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Remote or on-site visits were feasible for the initial setup meetings with hospitals in a multicenter surgical trial:
Laura Jefferson1, Caroline Fairhurst2, Stephen Brealey2
1Department of Health Sciences, University of York, Area 4, Seebohm Rowntree Building, Heslington, York YO10 5DD, United Kingdom.
Objectives:
To investigate the effects, costs, and feasibility of providing on-site compared with remote meetings to set up hospital sites in a multicenter, surgical randomized controlled trial.
Study Design And Setting:
Hospitals were randomized to receive the initial trial setup meetings on-site (i.e., face-to-face) or remotely (i.e., via teleconference). Data were collected on site setup, recruitment, follow-up, and costs for the two methods. The hospital staff experience of trial setup was also surveyed.
Results:
Thirty-nine sites were randomized and 33 sites set up to recruit (19 on-site and 14 remote). For sites randomized to an on-site meeting compared with remote meeting respectively, the time from first contact to the first recruit was a median of 246 days (interquartile range [IQR] 196-346] vs. 212 days (IQR 154-266), mean recruitment was 10 participants (median 10, IQR 2-17) vs. 11 participants (median 6, IQR 5-23), 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 setup.
Conclusion:
Remote or on-site visits are feasible for the initial setup meetings with hospitals in a multicenter surgical trial. This embedded trial should be replicated to improve generalizability and increase statistical power using meta-analysis. ISRCTN78899574.
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