WO2002019246A2

WO2002019246A2 - Early warning outbreak and recognition system

Info

Publication number: WO2002019246A2
Application number: PCT/US2001/027044
Authority: WO
Inventors: Andrew Lee Corwin; James R. Campbell; Ria Purwita Larasati; Maidy Pranata Putri; Cyrus H. Simanjuntak
Original assignee: The Government Of The United States Of America, As Represented By The Secretary Of The Navy
Priority date: 2000-09-01
Filing date: 2001-08-31
Publication date: 2002-03-07
Also published as: AU2001288551A1; WO2002019246A3

Abstract

The present invention relates to a computer-based system and method for aiding in the collection of synchromic data for making area-specific and regional comparisons for trend analysis of the syndromic data to target early warning outbreak recognition of infectious diseases. The system has 'real-time' capability which provides for periodic transfer of the syndromic data, for example, on a daily, weekly or monthly basis, form one or more local sites to a host site. The day-to-day analysis of the syndromic data is used to assist in dectecting a suspected infectious disease outbreak. A more detailed analysis is used to confirm the suspected infectious disease outbreak.

Description

EARLY WARNING OUTBREAK AND RECOGNITION SYSTEM

of which the following is a specification for a PCT Patent Application:

Related Application This application claims benefit of U.S. Provisional Application Ser. No. 60/229,286 filed September 1, 2000.

Background of the Invention

1. Field of the Invention

The invention relates generally to a computer-based system and method for aiding in the collection of standardized medical data and in particular, for making area-specific and regional comparisons for trend analysis of the standardized data to target early warning outbreak recognition of infectious diseases.

2. Description of the Prior Art

Heretofore, there has been a technology gap in regional surveillance capabilities for targeting early warning outbreak of infectious diseases and their trends. In Indonesia, for example, against a background of limited disease reporting particularly for outbreak response purposes, newspaper account suggestive of epidemic disease transmission often provide a principal source of information from which initial outbreak response activities are investigated. These conditions result in late reporting becoming the norm, thereby precluding reasonable investigation in identifying the outbreak. Thus, there is a need in the prior art to configure a surveillance and response system specifically targeting early warning outbreak recognition (EWORS) of infectious diseases and their trends.

The collection of disease data in the traditional fashion (ie. newspaper, refereed articles, etc.) is not useful for developing a trend analysis for any particular disease type. In many areas of the world, especially developing countries, this is the only form of disease measurement available. Thus, it has been difficult to differentiate outbreak vs. non- outbreak events. Analysis of trends is only possible when data are routinely obtained for comparison purposes using the same collection and reporting format. A well designed trend protocol provides a unique opportunity to describe changing patterns in epidemic transmission. Thus, there is a need in the prior art for developing a system for reliable baseline measurement of disease occurrences to better facilitate trend analysis.

Most outbreaks of disease in the developing world are recognized as previously mentioned long after an effective response *can be executed. Prior art surveillance efforts are generally slow and organizationally cumbersome and preclude validation of epidemic occurrence, identification of causative etiology, recognition of transmission determinants and appropriate public health intervention measures that include prevention containment. Therefore, there is a need in the prior art for real-time transfer of symptomatic data of infectious diseases to facilitate rapid response to outbreaks based on trend analysis.

Significant variability in clinical training, historical disease experience and staffing composition, in the absence of supportive laboratory diagnostics², characterizes the ! relatively "suspect" nature of presumptive disease reporting such as in the misdiagnosis of leptospirosis for hepatitis. The use of specific disease classification as a means of early warning outbreak recognition contradicts the premise that an epidemic occurrence has occurred despite the lack of correlation to a causative etiology. Outbreak response measures predicated on the wrong disease classification wastes scarce health resources and generates inappropriate intervention effort to retard the epidemic. Accordingly, there is a need in the prior art to provide a method of collecting syndromic conditions information to aid in developing infectious disease outbreak response measures by trend analysis of the data.

