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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The Digestive Health among Participants of the Woodstock Rock Festival in Poland—A Cross-Sectional Survey
Skonieczna‐Żydecka, K., Stachowska, E., Maciejewska, D., Ryterská, K., Palma, J., Czerwińska-Rogowska, M., Kaczmarczyk, M., Gudan, A., Mruk, H., Świniarska, B., et al. (2018) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph15102256 · Cited by 7
“Nevertheless, studies evaluating the worldwide prevalence of FGID sufferers using most recent ROME IV criteria, report the drop down of IBS to 5–6%.”
BackgroundInfluential
Reizdarmbehandlung mit Lactobacillus plantarum 299v: Längere Einnahme verstärkt Behandlungserfolg – Ergebnisse einer nichtinterventionellen Studie
Krammer, H., Storr, M., Madisch, A., & Riffel, J. (2021) · Zeitschrift für Gastroenterologie · doi:10.1055/a-1340-0204 · Cited by 7
Characterizing clinical features and location‐specific gene expression profiles associated with pain burden in children with functional dyspepsia
Mokha, J. S., Hyams, J. S., Glidden, N. C., Balarezo, F., & Young, E. E. (2021) · Neurogastroenterology & Motility · doi:10.1111/nmo.14185 · Cited by 7
Making a Confident Diagnosis of Irritable Bowel Syndrome
Goldstein, R. S., & Cash, B. D. (2021) · Gastroenterology Clinics of North America · doi:10.1016/j.gtc.2021.03.004 · Cited by 7
Current Incidence and Risk Factors of Fecal Incontinence After Acute Stroke Affecting Functionally Independent People
Lucente, G., Corral, J., Rodríguez‐Esparragoza, L., Castañer, S., Ortiz, H., Piqueras, A., Broto, J., Hernández‐Pérez, M., Domènech, S., Martínez‐Piñeiro, A., et al. (2021) · Frontiers in Neurology · doi:10.3389/fneur.2021.755432 · Cited by 7
Influence of Irritable Bowel Syndrome on Stress and Depressive Symptoms in Nurses: The Korea Nurses’ Health Study
Kim, O., Cha, C., Jeong, H., Cho, M., & Kim, B. (2021) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph182312324 · Cited by 7
Frequency and severity of irritable bowel syndrome in cigarette smokers, Turkey 2019
Başpınar, M. M., & Basat, O. (2022) · Tobacco Induced Diseases · doi:10.18332/tid/145925 · Cited by 7
A Starch- and Sucrose-Reduced Diet in Irritable Bowel Syndrome Leads to Lower Circulating Levels of PAI-1 and Visfatin: A Randomized Controlled Study
Roth, B., Myllyvainio, J., D’Amato, M., Larsson, E., & Ohlsson, B. (2022) · Nutrients · doi:10.3390/nu14091688 · Cited by 7
Effects of acupuncture on functional gastrointestinal disorders: special effects, coeffects, synergistic effects in terms of single or compatible acupoints.
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Sex-Discordant Fecal Microbiota Transplantation for Clostridioides difficile May Increase Risk of Postinfection Irritable Bowel Syndrome
Sehgal, K., Yadav, D., Saha, S., Mara, K. C., Grover, M., & Khanna, S. (2023) · Gastroenterology · doi:10.1053/j.gastro.2023.11.295 · Cited by 7
Advancements in drug development for diarrhea-predominant irritable bowel syndrome
Dothel, G., Barbaro, M. R., Raschi, E., Barbara, G., & Ponti, F. D. (2018) · Expert Opinion on Investigational Drugs · doi:10.1080/13543784.2018.1442434 · Cited by 7
Dynamic MRI of the pelvic floor: comparison of performance in supine vs left lateral body position
Schawkat, K., Pfister, B., Parker, H. L., Heinrich, H. S., Barth, B. K., Weishaupt, D., Fox, M. R., & Reiner, C. S. (2018) · British Journal of Radiology · doi:10.1259/bjr.20180393 · Cited by 7
Impact of occupational stress on irritable bowel syndrome pathophysiology and potential management in active duty noncombat Greek military personnel: a multicenter prospective survey
Papaefthymiou, A., Doulberis, M., Kountouras, J., Kolokytha, C., Galanopoulos, M., Liatsos, C. N., Kyriakos, N., Giakoumis, M., Papadomichelakis, M., Pοlyzos, S. A., et al. (2019) · European Journal of Gastroenterology & Hepatology · doi:10.1097/meg.0000000000001439 · Cited by 7
Chain length of dietary fatty acids determines gastrointestinal motility and visceromotor function in mice in a fatty acid binding protein 4-dependent manner
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Functional diseases of the gastrointestinal tract in the context with overlapping functional disorders: current status of the problem
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Incidence of Cancer in Patients with Irritable Bowl Syndrome
Loosen, S. H., Jördens, M. S., Luedde, M., Modest, D. P., Labuhn, S., Luedde, T., Kostev, K., & Roderburg, C. (2021) · Journal of Clinical Medicine · doi:10.3390/jcm10245911 · Cited by 7
Pelvic Floor Dysfunction
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The Transition From Rome III to Rome IV Irritable Bowel Syndrome: What We Gain and Lose
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Self-citation
Validation of body surface colonic mapping (BSCM) against high resolution colonic manometry for evaluation of colonic motility
Seo, S., Wells, C. I., Dickson, T., Rowbotham, D., Gharibans, A., Calder, S., Bissett, I., O'Grady, G., & Erickson, J. (2023) · Scientific Reports · doi:10.1038/s41598-024-54429-7 · Cited by 4
“…or comorbidities that affect bowel motility/function (Parkinson’s disease, thyroid function diseases, and diabetes mellitus), or if they had a regular prescription for agents affecting bowel function (including, but not exclusive to, loperamide, prokinetics, metformin, laxatives, and opioids).”
