U.S. patent application number 11/334747 was filed with the patent office on 2006-09-14 for data analysis system.
Invention is credited to Philip Jonathan Merrett, Loua Asad Hanna Al Shaikh.
Application Number | 20060206012 11/334747 |
Document ID | / |
Family ID | 9937862 |
Filed Date | 2006-09-14 |
United States Patent
Application |
20060206012 |
Kind Code |
A1 |
Merrett; Philip Jonathan ;
et al. |
September 14, 2006 |
Data analysis system
Abstract
A system and method for gathering and displaying information in
data intensive environments. It is particularly concerned with data
analysis in a critical care environment to provide a graphical
display of derived information, comprising a series of bar charts
(a-h) representative of a corresponding series of functions (32).
Each bar chart comprises a linear series of time-divided segments
(34) wherein each segment (34) of each bar chart (a-h) is assigned
a colour corresponding to the status of that function (32). The
status of each function (32) is derived by scoring contributory
data indicators in accordance with pre-set threshold values, and
logically combining to produce a status score for each function.
Interventions that affect particular functions may also be recorded
and displayed against those functions so that their effect is
readily discernible.
Inventors: |
Merrett; Philip Jonathan;
(Hampshire, GB) ; Shaikh; Loua Asad Hanna Al;
(Surrey, GB) |
Correspondence
Address: |
NIXON & VANDERHYE, PC
901 NORTH GLEBE ROAD, 11TH FLOOR
ARLINGTON
VA
22203
US
|
Family ID: |
9937862 |
Appl. No.: |
11/334747 |
Filed: |
January 19, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10230395 |
Aug 29, 2002 |
7081091 |
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11334747 |
Jan 19, 2006 |
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Current U.S.
Class: |
600/300 ;
128/920 |
Current CPC
Class: |
Y10S 128/92 20130101;
A61B 5/0205 20130101; A61B 5/339 20210101; G16H 50/30 20180101;
G16H 50/20 20180101; A61B 5/7445 20130101; G16H 10/60 20180101 |
Class at
Publication: |
600/300 ;
128/920 |
International
Class: |
A61B 5/00 20060101
A61B005/00 |
Foreign Application Data
Date |
Code |
Application Number |
May 31, 2002 |
GB |
0212700.9 |
Claims
1-20. (canceled)
21. A method of analysis of data measured in a time-varying
environment, the method comprising the steps of: (a) recording data
items generated during a selected time period from monitoring
equipment and recording intervention data entered by personnel; (b)
comparing each data item recorded at step (a) with preset threshold
values; (c) selecting a group of functions, each function having a
status which is contributory to an overall status of the
environment and the number of functions in the group being less
than the number of data items, scoring each function on the basis
of the comparisons made at step (b) for all data items indicative
of the status of that function; (d) displaying a series of bar
charts on a display screen, wherein each bar chart corresponds to
one of the group of functions and comprises a linear series of
time-divided segments; (e) repeating steps (a) to (e) for an
adjacent time period, while preserving bar chart segment coloration
for at least one previous time period; (f) recording intervention
data entered by personnel relating to interventions conducted at
known times; and (g) displaying data indicative of said
intervention data alongside the bar charts in temporal
correspondence with the time-divided segments, wherein the data
items relate to the physical condition of a patient.
22. A method according to claim 21, wherein the scoring step is
carried out in accordance with a Sequential Organ Failure
Assessment (SOFA) scoring system, or a modified version
thereof.
23. A method according to claim 21, wherein bar chart segment
coloration is preserved for at least 8 previous time periods.
24. A method according to claim 23, wherein each time period is one
hour long.
25. A method according to claim 23, wherein each bar chart extends
horizontally across the display with each successive time
period.
26. A computer system programmed to provide a graphical display of
derived information, the display comprising a series of bar charts
representative of a corresponding series of functions, each bar
chart comprising a linear series of time-divided segments wherein
each segment of each bar chart is one of a set of permitted colors;
to assign the colors to the segments in accordance with the status
of the corresponding function at the time period represented by
that segment; and to derive the status of each function from a
number of data indicators extracted from a database wherein each
data indicator comprises an experimental observation made on a
system at a time corresponding to the time period represented in
the bar chart by the relevant segment, and the status of each
function is derived by scoring contributory data indicators in
accordance with preset threshold values to produce a status score
for each function, wherein the data indicators comprise data
relating to data items read from a database, the data items
comprising data generated during a selected time period from both
monitoring equipment and intervention data entered by personnel,
and wherein data indicative of said intervention data is displayed
alongside the bar charts in temporal correspondence with the
time-divided segments.
27. A computer system according to claim 26, wherein the data
indicators comprise observations made on a hospital patient.
28. A computer system according to claim 27, wherein the data
indicators comprise information indicative of one or more of:
patient blood pressure, heart rate, temperature, central venous
pressure, pulmonary artery catheter data, cardiac output, vascular
resistance, urine output, respiratory rate, blood chemistry,
hemoglobin, white cells, coagulation profile and arterial blood
gases.
29. A computer system according to claim 27, wherein the functions
comprise the functioning of at least two of the following organ
systems: respiratory, cardiovascular, coagulation, renal, hepatic,
neurological and gastrointestinal.
30. A computer system according to claim 29, wherein the status of
each function is derived from the data indicators in accordance
with one of a Sequential Organ Failure Assessment (SOFA) scoring
system, or a modified SOFA scoring system.
