Manual - CTS - Collaborative Transplant Study
Contents
1. e the minimum and maximum allowable values for numerical fields Minimum and Maximum e the possible values for coded fields Values table If two decimal places are not adequate for the value to be entered the next smallest unit of measurement should be used Decimal fields can be transformed to whole numbers in the same manner Consequently a total of 12 fields are available for the entry of numerical data The Properties option in the Field menu can also be accessed by a single right mouse button click on the entry field Each of the 25 configurable entry fields can be deactivated by double clicking on the label in the case that the entry 1s unnecessary The activation of an entry field is also accomplished through double clicking on the label CTS Collaborative Transplant Study Page 31 User s Manual TaXi Configuration and Technical Support 5 3 Technical Support Despite extensive testing the absence of errors within the TaXi program cannot be guaranteed Please consider that the TaXi program is not commercial software and thus due to considerations regarding personnel capacity no telephone hotline is being made available Should problems with TaXi arise please contact us exclusively through email at taxi cts med uni heidelberg de Before contacting CTS Heidelberg please try the following alternatives e If problems are encountered with operation try to first resolve the problem with help of this user2. Taxi Login Name Description TaXi User Access Password New Password Confirmation Save Cancel The user name must be entered or selected from the user table using the F7 key in the Local Login field The administrator enters the appropriate access to be granted in the User Access field and the password in the New Password field which must then be reentered in the Confirmation field CTS Collaborative Transplant Study Page 29 User s Manual TaXi Configuration and Technical Support TaXi user access is separated into the following levels O Nothing no access user inactive 1 Read read only access 2 1 Write reading and writing access 3 2 Delete Print access to reading writing and deletion functions and the printing of lists 4 3 Export Send access to reading writing and deletion functions printing of lists data back up and the exporting of data e g sending data to CTS 9 Administrator Administrator access user configuration configuration of data entry forms loading of data A user cannot change his her own password Special attention should be paid to the administrator password Please consider that the password is case sensitive 5 2 Configuration of the Data Entry Windows for Center Specific Data The TaXi program can be used for the entry and management of center specific data A comments field and 25 additional configurable
3. List Type field the following lists can be selected e the number of transplantations per year Data Status e the available immunosuppressive therapy follow up data Immsupp Follow Up e the missing immunosuppressive therapy follow up data for the post transplantation years 1 2 3 5 10 and 15 Immsupp Missing e available data on malignancies Malignancies e transplant data including data pertaining to the recipient and the donor Section 1 to 4 e clinical evaluation of transplant function patient status and malignancies for those transplantations in which data is missing Update Section The output device can be specified in the Device field If the Printer PCL option is chosen data for PCL driver sequences will be incorporated into the list so that the printer must be a PCL printer or a printer with PCL Emulation If no such printer is available the CTS Collaborative Transplant Study Page 22 User s Manual TaXi Printing list can also be saved in ASCII file format Device field File option and then formatted and printed with the word processing software of your choice The ESC driver sequences for the PCL printer are saved in the printer ini text file found within the TaXi installation folder The list can be displayed directly on the screen Device field Screen option The last two fields TX Year to allow for the entry of a range for transplant dat
4. Three formats are available for the export of the data that can be selected using the Data Type field e XLS Format Excel Version 5 0 e CSV Format text files with fields separated by commas and character strings contained within quotations e dBASE Format The data format can be adjusted for exports in the CSV text file format using the Date Format field The following formats can be selected e British dd mm yyyy e German dd mm yyyy e American mm dd yyyy e USA mm dd yyyy e ANSI yyyy mm dd In this case dd refers to the two digit day mm the two digit month and yyyy the four digit year After selecting the Save button the filename and the destination path can be entered as a default value data will be saved in the Output subfolder located within the installation folder CTS Collaborative Transplant Study Page 25 User s Manual TaXi Data Exchange 4 2 Data Exchange with CTS Data transfer with CTS Heidelberg is accomplished with the menu options Send Data to CTS and Load CTS Data and is most easily carried out using email The use of email for data transfer can be carried out without concerns regarding data security since the data is encrypted using a RC4 Algorithm prior to transfer The Send Data to CTS menu option is also a simple option for the backing up of data when the data is saved to diskette or another computer 4 2 1 Sending of Data The Send Data
