design of effective homeless initiatives for veterans and other at-risk populations

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Using Aerospace Medicine in 21 st Century Medical Practice Design of Effective Homeless Initiatives for Veterans and other at-risk populations Real Solutions for Restoring a Veteran’s Work Capability, Greatly Reducing Homelessness and Disability, and Restoring Quality of Life Stephen D. Reimers, MS, PE Chief Financial Officer, IHMF William A. Duncan, Ph.D. Vice President of Development, IHMF IHMA & IHMF: Sister Organizations Translating Science into Medical Practice and Public Policy to Create Healthcare Solutions for the 21st Century

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Page 1: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

Using Aerospace Medicine in 21st Century Medical Practice

Design of Effective Homeless Initiatives for Veterans and other at-risk populations

Real Solutions for Restoring a Veteran’s Work Capability, Greatly Reducing Homelessness and

Disability, and Restoring Quality of Life

Stephen D. Reimers, MS, PEChief Financial Officer, IHMF

William A. Duncan, Ph.D.Vice President of Development, IHMF

IHMA & IHMF: Sister Organizations Translating Science into Medical Practice and Public Policy to Create Healthcare Solutions for the 21st Century

Page 2: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

Veteran Casualty Crisis: Source of Performance Challenges in Veteran Programs

• Military Med Confused: PTSD shares symptoms with Mild-TBI! – sleep cycle disruption, irritability, and difficulty concentrating

• About 600,000 IEF/IOF war veterans blast/concussion casualties– MOST DO NOT RECOGNIZE THEY HAVE A BIOLOGICAL INJURY!

- This is not because they were not “STRONG” enough to take it!- It is not a moral weakness!

• Each Untreated Casualty Costs $60,000 per year in safety net, substance abuse & incarceration costs & lost tax revenue

• Each Casualty that Returns to Work– Is a $10,000 minimum Annual Revenue Source to Federal,

State and Local governments– Reduced Need for Services– HBOT (biological repair) Treatment is paid for within 14 months– Each Active Duty Rescued-$2.6 million per veteran over lifetime

Page 3: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

National Emergency: A War Casualty Crisis• Service members in the All-Volunteer Force are some of the best

and brightest in the nation; risk-takers, leaders!

• If left untreated, a veteran’s brain injury destroys their life. They are a Casualty of War as much as if they had been left on the battlefield

– Divorce, unemployment, disability, substance abuse, incarceration, homelessness, suicide

– Cascade steep for the first 2 years and continues downhill thereafter

• Virtually ALL Homeless Veterans have a brain injury

• It costs society more per war casualty not to treat them

• End of World War II: by 1949 1/3 of all persons in prison were combat veterans

• Vietnam: 66% of prisoners today in jail for violent crimes “harmed someone they knew.”

We Do Not Need to Repeat the Tragedies of Previous Wars!

Page 4: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

Veteran Employment Picture• Veteran Unemployment Rate & Discouraged

Worker Rate EXCEEDS that of their non-serving peers!– March 12, 2010 (Last Comprehensive Report)

• 165,000 unemployed• 319,000 not in the labor force (Discouraged Workers)

– LAPD has had many MP ARNG return who are not redeployable to the field as working police officers

• Many Casualties are Hidden in the System• But these are America’s BEST & BRIGHTEST!

Page 5: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

The Effective Veterans Employment Program

• Places Veterans in Careers to match skills and interests

• Uses Executive Recruiter Tools– Uses Computer Software to Identify Aptitudes,

Interests, Talents and Capabilities– Screens for mTBI Injuries & PTSD & refers to

effective treatment• Tracks program outcomes under IRB-approved study

so accurate success & metrics can be reported.• Coordinates and Cooperates with Other non-profit

organizations and Veterans Service Organizations to use the unique talents of each.

Page 6: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

Real Solutions Are Here Today!

• Current medical interventions being applied are ineffective at solving underlying problems

• Effective and safer medical interventions are available and deployable NOW

• These new interventions must integrate well with current best practices.

