Dena M. Bravata, M.D., M.S. Policy Analysis MS&E 290 Bioterrorism: The Use of Information Technologies and Decision Support Systems

Case Presentation: Day 1 (11/16) Ottilie Lundgren, a 94 year old widow, living in Oxford, Connecticut presented with a 3-day history of fever, cough, and myalgias. Her physical examination showed an elderly woman with a fever (102.3F), elevated heart rate (118). Her chest x-ray and initial laboratory tests were all negative. She was admitted to the hospital for dehydration and an infection of the kidney tract.

Case Presentation: Days 2-4 Hospital Day 2-3 (11/17-11/18) Labs: Bacteria found in her blood and urine but not yet identified Mrs. Lundgren had progressive respiratory distress and confusion. Repeat CXR: fluid around the left lung with the suggestion of pneumonia Hospital Day 4 (11/19) A sample of fluid from around lung taken for culture. The Connecticut Department of Public Health was notified by the hospital laboratory of blood culture results

Case Presentation: Day 5-6 Hospital Day 5 (11/19) She was transferred to ICU on a ventilator Blood culture isolates identified as Bacillus anthracis at the State public health laboratory Hospital Day 6 (11/21) CDC confirms blood culture isolates as B. anthracis, molecular typing and susceptibility patterns identical to recent cases Ottilie Lundgren’s condition continued to deteriorate and she died.

Current Cases of Bioterrorism-related Anthrax ConfirmedSuspected Cutaneous75 Inhalational10 * 0 Total175 * 4 Deaths associated with inhalational anthrax

Biothreat Agents Variola major (smallpox) Bacillus anthracis (anthrax) Yersinia pestis (plague) Clostridium botulinum toxin (botulism) Francisella tularensis (tularemia) Filoviruses (Ebola hemorrhagic fever and Marburg hemorrhagic fever) Arenaviruses (Lassa fever, Junin/Argentine hemorrhagic fever) and related viruses

The Project The objective of our project was to synthesize the evidence on information technologies and decision support systems (IT/DSSs) that may serve the information needs of clinicians and public health officials in the event of a bioterrorist attack.

Methodologic Challenges of this Project Conceptualizing the problem –Complex topic, no single effect size Finding the literature –Not limited to peer-reviewed medical literature –Government documents –Web-based sources Evaluating the quality of the evidence –No single, published quality scale relevant

The Methodologic Approach Identify key research questions Develop a conceptual model Define the tasks IT/DSSs must perform to meet the information needs of clinicians and public health officials Perform literature searches Evaluate the evidence

The Method Identify key research questions Develop a conceptual model Define the tasks IT/DSSs must perform to meet the information needs of clinicians and public health officials Perform literature searches Evaluate the evidence

5 Key Questions What are the information needs of clinicians and public health officials in the event of a bioterrorist attack? What are the criteria by which IT/DSS should be evaluated for usefulness in a bioterrorist event? What IT/DSSs are available for detection and diagnosis, management, surveillance, and communication?

5 Key Questions Continued What is the quality of the evidence about IT/DSS usefulness? If no existing IT/DSSs meet the information needs of clinicians and public health officials, what considerations are important in the design of future IT/DSSs to support response to bioterrorism events?

The Method Identify key research questions Develop a conceptual model Define the tasks IT/DSSs must perform to meet the information needs of clinicians and public health officials Perform literature searches Evaluate the evidence

Structure of the Conceptual Framework Time period: 1 Decision maker: Clinicians Events: associated with the initial cases Time period: 2 Decision maker: Public health officials Events: associated with the initial cases Time period: 3 Decision maker: Clinicians Events: associated with subsequent cases

Diagram of the Conceptual Framework Outbreak Investigation Surveillance Alert Epidemiologic Control Surveillance Report Diagnosis Management Prevention Report Exposure Test Result Susceptible Infection Status (unobserved) Lives Saved Clinical Syndrome Diagnosis Management Prevention Report Exposure Test Result Susceptible Infection Status (unobserved) Clinical Syndrome Surveillance Alert Lives Saved Time period 2Time period 3Time period 1

Healthcare provider Reports Outbreak Investigation Surveillance Alert Epidemiologic Control Surveillance Report Detector Data School/Work Absenteeism Data Hospital Discharge Data EMT Data Pharmacy Sales Data Coroner Reports Veterinarian Reports Laboratory Reports Lives Saved Time period 2: Surveillance Systems Detect Potential Events Surveillance systems receive data from a variety of sources and provide reports to public health authorities. Foodborne Disease Reports

