Q. Is there any provision in the trial for pre-screening consent?
A. Not at this time but please record on the screening log any patients that have been excluded because certain screening tests (specifically viability assessment or angiogram) could not be done as part of routine care.
Dealing with patient’s preconceptions
Q. How do you deal with patients that have their mind set on one treatment or another?
A. Patients will sometimes have a preference for the treatment that they want but this is often based on what they’ve heard from friends and family. Patients need and want information to help them make the right choice. One important fact to get across is that this group should not get PCI if they are not in the trial as it is not a proven treatment for heart failure. If after talking to the patient and explaining their options, the patient is still set on a specific treatment, it is best not to include the patient as there is a greater chance they will withdraw if they are disappointed with their allocation.
Q. Once consent is taken, are we obliged to record events and if so, which arm are they counted in?
A. The patient is not officially in the trial until randomisation, which means that events don’t need to be recorded until a patient is randomised.
Q. Is there any worry that the patient will change their mind about being in the study between consent and randomisation?
A. From experience so far, this has not been an issue. By the time the patient is randomised, they will have been seen by either a trial doctor or nurse several times and hopefully will have built up a relationship with them.