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Multicenter Study
. 2023 Jan 6;13(1):e064117.
doi: 10.1136/bmjopen-2022-064117.

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

Mohammad Farhad Peerally  1   2 , Clare Jackson  3 , Pradeep Bhandari  4 , Krish Ragunath  5   6 , Hugh Barr  7 , Clive Stokes  8 , Rehan Haidry  9 , Laurence B Lovat  10 , Howard Smart  11 , John De Caestecker  12
Affiliations
Multicenter Study

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

Mohammad Farhad Peerally et al. BMJ Open. .

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.

Keywords: Adult gastroenterology; Endoscopy; Oesophageal disease.

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Conflict of interest statement

Competing interests: KR received educational grants from Erbe and Medtronic. RH received research infrastructure support from Medtronic, Cook Endoscopy and Pentax Europe. LBL received research infrastructure support from Medtronic. All other authors disclosed no financial relationships relevant to this article.

Figures

Figure 1
Figure 1
Practical considerations to maximise recruitment into randomised controlled trials comparing different endotherapies for the management of patients with early oesophageal cancer.
See this image and copyright information in PMC

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