Sloane et al. (U.S. Patent 5,911,132) "Method Using Central Epidemiological

Database" is a method of using electronic data communications or an Internet link between the physician and one or more entities, such as a hospital, local lab, diagnostic center, pharmacy, Center for Disease Control database, a patient, or medical database service for the purpose of diagnosing and/or treating disease for a particular patient. One such entity contains an epidemiological database computer facility which collects epidemiological transaction records from physicians, hospitals and other institutions which have medical facilities, such as schools and large businesses. The method is intended to assist the clinician in the diagnosis and treatment of an individual's disease. The method relies quite necessarily on diagnostic not syndromic information which is warehoused and is available to the physician to aid in the diagnosis of a particular patient. The method of Sloane does not target early warning recognition of infectious outbreak conditions and does not aggregate the data representing many cases with like syndromic conditions. The patient's identifying information is essential in matching various data bases, with the expressed purpose of contributing to the clinical, presumptive diagnosis and treatment of the patient. Epidemiological study using database generated information is possible using the Sloane method; however, analysis is not a programmed function.

OBJECTS OF THE INVENTION

Accordingly, it is a principal object of this present invention to develop a' system for collecting standardized symptomatic data from a plurality of local hospital sites, (ie. hospitals), having local analysis capability, for transmission to a remote site (central hub) where said data from a plurality of sites can be analyzed to spot medical trends

Another object of the present invention is to develop a system to allow for real-time data collection and transfer that is specifically configured to detect early outbreak situations.

Yet another important object of the present invention is to develop a standardized system that uses syndromic rather than disease specific case detection in enhancing reporting reliability for more targeted and effective response type actions.

It is a corollary object of the present invention to configure the system and software to include a remote site computer and a local site computer that are each entirely menu driven and programmed for data entry and analysis functions so as to allow flexible, simple, easy and quick data interpretation through graphic presentation in an improved manner.

It is another corollary objective of the present invention to allow for analytical comparisons between many sites, without compromising the integrity and confidentiality of privileged hospital data. It is another corollary objective of the present invention to input data into computers at local sites, on a daily basis, and to individually transfer data to a remote computer/server located at a Regional Health Surveillance Authority in an improved manner.

SUMMARY OF THE INVENTION

The early warning outbreak recognition/responsesystem (E ORS) fills a technology gap in predetermined locations surveillance capabilities that targeted early warning outbreak recognition. The EWORS invention provides for timely and accurate dissemination of outbreak recognition. The EWORS invention provides for timely and accurate dissemination of outbreak information leading to effective intervention measures, including investigative and containment activities. The EWORS invention is designed as a complementary, rather than an alternative system for conventional surveillance methodologies.

The EWORS invention is predicated on same day transfer of information from local hospital sites to a host site for instant, menu driven analysis provided via screens generated by local and host site computer programs. The success of the EWORS invention is predicated on a prompt and appropriate response to suggestive outbreak findings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a view of the surveillance and response system (EWORS) for infectious diseases;

FIG.2 is a pictorial flowchart of symptomatic data from the local hospital site to the host site; FIG. 3 shows an EWORS syndromic data entry screen;

FIG.4 shows an EWORS syndromic data entry screen;

FIG. 5 shows an EWORS syndromic data analysis screen;

FIG. 6 shows an EWORS syndromic data analysis screen;

FIG. 7 shows an EWORS syndromic data graph parameter screen;

FIG. 8 shows an EWORS syndromic data graph screen;.

FIG. 9 shows an EWORS syndromic data map parameter screen;.

FIG. 10 shows an EWORS syndromic data cluster map screen;

FIG. 11 shows a pictorial diagram of the EWORS system according to the present invention to explain the operation of the invention;

FIG. 12 shows an EWORS data entry screen having an expanded list of signs and symptoms for EWORS site (hospital or other medical treatment facility) data collection purposes;

FIG. 13 shows an EWORS data enty screen shows an expanded list of signs and symptoms that will be reflected in additional analytical options for use in graphic interpretation;

FIG. 14 shows an EWORS- AID screen that provides more detailed interpretation of analysis (based on signs and symptoms) at EWORS (hospital or other medical treatment facility) site and HOST locations, to reflect possible (presumptive-disease specific) working diagnoses, the lower portion of the screen lists, for analytical purposes, specific diseases of possible outbreak potential that correspond with signs/symptoms, reported either singularly or in combination; FIG. 15 is a flowchart of an integrated process of outpatient admission at a medical treatment facility to data entry of the patient symptomatic/syndromic data from the local hospital site to the host site to trend analysis of the syndromic data to predict a suspected infectious disease outbreak;

FIG. 16 is a pictorial flowchart of an integrated process of outpatient admission at a medical treatment facility to data entry of the patient symptomatic/syndromic data from the local hospital site to the host site to trend analysis of the syndromic data to predict a suspected infectious disease outbreak;

