ experience of VA is a customer-service approach. I call it the Platinum Rule.

You’ve heard the Golden Rule – treat others as you want to be treated. The Platinum Rule is treat others as THEY want to be treated. Their perspective is what counts.

From their perspective, we’ve already taken several MyVA steps to improve the veteran experience.

We’ve also brought aboard several key leaders with broad experience in business. Eleven of my 18 direct-reporting senior executives have joined VA since my swearing-in, and the entire leadership team is as committed as I am to making VA No. 1 in customer service.

We’re listening to veterans more, we’re listening to employees more, and together we are making lasting improvements at VA, so that in the future, veterans will say with pride, “That’s MyVA.” But we need the continued support of Congress, veterans, VSOs, and the American people to make the necessary changes to keep moving forward.

Obviously, VA is an agency that is all about delivering services to a focused customer base. Given the huge and varied personnel base that the department needs to maintain to succeed in its mission, how are you doing at recruiting and hiring new personnel across the enterprise to replace those lost to attrition and retirement?

Last year, we launched a national recruiting initiative to bring medical professionals into VA that we need to provide veterans with the high-quality care they have earned through their service.

Since then, I have gone from coast to coast recruiting these medical professionals.

We’re stepping up recruiting new personnel. We’ve hired over 38,000 people in the past year for a net increase of 12,000 new VHA [Veterans Health Administration] employees, 1,000 more physicians, and over 2,700 more nurses.

Relationships with academic institutions are vital to the work we do at VA.

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

U.S. DEPARTMENT OF VETERANS AFFAIRS PHOTO BY ROBERT TURTIL

■■ VA Secretary Robert A. McDonald speaks at the Analytics Summit in Crystal City, Virginia, held from June 29 through July 1, 2015. VA invited industry leaders and innovative minds from academia and across the public and private sectors to discuss how to collaborate to continuously yield accurate and actionable data-driven observations, leveraging information to improve VA’s products and services and engagement with veterans.

At VA, we have one of the most inspiring missions and the greatest clients of any health care system in the world.

There is no higher calling than caring for those who have served our nation in uniform.

We need the best doctors and nurses serving veterans – the best and brightest. That’s why [we are] looking into existing relationships and affiliations VA has with academic institutions and talking directly to medical professionals about joining us to fulfill our exceptional mission of caring for those who shall have borne the battle.

VA has three Nobel Laureates and seven winners of the Lasker Award. We are on the cutting edge of medicine.

VA pushed to increase pay for physicians and dentists coming to work at VA. This means an increase in pay of $20,000 to $35,000 annually for physicians and dentists who are providing care for veterans.

Thanks to the passage of the VA bill – the Veterans Access, Choice and Accountability Act – the loan repayment program has been expanded for medical providers.

This builds on our existing loan repayment and scholarship programs.

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In order to recruit and retain the highest quality medical professionals, VA needs to be competitive with other health care systems. Ultimately, that is how we provide the best care to our veteran patients.

What is the current state across the enterprise of your various hospitals, centers, and support facilities in terms of being able to maintain the existing facilities base along with updating and building required new facilities?

On average, enrolled veterans rely on VA for only 34 percent of their care. But if that percentage rises just 1 percentage point, only 1 percentage point, from 34 to 35 percent, the cost increase to the VA, the need for an increase in budget, is $1.4 billion. The more veterans come to us for care, the harder it is for us to solve the access problems, to balance supply and demand without additional resources. That’s the fundamental problem, and it’s only made worse by our aging infrastructure. Nine hundred VA facilities are over 90 years old and 1,300 are over 70 years old. And if we didn’t close the 17

THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

■■ VA Secretary Robert A. McDonald speaks during a Town Hall Meeting held Feb. 3, 2015 for VA employees in Washington, D.C. Participants included ranking members of the Senate Committee on Veterans Affairs (Chairman Johnny Isakson (R-GA); Ranking Member Richard Blumenthal (D-CT), and House Committee on Veterans Affairs (Chairman Jeff Miller (R-FL), Chairman; Corrine Brown (D-FL) Ranking Minority Member.

facilities gap now, we could be facing another access crisis in 20 to 30 years.

VA PHOTO BY MICHAEL L. MOORE

The VA has had the reputation of delivering some of the highest quality, state-of-the-art medical services to its customer base of any medical system in the United States. What is the current level and quality of care you feel that your facilities and personnel are delivering at present, what are you planning to do to improve on that, and can you also tell us about the role VA researchers, scientists, doctors, and technologists have had in producing some of the most cutting-edge medical knowledge, devices, and treatments in the world?

One thing I’ve learned since my confirmation as secretary is there is no substitute for the VA. Veterans need the VA, American medicine needs the VA, and Americans everywhere benefit from the VA. But what’s so special about VA health care? Well, VA’s health care is supported by three pillars. It’s a unique system that depends on the strength inherent in all three of these pillars: research, education, and clinical care.

VA researchers have made major contributions to medical science, earning three Nobel Prizes, seven Lasker Awards,

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many other awards, and many other recognitions. Among those achievements are the first implantable cardiac pacemaker, the first successful liver transplant, the first nicotine patch to help smokers quit smoking, multiple advances in prosthetics, traumatic brain injury, post-traumatic stress, spinal cord research – spinal cord research that no one else in the country does – groundbreaking strides. We invented the shingles vaccine, and it was a VA nurse that came up with the idea of using a barcode to connect patients with medicine and medical records.

This year, the VA will invest $1.8 billion in over 2,200 research projects involving nearly 3,400 VA researchers.

That research is what will help not just veterans, but American medicine, and a countless number of Americans who are not veterans.

We’re affiliated with many of the best medical schools and training programs in the country, over 1,800 educational institutions. This is a system that Omar Bradley set up in 1946-47 – it’s a great system. We train 120,000 health care professionals a year. That’s more than any other health care system in the United States – 62,000 medical students and residents, 23,000 nursing students, 33,000 students in other health care fields. We train an estimated 70 percent of all doctors in the United States, and we are the largest 19

THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

employer of nurses in the country. Who would do that work if there was no VA? VA researchers continue to receive awards for excellence like the ones you see here. For example, 26 years ago, Dr. Bill Bauman was an endocrinologist at the Bronx VA [James J. Peters VA Medical Center] when he hired Ann Spungen, an applied physiologist, to help test the respiratory functions of paralyzed veterans. When Bauman shared his dream of learning how spinal cord injuries caused many parts of the body to function poorly, Spungen quit her job to join that research.

In 2001, they established the National Center of Excellence for the Medical Consequences of Spinal Cord Injuries, where they and others have worked to improve the quality of life for paralyzed veterans.

Last year it was my honor to give Drs. Bauman and Spungen the Samuel J. Heyman Service Award, which is an award given to the federal government employees who make the biggest difference in the lives of others.

What do you want to tell our readers about the Department of Veterans Affairs that we have not asked you in our previous questions?

We’ve got great people at the VA. One-third of our employees are veterans. We operate almost 1,600 sites of care, serving 9.1 million veterans. Last year we completed over 55 million appointments for 6.6 million unique patients of the 9.1 million veterans that are signed up for VA health care. We’re a national leader in telehealth services, caring for 700,000 veterans through over 2 million telehealth visits in the last fiscal year.

We’re also a national leader in reducing hospital infections, down 68.6 percent since 2007, compared to down only 30 percent for non-VA hospitals.

Since 2004, the American Customer Satisfaction Index has showed that veterans give VA health care higher ratings than patients at most private hospitals.

We’ve extended hours by 880,000 appointments that we complete in the evenings and the weekends, and we’re doing this in virtually all of our facilities, because we don’t want veterans waiting for care. We’ve activated 80 new buildings to add 1.3 million square feet to our health care footprint, plus another 420,000 square feet in VA-owned properties.

We’re providing regular updates of patient access data, so you can see how well we’re doing. No private health care system is doing this; no private health care system wants to be measured by appointment wait times. This is not an accepted industry practice, but we’re doing it. Here are the results: seven million more appointments completed by VA or through VA in the community in the past 12 months. Ninety-seven percent of appointments are now completed within 30 days of the veteran’s preferred date. Eighty-eight percent are within seven days. Twenty percent are same-day appointments.

Of course, health care is just one of nine VA lines of business. Other lines include life insurance, mortgage insurance, 20

pensions, disability compensation, memorial affairs, and education. Now, we’ve got reasons to be proud in those areas, too.

We guarantee two million home loans a year, with the lowest foreclosure rate and highest satisfaction rating in the mortgage industry. For the past decade, the American Customer Satisfaction Index has ranked our cemetery system as the top customer service organization in the nation, public or private.

In the past two years, we’ve cut the disability claims backlog by about 80 percent. It peaked at 611,000 claims over 125 days in March of 2013; it’s now down to around 88,000 claims over 125 days. That’s the lowest it’s been in six years. And the average age of claims is already under our 125-day standard. How did we get there? Well, we fielded a new electronic system for handling claims. We hired more claims staff, and we’ve had them working mandatory overtime for much of the past four years.

We’ve also made a substantial dent in veterans’ homelessness, which has declined 33 percent from 2010 to 2014.

Ending veterans’ homelessness is a local effort, and so we’re working with over 2,000 partners all over the country. Over 700 civic leaders have accepted the first lady’s and the president’s Mayors Challenge to End Veteran Homelessness by the end of this year.

We’ve got 550 mayors who have signed up, eight governors, 151 county and city officials, and everywhere I go I meet with these people to make sure we have the plans in place. No veteran should ever have a night spent without a roof over their head.

The budget the president put forward will increase access to medical care and benefits for veterans. It’ll address the infrastructure challenges, including major and minor construction, modernization, and renovation. It will fund medical and prosthetics research, and it will address our IT infrastructure and modernization.

All of this is why I’m here, that’s why our partners and employees are here, and that’s why we need to press forward in putting veterans first.

We are listening hard to what veterans, Congress, employees, and VSOs are telling us. What we hear drives us to a historic, department-wide transformation, changing VA’s culture and making veterans the center of everything we do.

We want every employee working to improve the work, with the focus on how to improve our care for our veterans, and how to be better stewards of taxpayer money.

There’s so much more I could tell you about the work that we’re doing, more that we’ve accomplished, and more that we will accomplish in the coming months.

VA has the greatest opportunity to enhance care for veterans in its history. We have an opportunity not only to right the wrongs, but to lengthen our lead in areas where we’ve always excelled, take the lead in service delivery areas that are lagging, and chart new ground in emerging or evolving areas of health care.

But we need the continued support of Congress, of veterans, veterans service organizations, and the American people to make the necessary changes moving forward.

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(especially with calcification and surface irregularities) of the abdominal or thoracic

to avoid the potential risk of pacing lead perforation. There is an increased risk of

aorta, severe “unfolding” and tortuosity of the thoracic aorta; access characteristics

stroke in transcatheter aortic valve replacement procedures, as compared to

that would preclude safe placement of 14F or 16F Edwards eSheath introducer set,

balloon aortic valvuloplasty or other standard treatments. The devices are

such as severe obstructive calcification, severe tortuosity, or diameter less than 5.5

designed, intended, and distributed for single use only. Do not resterilize or

mm or 6 mm, respectively; or bulky calcified aortic valve leaflets in close proximity

reuse the devices. There are no data to support the sterility, nonpyrogenicity,

to coronary ostia.

and functionality of the devices after reprocessing. Incorrect sizing of the THV may lead to paravalvular leak, migration, embolization, and/or annular rupture.

Accelerated deterioration of the THV may occur in patients with an altered calcium metabolism. Prior to delivery, the THV must remain hydrated at all times and cannot be exposed to solutions other than its shipping storage solution and sterile physiologic rinsing solution. THV leaflets mishandled or damaged during any part of the procedure will require replacement of the THV. Caution should be exercised in implanting a THV in patients with clinically significant coronary artery disease. Patients with pre-existing mitral valve devices should be carefully assessed prior to implantation of the THV to ensure proper THV positioning and deployment. Do not mishandle the delivery system or use it if the packaging or any components are not sterile, have been opened or are damaged (e.g., kinked or stretched), or if the expiration date has elapsed. Use of excessive contrast media may lead to renal failure. Measure the patient’s creatinine level prior to the procedure. Contrast media usage should be monitored. Patient injury could occur if the delivery system is not un-flexed prior to removal. Care should be exercised in patients with hypersensitivities to cobalt, nickel, chromium, molybdenum, titanium, manganese, silicon, and/or polymeric materials. The procedure should be conducted under fluoroscopic guidance. Some fluoroscopically guided procedures are associated with a risk of radiation injury to the skin. These injuries may be painful, disfiguring, and long-lasting. THV recipients should be maintained on anticoagulant/antiplatelet therapy, except when contraindicated, as determined by their physician. This device has not been tested for use without anticoagulation.

Potential Adverse Events: Potential risks associated with the overall procedure including potential access complications associated with standard cardiac catheterization, balloon valvuloplasty, the potential risks of conscious sedation and/or general anesthesia, and the use of angiography: death; stroke/ transient ischemic attack, clusters, or neurological deficit; paralysis; permanent disability; respiratory insufficiency or respiratory failure; hemorrhage requiring transfusion or intervention; cardiovascular injury including perforation or dissection of vessels, ventricle, myocardium, or valvular structures that may require intervention; pericardial effusion or cardiac tamponade; embolization including air, calcific valve material, or thrombus; infection including septicemia and endocarditis; heart failure; myocardial infarction; renal insufficiency or renal failure; conduction system defect which may require a permanent pacemaker; arrhythmia; retroperitoneal bleed; AV fistula or pseudoaneurysm; reoperation; ischemia or nerve injury; restenosis; pulmonary edema; pleural effusion; bleeding; anemia; abnormal lab values (including electrolyte imbalance); hypertension or hypotension; allergic reaction to anesthesia, contrast media, or device materials; hematoma; syncope; pain or changes at the access site; exercise intolerance or weakness; inflammation; angina; heart murmur; and fever. Additional potential risks associated with the use of the THV, delivery system, and/or accessories include: cardiac arrest; cardiogenic shock; emergency cardiac surgery; cardiac failure or low cardiac output; coronary flow obstruction/transvalvular flow disturbance; device thrombosis requiring intervention; valve thrombosis; device embolization; device migration or malposition requiring intervention; valve deployment in unintended location;

Precautions: Long-term durability has not been established for the THV. Regular

valve stenosis; structural valve deterioration (wear, fracture, calcification, leaflet

medical follow-up is advised to evaluate THV performance. Glutaraldehyde may

tear/tearing from the stent posts, leaflet retraction, suture line disruption of

cause irritation of the skin, eyes, nose, and throat. Avoid prolonged or repeated

components of a prosthetic valve, thickening, stenosis); device degeneration;

exposure to, or breathing of, the solution. To maintain proper valve leaflet

paravalvular or transvalvular leak; valve regurgitation; hemolysis; device

coaptation, do not overinflate the deployment balloon. Appropriate antibiotic

explants; nonstructural dysfunction; mechanical failure of delivery system and/

prophylaxis is recommended post-procedure in patients at risk for prosthetic valve

or accessories; and non-emergent reoperation.

infection and endocarditis. Safety, effectiveness, and durability have not been

EDWARDS ESHEATH INTRODUCER SET AND EDWARDS CRIMPER Indications: The Edwards eSheath introducer set is indicated for the introduction and removal of devices used with the Edwards SAPIEN 3 transcatheter heart valve. The Edwards Crimper is indicated for use in preparing the Edwards SAPIEN 3 transcatheter heart valve for implantation.

Contraindications: There are no known contraindications.

Warnings: The devices are designed, intended, and distributed for single use only.

Do not resterilize or reuse the devices. There is no data to support the sterility, nonpyrogenicity, and functionality of the devices after reprocessing. The Edwards eSheath introducer set must be used with a compatible 0.035” guidewire.

Precautions: For the Edwards eSheath introducer set, caution should be used in vessels that have diameters less than 5.5 mm or 6 mm as it may preclude safe placement of the 14F and 16F Edwards eSheath introducer set, respectively. Use caution in tortuous or calcified vessels that would prevent safe entry of the introducer set. Do not use the Edwards eSheath introducer set if the packaging sterile barriers or any components have been opened or damaged. The Edwards eSheath introducer set temporarily enlarges to allow the passage of devices; ensure that the vasculature can accommodate the maximum diameter of the expanded sheath. When inserting, manipulating, or withdrawing the device through the expandable sheath, always maintain sheath position. When puncturing, suturing, or incising the tissue near the sheath, use caution to avoid damage to the sheath. For special considerations associated with the use of the Edwards Crimper prior to transcatheter heart valve implantation, refer to the Edwards SAPIEN 3 transcatheter heart valve Instructions for Use.

Potential

Adverse

Events:

Complications

associated

with

standard

catheterization and use of angiography include, but are not limited to, injury including perforation or dissection of vessels, thrombosis, and/or plaque dislodgement which may result in emboli formation, distal vessel obstruction, stroke, infection, and/or death. There are no known potential adverse events associated with the Edwards Crimper.

CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.

Edwards, Edwards Lifesciences, the stylized E logo, Edwards Commander, Edwards SAPIEN, Edwards SAPIEN 3, eSheath, SAPIEN, SAPIEN 3 and TFX are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. © 2015 Edwards Lifesciences Corporation. All rights reserved. PP--US-0056 v1.0

Edwards Lifesciences I edwards.com

One Edwards Way I Irvine, California 92614 USA

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

INTERVIEW

Dr. Timothy O‘Leary Chief Research and Development Officer, Veterans Health Administration, U.S. Department of Veterans Affairs

Dr. Timothy O’Leary, the Chief Research and Development Officer (CRADO) for the Veterans Health Administration (VHA), U.S. Department of Veterans Affairs (VA), oversees a research program that’s conducted at more than 100 VA medical centers around the nation, and which addresses a full range of health concerns affecting America’s veterans. The research program dates to 1925 and includes biomedical, clinical, rehabilitation, and health services research. Its investigators have earned three Nobel prizes, seven Lasker Awards, and numerous other national and international honors.

Dr. O’Leary’s career began during his undergraduate studies at Purdue University, where he majored in chemistry. He went on to earn a doctorate in physical chemistry from Stanford University and a medical degree from the University of Michigan. He conducted research for the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) before joining the faculty at the Armed Forces Institute of Pathology (AFIP), where he chaired the department of cellular pathology for more than 15 years.

Dr. O’Leary joined the VA in 2004, initially as director of Biomedical Laboratory Research and Development

24

(BLR&D), then director of BLR&D and Clinical Services Research and Development (CSR&D). In June 2014, he was named CRADO for VHA. His research interests include genomics, proteomics, and ultrasensitive detection of biological toxins. He is certified in anatomic pathology by the American Board of Pathology and in molecular genetic pathology by the American Board of Pathology and the American Board of Medical Genetics.

From 1979 to 2010, while he lived and worked in the Washington, D.C., area, Dr. O’Leary served as a reserve member of the Public Health Service Commissioned Corps, serving two tours on active duty.

He has served on numerous federal panels and advisory committees, including the Health and Human Services Clinical Laboratory Improvement Advisory Committee and the Food and Drug Administration Hematology and Devices Panel.

The holder of four patents, Dr. O’Leary has authored or co-authored more than 175 journal articles and numerous book chapters and technical reports. He is a past president of the Association for Molecular Pathology, and serves as editor-in-chief for its Journal of Molecular Diagnostics.

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U.S. DEPARTMENT OF VETERANS AFFAIRS PHOTO

By Craig Collins

THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

IMAGES BY US NATIONAL INSTITUTE ON AGING, ALZHEIMER’S DISEASE EDUCATION AND REFERRAL CENTER

THE YEAR IN VETERANS AFFAIRS AND MILITARY MEDICINE: The theme of this year’s VA Research Week, May 18-22, 2015, was “Celebrating 90 years of Research Excellence.” When you compare today’s program to that of 1925 or, say, the first few decades, what are some differences that illustrate important things about how VA research, and its interactions with other programs, have evolved?

DR. TIMOTHY O’LEARY: One of the differences that’s pretty clear is that in the early years, a much larger fraction of VA research was observational studies. These were very, very important observational studies – for example, the studies done in the cardiovascular research unit at the Washington, D.C. VA that looked at the early evolution of plaques in the arteries of veterans – younger veterans, in many cases. And then as the years went by, you saw an increasing focus on interventions to effectively treat. I’m thinking of things like the Freis study,1 which looked at the treatment of mild to moderate hypertension and showed that treating this was really good for reducing strokes and heart attack.

And now, while these types of studies go on, increasingly we’re seeing studies in which we’re comparing multiple ways of treating disease, where two or three different approaches have arisen, and we’re trying to see which is best.

An example – again, in cardiovascular disease – would be the COURAGE trial2 that was completed in the 2000s, in which coronary angioplasty plus optimal medical therapy was compared with optimal medical therapy alone for cardiovascular outcomes. And so we’ve got this evolution – which really goes along with the evolution of medical understanding in general, and of the way medical research is done – toward not only understanding interventions, but now that we do have effective interventions for many diseases, comparing them to see what’s best.

Another evolution that’s occurred over time has been the introduction, in

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■■ LEFT: PET scan of a normal human brain. RIGHT: PET scan of a human brain with Alzheimer’s disease. VA research into Alzheimer’s is extensive and multifaceted.

the last two decades, of research in health care delivery systems. The entire area of health services research was something that was very foreign to VA and to the health care community in general at the time that the VA research program got going 90 years ago. Starting in the latter part of the 20th century, VA was a pioneer in introducing health services research: Figuring out the best ways for the health system to deliver well validated medical therapies and to improve adoption of good medical therapies, as well as assessment of things like the cost effectiveness of medical therapy.

So it’s really kind of fun to see the maturation of the field, and at the same time to see that all these new technologies have come into medicine to improve diagnosis, starting in the early ’70s and ’80s with CT scanning and MRI becoming widely available and being brought together with other technologies for development.

One of the technologies that’s fascinated me has been, since the 1990s, the increasing penetration of genetic analysis into the understanding and treatment of cancer. In the early part of the 20th century – and in the 19th century – cancer was treated primarily

by surgery, and then in the mid-20th century physicians began using chemicals to poison cancer cells. Since 2000, we’ve recognized that you can look at genetic changes in cancer, and perhaps in other diseases, and target therapies to those specific changes – and get more effective treatment at lower cost. So it’s really an amazing evolution in medicine as a whole. And in many cases, VA has been at the leading edge of this transformation in medical research over the last 90 years.

And at the same time it’s begun to work more closely with other research institutions and programs.

Yes, and I think another evolution we’ve seen, really from the 1950s on, is increasing attention to those things that are specific consequences of military service. The first large multi-site trial done in the United States was a cooperation between VA and the Department of Defense on the treatment of tuberculosis in soldiers that had returned from the Second World War. And it showed that streptomycin was effective in treating this disease. This trial, followed by other trials that found yet other effective 25

THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

drugs, was a large part of the reason why the tuberculosis sanitariums that many of us saw as we were growing up in our communities have largely disappeared. This was later followed on by other large clinical trials, which were organized by VA, and which, in the 1960s, became the VA Cooperative Studies Program, which in turn provided a stable platform for the conduct of large multi-site trials.

As that platform was constructed, we see – and particularly over the last 20 years – increasing attention to things like post-traumatic stress disorder [PTSD], the treatment of traumatic brain injury, the long-term consequences of dealing with amputation. This is perhaps surprising, but it points to a post-Vietnam era evolution toward having this much stronger emphasis on those things uniquely related to service in the military, and uniquely related to service in combat, rather than simply being related to being a veteran who is eligible for care in VA. 26

But this growth hasn’t led us to neglect the issues associated with veterans we care for as they age. We consider having that broad research portfolio to be critical to assuring that we treat all the conditions veterans have in a scientifically and clinically meritorious way. But nonetheless it has been, it seems to me, a significant expansion.

And that expansion, over the last two or three years, has come to the point of very close collaboration and integration with the research program at the Department of Defense. And we routinely integrate our research programs in areas like traumatic brain injury and PTSD. We, in many cases, may plan studies together. When we don’t do that, we divide up the work, and more and more, although our focus is on different points in the lifespan, with theirs being on the activeduty military and ours being on the veteran coming out of military service, we do look at this as a continuum of research.

Both departments feel an obligation to make sure we view that

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U.S. ARMY PHOTO

■■ 4th Infantry Division soldiers descend the side of Hill 742, located five miles northwest of Dak To during the Vietnam War. Three major VA-funded studies to come out of the Vietnam War are yielding insights into the long-term course and consequences of PTSD.

THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

service member or veteran as a whole person who doesn’t fundamentally change when they take off the uniform for the last time. I think that’s a really good thing for service members and veterans, and a really good thing for the taxpayer.

Increasingly, too, we are engaging with the Department of Health and Human Services – predominantly the National Institutes of Health – to similarly balance and make sure that together our efforts cover the waterfront as well as we possibly can. And to the best I can tell, that was not a strong focus prior to a few years ago, and represents a really very recent evolution.

In addition to the examples you’ve already given from cardiovascular investigators, are there other particular focus areas that offer insight into the then-and-now of the VA research program?

I think research into topics related to aging and associated disorders, such as Alzheimer’s disease, has changed tremendously everywhere, and the research program in VA really is multifaceted. On the one hand, we have worked on things, such as the genetics of Alzheimer’s disease, which are very fundamental and general. But of course in response to the more recent conflicts, as well as to studies that VA investigators and others have done related to sport injuries, there is a lot of work aimed at determining how chronic low-grade trauma to the brain may lead to degenerative brain disease such as Alzheimer’s, and the development of a strong conjecture that chronic traumatic encephalography, an inflammation of the brain resulting from multiple episodes of trauma, can lead to cognitive decline. So again there’s been a shift in emphasis, with the consequences of military service, and of combat specifically, strongly influencing where we’re going.

Since the number of effective therapeutic interventions for Alzheimer’s is modest, this is also an area in which the clinical research program that addresses it is looking at an earlier phase than we did in the clinical COURAGE trial.

A good example of this kind of research was published by the VA Cooperative Studies Program in JAMA [Journal of the American Medical Association] in January 2014 on the effect of vitamin E and a drug called memantine on decline in Alzheimer’s disease.

I mentioned that there have been some genetic studies associated with Alzheimer’s disease. Another disease that some have related to military service is Lou Gehrig’s disease, ALS. As a result of that, VA has established a brain bank, collecting brains and spinal cords from veterans with ALS who volunteered to donate these after they died. VA investigators have done some very large studies on the genome of these patients with ALS, to try to understand genetic association. I can’t say that the work that has been done so far is providing a clear roadmap to how we treat ALS, but it does indicate, that as the technologies available to us are expanding, VA investigators are adopting them, trying them out and seeing whether they can help give us new insights into intractable

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problems that have sometimes, as in the case of ALS, been suggested to be of greater concern among veterans than in the general population.

VA’s 2009 study reported that 40 percent of Iraq and Afghanistan veterans enrolled to receive VHA care have at least one mental health diagnosis. So mental health is certainly a significant research concern. Has that always been the case?

There wasn’t a lot of emphasis on mental health at all back at the beginning of VA research. But you do see it beginning to show up early on in the 1950s and 1960s – and, in fact, studies done cooperatively by VA and the National Institutes of Health in the 1950s and early 1960s established the use of lithium for treating what we call bipolar disorder now. This was an amazing change, because at the time, mental health disorders were being treated primarily with psychotherapy.

The Freudian model had really taken hold. And while the initial work on lithium was not VA work – in fact it wasn’t even done in the United States – when this work was adopted and pushed to a larger scale by this cooperation involving the VA/ NIH collaboration, it really led to the understanding that yes, we can use drugs to effectively help people with mental illness. That also led to an explosion of research overall in what we call the discipline of biological psychiatry today.

Then, immediately after this, the Vietnam War occurs, and much more concern arises in VA about the returning veterans. They are suffering flashbacks and things of that sort, and they are talking about it to a much greater extent than the World War II generation had talked about it. And the result is that large studies begin to be done on what becomes known as post-traumatic stress disorder, to define first of all how frequent it is, the course of it, and how we treat it. And those topics over time came to be a major part of our research portfolio, understanding the causes and consequences of PTSD. There are three studies that we have funded coming out of the Vietnam War, and we’re now beginning to publish results that look at the long-term course and consequences of PTSD. One, called Health ViEWS, was a very large study that looked at health outcomes of about 5,000 women veterans of the Vietnam era. That doesn’t seem like a lot, in the context of women serving in the military today, but in terms of Vietnam, it was about half of the women who served overseas. A second, the Vietnam Era Twin Study, made it possible to begin to understand something about genetics in PTSD – in this case, the study design allowed one to find that PTSD is largely about combat exposure, but some of it is about genetic influence as well. Investigators could tell that by comparing identical twins with fraternal twins who served in combat A third study, funded at the same time, was the NVVLS, the National Vietnam Veterans Longitudinal Survey, which looked at outcomes in a large group of veterans, some of whom were not being taken care of by VA. 27

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

While all of this investigation into the background and the natural history of PTSD has been going on, there has also been work on therapy. One study that has had profound impact was a study by [Executive Director for the National Center for PTSD] Paula Schnurr, looking at the effect of cognitive processing therapy on PTSD and showing that this approach could be very effective in treating people with PTSD. It doesn’t help everybody. It doesn’t cure people, but it does reduce PTSD symptoms considerably. Interestingly, she focused on women who served in Vietnam, but other studies have grown into widespread adoption of cognitive processing therapy as a treatment for PTSD. And then since the adoption of that, a second therapy has become important and supported by evidence, called prolonged exposure. Now VA is undertaking a study to again compare these two established therapies to find out: Is prolonged exposure better? Is cognitive processing therapy better? Is one better for some people and the other better for other people? So it’s going through this evolution.

We’ve also studied the use of drugs for treating PTSD – but those studies have not yielded good pharmacologic interventions, so there’s a need to understand better what is happening in the brain in PTSD. And that’s being pursued in several different ways. One is studies using functional imaging technologies to see what communication looks like in PTSD. Investigators are using all sorts of technologies. Some of them are using something called functional magnetic resonance imaging. Apostolos Georgopoulos in Minneapolis has used something called magnetoencephalography, to look at communication pathways. And on the more basic side of things, a study building upon the Million Veteran Program has begun to look at the genetic heterogeneity, the actual gene changes, that may be associated with PTSD, building upon the Vietnam Twin study that showed there is a genetic influence.

The Million Veteran Program (MVP) is in its fourth year now, and has recruited more than 388,000 participants.

It’s been suggested that it served, in some ways, as a model for the NIH’s Precision Medicine Initiative (PMI), announced at the beginning of the year by President Barack Obama. How are the MVP and PMI related?

The Million Veteran Program is already the largest epidemiologic cohort ever seen in the United States, and by this time next year, we’ll be at about half a million. We’ve actually shown that in the United States, you can create a large cohort of volunteers that are willing to participate in this kind of research, and we’ve provided at least one model by which it can be done.

That model is one in which not only you interact with veterans at the time that they initially agree to become a part of the study; they also agree to allow us to take information developed over time, from their electronic health records, and relate it back to information about their genome.

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The NIH has also proposed a million-person cohort for its database and is really building on the concept that we’ve shown can be achieved – getting information from electronic health records from a broader group of Americans and moving forward. That initiative and ours have a lot of places where there is complementarity. I think we have a clear commitment to be able to exchange data for those veterans that wish to participate in their cohort and for us to be able to learn from veterans that may be participating in the NIH cohort but aren’t receiving care within VA. I think there’s also a developing likelihood that we’ll be helping the Department of Defense to create a framework for looking at precision medicine in the care of soldiers, sailors, airmen, and Marines. As I said, we’re serving the same people at different points in their lives. We also recognize there are things the NIH Precision Medicine cohort can do that we can’t, and vice versa. The NIH Precision Medicine cohort will have a much larger faction of women. We are only enrolling from our health care system, so to enroll 500,000 women in the Million Veteran Program would be an unrealistic expectation. But for a broad population cohort in the United States, enrolling 500,000 women is quite feasible. So there are questions they’ll be able to ask about women’s health that we won’t be as able to ask.

At the same time, we and the Department of Defense are interested in understanding what predisposes bad outcomes from traumatic brain injury or what predisposes combat-associated PTSD. We’ll be able to answer that question through the Million Veteran Program; that question will have a sufficiently large population of people exposed to military hazards to answer many of the questions we have.

Our efforts, I think, are beautifully complementary. We’re currently involved in the planning activities for the NIH Precision Medicine cohort, deeply involved with the White House staff trying to implement the president’s vision.

So what kind of innovations or advances do you think VA Research will be celebrating 90 years from now?

We have three really major thrusts or strategic directions we’re pursuing now. One of them is this movement toward genomics and precision medicine, and the Million Veteran Program is an important part of that. The movement from pure research into the clinical applications of genomics will be an important thrust going forward. At this point, we’re in the discovery phase, and one of our strategic directions is obviously to move from discovery to practical implementation.

Both for genomics and for other health care divisions, the use of informatics in high-performance data mining, hypothesis testing, and communications capabilities is a really, really important topic. We have a health care system, but like health care in the United States in general, we implemented electronic health records in the field some time ago in a way that was neither consistent nor homogeneous. The result is 29

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

PHOTO BY CPL. SARAH CHERRY

■■ The VA Office of Research and Development closely coordinates efforts with the Department of Defense in research programs devoted to PTSD, traumatic brain injury, mental health, and suicide.

that it takes some effort for VA researchers gathering health data from different parts of the health care system to make sure they’re looking at exactly the same thing. Researchers involved in our VINCI [VA Informatics and Computing Infrastructure] program are working to create a platform that basically cleans up the data, so that whether it comes from Palo Alto or it comes from Boston, it means exactly the same thing.

