Classifications

• • G—PHYSICS
  • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
  • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
  • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
  • G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
• • G—PHYSICS
  • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
  • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
  • G16H30/00—ICT specially adapted for the handling or processing of medical images
  • G16H30/40—ICT specially adapted for the handling or processing of medical images for processing medical images, e.g. editing
• • G—PHYSICS
  • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
  • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
  • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
  • G16H50/30—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for calculating health indices; for individual health risk assessment
• • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
  • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10S128/00—Surgery
  • Y10S128/92—Computer assisted medical diagnostics

Definitions

• the present invention relates generally to data analysis and, more particularly, to reporting and comparison of data analysis results.
• the method of reporting numerical laboratory test data has essentially remained unchanged since its modern inception, beginning in the first half of the twentieth century.
• the traditional method includes reporting a measured value (i.e., a test result) and its relevant set of normal values, known as a reference range. It is often inadequate to report only a measured value because different tests may have different respective reference ranges.
• all reference ranges include a set of two values with one value designated as an upper reference range limit and another designated as a lower reference range limit.
• the number of available laboratory tests has risen prodigiously and there are now many hundreds of numerically reported tests, each continuing to have its own unique set of reference ranges .
• test value that falls within the reference range has variable significance depending on whether the measured value is near the upper limit, the lower limit, or the mean value of the reference range.
• the relative significance of a test has to be qualitatively assessed and committed to memory because it is not typically quantified on the traditional report. If multiple tests are simultaneously reported, an interpreter of the test data typically tries to retain in his/her memory the relative position of each measured value and make qualitative interpretive decisions among the tests utilizing mentally calculated relative positions in the reported test data. For example, one test may have a measured value two points below the upper reference range value and another test may have a measured value eight points below the upper reference range value .
• the interpreter may wish to know if one of these tests is at more risk for being abnormally elevated than the other test.
• a qualitative evaluation may be required because the number of points in the reference range for each of these tests may be different .
• the relative closeness of one value to the upper reference range (or the lower reference range for that matter) may be dependent on the number of units in the reference range. Table 1 below illustrates this situation.
• the second column indicates a measured value two numbers less than the upper limit of the reference range.
• the third column indicates a measured value eight numbers less than the upper limit of the reference range.
• Each of the six measured values (MVs) in Table 1 are considered normal values because each lies within the reference range for a respective test. When measured values are viewed in the format of Table 1, which resembles traditional reporting formats, it may be difficult to determine which measured value is relatively greater than, or less than, any other measured value.
• 4,527,240 to Kvitash describes a process whereby measured patient values are transformed to units referred to as "Balascopic" units.
• the Balascopic units are plotted on an axial graph. These axial graphs may be somewhat difficult to use.
• the Balascopic process of Kvitash does not distinguish between test data reported as whole integers and decimals. Consequently, interpretative decisions that are made based on decimal values may be difficult to make with the Kvitash process.
• Another drawback of the Kvitash process is that it does not provide analytical variation associated with each measured value.
• U.S. Patent No. 5,541,854 to Yundt describes displaying conventional multi-level hematology quality control data (three levels) in a complex graphic form. Yundt is concerned with the presentation of tri-level quality control data and not with the presentation of measured unknown samples .
• Z scores are somewhat difficult to use to identify the relative value of one test result to another.
• Z score techniques are somewhat limited because data beyond the maximum and minimum limits of normal distribution cannot be used.
• a reference range for a test is unitized to a single number.
• a total number of possible test results within respective equal halves of the reference range is then determined. This is accomplished by determining a total number of possible test results within the reference range to produce a reference range spread, and then dividing the reference range spread in half.
• the fractional value of the plurality of test results in the respective halves of the reference range is then determined.
• the fractional value of the plurality of test results comprises a reciprocal of one-half of the total number of possible test results in the reference range.
• Each of the plurality of separately determined test results are then transformed into respective equilibrated values. This is accomplished by determining the mean of the reference range and then determining a difference between the mean and each of the plurality of test results.
• Each equilibrated value represents relative position of a respective test result with respect to a mean of the reference range.
• Each of the equilibrated values is then transformed into respective unitized values by multiplying each respective equilibrated value with a respective fractional value of the plurality of test results in one half of the reference range.
• Each unitized value represents relative normalcy or abnormalcy of a respective test result with respect to the unitized reference range.
• unitized values with the same numerical value indicate the same quantitative variation from any reference point (s) within the unitized reference range.