FIG. 17 shows a representative EWORS patient record database.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Fig. 1 shows the early warning outbreak and response system (EWORS) 10. EWORS 10 comprises a plurality of local hospital sites 12 which are disposed in predetermined locations. A plurality of field hospital sites 14 may be associated with the local hospital sites 12 or they may be stand alone sites in highly remote areas. A host site 16 is operatively connected to a plurality of local hospital sites 12 and a plurality of field hospital sites 14 via a communication medium 18. For the purposes of this invention the communications medium 18 could be modem, internet, telephone, mail, or wireless means.

The plurality of local hospital sites 12 each comprises an operatively connected local hospital computer 22, a local hospital entry device 24, and a local hospital monitor 26. The plurality of field hospital sites 14 each comprises an operatively connected field hospital computer 28, a field hospital entry device 30, and a field hospital monitor. The single host site 16 comprises an operatively connected host computer 34, a host entry device 36, and a host monitor 38.

Fig.2 shows the flow of syndromic data from a local hospital site 12, which may comprise a pediatric clinic 40, internal medicine clinic, and emergency room 44. Syndromic data is data on a patient's signs or symptoms that can be used to determine a trend in such symptoms that would indicate an infectious disease outbreak. It should be understood by one of skill in the art that the local hospital site 12 could comprise a plurality of different clinics for any medical purpose where syndromic data could be collected. The arrow at 46 illustrates the syndromic data collected from any of the clinics of the local hospital Site 12 and is recorded on form containing a partial list of standardized syndromic systems represented by the block at 48. It will be understood by one of skill in the art that additional symptoms of interest could be added such as watery and blood diarrhea and general bleeding. The arrow at 50 depicts the input of the syndromic data to be displayed on the local hospital monitor 26 as directed by the local hospital computer program which has been installed in each local hospital computer 22 via communications medium 18 to the host computer 34 where screens are displayed on the host site monitor 38. More detail on the operation of this program will be discussed on in the "Statement of the Operation" Section. The arrow at 52 depicts the flow of data through mailing of diskettes or other communication media 18 to a Local Health Authority of a state or foreign government, as a matter of comity.

Fig. 3 shows a syndromic data entry screen 54, Fig, 4 shows a syndromic data entry screen 56, Fig. 5 shows a syndromic data entry screen 58, Fig. 6 shows a syndromic data entry screen 60 , Fig. 7 shows a syndromic data graph parameter screen 62 , Fig. 8 shows a syndromic data graph screen 64, Fig. 9 shows a syndromic data map parameter screen 66, Fig. 10 shows a syndromic data map cluster screen 68 through which standardized syndromic data is entered, transferred, received, and analyzed for suspected trends indicating an infectious disease outbreak. A more detailed description of the operation will be provided in the discussion of the pictorial flowchart in Fig.l 1.

Referring now to Figs. 3 and 11 concurrently, the syndromic data entry screen 54 of Fig. 3 is used to enter syndromic data by a user at Block 78 of Fig. 11. This syndromic data is collected at block 76 of Fig. 11 via an EWORS patient form, which lists the standardized symptoms. The syndromic data is entered at block 78 of Fig.11 into the local hospital computer 22 of Fig. 1. The syndromic data is subsequently transferred at block 80 of Fig. 11 from a plurality of local sites 12 to the host site 16, both of Fig. 1 via communications medium 18. For the purposes of this invention, the communications medium 18 may be modem, internet, telephone, or regular mail delivery. U.S. Provisional Patent Application Serial Number 60/229,286, which is expressly incorporated by reference herein, includes two distinct software programs for the operation of a Local Site computerand one for a Host computer on CD-Rom and a Users Manual describing the operation of the software. Referring to Fig. 1 , the remote and mobile field hospital sites 14 are operatively connected to the host site 16 via communications medium 18 which maybe any of the above means or by hand-held wireless communication means. The syndromic data retrieval screen 56 of Fig. 4 is used at the host site 16 to retrieve the data. Referring now to Figs. 4 and 11 concurrently, this retrieval of data occurs at Block 82 of Fig. 11.

