The DOI matches its Crossref record, with a small difference in title or year; 19 of the 19 references it cites were found in a registry or an index.
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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“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]
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In the citing paper
“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]
In the citing paper
“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]
In the citing paper
“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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Citations
Cites
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The PHQ-15: Validity of a New Measure for Evaluating the Severity of Somatic Symptoms
Kroenke, K., Spitzer, R. L., & Williams, J. B. W. (2002) · Psychosomatic Medicine · doi:10.1097/00006842-200203000-00008 · Cited by 3,415
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Sheth, A. (2007) · Journal of Clinical Gastroenterology · doi:10.1097/mcg.0b013e31804bbe26 · Cited by 1,974
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Predictive Value of The Rome Criteria for Diagnosing The Irritable Bowel Syndrome
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Self-citationWong, R. K., Palsson, O. S., Turner, M. J., Levy, R. L., Feld, A. D., von Korff, M., & Whitehead, W. E. (2010) · American Journal of Gastroenterology · doi:10.1038/ajg.2010.200 · Cited by 204
Self-citationHeidelbaugh, J. J., Stelwagon, M., Miller, S. A., Shea, E. P., & Chey, W. D. (2015) · The American Journal of Gastroenterology · doi:10.1038/ajg.2015.67 · Cited by 159
Self-citationFord, A., Talley, N., van Zanten, S. V., Vakil, N., Simel, D., & Moayyedi, P. (2008) · Journal of the American Medical Association (JAMA) · doi:10.1001/jama.300.15.1793 · Cited by 132
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Utility of red flag symptom exclusions in the diagnosis of irritable bowel syndrome
WHITEHEAD, W. E., PALSSON, O. S., FELD, A. D., LEVY, R. L., VON KORFF, M., TURNER, M. J., & DROSSMAN, D. A. (2006) · Alimentary Pharmacology & Therapeutics · doi:10.1111/j.1365-2036.2006.02956.x · Cited by 118
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Sjödahl, J., Ingemansson, A., & Walter, S. (2026) · Neurogastroenterology & Motility · doi:10.1111/nmo.70403
“Current criteria for pediatric functional constipation even incorporate FI within the diagnosis and distinguish this from non-retentive FI [14, 15].”
Armstrong, J., Morley, S., & Utter, J. (2026) · American Journal of Lifestyle Medicine · doi:10.1177/15598276261472814
Sjölund, J., Hreinsson, J. P., Lacy, B. E., Törnblom, H., Bangdiwala, S. I., Palsson, O. S., Sperber, A. D., & Simrén, M. (2026) · United European Gastroenterology Journal · doi:10.1002/ueg2.70269
Self-citationThongchuenjit, S., Luo, X., Yuan, H., Li, Q., Zhang, X., Liu, X., & Wu, J. (2026) · Revista Española de Enfermedades Digestivas · doi:10.17235/reed.2026.12014/2026
Serum Ferritin and Inflammation in Isolated REM Sleep Behavior Disorder
Yin, W., Zhang, X., Ren, J., Mi, H., Zong, Q., Wing, Y. K., Xu, Y., & Zhou, J. (2026) · Neurology · doi:10.1212/wnl.0000000000218173
Baig, M., Alhammad, M. A., Alghamdi, W., Abualhamael, S. A., Alzahrani, A. H. J., Alharbi, A. A., AlHassan, K. J., Alsagoor, D. M., Alyoubi, B. H., Alkaabi, T., et al. (2026) · Frontiers in Public Health · doi:10.3389/fpubh.2026.1866985
Altuwayjiri, R., Martin, L. D., Zárate-López, N., Vari, C., Topan, R., Aziz, Q., & Fikree, A. (2026) · Neurogastroenterology & Motility · doi:10.1111/nmo.70417
Raymenants, K., de Bruaene, C. V., Jandee, S., Everaert, M., Sperber, A. D., Pálsson, Ó., Bangdiwala, S. I., Khatun, R., Rommel, N., Vanuytsel, T., et al. (2026) · United European Gastroenterology Journal · doi:10.1002/ueg2.70277
“Prevalence was assessed per continent, using the Rome IV questionnaire [22], as were baseline characteristics (age, sex, education, living area, country, height, weight, BMI).”
Self-citationIşık, G., Işık, C. M., & Öztürk, M. (2026) · European Journal of Pediatrics · doi:10.1007/s00431-026-07385-5
“Functional chronic constipation questionnaire based on Rome IV criteria, along with Bris-tol stool scale, were applied for patient group [22, 23].”
Jo, D., Farahmand, Y., Friedman, K., Shepherd, J. M., Garey, L., Redmond, B. Y., Rogers, A. H., Bradford, A., Lackner, J. M., Zvolensky, M. J., et al. (2026) · Journal of Dual Diagnosis · doi:10.1080/15504263.2026.2726789
Schipper, R. M., Heusschen, L., Schepers, L., Verstraete, F. F., Hazebroek, E. J., Kampman, E., & Berendsen, A. A. M. (2026) · BMJ Open · doi:10.1136/bmjopen-2026-119119
Mansouri, K., Hanh, T., Meyer, R., & Hahn, A. (2026) · Frontiers in Nutrition · doi:10.3389/fnut.2026.1924028
Xia, Y., Cai, Y., Zhang, Y., Cai, R., Liu, H., & Qiang, Z. (2026) · Food Science & Nutrition · doi:10.1002/fsn3.72370
“Even according to the Rome IV diagnostic criteria, FC remains a heterogeneous condition with marked differences in etiology and response to treatment (Palsson et al. 2016).”
El‐Chammas, K. I., Hagenstein, L., Chogle, A. S., Santucci, N. R., Graham, K., Dorfman, L., Kelly, D. R., Dranove, J. E., Rosen, R., Nurko, S., et al. (2026) · Neurogastroenterology & Motility · doi:10.1111/nmo.70447
Ayurvedic management of Spastic perineum syndrome with special reference to Vibandha: A case study
Rohit, N. R., Lekurwale, C. V., & Kumar, K. S. P. (2026) · Journal of Ayurveda Case Reports · doi:10.4103/jacr.jacr_29_26
Olsen, B. C., Hagen, M., Opheim, R., Kristensen, V. A., Lund, C. I., Aabrekk, T. B., Johansen, I., Holten, K. I. A., Strande, V., Glad, I. F., et al. (2026) · Inflammatory Bowel Diseases · doi:10.1093/ibd/izag196
Hod, K., Marasco, G., Colecchia, L., Sperber, A. D., Palsson, O. S., Bangdiwala, S. I., & Barbara, G. (2026) · Diabetes/Metabolism Research and Reviews · doi:10.1002/dmrr.70243
Self-citationGils, T. V., Törnblom, H., van Overveld, F. W. P. C., Palsson, O. S., Sperber, A. D., Bangdiwala, S. I., Trindade, I. A., Benninga, M. A., Bouma, G., & Simrén, M. (2026) · United European Gastroenterology Journal · doi:10.1002/ueg2.70311
Self-citationvon Mühlenbrock, C., Pacheco, N., Santos, N., Carbone, F., Tack, J., Madrid, A. M., & Vanuytsel, T. (2026) · Neurogastroenterology & Motility · doi:10.1111/nmo.70472
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Metadata
- 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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