Method for creating and using a treatment protocol

• US 7,461,046 B2
• Filed: 02/07/2003
• Issued: 12/02/2008
• Est. Priority Date: 02/07/2002
• Status: Expired due to Fees

• Current Assignee: University of Utah Research Foundation (State of Utah)
• Original Assignee: University of Utah Research Foundation (State of Utah)
• Inventors: Christenson, John C., Pavia, Andrew T., Byington, Carrie L.
• Primary Examiner(s): Holmes; Michael B
• Application Number:
  US10/503,033
• Publication Number:
  US 20060155663A1
• Time in Patent Office: 2,125 Days
• Field of Search: 706/47
• US Class Current: 706/62
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16H 70/00 ICT specially adapted for the handling or processing of medical references
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

Systems, devices, methods, and software are provided that are suitable for use in the creation, implementation, use and/or refinement of treatment protocols. The software is configured for use in a client-server environment where the server communicates with client devices such as PDAs, laptops, tablets, or desktop computers. The software is directed to programming for basing an assessment of risk of bacterial infection in a subject on the presence, or lack, of viral illness in that subject. The diagnosis of viral illness is made through the use of results obtained from an enterovirus polymerase chain reaction test or a direct fluorescent assay test for respiratory viruses. Such test data, in conjunction with ‘time to positivity’ data for urine, blood, cerebrospinal fluid, or other cultures, is then processed by the software to assess the individual risk of occurrence of various conditions, such as bacterial infection, in a particular subject.

Claims

1. A method for performing a risk assessment concerning a subject, the method being implemented in connection with a computing environment having a database associated therewith, and the method comprising:

receiving results of a viral diagnostic test;

receiving a status of a culture for identifying the existence or absence of at least one bacterial pathogen;

receiving results of a clinical analysis;

determining a risk of occurrence, in the subject, of a particular condition of interest, the risk determination being based at least in part upon;

results of the viral diagnostic test;

the clinical analysis; and

, the status of the culture for identifying the existence or absence of at least one bacterial pathogen; and

correlating the risk of occurence of the particular condition with at least one action.

2. The method as recited in claim 1, wherein receiving results of a viral diagnostic test comprises receiving results from one of the following tests:

EV PCR, and DFA.

3. The method as recited in claim 1, wherein the status of the culture is received on a periodic basis.

4. The method as recited in claim 1, wherein the risk determination is made on a periodic basis.

5. The method as recited in claim 1, wherein receiving results of a clinical analysis comprises receiving results of at least one Rochester criterion.

6. The method as recited in claim 1, further comprising receiving a status of at least one of:

hydration, and band count of the subject.

7. The method as recited in claim 1, wherein determining a risk of occurrence, in the subject, of a particular condition of interest comprises determining the risk of serious bacterial infection in the subject.

8. The method as recited in claim 1, further comprising generating an alert when culture status or test results are received.

9. The method as recited in claim 1, further comprising uploading test results and culture status to the database.

10. The method as recited in claim 1, further comprising uploading the determined risk of occurrence to the database.

11. A computer program product for implementing a method for performing a risk assessment concerning a subject, the computer program product being suitable for use in connection with a computing environment having a database associated therewith, and the computer program product comprising:

a computer readable medium carrying computer executable instructions for performing the method, wherein the method comprises;

receiving results of a viral diagnostic test;

receiving a status of a culture for identifying the existence or absence of at least one bacterial pathogen;

receiving results of clinical analysis; and

determining a risk of occurrence, in the subject, of a particular condition of interest, the risk determination being based at least in part upon;

results of the viral diagnostic test;

the clinical analysis; and

, the status of the culture for identifying the existence or absence of at least one bacterial pathogen; and

correlating the risk of occurence of the particular condition with at least one action.

12. The computer program product as recited in claim 11, wherein receiving results of a viral diagnostic test comprises receiving results from one of the following tests:

EV PCR, and DFA.

13. The computer program product as recited in claim 11, wherein the status of the culture is received on a periodic basis.

