Cited by 719Gastrointestinal motility and disordersPsychosomatic Disorders and Their TreatmentsGastroesophageal reflux and treatments

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Development and Validation of the Rome IV Diagnostic Questionnaire for Adults

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Palsson, Olafur S., Whitehead, William E., van Tilburg, Miranda A.L., Chang, Lin, Chey, William, Crowell, Michael D., Keefer, Laurie, Lembo, Anthony J., Parkman, Henry P., Rao, Satish S.C., Sperber, Ami, Spiegel, Brennan, Tack, Jan, Vanner, Stephen, Walker, Lynn S., Whorwell, Peter, Yang, Yunsheng·2016·Gastroenterology

DOI 10.1053/j.gastro.2016.02.014

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Abstract

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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Vork, L., Keszthelyi, D., van Kuijk, S. M. J., Quetglas, E. G., Törnblom, H., Simrén, M., Aziz, Q., Corsetti, M., Tack, J. F., Mujagic, Z., et al. (2020) · Clinical and Translational Gastroenterology · doi:10.14309/ctg.0000000000000209 · Cited by 28
Self-citation
Igg Food Antibody Guided Elimination-Rotation Diet Was More Effective than FODMAP Diet and Control Diet in the Treatment of Women with Mixed IBS—Results from an Open Label Study
Ostrowska, L., Wasiluk, D., Lieners, C., Gałęcka, M., Bartnicka, A., & Tveiten, D. (2021) · Journal of Clinical Medicine · doi:10.3390/jcm10194317 · Cited by 27
Vitamin D supplementation in people with IBS has no effect on symptom severity and quality of life: results of a randomised controlled trial
Williams, C. E., Williams, E. A., & Corfe, B. M. (2021) · European Journal of Nutrition · doi:10.1007/s00394-021-02633-w · Cited by 30
A starch‐ and sucrose‐reduced dietary intervention in irritable bowel syndrome patients produced a shift in gut microbiota composition along with changes in phylum, genus, and amplicon sequence variant abundances, without affecting the micro‐RNA levels
Nilholm, C., Manoharan, L., Roth, B., D’Amato, M., & Ohlsson, B. (2022) · United European Gastroenterology Journal · doi:10.1002/ueg2.12227 · Cited by 27
Work productivity and activity impairment in disorders of gut‐brain interaction: Data from the Rome Foundation Global Epidemiology Study
Frändemark, Å., Törnblom, H., Hreinsson, J. P., Andresen, V., Benninga, M. A., Corazziari, E. S., Fukudo, S., Mulak, A., Santos, J., Sperber, A. D., et al. (2023) · United European Gastroenterology Journal · doi:10.1002/ueg2.12425 · Cited by 27
Self-citation
Gut microbiota and irritable bowel syndrome
Zhao, Y., & Zou, D. (2023) · Journal of Digestive Diseases · doi:10.1111/1751-2980.13204 · Cited by 29
“into four subtypes, ie, constipation-predominant IBS (IBS-C), diarrheapredominant IBS (IBS-D), mixed-type IBS (IBS-M), and IBS unclassified.(3) The underlying etiology of IBS is not yet clear, though numerous factors have been reported to contribute to the pathogenesis of IBS,”
Background
Review article: A practical approach to persistent gastrointestinal symptoms in inflammatory bowel disease in remission
Aliu, A., Bosch, D. H. C. A., Keszthelyi, D., Ardabili, A. R., Colombel, J., Sawyer, R., Törnblom, H., Hart, A. L., Jonkers, D. M. A. E., Pierik, M. J., et al. (2024) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.17988 · Cited by 30
Bloating in Irritable Bowel Syndrome Is Associated with Symptoms Severity, Psychological Factors, and Comorbidities
Hod, K., Ringel, Y., van Tilburg, M. A. L., & Ringel‐Kulka, T. (2018) · Digestive Diseases and Sciences · doi:10.1007/s10620-018-5352-5 · Cited by 25
Sleep disturbances in children with functional gastrointestinal disorders: demographic and clinical characteristics
Jansen, J., Shulman, R. J., Ward, T. M., Levy, R. L., & Self, M. M. (2021) · Journal of Clinical Sleep Medicine · doi:10.5664/jcsm.9166 · Cited by 25
Cognitive behavioral treatment for irritable bowel syndrome: a recent literature review
Sugaya, N., Shirotsuki, K., & Nakao, M. (2021) · BioPsychoSocial Medicine · doi:10.1186/s13030-021-00226-x · Cited by 30
“Since its prevalence in the general population is as high as 5–10% [1], its associated medical and economic problems have also been pointed out [2].”
Background
Pros and Cons While Looking Through an Asian Window on the Rome IV Criteria for Irritable Bowel Syndrome: Pros
