Obtaining Federal Obtaining Federal Funding in Burns: Funding in Burns: What Worked and What Worked and

What Didn’tWhat Didn’tTina L. Palmieri MD, FACS, FCCMTina L. Palmieri MD, FACS, FCCM

President, American Burn President, American Burn AssociationAssociation

Professor, University of California Professor, University of California Davis Assistant Chief of Burns, Davis Assistant Chief of Burns, Shriners Hospitals for Children Shriners Hospitals for Children

Northern CaliforniaNorthern California

ObjectivesObjectives

Understand the unique aspects of Understand the unique aspects of burn research/careburn research/care

List what was and was not effective in List what was and was not effective in obtaining federal fundingobtaining federal funding

Identify the different potential funding Identify the different potential funding streams streams

Detail the requirements of Detail the requirements of Department of Defense fundingDepartment of Defense funding

Describe the ongoing challenges of Describe the ongoing challenges of Department of Defense fundingDepartment of Defense funding

Background on Burns and Background on Burns and Burn PractitionersBurn Practitioners

Concentrated in the American Burn Concentrated in the American Burn AssociationAssociation

Small (~300) number of surgeons dealing Small (~300) number of surgeons dealing with a low volume/high cost/impact with a low volume/high cost/impact diseasedisease

Diverse population of stakeholdersDiverse population of stakeholders SurvivorsSurvivors FirefightersFirefighters Rehabilitation therapistsRehabilitation therapists DieticiansDieticians IntensivistsIntensivists

OBJECTIVITY IN MEDICINE

Consumer: Rejection of Paternalism and Distrust of Managed Care

The Crisis of Cost Explosion of Information and technology

Burn Multicenter Trials: The Inspiration

.

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.

What Evidence is Available What Evidence is Available for Burn Care? for Burn Care?

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 Multicenter Trials Needed to Define Burn Careto Define Burn Care

Burn Multicenter Trials: Burn Multicenter Trials: LimitationsLimitations

Limited multicenter collaborationLimited multicenter collaboration Lack of fundingLack of funding Lack of organized set of research Lack of organized set of research

goalsgoals

The American Burn The American Burn Association Multicenter Association Multicenter

Trials GroupTrials Group Started as a “grass roots” effort by members Started as a “grass roots” effort by members

of American Burn Associationof American Burn Association Members share ideas for studies, solicit Members share ideas for studies, solicit

participationparticipation Open to any burn care practitioner interested Open to any burn care practitioner interested

in performing multicenter researchin 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

ABA Multicenter Trials Group Bibliography

1. 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.

2. Warner, PM, Kagan, RJ, Yakuboff, KP, et al. Current management of purpura fulminans: A multicenter study. J Burn Care Rehabil, 2003;24:119-126.

3. 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.

4. Palmieri, TL, Greenhalgh, DG. Blood transfusion in burns: What do we do? J Burn Care Rehabil, 2004;25:71-5.

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.

6. 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.

7. 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).

8. 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 What We Needed Was a Plan…Plan…

Identify and contact potential Identify and contact potential stakeholdersstakeholders

Develop a list of research prioritiesDevelop a list of research priorities Bring together burn researchers to Bring together burn researchers to

complete researchcomplete research Ask the granting agencies what they Ask the granting agencies what they

needed to seeneeded to see Apply for funding Apply for funding

““Traditional” Funding Traditional” Funding Sources ContactedSources Contacted

NIH: National Institute of the General NIH: National Institute of the General Medical SciencesMedical Sciences

NIDRR (National Institute of Disability NIDRR (National Institute of Disability and Rehabilitation Research)and Rehabilitation Research)

Veteran’s AdministrationVeteran’s Administration Shriners Hospitals for ChildrenShriners Hospitals for Children AHRQ: Agency for Health Care Research AHRQ: Agency for Health Care Research

and Quality and Quality CDC: Center for Disease Control CDC: Center for Disease Control HRSAHRSA And any other sources you can think ofAnd any other sources you can think of

““Traditional” Funding Traditional” Funding Sources ContactedSources Contacted

NIH: NIGMSNIH: NIGMS ““We don’t fund clinical trials”We don’t fund clinical trials”

