Obtaining Federal
Funding in Burns: What
Worked and What Didn’t
Tina L. Palmieri MD, FACS, FCCM
President, American Burn Association
Professor, University of California Davis
Assistant Chief of Burns, Shriners Hospitals
for Children Northern California
Objectives
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Understand the unique aspects of burn
research/care
List what was and was not effective in obtaining
federal funding
Identify the different potential funding streams
Detail the requirements of Department of
Defense funding
Describe the ongoing challenges of Department
of Defense funding
Background on Burns and Burn
Practitioners
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Concentrated in the American Burn Association
Small (~300) number of surgeons dealing with a
low volume/high cost/impact disease
Diverse population of stakeholders
Survivors
 Firefighters
 Rehabilitation therapists
 Dieticians
 Intensivists
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Burn Multicenter Trials: The Inspiration
Consumer: Rejection of Paternalism
and Distrust of Managed Care
OBJECTIVITY
IN MEDICINE
The Crisis of Cost
Explosion of Information
and technology
What Evidence is Available for Burn
Care?
.
13 Chapters
1. Not a SINGLE :”Standard”
supported by Class I
evidence
2. 5 “Guidelines” supported
by Class II evidence
3. 11 “Options” supported by
Class III evidence or a
preponderance of opinion.
Is there an Evidence-Based Practice for
Burns?
* Medline review 1990-1997
* 56 RCT’s for burns, most dealing with wound
care techniques or products.
“There is little evidence that burn
care is an evidence-based practice.”
-- Childs, Burns, 1998;24:29-33.
Multicenter Trials Needed to Define
Burn Care
Burn Multicenter Trials: Limitations
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Limited multicenter collaboration
Lack of funding
Lack of organized set of research goals
The American Burn Association
Multicenter Trials Group
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Started as a “grass roots” effort by members of
American Burn Association
Members share ideas for studies, solicit participation
Open to any burn care practitioner interested in
performing multicenter research
First meeting 2000, twice yearly (or more) since
100 registered members, 54 burn Centers
Accomplishments by 2008 WITHOUT funding:
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7 retrospective reviews
One prospective randomized, controlled multicenter trial
ABA Multicenter Trials Group Bibliography
1.
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8.
Palmieri, TL, Greenhalgh, DG, Saffle, JR, et al. A multicenter review of toxic
epidermal necrolysis treated in U. S. burn centers at the end of the Twentieth
Century. J Burn Care Rehabil, 2002;23:87-96.
Warner, PM, Kagan, RJ, Yakuboff, KP, et al. Current management of purpura
fulminans: A multicenter study. J Burn Care Rehabil, 2003;24:119-126.
Kagan, RJ, Gamelli, R, Kemalyan, N, Saffle, JR. Tracheostomy in thermally
injured patients: Does diagnosis-related group 483 adequately estimate
resource use and hospital costs? J Trauma, 2004;57:861-6.
Palmieri, TL, Greenhalgh, DG. Blood transfusion in burns: What do we do?
J Burn Care Rehabil, 2004;25:71-5.
Wolf, SE, Edelman, LS, Kemalyan, N, et al Effects of oxandrolone on
outcome measures in the severely burned: A multicenter prospective
randomized double-blind trial. J Burn Care Rehabil, 2006;27:131-9.
Palmieri, TL, Caruso, DM, Foster, KN, et al Impact of blood transfusion on
outcome after major burn injury: Critical Care Medicine, 2006;34:1602-8.
Caruso, DM, Cairns, BA, Baker, RA, et al. Utilization of do not resuscitate
orders in the Elderly. J Burn Care Rehabil, 2006;27:S68 (abstract).
Ballard J, Edelman L, Saffle J, Sheridan R, Kagan R, Bracco D, Cancio L,
Cairns B, Baker R, Fillari P, Wibbenmeyer L, Voight D, Palmier TL, et al.