Role for Information Technologies and Decision Support Decisions marked in blue indicate those that can be affected by decision support systems and arrows marked in blue indicate processes in which information technologies could play a role. Outbreak Investigation Surveillance Alert Epidemiologic Control Surveillance Report Diagnosis Management Prevention Report Exposure Test Result Susceptible Infection Status (unobserved) Lives Saved Clinical Syndrome Diagnosis Management Prevention Report Exposure Test Result Susceptible Infection Status (unobserved) Clinical Syndrome Surveillance Alert Lives Saved

The Method Identify key research questions Develop a conceptual model Define the tasks IT/DSSs must perform to meet the information needs of clinicians and public health officials Perform literature searches Evaluate the evidence

Task Decomposition Formal framework for specifying, documenting, and evaluating the data that should be contained within the knowledge base of a DSS in order for it to serve its purpose. Literature review to define tasks: –U.S. Offensive weapons program –Known bioterrorist events –Tabletop exercises –Infectious disease outbreaks 5 Tasks –Surveillance –Diagnosis and detection –Management –Prevention –Communication

Example: Task Decomposition: Surveillance SubtaskKey ConceptsData Requirement Collect surveillance data Continual, timely collection of sensitive and specific data from multiple sources for early detection of a bioterrorist attack Environmental detectors Pharmacy sales data School & work absenteeism data Clinicians’ reports Laboratory reports Analyze surveillance data Timely analyses and presentation to public health decision makers Baseline information for each data source to calculate expected trends over time Threshold information for each data source to know when an outbreak has occurred

The Method Identify key research questions Develop a conceptual model Define the tasks IT/DSSs must perform to meet the information needs of clinicians and public health officials Perform literature searches Evaluate the evidence

Literature Searches Literature Sources –Peer-reviewed articles and government documents from databases Medline, GrayLit, National Technical Information Service, Catalog of U.S. Government Publications –Government documents from websites –Web-based information Search Strategies –Professional librarians for peer-reviewed and government documents –Copernic 2001 metasearch engine for web-based information Search Terms: same for our Government document and Copernic searches

The Method Identify key research questions Develop a conceptual model Define the tasks IT/DSSs must perform to meet the information needs of clinicians and public health officials Perform literature searches Evaluate the evidence

Results of Literature Searches Reviewed 16,751 citations and 8,620 websites 251 articles and 41 websites met inclusion criteria Double abstractions (blinded to study author) for all peer-reviewed articles and single abstractions for web-based information Total of 204 systems –52 detection systems –23 diagnostic systems –14 management systems –88 surveillance systems –27 communication systems –7 systems that integrate surveillance, communication, and command and control functions.

Results Generally: few clinically evaluated systems No IT/DSSs for Diagnosis or Management have been developed specifically for bioterrorism Systems for Detection, Surveillance, and Communication have been developed for bioterrorism –Some show considerable promise but almost none has been evaluated for its sensitivity, specificity, or timeliness

Results Detection Systems General Diagnostic Systems Management Systems Surveillance Systems Communication Systems

Results Detection Systems General Diagnostic Systems Management Systems Surveillance Systems Communication Systems

Detection Systems: Overview Developed for Military need to be adapted to civilian use Promising projects include: –PROTECT (Program for the Response Options and Technology Enhancements for Chemical/Biological Terrorism) Detectors set up in subways, airports, government buildings Developing methods for signal-noise-processing –LEADERS (Lightweight Epidemiology and Advanced Detection and Emergency Response System) Integrates detector data with other surveillance data Particularly for event-based surveillance

Detection Systems: collection and identification BioThreatAlert (BTA) Strips Antigen/Antibody system available for a limited number of agents Sensitivity and Specificity not evaluated Used by first responders or clinicians BioCapture TM Only collection system clinically evaluated % collection efficiency of other devices Used by first responders Conclusions: Systems have not been clinically evaluated, sensitivity and specificity poorly characterized, can only test one sample at a time, tests not available for many worrisome agents (e.g., smallpox)

Results Detection Systems General Diagnostic Systems Management Systems Surveillance Systems Communication Systems

General Diagnostic Systems: Overview Purpose: Clinician enters patient information (usually manually) and system provides a differential diagnosis Examples: DXplain, Iliad, QMR (newer handheld versions now available) Clinical evaluations: the differential diagnoses provided are highly dependent on descriptors entered Conclusions: Have rarely been shown to improve patient outcomes in general, none has been evaluated for diagnostic capability for bioterrorism-related diseases