Ghoshal, U. C. (2017) · Journal of Neurogastroenterology and Motility · doi:10.5056/jnm17020 · Cited by 25
Impact of symptoms by gender and age in Japanese subjects with irritable bowel syndrome with constipation (IBS-C): a large population-based internet survey
Kosako, M., Akiho, H., Miwa, H., Kanazawa, M., & Fukudo, S. (2018) · BioPsychoSocial Medicine · doi:10.1186/s13030-018-0131-2 · Cited by 25
Detection and characteristics of rumination syndrome in patients presenting for gastric symptom evaluation
Murray, H., Pasricha, T., Jehangir, A., Thomas, J., Kuo, B., & Parkman, H. (2021) · Neurogastroenterology and Motility · doi:10.1111/nmo.14103 · Cited by 4
Self-citation
Irritable bowel syndrome and diet
Dimidi, E., Rossi, M., & Whelan, K. (2017) · Current Opinion in Clinical Nutrition & Metabolic Care · doi:10.1097/mco.0000000000000416 · Cited by 25
Prevalence and impact of faecal incontinence among individuals with Rome IV irritable bowel syndrome
Goodoory, V. C., Ng, C. E., Black, C. J., & Ford, A. C. (2023) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.17465 · Cited by 25
Drugs under development for the treatment of functional dyspepsia and related disorders
Tack, J. F., Masuy, I., den Houte, K. V., Wauters, L. I., Schol, J., Vanuytsel, T., Vandenberghe, A., & Carbone, F. (2019) · Expert Opinion on Investigational Drugs · doi:10.1080/13543784.2019.1673365 · Cited by 23
Self-citation
Associations among neurophysiology measures in irritable bowel syndrome (IBS) and their relevance for IBS symptoms
Midenfjord, I., Polster, A. V., Sjövall, H., Friberg, P., Törnblom, H., & Simrén, M. (2020) · Scientific Reports · doi:10.1038/s41598-020-66558-w · Cited by 24
Irritable Bowel Syndrome: Prevalence and Risk Factors in Jazan Region, Saudi Arabia
Arishi, A. M., Elmakki, E. E., Hakami, O., Alganmy, O. M., Maashi, S. M., Al-Khairat, H. K., Sahal, Y. A., Sharif, A., & Alfaifi, M. H. (2021) · Cureus · doi:10.7759/cureus.15979 · Cited by 26
“The Rome IV questionnaire evaluates several functional GI disorders, including IBS [4].”
BackgroundMethod
Augmenting Diaphragmatic Breathing With Behavioral Exposure: Single-Case Experimental Design for Rumination Disorder
Murray, H. B., Juarascio, A. S., & Thomas, J. J. (2020) · Cognitive and Behavioral Practice · doi:10.1016/j.cbpra.2019.12.001 · Cited by 23
The Prevalence and Burden of Avoidant/Restrictive Food Intake Disorder Symptoms in Adults With Disorders of Gut-Brain Interaction: A Population-Based Study
Flack, R., Brownlow, G., Murray, H. B., Pálsson, Ó., & Aziz, I. (2025) · Gastroenterology · doi:10.1053/j.gastro.2025.07.043 · Cited by 24
Factor Analysis Defines Distinct Upper and Lower Gastrointestinal Symptom Groups Compatible With Rome IV Criteria in a Population-based Study
Clevers, E., Whitehead, W. E., Palsson, O. S., Sperber, A. D., Törnblom, H., Oudenhove, L. V., Tack, J. F., & Simrén, M. (2018) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2018.02.042 · Cited by 23
Self-citation
Review article: Diagnosis and investigation of irritable bowel syndrome
Black, C. J. (2021) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.16597 · Cited by 24
Prevalence and associated factors of disorders of gut‐brain interaction in the United States: Comparison of two nationwide Internet surveys
Palsson, O. S., Sperber, A. D., Bangdiwala, S. I., & Whitehead, W. E. (2023) · Neurogastroenterology & Motility · doi:10.1111/nmo.14564 · Cited by 24
Self-citation
A Starch- and Sucrose-Reduced Diet Has Similar Efficiency as Low FODMAP in IBS—A Randomized Non-Inferiority Study
Roth, B., Nseir, M., Jeppsson, H., D’Amato, M., Sundquist, K., & Ohlsson, B. (2024) · Nutrients · doi:10.3390/nu16173039 · Cited by 23
Efficacy of acupuncture for the treatment of Parkinson’s disease-related constipation (PDC): A randomized controlled trial
Li, Y.-J., Leong, I.-I., Fan, J.-Q., Yan, M.-Y., Liu, X., Lu, W.-J., Chen, Y.-Y., Tan, W.-Q., Wang, Y.-T., & Zhuang, L.-X. (2023) · Frontiers in Neuroscience · doi:10.3389/fnins.2023.1126080 · Cited by 26
Early adverse life events and post‐traumatic stress disorder in patients with constipation and suspected disordered defecation
Hendrix, J. R., Ranginani, D., Montero, A. M., Lockett, C. J., Xu, H., James-Stevenson, T. N., & Shin, A. (2021) · Neurogastroenterology & Motility · doi:10.1111/nmo.14195 · Cited by 22
