Effectiveness of different recruitment strategies in an RCT of a surgical device:;Experience from the Endobarrier trial
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Published version
Author(s)
Type
Journal Article
Abstract
Recruiting participants into clinical trials is notoriously difficult and poses the greatest challenge when planning any investigative study. Poor recruitment may not only have financial ramifications owing to increased time and resources being spent but could adversely influence the clinical impact of a study if it becomes underpowered. Herein we present our own experience of recruiting into a nationally funded, multi-centre, randomised controlled trial (RCT) of the Endobarrier vs. standard medical therapy in obese patients with type 2 diabetes. Despite these both being highly prevalent conditions, there were considerable barriers to the effectiveness of different recruitment strategies across each study site. Although recruitment from primary care proved extremely successful at one study site, this largely failed at another site prompting the implementation of multimodal recruitment strategies including a successful media campaign to ensure sufficient participants were enrolled and the study was adequately powered. From this experience we propose where appropriate the early engagement and investment in media campaigns to enhance recruitment into clinical trials.
Date Issued
2019-11-14
Date Acceptance
2019-10-18
Citation
BMJ Open, 2019, 9
ISSN
2044-6055
Publisher
BMJ Journals
Journal / Book Title
BMJ Open
Volume
9
Copyright Statement
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
Sponsor
National Institute for Health Research
Imperial College Healthcare NHS Trust
Grant Number
12/10/04
FR668
Subjects
clinical trials
diabetes & endocrinology
endoscopy
general endocrinology
statistics & research methods
1103 Clinical Sciences
1117 Public Health and Health Services
1199 Other Medical and Health Sciences
Publication Status
Published
Article Number
ARTN e032439
Date Publish Online
2019-11-14