1. 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

2. Objectives 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

3. Background on Burns and Burn Practitioners
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

4. Burn Multicenter Trials: The Inspiration
Consumer: Rejection of Paternalism and Distrust of Managed Care
OBJECTIVITY IN MEDICINE
Explosion of Information and technology
The Crisis of Cost

5. 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.

6. Is there an Evidence-Based Practice for Burns?
* Medline review
* 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.

7. Multicenter Trials Needed to Define Burn Care

8. Burn Multicenter Trials: Limitations
Limited multicenter collaboration
Lack of funding
Lack of organized set of research goals

9. The American Burn Association Multicenter Trials Group
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:
7 retrospective reviews
One prospective randomized, controlled multicenter trial

10. ABA Multicenter Trials Group Bibliography
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:
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:
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):

11. BUT…. *Steering Committees *Patient Safety Boards
Real Multicenter Groups have
*Steering Committees
*Patient Safety Boards
*External Review Boards
*Compliance Monitoring
*Centralized Data Storage
*FUNDING!!!

12. What We Needed Was a Plan…
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

13. “Traditional” Funding Sources Contacted
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

14. “Traditional” Funding Sources Contacted
NIH: NIGMS
“We don’t fund clinical trials”
NIDRR (National Institute of Disability and Rehabilitation Research)
“We fund a model system already”
Veteran’s Administration
“Must be a VA Staff member”
Shriners Hospitals for Children
“Only fund Shrine centers”
AHRQ: Association for Health Related Quality
“We don’t have money for clinical trials”
CDC: Center for Disease Control

15. We Needed to Do Something Different: The Plan
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

16. Developing Research Priorities: Burn State of the Science Meeting
Organized conference held in Washington, DC in October 2006
Unified two groups: Burn Multicenter Trials Group and NIDRR model centers
Participants: burn survivors, researchers, clinicians, firefighters, federal grant agencies
Goal: to define the goals of burn research in the next 10 years

17. Burn State of the Science: Research Conference 2006
Developed burn research priorities
Inhalation injury Resuscitation
Nutrition/metabolism Infection/inflammation
Rehabilitation 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:
***Palmieri TL, et al. JBCR. 2009;30:

18. Burn State of the Science Meeting: What We Did Right
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

19. Burn State of the Science Meeting: What We Could Have Done Better
Increase involvement of “old time” burn researchers and surgeons
Involve more federal agencies
Have a follow-up conference to detail goals further

20. The Next Step…Contact Your Local Congressman…

21. ABA National Leadership Conference (NLC)
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

22. What Did We Do at the NLC?
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

23. It Wasn’t All Roses…
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
Met a few congress members in 2005
Began to doubt efficacy

24. And Then Came 2007…
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

25. The Saga Continues 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 $$

26. What Was the Proposal and Why Did it Succeed?
The Burn Outcomes Research Infrastructure (BORI) Project

27. Why were they interested?
>1 million people treated for burn injury yearly in the U.S.
45,000 hospitalized
4,500 die
Majority aged years
Burns as one of leading causes of work-years lost
Military implications: more than 800 soldiers treated for burn injuries in overseas conflicts

28. The Bottom Line: A Visible, Popular Concept that is Needed
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

29. The Burn Outcomes Research Infrastructure (BORI)
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

30. Detail Management
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

31. How to Get the Money Once Appropriated
Department of Defense (DOD) via MRMC disperse $$
Application process via DOD rules
The process:
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

32. First Roadblock: The DOD Does Not Support Infrastructure

33. Specific Aims of Proposal
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

34. The Model Non-Changeable Factors Changeable Factors
Patient Characteristics
Treatment
Outcomes
Injury Characteristics
Burn Center
Characteristics

35. How Things Worked Out… 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

36. A Few Months Later…Another Quest
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

37. Approved DOD Proposal #1: Blood Transfusion
Compare outcomes for patients with burn injury ≥20% TBSA randomized to one of two blood transfusion groups:
Hemoglobin (Hb) maintained at g/dL (traditional group)
Hemoglobin maintained at 7-8 g/dL (restrictive group)

38. Approved Proposal #2: Impact of Rehabilitation on Burn Outcomes
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

39. How Can These Help the Military?
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
Study #2
Rehabilitation time-consuming and expensive
Need to optimize soldier return to work
Emphasis by press

40. Military Priorities: The Key
Both studies directly address the needs of the military
Priorities taken from the State of the Science meeting
Need to have tangible results

41. The Next Step(s)
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

42. Projects Funded 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

43. The Challenges 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

44. And So Ends the Saga (For Now, at Least)
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

45. Questions?

46. ABA Multicenter Trials Group– The Administrative Aspect
Steering committee elected 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

47. Burn Multicenter Outcomes Research (BORI) Infrastructure
Non-invasive Study
Subcommittee

48. Practice Guidelines in Burn Care
Project Began, Meetings held throughout 1998,1999.
Experts in burn care and guideline development.
Funding from Paradigm Health Care, National Coalition of Burn Center Hospitals, American Burn Association.
To develop Practice Guidelines for the acute, early treatment of burn patients.
13 Chapters dealing with organization of burn care, initial assessment, fluid resuscitation, airway and inhalation injury management, Nutrition, DVT Prophylaxis.
Input sought from Society of Critical Care Medicine, American Association for the Surgery of Trauma, American College of Surgeons, American College of Emergency Physicians.
Presented 2000 meeting ABA

49. American Burn Association (ABA) TRACS™ Database
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

50. The TRACS™/ABA Burn Registry
A. Began in B. Over 300,000 patient records C. Requirement for ABA/ACS Burn Center Verification
American Burn Association National Burn Repository 2012.

51. Sponsors 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