The syndromic data analysis screen 58 of Fig. 5 is used to provide input as to how the data is to be treated and analyzed. The observed parameters could include one or more standardized symptoms by age range and sex. The syndromic data analysis screen 60 of Fig.6 is used to provide a range of time and the demographics over which the syndromic data is to be treated. The syndromic data graph parameter screen 62 of Fig.7 sets the parameters of the syndromic data graph screen 64 of Fig. 8, which shows a 5-month trend for coughs and colds. The data graph screen 64 depicts the male incidence of cases of coughs and colds as displayed by the red line on top. Females are depicted by the green line on the bottom of the graph. The syndromic data map parameter screen 66 of Fig. 9 depicts the signs and symptoms and the age range which may be used to display data on the syndromic data cluster map screen 68, Fig. 10. Screens 66 and 68 allow data to be analyzed and displayed by province and district and could be modified to indicate the region, county, or state of interest. Thus, a rapid, graphic geographical map cluster can be created based upon syndromic data treated using any of the standard parameters of interest. A cluster is an aggregation of cases in a given area over a particular period without regard to whether the number of cases is more than expected. This provides a useful tool in determining the frequency and distribution of symptoms and conditions, reported as syndromic data, which may constitute an outbreak of an infectious disease.

Referring concurrently to Fig. 11, screens 58-68 of Figs. 3-10, may be used in the daily analysis of trends at the host computer 34, as indicated in Block 84 of Fig. 11. FIG. 12 shows an EWORS data entry screen having an expanded list of signs and symptoms for EWORS site (hospital or other medical treatment facility) data collection purposes; FIG. 13 shows an EWORS data enty screen shows an expanded list of signs and symptoms that will be reflected in additional analytical options for use in graphic interpretation;

FIG. 14 shows an EWORS-AID screen that provides more detailed interpretation of analysis (based on signs and symptoms) at EWORS (hospital or other medical treatment facility) site and HOST locations, to reflect possible (presumptive-disease specific) working diagnoses, the lower portion of the screen lists, for analytical purposes, specific diseases of possible outbreak potential that correspond with signs/symptoms, reported either singularly or in combination;

FIG. 15 is a flowchart of an integrated process of outpatient admission at a medical treatment facility to data entry of the patient symptomatic/syndromic data from the local hospital site to the host site to trend analysis of the syndromic data to predict a suspected infectious disease outbreak;

FIG. 17 shows a representative EWORS patient record database.

In summary, the invention is a hospital- or medical treatment facility-based network of computerized linkages that provide surveillance for early detection of outbreaks of infectious diseases, by establishing trend information that distinguishes epidemic from endemic disease. The invention further provides standardized information, for example, by using a standardized EWORS form, over time for trend analysis of infectious diseases. By focusing initially on syndromic data rather than diagnostic data, the invention provides reliable data, as a care giver may not be adequately trained to provide an accurate medical diagnosis, while having sufficient training to provide an accurate medical description of a patient's symptoms. The invention also provides for real-time data relay and early recognition of possible outbreaks. Another significant feature of the invention is to provide for identification of outbreaks in both temporal and spatial clustering. An additional feature of the invention is to provide for rational interpretation of data into meaningful presentations.

In essence, the invention collects standardized data for making area-specific and regional comparisons. In the preferred embodiment, the invention is predicated on "same day" transfer of information from network hospitals to a central hub. The invention may be used to employ a syndromic approach in conjunction with a working diagnosis, which allows for reliable analysis of aggregate data to determine appropriate response measures. The invention relies on EWORS reporting to insure recognition of an incipient epidemic, by detecting similar signs and symptoms in the index and early cases associated with the same outbreak.

The invention has been described in regional or area-specific context. In fact, more than 150,000 case entries have resulted during two years of pilot implementation only in Indonesia. An indication of the utility and effectiveness of the software is the translation of the original Indonesian into English, Vietnamese, and Laotian. Use of the software has resulted in the recognition of five outbreak occurrences: two dengue outbreaks and two diarrheal outbreaks in Indonesia, as well as one possible febrile outbreak in Vietnam. In Sanglah Hospital, Bali, Indonesia, a dengue outbreak was recognized early on, so the hospital could prepare the blood stocks in their blood bank in anticipation of the possiblitily of numerous patients in the worst medical condition. No death was found during the outbreak. The EWORS invention was also validated by the recognition of an absence of cholera cases in association with flooding in Cambodia.

