Acceptability and accuracy of a non-endoscopic screening test for Barrett’s oesophagus in primary care: cohort studyBMJ 2010; 341 doi: https://doi.org/10.1136/bmj.c4372 (Published 10 September 2010) Cite this as: BMJ 2010;341:c4372
- Sudarshan R Kadri, clinical research fellow in gastroenterology1,
- Pierre Lao-Sirieix, group research manager1,
- Maria O’Donovan, consultant gastrointestinal pathologist12,
- Irene Debiram, research nurse1,
- Madhumita Das, laboratory assistant1,
- Jane M Blazeby, professor of surgery and honorary consultant oesophago-gastric surgeon3,
- Jon Emery, professor of general practice45,
- Alex Boussioutas, senior lecturer and consultant gastroenterologist6,
- Helen Morris, senior research associate in public health and primary care5,
- Fiona M Walter, NIHR clinical lecturer in general practice45,
- Paul Pharoah, reader in cancer epidemiology7,
- Richard H Hardwick, consultant oesophago-gastric surgeon8,
- Rebecca C Fitzgerald, MRC programme leader and honorary consultant gastroenterologist1
- 1MRC Cancer Cell Unit, Hutchison-MRC Research Centre, Cambridge CB2 2XZ
- 2Department Histopathology, Addenbrooke’s Hospital, Cambridge
- 3Department of Social Medicine, University of Bristol
- 4School of Primary, Aboriginal and Rural Health Care, University of Western Australia, Australia
- 5General Practice and Primary Care Research Unit, University of Cambridge
- 6Department of Medicine, University of Melbourne, Western Hospital, Melbourne, Australia, and Cancer Genomics and Predictive Medicine, Peter MacCallum Cancer Centre, East Melbourne, Australia
- 7Strangeways Laboratory, Department of Oncology, University of Cambridge
- 8Cambridge Oesophago-Gastric Centre, Addenbrooke’s Hospital
- Correspondence to: R C Fitzgerald
- Accepted 9 July 2010
Objectives To determine the accuracy and acceptability to patients of non-endoscopic screening for Barrett’s oesophagus, using an ingestible oesophageal sampling device (Cytosponge) coupled with immunocytochemisty for trefoil factor 3.
Design Prospective cohort study.
Setting 12 UK general practices, with gastroscopies carried out in one hospital endoscopy unit.
Participants 504 of 2696 eligible patients (18.7%) aged 50 to 70 years with a previous prescription for an acid suppressant (H2 receptor antagonist or proton pump inhibitor) for more than three months in the past five years.
Main outcome measures Sensitivity and specificity estimates for detecting Barrett’s oesophagus compared with gastroscopy as the ideal method, and patient anxiety (short form Spielberger state trait anxiety inventory, impact of events scale) and acceptability (visual analogue scale) of the test.
Results 501 of 504 (99%) participants (median age 62, male to female ratio 1:1.2) successfully swallowed the Cytosponge. No serious adverse events occurred. In total, 3.0% (15/501) had an endoscopic diagnosis of Barrett’s oesophagus (≥1 cm circumferential length, median circumferential and maximal length of 2 cm and 5 cm, respectively) with intestinal metaplasia. Compared with gastroscopy the sensitivity and specificity of the test was 73.3% (95% confidence interval 44.9% to 92.2%) and 93.8% (91.3% to 95.8%) for 1 cm or more circumferential length and 90.0% (55.5% to 99.7%) and 93.5% (90.9% to 95.5%) for clinically relevant segments of 2 cm or more. Most participants (355/496, 82%, 95% confidence interval 78.9% to 85.1%) reported low levels of anxiety before the test, and scores remained within normal limits at follow-up. Less than 4.5% (2.8% to 6.1%) of participants reported psychological distress a week after the procedure.
Conclusions The performance of the Cytosponge test was promising and the procedure was well tolerated. These data bring screening for Barrett’s oesophagus into the realm of possibility. Further evaluation is recommended.
We thank the participants as well as the managers, general practitioners, and administrative staff of York Street Medical Practice, Linton Health Centre, Nuffield Road Medical Practice, Woodland Surgery, Willingham Surgery, Papworth Surgery, Spinney Surgery, Priory Field Surgery, Cornford House Surgery, East Barnwell Health Centre, Acorn, and Mill Road Surgery; Paul Linehan and Kareem Shariff for their help with the endoscopies; Jeanette Kersey and Pauline Wait for their administrative help; and Sarah Vowler for her statistical advice. Clinical Research Network portfolio study (ID No 1525).
Contributors: SRK ran the study and collected the data. PLS designed the study, analysed the data, and wrote the manuscript. MO’D reviewed the pathology and reviewed the Cytosponge samples. ID ran the study. MD prepared and stained the samples. JMB, JE, AB, HM, FWM, and RHH designed the study and reviewed the manuscript. PP overviewed the statistics. RCF designed the study and wrote the manuscript. RCF is guarantor for the study.
Funding: This research was supported by the Medical Research Council development gap fund, NIHR School for Primary Care Research, BD Diagnostics, Cambridge Experimental Cancer Medicine Centre, and the National Institute for Health Research Cambridge Biomedical Research Centre. Surepath preservative fluid was a gift from BD Diagnostics.
Competing interests: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare that SRK, PLS, MO’D, ID, MD, JMB, JE, AB, HM, FWM, RHH, and RCF have no relationships with companies that might have an interest in the submitted work in the previous 3 years; their spouses, partners, or children have no financial relationships that may be relevant to the submitted work; and SRK, PLS, MO’D, ID, MD, JMB, JE, AB, HM, FWM, RHH, and RCF have no non-financial interests that may be relevant to the submitted work.
Ethical approval: This study was approved by Cambridge regional ethics committee (LREC 06/Q0108/272).
Data sharing: No additional data available.
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