31. A subject monitoring system which graphically displays derived
information, the system comprising: monitoring equipment arranged
to make periodic observations on a subject system, a database
arranged to store as data items results of periodic observations
made by the monitoring equipment; manual data input equipment
arranged to enable entering and recording of intervention data in
the database; a processor arranged to analyze periodically the
stored data items to provide an indication as to status of a
selected group of functions, the status of each function being
deducible as a score from a subset of the data items compared with
preset threshold values; and a display arranged to display a series
of bar charts representative of the group of functions, each bar
chart comprising a linear series of time-divided segments wherein
each segment of each bar chart is one of a set of permitted colors,
the colors being assigned to the segments in accordance with the
score obtained for the corresponding function at the time period
represented by that segment and to display data representative of
the recorded intervention data, wherein data indicative of said
intervention data is displayed alongside the bar charts in temporal
correspondence with the time-divided segments.
32. A monitoring system in accordance with claim 31, wherein the
monitoring equipment comprises medical monitoring equipment and the
subject system is a patient.
33. A monitoring system according to claim 32, wherein the data
indicators comprise information indicative of at least one of
patient blood pressure, heart rate, temperature, central venous
pressure, pulmonary artery catheter data, cardiac output, vascular
resistance, urine output, respiratory rate, blood chemistry,
hemoglobin, white cells, coagulation profile and arterial blood
gases.
34. A monitoring system according to claim 32, wherein the
functions comprise the functioning of at least two of respiratory,
cardiovascular, coagulation, renal, hepatic, neurological and
gastrointestinal organ systems.
35. A monitoring system according to claim 34, wherein the status
of each function is derived from the data indicators in accordance
with a Sequential Organ Failure Assessment (SOFA) scoring system,
or a modified SOFA scoring system.
36. A programmable digital computer programmed for: (a) reading
data items from a database, the data items comprising data
generated during a selected time period from monitoring equipment
and intervention data entered by personnel; comparing each data
item with preset threshold values; scoring each of a selected group
of functions, each function having a status which is contributory
to an overall status of the environment and the number of functions
in the group being less than the number of data items, scoring
being done on the basis of the comparisons made for all data items
indicative of the status of that function; (d) converting function
scores to a color representation and assigning these colors to
corresponding scoring functions in the time period, and (e)
displaying a series of bar charts on a display screen, wherein each
bar chart corresponds to one of the group of functions and
comprises a linear series of time-divided segments, and wherein
each segment corresponding to the time period on each bar chart is
colored with the color assigned to the corresponding function,
wherein data indicative of said intervention data is displayed
alongside the bar charts in temporal correspondence with the
time-divided segments.
37. A method of analysis of data measured in an environment that
varies with time, the method comprising the steps of: (a) recording
data; generated during selected time interval(s) from monitoring
equipment and intervention data entered by personnel; (b) comparing
each data item gathered at step (a) with preset threshold values;
(c) for each of a selected group of functions, each function having
a status which is contributory to an overall status of the
environment and the number of functions in the group being less
than the number of data items, scoring each function on the basis
of the comparisons made at step (b) for all data items indicative
of the status of that function; (d) converting scores obtained at
step (c) to one of a number of selected visual representations and
assigning those representations to correspondingly scoring
functions for a specific time period; (e) recording one or more
interventions conducted upon, and capable of affecting, the
environment; (f) displaying a series of graphical representations
on a display screen, wherein each graphical representation
corresponds to one of the group of functions and comprises a series
of time-divided segments arranged sequentially, and wherein each
segment corresponding to the time period on each graphical
representation is visually represented according to the visual
representation assigned to the corresponding function at step (d);
(g) displaying on the display screen the one or more interventions
adjacent to one or more of the segments corresponding to the time
of the intervention and adjacent to a timeline corresponding to the
time-divided segments, so as to facilitate a comparison of the
effect of the intervention on the environment; and (h) repeating
steps (a) to (e) for an adjacent time period, whilst preserving the
segment's visual representation for at least one previous time
period, wherein data indicative of said intervention data is
displayed alongside the bar charts in temporal correspondence with
the time-divided segments.
38. A program stored on a computer on a machine-readable medium,
said program comprising code portions for: (a) reading data items
from a database, the data items comprising data generated during a
selected time period from monitoring equipment and intervention
data entered by personnel; (b) comparing each data item with preset
threshold values; (c) scoring each of a selected group of
functions, each function having a status which is contributory to
an overall status of the environment and the number of functions in
the group being less than the number of data items, scoring being
done on the basis of the comparisons made for all data items
indicative of the status of that function; (d) converting function
scores to a color representation and assigning these colors to
corresponding scoring functions in the time period; and (e)
displaying a series of bar charts on a display screen, wherein each
bar chart corresponds to one of the group of functions and
comprises a linear series of time-divided segments, and wherein
each segment corresponding to the time period on each bar chart is
colored with the color assigned to the corresponding function,
wherein data indicative of said intervention data is displayed
alongside the bar charts in temporal correspondence with the
time-divided segments.
Description
[0001] This invention relates generally to systems and methods for
information analysis in data intensive environments and to
applications thereof for use as an aid in making decisions. It is
particularly concerned with data analysis in a critical care
environment.
[0002] Whilst computerisation has clearly been beneficial to
numerous aspects of modern life, its increasing use in data capture
has given rise to a new problem. Automated monitors and measuring
systems can take readings more frequently than was possible with
their manually operated predecessors. Whenever a decision or
assessment is to be made based on the readings from these systems,
there is accordingly a vast amount of data available. The sheer
volume of data alone may obscure judgment but, more often than not,
the assessment must also be made rapidly. Such situations will be
referred to as data intensive environments.
[0003] One example of a data intensive environment is that
encountered in a hospital, in particular in intensive care and high
dependency units. Current clinical practice requires that a
plethora of specific medical data are measured in the critically
ill patient. Different data are collected at various intervals and
are traditionally entered onto large paper-based observation
charts. Psychological studies have shown that the normal human
brain can handle some 20 variables at any one time. There is thus
always a danger of information overload, even for skilled staff.