The invention may be used in refugee or disaster situations to stop the spread of infectious disease that typically occurs in high-density populations that lack adequate sanitation and medical care. The invention may also be deployed as a biological and/or chemical defense monitoring and surveillance system for civilian or military populations. The inventors specifically wish to point out that the description of "local computers" includes desktop, laptop, notebook, subnotebookand hand-held computers such Palm and Handspring personal data assistants. The invention has been validated in a variety of settings. Obviously, many modifications and variations of the present invention are possible in light of the above teachings. It is therefore to be understood that, within the scope of the appended claims, the invention may be practiced otherwise than as specifically described.

REFERENCES

1. Corwin A. 1998. Impact of Epidemic Influenza A- Like Acute Respiratory Illness in a Remote Jungle Highland Population in Irian Jaya, Indonesia. Clinical Infectious Diseases. 26:880-8.

2. Bounlu K. 1998. Acute Jaundice in Vientiane, Lao People's Democratic Republic. J. Clinical Infectious Diseases. 27:717.

3. Corwin A. 1997. Emerging Disease Surveillance in Southeast Asia. Ann Acad Med Singapore. 26:628-31.

4. Corwin A. 1997. Emerging Disease Surveillance in Southeast Asia. Ann Acad Med ^■Singapore. 26:628-31.

5. Id.

Claims

What is claimed is:

1. An early warning outbreak response system for assisting in confirming a suspected infectious disease outbreak in predetermined locations comprising: a plurality of local hospital sites being disposed at said predetermined locations, each having a corresponding plurality of operatively connected local hospital computers, entry devices and monitors configured such that syndromic data can be entered via screens displayed on said local hospital monitors into corresponding ones of said plurality of local hospital computers by said plurality of local hospital entry devices, said screens being generated in accordance with a local hospital computer program; and a host site having a host computer, entry device and monitor; said plurality of local hospital computers being operatively connected to said host computer via a corresponding plurality of communication medium, such that said syndromic data as displayed on said screens are received at said host computer.

2. The early warning outbreak response system of Claim 1, wherein said syndromic data as displayed on said screens are further processed in said host computer in accordance with a host computer program, wherein trends in said syndromic data are determined so as to assist in confirming said suspected infectious disease outbreak.

3. The early warning outbreak response system of Claim 2, wherein said communication medium is selected from the group consisting of modems, internet connections, telephone connections, wireless connections, and regular mail delivery.

4. An early warning outbreak response system for assisting in confirming a suspected infectious disease outbreak in predetermined locations comprising: a plurality of field hospital sites being disposed at said predetermined locations, each having a corresponding plurality of operatively connected field hospital computers, entry devices and monitors configured such that syndromic data can be entered via screens displayed on said field hospital monitors into corresponding ones of said plurality of field hospital computers by said plurality of field hospital entry devices, said screens being generated in accordance with a local hospital computer program; and a host site having a host computer, entry device and monitor; said plurality of field hospital computers being operatively connected to said host computer via a corresponding plurality of communication medium, such that said syndromic data as displayed on said screens are received at said host computer.

5. The early warning outbreak response system of Claim 4, wherein said syndromic data as displayed on said screens are further processed in said host computer in accordance with a host computer program, wherein trends in said syndromic data are determined so as to assist in confirming said suspected infectious disease outbreak.

6. The early warning outbreak response system of Claim 5, wherein said communications medium is selected from the group consisting of modems, internet connections, telephone connections, wireless connections, and regular mail delivery.

7. The early warning outbreak response system of Claim 6, further including a handheld wireless communication device for transmitting said syndromic data to said host computer.

8. A method of determining trends in syndromic data in order to assist in confirming infectious disease outbreaks at predetermined locations comprising the steps of: collecting said syndromic data at said predetermined locations; entering said syndromic data via screens generated in accordance with a local computer program, displayed on monitors of corresponding local computers disposed at said predetermined locations; transferring said syndromic data as displayed on said screens to a host computer; receiving said syndromic data as displayed on said screens at said host computer; and performing a day-to-day syndromic data trend analysis in accordance with a host computer program so as to detect a suspected infectious disease outbreak.

9. The method of Claim 8 further comprising the step of performing a detailed syndromic data trend analysis so as to confirm said suspected infectious disease outbreak.

10. The method of Claim 9 further comprising the step of performing an infectious disease outbreak investigation designed to eradicate said infectious disease outbreaks.