Data Management Handbook

Transcription

1 Data Management Handbook January 2013, V8

2 This is Version 8 January 2013 of the Data Management Handbook. The changes have been made to the following sections since version 7 (August 2012), please read carefully: Contact and Appointment phone calls Page 16 Name of person completing the form Page 19 New data field for how the assessment was conducted Page 19 Comparing and Validating Forms Pages 30 and 31 Creating and Uploading files to the ICC Page 32 2

3 SECTION 1 USING THE DATA ENTRY PROGRAM... 4 Where is the program kept?... 4 Sub-Directories... 5 New Users and User Names... 5 Starting the CORONIS Follow-up data entry program... 7 File menu... 7 Upload files... 7 Log incoming data... 8 SECTION 2 ENTERING DATA Contact and Appointment details Main Data Forms for Double Entry Health Assessment Questionnaire HAQ Pregnancy Form Death Report Form Event Report Forms SECTION 3 COMPARING AND VALIDATING DATA FORMS Comparing forms Data form queries Things to Remember SECTION 4 UPLOADING DATA TO OXFORD SECTION 5 REPORTS Reports printed on a weekly basis Contact Reports Appointment Reports Monitoring Reports SECTION 6 Computer Maintenance HARDWARE: SOFTWARE URGENT QUERIES NOTES (for your use)

4 SECTION 1 USING THE DATA ENTRY PROGRAM This handbook explains how to enter information from the Contact Report Form (CRF), the Appointment Form, data from the Health Assessment Questionnaire (HAQ) and Event Report Forms for all women (excluding those who had a vaginal delivery and those who have chosen to opt out of the study) who have been entered into the CORONIS Trial. The program makes use of data collected during the recruitment phase of the trial. Every effort should be made to keep in contact with women after their discharge from hospital. You will have told the International Co-ordinating Centre (ICC) the interval at which you intend to contact the women and reports will be generated accordingly. This will be either every 3 months or every 6 months. As with the program for the main trial, the data forms must be logged before they can be entered, this includes Contact Report Forms and Appointment Forms. Data is processed in the following order: Log onto the data entry system all forms that come into the RTO from the hospital sites o Contact Report Form o Appointment Form o Health Assessment Questionnaire o Pregnancy Forms o Event Report Forms o Death Report Form Enter records of contact made with the women Enter data from the Appointment Forms Perform First and Second data entry for the HAQ, the Pregnancy forms and Event Report Forms Compare the two entries and check for incorrect or missing data Resolve any queries with the hospital sites Upload data to Oxford Contact details, appointment details, validated HAQ, Event Forms and Death Forms Where is the program kept? The database used during the recruiting stage of the trial is in C:\Coronis\Database and called Coronis_Data.mdb. All other folders and files created for data entry in the main trial should be kept as they are. The data from the main trial database is also used for the Follow-up program. Now that all RTOs have at least two computers, the databases are held on one computer (the Master) and they are accessed by the program from the remaining computer(s) (the Slave). For the recruiting stage of the trial, the folder structure will now looked like this: C:\Coronis Transfix Trial Entries Processed Upload Sent On the MASTER computer, the folder structure will be as follows: C:\Coronis Database FU Upload Sent Transfix Trial Entries Processed Upload 4

5 Sent There will be a small database on the C:\ drive of both computers called CoronisFU_Data.mdb. This only holds enough information to allow the program to know which RTO it is accessing. If you have a central IT department, it is possible that the folder structure is on a server and the drive letter will be different. On the Slave computer the folder structure will be: C:\Coronis (The small database will be in this folder) The slave computer accesses the program via the Master computer. The data entry program runs from a file CoronisFU.exe, and the underlying Access database is called CORONIS_FUDATA.mdb and the main trial database is called CORONIS_DATA.mdb. DO NOT DELETE THESE FILES. Sub-Directories For information about the sub-folders, Transfix, Trial Entries and Upload see the main Data Management Handbook for the recruiting phase of the trial. FU The Follow-up program, CORONISFU.exe, will be in this folder on the Master computer only. The Upload folder is where the follow-up data files that are to be to be sent to Oxford will be kept. Creation and encryption of the upload file should be done from the Master computer only. New Users and User Names Every person doing data entry must have a user name of their own. If you have an IT department and the database is held on a central server, you may need to liaise with them and ask them to create a user name and give you access to the location of the database. If you do not have an IT department, a current user will be able to create a new user name for you. Don t forget to create a password once your user name has been created. A record of who has entered and edited the data is kept in the database and it is important that all activity is attributed to the right person. If two users wish to use the same computer for doing data entry, you should close down the computer and re-start it with the new user s credentials. Do NOT use the Switch User option. Now that there are two computers for data entry at all the RTOs, it is easy to use one computer for first entry and one for second entry. Every user on both computers must make sure of the following: Short Date format should be set to dd/mm/yy, or dd-mm-yy. Both databases must be set as Trusted Documents from Access In the WINDOWS 7 operating system, these items are user-specific and not computer specific as they were in WINDOWS XP. To set the Short Date Format: Open Control Panel Click on Clock Language and Region Click on Region and Language Click on Change the Date, Time or Number Format Make sure the Short Date Format is dd/mm/yy and Short Time Format is HH:mm To set the databases as trusted documents: Open Access