Each patient's paper chart must be studied carefully in order to
detect important changes in his or her condition. Unfortunately,
there is often only recognition of an acute system failure once an
adverse trend has been established.
[0004] There is now the added complication that newer technological
advances have allowed closer monitoring of a patient, for example
heart rate and blood pressure changes may now be recorded every few
seconds; this has also increased the contribution to the data
burden. Although theoretically therefore, such close monitoring may
allow early detection of adverse trends so that prompt early
corrective measures may be instituted, in practice the amount of
data often makes its interpretation more difficult.
[0005] The clinical environment is rife with distractions which
often put staff under extreme pressure; this is particularly
exacerbated with the high level of alarms. Moreover, the level of
expertise amongst clinicians for signal interpretation can vary
considerably, with the lesser skilled staff more likely to make
errors in diagnosis and selection of the most appropriate
treatment. Particularly where it is necessary for staff to assess
medical data by referring to known organ system failure scoring
systems, lesser skilled staff are more likely to make an inaccurate
assessment of the patient's condition, or to take longer to
recognise an adverse trend.
[0006] A further problem is that the data available needs to be
assessed having regard to recent clinical interventions, which
interventions have traditionally only been recorded by nursing
staff as hand annotations to paper charts.
[0007] U.S. Pat. No. 5,921,920 to Marshall et al. describes a
patient monitoring system, which creates graphical displays of
pulmonary and other patient functions in order better to present a
wealth of information to the clinician. In a preferred display,
eight principal variables are displayed radially, with their
arrangement and size intended to assist the clinician. This prior
art system, although capable of providing a sophisticated modelling
capacity, does not display the overall patient status in such a way
as to be readily intelligible by lesser skilled staff (or indeed,
relatives of patients); nor does it display interventions or
facilitate an assessment of their effect on related organ
systems.
[0008] There is therefore a perceived need to provide a system
which assists an assessor in making a judgment based on analysis of
large amounts of data, by enabling an increase in the speed with
which the judgment is reached and potentially improving the
accuracy of the diagnosis. In particular, in the field of
critically ill patient care, there is a perceived need for a system
with which regularly-collected patient data can be distilled to
provide a reduced data set from which an assessment of patient
condition can more readily be made.
[0009] The present invention provides a method of analysis of data
measured in an environment, the method comprising the steps of:
[0010] (a) Gathering data, generated at selected time intervals,
from monitoring equipment and/or personnel;
[0011] (b) Comparing each data item gathered at Step (a) with
preset threshold values;
[0012] (c) For each of a selected group of functions, each function
having a status which is contributory to an overall status of the
environment and the number of functions in the group being less
than the number of data items, scoring each function on the basis
of the comparisons made at Step (b) for all data items indicative
of the status of that function;
[0013] (d) Converting scores obtained at Step (c) to one of a
number of selected visual representations and assigning those
representations to correspondingly scoring functions for a specific
time period,
[0014] (e) Displaying a series of graphical representations on a
display screen, wherein each graphical representation corresponds
to one of the group of functions and comprises a series of
time-divided segments arranged sequentially, and wherein each
segment corresponding to the time period on each graphical
representation is visually represented according to the visual
representation assigned to the corresponding function at Step (d);
and
[0015] (f) Repeating steps (a) to (e) for an adjacent time period,
whilst preserving the segment's visual representation for at least
one previous time period.
[0016] Different types of data may be gathered at different
intervals depending on their respective availability. The time
periods into which the displayed segments are divided are
preferably adjustable to allow a user to adjust the display. Hence,
the time periods will not usually match the sampling intervals of
the data, in which case the last available data will have to be
used. Where the display time period is altered by the user, the
status of each function for each new segment is recalculated.
[0017] The graphical representation may comprise any suitable
method of display, providing that it extends along a time line and
is formed of time-divided segments arranged adjacent or close to
one another in time order. Usually, a bar chart of straight,
parallel bars (or thick lines) will be most appropriate, as this
has been found to be the most readily intelligible display format.
However, other arrangements such as straight or curved lines,
usually arranged parallel to one another and representing the
various functions may be used as well. Circles divided into
respective sectors with a circumference representing the timeline
may also be appropriate, for example where only a few functions are
being monitored.
[0018] The visual representation found to be the most effective is
the use of different colours. For example, any functions at a
critical level could be represented in red or orange colours, while
other colours, possible matching the order of the spectrum, can
portray increasingly less critical levels. However, different forms
of hatching, different tones (i.e. light to dark variations), or,
for example, merely labelling with alphanumeric characters may also
be employed. The respective functions may be distinguished from one
another by a secondary visual indication. For example, where
hatching or tonal differences are employed to denote status, the
respective functions can be distinguished from one another by being
different colours, and vice versa.
[0019] In an important aspect of the present invention, there is
recorded in the above method one or more interventions conducted
upon, and capable of affecting, the environment, the method further
comprising displaying on the display screen the one or more
interventions adjacent to one or more of the segments corresponding
to the time of the intervention and/or adjacent to a timeline
corresponding to the time-divided segments, so as to facilitate a
comparison of the effect of the intervention on the
environment.
[0020] This aspect is of particular value in medical applications,
where the data relates to the physical condition of a patient.
[0021] The intervention may be displayed against the segments of
one or more, and preferably all, of the functions that it is
capable of affecting. Importantly, this allows a user at a glance
to recognise whether the intervention has had an impact on the
related functions. The intervention is usually displayed as
selected details and/or as a marker. Where a marker is solely
employed, further details of the intervention are preferably
accessible for display by the user.
