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-to-face) 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.
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.
Remote or on-site visits were feasible for the initial set-up meetings with hospitals in a multi-centre surgical trial. This embedded trial should be replicated to improve generalisability and increase statistical power using meta-analysis.