Gastroenterology

Gastroenterology

Volume 145, Issue 6, December 2013, Pages 1262-1270.e1
Gastroenterology

Original Research
Full Report: Clinical—Alimentary Tract
Validation of the Rome III Criteria for the Diagnosis of Irritable Bowel Syndrome in Secondary Care

https://doi.org/10.1053/j.gastro.2013.08.048Get rights and content

Background & Aims

There are few validation studies of existing diagnostic criteria for irritable bowel syndrome (IBS). We conducted a validation study of the Rome and Manning criteria in secondary care.

Methods

We collected complete symptom, colonoscopy, and histology data from 1848 consecutive adult patients with gastrointestinal symptoms at 2 hospitals in Hamilton, Ontario; the subjects then underwent colonoscopy. Assessors were blinded to symptom status. Individuals with normal colonoscopy and histopathology results, and no evidence of celiac disease, were classified as having no organic gastrointestinal disease. The reference standard used to define the presence of true IBS was lower abdominal pain or discomfort in association with a change in bowel habit and no organic gastrointestinal disease. Sensitivity, specificity, and positive and negative likelihood ratios, with 95% confidence intervals, were calculated for each diagnostic criteria.

Results

In identifying patients with IBS, sensitivities of the criteria ranged from 61.9% (Manning) to 95.8% (Rome I), and specificities from 70.6% (Rome I) to 81.8% (Manning). Positive likelihood ratios ranged from 3.19 (Rome II) to 3.39 (Manning), and negative likelihood ratios from 0.06 (Rome I) to 0.47 (Manning). The level of agreement between diagnostic criteria was greatest for Rome I and Rome II (κ = 0.95), and lowest for Manning and Rome III (κ = 0.59).

Conclusions

Existing diagnostic criteria perform modestly in distinguishing IBS from organic disease. There appears to be little difference in terms of accuracy. More accurate ways of diagnosing IBS, avoiding the need for investigation, are required.

Section snippets

Participants and Setting

The study was conducted among all individuals newly referred from primary care to secondary care for consideration of investigation of GI symptoms. Unselected consecutive new patients aged 16 years and older were approached in the GI outpatient clinics of McMaster University Medical Center or St Joseph's Healthcare, 2 hospitals in Hamilton, Ontario serving a local population of 520,000. From January 2012 to December 2012, 26% of the referrals were tertiary care in nature. There were no

Results

There were a total of 4224 consecutive patients who gave informed consent and were recruited in to the study between January 2008 and December 2012 (Figure 1). Mean age of recruited subjects was 47.6 years (range, 16−93 years) and 2617 (62.0%) were female. In total, 1981 (46.9%) of these 4224 patients underwent complete colonoscopic evaluation for their lower GI symptoms. Mean age among those undergoing colonoscopy was 49.3 years (range, 16−90 years), and 1251 (63.1%) were female.

Discussion

This study has attempted to validate the Rome III criteria for IBS against an accepted reference standard and to compare their performance against all previous symptom-based diagnostic criteria. It has demonstrated that the presence of the Rome III criteria in a patient with lower GI symptoms increases the likelihood of having IBS >3-fold, and their absence reduces the likelihood of IBS by 60%. These LRs mean that the Rome III criteria performed only modestly in predicting a diagnosis of IBS,

Acknowledgments

The authors are grateful to June Urquhart for entry of questionnaire data and administering questionnaires to patients attending clinic, and Sandra Arthur for administering questionnaires to patients attending clinic.

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  • Cited by (0)

    This article has an accompanying continuing medical education activity on page e15. Learning Objective: Upon completion of this CME activity, successful learners will be able to recognize organic conditions that may be mistaken for irritable bowel syndrome, as well as judge the utility of the Rome III criteria for the diagnosis of irritable bowel syndrome.

    Conflicts of interest The authors disclose no conflicts.

    Funding Supported by the Canadian Association of Gastroenterology (the study sponsor had no role in the study design, collection, analysis, or interpretation of data).

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