6 From File on the menu ribbon, click on Options (This is in the menu on the left hand-side) Select Trust Centre from the menu on the left hand side Click on the button Trust Center Settings Select Trusted Locations from the menu on the left hand side Put a tick in the box labelled Allow Trusted Locations on my network (not recommended) Click on the button Add new Location Use the Browse button to find the location of the databases. Select the root Coronis folder Put a tick in the box Subfolders of this location are also trusted Click OK and exit all the windows. If you have any problems with either of these procedures you must get in touch with the ICC in Oxford. 6

7 Starting the CORONIS Follow-up data entry program Click the CORONIS FU icon on your desk top. This opens the following window: The menu items at the top are: File Upload Files Log Incoming Data Contacts and Appointments Data Entry Event Report Forms Compare Forms Data Form Queries Reports Continued Contact Reports HAQ Appointment Reports Monitoring Reports File menu Select Exit to close the program. The database will be compacted on closure. As the database grows, this compacting process may take a few minutes. Do not switch off the computer until the programme has closed as this may corrupt the databases. Upload files Upload Completed Records Selecting this menu item creates a single text file containing all data ready to be sent to Oxford. Data is identified as being ready when: Contact Report Forms New contact information has been added Appointment Forms New appointments have been added HAQ and HAQ Pregnancy forms The data has been double entered, compared and any queries have been resolved. Event Forms The data has been double entered, compared and any queries have been resolved. Death Report Forms The data has been entered once and there are no queries All logged information is also uploaded.. This menu item should be selected once a week (usually on a Monday) to ensure that the completed data is sent to Oxford regularly. 7

8 Click <Create File> to create the file of data that is ready to send to Oxford. Once the file has been created the <Encrypt Files> button will be enabled. Click < Encrypt Files > to encrypt the file before attaching to an to send to Oxford. The file will be in C:\Coronis\Upload\. When you have sent the file, move it to the C:\Coronis\Upload\Sent folder. Only files that have NOT been sent to Oxford should be in the Upload folder. Click <Close> to close this form. See page 33 for more details on Uploading data to the ICC. Log incoming data Log Incoming Data All data forms that come into the office should be logged on to the database. This ensures that all forms are accounted for, that the date of receipt is known and a report, printed weekly, will show which forms have been received at the RTO but not yet processed. Selecting this menu item will display the following window: Select the form to log on from the list accessed by clicking the small arrow at the right. Forms to log on are: Contact Report Form Appointment Form Health Assessment Questionnaire Pregnancy Form Event Report Forms each event logged separately Death Report Form Select the name of the hospital where the form has come from. Where the RTO is responsible for one hospital site only, there will only be one name in the combo box entitled Select Hospital Name. When logging-on Contact details, enter the Study Number and a date the contact was made. For the HAQ and Death Forms, enter the study number only. Click <OK> to log the form onto the system. This is an 8

9 important step in correct administration of the trial data forms. It enables detailed tracking of all data forms and you will always know where they are and what the next process is. When logging an HAQ, check if the woman has had any further pregnancies. If she has, also log the Pregnancy Form. This only needs to be done once, even if the woman has had more than one pregnancy. Forms that have not been logged-on cannot be processed. If the form has been logged on before or the study number has not been allocated to a woman, an error message will be displayed on the screen. If contact has been made with a woman, another contact report form cannot be logged if the contact date is within a week of the one already logged. If a Death Form has been logged, nothing else for this woman can be logged. You should log an appointment form before you log an HAQ. Additional information required when logging forms: Contact forms or Appointment forms - enter the date the phone call was made. Event Report Forms if pregnancy related (see page 20), enter the delivery date of the pregnancy the form is related to. The information to be used for logging event forms is found at the bottom of the event form When the OK button is clicked, a pop-up window will show which pregnancy this relates to. If this is not already on the front of the form, write it on the form. If the delivery date does not relate to a known pregnancy this error message will appear on the screen: 9

10 You can then continue to log the form if the delivery date entered is correct. You will not be able to enter the data from this form since it does not relate to a known pregnancy. On exiting from the Log-In window the following report will be printed: Check that the delivery dates are correctly entered. If it has been logged incorrectly, delete the logged record (see below). If it has been logged correctly, you must go back to the hospital notes the information was taken from and re-check the information. If the problem cannot be resolved, you should the ICC and give full details of the problem. If an event not reported on the HAQ, has been found when looking at hospital notes for known event information, tick the Additional Event checkbox. Delete logged Data Any forms that have been logged in error, can be deleted if: The form has not been processed The logged record has not been sent to the ICC in the weekly upload file. Selecting this menu item will display the following window: 10

11 Select the form to delete from the list accessed by clicking the small arrow at the right. Forms that can be deleted are: Contact Report Form Appointment Form Health Assessment Questionnaire Pregnancy Form Event Report Forms each event logged separately Death Report Form Select the name of the hospital where the form has come from. Where the RTO is responsible for one hospital site only, there will only be one name in the combo box entitled Select Hospital Name. For the Contact and Appointment Forms, you will also need to enter the date of contact for the record that needs to be deleted. For Event Forms that are related to pregnancy, you will also need to enter the number of the pregnancy to which the Event relates before the record can be deleted. If the logged record has been sent to ICC in the weekly upload, you will need to make notes on the 'Forms logged and not processed report', scan and (i) the report (ii) the database, to ICC Oxford. The log data will then be removed manually. You will NOT be able to enter data on your database until the updated database has been returned to you. 11

