research during disasters - critical care canada
TRANSCRIPT
Research during
Disasters
Professor S Bhagwanjee
Department of Anesthesiology and Pain
Medicine
Disclosures: ASPR
Acknowledgements:
• ASPR / HHS
• NIH
• USCIIT Group
– CIOS
– PROOF
– PEIR
• Collaborators
Disaster and GDP
• Disaster mortality of a single person was found to reduce GDP by US$0.01828
• … to mitigate the effects of national disasters expeditiously and effectively will yield significant economic returns
Kirigia JM, Sambo LG, Aldis W, Mwabu GM. Impact of disaster-related mortality on gross domestic product in the
WHO African Region. BMC Emerg Med. 2004 Mar 15;4(1):1.
Disease burden
Time
Disease
burden –Outbreak
–IMAI –IMAI
Vulnerable populations: disaster
medicine … Hurricane Katrina of the 2005 hurricane
season was the costliest natural disaster,
as well as one of the five deadliest
hurricanes in the history of the US … Knabb, Richard D; Rhome, Jamie R.; Brown, Daniel P (December 20,
2005; updated August 10, 2006). "Tropical Cyclone Report: Hurricane
Katrina: 23–30 August 2005“. National Hurricane Center
Research challenges during
disasters • Clinical care needs come first
• Even less time than normal for research
• Adverse environment
• Lack of infrastructure (electricity,
telephone, communications)
• Lack of qualified data collectors
• IRB approval
EVENT
Retrieve data
Transfer data Analyse data
Release Data
Plan response
No, but we’ve got a plan… • Critical Care organization
• Emergency research mandate
• Program for Emergency Preparedness (USCIITG-PREP)
• Informatics
Big Data: Are we ready
for the next disaster?
Crit Care Med 37: 3158, 2009
Transformative Approach
• Inclusive, transdisciplinary, time continuum
• “Network-of-networks”
– Federally funded networks (ARDSnet, ROC,
NETT)
– Professional Organizations (CCSC)
• Triannual face-to-face meetings
– Fall at NIH in Bethesda
– Winter at SCCM (San Francisco)
– Spring at ATS (San Diego)
USCIITG 2013
• 200+ investigators across 68 ICU’s
• Four large Programs
– Prevention of Organ Failure (PROOF)
– Critical Illness Outcomes Study (CIOS)
– Early ICU Rehabilitation (PEIR)
– Program for Emergency Preparedness (PREP)
• ~$22m funding over last 4 years
– NIH, CMS, ASPR, DOD
No, but we’ve got a plan… • Critical Care organization
• Emergency research mandate
• Program for Emergency Preparedness (USCIITG-PREP)
• Informatics
Big Data: Are we ready
for the next disaster?
“Although responses to recent events have typically used the best available science at the time, additional research, done in parallel with and after the response itself, is often essential to address the most pressing knowledge gaps presented by public health emergencies and to ensure that they are addressed by the time another similar disaster strikes. Recent events have also illustrated gaps in planning for, and rapidly executing, scientific research in the context of disaster response.” [emphasis added]
N Engl J Med 368: 1251, 2013
OR
Floor ED Pre-hosp ICU Rehab
United States Critical Illness and Injury Trials Group
Program for Emergency Preparedness (USCIITG-PREP)
ASPR
• Develop mechanisms for rapid data collection in the
field, analysis, and dissemination of findings
– Professional organizations
– Homeland Security Information Network (HSIN)
• Pre-event work
– Protocols
– Data collection processes
– Rapid analysis techniques
– Mechanisms for immediate dissemination
Federal emergency response systems have insufficient capabilities to rapidly collect clinical data to inform 1) decision makers and 2) key end-users
Aim
To significantly enhance the national capability to rapidly glean crucial information regarding the clinical course of acute illness and injury and guide clinical resource requirements during emergent events
Clinical research ethics for critically
ill patients: a pandemic proposal
… we also propose strategies such as
expedited and centralized research ethics
committee reviews and alternate consent
models…
Cook et al. Crit Care Med 2010 Apr;38(4 Suppl):e138-42.
doi: 10.1097/CCM.0b013e3181cbaff4
No, but we’ve got a plan… • Critical Care organization
• Emergency research mandate
• Program for Emergency Preparedness (USCIITG-PREP)
• Informatics
Big Data: Are we ready
for the next disaster?
USCIITG-PREP Deliverables
• Key Analytic Outcomes
• Communication infrastructure
• Core Data Set
• Specialized Data Sets
• Clinical Pilot: Core Data Set
• Rapid Analysis Plan
• Data Dissemination Plan
Key Analytic Outcomes
• Clinician end-users and researchers
– What was the nature of the insult and the resulting
phenotype?
– As a responder, what, if anything, did you have to do
differently?
– Did diagnostics, countermeasures, and therapies
work as expected?
– What was the impact on the patient and care
setting?
• Systems and operational evaluations
– Was there anything essential needed that you did
not get?
– What is the best/worst case that could happen next
time? USCIITG-PREP Project Plan v.7
Kevin Yeskey
Lewis Rubinson
USCIITG-PREP
• Motivation: Insufficient capabilities internal
to HHS to rapidly collect data
– Decision makers
– Key end-users in public health emergencies,
especially on illness severity and physiology.