Page 7: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

Current DoD-VA Reimbursed Drug Treatments: Only 2 On-Label!

Clear Cause of Suicide Epidemic!

There is no drug currently approved by the FDA to treat TBI. The only drugs approved for PTSD are Zoloft and Paxil. All other treatment with drugs for these conditions is off-label and intended to treat symptoms. In fact, a significant percentage of psychiatric medications are prescribed off-label. Further, the use of antipsychotics in these patients is often as a chemical restraint. The following list of drugs are FDA approved for psychiatric and neurologic disorders. The great majority of these drugs have been and are currently prescribed by DoD Medicine off-label for TBI/PTSD in the service members Dr. Harch has treated with HBOT 1.5 in New Orleans.Neurology: Psychiatry Alzheimer's Anti-anxiety

• Ebixa Lectopam• Klonopin Tranxene• Neurontin Valium• Lyrica• Topamax• Dalmane• Symmetrel

• Psychiatry (Con’t)• Antidepressents (All Black Label Warning Suicide)• Celexa• Lexapro• Prozac• Luvox• *Paxil• *Zoloft• Cymbalta• Effexor• Wellbutrin• Remeron• Desyrel

• Antimanic• Tegretol• Lamictal• Eskalith• Topamax• Depakote• • Antipsychotics• Clozaril• Zyprexa• Seroquel• Risperdal• Geodon• Abilify

*FDA Approved for PTSD

All these carry a black label warning for suicidality in those under age 25!

The Veteran Suicide Rate is 120 per week (CDC Numbers)

Page 8: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

Typical Multiplace Hyperbaric Chamber

Hyperbaric Medicine is approved for 13 indications and treatment is reimbursed by all major third party payers including Medicare, Tricare and the Veterans Administration.

Typical Monoplace Hyperbaric Chamber

Hyperbaric oxygen therapy is the only non-hormonal treatment approved by the FDA for biologically repairing and regenerating human tissue.

It is FDA-approved and effective for the treatment of 3 kinds of non-healing wounds. It is currently FDA-approved as the primary treatment for 3 different kinds brain injuries:

carbon monoxide poisoning, arterial gas embolism, and cerebral decompression sickness.

Hyperbaric Oxygen Therapy is not Black-Labeled by the FDA, as are many drugs currently being prescribed for post-traumatic stress disorder or traumatic brain injury.Copyright retained: Paul G. Harch, M.D.,

2010 & IHMA

Page 9: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

It’s Just Oxygen!• O2 used in thousands of cellular

processes• Lack of oxygen is bad• We know how it works

– Acutely stops swelling/reperfusion injury

– Restarts stunned cellular metabolism– Regrows Blood Vessels– Activates Stem Cells 8x Normal

• No wound can heal without oxygen• Wounds that have not healed do• Wounds heal 50% faster with less scar

tissue• Broken bones 30% faster & 30%

stronger

Pressure causes oxygen to

saturate tissues at 7x to 12x

normal breathing.

Page 10: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

The Specific Science for HBOT 1.5• 1977 Study: Holbach & Wasserman: HBOT 1.5 puts the most oxygen into the brain because more

triggers an autonomic response to keep extra O2 out! Chronic Stroke patients treated at numerous locations.

• 1990: Harch treats first demented diver for delayed decompression sickness. Numerous small studies published. (See Memorandum)

• 2002: US Army verifies HBOT 1.5 repairs white matter damage in children.• 2007: Rat HBOT 1.5 study for Chronic TBI published in Brain Research. Human protocol in Animals.

