Optimization of Rome IV Diagnostic Criteria Based on Symptom Spectrum in the Chinese Constipated Patients

This study aims to systematically investigate the symptom spectrum of Chinese constipated patients, and to evaluate the diagnosis performance and clinical applicability of Rome IV criteria in Chinese.

Unselected outpatients (aged ≥ 16 years) who had a self-diagnosis of "constipation" were enrolled and administered the Rome IV questionnaire. Data on demographics, stool forms, defecation symptoms and frequencies were collected. Healthy controls (aged ≥ 16 years) were recruited to gather their demographics and defecation pattern data. The consistency of Rome IV criteria with respondents' self-assessment was evaluated and modifications were proposed based on newly-established thresholds.

A total of 6364 respondents with self-diagnosis of constipation and 1432 healthy controls were included. Among constipated individuals, the most prevalent bowel symptoms matched the six Rome IV diagnostic symptom indicators. However, Rome IV criteria manifested poor consistency with self-assessment (κ = 0.58, p < 0.001). To minimize the discrepancy between Rome IV criteria and self-assessment, we established clinically meaningful thresholds using the 90th percentile of symptom distribution in healthy controls. We made a comparative analysis and found that the diagnostic approach requiring ≥ 2 abnormal symptoms had the highest consistency (κ = 0.85, p < 0.001).

The standard Rome IV criteria demonstrated suboptimal performance in diagnostic consistency within the Chinese population. Our modified 2-symptom diagnostic framework significantly enhanced all performance metrics, offering a more tailored approach for constipation diagnosis in the Chinese population.