12 SECTION 2 ENTERING DATA Contact and Appointment details Clicking on this menu will display the following screen: Women NOT included in this list are those who have been randomised in error have had a vaginal delivery are known to have opted out are known to have died from the postpartum form or the six week follow-up form. Everyone else will be included and if you find out a woman has died when making a contact call or an appointment call, you should log the contact or appointment Form and enter the data. You should also log and enter a Death Report Form. Double-click the Study Number of the record you wish to edit, or highlight the Study Number and click <OK> to display: 12

13 There are three tabs on this form. The first tab has information about the woman s contact details. The second one displays a grid where the data from each contact can be entered. The third one displays a grid where the data can be entered that is obtained from phone calls made while making an appointment. Tab 1 Address & Phone Numbers The first time this form is opened for a woman, the address details are taken from the Postpartum Stay section of the DCB. These can be edited and saved as necessary. If any of the contact details change, these will automatically save when you close the form and a record will be kept of all the old addresses in the follow-up database. If there are records of old contact details, a button, Show Previous Address will be displayed. Click this button to show the previous contact details. The date the details were changed will also be displayed. Click Show Current Address to change it back to the current address details. On this tab is also shown: o Date of birth and age at randomisation o Hospital number at the time of randomisation o Date of recruitment o Date of surgery o If the woman had a hysterectomy or was sterilised (tubal ligation) o If the baby/babies was stillborn or it is known that the baby/babies died when the woman was followed up at 6 weeks. o If the woman wishes to have no further contact with the CORONIS trial. No further contact If the woman decides not to have any further contact (see the RTO handbook) with the CORONIS trial staff, tick the checkbox. Today s date will be displayed as a record of when the woman made this choice. You should also enter a reason why the woman has chosen to have no more contact with the CORONIS staff. It is important to enter this information as it will exclude her from any reports telling you to make contact with the woman. The ONLY reason you check this No More Contact box is if the woman herself decides she wants no further contact with CORONIS. DO NOT check this box, if her contact details are incorrect and you have been unable to make any contact by phone. Other means of contacting the woman should be explored. Tab 2 Contacts Made Enter the date and move to the next row using the mouse or the arrow keys. If this record has not been logged, an error message will be displayed. Close the window and log the contact form before proceeding. Type in the person with whom the contact was made. This could be the woman, her husband, her employer or a family relative. In the row headed Woman s Status click in the cell to display the following list: 13

14 Double click on the status that is appropriate for this contact to display it in the table. If the status you have selected for the woman is : Pregnant, enter an EDD in the next row. If the EDD is not entered, an error message is displayed on the screen when saving the data and the data will not be saved until a date has been entered. If the status you have selected for the woman is : Died, enter a date of death in the correct row. If the date is not entered, an error message is displayed on the screen when saving the data and the data will not be saved until a date has been entered. If the status you have selected for the woman is : Delivered baby, enter a date of delivery and if she had a c-section or not in the correct rows. If the woman had a c-section enter Y, or if she delivered vaginally, enter a N. If either the date or whether she had a c-section or not, is not entered, an error message is displayed on the screen when saving the data and the data will not be saved until the required data has been entered. If she has been sterilised enter Y in the column headed Sterilised. It is not necessary to enter N if the woman was not sterilised. If the status you have selected for the woman is : Cannot locate woman, enter No-one or Nobody in the Spoken to column. In the row headed Baby s Status, click in the cell to display the following list: Double click on the status that is appropriate for this contact to display it in the table. Contact records can be added in any order. When the form is closed and re-opened, the contacts will be displayed in date order. It is not necessary to enter the data on this form twice. Comments and Notes At the bottom of the screen, brief notes can be added about any additional information gleaned from the contact phone calls. Put a date in the notes each time something is added and add your initials at the end. This will assist in knowing who entered the note and when it was made. 14

15 Tab 3 Appointments made Enter the date of the phone call and move to the next row using the <Enter> key on the number pad, the mouse or the arrow keys. If this record has not been logged, an error message will be displayed. Close the window and log the appointment form before proceeding. In the row headed Call Outcome click in the cell to display the following list: Double click on the appropriate outcome for this phone call to display it in the table. If the status you have selected is: Call answered, enter to whom you have spoken. This could be the woman, her husband, mother-in-law etc In the row headed Woman s Health Status, click in the cell to display the following list: If the woman has Died, enter the date of death. DO NOT ENTER ANY OTHER INFORMATION. If the woman has Recently delivered a baby and you have entered an appointment date, the program will check that: o You have ensured the appointment date is more than 6 weeks after the birth o an appointment time has been entered o a place where the assessment interview will take place has been entered If an appointment date has not been made, you must enter a date for the next phone call. DO NOT ENTER ANY OTHER INFORMATION. If the woman is Pregnant, enter the EDD and a date for the next contact to be made. DO NOT ENTER ANY OTHER INFORMATION. If the woman is Alive and you can make an appointment, enter a date, time and place for the appointment and any information concerning the woman s return to hospital. If the woman has NOT returned to hospital for any obstetric or gynaecological reason, there is no need to put any information in the rows headed Returned to Hospital and Hospital Number. This record can also be used, to record any non-attendance to arranged appointments. Enter Y or y in the row headed Did NOT attend and a date for calling the woman to arrange another appointment. If the call is Not answered or Number not available, enter a date when another attempt should be made to contact the woman. Any additional notes can be added at the bottom of the tab in the Comments section. 15