First improvement of chronic brain injury in animals in the history of science.• August 14, 2008: Briefing to Surgeon General of the Navy & Deputy Commandant, US Marine

Corps: 5 blast injured veterans treated. All five made dramatic improvement. Four of five were able to return to duty or civilian full-time employment! Published April 2009

• September 2008: US Air Force Hyperbaric Researcher & Special Forces Command Physician treats two airmen. Results verified by ANAM neuropsych test. Both are restored to duty saving the Federal government an estimated $2.6 million each in lifetime costs. They continue their careers. More active duty personnel are treated. Published in January, 2010 in Peer Reviewed Journal (See www.HyperbaricMedicalFoundation.org)

• March 12, 2010: Report on 15 Blast Injured Veterans under LSU IRB-approved study. Report is clinically and statistically significant and sufficient proof because of dramatic improvement in patients. ½ of protocol given– 15 point IQ jump in 30 days p<0.001– 40% improvement in Post-concussion Syndrome p=0.002 (np)

• (10% is considered clinically significant enough to warrant approval and payment for HBOT according to DoD researchers in December 2008.

– 30% reduction in PTSD p<0.001– 51% Reduction in Depression p<0.001

• NBIRR-01 Begins Enrolling Patients

Page 11: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

Non-Healing Wound of the FootDiabetic Foot Ulcer: This Wagner Grade III was present for one

year and unresponsive to conventional therapy.

26 HBOT Treatments

50 HBOT Treatments

Hyperbaric Oxygenation prevents75% of amputations in diabetic patients.Therapy approved by CMS for Medicare upon application by IHMA to CMS forcoverage, 2003.

These photographs are the property of Kenneth P. Stoller, MD, FAAPPermission given by Dr. Stoller to the IHMA to publish on this CD (2004)

1 Day Prior to Scheduled Amputation

Copyright retained: Kenneth Stoller, M.D., 2010 & IHMA

Page 12: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

Pre-HBOT 1.5 Post-HBOT 1.5

Non-Healing Wound of the BrainPhysical Abuse - 9 years after Injury - 21 y. female

No wound will heal without oxygen!

What is the difference between the diabetic non-healing foot wound and the non-healing brain injury? Essentially nothing. FDA has already approved HBOT for 3

kinds of non-healing wounds and 3 neurological injuries!

Page 13: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

Case Report: Navy SG Meeting - Aug. 200825 year old Humvee Machine Gunner

40 HBOT 1.5 treatments (1/2 of the Protocol)

Treated in 2008. PTSD disappeared. From living in a dark room since returning from Iraq, he became gainfully employed, turned down ½ of his VA disability, worked and made $39,000 per year, and has returned to college after 2nd 40 treatments.

Non-Healing Wound in the Brain

Page 14: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

HBOT 1.5 Restores Brain Blood Flow & MetabolismScale actually goes from 0 to 2000 so it ENDS at 2000. Those pixels that are hitting near 2000 are red and are the most active, the less metabolically active are "cooler" colors of yellow, green and blue. So if you draw a line across the middle of the scale you can see what pixels are registering at 1000 by the corresponding color.

Both pre and post HBOT sets of images are exactly on the same scale. Below is a a quantitative assessment that shows the actually percent increase in up take to an area of the brain quite vulnerable to TBI. Note the mean uptake in the area went from 644 to 1008. Similar changes are evident everywhere else.

In ballpark numbers a change from green to red is a doubling of metabolism.

Analysis of blast injured veteran in LSU IRB Study # 7051: Edward Fogarty, MD, Neuro-radiologist, Chair, University of North Dakota School of Medicine, (701) 751-9579 40 Treatments: ½ of NBIRR Protocol

Page 15: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

0

10

20

30

40

50

60

70

80

90

100

Simple Reaction T ime Procedural ReactionTime

Code SubstitutionLearning

Code Substitution Delayed

MathematicalProcessing

Matching to Sample

Airman B ANAM Percentile Scores

11-Nov-07 21-Jul-08 10-Oct-08 16-Jan-09Pre-Deployment Post-Deployment 40 HBOT 1.5s 80 HBOT 1.5s

Page 16: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

Figure 1: The passenger side of the M915 truck showing the damage caused by the IED.

