Laura Jefferson1, Caroline Fairhurst2, Stephen Brealey3, Elizabeth Coleman2, Liz Cook2, Catherine Hewitt2, Ada Keding2, Matthew Northgraves2, Amar Rangan2, Garry A Tew2, David J Torgerson2, Joseph Dias4. 1. Department of Health Sciences, University of York, Area 4, Seebohm Rowntree Building, Heslington, York YO10 5DD, United Kingdom. 2. Department of Health Sciences, University of York, York Trials Unit, Lower Ground Floor, ARRC Building, Heslington, York YO10 5DD, United Kingdom. 3. Department of Health Sciences, University of York, York Trials Unit, Lower Ground Floor, ARRC Building, Heslington, York YO10 5DD, United Kingdom. Electronic address: stephen.brealey@york.ac.uk. 4. AToMS-Academic Team of Musculoskeletal Surgery, University Hospitals of Leicester NHS Trust, Leicester General Hospital, Undercroft (nr Ward 28), Gwendolen Road, Leicester LE5 4PW, United Kingdom.
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.
RCT Entities:
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.
Authors: Sharon B Love; Emma Armstrong; Carrie Bayliss; Melanie Boulter; Lisa Fox; Joanne Grumett; Patricia Rafferty; Barbara Temesi; Krista Wills; Andrea Corkhill Journal: Trials Date: 2021-04-14 Impact factor: 2.279