5. 2 Uninstallation The following options are available for the removal of the TaXi program from your system e Delete the software program through the normal Windows procedure by using the Windows Start menu option Settings option Control Panel Add Remove Software or e Run the Unistall program found in the Cts menu option of the Programs menu of the Windows Start menu CTS Collaborative Transplant Study Page 4 User s Manual TaXi Data Entry 2 Data Entry 2 1 User Login Working with the TaXi program requires a valid user id that is immediately entered in the Login window after starting the program If multiple individuals will be using the program each user should possess his her own login information so that each modification of database information will be saved in association with the appropriate information see 5l ndividual User Configuration Data Source VFP_CTS User Hame Password OK Cancel During login the database of interest is selected in the Data Source field There are two databases available e VFP_CTS Visual FoxPro database of the center s CTS data e VFP_TEST Visual FoxPro database with test data 10 records The test database can be used to thoroughly acquaint yourself will all program functions without risking the inadvertent modification of CTS data The login name should be entered in the User Name field followed by the corresponding password in
6. Cause1 Cause2 TX Date pot EE EE ET ET TE S o y S e Ooo EE ET EE EE TP The transplant center Center field and a reference date Qualifying field must be entered for selection of the transplants in addition the sorting criteria of the table can be selected in the Order field The default value for the reference date is the current date Transplants are displayed according to the following criteria e It is 3 months 6 months or 1 2 3 years past the transplant date and the corresponding entries for clinical assessment of transplant function are missing or e Itis 1 2 3 years past the transplant date and corresponding entries for the recipient date of death or date of last contact are missing 365 days per year with a tolerance of 16 days are used in the selection of transplants for the generation of this list The CTS number i e the CTS key without the last three digits is displayed in the first column No The clinical assessments of transplant function for the periods 4 7 1 2 3 20 year s post transplantation are entered in the 74 2 1 2 3 20 columns Entries and changes to clinical assessment entries for transplant function will be shown in bold type as long as the data has not been saved Entries can only be made to the clinical assessment in the activated blank fields whereby in the last highlighted field only a code for transplant failure can be enter
7. by using the Delete menu option in the File menu or the Xl icon CTS Collaborative Transplant Study Page 12 User s Manual TaXi Data Entry Transplant data that has already been reported to CTS should not be deleted or Should only be deleted after consultation with CTS administration since this could affect transplant data in other CTS projects such as the DNA study The Print command File menu and select Print icon or F12 key prints the currently selected data in CTS data collection format The data entry window can only be closed when no unsaved data is present If an attempt to close the data entry window is made in the presence of data modifications that have not been saved the following Unsaved Data warning will appear Unsaved Data 7 Revert all changes If No is selected data can be saved or further changes can be made If Yes is selected the changes will be discarded and data will revert to the original pre modified values In both cases the data entry window will remain open CTS Collaborative Transplant Study Page 13 User s Manual TaXi Data Entry 2 3 3 Center Specific Data In the Edit TX menu selection of the Specific TX Data option will allow for the entry of center specific data for the transplant recipient or donor Study CTS CTS Key Center Name TX Date fy Numeric Values Date Field 1 fi Date Field 2 ii Date Field 3 ff Integer Field 1 0
8. s manual e Consult the FAQs section on the TaXi homepage in which questions of general interest and currently known problems will be published http www ctstransplant org tax1 e In the event that TaXi updates are available they can likewise be obtained as downloads from the above listed internet site Downloads link e It has been observed that irregularities may occur while working with the TaXi program without the display of error warnings that can be corrected be closing and restarting the TaXi program e Program errors can only be resolved when they are reproducible Consequently please make a detailed documentation of the steps taken after restarting the TaXi program which lead to the error CTS Collaborative Transplant Study Page 32 User s Manual TaXi Configuration and Technical Support 5 4 License Agreement By obtaining TaXi from CTS and using this software you agree that you have read understood and will comply with the following terms and conditions e The software TaXi is distributed as is without any guarantee made as to its suitability or fitness for any particular use e No warranty of any kind is expressed or implied You use at your own risk CTS will not be liable for data loss damages loss of profits or any other kind of loss while using or misusing this software The entire risk as to the quality and performance of this software is with you Should this software prove defective you assume
9. see 2 4 1 and 2 4 3 a table is provided in the program for entry of missing clinical assessments of transplant function see 2 4 2 Furthermore print outs can be obtained that list the individual transplants from which follow up data is missing see 3 1 2 4 1 Transplant Function and Patient Status The Follow Up menu is used for entry of follow up data in respect to transplant function and patient status Tas FP_CTS Fle Field New Ts EditTs Imm upp Follow Up Update Section Print List Extras Help Heart Lung Kidney Liver Pancreas Specific FU Data An individual transplant is selected in the same way as in the case of editing of a transplant through entry of the CTS key or with help of the search window see 2 3 2 Follow Up Kidney CTS Key Center Recipient 0 Tx if Clinical Qutcome Grades Created i Transplant Grade After 3 Months a Grade After 6 Months Failure Date fy Graft Survival Time days h Created Jf a by LastModified Jf Y Fecipient Recipient Alive Code g Alive Date Last Seen ff Recipient Death Date if Causes of Death f Created Jf ee by LastModified Jf Malignancies Exclude Recipient From Malignancy Statistics CTS Collaborative Transplant Study Page 15 User s Manual TaXi Data Entry Transplant Function In the Clinical Outcome Grades table values can only be entered in the Gr clinical score for transplant funct