So VA researchers are discovering efficient and robust ways of pulling in information from the 150 medical centers, and nearly a thousand outpatient clinics and vet centers in VA. Those lessons will extend beyond VA to the nation. At the same time, they also use tools which make it possible to feed the genomics program with information about health care and health care outcomes for people participating in the Million Veteran Program and allow health services researchers to get a much better handle on what is going on across VA. The final strategic thrust is mainly in the area of interagency collaboration and cooperation. When I say we have a tight interaction with the Department of Defense, I mean we communicate multiple times a day. As the Precision

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Medicine Initiative develops, I think we’ll develop the same kind of tight interaction with our colleagues at Health and Human Services. We all have data and information we can use to help each other. Talent is sometimes uniquely available in one place or another. So we need to work more effectively as a government to solve these problems we face together – which doesn’t take away from our mission of serving veterans. Indeed I think it enhances it – and at the same time enhances the efforts of our colleagues in the Department of Defense to serve the active-duty and dependent and retiree population, and HHS’ efforts to serve the broader American population.

Edward Freis’ 1964 VA Cooperative Study on Antihypertensive Agents, a five-year study launched in 1964, earned Dr. Freis the 1971 Albert Lasker Clinical Medical Research Award, “For his demonstration of the life-saving effectiveness of drugs in the treatment of modern hypertension.”

2 The COURAGE Trial results were reported in the April 12, 2007 issue of the New England Journal of Medicine.

1

31

THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

VA RESEARCH:

By Craig Collins

n MORE THAN A QUARTER OF ALL AMERICANS experience a diagnosable mental health disorder in any given year, and a 2009 Department of Veterans Affairs (VA) study revealed that nearly 40 percent of Iraq and Afghanistan veterans enrolled to receive VA health care have at least one mental health diagnosis. This prevalence, and the variety and interrelatedness of many mental health conditions, have made mental health an area of particular focus for VA research in recent years.

32

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U.S. AIR FORCE PHOTO ILLUSTRATION/AIRMAN 1ST CLASS COREY HOOK

Mental Health and Suicide Prevention

THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

Philip Harvey, Ph.D., a health sciences researcher at the Miami VAMC and director of the Division of Psychology at the University of Miami Miller School of Medicine, has spent much of his career investigating debilitating mental health issues – including schizophrenia, for which about 100,000 veterans receive treatment at VA centers, and bipolar disorder, which affects about 120,000 Veterans Health Administration (VHA) patients. Though neither disorder is service-related, VA devotes considerable resources to discovering and dis- veterans are nevertheless at a higher risk for them, relative to seminating information about the causes and treatments of the population as a whole. mental health disorders: “Both [of these illnesses] are associated with very high levels • About a third of the 19 Centers of Innovation (COINs) of everyday disability across multiple domains: social, vocafunded by the VA’s Health Services Research and Development tional, and residential,” said Harvey. Schizophrenic patients Service (HSR&D) are focused on mental health and related encounter a disability rate of about 80 percent across those issues. domains, and those with bipolar disorder, a rate of about 60 • Within HSR&D, two Quality Enhancement Research percent. This level of impairment significantly reduces the Initiative (QUERI) programs – the Mental Health QUERI, quality of life for patients, and contributes greatly to overall coordinated in Little Rock, Arkansas, and the Substance Use costs of care.

Disorder QUERI, coordinated in Palo Alto, California – are In an attempt to identify possible genetic markers, not only dedicated to improving access to care and outcomes among for susceptibility to these diseases themselves but for other veteran patients. mental health conditions, Harvey led a recently completed • At VA Medical Centers (VAMCs) around the country, cooperative study of 9,500 veterans with a diagnosis of schizo15 Mental Illness Research, Education and Clinical Centers phrenia or bipolar disorder who were seen at 26 sites over a (MIRECCs) and Centers of Excellence (CoEs) conduct period of three years. In the largest genetic study of mental mental health research and help practitioners implement the illness conducted to date, each participant was extensively discoveries of VA investigators. genotyped and assessed for cognitive functioning, as well as VA investigators, who worked on a total of 539 funded for other illness-related variables such as PTSD, depression, research projects in FY 2014, study mental health issues or suicidality. The genomic data gathered over that period, from the molecular level to outcomes within the entire said Harvey, will help sort out whether disability and coghealth care system. VA’s mental health research topics nition – which look very similar among people with bipolar include addictive disorders; anxiety disorders; dementia, disorder and schizophrenia – share a genetic underpinning. cognitive and memory disorders; mood disorders; neuro“In terms of relevance to veterans, we’re very interested biology of mental illness; traumatic brain injury (TBI); psy- in figuring out, once genomic contributors are discovered, chotic disorders; post-traumatic stress disorder (PTSD); whether or not interventions can be tailored to people based sleep disorders; suicide; and mental health services on their genome,” Harvey said. delivery. Many of these topics are prioritized in response Harvey and colleagues have also recently completed a to the National Research Action Plan (NRAP), estab- clinical trial comparing the comparative efficacy of treating lished in 2013 to foster collaboration and streamlining in schizophrenic patients – veterans and nonveterans alike the mental health research of the – with a computerized cognitive Departments of Defense, Veterans remediation therapy intervention, Affairs, Health and Human or a more structured (and more Services, and Education. expensive) psychosocial interven■■ One of the tion, or both, to improve real-world functioning. The combined interchallenges in MENTAL ILLNESS AND COGNITION vention, the study revealed, yielded determining causes One of the challenges in detersignificant functional improveof and treatments for mining causes of and treatments for ments that lasted – and actually mental health disorders is that their improved, 12 weeks after the intermental health disorders symptoms or associated conditions vention was completed. is that their symptoms often overlap, and make it difficult Harvey – who last year became or associated conditions to determine whether they are tied the first psychologist to be awarded to one or the other, or both. Many the prestigious John Blair Barnwell often overlap.

VA investigators confront the task of Award, the highest honor for sciendisentangling these associations. tific achievement presented by the ■■ OPPOSITE: Suicide is the most preventable form of death, and the Department of Veterans Affairs and Department of Defense are conducting intensive efforts toward suicide prevention, including several research programs.

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Clinical Science Research and Development division of the VA’s Office of Research and Development – hopes to build on these studies with what he describes as, “a big VA-wide trial where you take people both with schizophrenia and with bipolar disorder, do this intervention, and also collect genomic information from them that we could then link back into the genomics of cognition we’re going to be examining in our big VA study. We’re very interested in expanding this.”

SUICIDE PREVENTION: IDENTIFYING RISK

Among the future benefits of the large-scale genomic study, Harvey said, may be the ability to compare the genomics of suicidality among veterans with schizophrenia and bipolar disorder. “What we discovered,” he said, “was that 68 percent of the veterans with bipolar disorder and 62 percent of the veterans with schizophrenia actually either had a suicide attempt or serious suicidal ideation at some point since they were diagnosed with their illness.”

In 2007, VA and several partners launched an intensive suicide prevention effort, aimed at both quantifying the problem and reducing suicide among veterans, in part by expanding 34

access to care. The clinical support system and surveillance network established through this effort has yielded data that researchers and clinicians are examining to determine if current suicide prevention programs are having an effect, whether gaps exist in access or results, and where there’s room for improvement.

VA researchers recently launched the Behavioral Health Autopsy Program, led by Dr. Janet Kemp of the Center of Excellence for Suicide Prevention at the Canandaigua, VA Medical Center in New York. Using death records provided by 11 participating state governments, program investigators continue to interview family members of the deceased and examine primary care medical records. “This is an organized effort to try to get as much information as we possibly can on veterans who died by suicide,” said Dr. Ken Conner, director of the CoE for Suicide Prevention, “in order to understand if and what gaps in care there might have been, or signs that they might have been at risk, as well as to help really characterize the struggles that people who take their own lives are having.”

Dr. Steven Dobscha, a psychiatrist at the VA Portland Health Care System in Oregon and director of HSR&D’s Center to Improve Veteran Involvement in Care (CIVIC), said that some of the most significant questions to emerge

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PHOTO COURTESY OF THE VETERANS HEALTH ADMINISTRATION

■■ The Mental Health Quality Enhancement Research Initiative (QUERI) program is coordinated from the John L. McClellan Memorial Veterans Hospital in Little Rock, Arkansas.

THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

PHOTO BY CPL. SARAH CHERRY

■■ Dr. Steven Dobscha, a psychiatrist at the VA Portland Health Care System and director of HSR&D’s Center to Improve Veteran Involvement in Care (CIVIC), is leading a clinical trial of Virtual Hope Box, a smartphone application, as an accessory to treatment.

The app was developed by the National Center for Telehealth and Technology (T2) at Joint Base Lewis-McChord, Washington.

concern the primary care veterans receive prior to suicide.

“We’re particularly interested in primary care,” he said, “because it turns out . . . probably half of veterans who die by suicide have contact with some type of clinician in the month prior to death – and less than half of these contacts are with mental health clinicians.”

His program’s analyses of health care records, said Dobscha, reveal that veterans who died by suicide had very high rates of depression and substance abuse disorders – which weren’t surprising. But the records also suggested, Dobscha said, “that anxiety disorder other than PTSD and functional decline were two variables that were fairly strong predictors of death by suicide. You’ll hear a lot about primary care providers detecting and treating depression when people endorse suicidal ideation, but there has not been quite as much emphasis in primary care on detection and treatment of anxiety disorders and on helping people cope with functional decline over time.”

VA researchers also recently completed a qualitative study – essentially, asking veterans to describe the experience of undergoing brief standardized suicide risk assessments – that has yielded two important insights: First, that veterans often don’t disclose suicidal ideation due to the sense that doing so will stigmatize them as weak. Second, said Dobscha,

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“they’re much more likely to talk about having suicidal ideation when they have a trusting relationship with a provider.

What this suggests is that the clinician who knows the patient best, and ideally who has an ongoing relationship with the patient, should be the one doing this suicide risk assessment, and probably not another staff member or person who doesn’t really know the veteran.”

SUICIDE PREVENTION: INTERVENTION AND TREATMENT

The data gathered through VA’s suicide prevention initiatives inform the design of new risk assessments and interventions. Because most veterans are not in mental health treatment at the time of suicide, the CoE for Suicide Prevention has adopted what Conner calls a “public health philosophy of suicide prevention. We prioritize interventions that cut across conditions, the things that are very common in veterans but nevertheless confer risk for suicide.” A growing body of research, for example, suggests that conditions such as sleep disturbance and pain increase risk for suicide – a finding that has significant implications for future intervention in primary care.

“We also prioritize interventions that can reach a large population of veterans,” said Conner. “We’ll try to go to 35

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

veterans who might be at risk, rather than simply rely on their coming to us.” HSR&D has funded a pair of such studies, both focused on primary care and led by Dr. Wilfred Pigeon, the CoE’s chief of Clinical Research, and Dr. Jennifer Funderburk of the VA’s Center for Integrated Healthcare. The first, a pilot study, tests whether a cognitive behavioral therapy intervention for insomnia has any effect on suicidal ideation; the second is a full-scale trial examining the efficacy of behavioral activation treatment for depression and suicidality.

Expanding the reach of suicide prevention efforts beyond the mental health care setting is a recurring theme in VA research: Conner is collaborating with Dr. Tracy Stecker, a psychologist at the White River Junction VAMC in Vermont, on a trial examining the effectiveness of a telephone intervention treatment for veterans who call the national Veterans Crisis Line and are experiencing suicidal ideation. At the Portland VAMC, Dobscha, in a study funded by the Military Suicide Research Consortium, is leading a randomized clinical trial of a smartphone application, the Virtual Hope Box, as an accessory to treatment. The application was developed by the National Center for Telehealth and Technology (T2) at Joint Base Lewis-McChord, Washington.

While much VA research is focused on identifying and reducing suicide risk in primary care and other nonmental health care settings, many veterans, already known to be at a high risk for suicide, receive services at VA mental health centers – and substantial clinical research is aimed at preventing suicide among these veterans. Dr. Peter Britton, a psychologist and investigator at the CoE for Suicide Prevention, is currently evaluating the efficacy of an intervention, called motivational interviewing, that he’s adapted to help psychiatric inpatients choose life and treatment over suicide.

“People who are thinking about suicide are often ambivalent,” Britton said. “They obviously have reasons for

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■■ Dr. Peter Britton, a psychologist and investigator at the CoE for Suicide Prevention.

thinking about suicide – but they also have reasons for why they haven’t made an attempt yet, why they called 911, why they’re on the inpatient unit.” Inpatient facilities offer an opportunity for treatment, said Britton, “but my concern was that if people are in so much pain that they’re thinking about killing themselves, where are they going to find the energy and motivation they need to engage in treatment?”

Britton’s intervention is composed of three sessions aimed at exploring veterans’ values, beliefs, and reasons for living – and ultimately using that information to help patients commit to life-enhancing and life-sustaining activities, such as treatment. The efficacy of this treatment will be measured in two ways: the severity of suicidal ideation afterward, assessed at one, three and six months; and the veteran’s continued engagement in treatment after discharge from the inpatient facility.

Another clinical trial – a large-scale, three-year effort to study 1,800 veterans from 28 VA medical centers – will be launched in the summer of 2015 to study the effects of the drug lithium on suicidal ideation. According to study chair Dr. Ira Katz, a psychiatrist and

senior consultant for the VA’s Office of Mental Health Operations, the idea that lithium might affect suicidality isn’t new.

Twenty years of observational studies, he said, have suggested a trend ripe for study: “Among patients with bipolar illness, manic-depressive illness, and possibly among patients with depression, individuals treated with lithium seem to have lower suicide rates than people treated with other medications or other combinations of medications.”

It’s an old hypothesis that hasn’t been tested in a clinical trial yet – but the VA offers a unique opportunity to recruit participants, Katz said. “In VA, we have an incredibly well-organized health system with an infrastructure of suicide prevention coordinators, and a hotline, and ongoing communications about issues like suicide. It means we’re the only system that has a shot at being able to do this study.”

There’s a reason much of VA’s suicide prevention research is aimed at reaching veterans where they are, and at getting them into treatment whenever possible: Evidence suggests its mental health services have helped stem overall increases in veteran suicide rates. A study reported in the spring of 2015 by Dr. Claire Hoffmire of the CoE for Suicide Prevention found that the suicide rates among veterans who used VHA mental health services is lower than among veterans who didn’t.

Over the past eight years, according to Katz, as the VA’s program in suicide prevention has gained momentum, the suicide rates among VHA patients have remained more or less the same.

Because suicide rates among other groups in the United States – especially among middle-aged men and veterans who don’t use VHA services – have increased significantly over those years, this relative stability suggests the VA’s efforts may be having a mitigating effect. “Nevertheless,” said Katz, “the fact that the rates haven’t come down is a real call for action and a reason why VA has to do more – and hence a major investment in research in suicide prevention in our system.”

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■■ Staff Sgt. Amanda Bower, 97th Air Mobility Wing safety technician, tests her eyesight using a visual acuity eye chart during the 2nd annual Wellness Exposition at the Freedom Community Center, Altus AFB, Oklahoma. Some 1.5 million veterans live with vision impairment, and younger victims of TBI often experience some vision loss among their other symptoms.

VA RESEARCH:

Vision Loss

By Craig Collins

AIRMAN 1ST CLASS MYLES STEPP

n TO AN OUTSIDER, the numbers may be surprising: About 167,000 veterans are legally blind, and about 285,000 have glaucoma, a disorder in which increasing fluid pressure inside the eye causes the gradual loss of sight. Overall, the VA estimates that as many as 1.5 million veterans live with vision impairments that interfere with everyday functioning.

The VA’s vision loss research program seeks to answer questions about how best to meet the needs of these veterans: to help improve vision by repairing or replacing damaged organs and tissues; to restore function to those living with vision loss; and, when possible, to prevent vision loss before it occurs.

For the vast majority of veterans who suffer vision loss, little can be done to reverse or treat damage once it has occurred.

Many VA researchers focus on the delivery of vision care itself – how it can best be administered to optimize outcomes and help patients make the most of their remaining sight.

Dr. Joan Stelmack, who was named 2014’s VA Optometrist of the Year by the Armed Forces Optometric Society, has been a VA clinician and researcher for 31 years, currently at the Edward Hines, Jr. VA Hospital in Hines, Illinois. Her work focuses on veterans with low vision: a term used to refer to visual impairment that’s not correctable with medicine, surgery, or glasses or contact lenses. “Low vision rehabilitation involves providing patients with vision enhancing and assistive devices,” Stelmack said. “They’re taught new strategies and adaptations to improve their ability to function independently, despite impaired vision. So the goal of the research program I’ve been involved in here at Hines is to measure the outcomes of low-vision rehab programs in the VA system, and to provide an evidence base to guide clinical care and service delivery.”

Stelmack has led two large-scale clinical trials of low-vision rehabilitation programs within the VA. The VA Low Vision Intervention Trial (VA LOVIT), reported in 2008, validated the outpatient model for treating low vision, and provided a low-cost model for expanding outpatient services at VA centers. A second trial currently underway, VA LOVIT II, conducted among 330 patients at nine different VA centers, is comparing the effectiveness of two types of treatment in the VA continuum of care: basic low-vision care, where the patient undergoes an optometry examination and is prescribed a lowvision aid such as a hand-held or electronic magnifier; and interdisciplinary care, where the patient also receives therapy

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and homework assignments that provide instruction in the use of devices and in the use of remaining vision.

Stelmack is at work now on a pilot study designed to improve outcomes for an increasingly older population of veterans, many of whom have cognitive impairments. “When I first came to VA,” she said, “my average patients were in their 60s. Today, I cannot tell you how many patients I see in their 90s. It’s a totally different population, and we have to change our service delivery to be most appropriate to the patients that we serve.”

At the VA Rehabilitation Research and Development Service’s Center for the Prevention and Treatment of Visual Loss in Iowa City, Iowa, investigators focus on strategies to maximize early detection, and possibly prevention, of vision loss. According to Dr. Randy H. Kardon, who directs the center, one of the biggest obstacles to early detection is simply access to an eye clinic; many veterans who live in rural areas, or who have limited mobility, may not have contact with an eye care professional before the progression of a disorder – diabetic retinopathy, glaucoma, or macular degeneration, for example – has gone too far to be treatable.

The center is also developing ways to monitor eye functioning remotely – for example, an objective functional test of the pupillary light reflex (PLR) that can be performed using a small portable device. Such a device could be used by veterans in their own homes, said Kardon: “They could test and monitor their own visual function longitudinally over time, to see whether treatment for some of these common disorders is on track, or whether the treatment needs to be changed or be more aggressive.”

Evaluations of these remote devices have suggested a new line of research for the center’s investigators, Kardon said: Veterans who have suffered head trauma display an abnormal PLR in the acute phase, and over the longer term, imaging devices often reveal a loss of nerve fibers in the retina after a concussion. “There is a concern about whether there is any progression of neurologic and visual deficits even after the injury has happened,” said Kardon. “So we’re studying this in veterans over time with recent funding, to see whether there is evidence for progression using the eye and the visual system as a window onto the brain.”

INSIDE THE EYE

■■ Because so little is known about how visual injury can occur to an eye that has suffered no overt damage, VA’s Office of Research and Development funds biomedical and clinical studies aimed at unraveling the connections between injury and vision loss.

Investigators at the Center for the Prevention and Treatment of Visual Loss are developing tools that can deliver vision care more easily and closer to home – for example, with sophisticated imaging devices that can be used without any special training by technicians in outpatient clinics. The devices take known imaging technologies – a retina camera, for example, used to image the retina and the optic nerve; or optical coherence tomography (OCT) – and add a layer of software. “We’re trying to develop software tools that would automatically analyze the imaging and say whether the person needs to be seen in the near future or urgently by a VA medical center or an eye specialist,” said Kardon. “The device would be useful not only for diagnosis of disorders, but also for following the course and monitoring treatment of these different disorders.”

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The findings of investigators at the VA’s Center for the Prevention and Treatment of Visual Loss are consistent with those found by other VA researchers. In a study reported in the New England Journal of Medicine in 2011, Dr. Glenn Cockerham, an ophthalmologist and researcher with the VA Palo Alto Health Care System, reported that among a group of Afghanistan and Iraq veterans who had sustained blastinduced traumatic brain injury (TBI), 43 percent had also suffered internal injuries to the eye that might have gone undetected in a functional examination. Many veterans with blast-related vision loss don’t report any trouble seeing until three or four months after the initial injury.

Because so little is known about how visual injury can occur to an eye that has suffered no overt damage, VA’s Office of Research and Development funds biomedical and clinical studies aimed at unraveling the connections between injury and vision loss. In early 2015, Dr. Steven J. Fliesler, research health scientist at the VA’s Western New York Healthcare System, and Meyer H. Riwchun Endowed Chair Professor, vice-chairman and director of research of ophthalmology at the State University of New York/University at Buffalo Jacobs School of Medicine and Biomedical Sciences, launched the Buffalo VA’s first study into the effects of blast overpressure, or the shock waves generated by an explosion, on the eye.

In a preliminary examination of the eyes of rats that had undergone experimental blast injuries, Fliesler noted molecular changes in retinal cells that indicated a degenerative process likely caused by oxidative stress – essentially, a failure to detoxify the effects of free radicals within cells. “That’s when I started thinking we should be looking at this in more detail,” said Fliesler. Fliesler’s study, using a novel rat model

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

VA PHOTO BY CURT CAMPBELL

■■ Improving the lives of war-injured veterans research at the VA Palo Alto Health Care System has led to improved eye examination and treatment for veterans who have sustained a TBI, and earned one of VA’s highest awards for the Palo Alto team led by Dr. Glenn Cockerham.

to simulate the effects of blast overpressure in humans, will unfold in two phases: “The first thing is to look at the time course for the degenerative sequelae following a blast overpressure exposure,” he said. “We want to study when degenerative and functional deficits are first observed: How long do they occur? Do they dampen with time or do they get progressively worse? And the second thing is to test the efficacy of an intervention.”

Fliesler’s team will evaluate outcomes after feeding the rats a specially formulated antioxidant compound – importantly, beginning the treatments at different intervals following the blast. “Ultimately what we want to know,” he said, “is if you get a blast-exposed soldier into the field hospital within, let’s say six hours, 24 hours, 48 hours, and you start giving him or her a high dose of this multifunctional antioxidant, will that in fact lessen the severity of their degenerative sequelae?

And how long before it is no longer efficacious?” In a separate series of studies, Fliesler’s team will treat rats with the

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antioxidant compound at intervals prior to blast exposure, to test whether or not such prophylactic treatment can actually offer some degree of protection against the damaging effects of blast overpressure on the retina. “We envision the possibility that soldiers would take a potent antioxidant pill – in the same way that many people take a daily multivitamin supplement – prior to being deployed in war zones, as part of their daily routine.”

When veterans do suffer overt injuries to the eye, they most often involve the cornea, the transparent covering of the iris, pupil, and anterior chamber. Dr. Balamurali Ambati, an ophthalmologist and research scientist at the Salt Lake City VA and director of corneal research at the University of Utah School of Medicine, has been studying a problem unique to patients with blast injuries of the eye: The cornea, typically free of blood vessels, is often invaded by blood vessels during the healing process. “That leads to a vicious cycle of inflammation and scarring in the cornea,” said Ambati, “and 41

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increases the risk of rejection of any corneal transplant. This is a major problem for our returning warfighters.”

Ambati’s laboratory is working on intracellular therapies that target the proteins, known as chemokines, that signal for the formation of these abnormal blood vessels. “By doing so, we prevent blood vessel invasion of the cornea, reduce the invasion or infiltration of the cornea and thereby improve the probability of success with corneal transplants,” said Ambati.

“We’ve shown benefits both for low-risk and high-risk corneal transplant models in mice. And we hope to soon pursue that in larger animals.”

TBI is one of several things, along with glaucoma, optic nerve stroke, and other vascular problems, that can damage the retinal ganglion cells (RGC), the neurons that translate visual information from photoreceptors and send this information to the brain. “Retinal ganglion cells are particularly sensitive to injury,” said Dr. Nicholas Brecha, a research career scientist with the VA’s Los Angeles Healthcare System and a distinguished professor of neurobiology, ophthalmology, and medicine at the UCLA David Geffen School of Medicine, “and they’re particularly sensitive to a type of injury that occurs when there’s an increase in calcium levels within the ganglion cells. The increase in cellular calcium initiates a vortex of cellular changes that kills the ganglion cells. Once the ganglion cells are killed, this results in blindness, obviously, because you cannot get the visual signal from the eye to the brain.”

Throughout his career, Brecha has studied the problems associated with retinal cell damage and vision loss; more recently he’s begun to isolate the type of calcium channel – the membrane pores that regulate the flow of calcium ions into the RGC – involved in these kinds of injuries. “We’ve approached a fundamental question,” he said, “and we’re asking if we can control the calcium levels within ganglion cells by manipulating the calcium channel.”

In mice and rats with injured optic nerves, Brecha’s team has investigated several drugs that regulate calcium levels in the RGCs. “We have preliminary data for two drugs,” he said.

■■ “We’ve found in animal studies that a particular wavelength of red light, administered for three to four minutes a day, has very beneficial effects on things that we believe cause the retinopathy,” Kern said.

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“These are basic research findings in animal models, and of course we don’t know how far this is going to go. The findings look good, but we’ll learn more as we go forward.”

A common cause of retinal injury – particularly among older Americans, a group disproportionately represented among veterans – is the vascular damage associated with diabetes. Dr. Timothy Kern, research career scientist at the Louis Stokes Cleveland VA Medical Center and professor of medicine, pharmacology, and ophthalmology at Case Western Reserve University, has spent much of his career studying diabetic retinopathy. “The focus in my lab,” said Kern, “is trying to figure out what’s going on in the early stages of the retinopathy, so can we prevent that from ever developing. Oxidative stress seems to play a major role – and if we block the oxidative stress, we can block the early lesions, which clearly lead to the later, clinically significant aspects of the retinopathy.”

Kern’s research is two-pronged: first, looking at how oxidative stress triggers the inflammatory response in photoreceptors, the neurons that convert light into neural signals; and second, observing – in animal models and more recently in a limited number of VA patients – the effects of light therapy in reducing this inflammation. “We’ve found in animal studies that a particular wavelength of red light, administered for three to four minutes a day, has very beneficial effects on things that we believe cause the retinopathy,” Kern said. “And in a small number of patients, we have actually shown that the exact same therapy reverses existing retinal edema that is caused by diabetes.” Kern’s laboratory is gearing up for a larger VA-sponsored trial, to see if these initial findings hold up.

The reason light therapy works isn’t yet fully understood, Kern said: “It has many beneficial effects. It seems to inhibit the oxidative stress. It inhibits the inflammation that is developing within the retina. And the interesting thing is this is having a beneficial effect also in other parts of the body. It’s simply such a low-cost therapeutic approach that it could have some pretty significant implications.”

Diabetic retinopathy accounts for 12 percent of all new cases of blindness every year in the United States, and it’s the leading cause of blindness for people between the ages of 20 and 64. If Kern and his colleagues can find a way to inhibit or delay its onset, it would be a discovery that would literally benefit millions of Americans.

There’s a simple reason, said Nicholas Brecha, for VA researchers to be focusing on the prevention side of vision loss: “Blindness is a horrible disease. And it’s not reversible when retinal cells die. The new therapies many people are talking about – genetic therapies, stem cell replacement, and prosthetic devices – are very promising but they’re a long way off, in my opinion. I think we’ll be much better off in the immediate future if we attack these problems on the front end and prevent deleterious progressive changes to retinal cells.”

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VA RESEARCH:

Heart Health

By Craig Collins

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STUDYING THE DISEASED HEART

The basics of heart attack are well known: When blood flow to the heart muscle is slowed or stopped, those cells are not getting oxygen, and they’re dying. What happens after an attack, when a medical team has established “reflow” of blood to the heart, is more mysterious: About 30 to 40 percent of heart cell death happens during this aftermath – and we still don’t understand why, but Dr. Ed Lesnefsky, chief of cardiology at the McGuire VA Medical Center (VAMC) in Richmond, Virginia, and professor of internal medicine at Virginia Commonwealth University, is leading studies that are shedding light on this phenomenon.

In animal models, Lesnefsky and his team have established that the mitochondria – the “powerhouses” – of oxygenstarved heart cells don’t function normally during reflow, 44

■■ Dr. Anthony Baker, a research biologist at the San Francisco VAMC, is investigating the processes involved in right ventricle failure.

producing harmful compounds and triggering mechanisms that result in cell death, rather than survival. “For example,” he said, “these mitochondria, instead of making ATP – making energy – divert their biochemical processes to produce bad things, one of which is, in laymen’s terms, bleach.

So we’re interested in how these mitochondria can be modulated or biochemically manipulated to reduce cardiac injury during the reflow period, with the idea not only of preserving heart tissue, but also to minimize the transition to chronic heart failure states.”

This post-attack damage is greatest among higher-risk populations – elderly and diabetic patients – making it a problem of particular concern for the VA, whose researchers are taking what they know about mitochondrial malfunctioning and looking for ways to modulate it at the molecular level. It might be a new drug, Lesnefsky said, but “obviously the quickest pathway from laboratory bench to the coronary care unit would be for us to discover a currently approved drug can be successfully used to reduce this component of mitochondrial injury.”

Because most heart failure involves the left ventricle (LV) of the heart, that’s where most research is focused. But while it occurs less often, failure of the right ventricle (RV) – which pumps deoxygenated blood back to the lungs for oxygenation – is nevertheless a serious disease, and poorly understood. The traditional assumption that it can be treated in the same way as LV failure is being proven wrong, according to Dr. Anthony Baker, a research biologist at the San Francisco VAMC and professor of medicine at the University of California, San Francisco School of Medicine.

“Studies from our lab and others,” Baker said, “have suggested that actually the right ventricle has distinctive

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PHOTO BY STAFF SGT. AMBER KELLY-HERARD

n CARDIOVASCULAR DISEASE IS THE LEADING cause of death among Americans, and the most frequent reason for hospitalization in the VA health care system – and as such, it’s been a significant focus since the agency’s early years; the first VA cardiovascular research unit was established in 1935, at the Washington, D.C., VA hospital. In the 1960s, VA researchers provided the first definitive evidence that treatment for moderate high blood pressure could help to delay or prevent complications such as stroke or congestive heart failure.

VA cardiovascular research, aimed at improving the quality of life and patient care for veterans and their families, covers a broad spectrum, including the basic biological science behind the risk factors and pathological processes associated with heart failure; in vitro, animal model, and clinical trials of new treatments and therapies; and establishing or improving treatment methods and protocols in the health care setting, particularly within the context of chronic interrelated disorders.

According to Dr. Michael Burgio, who manages the VA’s Biomedical Laboratory and Clinical Sciences cardiovascular research and development programs, VA researchers are currently engaged in 38 clinical sciences studies and 26 clinical trials, nine of which are large, multi-site trials of particular medications or treatments. More than half – 155 – of the 307 cardiovascular research projects funded for 2015 were biomedical laboratory studies of the basic processes behind heart disease and related conditions.

“About 40 percent of the dollars we’re spending,” said Burgio, “are going toward basic research to understand what’s going on with cardiovascular diseases at the molecular and cellular level.” Such studies are difficult and complex, he said, but their share of VA’s cardiovascular research budget reflects their importance: “If we’re going to come up with innovative new ways to try to intervene and create new therapies, we really have to understand what’s happening in both the normal heart and the diseased heart, or in the normal and diseased vasculature, at this really fundamental level.”

THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

VA IMAGE

■■ Dr. Baker’s research at the San Francisco VAMC is investigating the use of a drug that stimulates the a1A adrenergic receptor, spurring an improvement in right ventricle function.

properties that are different from the LV.” How RV failure damages a heart cell is a complicated process, involving the release of an enzyme that destroys certain intracellular structures. Baker and his team have discovered that levels of this enzyme are markedly reduced in animal models with RV failure that receive a particular adrenergic drug – a medicine that stimulates the release of neurotransmitters from the adrenal gland – targeting specific receptors in heart cells.

“We’ve found that in experimental models of RV failure, when we chronically treat animals with a drug that specifically stimulates the alpha-1A adrenergic receptor,” said Baker, “there is an improvement in RV function and there is less injury to the RV.” Baker and his team hope further studies of animal models, now in the developmental phase, may eventually lead to new therapies for patients with RV failure.

The most common cause of heart disease is atherosclerosis – the narrowing or blockage of blood vessels that supply blood to the heart. Dr. Lisa Tannock, chief of endocrinology and molecular medicine for University of Kentucky Healthcare and a physician researcher for the Lexington VAMC, is leading investigations into the causes of atherosclerosis, with the goal of identifying biomarkers or mechanisms that could suggest new methods of reducing risk.

“My focus,” said Tannock, “is on how elevated lipids, or dyslipidemia, impacts cardiovascular disease.” Though her ultimate aim is to answer a big-picture question – “Are we identifying people a little bit too late in the disease, and therefore missing opportunities to intervene earlier when we

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actually really could prevent disease?” – her current investigations drill down to a particular molecule: serum amyloid A (SAA), a protein that binds with lipids to form lipoproteins.

Considered an “acute phase reactant,” SAA is normally seen at low levels in a healthy person, but spikes – up to 100 or 1,000 percent – in a person with an infection, or who has just undergone surgery.

Interestingly, chronic inflammatory conditions associated with increased heart attack risk, such as obesity, diabetes, lupus, or rheumatoid arthritis – are also associated with chronically elevated levels of SAA – in many cases, the acute-phase reactant is elevated for a period of decades. “So my question is,” said Tannock, “instead of being just a biomarker, is SAA actually causing atherosclerosis?”

Tannock and a team of investigators have demonstrated that overexpression of SAA in animal models causes atherosclerosis. Her current project focuses on the physical location of SAA in the body. Typically, it’s attached to high-density lipoproteins (HDL) – the “good” cholesterol – suggesting that HDL may function, in part, to sequester or neutralize SAA. But other research data suggests that in people with insulin resistance, SAA is prone to hopping onto the low-density lipoprotein, the “bad” cholesterol, especially just after eating.

Tannock’s study will examine blood samples taken from obese and diabetic human subjects, before and after consumption of a high-fat meal, to try to learn more about how, why, and in whom SAA makes this critical shift from HDL to LDL molecules.

