The WTC FDNY Rescue/Recovery Worker Cohort
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1 The WTC FDNY Rescue/Recovery Worker Cohort Research Challenges & Lessons Learned David J. Prezant, MD Special Advisor to the Fire Commissioner on Health Policy Chief Medical Officer, FDNY Co-Director FDNY NIOSH WTC Health Program PI, FDNY NIOSH WTC Data Center Professor of Medicine, Albert Einstein College of Medicine Division of Pulmonary Medicine
2 Disaster Response: Health Research Challenges Non-Disaster: Plan, Collect Data & Analyze Intervention = Clinical Services Systems Improvements Disaster Unexpected: Intervention is immediate Clinical Services Systems Provided Data Confounded Collect Data Under Difficult Circumstances More Interventions Re-Collect & Analyze Analysis Impacted By Many Confounders
3 9/11/01
4 2 TOWERS ~110 STORIES & SEVERAL OTHER BLDS. BECAME ~4 STORIES OF PULVERIZED RUBBLE
5 The WTC Dust Cloud Engulfed Later On Day Lower 1 Manhattan
6 September 11, 2001 The terrorist attack on the World Trade Center and its consequent collapses killed 2,900 persons, including 343 FDNY rescue/recovery workers. Overall, ~ 16,000 FDNY rescue workers participated in the intense rescue/recovery effort, which started immediately and continued for more than 10 months. 1,600 FDNY firefighters and EMS workers were present when the buildings came down and 6,600 were there by the end of day 1.
7 WTC Exposures Multiple Agents Kindly Provided by Firefighter The exposure mix (partial list): High Dust concentrations (100mg/m 3 ) with ph ~10), causing airway burn & chronic inflammation Pulverized cement, gypsum Pulverized glass Asbestos Silica Fibrous glass Heavy metals Volatile organic compounds Organic combustion/pyrolysis products of bldg components & jet fuel PAHs, dioxins, PCBs, etc
8 Firefighter Bronchoscopic Alveolar Lavage Inhaled Asbestos, Glass and Ash
9 Sputum collected 10 months after 9/11 contained World Trade Center Dust Firefighter Sputum has dust similar to WTC dust Macrophage with dusts Environ Health Perspect November; 112(15):
10 FDNY-WTC Cohort The FDNY WTC responder population forms a wellcharacterized cohort The only cohort with pre-9/11 health data including PFTs that has been systematically captured since 1996 The highest exposure to respiratory irritants and combustion byproducts than any other WTC cohort A well-organized medical monitoring program has minimized longitudinal dropout with consistently high retention rates [92-95%] Baseline Serum Obtained Post-exposure
11 FDNY WTC Monitoring & Treatment Program 9/11 WTC Exposures FDNY MEDICAL MONITORING & TREATMENT PROGRAM BEGINS Sept Mental Health Respiratory Late Emerging Diseases: Cancer, AID
12 Disaster Response: Health Research Challenges 1. Coordinating Logistics to Execute Rapid & Sustained Research in Disaster Response 2. Partnering With Communities (Systems or Cohorts) to Allow Access for Pre-event, Baseline, & Longitudinal Assessments 3. Obtaining Rapid & Sustained Research Funding 4. Improving the Role of Extramural Clinical & Academic Researchers, Centers & Networks 5. Improving Data Collection Capabilities & Resources 6. Institutional Review Board (IRB) Barriers
13 Disaster Response: Health Research Challenges 1. Coordinating Logistics to Execute Rapid & Sustained Research in a Disaster Response Research is Slow, Deliberative, Thoughtful & Collaborative. But Disaster Research Must Absorb the Immediacy of the Event and Without that Information Any Outcomes Of Interest Will Remain Elusive What Did or Did NOT Happen? Who Was Exposed? What Appears to be the Immediate Impact? Research Questions are Similar at Every Disaster Preparedness = Pre-arranged Studies Ready to Go
14 Disaster Response: Health Research Challenges 2. Partnering With Communities (Systems or Cohorts) to Allow Access for Pre-event, Baseline, & Longitudinal Assessment RESEARCH PARTICIPATION REQUIRES: A REASON TO PARTICIPATE Too often, participants view research as an experiment. They already lived through one experiment (the disaster), they don t feel like volunteering for another They are dealing with the aftermath of the disaster and their energy and patience is limited
15 Disaster Response: Health Research Challenges 2. Partnering With Communities (Systems or Cohorts) to Allow Access for Pre-event, Baseline, & Longitudinal Assessments RESEARCH PARTICIPATION REQUIRES: TRUST WHICH REQUIRES CREDIBILITY IRB Approval is NOT enough Need LOCAL partner(s) with a history of SERVICE that preferably began before the disaster Stamp of EXCELLENCE AHA, ACS, Academic Ctr.?, CDC? Local Buy-in, Public, Labor and Management SUPPORT PROVIDE A REASON TO PARTICIPATE A reason to believe that this research effort is worth devoting remaining energies and time in the aftermath