10. the cost of all necessary servicing repair or correction e CTS reserves the right to update the contents of this software and its associated files documentation and or other elements at its discretion from time to time without the consent of or any obligation to any users e TaXi is not commercial software and thus there is no right of technical support and any other services for using this software CTS Collaborative Transplant Study Page 33
11. the free text fields found in the center specific data entry windows all letters entered will automatically be capitalized No foreign letters or accents will be allowed in the donor and recipient name fields In order to continue onto the next entry field the entry must be completed by using the Enter 1 or Tab keys It is possible to move between the entry fields by using the cursor keys T gt and J The fields are organized into groups separated by frames in which you can jump to the first entry field by using the Ctrl T or Ctrl J key combinations You can switch between index cards pages in a window by clicking on the header or by using the single keys Pagel and Page or the key combinations Ctrl Tab and Ctrl Shift Tab Dates can be entered using two digit day and month numbers without separation or can be entered separated by periods or forward slashes combined with 2 or 4 digit numbers for the year Some examples of correct entry formats for dates are 290601 29 6 01 and 29 6 01 A raised dot will be displayed in the empty fields within the entry window In tables such as Cross match in the transplant category New TX and Edit TX menus or Clinical Outcome Grades and Malignancies in the follow up section Follow Up menu new lines can be inserted by using the Enter key in the last field or the J cursor key in the last row CTS Collaborative Transp
12. to CTS menu option is used to send data to CTS Heidelberg The use of this menu option requires TaXi user access level 4 or TaXi administrative access see 5 1 If TaXi is to be used for CTS data transfer the data should be sent to CTS every three months preferably approx 2 3 weeks before the release date of the Heidelberg data update The data from the VFP_TEST test databank cannot be sent by email Study I Center Last Send or Save Date 0203 2001 Subject Message Cancer Confirmation Completion Status E Skin Cancers Include all Basal Cell Carcinomas F squamous Cell Carcinomas J Completion Date rr Diskette send Ermaill The entry or selection of the study and transplant center Study and Center fields is required prior to the sending of data The date of the last successful sending of data by email or the backing up of the VFP_CTS database is displayed in the Last Send or Save Date field CTS Collaborative Transplant Study Page 26 User s Manual TaXi Data Exchange A subject can be entered in the Subject field and an accompanying message in the Message field When the data is saved to diskette the message is saved as a Separate text file The current status for entry of new malignancies should be entered in the Cancer Confirmation section If the date for the entry of new malignancies is not changed the following warning will be displayed AN Cancer co
13. CD is located e in the Windows Start menu click on the Run menu option in the Open dialog box enter the file name and appropriate drive letter e g D setup exe The default installation folder for the TaXi program can be changed during the installation process Destination Directory A currently existing folder can be chosen or a new folder name can be entered A new program item named TaXi will be created in the Cts menu option of the Programs menu option of the Windows Start menu with which the program can be started Alternatively the file TaXi exe can be dragged onto the desktop in the form of a shortcut icon The symbol for the TaXi desktop shortcut icon is Restarting the computer after completion of the installation procedure is not required Notes for Network Installation There are no special installation procedures for network installation The TaXi program can be installed on a drive of the desired network server and started from this location Entry of TaXi into the Windows Start menu or creation of a desktop shortcut can then be manually accomplished on network clients where the program will be run The loading time required for starting TaXi from a network server can be shortened by copying the vfp6r dll and vfp6renu dll files into the Windows system folder on respective client computers CTS Collaborative Transplant Study Page 3 User s Manual TaXi Installation and Uninstallation 1
