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SYSTEM FOR PROVIDING RECOMMENDATIONS TO PHYSICIANS
AND
FOR MANAGING HEALTH CARE DATA
RELATED APPLICATIONS
1'kiis application claims priority under 35 U.S.C. ~ 119(e) based on the
' disclosure of U.S. Provisional Application Serial No. 60/050,978, entitled
"SYSTEM FOR PROVIDING RECOMMENDATIONS TO PHYSICIANS AND
FOR MANAGING HEALTH CARE DATA," by Kevin J. Graham and John R.
Lesser, filed on June 19, 1997.
BACKGROUND OF INVENTION
The invention is an application of decision support technology to the
medical field using computers and relates to the fields of medical diagnosis
and treatment, as well as to data processing and recordkeeping. The
invention provides decision support to physicians based on data entered
from a standard clinical contact such as a physician, nurse, or physician
assistant. The invention also generates reports based on a database of
diagnostic evaluations performed by physicians and updates the decision
support recommendations based on an analysis of the aggregate data.
1. Field of The Invention
It is critical that health care providers correctly diagnose and treat
individuals with health problems. Health care providers must provide an
accurate diagnosis and complete and appropriate treatment in an
economical and efficient manner.
In order to properly diagnose and treat an individual's potential health
problem, the individual's past medical history and other information may
be needed for evaluation by the health care provider. Thus, the health care
provider must maintain detailed records on each individual who presents
' 30 for diagnosis and/or treatment. An economical system for efficiently
managing and utilizing these records is necessary to provide proper service.
It is necessary for health care providers to maintain detailed
longitudinal records of patients with chronic diseases. The individual may
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need to undergo further testing, treatment and/or monitoring. Many
patients need to return for a follow up examination to assess the
progression of the medical problem, a prior test, or the results of an earlier
treatment. The diagnosis (including testing), treatment, and follow up must
be competent and economical.
The invention establishes a system which assists the health care
provider in its mission to provide competent and economical service.
2. Description of Related Art
Previously, an individual's diagnosis and treatment were recorded on
documents and forms. These forms were filed manually in file folders and
stored in a central location at the health care provider's place of business.
Additionally, some individuals kept their own copies of their past medical
diagnosis and treatment. These manual systems of the prior art are
cumbersome and inefficient. It is difficult to locate the appropriate forms,
and it is possible for forms to be lost or destroyed.
The forms may be difficult to read and may contain incomplete information.
With the advent of computer technology, many health care providers
have attempted to computerize the forms of the prior art. The health care
providers who attempted to standardize these forms have met with mixed
results. However, the result of this "computerization" has been merely to
expensively record standard medical practices by transferring the old paper
based system to a computer without attempting to aid physicians in patient
diagnosis and treatment selection.
Computerized forms are not a major improvement in the sense that
they do not use the capabilities inherent in computer technology. They do
not provide an analysis of data and do not synthesize the data to form a
recommended course of action to aid in accurate patient diagnosis.
Computerized forms do not synthesize data and provide a performance
evaluation of a physician or health care facility.
The conventional computerized format shares the shortcomings of
historical documents and folders in that the forms may be incomplete and
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the coding system employed is based on financial reimbursement and not
structured to provide the clinical "best practice."
In the prior art, suspected cardiac chest pain has been diagnosed and
' treated based on an individual physician's knowledge and ability. An
embodiment of the present invention assists a physician to diagnose and
treat suspected cardiac chest pain via aggregate knowledge and using the
expertise of cardiac specialists.
What is needed is to improve the prior art.
What is needed is a system which aids in the diagnosis and treatment
of a patient based on symptoms and signs, not on an already established
diagnosis.
What is needed is a system which aids in the diagnosis and treatment
of suspected cardiac chest pain.
What is needed is a system for informing a physician that he/she is
deviating from a recommended course of treatment, but which allows for
deviations in order to potentially identify better approaches in establishing
what is the "best practice."
What is needed is a computerized system which identifies and
supports proposed courses of treatment to a physician.
What is needed is a computerized health care system, which
generates reports and statistical analyses concerning the medical service at
a health care institution.
What is needed is a system for ensuring that a physician's diagnosis
and treatment plan is fully recorded, in order to help provide feedback to
individuals and groups of physicians, and a system designed to change and
improve physician practice.
SUMMARY OF INVENTION
The invention is a system which supports a physician performing a
diagnostic evaluation and treatment on a patient. The information
concerning this evaluation is stored as part of the patient's medical history
in a database. An exemplary embodiment is disclosed which relates to a
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system for aiding in the diagnostic evaluation and treatment of chest pain.
This embodiment is directed at diagnosing and treating cardiac ischemia,
which is a condition resulting in low blood flow to the heart.
To assist the physician in the evaluation and treatment of a patient,
the present invention provides decision support and presents a reasonable
course of action, such as tests to run or treatments to consider based on the
patient's symptoms, risk factors, or the results of an earlier test. The
physician may choose a recommended or a nonrecommended course of
action. In the case where the physician chooses a nonrecommended action,
the system will notify the physician that he is deviating from a
recommended action. The physician then enters reasons why the
recommended action was not followed.
By storing the diagnostic evaluations and treatment decisions (i.e.
work-ups) in a database, the system is able to generate reports which are
useful for the health care provider. In the chest pain example, the reports
include, for example, work-up {i.e. diagnostic evaluation and treatment)
reports, pretest assessments, stress tests, angiograms, work-ups per
physician, pretest assessments per physician, stress tests per physician,
angiograms per physician, facilities, patients, pretest assessment changes,
stress test changes and angiogram changes.
The invention of the present system prompts the physician to enter
data from menus or lists. The system does not allow the physician to
proceed unless a sufficient amount of data is entered. Accordingly, the
process of the present invention helps ensure that the evaluation
information recorded in the database is complete.
It is an object of the invention to use stored data to assist a physician
in diagnosing and treating the patient.
It is an object of the invention to assist a physician in the diagnosis
and treatment of a patient based on clinical information entered by the
physician.
It is an object of the invention to assist a physician in the diagnosis
and treatment of chest pain.
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It is an object of the invention to inform a physician when the
physician deviates from a recommended course action, but allow for
deviations based on professional judgment to identify better diagnostic and
' treatment methods.
5 It is an object of the invention to recommend proposed courses of
action to a physician, such as tests to conduct or treatments to follow.
It is an object of the invention to provide a computerized health care
system, which generates reports and statistical analyses concerning the
medical service at a health care institution or group of health care
institutions.
It is an object of the invention to provide an aggregate record of
similar diagnoses and treatments to a health care system in order to
improve diagnostic and treatment methods.
It is an object of the invention to help ensure that a physician's
diagnosis and treatment are fully recorded.
It is an object of the invention to analyze the aggregate data and
refine/ change the decision support system based on the outcome of the
previously recommended diagnoses and treatments.
DESCRIPTION OF THE DRAWINGS
Figure 1 is a block diagram generally showing "Phase I" and "Phase
IV" embodiments of the present invention, including the steps for obtaining
information for use in the hardware of Figure 2.
Figure 2 is a diagram showing the hardware components of the
present system in the "Phase II" embodiment.
Figure 3A is a block diagram generally showing the routines used in
the Phase II system of Figure 2.
Figure 3B is a block diagram generally showing the routines within
the Evaluation Routine 600 of Figure 3A.
Figures 4A, 4B, and 4C are exemplary screen displays from the
routines shown in Figure 3A.
Figures 5 is a block diagram showing the Symptoms Subroutine of the
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Evaluation Routine shown in Figure 3B.
Figures 6A, 6B, and 6C are exemplary screen displays from the
Symptoms Subroutine shown in Figure 5.
Figure 7 is a block diagram showing the Risk Factor Subroutine of the
Evaluation Routine shown in Figure 3B.
Figures 8A, 8B are exemplary screen displays from the Risk Factor
Subroutine shown in Figure 7.
Figure 9 is a block diagram of the Post Risk Selection Subroutine from
the Evaluation Routine shown in Figure 3B.
Figure 10 is a block diagram of the Angiography Subroutine of the
Evaluation Routine shown in Figure 3B.
Figures 11A and 11B are exemplary screen displays from the
Angiography Subroutine shown in Figure 7.
Figure 12 is a block diagram of the Stress Test Subroutine of the
Evaluation Routine shown in Figure 3B.
Figures 13A, 13B, 13C, 13D, 13E, and 13F are exemplary screen
displays from the Stress Test Subroutine shown in Figure 12.
Figure 14 is a block diagram of the Post Test Recommendation
Subroutine of the Evaluation Routine of Figure 3B.
Figure 15 is a block diagram of the System Installation Software.
Figure 16 is a block diagram of a screen display used to enter a
password, for the systems of Figure 15 and Figure 17.
Figure 17 is a block diagram of the Administrative Software used in
Phase III of the invention.
Figure 18 is an exemplary screen display of the display options step
shown in Figure 17.
Figure 19 is an exemplary screen display of the system maintenance
option shown in Figure 18.
Figure 20 is an exemplary screen display of the export data option
shown in Figure 19.
Figure 21 is an exemplary screen display of the generate reports
option shown in Figure 18.
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Figures 22A and 22B are exemplary screen displays (reports)
generated in response to the stress test option 903 shown in Figure 21.
Figure 23 is an exemplary screen display (report) generated in
response to the workups per physician option 905 shown in Figure 21.
Figure 24 is an exemplary screen display (report) generated in
response to the physicians option 907 shown in Figure 21.
Figures 25A and 25B an exemplary screen displays (reports)
generated in response to the pretest assessment changes option 909 shown
in Figure 21.
