Comparison of demographic, clinical, and psychological characteristics among patients with irritable bowel syndrome meeting the Rome clinical, Rome V, and Rome IV criteria

BACKGROUND: The Rome clinical criteria for irritable bowel syndrome (IBS) were introduced to improve clinical applicability and represent an important advancement within the Rome V process. However, their clinical profiles relative to the standard Rome criteria remain unclear. METHODS: Consecutive adults with suspected IBS were prospectively recruited at a tertiary outpatient clinic in China. Participants completed symptom questionnaires and underwent clinical investigations to exclude organic disease. Patients were classified into three mutually exclusive groups: meeting Rome clinical criteria only, meeting Rome V only, and meeting Rome IV. We examined diagnostic discordance and compared demographic, clinical, and psychological characteristics across the three groups. RESULTS: Among 685 participants with suspected IBS, 533 (77.8%) met the Rome clinical criteria, 443 (64.7%) met Rome V, and 238 (34.7%) met Rome IV. The Rome IV criteria missed nearly half (46.3%) of Rome V-defined patients. Of those identified by the Rome clinical criteria, 90 (20.3%) were not captured by the Rome V criteria, primarily due to insufficient symptom duration (51.1%) and inadequate symptom frequency (48.9%). These missed patients showed gastrointestinal symptom severity, psychological burden (gastrointestinal-specific anxiety, somatic symptoms, and perceived stress), quality of life impairment, and healthcare utilization comparable to those meeting Rome V only, while both groups were less severe than Rome IV-defined patients (P < 0.001). DISCUSSION: The Rome clinical criteria identify a clinically meaningful IBS population, with approximately one in five individuals missed by the Rome V criteria. These patients have a disease burden comparable to those meeting the Rome V criteria only.