14. CLS Collaborative T ransplant Study TaXi CTS Data Management System Version 1 2 User s Manual August 2001 Copyright 2000 2001 by Collaborative Transplant Study CTS Heidelberg Germany All rights reserved University of Heidelberg e Transplantation Immunology Im Neuenheimer Feld 305 e D 69120 Heidelberg Germany e Internet http www ctstransplant org tax1 e E Mail taxi cts med uni heidelberg de User s Manual TaXi Contents Contents CTS Collaborative Transplant Study Page 2 User s Manual TaXi Installation and Uninstallation 1 Installation and Uninstallation The installation of the TaXi Program is accomplished through use of the Setup exe file found on the installation CD which will install both the application and the database The installation requires no special Windows NT 2000 administrative access since no files will be copied into the Windows folder After installation the TaXi program can only be used if a valid user id and password are available If multiple users will be working with the TaXi program or if the data entry windows for center specific data will be used the program should be configured according to the procedures described in Chapter 5 1 1 Installation The installation program can be started through both of the following methods e in Windows Explorer double click on the file Setup exe found in the folder corresponding to the drive in which the installation
15. Integer Field 2 0 Integer Field 3 0 Integer Field 4 0 Integer Field 5 T Integer Field amp 0 Humeric Field 1 Humeric Field Numeric Field 3 Numeric Field 6 Numeric Field 4 Numeric Field 5 Character Values Character Field 1 Character Field Character Field 3 Character Field 6 Text Field 1 Text Field 2 Text Field 3 Text Field 4 Comment Hints Double Click on Label EnableDisable Field Right Click on Field Context Wenu Created ff oc by Record ID 0 LastModified ff 2 hy Character Field 4 Character Field 5 The creation of a user friendly data entry window requires configuration by the TaXi administrator see section 5 2 An appropriate configuration process consists of e the sensible naming of entry fields e the definition of field data ranges and e the deactivation of unnecessary fields The entry window will be displayed in a form appropriate to the configuration after entry or selection of the study in the Study field The selection of a transplant the saving of entered data and the completion of the entry process occurs analogously to the entry of the CTS data see 2 3 2 CTS Collaborative Transplant Study Page 14 User s Manual TaXi Data Entry 2 4 Follow Up Data The completeness and quality of the follow up data play a large role in the statistical analysis of transplant data Because of this in addition to the data entry table for individual transplant
16. an be exported using the Export menu option The use of this option is restricted to TaXi user access level 4 or TaXi administrator status see 5 1 Study I Center Table Transplantations Fields Mot Selected selected er dd 44 Ea xl zl Type Excel Version 5 0 xls Format British ddim yy ave Cancel The selection of the study and transplant center Study and Center fields is required for the export of data According to the configuration of the database the following tables can be exported Table field e transplantation data including recipient donor and center specific data without crossmatch test results Transplants e clinical evaluation of transplant function Clinical Outcome Grades CTS Collaborative Transplant Study Page 24 User s Manual TaXi Data Exchange e immunosuppressive therapy follow up data Immsupp Follow Up e center specific follow up data Specific FU Data e data on malignancies Malignancies e Crossmatch test results Crossmatches e table columns descriptions Field Descriptions e description of the coded values Look up Tables In addition to the descriptive table all tables receive a column for the study center and the CTS key In this manner the CTS key can be used to link separate tables with one another The exported fields and their order can be specified with the arrow buttons or mouse drag and drop
17. asic List and the list type Immsupp Missing see 3 1 The entry window is composed of two pages Basics Treatment Therapy and Other Evidence ta Immsupp Questionnaire Kidney Key Year Center Name Age o Grade TX Date iy Basics Treament Therapy Other Evidence Basics Renal Function Stable Current Plasma Creatinine Jo Antihypertensive Drugs B Unstable for any Reason H Blood Pressure Systolic o mm Hg Receive ACE Inhibitor E Diastolic 0 mm Hg After entry of the year post transplantation Year field the transplant is selected through entry of the CTS key or through use of a search function Find Browse Recipient Browse Donor or Browse Transplant found in the File menu or in the icon bar Data entry is only possible if a clinical assessment of transplant function is scheduled for that respective year CTS Collaborative Transplant Study Page 19 User s Manual TaXi Data Entry If data for immunosuppressive therapy is already present for the respective year it will be displayed and can be modified If a CTS key has already been entered or selected a previously entered record can be selected in the Year field using the F7 key The use of this key will result in the display of a selection window in which the year post transplantation and the date of the creation of the record are shown If the number entered is too large it will be replaced with the largest numbe
18. e the menu bar with access to submenus for specific menu options e the CTS logo e important tips for working with TaXi Hints section e links to the most frequently used functions Main Options section e the status bar Status bar Common functions generally accessible through mouse clicks or Windows shortcut key combinations can be used during program operation The selection of individual menu items is accomplished through a single mouse click on the appropriate item or the use of the key combination ALT underscored letter CTS Collaborative Transplant Study Page 6 User s Manual TaXi Data Entry The most frequently used functions can be selected through a single mouse click on the underscored category The following information will be displayed in the left side of the status bar e information for working with tables or e entry field formats e description of coded values and e functions associated with additionally available shortcut key combinations The three boxes on the right side of the status bar display the activated keyboard input States e OVR Overwriting activated Ins key e NUM Numerical keypad lock activated Num key e CAPS _ Caps Lock activated th key During data entry an icon bar containing the most frequently used functions will appear above the data entry window e g CTS Collaborative Transplant Study S Sl da kae FR Bap P se Ful 2 Moving the
