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