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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

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JournalJournal of Clinical Epidemiology
DateAccepted/In press - 11 Apr 2018
DateE-pub ahead of print (current) - 19 Apr 2018
Volume100
Pages (from-to)13-21
Early online date19/04/18
Original languageEnglish

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-toface) 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 are feasible for the initial set-up meetings with hospitals in a multicentre surgical trial. This embedded trial should be replicated to improve generalisability and increase statistical power using meta-analysis. ISRCTN78899574.

Keywords: Study Within a Trial; Randomised Controlled Trial; Recruitment; Response rate; Costs; Feasibility

A running title: Remote and on-site visits were feasible for the initial set-up meetings with hospitals in a multi-centre surgical trial

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© 2018 Elsevier Inc.This is an author-produced version of the published paper. Uploaded in accordance with the publisher’s self-archiving policy.

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