emergency care research - feinberg school of medicine€¦ · professional or student) conducting...
TRANSCRIPT
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Emergency Care
Research Strengths
Challenges
Networked Collaboration
Realistic Opportunities for the future
D. Mark Courtney
Department of Emergency Medicine
Northwestern University
Chicago
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Why this talk?
• Discuss opportunities and challenges of
conducting research in the emergency
setting.
• Identify opportunities for collaboration
within Northwestern Medicine
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Perina et al. Annals of EM 2010
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Emergency Research: at a
tipping point
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The 2008 Emergency Care Research Networks (ECRN) Conference:
design, summary of findings, and an update.
Unique characteristics of emergency care research: scope,
populations, and infrastructure.
Facilitating emergency care research networks: integration into the
Clinical Translational and Science Award (CTSA) infrastructure.
Structure and Function of Emergency Care Research Networks:
Strengths, Weaknesses, and Challenges
Evaluating Emergency Care Research Networks: What Are the Right
Metrics?
AEM October 2009
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What is Emergency Medicine?
what domains? topics?
sepsis
shock
PE/DVT
stroke
seizure
psychiatry
wounds
trauma
fractures
sprains
AMI
EP
asthma
COPD
pneumonia
pain
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(d) “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge....
(f) Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains...
-Data through intervention or interaction with the individual, or -Identifiable private information.”
What is Research:
Code of Federal Regulations. TITLE 45 PUBLIC WELFARE DHHS
PART 46
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What is Emergency Research?
What is unique about our approach?
sepsis
shock
PE/DVT
stroke
seizure
psychiatry
wounds
trauma
fractures
sprains
AMI
EP
asthma
COPD
pneumonia
pain
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What is unique about Emergency
Research?
undifferentiated symptoms
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stabilize
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diagnose
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treat
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What makes Emergency Research
unique are the same things that
make Emergency medicine unique
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What else is unique about
Emergency Medicine Research?
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What else is unique about
Emergency Medicine Research?
Health Care Delivery Research:
diagnostic test assessment
resource utilization
cost effectiveness
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Health Care Delivery Research:
access to care
psychiatric
substance abuse
Patient flow-ED operations
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Education Research:
Simulation
Procedural competency
Accreditation
Curriculum
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Organ system –
Disease specific
Education
Health care delivery
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Definition of Emergency Care
Research:
“the systematic examination of patient
care that is expected to be continuously
available to diverse populations
presenting with undifferentiated
symptoms of acute illness, or acutely
decompensated chronic illness and
whose outcomes depend on timely
diagnosis and treatment”
Courtney DM et al. AEM 2009
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Why networked Research?
32 year old female
pleuritic chest pain
brief
some shortness of breath
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What next……..
Where do you turn for information?
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Heit JA et al. Arch Int Med 2000
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What about OCPs?
Heit JA et al. Arch Int Med 2000
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Why didn’t Estrogen/OCPs
show up as a risk factor for PE?
Lack of true relationship
Inadequate power
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Pulmonary Embolism
Research Consortium
Courtney et al Annals of EM 2010
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Who is at risk for PE?
Reasons to not test
Reasons to test
Courtney et al Annals of EM 2010
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Courtney et al Annals of EM 2010
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Two step approach to interpreting
scientific literature
• Internal Validity
• External Validity (generalizability)
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Courtney et al Annals of EM 2010
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Increase power
Increase external validity (generalizability)
Why Networked ECR?