16 Women who did not attend an appointment If a woman does not attend her appointment, a Y or a y should be added in the row headed Did not attend. A date for making another appointment phone call should also be added. If these are not entered, the woman s name will be listed on two reports HAQ not logged (see page 39 ) and/or Did not attend appointment (see page ). Remember that you do NOT need to enter a contact record AND an appointment record for the same phone call. Enter contact records until the woman is due for her assessment, this will be indicated on the reports you are using to call women. If a woman is due for her assessment appointment enter an appointment record only, once you have made the first phone call to try and fix an appointment for her assessment, you do not need to enter any further contact records. All phone calls will now be appointment calls. If you find a woman has died while making a phone call to fix an appointment, this information can be recorded on the Appointment Form, and does not need to also be recorded on a Contact Form. 16

17 Main Data Forms for Double Entry There are 3 forms that need to be double entered: HAQ HAQ pregnancy form Event Report Forms and one that only needs single entry Death Form Each event has a separate data entry form, (there are 15 of them), but most are very short. Health Assessment Questionnaire In September 2011, health assessment interviews with the women began and a Health Assessment Questionnaire is completed for each woman. You will need to double enter this data and upload it to Oxford each week. Please refer to the inside of the front cover of the HAQ, for some definitions of terms used on the form and for guidelines on data entry, particularly to do with entry of dates guideline (e). Select Data Entry -> HAQ to display the following screen: The names of the hospitals attached to your RTO will appear in the drop-down list. Selecting a hospital name will list all the study numbers for the women who are eligible for follow-up at that hospital site. Health Assessment Questionnaire will be shown at the top of the window. Select a woman s name, First or Second Entry and click <OK> to display the HAQ As with all data forms in the CORONIS program, the data from the form cannot be entered unless it has been logged-on. The following error message will be displayed when you click OK if the form has not been logged: 17

18 The HAQ has several tabs and looks like this:. The responses that would generate an EVENT are in purple and the name of the treating hospital will need to be given. For example: If you enter a response of Yes to the question Did the woman have a laparoscopy, you will need to enter the name and address of the hospital where the woman had the laparoscopy on the tab headed Section A: Coronis Children/Events. There is space for the data for the first baby delivered at the CORONIS c-section. This is Baby Number 1. If the CORONIS pregnancy was a multiple pregnancy, additional babies can be added by using the <Add a baby> button. The second baby delivered at the CORONIS c-section will be Baby Number 2. Use the 18

19 <Previous baby> and the <Next baby> buttons to move between the baby records. The number of babies you can add is limited by the number of babies the woman actually delivered in the CORONIS delivery. Name of Person Completing the Form. To enter the name of the person completing the form, click on the drop-down list. This will give you the names of all the assessment doctors. These names are taken from the list of personnel sent to the ICC. If someone fills in the form whose name is not on the list please do the following: Select Other Name from the drop-down list Write the name of the doctor who completed the HAQ in the Comments box and indicate if this doctor will be added to the list of Assessment Doctors as a new Assessment Doctor OR if this doctor conducted an Assessment but will not need to be added to the list including details regarding the circumstances If the doctor should be added to the list of Assessment Doctors you must: Update the Personnel involved in the Follow-up Study Form The Regional Co-ordinator must sign this Form to indicate that they consider the Assessment Doctor to have been trained and competent in Assessment procedures Scan and or fax this Form to the ICC If this is NOT done, once the data comes to the ICC, you will be asked who the Other Named person is. Any additional names which need to be added to the list will be done by the programmer and sent to the RTO. Saving the data Enter the data and click <Save> to save the record. If you wish to check if there are any queries on a single form (see Section 3 for Comparing and Validating the forms), re-open the form and click on the <Query Check> button. If required, you can click <Print> to print the queries. If a form has been doubled entered and clicking the <Compare> button has produced no comparison or validation errors, the status of the form will be Matched Pair. The status will not say Validated until you have clicked the <Compare Forms> menu item. New data field added in January 2013 Since January 2013, a new data field to record how the HAQ was conducted has been added to the form. The new data boxes look like this: Record here how the HAQ was conducted, either as a Face-to-Face interview or over the phone. Phone interviews should only be conducted if it has been agreed by the Data Co-ordinator and should be conducted by an assessment doctor who has been given some guidance in how to conduct the interview over the phone. Write in the text box the NUMBERS of the reasons why the interview has been done by phone. These will be listed on the paper HAQ form on the stamp which has been put at the end of the form. Please see the guidance notes sent from the ICC regarding telephone interviews. 19

20 HAQ Pregnancy Form Select Data Entry -> HAQ Pregnancy to display the following screen: As with all data forms in the CORONIS program, the data from the form cannot be entered unless it has been logged-on. The following error message will be displayed when you click OK if the form has not been logged: If no appointment has been entered for this woman, you will not be able to enter the HAQ data. Select the envelope, name of the woman for whom you wish to enter data, select First Entry or Second Entry and click OK to display the following screen: 20

