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

Mohammad Farhad Peerally; Clare Jackson; Pradeep Bhandari; Krish Ragunath; Hugh Barr; Clive Stokes; Rehan Haidry; Laurence B Lovat; Howard Smart; John De Caestecker

doi:10.1136/bmjopen-2022-064117

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

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

Authors

Mohammad Farhad Peerally^{1

2}, Clare Jackson³, Pradeep Bhandari⁴, Krish Ragunath^{5

6}, Hugh Barr⁷, Clive Stokes⁸, Rehan Haidry⁹, Laurence B Lovat¹⁰, Howard Smart¹¹, John De Caestecker¹²

Affiliations

¹ SAPPHIRE, Department of Health Sciences, University of Leicester, Leicester, UK mfp6@le.ac.uk.
² Digestive Diseases Unit, Kettering General Hospital, Kettering, UK.
³ Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK.
⁴ Queen Alexandra Hospital, Portsmouth, UK.
⁵ Department of Gastroenterology & Hepatology, Royal Perth Hospital, Perth, Western Australia, Australia.
⁶ Faculty of Health Sciences, Curtin Medical School, Perth, Western Australia, Australia.
⁷ Department of Surgery, Gloucestershire Royal Hospital, Gloucester, UK.
⁸ Chestnut House, Gloucester Royal Hospital, Gloucester, UK.
⁹ Department of Gastroenterology and Hepatology, University College Hospital, London, UK.
¹⁰ Division of Surgery and Interventional Science, University College London, London, UK.
¹¹ Department of Gastroenterology, Royal Liverpool Hospital, Liverpool, UK.
¹² Digestive Diseases Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.

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.

Publication types

Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Barrett Esophagus* / surgery
Esophageal Neoplasms* / surgery
Humans
Neoplasm Recurrence, Local
Precancerous Conditions*
Qualitative Research
Randomized Controlled Trials as Topic