title: Barrett's Oesophagus Surveillance versus endoscopy at need Study (BOSS): protocol and analysis plan for a multicentre randomized controlled trial.
abstract: OBJECTIVE
  The absolute annual risk of patients with Barrett's oesophagus (BO) developing oesophageal adenocarcinoma (OAC) is ≤ 0.5%. Screening BO patients for malignant progression using endoscopic surveillance is widely practised. To assess the efficacy and cost-effectiveness of this, we developed a protocol for a randomized controlled trial of surveillance versus 'at need' endoscopy.
  
  
  METHODS
  In a multicentre trial, 3400 BO patients randomized to either 2-yearly endoscopic surveillance or 'at need' endoscopy will be followed up for 10 years. Urgent endoscopy will be offered to all patients who develop symptoms of dysphagia, unexplained weight loss > 7lb (3.2 kg), iron deficiency anaemia, recurrent vomiting, or worsening upper gastrointestinal symptoms. Participants must have endoscopically and histologically confirmed BO, with circumferential BO ≥ 1 cm or maximal tongue/island length ≥ 2 cm. Candidates with existing oesophageal high-grade dysplasia or cancer, or previous upper gastrointestinal cancer will be excluded. Primary outcome will be overall survival. Secondary outcomes will be cost effectiveness (cost per life year saved and quality adjusted life years); cancer-specific survival; time to OAC diagnosis and stage at diagnosis; morbidity and mortality related to any interventions; and frequency of endoscopy.
  
  
  CONCLUSIONS
  This randomized trial will provide data to evaluate the efficacy and cost-effectiveness of screening BO patients for OAC.
authors.affiliation: Gloucestershire Royal Hospital, Great Western Road, Gloucester, GL1 3NN.
authors.forename: Oliver
authors.initials: O
authors.lastname: Old
authors.affiliation: Division of Gastroenterology, McMaster University Medical Centre, 1200 Main Street West, Hamilton, Ontario, Canada L8N 3Z5.
authors.forename: Paul
authors.initials: P
authors.lastname: Moayyedi
authors.affiliation: Centre for Statistics in Medicine, University of Oxford, Botnar Research Centre, Windmill Road, Oxford, OX3 7LD.
authors.forename: Sharon
authors.initials: S
authors.lastname: Love
authors.affiliation: Centre for Statistics in Medicine, University of Oxford, Botnar Research Centre, Windmill Road, Oxford, OX3 7LD.
authors.forename: Corran
authors.initials: C
authors.lastname: Roberts
authors.affiliation: Gloucestershire Royal Hospital, Great Western Road, Gloucester, GL1 3NN.
authors.forename: Julie
authors.initials: J
authors.lastname: Hapeshi
authors.affiliation: Gloucestershire Royal Hospital, Great Western Road, Gloucester, GL1 3NN.
authors.forename: Chris
authors.initials: C
authors.lastname: Foy
authors.affiliation: Gloucestershire Royal Hospital, Great Western Road, Gloucester, GL1 3NN.
authors.forename: Clive
authors.initials: C
authors.lastname: Stokes
authors.affiliation: University of Glasgow, Health Economics and Health Technology Assessment, Institute of Health & Wellbeing, 1 Lilybank Gardens, Glasgow G12 8RZ.
authors.forename: Andrew
authors.initials: A
authors.lastname: Briggs
authors.affiliation: University Hospitals Coventry and Warwickshire, University of Warwick, Warwickshire, CV2 2DX.
authors.forename: Janusz
authors.initials: J
authors.lastname: Jankowski
authors.affiliation: Gloucestershire Royal Hospital, Great Western Road, Gloucester, GL1 3NN hugh.barr@glos.nhs.uk.
authors.forename: Hugh
authors.initials: H
authors.lastname: Barr
mesh_terms: D000230:Adenocarcinoma / Q000175:diagnosis*; D000328:Adult; D000368:Aged; D001471:Barrett Esophagus / Q000175:diagnosis*; D003362:Cost-Benefit Analysis; D018450:Disease Progression; D055088:Early Detection of Cancer / Q000191:economics / Q000379:methods*; D004724:Endoscopy / Q000379:methods*; D004938:Esophageal Neoplasms / Q000175:diagnosis*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D012107:Research Design; D012306:Risk; D016896:Treatment Outcome; D055815:Young Adult
keywords: Barrett's oesophagus; Endoscopy; Gastro-oesophageal reflux disease; Oesophageal adenocarcinoma; Randomized controlled trial; Surveillance