[0022] Advantageously, a protocol by which an intervention is
conducted is additionally recorded and is displayed or accessible
for display by the user. The protocols may be pre-grouped to a
particular function, for example an organ system in medical
applications, so that the intervention can be displayed against the
functions (e.g. organ systems) it affects. Alternatively, the
intervention can designate the functions it affects when it is
first entered. Either way, it is advantageous to have a default
setting whereby the intervention is indicated next to a general
timeline or general condition indicator.
[0023] As a result of the above, the invention is able to provide a
real-time single-screen display that allows direct comparison of
the functions of the environment and their correlation with any
interventions performed.
[0024] The present invention further provides a method of analysis
of data measured in a time-varying environment, the method
comprising the steps of:
[0025] (a) Gathering data, generated during a selected time period,
from monitoring equipment and/or personnel;
[0026] (b) Comparing each data item gathered at Step (a) with
preset threshold values;
[0027] (c) For each of a selected group of functions, each function
having a status which is contributory to an overall status of the
environment and the number of functions in the group being less
than the number of data items, scoring each function on the basis
of the comparisons made at Step (b) for all data items indicative
of the status of that function;
[0028] (d) Converting scores obtained at Step (c) to a colour
representation and assigning these colours to correspondingly
scoring functions at the time period,
[0029] (e) Displaying a series of bar charts on a display screen,
wherein each bar chart corresponds to one of the group of functions
and comprises a linear series of time-divided segments, and wherein
each segment corresponding to the time period on each bar chart is
coloured with the colour assigned to the corresponding function at
Step (d); and
[0030] (f) Repeating steps (a) to (e) for an adjacent time period,
whilst preserving bar chart segment colouration for at least one
previous time period.
[0031] In this aspect bar chart segment colouration is preferably
preserved for at least eight previous time periods, particularly
where those are one hour periods. Typically, it will be useful to
preserve such information for the previous 4, 8, 12 or 24
hours.
[0032] Although the manner of collection of data is not a part of
this invention and may be entirely manually input data, more
usually automatically monitoring equipment will supply most or all
of the data.
[0033] In a second aspect, the present invention provides a
computer system configured:
[0034] to provide a graphical display of derived information, the
display comprising a series of bar charts representative of a
corresponding series of functions, each bar chart comprising a
linear series of time-divided segments wherein each segment of each
bar chart is one of a set of permitted colours,
[0035] to assign the colours to the segments in accordance with the
status of the corresponding function at the time period represented
by that segment
[0036] to derive the status of each function from a number of data
indicators extracted from a database wherein each data indicator
comprises an experimental observation made on a system at a time
corresponding to the time period represented in the bar chart by
the relevant segment, and the status of each function is derived by
scoring contributory data indicators in accordance with preset
threshold values to produce a status score for each function.
[0037] In an alternative aspect the present invention provides a
monitoring system which graphically displays derived information,
the system comprising:
[0038] monitoring equipment arranged to make periodic observations
on a system,
[0039] a database arranged to store as data items results of
periodic observations made by the monitoring equipment,
[0040] a processor arranged to analyse periodically the stored data
items to provide an indication as to status of a selected group of
functions, the status of each function being deducible as a score
from a subset of the data items compared with preset threshold
values, and
[0041] a display means arranged to display a series of bar charts
representative of the group of functions, each bar chart comprising
a linear series of time-divided segments wherein each segment of
each bar chart is one of a set of permitted colours, the colours
being assigned to the segments in accordance with the score
obtained for the corresponding function at the time period
represented by that segment.
[0042] The monitoring system preferably also includes a manual data
input arranged to write information to the database in the form of
data items, these data items corresponding to results of manual
observations made on the system.
[0043] In a fourth aspect, the invention provides a computer
readable medium embodying instructions for execution by a
processor, the computer readable medium comprising:
[0044] (a) Program code for reading data items from a database, the
data items being generated during a selected time period from
monitoring equipment and/or personnel;
[0045] (b) Program code for comparing each data item with preset
threshold values;
[0046] (c) Program code for scoring each of a selected group of
functions, each function having a status which is contributory to
an overall status of the environment and the number of functions in
the group being less than the number of data items, scoring being
done on the basis of the comparisons made for all data items
indicative of the status of that function;
[0047] (d) Program code for converting function scores to a colour
representation and assigning these colours to correspondingly
scoring functions at the time period,
[0048] (e) Program code for displaying a series of bar charts on a
display screen, wherein each bar chart corresponds to one of the
group of functions and comprises a linear series of time-divided
segments, and wherein each segment corresponding to the time period
on each bar chart is coloured with the colour assigned to the
corresponding function.
[0049] All these aspects of the invention provide a means with
which a wealth of information (data items) can be displayed
graphically as a series of coloured bar charts, each bar chart
representing the status of a particular contributory factor to the
overall condition of the environment. The colours of each bar chart
provide a readily assimilated visualisation of both the fluctuating
status of each component factor and a quick means of comparison
between the various components. In this way, complex assessments
can be made more rapidly than known in the prior art.
[0050] It is preferred that each bar chart extends horizontally
across the display with each successive time period. This
arrangement provides a display which is more intuitively understood
by a human observer as a time progression chart.
[0051] The data items or indicators preferably relate to
observations made on the physical condition of a hospital patient.
They may, for example, be indicative of one or more of: patient
blood pressure, heart rate, temperature, central venous pressure,
pulmonary artery catheter data, cardiac output, vascular
resistance, urine output, respiratory rate, blood chemistry,
haemoglobin, white cells, coagulation profile and arterial blood
gases.
[0052] Depending on the patient's illness, a sufficient number of
organ systems should be selected and displayed to provide an
assessment of the patient's overall condition. The functions
preferably comprise the functioning of at least two, and preferably
at least four of the following organ systems: respiratory,
cardiovascular, coagulation, renal, hepatic, neurological and
gastrointestinal. Scoring values may be derived for these systems
using the Sequential Organ Failure Assessment (or SOFA) scoring
system, or a modified version based thereon. Where alternative
scoring systems are employed which relate to other major
indicators, a selected group of those indicators may be represented
by respective bar charts.
