Remote or on-site visits were feasible for the initial set-up meetings with hospitals in a multi-centre surgical trial: an embedded randomised trial

Jefferson, Laura, Fairhurst, Caroline, Brealey, Stephen, Coleman, Elizabeth, Cook, Liz, Hewitt, Catherine, Keding, Ada, Northgraves, Matthew, Rangan, Amar, Tew, Garry, Torgerson, David and Dias, Joseph (2018) Remote or on-site visits were feasible for the initial set-up meetings with hospitals in a multi-centre surgical trial: an embedded randomised trial. Journal of Clinical Epidemiology, 100. pp. 13-21. ISSN 0895-4356

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Abstract

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-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.

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 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.

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