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

RISK MANAGEMENT, TREATMENTS, AND OUTCOMES

The prevention and management of heart failure, despite many innovations and new therapies, remains a significant issue for the American health care system overall and the VA’s in particular. Many VA researchers are focused on optimizing therapies and care to deliver the highest possible quality of life for heart patients. Dr. Patricia Kelley, a registered nurse and portfolio manager for care of complex chronic conditions in the VA’s Health Services Research and Development (HSR&D) Service, described this research as multimodal, collecting data from throughout the VA’s health care system. “We look at the patient-level data, patient outcomes and satisfaction,” she said. “Health Services looks at the effectiveness of interventions, and the effective improvement on patient outcomes, as well as different innovative ways of delivering health care delivery to this complex patient population.”

Because risk factors for cardiovascular disease, such as SAA, are often observed to accumulate over a period of 46

years, much VA research is aimed at interventions that can lower these risks and prevent heart failure – and some of this research has challenged the medical profession’s working assumptions. When the American College of Cardiology and the American Heart Association issued new guidelines for lipid management in 2013, it was a direct result of investigations conducted by Dr. Rod Hayward and colleagues at the VA Center for Clinical Management Research in Ann Arbor, Michigan. Hayward’s work suggested that the prevailing practice of setting fixed targets for LDL cholesterol levels among heart patients wasn’t supported by clinical evidence, and that a more tailored, individualized approach to treatment could improve outcomes.

Dr. Karen Saban, an associate professor at Loyola University Chicago and health research scientist and nurse at the Center for Innovation in Complex Care Management at the Edward Hines,p Jr. VA Hospital, is investigating the efficacy of an eight-week stress-reduction therapy aimed at reducing cardiovascular risk in women veterans. “We know that women veterans do have higher levels of stress,” said Saban. “And we also know that their use of VA services has

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U.S. AIR FORCE PHOTO ILLUSTRATION BY SENIOR AIRMAN AUBREY WHITE

■■ U.S. Air Force Staff Sgt. Arjune Haynes, 633rd Medical Operations Squadron, cardiopulmonary services assistant, noncommissioned officer in charge, reviews an echocardiogram at Langley Air Force Base, Virginia, Jan. 16, 2015. Echocardiography is used three times as frequently in the civilian world than in the case of veterans who have entered the VA System, yet outcomes don’t seem to differ in any significant way.

THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

VA PHOTO

■■ Dr. Peter Groeneveld and his colleagues at the Corporal Michael J. Crescenz VAMC are studying whether the proliferation of expensive imaging technologies has an effect on outcomes.

more than doubled in the last decade.

The peak age of women who are using VA services is around 47. So they are getting close to that age where cardiovascular disease can be a real issue.”

The eight-week course used for Saban’s study is a standard intervention known as Mindfulness-Based Stress Reduction (MBSR), which was developed in the 1970s and has been validated through applications among diverse populations; Saban’s study is the first to examine the extent to which MBSR improves quality of life and cardiovascular health in women veterans.

The effectiveness of mindfulness techniques, such as meditation and yoga, in reducing stress will be measured by means of several known inflammatory biomarkers – including cortisol, a stress-response hormone – before, during, and up to six months after the program. “We’re hoping,” she said, “to see sustainability of the program for intervention.”

Interventions such as that designed

by Saban, if proven effective, are attractive because of their relatively low cost, which is of increasing concern as health

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care costs rise and the VA patient population continues to age. Over the past several years, at the Corporal Michael J. Crescenz VAMC in Philadelphia, Dr. Peter Groeneveld, a staff physician and researcher, has focused research on whether some of cardiology’s highercost technologies have influenced the outcomes of heart failure care. Most recently, Groeneveld and his colleagues have studied the proliferation of cardiovascular imaging technologies, such as echocardiography, computed tomography (CT), cardiac MRI, and nuclear imaging.

“There is not a lot of good data to guide the appropriate use of these technologies,” said Groeneveld.

“They’re costly to use, involving expensive equipment and interpretation by highly trained radiologists.

So the question really is, in terms of using limited heart failure clinical dollars most effectively: What is the right frequency for using these imaging tests?”

Groeneveld and his colleagues examined patient data from the nation’s 50 largest urban centers, comparing the use of echocardiography among 65-and-older veterans from both the VA and Medicare populations, who were matched on a wide array of demographic and clinical data. The investigators discovered that echocardiography is used three times more frequently outside of VA than within the VA health care system. “Roughly speaking, a heart failure patient outside of VA gets an echocardiogram about once every eight months,” he said, “and a VA patient gets one every two years.”

The most interesting result of Groeneveld’s study is that outcomes for veterans in the VA system didn’t differ in any significant way from those who opted for care within the Medicare system. “[They] are doing just as well clinically, and they’re surviving just as long. They are hospitalized just as frequently. They’re living independently with the same frequency. So there’s not a lot of good evidence that the three

times greater rate of echocardiography used outside of VA is leading to better outcomes among veterans who don’t get their care at VA … And in this era, where VA – and really everyone – is facing constrained budgets for managing high-cost chronic disease populations, it really is going to become critical to understand and guide the use of expensive technologies in a way that really optimizes patient outcomes without overusing tests that don’t improve veterans’ health.”

With a chronic condition such as heart failure, where comprehensive, patient-centered care is difficult and resource intensive, Kelley said it’s more important than ever to weigh the costs and benefits of interventions – for the patient as well as the health system. A newly launched study by Dr. Wen-Chih Wu, a physician researcher at the Providence VAMC and an associate professor at the Brown University School of Medicine, is recruiting participants from among veteran heart patients who have been recently discharged from the Providence and Phoenix VA Hospitals, to test the efficacy of shared medical appointments involving a multidisciplinary group approach: A team involving experts in nutrition, nursing, behavior, and medication management, in addition to a patient’s regular physician.

The ultimate aim of such an approach, said Kelley, is to reduce the rate of cardiac re-hospitalizations – which are traumatic for patients and their families, and costly to the system. “There is a point in a patient’s trajectory,” she said, “where we need to look at palliative care modalities in helping people have a good quality of life as they live with their chronic conditions.” The VA research program, embedded within its nationwide network of health care facilities, is perhaps uniquely positioned to measure the effectiveness of this multidisciplinary approach, to help the VA’s medical professionals leverage their expertise, and ultimately to improve the quality of life for veteran heart patients.

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

VA RESEARCH:

Alzheimer’s Disease

By Craig Collins

n ALZHEIMER’S DISEASE, a neurodegenerative disorder involving the deterioration of the brain’s nerve cells, is one of the most common forms of dementia – a generalized decline in memory, judgment, thinking, and learning ability. A progressive disease, Alzheimer’s can ultimately rob a person of capabilities or personality traits that have defined him or her for a lifetime, a consequence that’s often traumatic for family members, friends, and caregivers.

Though discovered more than a century ago, Alzheimer’s remains a mysterious ailment. Researchers have discovered risk factors – such as head trauma, hypertension, or genetics – as well as brain abnormalities associated with Alzheimer’s: the accumulation of beta-amyloid protein plaques between neurons, and fibrous tangles of tau proteins within neural cells.

But establishing a cause-effect relationship between these conditions and Alzheimer’s has proven elusive. As imaging technologies have matured to the point where amyloid plaques can be identified, for example, investigators have sometimes found the brains of patients with Alzheimer’s-like dementia to be free of amyloid plaques.

Because there remains no known cause nor cure, nor even a universally effective treatment for Alzheimer’s disease, the Department of Veterans Affairs’ (VA) Office of Research and Development (ORD) devotes considerable resources to investigating the basic mechanisms underlying the cause and progression of the disease. According to Dr. Lisa Opanashuk, scientific program manager for neurodegenerative disorders for ORD’s Biological Laboratory and Clinical Sciences R&D Services, more VA researchers are involved in studying Alzheimer’s than any other neurodegenerative disease. “The program for Alzheimer’s disease, and neurodegenerative diseases in general,” she said, “encompasses a wide variety of topics: genetic and/or proteomic markers, genetic susceptibility risk factors, gene/environment interactions in animal models, alterations in the processing or metabolism of specific proteins related to these diseases, and the identification of new targets so we can work on developing new therapies. We look at neuronal death, inflammation, oxidative stress, and free-radical injury in animal models of these neurodegenerative diseases, along with mitochondrial dysfunction and signaling factors.”

THE MOLECULAR MYSTERIES OF ALZHEIMER’S

Some of the most extensive Alzheimer’s-related proteomic studies (investigations of the structures and functions of

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proteins) are being conducted at the laboratory of Tony WyssCoray, Ph.D., a professor of neurology and neurological sciences at the Stanford University School of Medicine and senior research career scientist at the Palo Alto Health Care System.

Wyss-Coray and colleagues seek to understand more about how the proteins involved in cellular communications – a wide variety of compounds, generally known as cytokines – change in normal aging and in the neurodegenerative disease process.

“We measure now more than 500 of these types of proteins,” he said. “When these factors change due to aging or disease, we hope to get information about the biological changes that occur in the organism.” Wyss-Coray’s laboratory measures the presence of these proteins both in mice that model either normal aging or Alzheimer’s disease, and also in human plasma samples taken from healthy aging individuals and people with early- or late-stage Alzheimer’s disease.

Normal aging, said Wyss-Coray, can change the levels of some of these proteins dramatically – by 50 percent, 100 percent, or more. The question then becomes, he said, whether these changes are simply part of normal aging, or involved some way in neurodegeneration. His laboratory’s approach toward investigating this question involves a method known as parabiosis: the surgical connection of two mice – one old, one young – at their flanks, creating a capillary network that interconnects their blood supplies.

“What we find is that the old brain gets basically rejuvenated,” said Wyss-Coray. “The old mouse makes more neural stem cells and increases production of neurons that are involved in learning and memory. It increases expression of many genes that are involved in memory formation. Synaptic density goes up, and synaptic plasticity in electrophysiological recordings is also improved.”

Having established that the introduction of soluble factors can help restore function and plasticity to an aging brain, WyssCoray and his team are hunting for the specific factors involved in this rejuvenation. The team has already identified and reported on one cytokine – colony stimulating factor 2, or CSF2 – that appears to be involved in mediating some of these effects.

The team is currently conducting a clinical trial aimed both at creating some of these rejuvenating effects in Alzheimer’s patients and in gaining a better understanding of the soluble cytokines involved in the disease: Once a week, participants with mild to moderate Alzheimer’s are given an infusion of plasma from donors between the ages of 20 and 30; after a month, they’re given functional evaluations. “The study has 49

THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

Puta%ve Altera%ons in Neurotransmi2er Ac%vity in SAMP8 Mice Leading to Altera%ons in Learning and Memory

↑Amyloid Precursor Protein ↑β -Amyloid protein

↓Serotonin GSK-3 ↑Gamma amino butyric acid ↓NMDA activity

TAU

PHOSPHORYLATED TAU

↓Protein kinase C

↓Calcium influx ↓Phosphorylation of cyclic AMP response element

↓Response to Acetylcholine ↓Long term potentiation

↓Memory

■■ LEFT: Dr. Chad Dickey’s research is investigating the role of a class of proteins know as “chaperones” in Alzheimer’s. ABOVE: Senescence-accelerated mice, such as the SAMP8 mouse, are a way for researchers to be able to examine the pathophysiology of Alzheimer’s disease.

18 subjects and it’s still ongoing,” said Wyss-Coray. “And we hope to have it completed by the end of the year.”

Another investigator of Alzheimer’s at the molecular level is Chad Dickey, Ph.D., an associate professor of molecular medicine at the Byrd Alzheimer’s Institute at the University of South Florida and a research scientist at the James A. Haley VAMC in Tampa, Florida. Dickey studies the workings of a class of proteins known as “chaperones,” which ensure the correct assembly or disassembly of intracellular structures – the folding and unfolding of other proteins – in the brain.

“If [a protein] is not folded properly, chaperones can either degrade it or they can try to refold it,” explained Dickey. “We think that’s a really critical point for a lot of problems inside neurons, because these chaperones aren’t doing their job quite right.” Sometimes a chaperone can get stuck, trying to fold a malformed protein that should simply be discarded – and this can lead to the accumulation of tau proteins within the cell, which interferes with healthy protein signaling. “[Tau accumulation] is basically clogging up this really important system, and that triggers a sort of toxic pathway,” Dickey said. “We think of it as a toxic pathway that eventually leads to neuronal loss and to some of the cell damage that occurs inside the Alzheimer’s brain.”

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In his laboratory, Dickey and his team are looking for compounds that can inhibit these toxic pathways and steer chaperones back on track in the neurons of mice that model Alzheimer’s. “I think the chaperone field has lagged behind as far as drug development goes,” he said. “We’re trying to find better targets in the chaperone family that would be specific for tau.”

Susan Farr, Ph.D., a research physiologist at the St. Louis VAMC and professor of medicine at Saint Louis University, is investigating other ways of inhibiting Alzheimer’srelated brain abnormalities using mouse models of aging or Alzheimer’s. Farr’s work focuses on countering the synthesis and accumulation of disease-associated proteins with “antisense” compounds, or chains of nucleotides engineered to bind with a segment of messenger RNA (mRNA) and effectively deactivate a faulty gene signal – the instruction, for example, to create more beta-amyloid protein. In the spring of last year, her team reported the development of an antisense compound that reversed Alzheimer’s symptoms in mice.

The antisense used by Farr’s team, oligonucleotide-1 (OL1), works by inhibiting the amyloid precursor proteins (APPs) concentrated in the synapses of neurons. “The antisense

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

gets in to the central nervous system and binds to APP,” she explained, “blocking the cleavage of APP and thereby decreasing the production of beta-amyloid. So we’ve gone through a whole process of creating multiple antisenses, and identifying the sequences of oligonucleotides that produce the best effect on learning and memory.”

Farr’s work has also demonstrated that antisense is capable of crossing the blood-brain barrier, reducing oxidative stress and neuroinflammatory cytokines, and improving the outflow of overproduced beta-amyloid from the brain. “We really think antisenses have great potential for treating Alzheimer’s disease,” she said. “And we’re moving over now to the tau side.”

Farr’s team is hoping to develop an antisense that can bind with glycogen synthase kinase (GSK), one of the proteins involved in the phosphorylation of tau protein. “We’ve found, at least in our mouse models,” she said, “that we can indeed improve learning and memory when we decrease these proteins.”

REHABILITATION RESEARCH: TREATMENTS AND THERAPIES

Because there is still so much to learn about the etiology of Alzheimer’s disease, the bulk of VA’s research concerns basic biomedical science. “The research has to mature to a certain point before it can be moved into a clinical setting and studied in the context of a rehabilitation intervention,” said Tshaka Cunningham, Ph.D., scientific program manager for aging and neurodegenerative diseases in VA’s Rehabilitation Research and Development (RR&D) Service.

One of the best examples of research maturing along this trajectory is the work of Dr. Sam Gandy, Ph.D., director of the Center for Cognitive Health and NFL Neurological Care at the Icahn School of Medicine at Mount Sinai, and a physician researcher at the James J. Peters VAMC in the Bronx. A worldrenowned expert in the metabolism of beta-amyloid since the 1980s, Gandy several years ago, with funding from VA’s Biomedical Laboratory Research and Development Service, collaborated with Dr. Michelle Ehrlich, a professor of pediatric neurology, genetics and genomic sciences, and pediatrics at Mount Sinai, to develop a breakthrough animal model, a mouse in which brain amyloid aggregated – rather than into the classical plaques – into floating clumps called oligomers.

These clumps, explained Gandy, are misshapen in such a way as to be invisible to existing amyloid imaging technology.

“The mice were just as behaviorally impaired as the mice with plaques,” said Gandy. “And this ‘oligomer only’ mouse reinforced the idea that while the plaques themselves may be an obvious thing we can see with the microscope, the real poisons may be these floating clumps that we cannot see.”

This finding, along with several others – today’s imaging tools have demonstrated, for example, that amyloid buildup can begin up to 30 years before the first symptoms of Alzheimer’s emerge – has led Gandy and most researchers to target prevention of the disease, rather than treatment. “Until

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recently – and probably because we were treating too late – our efforts at reducing amyloid made their brain scans look better, but didn’t help them at all clinically,” he said. “So we’ve long believed if amyloid is going to be the target, then the earlier the better.”

In a study reported in August 2014 in the journal Molecular Psychiatry, Gandy and colleagues reported one of the most promising results yet in an animal model: Mice with amyloid clumps, treated with an experimental drug known as BCI838, not only showed a reduction in amyloid, but also formed new nerve cells in the hippocampus – the memory center of the brain and one of the first regions of the brain to suffer Alzheimer’s damage. The drug, originally developed to treat depression, raises the possibility that treatment may be possible for patients who are already symptomatic. “Right now,” Gandy said, “we’re working to develop a derivative of this compound that we can use in clinical trials.”

Amyloid accumulation is clearly part of what defines Alzheimer’s pathology, Gandy said, but genetic analyses of typical non-familial Alzheimer’s patients have revealed about two dozen genetic changes common among them – and only a few were obviously related to amyloid metabolism. “Most were either cholesterol-related genes, or inflammation-related genes, or protein-sorting or intracellular trafficking-related genes. So there’s a lot of interest now in the roles of cholesterol and inflammation in Alzheimer’s, for a variety of reasons.”

Early in her investigative career, Sally Frautschy, Ph.D., chief of neurogerontology at the Geriatric Research, Education and Clinical Center (GRECC) at VA’s Greater Los Angeles Health Care System and professor-in-residence in the Department of Neurology at UCLA’s David Geffen School of Medicine, began to focus on the role of inflammation in Alzheimer’s. For the past 20 years she’s been investigating the anti-inflammatory properties of curcumin, a molecule in the turmeric plant known to affect both inflammation and oxidative damage – and, Frautschy has discovered, to enhance the mechanism for removal of toxic tau aggregates from the brain. The knowledge gained from those studies has led to her most recent clinical trial, which she’s conducting in partnership with Dr. Edmond Teng, Ph.D., another VA GRECC and UCLA investigator who also is directing clinical trials at the UCLA Alzheimer’s Center.

The trial combines a regimen of curcumin, molecularly customized to pass through the blood-brain barrier, combined with yoga therapy, and administered to veterans with mild memory loss who may be at risk for developing Alzheimer’s disease. Typically, factors increasing risk for cardiovascular disease, such as insulin resistance and inflammatory dysregulation, present risk factors for mild cognitive impairment (MCI), the early stage of Alzheimer’s disease.

Yoga was chosen as the behavioral component for the trial, Frautschy said, not only because exercise has been shown to reduce the risk for Alzheimer’s, but also because yoga, in particular, involves cognitive and circulatory components that might 51

THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

■■ Drs. Sam Gandy and Greg Elder (at microscope), with the Bronx VA Medical Center, are studying a neuron-generating compound that shows promise for both Alzheimer’s disease and traumatic brain injury.

prove beneficial. Because of their relatively low cost, behavioral interventions for facilitating brain health are receiving significant attention from researchers. One of them is Michael Cole, Ph.D., a research scientist and neuropsychologist in the VA’s Northern California Health Care System and the Alzheimer’s Disease Center at the University of California-Davis. Cole’s work examines neurocognitive rehabilitation approaches – cognitive exercises, compensatory technique training, memory strategies and memory aids – that have proven successful in normal aging, and which have shown some promise in countering symptoms of MCI and mild dementia.

Behavioral therapies have also proven effective in countering the elevation of stress-related hormones such as cortisol, which has been linked to hippocampal injury and associated cognitive decline. Cole, along with co-primary investigator Juliana Baldo, Ph.D., and colleagues at UC-Davis, has designed a series of studies examining the efficacy of an eight-week course on mindfulness-based stress reduction (MBSR). The first course is being taught by a certified instructor – Cole – to patients with mild cognitive complaints that don’t rise to the level of an MCI or Alzheimer’s diagnosis. “Preliminary effects so far,” Baldo 52

said, “seem promising in reducing things like blood pressure, heart rate, and cortisol levels.”

The group is planning future studies of course outcomes among patients with MCI and Alzheimer’s disease. “For those folks, we realize mindfulness training has definitely been shown to be more efficacious for executive functioning and attention, rather than for directly treating memory deficits,” Baldo said. The program for these groups is likely to be a hybrid intervention, combining mindfulness training with memory exercises.

Cole’s mindfulness training evaluation lies near one end of the continuum of VA’s Alzheimer’s research, in which the smallest unit of study is the individual patient. Such a broad spectrum is necessary, said Cunningham, given a topic that has confounded researchers for so long. “The reality of it is that this particular disease condition, Alzheimer’s, is just very intractable, very difficult to treat,” he said. “There is still a lot of etiology that needs to be understood, and we’re discovering new methods for rehabilitation while we’re discovering more about how the disease happens, and how new molecules and compounds might be used in treatment. The story of our Alzheimer’s research isn’t done yet, by any stretch of the imagination.”

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

INTERVIEW

DAVID J. SHULKIN, M.D. VA Under Secretary for Health

By John D. Gresham

The Honorable Dr. David J. Shulkin is under secretary of health for the United States Department of Veterans Affairs. As the chief executive of the Veterans Health Administration, Shulkin leads the nation’s largest integrated health care system, with more than 1,700 sites of care, serving 8.76 million veterans each year. The Veterans Health Administration is also the nation’s largest provider of graduate medical education and major contributor of medical research. Shulkin will have oversight over the system that employs more than 300,000 people who work in the health system.

Prior to being nominated by President Barack Obama and being confirmed by the United States Senate as under secretary of health, Shulkin served in numerous chief executive roles, including serving as president at Morristown Medical Center, Goryeb Children’s Hospital, and Atlantic Rehabilitation Institute, and the Atlantic Health System Accountable Care Organization. Shulkin also previously served as president and CEO of Beth Israel Medical Center in New York City. He has held numerous

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physician leadership roles, including the chief medical officer of the University of Pennsylvania Health System, the Hospital of the University of Pennsylvania, Temple University Hospital, and the Medical College of Pennsylvania Hospital. Shulkin has also held academic positions including the chairman of medicine and vice dean at Drexel University School of Medicine.

As an entrepreneur, Shulkin founded and served as the chairman and CEO of DoctorQuality, one of the first consumer-oriented sources of information for quality and safety in health care.

Shulkin is a board-certified internist, a fellow of the American College of Physicians. He received his medical degree from the Medical College of Pennsylvania, his internship at Yale University School of Medicine, and a residency and fellowship in general medicine at the University of Pittsburgh Presbyterian Medical Center. He received advanced training in outcomes research and economics as a Robert Wood Johnson Foundation Clinical Scholar at the University of Pennsylvania.

Over the course of his career, Shulkin has been named as one of the “Top 100 Physician Leaders of Hospitals and Health Systems” by Becker’s Hospital Review and one of the “50 Most Influential Physician Executives and Leaders” by Modern Healthcare and Modern Physician. He has also previously been named one of the “One Hundred Most Influential People in American Healthcare” by Modern Healthcare.

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

THE YEAR IN VETERANS AFFAIRS AND MILITARY MEDICINE: You started 2015 as president of the Atlantic Accountable Care Organization (ACO). Then you got a call from the White House asking you to take over as VA under secretary for health. What made you want to leave Atlantic ACO and take over a federal department with the problems of the Veterans Health Administration (VHA) of the Department of Veterans Affairs (VA)?

UNDER SECRETARY DAVID J. SHULKIN, M.D.: I was sworn in on July 6, so I’m just coming up on nearly three months on the job and learning more and more about VA each day. My experience in the private sector and relooking at business models has allowed me to come in and challenge some of the issues in the Veterans Health Administration that frankly needed to be questioned. Bringing best practices from the private sector will help me achieve our outcome, which is to provide better care to our veterans.

I think what’s relevant to know is that the reason I came to VA, and the reason Secretary [Robert A.] McDonald and President [Barack] Obama asked me to come here, was to tackle head-on the types of issues that did arise in April of 2014 and make sure that we were not only making progress, but that I was able to take a look at this using my experience running hospitals and health systems in the private sector.

When you accepted the position of under secretary for health, did you have a personal goal set in mind?

The issues in VHA over the past 15-18 months have been a very public story, and certainly when I read about the wait time crisis, I had the reaction of so many people – disappointment that our veterans were not getting the care they’ve earned and deserve. When I was approached with the opportunity to be part of the solution, I felt that I just could not walk away from something so important to this nation’s veterans and their family members.

For readers who may not be aware of just how vast an enterprise VHA is, can you please lay out some metrics for them to consider, such as personnel employed, number of facilities, annual budget, number of patients served, and number of medical professionals within VHA?

As under secretary, I direct a health care system with an annual budget of approximately $59 billion, overseeing the delivery of care to more than 9 million enrolled veterans. VA, the nation’s largest health care system, employs more than 305,000 health care professionals and support staff at more than 1,200 sites of care, including hospitals, communitybased outpatient clinics, nursing homes, domiciliaries, and 300 Vet Centers.

Nationally, VA completed more than 61.5 million appointments between July 1, 2014 and July 31, 2015. This represents an increase of 2.36 million more appointments than

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were completed during the same time period in 2013/2014.

Veterans have access to outpatient care at more than 1,200 locations; acute inpatient (hospital) care at 144 locations; Community Living Centers (CLCs) at 134 locations; and residential rehabilitation at 114 locations.

While bureaucratic problems such as wait times for appointments are well-known publicly, VHA is known for delivering some of the highest quality health care services of any medical system in the United States.

Given the overall public confusion about VA, can you give us a sense of the state of the VHA today?

With the implementation of VHA’s “Blueprint for Excellence” we are going through a major transformation focused on the veteran and providing consistently highquality health care that is timely, efficient, and effective. Our goals are to improve performance, promote a positive culture of service, advance health care innovation for veterans and the country, and to increase operational effectiveness and accountability.

When you arrived and took over your duties this previous July, what did you discover was awaiting you, and could you characterize the top initial priorities for action that you found?

My five priorities: • Fix access • Staff and physician engagement • Consistency of best practices and resource prioritization • Development of a high performance network • Restore trust and confidence Restoring the trust is the overwhelming and overarching objective.

Ultimately we are not going to be successful in the end if we don’t have that confidence back into our system.

Your background in the civilian world is as someone who emphasizes “best practices,” better care and service through continuing education and making organizations take a hard look at themselves and their people. What message do you think your recruitment sent to both the veterans community and your own organization about VA’s/VHA’s future commitment to improved veteran care?

Our stakeholders were ready for someone different who was outside of VA. Of course, as you know, one of the things that I bring to the table is the private-sector perspective. I have not worked in the VA system for quite a long time. The last time was when I was a resident rotating through the medical centers, which was quite a long time ago.

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

VHA has been making a sustained and continuing effort to understand, assess, and treat traumatic brain injury (TBI). This has been a truly impressive effort, which is trickling down into the civilian world into places such as the National Football League and the automobile industry. So what is the current state of TBI understanding and treatment within VHA, and what do you see in the near future for veterans with this condition?

VHA is investing heavily in improving diagnostics for TBI with cutting-edge efforts that focus on detecting TBI in veterans who have not been previously diagnosed with a TBI. These efforts include novel research on cerebrospinal fluid and serum biomarkers, validating new positron emission tomography (PET) ligands, and devices that calibrate magnetic resonance imaging (MRI) so that repeated scans over time can be made reliably to monitor brain changes.

In addition, the field of TBI research is in agreement that repetitive mild TBI can result in a loss of abilities and is linked to behavioral health issues. What has not been directly confirmed is whether repetitive mild TBI can cause a progressive neurodegenerative condition, such as chronic traumatic encephalopathy (CTE). Currently the VA is working with the DOD [Department of Defense] on a joint initiative (Chronic Effects of Neurotrauma Consortium) to determine if there is a causal relationship between repetitive mild TBI and CTE and if therapeutic development is possible.

Finally, VHA funded over 140 research studies during the past fiscal year, including research on both pharmacological and non-pharmacological therapies for TBI, and research on tele-rehabilitation and how the VA can improve its support of caregivers of veterans with TBI. [Editor’s note: The department has a Traumatic Brain Injury Advisory Committee and its last report to Congress is available at http://www.healthquality.va.gov/guidelines/ Rehab/mtbi/concussion_mtbi_full_1_0.pdf] As America has drawn down its overseas military deployments and commitments, along with the size of its military personnel base, what are you seeing as the major trends in regard to posttraumatic stress disorder (PTSD), including the patient base size, new research and treatments, and your overall understanding of the condition itself?

Approximately 1 in 5 veterans of the wars in Iraq and Afghanistan has been diagnosed with PTSD, often cooccurring with another mental disorder or a physical illness.

One major effort is the Marine Resiliency Study (MRS), involving some 2,600 Marines who deployed to Iraq and Afghanistan. Beginning in 2008, the research team conducted clinical interviews on Marine bases and collected psychological, social, and biological data before

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deployment and then multiple times after deployment.

Researchers are analyzing the data to identify risk and resilience factors for combat-related PTSD. The team recently published two articles in JAMA Psychiatry. One shows deployment-related brain injury to be a significant risk factor for PTSD. Another implicates high levels of inf lammation in the body as a PTSD risk factor.

VA clinical trials provided much of the evidence that cognitive processing therapy (CPT) and prolonged exposure therapy are effective treatments for PTSD. In 2013, VA researchers demonstrated that veterans using either therapy not only showed reductions in their PTSD symptoms, but also used VA’s mental health services considerably less than in the year before they began therapy. Now, a head-to-head comparison of CPT and prolonged exposure therapy is underway (CSP #591 – CERV PTSD) to learn more about which type of therapy is better for a patient.

Additional areas of PTSD research include studies of alternative treatments, such as meditation and yoga and studies to increase the use of evidence-based treatments.

Other researchers are working on projects to improve veterans’ access to and engagement in evidence-based PTSD treatments. Large-scale investigations promise additional insight into risk factors for PTSD that could prevent or mitigate onset following traumatic exposure.

VA is also studying the use of service dogs for veterans with PTSD. A multisite study will provide eligible veterans with either an emotional support dog or a service dog that has been specifically trained to perform tasks that mitigate PTSD. Researchers will look for improvements in participants’ PTSD symptoms, quality of life, participation in society, and employment status. Another study will examine the impact of dogs adopted from an animal shelter on PTSD symptoms.

During the last 18 months, VA and other federal research funding agencies have worked together to address the mental health needs of veterans through the National Research Action Plan (NRAP), developed in response to President Obama’s Executive Order. The plan outlines the vision for PTSD, TBI, and suicide prevention research and describes requirements intended to help the agencies successfully reach important research goals over the next few years.

One major result of the plan has been the establishment of new research consortia devoted to PTSD and TBI. These consortia were jointly developed by VA and the Department of Defense and approved for funding for five years at the beginning of FY 2014.

The overall funding level is estimated at $107 million from the two departments. PTSD consortium studies focus on potential biomarkers (e.g. indicators that can be determined from a laboratory test) and the use of advanced brain imaging to gain a deeper understanding of the condition.

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One of the most impressive achievements of your organization since the inception of VA has been the continuing commitment and investment through the VHA into state-of-the-art medical/health research and development (R&D). Can you give our readers a sense of what the annual investment of finance and personnel by VHA is in this area?

VA Office of Research and Development (ORD) plays a key role in advancing the health and care of veterans and is uniquely positioned to lead a national transformation of American health care. As part of the largest integrated health care system in the United States, VA R&D draws upon engaged patients and families, committed clinician-scientists, and an unparalleled national health care delivery structure.

These resources provide a rich base for VA to deliver the best health care and develop cutting-edge medical treatments for veterans, their families, and the nation. VA is committed to using evidence-based results to address the needs of the entire veteran population. Although the VA research program focuses on benefiting current and future veterans, the outputs of VA research ultimately affect the entire nation. Through VA’s focused mission to advance health care for veterans, VA research serves as a 21st-century model for how American medicine is transformed through scientific inquiry and innovative thought, leading to evidence-based treatments successfully implemented into practice.

For fiscal year 2015, VA Research recognized appropriations that approximated some $588 million encompassing some 2,200 research projects. To fulfill the commitment to provide superior health care to our veterans and their beneficiaries, VA is requesting $618 million in direct appropriations in 2016, which is an increase of $29 million, or 5 percent, over the 2015 level. The estimated direct research program employment level is 3,531 full-time equivalents (FTEs); all VA researchers are VA employees.

Over the years, we have followed some of the more interesting and impressive R&D efforts by VHA into everything from prosthetic development to MRSA abatement. Can you please give us a preview of what is coming out of your R&D personnel/facilities in the near future?

VA Office of Research and Development works continually to ensure that the research portfolio is appropriately rebalanced to meet the most pressing needs of veterans. In 2016 and 2017, VA’s research priorities will emphasize ensuring continued care for veterans throughout their life span. A robust health services research program will continue to improve the way VA delivers health care and the methods through which veterans can access VA services. VA will also support 58

a wide array of research and development in engineering and technology to improve the lives of veterans with disabilities.

Work includes both prosthetic systems that replace lost limbs and those that activate residual or paralyzed nerves, muscles, and limbs. Some VA research and development highlights we anticipate to generate innovative discoveries and advancements in veterans’ health care include: GENOMICS

Enhancing research on genomic medicine and continuing the Million Veteran Program (MVP) remain major goals for VA Research in 2016 and 2017. MVP, a groundbreaking genomic medicine program, seeks to collect genetic samples and general health information from 1 million veterans in the next five years. The program is on track to establish one of the largest genomic and health information research resources available in the world, which will help provide answers to many pressing medical questions and lead to improvements in care and prevention to veterans and the nation. As of Sept. 18, 2015, MVP had enrolled more than 411,000 veterans, and is conducting initial genetic analysis of these specimens at the rate of more than 10,000 per week. These data are available to VA investigators starting in FY 2015; studies that will use these data, concentrating on posttraumatic stress disorder and chronic multisymptom illness in 1990-1991 Gulf War veterans, are in development.