21 Enter the data for each pregnancy. The first pregnancy after the CORONIS pregnancy is always 1. Use the <Add a pregnancy> button to add additional pregnancies. These will be automatically numbered 2, 3 etc. Click on the <Previous pregnancy> and the <Next pregnancy> buttons to move between the pregnancy records for a woman. A question on the HAQ asking how many pregnancies the woman has had, limits the number of pregnancies you can add. So, if the woman has only had one pregnancy, the <Add a pregnancy> button will be disabled. There is space for the data for the first baby delivered at each pregnancy. This is Baby Number 1. If the pregnancy was a multiple pregnancy, additional babies can be added by using the <Add a baby> button. The second baby delivered at the in this pregnancy will be Baby Number 2. Use the <Previous baby> and the <Next baby> buttons to move between the baby records. The number of babies you can add is limited by the number of babies the woman actually delivered in this pregnancy. Click <Add a pregnancy> to save the data for the current pregnancy before clearing the form so you can enter the data for the next pregnancy. Click <Add a baby> button to save the data for the current baby before clearing the baby section of the form so you can enter the data for the next baby. Name of Person Completing the Form. To enter the name of the person completing the form, click on the drop-down list. This will give you the names of all the assessment doctors. These names are taken from the list of personnel sent to the ICC. If someone fills in the form whose name is not on the list please do the following: Select Other Name from the drop-down list Write the name of the doctor who completed the HAQ in the Comments box and indicate if this doctor will be added to the list of Assessment Doctors as a new Assessment Doctor OR if this doctor conducted an Assessment but will not need to be added to the list including details regarding the circumstances If the doctor should be added to the list of Assessment Doctors you must: Update the Personnel involved in the Follow-up Study Form The Regional Co-ordinator must sign this Form to indicate that they consider the Assessment Doctor to have been trained and competent in Assessment procedures Scan and or fax this Form to the ICC If this is NOT done, once the data comes to the ICC, you will be asked who the Other Name person is. Any additional names which need to be added to the list will be done by the programmer and sent to the RTO. Saving the data 21

22 Enter the data and click <Save> to save the record. If you wish to check if there are any queries on a single form (see Section 3 for Comparing and Validating the forms), re-open the form and click on the <Query Check> button. If required, you can click <Print> to print the queries. If a form has been doubled entered and clicking the <Compare> button has produced no comparison or validation errors, the status of the form will be Matched Pair. The status will not say Validated until you have clicked the <Çompare Forms> menu item. Remember that you can compare and validate all the forms at once from the menu item <Compare Forms>. See section 3. 22

23 Death Report Form When making routine contact calls or appointment calls, it may be found that a woman has died since the last phone call. You should record this information on EITHER the Contact Report Form OR on the Appointment Form. It does not need to recorded in both places. Log the form in the usual way. Select Data Entry -> Death Form to display the following screen: Select the correct envelope number to display the data entry screen for the Death Report Form. 23

24 Enter all information as shown on the form. The precise date of death may not be known and year only or month and year only can be entered. If the cause of death is unknown, enter Not Known. If the death certificate is unavailable or the relative to whom you are speaking does not know what was written on the death certificate, enter Death certificate not available. Once completed, click on Query Check to ensure no data is missing. The form will then be included in the next upload file. This form does not need to be double entered. 24

25 Event Report Forms For some women, it will be necessary to collect additional data on some of the things that may have happened to her. This information is NOT taken from the woman, but is collected from hospital notes after an assessment doctor has interviewed the woman. There are 15 possible events and each one has a separate data entry form. Related to the woman s general health 1. Laparoscopy/laparotomy (not related to pregnancy) 2. Bowel obstruction surgery (not related to pregnancy) 3. Abdominal hernia with bladder and/or bowel complications (not related to pregnancy) 4. Hysterectomy (not related to pregnancy) 5. Tubal/ovarian surgery (not related to pregnancy) 6. Other major abdominal or pelvic morbidity requiring surgery (not related to pregnancy) Related to any further pregnancies 7. Uterine rupture or uterine scar dehiscence 8. Placenta praevia 9. Morbidly adherent placenta (This includes placenta accreta, increta and percreta) 10. Placental abruption 11. Postpartum haemorrhage 12. Hysterectomy (at the time of birth and up to six weeks postpartum) 13. Bladder damage at caesarean section 14. Bowel damage at caesarean section 15. Abdominal surgery during pregnancy The format of data entry for the Event Forms is the same as that for the HAQ and the Pregnancy forms. All forms must be logged, first and second entered, compared and any queries resolved before they will be included in the upload file to send to the ICC. The source data for these forms may not be held at your hospital and whoever is filling them in, must be sure they answer ALL questions. If a particular question cannot be answered from information in the hospital notes, a response of Not Recorded or Not Known should be given. It could be difficult to go back and look at the notes again. As with the HAQ and Pregnancy forms, these forms are included when you run <Compare Forms> and <Data Form Queries>. All Event Forms are entered from this menu item: Select Event Forms and then a form type to display the following screen: 25

26 As with all data forms in the CORONIS program, the form cannot be entered unless it has been logged-on. The following error message will be displayed when you click OK if the form has not been logged: All Event Forms There are some things that are common to all of these forms: They should all be logged before doing data entry. All forms have options to tick if the notes cannot be found (Option A), or there is no evidence of this event in the notes. (Option 2) Ticking either of these will disable the remainder of the form. Comments, name of person completing the form and the date the form was completed should still be entered. If there is evidence of an event in the hospital notes that has not been recorded on the HAQ (additional event), Option C should be ticked and the number(s) of the forms completed for the additional events. All forms (except Forms 13 and 14) ask for details of any blood transfusions given during the woman s stay in hospital for the given event. Forms 7 to 10 and 15, ask for information about the babies born during the delivery. As with the HAQ and the HAQ Pregnancy forms, the baby number relates to the babies born during that pregnancy. A singleton ALWAYS has Baby Number 1. Examples of all the Event Forms are not given in following pages. Only Event Forms that have something a little different from the others will be detailed. Laparoscopy/Laprotomy Form Select an envelope number and click First Entry to display the following window: 26