Figure 2f is an exemplary screen display generated in response to the
statistics option of Figure 18.
Figure 27 is an exemplary screen display of statistical graph
generated in response to selection of the workups per physician option of
Figure 26.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
The invention is a system which enables a physician to follow a
guided diagnostic evaluation and treatment recommendation for a patient
(a "work-up" or "evacuation"). This "work-up" allows a physician to make a
diagnosis and to establish the probability, in a specific embodiment, of
whether significant coronary disease is present and to assess its degree of
severity. The "work-up" also includes symptoms and signs observed by the
physician, the results of tests performed on the patient or conclusions
reached by the physician, as well as any unique facts or circumstances
specific to the patient. The "work-up" conducted on the patient is stored as
part of the patient's medical history in a computer database. The
evaluation or "work-up" may also include information related to the
treatment (actual and/or recommended), if desired.
The invention involves four "phases" of operation. In the first phase,
shown in Figure 1, the information necessary to run the system, the
"knowledge base" is obtained. This information is used as the basis for
providing recommendations to physicians based on the physician's
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observations, patient information, test results, etc.
In the second "phase," shown in Figures 2-14, the system is used by
physicians in their practice. The physicians utilize the present invention to
support their courses of action. The invention provides recommendations/
suggestions to the physicians based on input data. The physicians consider
the recommendations using their professional judgment, and decide
whether to follow the recommendations. The "work-ups" are stored in a
central database and are accessible to all the physicians.
In the third "phase," shown in Figures 2 and 16-27, the system is
used by a system administrator to generate reports and statistical graphs
based on the stored "work-ups." The system administrator may or may not
be the person who installed the system of Phase II, as shown in Figure 15.
in the fourth "phase," shown in Figure 1, the decision report
recommendations are periodically refined and updated after a review of the
aggregate data and in view of the results of the latest research as
determined by an expert review panel.
Thus, the present invention provides a system for recommending
courses of action to a physician and compiles the physicians' actions and
patient's data in a database. The system also generates reports and
statistical analyses based on the data. The system updates
recommendations periodically to strive to achieve the "best practice."
I. System Phase I: Developing A Knowledge Base and Code.
This invention uses a system/process known as the "best practice,"
in that the best available clinical information is used. This means that the
system has the "best" clinical information available and will provide
consistent recommendations based on an action's likelihood of success in
a specific patient. The "best practice" uses information that is thought to
be the most advanced in the field by the practicing experts in the field. Of
course, the system could be set up in an alternative embodiment to
recommend the most economical procedures in view of the potential health
risks. This alternative is not the preferred embodiment, but may be easily
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implemented by focusing on different criteria in the Phase I process.
Figure 1 shows Phase I of the invention. In this phase the system
obtains the information necessary to form a "knowledge base" of
information. The knowledge base is the information which allows a
recommendation to be given based on previously known data and, if
necessary, various algorithms.
As shown in Figure 1, the first step 10 is to identify the problem. In
a preferred embodiment, the problem is chest pain, i.e. cardiac ischemia 20.
The next step is to identify factors which tend to indicate an increased
risk ?0 of the medical problem, here cardiac ischemia, using the "best
practice" process (meaning that the risk factors chosen are the ones which
"best" indicate or refute the problem). The factors, known as "risk factors"
include old age, obesity, and status as a smoker, among others 80 for
cardiac ischemia. The risk factors for chest pain are more fully discussed
with reference to Figures 7-9 herein.
Next, the presenting symptoms are identified 50, using the "best
practice" system. For the chest pain embodiment, the presenting symptoms
include: chest pain, arm discomfort, epigastric discomfort, etc. . . 60. The
presenting symptoms are more fully discussed with reference to Figures 5
and 6 herein. The presenting symptoms may either tend to indicate cardiac
ischemia or tend to negate it. When a symptom negates the medical
problem undergoing evaluation, the symptom is helpful because it indicates
that the problem is not present.
The "best practice" process is again used, this time to identify the
available diagnostic testing techniques 90 used in the diagnosis of the
problem. The results of the diagnostic techniques or tests support or reject
the existence of the problem in an individual. The available diagnostic
techniques for chest pain include, among others, stress tests. The specific
stress tests are exercise stress tests, imaging stress tests, and
pharmacologic stress tests 100. These specific tests, and other tests, are
described more fully with respect to Figures 10-13 herein.
The next step is to identify existing treatments 30 for the problem.
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Treatments for patients presenting for possible cardiac ischemia are, for
example, medical treatment of coronary artery disease (CAD), interventional
cardiology procedures, and bypass surgery 40. Treatments, and the other
information that is identified in Phase I, are identified from the medical
5 literature, experts in the field, experimentation and validation, or other
techniques.
The information is then analyzed 110 to determine all the possible
presenting symptoms, risk factors, and diagnostic techniques, and as a
result a "knowledge base" is built. The analysis includes identifying all the
10 information necessary to obtain the symptoms, risk factors, and the
information necessary to conduct diagnostic tests, as well as the
information obtained from the results of diagnostic tests. The analysis uses
the "best practice" technique 120 to determine the "best" techniques for
correctly diagnosing the patient. The analysis may also consider other
information not falling into the previously described categories, such as
patient signs or conditions. As a result, in Phase II the "best" diagnostic
techniques and treatments are recommended to the physician.
The "best practice" knowledge base is coded into computer r outines
I30 and data in the next step. The computer is configured to accept the
data needed by the "best practice" analysis and to provide a consequent
"best" recommendation. Figures 5-13, Table 1, Table 2, and the Appendix
show one example of the "best practice" computer routines 140 for the chest
pain embodiment, as determined from the analysis performed by the
present inventors.
The data for analysis by the "best practice" routines must be selected
or entered by the physician/user. A staff member, such as a physician
assistant, or even the patient, may enter/select the data. Therefore,
input/output routines must be coded 150 into the "best practice" routines.
The input/output (I/O) routines are important because they are designed
to elicit all the necessary information from the physician before proceeding
to the next request for input or before providing output. The I/O routine
may be developed (using known methods) to await the entry of one field of
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information before providing output or before allowing entry of other fields
of information. This means that each field of information must be entered.
Using this type of I/O system, it is highly likely that the evaluation will
contain a complete record of all the pertinent information known to the
physician. For example, in Figures 6B and 6C, the "initial clinical
impression" selection cannot be made unless (and is preferably not
displayed until) suitable "presenting symptoms" are first entered. Likewise,
in Figures 8A, 8B, 13C, 13E and 13F it is preferred not to display a
recommendation or option (in the last righthand column) until data for each
preceding column is present. In an alternative embodiment, each
succeeding option for selection or data entry in the I/O system of the
present invention would not be displayed until the preceding information
was entered or selected.
Preferably the I/O routines are in the form of lists 160 (for example,
as shown in Figure 6B). The options in the list are toggled by the physician,
preferably by moving a cursor (via mouse or keyboard) over the option and
then typing a "select" command, i.e. such as a mouse button. In some
cases, more than one option may be selected. For example, Figure 8A
shows both the "H'TN" and "Diabetes" options selected from the "Risk Factor"
list of options.
A "help" box is preferably used with and encoded with the I/O
routines of the present invention. When the cursor overlays a possible
selection or data entry field the "help" box displays information concerning
the selection. For example, in Figure 4A, the cursor is over the "Next
Screen" selection. In this case, the "help" box states "Choose this option to
go to the next screen." Multiple "help" boxes may be used, one for the
screen generally, and one for the selection. An example of multiple "help"
boxes is shown in Figure 13D at 163, 165.
A feature improving the usability of the present invention is
presenting terms or definitions only at the time they are needed for the
particular decision.
The "best practice" routines are integrated 170 with the I/O routines
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so that the necessary information is entered/selected when it is needed.
The combination of the coded "best practice" routines and the simple
and informative I/O routines results in an easy to use and effective system,
which maintains all the critical information available to the physician.
The system uses "evaluation software" 340 to provide
recommendations to the physicians, and "administrative software" 330 to
maintain the system and generate reports.
Preferably, the system is next tested 180 until it has achieved a high
degree of reliability. During testing, the analysis and building of the
"knowledge base" I 10, the coding of the "best practice" routines 130, the
coding of the I/O routines 150, and the integration 170 continues.
Preferably a test group of patients is used to help determine patient safety,
physician acceptance, and improve the ability of the system to accurately
identify disease. A validation study at a hospital may be part of the testing
process.
This enables the system to be fine-tuned and peer-reviewed before it
is completed 190 and released for general use.
II. System Phase II
Phase II of the system is for the use of physicians, when appropriate,
in their daily practice.
IL 1 Hardware Components.
Figure 2 shows the hardware components of the present system
which are generally used in the Phase II embodiment (as well as the testing
stage of the Phase I embodiment).
As shown in Figure 2, the system 200 utilizes a computer network
210, including a server 220, with database 230, connected to an
administrative computer terminal 240 and a number of local computers 250
(preferably personal computers). The computer network 210 may be
connected by a firewall & modem 260 to remote computers 280 using
telephone communications and telephone network 270. The remote
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computers may connect by modem 290 to the telephone network 270 or be
connected in their own network 300 which is, in turn, connected by modem
290 to the telephone network. Each computer has an input device such as
a keyboard 300, a display 312 or monitor, and may have a printer 320, if
desired.
The database 230 is preferably a relational database.
The hardware configuration of this system allows the data from the
server 220 to be available to any of the local 250 or remote 280 computers.
Each computer 280 is in operative communication with the server and
database. The remote computers may be connected via ordinary telephone
lines, via the Internet, via a dedicated computer network, or via other
communications media.