[0053] It is convenient when using such a system in an intensive
care unit for the time period spanned by each segment to be one
hour long. Intervals of 15, 20 or 30 minutes may, however,
sometimes be preferred.
[0054] Although a fixed time base can be used, advantageously the
time base is variable, so that the period or interval of the
displayed segment can be changed by the viewer, thereby providing a
"zoom in" or "zoom out" function. Where the system comprises a
plurality of displays that may be selected (usually in place of one
another, but possibly also in split screen format), it is usually
desirable for a change in the time base in any one display to be
reflected in all displays. For example, in the main display, a
specific time (e.g. 2 o'clock) may be selected (eg by a cursor),
and then the time base may be increased or decreased to display
more or less information, the colour of the newly displayed
segments being freshly derived from the original data.
[0055] Although the clinical display system will usually be
associated with an individual patient, it is possible for the
system to monitor a plurality of patients simultaneously.
[0056] An embodiment of this invention has been implemented for use
in patient assessment in an ICU. The improvement it has brought has
been remarkable. In a study made of the responses of nineteen
medical and intensive care nursing staff it was found that over six
clinical scenarios accuracy of the judgment made as to a patient's
status was nearly doubled and the time taken to complete an
assessment was reduced by nearly 90% when information was displayed
in accordance with this invention rather than as in the prior art
patient charts. This, in any situation, represents a dramatic and
surprising degree of improvement.
[0057] Embodiments of the invention will now be described by way of
example only and with reference to the accompanying drawings.
[0058] FIG. 1 is a block diagram illustrating equipment used in an
intensive care unit with a computer system configured in accordance
with an embodiment of this invention.
[0059] FIG. 2 is an exemplary output screen generated by the
computer system embodiment of FIG. 1.
[0060] FIG. 3 is a functional diagram indicating the process steps
carried out by the computer system of FIG. 1 in implementing a
second aspect of the invention.
[0061] FIG. 4 is an exemplary subscreen display indicating actual
data values used to derive one of the bar charts of FIG. 2.
[0062] FIG. 5 is an exemplary subscreen display of a protocol
screen, which is generated by the computer system of FIG. 1.
[0063] FIG. 6 is an expanded view of one of the bar charts of FIG.
2.
[0064] FIG. 1 illustrates equipment 10 maintained in an intensive
care unit (ICU) environment; that equipment may be regarded as a
decision support system capable of assisting a clinician at
arriving at a decision concerning treatment/discharge, etc of a
patient. It is to be noted that the system to be described for use
in this environment is a preferred embodiment of the invention, and
one skilled in the art will readily appreciate how this embodiment
may be adapted for implementation of the invention in alternative
data intensive environments.
[0065] The equipment 10 comprises a computerised bedside system 12
which collects and stores data relating to a patient from a variety
of inputs such as a manual input 14, automated patient monitoring
systems 16 and a respiratory ventilator 18. The bedside system 12
is in communication with a database 20, which is populated with
data extracted from a pathology server 22 and also from data passed
to it from the bedside system 12. A clinical display system 24,
which includes a processor (not shown) is arranged to analyse
patient information collected by the bedside system 12 and stored
in the database 20 in accordance with previously stored data
standards.
[0066] All the above components, with the exception of the clinical
display system are standard commercially available devices. The
bedside system 12 comprises a computer running data-gathering
software; such software is also readily available in the
marketplace. This software enables data capture, storage and
manipulation, data being collected both through an automatic
interface to standard bedside monitoring equipment 16, 18 and
through a manual interface operable by clinical or administrative
staff. The patient monitoring systems 16 may include patient
support systems that incorporate a monitoring capability. In
particular, the patient monitoring systems may include meters, MVO2
devices, cardiac outputs, as well as support devices such as
infusion pumps (none shown); thus, there is encompassed any device
that traditionally provides information in an ICU which may need to
be acted on with urgency.
[0067] The database 20 may store, for example, four data types:
patient information (i.e. name, date of birth, admission time,
etc.), department information (i.e. ward, bed number, consultant in
charge, etc), system information (i.e. blood pressure readings,
cardiac output, etc) and analysis information (i.e. threshold
values for critical indications, conversion values, display
characteristics). These data are input or extracted from the
various sources 14, 16, 18, 22. It is to be appreciated that whilst
the database shown in this preferred embodiment is referred to for
convenience as a single database 20, it may in fact comprise a
number of physically separate databases, depending on the
particular implementation and available equipment. For example, the
CIS, referred to above, itself comprises three databases, which
store the first three data types. The clinical display system 24 is
then configured to include an additional database which stores the
analysis information. What is important is the functionality and
accessibility of the database(s), not physical location.
[0068] Also stored in the database 20 is protocol information,
which is text information entered by users. A protocol is a
documented description of a process by which a medical intervention
is performed. The provision of a defined process by which a
treatment is performed facilitates evidence based process
improvement and audit. For example, if two alternative protocols
for administering a treatment are used for a year in an ICU, and
one is found by audit to have a lower risk of subsequent infection,
the latter may be solely adopted. The protocol information can be
amended as well as deleted, and this may occur through the manual
input 14, in order to allow new protocols to be added. The
pathology server 22 is a data source which stores the results of
pathology laboratory tests and will therefore usually form a
separate database. Subject monitoring may therefore involve the
remote processing of samples from the subject, and those results
may be retrieved by electronic transfer or input manually.
