Study Design
Q. It would be useful to have a timeline of the patient, showing all the different visits and what happens where.
A. This has been produced by CTU and is available here.
Q. What happens if a patient drops out and doesn’t have their planned surgery for some reason?
A. The protocol covers this situation and we would like to follow these patients. If they agree, these patients will still be followed-up and analysed as ‘intention to treat’.
Q. How many patient drop outs have you allowed for?
A. We have allowed for a 5% loss to follow-up for patients.
Q. In relation to hospital stays, what counts as a day?
A. Any portion of any day will count as one day. For example, if a patient is admitted in the morning and is discharged 5 hours later, their stay will count as 1 day. If a patient is admitted on one day and discharged the next, their stay will count as 2 days.
Q. If during a transfusion, not all of a blood pack is used, does it count as a whole used unit?
A. Yes. If a blood pack is allocated, delivered and opened, it will count as one until of blood used no matter how much of the pack is actually used. If a blood pack is allocated and delivered but not opened/used, it is counted as blood wastage and does not count. So any blood given even a drop is counted as a transfusion.
Q. When should the baseline and pre-operative quality of life questionnaires be completed by the patient?
A. The baseline quality of life questionnaires should be completed by the patient when they attend hospital for the administration of the trial treatment. The pre-operative questionnaires should be completed by the patient at home 8-10 days after the administration of the trial visit before they are admitted for surgery. Copies of these questionnaires should be given to the patient to take home and they can then be collected when they are admitted for surgery.
Q. Do we need to ask the patients to complete the baseline SQOM?
A. Yes, even though the patient has only just been randomised into the trial, they still need to complete the baseline SQOM.