In the simplest embodiment (not shown) the system merely consists
of one computer connected to the database. In this system, the computer
functions as the administrative unit as well as the input device, and the
computer's hard disk drive or floppy disk drive stores the database of
information.
The computers 250, 280, except for the administrative unit 240, are
each located at the place where the physician performs either a diagnosis
or a treatment. The physician uses the input 300 of the computer to
provide data concerning the patients and observes recommendations and
confirmation of the entered information on the display 310 or printer 320.
The computer 250, 280 used by the physician accesses the database to
obtain the stored information required for it to function properly.
While each computer 250, 280 could execute software stored at the
server, it is desired in the preferred embodiment that each computer 250,
280 is loaded with its own copy of the "evaluation software" 340 of the
present invention. The speed of this type of system is improved over the
system which executes software stored at the server 220. The
administrative computer is loaded with "administrative software" 330 of the
present invention. There may be one or several administrative computers
240, each loaded with the administrative software 330 of the present
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invention.
IL2. Software Routines- General Overview.
The present invention provides recommended actions to physicians,
but is not designed to supercede, question, or substitute for, the physician's
professional judgment. The recommendations are to be used by the
physician as a decision support tool during the physician's decision process.
This may be stated in an introductory screen prior to actually executing any
software routines. The introductory screen (not shown) may state, for the
chest pain embodiment described herein:
"This physician decision support tool is designed to be an
informational guideline solely for use by licensed physicians in
aiding their clinical diagnosis of possible ischemic cardiac chest
pain. This tool was validated by a prospective study conducted
at (hospital name), on (number ofl patients from (dates). The
information derived from that study and contained herein may
not apply in every instance to an individual patient or the
symptoms presented by such patient. This tool should
therefore not be construed as individualized medical advice and
is not intended to be a substitute for the individualized medical
advice and clinical judgment of a licensed physician."
The introductory screen (not shown) is preferably displayed prior to
running the Phase II routines described herein.
Figure 3A is a block diagram generally showing the operation of the
evaluation software 340 of the Phase II embodiment. As shown in Figure
3A, the Select Facility Routine 400 is executed. This routine prompts the
physician to enter the facility at which the computer 250, 280 is located.
This may be done by either typing the facility name or selecting a facility
from the list of facilities which exist in the database 230. An example of a
facility is the name of the hospital or clinic. This routine is optional
because
the facility could be preprogrammed into the physician's computer and
would not need to be entered. Also, in the case where there was only one
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facility per database, the facility would not need to be entered. An example
of a screen display 405 for the Select Facility Routine is shown in Figure 4A.
After entering the facility, the Select Physician Routine 410 is
' executed. This routine prompts the physician 420 to enter his/her name
5 into the computer. The physician also indicates 420 whether their status
is the primary care physician or a consulting physician. Alternatively, the
physician would choose a name from a primary care physician list or
consulting physician list, thus, simultaneously entering the status of the
physician as well as the physician's name. The physician also enters 420
10 his/her own personal physician ID code, which is preferably not displayed
on the computer screen. The physician is only allowed to proceed if the
physician ID code is correct. This is shown at the decision box 440.
If the "select facility" routine is used, the "select physician" routine
only allows the physician to proceed if the physician is authorized at with
15 the previously entered facility. This is shown by the second decision box
440.
In either case, if the physician is denied access a "not authorized"
message is displayed 450 and the physician has another opportunity to
enter the correct information 420. Additional security features known in
the art may be incorporated into the present system but are not specifically
discussed herein. An example of one screen display 415 for the Select
Physician Routine 410 is shown in Figure 4B.
The next routine is the Patient Identification Routine 460, which
requires the entry of a patient's identification number 470, such as the
patient's Social Security Number. If the patent's identification number is
not stored 480 within the database, the Add Patient Routine 490 prompts
the physician to enter the patient's relevant information. This information,
for example, is the name of the patient, the patient's gender, the patient's
race, and the current date. The patient information is displayed for
verification 495 by the physician, as shown for example in the screen
display 465 of Figure 4C.
The next routine is the Select Practice Routine 560. This routine
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displays further nonlimiting examples of the practices covered by the
present invention, for example: chest pain, congestive heart failure, valvular
heart disease, etc. . . . An example of a display screen 505 that includes the
Select Practice Routine list 515 is shown in Figure 6A. Because the system
of the present invention will be updated periodically to add additional areas
of medicine to its coverage, this screen allows the physician to select the
area undergoing investigation for the entered patient.
Medical practitioners will realize that not every conceivable symptom
will need to undergo processing via the present invention. As a result, the
present inventors have provided an Inclusion Criteria Routine 510. This
allows the physician to screen out patients who do not fit within the
analysis capabilities of the present invention. The inclusion criteria screen
is designed as a "gatekeeper" to help ensure that only the type of patients
fitting within the analysis capabilities of the invention are processed by the
invention. The Inclusion Criteria Routine 510 is closely tied to the scope of
the knowledge base. As the complexity of the present invention increases,
the inclusion guidelines become broader.
The inclusion criteria are first displayed 572. The physician selects
whether the inclusion criteria are met 574 as applied to the patient. If the
inclusion criteria are not met the Phase II embodiment restarts, as shown
in Figure 3A. If the inclusion criteria are met, the Phase II embodiment
continues.
For the chest pain embodiment of the invention disclosed herein, the
inclusion criteria is generally as follows: "possible or probable myocardial
ischemia presenting as chest pain, arm, jaw, infrascapular, or epigastric
discomfort; if patient has chronic chest pain, symptoms must have
worsened since previous evaluation; do not use if the patient exhibits any
of the following: shortness of breath as a solitary symptom, myocardial
infarction within six weeks, congenital heart disease, significant valwlar
disease, idiopathic dilated cardiomyopathy, or post-heart transplantation."
In these latter cases there is an extremely high probability that the patient
is not suffering from cardiac ischemia, thus making use of the present
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invention inappropriate for the specific chest pain embodiment described
herein.
After the patient is screened for the appropriate inclusion criteria, the
evaluation routine 600 is executed. The evaluation routine 600 allows the
physician to select the presenting symptoms and/or risk factors and
provides a recommendation for further testing or treatment. All of the
information concerning the patient, symptoms, risk factors, diagnosis
and/or treatment are stored in an evaluation file (not shown) in the
relational database 230.
The Evaluation Routine 600 is the most complicated routine, and is
preferably modular in design so that a separate evaluation routine 600 is
used for each practice 515 listed in the Select Practice Routine 560.
Alternatively, the Evaluation Routine may be one large routine covering
every practice 515 listed in the Select Practice Routine 560. One of ordinary
skill will generally realize that modular Evaluation Routines may be
conceptually simpler in design, but require more overall code when
implemented with the other Evaluation Routines. A single Evaluation
Routine will generally require less code because sub-routines may be shared
between the practices, but will be conceptually more complicated.
The evaluation is complete after the Evaluation Routine 600 is
finished executing. At this point, or if the inclusion criteria are not met,
the
system returns to either the Select Facility Routine 400, Select Physician
Routine 410 or Select Patient Identification Routine 460 so that the system
may be used for additional facilities, physicians or patients, as appropriate.
Preferably the software returns to the "Select Physician" Routine 410 so that
the system is available for the next physician who requires its use.
IL3. Subroutines for theEvaluationRoutine inthe Chest Pain
Embodiment.
Figures 5-13 depict the Evaluation Routine 600 for the chest pain
embodiment. As shown in Figure 3B, the Evaluation Routine contains a
number of subroutines. The subroutines, for the chest pain embodiment,
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are: the Presenting Symptoms Subroutine 500 (Figures 5,6), the Risk
Factor Subroutine 510 (Figures 7,8), the Post Risk Selection Subroutine 520
(Figure 9), the Stress Test Subroutine (Figures 12, 13), the Post Test
Recommendation Subroutine 550 (Figure 14), and the Angiography
Subroutine 530 (Figures 10,11). When the Evaluation Routine is exited, the
evaluation is saved 531 in the database 230.
A. Presentation Symptoms Subroutine.
Figure 5 shows the Presentation Symptoms Subroutine 500. The first
step, shown in Figure 5, is to ask the physician whether this is a new
evaluation. Figure 6A shows a sample display screen 505 when the
Presentation Symptoms Subroutine is entered.
If the evaluation is not a new workup, the physician may select
"review previous workup" or "finish existing workup" 517, as shown in
Figure 6A. When these options are selected 604, the physician selects a
prior workup 606 by date and then whether to go to the beginning or end
of the workup 608. At this point, the workup is loaded 610 and processing
continues at the desired point. Note that evaluations/workups may be
saved and exited and virtually any point in the subroutines.
If this is a new evaluation, the physician is prompted to enter the
date 612 and the patient's symptoms 614. Preferably, the computer
defaults to the current date stored in the computer. Figure 6B shows
typical screen display 525 for a new workup.
The possible symptoms are presented in a list for selection 614 by the
physician: The displayed symptoms, in this embodiment, are shown in
Figure 6B. They are: "chest pain," "arm discomfort," "neck/jaw discomfort,"
"epigastric discomfort," "shortness of breath," and "palpitations." The
physician selects 614 each of the symptoms applicable to the patient.
As usual, the "help" box is used to display further information about
a selection underneath the pointer/cursor, or having to do with the page in
general. For example, the "help" box 519 of Figure 6A is the same no matter
where the cursor is positioned, and states, for example: "shortness of
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breath and/or palpitations alone do not qualify for this guideline." This
informs the physician that insufficient data is available to arrive at an
initial
clinical impression based on just these two symptoms. If the presenting
symptoms are insufficient to provide an initial clinical impression, the
physician may select "previous screen" or "save and exit" to restart or end
the Evaluation Routine.