14. The computer program product as recited in claim 11, wherein the risk determination is made on a periodic basis.

15. The computer program product as recited in claim 11, wherein receiving results of a clinical analysis comprises receiving results of at least one Rochester criterion.

16. The computer program product as recited in claim 11, further comprising receiving a status of at least one of:

hydration, and band count of the subject.

17. The computer program product as recited in claim 11, wherein determining a risk of occurrence, in the subject, of a particular condition of interest comprises determining the risk of serious bacterial infection in the subject.

18. The computer program product as recited in claim 11, further comprising generating an alert when culture status or test results are received.

19. The computer program product as recited in claim 11, further comprising uploading test results and culture status to the database.

20. The computer program product as recited in claim 11, further comprising uploading the determined risk of occurrence to the database.

21. A method for performing a risk assessment concerning a subject, the method being implemented in connection with a client-server computing environment, and the method comprising:

receiving results of a viral diagnostic test selected from the group consisting of;

EV PCR, and DFA;

receiving results of a clinical analysis;

receiving a status of at least one of;

hydration, band count, and a culture for identifying the existence or absence of at least one bacterial pathogen; and

determining a risk of occurrence, in the subject, of a particular condition of interest, the risk determination being based at least in part upon;

results of the viral diagnostic test;

the clinical analysis; and

, the status of one or more of the hydration, band count, and culture for identifying the existence or absence of at least one bacterial pathogen.

22. The method as recited in claim 21, wherein receiving results of a viral diagnostic test comprises receiving results of a viral diagnostic test for at least one of:

enterovirus, RSV, Influenza A, Influenza B, parainfluenza 1, parainfluenza 2, parainfluenza 3, adenovirus, HHV 6, and rhinovirus.

23. The method as recited in claim 21, wherein receiving a status concerning a culture for identifying the existence or absence of at least one bacterial pathogen comprises receiving status of a culture for identifying a Gram-negative bacterial pathogen.

24. The method as recited in claim 21, wherein receiving a status concerning a culture for identifying the existence or absence of at least one bacterial pathogen comprises receiving status of at least one of:

a blood culture for identifying at least one bacterial pathogen;

a urine culture for identifying at least one bacterial pathogen; and

a cerebrospinal fluid culture for identifying at least one bacterial pathogen.

25. The method as recited in claim 21, further comprising correlating the risk of occurrence of the particular condition with at least one action.

26. The method as recited in claim 21, wherein receiving results of a clinical analysis comprises receiving results of at least one Rochester criterion.

27. A computer program product for implementing a method for performing a risk assessment concerning a subject, the computer program product comprising:

a computer readable medium carrying computer executable instructions for performing the method, wherein the method comprises;

receiving results of a viral diagnostic test selected from the group consisting of;

EV PCR, and DFA;

receiving results of a clinical analysis;

receiving a status of at least one of;

hydration, band count, and a culture for identifying the existence or absence of at least one bacterial pathogen; and

determining a risk of occurrence, in the subject, of a particular condition of interest, the risk determination being based at least in part upon;

results of the viral diagnostic test;

the clinical analysis; and

, the status of one or more of the hydration, band count, and culture for identifying the existence or absence of at least one bacterial pathogen.

28. The computer program product as recited in claim 27, wherein receiving results of a viral diagnostic test comprises receiving results of a viral diagnostic test for at least one of:

enterovirus, RSV, Influenza A, Influenza B, parainfluenza 1, parainfluenza 2, parainfluenza 3, adenovirus, HHV 6, and rhinovirus.

29. The computer program product as recited in claim 27, wherein receiving a status concerning a culture for identifying the existence or absence of at least one bacterial pathogen comprises receiving status of a culture for identifying a Gram-negative bacterial pathogen.

30. The computer program product as recited in claim 27, wherein receiving a status concerning a culture for identifying the existence or absence of at least one bacterial pathogen comprises receiving status of at least one of:

a blood culture for identifying at least one bacterial pathogen;

a urine culture for identifying at least one bacterial pathogen; and

a cerebrospinal fluid culture for identifying at least one bacterial pathogen.

31. The computer program product as recited in claim 27, further comprising correlating the risk of occurrence of the particular condition with at least one action.