27 You will not be asked to complete this form if the laparoscopy was performed for any of the following reasons AND THIS INFORMATION HAS BEEN RECORDED ON THE HAQ: Bowel obstruction Abdominal hernia Hysterectomy not related to pregnancy Tubal/ovarian surgery Major abdominal or pelvic morbidity If, when the data is being completed from the hospital notes, it is found that the laparoscopy was performed for one of the above reasons, the appropriate reason on the front of the form should be ticked and the correct form completed. When doing data entry, these reasons are listed at the top left of the screen in purple. Selecting the appropriate condition will disable the rest of the form. However, any comments, the name of the person completing the form and the date the form was completed must still be entered. As on the HAQ and Pregnancy forms, the name of the person completing the form is selected from the drop-down list. See information on page 21, as to what to do if the name of the person completing the form is not in the drop-down list. Forms 7 to 15 Pregnancy Related Events If the woman has had more than one pregnancy, once the name and envelope have been selected, the pregnancy number must also be selected: 27

28 Double clicking on the pregnancy number will open the required form. The pregnancy number must always be entered before the form will save. This applies even if either Option A or Option B is ticked. Event Form 11 - Postpartum Haemorrhage Form As with the Laparoscopy Form (ERF 1) You will not be asked to complete this form if the laparoscopy was performed for any of the following reasons AND THIS INFORMATION HAS BEEN RECORDED ON THE HAQ: Uterine rupture Placenta praevia Morbidly adherent placenta Placental abruption Hysterectomy related to pregnancy If, when the data is being completed from the hospital notes, it is found that the PPH was due to one of the above reasons, the appropriate reason on the front of the form should be ticked and the correct form completed. When doing data entry, these reasons are listed at the top left of the screen in purple. Selecting the appropriate condition will disable the rest of the form. However, any comments, the name of the person completing the form and the date the form was completed must still be entered. All Event Forms must be double entered, compared and validated. They will automatically be included in every time you run the <Compare Forms> menu and the <Data Form Queries> menu. (See next section) 28

29 SECTION 3 COMPARING AND VALIDATING DATA FORMS When a batch of forms (HAQ, HAQ Pregnancy and Event Report Forms) has been entered, they should be compared and validated as soon as possible. Comparing forms Select Compare Forms to compare all records that have been entered twice and are not yet compared and or validated. A list is automatically printed of the records that have been compared. The Study Number is listed with the state the records are now in. Either Not matched, Matched or Validated. You will be asked if you wish to print out the report showing the comparison differences. It will look similar to the one shown below. Reports are shown on the screen and can be printed if necessary. Using this report and by reviewing the paper forms you can mark which data is correct and the data operator can correct First or Second entry as appropriate. The comparison process can then be repeated until the forms are all compared successfully. When the two records (First and Second) are the same, the program will go on to validate the forms. Although the data entered may have been correctly transferred from the paper form, there could be errors and/or missing data on the paper form. Data form queries To generate and print out all the queries select this menu item. You will be asked if you wish to continue to generate queries for all the data forms. Click <Yes> to start the process. When the process is complete you will be asked if you wish to print the list. Click <Yes> to print a list similar to the one shown below: 29

30 There will be a page (or pages) for each hospital listing the queries for study entries from that site. These should be sent to the hospital site regularly for the queries to be resolved. The person finding the correct information should write the correct information in the space provided edit, initial and date the copy of the paper form held at the hospital site sign, print their name and date the list before returning to the RTO When the sheet is returned to the RTO, the administrator should: Edit the copy of the paper forms held at the RTO Put the forms through the correct process of first and second entry, with the edits being entered by two different people Re-run the Compare Forms process Re-run the Data Form Queries process to ensure that the data is now complete and correct. Once forms are complete and correct and the data has been sent to the ICC, they can no longer be edited. If further edits are necessary, copies of these should be sent to the ICC. Things to Remember Forms are NOT marked as Validated until you have run the <Compare Forms> menu item. Run <Data Form Queries> to see where there are queries or missing data on any forms not validated from <Compare Forms> HAQ records will not be sent to the ICC until both the HAQ and any pregnancy forms have been double entered and matched and validated. If you cannot see why an HAQ has not been sent to the ICC, please check the following reports to see if there is any data that has either not been entered at all, or not yet second entered: Forms with NO second entry and Pregnancy forms not entered Once records have been sent to the ICC, they cannot be edited. Any additional data you find should be ed directly to us. You only have ONE chance to get the information for the HAQ from the women. Make sure the Assessment Doctors answer EVERY question. 30

31 Reports are now printed to the screen and you can save them to a pdf, WORD or EXCEL file rather than print them if that is easier for you. 31