Conclusion by article authors:

Several aspects of these two cases demonstrate the efficacy of HBO for the airmen treated. Although both airmen had stable symptoms of mTBI/post-concussive syndrome, which had not improved for seven months; substantive improvement was achieved within ten days of HBO treatment. The headaches and sleep disturbances improved rapidly while the irritability, cognitive defects, and memory difficulties improved more slowly.

Fortunately both airman had taken the ANAM and presented objective demonstration of their deficits from TBI and their improvements after HBO treatment. Both airmen, who were injured by the same blast sitting side by side, had similar symptom complexes of TBI and improved at similar rates after initiation of HBO treatment. Neither airman had any other form of treatment for TBI. It seems unlikely to the authors that any explanation other than the HBO treatments can be offered for their improvements.

“Case report: Treatment of Mild Traumatic Brain Injury with Hyperbaric Oxygen: Colonel James K. Wright, USAF, MC, SFS; Eddie Zant, MD; Kevin Groom, PhD; Robert E. Schlegel, PhD, PE; Kirby Gilliland, PhD”

Page 17: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

Public Health Cost of Untreated Brain Insults• An estimated 30-40 million working age Americans are living with an untreated brain

injury. CDC reports 1.7 million new injuries per year and only 50,000 die.• Lost Tax Revenue & Productivity: mTBI patients have ½ of the life-time income of

their non-injured counterparts, matched for education, intelligence, etc.• Incarceration: 61% County/56% State/45% Fed

Mental Illness (w/ Underlying untreated brain insult)– National Prison System Cost: 2.3 mil Jail; 5.1 m Supervision

• $51.7 billion on corrections $29,000 each• $10.2 billion for supervision @ $2,000 each• Cut cost in half over 10 years: Savings $30 billion

• Veterans: (33%+ of all deployed) (All with PTSD)– Cost? Current ineffective treatments $8,000-$32,000/yr

• Education (IDEA Children): 50%+ have brain injury. If 20% were brought to normal, savings would be $18 billion per year.

• Welfare: Almost all women on Welfare (Avg IQ = 85)• Homelessness: 100% Vets, 72-80% all others• Disability (Worker’s Comp & Social Security): 61,000 TBI, most mentally retarded• Nursing Home Residents: Dementia, Stokes• Mental Illness: Most traceable to an insult• Trafficked & Battered Women & Children: Traumatic Brain Injury

Cost to biologically repair and regenerate brain insults: Acute: $200 - $1,000 (59% Reduction in Mortality for Severe) or

chronic one time cost $16,000 (80% return to duty, work or school)(CMS Reimbursement Rate)

Page 18: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

Saving Real Money: Treating is CheaperScale of Cost of Untreated mTBI to Society

For a person sufficiently impaired that he/she cannot work: Lifetime Social Safety Net Costs (approx): $60,000 per year $2,400,000 or more based on 40 year duration

Lifetime Loss of tax revenue (approx) Assuming annual income of $75,000 per yr Federal tax = $19,500 per yr (based on 25% total rate) State tax (CA rates) = $3,600 per yr Total over 30 year working life = $693,000

•Total cost to governmental entities = $3.09 million per person•If have 150,000 such people, lifetime cost = $463.9 billion• Minimum 30 million estimated Americans living with untreated traumatic brain injury

• Source: IHMA Public Policy Brief 2010-1a. Other estimates vary widely, but the overall numbers are all huge. • Annual cost estimate presented to 07/21/10 House VA Committee Hearing was $60,000 per patient per year

without intervention.

Page 19: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

FDA Cleared HBOT IndicationsHBOT as used by the team is currently in use for 13 FDA-cleared indications (which means the

manufacturer or practitioner can advertize those indications) by hundreds of physicians at nearly 1,000 locations across the nation, delivering approximately 10,000 treatments per day.