Positive fungal cultues in burn patients: a multicenter review. Journal of Burn
Care and Research. 2008:29(1):213-21.
BUT….
Real Multicenter Groups have
*Steering Committees
*Patient Safety Boards
*External Review Boards
*Compliance Monitoring
*Centralized Data Storage
*FUNDING!!!
What We Needed Was a Plan…
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Identify and contact potential stakeholders
Develop a list of research priorities
Bring together burn researchers to complete
research
Ask the granting agencies what they needed to
see
Apply for funding
“Traditional” Funding Sources
Contacted
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NIH: National Institute of the General Medical
Sciences
NIDRR (National Institute of Disability and
Rehabilitation Research)
Veteran’s Administration
Shriners Hospitals for Children
AHRQ: Agency for Health Care Research and Quality
CDC: Center for Disease Control
HRSA
And any other sources you can think of
“Traditional” Funding Sources
Contacted
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NIH: NIGMS
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NIDRR (National Institute of Disability and Rehabilitation
Research)
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“Only fund Shrine centers”
AHRQ: Association for Health Related Quality
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“Must be a VA Staff member”
Shriners Hospitals for Children
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“We fund a model system already”
Veteran’s Administration
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“We don’t fund clinical trials”
“We don’t have money for clinical trials”
CDC: Center for Disease Control
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“We don’t have money for clinical trials”
We Needed to Do Something
Different: The Plan
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Develop a consolidated research priority list
agreed upon by all stakeholders
Publish priority list
Approach federal agencies, congress members,
military with the funding list
Ask for funding
Developing Research Priorities: Burn
State of the Science Meeting
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Organized conference held in Washington, DC
in October 2006
Unified two groups: Burn Multicenter Trials
Group and NIDRR model centers
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Participants: burn survivors, researchers, clinicians,
firefighters, federal grant agencies
Goal: to define the goals of burn research in the
next 10 years
Burn State of the Science: Research
Conference 2006
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Developed burn research priorities
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Inhalation injury
Nutrition/metabolism
Rehabilitation
Resuscitation
Infection/inflammation
Psychosocial effects
All granting agencies previously contacted invited to
speak
Priorities published*
Further consensus conference on burn infections**
Consensus conference on inhalation injury***
*Palmieri TL, et al. JBCR. 2007;28:544-5.
**Greenhalgh DG, et al. JBCR. 2007;28:776-90.
***Palmieri TL, et al. JBCR. 2009;30:141-210.
Burn State of the Science Meeting:
What We Did Right
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Unified different factions in burn care to agree
on a research agenda in Washington, DC
Involved burn survivors, firefighters in the
process; gave them a voice
Involved major federal funding agencies; they
heard and participated in the discussion
Published the findings of the conference
Burn State of the Science Meeting:
What We Could Have Done Better
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Increase involvement of “old time” burn
researchers and surgeons
Involve more federal agencies
Have a follow-up conference to detail goals
further
The Next Step…Contact Your Local
Congressman…
ABA National Leadership
Conference (NLC)
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Yearly pilgrimage to Washington, DC by Burn
Center Directors
Began in 2002, generally in January
Enlisted assistance of lobbyist to establish
contacts
Opportunity to speak with our national political
leaders
What Did We Do at the NLC?
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ABA Board of Trustees developed 2-3 priority
items to present to congressmen/women
Pre-appointment discussion of how to present
goals, handout of goals provided
Update on progress of individual proposals
Prearranged meeting with 4-5 members of
congress
Luncheon with speaker who supported ABA
Final day: discussion with an important staffer
It Wasn’t All Roses…
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First 4 years met with primarily staffers, mean
age of 22 years, in a back hall
Many skeptical regarding supporting burns
Needed to distinguish what made us different
 Self-serving (i.e. asking for more money) ideas not
successful
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Met a few congress members in 2005
Began to doubt efficacy
And Then Came 2007…
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Lobbyists provided staffers with our publication on
research priorities
Long-shot meeting with Barbara Boxer…met her
between Senate meetings
Two proposals presented-interested in research
Follow-up with Boxer staff, proposal written and
submitted to Barbara Boxer’s office
Revision, clarification of proposal
Proposal submitted to Senate Appropriations
Committee for $3 million by Barbara Boxer
The Saga Continues
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Needed House support
Doris Matsui, Dan Lungren offices approached,
Matsui (with Lungren support) sponsors
proposal in House for $2.4 million
Both proposals approved by Appropriations
Committee and signed off by President Bush in
summer 2008
Department of Defense as manager of $$
What Was the Proposal
and Why Did it Succeed?