[0069] When the system is in use, the status of a critically ill
patient is constantly checked both by means of readings taken
automatically by the monitoring system 16 and also usually by
manual tests and observations made by trained staff. Monitoring
system measurements are input to the bedside system 12 via the
automatic interface and these data are supplemented by the manual
test results entered onto the system 12 via the manual data input
14. Such measurements and results will include, for example,
information concerning blood pressure, heart rate, temperature,
central venous pressure, pulmonary artery catheter data, cardiac
output, vascular resistance, urine output, respiratory rate and, if
the patient is on a ventilator, the amount of oxygen dispensed, the
ventilatory pressure, PEEP, together with laboratory data relating
to blood chemistry (some 14 variables), haemoglobin, white cells,
coagulation profile (4 variables) and the variables (6) estimated
from arterial blood gases. Some of these data are collected every
15 minutes, some on an hourly basis and others several times a day.
Together, all this data comprises the information which was
traditionally recorded on a chart beside the patient's bed. In this
embodiment of the invention, this data, which can be seen to be
tracking the progress of the patient is captured electronically and
stored in the database 20 of the system 10.
[0070] In addition, in contrast to prior art systems, all
interventions and manoeuvres undertaken by a doctor or nurse for a
patient under their care are entered on the system 12 via the
manual input 14. Such interventions will follow one of a number of
the pre-recorded protocols described above. Alternatively, any
non-standard interventions will be recorded as usual, and, in
addition, the associated protocol will be entered on the database
20. This completes the electronic record for an individual patient.
Both progress data and treatment data together constitute a stream
of patient information that is stored in the database 20 for
processing by the clinical display system (CDS) 24. After
processing, the CDS 24 displays the information in a format that
better facilitates its use by doctors and nurses to improve their
management of the seriously ill patients under their care.
[0071] Traditionally, doctors and nurses have used their skill and
experience in interpreting the wealth of information presented on a
patient's chart. Attempts have been made to codify the largely
intuitive assessment made by these skilled clinicians. One scoring
system which has been developed over the past 10 to 15 years is the
Sequential Organ Failure Assessment, or SOFA. This system, which
has been extensively validated and is widely accepted, is based on
the finding that patient outcome is strongly correlated to the
number of dysfunctioning organs. A systematic interpretation of
chart data is used to provide some indication of which of the major
organs are liable to fail, an approach which is routinely taught to
trainee doctors and nurses.
[0072] The SOFA scoring system assigns a score within a range from
0, indicating normal function, to 4, indicating severe dysfunction,
to each of the major organ systems. The CDS 24 is programmed and
configured to implement a modified SOFA and to display the results
on a screen. The CDS SOFA additionally includes an assessment of
the gastrointestinal system, based on the criteria of feeding
method and attainment of target feed rate. In total therefore the
CDS 24 performs an automatic scoring assessment of each of seven
major organ systems (including gastrointestinal). After scoring
each organ system, the CDS 24 prepares the results for display.
[0073] A GENERAL status indicator may also be displayed, to enable
the clinician to display one or more selected measured (or observed
and manually input) parameters that they associate with the
subject's overall status. This is not defined by an established
scoring system, but rather is derived on an implementation basis by
those responsible for the system. For example, the patient's
lactose level may be measured and displayed.
[0074] An example of a display output from the CDS 24 is shown in
FIG. 2. The display 30 consists of eight time bars (a to h) divided
into hours. Each monitored organ system 32 is listed on the display
30 adjacent a corresponding single bar. The eighth bar h is used to
display the general patient condition. Within each band a-h, each
hour segment 34 is colour coded to reflect the status of the
particular organ system 32 being monitored within that time frame.
A key 36 to the colour coding is presented at the bottom left of
the display 30 and in Table 1 below. TABLE-US-00001 TABLE 1 Colour
Status Dark green System is normal Light green Mild dysfunction
Yellow Mild/moderate dysfunction Orange Moderate/severe dysfunction
Red Severe dysfunction
[0075] Also present on the display 30 are intervention indicators
38 and a button 40 on which to click a mouse cursor (not shown) for
access to a protocol display screen, which will be described later.
Patient information such as bed number 42, admission time 44 and
name 46 are displayed at the bottom left of the screen 30. A scroll
bar 48 may be used to adjust the time frame of displayed
information, with separate buttons 50, 52 to allow jumps to patient
admission time and to most recent time data. To the bottom right of
the screen 30 time of the last CDS update 54 and present time 56
and date 58 are displayed.
[0076] The seven systems 32 for which the CDS 24 displays
information are the central nervous system (written on screen as
CNS), corresponding to the neurological SOFA indicator, respiratory
system (written as RESP), cardiovascular system (CVS),
corresponding to the circulatory SOFA indicator, and the
gastrointestinal (GI), renal, hepatic, and coagulation systems, the
latter corresponding to the haematological SOFA indicator; a
general condition status indicator may also be displayed, as
discussed above.
[0077] In this way the CDS is arranged to display clearly and
concisely indications as to the status of each major organ system
32 of a critically ill patient over a period of time. Changing
colours on each indicator bar a-h, provide a doctor or nurse with a
rapidly assimilated indication as to whether each organ's status is
improving or failing.
[0078] The intervention indicators 38 are placed on a time line
above selected bar charts a-h. An intervention is a procedure which
may be performed by a doctor or nurse with the aim of improving the
patient's condition. A significant proportion of interventions will
be scheduled events, although some will be random events made in
response to a change in the patient's state. The placing of the
indicator on the time line therefore provides a clearly visible
indication of the time at which an intervention has been made. The
bars a-h it appears adjacent to are those displaying the status of
the organ system(s) that the particular intervention is known to
affect. In this way, it may be readily confirmed whether or not its
intended result, in terms of an improvement of a particular organ's
status, is achieved. Each time period may have only one
intervention symbol 38 above it, although obviously a number of
different procedures may have been tried. However the CDS 24 is
arranged such that an intervention window may be opened by clicking
a mouse cursor on the intervention symbol 38. The window contains
information as to the number and type of interventions made as well
as any further information recorded by the clinician; for example
timings, reasons and action taken. This window also provides a
further access route identifying the relevant protocol(s) used in
the intervention(s).
