Pre-endoscopy serological testing for coeliac disease: evaluation of a clinical decision toolBMJ 2007; 334 doi: http://dx.doi.org/10.1136/bmj.39133.668681.BE (Published 05 April 2007) Cite this as: BMJ 2007;334:729
- Andrew D Hopper, gastroenterology specialist registrar1,
- Simon S Cross, reader in pathology and honorary consultant in pathology3,
- David P Hurlstone, consultant gastroenterologist1,
- Mark E McAlindon, consultant gastroenterologist1,
- Alan J Lobo, consultant gastroenterologist1,
- Marios Hadjivassiliou, consultant neurologist4,
- Marion E Sloan, general practitioner5,
- Simon Dixon, senior lecturer in health economics2,
- David S Sanders, consultant gastroenterologist1
- 1Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield
- 2Health Economics and Decision Science (HEDS), University of Sheffield, Sheffield
- 3Section of Oncology and Pathology, Division of Genomic Medicine, University of Sheffield Medical School, Sheffield
- 4Department of Neurology, Royal Hallamshire Hospital
- 5Surgery, 29 Blackstock Road, Sheffield S14 1AB
- Correspondence to: A D Hopper, 15 Nairn Street, Sheffield S10 1UL
- Accepted 30 January 2007
Objective To determine an effective diagnostic method of detecting all cases of coeliac disease in patients referred for gastroscopy without performing routine duodenal biopsy.
Design An initial retrospective cohort of patients attending for gastroscopy was analysed to derive a clinical decision tool that could increase the detection of coeliac disease without performing routine duodenal biopsy. The tool incorporated serology (measuring antibodies to tissue transglutaminase) and stratifying patients according to their referral symptoms (patients were classified as having a “high risk” or “low risk” of coeliac disease). The decision tool was then tested on a second cohort of patients attending for gastroscopy. In the second cohort all patients had a routine duodenal biopsy and serology performed.
Setting Teaching hospital in Sheffield.
Participants 2000 consecutive adult patients referred for gastroscopy recruited prospectively.
Main outcome measure Evaluation of a clinical decision tool using patients' referral symptoms, tissue transglutaminase antibody results, and duodenal biopsy results.
Results No cases of coeliac disease were missed by the pre-endoscopy testing algorithm. The prevalence of coeliac disease in patients attending for endoscopy was 3.9% (77/2000, 95% confidence interval 3.1% to 4.8%). The prevalence in the high risk and low risk groups was 9.6% (71/739, 7.7% to 12.0%) and 0.5% (6/1261, 0.2% to 1.0%). The prevalence of coeliac disease in patients who were negative for tissue transglutaminase antibody was 0.4% (7/2000). The sensitivity, specificity, positive predictive value, and negative predictive value for a positive antibody result to diagnose coeliac disease was 90.9%, 90.9%, 28.6%, and 99.6%, respectively. Evaluation of the clinical decision tool gave a sensitivity, specificity, positive predictive value, and negative predictive value of 100%, 60.8%, 9.3%, and 100%, respectively.
Conclusions Pre-endoscopy serological testing in combination with biopsy of high risk cases detected all cases of coeliac disease. The use of this decision tool may enable the endoscopist to target patients who need a duodenal biopsy.
Contributors: ADH helped design the study; collect, analyse, and interpret data; draft the article; and recruit patients. ADH is guarantor. SD helped analyse and interpret the data and review the final version of the manuscript. DPH, MEMcA, AJL, MES, and MH helped recruit patients, analyse and interpret the data, and review the final version of the manuscript. SSC helped review the histopathology, analyse and interpret the data, and review the final version of the manuscript. DSS conceived and designed the study. DSS helped recruit patients, analyse and interpret data, and review the final version of the manuscript.
Competing interests: DSS is an associate medical adviser for Coeliac UK (National Medical Charity). This is an honorary post with no financial benefits.
Ethical approval: South Sheffield research and ethics committee.
- Accepted 30 January 2007