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

Jefferson, Laura; Fairhurst, Caroline; Brealey, Stephen; Coleman, Elizabeth; Cook, Liz; Hewitt, Catherine; Keding, Ada; Northgraves, Matthew; Rangan, Amar; Tew, Garry A.; Torgerson, David J.; Dias, Joseph

Abstract

© 2018 Elsevier Inc. 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.

Citation

Jefferson, L., Fairhurst, C., Brealey, S., Coleman, E., Cook, L., Hewitt, C., …Dias, J. (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, 13-21. https://doi.org/10.1016/j.jclinepi.2018.04.011

• Journal Article Type: Conference Paper
• Acceptance Date: Apr 11, 2018
• Online Publication Date: Apr 19, 2018
• Publication Date: 2018-08
• Deposit Date: May 22, 2019
• Journal: Journal of Clinical Epidemiology
• Print ISSN: 0895-4356
• Electronic ISSN: 1878-5921
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 100
• Pages: 13-21
• DOI: https://doi.org/10.1016/j.jclinepi.2018.04.011
• Keywords: Costs; Feasibility; Study within a trial; Randomized controlled trial; Recruitment; Response rate
• Public URL: https://hull-repository.worktribe.com/output/1791452
• Related Public URLs: https://eprints.whiterose.ac.uk/131295/