User manual - Project AHEAD
Contents
1. User manual Version 1 0 AHEAD REGISTRY User manual May 2007 CONTENTS ON LINE REGISTRY GENERAL FEATURES ON LINE REGISTRY AHEAD BASIC PRINCIPLES OVERVIEW OF FORMS ADMISSION MEDICATION HOSPITALIZATION FOLLOW UP WORKING WITH THE AHEAD REGISTRY ACCESS TO THE REGISTRY BASIC SCREEN OF THE REGISTRY EXAMINING AN EXAMPLE RECORD DISPLAYING CREATED FORMS VIEWING AND EDITING PREVIOUSLY CREATED FORMS AN EXAMPLE FORM HOSPITALIZATION ANSWER TYPES 1 PARAMETRIZED ANSWERS 2 DATE 3 SIMPLE TEXT JUMPING BETWEEN THE ITEMS CLOSING THE FORM ENTERING REAL PATIENTS DATA ENTERING A NEW PATIENT GENERAL FORM OF PATIENT S IDENTIFICATION CODE ID CREATING AND FILLING IN FORMS FOR REGISTERED PATIENTS FIRST FORM ADMISSION OTHER FORMS ADDITIONAL FUNCTIONS OF THE SYSTEM CLOSING REMARK CONTACTS Coordination and technical support Institute of Biostatistics and Analyses Fac of Medicine and Fac of Science MU Brno Page U U RB A A A 10 10 10 10 11 11 12 12 13 14 14 15 16 17 18 AHEAD REGISTRY User manual May 2007 Page 3 On line registry general features gt The on line registry is based on a system collecting data from clinical trials TRIALDB which is being developed and widely used at the Yale University Connecticut USA The system is easily comprehensible for users all data are entered through web forms which are analogous to classical CRF paper forms2. Data can be entered into the registry from any computer connected to internet and equipped with the browser MS Internet Explorer 5 5 or higher it must support secure communication with 128 bit encoding No additional software needs to be installed in order to use the on line registry Only authorized persons have access to the registry based on their login and password Data in the registry are anonymized i e patients records are kept under codes ID which do not allow the personal identification In this way valid rules are met about the protection of personal data All data transfer is encrypted This prevents any potential data misuse during the transfer All entered data are collected in a central computer server where they are safely stored in a database administered by the ORACLE 9i system Data can be exported for authorized users as a local database for further processing The completed forms can be printed or saved on a local PC in the MS Excel format Welcome to the Yale Clinical Trials System Copyright 1997 2001 Prakash Nadkarni Cynthia Brandt and Yale University Coordination and technical support Institute of Biostatistics and Analyses Fac of Medicine and Fac of Science MU Brno AHEAD REGISTRY User manual May 2007 Page 4 On line registry AHEAD Basic principles gt You add new patients into the database yourself gt After adding the patient into the registry you can enter clinical data the col
3. can only be found using an extended search Search for Patient button in the main screen after this patient s retrieval it is necessary to assign him to the registry General form of patient s identification code ID K 195006M000 Seguence number of Year of birth oa of the patient in a given centre Coordination and technical support Institute of Biostatistics and Analyses Fac of Medicine and Fac of Science MU Brno AHEAD REGISTRY User manual May 2007 Page 14 Creating and filling in forms for registered patients First form Admission This form is filled in for all patients all items can be entered immediately Follow the red instruction in the upper part of the basic screen Select a patient using the mouse then select the first event i e 1st hospitalization by a double click Four forms will appear in the right column which can be created and filled in continuously for all registered patients Select the form Admission using the mouse and create it by clicking on the button Open New Form Instructions to create a new form TrialDB Microsoft Internet Explorer a Soubor pravy Zobrazit Obl ben N stroje N pov da O z x E KA DO Hedat 5 Obl ben S S H rel Adresa https f trials cba muni cz trialdbsinterface_forms trialdb asp name starttrialdb amp idt 17 5 2007 208 32 48 v P ejt Odkazy r AHEAD engli
4. AD registry will be displayed USE ONLY THIS BUTTON WHEN ENTERING A NEW PATIENT AND SAVING HIS PERSONAL DATA Coordination and technical support Institute of Biostatistics and Analyses Fac of Medicine and Fac of Science MU Brno AHEAD REGISTRY User manual May 2007 Page 13 gt By clicking on Save the entered data will be saved If you entered data for a new patient the Patient ID will not be available the patient is added into the system but it is still not assigned to the AHEAD registry USE THIS BUTTON ONLY FOR THE CORRECTION OF PERSONAL DATA gt By clicking on Back you will be returned to the main screen of the registry If any modification of data has been performed and not saved using the button Save a warning will appear If a new patient was added it will not be available in the main screen of the registry because it has not been assigned to the AHEAD registry USE THIS BUTTON ONLY FOR THE CORRECTION OF PERSONAL DATA gt By clicking on Reset all data modifications are restored if they had not been saved yet Attention In the case that a new patient is added his personal data is saved in the system Save button but it is not added to the AHEAD registry return to the main screen by clicking on Enter Edit Clinical Data without filling the data in the form for adding the patient into the registry the identification code of this patient is be available in the list Patient ID in the main screen This patient