19. ed because follow up for that year is not yet completed CTS Collaborative Transplant Study Page 18 User s Manual TaXi Data Entry The abbreviation AC in the column heading refers to Alive Code i e whether the patient is still alive The cause s of death are entered into the Cause1 and Cause2 columns The Ctrl lt and Ctrl gt key combinations can be used to jump to the first and last field within a row If the Enter 1 key is used while the cursor is positioned in the last field of a row the cursor will move to the next empty entry field in the following row 2 4 3 Follow Up Data for Immunosuppressive Therapy The entry and editing of follow up data for immunosuppressive therapy is accomplished through the Immsupp menu The data entry window is arranged according to the same format as the hard copy Questionnaire 1 e Immunosuppressive Follow up Tas FP_CTS File Field New Ts Edit Tx Imimeupp Follow Up Update Section PrintList Extras Help Heart Lurg Kidney Liver Data for immunosuppressive therapy for each year post transplantation can be documented using this menu whereby CTS Heidelberg currently requires data for the year s 1 2 3 5 10 and 15 post transplantation A list can be created containing the individual transplantats in which data for immunosuppressive therapy are missing for these post transplant time points by using the Print List menu and the menu options B
20. ed by clicking on the folder name shown in square brackets under the horizontal line or on the appropriate file name If a file with the SEND CTS format is highlighted the Load option button is then activated for the importing of the selected file After selecting Load the confirmation window is displayed Confirmation E Ovenite database VFP_CTS now Selection of Yes will irreversibly overwrite all data in the database ATTENTION Using Load CTS Data will overwrite all previous existing data CTS Collaborative Transplant Study Page 28 User s Manual TaXi Configuration and Technical Support 5 Configuration and Technical Support A TaXi administrator login and nine user logins are available for the operation of the TaXi program The TaXi administrator is solely responsible for allocation of user access rights and changing of user passwords After installation users must be configured by the administrator according to the following section Two entry windows are available for entry of center specific data e Edit TX menu Specific TX Data option e Follow Up menu Specific FU Data option If these entry windows are to be used for entry of data they must be configured by the TaXi administrator see 6 2 5 1 Individual User Configuration Configuration of the user is accomplished using the Change Password menu option found in the Extras menu fe Change Password Ea User
21. es thus narrowing the transplant list selection criteria 3 2 Forms The printing of blank forms is accomplished through use of the Blank Form menu option Print Blank Form Center Form Type initial Transplant Device Printer Print Cancel The entry or selection of a study in the Study field is required The entry or selection of a center 1s not required but will be displayed on the form if entered Using the Form Type field the type of form can be selected for either the entry of new transplant data Initial Transplant or for immunosuppressive therapy follow up data Immsupp Questionnaire If the form for the immunosuppressive therapy follow up data is chosen the post transplantation year can be entered in the Year field This entry field is only visible if the form type Immsupp Questionnaire is chosen Selection of the Printer or Screen options in the Device field determines whether the form will be respectively printed or displayed as a preview on the screen CTS Collaborative Transplant Study Page 23 User s Manual TaXi Data Exchange 4 Data Exchange The option for the transferring of data to CTS Heidelberg or other applications is found in the Extras menu Taar FP_CTS File Field New Ts Edit TX Immeupp Follow Up Update Section Print List Extras Help Export Send Data to CTS Load CTS Data Change Password 4 1 Exporting of Data Data c
22. fields are made available for the Specific TX Data entry window in the Edit TX menu and in the Specific FU Data entry window in the Follow Up menu including a 3 date fields b 6 fields for whole numbers without decimal places in the range 0 to 999999 c 6 fields for numbers with a maximum of 2 decimal places in the range of 0 00 to 9999 99 d 6 fields for coded values with a maximum allowance of 5 capital letters e 4 free text fields with a maximum of 32 characters of choice CTS Collaborative Transplant Study Page 30 User s Manual TaXi Configuration and Technical Support Field Properties of EXC1 Layout Description e cee Label Character Field 1 Length 5 Decimals 0 Data Minimum f Maximum f Values a Value Description After entry of the study and selection of a transplant through the entry of the CTS key or the recipient name with use of Ctrl F or Find option of File menu the following characteristics can be defined in the Field Properties of Field menu Properties option entry window e data entry hints that are displayed when the mouse pointer is positioned over the entry field Description e the label of the entry field in the entry window Label e the length of the entry field for numerical fields including the decimal places in the case of decimal fields Length e the number of decimal places allowed for decimal fields Decimals