16 Disaster Response: Health Research Challenges 2. Partnering With Communities (Systems or Cohorts) to Allow Access to Pre-event, Baseline, & Longitudinal Assessments. Participation is maximized if everyone agrees that: Disaster Research is NOT an experiment. It is PROMISE with an end towards RECOVERY Monitor - > Assess -> Provide / Intervene -> Reassess Endpoint is not data but knowledge that can be used to guide recovery. To provide what is needed in terms of clinical services &/or systems improvements Continued Participation Requires Fulfillment Short, medium & long-term deliverables to the system, cohort, labor, management and public
17 Disaster Response: Health Research Challenges 3. Obtaining Rapid & Sustained Research Funding Several Phases to Public Perception & Funding: Initially, Funding Flows Its the Right Thing to Do Followed by Disbelief Were the subjects actually exposed? Isn t this an acute issue that will resolve spontaneously? Did the exposure actually cause disease? Followed by Apathy Is this still important? How much is enough? The Nation has other priorities? The Answer is Data Driven Advocacy
18 Disaster Response: Health Research Challenges 3. Obtaining Rapid & Sustained Research Funding Data Driven Advocacy Requires Research But No Study Is Ever Perfect Multiples Studies Showing Similar Affects Lead to a More Perfect Understanding And Understanding Leads to a More Perfect Response Improved Clinical Services Improved Systems for this Disaster and the Next. Research Requires Educating Everyone Involved (Researchers, Participants & FUNDING AGENCIES) as to What is Achievable Given the Territory. Expectation Adjustments Are Needed
19 Disaster Response: Health Research Challenges 4. Improving the Role of Extramural Clinical & Academic Researchers, Centers & Networks Everyone thinks their idea is worthy of immediate study. We need to remain focused on the main questions But, we always want to but leave open possibility that novel issues may occur. Affected Systems and Populations have limited time for questionnaires and tests. Overburdening them leads to longitudinal dropout. Too much Data can Reduce Focus and Lead to Paralysis Questions, Data Collection & Analyses Need to be Part of a Pre-Disaster Agreed Upon Focused Agenda
20 Disaster Response: Health Research Challenges 5. Improving Data Collection Data collection should allow for immediate collection and real-time access Ex. On-line disaster questionnaires developed pre-disaster Pro Use validated questionnaires Con - Validation is an illusion Different population than original Validation was to 1 disease but disasters cause multiple diseases. Multiple validated questionnaires present numerous problems that were not part of the original validation Attention Deficit Questions with different time spans cause confusion Similar questions in each disease set reduce specificity
21 FDNY WTC MONITORING EXAM: Patient Flow FDNY WTC HEALTH PROGRAM Monitoring Sign In Medical Questionnaire Vitals PFT EKG Hearing Chest Xray Every 2 yrs Blood Urine Immunizations Stair Master (Active Only) Vision (Active only) Physician Wellness Check or Mental Health Structured Interview (DIS) by MSW or RN Self- Administered Mental Health Questionnaire Treatment / Referral Options if Needed Sign Out & Reschedule Annually Mental Health Treatment Referral Physical Health Diagnosis & Treatment Referrals Medications Benefits Counseling
22 FDNY-WTC Monitoring & Treatment Program Delivered Through a Health Benefits Program Model FDNY WTC Health Monitoring and Treatment Program 1. Patient Care Coordination & Services Clinical Center for Physical & Mental Health Data Center for Coordination Analysis & Reporting FDNY WTC Health Benefits Program & Data Administration Monitoring Diagnostic Testing & Treatment In - Network Out of Network 4. Claims Processing 3. Pharmacy Benefits
23 Clinical < > Data Integration Patient Micro Level Exposure documentation Monitoring Pre. vs Post WTC Data Diagnostic Testing Treatment Prescription Meds. Medical Records Clinician-Patient Relationship Patient needs to see benefit Cohort Macro Level Diagnostic Definitions Monitoring Protocols Treatment Protocols Pre. vs Post WTC Data Analyses Disease Surveillance Outcomes Leverage Relationships FDNY, Labor, Patient Groups Medical Community, ACCP Government
24 Disaster Response: Health Research Challenges 6. Institutional Review Board (IRB) OUR APPROACH Leverage Pre-existing IRB relationship Disaster, Urgency, Duty, Service, Patriotism Partner with local unit responsible for healthcare and submit IRB only for the analytic piece using de-identified data with study ID that allows for follow-up longitudinal analyses. As long as the questionnaires, tests and interventions (if any) are standard of care that the local healthcare entity was going to do anyway, then IRB may be willing to review only the analytic portion.