VA works closely with other federal research agencies to assure effective use of scarce taxpayer resources in executing its research mission. We carry out joint programmatic reviews with the Department of Defense and National Institutes of Health to ensure that our research efforts are complementary and not overlapping. Under the auspices of the President’s National Research Action Plan, VA has worked with DOD to create two research consortia for traumatic brain injury and posttraumatic stress disorder, at a combined investment of $107 million over five years. This tight coordination has become routine for all three agencies, with benefits that accrue to veterans and the American public at large.

WOMEN’S HEALTH

A comprehensive research program supports VA’s commitment to the health and care of the increasing number of women veterans. Recent areas of inquiry include studying how VA provides for women veterans’ general and genderspecific health care needs, and understanding the experiences of women veterans while in service and their health risk factors later in life.

Recognizing the dramatic increase in the number of women veterans, VA Research established the Women’s Health

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

■■ Dr. David Shulkin shown during his confirmation hearing in May 2015.

Research Network to accelerate research that addresses needs of women veterans. This innovative network is building capacity to develop research that will benefit women veterans of all ages, including studies on women’s health during and after deployment, reproductive health, primary care, and prevention. The network also fosters large multisite studies through a group of 37 VAMCs [VA Medical Centers] that work together to facilitate research-clinical partnerships. The overall goal is to develop, test, implement, and disseminate effective innovations in care.

U.S. DEPARTMENT OF VETERANS AFFAIRS PHOTO BY ROBERT TURTIL

GULF WAR VETERANS

Some 1990-1991 Gulf War veterans are affected by a debilitating cluster of medically unexplained chronic symptoms that may include fatigue, headaches, joint pain, indigestion, insomnia, dizziness, respiratory disorders, and memory problems – referred to by VA as chronic multisymptom illness (CMI). VA researchers are dedicated to learning more about these problems and identifying the best ways to diagnose and treat them.

Two new studies that may benefit this cohort involve functional magnetic resonance imaging of the brains of Gulf War veterans. One study is designed to understand the mechanism of cognitive fatigue by giving memory tests to patients while the images are being collected. The other will examine patients with cognitive difficulties who might have been exposed to nerve agents in Iraq and compare their brain images with those from Gulf War veterans who are unlikely to have been exposed.

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In other work, researchers are studying blood plasma in mice in the hopes of discovering biomarkers that could ultimately be useful for diagnosing Gulf War veterans with chronic multisymptom illness. Other projects involving animal models will address brain changes related to free radicals, therapies that target nerve tissue in the brain, and paternal reproductive risks.

ALZHEIMER’S DISEASE

Alzheimer’s disease is a progressive, degenerative brain disease with no known cure. It is the most common cause of dementia, and eventually leads to death. Dementia is a prevalent chronic condition in veterans treated by VA. The department projects that roughly 218,000 veterans will be diagnosed with dementia in 2017, an increase of more than 40,000 such diagnoses from 2008.

In patients with Alzheimer’s disease, a protein called beta amyloid clumps up and forms hard plaques between neurons in the brain. Until recently, these amyloid clumps could be seen only after a patient died and underwent an autopsy, when brain tissue could be sliced and viewed under a microscope. VA researchers associated with the Alzheimer’s Disease Neuroimaging Initiative (ADNI) are developing new tests to determine beta amyloid levels in the body, and several such tests are already in use in clinical trials. The goal is to enable early detection, which will become more important as new treatments become available. ADNI is led by a VA researcher and funded mainly by the National Institute on Aging.

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PAIN MANAGEMENT

Safe and effective treatment of pain has become a critical health issue in VA, driven by the high prevalence of musculoskeletal pain in Iraq and Afghanistan veterans, the variable management of pain in older veterans with chronic diseases, and concerns about excessive use of opiates and resultant overdose deaths in veterans with chronic pain.

VA has a National Pain Management Strategy to provide a system-wide standard of care to reduce suffering from preventable pain. VA researchers have played an integral role in shaping the strategy, which in turn helps to set the course for VA research and innovation in pain care.

As part of this strategy, VA researchers helped establish the VA Stepped Care Model of Pain Management. A recently funded multisite study will evaluate the effects of pain screening and assessment approaches in primary care settings. Researchers are also identifying and helping to address any disparities in veterans’ access to opioid therapy, non-medication treatments such as cognitive behavioral and physical therapies, and complementary and alternative approaches to treat or manage pain.

patients, including yoga, acupuncture, and meditation training. VA researchers are committed to filling in scientific gaps relating to these treatments to determine which CAM therapies are truly effective, and for which conditions and populations. Studies cover a range of common and promising therapies across a range of mental and physical health problems.

VA is also collaborating with the National Institutes of Health to support studies on effective non-pharmacological approaches to pain and symptom management in veterans with co-morbid physical and mental conditions.

This effort will provide a better understanding of how complementary approaches can be effectively integrated with regular care.

One study is examining the feasibility of conducting a trauma-sensitive hatha yoga intervention in female veterans with military sexual trauma and PTSD. Early findings showed that yoga may be acceptable to and preferred by many participants as an alternative to trauma-focused psychotherapy. Two other randomized controlled trials are underway to test mindfulness-based therapies: one targets suicidal thoughts, the other looks at reducing the risk of cardiovascular disease in women. Two additional PTSD studies are looking at the effectiveness of mindfulness-based stress reduction.

CANCER

VA researchers are conducting a broad array of research on cancers common in the veteran population. These include prostate, lung, colorectal, bladder, kidney, pancreatic, esophageal, and breast cancer, as well as lymphomas and melanomas. Researchers are conducting lab experiments aimed at discovering the molecular and genetic mechanisms involved in cancer. They also conduct studies looking at the causes of the disease, clinical trials to evaluate new or existing treatments, and research focused on improving end-of-life care, or bolstering caregiver support.

One highlight of these efforts is a new study that aims to enroll 50,000 veterans to compare colorectal cancer screening strategies. Colorectal cancer is among the most preventable of cancers. While colonoscopy is seen as the gold standard for screening, some recent findings raise questions about its effectiveness at preventing colorectal cancer deaths. A cooperative study (CSP #577 – CONFIRM) is comparing the value of screening colonoscopy to annual non-invasive fecal immunochemical testing for the prevention of colorectal cancer deaths over 10 years.

COMPLEMENTARY AND ALTERNATIVE MEDICINE

A growing number of VAMCs are offering complementary and alternative [medicine] (CAM) therapies to their

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What are your goals to accomplish at VHA by the end of this administration in 2017? And what is your longterm vision for VHA? What do you want to tell our readers about the Veterans Health Administration that we have not asked you in our previous questions?

Our “Blueprint for Excellence” outlines strategies for sustaining excellence within the system. Those strategies are to: • Operate a health care network that anticipates and meets the unique needs of enrolled veterans, in general, and the service-disabled and most vulnerable veterans, in particular; • Deliver high-quality, veteran-centered care that compares favorably to the best of private sector in measured outcomes, value, access, and patient experience; • Leverage information technologies, analytics, and models of health care delivery to optimize individual well-being and population health outcomes; • Grow an organizational culture, rooted in VA’s core values and mission, that prioritizes the veteran first, engaging and inspiring employees to their highest possible level of performance and conduct; and • Foster an environment of continuous learning, responsible risk-taking, and personal accountability.

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SPECIAL SECTION: VA Research INTERVIEWS VA Secretary Robert A. McDonald VA Under Secretary for Health David J. Shulkin VHA Chief Nursing Officer Donna Gage 2015-2016 Edition

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Creating High-reliability Health Care for Veterans Robin R. Hemphill, MD, MPH Acting Assistant Deputy Under Secretary for Health Office of Quality, Safety and Value VHA Chief Patient Safety and Risk Awareness Officer Gary L. Sculli, MSN, ATP Director Clinical Training Programs Patient Safety Program Manager At a Department of Veterans Affairs (VA) hospital unit, a nursing assistant notices a change in a veteran’s condition and immediately notifies a nurse. The nurse listens carefully to the assistant’s observations, then promptly assesses the veteran’s status. She detects low blood pressure, a rapid heart rate, changes in mental status, and a fever. Considering these elements together, she forms a “big picture” view of the veteran’s condition that indicates severe infection. She projects that, without immediate intervention, his condition will deteriorate rapidly. This process leads the nurse to contact a physician and request that the veteran be immediately transferred to a higher level of care, where specific drugs can be administered and intensive monitoring take place.

n THE ABOVE SCENARIO, where clinicians communicate effectively as a team, apply expert clinical knowledge, and enlist resources to effectively manage a patient’s care, shows what “high-reliability health care” looks like. The nurse on duty was open to feedback from a team member. Focused and aware, she recognized vital changes in the patient’s condition. She then processed new information on the spot, and clear about her hospital’s protocol, immediately arranged for transfer, thereby preventing further deterioration in the veteran’s condition, and, quite possibly, saving his life.

This heightened state of awareness, or situational awareness, is one of three skillsets taught in Clinical Team Training (CTT). Developed by the VA National Center for Patient Safety (NCPS), CTT infuses the principles of high-reliability organizations (HROs) into everyday health care to enhance patient safety. The program’s goal is to teach Veterans Health Administration (VHA) clinicians the skills necessary to: (1) effectively transfer and exchange patient information in a timely manner; (2) improve team decision-making in times of high and low stress; and (3) manage human error and threats to safety before they become harmful adverse events.

Together, these skills lead to high-reliability patient care.

Implemented by VHA emergency rooms (ERs), intensive

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care units (ICUs), operating rooms (ORs), and other hospital units, CTT has improved patient care, prevented adverse events, and saved veterans’ lives. At a time when VHA overall is working to transform patient care, CTT is already sparking culture change and creating engaged providers at VA hospitals nationwide.

ORIGINS OF CHANGE

“High-reliability,” a term also found in the “Blueprint for Excellence” (VHA’s strategic document for transformation), is a driving principle of CTT. HROs are organizations that have designed their systems to expect human error and to proactively manage or “trap” that error to avoid failure. In order to apply these principles to veterans’ health care, NCPS established its CTT program, with particular emphasis on developing high-performing clinical teams. Doctors, nurses, pharmacists, respiratory therapists, technicians, and ancillary staff are all part of the clinical team. While each has expertise in their particular discipline, working together and communicating effectively as a team takes practice.

At the core of CTT is crew resource management (CRM), an approach that originated with the airline industry during 67

THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

the 1980s. CRM “focuses on behaviors and strategies that are used by leaders and subordinates to ensure that effective teamwork and communication take place…”1 While clinicians are not pilots, and patients are not airplanes, CRM’s key concepts, methods, strategies, and tools are applicable to health care and have been successfully used by other health care organizations as well. In fact, the Institute of Medicine, in its 1999 landmark report “To Err is Human,” specifically recommended CRM as a means for improving patient safety.

CRM enables teams to effectively prioritize immediate needs, use resources efficiently, and communicate openly, all while working in the highly complex environment of health care.

Through CRM, communication is standardized, teamwork is enhanced, and clinical decision-making is improved.

VA’s journey toward becoming an HRO for patient safety began in the early 2000s when CRM training was required in all surgery departments. As part of that initiative, the VHA 68

embarked upon a pilot program that required routine use of briefing checklists both before and after surgical procedures.

Following the pilot program, VHA implemented checklist use nationwide through Medical Team Training (MTT, CTT’s precursor).

Further, as an early adopter of CRM, NCPS pioneered the specific application of this approach to VA nursing practice. In 2010, VHA piloted a program called Nursing Crew Resource Management, or NCRM. This program took the salient teamwork, communication, and decisionmaking strategies of CRM and tailored them for use at the front line of VA nursing units nationwide. The initial cohort, which consisted of 11 units in nine VHA facilitates, demonstrated improved clinical outcomes and staff perceptions of safety.

In 2013, NCPS consolidated several inter-related training efforts into CTT. Since that time, NCPS’s CTT program has

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PHOTO COURTESY OF OFFICE OF QUALITY, SAFETY AND VALUE

■■ A physician and nurse practice a simulation module during Clinical Team Training.

THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

trained clinical staff at approximately 80 individual clinical units in 50 VA Medical Centers (VAMCs) nationwide (see Figure 1.).

CTT’S CURRICULUM OF CHANGE

CTT’s curriculum emphasizes the development of three CRM skill categories: clinical leadership, situational awareness, and effective followership.

CLINICAL LEADERSHIP

The CTT program develops the skills of doctors and nurses who lead clinical patient care teams at the bedside or in the outpatient setting. As leaders, these professionals must be able to foster an environment that encourages timely communication of relevant clinical information among their team members. How can this be achieved? One simple strategy is for leaders, as part of a standardized briefing before a shift or a procedure, to invite team members to “speak up” if they have a concern about operational safety. Another strategy is for leaders to ensure that the team practices “closed loop communication.” This practice ensures that formal acknowledgments occur when important information (e.g., the time a medication was administered or a significant change in a patient’s condition) is exchanged among team members.

SITUATIONAL AWARENESS

In addition to the example cited earlier, situational awareness can be understood at its most fundamental level as “knowing what’s going on around you.” More specifically, situational awareness requires: (1) attention to elements in the environment; (2) understanding what those elements mean; and (3) making projections about the likely course of events in the immediate future. In the example described above, the nurse’s level of situational awareness was high, leading to appropriate decision-making.

During CTT, participants receive coaching on strategies and related tools that are used to manage threats to situational awareness in the clinical environment, such as distractions and high task load. One such strategy is the recognition of red flags which, when present, indicate a potential loss of situational awareness. For example, when a nurse administers oxygen to a patient having breathing difficulty, she expects that the patient’s condition will improve. If it doesn’t, this represents an “unmet target.” By deciding to investigate this red flag – and therefore not assuming the oxygen is being delivered – the nurse is looking more closely and intentionally at possible explanations or malfunctions in the oxygen delivery system. Another tool that serves as a method to regain situational awareness is the 1-2-3 Rule. This rule encourages the following: (1) ask team members to take a step back; (2) analyze the immediate situation; and (3) utilize all available resources (equipment, information, and people).

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Figure 1. Facilities Participating in Clinical Team Training (2013 to the present)

DEPARTMENT OF VETERANS AFFAIRS ADMINISTRATION MEDICAL CENTERS Albany, NY Alexandria, LA Amarillo, TX Asheville, NC Atlanta, GA Augusta, GA Beckley, WV Bedford, MA Birmingham, AL Bronx, NY Charleston, SC Cheyenne, WY Chicago, IL (Jesse Brown) Columbia, MO Columbia, SC Dublin, GA Durham, NC El Paso, TX Las Cruces, NM Fresno, CA Ft. Harrison, MT

Billings, MT Ft. Wayne, IN Hampton, VA Huntington, WV Lexington, KY Los Angeles, CA Madison, WI Manchester, NH Marion, IN Memphis, TN Montgomery, AL Mt. Home, TN Omaha, NE Portland, OR Prescott AZ Richmond, VA San Francisco, CA Shreveport, LA Tuscaloosa, AL West Haven, CT White River Junction, VT

EFFECTIVE FOLLOWERSHIP

Effective followership refers to the active participation of clinical team members who are not formal leaders. It is an especially important skillset in the area of patient safety, where being an effective follower may require speaking up to leadership. With this in mind, NCPS developed the Effective Followership Algorithm, a tool that provides clinical team members with a method for facilitating assertive communication, especially when hierarchy might normally preclude them from saying anything. The algorithm includes what is known throughout VHA as the 3Ws©: “Say what you see; say what you are concerned about, and say what you want to happen to keep patients safe.”

Notably, the 3Ws© have become part of a VHA-wide initiative known as “Stop the Line for Patient Safety.” The campaign empowers VHA employees at all levels and disciplines to speak up immediately if they see any risk to patient safety. The initiative also makes clear that employees who report patient safety concerns to team members, supervisors, 69

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■■ An aerial photograph of the Harry S. Truman Memorial Veterans’ Hospital in Columbia, Missouri. It is the first VAMC to implement CTT hospital-wide.

or VA leadership will be protected from retribution. VA Secretary Robert A. McDonald has endorsed the Stop the Line campaign, encouraging all VA staff to use the 3Ws. See video at http://www.qualityandsafety.va.gov/StoptheLine/ StoptheLine.asp

PHOTO BY JUSTIN KELLEY

ACHIEVING AND SUSTAINING CULTURAL CHANGE: STEP-BY STEP

Culture change starts when NCPS conducts its initial phone conversation with the participating VAMC’s top leadership. During this initial call, leadership must understand and agree that enrolling in CTT is a long-term commitment, one that must include leader engagement with the unit about to undergo training. Once that agreement is secured, CTT faculty meet with VAMC facility staff to identify specific

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concerns and challenges and thereby customize training.

NCPS then dispatches faculty comprised of physicians and nurses to conduct on-site training.

Listed below are some of the program’s key elements and milestones: • On-site training – Training consists of three interactive classroom modules and a fourth module that features the use of high fidelity human patient simulators (mannequins). The patient simulators are used to practice tools and strategies for effective leadership, followership, and situational awareness.

• Project implementation – Clinical units implement a quality/safety improvement initiative at the front line over the course of one year. Examples of such projects include the implementation of a team briefing, use of a procedural checklist, or the reduction of distractions during the completion of 71

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

a critical task such as administering medications. Progress and outcomes are tracked via regularly scheduled teleconference calls with the unit and NCPS. • Cultural analysis – Formal assessment of the unit’s safety culture is taken at the start of the training, then at six months and again at one year. The measurements show the degree to which specific high-reliability behaviors are practiced and how staff attitudes about teamwork, team communication, and overall safety have improved.

• On-site repeat (refresher) training – CTT is about promoting the high-reliability behaviors among clinical teams.

High-reliability industries never stop training front line staff; therefore, NCPS returns to the facility at the one-year point to repeat the training.

• Sustainment – Unlike other processes and methods, CTT is about standardizing behavior so that change becomes a way of working, and is sustained over time.

BETTER OUTCOMES IN VETERANS’ HEALTH CARE

Over the years, specific elements of the CTT program have been analyzed to measure the strength of their effect on patient safety. The results have been overwhelmingly positive.

For example, CTT participant groups exposed to the Effective Followership Algorithm during classroom modules and simulation practice demonstrated significant improvements in safety attitudes, ratings of self-efficacy, and clinical teamwork. In one VAMC, when the sterile cockpit principle was applied to medication administration, medication-related errors decreased by nearly 43 percent. (The sterile cockpit principle reduces distractions during crucial or safety-sensitive tasks.) On one inpatient intermediate intensive care unit, the introduction of a Read-and-Do Checklist was associated with significant increases in the frequency of activations of rapid response teams as well as a significant decrease in failure to rescue events (the latter refers to instances where patients die from conditions and complications not present upon hospital admission).

One of the most dramatic findings about CRM training to improve patient safety came from a study about surgical mortality. The study, which looked at deployment across more than 100 VAMC facilities, found that departments which had already undergone training saw an 18 percent reduction in annual surgical mortality, whereas departments yet to receive the training showed only a 7 percent reduction.

As part of a “Hospital of the Future” Project, the Truman VAMC is partnering with NCPS to become a high-reliability hospital. This joint project includes multiple initiatives, such as use of Leadership Walk rounds and the establishment of a Just and Fair Culture (where staff feel free to report honest errors and safety concerns without fear of reprisal and also have established transparent accountability principles). The addition of a hospital-wide CTT program to this effort, says Truman VAMC Director Wade Vlosich, is a “key step in our journey to achieving high-reliability care for our nation’s heroes.” Because communication and team decision-making are major causes of adverse events and harm involving hospitalized patients, Vlosich’s goal via CTT implementation is to standardize communication and improve teamwork not only within specific departments, but also across departments and throughout the facility. He has therefore designated CTT as a top priority for all clinicians from all disciplines at Truman.

“For our facility to be successful,” he says, “the staff need to know that leadership is 100 percent behind them. I have and will continue to be closely involved in rolling out Clinical Team Training, and will make sure that our staff have the resources they need to be successful.” The Truman VAMC’s “Hospital of the Future” Project plans to implement CTT quarterly starting in 2016 and continuing through 2019. By partnering with NCPS and implementing CTT in all clinical areas to all disciplines over a three-year period, the Truman VAMC has committed to becoming a HRO. CONCLUSION

CTT AND “THE HOSPITAL OF THE FUTURE”

In its preamble, the “Blueprint for Excellence” states that “although the covenant with veterans is immutable, health care evolves and so must VHA.”2 With origins reaching back to the early 2000s and implementation at 50 VAMCs, CTT demonstrates how VHA’s patient safety program has not only kept pace with change, but emulates a model for other VHA programs to follow. By aspiring to become an HRO for patient safety, VHA has successfully used CTT to achieve the type of culture change that leads to standardized communications, high-level clinical teamwork, and the safest care possible for veterans.

To learn more about the CTT program, or to arrange for a presentation about CTT, please contact Gary L. Sculli, Clinical Team Training Program Director, at vhancpsctt@va.gov. To learn more about the Truman VAMC “Hospital of the Future” Project, please contact Timothy Anderson, Supervisory Patient Manager, at timothy.anderson@va.gov.

To date, culture change through CTT has been implemented one VAMC medical unit at a time. As this article goes to press, one VAMC recently has become the first to implement CTT hospital-wide, and with top leadership involved at the most basic levels of program administration: the Harry S. Truman Memorial Veterans’ Hospital in Columbia, Missouri.

Sculli GL, Fore AM, Neily J, Mills PD, and Sine DM. The case for training Veterans Administration frontline nurses in Crew Resource Management. JONA, 2011;41: 524-530.

2 U.S. Department of Veterans Affairs, Blueprint for ExcellenceVeterans Health Administration, Washington, DC, 2014.

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

VA & Military Health Benefits n DEPARTMENT OF VETERANS AFFAIRS (VA) scandals, attempts to increase TRICARE costs to patients, especially prescriptions, reductions in numbers of active-duty service members combined with tight budgets, and the highest number of new veterans relying on VA medical care since Vietnam have raised concerns throughout the military and veteran communities about the future of health care for them and their dependents.

One of the most public complaints with respect to VA medical services in recent years has been long wait times to secure appointments. That is not only a VA issue, however. Maj. Vu Q. Nguyen, program manager of the Primary Care Service Line at the U.S. Army Medical Command (MEDCOM) Soldier-Centered Medical Home at Joint Base San Antonio, Texas, said it “remains an issue for all the services.”

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“We understand the issues facing the VA, but we are trying to provide multiple options for our patients. It’s not an easy problem, but is less of an issue for our active duty population.

If a clinic has 10 patients, half active duty, those five would be pushed to the front for care. Retirees and dependents would be seen by network providers, where necessary. We call it a ‘pop-off valve’ – if we are short on providers for whatever reason, we will allow more patients than usual to be seen by the network,” he said.

“A lot of that is due to the increase in our beneficiary population due to the past years of war. But making sure our soldiers and dependents are seen always has been and remains a primary focus, whether [they are seen by] civilian providers or those working for us. Certain locations are healthy enough

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U.S. MARINE CORPS PHOTO BY LANCE CPL. JACOB D. BARBER

By J.R. Wilson

THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

■■ OPPOSITE: Capt. Lucas Frokjer, officer in charge of the flight line for Marine Heavy Helicopter Squadron 463 (HMH-463), reunites with his family after returning from a seven-month deployment with HMH-463. A number of factors have put added stress on the military health care system and aroused concerns among service members and veterans.

to handle that, but in some others, we depend heavily on active-duty providers. But for all intents and purposes, we do meet care needs, including the use of the Nurse Advice Line, online scheduling, and other avenues where the patient can reach out.”

Both military and VA officials insist overall care actually is improving, despite some high-profile glitches in recent years.

“Since 2001, new programs have been added, including TRICARE for Life, TRICARE Reserve Select, and TRICARE Retired Reserve, as well as ramping up coverage in behavioral health,” according to Bill Voelkner, program analyst for Health Plan Management in the Office of the Army Surgeon General (OTSG). “So Congress has allocated additional benefits in statutory TRICARE benefits in this time frame.

“Active duty receive the bulk of their care in the MTF – Military Treatment Facility or direct care – or network providers; dependents have the option of standard [intraservice] or TRICARE Extra or TRICARE Prime. In Extra, costs are a little less because they see network providers; Standard gives access to out-of-network providers. There is never a cost for active duty, but there may be for dependents, depending on what care they use.”

Managed by the Defense Health Agency under the Assistant Secretary of Defense (Health Affairs), TRICARE provides health care services for almost 9.5 million beneficiaries worldwide. That includes active duty members of all seven U.S. uniformed services – Army, Navy, Air Force, Marine Corps, Coast Guard, Commissioned Corps of the U.S. Public Health Service, and the National Oceanic and Atmospheric Administration – National Guard and Reserve service members, retirees, their families, survivors, certain former spouses, and others registered in the Defense Enrollment Eligibility Reporting System (DEERS).

TRICARE was phased into existence between 1994 and 1997 as a replacement for CHAMPUS (Civilian Health and Medical Program of the Uniformed Services), which had been in effect since 1966. Since then, it has gone through a number of reorganizations, until today it comes in a wide range of program options for health care, dental, and pharmaceutical services (see sidebar).

“It’s a very robust plan compared to the coverage of other health care plans, especially in terms of the cost to the recipient. What we have attempted to do, as we draw down, is pay close attention to maintain our medical capabilities to support future conflicts. So as some of our MTFs get smaller and we are unable to maintain the skill sets of all our military

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providers, we are looking to put them into those facilities that will maintain their skills and abilities,” Lt. Col. Tammie Jones, OTSG Senior Health Policy Officer, said.

“There is scrutiny from all levels to make sure we are running an efficient health care operation. We run routine performance reviews against national standards, evaluating quality and effectiveness of the care we deliver. We’ve also looked at where we have health care facilities and make sure there is still a need to deliver what has been historically delivered at each of those and where we may have less need for the type of care we have been giving as units have moved from one base to another, for example.”

Jones adds the benefits for dependents differ little from pre-9/11.

“If anything, there have been increases in coverage of certain things. Telehealth is an example, with increasing capabilities to reach out to active duty service members and dependents. DOD [the Department of Defense] also added, in August 2014, a Nurse Advice Line that gives all recipients access to expert advice when some of our smaller clinics are not open for urgent care situations,” she said.

There have been recommendations for significant changes in recent years, but to date those have been rejected by Congress. Nor do OTSG officials expect any major changes in direct coverage or benefits in the next five to 10 years, although increased cost scrutiny and planned reductions in the size of the military services could have impacts.

“That changes the scope of what we deliver in our MTF, where we must ensure we deliver the proper scope of care.

So if we only deliver a handful of babies a month, it might be better to provide that outside the MTF because our nurses and doctors may not be getting enough continuing experience,” Jones said.

“Most discussion is on cost-share involved in various care.

There have been some increases in non-active duty pharmacy fees and increased enrollment fees for TRICARE Prime enrollees under age 65. DOD does not have the authority to make changes in these statutory benefits without the agreement of Congress,” Voelkner said.

Ever-tighter federal budgets and military force downsizing are concerns throughout the services, requiring greater diligence in the use of what funds are available. That also applies to health care, but, so far, not as seriously.

“In terms of its effect on medical readiness, that is our primary mission and the last thing that would be affected. So if it hurts anything, it would be the other aspects – beneficiaries and retirees,” Nguyen said.

“Has it affected our ability to deliver care globally? No. Where it has been tightening has been extraneous items, such as funding for providers to go to medical conferences, which has gone away. But, overall, in terms of our focus, we haven’t seen much detriment and, in terms of dependents and retirees, they still get the same level of care and we’ve tried to augment that by rolling out new tools.”

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U.S. AIR FORCE PHOTO BY AIRMAN 1ST CLASS ALEXXIS PONS ABASCAL

THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

Blast injuries – from severe burns, especially to the face, to amputations – have become a major expansion of military health care in recent years. But not the only one.

“That was another significant change, using case management to keep track of complex patients coming back with multiple conditions – amputations, PTSD, and so on – that we had to learn to address. That changed the shape and development of the Warrior Transition Command, which is associated with the Army Medical Department, but a separate command,” Jones explained.

Operations Iraqi Freedom and Enduring Freedom (OIF and OEF, respectively) also saw a major change in the role of women in the military – and their active duty and subsequent VA health care needs.

The Army’s Soldier Centered Medical Home (SCMH) uses primary care doctors and nurses to provide all-out patient services for active duty personnel, dependents, and retirees.

“It focuses on active duty soldiers; there are two others, one for dependents and one for retirees. The community-based homes, for dependents, tend to be off-base, while the other two tend to be located with every military medical facility,” Nguyen said.

“This is all relatively new. The original operations order was sent out in 2009, saying we would go toward transitioning our clinics to the medical home model concept outside the civilian sector, where the concept already had been shown to work well. There also is a Navy patient center version and an Air Force medical home structure.”

That is among a number of new tools and initiatives from MEDCOM in the past couple of years.

“For example, the Army Medicine Secure Messaging Service, part of our Relay Health Initiative, allows patients to contact their primary care nurses and providers for medical refills; if the doctor is comfortable with that, it can be refilled without an appointment. Or the patient can ask questions that don’t really require an appointment, giving better access to medical information,” he said.

“There is another initiative, still in its infancy, called telemedicine, where instead of an office visit, a remote patient can set up a video conference with a provider, ask questions, and set up a treatment plan. We’re in the initial phase of testing its applicability to our patient population,” Nguyen said, adding it also is seen as helping with the long wait for care issues.

Telemedicine, a term used interchangeably with telehealth in Army medicine, is a growing component in military health care, for both active duty and veterans. It employs interactive audio/video technology to provide clinical consultations and office visits when appropriate and medically necessary. Most recently, that includes a U.S. network of telemental health care originating sites for beneficiaries and networks of offsite providers who can evaluate and treat patients by video. This TRICARE benefit covers all aspects of behavioral health services, including psychotherapy and medication management.

Telemedicine also is used to deal with emergency situations involving the military. One such instance was the 2009

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■■ U.S. Air Force Staff Sgt. Dena Levari, 27th Special Operations Medical Operations Squadron NCOIC of immunizations, prepares to vaccinate 2nd Lt. Jose Valadez, 27th Special Operations Aircraft Maintenance Squadron, with GARDASIL® in the clinic at Cannon Air Force Base, New Mexico, May 29, 2012.

shootings at Fort Hood, Texas, in which 13 unarmed soldiers were killed and 30 wounded by Maj. Nidal Malik Hasan, an Army psychiatrist.

“When the Fort Hood shootings happened, we were there with telebehavioral, piping in psychiatric workers from all over the world, which enabled health assets on the ground to take care of the most critical needs,” Colleen Rye, Ph.D., chief of the OTSG’s Telehealth Service Line, recalled. “We’re very much down the [telehealth] road and have a rich history reaching back at least 20 years; much of the telemedicine you see in the world today originated in MEDCOM. “We have about 45,000 provider-to-patient and providerto-provider consultations around the world, strategically located to cover deployed needs. About 88 percent of those in FY 14 were telebehavioral health, of which 10 percent are teleconsultations – specialty providers helping each other.

For example, if you have clinicians at Kwajalein [Atoll in the western Pacific] facing something with which they are not up-to-date, they can upload the information and a specialist anywhere in the world can look at photos or X-rays or other information and provide the best Army medicine has to offer.”

Army telehealth officials talk regularly with the VA, which has been heavily involved with telemedicine for many years.

Rye’s office also meets weekly with their partners in the combatant commands to exchange lessons learned and with the Air Force and Navy chiefs of telemedicine.

“We have an effort to meet at least once a week to talk about joint issues. The Army already reaches out to other 77

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services, especially for our teleconsultation system, which is used by all the services, and we have agreements for telemedicine of various types. It’s a very collaborative environment,” Rye explained.

“Our current system also is still facility oriented, although we are working toward moving to the home, but we have some restrictions to deal with first. If someone lives near a small facility that does not have the specialists they may need, they can connect with a specialist using their facility’s telehealth system. We operate across 18 time zones, so there is a likelihood there are teleservices going on 24 hours a day.”

Most patient contact is done by psychiatrists and clinical psychologists for telebehavior, while others are more of a mixed bag, she added.

“We have future plans that anticipate greater inclusion of nurses and technicians, especially as we get more into telehealth monitoring. We are planning for remote home monitoring in the future, which would include sensors taking vital signs, blood sugar levels, etc., that will allow us to keep an eye on our patients and keep them healthier. That all ties into the Surgeon General’s focus on what she calls the ‘life space,’” Rye said.

“We also have several training modules, focusing on two specific areas.

One is policies and procedures, such as differing legal requirements. We want to make those … standard as our military personnel change stations every two or three years. The second is ‘connect and communicate,’ which looks at what it takes to develop rapport with the patient online that differs from personto-person, such as where the provider is looking while on camera.”

The Telehealth Service Line also is partnered with the Integrated Disability Evaluation System, enabling the use of telehealth to help service members deal with a lot of the requirements involved in transitioning from military health care to the VA without the need to travel as much.

“We see the future of Army telehealth as a connected, consistent patient

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TRICARE PLANS n TRICARE Prime – includes: n TRICARE Prime Remote and Prime Remote for Active Duty Family

Members – managed care option available in remote areas in the United States, usually more than 50 miles (or one hour’s drive time) from a military hospital or clinic. n TRICARE Young Adult Prime, Prime Overseas, and Prime Remote covers: n Active duty service members and their families n Retired service members and their families n Activated Guard/Reserve members and their families n Non-activated Guard/Reserve members and their families who qualify for care under the Transitional Assistance Management Program n Retired Guard/Reserve members (age 60 and receiving retired pay) and their families n Survivors n Medal of Honor recipients and their families n Qualified former spouses

n TRICARE Standard and Extra and TRICARE Standard Overseas A fee-for-service plan available to all non-active duty beneficiaries; Standard Overseas has higher out-of-pocket costs than the overseas Prime options

n TRICARE for Life Secondary coverage to TRICARE beneficiaries who have both Medicare Parts A & B.

n TRICARE Reserve Select Premium-based health plan for qualified National Guard and Reserve members

n TRICARE Retired Reserve Premium-based health plan for qualified retired Reserve members and survivors

n TRICARE Young Adult Premium-based worldwide health plan for qualified adult children of eligible sponsors

n U.S. Family Health Plan Option available through networks of community-based, not-for-profit health care systems in six areas of the United States for: n Active duty family members n Retired service members and their families n Family members of Activated National Guard/Reserve members n Non-activated National Guard/Reserve members and their families who qualify for care under the Transitional Assistance Management Program n Retired National Guard/Reserve members (age 60 and receiving retired pay) and their families n Survivors n Medal of Honor recipients and their families n Qualified former spouses

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experience. We have just begun a three-year telehealth expansion plan that creates a 360-degree care continuum. We’re trying to augment our current system to work with partner nations,” Rye continued. “At the end of the day, we will have a single global telehealth platform that connects everyone from battlefield to bedside, providing telehealth expertise wherever and whenever it is needed.

