Question: Can I run the FLARE Trial if our site is already participating in the FIRST Trial?

Answer: Our co-CI's (Matt Gardiner and Emma Reay) are working with Emma Bamford and the FIRST trial team to ensure that sites can deliver both trials at the same time. FLARE has a narrower set of inclusion criteria so patients that are screened out of FLARE will still be eligible for FIRST. Delivery of the FLARE Trial is designed to be as efficient and straightforward as possible and is registered with the NIHR Associate PI scheme too, with the intention that surgical trainees can take on some of the tasks that research staff would usually perform.

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Question: How are the patients selected for the qualitative interviews?

Answer: Participants will be selected via a sampling framework will be approached about the interview (including separate consent) by the qualitative researcher.

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Question: How will consent forms be sent to the York Trials Unit?

Answer: The FLARE REDCap database has a consent instrument where site teams can either use this to receive online consent or use it to upload a copy of the completed paper version. There will be no need to transfer of consent forms via post or email.

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Question: Do we complete accruals for this trial?

Answer: The study is adopted onto the CRN portfolio (CPMS ID: 54953). Each patient that is consented and randomised will be credited as an accrual.

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