[0079] FIG. 3 is a functional diagram indicating the process steps
carried out by the CDS 24 in generating the display 30 of FIG. 2.
External to the CDS 24 is a data storage facility 72 (corresponding
to the database 20 of FIG. 1). At selected intervals, here every 10
minutes, the CDS 24 performs step 74 and extracts data from this
storage facility 72. In this way the CDS 24 is kept updated with
the most recently taken patient information. At step 76, the
extracted data is compared with preset scoring parameters and a
score is derived from that data for each organ system. For example,
one test result which is included in the extracted data will be
information as to the creatinine level in the patient's blood. If
this level is greater than 440 mcgmol/l (.mu.gmol/l) this is
indicative of severe dysfunction of the renal system and scores 4
(using the SOFA scoring scale from 0, indicating normal level to 4
indicating severe dysfunction). On the other hand, if the measured
creatinine level is between 100 and 170 mcgmol/l, this is
indicative of a mildly dysfunctional renal system and scores 1. The
complete scoring parameters across the organ systems and as used in
this embodiment of the invention are indicated in Appendix 1.
[0080] At step 78 the status indicators derived in step 76 are, if
necessary, logically combined. Logical combinations are required
when the scoring system dictates that there are two or more data
items needed to assess the current function of a particular organ
system. Each data item has been evaluated and scored individually
at step 76. If the data items needed for one organ system
assessment differ in their assigned scores, the function of the
organ system is considered to be that of the worst case. For
example, analysis of the renal system involves both the assessment
of blood creatinine and daily urine output. If the creatinine level
is between 100 and 170 mcgmol/l and therefore scoring 1 (as
described above) and the daily urine output is less than 200 ml,
which indicates a severe dysfunction of the renal system and scores
4, logical combination will result in an overall score of 4. This
function is defined as `Logical Inclusive OR`. However, the system
may be adapted to support the full range of logical and
mathematical functions that could be employed in the assessment of
a combination of individual factors both relatively or absolutely.
3
[0081] At step 80, for each respective organ system 32, its level
of function is determined. Thus, using the example of the renal
system, its score with the data values given above is 4 for the
relevant time period. Other systems make use of different data
indicators, which may or may not need to be combined, and a system
score is derived at this step 80 each.
[0082] At step 82 each score is assigned an appropriate colour
representation. From Table 1, it can be seen that a score of 4 for
the renal system means the assigned colour to indicate renal status
is red. For each status bar a-h, an additional colour segment block
is then added to the display 30 at step 84, each block being placed
at the appropriate point of the timeline and given the status
indicator colour derived at step 82.
[0083] The individual bar charts have time-divided segments
arranged abutting one another so that the bar extends continuously
from left to right along a timeline. The bar chart therefore
appears to the eye of the beholder to provide a continuous
representation of the patient's state, when infact each time
segment is displaying the state of that organ at a particular
selected point in time (corresponding to the time interval
selected). Thus, in contrast to prior art continuous displays, no
assumption is made by the display of the data values between the
interval times which is significant when the time interval exceeds
the contributing data sample rates and not all changes in state are
shown although the display appears continuous. In contrast to the
prior art, the system incorporates variable "data persistence"
facilitating the evaluation of less frequently sampled data with
more frequently sampled data where the data sample rate can be
adjusted to a time consistent with the data change rate; this "data
persistence" element of the display improves intelligibility for
the clinician.
[0084] Concurrently with the status colour determination, the CDS
24 is also arranged to carry out a number of other processes. From
the data extracted at step 74, at step 86 the CDS 24 checks whether
there has been a clinical intervention. If the result is positive,
an intervention marker is created at step 88 and displayed 90 at
the appropriate point on the timeline (see, for example, symbol 38
of FIG. 2).
[0085] The intervention marker and coloured time profile for each
organ system are the only processes carried out by the CDS 24 the
results of which are displayed on a main screen display 92, as
shown in FIG. 2. However an additional two sub-screen displays 94,
96 are also created by the CDS 24 and may be accessed via the main
screen display 92.
[0086] The first of these subscreen derivations is indication at
step 98. At this step the CDS 24 derives for each data type
(individual reading) extracted from the database 20 at step 74, a
graphical display of actual values of that reading against time.
For each data type, this graph is displayable on respective
subscreens 94 which are accessible from the main display 92 by
double clicking on the relevant segment of the organ system
concerned: all the data type readings associated with that organ
system are simultaneously displayed on subscreen 94. The subscreen
may have a data cursor for selecting the display of individual
values in the data value windows on the detailed display. Where
displayed the cursor is the time point about which the display is
redrawn in the event of the time scale being altered. FIG. 4 is an
example of such a graphical display showing a patient's mean
arterial pressure and dopamine levels
[0087] If protocol information is requested, the CDS 24 at step
100, extracts it from the database 20 for display on a second
subscreen 96. Protocol screens can be accessed from the main
display 30 with button 40. At any given time, clinical staff can
access detailed protocol information for any given organ system. An
example of a protocol screen is shown in FIG. 5.
[0088] Referring to FIG. 4 (showing an example of the first
subscreen display), there is shown a graphical display 120 of
actual indicator values for the cardiovascular system. The relevant
indicators for this system are systemic arterial blood pressure and
inotrope (for example dopamine) levels. A blue cursor 122 is
activated by clicking the mouse on the graph and, above the cursor
position are shown date and time 124 that the highlighted data
value was measured and, to the right of the graph, the actual
values 128 recorded at that time. Interventions 126, if any, are
also shown on this display 120.