32 SECTION 4 UPLOADING DATA TO OXFORD Selecting <Upload Data> creates a single text file containing all data ready to be sent to Oxford. Data is identified as being ready when: Logged Data Contacts Appointments New data has been logged since the data was last sent New contacts have been added since the data was last sent New appointments have been added since the data was last sent HAQ and HAQ Pregnancy Forms The data has been double entered, compared and any queries have been resolved. These forms will not be sent until BOTH the main part of the HAQ and all pregnancy forms are double entered and without queries. Death Forms Event Report Forms The data has been single entered any queries have been rectified The data has been double entered, compared and any queries have been resolved. This menu item should be selected once a week to ensure that the completed data is sent to Oxford regularly. Click <Create File> to create the file of data that is ready to send to Oxford. Once the file has been created the <Encrypt Files> button will be enabled. Click < Encrypt Files > to encrypt the file before attaching to an to send to Oxford. The file will be in C:\Coronis\FU\Upload\. The name of the file will be similar to DELUploadUF txt_enc. The first three letters will be specific to your RTO. This example is for Delhi. This is the file you should to the ICC. When you have sent the file, move it to the C:\Coronis\FU\Upload\Sent folder. Only files that have NOT been sent to Oxford should be in the Upload folder. Click <Close> to close this form. When you click <Close>, a second file is created which lists all the records included in the upload file. The name of the file will be similar to FileList txt. The encrypted file is not easy to understand, and this text file lists the forms included in the encrypted file in a format that is easy to understand. Check this file to ensure that the forms you think should be included in the upload file are there. Do not send this file to the ICC. If you are using more than one computer for data entry, this process should ONLY be done on the Master computer the one where the database is held. This is an important process and if any errors occur while creating the file, it is essential the ICC is informed immediately. 32

33 SECTION 5 REPORTS There are a number of reports you can generate at any time. Some are printed automatically every week, if you have not printed them for over a week. If there are women to call today, this list will be printed when you start the program each morning. Make sure you have the printer switched on before generating any report. Reports printed on a weekly basis. The reports printed each Thursday morning are: HAQ not logged - monitoring report 1b Callback overdue - monitoring report 1c Did not attend appointment - monitoring report 1d Event Report Forms to be completed - monitoring report 2 Forms logged and not processed - monitoring report 3 Forms with NO second entry - monitoring report 4 Women died and death form not logged - monitoring report 5 These reports should be checked each week and any anomalies put right. Doing this will ensure that the data is correct and up-to-date. If any of these reports have been generated within the last week, they will not print on a Thursday morning. However, you should not only generate them, but MUST print and look at them and check why the women listed are in the report and take any necessary action. Some reports are not printed each week, but if they have not been printed within the last week you will be prompted to print them. Women to contact next week - Continued contact report 1 Women overdue for contact - Continued contact report 2 You will be prompted to print this report if it has not been printed within the last month. Women for HAQ Appointment - HAQ Appointment reports Make appointment by phone for HAQ There are three groups of reports available: Continuing Contact Reports Appointment Reports Monitoring Reports Contact Reports 1. Women to contact next week 2. Women overdue for contact 3. ALL Women in trial not yet contacted 4. Contacts audit 1 Women to contact next week This report lists all the women who are due for contact next week. Some RTOs intend to contact the women every 3 months and some every 6 months. This variation is built into the program and if you intend to contact the women at 6 monthly intervals, the women s names will only be listed at the appropriate time, ie 6 months after the previous contact. This report will look like this: 33

34 The study number, her name, date of last contact, and all contact telephone numbers are listed. In addition the woman s health status is shown, if she cannot be located or has moved from the region, has been sterilised or had a hysterectomy. If her CORONIS baby(ies) was stillborn or died before discharge from hospital, this will also be displayed. Alongside this list is a space where any notes written on the woman s contact form will be shown. This space can also be used to write notes when making the phone calls to the women. Since this report prints to the screen, it is NOT printed automatically. Please make sure you print it each week. If a woman has any appointment data logged, she will NOT appear on this report. 2 Women overdue for contact This report will list all women who are more than a month overdue for contact. If the woman has yet to be contacted for the long-term follow-up, the date of last contact is shown. This may be from the 6 weeks follow-up or from the Postpartum Stay form if you failed to contact the woman for her 6 week appointment. 34

35 This report is similar to the previous one, but in addition the length of time since her last contact is also shown. If it is more than 3 years since this woman had her CORONIS c-section, a note in red is displayed stating that instead of just contacting the woman, you can make an appointment for her to attend an HAQ interview. Since this report prints to the screen, it is NOT printed automatically. Please make sure you print it each week. If a woman has any appointment data logged, she will NOT appear on this report. 3 ALL Women in trial not yet contacted This report is similar in design to the previous two, but lists ALL the women in the trial who have not yet been contacted and are more that 3 (or 6 months) since last contact. If many women have not been successfully contacted and a CRF logged for the contact, this report will be very long. For some centres who have recruited hundreds of women, it may be over 100 pages long. As women are contacted and a CRF logged, this report will get shorter. This report is NOT printed each week. If a woman has any appointment data logged, she will NOT appear on this report. 4 Contacts audit Select which hospital you wish to view this report for, and click <OK>.The report gives the last contact date and the date the next contact is due for each woman. Use this to keep track of when the women were last contacted and the date they are due for another contact phone call to be made. Some women are excluded from this list if the woman has/has been: Not had a c-section at the CORONIS birth Opted out. These are women who wish to have no further contact with the RTO. Recorded as having died on postpartum or six week forms Found to have died when a contact phone call was made Women who have had the data for an HAQ entered. 35