The Burn Outcomes Research
Infrastructure (BORI) Project
Why were they interested?
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>1 million people treated for burn injury yearly
in the U.S.
45,000 hospitalized
4,500 die
Majority aged 20-40 years
Burns as one of leading causes of work-years
lost
Military implications: more than 800 soldiers
treated for burn injuries in overseas conflicts
The Bottom Line: A Visible, Popular
Concept that is Needed
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Potential to tangibly improve care of the soldier
Benefits constituency
Good public relations opportunity
Popular
State of Science Conference detailed tangible
goals
Chance at success; preparation prior to
presentation
The Burn Outcomes Research
Infrastructure (BORI)
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BORI provides burn researchers with an
infrastructure for multicenter trial research
Center for data collection, maintenance
 Human Subjects Review Board
 Statistical support
 Data safety monitoring board
 Protocol review committee to assure quality study
 Quality control of data
 Coordination of resources
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Detail Management
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Once congress member approves, need to
supply supporting documentation
Follow-up forms for each congress member that
is supporting
Letters, phone calls to keep on target
Find the funding stream
Submit the proposal
How to Get the Money Once
Appropriated
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Department of Defense (DOD) via MRMC disperse $$
Application process via DOD rules
The process:
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Write/submit preproposal
After preproposal approved, submit full proposal
Proposal reviewed, written response needed
After proposal approved, budget justification, IRB
Funding only after approved by military AND local IRB
First Roadblock:
The DOD Does Not Support
Infrastructure
Specific Aims of Proposal
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Develop a system for data validation/analysis
for National Burn Repository outcomes
Profile burn care outcomes for the database as a
whole and trends over time
Describe variability in factors on outcomes
Develop a predictive model adjusted over time
to estimate mortality, LOS, resource utilization
Resource for design of future multicenter
clinical/database studies to optimize burn
patient outcomes
The Model
Non-Changeable Factors
Changeable Factors
Patient Characteristics
Treatment
Outcomes
Injury Characteristics
Burn Center
Characteristics
How Things Worked Out…
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Pre-proposal submitted and accepted
Proposal submitted, reviewed, and response to reviewer
written
Final review by military board
Money allocated October 1, 2009
Follow-on proposal supported by Boxer for 2010;
writing $2.4 million pre-proposal due June 15
Analysis almost complete; multiple publications
Lots of hoops, but if you jump through them all, you
will succeed
A Few Months Later…Another
Quest
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K30 course, suggested that I contact the DOD
New grant cycle by DOD with short turnaround
Buy-in by Burn Center Director at DOD, started
process to submit pre-proposal
24 hours to write and submit proposal for $2.4
million
Second proposal for $2.2 million for
rehabilitation research
Approved DOD Proposal #1: Blood
Transfusion
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Compare outcomes for patients with burn injury
≥20% TBSA randomized to one of two blood
transfusion groups:
Hemoglobin (Hb) maintained at 10-11 g/dL
(traditional group)
 Hemoglobin maintained at 7-8 g/dL (restrictive
group)
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Approved Proposal #2: Impact of
Rehabilitation on Burn Outcomes
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Burn patients with decreased strength, range of
motion, mobility
Rehabilitation important in improving outcomes
after burn injury
Need to optimize return of soldier to active
duty
Little data on when, how best to deliver therapy
How Can These Help the Military?