“Remote health monitoring using advanced biometric devices will have a significant impact on our ability to reach patients wherever they live and work, especially those with chronic conditions. One of our evaluations shows 70 percent of patient encounters with deployed assets in a combat zone would not have happened without telehealth. In that particular theater, travel is very difficult, and when providers did go out to see patients, they often got stuck due to weather or combat problems and patients elsewhere on the route had to postpone or skip their meetings. We’re looking at ways to leverage telemedicine further in those kinds of situations.”

That is being done within what MEDCOM calls an operating company model. The Surgeon General established the service line to promote and support telehealth, developing tools and programs to push it out to health care centers, making it faster and more standardized so a patient gets the same services in Guam as in Virginia.

“Our capabilities today are more robust, with more services and entryways into primary care. Many of our clinics offer in-house clinical pharmacists, physical therapy (PT), dieticians, case management for active duty, consultants who work with the primary care team,” Nguyen said.

“If an active duty soldier sustains an ankle injury during training, he would be referred to PT within the clinic, but also might be set up with a nutritionist to lose some weight, see a clinical pharmacist to ensure there are no complications with any pain medications prescribed, etc. In the past, those operated separately and independently; today that care is more coordinated and located in one location rather than sending the patient to multiple facilities. That means a lot more capability for primary care than a decade or two ago.”

The SCMH is a major change from how military medicine was conducted in the past, where having primary doctors as gatekeepers created bottlenecks. Now the patient is the focus through and around which everything flows, he added.

Providers are no longer gatekeepers, but part of a larger corps of caregivers, including nurses, physical therapists, dieticians, behavioral health consultants, case management for long-term care – a whole team talking to each other with the patient at the center.

Nguyen said such changes serve two purposes – getting soldiers ready for deployment as healthy as possible and ensuring those leaving service do so with complete and upto-date health records.

“All separating service members, including Reserve and National Guard activated longer than 30 days, undergo a full head-to-toe exam. That’s how we ensure we haven’t neglected

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anything or the soldier hasn’t told us about any problems before being released into the general population. We started that 1 April [2015] for active duty and will officially start for the Guard and Reserve on 1 Jan. 2016,” he said.

“We’ve asked the VA to join us in doing the separation health exam; if the soldier plans to apply for VA benefits, then they don’t have to do two exams but would get their separation physical from the VA. The VA is still working on that, but we’ve already implemented those exams on the military side.”

The Army Reserve, aside from those receiving care through the VA, has a different take on telehealth.

“At this time, the Reserve does not employ any telemedicine or telehealth care because we have a number of providers through TRICARE Select or on active duty with TRICARE Prime,” according to Army Reserve deputy surgeon for Health Affairs, Policy & Fiscal Administration Col. Joe Ignazzitto. “There is eligibility for telehealth for 180 days after return from deployment.”

Although the Reserve does not have its own system of doctors and nurses, it does have medical personnel in its ranks.

“Our Reserve physicians, nurses, combat medics, and other health care personnel routinely work in a civilian setting, but focus on the military environment during their weekend duty and drills,” he said. “When a reservist is on duty more than 30 days, dependents are eligible for benefits; whenever a reservist is on duty, he/she is referred to a military medical facility, where they are seen the same as an active duty soldier.”

The Army Reserve Medical Management Center, under the Defense Health Agency, is a centralized process that casemanages Reserve soldiers from their point of injury.

“Today’s medical benefits for reservists are head-andshoulders above where they were in the past. We ensure all the benefits available to service members are available to reservists and [ensure] the highest medical readiness of our soldiers to call to combat. The good news is we continue to improve, both internal to the Army Reserve and DOD-wide, and that all checks and balances are done so those programs are in place for reservists as well as active component soldiers,” he said.

“The Army Select Medical Readiness Program started in 2009 to improve the overall readiness and health of our soldiers. There was no health benefit available [for reservists] until TRICARE Reserve Select went into effect in the Defense Authorization Act of 2005. Current law says the Army Reserve will go down to 195,000, but I’ve seen nothing indicating that will diminish any health benefit an Army Reserve soldier is entitled to receive.”

New approaches to delivering health care to everyone who is or has served and their dependents – from a variety of plans to meet a variety of needs and circumstances, to implementing the latest technologies to assist both patients and providers – have dramatically changed the face of DOD and VA health services.

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

3-D Bioprinting Many challenges remain for game-changing technology

By J.R. Wilson

n IT HAS BEEN CALLED the “poor man’s replicator,” but since the first tentative effort at additive manufacturing (aka 3D printing) by Hideo Kodama of Japan’s Nagoya Municipal Industrial Research Institute in 1981, the real-world technology already has advanced to capabilities rivaling the Star Trek series’ ubiquitous replicator.

The first real boost came in 1984, when Chuck Hull of 3D Systems, Inc. used Kodama’s work as the base on which he created a prototype for stereolithography, a process in which layers of material – at the time, limited to photopolymers – were shaped using ultraviolet lasers. In subsequent years, the process was used on other plastics, then metals, paper, sand – even chocolate. And where early items were bland in terms of color, the process grew to allow the use of multiple materials and multiple colors in the creation of a single item.

Originally pursued by industry to build rapid and more accurate prototypes, 3-D printing has evolved to produce the final product, as well. The materials available have grown more numerous, the types of products produced more diverse and the printers both more capable and dramatically less costly with each passing year.

Led by military medical requirements, that now includes “printing” bone, teeth, entire jaw structures, and even skin.

In August 2015, the Food and Drug Administration approved the first 3-D-printed prescription pill for consumer use, an anti-seizure medication for epileptics.

Three months earlier, L’Oréal USA, the largest subsidiary of the global beauty products giant, announced a partnership with Organovo Holdings, Inc. to leverage the latter’s proprietary NovoGen BioprintingTM Platform and L’Oréal’s expertise with human skin to develop 3-D-printed skin tissue for product evaluation and advanced research.

“We developed our technology incubator to uncover disruptive innovations across industries that have the potential to transform the beauty business,” Guive Balooch, global vice president of L’Oréal’s Technology Incubator, said at the time.

“Organovo has broken new ground with 3-D bioprinting, an area that complements L’Oréal’s pioneering work in the research and application of reconstructed skin for the past 30 years. Our partnership will not only bring about new advanced in vitro methods for evaluating product safety and performance, but the potential for where this new field of technology and research can take us is boundless.”

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One possibility immediately put forth was eventual 3-D printing of skin grafts for burn patients, rather than using slices of healthy skin from unaffected areas of the patient’s own body, a forerunner to using living cells to bio-print replacement tissues and organs. The Wake Forest Institute for Regenerative Medicine (WFIRM) already has successfully used its 3-D printer to produce ear and finger bone scaffolds and even a prototype kidney, although the latter was nonfunctional because it lacked the intricate inner cellular structures required for a functioning kidney.

In an article written for the February 2015 issue of Mechanical Engineering magazine, Institute Director Anthony Atala and Chief Scientific Officer Dr. James Yoo said they used the same “recipe” previously employed to engineer human organs and tissue by hand to produce bone, cartilage, blood vessels, cardiac tissue, and heart valves for clinical use.

“The ultimate goal is to print complex organs such as livers and kidneys for transplant and to create composite tissues made up of skin, muscle, tendon, nerves, bone and blood vessels for reconstructive surgery,” they wrote. “The advantages of printing tissues, rather than engineering them by hand, are many.”

“Printers allow the proper placement of multiple cell types, biomaterials and bioactive molecules in defined locations.

They also offer the ability to control the size, microarchitecture and interconnectivity of pores in the scaffolds essential to transporting oxygen and nutrients for cell survival. The technology also offers the option of using a patient’s medical images, such as MRI or CT scans, to tailor-make organs.”

WFIRM is leading the Armed Forces Institute of Regenerative Medicine: Warrior Restoration Consortium, known as AFIRM II, funded through a cooperative agreement with the U.S. Army Medical Research and Materiel Command, the Office of Naval Research, the Air Force Medical Service, the VA Office of Research and Development, the National Institutes of Health, and the Office of the Assistant Secretary of Defense for Health Affairs.

AFIRM II follows the path set by the original AFIRM program, first funded in 2008 with a focus on limb, burn, craniofacial, and scarless wound repair and compartment syndrome, moving projects through advanced development to speed innovations to patients who needed them.

In reviewing its future efforts, independently and with AFIRM, WFIRM is looking at how 3-D printing can be employed to help provide the complex tissue components

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PHOTO COURTESY OF WFBH PHOTOGRAPHY

THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

needed to deal with craniofacial trauma, a debilitating injury due to the important functional and aesthetic roles of the face and skull. Injuries from blasts and high-velocity projectiles, common from combat in Iraq and Afghanistan, are difficult to repair with current methods, requiring more imaginative ways to generate replacement bone, nerves, blood vessels, fat, and muscle.

The potential applications of this rapidly developing new technology include treating active-duty service members and veterans, from the first medical treatment facility (MTF) in theater to both major and remote hospitals and clinics in the United States and around the globe. For example, eye surgeons at Hong Kong Polytechnic University are using extremely accurate 3-D-printed customized molds to repair fractured eye sockets and achieve higher success and faster recovery rates for implant surgery.

“Apart from using ready-made implants, which is the most common surgical approach at present, 3-D printing has provided us with an alternative and more precise way to reconstruct different orbital bones,” according to Dr. Kelvin Chong, assistant professor at the Chinese University of Hong Kong (WHK) Department of Ophthalmology and Visual Science and coordinator of Orbital and Oculoplastic Surgery Service at two hospitals: WHK and Prince of Wales Hospital Eye Centre. “Customized molds can be 3-D-printed within three to four hours and we can simply press the two halves together to create the necessary shape.”

The most prolific user of 3-D-printed replacement body parts is dentistry, with an estimated one million dental parts printed and implanted worldwide.

Again, the U.S. military has been a leader in this arena as it sought to deal with one of the least publicized but most common combat injuries of the past 15 years – IED blasts that caused serious facial damage, in some cases resulting in the loss of teeth, jaws, and related structures.

Using extensive dental records and facial X-rays now taken before any service

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■■ At the Wake Forest Institute for Regenerative Medicine (WFIRM), a 3-D printer seeds different types of cells onto various scaffolds including ear cartilage, finger bone, and kidney.

member is deployed, Army dental labs are able to rapidly 3-D print highly accurate crowns, bridges, jaws, and a range of other orthodontic appliances.

“Global Dental 3D Printing Market Outlook: 2014-2020”, a market research report from Meticulous Research, predicts a compound annual growth rate of 23.3 percent in the global dental 3-D printing market by the end of 2020.

DOD – and especially the VA – are expected to be among the leaders in that market.

The two biggest obstacles to 3-D printing of complex organs, such as hearts, eyes, and kidneys, are vascularization – the networks of veins, arteries and capillaries required to nourish a functioning body part and filter out waste – and tissue rejection, in which the body sees an implant as a dangerous foreign invader and marshals whatever efforts are needed to destroy it.

Dental and hip implants and prosthetics, however, rely on bone tissue rather than vascularization and so

are leading the way in 3-D-printing of body parts. To date, other successful efforts have produced 3-D printed ears, skulls, arms, and legs (but not fingers due to required nerve endings and blood flow), hip implants, and breast tissue (used with scaffolds to regenerate fatty tissue in women with mastectomies).

The 3D Medical Applications Center (3DMAC) at Walter Reed-Bethesda National Military Medical Center provides computer aided design (CAD) and computer aided manufacturing (CAM) for fabrication of medical models and custom implants, technical support for virtual treatment planning, and image capture in support of patient treatment, graduate medical/dental education, and research. 3DMAC serves the Medical Center, Uniformed Services University of the Health Sciences, Naval Postgraduate Dental School, DOD MTF/dental treatment facilities, other federal entities, and worldwide allied medical institutions.

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PHOTO COURTESY OF WFBH PHOTOGRAPHY

■■ Young-Joon Seol of Wake Forest Institute for Regenerative Medicine (WFIRM) demonstrates bioprinting muscle tissue in the Richard H. Dean Biomedical Building (A1).

Services include custom implants, from polymethyl methacrylate (PMMA) cranial plates to custom titanium and other reconstruction plates.

3-D printing also has been used to create inexpensive, but functional, robotic hand and arm prosthetics for some 1,500 children around the world.

3-D printing is being combined with other new technologies to create a host of new possibilities in medicine, but also advanced laser technology, microscopy, solar cells, electronics, environmental testing, disease detection, and more.

Researchers at the Wyss Institute for Biologically Inspired Engineering at Harvard University, for example, recently created a way to form prescribed shapes and dimensions using 3-D-printed metal nanoparticles and DNA as a construction mold.

Wyss researchers have been pursuing the combined potential of 3-D printing and DNA nanotechnology for years.

“The properties of DNA that allow it to self-assemble and encode the building blocks of life have been harnessed, repurposed, and re-imagined for the nanomanufacturing of inorganic materials,” Wyss Institute founding director Dr. Don Ingber explained. “This capability should open up

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entirely new strategies for fields ranging from computer miniaturization to energy and pathogen detection.”

In April 2015, 3-D printing took center stage at the Co-Engineering the Future of Healthcare global conference in Brussels. It also has become a growing topic of discussion at medical conferences, industry shows, corporate and academic research proposals, congressional funding requests, and even popular TV talk shows.

“If functional human tissue printing – livers, heart, ears, hands and eyes – turns out to be a reality, then it is indeed going to be a potential game changer. With the current advancements in 3-D printing technologies for customized fabrication of complex polymer-based objects, there is much focus on adapting 3-D printing technologies for health care applications. This has aroused interest in engineering bioprinting devices that can develop 3-D structures and, at the same time, accommodate the incorporation of living cells,” according to a January 2015 Frost & Sullivan report – “3D Printing Reshapes Healthcare and Medicine” – by health care research analyst Swathi Allada.

Although the health care industry historically has been a late adopter of electronics and digital applications, the 85

THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

industry has embraced 3-D printing with great speed and enthusiasm, seeing it as a specialized technology with almost universal applications. In that respect, it is seen as a truly “disruptive” technology with potential implications far beyond computers, the Internet, and robots.

“In the near future, 3-D printing technology will be able to address the global shortage of organs for transplant. The medical industry is focusing all its resources into developing technologies and prototypes that will transform this idea into a reality. It is expected that, in the near future, strips of printed tissue will soon be advanced enough to test new drugs under development,” Allada wrote.

“Alongside human tissue, 3-D printing technology can be used to develop body parts. 3-D printing has been used for pioneering work on foetal medicine apart from usage in orthotics, prosthetics printing and surgery planning.”

Frost & Sullivan predicts the medical industry will see large-scale adoption of 3-D printing by 2018, but also warns of side effect impacts concerning legal liability issues, disruption to medical device supply chains, government regulations (what agencies, what regulations, how quickly both can be resolved), copyright and patent claims and counterclaims, and even ethical and moral questions.

“It can be expected that in another decade, 3-D printing will be able to address most of the unresolved healthcare

ATTENTION:

issues we have now. With the convergence of nanotechnology and genetic engineering, it can be expected that it will play a significant role in life extension,” Allada concluded.

“Though some of the future applications may sound bizarre and absurd, it will ultimately rest on the technology developers and adopters to decide which applications are to be pursued and which rejected. From the vast scope for application of the technology, it is expected the health care industry will be one of the top industries in driving the growth and adoption of the 3-D printing market in the next decade.”

Atala and Yoo identified three primary approaches to 3-D bioprinting, all of which, individually and in combination, probably will be required to print complex 3-D biological structures: 1. Biomimicry – manufacturing structures identical to the cellular and extra-cellular components of a tissue or organ; it requires duplication of the organ’s microenvironment as well as form and structure 2. Autonomous self-assembly – based on natural embryonic organ development, where the cell drives tissue formation through the production of extra-cellular matrix and autonomous organization and patterning, which require detailed knowledge of the developmental mechanisms of embryonic tissue and organs 3. Mini-tissues – a combination of biomimicry and selfassembly; organs and tissues are composed of smaller,

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functional building blocks that can be fabricated for assembly into larger structures “As the field of bioprinting moves forward, new types of printers will likely be designed to meet the goal of printing functional replacement organs,” they wrote. “Currently, there are three main printer types used to deposit and pattern biological materials – inkjet, microextrusion and laserassisted. In addition, our institute has designed a system that is integrated, allowing for the printing of both solid and flexible materials.”

Inkjet printers – originally commercial desktop models modified with a third axis and ink replaced with a biologic material – deliver controlled volumes of liquid to predefined locations.

Inkjets have been used in preclinical studies to regenerate functional skin and cartilage and fabricate bone constructs.

Microextrusion printers use mechanical or pneumatic dispensers to extrude continuous material segments. Structures first are printed in 2-D with hydrogel, then solidified – either physically or chemically – for combining into 3-D shapes.

The principles of laser-induced foreign transfer comprise the third printer type – laser-assisted bioprinting – using a focused pulsed laser beam and a “ribbon” with donor transport support, a layer of biological material and a receiving substrate. To date, they have successfully been applied to biological materials such as peptides, DNA, and cells.

“As scientists move away from hand-fashioning scaffolds to bioprinting them, additional biomaterials will need to be identified. The material must not only be printable, but also must be compatible with the body and support cellular attachment, proliferation and function,” the Wake Forest researchers noted.

“Also important is how quickly the material will degrade in the body. The degradation rates of the scaffold must match the cells’ activity in building a ‘home’ from their own extracellular matrix, the molecules they secrete to provide structural and biochemical support.”

The material used must be based on the required mechanical properties of each structure, whether skin, bone, or liver.

“While numerous biologic tissues have been printed and tested pre-clinically, challenges remain to further develop and harness 3-D printing technologies for more complex tissues and organs. As scientists move away from modifying existing printers and begin to design new technologies, the range of materials can be extended and methods to deposit materials and cells with increasing precision and specificity can be developed,” Atala and Yoo wrote.

Future focus areas to achieve that include developing new biocompatible materials able to withstand external stress and maintain their shape after implantation; improving printer resolution to duplicate the detailed inner architecture of complex organs; creating new ways to vascularize and innervate 3-D-printed tissue and organs, especially complex volumetric organs; increasing printer speed while overcoming current issues of extrusion-based cell damage; and

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developing in vivo bioprinting for real-time tissue regeneration at the point of injury or during surgery.

The VA conducted a two-day “Make-a-Thon” July 29-30, 2015, hosted by the VA’s Center for Innovation, at the VA Medical Center in Richmond, Virginia. The first-of-its-kind event brought together 3-D researchers and manufacturers to discuss – and immediately begin working on – VA needs and challenges the evolving technology may help to resolve.

Attendees were a mix of professionals and students, from high school to college, interested in new approaches to the science and technology of prosthetics.

On the first day, individuals and teams pitched their ideas to VA staff, veterans, each other, and additive manufacturing company reps. The latter provided more than a dozen 3-D printers to the forum to immediately convert any promising new ideas into actual products or prototypes. On day two, the proposed solutions were placed in competition and judged by a six-member panel that included representatives from the VA, Toyota, 3D Systems, and Google.

The winning team, whose members ranged from high school students to a nuclear engineer, received $20,000 from Google for their design of a three-piece coupler that allows for the removal and replacement of a lower-body prosthesis in minutes without having to switch the socket or full prosthetic leg. They began brainstorming ideas after the VA briefings, then designed and printed their winning device within two days.

They were helped by prosthetic user advice from Lisamarie Wiley, a 10th Mountain Division veteran human intelligence collector who lost much of her lower left leg to a land mine in Afghanistan. Wiley was one of several veterans who participated in the VA’s first Make-a-Thon, bringing with her half the 12 prosthetic legs she owns, each custom-made for a different activity. She would rather have fewer legs, preferably bought off the shelf and able to be adjusted to fit. Among other drawbacks, she told attendees, packing even half of those requires a bag too large for carry-on and so has to be checked.

“This leg cost about $70,000,” she said, holding up one, then pointed to two others. “These together cost about $50,000. I mean, do you really want to give your Porsche to some baggage handlers to throw around?”

The winning team’s Robotics Club coach, Ty Sayman, from Green Hope High School in Cary, North Carolina, said the new coupling design is simple, but could have a “game-changing” effect on the manufacture of lower-limb prosthetics.

3-D printing already has demonstrated the kind of versatility Frederick Downs Jr., a prosthetics consultant for the Paralyzed Veterans of America and former national director of the VA’s artificial limb program for 30 years, has found in other technologies.

“You never know what new technology will come out in the future that, while not originally intended for the disabled, may make things a lot better for them,” he said.

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

PTSD Progress n IN TESTIMONY BEFORE the U.S. Senate Committee on Veterans’ Affairs in late November 2014, medical representatives from the Department of Veterans Affairs (VA) Veterans Health Administration (VHA) quantified more than two million service members who had deployed to Iraq or Afghanistan since Sept. 11, 2001.

What is surprising to some is the fact that this recent group of veterans reflects just one-third of the number of Vietnam veterans in America today, while other veterans cohorts trace their service to the Korean War or World War II. In total, there were approximately 22.5 million living U.S. veterans in FY 14. Of that number, approximately 9 million were enrolled in the VA, with 5.7 million of those actually receiving services.

And an increasing number of those services involve mental health treatment.

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Highlighting the continuing development and expansion of the VA mental health system, VA Chief Consultant for Mental Health Dr. Harold Kudler explained at the committee hearing that the number of veterans receiving specialized mental health treatment from VA had risen each year; from 927,052 in FY 06 to more than 1.4 million in FY 13. Reasons cited for the increase included proactive screening to identify veterans experiencing symptoms of depression, substanceuse disorder, those who have experienced military sexual trauma, or post-traumatic stress disorder (PTSD).

Kudler’s career with the VA began in 1980, coincidentally the same year that the American Psychiatric Association added PTSD to the third edition of its Diagnostic and Statistical Manual of Mental Disorders (DSM-III) nosologic classification scheme. The significant change ushered in by the PTSD concept was the stipulation that the triggering

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U.S. ARMY PHOTO BY SGT. 1ST CLASS MICHEL SAURET

By Scott R. Gourley

THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

■■ OPPOSITE: Maj. Rudolph Vaca, an Army Reserve operations officer with the 416th Theater Engineer Command, marches alongside approximately 450 military veterans, service members, and supporters during a 22-mile rucksack march on May 22, 2015, just days before Memorial Day, to honor military men and women who suffer from post-traumatic stress disorder or have committed suicide. This march was the Honor the Fallen Ruck March, Illinois.

agent was a traumatic event outside the individual rather than an inherent individual weakness.

“I’ve seen what [the] VA looked like when it didn’t recognize PTSD at all,” Kudler told The Year in Veterans Affairs and Military Medicine almost a year after his Senate committee testimony. He described that early environment as so new that treatment studies “required researchers to invent their own scales to measure treatment effects,” adding that his earliest experiences with veterans quickly convinced him that the concept of PTSD was “valuable and valid.”

“It helps people understand their own situation,” he said.

“But what was really a shocker was that it wasn’t until the ’90s that people went back and asked World War II veterans, ‘What about you? Do you have these 17 symptoms?’ And the answer was: Yes, they did. But nobody had asked them.

“So it’s important to note that PTSD is an important issue and continues to be over 40 years,” he said.

Kudler expressed hope that the large body of Department of Defense (DOD) and VA studies of PTSD would help to dispel what he dubbed “the romantic notion” of some underlying issues as depicted in movies like Rambo.

“We often mistake ‘the romance’ for the facts,” he asserted.

“But I think VA has done more than any other organization – from the scientific community to veteran support – to get the facts out. This is something we are exceptionally good at.”

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Kudler credits the increased number of veterans being assisted by the VA for PTSD to “a combination of factors.”

“One is the increasing awareness of PTSD in the community,” he explained. “Another is the fact that the criteria for being diagnosed in VA for service-connected PTSD changed a few years ago.”

In the past, veterans had to prove that they were in a specific traumatic incident in a specific location at a specific time. Under the new criteria, if a VA psychiatrist says that a client meets the symptom criteria for PTSD, and they have documentation that they physically served in a particular war zone, that will be accepted as criteria for service-connection.

“That opened the gates,” Kudler said. “And another reason [for the increase] is the aging and retirement of the Vietnam generation, because that’s still our largest cohort. As many people as we have from Iraq and Afghanistan, there were more than three times that number of Vietnam veterans.

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And as they age [many of them] have been driven towards VA as the only place they can possibly get assistance.”

He noted that the apparent retirement bubble reinforces earlier World War II- and Korean War-generation findings that veterans often used their work to distract themselves from some of their symptoms, and that the post-work environment allowed many of these symptoms to come forward.

“These are all factors, I believe, in why we are seeing more people,” he said. “And frankly I think it’s a good development.”

And those numbers are likely to increase. According to Kudler, the National Vietnam Veterans Longitudinal Study used a representative sampling of veterans to project that 250,000-275,000 living Vietnam veterans would have PTSD. “And they haven’t all come yet,” he observed. “In fact, most of them aren’t even enrolled in VA.” Citing other findings from the 1990 National Vietnam Veterans’ Readjustment Study, he added that “80 percent of the veterans who actually had PTSD from Vietnam had never, at the time of the study, sought VA mental health services. So there was a huge group that had never come – and might never come. But I’m glad to say that I think they are coming now and I think you are seeing that reflected in the growing numbers.”

RESPONDING TO THE CHALLENGE

Kudler said that VA’s response to the growing challenge begins with the “screening” of every enrolled veteran, with current rules calling for annual screenings for the first five years following return from combat and then shifting to every five years after that.

Another tier of support has been the development of PTSD clinical teams or PTSD specialists at every VA Medical Center in the nation. In addition, the VA’s community-based outpatient clinics – some serving 5,000-10,000 people – either have their own PTSD specialist or can reach back to their “parent facility” medical center for this expertise.

“The idea was that we wanted to disseminate expertise,” Kudler explained. “And expertise is not just what you can get in a book.”

He offered the example of a patient diagnosis that might lead to a prescription for “an SSRI [selective serotonin reuptake inhibitor] like Citalopram” but some uncertainty surrounding dosage adjustments.

“We want the experts on site, so you know who to ‘curbside’ to get the answer to questions like that,” he said.

He continued, “To take the process even farther, the [VA’s] National Center for PTSD has developed the PTSD Consultation Service, so that any clinician in the VA, if they didn’t know who to call in their facility – maybe they were new or were at a great distance where they couldn’t access a local expert – could pick up the phone and call a consultation center where they could get expert advice on how to manage the case they presented.”

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DOD PHOTO BY STAFF SGT. BRYAN DOMINIQUE

■■ The 32nd Vice Chief of Staff of the Army, retired Gen. Peter W. Chiarelli, leads a discussion about suicide, post-traumatic stress disorder, and traumatic brain injury with senior leaders from across Joint Base Lewis-McChord, Washington, Sept. 24, 2014. Chiarelli was an early leader in calling attention to and seeking help for victims of PTSD.

Congress further expanded the consultation process last year with funding to allow the National Center to provide similar consultation to community providers working with veterans who may not be enrolled in the VA system.

“We’re not going to tell people to do something,” Kudler clarified. “But we will connect them to a body of knowledge and possibly use it as an opportunity to also ask if the provider has considered coordinating this veteran’s care with VA. For example, did you tell me that the veteran can’t afford Citalopram? Well, did you know that the VA would pay for it if he or she enrolls in VA? And we can do neuropsychological testing. You say that he might have traumatic brain injury (TBI). Well, we can screen for that.

We can do a lot of workup that you might not be able to do in your part of the world or that the patient can’t afford with their insurance.”

The significance of VA’s community resource outreach was further expanded by the 2015 Veterans Choice and Act, which identified distance or appointment delay situations in which veterans could seek care from participating non-VA providers.

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Kudler acknowledged some appointment delays in receiving VA mental health care, but quickly asserted that the situation is “way, way worse” in many community settings.

“What the VA secretary has been saying is, when it comes to mental health care in America, the VA is ‘the canary in the coal mine,’” he said. “If, with our huge integrated mental health program, we can’t see people within 30 days of when the patient wants to be seen, what’s happening in the community? In many cases, they aren’t being seen at all. In many, many cases, they can’t be seen. Period.”

However, for those situations where veterans want to and can be seen in community provider settings, VA has recently created a Community Provider Toolkit website (www.mental health.va.gov/communityproviders/) that offers free training for nearly any health care provider discipline on military cultural competence. The training is arranged in four separate modules – providing basic familiarization with the military and related issues – and accredited for up to eight hours of continuing education credits. More than 16,000 community providers participated in 2014.

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

“We established this training with the Department of Defense and we put it up from the National Center,” he noted. “It’s actually the first public-facing education program of its kind ever done by VA.” He said that the critical need for this type of program is supported by one recent study that found “only 13 percent of all community providers in America have the military cultural competence and clinical skills to provide basic care to veterans. Whereas among people who worked in the VA, it was 70 percent, which is still not as good as it ought to be but is a lot better.”

The summer of 2015 also witnessed the third annual round of Community VA Mental Health Summits at every VA medical center, to discuss things like the military competence training.

“So what we have done is to establish the largest integrated mental health system in the country,” Kudler summarized. “And PTSD is one of the things it drills for. We teach providers in our system and we reach out to train other providers.”

Other VA PTSD initiatives include avatar-based apps, like Kognito Interactive’s 2011 Family of Heroes or 2014 Together Strong, or applications of the University of Southern California’s Institute for Creative Technologies’ Virtual Reality Exposure Therapy.

Additionally, several VA organizations cooperated to create PTSD Coach, a mobile app that provides basic information about PTSD and the VA, allowing for a private self-assessment, and identifying how to get different types of help if desired.

Kudler also highlighted online technologies incorporated into national public awareness campaigns like Make the Connection, on which actual veterans offer candid personal testimonials “for people who aren’t sure if they have a problem or if they should do anything about the problem they think they have.”

AboutFace is yet another VA-developed online tool that utilizes treatment testimonials to educate veterans and help them decide initial courses of action.

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■■ Shay Little, a medical assistant in family practice at the Naval Medical Center Portsmouth, Virginia, explains the PTSD Coach to a staff member during National PTSD Screening Day 2013.

Other successful outreach efforts include 300 community-based Vet Centers and 80 Mobile Vet Centers that can respond to unique needs nationwide.

Across the myriad programs, Kudler was quick to cite the importance of cooperation between VA’s PTSD efforts and the work of other government organizations.

As an example, he offered, “Even though technically TBI is a rehab issue and not a psychiatry issue, we have many experts. There is a huge psychology component as well as a psychiatry component in TBI and we work very closely with VA and DOD TBI experts. That’s an area with tremendous overlap.”

FUTURE CHALLENGES

In his November 2014 Senate testimony, Kudler included the anticipation that “VA’s requirements for providing mental health care will continue to grow for a decade or more after current operational missions have come to an end.”

Today he sees two major challenges in that future vision. The first involves getting the broader health care community

to coordinate care with the VA. The second involves providing a national level of what he called “basic mental health literacy.”

“In other words, people don’t always have words to describe a mental health issue and wouldn’t know where to go if they had a mental health issue,” he said. “Providing basic mental health literacy in America is foundational to having an effective VA and military mental health system.”

Emphasizing that “most people coming through military service, including deployments, will not develop a mental health diagnosis,” he added, “Everyone involved in the deployment cycle and everyone transitioning between military and civilian life faces significant stress, as do their families – even if it’s ‘good stress,’ like new babies, new jobs, new opportunities, or moves to new communities.

But it’s significant stress. And sometimes this will require help from somebody who knows how to help.

“Both VA and DOD assets are there to provide that help,” he concluded. “And that help is effective. So we encourage people to ask good questions and seek good answers.”

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

Prosthetic Advances n THE WARS IN SOUTHWEST ASIA, where blast-related amputations reached a new high as a percentage of combat injuries, pushed prosthetics R&D and implementation to previously unimagined levels. Now military, Department of Veterans Affairs (VA), industry and academic researchers are close to bringing to practical application technologies previously seen only in science fiction.

“All of the advances we’ve had since 9/11 were motivated by injuries from that war. Most prosthetic development in the past has been the result of war, starting with lower extremities during and after World War II,” according to Dustin J. Tyler, Ph.D, associate professor of biomedical engineering at Case Western University and a biomedical engineer at the Cleveland VA Medical Center.

“With all the improved body armor in this conf lict, people survived blasts that would have killed them in the past, but experienced greater loss of limbs. That motivated most commercial companies to work on more articulated hands.”

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Those efforts include so-called “mind control” techniques, in which brain activity and messages to the nerves controlling a limb are mapped, translated into computer code, and fed into a robotic prosthetic, which then mimics the movements the lost limb would have performed. Successful or promising tests of this technology began on lab monkeys but soon moved to humans with amputations or spinal dysfunctions, whether caused by injury or disease.