5. Analyses Fac of Medicine and Fac of Science MU Brno Hospitalization This form contains four data units involving more detailed information about the hospitalization about the results of biochemistry and echocardiography examinations and about the patient s discharge from hospital Follow up This simple form contains a single data unit monitoring the patient s condition after his discharge from hospital Working with the AHEAD registry Access to the registry You can access the registry for example from the web portal AHEAD http ahead registry cz AHEAD Project AHEAD Mozilla Firefox Soubor pravy Zobrazit Historie Z lo ky N stroje N pov da 05 GD Biele i O W Wikipedia s Seznam Eal EN FR Dico FBE BBC Vodafone Yolmail ur IBA A Linkos NOP online cso NI P ehled zpr v PL Local ka vocab IBA N M Registry entry which will redirect you to https trials cba muni cz ahead ull Registi Sonware AHEAU Vala and resuns LomacIs entry Project AHEAD Participating centres About the project v straha zabezpe en nn x Informace kter si s t mto serverem vym nite nemohou zobrazit The acute heart failure is a clinical syndrome which can be a result In the security warning choose Yes to continue in the login process Registries and databases which were dev t Europe demonstrate a big diversity of this syndrome We have decided to m
6. Brno Director Assoc Prof RNDr Ladislav Du ek Ph D http iba muni cz If you encounter any technical problems please contact our helpdesk technick podpora tech support tel 420 549 498 281 e mail fhelpdesk amp iba munt cz
7. Medication select the patient using the mouse then select the event 1st hospitalization and select the form Medication on the right Click on the button Open New Form AHEAD REGISTRY User manual May 2007 Page 16 Additional functions of the system When working with the registry you will probably notice that the system enables more functions However in the case of this simple registry the description given above is sufficient and several functions are not even available We mention here just several additional functions which you might find useful gt The button Delete in the form footer deletes irreversibly the respective form It is not necessary to use this button as each form is created only one for each patient and can be updated at any time gt Search for Patient you can scroll the list of patients using the mouse the roll bar on the right side of the list or arrow keys T and 4 If the patient list is too long you can use the function Search for Patient You will probably not use this function very frequently as only patients from the given centre are visible and the list will probably not be very long gt Note you can add notes and comments to individual items in the form This function is sometimes used in more complex records or in the case that more persons within one centre fill in the form s Move the mouse over the item in the form and click on the right button A message window will appear no
8. ation A Open New Form ia d l Click on this button gt a list of created forms from all events will appear in the lower part of the screen v Patient TEST 01 mn in ascending order click on the corresponding button Overview of created Date Entered Date Last Modified Problems Status View Edit Printable Form forms for the HTML Excel selected patient 05 01 2007 Pending HTML Excel 1 line 1 form HIML Excel 05 01 2007 Pending HTML Excel Buttons to view and update previously created forms Hotovo B internet Coordination and technical support Institute of Biostatistics and Analyses Fac of Medicine and Fac of Science MU Brno AHEAD REGISTRY User manual May 2007 Page 9 Viewing and editing previously created forms You can view and edit previously created forms by clicking on the gray button View Edit in the overview of created forms in the lower part of the screen see the figure on the previous page Please examine all forms and get acquainted with all required data All forms have a similar structure and you can change the entered data arbitrarily The following example shows the form of Hospitalization An example form Hospitalization z https ftrials cba muni cz Edit and Browse Patient Data 66508 AH HOSPITALIZATION Microsoft Internet Explorer Form header Hospita lization version 1 Modified 01 04 2007 Generated 01 04 2007 basic data ID Patient TEST O1 Initia