• a unitized value of 1.5 for a glucose level within a patient and a unitized value of 1.5 for a sodium level within a patient will mean the same quantitative increase for each test.
• the present invention may allow an interpreter to recognize problems and undertake corrective actions sooner.
• unitized values By utilizing unitized values according to the present invention, an interpreter could more easily recognize that a unitized sodium value of 1.5 is more severe than a unitized glucose value of 1.1 and, therefore, take action to rectify the sodium level.
• the present invention may be applied to the interpretation of any type of laboratory test data, both biological and non-biological, and particularly where the test data is interpreted by referring to a reference range.
• the present invention is particularly useful where multiparametric data is obtained from testing.
• FIG. 1 schematically illustrates operations for unitizing test data having different reference ranges, according to an embodiment of the present invention.
• Fig. 2 illustrates an exemplary data processing system in which the present invention may be implemented.
• the present invention may be embodied as a method, data processing system, or computer program product.
• the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment or an embodiment combining software and hardware aspects.
• the present invention may take the form of a computer program product on a computer-readable storage medium having computer- readable program code means embodied in the medium. Any suitable computer readable medium may be utilized including hard disks, CD-ROMs, optical storage devices, or magnetic storage devices.
• the present invention is described below with reference to flowchart illustrations of methods, apparatus (systems) and computer program products according to an embodiment of the invention. It will be understood that each block of the flowchart illustrations, and combinations of blocks in the flowchart illustrations, can be implemented by computer program instructions .
• These computer program instructions may be loaded onto a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions which execute on the computer or other programmable data processing apparatus create means for implementing the functions specified in the flowchart block or blocks.
• These computer program instructions may also be stored in a computer-readable memory that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory produce an article of manufacture including instruction means which implement the function specified in the flowchart block or blocks .
• the computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer or other programmable apparatus to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide steps for implementing the functions specified in the flowchart block or blocks.
• blocks of the flowchart illustrations support combinations of means for performing the specified functions, combinations of steps for performing the specified functions and program instruction means for performing the specified functions. It will also be understood that each block of the flowchart illustrations, and combinations of blocks in the flowchart illustrations, can be implemented by special purpose hardware-based computer systems which perform the specified functions or steps, or combinations of special purpose hardware and computer instructions.
• Operations include: unitizing a reference range (Block 100) ; determining the number of measured values in the reference range (Block 102) ; unitizing the equal halves of the reference range (Block 104); determining the number of measured values in the upper one half and the lower one half of the reference range (Block 106) ; determining the fractional value of the measured values in the equal one halves of the reference range (Block 108) ; equilibrating the measured values (Block 110) ; unitizing the equilibrated values (Block 112) ; unitizing the analytical variation (Block 114) ; and reporting the unitized values (Block 116) .
• Each of these operations will be described in detail below.
• a data processor 10 may have an operating system 11 resident therein.
• An application program 12 for performing operations according to the present invention typically executes via the operating system 11.
• the processor 10 displays information on a display device 13 which has a plurality of picture elements (collectively referred to as a screen) .
• the information is displayed on the display device 13, preferably within a graphical user interface.
• the contents of the screen of the display device 13 and the appearance of a graphical user interface may be controlled or altered by an application program 12 or the operating system 11 either individually or in combination.
• the operating system 11 and the application program 12 may utilize user input devices
• User input devices 14 may include a pointing device
• keyboard 16 such as a mouse, and a keyboard 16 or other input devices known to those of skill in the art.
• measured value is synonymous with the term “test result”, such as a blood glucose level produced by a blood test.
• Unitizincr a Reference Range An initial operation of the present invention involves unitizing a reference range (Block 100) .
• Unitization of a reference range is defined as grouping all measured values for each laboratory (or other) test within a reference range into a single number.
• a RR inherent in the definition of a RR is the possibility that any MV that falls within a RR is as potentially normal, in an equivalent biological sense, as any other MV within the same RR, or any other RR. Since this potential exists, it is conceptually feasible to consider all MVs in any RR as equivalent values. As a derivative of this consideration, all of the MVs in any RR can be conceptually consolidated into one number which would have no need of any assigned concentration units.
• the reference range may be any value greater than 0.0 and equal to or less than 1.0, since this comprises the number 1.0.
• any number can be used for this purpose. From this concept, it does follow that if one test has a MV of 100 milligrams per deciliter (mg/dl) in its RR and another test has a MV of 10 millimoles per liter (mmol/L) in its RR, these different MVs lose the concentration units (mg/dl and mmol/L) ; and, the 100 MV and the 10 MV are biological equivalents.
