Validating Simple Modifications to the Rome IV Criteria for the Diagnosis of Irritable Bowel Syndrome in Secondary Care.

Abstract

The Rome IV criteria for irritable bowel syndrome (IBS) may be too restrictive for clinical practice and research. To validate the Rome IV criteria and study the diagnostic performance of simple modifications to them. We collected symptom data from consecutive adults with suspected IBS seen in a single clinic. We used a reference standard to confirm IBS (presence of lower abdominal pain associated with altered stool form or frequency; no evidence of organic gastrointestinal disease after limited investigation). We applied Rome IV criteria, but also two modifications. First, we re-incorporated abdominal discomfort but kept symptom frequency required for both abdominal pain and discomfort to at least 1 day per week. Second, we included only abdominal pain but relaxed symptom frequency back to 3 days per month. We calculated sensitivity, specificity and positive and negative likelihood ratios (LRs), with 95% confidence intervals (CIs), for each diagnostic criterion. We recruited 170 patients (76.5% female, mean age 37.9 years). Sensitivity and specificity of the Rome IV criteria were 82.1% and 85.1%, respectively; positive and negative LRs were 5.51 (95% CI 2.95-11.3) and 0.21 (95% CI 0.14-0.31), respectively. Modifying the criteria by relaxing the frequency of abdominal pain to 3 days per month led to the best performance [sensitivity 90.2%, specificity 85.1%, positive LR 6.06 (95% CI 3.25-12.2), and negative LR 0.11 (95% CI 0.07-0.19)]. The Rome IV criteria performed well in diagnosing IBS. A simple modification relaxing the required frequency of abdominal pain improved their performance.