9. gistry will be now displayed AHEAD REGISTRY User manual May 2007 Page Basic screen of the registry List of events List of patients Rollbar for a vertical movement in the list of patients appears List of forms available for a TrialDB Micro when more patients are given event These forms available are only displayed after the event selection pravy Zi Gm https trials AHEAD english Soubor f P ejt Odkazy Ga Log Out Adresa ent User Le ect patient event amp form to enter data Pati Form Search patient O starts with TEST 01 1 hospitalization Mark Forms by Selected Status contains 2 hospitalization Created v CE 3 hospitalization 4 hospitalization 5 hospitalization v Open New Form View data View Enrollment View Demographics Search for Patient Add New Patient Change password Gray function buttons Only 3 Separation line between the functions are usually active upper and lower part of the gt Open New Form screen it can be arbitrarily gt View Data move by the mouse The line gt Search for Patient appears only in more advanced screens of the registry than this basic one Hotovo B Internet The upper part of the screen displays gt on the left list of patients gt in the middle column with event titles valid f
10. it can obviously happen that the system will be temporarily unavailable The system malfunction can be also caused by an inappropriate web browser If the AHEAD registry does not work correctly please contact the technical support immediately the contacts are given at the end of this manual TRIALDB is an universally applicable system and some of his parameters are fixed However during the development of the AHEAD registry we have made a big effort to adapt it to the given purpose and we believe that the system will fulfil its function optimally Any suggestions are welcome you might give us valuable information leading to the improvement of registry and clinical data assessment We believe that the results of our common work will be reflected in the ever increasing quality of health care provided to your patients Coordination and technical support Institute of Biostatistics and Analyses Fac of Medicine and Fac of Science MU Brno Involved centres General University Hospital in Prague U Nemocnice 2 128 08 Praha 2 http www vfn cz St Anne s University Hospital Brno Pekarska 53 656 91 Brno http www fnusa cz IKEM Prague Videnska 9 140 00 Praha Kr http www ikem cz University Hospital Brno Jihlavsk 20 625 00 Brno http www fnbrno cz Technical coordination of the project Institute of Biostatistics and Analyses Faculty of Medicine and Faculty of Science at MU Brno Kamenice 126 3 625 00
11. le form The system will generate the appropriate form in the chosen format which is ready to be printed or saved The overview of created forms indicates that there is a pending problem in the form of Hospitalization When you open the form the problem item will be highlighted in red Attention If you change any feature of the form e g status of the form or solve the problem and save the form the performed modification will not be displayed in the basic screen with forms overview immediately The data in the basic screen have not changed since the last data load from the server Click again on View Data and the forms overview will be reloaded with the modifications you have just performed Coordination and technical support Institute of Biostatistics and Analyses Fac of Medicine and Fac of Science MU Brno AHEAD REGISTRY User manual May 2007 Page 1 Closing remark Please keep in mind that the system of on line registry is not common software installed into your computer When working with the system you exchange information with the server using the internet The speed of response thus does not depend on the efficiency of your computer but rather on the transmission speed As it has been already mentioned the registry is universally accessible from throughout the world the only condition being a computer connected to internet and equipped with an adequate web browser In the case of a connection failure
12. lected data should be available for all patients within standard practice gt The registry does not prescribe any treatment it merely monitors clinical data in a retrospective fashion gt Each patient s record is formally divided into individual events hospitalizations its number can vary for a given patient which are subsequently divided into four forms and further into data units For a given patient each form can be created only once the data in the form can be arbitrarily revised and updated Overview of forms Patient Event Form Data unit Patient ID 1 hospitalization Admission History Examination Admission ECG Medication Medication admission Medication hospitalization Medication hospital discharge Hospitalization Hospitalization Biochemistry Echocardiography Hospital discharge Follow up Follow up 2 hospitalization analogous data structure as in the 1 hospitalization 3 hospitalization analogous data structure as in the 1 hospitalization etc Admission This form contains three data units which are completed for all patients history examination height weight body mass index admission ECG heart rate heart rhythm ST segment Medication This form contains three data units as well monitoring the temporal distribution of medication in particular stages of medical treatment admission hospitalization hospital discharge Coordination and technical support Institute of Biostatistics and
