TeleForm in The PREVENT Trial

• Participants were• Taking Antidepressants• Had had 3 or more previous episodes

of depression• Currently well

• They were randomised to either• Take part in an MBCT class and

consider coming off their antidepressants OR

• Continue taking their antidepressants

• Participants were followed-up over two years at 6 different times

• There were 26 different CRFs, some interview administered other self-report questionnaires

• In total 2,698 data points for each participant

• In total 1,143,952 items of data

How much data?

• Drastically reduce the time to enter data• Inbuilt data verification tools• No out of range scores allowed• Custom verifications – age of participant• Data required – trial id• Format dates correctly

• Can handle many different sorts of data• Likert Scales• Thermometer Scales• Block capital text boxes• Free form text boxes• Screen shot from scanned image of CRF

TeleForm

• Design the form• Scan CRF• Verify data TeleForm was unsure of• Export Verified Data• Excel• SPSS• Access• SQL Database• Text File• ……

Stages of TeleForm

• The second most important aspect of TeleForm• Reads Data• 100% sure its read the data

correctly – Sends data for export• Not 100% sure its read the data

correctly – Asks user to verify

Verification

• TeleForm is not 100% sure ‘No’ is ticked• So the User is asked to confirm• User confirms with ‘Tab’ key.

• With Tick Boxes• TeleForm measures the percentage of ink in

a box• If less than 15% TeleForm will confidently

report no tick• If more than 25% TeleForm will confidently

report a tick• If between 16% and 24% TeleForm will ask

user for verification• At design stage all of these variables can be

changed to suit your CRF

Why not sure?

• Only one value allowed

Item crossed out

• Always verify

• Block Capital Text

Can choose values from a database to correspond

Free Form Text

• Once all items are verified the user will be asked if data should be exported

Export

• Setting the form up well leads to fewer verifications and crucially fewer potential errors

• TEST, TEST and TEST again• The following can influence success of form• Physical size of tick boxes• Paper printed on• Colours used• Export CRF as a whole or as individual

questionnaire• Constraining allowed data• Checking that the form is user friendly

• Once form is finalised you can’t change the key elements – Training is Crucial

Form Design