Background
Symptoms of functional dyspepsia and irritable bowel syndrome among medical students in Slovakia and their relation to diet and exercise
Lipták, P., Ďuríček, M., Schnierer, M., Žiačiková, I., Rosoľanka, R., Baranovičová, E., Šturdík, I., Jackuliak, P., Veselíny, E., Varady, A., et al. (2024) · European Journal of Gastroenterology & Hepatology · doi:10.1097/meg.0000000000002793 · Cited by 7
Global prevalence and gastrointestinal symptom burden of individuals with a history of cholecystectomy
Konings, B., Balsiger, L. M., Hreinsson, J. P., Simrén, M., Bangdiwala, S. I., Sperber, A. D., Palsson, O. S., Törnblom, H., & Tack, J. F. (2025) · Gut · doi:10.1136/gutjnl-2024-334531 · Cited by 9
“The effect was moderate for most symptoms and large for the frequency of faecal urgency (online supplemental eTable 20).”
Self-citation
Determining patient treatment preferences for management of acute pain episodes in irritable bowel syndrome
Almario, C. V., Eberlein, S. A., Khalil, C., & Spiegel, B. M. R. (2021) · Neurogastroenterology & Motility · doi:10.1111/nmo.14145 · Cited by 6
Self-citation
Co‐occurrence of fecal incontinence with constipation or irritable bowel syndrome indicates the need for personalized treatment
Sun, G., Trzpis, M., Ding, H., Gao, X., Broens, P. M. A., & Zhang, W. (2023) · Neurogastroenterology & Motility · doi:10.1111/nmo.14633 · Cited by 6
The impact of a prebiotic-rich diet and/or probiotic supplements on human cognition: Secondary outcomes from the ‘Gut Feelings’ randomised controlled trial
Freijy, T. M., Cribb, L., Oliver, G., Metri, N., Opie, R., Jacka, F. N., Hawrelak, J. A., Rucklidge, J. J., Ng, C. H., & Sarris, J. J. (2024) · Nutritional Neuroscience · doi:10.1080/1028415x.2024.2425570 · Cited by 6
Differentiating Between Lactose Intolerance, Celiac Disease, and Irritable Bowel Syndrome-Diarrhea
Luthy, K. E., Larimer, S. M., & Freeborn, D. (2017) · The Journal for Nurse Practitioners · doi:10.1016/j.nurpra.2017.01.018 · Cited by 7
“1% specificity.(21) The IBSchek was approved by the United States Food and Drug Administration for use in 2015 and is an enzyme-linked immunoassay‒based serum test that is predictive of IBS-D based on the presence of 1 or 2 antibodies: anti‒cytolethal distending toxin B and anti-vinculin.”