23. hich means that individual data is available for the donor and recipient for each transplant In the case of retransplant however the recipient data from the previous transplant record should be overtaken Data transfer for the recipient is accomplished through the Browse Recipient menu option found within the File menu or alternatively through use of the Ctrl R key combination or the E icon in that the table with the search result of the previous transplant is selected with the Enter key the F2 key the icon or by double clicking on the CTS key If donor data is already available this can be analogously transferred with the Browse Donor menu option in the File menu the key combination Ctrl D or the Be icon CTS Collaborative Transplant Study Page 10 User s Manual TaXi Data Entry The recipient date of birth can be saved by opening the following entry window through use of the F6 key within the recipient date of birth entry field Recipient page Age field Date of Birth I Fields for the transplant center Recipient page Center field the recipient name Recipient page Last Name field and the transplant date Immsupp Protocol Transplant page Transplant Date field must contain data A blank recipient or donor field will be automatically completed upon exiting the entry field with the entry UNKNOWN The and symbols in the Highest Serum and Latest Serum columns
24. ion column the year post transplantation will be automatically displayed in the Yr column A new row will be created if the Enter key or the J cursor key is pressed while the cursor is positioned in the last row The entry of the date of transplant failure Failure Date is only possible if the code for transplant failure is entered as the clinical grade Clinical Outcome Grade signified by the value 1 in the Failure column of the F7 selection table The entry of a date of death Recipient Death Date field and the cause s of death Causes of Death fields requires the entry of a date for transplant failure and of the code N in the Recipient Alive Code field If a patient with a functioning transplant dies the date of death should be entered as the date of transplant failure with the cause of transplant failure entered as N Non immunological Failure The entry of the date of the last contact with the patient in the Alive Date Last Seen field requires an entry for transplant failure The Recipient Alive Code field specifically the question as to whether the patient is still alive must be answered as Y In the case of retransplantation the values for the recipient such as the date of death for example will not be automatically transferred from the previous transplant s but rather must be entered for each transplant When incorrect data is entered for clinical assessment of transplant function G
25. is selected with a mouse click or the key combination Alt underscored letter the corresponding description will be displayed in the status bar CTS Collaborative Transplant Study Page 9 User s Manual TaXi Data Entry 2 3 Transplant Data 2 3 1 New Entry New entry of transplant data is accomplished through the link Enter new transplant data in the main window or alternatively through the New TX menu found in the menu bar Tas FP_CTS File Field New Ts Edit T Immsupp Follow Up Update Section PrintList Extras Help HeartLurg Kidney Liver The menu contains an entry respective to the transplant organ and the respective CTS study e CHTS heart and or lung Heart Lung e CTS kidney and or pancreas Kidney e CLTS liver Liver The format of the data entry window is orientated according to the study s hardcopy forms Menu entries are only active if at least one transplant center is available in the database for that respective study The entry window is thematically separated into three pages for recipient Recipient immunosuppressive medication and transplantation Immsupp Protocol Transplant and donor Donor data Recipient Immsupp Protocol Transplant Donor CTS Key Center I Local Key ET No Recipient Cha Last Name First Name CMY pos neg E Age oy days fi Sex E Race E ABO Hi Prophylaxis E The database is transplant and not patient orientated w
26. lant Study Page 8 User s Manual TaXi Data Entry Menu items in the Field menu can also be selected from the context menu which is opened by clicking with the right mouse button key on the input field Unda Chez Cut Ctrl Copy Ctrl C Paste Ctrl Select Code F7 Frequencies Properties The menu contains common Windows commands that are normally found in the Edit menu of other applications such as Word or Excel specifically undo the last action undertaken Undo delete the selected text and copy it into the clipboard Cut e copy the selected text into the clipboard Copy e insert text from the clipboard Paste In addition the menu contains options for selection of the possible values F7 and for opening of the Properties of Field window which contains the description of the entry field see also 5 2 Except for the center specific data entry windows this window only contains informative items with inactive entry fields The Frequencies menu option creates a frequency table calculated from data entered in the input field A table is displayed showing the value in the Value column and the absolute frequency in the Count column For example in the case of blood types the following table could be displayed Transplantations in which the field is blank will also be counted and then displayed with a raised dot in the Value column If a menu or menu option