After selecting a symptom, the Presentation Symptoms Subroutine
processes the symptom to determine if it is sufficient, along with the
previously selected symptoms, to provide an initial clinical impression. The
subroutine is preprogrammed with the "best practice" system. In this
embodiment, any symptoms, except the "shortness of breath" and
"palpitations" (either singly or both) are sufficient to provide an initial
clinical impression. Thus, if any symptoms are present other than
shortness of breath or palpitations 616, the Presenting Symptoms
Subroutine proceeds to the selection of an initial clinical impression.
When sufficient presenting symptoms are entered, the "initial clinical
impression" options are displayed 618. The physician, using his/her own
judgment, selects an initial clinical impression, in this case "definite
cardiac
ischemia," "probable or possible cardiac ischemia" or "discomfort/pain not
from cardiac ischemia," as shown in Figure 6B.
If the initial clinical impression is that "discomfort/pain not from
cardiac ischemia" 620, then the evaluation is complete because the
physician has decided that the symptoms indicate that cardiac ischemia is
definitely not a possibility. At this point the physician is prompted to enter
notes 622, if desired. A sample screen 527 where this has occurred is
shown in Figure 6C. The Presentation Symptoms Subroutine 500 generates
a short report 624 to state the information entered and the conclusion, and
saves the evaluation. The report may be printed, at the physician's
discretion 626. The Evaluation Routine 600 is then complete.
If the physician's initial clinical impression is "definite cardiac
ischemia," or "probable or possible cardiac ischemia" the evaluation routine
progresses to the risk factor analysis. The Risk Factor Subroutine is used
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to perform the risk factor analysis.
B. Risk Factor Subroutine.
The Risk Factor Subroutine 510 , shown in Figure 7, is used to
5 analyze risk factors which may help in the diagnosis of the chest pain.
'I~vo
sample Risk Factor Subroutine screen displays 535, 537 are shown in
Figures SA and 8B.
First, the physician selects risk factors 630 associated with ischemia.
As shown in Figures 8A and 8B, the factors indicating a risk of cardiac
10 ischemia are: age (i.e. male over 55, female over 60), HTN or hypertension
(i.e. blood pressure greater than 140/90 or treated for HTN), smoker (i.e.
current or quit within Iast two years), family Hx or history (i.e. first
degree
relative with known CAD less than 60 years old), obesity (i.e. greater than
30% over ideal body weight), diabetes (i.e. fasting blood sugar greater than
15 140 mg/dl or treated for diabetes), dyslipidemia (i.e. total cholesterol
greater
than 240 or LDL (Iow density lipoprotein) cholesterol over 130 or HDL (high
density lipoprotein) cholesterol under 35 in males/45 in females or
triglycerides over 240 or treated for dislipidemia), known CAD (previously
diagnosed by objective criteria for significant CAD).
20 When the cursor overlays a risk factor, the "help" box preferably
displays information concerning the risk factor. Information is only
presented when it would be of help to the user. For example, when the
cursor overlays HTN, the "help" box states "blood pressure greater than
140/90 or treated for HTN."
The computer processes the risk factors to determine the "pretest risk
for CAD." In the preferred "best practice" embodiment, three or more risk
factors (or "known CAD") 632 result in a high pretest risk 634, two risk
factors 636 result in an intermediate pretest risk 638, and zero to one risk
factor results in a low pretest risk 640.
The pretest risk is then displayed for reference by the physician, and
is used by the processing step in formulating a recommendation.
The physician also selects the anginal type 644. As shown in Figure
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8A, the possible types include "typical," "typical/atypical," "atypical." The
"help" box may display further information when the cursor overlays the
anginal type possibilities. For example when the cursor overlays "typical"
the help box displays "Symptoms definitely characteristic of myocardial
ischemia, reproducibly precipitated by increased cardiac workload (usually
exercise) and relieved promptly with rest or NTG (nitroglycerin). An anginal
equivalent in the appropriate setting is also considered typical angina.
Shortness of breath alone is not considered an anginal equivalent."
For "typical/atypical" anginal type the whelp" box may state:
"Symptoms with characteristics of typical (exertional) and atypical
components. Shortness of breath alone is not considered an anginal
equivalent. "
For the "atypical" anginal type the "help" box may state "Symptoms
are possibly due to myocardial ischemia, but have one or more features
atypical for angina. Shortness of breath alone is not considered an anginal
equivalent."
After entering the anginal type, the physician enters the Canadian
Anginal Classification ("C.A.C.") 646, from the list of classifications. The
C.A.C. types, which may be described in the "help" box, are listed on the
screen when the cursor is over the selection. The type I help box states that
this classification applies if ordinary physical activity, such as walking and
climbing stairs, does not cause angina; angina present with strenuous or
rapid or prolonged exertion at work or recreation.
The "help" box 533 of Figure 8A is shown displaying the further
information for C.A.C. type II: Slight limitation of ordinary activity;
walking
or climbing stairs rapidly, walling uphill, walking or stair climbing after
meals, in cold, in wind, or when under emotional stress, or only during the
few hours after awakening; walking more than two blocks on the level and
climbing more than one flight of ordinary stairs at a normal pace and in
normal conditions. The type III "help" display would relate to a marked
limitation or ordinary physical activity; walking one to two blocks on the
level and climbing more than one flight in normal conditions. The type IV
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classification is broken into two subclassifications, stable and unstable. For
the type IV (stabilized), the "help" display would relate to an inability to
carry on any physical activity without discomfort; discomfort may be
present at rest; rest discomfort has not recurred in 48 hours; no previous
or current objective evidence of ischemia at rest (ST depression >_ 1 mm, 80
msec after the J point on EKG. The "help" for the type IV (unstable)
classification would state: inability to carry on physical activity without
discomfort; discomfort may be present at rest; rest discomfort has occurred
within last 48 hours, and/or EKG shows objective evidence of ischemia at
rest (ST depression >_ 1 mm, 80 msec after the J point on EKG); type V
(atypical chest discomfort (or anginal equivalent) NOT associated with
increased cardiac workload (usually exercise), an NOT promptly relieved
with rest and/or nitroglycerin).
The Risk Factor Subroutine processes the information 648 previously
entered or already determined from the inputs, namely the pretest risk of
CAD (either high, intermediate, or low), the anginal type (either typical,
typical/atypical, or atypical), and the C.A.C. (either I, II, III, IV
(stabilized),
IV (unstable), or V.
The processing of this information 648, in the preferred embodiment,
uses a lookup table preset with each of the possible entered conditions. The
lookup table is also preset with recommendations. The recommendations
correspond to the "best practice" previously discussed, meaning that they
are preferred clinical recommendations, as understood by most advanced
thinking in the field.
The lookup table used in the processing of risk factors is as follows
(note that multiple recommendations may be made and display notes may
be shown on the screen):
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Table 1: Risk Factor Lookup Table.
PROBABILITYANGINAL TYPE ~C.A.C.~ RECOMMENDATIONS)
--~- _
Low Typical 1 Non-Invasive Testing
Low Typical 2 Non-Invasive Testing
Low Typical 3 Non-Invasive Testing
Low Typical 4-S (stabilized)Non-Invasive
Low Typical 4-U (unstable)Noninvasive/ Angiography
Display Note: use of
non-
invasive testing assumes
adequate symptom stability
Low Typical/Atypical1 Non-Invasive Testing
Low Typical/Atypical2 Non-Invasive Testing
Low Typical/Atypical3 Non-Invasive Testing
Low Typical/Atypical4-S Non-Invasive
Low Typical/Atypical4-U Non-Invasive/ Angiography
Display Note: use of
non-
invasive testing assumes
adequate symptom stability
Low Atypical 1 No Further Diagnostics/
Non-Invasive Testing
Low Atypical 2 No Further Diagnostics/
Non-Invasive Testing
Low Atypical 3 No Further Diagnostics/
Non-Invasive Testing
Low Atypical 5 No Further Testing/
Non-
invasive Testing
IntermediateTypical 1 Non-Invasive Testing
IntermediateTypical 2 Non-Invasive Testing
IntermediateTypical 3 Non-Invasive Testing
IntermediateTypical 4-S Non-Invasive/ Angiography
Display Note: use of
non-
invasive testing assumes
adequate symptom stability
IntermediateTypical 4-U Angiography
IntermediateTypical/Atypical1 Non-Invasive Testingo
IntermediateTypical/Atypical2 Non-Invasive Testing
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IntermediateTypical/Atypical3 Non-Invasive Testing
IntermediateTypical/Atypical4-S Non-Invasive
IntermediateTypical/Atypical4-U Non-Invasive/ Angiography
Display Note: use of
non-
invasive testing assumes
adequate symptom stability
IntermediateAtypical 1 No Further Diagnostics/
Non-Invasive Testing
IntermediateAtypical 2 No Further Diagnostics/
Non-Invasive Testing
IntermediateAtypical 3 No Further Diagnostics/
Non-Invasive Testing
IntermediateAtypical 5 No Further Testing/
Non-
Invasive
High Typical 1 Non-Invasive Testing
High Typical 2 Non-Invasive Testing
High Typical 3 Non-Invasive Testing
High Typical 4-S Angiography
High Typical 4-U Angiography
High Atypical 1 Non-Invasive Testing
High Atypical 2 Non-Invasive Testing
High Atypical 3 Non-Invasive Tesring
High Atypical 5 Non-Invasive Testing
High Typical/Atypical1 Non-Invasive Testing
High Typical/Atypical2 Non-Invasive Testing
High Typical/Atypical3 Non-Invasive Testing
High Typical/Atypical4-S Non-Invasive/
Angiography
- Display Note: invasive
testing preferred as
a first
step: non-invasive
testing
acceptable if symptom
stability allows.
