title: The Rome III criteria for the diagnosis of functional dyspepsia in secondary care are not superior to previous definitions.
abstract: OBJECTIVE
  Although the Rome III criteria for functional dyspepsia were defined 7 years ago, they have yet to be validated in a rigorous study. We addressed this issue in a secondary-care population.
  
  
  METHODS
  We analyzed complete symptom, upper gastrointestinal (GI) endoscopy, and histology data from 1452 consecutive adult patients with GI symptoms at 2 hospitals in Hamilton, Ontario, Canada. Assessors were blinded to symptom status. Individuals with normal upper GI endoscopy and histopathology findings from analyses of biopsy specimens were classified as having no organic GI disease. The reference standard used to define the presence of true functional dyspepsia was epigastric pain, early satiety or postprandial fullness, and no organic GI disease. Sensitivity, specificity, and positive and negative likelihood ratios (LRs), with 95% confidence intervals (CIs), were calculated.
  
  
  RESULTS
  Of the 1452 patients, 722 (49.7%) met the Rome III criteria for functional dyspepsia. Endoscopy showed organic GI disease in 170 patients (23.5%) who met the Rome III criteria. The Rome III criteria identified patients with functional dyspepsia with 60.7% sensitivity, 68.7% specificity, a positive LR of 1.94 (95% CI, 1.69-2.22), and a negative LR of 0.57 (95% CI, 0.52-0.63). In contrast, the Rome II criteria identified patients with functional dyspepsia with 71.4% sensitivity, 55.6% specificity, a positive LR of 1.61 (95% CI, 1.45-1.78), and a negative LR of 0.51 (95% CI, 0.45-0.58). The area under a receiver operating characteristics curves did not differ significantly for any of the diagnostic criteria for functional dyspepsia.
  
  
  CONCLUSIONS
  In a validation study of 1452 patients with GI symptoms, the Rome III criteria performed only modestly in identifying those with functional dyspepsia, and were not significantly superior to previous definitions.
authors.affiliation: Leeds Gastroenterology Institute, St. James's University Hospital, Leeds, United Kingdom; Leeds Institute of Biomedical and Clinical Sciences, University of Leeds, Leeds, United Kingdom. Electronic address: alexf12399@yahoo.com.
authors.forename: Alexander C
authors.initials: AC
authors.lastname: Ford
authors.affiliation: Farncombe Family Digestive Health Research Institute, Gastroenterology Division, McMaster University, Health Sciences Center, Hamilton, Ontario, Canada.
authors.forename: Premysl
authors.initials: P
authors.lastname: Bercik
authors.affiliation: Gastroenterology Department, St. Joseph's Healthcare, Hamilton, Ontario, Canada.
authors.forename: David G
authors.initials: DG
authors.lastname: Morgan
authors.affiliation: Farncombe Family Digestive Health Research Institute, Gastroenterology Division, McMaster University, Health Sciences Center, Hamilton, Ontario, Canada.
authors.forename: Carolina
authors.initials: C
authors.lastname: Bolino
authors.affiliation: Farncombe Family Digestive Health Research Institute, Gastroenterology Division, McMaster University, Health Sciences Center, Hamilton, Ontario, Canada.
authors.forename: Maria Ines
authors.initials: MI
authors.lastname: Pintos-Sanchez
authors.affiliation: Farncombe Family Digestive Health Research Institute, Gastroenterology Division, McMaster University, Health Sciences Center, Hamilton, Ontario, Canada.
authors.forename: Paul
authors.initials: P
authors.lastname: Moayyedi
mesh_terms: D015746:Abdominal Pain / Q000175:diagnosis / Q000453:epidemiology; D000328:Adult; D000368:Aged; D019540:Area Under Curve; D003938:Diagnostic Techniques, Digestive System; D004415:Dyspepsia / Q000175:diagnosis* / Q000453:epidemiology / Q000473:pathology / Q000523:psychology; D016099:Endoscopy, Gastrointestinal; D005260:Female; D006801:Humans; D016013:Likelihood Functions; D008297:Male; D008875:Middle Aged; D009864:Ontario / Q000453:epidemiology; D010147:Pain Measurement; D019518:Postprandial Period; D011237:Predictive Value of Tests; D015995:Prevalence; D011379:Prognosis; D012372:ROC Curve; D015203:Reproducibility of Results; D012527:Satiation; D063127:Secondary Health Care; D012720:Severity of Illness Index
keywords: Accuracy; Functional Dyspepsia; Sensitivity; Specificity