Dr Alexander Ford and colleagues from the United Kingdom 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.
|The Rome II criteria identified patients with functional dyspepsia with 71%|
Of the 1452 patients, the researchers reported that 50% met the Rome III criteria for functional dyspepsia.
The researchers found that endoscopy showed organic GI disease in 24% of patients who met the Rome III criteria.
The team noted that Rome III criteria identified patients with functional dyspepsia with 61% sensitivity, 69% specificity, a positive LR of 1.94, and a negative LR of 0.57.
In contrast, the Rome II criteria identified patients with functional dyspepsia with 71% sensitivity, 56% specificity, a positive LR of 1.61, and a negative LR of 0.51.
The researchers found that the area under a receiver operating characteristics curves did not differ significantly for any of the diagnostic criteria for functional dyspepsia.
Dr Ford's team concludes, "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."