Hi h ical A ical 4-U An io ra h
The "recommendation" from the lookup table corresponding to the entered
information is displayed 650, and highlighted in the list of options. For
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example, Figure 8A shows that the recommendation is "non-invasive
testing", and this option is highlighted in the list of options.
. In the chest pain embodiment, the recommendation options (shown
in Figures 8A and 8B) are testing options, including: (a) no further
5 diagnostics, (b) non-invasive testing, (c) angiography. The recommendation
may also be a treatment or combination of two or more of these options, as
indicated in the lookup table.
The recommended post risk options, in this case testing options, are
displayed on the computer screen for selection by the physician 650, with
10 the recommendation shown at the top and the recommended options
highlighted in a specific color, preferably green. The physician may select
652 any of the possible post risk options, including options which are not
recommended.
If the selected post risk option is not a recommended option 654, the
15 physician is prompted to enter reasons for deviating from the recommended
treatment 656. A screen display 539 showing this "guideline deviation" is
depicted in Figure 8B. The reasons for deviation, as shown in Figure 8B,
could be: (a) professional judgment, (b) referral physician's preference, (c)
public safety, (d) patient request, or (e) other. Thus, the physician is
20 prompted to carefully consider a situation when he is deviating from a
recommended course of treatment.
After entering an option, the Post Risk Selection Subroutine 520 is
executed.
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C. Post Risk Selection Subroutine.
The Post Risk Selection Subroutine 520, shown in Figure 9, processes
the selected post-risk option.
If the selected option is "no further diagnostics" 660, the Post Risk
Selection Subroutine allows the physician to enter comments 662, and then
ends the Evaluation Routine, saving the evaluation/workup. The physician
has decided to forgo further testing.
If the selected option is not "angiography" 664, then it is "non-invasive
testing." In this case the Post Risk Selection Routine 520 branches to the
Stress Test Subroutine 540. The Stress Test Subroutine 540 is described
below with reference to Figures 12 and 13.
If the selected option is "angiography," the Post Risk Selection
Subroutine 520 branches to the Angiography Subroutine 530.
D. An io~raphy Subroutine
The Angiography Subroutine 530, shown in Figure 10, first asks the
physician whether the angiography has been completed 670. If the
angiography has not been completed, the physician is asked whether an
angiography is pending 672. If an angiography is not pending, then the
patient must have declined an angiography and the physician is prompted
to enter reasons why the patient has declined angiography 674.
If the angiography is pending, the physician is asked whether the
angiography has been scheduled 676. If the angiography has not been
scheduled, the Evaluation Routine is ended and the evaluation saved. The
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physician will reload the evaluation after the angiography has been
scheduled.
- If the angiography is pending and scheduled, the physician is asked
to enter the date the angiography will occur 678. The Evaluation Routine
is then ended and the evaluation saved. The physician will reload the
evaluation after the angiography has been completed.
If the angiography has been completed, then the display 545 shown
in Figure 1 lA is generated. The physician is prompted to enter the date of
the angiography 680. The physician then is prompted to select a visual
assessment of stenosis, and the general results of the angiography 682.
Specifically, the physician may select one or more of the following stenosis
options (with information about the stenosis option displayed in the "help"
box): (a) left main 50% or greater stenosis (visually assessed diameter
stenosis in left main coronary artery of 50% or greater); (b) Other Coronary
Arteries- 70% or greater stenosis (severest visually assessed diameter
stenosis is 70% or greater in at least one major coronary vessel or first
order
branch); (c) Other Coronary Arteries- 50-69% stenosis (severest visually
assessed diameter stenosis is 50-69% in at least one major coronary vessel
or first order branch); (d) Other Coronary Arteries- less than 50% stenosis
(severest visually assessed diameter stenosis is less than 50% in at least one
major coronary vessel or first order branch).
After selecting the appropriate stenosis options, the physician is
prompted to compare the stenosis to any previously observed stenosis (682),
as shown in Figure 1 lA. The options for selection (with "help" text) include:
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"new or progressed" (stenosis is new or has progressed in severity since
previous coronary angiogram), "previously noted" (the stenosis was noted on
a previous angiogram and has not changed significantly), and "no previous
angiography" (no prior angiography for comparison).
The Angiography Subroutine next asks the physician for the
physician's initial recommendation following angiography 684, as shown in
Figure 11B. A list of options 547 is presented for selection, including:
°no
treatment of coronary artery disease (CAD)," "medical Treatment of CAD,"
"interventional cardiology procedure," and "coronary artery bypass surgery
(CABG)".
After selecting an initial recommendation following angiography 684,
the physician enters any notes or data specific to the patient 686, 544. The
evaluation is then complete. The Angiography Subroutine and Evaluation
Routines end, and the workup is saved.
The Angiography Subroutine 530 may be programmed to recommend
an initial recommendation following angiography, in the same manner
(lookup table) as previously provided for. However, the embodiment shown
herein allows the physician to use his/her judgment in selecting the initial
recommendation following angiography.
E. Stress Test Subroutine.
Referring back to the Risk Factor Subroutine 5I0 (Figures 7, 8A, 8B),
and the Post Risk Selection Subroutine 520 (Figure 9) one option following
the pretest risk is "non-invasive testing" (Figures 9, 8A, 8B) If this option
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is selected, the Stress Test Subroutine 540 is executed.
E 1: Selecting A Stress Test.
The Stress Test Subroutine 540 prompts the physician to select from
a list of tests 555 which could be performed, shown, for example in Figures
13A and 13B. In the chest pain embodiment, these tests are stress tests.
In the present embodiment shown in Figures 13A and 13B, the physician
may select from: an imaging stress test, a pharmacologic stress test, or an
exercise stress test. The "help" box 557 may provide selection criteria
concerning the selection of a stress test, when the cursor overlies the stress
test selection. Alternatively, each listed stress test may have an adjacent
"help" box to provide selection criteria about the test.
The information criteria for the exercise stress test may be as follows:
( 1 ) preferred stress test for most patients, (2) patient must be able to
exercise adequately, (a) double product > 20,000 needed for test, (b) B-
blockade may limit heart rate response and decrease sensitivity, (3) EKG (ST
segments) must be interpretable at rest, (a) no LBBB, pre-excitation, (b) no
resting ST segment abnormalities (examples: digoxin ST changes, left
ventricular hypertrophy (LVH) ST segment changes, Ischemic ST
depression).
The information criteria for the imaging stress test may be as follows:
( 1 ) most useful for patients with (a) intermediate pre-test probability of
CAD,
(b) previous indeterminate stress test with double product > 20,000, (c)
. uninterpretable resting EKG (LBBB, pre-excitation, resting ST segment
abnormalities), (2) imaging increases sensitivity and specificity, (3) patient
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must be able to exercise adequately, (a) double product > 20,000 needed for
diagnostic tests, (b), B-blockade may limit heart rate response and decrease
sensitivity, (4) may be useful in patients with known significant CAD to
localize ischematic bed.
5 The information criteria for the pharmacologic stress test may be as
follows: ( 1 ) most useful for patients who cannot exercise adequately, (a)
severe peripheral vascular disease, (b) other physical limitations, (examples:
musculo-skeletal, neurologic disease, general debility), (2) test of choice
with
previous indeterminate stress test as a result of double product < 20,000,
10 (3) helpful in patients with documented chronotropic incompetence leading
to inadequate double product, (a) fixed rate heart pacing, (b) severe B-
blockade.
The Stress Test Routine 540 prompts the physician to enter a stress
test type 701 (either exercise, imaging, pharmacological, or other). The
15 Stress Test Routine 540 tests to see whether the exercise stress test was
selected 700. If the exercise stress test was not selected, the routine checks
to see whether the imaging stress test was selected 702. If the imaging
stress test was selected, then the physician is prompted to select imaging
stress test indications ?04, as shown in Figure 13A.
20 The imaging stress test indications 561, shown in Figure 13A, are
presented in a list and the "help" box may display information concerning
each test indication when overlaid by the cursor. The imaging stress test
indications are (with Help screen information): (a) left bundle branch block
(left bundle branch block is present on resting EKG); (b) baseline ST
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segments abnormality (baseline EKG shows ST segment abnormalities that
will make definitive ST interpretation with stress nondiagnostic (baseline
LVH with repolarization changes); (c) known CAD-localization of ischemic
bed (patient has known CAD; localization os ischemic bed desirable for
prognosis and/or treatment); (d) on medication known to cause ST segment
changes (on medication that is known to cause "false positive" ST segment
changes (digitalis)); (e) previously indeterminent stress test (results of
previous stress testing inconclusive for diagnosis and/or prognosis of CAD);
(~ female under 55 years old (risk group where regular exercise stress
testing is thought to have a poorer predictive value because of lower
incidents of CAD in this population); (g) other (includes physician
discretion) .
The imaging stress test indications are saved in the database 230.
Referring to Figures 12 and 13B, if the exercise stress test has not
been selected and the imaging stress test has not been selected, then the
pharmacologic stress test has been selected 706. In this case, the physician
is prompted to select from the pharmacologic stress test indications 707, as
shown on screen 563 in Figure 13B.