NIDRR (National Institute of Disability and NIDRR (National Institute of Disability and Rehabilitation Research)Rehabilitation Research) ““We fund a model system already”We fund a model system already”

Veteran’s AdministrationVeteran’s Administration ““Must be a VA Staff member”Must be a VA Staff member”

Shriners Hospitals for ChildrenShriners Hospitals for Children ““Only fund Shrine centers”Only fund Shrine centers”

AHRQ: Association for Health Related QualityAHRQ: Association for Health Related Quality ““We don’t have money for clinical trials” We don’t have money for clinical trials”

CDC: Center for Disease Control CDC: Center for Disease Control ““We don’t have money for clinical trials”We don’t have money for clinical trials”

We Needed to Do We Needed to Do Something Different: The Something Different: The

PlanPlan Develop a consolidated research Develop a consolidated research

priority list agreed upon by all priority list agreed upon by all stakeholdersstakeholders

Publish priority listPublish priority list Approach federal agencies, congress Approach federal agencies, congress

members, military with the funding members, military with the funding listlist

Ask for fundingAsk for funding

Developing Research Developing Research Priorities: Burn State of the Priorities: Burn State of the

Science MeetingScience Meeting Organized conference held in Organized conference held in

Washington, DC in October 2006Washington, DC in October 2006 Unified two groups: Burn Multicenter Unified two groups: Burn Multicenter

Trials Group and NIDRR model centersTrials Group and NIDRR model centers Participants: burn survivors, researchers, Participants: burn survivors, researchers,

clinicians, firefighters, federal grant clinicians, firefighters, federal grant agenciesagencies

Goal: to define the goals of burn Goal: to define the goals of burn research in the next 10 yearsresearch in the next 10 years

Burn State of the Science: Burn State of the Science: Research Conference 2006Research Conference 2006

Developed burn research prioritiesDeveloped burn research priorities Inhalation injuryInhalation injury ResuscitationResuscitation Nutrition/metabolismNutrition/metabolism Infection/Infection/

inflammationinflammation RehabilitationRehabilitation Psychosocial Psychosocial

effectseffects All granting agencies previously contacted All granting agencies previously contacted

invited to speakinvited to speak Priorities published*Priorities published* Further consensus conference on burn Further consensus conference on burn

infections**infections** Consensus conference on inhalation Consensus conference on inhalation

injury***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 Burn State of the Science Meeting: What We Did Meeting: What We Did

RightRight Unified different factions in burn care Unified different factions in burn care

to agree on a research agenda in to agree on a research agenda in Washington, DCWashington, DC

Involved burn survivors, firefighters in Involved burn survivors, firefighters in the process; gave them a voicethe process; gave them a voice

Involved major federal funding Involved major federal funding agencies; they heard and participated agencies; they heard and participated in the discussionin the discussion

Published the findings of the conferencePublished the findings of the conference

Burn State of the Science Burn State of the Science Meeting: What We Could Meeting: What We Could

Have Done BetterHave Done Better Increase involvement of “old time” Increase involvement of “old time”

burn researchers and surgeonsburn researchers and surgeons Involve more federal agenciesInvolve more federal agencies Have a follow-up conference to Have a follow-up conference to

detail goals furtherdetail goals further

The Next Step…Contact The Next Step…Contact Your Local Congressman…Your Local Congressman…

ABA National Leadership ABA National Leadership Conference (NLC)Conference (NLC)

Yearly pilgrimage to Washington, DC Yearly pilgrimage to Washington, DC by Burn Center Directorsby Burn Center Directors

Began in 2002, generally in JanuaryBegan in 2002, generally in January Enlisted assistance of lobbyist to Enlisted assistance of lobbyist to

establish contactsestablish contacts Opportunity to speak with our Opportunity to speak with our

national political leadersnational political leaders

What Did We Do at the What Did We Do at the NLC?NLC?