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Uncommon disease or
small effect size? • Who does not need a CT in pediatric
trauma
• C-spine injury in pediatric trauma
• Cerebral injury from IVF in pediatric DKA
• Pediatric status eplilepticus
• Dexamethasone in mod-sev bronchiolitis
• Hypothermia in pediatric cardiac arrest
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Prediction rule: peds head
trauma
Kuppermann N et al. Lancet 2009
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600 children
20 different centers
double blind RCT
NO change in admission, resp status 4
hours later, or later outcomes
Corneli HM et al NEJM 2007
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Overview of Current ECR
networks:
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Population-Public Health
Pulmonary Embolism Research Consortium
ProCESS: Sepsis
NETT - Neuro
EmergencyID Net - Infectious Disease
EMNet - Pulmonary and Public Health
PECARN - Pediatric
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Disease-Organ system
Pulmonary Embolism Research Consortium
ProCESS: Sepsis
NETT - Neuro
EmergencyID Net - Infectious Disease
EMNet - Pulmonary and Public Health
PECARN - Pediatric
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Disease or organ
system specific
networks
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• Neurological Emergencies Treatment Trials
(NETT)
• Large simple trials
• Goal: reduce burden of very acute
injuries/illnesses brain, spinal cord, and
peripheral nervous system.
• Funded by NINDS
• Time dependent interventions at the EMS or ED
level
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• Phase 3 clinical trials only
• Hub and Spoke Network
• Separate awards for:
CCC
SDMC
Hubs
NINDS funding only for infrastructure
• Specific study funding must be secured
• NETT is an “open” network
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• ALIAS - High-Dose Albumin Therapy for
Neuroprotection in Acute Ischemic
Stroke
• RAMPART - Rapid Anticonvulsant
Medication Prior to Arrival Trial
• ProTECT - Progesterone for Traumatic
Brain Injury: Experimental Clinical
Treatment
• POINT - Platelet-Oriented Inhibition in
New TIA Trial
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NETT: leading the way in Consent
issues
• Exception to informed consent for ECR
• Optimize methods that respect human subjects
• Dedicate network resources to facilitate local
efforts
• Help develop centralized IRB review
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Protocolized Care for Early Septic Shock
(ProCESS)
GROUPS:
1. Early Goal Directed Therapy (EGDT) - CVP monitoring and
(Scv02).
2. Protocolized Standard Care (PSC)- Monitor blood pressure and
blood oxygen level with routine equipment. Central lines only
when standard IVs are unable to give the proper amount of fluids
and medicines.
3. Active Comparator-Usual Care - standard treatment and without
any influence from the study team. A member of the study team
will simply observe and record what happens. Procedure: Usual
Care (UC)
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Courtney et al. AEM 2009
Text
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Courtney et al. AEM 2009
Text
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Courtney et al. AEM 2009
Text
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Courtney et al. AEM 2009
Text
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Pulmonary Critical Care
Cardiology
Neurology
ID
? Transplant
?GI
Opportunities
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NUEM Completed Clinical Research Project Funding Collaborators Status N enrolled
in NUEM ED
D-dimer and Pretest Probability
for PE
NIH -
NHLBI
Hematology, 9 other US
EDs
Data Collection, Analysis, &
Publication - Complete
1797 (at NU)
A Phase II/III, Multicenter,
Randomized, Double-blind,
Placebo-Controlled Study to
Evaluate the Efficacy and Safety
of Relaxin in Subjects With Acute
Heart Failure
Industry Cardiology Data Collection & Analysis –