13. ls Sex M Age 57 Race white Phase 1 hospitss Investigator Petr Brabec Study AHEAD ENGLISH Date Collected 4 1 2007 Last modified 5 1 2007 Buttons for quick jumping between form sections ll Hospitalization x ray Non invasive ventilation yes we ventilation with necessity of intubation yes no Failure of non in Invasive ventilation Hypotensis requiring IABC yes no Permanent cardiac stimulation during this hospitalization yes no Temporary cardiac stimulation during this hospitalization yes no Coronarography is known recoronarography or revascularization is not indicated yes no I j i i Items to be filled in answers Coronarography during hospitalization yes no Significant coronary artery disease stenosis over 50 of diameter v PCI during hospitalization yes no v CABG during hospitalization yes no v RLYG yes no v EF RLVG 9 Pending y Current User Lenka najdrov m v Hotovo ka i amp Internet i Form footer with function buttons Indication of form status gt Form header contains the form title patient s identification code ID and basic data investigator s identification date of form creation and date of last modification s gt Each form usually consists of several sections four in this instance Hospitalization Biochemis
14. m anywhere off the answer box 2 Date Apart from parametrized items which have been described above you may be asked to fill the item of date Please enter the date in the format DD MM YYYY If the day or month is a one digit number it is sufficient to enter the single digit i e you are expected to use 5 5 instead of 05 05 for instance The year can be entered using four digits 2004 two digits 04 even one digit 4 In such case the system will complete the number automatically If you enter the date in an incorrect format you will be given a warning 3 Simple text The last option of items to be entered is a simple text You can write into these boxes using the keyboard It is not practical to enter long texts Please try to give brief and clear information Note Some items can only be filled in conditionally i e the corresponding boxes are active only if a certain option is selected Please check it out on the example of the Admission form Scroll down to the question Height and select the option available Click on the following box Height cm now you are allowed to enter a number However if you choose not available instead of available further specification of height is not required nor possible If you try to click on the box Height cm this will be highlighted in gray and you will not be allowed to enter any text This item will thus remain empty Coordination and technical support Institu
15. nt TEST 01 by a mouse click the selection is highlighted in blue 2 Select an event by a double click your choice depends on which forms you wish to examine the selection is again highlighted in blue After the event selection a list of available forms appears on the right 3 Click on the gray button View Data The lower part of the screen gives an overview of forms which have already been created for a given patient and event If you want to check all forms created in all events recommended select the event i e the box above the event titles see the figure below This means all events together If you click on View Data now the lower part of the screen displays ALL forms that had been created for a given patient One form one line in the list Now you can see also the separating line between the upper and lower part of the screen Selected virtual patient nternet Explorer mt Obliben N stroje N pov da G z t x A C JP Heat sled Selection of the event means all events together Adresa E https cba muni c2 trialdb interface forms trialdb 2 S v P ej t Odkazy M AHEAD engli urrent User Lenka najdrov Log Out M P bnviD Event Form Search patient E A EN m F O sana auh 1 hospitalization Mark Forms by Selected Status contains 2 hospitalization Created wl 3 hospitalization 4 hospitalization iais 5 hospitaliz
16. onitor the ways of diagnosis and treatment o established the database AHEAD Acute HEAn Failure Database v big clinical centres General University Hospital in Prague IKEM Pr Hospital Brno This produces a pilot registry of health care facilities lt https trials cba muni cz ahead ani upravit jin u ivatel Nastaly v ak pot e s certifik tem zabezpe en serveru Certifik t zabezpe en vydala spole nost kter ned v ujete Prohl dn te si certifik t a rozhodn te se zda chcete dan mu certifika n mu adu d v ovat Datum certifik tu zabezpe en je platn N zev na certifik tu zabezpe en souhlas s n zvem str nky kterou se pokou te zobrazit f Prof MUDr Jind ich pinar CSc Head of the Department of Internal Medicine Cardiology University Hospital Brno Chcete pokra ovat Zobrazit certifik t JU The login window into the system appears Acute Heart Failure Database Fill in your login and password confirm by clicking on Login Pakalk 63 050 Ot Bene 3 H i d i H smiiid H nt Login i Password Ek i E Login wo H es Viesbecns tae Jihlavsk 20 026 00 Rene 1 eee fe ETE i j 2 Cawetoped by natbuoe af otani and Anamnes Maranh Unene Ama Coach Republic Midt a erparmentaine medics Vide 10500 19021 Puta g vw ken cz U Nemaenine 2 128 08 Pusha 2 The basic window of the re