• Goal: Provide timely clinical data to
markedly improve situational awareness of
acute illness and injuries
• HHS/ASPR/OPEO contract (18 month)
• Co-PI’s: JP Cobb, C Cairns, S Bhagwanjee
USCIITG-PREP
Governance
• Steering Committee
• Data Set Working Group
– Core Data Set
– Specialized Data Sets
• Rapid Analysis Group
– Electronic platform
• USCIITG-Burn
– Clinical Feasibility Pilot
Jim Blum
Michigan
Jimmie Holmes
Wake Forest
Jon Sevransky
Emory
Bruce Cairns
UNC
USCIIT
ASPR/HHS
• Co-chairs: Lewis Rubinson and Perren Cobb
• USCIIT Group
• HHS
Steering Committee
– Albert Einstein College
– Duke U
– Emory U
– Harvard U
– St. Agnes Hospital
– Stanford U
– U Arizona
– U Michigan
– U North Carolina
– U Utah
– U Washington
– ASPR
– CDC
– HRSA
– NIH
– FDA
Tactical Approaches
http://www.atworkmgt.nl/en/services/crawl-walk-run
Core Data Set
1st Face-to-face meeting, March 13-14, 2012
All-hazard, “minimal” data set
Modified Delphi process (4 rounds)
– Prehospital phase
– ED phase
– ICU phase
– Discharge/follow-up phase
Electronic format (REDCap)
Specialized Data Sets
2nd face-to-face meeting, November 7-8, 2012
Specific hazards
Modified Delphi process (3
rounds)
– Infectious injury (pandemic)
– Radiation injury (IND)
– Traumatic injury (IED, earthquake)
Michelle Gong Albert-Einstein
Ziad Kazzi:Emory
Kristen Staudenmayer: Stanford
Clinical Pilot: Feasibility Test January 24-25, 2013
• Goals
– Field usability of the Core Data Set
– Logistics of human subjects research during
public health emergency, especially IRB
• Requirements
– 150 patients across 10 sites, minimum
– Rapid analysis (24 hours)
Results: 12 USCIITG-Burn Centers
enrolled 195 patients in 24 hours
U.S. Burn Center Bed Capacity 2012
Rapid Analysis and
Data Dissemination Plan
points-of-care http://www.porterhealth.com/Pages/Portage%20Hospital.aspx
HSIN ASPR
Government Partners
Summary: USCIITG-PREP
Aim and Deliverables
“To significantly enhance the national capability to rapidly glean crucial information regarding the clinical course of acute illness and injury and guide clinical resource requirements during emergent events”
Key Analytic Outcomes
Communication infrastructure
Core Data Set
Specialized Data Sets
Clinical Pilot
Rapid Analysis Plan
Dissemination Plan
Lessons Learned
Challenges for Clinical Research during public health emergencies
• IRB
– What is defined as “research” (OHRP)
– Expedited vs. full IRB review
– Variance in IRB responses (bureaucracy, use agreements, etc.)
• Data collection
– Timing (when and where, frequency)
– Skill sets and training
– Missing data
No, but we’ve got a plan… • Critical Care organization
• Emergency research mandate
• Program for Emergency Preparedness (USCIITG-PREP)
• Next steps: Informatics
Big Data: Are we ready
for the next disaster?
Next Steps: Evolution of Clinical Studies
Epidemiology to Improved Outcomes
1. Detection (epidemiology,
syndromic)
2. Illness severity
(pathophysiology across
time)
3. Intervention (responses
to MCM)
4. Improved outcomes
Next Steps: Data Harmonization
Standardized Reporting Platforms
for Public Health Emergencies
• Coordinate national efforts
to evaluate Medical
Counter Measure (MCM)
product efficacy, safety,
and quality across the care
continuum
• Standardize and test data
collection technologies for
MCM, using seasonal
influenza as a test case
USCIITG-PREP Pulse
• Strategic vulnerability: inability to query medical centers nationally (academic and community) as to system “stress”
• Need: “To appropriately care for patients, ASPR has identified a need to define, develop, and implement a tiered process to assess the impact an incident is having on the healthcare delivery system stress. Specifically, ASPR needs to identify the surge strategies being used to address increased stress on the healthcare system due to conditions prompted by the incident.”
• Award: one year ASPR contract to create internet-based forums to assess system stress (“the pulse”).
USCIITG-PREP Pulse
Sample Questions • Are the EMS systems having difficulty finding
open/available hospitals above normal baseline?
• Have Emergency Department volumes increased from baseline?
• Are hospitals implementing surge strategies?
• Have hospitals cancelled elective admissions, or surgical procedures?
• What is the number of hospitals on diversion?
• Is the hospital in which you primarily practice overwhelmed?
• Have clinical standard protocols been changed?
• Are additional ventilators needed?
• Have communities implemented alternate care or triage sites?
Informatics
• Benefits of proposed technology – Novel, national MCM communication network for
seasonal influenza, extending from pre-hospital to rehabilitation
– National consensus on use of human data, research, and patient protection during a public health emergency
– HL7/SDTM-compliant data tools to improve influenza diagnosis, therapy, and outcomes
• Challenges – Integration of HL7/SDTM tools with Epic/eCare
– Patient protection and privacy concerns for data collection
Next Steps: Global Health
International Networks
• USCIITG helps represent U.S. interests
– International Forum of Acute Care Trialists
– International Severe Acute Respiratory
Infection Consortium
– World Federation of Societies of Intensive and
Critical Care Medicine
No, but we’ve got a plan… • Critical Care Organization
• Emergency research mandate
• Program for Emergency Preparedness (PREP)
• Informatics
• “Pulse”
Big Data: Are we ready
for the next disaster?
www.usciitg.org