Complete; Publication -
Ongoing
8
Chicago Community-Acquired
Pneumonia Consortium
CDC Pulmonary & Critical
Care (Wunderink); 5
other US EDs
Data Collection - Complete;
Analysis & Publication -
Ongoing
971 (at NU)
Rule Out Myocardial Ischemia/
Infarction Using CT (ROMICAT)
NIH -
NHLBI
Cardiology (Mikati) Data Collection – Complete;
Analysis & Publication -
Ongoing
21
Expired CO2/O2 Analysis to
Diagnose Pulmonary Embolism
Industry 3 US other EDs Data Collection – Complete;
Analysis & Publication -
Ongoing
172
Randomized Trial of Tenecteplase
to Treat Severe Submassive
Pulmonary Embolism
Industry Pulmonary & Critical
Care, 7 other US EDs
Data Collection – Complete;
Analysis & Publication -
Ongoing
7
Assessment of Early Renal Injury
in Acute Heart Failure Syndrome:
A Prospective, Observational,
Biomarker Study
Industry Cardiology Data Collection – Complete;
Analysis & Publication -
Ongoing
7
Hypoperfusion in Acute Heart
Failure Syndromes
Industry Data Collection – Complete;
Analysis & Publication -
Ongoing
50
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NUEM Current Clinical Research Project Funding Collaborators Status N enrolled
in NUEM ED
Consumer Understanding of
Opioid Pain Relievers
EMF -
Purdue
Pharma
IPHAM Data Collection - Ongoing 265 Enrolled,
201(Complet
e w/ Follow-
Up)
Neuromuscular Mechanisms
Underlying Chronic Pain in
Whiplash
KL2
(NUCATS)
PT and Human
Movement Sciences
(Elliott)
Data Collection – Ongoing
65 Enrolled
Identification of Patient
Phenotypes Associated with
Elevated Aldosterone Levels
KL2
(NUCATS)
Cardiology (Shah) Data Collection – Ongoing 43 Enrolled
Procalcitonin MOnitoring SEPsis
Study (MOSES)
Industry Pulmonary & Critical
Care, 7 other US EDs
Data Collection – Ongoing 28 Enrolled
Pre-test Probability and
Diagnostic Testing for Deep
Venous Thrombosis in the
Emergency Department
Pilot Data Collection – Ongoing 213 Enrolled
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NUEM Pending Clinical Research Project Funding Collaborators Status
Rapid Administration of Carnitine in sEpsis NIH - NIGMS Pulmonary & Critical Care, 4
Other Academic Centers
Pending
Start-Up
Effects of Early Versus Delayed Antibiotic
Treatment for Febrile Neutropenia
NIH Hemotology-Oncology, Infectious
Disease, Preventative Medicine
Submitted
(R21)
Measuring Out-of-Hospital Cardiac Arrest at NMH
(MOHCA-NMH)
Women’s Board of
NMH
Submitted
Inter-Unit Handoffs: Direct Observations of Handoff
Communication between Emergency Physicians
and Hospitalists
Women’s Board of
NMH
Hospital Medicine, Western
Michigan University
Submitted
A TBI Patient Registry to Examine Variations in
Diagnosis, Treatment, and Outcomes
NIH - NINDS Internal Medicine, IPHAM, RIC,
Neurology, Trauma
(Kho/Heineman)
Submitted
(U01)
Neuromuscular Mechanisms Underlying Poor
Recovery from Whiplash Injuries
NIH PTHMS (Elliott) Submitted
(R01)
Acute heart failure patients with high Copeptin
levels treated with Tolvaptan targets Increased
AVP Activation for Treatment Efficacy (ACTIVATE)
Industry Cardiology, Pulmonary & Critical
Care
Submitted
Retrievable Inferior Vena Cava Filters with Acute
Pulmonary Embolism
NHLBI One of 20 sites. CCC = MSU.
DCC = GWU
Submitted
(R01)
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NUEM Health Services Research Project Funding Collaborato
rs
Status
Emilie Powell Fellowship T32 (Institutional NRSA
Fellowship)
IPHAM Complete
Danielle McCarthy T32 (Institutional NRSA
Fellowship)
IPHAM Complete
Critical Areas for Improvement in Care
Delivery of ED Severe Sepsis
Resuscitation
F32 (Individual NRSA Post
Doctoral Fellowship)
IPHAM Complete
Improving ED Quality and Safety by
Enhancing Operations and Quality
Management
AHRQ (K08 - Mentored
Clinical Scientist Career
Development Award)
IPHAM Ongoing – Year 3 of 5
Scott Dresden Fellowship T32 (Institutional NRSA
Fellowship)
IPHAM Ongoing - Year 2 of 2
Chris Richards Fellowship T32 (Institutional NRSA
Fellowship)
IPHAM Ongoing - Year 1 of 2
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Discussion