Patent Application: US-91579001-A

Abstract:
in a computer system having a storage device , a method for gathering clinical data useful in the clinical analysis and treatment of mood disorders . the method includes such steps as displaying a main menu including a multiplicity of icons depicting inquiries to be answered by a patient ; and , storing the patient &# 39 ; s answers to the inquiries as clinical data generated on a regular basis by the patient . the method further includes selecting a point on a scale depicting the patient &# 39 ; s current mood ; selecting a sleep icon for updating sleep data ; and , selecting a medication icon for updating type and amount of medication taken . the present invention is also capable of creating longitudinal charts and statistics based on selections made by a patient over a given period of time .

Description:
fig1 depicts the components of an example system 100 for longitudinal analysis of mood disorders . at a central physician &# 39 ; s office 101 the system 100 for longitudinal analysis of mood disorders contains computers used for training patients 102 , system administration 103 and for aggregating data from multiple patients and from multiple sites 104 . another physician office 105 may have a computer with a training system 102 and a computer 103 for system administration . the system administration computer 103 is used to enroll patients , receive and analyze data and display or print reports . the training computer 102 is used to train patients on how to install and use the software at home or at a clinic . mental health providers , such as a day treatment facility 110 , contain clinic system computers 111 for data entry by patients who do not have a computer at home . patients with a computer at home 108 install a patient data entry system software 109 . every day patients enter mood data directly onto the software on their home computer 109 . patients return data to the system administration computer 103 at the physician &# 39 ; s office 101 or 105 , by e - mail over the internet 107 or via diskette 106 . patient data from clinic systems computers 111 likewise is returned to the system administration computer 103 by e - mail over the internet 107 or via diskette 106 . after patient data is returned , mood charts and statistical charts are displayed or printed on the system administration computer 103 in the physician &# 39 ; s office 101 or 105 . if the patient data collection is part of a research study , data from all physician office sites 105 is returned to the aggregate system 104 in the central physician &# 39 ; s office 101 by e - mail over the internet 107 or via diskette 106 . the aggregate system 104 will merge the data of all patients from all sites , remove all patient identifiers and format the output file for analysis in commercial programs . fig2 illustrates a method to provide longitudinal analysis of mood disorders in accordance with the present invention . the system 100 of fig1 can be used to implement the method of fig2 . the first step is to verify the patient &# 39 ; s diagnosis ( step 200 ) to ensure that the patient has a mood disorder . after determining the patient is an appropriate candidate for mood charting , the configuration of the computer the patient has at home is verified ( step 201 ). if the configuration of the home computer is adequate , the patient is trained to use the software ( step 202 ) at the physician &# 39 ; s office . the training includes a demonstration of how to install the software on a home computer , instructions on how to enter data accurately and an overview of mood charting . next , the patient is enrolled ( step 203 ) on the system administrator computer ( 103 of fig1 ). the patient is then given software to install on their home computer ( step 204 ). the patient installs the software on a home computer and enters data every day ( step 205 ). every month , or at a frequency determined by their physician , the patient returns data to the system administrator computer ( 103 of fig1 ), either by e - mail over the internet or by diskette ( step 206 ). the data from the patient is analyzed and reports are displayed and printed ( step 207 ). if the patient is part of a research study , data from the physician site can be aggregated with data from other patients and study sites for statistical analysis ( step 208 ). fig3 and 4 are high - level flowcharts that refer to the operation of the software of the present invention , which is installed on a patient &# 39 ; s computer at home . the process begins with a start bubble 300 . the patient starts up the software and enters their password . the process then decrypts the patient &# 39 ; s data file and verifies that the password is correct ( block 301 ). after this , the main menu is displayed ( block 302 ) and updates are made to the entry status for the current date . the entry status graphically displays whether the patient completed entry of all required data in each major section ( mood , sleep , and medications ). an inquiry is then made to determine if the date is being changed ( diamond 303 ). if the response is no , the process proceeds to the next step depicted by a block 306 . if the response to decision block 303 is yes , block 304 verifies the new date selected . any data previously entered for the selected date is retrieved and the entry status reset accordingly at block 305 . block 306 allows entry of a day of data as in fig4 . decision block 308 checks if the data is to be exported back to the clinic for analysis . if the response to decision block 308 is yes , block 309 encrypts all the patient &# 39 ; s data for export by e - mail via internet or by diskette . if the response to decision block 308 is no , the process proceeds to block 310 where the patient exits the program and data is encrypted and saved . at connector a of fig4 the process allows the entry of a day of data . decision block 401 selects the main menu choice to allow entry of mood data . if the response to