Development and Validation of the Rome IV Diagnostic Questionnaire for Adults
Open accessAbstract
The Rome IV Diagnostic Questionnaires were developed to screen for functional gastrointestinal disorders (FGIDs), serve as inclusion criteria in clinical trials, and support epidemiological surveys. Separate questionnaires were developed for adults, children/adolescents, and infants/toddlers. For the adult questionnaire, we first surveyed 1,162 adults without gastrointestinal disorders, and recommended the 90 th percentile symptom frequency as the threshold for defining what is abnormal. Diagnostic questions were formulated and verified with clinical experts using a recursive process. The diagnostic sensitivity of the questionnaire was tested in 843 patients from 9 gastroenterology clinics, with a focus on clinical diagnoses of irritable bowel syndrome (IBS), functional constipation (FC), and functional dyspepsia (FD). Sensitivity was 62.7% for IBS, 54.7% for FD, and 32.2% for FC. Specificity, assessed in a population sample of 5,931 adults, was 97.1% for IBS, 93.3% for FD, and 93.6% for FC. Excess overlap among IBS, FC, and FD was a major contributor to reduced diagnostic sensitivity, and when overlap of IBS with FC was permitted, sensitivity for FC diagnosis increased to 73.2%. All questions were understandable to at least 90% of individuals, and Rome IV diagnoses were reproducible in ¾ of patients after one month. Validation of the pediatric questionnaires is ongoing.
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The Rome IV criteria are potentially more specific than Rome III.
“This feature makes the Rome IV criteria potentially more specific than Rome III.”
From British Society of Gastroenterology guidelines on the management of irritable bowel syndrome (2021) · cites this paper as [9]
In the IBS sensitivity analysis (page unavailable), the paper says Rome IV uses the more restrictive requirement of abdominal pain rather than Rome III’s abdominal pain or discomfort. It also estimates Rome IV specificity in a population survey, but the passages do not compare Rome IV and Rome III specificity, so they do not establish that Rome IV is more specific. (LLM, conf=0.78)
Experimental — accuracy not yet measuredThe change in minimum frequency of abdominal pain reflected findings of a normative survey showing that adopting a higher threshold would lead to fewer healthy people in the general population being misclassified as having IBS.
“This change reflected the findings of a normative survey showing that adopting a higher threshold for the frequency of abdominal pain required to meet criteria for IBS would lead to fewer healthy people in the general population being misclassified as having IBS, 9 and therefore risk being 'medicalised', and having to take drugs for the condition.”
From British Society of Gastroenterology guidelines on the management of irritable bowel syndrome (2021) · cites this paper as [9]
Our study should not be extrapolated to the other EDS subtypes, such as vascular EDS, which have recognised and potentially catastrophic gastrointestinal complications.
“Our study should also not be extrapolated to the other EDS subtypes, such as vascular EDS, which have recognised and potentially catastrophic gastrointestinal complications. 14”
From Rome IV Functional Gastrointestinal Disorders and Health Impairment in Subjects With Hypermobility Spectrum Disorders or Hypermobile Ehlers-Danlos Syndrome (2021) · cites this paper as [14]
An international consortium published updated guidelines in 2017, whereby far more stringent criteria will hopefully improve the diagnostic specificity of hEDS and allow clear distinction from HSD.
“To overcome these issues, an international consortium published updated guidelines in 2017, whereby far more stringent criteria will hopefully improve the diagnostic specificity of hEDS and allow clear distinction from HSD. 14,15”
From Rome IV Functional Gastrointestinal Disorders and Health Impairment in Subjects With Hypermobility Spectrum Disorders or Hypermobile Ehlers-Danlos Syndrome (2021) · cites this paper as [14]
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- Authors
- Palsson, O. S., Whitehead, W. E., van Tilburg, M. A. L., Chang, L., Chey, W., Crowell, M. D., Keefer, L., Lembo, A. J., Parkman, H. P., Rao, S. S. C., Sperber, A., Spiegel, B., Tack, J., Vanner, S., Walker, L. S., Whorwell, P., & Yang, Y.
- Affiliations
- University of North Carolina at Chapel Hill (US)
- University of California, Los Angeles (US)
- Michigan Medicine (US)
- Mayo Clinic in Arizona (US)
- Northwestern University (US)
- Harvard University (US)
- Temple University (US)
- Augusta University (US)
- KU Leuven (BE)
- Kingston General Hospital (CA)
- Vanderbilt University Medical Center (US)
- Chinese PLA General Hospital (CN)
- Corresponding author
- Palsson, Olafur S.
- ORCID
- Venue
- Gastroenterology
- Publisher
- Elsevier BV
- Published
- 2016-05
- Volume
- 150
- Issue
- 6
- Pages
- 1481-1491
- ISSN
- 0016-5085 (ISSN-L)
- OpenAlex
- W2344547018
- Cited by
- 719
- References
- 19
- Citations by year
- 2026: 79 · 2025: 99 · 2024: 92 · 2023: 88 · 2022: 70 · 2021: 92 · 2020: 76 · 2019: 41 · 2018: 46 · 2017: 24 · 2016: 10
- FWCI
- 43.99
- Type
- journal article
- Language
- en
- Open access
- green
- doi.org
- Locations
- Gastroenterology (publishedVersion)
- PubMed (publishedVersion)
- Research Explorer (The University of Manchester) (publishedVersion)
- Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
- UNC Libraries
- Topics
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Health Sciences › Medicine › Psychiatry and Mental health › Psychosomatic Disorders and Their Treatments
- Health Sciences › Medicine › Gastroenterology › Gastroesophageal reflux and treatments
- Keywords
- Rome IV criteria, functional gastrointestinal disorders, irritable bowel syndrome, functional constipation, functional dyspepsia, sensitivity and specificity, diagnostic overlap, reproducibility, questionnaire validation, adults
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