The thirteen accepted indications for HBOT treatment include:1. Air or gas embolism.2. CO poisoning, CO poisoning complicated by cyanide poisoning (Neurological)3. Clostridial myositis and myonecrosis (gas gangrene)4. Crush injury, compartment syndrome, and other acute traumatic ischemias5. Decompression sickness (Neurological)6. Arterial Insufficiency: (Non-Healing Wound)

Enhancement of healing in selected problem wounds (includes uses like Diabetic Foot Wounds, Hypoxic Wounds, and other non-healing wounds, etc.)

7. Exceptional blood loss anemia8. Intracranial abscess (Neurological)9. Necrotizing soft tissue infections10. Osteomyelitis (refractory)11. Radiation tissue damage (soft tissue and bony necrosis) (Non-Healing Wound)12. Skin grafts and flaps (compromised) (Non-Healing Wound)13. Thermal burns[1]

[1] Hyperbaric Oxygen Therapy: 1999 Committee Report. Editor, N.B. Hampson. Undersea and Hyperbaric Medical Society, Kensington, MD. See also: Harch PG. Application of HBOT to acute neurological conditions. Hyperbaric Medicine 1999, The 7th Annual Advanced Symposium. The Adams Mark Hotel, Columbia, South Carolina, April 9-10, 1999; and Mitton C, Hailey D. Health technology assessment and policy decisions on hyperbaric oxygen treatment. Int J of Tech Assess in Health Care, 1999;15(4):661-70.

Page 20: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

Returning Athletes to Competition• U.S. Olympic Team

– Treated at San Diego IHMF-NBIRR Site

– Sports Injuries– Concussions– Summer & Winter Sports

• U.S. Navy SEALs & SOCOM Members– Treated for Fractures– Treated for Knee

Replacement– Treated for TBI and PTSD

Page 21: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

Fractures• Air Force Research

Demonstrated that Fractures heal 30% faster and 30% stronger when Hyperbaric Oxygen is used.

• Shorter back to work time• Stronger Fusion• Cost Effective through

reduced down timeThe effect of hyperbaric oxygen on fracture healing in rabbits, completed 2003. J Wright

Page 22: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

Retired NFL Player: Age 58Pre-Post HBOT 1.5

4 NFL Players now treated with similar results

Source: MicroCog Assessment-- Independent Evaluation by Amen Clinic.

Page 23: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

Savings Directly to Worker’s Comp Funds• Recovery of Disabled Persons On the Roles, War Veterans who

have returned to Law Enforcement Service• Prevention of Long Term Disability through “Routine”

treatment provided to improve neurological longevity• A single or series of HBOT treatments post-concussion without

regard to “diagnostic” based on best-clinical practice» Known damage that accumulates over time.» Not symptomatic but cumulative

• “Athletic” or “Sports Medicine” injuries, Falls, Fractures, Motor Vehicle Accidents, Altercations, “Significant Emotional Event” such as a shooting

• COLLECTED UNDER IRB-APPROVED PROTOCOLS No Placebos!– BAYESIAN ANALYSIS provides Real-time Feedback & Best Practices.– Comparison with Historical Costs – For normal market cost of hyperbaric treatment at CMS Facility Rate

Page 24: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

Evidence-based Medicine

• Real Evidence-based Medicine Three Principles– Clinical Expertise– Medical Evidence (Lowest to Highest)

• Only Humans Count: Anecdote, Case Study, Case Series, Single Center then Multicenter Observational (Bayesian Level I), Randomized Controlled (RCT Level I)

• Invitro, Invivo, animal research counts to explain not determine– Patient PreferenceSaves Money: Rationalizes Disparate Evidence & Focus on Effective & Efficient Treatments

• Nihilistic Evidence-based Medicine: – Only RCTs count. Clinical Expertise & Patient Preference have no bearing. If

you do not have an RCT, you have no evidence.

Bias toward patentable processes and restriction of available treatment.Expensive! Cochrane Reviews are being paid for by BC/BS, Aetna & others and are following

these recommendations to restrict treatment options.