decision block 401 is no , the process proceeds to a decision block 404 . on the other hand , if the response to decision block 401 is yes , the mood dialog box will appear and decision block 402 verifies that all required data has been entered . mood data is entered using a vas scale between 0 and 100 . the most extreme feelings of depression and mania the patient has ever experienced define the anchor points . the patient slides the scale to the number that best represents mood over the past 24 hours , in relation to these anchor points . other data entered here are optionally any significant life events and , if female , menstrual data . if the response to decision block 402 is no , the process returns to decision block 401 to allow re - entry of the data . if the response to decision block 402 is yes , the data entry status for the mood section for the current date is updated to complete at block 403 . the process proceeds to decision block 404 . decision block 404 selects the main menu choice to allow entry of sleep data . if the response to decision block 404 is no , the process proceeds to decision block 407 . on the other hand , if the response to decision block 404 is yes , the sleep dialog box will appear and decision block 405 will verify that all required data has been entered . for each hour of the day , a graphical toggle switch is used to select if awake , asleep or in bed and awake . if the response to decision block 405 is no , the present process returns to decision block 404 to allow re - entry of the data . on the other hand , if the response to decision block 405 is yes , the data entry status for the sleep section for the current date is updated to complete at block 406 . then the process proceeds to decision block 407 . decision block 407 selects the main menu choice to allow entry of medication data . if the response to decision block 407 is no , the process proceeds to decision block 400 ( fig3 ) as denoted by the connector a . on the other hand , if the response to decision block 407 is yes , the medications dialog box will appear and decision block 408 will verify that all required data has been entered . medications are displayed by trade and generic name , as well as strength . for each medication displayed , data is entered by the count of pills taken for the day . the strength of each pill and the number of pills can be changed . current medications can be deleted and new medications can be selected from an internal list of psychotropic medications . if the response to decision block 408 is no , the process returns to decision block 400 ( fig3 ) to allow re - entry of the data . on the other hand , if the response to decision block 408 is yes , the data entry status for the medications section for the current date is updated to complete at block 409 . then the process proceeds to block 307 ( i . e ., connector a ) of fig3 . fig5 and 6 are high - level flow charts that refer to the operation of the administrative system of the present invention , which is installed on a computer in the physician &# 39 ; s office . in fig5 block 501 validates the user &# 39 ; s password . decision block 502 allows changes to the system configuration . if the response to decision block 502 is no , the process proceeds to decision block 504 . on the other hand , if the response to decision block 502 is yes , block 503 sets system parameters including system demographics , physician names , printing in color and use of pounds or kilograms . decision block 504 asks if there is a new patient to enroll in the system . if the response to decision block 504 is no , the process proceeds to decision block 507 . on the other hand , if the response to decision block 504 is yes , a new patent is enrolled in block 505 . enrollment includes entering patient demographic information and defining patient specific anchor points on the mood scale . the patient selects a password that is easy to remember . block 506 exports a patient specific file required for installation of the software on the patient &# 39 ; s home computer or on a clinic system . decision block 507 allows patient demographic data to be modified . this does not refer to the daily mood data entered by the patient at home . this refers to patient demographic , diagnostic data ( dsm - iv diagnoses with specifiers ) entered during enrollment and test results ( hamd , ymrs , bdi , etc ). if the response to decision block 507 is no , the process proceeds to decision block 509 . on the other hand , if the response to decision block 507 is yes , block 508 modifies , adds and deletes patient data . decision block 509 checks if there is patient data ready for importing . if the response to decision block 509 is no the process proceeds to decision block 511 . on the other hand , if the response to decision block 509 is yes , block 510 validates the import file and adds the data to the patient &# 39 ; s folder . decision block 511 allows display and printing of mood charts as in fig6 and denoted by a connector b . block 601 sets the desired time duration of the mood chart . the duration may be 30 , 60 , 90 or 120 days . decision block 602 allows the most recent days that meet the specified duration to be used . if the response to decision block 602 is no , the process proceeds to block 604 . on the other hand , if the response to decision block 602 is yes , the most recent days that meet the specified duration are set . block 604 sets the starting date for the mood chart . decision block 605 selects statistical charts . if the response to decision block 605 is no , the process proceeds to block 608 . on the other hand , if the response to decision block 605 is yes , block 606 sets the period used for the statistical calculations to either 7 or 30 days . block 607 makes the statistical calculations . block 608 sets the drug legend that annotates which medications the patient was taking . decision block 609 determines if the mood chart should be printed . if the response to decision block 609 is no , the process proceeds to block 611 . on the other hand , if the response to decision block 609 is yes , mood charts are printed at block 610 . block 611 displays the mood charts on the screen . block 600 returns to fig5 at the connector b . decision block 513 determines whether or not printing of patient reports on demographic , diagnostic and test result data is to be made . if the response to decision block 513 is no , the process proceeds to block 515 . on the other hand , if the response to decision block 513 is yes , reports can be selected and printed ( block 514 ). thereafter the process exits ( block 515 ). fig7 is a high - level flow chart illustrating the operation of the program patients use to enter data on a computer in a mental health clinic . at block 701 , the patient enters their name . decision block 702 verifies the name is in the system . if the response to decision block 702 is yes , the process proceeds to block 705 . on the other hand , if the response to block 702 is no , decision block 703 checks if this is a new user . if the response to decision block 703 is no , the system returns to block 701 for re - entry of the name . on the other hand , if the response to decision block 703 is yes , block 704 loads the program diskette and the patient is installed as a new user . after installation , the system returns to block 705 . block 705 allows entry of patient data in a fashion identical to that described in fig3 and fig4 . after data entry is finished in block 706 wherein the patient data is encrypted and saved ; thereafter the process exits ( bubble 707 ). fig8 is a high - level flow chart illustrating the operation of the process used to aggregate patient data from multiple sources for research . the step depicted by a block 801 configures the aggregate system including setting the data path , and making all data anonymous ( removing all fields that contain patient identifying information ). at the step depicted by the block 802 , the name of the file to be included is input , along with the input password and input site name . decision block 803 finds the file described in block 802 . if the response to decision block 803 is no , the system returns to block 802 . if the response to decision block 803 is yes , the process proceeds to decision block 804 to check if there are more input files to merge . if the response to decision block 804 is yes , then the process returns to block 802 . on the other hand , if the response to decision block 804 is no , block 805 selects a database , spreadsheet or text file output format for the aggregated data . the format selected will allow the aggregated data to load directly into popular spreadsheets , databases or statistical programs for analysis . block 806 generates the output file of the aggregated data ; thereafter the process exits ( bubble 807 ). fig9 through 12 illustrate the screens used by the patient to enter data daily on a home computer . fig9 view 900 shows the main menu screen with a graphical button to select all activities : change the date icon 901 , record mood icon 902 , record sleep pattern icon 903 , record medications icon 904 , online help icon 905 , manage data icon 906 and exit icon 907 . fig1 shows an example of the mood dialog box for a female with vas scale 1001 for entering mood , window 1002 shows the optional significant life events field , window 1003 is used for weight entry and buttons 1004 are used for answering the question regarding whether or not the patient is having a period today . fig1 shows an example of the sleep dialog box with the 24 toggle switches 1101 . the positions of the switch are as follows : awake icon 1102 , in bed and asleep icon 1103 and in bed but awake icon 1104 . fig1 shows an example of the medication dialog box with medication name and strength 1201 and number of pills taken 1202 . fig1 through 15 illustrate exemplary mood charts . on all of the charts , the data is displayed in three graphs : mood versus time , sleep versus time and medications versus time . all three graphs are directly aligned on the same horizontal axis equal to the time period selected for the chart ( 30 , 60 , 90 , 120 or 180 days ). for fig1 , 30 days is the selected time period . for fig1 and 15 , 90 days is the selected time period . in fig1 , mood chart 1300 , the top graph mood versus time 1301 shows mood data over the 30 - day time period selected . the vertical axis 1302 ranges between 0 and 100 with 50 representing normal mood , 0 the most depressed the patient has ever been and 100 the most manic the patient has ever been . triangles 1303 show the mood value entered daily . the daily values are connected with a line 1304 . along the top of the graph , the patient &# 39 ; s weight 1306 is entered once a week . if the patient entered a significant life event 1305 , the date is outlined by a square on the horizontal axis . for female patients , days of menstrual period 1307 are outlined by an inverted triangle on the horizontal axis . the middle graph sleep versus time 1308 shows patient sleep data over the 30 - day period selected . the vertical axis 1309 ranges between 0 and the total number of hours the patient was asleep plus in bed awake for the time period selected . the daily hours asleep 1310 are displayed as a dark colored bar topped by a lighter colored bar containing for any hours in bed awake 1311 . the bottom graph medications versus time 1312 shows which medications were taken each day by the patient for the time period selected . the vertical axis 1313 represents each of the different pills taken by the patient during the time period selected . different pills may represent different medications or different strengths of the same medication . a colored box appears for each medication 1314 . the medications are displayed in the same color on all charts , arranged in medication class order alphabetically within each class . on the 30 - day graph , the number of pills taken daily for each medication is shown in the middle of the