17. or all patients gt onthe right column with form titles this is only active after the event selection The lower part of the screen is initially empty it is used for the selection of created forms In the further work with the registry the upper and lower parts of the screen will be separated by a gray line which can be moved arbitrarily Move your mouse over the line a symbol of double arrow will appear Press and hold left mouse button and move the mouse in order to get the line into the desired position You can move the border between two parts of the screen in other parts of this application too The navigation within the screen is easy and the control is intuitive Follow the instruction displayed on the screen Note that it is not possible to create two forms bearing the same title We recommend you to examine an example record so that you get acknowledged with the on line registry Coordination and technical support Institute of Biostatistics and Analyses Fac of Medicine and Fac of Science MU Brno AHEAD REGISTRY User manual May 2007 Page 8 Examining an example record The list of patients involves one example record a virtual patient The identification code of this patient is TEST 01 The aim of this record is to make you acquainted with the functions of the registry The database administrator had already created several example forms for this patient Displaying created forms 1 Select the virtual patie
18. sh Current User Lenka najdrov select patient event 8 form to enter data Log Out Patient ID Event Form Search patient J O n with Shospitalizatio Medication Mark Forms by Selected Status contains 2 hospitalization Hospitalization Created v X hospitalization atin Add New Patient View Demographics 1 Patient selection 2 Event selection 3 Form selection 4 Create a new form by clicking on the button Open New Form Hotovo R A amp Internet Please check all data in the header of the form which is now opened particularly the patient s initials and age If you encounter any discrepancy please call the administrator see the contacts at the end of this manual Fill in truly all required items Please respect notes in small font if there are any After entering all data indicate the status of the form in the footer If you have completed the form entirely so that it will not be necessary to make any changes or updates in the future select Completed Save the form by clicking on Save Check the data in the re loaded form if they have been saved correctly Coordination and technical support Institute of Biostatistics and Analyses Fac of Medicine and Fac of Science MU Brno Close the form by clicking on Close Other forms Other forms are created and filled in similarly to the Admission form which has been described above For example in order to create the form
19. te of Biostatistics and Analyses Fac of Medicine and Fac of Science MU Brno AHEAD REGISTRY User manual May 2007 Page 11 J umping between the items You can jump between the items boxes either by mouse or by the Tab key This means do not press Enter after filling in the answer move directly to another question instead Closing the form After filling in viewing or modifying the data you can quit close the entire form by the buttons in the footer JES Incomplete Current User Lenka najdrov Indication of the status of the Sending the data to Closing the form WITHOUT saving the form you can select one choice the server saving after clicking on the blue button the modifications with an arrow modifications We recommend you to indicate the status of the form in the footer item on the very left The option Pending is quite useful you can choose it if you envisage to complete the form in the future The option Completed is used for forms that have been completed as could be expected The list of options indicating the status of the form is displayed after clicking on the gray button with an arrow on the right side of the box similarly to the parametrized answers to some questions You can now quit the form either saving the modifications that have been done or not saving them i e if you are only viewing the form You might use the following buttons gt Save this means save