27. mouse over the icons will display explanations of the functions of these symbols All of the functions displayed in the following table with the exception of Switch to Window and Help can be found in the File menu Icon Function Key s Ei Check F9 Save F10 E Print F12 A Find Recipient Name Ctrl F x Delete E Close Form ESC BR Browse Recipient Ctrl R Browse Donor Ctrl D ay Browse Transplant Ctrl T TX Switch to Window Edit TX F3 Ei Switch to Window Edit Specific TX Data Shift F3 FU Switch to Window Follow Up F4 Help F1 CTS Collaborative Transplant Study Page 7 User s Manual TaXi Data Entry 2 2 2 Program Operation All entry fields within the data entry window require alphanumeric entries that correspond with database entries The status bar will always display the appropriate format required for the entry 9 to represent that a number must be entered or X to represent that data should be entered in the form of a letter Values from fields connected to a data table can be selected with the F key or the Select Code menu option which is found in the Field menu or the context menu displayed by clicking with the right mouse button key Fields with data tables will be automatically completed when the meaning is clear from the beginning of the entry e g TR in the Donor Death field will be completed as TRAUM With the exceptions of the comments and
28. mpletion date has not been changed Cancel A compressed and encrypted file with the name format SEND CTS where the number symbol refers to a four digit number is created from the database tables when the button options Diskette Send Email or Save As are selected When the data is to be automatically sent by email a Confirmation window will appear Confirmation E in lt gt Email data ta CTS now in which the action must be confirmed If No is selected the file can be saved to the folder of your choice CTS Collaborative Transplant Study Page 27 User s Manual TaXi Data Exchange 4 2 2 Loading Data A database update from CTS Heidelberg or a back up copy of your database can be loaded using the Load CTS Data menu option Administrative access is required for the use of this option in the TaXi program A TaXi program created file with the name format SEND CTS where the number symbol refers to a four digit number must be present in order to load a new CTS Heidelberg database update Mode Overwrite user data descr grant passw F Overwrite center specific data Tx FU Load Cancel The entry or selection of the study and the transplant center in the Study and Center entry fields is required The drive can be selected by clicking with the mouse on the first line in the File field The second line displays the current folder A folder or file can be select
29. nistrator see is required for a user friendly format Configuration should be made so that e entry fields are meaningfully labeled e the data range for each field is defined e unnecessary fields are deactivated After entry of the study in the Study field a CTS key can be entered or a transplant can be selected from the search window The number of a previously entered data record can be entered into the No field in order to edit previously entered data or a new number can be entered for creation of a new record It is also possible to select a previous record by using the F key in the No field The number and the record creation date will then be displayed in the appropriate window CTS Collaborative Transplant Study Page 21 User s Manual TaXi Printing 3 Printing The Print List menu can be used to print the familiar hard copy forms and lists usually produced by CTS Heidelberg Fle Field New Ts Edit TX Immeupp Follow Up Update Section Print List Extras Help Basic List Blank Form 3 1 Lists The Basic List menu option within the Print List menu requires a minimum TaXi user access of level 3 see 5 1 Print Basic List Study Center List Type Device Printer PCL TX Year 01 01 1964 to 1408 2001 ddimmiyyyy Print Cancel The entry or selection of the study in the Study field and the transplant center in the Center field are required In the
30. on of a transplantat record can be accomplished through entry of the CTS key or through the search applications Find Browse Recipient Browse Donor or Browse Transplant which can be activated through the File menu or by use of the appropriate key combinations found in the shortcut list A simple search on the recipient name is accessible through the Find menu option in the File menu the Ctrl F key combination or the iy icon i Find CTS Recipient search Term Recipient Name m 2 E Search Results S S Mame RecipientName CTS Key Center_ TXDate ee ee ed ee The beginning of the surname for the desired recipient record should be entered in the Recipient Name field The following wildcard symbols are allowed e Underscore any letter e Percent character string of indeterminate length The search is initiated through the T icon or the Ctrl Enter key combination The order of the returned search results can be modified through a double click on the appropriate column header The selection of the specific transplant record is accomplished by double clicking on the name or by highlighting it and then using the Enter key the F2 key or the El icon When a subsequent search is initiated the results of the previous search will initially be shown For TaXi users with the appropriate level of access see 5 1 transplant records can be deleted
31. quisition of this information is not possible a Y should be entered in the Unkn column Unknown Diag Date Confirmed If a more in depth description for a malignancy such as the localization or type is expected the respective field in the Type column Tumor Localisation or Type will be activated The stage of the malignancy can be entered into the Stag column A further characterization of the malignancy can by accomplished through the Subt column Tumor Subtype for example the cell type for malignancies in the lymphatic tissues CTS Collaborative Transplant Study Page 17 User s Manual TaXi Data Entry 2 4 2 Follow Up Data for all Transplants at a Center A list can be generated using the Update Section menu that lists each individual transplant with incomplete data in regards to transplant function or patient status Tas FP_CTS Fle Field New Ts Edit TX Imm upp Follow Up Update Section Print List Extras Help Hear Lurig Kidney Liver Pancreas The follow up data is entered in a table formatted for one row per transplant In order to be able to display all possible columns the TaXi program window will be converted to full screen display when the update section window is opened Z Update Section Kidney Center I 375 Qualifying 14 08 2001 Order Recipient Name gt Select No Name 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Failure AG Alive Death
