Remote or on-site visits were feasible for the initial setup meetings with hospitals in a multicenter surgical trial:an embedded randomized trial

Objectives To investigate the effects, costs and feasibility of providing on-site compared with remote meetings to set-up hospital sites in a multi-centre, surgical randomised controlled trial. Study Design and Setting Hospitals were randomised to receive the initial trial set-up meetings on-site (i.e. face-toface) or remotely (i.e. via teleconference). Data were collected on site set-up, recruitment, follow-up and costs for the two methods. The hospital staff experience of trial set-up was also surveyed. Results Thirty-nine sites were randomised and 33 sites set-up to recruit (19 on-site and 14 remote). For sites randomised to an on-site meeting compared with remote meeting respectively, the time from first contact to first recruit was a median of 246 days [interquartile range (IQR) 196 to 346] vs 212 days [IQR 154 to 266], mean recruitment was 10 participants [median 10, IQR 2 to 17] vs 11 participants [median 6, IQR 5 to 23] and participant follow-up at 12 months was 81% vs 82%. Sites allocated to an initial on-site visit cost on average 289.83 more to set-up. Conclusion Remote or on-site visits are feasible for the initial set-up meetings with hospitals in a multicentre surgical trial. This embedded trial should be replicated to improve generalisability and increase statistical power using meta-analysis. ISRCTN78899574. Keywords: Study Within a Trial; Randomised Controlled Trial; Recruitment; Response rate; Costs; Feasibility A running title: Remote and on-site visits were feasible for the initial set-up meetings with hospitals in a multi-centre surgical trial