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Factors influencing participation in randomised clinical trials among patients with early Barrett's neoplasia: a multicentre interview study

Peerally, Mohammad Farhad; Jackson, Clare; Bhandari, Pradeep; Ragunath, Krish; Barr, Hugh; Stokes, Clive; Haidry, Rehan; ... De Caestecker, John; + view all (2023) Factors influencing participation in randomised clinical trials among patients with early Barrett's neoplasia: a multicentre interview study. BMJ Open , 13 (1) , Article e064117. 10.1136/bmjopen-2022-064117. Green open access

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Abstract

OBJECTIVES: Strong recruitment and retention into randomised controlled trials involving invasive therapies is a matter of priority to ensure better achievement of trial aims. The BRIDE (Barrett's Randomised Intervention for Dysplasia by Endoscopy) Study investigated the feasibility of undertaking a multicentre randomised controlled trial comparing argon plasma coagulation and radiofrequency ablation, following endoscopic resection, for the management of early Barrett's neoplasia. This paper aims to identify factors influencing patients' participation in the BRIDE Study and determine their views regarding acceptability of a potential future trial comparing surgery with endotherapy. DESIGN: A semistructured telephone interview study was performed, including both patients who accepted and declined to participate in the BRIDE trial. Interview data were analysed using the constant comparison approach to identify recurring themes. SETTING: Interview participants were recruited from across six UK tertiary centres where the BRIDE trial was conducted. PARTICIPANTS: We interviewed 18 participants, including 11 participants in the BRIDE trial and 7 who declined. RESULTS: Four themes were identified centred around interviewees' decision to accept or decline participation in the BRIDE trial and a potential future trial comparing endotherapy with surgery: (1) influence of the recruitment process and participant-recruiter relationship; (2) participants' views of the design and aim of the study; (3) conditional altruism as a determining factor and (4) participants' perceptions of surgical risks versus less invasive treatments. CONCLUSION: We identified four main influences to optimising recruitment and retention to a randomised controlled trial comparing endotherapies in patients with early Barrett's-related neoplasia. These findings highlight the importance of qualitative research to inform the design of larger randomised controlled trials.

Type: Article
Title: Factors influencing participation in randomised clinical trials among patients with early Barrett's neoplasia: a multicentre interview study
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1136/bmjopen-2022-064117
Publisher version: http://dx.doi.org/10.1136/bmjopen-2022-064117
Language: English
Additional information: 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/.
Keywords: Adult gastroenterology, Endoscopy, Oesophageal disease, Humans, Barrett Esophagus, Esophageal Neoplasms, Neoplasm Recurrence, Local, Precancerous Conditions, Qualitative Research, Randomized Controlled Trials as Topic
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Surgery and Interventional Sci
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Surgery and Interventional Sci > Department of Targeted Intervention
URI: https://discovery.ucl.ac.uk/id/eprint/10163262
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