• This conceptual process is an initial necessary process in order to restructure the ordinarily disparate MVs in RRs into one number. The equation that expresses this relationship is
• Equation 1 states that a unitized RR is greater than zero but less than or equal to one .
• Block 102 a determination of the number of measured values that are included in the reference range from the lower reference range limit to, and including, the upper reference range limit is made (Block 102) .
• the number of measured values in this range is determined by both the unique analytical properties of the test and by the actual measured values discovered in the reference (normal) population, and represents a fixed number of MVs peculiar to each test and the methodology used in the testing procedure.
• the RR is not only different for each test, but the RR will also change for any given test if the methodology for that test is changed, which further adds to the memory requirements of an interpreter and the need for advance notice by a laboratory when methodology is changed.
• the number of MVs within the RR is calculated from the high and low numbers listed under the heading "Reference Range”, or sometimes otherwise described as “Reference Interval” or “Normal Range” .
• the total number of measured values in the reference range spread is preferably determined by Equation 2 below.
• the URRL and LRRL when used in Equation 2, refer to the numbers given in a traditional report ( e . g. , Table 1 above) under the heading of RR, and not to the unitized reference range of 1.0.
• Equation 2 includes all units in the reference range by the addition of a whole integer to the difference between the minimum and maximum of the reference range.
• all reported decimal values in the reference ranges and all measured values reported in decimals need to be converted to their equivalent whole values.
• Measured decimal values are also converted to their equivalent whole numbers. All subsequent calculations are performed on the converted whole numbers. This modification is required because the interpreter would have most likely used "tenths" of a number in evaluating increases or decreases in measured values.
• the subsequently calculated UV reflects the original MV as it was expressed in tenths, or other decimal points.
• the traditionally given upper and lower limits of a RR represent ⁇ 2 standard deviations of the MVs from the mean of the normal population studied, which includes only 95% of the MVs of the normal population.
• the 5% that are not included in the RR are represented by a deletion of 2.5% at both the upper and lower limits of the RR. Consequently, the determination of the RRS does not include the 2.5% of the MVs at either extreme of the RR.
• a total number of the MVs in the RRS could be determined by returning the deleted 5% to the RRS; however, since interpreters of MVs are conditioned to interpreting MVs on the traditional basis of a RR defined as ⁇ 2 standard deviations from the mean, the calculation for the total RRS is not incorporated herein.
• the initial unitization of the reference range and the subsequent determinations of the RRS need to be restructured for the following reason.
• a low abnormal measured value, subsequently unitized to -0.5 would be the analytical equivalent, in the opposite direction, of a high abnormal unitized value of +1.5, since both values would be a 0.5 units beyond the lower and upper limits, respectively, of the unitized reference range.
• a reviewer would find these equidistant analytical values disconcerting since they are different numbers.
• the above anomaly can be rectified by dividing the reference range into equal halves and then unitizing the separate equal components (Block 104) .
• the mean of the reference range then becomes 0.0.
• the range from the mean to the LRRL is defined as 0.0 to - 1.0.
• the range from the mean to the URRL is defined as 0.0 to +1.0.
• any number can be used. For purposes of this discussion, the number 1.0 is retained, but modified to -1.0 and +1.0 for the equal halves of the reference range spread. Determining the Number of Measured Values in Upper and Lower Halves of Reference Range
• Equation 2 the previously calculated number of MVs in the RRS (Equation 2) needs to be divided between the two halves.
• the number of MVs in each half of the RRS can be determined by the following equation:
• the HRRS for glucose is:
• FV fractional value
• the FV for glucose is:
• the FV can be expressed as either a fraction or a percent .
• the division of the RRS into two equal halves, each containing 2 standard deviations of the normal distribution is based on the conventional definition of normalcy as +2 standard deviations of the mean. It would be feasible to unitize on the basis of +1 standard deviation from the mean which would define the unitary values in synchrony with unitary divisions of the standard deviations . For example +1 standard deviation would equal +1.0 unit, -1 standard deviation would equal -1.0 unit; +2 standard deviations would equal +2.0 units; and, -2 standard deviations would equal -2.0 units. This additional separation of the reference range brings greater sensitivity to the process, and fractional values can be proportioned accordingly.
• Equation 6 illustrates how to determine the unitized value (UV) of an equilibrated value (EV) .
