Bioterrorism: The Use of Information Technologies and Decision Support Systems

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

2. 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.

3. 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

4. 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.

5. Current Cases of Bioterrorism-related Anthrax * 4 Deaths associated with inhalational anthrax

6. 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

7. 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.

8. 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

9. 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

10. 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

11. 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?

12. 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?

13. 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

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

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

16. 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 Healthcare provider Reports Veterinarian Reports Coroner Reports Laboratory Reports Surveillance Report Epidemiologic Control Detector Data Lives Saved Outbreak Investigation Surveillance Alert School/Work Absenteeism Data Pharmacy Sales Data Hospital Discharge Data EMT Data

17. Role for Information Technologies and Decision Support Exposure Exposure Infection Status (unobserved) Infection Status (unobserved) Clinical Syndrome Clinical Syndrome Surveillance Alert Susceptible Susceptible Diagnosis Diagnosis Test Result Test Result Lives Saved Lives Saved Management Management Prevention Prevention Report Report Surveillance Report Epidemiologic Control Outbreak Investigation Surveillance Alert 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.

18. 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

19. 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

20. Example: Task Decomposition: Surveillance

21. 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

22. 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

23. 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

24. 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.

25. 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

26. Results • Detection Systems • General Diagnostic Systems • Management Systems • Surveillance Systems • Communication Systems

27. Results • Detection Systems • General Diagnostic Systems • Management Systems • Surveillance Systems • Communication Systems

28. 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

29. Detection Systems: collection and identification • BioCaptureTM • Only collection system clinically evaluated • 50-125% collection efficiency of other devices • Used by first responders • BioThreatAlert (BTA) Strips • Antigen/Antibody system available for a limited number of agents • Sensitivity and Specificity not evaluated • Used by first responders or clinicians 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)

30. Results • Detection Systems • General Diagnostic Systems • Management Systems • Surveillance Systems • Communication Systems

31. 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

32. Results • Detection Systems • General Diagnostic Systems • Management Systems • Surveillance Systems • Communication Systems

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

34. 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.

35. Results • Detection Systems • General Diagnostic Systems • Management Systems • Surveillance Systems • Communication Systems

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

37. 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)

38. 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

39. HealthBuddy®

40. ESSENCE

41. Integrated Systems Data Analysis and Presentation

42. Results • Detection Systems • General Diagnostic Systems • Management Systems • Surveillance Systems • Communication Systems

43. Communication Systems: Overview • Email 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

44. Communication Systems for Bioterrorism Local Public Health

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

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

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

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

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

50. 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