32. The computer program product as recited in claim 27, wherein receiving results of a clinical analysis comprises receiving results of at least one Rochester criterion.

33. A method for performing a risk assessment concerning a subject, the method being implemented in connection with a client-server computing environment, and the method comprising:

receiving results of a DFA viral diagnostic test that tests for at least one of;

enterovirus, RSV, Influenza A, Influenza B, parainfluenza 1, parainfluenza 2, parainfluenza 3, adenovirus, HHV 6, and rhinovirus;

receiving results of a Rochester criteria analysis;

receiving a status of at least one of;

hydration, band count, a blood culture for identifying the existence or absence of at least one bacterial pathogen, a urine culture for identifying the existence or absence of at least one bacterial pathogen, and a cerebrospinal fluid culture for identifying the existence or absence of at least one bacterial pathogen; and

calculating a risk of occurrence, in the subject, of a bacterial infection, using;

results of the DFA viral diagnostic test;

the Rochester criteria analysis; and

, the status of at least one of said blood, urine, and cerebrospinal fluid cultures, hydration, and band count.

34. The method as recited in claim 33, further comprising transmitting the risk of occurrence to a client device.

35. The method as recited in claim 33, further comprising correlating the risk of occurrence of the particular condition with at least one action.

36. A computer program product for implementing a method for performing a risk assessment concerning a subject, the computer program product being suitable for use in connection with a client-server computing environment, and the computer program product comprising:

a computer readable medium carrying computer executable instructions for performing the method, wherein the method comprises;

receiving results of a DFA viral diagnostic test that tests for at least one of;

RSV, Influenza A, Influenza B, parainfluenza 1, parainfluenza 2, parainfluenza 3, adenovirus, HHV 6, and rhinovirus;

receiving results of a Rochester criteria analysis;

receiving a status of at least one of;

hydration, band count, a blood culture for identifying the existence or absence of at least one bacterial pathogen, a urine culture for identifying the existence or absence of at least one bacterial pathogen, and a cerebrospinal fluid culture for identifying the existence or absence of at least one bacterial pathogen; and

calculating a risk of occurrence, in the subject, of a bacterial infection, using;

results of the DFA viral diagnostic test;

the Rochester criteria analysis; and

, the status of at least one of said blood, urine, and cerebrospinal fluid cultures, hydration, and band count.

37. The computer program product as recited in claim 36, further comprising transmitting the risk of occurrence to a client device.

38. The computer program product as recited in claim 36, further comprising correlating the risk of occurrence of the particular condition with at least one action.

39. A method for calculating a risk that a particular condition will occur in a subject, the method being implemented in connection with a client-server environment having a database associated therewith, the database including viral illness data and bacterial culture data for a plurality of subjects, and the method comprising:

determining, from the viral illness data of the database, a risk R1 of bacteremia in any given subject testing positive for a viral illness;

determining, from the bacterial culture data of the database, a risk R2 of a bacterial culture becoming positive for a specified pathogen after a predetermined time period; and

calculating, by multiplying risks R1 and R2 together, a risk R3 of bacteremia in any given subject testing positive for a viral illness and having a negative bacterial culture after expiration of the predetermined time period.

40. The method as recited in claim 39, further comprising transmitting the risk of bacteremia to a client device.

41. The method as recited in claim 39, further comprising correlating the risk of bacteremia with at least one action.

42. A computer program product for implementing a method for performing a risk assessment concerning a subject, the computer program product being configured to receive data from a database that includes viral illness data and bacterial culture data for a plurality of subjects, the computer program product comprising:

a computer readable medium carrying computer executable instructions for performing the method, wherein the method comprises;

determining, from the viral illness data of the database, a risk R1 of bacteremia in any given subject testing positive for a viral illness;

determining, from the bacterial culture data of the database, a risk R2 of a bacterial culture becoming positive for a specified pathogen after a predetermined time period; and

calculating, by multiplying risks R1 and R2 together, a risk R3 of bacteremia in any given subject testing positive for a viral illness and having a negative bacterial culture after expiration of the predetermined time period.

