Objectives Despite being proposed 4 years ago, there has been no independent validation study of the Rome IV criteria for IBS. We assessed their performance for the diagnosis of IBS in secondary care and compared them with the previous iteration, the Rome III criteria.
Design We collected complete symptom data from consecutive adult patients with suspected IBS referred to a single UK clinic. All subjects underwent relatively standardised workup, with assessors blinded to symptom status. The reference standard used to confirm IBS was the presence of lower abdominal pain or discomfort in association with altered stool form or frequency, in a patient with no evidence of organic gastrointestinal disease after investigation. Sensitivity, specificity and positive and negative likelihood ratios (LRs), with 95% CIs, were calculated for each of the diagnostic criteria.
Results The level of agreement between the Rome IV and Rome III criteria was good (kappa=0.65). Compared with the reference standard, sensitivity and specificity of the Rome IV criteria in 572 patients (431 (75.3%) women, mean age 36.5 years) were 82.4% and 82.9%, respectively. Positive and negative LRs for the Rome IV criteria were 4.82 (95% CI 3.30 to 7.28) and 0.21 (95% CI 0.17 to 0.26), respectively. The Rome IV criteria performed best in those with IBS with constipation or mixed bowel habits. In 471 patients (350 (74.3%) women, mean age 36.7 years), compared with the reference standard, the sensitivity and specificity of the Rome III criteria were 85.8% and 65.0%; positive and negative LRs were 2.45 (95% CI 1.90 to 3.27) and 0.22 (0.16 to 0.29), respectively. Incorporating mood and extraintestinal symptom reporting into diagnostic criteria did not improve their performance significantly.
Conclusions The Rome IV criteria performed significantly better than the Rome III criteria in diagnosing IBS in this single centre secondary care study, although the clinical relevance of this is uncertain.
- irritable bowel syndrome
- abdominal pain
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Contributors CB, OC, DJG, and ACF conceived and drafted the study. ACF and CB collected all data. ACF analysed and interpreted the data. ACF drafted the manuscript. All authors have approved the final draft of the manuscript.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement No additional data available.
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