The pharmacologic indications 707 shown in Figure 13B (along with
the "help" box text) are: (a) inability to exercise due to PVD or peripheral
vascular disease (inability to exercise due to symptomatic peripheral
vascular disease); (b) inability to exercise other (inability to exercise due
to
causes other than peripheral vascular disease); (c) previous indeterminate
stress test (previous stress test has been indeterminent for diagnosis and/or
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prognosis of CAD); (d) chronotropic incompetence (documented chronotropic
incompetence (fixed rate pacing, severe B-blockade)); (e) other ("other"
indications for pharmacologic stress testing including "physician discretionn;
please enter indication).
The selected stress test indications are saved to the database 230
working file.
Referring back to Figure 12, if the exercise stress test has been
selected, then no indications (in this embodiment) need be entered.
E2. Selecting Ima~in~ and Pharmacologic Stress Test Types.
With reference again to Figure 12, if the exercise stress test has been
selected 700, then the physician is prompted to enter the exercise stress
test data 708, as shown on screen 565 in Figure 13C, without first selecting
an exercise stress test type (in this embodiment). If the imaging stress test
has been selected 702 (Figure 13A), and the imaging stress test indications
selected 704 (Figure 13A), then the imaging stress test type must be
selected, as shown in Figure 13D, and the imaging data entered 712, as
shown in Figure 13E. If the pharmacologic stress test has been selected
(Figure 13B) and the pharmacologic stress test indications selected 707
(Figure 13B), then the pharmacologic stress test type 714 must be selected
(not shown) and the pharmacologic data entered 716, as shown in Figure
13F. The screen display for entering the pharmacologic stress test type 714
(not shown) would be similar to the screen 567 of Figure 13D (imaging
stress test type).
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First, with respect to the imaging stress test types shown in on the
screen 567 of Figure 13D, the possible types of stress test may be exercise
echo, exercise thallium, exercise cardiolite, or "other".
As shown in Figure 13D, the "help" box 165 for the exercise echo
imaging stress test may state: (1) most useful for patients with no wall
motion abnormality or previous infarction; (2) patient must be able to
exercise adequately; (3) must be able to obtain diagnostic echo images; (4)
produces resting echo image as secondary benefits.
The exercise thallium imaging stress test help box may state: (1) most
useful for patients with wall motion abnormality or previous infarction; (2)
patient must be able to exercise adequately; (3) imaging quality good in
almost ali patients; (4) delayed valium imaging (24 hours with reinjection),
may be helpful to check for viable myocardium in patients with resting
perfusion defects.
i 5 The help box for the exercise cardiolite imaging stress test may state:
( 1 ) most useful for patients with wall motion abnormality or previous
infarction; (2) patient must be able to exercise adequately; (3) imaging
quality good in almost all patients.
If desired, the help boxes could also indicate the relative expense of
the different tests. For example, the bottom of the exercise echo help box
could state "less expensive than exercise nuclear imaging," as shown in
Figure 13D. The help box for the exercise thallium test could state at the
bottom "more expensive than exercise echo by 2% - 3%." The exercise
cardiolite test help box could state at the bottom "more expensive than
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exercise echo by 2 - 3 times." This would enable the physicians to take into
account the relative costs of the tests for their patients.
With respect to selecting the pharmacologic stress test type (Figure
12), numerous types may be provided for, including dobutamine echo,
adenosine cardiolite, adenosine thallium, dipyridamole thallium, and
dipyridamole cardiolite (note that PERSANTINE is the trade name for
dipyridamole).
For the dobutamine echo pharmacologic stress test, the "help" box
may state: (1) most useful for patients with normal ventricles or with wall
motion abnormality and/or previous infarctions (provides data on possible
mycocardial viability); (2) must be able to obtain adequate echo images; (3)
may aggravate tachyarrhythmias (atrial fib, v. tach); (4) better test than
adenosine/dipyridamole for patients with bronchospastic disease).
For the adenosine cardiolite, adenosine thallium, dipyridamole
thallium, or dipyridamole cardiolite pharmacologic stress tests, the "help"
box may state: (1) most useful for patients with resting LBBB or potential
stress induced tachyarrythmias; (2) useful in patients with normal
ventricles, wall motion abnormalities, and/or previous infarctions; (3)
imaging quality good in almost all patients; (4) cardiac medications (B-
blockade, etc.) and large patient size do not limit its usefulness; (5) may
aggravate bronchospasm.
Other types of stress tests can be added to the system, including
cardiopulinonary, nuclear, exercise MUGA, etc...., although these are not
included in the present embodiment.
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Referring back to Figure 12, after the imaging/pharmacologic stress
test types are selected 710, 714, the test data for the pertinent stress test
is entered 12, 71fi.
5 E3: Entering the Stress Test Data.
Again, with reference to Figure 12, if the exercise stress test is
selected by the physician, the physician is prompted to enter the exercise
test data 708, as shown in Figure 13C. This data includes the testing
protocol (Bruce, modified Bruce, Naughton, Balke, other). The double
10 product (heart rate times systolic blood pressure at maximum exercise),
exercise time (minutes, seconds), and date performed are also entered.
Next, the physician checks whether any negative/positive subjective
results and negative/positive/ indeterminate objective results (by EKG) were
observed. The "help" box may display information concerning the subjective
15 and objective results.
For a negative subjective result, the help box may state: "no
symptoms compatible with myocardial ischemia, (angina or anginal
equivalent); shortness of breath alone is not considered anginal equivalent."
For a positive subjective result, the help box may state: "symptoms
20 compatible with myocardial ischemia (angina or anginal equivalent);
shortness of breath alone is not considered anginal equivalent."
For a negative objective result (by EKG), the help box may state: "less
than 1 mm ST segment depression 80 rnsec after the 'J' point in exercise or
recovery."
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For a positive objective result (by EKG), the help box may state:
"greater than or equal to 1 mm ST segment depression 80 msec after the 'J'
point in exercise or recovery."
For an "indeterminate" objective result (by EKG), the help box may
state: "ST segments cannot be interpreted with reasonable certainty
secondary to baseline ST changes, artifact, medications or physiologic cause
ST segment changes, LBBB, pre-excitation, etc..."
Additionally, a "high risk positive" objective result (by EKG) may be
provided as a selection. For this result, the help box may state: u(1)
exertional or transient ST segment elevation not subtending a '(,~' wave with
symptoms at any level of exercise; (2) exertional or transient ST segment
depression > 2 mm 80 msec after the 'J' point at any Ievel of exertion with
symptoms of ischemia."
Further, another option in an "other" category, relating to "exertional
hypotension" may be provided. The help box for this result may indicate
that the result should be selected if "greater than 10 mm Hg drop in blood
pressure during exercise."
Referring back to Figure 12, if the physician had selected an imaging
stress test 702, he would have already selected the imaging stress test
indications 704 and the imaging stress test type 710, as shown in Figures
13A and 13D, respectively.
The physician is then prompted to enter the test data 712, as shown
on the screen 569 of Figure 13E. The test data is identical to the data
entered in the exercise stress test described previously and shown in Figure
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13C. However, the imaging stress test, shown in Figure 13E, has an
additional field specific to the type of imaging test. This field is the
. "objective special results" field, which lists "negative," "positive," and
"intermediate" as required selections for the imaging stress test type
selected.
For a stress echo test, the field relates to "objective results by echo."
In this case "negative" may be explained by the "help" box to refer to "no
wall
motion abnormality consistent with reversible ischemia in exercise or
recovery." The "positive" objective result would be caused by "wall motion
abnormality consistent with ischemia during exercise," as explained by the
"help" box. The "indeterminate" selection corresponds to "assessment of
wall motion abnormalities cannot be made with reasonable certainty."
Additionally, other options may be added to the "objective results by echo"
screen, including a "high risk positive" selection which relates to "large
amount of ischemic myocardium with exercise (multiple wall motion
abnormalities), left ventricular (LV) dilation with exercise, decreased or
unchanged LV ejection fraction with exercise, ischemic area remote from
fixed defect."
Similar "help" text is provided for the other types of imaging stress
tests provided for by the present invention.
Referring back to Figure 12, if the physician had selected a
pharmacologic stress test 706, he would have already selected the
- pharmacologic stress test indications 707 (not shown) and the
pharmacologic stress test type 714 (Figure 13B).
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The physician is then prompted to enter the pharmacologic test data
716, as shown in Figures 12, using a display similar to the screen 571 of
Figure 13F. The pharmacologic data is identical to the imaging stress test
data, previously discussed (Figure 13E) with the following exceptions.
The protocol, double product, and exercise time (as well as the other/
"exertional hypotension") fields are not used for any of the pharmacologic
tests. In the case of a dobutamine echo pharmacologic stress test, a
"maximum heart rate" field and umaximum dobutamine dose (/.cg/Kg/Min)"
field are added (not shown).
As with the imaging stress test data, the pharmacological stress test
data contains an "objective special result" field. This field provides a
"negative," "positive," and "indeterminate" selection based on the type of
pharmacological stress test.
The "help" field provides information concerning which special result
should be selected. For the dobutamine echo test, "negative" should be
selected if the result is "no wall motion abnormality consistent with
reversible ischemia during stress." The "positive" selection should occur
when "wall motion abnormality consistent with ischemia during stress."
The "indeterminate" selection is proper when "assessment of wall motion
abnormalities cannot be made with reasonable certainty." Additionally, a
"high risk positive" selection may be provided for situations where "large
amount of ischemic myocardium identified with stress (multiple wall motion
abnormalities), LV dilation with stress, decreased or unchanged LV ejection
fraction with stress, and/or ischemic area remote from fixed defect."