ABA Board of Trustees developed 2-3 priority ABA Board of Trustees developed 2-3 priority items to present to congressmen/womenitems to present to congressmen/women

Pre-appointment discussion of how to present Pre-appointment discussion of how to present goals, handout of goals providedgoals, handout of goals provided

Update on progress of individual proposalsUpdate on progress of individual proposals Prearranged meeting with 4-5 members of Prearranged meeting with 4-5 members of

congresscongress Luncheon with speaker who supported ABALuncheon with speaker who supported ABA Final day: discussion with an important Final day: discussion with an important

stafferstaffer

It Wasn’t All Roses…It Wasn’t All Roses…

First 4 years met with primarily staffers, First 4 years met with primarily staffers, mean age of 22 years, in a back hallmean age of 22 years, in a back hall

Many skeptical regarding supporting Many skeptical regarding supporting burnsburns Needed to distinguish what made us differentNeeded to distinguish what made us different Self-serving (i.e. asking for more money) Self-serving (i.e. asking for more money)

ideas not successfulideas not successful Met a few congress members in 2005Met a few congress members in 2005 Began to doubt efficacyBegan to doubt efficacy

And Then Came 2007…And Then Came 2007… Lobbyists provided staffers with our Lobbyists provided staffers with our

publication on research prioritiespublication on research priorities Long-shot meeting with Barbara Boxer…met Long-shot meeting with Barbara Boxer…met

her between Senate meetingsher between Senate meetings Two proposals presented-interested in Two proposals presented-interested in

researchresearch Follow-up with Boxer staff, proposal written Follow-up with Boxer staff, proposal written

and submitted to Barbara Boxer’s officeand submitted to Barbara Boxer’s office Revision, clarification of proposalRevision, clarification of proposal Proposal submitted to Senate Appropriations Proposal submitted to Senate Appropriations

Committee for $3 million by Barbara BoxerCommittee for $3 million by Barbara Boxer

The Saga ContinuesThe Saga Continues

Needed House supportNeeded House support Doris Matsui, Dan Lungren offices Doris Matsui, Dan Lungren offices

approached, Matsui (with Lungren approached, Matsui (with Lungren support) sponsors proposal in House for support) sponsors proposal in House for $2.4 million$2.4 million

Both proposals approved by Both proposals approved by Appropriations Committee and signed off Appropriations Committee and signed off by President Bush in summer 2008by President Bush in summer 2008

Department of Defense as manager of $$ Department of Defense as manager of $$

What Was the What Was the Proposal and Why Proposal and Why

Did it Succeed?Did it Succeed?The Burn Outcomes Research The Burn Outcomes Research Infrastructure (BORI) ProjectInfrastructure (BORI) Project

Why were they Why were they interested?interested?

>1 million people treated for burn >1 million people treated for burn injury yearly in the U.S.injury yearly in the U.S.

45,000 hospitalized45,000 hospitalized 4,500 die4,500 die Majority aged 20-40 yearsMajority aged 20-40 years Burns as one of leading causes of work-Burns as one of leading causes of work-

years lostyears lost Military implications: more than 800 Military implications: more than 800

soldiers treated for burn injuries in soldiers treated for burn injuries in overseas conflictsoverseas conflicts

The Bottom Line: A Visible, The Bottom Line: A Visible, Popular Concept that is Popular Concept that is

NeededNeeded Potential to tangibly improve care of Potential to tangibly improve care of

the soldierthe soldier Benefits constituencyBenefits constituency Good public relations opportunityGood public relations opportunity PopularPopular State of Science Conference detailed State of Science Conference detailed

tangible goalstangible goals Chance at success; preparation prior to Chance at success; preparation prior to

presentationpresentation

The Burn Outcomes The Burn Outcomes Research Infrastructure Research Infrastructure

(BORI)(BORI) BORI provides burn researchers with BORI provides burn researchers with

an infrastructure for multicenter trial an infrastructure for multicenter trial researchresearch Center for data collection, maintenanceCenter for data collection, maintenance Human Subjects Review Board Human Subjects Review Board Statistical supportStatistical support Data safety monitoring boardData safety monitoring board Protocol review committee to assure Protocol review committee to assure

quality studyquality study Quality control of dataQuality control of data Coordination of resourcesCoordination of resources

Detail ManagementDetail Management

Once congress member approves, Once congress member approves, need to supply supporting need to supply supporting documentation documentation

Follow-up forms for each congress Follow-up forms for each congress member that is supportingmember that is supporting

Letters, phone calls to keep on targetLetters, phone calls to keep on target Find the funding streamFind the funding stream Submit the proposalSubmit the proposal