32. r possible after the following warning 1s displayed AN Invalid year in future or after graft Failure Through use of the Print command option Print of File menu f icon or F12 key a completed CTS questionnaire can be printed The entry window can only be closed if no unsaved data is present If an attempt to close the data window is made while unsaved data is present the following Unsaved Data warning will be displayed Unsaved Data x F a Revert all changes If No is selected the data can be saved or further changes can be made If Yes is selected all changes will be discarded and data will revert to the original form In both cases the entry window will not be closed CTS Collaborative Transplant Study Page 20 User s Manual TaXi Data Entry 2 4 4 Center Specific Follow Up Data Center specific follow up data can be entered with use of the Specific FU Data menu option found in the Follow Up menu CTS Key Nof Center Name TX Date fy Study SiR A further 99 records per transplant that are assigned a number from 1 to 99 in the No field can be entered using this entry window The meaning of this assigned number is user defined and can refer to for example the date post transplantation or an abstract number with an in house specific meaning Sequential order is not a requirement for the record numbers Configuration of the entry window by the TaXi admi
33. rade After 3 Months Grade After 6 Months Clinical Outcome Grade a warning will be displayed on the screen AN Invalid clinical outcome grade All data in the Recipient group and the date of the transplant failure Failure Date must first be deleted in order to reverse the entry of a transplant failure CTS Collaborative Transplant Study Page 16 User s Manual TaXi Data Entry Malignancy A key focus in present scientific transplantation research is the incidence of malignancies in transplant patients Therefore an accurate and complete documentation of these illnesses ICD 9 140 208 ICD 10 C00 C97 is very important Additionally malignancies of uncertain or unknown character e g Myelodysplastic Syndrome D46 should also be documented Moreover in situ malignancies DOO D09 and non malignant tumors D10 D36 can also be entered into the record Diagnoses of malignancies should be entered into the Malignancies table A date of diagnosis Diag Date column that proceeds the transplant date must be confirmed by selecting Yes in the Confirmation window Confirmation E 2 Pre Tes Tumor The text PRETX will automatically be entered in the Diagnosis column and the number 1 will be entered as the code in the ICD column Non malignant tumors can be entered with the code O but the diagnostic text should still begin with the word BENIGN If the diagnosis date is unknown and the ac
34. the Password field Since the password is case sensitive pay special attention in regards to case during password entry and ensure that Caps Lock is not activated CTS Collaborative Transplant Study Page 5 User s Manual TaXi Data Entry 2 2 Screen Layout and Program Operation 2 2 1 Screen Layout The following TaXi program main window appears after login Taxi VFP_CTS OF File Field Mew Ts Edit Ts Immsupp Follow Up Update Section PrintList Extras Help CIS Collaborative Transplant Study CIS amp Hints Important Notice hints displayed inthe status bar atthe bottom of the application window Usethe menu or icon bar located at the top of the window for saving printing closing Complete text box data entry by using the Enter or Tab keys oD Main Options click on underlined options Enter new transplant data including recipient and donor dataj Edit existing transplant data including recipient and donor dataj Immunosuppressive follow up 1 2 3 5 10 15 years after transplantation Individual transplant follow up data clinical outcome grades failure date death date alive date malignancies Allfollow up data of the center Update section without malignancies See menu or user s manual for additional options Status bar The window contains the following areas which are listed from top to bottom e the title bar displaying the name of the active database
35. will automatically be converted into the letters P and N in the cross match test table Cross match All entries are verified and appropriate error messages or warnings will be displayed for example incompatible blood groups would be displayed in the following warning message AN Recipient and donor ABO are incompatible The saving of the data record for a new transplant is completed by selecting the Save menu option from the File menu or alternatively by clicking on the El icon or using the F10 key A CTS key will automatically be assigned and displayed in the window entitled Record saved Record saved x G CTS Kep 249375 When closing the data entry window the message window entitled Unsaved Data will appear regardless of whether data has been entered or not Unsaved Data E pi 7 Cancel data capture and can be closed by selecting Yes CTS Collaborative Transplant Study Page 11 User s Manual TaXi Data Entry 2 3 2 Editing Viewing Printing and Deleting The Edit TX menu can be used for the modification and completion of a previously entered transplantat record Taxi FP_CTS File Field New TH Edit T Immsupp Follow Up Update Section Print List Extras Help Heart Lurid Kidney Liver Speciic Ts Data The entry windows for the three studies CHTS Heart Lung CTS Kidney Pancreas and CLTS Liver are identical in regards to new entry The selecti
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