Results Detection Systems General Diagnostic Systems Management Systems Surveillance Systems Communication Systems

Management Systems: Overview Generally: Depend on electronic medical record to derive patient-specific recommendations Most commonly for antibiotic recommendations for hospitalized patients

Management Systems Example: HELP system at LDS hospital in Salt Lake City –When patients present to the ED, HELP’s databases are queried every 10 minutes for any new clinical information on the patient. Uses this information to calculate the probability of pneumonia. –Specificity 92%, PPV 15.1%, NPV 99.9% Conclusions: No evidence for their usefulness in a bioterrorist event; would have to incorporate new guidelines for biothreat agent diagnosis and management; typically require EMR.

Results Detection Systems General Diagnostic Systems Management Systems Surveillance Systems Communication Systems

Data Sources for Biosurveillance School & Work Absenteeism Phone Triage Nurses Pharmacies (OTC) Environmental detectors Sentinel Physicians Pharmacies (Rx) Emergency Department 911 Calls Laboratory Hospital admissions & discharge Earlier Detection Data Later Detection Data

Surveillance Systems Syndromal surveillance reports (7) Reports from clinicians (6) Influenza-related data (10) Systems for laboratory and antimicrobial resistance data (23) Systems for nosocomial infections (15) Food-borne illnesses (10) Zoonotic illnesses (5) Other types of surveillance data (12)

Syndromal Surveillance Syndromes associated with biothreat agents –Flu-like illness –Acute respiratory distress –Gastrointestinal symptoms –Febrile, hemorrhagic syndromes –Fever and rash –Fever and mental status change

HealthBuddy ®

ESSENCE

Integrated Systems Data Analysis and Presentation

Results Detection Systems General Diagnostic Systems Management Systems Surveillance Systems Communication Systems

Communication Systems: Overview systems for communication between patients and clinicians Web-based secure networks linking branches of the public health Radio/Microwave-based systems for linking emergency personnel in the field with EDs Alert systems to notify clinicians of abnormal laboratory tests

Communication Systems for Bioterrorism Local Public Health

Communication Systems for Bioterrorism CDC State Public Health Local Public Health WHO

Communication Systems for Bioterrorism CDC State Public Health HazMat Police Local Public Health Fire Pharmacies Coroner & Medical Examiner Laboratories Clinicians The Public The Media Schools Zoo Food Inspectors Hospitals & Nursing Facilities WHO FBI

CDC State Public Health HazMat Police Local Public Health Fire Pharmacies Coroner & Medical Examiner Laboratories Clinicians The Public The Media Schools Zoo Food Inspectors Hospitals & Nursing Facilities WHO FBI * * * * * * * * * Communication Systems for Bioterrorism

CDC State Public Health HazMat Police Local Public Health Fire Pharmacies Coroner & Medical Examiner Laboratories Clinicians The Public The Media Schools Zoo Food Inspectors Hospitals & Nursing Facilities WHO FBI * * * * * * * * S S S S * Communication Systems for Bioterrorism

CDC State Public Health HazMat Police Local Public Health Fire Pharmacies Coroner & Medical Examiner Laboratories Clinicians The Public The Media Schools Zoo Food Inspectors Hospitals & Nursing Facilities WHO FBI * * * * * * * * S S S S * Communication Systems for Bioterrorism

Conclusions Overall: IT/DSSs have not be subjected to critical evaluations Detection Systems: –Rapid –Portable –Sensitive and Specific –Can test for more of the worrisome biothreat agents General Diagnostic Systems: – Link to EMR Management systems: –Utilize available bioterrorism guidelines Surveillance systems: – Greater integration – Early warning data – Methods for the determination for what constitutes an outbreak Communication systems: – Single system for public health officers at various levels – Public health  media

Future analysis Models of natural history of disease processes of biothreat agents Cost-effectiveness analyses of surveillance systems using different sources of data Cost-effectiveness of prevention and management strategies for the most worrisome biothreat agents Analyses of the adequacies of current capacity of hospitals, law-enforcement, and public health to respond to a bioterrorist attack.

Collaborators Douglas K. Owens Kathryn McDonald Wendy Smith Chara Rydzak Herbert Szeto Corinna Haberland David Buckeridge Mark Schleinitz Dean Wilkening Mark Musen Bahman Nouri Bradford W. Duncan Mariana B. Dangiolo Hau Liu Scott Shofer Justin Graham Sheryl Davies