How to Get the Money Once How to Get the Money Once AppropriatedAppropriated

Department of Defense (DOD) via MRMC Department of Defense (DOD) via MRMC disperse $$disperse $$

Application process via DOD rules Application process via DOD rules The process: The process:

Write/submit preproposalWrite/submit preproposal After preproposal approved, submit full proposalAfter preproposal approved, submit full proposal Proposal reviewed, written response neededProposal reviewed, written response needed After proposal approved, budget justification, IRBAfter proposal approved, budget justification, IRB Funding only after approved by military AND Funding only after approved by military AND

local IRBlocal IRB

First Roadblock:First Roadblock:

The DOD Does Not Support The DOD Does Not Support InfrastructureInfrastructure

Specific Aims of ProposalSpecific Aims of Proposal Develop a system for data Develop a system for data

validation/analysis for National Burn validation/analysis for National Burn Repository outcomes Repository outcomes

Profile burn care outcomes for the Profile burn care outcomes for the database as a whole and trends over database as a whole and trends over timetime

Describe variability in factors on Describe variability in factors on outcomesoutcomes

Develop a predictive model adjusted Develop a predictive model adjusted over time to estimate mortality, LOS, over time to estimate mortality, LOS, resource utilizationresource utilization

Resource for design of future Resource for design of future multicenter clinical/database studies to multicenter clinical/database studies to optimize burn patient outcomesoptimize burn patient outcomes

Patient Characteristics

Injury Characteristics

Treatment

Burn Center Characteristics

Outcomes

Non-Changeable Factors Changeable Factors

The ModelThe Model

How Things Worked How Things Worked Out…Out…

Pre-proposal submitted and acceptedPre-proposal submitted and accepted Proposal submitted, reviewed, and response to Proposal submitted, reviewed, and response to

reviewer writtenreviewer written Final review by military boardFinal review by military board Money allocated October 1, 2009Money allocated October 1, 2009 Follow-on proposal supported by Boxer for Follow-on proposal supported by Boxer for

2010; writing $2.4 million pre-proposal due 2010; writing $2.4 million pre-proposal due June 15June 15

Analysis almost complete; multiple Analysis almost complete; multiple publications publications

Lots of hoops, but if you jump through them Lots of hoops, but if you jump through them all, you will succeedall, you will succeed

A Few Months Later…A Few Months Later…Another QuestAnother Quest

K30 course, suggested that I contact K30 course, suggested that I contact the DODthe DOD

New grant cycle by DOD with short New grant cycle by DOD with short turnaroundturnaround

Buy-in by Burn Center Director at DOD, Buy-in by Burn Center Director at DOD, started process to submit pre-proposalstarted process to submit pre-proposal

24 hours to write and submit proposal 24 hours to write and submit proposal for $2.4 millionfor $2.4 million

Second proposal for $2.2 million for Second proposal for $2.2 million for rehabilitation researchrehabilitation research

Approved DOD Proposal #1: Approved DOD Proposal #1: Blood TransfusionBlood Transfusion

Compare outcomes for patients with Compare outcomes for patients with burn injury burn injury ≥20% TBSA randomized ≥20% TBSA randomized to one of two blood transfusion to one of two blood transfusion groups:groups: Hemoglobin (Hb) maintained at 10-11 Hemoglobin (Hb) maintained at 10-11

g/dL (traditional group)g/dL (traditional group) Hemoglobin maintained at 7-8 g/dL Hemoglobin maintained at 7-8 g/dL

(restrictive group)(restrictive group)

Approved Proposal #2: Approved Proposal #2: Impact of Rehabilitation on Impact of Rehabilitation on

Burn OutcomesBurn Outcomes Burn patients with decreased Burn patients with decreased

strength, range of motion, mobilitystrength, range of motion, mobility Rehabilitation important in improving Rehabilitation important in improving

outcomes after burn injuryoutcomes after burn injury Need to optimize return of soldier to Need to optimize return of soldier to

active dutyactive duty Little data on when, how best to Little data on when, how best to

deliver therapydeliver therapy

How Can These Help the How Can These Help the Military?Military?

