Development and Validation of the Korean Rome III Questionnaire for Diagnosis of Functional Gastrointestinal Disorders

BACKGROUND/AIMS A self-report questionnaire is frequently used to measure symptoms reliably and to distinguish patients with functional gastrointestinal disorders (FGIDs) from those with other conditions. We produced and validated a cross-cultural adaptation of the Rome III questionnaire for diagnosis of FGIDs in Korea. METHODS The Korean version of the Rome III (Rome III-K) questionnaire was developed through structural translational processes. Subsequently, reliability was measured by a test-retest procedure. Convergent validity was evaluated by comparing self-reported questionnaire data with the subsequent completion of the questionnaire by the physician based on an interview and with the clinical diagnosis. Concurrent validation using the validated Korean version of the Short Form-36 Health Survey (SF-36) was adopted to demonstrate discriminant validity. RESULTS A total of 306 subjects were studied. Test-retest reliability was good, with a median Cronbach's α value of 0.83 (range, 0.71-0.97). The degree of agreement between patient-administered and physician-administered questionnaires to diagnose FGIDs was excellent; the κ index was 0.949 for irritable bowel syndrome, 0.883 for functional dyspepsia and 0.927 for functional heartburn. The physician's clinical diagnosis of functional dyspepsia showed the most marked discrepancy with that based on the self-administered questionnaire. Almost all SF-36 domains were impaired in participants diagnosed with one of these FGIDs according to the Rome III-K. CONCLUSIONS We developed the Rome III-K questionnaire though structural translational processes, and it revealed good test-retest reliability and satisfactory construct validity. These results suggest that this instrument will be useful for clinical and research assessments in the Korean population.