Other cutting-edge approaches to help overcome limb dysfunction include: • Direct interface to the nervous system – enabling not only controlled movement of a robotic hand, but also returning the patient’s sense of touch • Pattern recognition – using “muscle memory” to help prosthetic movement • Muscle reinnervation – the higher the amputation, the more of the muscles and nerves are missing, but they can reconnect to muscles that no longer have a use, such as biceps if the forearm is missing

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PHOTO BY RUSSELL LEE, CASE WESTERN UNIVERSITY

By J.R. Wilson

PHOTO BY RUSSELL LEE, CASE WESTERN UNIVERSITY

THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

• Permanent implants – linking prosthetics to the patient’s nerves, muscles, and bones • Better power systems – greater energy densities and management, in a small, lightweight form factor • Self-repairing materials – improving prosthetic durability while reducing maintenance needs • Non-slip materials – giving a prosthetic hand the ability to not only grip an object, but hold onto it without slipping • Sensor skin – artificial skin with built-in nanosensors that can mimic human skin’s ability to sense – and usually identify – anything it touches • 3-D printing – using additive manufacturing to create components or complete prosthetics • Exoskeletons – developed to help warfighters lift and carry heavy items or travel long distances without tiring or straining human muscles, but with obvious potential applications to paraplegics, quadriplegics, and amputees • Direct skeletal prosthesis (osseointegration) – a direct structural and functional connection between ordered, living bone and the surface of a load-carrying implant • Intelligent powered robotic limbs – next-gen powered limbs with the ability to stably respond to disturbances or changing terrain “The new generation [in the United States] is much more of a savvy, tech-integrating society. But there is still a huge stigma to robotics elsewhere in the world. I think we have to be careful, even in the U.S., about people accepting these new technologies in the long run, when it comes down to ease of use,” Tyler said. “The fundamental challenge for future generations is we are still way behind the information content available within the normal human neuromuscular system.

“The challenge is to develop technology that can interact at the same level of fidelity, in either stimulating or recording.

We don’t have a technology that can connect living nerves across a break. The body also tries to destroy or wall off foreign elements we try to implant. Conceptually, jumping the gap is a good idea, but there is a lot of work yet to be done to make it work properly. And spinal cord injury or any disease that interferes with neural transmission has the most to gain from that.”

According to Frederick Downs Jr., a prosthetics consultant for the Paralyzed Veterans of America and former national director of the VA’s artificial limb program for 30 years, advances in lower limb prosthetics have always come first, largely due to economics, but also to the greater difficulties in artificially replicating the complex movements and capabilities of the human hand.

“Last year we bought about 12,000 lower limb prosthetics and only 150 upper limbs. When I took over the VA program, lower limbs came from World War II and there weren’t many upper extremities because the blast that would cause that damage also killed the warfighter,” he explained. “Today, body armor has improved significantly, as has the quality of medical care far forward. And the survival rate for both lower

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■■ ABOVE: “Smart skin” with embedded sensors mimics real skin in flexibility and stretching. OPPOSITE: Case Western University volunteer Igor Spetic holds a cherry tomato in his touch-sensitive prosthetic hand without spilling a drop of juice.

and upper extremities has improved dramatically in the past 10 or 15 years.

“But it wasn’t until recent times that DARPA [the Defense Advanced Research Projects Agency] began driving interest in developing upper limb prosthetics – funding the robotic arm that private industry probably would not have because there still weren’t that many who needed it. It’s not being callous, it’s just practical. You can’t manufacture something that doesn’t sell enough to cover its costs – or price it out of reach.

You also need software engineers who can do a lot of programming, then repair and maintenance – all hard core business issues that have to be addressed.”

Neuroprosthetics, linking the brain to a robotic prosthetic – hard-wired or wireless – has been in development for several years and has been showing remarkable success in lab tests since the beginning of this decade. The technology has advanced to the point where the Federal Drug Administration (FDA) held a meeting in November 2014 with researchers from DARPA, industry, and academia to discuss the regulations governing bringing a neuroprosthetic to market and the steps that must be taken to achieve that.

While welcoming the agency’s willingness to consider the future of such devices as an approved way to assist amputees and those with spinal dysfunctions, some also have voiced concern about the FDA’s tough regulations and paperwork requirements moving forward. They are perhaps the most stringent in the world, affecting not only American researchers and development companies, but foreign manufacturers whose own regulatory agencies are less demanding – but still must meet FDA requirements to market their products in the United States.

Even with FDA approval, doctors prescribing the devices still will have to deal with insurance companies, which tend 95

THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

to be slow to approve new procedures and technologies and make extensive demands for proof they are needed and will work for each individual patient.

Military personnel – active duty and veterans – have an advantage there because both the Department of Defense (DOD) and the VA have committed to providing the latest technology to those qualified to receive it, unlike civilian insurers, who are more likely to delay or even deny approval for the newest advanced prosthetics.

Another “double-edged sword” issue is the speed with which technology is advancing. While initially that would appear to be a good thing, it actually can stifle R&D because by the time a company gets FDA and insurance approval – spending millions of dollars in the process – one or more new generations of technology may have made the initial device obsolete before the first patient, outside the lab, has a chance to use it.

Some military surgeons have reported being asked, by wounded warriors whose legs were saved by improved technologies and far-forward efforts of combat medics, nurses, and doctors, to amputate those limbs, anyway. One surgeon said a young soldier who could expect his injured leg to have about 85 percent of its former capability demanded it be amputated and replaced with a cutting-edge prosthetic some have rated at 120 percent of normal human ability.

“Most people see people in the news with lower extremity prosthetics who are running and playing basketball, but that’s because they’re on level surfaces,” Tyler said. “But if they start walking in a dark room or uncertain terrain, they have a hard time. We believe that by giving them a sense of touch and, hopefully, position in the foot, they will be able to do a lot better.”

Although more lower limb amputees from the last 15 years of war in Southwest Asia are walking on advanced prosthetic legs and feet, another device most people don’t think of as a prosthetic is far from museum status.

“There have been advances in wheelchairs to help make veterans mobile and independent – lightweight, better materials, more sophisticated electronic controls, hubs that use battery energy to propel a manual wheelchair forward, which helps a quadriplegic maintain the cardiovascular system,” Downs said. “The iBot, which was invented by DEKA, can stand up on two wheels, but it didn’t generate enough customers to stay in production, an example of what might be called an orphan product, which is a danger with a lot of expensive, high-tech stuff.

“Experiments also are underway on implants into muscles above the break. Signals come down the nervous system, but when they hit the injury, they stop. So researchers are looking at hooking the nerves above the break to viable muscles below the break. Bypassing the break would be a great advance because the individual, perhaps, would be capable of greater mobility.”

The real cutting edge in prosthetic research development test and evalution (RDT&E) is neurological, from invasive 96

brain implants to non-invasive skullcaps. At the University of Pittsburgh, a female quadriplegic with brain implants was able to move a robotic arm by consciously thinking about how she would have done so with her own arm. And for the first time in three decades, she was able to pick up a piece of chocolate and feed it to herself.

Downs himself, who lost an arm in Vietnam, is taking part in a one-year Army evaluation of a robotic arm with 10 internal computers. Funded by DARPA and built by DEKA Research & Development Corp. (Manchester, New Hampshire), the arm’s movements are controlled by the user’s feet – tilting the foot forward creates electrical signals in the brain that are translated, resulting in the robotic hand grasping. Other foot movements enable different arm movements and hand actions.

“The future is the neural interface, being able to wear a skullcap that is not invasive and move arms by just thinking about it,” Downs said, but added that is only the first step toward user-controlled, multi-function robotic hands.

“When I first got the robotic arm, touching something caused a buzzer to go off, just to let me know I was touching something. I didn’t particularly like it because it buzzed too often, but it was a step toward developing a sense of feel. Now they are looking at sensing cold and heat.”

The current generation of neural interface technology, while showing remarkable potential, is largely a one-way street – signals can be sent from the brain to a prosthetic’s robotic controller, but there is no sense of touch going back to the brain. That is the latest focus for far edge research – installing nano-sensors, even sensor-optimized artificial skin, on robotic hands.

“There has been some work in the past with residual limbs.

We implant a small device on the nerves that once led to the hand, then stimulate that nerve. The person feels as though they have touched something with their finger, so when we connect that to the prosthetic and they touch something, it feels to them as though it is their hand touching something,” Tyler explained.

“While sensory is the most important goal, the other side is placing electrodes within the remaining muscles in the forearm that once made fingers move. So when you think about moving your finger, that implant stimulates those muscles. We also are working on processes called pattern recognition and targeted muscle reinnervation.”

Researchers throughout the world comprise a dedicated effort to ultimately produce robotic powered arms and hands indistinguishable – at least in function – from a biological limb.

“Advanced hands have been wonderful in terms of prosthetics that look like actual hands and have greater capabilities, but without a sense of feeling, users see them as a tool.

But when we turn on the sense of touch, they feel like they are using their own hands. Our data also show they are better able to control the prosthetic, even without changing the control algorithm,” he said.

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

DOD PHOTO BY SENIOR AIRMAN TIFFANY DENAULT, U.S. AIR FORCE

■■ U.S. Navy Hospital Corpsman 3rd Class Redmond Ramos warms up before competing in the athletics portion of the Invictus Games at the Lee Valley Athletics Centre in London Sept. 11, 2014. The Invictus Games are the United Kingdom’s version of the Warrior Games, bringing together wounded veterans from 14 nations for events including track and field, archery, wheelchair basketball, road cycling, indoor rowing, wheelchair rugby, swimming, sitting volleyball, and a driving challenge. Along with high-performance “blades” for athletics, researchers have developed lower-limb prosthetics with multiple computers running “smart” joints to give amputees a more natural gait, and are working on sense of touch.

“So the sense of touch gives them a better sense of embodiment, which means they incorporate the prosthetic into their body image and begin to see it as part of themselves. Our subjects refer to it as their ‘hand’ rather than as a prosthetic.”

Tyler’s group at Case Western is in early feasibility clinical trials, but he predicted it will be another five to ten years before it becomes widely available – depending on funding and other aspects.

“That being said, in the development components, most of the technology exists and has been around for a long time. We’re working with a lot of companies to develop components we believe will make it available – we just need to put the technologies together for the prosthetic application and do the clinical work,” he added. “In terms of sensory feedback, upper limbs are further along. We’ve had people working with those for up to three years. We’re not in trials yet on lower limbs, but hope to be within months, not years.

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“Another thing we’re excited about investigating is what’s called ‘phantom limb sensation’ … [sometimes described as] a nail being driven in or the hand being crushed. But when we started testing our sensory feedback component, they said the pain went away. Right now, they only get stimulation in the lab, about six hours every two weeks. But even with just that, they report the pain has disappeared.

We think that is a very significant component, having to do with the absence of information and how the brain fills in that space.”

While head of the VA’s artificial limb program for 30 years, Downs changed the rules to allow veterans to have whatever technologies were available – including multiple devices for multiple applications.

“I still have the old hook I’ve had for 47 years, but the DEKA arm I have is the third generation and is much more functional. And each new generation of arm or wheelchair that comes out is better because it is based on previous versions,” 97

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

PHOTO BY DALE OMORI, CASE WESTERN UNIVERSITY

■■ Case Western University volunteer Keith Vonderheuvel is provided feedback from 16 contacts taped to his prosthetic hand, enabling him to squeeze toothpaste onto a toothbrush.

he said. “There are different types of prosthetic limbs for different activities – walking, running, showering. The human limb does it all.

“With prosthetics, we’re trying to improve function as much as possible with the available technologies. The more tools you have, the more accomplished you can become. I look at the hook and the robotic hand and both have function for me, so I need them both to be complete.”

Not every amputee shares that view in the long run, however.

“Abandonment is a big issue with prosthetics,” Tyler noted.

“The lack of sensation, we believe, is a big part of that, especially if it is a single limb loss. Many people can accommodate and function quite effectively with only one hand or arm, so is it really worth everything that comes with using a marginally effective artificial hand to which you have no real connection, in terms of feeling?

“I think a lack of connection has always been one of the biggest challenges with prosthetics, not just using the hand, but connecting to the world in ways you could not before. Even with complex-looking and -performing hands, the biggest gains will be sensory feedback, leading to more fine control.”

Having been a central part of the process for nearly half a century, Downs has had a closer look than most Americans at how war generates technology development, especially in medicine, but also what happens when the war ends. As Operation Enduring Freedom and Operation Iraqi Freedom retreat to the history books, he predicts RDT&E to push

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prosthetic development will fade into the background again, as it did after Vietnam and Desert Storm.

“There has been so much press about [prosthetics] in the past few years, but as the war fades into memory, so will the money and congressional interest in pursuing more advances. And there will be fewer numbers of new amputees and it won’t be big news anymore,” he said, adding that may delay development and availability of future breakthroughs.

“I’ve long been interested in neurological implants, probably the most feasible way to go right now, but I’m not sure it can be done in the next five years. Once they do, however, it will move quickly into all kinds of applications. The big question now is how long can that neural interface exist before the nerve loses its ability to stimulate effects.”

While he sees a slowdown as inevitable and user attitudes changing with time and age, Downs does not see prosthetic evolution – even revolution – stopping.

“But it has to be practical and functional to be effective enough for an individual to want to wear it. A lot of leg amputees discover that with higher amputations, wheelchairs are a lot easier to use,” he said. “The body only has so much tolerance for gadgetry, and if it causes pain or breaks down too easily or often, then it won’t be used.

“I don’t feel handicapped when I’m wearing my robotic arm. The hook was psychologically difficult to adjust to – and the Army left it up to me to figure out how to use it. The current generation is far more accepting of technology and today’s soldiers are proud of their prosthetics, which is a definite change of attitude from my day.”

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

Paralyzed Veterans of America n THE PARALYZED VETERANS OF AMERICA was founded in 1946 by a small group of paralyzed veterans, coalesced around shared problems resulting from combat spinal cord injuries. The number of World War II warfighters who survived such injuries was relatively small, but despite undergoing treatment at different hospitals around the country – none specific to spinal care – they learned about each other and decided to meet at the veterans hospital in Hines, Illinois.

That original group became a grassroots, self-activating advocacy group. There were other veterans service organizations (VSOs) in existence at the time, but they weren’t advocating for paralyzed veterans, whose life expectancies were then only about two years.

“These guys beat the odds by outliving that expectation, but they had to get society and science to do more for them,” according to Paralyzed Veterans of America Deputy Executive Director Sherman Gillums Jr. “They were a cross section of society, all injured in battle and 100

with the wherewithal to advocate for themselves at a time when we didn’t have today’s advantages, such as the Internet. They coordinated transfers from their facilities to Hines, citing medical reasons, but the true intent was to enable them to meet, and they knew enough about the system to work it.”

After World War II, there were additional paralyzed veterans from the Korean War, but many of Paralyzed Veterans’ new members were injured outside combat, mostly the result of automobile accidents. As active-duty, National Guard, Reserve, or former military personnel, they were still eligible for treatment at veterans medical centers, where they came in contact with other paralyzed veterans and, over time, joined Paralyzed Veterans.

It would be 32 years before Paralyzed Veterans, swelled with Vietnam veterans, was large enough to seek a congressional charter, which was needed to have the legitimacy to speak before government on behalf of a constituency of paralyzed veterans.

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ALL IMAGES COURTESY OF PARALYZED VETERANS OF AMERICA

By J.R. Wilson

THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

■■ OPPOSITE: Early members of Paralyzed Veterans of America demonstrating for the VA to provide accessible housing in the late 1940s.

“That was the birth of the official identity of the PVA, which then could represent veterans before the VA and military to obtain benefits,” Gillums said.

While it was long run by volunteers – many of them paralyzed veterans – today Paralyzed Veterans has a largely paid, professional staff working for its roughly 20,000 members.

Any veteran not dishonorably discharged who has a spinal cord dysfunction, whether from injury or disease, is eligible for membership. The organization also tracks paralyzed dependents – basically anyone entitled to some sort of benefits.

“Vietnam is the hump in the histogram, with fewer World War II and Korea veterans,” Gillums said. “There was a major ‘peacetime’ era after Vietnam and another between the two Gulf wars. Most of our older members are from the Vietnam era, although most are not combat related.

“To the credit of science and medicine, [many of] those injured in the current conflict were able to walk out of hospitals, where anyone shot in the spine during Vietnam typically was done. That has changed the concept of the paralyzed vet – many are not in wheelchairs.”

Paralyzed Veterans’ website states its goal is “to change lives and build brighter futures for our seriously injured heroes – to empower these brave men and women with what they need to achieve the things they fought for: freedom and independence. [Our founders] returned to a grateful nation, but also to a world with few solutions to the challenges they faced. They made a decision not just to live, but to live with dignity as contributors to society [by forming] an organization dedicated to veterans service, medical research and civil rights for people with disabilities. Today, the work continues to create an America where all veterans and people with disabilities – and their families – have everything they need to live full and productive lives.”

Paralyzed Veterans currently has 69 field offices in all 50 states, the District of Columbia, and Puerto Rico, a national paid staff of some 270 employees, and 34 chapters with volunteers. Having worked with paralyzed veterans from seven wars, numerous other military actions and non-combat injuries and diseases for nearly 80 years, Paralyzed Veterans of America has developed a unique expertise on a wide variety of issues involving the special needs of its members.

Paralyzed Veterans has seen a significant shift not only in the public perception of the paralyzed, but also in the attitudes of its members toward the treatments and technologies now available to them.

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“Attitudes toward mechanical devices run along generational lines. To use an exoskeleton, you need a second person trained in its use and maintenance, where with a wheelchair you just get in it and go. But the younger veterans are much more interested in these advanced technologies and are willing to endure the discomfort of walking around like a robot,” Gillums said.

Exoskeletons were originally designed to help warfighters lift heavier objects and work longer and harder with less effort or fatigue.

“Our Vietnam era members are largely not interested in exoskeletons, but today’s men and women are – and there are a lot more women who have served and now have spinal injuries. And because more and more information on these advances is available on the Internet, it gives them more and more hope about walking rather than sitting,” he continued.

“One of the things we battle in terms of public image is the idea that the wheelchair is an inferior state of being, but the exoskeleton won’t be for everybody, and those who are disappointed in not being a candidate for an exoskeleton need to see wheelchairs as a viable alternative and not see themselves as a failed version of a paralyzed vet because they are not up and walking.”

Gillums sees the future as being increasingly bright for those with spinal cord injuries or disease-related dysfunctions – not only veterans, but the estimated 5.5 million paralyzed Americans who have never served. That applies not only to science fiction-like technologies such as exoskeletons, but to cutting-edge research into neuro-muscular interconnects with robotic prostheses, “jumping” the point of injury to reconnect nerves above and below it – especially important for spinal cord patients – even transplants and regeneration.

Just how those may evolve from the research lab to daily use is yet to be seen. And some may never make the transition.

“The first time I got a pager back in 1990, I never would have seen it evolving into the iPhone®. And that will happen with this current technology. There are some practical problems with putting warfighters in those kinds of suits [exoskeletons and other advanced capability gear] in actual battlefield conditions, so I don’t think we can expect that to be a major help in carrying the technology forward to noncombat applications,” he said, adding that does not necessarily mean exoskeletons won’t continue to be developed for non-military use.

“It’s rather like an ‘orphan’ disease. A lot of people see research in that area applying to many veterans, but you still need a second individual helping you, you’ll need power and maintenance – you won’t have someone in your neighborhood who can fix it – and it has to work in rain and cold. It has to go mainstream to drive down the costs, but there’s no easy way to start that process. And more veterans have to test it in order 101

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

for the costs to come down. It also is up to the paralyzed vets to consider whether that technology is right for them.”

Whatever happens with the current cutting-edge technologies still in research labs, however, Gillums said the high profile of veterans from the wars in Southwest Asia who suffered spinal injuries or amputations has heightened awareness of both the problem and those possible solutions. And that has resulted in more researchers and manufacturers working on solutions – some with help from Paralyzed Veterans.

“We have a PVA health summit every year and many new competitors come to those,” he said. “But many of those are not American companies, which face a lot of red tape to get approved for public use. But the barrier to market penetration for U.S. companies also faces manufacturers outside the U.S. who want to sell their devices here. And tougher regulations can stifle R&D. Paralyzed Veterans also offers research grants to applicants seeking funding for new technology development, among other things. We’re sustained by corporate sponsors and private donors, so we only have about a million dollars a year for grants.

“We also provide our expertise to the DOD [Department of Defense] for their research program grants for spinal injuries. And we have reviewed grant applications that did result in millions of dollars. And we have a legislative advocacy department that will lobby for certain bills to be passed.

One of those did involve DOD making access to exoskeletons available to veterans. But the VA [Department of Veterans Affairs] also has to hire and train people to work with and on exoskeletons. I think all these technologies merit consideration and veterans should be able to choose among them to see what is the best fit for them.”

Paralyzed Veterans also takes a more direct role in helping its members, with a team of nurses and a clinician who make site visits at all 25 centers in the United States. A member of its grant review committee for research and education, for example, is a paralyzed veteran who is working as a research engineer at a lab at the University of Pennsylvania looking at a wheelchair that reduces strain on the user’s arms. Gillums said they also occasionally have an opportunity to be more intimately involved in research from a consumer education perspective, making themselves available as consumers to help close the gap between a good idea and practicality.

“If I had to rank concerns, I would say No. 1 is access to quality health care. The VA has 110 hospitals and thousands of caregivers, all of whom have been tainted by those that became involved in scandals. Our goal is to ensure future paralyzed veterans have access to the care they need. That’s the basic lower order need that has to be in place for any of the other benefits to matter.

“Second would be a cross of independence and opportunity.

Our advocacy efforts include barrier-free designs, educating employers with our Paving Access for Veterans Employment [PAVE] program. PAVE has two parts – first prepping the veteran for the right opportunity for him or her, the other

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■■ As a leader in the development of adaptive sports and recreation, Paralyzed Veterans of America encourages veterans like Operation Iraqi Freedom veteran John Vail to keep active and healthy by continuing strength training, such as here at the James A. Haley VAMC in Tampa, Florida.

part is taking the mystery out of hiring a disabled veteran by offering ways to make the workplace more accessible, getting over the stigma that disabled workers are likely to be the next lawsuit they have to worry about.

“Third is benefits and entitlements, not just for veterans but also dependents, caregivers, and survivors. Veterans earn their benefits – not just disability compensation, but vehicle grants to enable them to drive, home modifications, education grants, etc. We’re constantly advocating that veterans [benefits] be delivered faster and more accurately and any appeals are decided more fairly and quickly. We represent more than 40,000 people with powers of attorney; the most complex disability claims tend to end up with us because of our history and expertise. We’re the SMEs [subject matter experts] on that front.”

Paralyzed Veterans helped form a committee with three other VSOs – Disabled American Veterans (DAV), American Veterans (AMVETS), and Veterans of Foreign Wars (VFW) – to create their own annual VA budget proposal for Congress, 103

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

■■ Paralyzed Veterans of America Senior Benefits Advocate Winston Woodard III explains veterans benefits to hospitalized Operation Iraqi Freedom veteran Alberto Velasco.

with additional input from a long list of contributors with a stake in veterans advocacy. DAV represents service-connected veterans, AMVETS veterans of combat service, and the VFW those who served overseas, whether in combat or not.

“So it’s a good mix of interests that combine into a single voice. Some of those overlap – you could have a veteran who belongs to all four – but we are the voice for veterans with non-service connected injuries. And about 100 percent of our members rely on VA health care, which is higher than the other VSOs’ members,” Gillums said.

“The document presents what we believe, based on empirical and anecdotal data and what we get from the VA, is the right budget to meet the full demand.

“What often happens is the Congress and president will consider what we present, but run their own numbers and often end up with numbers a lot lower than ours. A lot of the shortfall we see now with the VA can be associated with the difference between our budgets and their budgets. A good example is in construction, where there was a $10 million gap. And that is cumulative, as those gaps

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repeat year after year. The whole purpose is to provide the most honest and objective view of what the VA budget needs to be to serve the veterans who need them.”

But Gillums points out Paralyzed Veterans has expanded its efforts beyond just veterans to the wide range of disabilities, regardless of cause or victim.

“We take great pride in the fact we are distinguished as disability advocates. We were at the table when the Americans with Disabilities Act [ADA] was put together and ratified 25 years ago. We’re also a part of the effort to expand the standards outlined in the ADA to the entire globe. There is a lot of opposition to that, but is a big part of our advocacy that has nothing to do with veterans, but making things better for anyone who has an impairment or disability,” he said.

“Attitudes are changing in other countries, both governments and societies. It may take awhile, but at least countries such as South Korea – which opened two spinal cord injury centers in the last two years and has invited us to look at those centers for veterans – recognize it is an issue, and changes are being made that will help the next generation.”

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

New Hope for Patients with Spinal Cord Injury

By Gail Gourley n AS THE WORLD’S LARGEST HEALTH CARE SYSTEM providing care to people with spinal cord injury (SCI) and related conditions – more than 26,000 annually – the Department of Veterans Affairs (VA) is at the forefront of supporting and conducting research through a network of sites and facilities to address multiple aspects of SCI, benefitting paralyzed veterans and all people with SCI. Some advances are very dramatic, others less visible, but on multiple fronts, research is moving forward in ways that provide continuing hope for those with SCI to have increased mobility, fewer medical complications, and better quality of life.

According to Audrey Kusiak, Ph.D., scientific program manager for the VA Rehabilitation Research & Development Service (RR&D) Spinal Cord Injury Program, the Office of Research and Development (ORD) funded 97 projects in FY 2014 on SCI and peripheral nerve injury. “The portfolio is very well rounded,” said Kusiak. “We have a multitude of approaches to study and to help restore function in individuals with spinal cord injury.”

The portfolio’s scope includes medical consequences of SCI on multiple body systems, neural engineering, wheelchair engineering, plasticity (the body’s own reparative process), regenerative medicine or cell therapies, rehabilitation, robotics or exoskeletons, and community reintegration.

REGENERATIVE MEDICINE

The VA has a consortium of researchers conducting ongoing investigations to develop a cell-based therapy that can regenerate damaged spinal cord tissue and restore function. The concept is to regenerate axons, extensions of nerve cells that carry impulses from the cell.

“The good news is that many cell types have been shown to be safe in both animal models and in Phase 1 human clinical trials,” Kusiak said. These cells that assist axonal regeneration include oligodendrocyte precursor cells, olfactory ensheathing cells, mesenchymal stem cells, and neural progenitor cells.

“This is a really big step for the cell therapy/regenerative approach,” she added, because if these cell types are safe, the research can move to combining the cells with growth factors and possibly bio-material scaffolds with the goal of restoring function.

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With studies having been done in rodents, the research is moving toward a long-term chronic SCI model to more appropriately represent the chronically injured patient. “The model is now a non-human primate model that has been injured three to six months and then transplanted with the cell therapy. The team is seeing some very interesting results from this,” said Kusiak, noting that the cell therapy is combined with a targeted rehabilitation program “to take advantage of the body’s own reparative processes.”

Obtaining results is very slow because the animals must survive two years in order to gather data, she continued.

“We’re seeing from MRIs that the cells are surviving, and we do see the anatomical extension of axons, much like we did see in the rodent model. So the anatomy looks really good.

We’re trying to see what’s happening in terms of the function now.”

MEDICAL CONSEQUENCES OF SCI

In addition to paralysis, people with SCI face multiple complex medical problems, including muscle and bone atrophy, pressure ulcers, pain, cardiovascular disease, pulmonary disease, bowel and bladder issues, and many others. Founded

by William A. Bauman, M.D., and Ann M. Spungen, Ed.D., director and associate director, respectively, the RR&D National Center of Excellence for the Medical Consequences of Spinal Cord Injury at James J. Peters VA Medical Center (VAMC) in Bronx, New York, works to improve the quality of life and increase the longevity of patients with SCI by identifying problems and finding solutions to these issues.

“We all appreciate that if someone has a spinal cord injury, they have difficulty moving their legs, or if it’s a higher lesion, their arms and their legs,” said Bauman. “That has been the focus of much of the interventions and research that was performed for decades, and the medical consequences of spinal cord injury, which is what patients deal with on a day-to-day basis, got short shrift.”

Research at this center focuses on precisely these issues that affect SCI patients in their daily lives. Their method is to understand the mechanisms responsible for the problem, and then design an intervention to improve function, applying that paradigm to every organ system.

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

For example, investigators recently addressed diminished bowel motility, a significant quality-of-life problem for people with SCI, and developed a drug combination that safely and effectively empties the gut. Additionally, it has improved colonoscopy preparation, formerly often inadequate for people with SCI, permitting a more thorough exam with improved polyp detection.

Representative examples of current research topics include: interventions to reduce or prevent bone loss after acute SCI, or if marked bone loss has already occurred in those with chronic injury, treatments for osteoporosis; new therapies to preserve muscle; assessing body composition changes and treatments for metabolic abnormalities; evaluating cardiovascular consequences resulting from autonomic nervous system impairment and how low blood pressure adversely affects cognition; development of measures to enhance the ability to maintain a constant core body temperature despite extremes in environmental temperature; assessing the mechanisms for the high prevalence of gastroesophageal reflux disease and effective treatment approaches; improving pulmonary function by strengthening respiratory muscles and reducing the obstructive, asthma-like component in higher cord lesions; and strategies to strengthen nerve connections using specific exercises and combinations of magnetic and electrical nerve stimulation.

Research findings have translated to increased awareness and improvements in standards of care for veterans and all SCI patients. “Knowledge is universal. If you make an observation and you publish it, it’s out there,” said Bauman.

“So if you find that an individual can be treated more effectively with one form of therapy, and that work is supported by the VA, it then will quickly be translated to the civilian arena as well.”

“No other entity has supported SCI research the way the VA has, and the rest of the world truly has learned from the medical research on SCI that our group and others have done in the VA system,” Spungen added. “I really would love to see the VA get the credit for this, because they truly have led the way in supporting this kind of research that has helped the entire field of SCI. And our center is truly recognized as the leader in the medical consequences of SCI in the entire world.”

VA IMAGE

AMBULATION ADVANCES

Early efforts for development of exoskeleton devices to assist paralyzed patients to walk appeared in the 1990s, according to Spungen. A milestone occurred in 2014 when the ReWalkTM system received FDA approval for home use. The system, developed by an Israeli bioengineer after becoming a tetraplegic, consists of motor-driven exoskeleton braces that enable ambulation.

Spungen had led a VA-funded 2011 pilot study to assess its safety and efficacy. “With those 12 patients, we learned

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■■ At the Advanced Platform Technology (APT) Center at Louis Stokes Cleveland Veterans Affairs Medical Center, a number of technologies are being developed to aid mobility, including bracing and hybrid orthosis.

a whole lot,” Spungen said. “We learned how to best train somebody, how to best fit them for the device, who could tolerate what amount of walking in them. We did indeed find that we could get almost everybody up and walking in the device. Some needed more assistance than others; some could go faster than others.”

Spungen utilized standardized ambulation assessment tools – the six-minute walk test, how far a person can walk in six minutes, and the 10-meter walk test, how fast a person can walk 10 meters. The “magic number” is a walking rate of about 0.4 meters per second, equating to about 1 mile per hour. “Studies in the disabled population have shown that an individual who can ambulate with an assisted device or without one at least 0.4 meters per second or greater is likely to ambulate in the community, but when they go much slower 107

ReWalk Robotics is proud to provide exoskeleton technology to America’s veterans and wounded warriors so that they can stand and walk again.

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Clinical studies* show that standing and ambulation with the ReWalk provides potential health benefits such as: » Reduction of some medications for certain ailments » Improved bowel and bladder function » Improved mental health » Improved sleep and reduced fatigue » Decreased body fat » Decreased pain » Improved posture and balance

ReWalk Robotics extends our utmost gratitude to our service members and veterans serving the U.S. around the world. We thank you for your service and dedication to our country.

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IMAGE COURTESY OF REWALK ROBOTICS

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than that, it’s too frustrating, it takes too long, it’s too hard, and they’ll use a wheelchair. So that’s a very key component to whether these devices are going to be used as a mobility device out in the community, or as an exercise device,” said Spungen.

Another significant aspect reflects health and quality-of-life benefits.

Spungen said all 12 patients reported improvements in varying degrees – some had many benefits, some had only one or two – in terms of bladder and bowel function, fat tissue loss, reduction in pain and spasms, better sleep, less daytime fatigue, and better overall quality-of-life measures.

Spungen is the principal investigator of a new clinical trial, begun this year, to predict functional milestones reached by participants in an institutional-based exoskeletalassisted walking training program, and to assess several likely medical benefits from regular use of these devices. The Department of Defense (DOD)-funded three-site study, the first controlled study in this field, includes the Bronx VAMC as the lead site, the University of Maryland Rehabilitation & Orthopaedic Institute, and the Kessler Institute for Rehabilitation as study data-collection sites. The study will use the ReWalk device and another called Ekso, currently seeking institutional approval. Spungen is also the chairperson of a 10-site nationwide VA Cooperative Study to investigate community-based exoskeleton-assisted walking to determine its benefits on quality of life and health.

With that study now recruiting participants, Spungen said that one SCI research challenge is finding enough eligible individuals in any one geographic location, adding that this is a problem for all research for people with disabilities.

Spungen noted that recent FDA approval of the ReWalk has raised awareness of exoskeleton walking devices and heightened expectations of people with paraplegia, which in turn brings support

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for additional research funding and development of similar devices. “In the end, this progress equals hope and the prospect of walking for many who may have believed they would never walk again. And hope is always a good thing,” she concluded.

■■ Army veteran Gene Laureano utilizes the ReWalk exoskeleton technology to stand and walk. Laureano received his ReWalk training at the James J. Peters VA Medical Center in the Bronx, New York – a leading institution in research and study of exoskeleton technology and the spinal cord injured community.

NEURAL ENGINEERING

Researchers at the Advanced Platform Technology (APT) Center at Louis Stokes Cleveland VAMC, another center of excellence, are 109

Early Detection of Patient Deterioration Using Novel Monitoring System Outcomes: Effect of Safety Initiatives

Overview Patient safety for Non-ICU patients in the hospital is an ongoing challenge. The SCI Center incorporated a novel technology system for early detection of patient deterioration and reduction of adverse events.

Objective Describe the EarlySense Monitoring System (ESMS) and discuss its benefits for detecting early signs of a potentially worsening clinical condition in a Spinal Cord Injured (SCI) Medical/Surgical inpatient population.