36 Appointment Reports 1. Make appointment by phone for HAQ 2. Women to call back to make appointments 3. Clinic list report 4. Data for front of HAQs 1 Make appointment for HAQ This report will list all women who are due an assessment within the next 3 months. Most RTOs will have a backlog, i.e.women who were randomised MORE than 3 years ago. A proportion of this backlog will be included for each of the three months of the report. Women who have already had an HAQ completed, died, opted out or those who had a vaginal delivery are NOT included in these lists. These women should be contacted by telephone and appointments made. This report is NOT printed each week, but you will be reminded to print it if it is more than a month since it was last printed. If a woman has any appointment data logged, she will NOT appear on this report. 36

37 2 Women to call back to make an appointment This report will show all women who should be phoned today. If the woman has not attended for an appointment this will be shown on the report. This report will also print out automatically when the program is first opened in the morning. It can be printed at any time for a selected period. 3 Clinic list for HAQ appointments This report can be printed to show appointments made between any two dates. Click <Clinic list for HAQ appointments> to show: Enter the start and end date and click <OK> to show this report: 37

38 The report lists where the clinics are to take place, the women s names, appointment date and time, phone numbers and a box to tick if the woman did not attend. If women did not attend for their appointment, the Did not Attend box can be ticked and this information added to the woman s appointment record. (See page 15) 4 Data for Front of HAQs As with the previous report, this report can be printed for appointments made between any two dates. Select dates as for the Clinic List and click <OK> to show this report: All the information needed for the front of the HAQ form is shown for all the women who will be attending the clinic on the selected dates. Also shown are any comments entered either in the Contacts tab and/or OXTREC ISRCTN January 2013 V8 38

39 the Appointments tab. If these will be of any help to the doctor conducting the assessment, they can be printed out from the Contact and Appointments window for that woman. Monitoring Reports 1. Appointments and HAQ a. All women and HAQ appointments b. HAQ not logged c. Callback overdue d. Did not attend appointment 2. Event Report Forms to be completed 3. Forms logged and not processed 4. Forms with NO second entry 5. Pregnancy forms not entered 6. Women died and death form not logged 7. Women marked as No Further Contact 1. Appointments and HAQ (a) All women and HAQ Appointments This report gives an overview of where each woman is in the process of making an appointment and then entering and validating the HAQ. The last appointment date is shown (if more than one has been made, only the most recent will be displayed), whether the woman did not attend, the date the HAQ was logged, processed and also the date the form was sent to Oxford. OXTREC ISRCTN January 2013 V8 39

40 (b) HAQ not logged This report is printed each week and lists all women where the HAQ is not logged and the woman s appointment was more than 14 days ago. If Did Not Attend has been marked as Yes for the appointment, these women will be excluded since it is assumed that a new appointment will be made. The report looks like this: This report is printed automatically every week if it has not been printed within the last 7 days. OXTREC ISRCTN January 2013 V8 40

41 (c) Callback Overdue This report lists women where the call back phone call was not made on the date entered into the system. The report includes women where the date to call back is more than a week ago. It includes women who have not attended the clinic and those where it was not possible to make an appointment at the first attempt. Please ensure that you call these women soon and attempt to make another appointment. The report looks like this: This report will print each week if it has not been printed within the last 7 days. (d) Did not attend appointment and no date to call back again This report lists all the women who did not attend their last appointment, but no date has been entered to call them again to make another appointment. This report is printed automatically every week if it has not been printed within the last 7 days. OXTREC ISRCTN January 2013 V8 41

42 2. Event Report Forms to be Completed This report lists all events from the HAQs and the Pregnancy sections of the HAQ where the event data has not yet been collected. Once an event form has been logged, it will no longer appear on the list. This report is printed automatically every week if it has not been printed within the last 7 days. 3. Data forms logged and not processed This report lists all the data forms (including CRFs and Appointment forms) that have been logged and not processed. The report will look similar to the one below: This report is printed automatically every week if it has not been printed within the last 7 days. Any forms that have been logged in error can be deleted at the RTO if: The form has not been processed The logged record has not been sent to the ICC in the weekly upload file. If the logged record has been sent to ICC in the weekly upload, you will need to make notes on the 'Forms logged and not processed report', scan and (i) the report (ii) the database, to ICC Oxford. The log data will then be removed manually. You will NOT be able to enter data on your database until the updated database has been returned to you. OXTREC ISRCTN January 2013 V8 42

43 4. Forms with NO second entry This report lists all the forms where second entry has not yet been completed. Please enter this data as soon as possible, particularly if the date of first entry is some time ago. This report is printed automatically every week if it has not been printed within the last 7 days. 5. Pregnancy forms not entered This report lists all the records where an HAQ has been entered, but the pregnancy forms have not been entered. This report is printed automatically every week if it has not been printed within the last 7 days. 6. Women died death form not logged This report lists the women for whom it has been noted from a Contact Report Form (CRF) that she has died and a Death Report Form has not been logged. This report is printed automatically every week if it has not been printed within the last 7 days. 7. Women marked as No Further Contact This report will list all the women you have marked as not wanting any further contact from the RTO. There is only one reason why women should be marked like this if the woman herself has said she does not want you to phone her any more. THERE IS NO OTHER REASON FOR WOMEN TO BE MARKED AS NO FURTHER CONTACT. OXTREC ISRCTN January 2013 V8 43