color box 1314 . the specific medications are shown in the drug legend 1315 . the numbers in the legend 1315 correspond to the numbers on the vertical axis of the graph 1313 . each number in the legend 1315 lists the specific medication and strength taken by the patient . fig1 , mood chart 1400 , is an example of a mood chart that extends for a 90 - day period . the only difference from fig1 is that the number of pills does not appear on the medication box 1401 . fig1 , mood chart 1500 , is an example of a statistical chart calculated for a 7 - day period and extending for 90 days . the statistical charts contain three graphs : mood versus time , sleep versus time and medications versus time . all three graphs are aligned on the same horizontal axis with the total number of days displayed . calculations can be made for a 7 or 30 - day period . the results are positioned in the middle of the period . for the 7 - day period , the period extends from 3½ days before to { fraction ( 3 / 12 )} days after the displayed result . the top graph mood versus time 1501 shows statistics based on mood data , calculated for a 7 - day period . the vertical axis 1502 ranges between 0 and 100 with 50 representing normal mood . the 0 represents the most depressed while 100 represents the most manic the patient has ever been . for each 7 - day calculation , at least 5 days of mood data are required or the result is left blank . for each 30 - day calculation , at least 20 days of mood data were entered or the result is left blank . for the count of mood switches , one or more blanks will restart the count . in the middle of each 7 - day period , the maximum mood will appear as an inverted triangle 1503 , mean mood as a square 1504 , and minimum mood as a triangle 1505 . a dotted line connects the values in each period : 1507 connects the maximum mood from period to period , 1508 connects the mean mood from period to period and 1509 connects the minimum mood from period to period . standard deviation 1506 is shown as a circle . a dotted line 1510 connects the standard deviation from period to period . on the top of the graph is the number of mood switches in the time period 1511 , above the percent change in mean mood from period to period 1512 . the middle graph 1513 shows statistics based on sleep data calculated for either a 7 - day period and extending for either 60 or 90 days . the vertical axis 1514 ranges between 0 and the total number of hours the patient was asleep . for each 7 - day calculation , at least 5 days of sleep data are required or the result is left blank . for each 30 - day calculation , at least 20 days of sleep data are required or the result is left blank . in the middle of each 7 - day period , the maximum sleep will appear as an inverted triangle 1515 , mean sleep as a square 1516 , and minimum sleep as a triangle 1517 . a dotted line connects the values in each period : 1519 connects the maximum sleep from period to period , 1520 connects the mean sleep from period to period and 1521 connects the minimum sleep from period to period . standard deviation 1518 is shown as a circle . a dotted line 1522 connects the standard deviation from period to period . the bottom graph 1524 shows statistics based on medication data , calculated for either a 7 - day period and extending for 120 days . the vertical axis 1525 represents each different medication taken . the drug legend 1527 numbers correspond to the numbers on the vertical axis of the graph 1525 . each number in the drug legend 1527 lists the specific medication and strength taken . for each time period , the average dosage taken for each medication is calculated 1526 . the calculations will include all strengths for the same medication . no averages are calculated for birth control pills , dermal patches or combination drugs . for each 7 - day calculation , at least 5 days of drug data were entered or the result is left blank . for each 30 - day calculation , at least 20 days of drug data were entered or the result is left blank . the methods and apparatus of the present invention , or certain aspects or portions thereof , may take the form of program code ( i . e ., instructions ) embodied in tangible media , such as floppy diskettes , cd - roms , hard drives , or any other machine - readable storage medium , wherein , when the program code is loaded into and executed by a machine , such as a computer , the machine becomes an apparatus for practicing the invention . the methods and apparatus of the present invention may also be embodied in the form of program code that is transmitted over some transmission medium , such as over electrical wiring or cabling , through fiber optics , or via any other form of transmission , wherein , when the program code is received and loaded into and executed by a machine , such as a computer , the machine becomes an apparatus for practicing the invention . when implemented on a general - purpose processor , the program code combines with the processor to provide a unique apparatus that operates analogously to specific logic circuits . although the invention has been described with reference to a specific embodiment , this description is not meant to be construed in a limiting sense . various modifications of the disclosed embodiment as well as alternative embodiments of the invention will become apparent to one skilled in the art upon reference to the description of the invention . it is therefore contemplated that the appended claims will cover any such modifications of embodiments that fall within the true scope of the invention . aagaard j , vestergaard p , maargjerg k . adherence to lithium prophylaxis : 1 . clinical predictors and patient &# 39 ; s reasons for nonadherence . pharmacopsychiatry 1988 ; 21 : 121 - 125 . american psychiatric association . diagnostic and statistical manual of mental disorders , 4th revision ( dsm - iv ). washington : american psychiatric press , 1994a . bauer m s , crits - 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