43. The computer program product as recited in claim 42, further comprising transmitting the risk of bacteremia to a client device.

44. The computer program product as recited in claim 42, further comprising correlating the risk of bacteremia with at least one action.

45. A method for facilitating development of a treatment protocol, the method being implemented in connection with a computing environment having a database associated therewith that includes viral illness data and bacterial culture data for a plurality of subjects, the method comprising:

accessing viral infection test results from the viral illness data, the viral infection test results including at least one of an EV PCR and DFA test result for each of the plurality of subjects;

accessing time to positivity data from the bacterial culture data, the time to positivity data including the results of at least one of a urine, blood, and CSF culture for each of the plurality of subjects;

statistically analyzing the accessed viral infection test results and the accessed time to positivity data to identify the occurrence of viral infections and the occurrence bacterial infections in the plurality of subjects;

assessing, based upon the statistical analysis, the risk of a subject that has a viral illness also having a concomitant bacterial illness; and

using the risk assessment to define a rule suitable for use as part of the treatment protocol for treating subsequent subjects at risk for bacterial infection.

46. The method as recited in claim 45, wherein statistically analyzing the accessed viral infection test results and the accessed time to positivity data comprise using Bayesian analysis techniques.

47. A computer program product for use in a computer system, the computer program product for implementing a method for facilitating development of a treatment protocol, the computer program product being configured to receive data from a database that includes viral illness data and bacterial culture data for a plurality of subjects, and the computer program product comprising:

a recordable-type computer readable medium carrying computer executable instructions that, when executed at a processor, cause the computer system to perform the method, including the following;

accessing viral infection test results from the viral illness data, the viral infection test results including at least one of an EV PCR and DFA test result for each of the plurality of subjects;

accessing time to positivity data from the bacterial culture data, the time to positivity data including the results of at least one of a urine, blood, and CSF culture for each of the plurality of subjects;

statistically analyzing the accessed viral infection test results and the accessed time to positivity data to identify the occurrence of viral infections and the occurrence bacterial infections in the plurality of subjects;

assessing, based upon the statistical analysis, the risk of a subject that has a viral illness also having a concomitant bacterial illness; and

using the risk assessment to define a rule suitable for use as part of the treatment protocol for treating subsequent subjects at risk for bacterial infection.

48. The computer program product as recited in claim 47, wherein statistically analyzing the accessed viral infection test results and the accessed time to positivity data comprise using Bayesian analysis techniques.

49. In a computing environment having a database associated therewith, a method for refining an assessment of risk for bacterial infection in a febrile infant as medical information for the febrile infant becomes available, the method comprising:

an act of accessing Rochester criteria data including historical data and physical examination data corresponding to a febrile infant;

an act of assessing a risk of occurrence of a bacterial infection in the febrile infant based on the historical data and physical examination data;

an act of accessing Rochester criteria data including laboratory result data corresponding to the febrile infant subsequent to accessing the Rochester criteria data including the historical data and the physical examination data;

an act of re-assessing the risk of occurrence of a bacterial infection in the febrile infant based on the laboratory result data in combination with the historical data and the physical examination data;

an act of accessing viral diagnostic test result data corresponding to the febrile infant subsequent to accessing the Rochester criteria data including the laboratory result data;

an act of re-assessing the risk of occurrence of a bacterial infection in the febrile infant based on the viral diagnostic test result data in combination with the laboratory result data, the historical data, and the physical examination data;

an act of accessing bacterial culture result data corresponding to the febrile infant subsequent to accessing the viral diagnostic test result data; and

an act of re-assessing the risk of occurrence of a bacterial infection in the febrile infant based on the bacterial culture result data in combination with the viral diagnostic result data, the laboratory result data, the historical data, and the physical examination data.

50. The method as recited in claim 49, wherein the act of accessing Rochester criteria data including historical data and physical examination data corresponding to a febrile infant comprises an act accessing one or more of history of prematurity and history of chronic illness corresponding to the febrile infant.

51. The method as recited in claim 50, wherein the act of assessing a risk of occurrence of a bacterial infection in the febrile infant based on the historical data and physical examination data comprises an act of assessing the risk of occurrence of a bacterial infection in the febrile infant based on one or more the history of prematurity and the history of chronic illness corresponding to the febrile infant.

