For electronic baseline questionnaires:

If the “Electronic” box is ticked on the ENROLMENT CRF, a patient will receive an automated email with a link to the baseline questionnaire. This will be issued after the “Enrolment”, “Randomisation”, and “Patient Information” forms are marked as complete and saved.

For paper baseline questionnaires:

• If the “Paper” box is ticked on the ENROLMENT CRF, a patient should be provided with a paper copy of the baseline questionnaire. They should complete and return this questionnaire to the sites, who can then send the completed questionnaire to the central study team.

• Please add relevant participant ID number in footer of the paper copy provided to the patient.

• Please send completed questionnaires in batches (by the first day of each month) to the central study team.

• If the patient takes the questionnaire home to complete, please provide them with a freepost envelope to return it directly to the central study team.

It is a site team responsibility to ensure baseline questionnaires are returned to the central team.

The central study team will send out the post-decision and post-test result questionnaires (21 days, 6 months and 12 months) either via post or electronically (patient emailed a link to complete) dependent on patient preference recorded on the PATIENT INFORMATION CRF.