Associations of Food Intolerance with Irritable Bowel Syndrome, Psychological Symptoms, and Quality of Life
Jansson‐Knodell, C. L., White, M. K., Lockett, C. J., Xu, H., & Shin, A. (2021) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2021.12.021 · Cited by 26
A postbiotic fermented oat gruel may have a beneficial effect on the colonic mucosal barrier in patients with irritable bowel syndrome
Bednarska, O., Biskou, O., Israelsen, H., Winberg, M. E., Walter, S., & Keita, Å. V. (2022) · Frontiers in Nutrition · doi:10.3389/fnut.2022.1004084 · Cited by 23
The prevalence and burden of Rome IV faecal incontinence in ulcerative colitis: A cross‐sectional study
Vasant, D. H., Nigam, G. B., Bate, S. G., Hamdy, S., & Limdi, J. K. (2023) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.17502 · Cited by 22
Impact of auricular percutaneous electrical nerve field stimulation on gut microbiome in adolescents with irritable bowel syndrome: A pilot study
Bora, G., Atkinson, S. N., Pan, A., Sood, M., Salzman, N. H., & Karrento, K. (2023) · Journal of Digestive Diseases · doi:10.1111/1751-2980.13203 · Cited by 22
The aging gastrointestinal tract: Epidemiology and clinical significance of disorders of gut‐brain interaction in the older general population
Sperber, A. D., Freud, T., Palsson, O. S., Bangdiwala, S. I., & Simrén, M. (2024) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.18103 · Cited by 22
Self-citation
The prevalence and characteristics of complementary medicine use by Australian and American adults living with gastrointestinal disorders: A systematic review
Gan, W. C., Smith, L. D., Luca, E., & Harnett, J. (2018) · Complementary Therapies in Medicine · doi:10.1016/j.ctim.2018.08.016 · Cited by 23
Rome IV Diagnostic Questionnaire Complements Patient Assessment of Gastrointestinal Symptoms for Patients with Gastroparesis Symptoms
Jehangir, A., & Parkman, H. P. (2018) · Digestive Diseases and Sciences · doi:10.1007/s10620-018-5125-1 · Cited by 24
Self-citation
Worldwide population prevalence and impact of sub‐diagnostic gastrointestinal symptoms
Palsson, O. S., Tack, J. F., Drossman, D. A., Nevé, B. L., Quinquis, L., Hassouna, R., Ruddy, J., Morris, C. B., Sperber, A. D., Bangdiwala, S. I., et al. (2024) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.17894 · Cited by 21
Self-citation
A combination of fecal calprotectin and human beta-defensin 2 facilitates diagnosis and monitoring of inflammatory bowel disease
Gaćeša, R., Vila, A. V., Collij, V., Mujagic, Z., Kurilshikov, A., Voskuil, M. D., Festen, E. A. M., Wijmenga, C., Jonkers, D. M. A. E., Dijkstra, G. D. H., et al. (2021) · Gut Microbes · doi:10.1080/19490976.2021.1943288 · Cited by 21
Efficacy of FODMAP Elimination and Subsequent Blinded Placebo-Controlled Provocations in a Randomised Controlled Study in Patients with Ulcerative Colitis in Remission and Symptoms of Irritable Bowel Syndrome: A Feasibility Study
Melgaard, D., Sørensen, J., Riis, J., Ovesen, T. S., Leutscher, P. D. C., Sørensen, S., Knudsen, J. K., Bundgaard‐Nielsen, C., Ejstrup, J., Jensen, A.-M., et al. (2022) · Nutrients · doi:10.3390/nu14061296 · Cited by 24
“Calculations of daily FODMAP intake were performed using the FODMAP calculator from Monash University [18].”
Method
Latent class analysis does not support the existence of Rome IV functional bowel disorders as discrete entities
Black, C. J., Houghton, L. A., & Ford, A. C. (2022) · Neurogastroenterology & Motility · doi:10.1111/nmo.14391 · Cited by 21

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: Palsson, Olafur S.
Whitehead, William E.
Chang, Lin
Chey, William
Crowell, Michael D.
Keefer, Laurie
Lembo, Anthony J.
Parkman, Henry P.
Rao, Satish S.C.
Sperber, Ami
Spiegel, Brennan
Tack, Jan
Vanner, Stephen
Walker, Lynn S.
Whorwell, Peter
Yang, Yunsheng
Venue: Gastroenterology
Publisher: Elsevier BV
Published: 2016-05
Volume: 150
Issue: 6
Pages: 1481-1491
ISSN: 0016-5085 (ISSN-L)
DOI: 10.1053/j.gastro.2016.02.014
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
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
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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Development and Validation of the Rome IV Diagnostic Questionnaire for Adults

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