20. the changes which have been done in the form The data in the form will be sent to the central database on the server Then the form will be reloaded i e displayed exactly as it has been saved This might be useful for your check if the data have been saved correctly If the data correspond you can now quit the form using the button Close gt Close this means quit the form without saving the changes that have been done If you have done any modifications and click on Close you will be given a warning that the changes will not be saved In this moment you can return by pressing Cancel and to save the modified data using the button Save Coordination and technical support Institute of Biostatistics and Analyses Fac of Medicine and Fac of Science MU Brno AHEAD REGISTRY User manual May 2007 Page 12 Entering real patients data We recommend you to enter real patients data after getting a basic knowledge of the system s structure This can be most easily done by viewing the forms of a test record a virtual patient designed as TEST 01 see the section Examining an example record Entering a new patient Click on the button Add New Patient a special form will be displayed to enter personal data All data in this form are compulsory and must be filled in These involve Date of birth which needs to be entered in the format DD MM YYYY and Sex which is to be selected from the list of options Male Female Finally press the bu
21. tifying you that you are about to create a note a problem message After the confirmation you will be allowed to insert your comment or question e g your doubt if the value you have just entered is correct This will be indicated as an unsolved problem After saving the form the problem item will be highlighted in red and the overview of filled in forms will indicate that there is a pending problem in the respective form You can solve the problem in a similar way Open the form move the mouse over the item highlighted in red and display the comment by clicking on the right button of the mouse You can fill in the answer or otherwise specify the item and change the problem status to Resolved After resolving the problem the item will remain highlighted in green If you click on HTML or Excel the form will be displayed in the chosen Status format and ready to be printed or saved in your local 1 hospitalization Admission 04 01 2007 computer h hospitalization Hospitalization 04 01 2007 17 05 2007 Incomplete 1 hospitalization Follow up 05 01 2007 El HTML 1 hospitalization Medication 04 01 2007 05 01 2007 Pending gt HTML Excel 5 hospitalization Hospitalization 14 05 2007 o HTML Excel gt Printing or saving the forms You can print the forms or save them anywhere on your local computer in HTML or Excel format Click on the preferred option in the last column of the forms overview Printab
22. try Echocardiography Hospital discharge The sections are highlighted by distinct titles To jump quickly between the sections please use the buttons below the form header gt Each section contains several questions which can be specified in more detail by notes in little font on the right Please fill the boxes with appropriate answers Coordination and technical support Institute of Biostatistics and Analyses Fac of Medicine and Fac of Science MU Brno AHEAD REGISTRY User manual May 2007 Page 10 Answer types 1 Parametrized answers Most answers are parametrized i e there is a choice of pre defined options You can recognize the parametrized items by a blue button with an arrow The blue button with an arrow indicates a list of options from which you can choose one Peripheral The list of options is displayed after clicking on the blue button with an arrow COPD yearn State of consciousness dy Reason of admission Paste eee ner conscious I a P somnolence p List of options Investigation soporous ee Choose the correct option with the mouse Date of admission Attention Immediately after the selection the list of options is still active If you use now the scroll wheel of the mouse in order to scroll the form you will select another option instead of scrolling the form Before using the mouse wheel or arrow keys on the keyboard please leave the list of options by clicking on the for
23. tton Generate ID which generates a new patient ID from the date of birth the sex and the number of your centre If a patient with the same personal data already exists in the database the system notifies you and proposes another patient ID with a higher sequence number In this case please continue only if this is a different patient with the Same personal data AHEAD english Current User Lenka Snajdrova Select patient event form to enter data Log Out Patient ID Event Form Search patient starts with TEST O1 1 hospitalization Button Add New Patient contains 2 hospitalization 3 hospitalization 4 hospitalization 5 hospitalization A M4 Open New Form View data View Enrollment View Demographics Search for Patient Add NewFatient Change password Current User Lenka Snajdrova Indicates required fields Patient ID generated automatically after pressing Generate ID Patient ID Date of birth mm yyyy 1900 1999 Date of birth Sex v O e Pool ALERT CML HARDROCK Fill in appropriate data and click Save and Proceed Enroll to corres Navigation buttons After completing the form add the patients data into the registry by clicking on the button Save and Proceed Enroll gt By clicking on Save and Proceed Enroll the entered data will be saved and a form for the patient s addition into the AHE
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