25 Disaster Response: Health Research Challenges 6. Institutional Review Board (IRB) BARRIERS Federal Confidentiality Certificate - Further Protection that is useful for mental health studies but most IRBs have little experience with it IRB Consents - Workers & Victims Compensation Consent typically states that the researchers and their institutions are not responsible for any complications the subject may directly or indirectly suffer from the testing protocol. Unless this line is removed, most workers will not sign this consent because they correctly or incorrectly presume they are giving up their rights to workers comp and any litigation for damages Trust required if consent is to be signed. Need local IRB buy-in
26 Disaster Response: Health Research Challenges 6. Institutional Review Board (IRB) BARRIERS After a Disaster you often need to obtain multiple Institutional IRB approvals This should be CHANGED Multiple clinical centers involved in the WTCHP. Each has its own IRB, consent forms, & approval processes. A single IRB (ex. multi-center study/trial) reduce the delays and red-tape Cancer studies require matching with State Tumor Registries. Each state has its own tumor registry. To prevent longitudinal dropout after patients move out of state, WTCHP currently needs to receive IRB approval from >10 States. They are all funded by CDC, why not a single IRB?
27 FDNY WTC MEDICAL MONITORING & TREATMENT GOALS AGREED UPON BY ALL PARTIES -- SEPTEMBER 2001: Treat acute injuries/illnesses Exposures made a scientific, emotional & political case for medical monitoring of the exposed survivors of the collapse and the rescue/recovery workers FDNY was the only population with: Defined cohort and documented exposures Pre-9/11 data including chest radiographs and spirometry In-house Health Services able to immediately perform medical monitoring & treatment with buy-in from the workforce labor and management Funding would maximize participation, reduce longitudinal drop-out and allow for scientific data driven interventions and data driven advocacy If illnesses develop, treatment would be provided
28 WTC Exposure & Disease: Scientific Data Driven Findings 1. WTC Cough Syndrome 2. Accelerated Lung Function Declines Due to Obstructive Airways Disease 3. Parenchymal Lung Disease (Sarcoidosis) 4. Post-Traumatic Stress Disorder 5. Cancer Early Signal in First 7 Years
29 Sept 2002 Cough, DOE, Intermittent Wheeze, Sinusitis, & GERD Decreased FEV1 & FVC with normal FEV1/FVC ratio
30 Adjusted Average FEV1 (liters) FDNY PFT from MEDICALS Pre-WTC vs. 1- year Post-WTC Longitudinal FEV1 Decline Annual FEV1 decline before 09/11/2001: -31 ml/yr -372ml =12 time annual pre-wtc decline FEV1 adjusted for: Gender Race Height Age Cigarette smoking Date 09/11/ /11/ /11/ /11/ /11/ /11/2002??? Not shown: + Significant Exposure Response Effect: Arrival Time Duration Source: Banauch, Kelly, Prezant et al; Am J Respir Crit Care Med 2006
31 OBJECTIVE: To assess the longer-term lung function trends in FDNY workers exposed to WTC dust On average, did the initial decline in lung function recover, persist, or worsen?
32 Adjusted FEV1 (L) RESULTS: Lung Function Decline Since 9/ Fire, Never Smokers (n=7,364) Fire, Post-9/11 ever Smokers (n=611) predicted Years since 9/11/2001 For both Fire & EMS (not shown), cigarette smokers had lower lung function at all time points, but main impact was 9/11 exposure.
33 Preliminary biomarker study design decline or improvement in FEV 1 as outcome
34 Multiple serum biomarkers predict future decline or improvement in FEV 1 Inflammation Metabolic Syndrome Vascular Injury Susceptibility GM-CSF MDC Leptin Dyslipidemia Glucose Intolerance CRP Apo AII Resistance Chitotriosidase Amylin VCAM MIP-4 Nolan et al. Chest 2012,142: Naveed et al. AJRCCM 2012, 185: Weiden et al. Eur Respir J Cho et al., J Clin Immunol :
35 Lancet 9/3/2011
36 Disaster Response: Health Research Our Goal In Summary, The Goal Of Research In Response To A Disaster Is NOT Just To: Record events Determine mechanisms and outcomes Design and authenticate interventions directed at systems improvements or clinical services All of the above is needed but the most important goal after a disaster and the one required for all of the above to be possible Is To Stimulate Human Decency To add focus to our natural impulse to reach out & help To build a lasting relationship where at first there was only infatuation
37 THANK YOU
38 Acknowledgements FDNY Rescue/Recovery Workers Weiden Lab - NYU Anna Nolan Soo-Jung Cho Jun Tsukiji Sophia Kwon Ashley Comfort Leopoldo Segal Environ Med. - NYU Lung-Chi Chen Mitchell Cohen Terry Gordon FDNY - AECOM David Prezant Tom Aldrich Mayris Webber Rachel Zeig-Owens Theresa Schwartz Charles Hall Hillel Cohen & co-workers Tel-Aviv Sourasky Medical Ctr Elizabeth Fireman WTC Health Ctr - HHC William Rom Joan Reibman Linda Rogers Angeliki Kazeros Denise Harrison Meredith Turetz
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