Comparison of the Rome IV criteria with the Rome III criteria for the diagnosis of irritable bowel syndrome in secondary care
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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.
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Up to 50% of patients who believe they have IBS will no longer meet criteria for the condition when moving from Rome III to Rome IV.
“up to 50% of patients who believe they have IBS will no longer meet criteria for the condition.”
From British Society of Gastroenterology guidelines on the management of irritable bowel syndrome (2021) · cites this paper as [21]
The Introduction says Rome IV tightened the symptom requirements, and the Results report that some patients meeting Rome III did not meet Rome IV. But the paper does not report that up to 50% of patients who believe they have IBS lose eligibility; it studied a secondary-care referral population, not patients identified by that belief. (LLM, conf=0.84)
Experimental — accuracy not yet measuredPatients meeting the Rome IV criteria were 21 times more likely to have IBS-C than to not have IBS-C, and 11 times more likely to have IBS-M than to not have IBS-M after limited diagnostic workup.
“Patients meeting these criteria were 21 times more likely to have IBS-C than to not have IBS-C, and 11 times more likely to have IBS-M than to not have IBS-M after limited diagnostic workup.”
From British Society of Gastroenterology guidelines on the management of irritable bowel syndrome (2021) · cites this paper as [21]
The Validation of the Rome IV Criteria for IBS section reports positive likelihood ratios of 25.7 for IBS with constipation and 10.6 for IBS with mixed bowel habits; the latter is approximately 11, but the former is not 21. The Introduction’s figure of 21 concerns IBS overall in an earlier validation study, not IBS-C in this study. The Investigative Work-up section describes a standardised but non-exhaustive work-up. (LLM, conf=0.89)
Experimental — accuracy not yet measuredA validation study of the Rome IV criteria in secondary care demonstrated that the diagnosis of IBS was particularly secure for IBS-C and IBS-M.
“A validation study of the Rome IV criteria in secondary care demonstrated this was particularly the case for IBS-C and IBS-M.21”
From British Society of Gastroenterology guidelines on the management of irritable bowel syndrome (2021) · cites this paper as [21]
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- Authors
- Black, C. J., Craig, O., Gracie, D. J., & Ford, A. C.
- Affiliations
- University of Leeds (GB)
- Leeds Teaching Hospitals NHS Trust (GB)
- Corresponding author
- Ford, Alexander C
- Venue
- Gut
- Publisher
- BMJ
- Published
- 2020-09-24
- Volume
- 70
- Issue
- 6
- Pages
- 1110-1116
- ISSN
- 0017-5749 (ISSN-L)
- 1468-3288
- OpenAlex
- W3089239219
- Cited by
- 86
- References
- 55
- Citations by year
- 2026: 10 · 2025: 12 · 2024: 14 · 2023: 10 · 2022: 21 · 2021: 15 · 2020: 2
- FWCI
- 10.42
- Type
- journal article
- Language
- en
- Open access
- Locations
- Gut (publishedVersion)
- PubMed (publishedVersion)
- White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
- Topics
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Health Sciences › Health Professions › Pharmacy › Infant Health and Development
- Health Sciences › Medicine › Rheumatology › Pelvic floor disorders treatments
- Keywords
- irritable bowel syndrome, Rome IV criteria, Rome III criteria, diagnostic criteria validation, diagnostic accuracy, sensitivity and specificity, likelihood ratios, irritable bowel syndrome with constipation, mood symptoms, extraintestinal manifestations
- MeSH terms
- Adult, Constipation, Diarrhea, Female, Humans, Male, Middle Aged, Sensitivity and Specificity, Abdominal Pain, Likelihood Functions, Irritable Bowel Syndrome, Secondary Care, Secondary Health Care, Symptom Assessment
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