Jefferson, Laura, Fairhurst, Caroline, Brealey, Stephen, Coleman, Elizabeth ORCID: https://orcid.org/0000-0003-4210-1865, Cook, Liz, Hewitt, Catherine, Keding, Ada, Northgraves, Matthew, Rangan, Amar, Tew, Garry ORCID: https://orcid.org/0000-0002-8610-0613, Torgerson, David J. and Dias, Joseph (2018) Remote or on-site visits were feasible for the initial setup meetings with hospitals in a multicenter surgical trial: an embedded randomized trial. Journal of Clinical Epidemiology, 100. pp. 13-21.

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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 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.

Item Type:	Article
Status:	Published
DOI:	10.1016/j.jclinepi.2018.04.011
School/Department:	School of Science, Technology and Health
URI:	https://ray.yorksj.ac.uk/id/eprint/6830

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