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For the adenosine thallium and adenosine cardiolite pharmacological
stress tests, "negative" should be selected when "no area of reversible
ischemia identified with stress." The "positive" objective result by adenosine
thallium or adenosine cardiolite should be selected when "area of reversible
ischemia identified with stress." The "indeterminate" selection corresponds
to "assessment of perfusion defects cannot be made with reasonable
certainty". Additionally, a "high risk positive" selection may be provided for
cases where ularge amount of ischemic myocardium identified with stress
or multiple defects, LV dilation with stress, ischemic area remote from fixed
defect, and/ or lung uptake (thallium) . "
Similar "help" box messages apply for the PERSANTINE cardiolite and
PERSANTINE thallium tests, as well as other tests which may be added to
the present invention.
After the exercise, imaging, or pharmacologic test data is entered 708,
712, 716, the data is ready for processing.
E4: Processing the Stress Test Data.
Referring back to Figures 12 and 13C, in the case of the exercise
stress test data being entered, the data is processed 718 for post test risk
720. The preferred embodiment uses a lookup table containing all the
permutations of information which are possible in response to the selections
and ranges input by the physician. The exercise stress test lookup table (for
the Balke testing protocol) is disclosed at pages 2-4 of the Appendix
attached hereto. The lookup table for the other testing protocols (Bruce,
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modified Bruce, or Naughton) may be identical to the Balke lookup table,
since each results in the "double product" information. The result of the
analysis from the lookup table is a post-test risk of either "low,"
"intermediate," "high," or "indeterminate." The post-test risk is used to
5 obtain a post-test recommendation, using logic chart of Table 2.
Note that it is unnecessary to include the "high risk positive" option
in the lookup table of the Appendix (pages 2-4) because whenever this
option is selected, the post-test risk is always set to "high". This is also
true
with the "exertional hypotension" option. Whenever this option is selected,
10 the post-test risk is always set to "high".
Referring back to Figures 12 and 13E, the imaging stress test
analyzes the imaging stress test data 722, 724 in the same way as that
previously described for the exercise stress test. The image stress test data
is processed by using a lookup table containing the possible permutations
15 of the data which it was possible to enter. The lookup table for the
imaging
stress test (Bruce testing protocol) is shown at pages 5-34 of the attached
appendix. The lookup table for the other testing protocols (Balke, modified
Bruce, or Naughton) may be identical to the Bruce lookup table, since each
results in the "double product" information. The result of the analysis from
20 the lookup table is a post-test risk 774 of either "low," "intermediate,"
"high,"
or "indeterminate." These results are converted into a recommendation via
the logic of Table 2.
Note that it is unnecessary to include either the other field/
"exertional hypotension" or the objective special result/ "high risk positive"
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fields in the lookup table. Whenever either of these fields are selected, the
"high" post-test risk result occurs.
Referring back to Figures 12 and 13F, in the case where the
pharniacologic stress test data is entered 716 , it is processed 726 in a
similar manner as that of the exercise and imaging stress tests. The
pharmacologic stress test data is processed by using a lookup table
containing the possible permutations of the data which it was possible to
enter. The lookup table for the pharmacologic stress test (adenosine
cardiolite, adenosine thallium, dobutamine echo, dipyridamole
(PERSANTINE) cardiolite, dipyridamole (PERSANTINE) thallium) is shown
at pages 35-41 of the attached Appendix. The result of the analysis from
the lookup table is a post-test risk 728 of either "low," "intermediate,"
"high,"
or "indeterminate." The post-test risk is used with the logic of Table 2 to
provide a recommended action.
Note that it is not necessary to include the "high risk positive" (special
objective result) selection in the lookup table because if this field is
selected
the result of post-testing will always be a "high" risk.
As previously stated, the processing routines always provide a post-
test risk of either "low," "intermediate," "high," or "indeterminate." The
post-
test risk is then displayed on the computer screen, as shown in Figures
13C, 13E, and 13F.
A post-test recommendation routine 730 then uses its own lookup
- table to provide a post-test recommendation. The post-test
recommendations are selected from one or more post-test options, and may
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be a combination of: "no further testing or ischemia treatment," medical
treatment of ischemia," "medical treatment and non-invasive retesting,"
"imaging or pharmacologic stress testing," and "angiography."
The lookup table (with "help" text) is as follows:
Table 2: Post-Test Risk Recommendations Based on Post-Test Risk
POST-TEST RISK RECOMMENDATIONS) & "Help" text
Low 1. No further testing or ischemia treatment
(Help text: Patient is either believed to
have
ischemic coronary artery disease or be
adequately treated on current regimen.)
2. Medical treatment of ischemia
(Help text: Patient is believed to have CAD
and medical regimen will be intensified.)
Intermediate 1. Medical treatment and non-invasive
retesting
(Help text: Patient is believed to have CAD,
will be given medical treatment and then
non-invasive re-tested to determine
adequacy of treatment.)
2. Angiography
(Help text: Recommended to define coronary
artery anatomy for diagnosis and prognosis.)
High 1. Angiography
(Help text: Recommended to define coronary
artery anatomy for diagnosis and prognosis.)
Indeterminate 1. Imaging or Pharmacologic stress testing.
(Help text: Imaging or pharmacologic stress
testing recommended to increase
sensitivity/specificity of previous testing
for
dia nosis and ro nosis.)
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The post-test options are displayed 732, with the recommended
option displayed at the top and highlighted in the list, as shown in Figures
13C, 13E, and 13F. The "help" box may provide more information, as
indicated in the table, on the option on which the cursor is present.
The physician selects a post-test option 732 and, if a non-
recommended option 734, enters reasons 736 why the option was selected
(in a similar manner to that shown in Figure 8B). As stated previously, the
reasons include: "professional judgment," "referral physician preference,"
"public safety," "patient preference," and "other".
F. Post Test Recommendation Subroutine.
After the selection has been entered (Figure 12), the Post Test
Recommendation Subroutine 550, shown in Figure 14, is executed.
If the selection was "angiography" 740, the Angiography Routine 530,
previously discussed with reference to Figure 10, is executed.
If either "no further testing or ischemia treatment" or the "medical
treatment of ischemia" options are selected 742, the workup is completed.
The physician enters any relevant comments 746 and the Evaluation
Routine ends and saves the workup.
If none of these options were selected, then the "medical treatment
and non-invasive retesting" or the "imaging or pharmacologic stress testing"
options must have been selected. In this case, the Stress Test Subroutine
540, previously discussed with reference to Figure 12, is executed a second
time. This enables the physician to select an imaging or pharmacologic
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stress test, or to perform a retest on any of the non-invasive tests.
IL4. Conclusion of Phase II.
Thus, Phase II of the invention provides a system which is able to
recommend proposed diagnostic tests and treatments based on a set of test
results, risk factors, and symptoms. This type of process is capable of being
reproduced in other situations where a cause and effect is known between
symptoms, risk factors, and test results.
Because the I/O is configured to require preceding fields of
information to be entered before displaying later fields of information, the
maximum amount of information is retained by the system, assuring the
generation of complete records.
III. Phase III - Report Generation and System Installation.
Phase III of the invention, shown in Figures 16, 17, 18, 19, 20, 21,
22A, 22B, 23, 24, 25A, 25B, 26 and 27, involves the generation of reports
and statistical analyses by a system administrator. Preferably, the system
administrator also installs the system and maintains the files, as shown in
Figures 15 and 16.
IIL 1 The System Administrator
In the preferred embodiment, a system administrator has the relevant
software files for Phases II and III installed, maintains the database 230,
and generates reports/statistics. Normally, the present invention is
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provided with System Installation Software 245. This software, shown in
the block diagram of Figure 15, is preset with a system administrator
password.
A system administrator manual (not shown) will normally be provided
5 with the System Installation Software 245 to assist the system
administrator in configuring and maintaining the system. The system
administrator manual will contain the preset password so that the system
administrator may gain entry to the system. As shown in Figure 15, after
startup 800, the system administrator enters the (preset) system
10 administrator password 810. An exemplary screen display 815 for entering
the system administrator password is shown in Figure 16.
After entering the preset password, the system administrator will be
presented with a number of options 812 for selection 814. The options, as
shown in Figure 15, may be to install the system on a network 820 (network
15 210 and server 220 shown in Figure 2), install a workstation 830 (a
computer 250, 280 shown in Figure 2), install a stand alone system 840
(not shown), or to install a software upgrade 850 (to either the network 210,
server 220, or computers 250, 280 shown in Figure 2).
The network and workstation installations run together, on a network
20 computer system, i.e. network 210 and computers 250 of Figure 2. In a
networked system, the appropriate files are stored on the network server
220 and accessed by physicians at specified workstations, i.e. the
computers 250, 280 shown in Figure 2.
The install network option 820 runs a routine which installs the
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relevant files on the network server 220 such as the database 230 (which
is installed empty or with sample data) and installs the Administrative
Software 240 on the Administration Computer 240. Next, the install
workstation option 830 may be chosen, which runs a routine to install the
Evaluation software 340 on the relevant computers 250, 280 Alternatively
this option could be run at the computers 250, 280 to install the Evaluation
Routine without using network communication.
The install stand alone option 840 runs a routine to install the
database 230, the Administrative Software 330, and the Evaluation software
340 on a single computer.
The install upgrade option 850 runs a routine which adds new files
or overwrites previously installed files with the latest version of the
software.
This enables additional features to be added yet maintains the integrity of
the system.
After installation, the system administrator can run the
Administrative Software 330. Figure 17 shows a block diagram of the
Administrative Software.
First, the system administrator enters the system administrator
password. The previously mentioned screen 815 of Figure 16, may be used
to enter the password.
A number of options 875 are displayed 870 for selection by the
administrator 880. The options, shown in Figure 18, are "system
maintenance," "generate reports," or "statistics."