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Study #1
Blood precious resource; appropriate use paramount
 Improve outcomes for burned soldier by defining
appropriate transfusion threshold and optimizing
risk/benefit ratio
 Standardize practice for blood transfusion
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Study #2
Rehabilitation time-consuming and expensive
 Need to optimize soldier return to work
 Emphasis by press
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Military Priorities: The Key
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Both studies directly address the needs of the
military
Priorities taken from the State of the Science
meeting
Need to have tangible results
The Next Step(s)
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Further funding ($8 million) obligated for burn
multicenter clinical trials research by DOD
Call for pre-proposals in January 2009
DOD determines priorities
ABA MCTG screens grants for meeting DOD
priorities, scientific integrity, multicenter nature
29 proposals received; four selected for funding
Proposals approved, funded
Further $3 million funded for 2010, 2011, 2012
Projects Funded
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Grading system for inhalation injury
Early identification of MRSA infection via polymerase
chain reaction
Glutamine supplementation and infection
Use of CRRT during burn shock
Effects of exercise program on return to work
Propranolol use to decrease hypermetabolic response
Analysis of factors contributing to morbidity/mortality
in combined burn/trauma
Total funding to date approximately $28 million
The Challenges
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Whenever there is money, everyone wants some
Making sure the research gets done the right way
Contracting
Human Subjects Review
Development of integrated information
technology capabilities for multicenter trials
Coordination of biostatistics with data
collection
Actually doing the study
And So Ends the Saga (For Now, at
Least)
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Federal funding for burn multicenter outcomes
research from varied sources
Timing, persistence, follow-up essential
Never assume it will happen; make it happen
Getting to know congress members key, but
need to be patient…it takes time
Questions?
ABA Multicenter Trials Group– The
Administrative Aspect
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Steering committee elected 2005
Jeffrey Saffle, MD, Salt Lake City
Linda Edelman, RN, PhD, Salt Lake City
Dan Caruso, MD, Phoenix
Karen Richey, RN, Phoenix
Steve Wolf, MD, San Antonio
Michael Peck, MD, Chapel Hill
Tina Palmieri, MD, Davis
First meeting September, 2005
Bylaws drafted, presented to members April, 2006,
and approved
Burn Multicenter Outcomes
Research (BORI) Infrastructure
Non-invasive Study
Subcommittee
Practice Guidelines in Burn Care
1. Project Began, 1998. Meetings held throughout 1998,1999.
2. Experts in burn care and guideline development.
3. Funding from Paradigm Health Care, National Coalition of Burn
Center Hospitals, American Burn Association.
4. To develop Practice Guidelines for the acute, early treatment of
burn patients.
5. 13 Chapters dealing with organization of burn care, initial
assessment, fluid resuscitation, airway and inhalation injury
management, Nutrition, DVT Prophylaxis.
6. Input sought from Society of Critical Care Medicine, American
Association for the Surgery of Trauma, American College of
Surgeons, American College of Emergency Physicians.
7. Presented 2000 meeting ABA
American Burn Association (ABA)
TRACS™ Database
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National burn registry supported by the
American Burn Association and the American
College of Surgeons
Multicenter data collection on burn
demographics, treatment, outcomes
Nation-wide participation
Secure database, >300,000 records
The TRACS™/ABA Burn Registry
A. Began in 1988
B. Over 300,000 patient records
C. Requirement for ABA/ACS Burn Center Verification
Burn Mortality by Size
90
80
70
Mortality (rate)
60
50
40
30
20
10
0
0.1-9.9
10-19.9
20-29.9
30-39.9
40-49.9
50-59.9
60-69.9
TBSA Burn (%)
American Burn Association National Burn Repository 2012.
70-79.9
80-89.9
>90
Sponsors
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American Burn Association
Shriners Hospitals for Children
National Institute of General Medical Sciences
National Institute on Disability and
Rehabilitation Research
Veteran Administration
Department of Defense