• MV#1, MV#2, and MV#3 are -2, -8, and +8, respectively, from the upper limit of the reference range .
• an interpreter can readily determine that a sodium value of 145 (a -2 MV) with a UV of 0.51 is essentially the analytical equivalent of a glucose value of 105 (a -8 MV) with a UV of 0.56. Similarly, an interpreter can quickly observe that a sodium value of 139 (a -8 MV) is significantly different from a glucose of 105 (also a -8 MV) , which have UVs of -0.51 and 0.56, respectively.
• the traditional method of reporting laboratory data does not allow one to determine the relative relationships that can be readily perceived by evaluating the unitized values seen in the columns listing the UVs.
• users may develop variably refined cognitive perceptions of relative normalcy and abnormalcy of MVs.
• the relative normalcy and abnormalcy are quantified on the report and a new user will more quickly develop a refined capacity to engage in multiparametric analyses, with sundry benefits to the diagnostic process (es) , many years prior to that learned by only utilizing the current state of the art.
• the control closest to the measured value may be the most applicable value; however, in practice it may be a complex process to align the measured value and the closest control value.
• the average of the standard deviations of the controls can be used.
• the standard deviations of the controls are traditionally calculated from the MVs of the controls in such a manner that they do not need to be equilibrated. Since there is no need to perform the equilibration step on the standard deviation of the control value, and the FV has already been calculated, the conversion of the unitized analytical variation (Block 114) (UAV) may be accomplished by Equation 7.
• the following eight examples represent formats that can be used in reporting the unitized values, as well as traditional values (Block 116) .
• the MVs, RRs and the standard deviations (used to calculate the UAVs) set forth below are representative and not specific to an individual, a particular testing system, or a designated lab site.
• abnormal measured values have been accentuated for instant recognition.
• the abnormal values have been notated as HI or LO .
• Abnormal values may also be printed in bold, offset or printed in a different color in order to alert an interpreter to the abnormal value.
• the tests are listed alphabetically. They are not ranked by high or low values because the data in this traditional report does not allow the interpreter to determine the relative value among the various tests.
• Example 3 represents the unitized report in an enhanced manner, with the tests ranked highest to lowest. This example demonstrates the deletion of the reference ranges and their replacement with a + 1.0 unitized reference range. Also reported is the unitized analytical variation. These tests can be ranked because all of the tests have been unitized and the unitized results represent the true relationships among the tests.
• a greater enhancement of the data could be accomplished by color printing the background so that the higher normal values (greater +0.5 to +1.0) and the lower normal values (less than -0.5 to -1.0) would be in amber; mid normal ranges (-0.5 to +0.5) would be in green; abnormally low values would be in blue; and, abnormally high values would be in red, or in any other color enhanced schemes.
• Bilirubin total HI +9. .1 0. .3
• Example 4 represents the unitized data restructured to present the tests in a horizontal graphic format. The hierarchical ranking is retained.
• Example 5 displays a composite report including both the traditional report and the newly invented unitized report.
• This example represents the combining of Examples 2 and 3.
• the interpreter could compare the conventionally used reporting format with the new Unitary Report, without any loss of informational content.
• the traditional report format has been altered to place the tests in the same rank that can be found in the Unitary Report. This minor rearrangement of the traditional alphabetically formatted data further enhances the interpreter's ability to compare the results.
• Bilirubin total HI +9.1 0. .3
• Example 6 represents the traditional data and the graphed unitized data combined into a composite report. This example essentially combines Examples 2, 3, and 4 into one report, allowing maximal extraction of information from the data.
• Example 7 illustrates the combination of two different styles of reporting unitized data, according to the present invention.
• the traditional reporting format has not been incorporated into this report . In some circumstances, it may not be necessary to utilize the traditional format .
• Bilirubin total HI +9 1 0 3
• This example illustrates the utilization of unitized data in the setting of repeat analyses of the same test.
• Both traditional and unitized data according to the present invention have been incorporated into the report.
• day-to-day running averages of both types of data and a graphic report of the unitized data have been included.
• the data may also be presented without averaging or a cumulative type of running average may be used.
• the type of averaging used can be adapted to accommodate the user's requirements. Again, maximal information has been extracted from the primary data .
• a vertical graphic presentation is illustrated in this example. As was mentioned in earlier examples, the background could be color enhanced. This type of presentation may be preferred in some settings.

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• 1998
  • 1998-09-02 US US09/145,999 patent/US6292761B1/en not_active Expired - Lifetime
• 1999
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• 2000
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