Study #1Study #1 Blood precious resource; appropriate use Blood precious resource; appropriate use

paramountparamount Improve outcomes for burned soldier by Improve outcomes for burned soldier by

defining appropriate transfusion threshold defining appropriate transfusion threshold and optimizing risk/benefit ratioand optimizing risk/benefit ratio

Standardize practice for blood transfusionStandardize practice for blood transfusion Study #2Study #2

Rehabilitation time-consuming and Rehabilitation time-consuming and expensiveexpensive

Need to optimize soldier return to workNeed to optimize soldier return to work Emphasis by pressEmphasis by press

Military Priorities: The Military Priorities: The Key Key

Both studies directly address the Both studies directly address the needs of the military needs of the military

Priorities taken from the State of the Priorities taken from the State of the Science meetingScience meeting

Need to have tangible resultsNeed to have tangible results

The Next Step(s)The Next Step(s) Further funding ($8 million) obligated for Further funding ($8 million) obligated for

burn multicenter clinical trials research by burn multicenter clinical trials research by DODDOD

Call for pre-proposals in January 2009Call for pre-proposals in January 2009 DOD determines prioritiesDOD determines priorities ABA MCTG screens grants for meeting DOD ABA MCTG screens grants for meeting DOD

priorities, scientific integrity, multicenter priorities, scientific integrity, multicenter naturenature

29 proposals received; four selected for 29 proposals received; four selected for fundingfunding

Proposals approved, fundedProposals approved, funded Further $3 million funded for 2010, 2011, Further $3 million funded for 2010, 2011,

20122012

Projects FundedProjects Funded Grading system for inhalation injuryGrading system for inhalation injury Early identification of MRSA infection via Early identification of MRSA infection via

polymerase chain reactionpolymerase chain reaction Glutamine supplementation and infectionGlutamine supplementation and infection Use of CRRT during burn shockUse of CRRT during burn shock Effects of exercise program on return to workEffects of exercise program on return to work Propranolol use to decrease hypermetabolic Propranolol use to decrease hypermetabolic

responseresponse Analysis of factors contributing to Analysis of factors contributing to

morbidity/mortality in combined burn/traumamorbidity/mortality in combined burn/trauma Total funding to date approximately $28 Total funding to date approximately $28

millionmillion

The ChallengesThe Challenges Whenever there is money, everyone wants Whenever there is money, everyone wants

somesome Making sure the research gets done the right Making sure the research gets done the right

wayway Contracting Contracting Human Subjects Review Human Subjects Review Development of integrated information Development of integrated information

technology capabilities for multicenter trialstechnology capabilities for multicenter trials Coordination of biostatistics with data Coordination of biostatistics with data

collectioncollection Actually doing the studyActually doing the study

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

Federal funding for burn multicenter Federal funding for burn multicenter outcomes research from varied sourcesoutcomes research from varied sources

Timing, persistence, follow-up essentialTiming, persistence, follow-up essential Never assume it will happen; make it Never assume it will happen; make it

happenhappen Getting to know congress members key, Getting to know congress members key,

but need to be patient…it takes timebut need to be patient…it takes time

Questions?Questions?

ABA Multicenter Trials Group– The Administrative

Aspect 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 Burn Multicenter Outcomes Research (BORI) Research (BORI)

InfrastructureInfrastructure

Non-invasive StudySubcommittee

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 American Burn Association (ABA) TRACS(ABA) TRACS™™ Database Database

National burn registry supported National burn registry supported by the American Burn Association by the American Burn Association and the American College of and the American College of SurgeonsSurgeons

Multicenter data collection on burn Multicenter data collection on burn demographics, treatment, outcomesdemographics, treatment, outcomes

Nation-wide participationNation-wide participation Secure database, >300,000 recordsSecure 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 VerificationBurn Mortality by Size

0

10

20

30

40

50

60

70

80

90

0.1-9.9 10-19.9 20-29.9 30-39.9 40-49.9 50-59.9 60-69.9 70-79.9 80-89.9 >90

TBSA Burn (%)

Mo

rtali

ty (

rate

)

American Burn Association National Burn Repository 2012.

SponsorsSponsors

American Burn AssociationAmerican Burn Association Shriners Hospitals for ChildrenShriners Hospitals for Children National Institute of General National Institute of General

Medical SciencesMedical Sciences National Institute on Disability and National Institute on Disability and

Rehabilitation ResearchRehabilitation Research Veteran AdministrationVeteran Administration Department of DefenseDepartment of Defense