[0089] Accessing this display enables a skilled clinician to
investigate further indicators as to the functioning of any
particular organ system.
[0090] FIG. 5 illustrates an example of a protocol display 140.
Protocol information 142 is displayed on the screen once one of the
eight systems (organs and general) 32 have been selected from a
first drop down box 144 and a particular protocol is selected from
a second drop down box 146.
[0091] FIG. 6 is an expanded view of the coagulation indicator bar
g, shown in FIG. 2. It illustrates more clearly the segmented
coloured blocks which provide for rapid visual assimilation of
information by the clinician. A double headed arrow 150 indicates
the length of time period covered by each block. A default value
for this embodiment of the invention is one hour, but the CDS 24 is
arranged to permit this to be amended by means of a menu which
appears when a mouse is right-clicked above any system bar a-h.
[0092] In this system software algorithms filter the extracted data
using a clinically agreed scoring system which involves some
logical combinations. As mentioned previously this embodiment of
the invention uses a modified SOFA system to present a
visualisation of the status of a patient. It will be clear to one
skilled in the art however that other algorithms implementing other
known scoring systems can also be used as intelligence filters.
Appendix 2 lists a number of other established scoring systems
which may be used in accordance with the present invention.
[0093] Equally, the invention may be of assistance in assessing the
status of animal patients.
[0094] Further, it will also be appreciated by one skilled in the
art that this invention is not limited to application in an
intensive care unit, but to any situation in which a judgment has
to be made based on interpretation of a vast amount of data. It is
particularly applicable to environments that require tracking of
multi-system functioning. In a clinical environment these may be
high dependency wards (using discharge criteria as a scoring
system), general wards (clinical state of a patient could provide a
scoring system) and home monitoring (using custom scoring values).
Other environments where the application of this invention may
prove useful is to factories, power stations and water treatment
plants.
[0095] Further applications may be found in auditing and resource
management. TABLE-US-00002 APPENDIX 1 Clinical Display System SOFA
threshold levels Organ System Vital Sign State Threshold Unit
Central Nervous System Glasgow Coma 0 15 Points Score 1 <15 2
<13 3 <9 4 <6 Respiratory PaO2/FIO2 0 >=53 kPa
FIO2(0.21-1.0) 1 <53 2 <40 3 <27 4 <13 Cardiovascular
Mean Arterial 0 >=70 mmHg Pressure 1 <70 mcg/kg/min Inotropes
2 Use of Dopexamine <= 0.5 Use of Dopamine <= 5.0 Use of
Dobutamine 3 Any of the following: Dopexamine > 0.5 Dopamine
> 5.0 Noradrenaline < 0.1 Adrenadine < 0.1 4 Any of the
following: Dopexamine > 1.5 Dopamine > 5.0 Noradrenaline >
0.1 Adrenadine > 0.1 Use of Milrinone Gastro-Intestinal
Nutrition type 0 Diet/Target feed rate attained 1 51-99% of target
feed rate 2 20-50% of target feed rate 3 <20% of target feed
rate 4 On TPN or IV fluids only Renal Creatinine 0 <100 mcgmol/l
1 <=170 2 <300 3 <440 4 >440 Urine Output 0 >500
mls/24 Hrs 1 N/A 2 N/A 3 <500 4 <200 Hepatic Bilirubin 0
<=20 mcgmol/l 1 >20 2 >34 3 >102 4 >204 Coagulation
Platelet level 0 >=150 E9/l 1 <150 2 <100 3 <50 4
<20 State 0 - Normal State 1 - Mild dysfunction State 2 -
Mild/Moderate dysfunction State 3 - Mod/Severe dysfunction State 4
- Severe dysfunction
Appendix 2
Established Scoring Systems
[0096] Adults
[0097] General scores [0098] SAPS II and predicted mortality [0099]
APACHE II and predicted mortality [0100] MODS (Multiple Organ
Dysfunction Score) [0101] ODIN (Organ Dysfunctions and/or
INfection)
[0102] Pediatrics
[0103] General Scores [0104] PRISM (Pediatric RISk of Mortality)
[0105] DORA (Dynamic Objective Risk Assesment) [0106] PELOD
(Pediatric Logistic Organ Dysfunction) [0107] PIM (Paediatric Index
of Mortality)
[0108] Adult
[0109] Specialized and Surgical Intensive Care--Preoperative
Evaluation [0110] EUROSCORE (cardiac surgery) [0111] ONTARIO
(cardiac surgery) [0112] Parsonnet score (cardiac surgery) [0113]
System 97 score (cardiac surgery) [0114] QMMI score (coronary
surgery) [0115] MPM for cancer patients [0116] POSSUM (Physiologic
and Operative Severity Score for the enUmeration of Mortality and
Morbidity) (surgery, any) [0117] Portsmouth POSSUM (surgery,
any)
[0118] Specialized (Neonatal, Surgical) [0119] CRIB (Clinical Risk
Index for Babies) [0120] SNAP (Score for Neonatal Acute Physiology)
[0121] SNAP-PE (SNAP Perinatal Extension) [0122] SNAP II and SNAPPE
II
[0123] Adult Trauma Scores [0124] ISS (Injury Severity Score), RTS
(Revised Trauma Score), TRISS (Trauma Injury Severity Score) [0125]
ASCOT (A Severity Characterization Of Trauma) [0126] 24 h--ICU
Trauma Score
[0127] Pediatric Trauma Scores [0128] Pediatric Trauma Score
[0129] Therapeutic Intervention, Nursing ICU Scores P1 TISS
(Therapeutic Intervention Scoring System)
* * * * *