OTHER
Q: Will stamps be provided to sites for the participant and GP questionnaires? A: Yes they will on request. Please send an email to ctu.optimas@ucl.ac.uk letting us know how many you require
Q: A participant has capacity to sign the consent form but then does not give reliable answers when completing the questionnaires. What should we do in this instance? A: It should be made sure that the participant understands the question and also what the answer they are giving means. The participant should not be led to a certain answer though and therefore what they say will need to be recorded.
Q: How do we claim travel expenses for participants attending the appointment by car? A: To claim these travel expenses, please do the following: 1. Calculate the car mileage travelled to the hospital from the participant’s home/other accommodation using an appropriate mileage calculator – I recommend using the AA Mileage Calculator (http://www.theaa.com/driving/mileage-calculator.jsp) as you can then print off the result so a record can be kept. The CCTU trial team should not have copies as this will contain identifiable information about the participant’s address. 2. Then, please arrange reimbursement to the participant based on £0.45 per mile. This is the standard rate according to UCL policy and is the HMRC approved allowance rate.
The maximum amount that can be claimed per participant is £34.50. Please ensure that your local procedures for recording travel expense claims are followed.
Q: How do you send an encrypted email? A: the person needs to have a @nhs.net account, and put [secure] in the subject line. This needs to be done with square brackets only.
Q: Is there an easy access informed consent form (ICF) to go alongside the easy access patient information sheet (PIS)? A: No, there is not an easy access ICF. Please use the short ICF and also give the participant the short PIS for their records.
Q: Will we be required to continue to complete the screening logs for the entirety of the trial; they are labour intensive A: We will want the screening data throughout the trial and are aware of the extra work this creates. We will be clarifying the definition of the term ‘screening’ due to discrepancies in the amount of patients screened per site. Hopefully this will reduce the workload.
Q: For travel expenses reimbursement, what is the process? A: We ask sites to reimburse patients first for any travel expenses. Please keep a log of who you have reimbursed. In accordance to the site agreement, you can email an invoice to us every 6 months to claim back those expenses.
Q: We have consultants who start DOACs early; some are saying there is evidence for this. Is there evidence for this? A: There is no high quality (randomised) data supporting early DOAC. Increasing observational data show promise but are biased and cannot be used to change practice and guidelines! We need to randomise to get the answer for our patients!
Q: Patients and relatives can be quite concerned after the trial has been presented in relation to the risks of recurrent stroke and potential bleeding depending on the timing of anticoagulant initiation. Do you have any suggestions on how to deal with these concerns please? A: The uncertainty around this needs to be emphasised that people think they know what to do based on observational data, which is extremely biased. There is not a high quality of randomised evidence to be able to know the safety and efficacy of that approach.
Q: Do people find that consultants are more reluctant to consider the more severe stroke patients and if so how do you get around this? A: There is no data on severe strokes and DOACS. They have high recurrence risk but also worry about bleeding risk. As long as not PH type 2 (bleeding 30% of infarct with mass effect) we should randomise!
Q: A patient was admitted to site for an elective procedure, and had a stroke, when still in hospital: what site admission date should be entered: the stroke onset date or the admission date? A: It would be most appropriate to use date of stroke as site admission. Please also right-click in MACRO and leave a comment explaining the patient had already been admitted.
Q: Can we continue recruiting after meeting the site target? A: Yes, absolutely. We are keen for you to recruitment as many people as you can!
Q: We are having trouble uploading zip files from PACs team CDs. Can we post them instead? A: If you are having any issues with uploading images please can you send an email to ctu.optimas-imaging@ucl.ac.uk with more details.
Q: Do we need to send copies of the CRF for participants who withdraw their consent from the trial? A: Yes, Please can the paper CRF (Cessation of trial treatment or withdrawal CRF v2.0 30 Apr 2020) for any participants who withdraws their consent to taking part in the trial be scanned and emailed to the CCTU trial team. This is alongside data being entered into MACRO with this information. When a participant chooses to withdraw consent from the trial, please ask if they will consent to their GP being contacted to get follow-up information on the primary outcomes.
Q: If the participant has not been weighed for the randomisation documentation, can we use an estimate or use the last known weight? If the last known weight, what would be the max time period that we can use? A: Last known weight would be fine if the team think it’s still broadly reliable i.e. they have no reason to think the patient’s weight has changed greatly since then. There is no specific timescale on it.