Page 25: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

HR396: TBI Treatment Act• Changes Focus from “Bureaucratic Decision” on Health Care

Coverage to:– “What Actually Worked for the Patient?”– ALL TREATMENT MODALITIES INCLUDED

• Outlines a “Rational” Way of Determining What Works and What Doesn’t

• HC Provider is ONLY paid if the treatment works (True Pay for Performance)

• All data is collected under OHRP Rules for Patient Protection• Provides Valid Evidence-based Medicine data very

inexpensively! (10% of the cost of Standard NIH-funded Study!)

• As a Principle of Federal Law, the Bill Radically Alters the Ability of Patients to get Effective Treatment!

Page 26: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

HR 396: TBI Treatment Act• Subject must have TBI or PTSD and be a Veteran under 66• Voluntarily Treated by Civilian Physician• ANY FDA-approved or Cleared Treatment (Any Purpose)• Must Improve to be Paid

– Neuropsych Testing (IQ, ANAM, CNS Vital Signs, etc.)– Standardized Instruments (PCS, PTSD, Depression Scales)– Neurological Imaging (Functional MRI, SPECT, QEEG)– Clinical Examination (Coma State, Gate & Balance)

• Must be Enrolled in IRB-approved Study• No Discrimination Against Practitioner for Any Reason• Paid 30 days after presentation of valid bill to MM or VA

Page 27: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

International Hyperbaric Medical Foundation• Conducts Scientific Research:

– Uses Medical Information & Treatment Access Act principles to create New Scientific Information then Used by IHMA to Create New Indications (First was Diabetic Foot Wound, 2003)

– John Eisenberg Treatment Registry (JETR) for Off-Label Use of Approved Drugs and Devices

– Set up to permit other medical specialties to use the JETR– Just like American Airlines and IBM worked together to create the

Airline Reservation System, used by Every Airline to make Reservations.

• Reimbursement Assistance for Sites: Administrative and Legal Team under Contract to assist with reimbursement for patients under IHMF-sponsored JETR studies

Page 28: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

John Eisenberg Treatment Registry Dynamic Translational Medical Practice Research

• Available to ANY Medical Society or Practitioner Group who wishes to organize a study (Admin Costs to Study Organizer!)– Off-label use of FDA-approved or cleared drugs or devices– Nutritional Protocols– Acupuncture– Environmental Medicine Protocols– Surgical Protocols

• Bayesian Analysis• Adaptive Clinical Trial Design• Study Design Assistance with Cooperative Partners• Relationship with Western IRB• Data Safety Monitoring Board• OHRP approved Human Research Certification through CITI

Page 29: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

NBIRR-01: Principles• 1,000 patient observational multi-center study of Military or Civilian subjects with an Independent diagnosis of mild-moderate TBI/PTSD. (Patients MUST be >6 months post injury in the “chronic” stage, and ages 18-65.)•Bayesian data analysis (Level 1 Evidence)

– IRB-Oversight– Patient is their own control– Methodology of “Comparative Effectiveness Research” outlined in Obama Health

Care Plan. – Methodology of “Coverage with Evidence” at CMS– Multiple objective measures: ANAM, CNS-Vital Signs, Post- Concussion Syndrome

Scale, PTSD Scale, Depression Scale•All Participants get Real Services (No Placebo)

• Third Party Payment is therefore justified. • Therefore cost of “research” is limited to the administrative overhead costs

necessary in addition to the treatment costs, about 10% of treatment cost.

•John Eisenberg Treatment Registry – Integrated Software with built-in metrics– Secure & Web Based

•Low Cost Research ($16,000 per patient = $16 million w/ $1.6 million Admin)•Treatment Normally Paid 1/3rd of the time. Reimbursement Likelihood Increased Under IRB-approved study!