67%

50%

40%

83%

Medical Response Team (MRT) Activations decreased

Code Blue Activations decreased

ICU Transfers decreased

Mortality following MRT/ Code Blue Activations decreased

Enrolled patients were continuously monitored for heart rate (HR) and respiration rate (RR).

Conclusions Highly significant clinical reduction of MRT/Code Blue activations, ICU Transfers, and Mortality was noted among patients on the SCI unit using EarlySense Monitoring System (ESMS).

Participants/Methods EarlySense provides continuous monitoring of heart and respiratory rate through non-contact technology.

Poster Presentation

Two Spinal Cord Injury med/surg units with similar patient populations were compared during the twelve month period from February 2013 through February 2014 (n=932). This pre implementation data was collected to create a baseline of clinical indicators. During the twelve month period from February 2014 through February 2015 (n=1,150), post implementation data was collected and evaluated in comparison to baseline.

To learn more about the EarlySense System E-mail: salesusa@earlysense.com Tel: 781-373-3228 www.earlysense.com

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VA IMAGE

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working to advance mobility and increase balance for those with SCI. “We have a number of projects that address primarily the motor limitations that occur after paralysis,” said APT Executive Director Ronald Triolo, Ph.D. “We are investigating different kinds of techniques to allow people to be more mobile, more functional in their wheelchairs, and to ambulate, climb stairs, or function in unadapted environments; to get back into home and community situations with a minimal amount of assistance.”

One significant project is development of the hybrid orthosis system, which combines exoskeleton braces with electrical stimulation of muscles that results in body movement. “The main concept is that this approach doesn’t utilize any external motors at all,” Triolo said. “We call it a ‘muscle first’ strategy.” He explained that if the peripheral nerve that connects the spinal cord to the muscle has remained intact, stimulation of the peripheral nerve with a tiny electrical current elicits contraction of the paralyzed muscle.

“Electrical activation of the peripheral nervous system is really good at generating large, propulsive forces out of the paralyzed muscle, and we use the contractions of the person’s own musculature to drive the standing and walking and stair-climbing movement rather than relying on an external motor,” he said.

The electrical current can be delivered through surface electrodes or through implanted, pacemaker-like stimulation systems. “There’s a control system that runs the brace, there’s a control system that coordinates stimulation, and there’s a coordinating system that makes sure that both of them work together, that they’re not at cross-purposes,” said Triolo.

“Essentially, the brace has sensors on it that detect where you are in the gait cycle and then start the stimulation appropriately. But that stimulation can change the orientation of the brace, so both systems have to know what they’re doing.

That’s why we call it a hybrid system – it’s a combination of stimulation and bracing.”

Triolo said this DOD-funded project was geared toward streamlining the external hardware and untethering it from the laboratory computer to operate in a self-contained mode, which was recently accomplished when it was used outside the lab in hallways. “We’re looking forward to actually getting this out of the laboratory and into the community, and putting it through its paces to see if it’s really going to be functional for people,” he said.

In addition to continuing development of the hybrid orthosis system, other APT research involves extending the reach of that technology to patients with incomplete SCI, as well as to stroke survivors and those with multiple sclerosis.

Researchers in Cleveland are also using the implanted technology developed through the VA and Case Western Reserve University to help people stand without braces for long periods, with emphasis on standing balance, and exploring new kinds of electrode technologies through various projects funded by the VA and the National Institutes of Health.

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■■ VA researchers are also working on muscle-stimulating technology to help stabilize those in wheelchairs by stiffening the trunk and hip muscles.

Because a large number of people with SCI depend on wheelchairs, Triolo is enthusiastic about work they’re doing that uses muscle-stimulating technology to help stabilize people while they’re seated in wheelchairs by stiffening the hip and trunk muscles. This aids sitting posture and balance and allows them to propel their manual wheelchair more effectively and with less incidence of shoulder injury, a common pathology in wheelchair users.

Triolo said his message to paralyzed veterans is “to have faith that the VA and other researchers are working hard to develop technology that will address their most pressing needs in terms of exercise, daily function, personal mobility, and that these things are on the cusp, if they’re not already on the market like ReWalk, of being clinically viable. There are lots of opportunities to get involved in this translational research to help refine many of the new sophisticated and life-enhancing technologies that, in the near future, will be widely available to improve the overall health and capabilities of people with SCI.” For additional information, visit www.aptcenter.research. va.gov, fescenter.org, or clinicaltrials.gov.

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INTERVIEW

DONNA GAGE, PH.D., R.N. Chief Nursing Officer Veterans Health Administration

By Chuck Oldham

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ALL PHOTOS COURTESY OF THE OFFICE OF NURSING SERVICES

Donna Gage is an accomplished health care executive with a focus on health care delivery leadership. In her current role, she leads the development, implementation, and evaluation of a strategic plan and activities that support the continued advancement of nursing practice, education, and research across the Veterans Health Administration (VHA).

Prior to her current position, Gage was a consultant and mediator with BMC Associates, consulting to leaders in the health care industry on management and leadership issues, including labor and management relations. Previously, she was vice president/chief nursing officer at MedStar Georgetown University Hospital, and from 2001 to 2011 she was the chief nursing officer at Penn State Milton S. Hershey Medical Center.

Gage is a member of several professional organizations, including the American Nurses Association, the American Organization of Nurse Executives, and Sigma Theta Tau International Honor Society of Nursing. She is Board certified in nursing administration from the American Nurses Credentialing Center. She has received numerous awards and honors, including the Service Employees International Union (SEIU) Nursing Leadership Award.

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

THE YEAR IN VETERANS AFFAIRS AND MILITARY MEDICINE: How has the influx of veterans from Iraq and Afghanistan had an effect on the roles of specialized nursing in Department of Veterans Affairs (VA) medical centers?

DR. DONNA GAGE: I think that the influx of the veterans from the OEF [Operation Enduring Freedom] and OIF [Operation Iraqi Freedom] wars has really resulted in helping the nurses become even more specialized. The nurses that care for these veterans have really played a key collaborative role in helping to establish a national multitiered level of care system. That’s known as the polytrauma system of care [PSC] that we provide. What’s really important about that is the nurses have had to build upon their knowledge and skills and bring all of that together to meet the rehabilitation needs of our very young veterans who have very complex and severe wounds. At the same time, they’re also having to support and educate the young families and extended families who are involved in the care of these veterans. Bringing all of that together, they’ve been providing care with a more holistic focus that is much more a total, inclusive approach to the care.

What’s great to watch is how quickly the nurses have adapted in providing care for this much younger population of veterans. Their injuries are much more complex than we have seen in the past. They have both visible and invisible wounds and, as I mentioned, their young spouses and children and parents and everyone are coming together and wanting to be a part of that care.

I think that, while rising up to those challenges, at the same time these nurses have established a wonderful network for each other and with others in the VA, the VHA, and, as well, within the community to serve as positive role models in sharing their knowledge and expertise as they care for these veterans. They rose to the challenge with an excellence in care delivery that has positively impacted the care of all veterans and serves as a benchmark for the level of care for our nation. What I mean by that is there are multiple trauma centers across the country, and so they are helping to establish a very high level as a benchmark for trauma care.

Nurses within the PSC serve in the capacity of nurse liaisons between the Department of Defense (DOD) and the VA. They collaboratively developed a transfer summary tool that crosses both electronic data systems, a previously non-existent capability that enhances safe transfers of these warriors. The nurses play a significant role in case management of the OEF/OIF veterans that is a lifelong service for the severely injured. There were newly established roles as polytrauma nurse and polytrauma nurse educator that contribute expertise to this patient population as members of the Polytrauma Interdisciplinary Team, assuring that services and education are made available to these veterans, family members, and caregivers. They

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played a significant role in the implementation of the caregiver legislation, development of brain injury and upper extremity amputation clinical practice guidelines, fact sheets, and much more.

In 2009, the Office of Nursing Services [ONS] established the Polytrauma Rehabilitation Field Advisory Committee (PFAC) to serve as a bi-directional conduit between the VA chief nursing officer and the field of polytrauma nurses. The PFAC serves to promote standardization of practice, development of evidence-based competencies, and dissemination of education and best practices.

The collaborative influence of these polytrauma nurses is seen at local, state, and national levels encompassing the DOD, VA Centers of Excellence, VA national program offices, national and state brain injury associations, the Blind Veterans of America, the Paralyzed Veterans of America, the Association of Rehabilitation Nurses, and the Academy of Spinal Cord Injury Professionals. They present on the latest care techniques and best practices, hold national office, submit poster presentations, and publish articles to reflect the excellence of polytrauma rehabilitation care within the VA. Overall, polytrauma nurses have been instrumental in the development of veteran, family, [and] caregiver support groups; serve in roles that optimize positive reintegration outcomes in the Polytrauma Transitional Rehabilitation Program; [and] promote academic outreach to enhance educational achievement with the White House Joining Forces campaign and the Veterans Integration To Academic Leadership (VITAL) program. They endorse the use of complementary alternative medicine modalities such as healing touch, acupuncture, mindfulness, cognitive behavioral therapy, service dogs, and so forth, in managing invisible wounds of war such as pain, posttraumatic stress disorder, and traumatic brain injury.

The polytrauma nurses are dedicated to the care and ongoing advocacy of our OEF/OIF warriors, their families and caregivers. In order to accomplish this, these nurses have had to acquire new knowledge and skills for complex care needs, diplomatically negotiate care terms to serve the best interests of the veteran, collaborate with many other stakeholders, and be a guiding inf luence in improving practice.

It seems that there really is a nationwide shortage of health care professionals, and that shortage is bound to worsen in the future. How can the Veterans Health Administration attract nurses and nurse practitioners when they are in competition with the private sector?

Yes, there is a shortage of health care professionals, but I believe that we have some very distinct advantages, and the first for us in VHA is that we have a great mission. It really is such an honor to care for those who have served our country 113

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and, in my opinion, it’s second to none.

We have so many nurses and advanced practice nurses and other colleagues that are drawn to the opportunity to serve our nation’s veterans. I will just say that in my first year traveling around to the different medical centers, I have been in awe of the commitment and dedication that the nurses and others have demonstrated in caring for our veterans. I think our mission is really, really fabulous. A second attraction is the benefits of working in such a large national system. There are so many opportunities for nurses to move around the country and move from one state to another, and when they do that, they don’t lose any of their seniority or any other benefits, which is really unlike moving around the country if working in the private sector.

True.

And we have many scholarship and continuing education opportunities, and very strong commitment and support for ongoing education and help support for staff to pursue additional degrees. I think that all of those are of tremendous benefit, and at the same time we have, internally, some very good programs and well-defined clinical ladders for advancement to help retain those individuals who want to remain at the bedside caring for our veterans.

There are, as well, many other roles for nurses … in expanded roles that are not traditional roles we think of when we think about providing direct care at the bedside. So I do think that we have a number of distinct advantages when looking at the shortages that we face as a profession across the country.

In terms of challenges, it is difficult to continuously stay current with all the various market changes to ensure we are capable of hiring the most qualified nurses for the most deserving of patient populations. Another significant challenge facing our workforce is the number of retirement-eligible nurses and nurse leaders. Establishing programs to ensure we have prepared

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■■ The VHA offers nurses, advanced practice registered nurses, nurse practitioners, and their colleagues educational opportunities, expanded roles, the benefits of working in a large national system, and the opportunity to serve our nation’s veterans.

the next generation of nurses and leaders requires collaboration with our external partners, such as colleges of nursing, and continually looking for creative ways to sustain the great workforce we have today.

When you talk about expanded roles, would that include things like the clinical nurse leader (CNL) initiative?

Yes. Actually that is one of those programs that we support, fully endorse, and encourage our staff to go back to school to pursue. This role is actually a role that we have been supporting since 2003, when it was first introduced by the American Association of Colleges of [Nursing] [AACN]. The CNL is a master’s prepared generalist nurse clinician positioned at the front lines where care is delivered.

The AACN developed this role as a clinical nurse leader to really provide more highly skilled clinicians that remain in the direct care setting.

They provide support to the nursing

staff and all members of the team, and they serve as an expert resource. So, for example, if someone has a clinical question about a specific disease, the clinical nurse leader can serve as a resource for that nurse. In addition, they provide really valuable leadership in bringing staff together to focus on patient safety issues, quality outcomes, and effective coordination and continuity of care for veterans. They are there to help the staff and interact with the families and then, last but certainly not least, they are also helping to increase efficiency and sustainability of improvements and looking at areas in which we can make some process improvements, or redesign systems and integrate them into the way that we practice and the care that we provide to our veterans.

So it’s really that one individual that helps bring together and integrate all of the change and improvements to the delivery of care.

In 2011, the Office of Nursing Services launched the CNL Implementation and Evaluation Service to provide assistance, guidance, and onsite consultation to VA 115

THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

■■ Nurses play a significant role in case management of severely injured veterans.

medical facilities. Today, there are over 400 CNLs in the VA nursing workforce, and the integration of CNL practice continues to expand throughout our inpatient, outpatient, longterm care, and specialty care areas across the entire VHA health care system.

Are clinical nurse leaders also becoming more common outside the Veterans Health Administration?

Yes, I believe they are. In fact, I’m aware of a number of academic institutions that have just started new programs or are getting ready to start their new program this fall. But over the last decade, 10 years, since its inception, there are now several thousand CNLs across the nation, and they’ve developed a certification to test the knowledge and expertise for this group. I think that as people see the demonstrated value in the workforce that more and more institutions are employing them and encouraging their staff to go back to school to become a clinical nurse leader.

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Could you describe the role nurse practitioners play today in the Veterans Health Administration?

They play a very critical role for us here in the VA. I can tell you that we have over 6,000 nurse practitioners practicing and working here in the VA currently. What’s important about them and their role is that they really help provide care to our veterans. The majority work in primary care, but also specialty care. Many nurse practitioners have specialized in different areas of care, and so they have been providing those specialized services to our veterans both in the medical centers and in our clinics as well.

Do you see that demand for nurse practitioners increasing because of the demographics that are at work today?

Yes. I actually see the nurse practitioner role helping with our access issues and the demand with our veteran population and, also in the private sector, the demand and the need for health care as our population continues to age. There 117

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is increasing demand due to, as we know, the graying of America, with the baby boomers retiring, and with the implementation of the Affordable Care Act. There is, as well, the projected shortage of primary care physicians. All of these factors will overburden our nation’s health care system and the VA will experience many of the same issues. So, the nurse practitioners really are part of the solution to assisting with our shortage of clinicians in providing primary and specialty care services and meeting the rising demand of our health care needs for us in the VA and as a nation.

Often, nurse practitioners very much want to and enjoy practicing in rural health care settings, and in particular if they come from a rural setting, they really want to stay or go back home to their hometowns and enjoy providing care to their neighbors, back in the rural setting, so I really do see nurse practitioners as part of the solution.

I know that’s definitely a need, to try to expand access to care, so that seems like a good thing.

Yes, yes, most definitely.

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When did nurse practitioners first begin practicing within the VA?

It’s interesting – because it was hard to believe myself, looking at that – but we actually had nurse practitioners that were added to the VA model of care back in 1973. So we have gone from having 43 nurse practitioner positions beginning in 1973 to having, now, over 6,000 nurse practitioners working in the VA. They certainly have assisted us in providing care and meeting that demand for care.

What recent technological or medical advances do you think have had a large impact on nursing in the VA system?

I think what’s exciting about that is we’ve been able to use technology to really help support and enhance the delivery of care. Not replace it, but enhance it.

One of the things that nurses have been involved in, and as well have employed, is the use of mobile apps. They are being built to really help meet the needs of nurses. They are designed to help nurses do their job more effectively and efficiently and incorporate the VHA principles of patient-centered care by engaging the veteran. We have been talking with nurses and 119

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asking how we could help them be more efficient and effective.

In doing that, we have developed a number of mobile apps.

An example of one is a mobile app that’s called, or affectionately referred to, as “ANNIE,” and it really helps the nurses to send motivating messages and communicate with patients and help engage them in their care and, as well, we’re using some mobile apps for education, and then also to assist the communication, collaboration, and coordination of care with our physician colleagues with regard to some of the patients.

An example of another mobile app that we’re using is an app that helps support the nurses that work as part of the stroke team – working with patients … veterans who have had a stroke. That’s really been very helpful because the way that it works is that it is an application that allows the nurse as well as other providers to use the same information, so that even though you’re not physically in the same room together, you can access the mobile app and use the checklist. So, that’s been very, very helpful.

Where do things stand with respect to expanding scope of practice for nurse practitioners?

Well, this is very exciting. We are making progress. I don’t know how familiar you are with the process to expand the scope, but here in the Office of Nursing Services we began this process in 2009 to establish a policy that would really look at the process of care delivery and expand the elements of practice for nursing. And, then as you mentioned, within the nursing handbook as everyone is referring to it, we are proposing the authorization of full practice authority (FPA) for advanced practice registered nurses (APRN)… . There are four different categories of APRNs under that umbrella term.

So, we have put forward some language in a regulation to allow the APRNs to practice without regard to their individual State Practice Acts, except for dispensing and prescribing controlled substances and administration of controlled substances. So it’s really consistent with the Institute of Medicine’s (IOM) recommendation to remove scope-ofpractice barriers, including the variation in APRN practice, and this proposed change would really help us standardize the APRN practice across the VA system. At present, that proposed language and policy is currently under review, and once it goes through our internal review, it will be published in the Federal Register for public notice and comment. So, it’s currently undergoing internal review.

How does that process work? Does the federal government decide what the standard would be and then do the state medical boards have to approve this?

Or can you just set the standard?

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Well, what would happen is that we would have a regulation that would standardize APRN practice throughout the VA system and we would be able to have one standard and invoke federal supremacy, and so that’s how we would be able to do that within the VA. We would have established standardized practice with credentialing and privileging to assure that all of the APRNs have the competencies to care for our veterans and practice with full practice authority. And that would be an internal process that would parallel current policies in the Department of Defense and the Indian Health Service.

Could you describe the nursing research initiative?

This is also an important initiative for us and is similar to FPA in supporting the IOM recommendation to double the number of nurses to have a doctorate by 2020. We support that, and one of our goals is to increase the number of nurses with research doctoral degrees conducting research here in the VA. What we’re currently doing to help increase the number of nurse scientists, because that’s a very important member of the team with all of our other colleagues, is we have been working with the Office of Academic Affiliations. They offer several postdoctoral fellowships for Ph.D. prepared nurses who want to become nurse scientists.

We also offer some small grants to help nurses who currently have programs of research. They can submit a proposal and have that competitively awarded to continue their research programs.

We also have a field advisory group that specifically looks at our research, and it’s made up of a number of individuals from across the nation with experience in research. They really help coach and mentor and offer guidance to other nurses interested in pursuing research or a specific field of study. And then we also partner with two VA Health Services Research and Development (HSRD) Centers to really assist us in doing some very highlevel critical evaluations of ONS initiatives of high priority and impact. Our goal is for VA nurses to look at the research and engage in evidence-based practice that integrates the evidence, clinical expertise, and patient preferences into patient care. It’s really finding ways to help us take the research and translate that into practice.

What haven’t I asked you that I should have? Is there anything that you’d like to add?

I would just underscore what I have shared with you: that the dedication and professionalism of the nurses who have chosen to work here is just really fabulous and second to none. And while we have our challenges, we really provide the very, very best care here to our veterans. I personally feel very honored and privileged to have been selected to be the chief nurse and to continue to guide the practice and education and research for our national health system.

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The Ebola Epidemic and DOD’s Global Health Engagement How the 2014 West African Ebola response showcased the U.S. military’s infectious disease expertise

By Craig Collins n BY SEPTEMBER 2014, the most widespread epidemic of Ebola virus disease in history had claimed more than 1,427 lives in West Africa, mostly in the countries of Sierra Leone, Liberia, and Guinea. The nongovernmental organization (NGO) with the largest working presence in the region, Médecins Sans Frontières (MSF, or Doctors Without Borders), had been critical of the international response since the first cases were reported in March, but on Aug. 27, in the Frenchlanguage daily newspaper Le Temps, MSF’s president and general director warned that the epidemic had spun out of control; the health care systems in the region had completely broken down, governments were struggling to maintain control, and the region was in “exceptional crisis.” In Liberia, the hardest-hit country, hospitals had become deserted. Many people were dying of easily preventable and treatable diseases such as malaria and diarrhea.

“The situation can only be reversed,” wrote MSF’s leaders, “if there is a significant commitment of states with available effective disaster response capacity – be it through civil protection mechanisms, the support of military medicine units or of logistics or medical staff who are used to working with strict infection prevention and control measures.”

Less than two weeks after MSF’s plea, when the death toll had risen to more than 2,200, Liberia’s president, Ellen Johnson Sirleaf, wrote directly to President Barack Obama asking for help: “I am being honest with you,” she wrote, “when I say at this rate, we will never break the transmission chain and the virus will overwhelm us.”

The preference for military assistance was in line with the opinions of international infectious disease experts who believed only the American military had the experience and capability to work with viral hemorrhagic fevers such as Ebola. Just days earlier, Obama had publicly declared the West African Ebola epidemic to be a national security priority, and on Sept. 16, at the Atlanta headquarters of the Centers for Disease Control and Prevention (CDC), he announced a more aggressive, $750 million effort.

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The military’s component of the CDC-led government response, Operation United Assistance, was conducted

by U.S. Africa Command (AFRICOM) from a Joint Force Command (JFC) headquartered in the Liberian capital of Monrovia. Over the next several months, the military’s unique capabilities would support U.S. government efforts to contain the Ebola virus, save lives, and alleviate suffering while promoting stability in the region.

It probably wouldn’t surprise most Americans that the military capabilities applied to the Ebola epidemic included command/control and logistical support for the transport of equipment, supplies, and people to the region, or the construction, by Navy Sea Bees and soldiers from the Army’s 15th Engineer Battalion, of training and treatment centers.

But fewer Americans are probably aware that some of the world’s leading experts in the prevention and treatment of infectious diseases are U.S. military personnel, and that these experts played a crucial role, during the West African Ebola epidemic, in diagnosing cases, preventing the spread of the virus, and researching and field-testing Ebola treatments and vaccines.

A GLOBAL ENGAGEMENT

Where did the military’s infectious disease expertise come from, and how did it become so crucial to fighting viral hemorrhagic fever in West Africa? The explanation begins with the simple fact that for decades, diseases killed far more service members in wartime than did enemy combatants. The Army, in fact – under the man recognized as the nation’s first bacteriologist, Army Surgeon General George M. Sternberg – established the first school of public health and preventive medicine in the United States, the Army Medical School, in 1893.

The researchers Sternberg dispatched to the Caribbean and Pacific tropics during the Spanish-American war – including a military physician named Walter Reed – achieved several

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U.S. ARMY PHOTO BY SGT. 1ST CLASS BRIEN VORHEES, 55TH SIGNAL COMPANY

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historic breakthroughs in public health, including the first typhoid vaccine; the use of chlorine as a water purification agent; the identification of two of the first known human viruses (yellow fever and dengue) and the mosquito as their infecting agent; and the dramatic reduction of malaria cases among service members and others working in the Panama Canal Zone.

These advances laid the groundwork for the complex network of military infectious disease research and development that exists today – a program of global reach that increasingly involves joint planning, coordination, and execution. The agencies and laboratories within this program are focused on infectious disease as an obstacle to military missions, but for reasons both strategic and humanitarian, are engaged in a growing number of international partnerships.

The Cooperative Biological Engagement Program (CBEP), for example, conducted by the Defense Threat Reduction Agency (DTRA, the Department of Defense [DOD] agency devoted to countering weapons of mass destruction), is designed to prevent the proliferation of biological agents, in part by strengthening the detection, diagnostic, and reporting systems of partner nations.

At the time of the West African Ebola outbreak, U.S. military researchers had an established presence on the African continent, many of them attached to the infectious disease directorates of the Walter Reed Army Institute of Research (WRAIR) and the Naval Medical Research Center (NMRC) in Silver Spring, Maryland. Naval Medical Research Unit Number 3 (NMRU-3) had been monitoring infectious diseases in western Africa since 1946. Army researchers, most of them associated with WRAIR’s HIV research program, were working in Kenya, Uganda, Mozambique, and Tanzania; the first Ebola vaccine trial ever conducted in Africa was conducted by WRAIR’s HIV group in 2008 and 2009.

When Guinea’s Ministry of Health reported an outbreak of Ebola hemorrhagic fever in the region – 86 suspected cases, 59 of which proved fatal by March 24, 2014 – members of the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID, the Army’s main institution for research into countermeasures against biological warfare) had been supporting diagnostic capabilities at the Kenema Government Hospital in Sierra Leone, developing diagnostic procedures to detect Lassa virus, another causative agent of viral hemorrhagic fever. Because USAMRIID personnel had developed Ebola diagnostics after the 1995 Ebola outbreak in Kikwit, Zaire (now the Democratic Republic of the Congo), they were able to provide updated assays and diagnostics. These tests and the necessary equipment were delivered to medical personnel in afflicted countries through CBEP and the Critical Reagents Program, an initiative administered by DOD’s Medical Countermeasure Systems. A research team from the Navy’s Biological Defense Research Directorate (BDRD) began producing diagnostic assays – more than 100,000 total,

by October 2014 – for use in Sierra Leone and Liberia. These

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■■ A worker decontaminates a caregiver leaving the patient area of an active Ebola treatment center built as part of Operation United Assistance in Suakoko, Liberia, Nov. 22, 2014. United Assistance was a Department of Defense operation to provide command and control, logistics, training, and engineering support to U.S. Agency for International Development-led efforts to contain the Ebola virus outbreak in West African nations.

tests, which definitively confirmed or ruled out the presence of Ebola virus, proved invaluable in focusing the efforts of health care workers and preventing further transmissions of the virus.

OPERATION UNITED ASSISTANCE

The Ebola virus, transmitted through direct contact with infected blood or body fluids, causes severe hemorrhagic fever, and is considered a Risk Group 4 Pathogen by the World Health Organization. At the time of this writing, there 123

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is no proven treatment for Ebola virus disease, nor a fieldready vaccine, and its extreme fatality rate – as high as 70 percent in some areas; even among those who found their way to hospitals, more than half died – was the root cause of the panic that proliferated among West African countries in the summer of 2014.

Obama’s plan for West Africa included a detachment of 3,000 military personnel whose work would be coordinated by a DOD Ebola Working Group, established within the Office of the Assistant Secretary of Defense for Special Operations/Low-Intensity Conflict (SO/LIC). The JFC in Monrovia, eventually led by Maj. Gen. Gary Volesky, commander of the Army’s 101st Airborne Division, was set up to execute a mission that included command and control; engineering support (including the construction of a 25-bed hospital in Monrovia for international aid workers and 12 Ebola treatment units); medical support, focused on protecting the health of international responders (U.S. military medical personnel did not provide direct patient care); and sustainment of the expeditionary infrastructure.

At the same time, military infectious disease experts began to focus efforts on the Ebola virus itself.

USAMRIID experts began tracking the genome of the virus, to ensure diagnostics, experimental therapeutics, and vaccines would continue to target the right organism.

According to Col. Neal Woollen, USAMRIID’s director of biosecurity, mobile teams of USAMRIID experts also spent 1,800 man-hours providing pre-deployment training to 4,000 personnel in the use of personal protective equipment (PPE) – clothing, masks, and other equipment designed to protect wearers from infection. In October, when the first case of Ebola virus disease was reported in the United States, USAMRIID experts provided similar training to the 30-member rapid-response team, composed of volunteers from the Army, Navy, and Air Force, formed by the Pentagon to support civilian health care workers.

The DOD’s Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD), normally tasked with developing diagnostics, drugs, and vaccines to protect U.S. military forces from chemical and biological agents, stepped up its existing programs in the development of Ebola treatments and vaccines. As Col. Russell Coleman, program manager for Medical Countermeasure Systems, explained, his group worked with commercial partners in the development and testing of therapeutic drugs specifically targeting the West African strain of Ebola. Building on vaccine research and development that began in 2010, the group also worked to identify the most promising candidates for vaccine research – one of which, the vaccine now known as VSV-EBOV, has proven to be the most promising candidate yet.

After early development testing of the vaccine at USAMRIID, at the request of the DTRA, the Walter Reed Army Institute of Research conducted the first human trials of VSV-EBOV in mid-October 2014. According to Col. 124

Stephen Thomas, M.D., WRAIR’s deputy commander for operations and the leader of its Ebola Response Management Team, this first trial, conducted in coordination with the National Institute of Allergy and Infectious Diseases, was aimed at demonstrating that the vaccine was safe and produced the desired immune response.

In August 2015, WRAIR began a second clinical trial of two experimental Ebola vaccines in Uganda, and will conduct further trials of one of these candidates at 10 sites in Nigeria later this year. In late July 2015, a trial of VSV-EBOV among 4,000 subjects in Guinea funded by the World Health Organization (WHO) demonstrated 100 percent efficacy among patients who received the vaccine immediately after exposure to Ebola. The WHO authorized the immediate immunization of anyone currently at risk, and is currently helping to lead a Phase III study of VSV-EBOV among more than 7,500 residents of Guinea, Liberia, and Sierra Leone.

LESSONS LEARNED

At the end of January 2015, WHO reported that for the first time in eight months, there were fewer than 100 new weekly cases in the three most-affected countries. Liberia was officially declared Ebola-free in May 2015, but a few new cases were later reported in June and July.

While Operation United Assistance played an important role in building the capacity of health systems and providing expertise, military infectious disease experts – including Coleman and Thomas – view the overall response to have been a mixture of successes and failures.

To Thomas, one of the operation’s greatest successes was the fact that none of the deployed service members got malaria, let alone Ebola. Many of the U.S. Marines deployed to Liberia in 2003 to help stabilize the country during its civil war suffered from malaria, and the prospect of sending 3,000 people into the same area worried many leaders, said Thomas. “I can tell you,” he said, “we were more concerned about malaria and diarrhea than we were about Ebola.”

Thomas also pointed out that one of the region’s most populous countries, Nigeria, suffered only 20 Ebola cases during the outbreak, a circumstance, he said, due in part to U.S. military expertise. “Nigeria dodged a bullet,” he said, “in large part because there was a Navy infectious disease physician who was liaison to the WHO . . . he’s the guy who held down the fort in Nigeria, and probably saved that country a lot of pain and suffering.”

Though new Ebola cases are increasingly few and far between, there has been pain and suffering enough in West Africa: As of August 2015, nearly 28,000 people had been infected with the virus (a number the CDC believes to be underreported), and nearly 11,300 of them had died.

Humanitarian assistance isn’t a new mission for the U.S. military, but it’s a mission in which it plays an increasingly significant supporting role, partnering with the U.S.

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U.S. ARMY PHOTO BY SGT. 1ST CLASS BRIEN VORHEES, 55TH SIGNAL COMPANY

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government and the international community. Several JFC leaders, in their own review of Operation United Assistance, published in the July-August 2015 edition of Military Review magazine, called for a more refined doctrine, better training, and a common operating picture for the DOD and these partners, to ensure the timeliness, efficiency, and effectiveness of future responses.

Two circumstances, in particular, point to room for improvement in the military’s global health engagement: • First, Guinea’s government reported the Ebola outbreak in March 2014, but it was later determined that the first confirmed case of Ebola virus disease was in December 2013, in the remote village of Meliandou. “The Army has worked with its partners to develop pretty advanced tools to support infectious disease surveillance, to support data collection, data consolidation and data reporting, and putting that data in a format that’s easily analyzable,” said Thomas. But such systems rely on computerized recordkeeping, which renders them useless in places such as rural Guinea. “I think what we saw with Liberia and Sierra Leone and Guinea revealed a huge blind spot in that network, and that if people are really serious about avoiding this scenario again,” Thomas said, “there’s going to have to be a lot more coordination and collaboration.”

• Second, despite the promise of VSV-EBOV, the “short game” in product development – fielding drugs or vaccines during an outbreak to treat or prevent infection – failed to help anyone within the given time frame: “By the time they got the vaccines over there and everything set up,” Thomas said, “the epidemic was on the downward slope.”

Part of the problem, Coleman said, is that, “Our business model is terrible. We don’t buy a lot. We don’t know when these products are going to be used – we actually hope they’ll never be used. But then we suddenly want [companies] to surge and potentially provide millions of doses all at once.”

Still, Coleman said, many companies stepped up at the height of the Ebola crisis. “Some companies that had been working on Ebola vaccines or therapeutics diverted resources from other projects to more aggressively respond to this Ebola outbreak,” Coleman said. “And that was tremendous.

But you don’t want to wait for an emergency to start thinking about it. In the U.S. government, we’re thinking continuously about this, but we have difficulty attracting the right partners in the absence of an outbreak like this one. So it’s worth asking: Can that model be changed?”

Despite remaining challenges, the comparison of West Africa before and after Operation United Assistance is stark: In September 2014, the CDC’s worst-case projection was for 1.4 million total Ebola cases by Jan. 20, 2015. In an October speech, Dr. Margaret Chan, WHO’s director-general, said: “I have never seen a health event threaten the very survival of societies and governments in already very poor countries. I have never seen an infectious disease contribute so strongly to potential state failure.”

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■■ A technician with the Navy Medical Research Center starts the process to test blood samples collected from the Ebola treatment unit built as a part of Operation United Assistance in Suakoko, Liberia, Nov. 22, 2014.

About six weeks later, with Operation United Assistance well underway, the Liberian government and WHO reported the number of new Ebola cases was falling. U.S. military leaders won’t claim credit for this result, but they understand the unique capabilities they bring to infectious disease response, and they know they had something to do with it.

“We’ve always been very good at expeditionary medicine,” said Thomas. “We’ve also been uniquely good at the expeditionary research and development of products, going back to the time of Walter Reed and his team in Central America. Our overseas Army and Navy laboratories have 50- and 60-yearold relationships that have produced an incredible amount of knowledge that has supported the large-scale testing of vaccines and drugs that were later licensed. It’s part of our DNA. It’s what we do.”

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NIAID IMAGE BY DAVID DORWARD, PH.D.