If "system maintenance" is selected, the System Maintenance Routine
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890 is executed. A sample screen display 895 for the System Maintenance
Routine is shown in Figure 19. This routine allows standard system
- maintenance operations to be performed. For example the system
administrator may perform the following operations: edit patients (to add,
delete or edit patients), edit consulting physicians (to add, delete or edit
consulting physicians), edit primary physicians (to add, edit or delete
primary physicians), edit facilities (to add, edit or delete facilities), and
set
system password. Additionally, the System Maintenance Routine 890
allows workups to be deleted and data to be exported for use in other
application programs.
When the system administrator desires to edit or add facilities, "edit
facilities" option is selected and the list of prior facilities is displayed.
The
system administrator may select a prior facility and delete it, or select an
"add facility" option (not shown) and enter the name of new facilities. If a
facility is to be deleted, the system prompts the administrator with a
warning message. The system may be configured so that the deletion of
facilities also deletes the associated workups, or the system may require the
workups to be individually deleted.
Adding, deleting and editing consulting physicians, primary
physicians and patients is done in the same manner.
The delete workups option may be selected to delete a prior workup.
This may be necessary, for example, if a patient is deleted. It therefore
becomes unnecessary to maintain the patient's workup. This may also be
necessary if a physician runs a workup on a patient who does not meet the
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inclusion criteria. In this case the workup may be deleted to prevent the
skewing of results in the reports. When the "delete workups" option (not
shown) is selected, the Iist of workups is displayed on the screen. A workup
may be highlighted and then deleted by the delete workup option.
To set the system password, the system administrator types in the
prior password and the new password. Preferably the new password is
entered twice to ensure that the system administrator has not mistyped the
password.
Additionally the database may be repaired by selecting a "repair
database" option. This option basically rearranges the data within the
database 230 to be more efficiently retrieved. This should normally be
selected every thirty days, depending upon the frequency with which data
is entered into the database.
An "export data" selection is provided by the System Maintenance
Routine 890, as shown in Figure 19. Figure 20 shows sample screen
displays of the "export options" 897 and "export file name" screens 899 from
the "export data" selection. The "export data" selection is used to output
data to different types of application programs, such as spread sheets or
word processors. In a preferred embodiment, shown in Figure 20, the type
of information to export may be selected, i.e., pretest assessment, stress
test, angiograms. The information for all of the physicians, or for
specifically selected physicians, may be selected for export. Further, the
information from a specific date range or all date may be selected.
Additionally, a record header may be selected for inclusion with the field
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names. The "export data" option is useful for exporting column headings to
application programs. After selecting the data for export 897, the file type
and file location 899 may be specified, as shown in Figure 20.
IIL2. Report Generation.
A useful feature of the present invention is to generate reports of
physician's activities or related to workups, facilities, or patients. As
shown
in Figure 17, a Report Routine 900 is provided. The Report Routine 900
generates different types of reports.
The system administrator may choose a type of report and then print
or view the report. The types of reports are generally shown in Figure 21
(screen display 901) and include: workup table reports (workups, pretest
assessments, stress tests, or angiograms) statistics (workups per physician,
pretest assessments per physician, stress tests per physician, angiograms
per physician) list table reports (tables of facilities, physicians,
patients),
and change table reports (tables of pretest assessment changes, stress test
changes, angiogram changes).
A workup table report of stress tests 903 is shown in Figure 22A and
Figure 22B. A statistics report of workups per physician 905 is shown in
Figure 23. A list table report of physicians 907 is shown in Figure 24. A
change table report of pretest assessment changes 909 is shown in Figure
25A and Figure 25B. The format and content of the reports is easily
modified to include any data in the database.
As examples, the workup table reports may list tables of information
related to evaluations. Specifically, the workups report may list workups by
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date, including patient name, physician name, facility and workup
comments. The pretest assessment report may list the contents of the
pretest risk screen for all workups, including symptoms and risk factors
listed by workup date. The stress tests report 903 may list the results of all
5 tests run on patients, by workup date (see Figure 22A and Figure 22B). The
angiogram report may list the results of complete angiograms, by workup
date.
The statistical reports list statistics concerning the physicians. For
example, the statistics could include the number of workups (Figure 23),
10 pretest assessments, stress tests, or angiograms per physician. The
workups per physician report 905 may Iist the number of completed and
uncompleted workups performed by each physician. The pretest
assessments per physician report may list the actions selected by
physicians following the pretest risk assessment, including any guideline
15 deviations. The stress tests per physician report may list the number of
completed and uncompleted tests per physician. The angiograms per
physician report may list a number of completed and uncompleted (pending
or declined) angiograms performed per physician.
The list table reports generally list the facilities, physicians and/or
20 patients. For example, the facilities report may list all the hospitals and
clinics included in the database. The physicians report 907 may list all the
physician information recorded in the database, including physician
security numbers, as shown in Figure 24. The patients report may list the
names and Social Security Numbers of the patients in the database.
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The change table reports list changes made by the physician. For
example, the pretest assessment changes report 909 may list all the
changes made to previously recorded data on the pretest risk screen, as
shown in Figure 25A and Figure 25B. The stress test changes report may
list all changes made to previously recorded stress test results. The
angiogram changes report may list all changes made to previously recorded
angiogram results.
A report viewer is also included in the present system. The report
viewer is shown in Figures 22A, 22B, 23, 24, 25A and 258. Referring to
Figure 22A, the report viewer 955 rnay list the number of database records
queried 911 for the report, the number of database records that fit the query
requirements 913, the number of records used for the report 915, and the
percentage of queried records used for the report 917. The viewer also
displays the contents of the report 9I9. Viewer commands include go to the
first page of the report 921, go to the last page of the report 923, move
ahead one page 925, move back one page 927, stop reading database 929
(if databases access is taking a long time), magnify 931, and print report
933, and may include other well known viewing commands.
The viewer enables the system administrator to quickly page through
the report for information needed by the health care provider's management
and to print the report.
. IIL3. Statistical Graphs.
Despite the statistics report, a separate Statistics Routine 910 (Figure
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17) is used to generate graphs of the data stored in the database. Figure 26
shows a screen display 941 for the Statistics Routine 910. As shown in
Figure 19, the Statistics Routine generates statistics for the physicians,
either separately or in a selected combination. The number of workups,
pretest evaluations, stress tests, angiograms, pretest evaluation deviations,
and stress test deviations per physician may be plotted. Additionally, the
types of deviations (such as for deviations from pretest or stress test
recommendations) may be plotted per physician. The graphs may be
formatted for overall total numbers or broken down by physician (either by
ID number or by name). Figure 27 shows a statistical graph 945 of workups
per physician, by physician number.
The specific reports and statistical graphs listed herein are only for
illustration only. It is to be understood that any information within the
database may be included on a report or statistical graph.
IV. Phase IV- Updating the Phase II Embodiment.
In the fourth "phase" of the invention, the decision support
recommendations of Phase II are periodically refined and updated after a
review of the aggregate data and in view of the results of the latest research
as determined by an expert review panel.
Phase IV involves the same basic steps shown in Figure 1, and is
performed periodically to refine and update the phase II system. In Phase
IV of the invention, advances in medicine occurring after the previous Phase
I/II stages are considered, as relating to risk factors ?0, presenting
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symptoms 50, diagnostic techniques 90, treatments 30 and other
information ( 110), such as patient signs or the medical literature. Based on
. the prior knowledge base and the newly available information, the "best
practice" knowledge base is updated.
An important part of the Phase IV embodiment is an analysis, in the
aggregate, of the stored evaluations/workups from the databases 230. This
is shown at step 115 of Figure 1. Databases 230 contain actual data which
was in many cases entered firsthand by physicians, often in the presence
of their patients. Much can be learned from this data, including new risk
factors, presenting symptoms, diagnostic techniques, treatments, or other
information. The data is valuable because it is obtained firsthand from
practicing physicians and relates to actual patients.
This phase makes use of all the prior workup data. Data entered by
physicians when they do not select a recommended course of action, or
select an option not provided for in the knowledge base (such as "other" as
shown in the various screen displays) is especially helpful. This data
provides new information which may be studied by experts in the field to
improve the phase II "best practice" system.
The knowledge base is thus expanded using the experiences
(evaluations) recorded in the database 230. New code is generated 130 and
new I/O routines coded 140 to implement the new knowledge in the
knowledge base. Coding the I/O routines preferably also involves
generating °help" boxes to explain new options or input fields, or the
latest
advances incorporated into the system. Testing 180 is performed as before,
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and when complete an update or new program 190 is generated. The new
program may be installed as shown and described with respect to Figures
15-16. A program update may be installed as shown at option 850 in
Figure 15.
Thus, Phase IV updates the present invention to incorporate the latest
knowledge in the medical field. Practicing physicians who use the present
invention in Phase II may at once alter their practices without training to
implement the newest advances in medicine, as they perform and store
workups which will be used in the future to further advance the field.
The foregoing description of the present invention has been presented
for purposes of illustration and description. Furthermore, the description
is not intended to limit the invention to the specific embodiments described.
Consequently, variations and modifications commensurate with the above
teachings, and within the skill and knowledge of the relevant art, are part
of the scope of the present invention. The embodiments described
hereinabove are further intended to explain best modes known of practicing
the invention and to enable others skilled in the art to utilize the invention
in such, or other embodiments and with various modifications required by
the particular application or use. It is intended that the appended claims
be construed to include alternative embodiments to the extent permitted by
law.
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Appendix
Appendix p. 1
CA 02306017 2000-03-29
PCTIUS98I12849
W O 98158338
56
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