Page 30: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

John Eisenberg Treatment Registry Provides Structure forN-BIRR HBOT 1.5 Clinical Research Platform

Powered by CareVector®

• Supports Multi-Site Observational Study

• Online Data Entry Forms available World-Wide

• Security Roles protect patient privacy

• DoD ANAM Test Scores & Record all Diagnostics

• Monthly Web-based Reporting & Analysis

• All Patients get Real Treatment (No Placebo)

• NO BARRIER To 3rd Party Reimbursement

• EBM & Bayesian Analysis Permits Rapid Publication, Approval by FDA of New Indication, Treatment Payment

IRB Workflow

Analysis &Reporting

Post-Rx Exam& Testing

Treatments(40 HBOT)

Pre-Rx Exam& Testing

Screening &Capture Demographics

IdentifyPatient

PatientFollow-up

Page 31: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

Sponsor: International Hyperbaric Medical FoundationLocations for N-BIRR HBOT 1.5 Study N=1,000

Sites with Confirmed InvestigatorsSites Being Planned

Investigators with Capacity for 2,000 Treatments per DayAnticipate 1,000 veterans or service personnel being able to return to full duty status every 150 days. 90 total sites have sufficient equipment, training and skill to join the effort and treat these casualties. 1,000 could be brought on line.NBIRR Study Sponsored by Int’l Hyperbaric Medical Foundation

Sites Being Planned as MobileUnits Under an Investigator

Page 32: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

NBIRR: Why Bayesian Analysis?• New Application of Probability Mathematics Published in 1763 of Reverend

Thomas Baves (1702–1761). FDA Final Acceptance in 2010.

• Accepted by the FDA-Devices Division for Level 1 Evidence in 2006, with a final rule published in 2010.

• Approx 50% of all new applications to the FDA for new devices or new applications for existing devices/drugs use this methodology.

• Hyperbaric Oxygen is Delivered in a Device.

• Bayesian Analysis was Adopted by FDA after repeated failures of randomized-Controlled Trials to provide valid data.

• Bayesian Analysis now used by VA, CDC, and throughout HHS to quickly answer health and other program performance questions.

• Very effective, at low cost, in disease states where the disease trajectory over time is predictable. Not a “one size fits all tool”.

• Not a good choice when looking at the effects of a new molecule. • However, the time trajectory of chronic mTBI is VERY predictable. Once a patient is 6 months

post injury, change in status occurs VERY slowly. Consequently, the NBIRR study design is appropriate.

Page 33: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

Bayesian Methodology Uses the Known and Compares Intervention Result

• Example:– “Graduation” from Homeless Program in California

43% (“Best” Program may be 57%)

– Addition of Biological Repair of NBIRR protocols result is 80% return to work, duty, or school

• Expected Placement Earnings Known by Region• Expected Retention at new job is known.• Because of 15 point IQ increase, plus increase in

executive function, Expected Homeless program incorporating NBIRR is expected to be higher.

Page 34: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

Adaptive Clinical Trial Design:Allows Development of the Most Effective Protocol to Treat Brain

Injury & Brain Insults

When the Bayesian HBOT 1.5 NBIRR biological-repair protocol baseline is established, then treatment modules can be added until an entire

Integrative Medicine Protocol is developed for maximum patient recovery

• Example: Post-Traumatic Stress Disorder– All sites have base-line improvement of 30% reduction

– A site adds a module with IRB-approval• Result is better than baseline. • One or more sites assigned the new program• Results verify incremental improvement• Program adapted at all sites and “Treatment Protocol” is advanced

– NBIRR software allows for direct comparison of the “intake” condition of veterans tagged with PTSD.

ENTIRE PROTOCOL IS UPDATED AND REFINED!

Page 35: Design of Effective Homeless Initiatives for Veterans and other at-risk populations

IHMF Stands Ready to Help

• Our Team Leaders have decades of experience with Hyperbaric Medicine

• Our Team Leaders have over 20 years of experience treating Brain Injury with this protocol

• The NBIRR-01 Study is IRB-approved• The Study is Listed at www.ClinicalTrials.gov• The National Call Center Number is: (800) 288-9328• We have numerous clinics throughout the nation• We Are Helping to Solve the Real Problems of Brain

Injured Persons with Biological Repair for their Injury