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■■ A scanning electron micrograph of two red-colored Klebsiella pneumoniae bacteria being surrounded by a blue human white blood cell, or neutrophil. Klebsiella can cause pneumonia, bloodstream infections, wound- or surgical-site infections, and meningitis.

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Strategies to Fight Viruses and Multidrug-resistant Bacteria

By Gail Gourley n With challenges to address the problems of viral diseases and multidrug-resistant bacteria becoming more urgent, investigators at Walter Reed Army Institute of Research (WRAIR), a unit of U.S. Army Medical Research and Materiel Command (USAMRMC), are at the forefront of research and intervention to meet these challenges, benefitting not just military health care, but all of medicine.

According to Col. Emil Lesho, D.O., director of WRAIR’s Multidrug-resistant Organism Repository and Surveillance Network (MRSN), a number of international and domestic health organizations list antibiotic-resistant bacteria as one of the top, if not the greatest, threats to global public health, both military and civilian.

Lesho characterizes the state of the problem of multidrug-resistant organisms in the U.S. Military Health System (MHS) as “very problematic, very concerning, but currently stable.”

“The reason why the incidences and the prevalence are not continuing to increase is because the activity in Iraq and Afghanistan, at least for the time being, has markedly decreased,” he explained. “The problem really began, or really peaked, after Operations Enduring Freedom and Iraqi Freedom. Highly resistant bacteria were fairly rare even at the tertiary care centers before that, and afterwards there was a huge increase.”

“Antibiotic-resistant bacteria threaten our ability to provide basic, safe, effective patient care – not only causing infections, but making medical procedures we tend to take for granted very difficult,” Lesho said, “because without antibiotics, you can’t do elective surgery; you can’t do cancer therapy; you can’t do transplants; you can’t do joint replacement.”

Lesho characterized the current outlook as not very promising in terms of winning the war on these pathogens, a situation he attributes to “a confluence of factors.”

“Drug companies are disincentivized to develop antibiotics for many reasons, so there’s a dry pipeline – there are no new antibacterials coming out,” he said. Additionally, “The bacteria are emerging new resistance mechanisms and sharing those with other bacteria at a rapid rate.”

Lesho identified the most problematic organisms as Escherichia coli along with those organisms known by the “ESKAPE” acronym – Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter species. These pathogens are frequently linked to health care-associated

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infections, but are increasingly found in the community and highly prevalent in long-term care facilities.

One response to address the threat was the establishment of MRSN in 2009. As co-founder, Lesho identified the overall mission as “collecting and characterizing these multidrugresistant organisms and providing actionable feedback to the individual units, and aggregate reports across the enterprise to enhance countermeasures, to help predict or prevent transmission of these pathogens.”

The MRSN’s laboratory, organism repository, and network of Army hospitals coordinate with other military medical facilities and plan eventual expansion to all U.S. military hospitals. They’re working closely with the Defense Health Agency to unify and standardize MRSN activity across the MHS. Lesho pointed to several unique aspects of the organization in both military and civilian sectors. One is the identifying information they collect. “We don’t just collect the organism,” he said. “We collect the organism, the actual bacterial isolates, and we collect all the clinical and demographic information associated with that organism. That’s needed to track the pathogen and the spread across the military evacuation system, where patients are rapidly transferred across several continents, many hospitals, in a very short period of time.”

Another unique feature is the repository, and a third is how the organisms are characterized – as a combination of the clinical situation and an applied state-of-the-art research process.

When they receive a sample from a hospital lab, they not only confirm the pathogen’s identity, but also conduct complete genome sequencing (deciphering the organism’s genetic information) and multiple “high-level molecular tests to help us figure out where the organism evolved from, what makes it so resistant and what makes it so virulent,” Lesho said. “After we’re done with that, we preserve these pathogens in our repository for future use, for other investigators, or for lookback situations to develop vaccines and antibiotics.”

The information gathered about the organisms is maintained not only for research, but also for clinical action in treating a particular patient as well as monitoring possible outbreaks in a facility. Lesho said information about the bacterial isolate from a patient is provided to the hospital that submitted it, informing them whether the organism is genetically identical to organisms from other patients at the same location.

“We do genetic fingerprinting and we feed that right back,” Lesho said. “So if the hospital suspects or is wondering if they’re having an outbreak, that’s the first type of information 127

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we send them, saying, ‘yes, you are having an outbreak, [the isolates] are all related,’ or ‘no, this is not an expansion of one strain so you’re not having an outbreak.’”

Lesho characterized MRSN research as “genome-scale epidemiology.” He explained that the way in which bacteria become resistant is often due to a highly mobile genetic element that they acquire in the environment and share. And they can share between species, he said. “It’s not limited to E. Coli giving resistant genes to E. Coli; E. Coli can give genes to Acinetobacter.”

Lesho said these highly mobile genetic elements pose special challenges for detection and even more challenges for infection prevention and control measures because they are easily transmitted between patients and among bacteria. “You can’t detect or fully characterize or understand these mobile genetic elements without sequencing the entire genome of the pathogen at a very high resolution. So that’s where we’re bringing in a state of the art to it, and that requires specialized sequencing.”

Beyond establishing a pathogen’s genome sequence, it must also be assessed in the context of everything else that’s been sequenced in order to be valuable information. Lesho identified a promising upcoming advance as development of a bioinformatics sequencing pipeline database, “to make it faster and more convenient to compare that sequence to everything else that’s been sequenced, and determine if there’s anything unique or special in that sequence.”

The MRSN algorithms and procedures are seen as a model for the entire nation, Lesho said. In the 2015 “National Action Plan for Combating Antibiotic-Resistant Bacteria,” advanced by the White House as a roadmap to meet these challenges, MRSN is specifically recognized as a reference laboratory network for reporting data and characterizing resistance patterns in military treatment facilities.

Pathogen surveillance, identification, and sharing of information by researchers at MRSN are all identified priorities to combat this problem.

Lesho summarized other considerations. “The proper use of antibiotics is critical. We have to be mindful that widespread indiscriminate use of antibiotics in humans, in agriculture, can worsen this problem,” he said. “It’s a global problem that’s easily spread, and the world’s populations are increasingly mobile and displaced, so the potential for moving these organisms around is even greater.”

Those demographic factors significantly affect another focus of WRAIR research – that of viral disease threats.

According to Col. Paul B. Keiser, M.D., director of WRAIR’s Viral Diseases Branch, viral threats in the military are situation-dependent.

In basic training environments, for example, where new recruits come together from different geographic areas and are in close contact, respiratory infections like adenovirus pose the biggest problem. For deployed soldiers, “The threat depends on the geography, whether they’re in a tropical area

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■■ Mosquito-borne diseases, such as dengue fever, malaria, and chikungunya, are research focuses for WRAIR.

versus a non-tropical area, and also how mature the environment is,” said Keiser. “Are we talking about Special Forces going to an area where there are no other U.S. forces? Or are we talking about an established forward operating base in a country where we’ve had a sustained presence for 10 years and we’ve already got chow halls run by contractors?”

Mission-threatening viruses are the primary concern, Keiser said. “In a forward combat environment, if you lose a bunch of people to an illness at the same time, then you have to cancel missions, you have to cancel convoys, you have to adjust your personnel.”

Current research focuses on vaccine development for two mission-threatening mosquito-borne infections – dengue and chikungunya. Both cause acute fever, rash, and severe muscle or joint pain.

Increasingly problematic since 2005, chikungunya began to spread from east Africa and southeast Asia to India, and then a few years ago to the Caribbean, where there have been more than 1.5 million cases since 2013.

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THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

Although an operational U.S. troop presence in the Caribbean is relatively low, Keiser said, given the scenario of a significant mission there, a humanitarian crisis in Haiti, for example, involving large numbers of troops, “there’s a good chance that a lot of them could acquire it and it could really compromise the mission.”

“We’re tracking that as a high priority right now,” continued Keiser. “In the past, chikungunya has tended to blow through an area, infect everybody, then everybody’s immune, and it goes away. Dengue fever virus, in contrast, is something that is always there, and there are multiple serotypes circulating. Dengue is the persistent threat, whereas chikungunya is a fire that flared up recently.”

Keiser said WRAIR’s focus on vaccines is multifaceted.

They’re currently conducting clinical trials of dengue vaccines, while also working to develop a blood test to determine a vaccine’s effectiveness. “For some infectious diseases you can say, ‘based on this blood test result I know you’re protected from that infection.’ Right now there’s not a good blood test like that for dengue,” he said.

Because there’s no blood test to ascertain the potential dengue vaccine’s effectiveness, Keiser explained that they’re developing a challenge model, where volunteers would be exposed to an attenuated version of a dengue virus in a monitored setting. The process is nearing the volunteer recruitment phase.

“The idea is to give them a very mild and safe infection with dengue fever,” he said. “If we can prove that the model is safe and predictable, we can use that model to test vaccines and antiviral drugs and do all sorts of other studies. We could take 10 volunteers and give them a candidate vaccine and give 10 other volunteers a placebo vaccine. If we give them all this challenge strain, we could quickly get an idea of whether or not this vaccine prevents dengue.”

Noting that challenge models already exist for influenza and malaria, Keiser characterized a successful challenge model for dengue as a tool that could enable many breakthroughs for vaccines and antiviral drugs.

Keiser said a unique aspect of their institution is that, although they collaborate with industry, they work for the warfighter. “Our motivation is not the short-term economic interest; our motivation is to find a solution.”

Complex circumstances in vaccine development involve factors like how widespread the need is and its financial feasibility. For example, there has not been a civilian need for the adenovirus vaccine, but clearly there is a military need.

“When the vaccine is not given, not only do a lot of soldiers who are in basic training miss days of training because they’re ill and have to recycle, but there have actually been deaths reported – not commonly, but it can be a fatal respiratory infection,” Keiser said. “Because there’s no civilian market for an adenovirus vaccine, it ends up falling on the government, really, to support that whole product line.”

In a collaborative effort, Keiser said vaccine manufacturers, under government contract, have made the

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■■ A digitally colorized electron micrograph of chikungunya virus particles. In late 2013, chikungunya was found for the first time in the Americas, on an island in the Caribbean. Since then there have been more than 1.5 million cases reported in the region.

adenovirus vaccine for defined periods. WRAIR scientists continue efforts to secure an uninterrupted supply of vaccine. But, he added, there are other vaccines that fall into the category of good for the military but not financially feasible for a vaccine manufacturer to make. With chikungunya, for example, the pattern is that epidemics rise and fall in a shorter period than a vaccine can go through development and manufacture. “I mention that as one of the top threats for the warfighter; meanwhile, it may not be a top priority for the industry,” he said.

“That’s not just a scientific problem,” he continued. “It may be more of a financing problem.”

In terms of new advances in viral research, Keiser noted that utilizing genomic sequencing technologies being applied in the antibacterial fight might enable discovery of specific elements that apply to a group of viruses with genetic similarities, enabling vaccine development that targets those shared genetic features. For example, dengue, a Flavivirus, has structural similarities with other Flaviviruses for which vaccines exist, like yellow fever or Japanese encephalitis.

It is a certainty, Keiser concluded, that with increased air travel, expanded range of mosquito vectors, and continued expansion of human activity into underdeveloped areas, the need exists to identify the optimum viral targets and develop vaccines more quickly.

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Embracing Medical Simulation n WHILE THE TRADITIONAL MANTRA on many medical procedures has long been a risky: “See one, do one, teach one,” the recent expansion of available medical simulation technologies has brought a remarkable paradigm shift in both civilian and military health care thinking.

One of the best examples of the paradigm shift for veterans can be found in the Simulation Learning, Education and Research Network (SimLEARN), a national simulation training and education program that has been established for the Veterans Health Administration (VHA). Although VHA has long embraced the use of simulation for health care training and education, SimLEARN provides an integrated approach to expand and maximize those benefits for VHA staff and the veterans they serve.

According to SimLEARN National Program Manager Harry Robinson, Ph.D., the program was established in 2009 under an Executive Decision Memorandum (EDM) signed by the Department of Veterans Affairs acting under secretary for health, “Because they understood the need for simulationbased clinical training within VA, and they really wanted to put some backbone on what we were trying to accomplish.”

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Established in Orlando, Florida, SimLEARN’s first responsibility under the EDM was the creation of a national program office for simulation training education and research, a successful effort that aligned program operations and management under three major VHA offices: the VHA Employee Education System (EES); VHA’s Office of Patient Care Services (PCS); and the Office of Nursing Services (ONS).

“We have three co-leaders at SimLEARN,” Robinson said. “I have the honor to work with Dr. Haru Okuda, the national medical director who reports to PCS, and Dr. Lygia Arcaro, our national director for nursing programs, who reports to ONS. I’m the national program manager and I work under EES.” “Part of our initial charge was to look at how to best employ the use of simulation-based training,” he explained. “Second was to do it in a means that would have VHA-wide implications.

And third, it called for building a national simulation center.”

He described current SimLEARN status as “up and operational,” noting the “delivery of classes for training the trainers” both in Orlando and at a satellite facility in Palo Alto, California.

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PHOTO BY SONOSIM, INC.

By Scott R. Gourley

U.S. ARMY PHOTO BY SPC. ROBERT FARRELL

THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

“We train folks here and in Palo Alto and then send them back to their facility where they deliver local-based training to the providers,” he said, adding that the SimLEARN graduates are teaching classes at 150 VA Medical Centers around the country.

The Hunter Holmes McGuire VA Medical Center, located in Richmond, Virginia, provides multiple examples of medical simulation applications at the local level.

Michael S. Czekajlo, M.D., Ph.D., is an intensivist in the center’s surgical ICU as well as medical director for its Simulation Center.

“Considering that the VA is the largest health care system in the country, I’m not sure that everyone realizes the impact that simulation is having and will have as it continues to roll out,” Czekajlo said. “In fact, one of the reasons I took over as medical director to build the sim[ulation] program here is that I see if I do anything here that works out on a pilot basis it can have national implications, because I can talk to the SimLEARN people and they can help move it along.”

He currently sees “three main audiences” for medical simulation at the Richmond Center: residents and students from Virginia Commonwealth University who rotate through the VA; VA personnel; and the community at large.

With those constituencies in mind, Czekajlo is crafting the local simulation center “from the ground up,” with approximately 3,000 square feet of dedicated space in the hospital and initial funding arriving in fall 2014. That funding allowed the acquisition of several medical simulators, including SonoSim® ultrasound simulators, a Simbionix vascular surgery simulator, and a “surgical cut suit” from Strategic Operations.

With the look, feel, and smell of live tissue, the “cut suit” was developed to be worn by “role players” to provide medics and combat lifesavers with simulated effects of severe traumatic events on a live human. Design features allow dozens of realistic medical procedures, from extremity hemorrhage control to thoracotomy and intra-thoracic exploration.

According to Executive Vice President of Strategic Operations Kit Lavell, the VA heard about the suit through the work the company had been doing with the medical school at Rocky Vista University. Instructors there had seen an early prototype a few years prior at a Special Operations Medical Association (SOMA) conference.

“We were using the original cut suit for Tactical Combat Casualty Care,” Lavell explained. “But they asked us if we could build a surgical version.”

“So we are now introducing what we call advanced surgical skills packages designed for advanced training of specific procedures,” he added. “It will be offered as a package that can be used and then sent back to us for refurbishment.

We’ll be making specific packages for different pathologies and trauma surgeries.”

“The cut suit allows you to do a lot more than some of the manikins,” Czekajlo observed. “You can train skills like a cricothyrotomy or chest tubes on a manikin, and stuff like

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■■ ABOVE: U.S. Army Col. Rob Sheridan, left, and Lt. Col. Michael Yaffe, right, from the 399th Combat Support Hospital, conduct simulated surgery on Spc. John Tofth from the 388th Medical Support Company at Fort McCoy, Wisconsin, April 2, 2014. Tofth was wearing a cut suit, a human-worn surgical simulator, as part of an annual War Exercise (WAREX) involving more than 4,500 soldiers. OPPOSITE: A male subject employs SonoSim technology to learn and practice ultrasound maneuvers using a hand-held probe. The probe is connected to a personal laptop computer via USB port, and the program walks the user through modules and training. Both the probe and program are commercially available from SonoSim, Inc.

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■■ From the right, Maj. Sina Haeri, medical surgeon and Lt. Col. Raymond Frost, 320th Medical Company, 324th Combat Support Hospital, San Antonio, cut into a patient wearing a “cut suit” to conduct an emergency laparotomy. Acting patient Spc. Kevin Stebler, 912th Dental Company, was brought into the operating room after his arrival for injuries due to an improvised explosive device.

that. But it’s a little different if you have somebody who is awake, scared and swinging at you while you are trying to put a tube into their throat.”

Czekajlo himself wore a cut suit during a recent unannounced disaster drill. Although the facility is not a designated “trauma center,” the scenario brought him into the emergency department presenting symptoms of a potential pneumothorax.

“They picked up on that pretty quickly and they wanted to get a chest tube into me,” he offered. “But then they couldn’t find a scalpel for nine minutes.”

In addition to the dedicated simulation space, Czekajlo emphasized the ability to use many of the capabilities on the wards themselves, where he targets issues related to “knowledge, skills, and logistics.”

“Knowledge is important, but doesn’t always translate into performance,” he said. “So we can use task 134

trainers and simulators to improve performance of skills.”

He offered the example of the Advanced Cardiovascular Life Support (ACLS) course, where “the best data is that retention of skills at six months is about 30 percent. But the certification is valid for two years … So my thought is that we have to do the training on the wards.”

One recent representative simulation activity involved a “mock drill” in the MRI suite, in which a simulated patient went into cardiac arrest during an MRI. The event highlighted a range of challenging issues: from removing the patient from the scanner to the way the oxygen was positioned outside the machine.

“I want each unit to come up with their top three goals for education and patient safety hazards that they see on their particular ward,” Czekajlo said.

“Then we’ll sit down and the Sim Lab staff will help them design the curriculum for that. We’re the experts in the

technology. But they are the experts from their ward. So that’s how I see this going. We can take simulators and try a couple different ways of doing it.

Instead of just thinking it through we can actually test it.”

Other recent VA simulator acquisitions, including new “birthing simulators,” reflect changing demographics within the U.S. veteran population.

“We have more women vets,” Czekajlo observed. “So that should translate to more birthing simulators and other kinds of gynecological designs moving forward as well.”

According to SimLEARN’s Robinson, the next milestone in VHA’s growing embrace of medical simulation will be the opening of a 51,000-square-foot “immersive training facility” at the Orlando location.

“What we’re building here is an immersive training environment with nine clinical exam rooms, an operating room, a catheter lab, three intensive care units that convert to medical/surgical with one converting to a bariatric surgical suite, a trauma room, and a triage room. We’re also going to have things like the back end of an ambulance on casters,” he said.

“There is absolutely no health care that is going to be delivered in this building,” he added. “But it’s going to be representative of any VA clinic on the outpatient side or any VA hospital on the inpatient side. It will provide a level of ‘suspension of disbelief’ to create and maintain an immersive training environment.”

Robinson highlighted a “team” behind the immersive environment that has included architects RLF (Rogers, Lovelock and Fritz), architectural engineers Ellerbe Becket (now AECOM), input from multiple medical training centers, support from VA Office of Construction and Facilities Management, general construction contractor (joint venture) Archer Western/ Demaria, and extensive support from the Orlando VA Medical Center.

Current schedules reflect completion of the new facility around the end

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U.S. ARMY PHOTO BY STAFF SGT. CARRIE A. CASTILLO

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of 2015, with the active delivery of courses around spring 2016. Estimated training throughput for the facility will be approximately 2,000 instructors annually.

“SimLEARN is already the VHA’s national simulation center and will be even more so once we get into the building,” Robinson continued. “But right now we’re essentially a hub with 150 spokes – all the VA Medical Centers that have facility simulation training centers.”

As a representative example of recent results from the hub-and-spoke concept, he pointed to the 2015 creation of a Facility Simulation Training Center Certification Program. The three-tiered process identifies criteria for basic, intermediate, or advanced certification, with VA Centers solicited to apply for certification on a bi-annual basis. The initial rollout occurred in February 2015 and resulted in certification for 20 of the centers.

Another significant activity example identified by Robinson is SimLEARN’s “Hospital Activations” program.

“VA is opening a number of new hospitals,” he explained. “They did one in Las Vegas about 12-18 months ago. They are opening the Orlando VA Medical Center this year. Next on the schedule is New Orleans and then Denver.

These are major facilities being built. If you look at the one in Orlando, for instance, you’re talking about a 1.2-million-square-foot facility. And one of the services we’re providing for hospital activations is to go in before they open and help them by running them through various processes and patient flows and to see how they will handle various emergencies. For example, what if somebody ‘codes’ in the cafeteria? What if a patient becomes belligerent in a dental chair? We use confederates [role players] or manikins and we will run them through all their procedures. We’ll document how they did and give them feedback. Then at the end, for each subsection that participated, we will identify the latest safety hazards, classify them for probability and severity, and then give the report to their leadership so that they can address these scenarios even before they open the doors.”

The SimLEARN simulation activities take place prior to new hospital accreditation by the Joint Commission of Accreditation of Healthcare Organizations (JCAHO).

“Even before JCAHO and ribbon cutting they’ve already seen a number of adverse scenarios and are well versed on how to handle the situations,” he said. “It’s a little different than simulation-based clinical training. Instead, it’s simulation-based process evaluation.”

“We’ve done it on a smaller scope for some of the clinics or wings that have opened at existing hospitals,” he added. “And we’re in the process of developing a course here so that we can teach facilities how to do this on their own.”

“Applying simulation-based training in the medical field clearly provides numerous benefits,” Robinson summarized. “It provides a safe training environment where no harm can ever come to a patient. You can also target exactly what you want to train on a given day. And we get to teach to a mastery level, where the students can perform a procedure numerous times, just like a military pilot can practice in a simulator for landing on the ship at night. They can learn the muscle memory and all the cognitive skills. They can do it so many times in the simulator that they become proficient at the task. And this is key in health care, where there are numerous procedures that providers might not get to see without the opportunity of simulation.”

“I see the use of medical simulation continuing to grow across the Department of Veterans Affairs,” he concluded. “We have great leaders in VA who see its utility and strongly support it. They ‘get’ what we do and see further applications in the future.”

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MILITARY EXPOSURES:

A New Era in Post-deployment Health n IN JUNE 2015, when the the Department of Veterans Affair’s (VA) Post-9/11 Era Environmental Health Program released its “Report on Data from the Airborne Hazards and Open Burn Pit (AH&OBP) Registry,” it signaled an important first step toward characterizing, to the greatest extent possible, the health risks posed by certain health hazards military personnel had encountered while deployed to the Middle East.

The AH&OBP Registry was mandated by a law signed

by President Barack Obama in January 2013, after several years of anecdotal reports from service members and veterans suffering long-term health problems, including respiratory illnesses, recurrent headaches, and chronic fatigue. Many of these people had served near one of the hundreds of open-air pits used to dispose of waste – anything from Styrofoam to medical waste to entire vehicles – at installations in Iraq and Afghanistan. The military’s policy on these burn pits was updated in 2009 to prohibit the burning of toxic materials such as batteries, tires, and certain medical wastes.

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The reports of returning service members, along with several limited-scale investigations of their health and the environments they served in, increased the pressure on the federal government to learn more about these exposures, and to determine a course of action. Both the Pentagon and the VA, however, voiced concerns about trying to extrapolate isolated findings to the experiences of more than 2 million post-9/11 veterans.

The VA requested that the Institute of Medicine (IOM) of the National Academy of Sciences study the problem and make recommendations for how to approach the issue of airborne environmental hazards in Iraq and Afghanistan.

The IOM report was made public in 2011; it concluded, according to the VA, that there was “limited but suggestive evidence of an association between exposure to combustion products and reduced pulmonary function.”

Nevertheless, the evidence gathered by IOM was insufficient to provide a clear association between these exposures and diseases such as cancer or respiratory, circulatory, or neurologic disorders.

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USMC PHOTOGRAPH BY CPL. SAMUEL D. CORUM

By Craig Collins

THE YEAR IN VETERANS AFFAIRS & MILITARY MEDICINE

■■ OPPOSITE: Sgt. Robert B. Brown, with Regimental Combat Team 6, Combat Camera Unit, watches over the civilian fire fighters at the burn pit at Camp Fallujah as smoke and flames rise into the night sky behind him on May 25, 2007.

After reviewing the IOM report, then-Secretary of Veterans Affairs Eric Shinseki directed the Veterans Health Administration to conduct a long-term prospective study on all adverse health effects that might be related to deployment in Iraq and Afghanistan, including health effects potentially related to exposure to airborne hazards and burn pits. The most recent step in these studies – the post-deployment datagathering phase – has been the AH&OBP Registry, launched online last summer.

POST-DEPLOYMENT HEALTH: A BRIEF HISTORY

Health problems that may or may not be related to military deployment have been an issue for the military and veterans for more than a century, as service members have departed the familiar and relatively well-regulated environments of home to serve in the more fluid – and often chaotic – environments of war.

How does today’s post-9/11 program for gathering information and addressing veterans’ health concerns differ from those of the past? According to Dale Smith, professor of military medicine and history at the Uniformed Services University of the Health Sciences in Bethesda, Maryland, it has to do with when, how, and what kind of information is gathered.

Before the 20th century, explained Smith, little was expected of military medicine; disease killed far more troops than combat did. “But with the rise of germ theory, and the development of aseptic surgery as the world moved into World War I,” said Smith, “there was a fundamental mindset change. Medicine seemed to be making so much progress that perhaps it could change the outcome of war for some people.” The induction physical performed by military physicians was far more thorough and informative than those performed, for example, on Civil War inductees.

“But,” Smith said, “we still didn’t know what we didn’t know.” World War I inductees were mostly young, healthy men, tested for obvious problems: hernias, heart defects, dental problems, and vision and hearing impairments.

They were not, despite the generally widespread exposure to Mycobacterium tuberculosis among 19th century Americans, tested for the latent form of tuberculosis (TB). That became a problem when young veterans began returning home from Europe, where the Germans and Allies both made use of poison gas weapons, and complained of respiratory trouble.

Many of these veterans came down with active TB, and made

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the argument that their exposure to chemical weapons had been the factor that led to their pulmonary problems. Without any evidence to argue otherwise, the Veterans Bureau compensated large numbers of World War I veterans and treated them in hospitals.

The government made notable attempts to learn more about what it didn’t know during and after World War II. Because the damaging effects of radiation were well-known by the time the United States dropped atomic bombs on Hiroshima and Nagasaki in 1945, the government commissioned studies among veterans who were part of the ensuing occupations of the two cities, were prisoners of war in the area, or participated in the above-ground nuclear tests conducted between 1945 and 1962. Evaluations of illness and mortality among “atomic veterans” continued for decades, and in accordance with these findings, Congress authorized the VA to establish disability ratings and benefit payments to veterans who had been exposed, to any degree, to ionizing radiation. In 1986, it also directed the VA to create an Ionizing Radiation Registry, allowing atomic veterans to receive free health examinations and to receive information about the potential long-term consequences of their exposures. As of May 2015, more than 25,000 veterans have signed up to participate in the Ionizing Radiation Registry program.

One of the most studied cases of deployment-related exposure occurred during the Vietnam War, when U.S. military forces sprayed more than 19 million gallons of herbicides over the region’s tropical foliage to expose concealed opposition forces, destroy crops, and clear perimeters around U.S. bases.

As anecdotal and clinical evidence emerged that these defoliants – particularly a contaminant in the herbicide known as Agent Orange – could cause a variety of health problems, a familiar series of events unfolded: Both the White House and Congress commissioned studies; Congress passed a series of laws focusing on health care and compensation for veterans exposed to Agent Orange; and the VA launched both a registry and compensation program for veterans who had one of the disorders for which there was a scientific association with herbicide exposure.

The first Gulf War of 1990-1991 presented a new challenge to the federal government’s approach to handling military exposures: a chronic multi-symptom disorder, affecting veterans and civilian workers returning from the Persian Gulf, that became known as Gulf War syndrome. IOM studies of returning veterans have revealed much higher rates of chronic multi-symptom illness among Gulf War veterans than among the general population: About 250,000 of the 700,000 U.S. personnel deployed to the region, the report said, suffered from persistent, unexplained symptoms including fatigue, muscle and joint pain, rashes, and cognitive problems. Nine IOM reports filed since 1998 have catalogued a unique combination of hazards never before experienced during wartime, including medications given to protect troops from nerve agents, munitions containing depleted 137

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uranium, organophosphate pesticides, vaccines for anthrax and botulinum, and persistent smoke from oil well fires.

Some of these factors have since been ruled out by investigators as causes for these symptoms, but because there is still no identifiable cause for what’s known as Gulf War syndrome, its history is riddled with controversy. The short version of the outcome is that the VA has both a Gulf War Registry program, and has also extended its disability compensation to Gulf War veterans with “medically unexplained illnesses” and certain infectious diseases associated with Southwest Asia.

Despite many circumstantial differences, the government’s response to exposures in World War II, Vietnam, and the Gulf War shared one key similarity, according to Smith: Despite an obvious effort to anticipate, prevent, and document deployment-related exposures, the military and the VA still didn’t know much about what they didn’t know. The chaos of war made data-gathering difficult, and limited our understanding of many deployment-related exposures. For example, said Smith, “Keeping track of where every unit went at the end of the Second World War turned out to be really hard, because a lot of people were moving around and theater orders were not necessarily getting back to the central database. Those kinds of problems, of knowing where a unit is this month, have always been difficult for deployed military. The mission is the primary goal, and bookkeeping kind of secondary.”

This difficulty, and the determination of the military and the VA to overcome it, are at the heart of what’s different about today’s post-deployment health program.

DOD PHOTO

THE POST-9/11 ERA ENVIRONMENTAL HEALTH PROGRAM AND THE AH&OBP REGISTRY

It’s worth pointing out a couple of things about the VA’s exposure-related registry programs and compensation: • The Ionizing Radiation, Agent Orange, Gulf War, and AH&OBP registries are for the purpose of expanding knowledge: Registry data helps the VA understand and respond to health problems more effectively, alerts veterans to possible long-term health problems, and connects them with health care resources; it’s also used to help DOD and VA refine and update their clinical practice guidelines for the treatment of exposure-related diseases and disorders.

The registry programs’ health examinations have nothing to do with assigning a disability rating, which is an entirely different process.

• In determining exposure-related disability compensation, the VA doesn’t place a burden of proof on veterans; it has the authority to establish a “presumption” that an illness was caused by exposure to an environmental hazard. An atomic veteran, for example, doesn’t have to prove that her ovarian cancer was caused by her exposure; nor does a Gulf War veteran have to link his chronic fatigue syndrome to a particular deployment-related hazard. Such a link, in fact, is impossible,

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■■ A UH-1D helicopter from the 336th Aviation Company sprays a defoliation agent on agricultural land in the Mekong Delta during the Vietnam War.

said Smith, for the same reason that epidemiological studies that might pinpoint hazard-related health problems in the theater are impossible: “It’s not an experiment. It’s a war.”

Even so, preventive medicine experts with DOD and VA agreed, at the turn of the 21st century, that they could do a better job of gathering data both before and during military deployments during wartime. They collaborated on a program to collect data and track personnel individually, every day, throughout their deployments. “We’re tapped into a list of who deployed,” said Dr. Paul Ciminera, director of the Post-9/11 Era Environmental Health Program in the VA’s Office of Public Health, “and we receive country-level information. This type of information was nonexistent during Desert Storm/Desert Shield. That all had to be reconstructed after the fact. And that took up time. It delays our ability to respond.”

The DOD/VA collaboration has meant that the creation of the AH&OBP Registry differs from its predecessors in one significant way: It began long before Congress ordered it.

“Before the registry was established,” said Ciminera, “DOD was providing a list to VA of everyone who had separated from service, and among those, who was deployed, and where. And so we had been looking at our health care data for those individuals, and producing quarterly reports. We’d been talking with DOD about the issue of respiratory symptoms that were 139

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reported in the DOD’s Millennium Cohort Study. And then we worked with the IOM to produce the burn pits study, which they released in October 2011.” When the AH&OBP registry was mandated, Ciminera said, it became another tool in the existing action plan for the VA to look at the overall population of deployed Iraq and Afghanistan veterans and to determine, and respond to, their health needs.

The new registry is open to anyone – veteran or active duty military – who served in the wars in Iraq and Afghanistan, was stationed in Djibouti after Sept. 1, 2001, or who served in the 1991 Persian Gulf War and may have been exposed to oil fires and dust. Registrants may also request a free medical exam – which, unlike the examinations administered under previous VA registry programs, is optional. “It’s also an online registry,” said Ciminera, “which is a new approach that really improves access. Individuals can go on that registry, and create a snapshot of their health, and learn more about the health concerns and the science and summaries of science as it is today. They can also receive resources to help them with next steps, and to be evaluated or, if they wish, to file a compensation claim. The online registry also provides a way we can reach back to them if new developments occur.”

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As of May 2015, more than 43,000 participants had signed on to the AH&OBP Registry. The June report issued by the Office of Public Health was, for the most part, a summary of the basic raw data it’s collected so far on the participants themselves and the type of exposures they’re reporting.

“That’s really the first step,” said Ciminera. “[That data] helps us focus our outreach. It helps us improve our education to our staff, based on the exposures people report. And it helps us guide research studies to see what exposures we should be focusing on.”

Ciminera hopes that in the future, more of the 2 million people eligible for the registry will participate – not only so more people will become more aware of what to expect, what resources are available to them, and what to do if they notice changes in their health, but also so that researchers can expand the knowledge base about exposures in Iraq and Afghanistan. “The statistical tools available to us are so much more robust and capable now,” he said. With these tools analyzing data collected both before and during deployments, DOD and VA are closer than ever to understanding the connections between deployment-related exposures and the health of individual service members.

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DOD PHOTO BY JOE GAWLOWICZ/JO1

■■ A Kuwaiti oil field set afire by retreating Iraqi troops burns in the distance beyond an abandoned Iraqi tank following Operation Desert Storm.