52. The method as recited in claim 51, wherein the act of an act of accessing Rochester criteria data including laboratory result data corresponding to the febrile infant comprises an act accessing one or more of a white blood cell count, a band count, and urinalysis result data.

53. The method as recited in claim 52, wherein the act accessing one or more of a white blood cell count, a band count, and urinalysis result data comprises an act of accessing a white blood cell count that is one of less than 5,000/mm³ or more than 15,000/mm³;

and

wherein the act of re-assessing the risk of occurrence of a bacterial infection in the febrile infant based on the laboratory result data in combination with the historical data and the physical examination data comprises an act of determining that the febrile infant is at increased risk for bacterial infection based on the white blood cell count.

54. The method as recited in claim 52, wherein the act accessing one or more of a white blood cell count, a band count, and urinalysis result data comprises an act of accessing a band count that less than 1,500 bands/mm³;

and

wherein the act of re-assessing the risk of occurrence of a bacterial infection in the febrile infant based on the laboratory result data in combination with the historical data and the physical examination data comprises further comprises an act of determining that the febrile infant is at increased risk for bacterial infection based on the band count.

55. The method as recited in claim 52, wherein the act accessing one or more of a white blood cell count, a band count, and urinalysis result data comprises an act of accessing urinalysis result data indicative of more than 10 white blood cells/hpf;

and

wherein the act of re-assessing the risk of occurrence of a bacterial infection in the febrile infant based on the laboratory result data in combination with the historical data and the physical examination data comprises further comprises an act of determining that the febrile infant is at increased risk for bacterial infection based on urinalysis result data.

56. The method as recited in claim 49, wherein the act of accessing viral diagnostic test result data corresponding to the febrile infant subsequent to accessing the Rochester criteria data including the laboratory result data comprises an act of accessing viral diagnostic test result data indicative of the febrile infant having a viral infection.

57. The method as recited in claim 56, wherein the act of accessing viral diagnostic test result data indicative of the febrile infant having a viral infection comprises an act of accessing viral diagnostic data indicative of the febrile infant being infected with a virus selected from among RSV, Influenza A, Influenza B, parainfluenza 1, parainfluenza 2, parainfluenza 3, adenovirus, HHV 6, and rhinovirus.

58. The method as recited in claim 56, wherein the act of re-assessing the risk of occurrence of a bacterial infection in the febrile infant based on the viral diagnostic test result data in combination with the laboratory result data, the historical data, and the physical examination data comprises an act of determining that the febrile infant is at reduced risk for bacterial infection based on the viral diagnostic test result data indicating that the febrile infant has a viral infection.

59. A computer program product for use in a computing environment having a database associated therewith, the computer program product for implementing a method for refining an assessment of risk for bacterial infection in a febrile infant as medical information for the febrile infant becomes available, the computer program product comprising one or more computer-readable media have stored thereon computer-executable instructions that, when executed at a processor, cause the computing environment to perform the method including the following:

access Rochester criteria data including historical data and physical examination data corresponding to a febrile infant;

assess a risk of occurrence of a bacterial infection in the febrile infant based on the historical data and physical examination data;

access Rochester criteria data including laboratory result data corresponding to the febrile infant subsequent to accessing the Rochester criteria data including the historical data and the physical examination data;

re-assess the risk of occurrence of a bacterial infection in the febrile infant based on the laboratory result data in combination with the historical data and the physical examination data;

access viral diagnostic test result data corresponding to the febrile infant subsequent to accessing the Rochester criteria data including the laboratory result data;

re-assess the risk of occurrence of a bacterial infection in the febrile infant based on the viral diagnostic test result data in combination with the laboratory result data, the historical data, and the physical examination data;

access bacterial culture result data corresponding to the febrile infant subsequent to accessing the viral diagnostic test result data; and

re-assess the risk of occurrence of a bacterial infection in the febrile infant based on the bacterial culture result data in combination with the viral diagnostic result data, the laboratory result data, the historical data, and the physical examination data.