Background
Understanding the Rome IV: Irritable Bowel Syndrome and Functional Diarrhea
Kim, H. J., Cha, R. R., & Kim, H. J. (2017) · Korean Journal of Medicine · doi:10.3904/kjm.2017.92.4.366 · Cited by 6
Gynecological history up to diagnosis and pregnancy outcomes in diagnosed Wilson's disease under therapy � a bicentric matched control cohort study
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Outbreak of Cryptosporidium hominis in northern Sweden: persisting symptoms in a 5-year follow-up
Sjöström, M., Arvidsson, M., Söderström, L., Lilja, M., Lindh, J. G., & Widerström, M. (2022) · Parasitology Research · doi:10.1007/s00436-022-07524-5 · Cited by 7
Masticatory performance in patients with jaw muscle pain: A case–control study
Sayegh, S. A., Christidis, N., Kumar, A., Svensson, P. J., & Grigoriadis, A. (2022) · Frontiers in Dental Medicine · doi:10.3389/fdmed.2022.963425 · Cited by 6
The prevalence and burden of Rome IV bowel disorders of gut brain interaction in patients with non-alcoholic fatty liver disease: a cross-sectional study
Purssell, H., Bennett, L., Street, O., Hanley, K. P., Hanley, N. A., Vasant, D. H., & Athwal, V. S. (2023) · Scientific Reports · doi:10.1038/s41598-023-35774-5 · Cited by 6
Manipulation of the intestinal microbiome-a slow journey to primetime
Kriger-Sharabi, O., Malnick, S. D. H., & Fisher, D. (2023) · World Journal of Clinical Cases · doi:10.12998/wjcc.v11.i21.4975 · Cited by 6
Irritable bowel syndrome (IBS) among Lebanese adults: unidentified IBS and associated factors
Yazbeck, G., Malaeb, D. N., Shaaban, H. S., Dine, A. S. E., Hallit, S. R., & Hallit, R. R. (2023) · BMC Public Health · doi:10.1186/s12889-023-16543-5 · Cited by 6
“Rome IV diagnostic questionnaire (for adults) This questionnaire was used for the diagnosis of irritable bowel syndrome [51].”
Method
The Alignment of Dietary Intake and Symptom-Reporting Capture Periods in Studies Assessing Associations between Food and Functional Gastrointestinal Disorder Symptoms: A Systematic Review
Duncanson, K., Burrows, T. L., Keely, S., Potter, M. D. E., Das, G., Walker, M. M., & Talley, N. J. (2019) · Nutrients · doi:10.3390/nu11112590 · Cited by 6
“Self-report Minutes, prospective (5 min intervals vs. protocol) Y BSF: Bristol stool form, CHO: carbohydrate, FD: functional dyspepsia, FFQ: food frequency questionnaire, FGIDs: functional gastrointestinal disorders, FODMAP: fermentable oligosaccharides, disaccharides, monosaccharides and polyols, g/d: grams per day,…”
BackgroundResultInfluential
Usefulness of the hydrogen breath test in patients with functional dyspepsia
Chojnacki, C. J., Konrad, P., Błońska, A., Chojnacki, J., & Mędrek-Socha, M. (2020) · Gastroenterology Review · doi:10.5114/pg.2020.92690 · Cited by 6
Comparison of anorectal function measured using wearable digital manometry and a high resolution manometry system
Attari, A., Chey, W. D., Baker, J. R., & Ashton‐Miller, J. A. (2020) · PLoS ONE · doi:10.1371/journal.pone.0228761 · Cited by 7
Self-citation
Translation and validation of the traditional Chinese version of the Constipation Severity Instrument
Tsai, Y.-J., Yang, Y.-W., & Lan, Y. (2020) · Journal of the Chinese Medical Association · doi:10.1097/jcma.0000000000000462 · Cited by 6
Self-citation
Disorders of Gut-brain Interaction on the US-Mexico Border
Bashashati, M., Schmulson, M. J., Sarosiek, I., Robles, A., Casner, N. A., Espino, K., Elhanafi, S. E., & Zuckerman, M. J. (2023) · Journal of Clinical Gastroenterology · doi:10.1097/mcg.0000000000001858 · Cited by 6
Editorial: new insights into the global prevalence of uninvestigated and functional dyspepsia
Potter, M. D. E., & Talley, N. J. (2020) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.16059 · Cited by 6
Anxiety and Depression Disorders in Vietnamese Patients With Irritable Bowel Syndrome: A Cross‐Sectional Clinic‐Based Study
Phan, T. N., Tran, Q. K., Truong, X. L., & Nguyen, T. H. T. (2025) · JGH Open · doi:10.1002/jgh3.70116 · Cited by 7
Symptoms of Constipation: Relationship Between Questionnaires and Diaries and Impact on Quality of Life
Snih, G. M. A., Bailey, K. R., Oblizajek, N. R., & Bharucha, A. E. (2025) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2025.05.005 · Cited by 5
Epidemiology of Meal‐Related Abdominal Discomfort or Pain in Irritable Bowel Syndrome
Cuffe, M. S., Goodoory, V. C., Ng, C. E., Black, C. J., & Ford, A. C. (2025) · Neurogastroenterology & Motility · doi:10.1111/nmo.70174 · Cited by 7
“We defined the presence of IBS using the Rome IV questionnaire [18], assigning presence of Rome IV-defined IBS according to the scoring algorithm proposed for its use [19].”
Altered gut microbial functional pathways in people with irritable bowel syndrome enable precision health insights
Patridge, E. V., Gorakshakar, A., Molusky, M. M., Ogundijo, O., Julian, C., Hu, L., Antoine, G., Vuyisich, M., Wohlman, R., & Banavar, G. S. (2025) · BMC Gastroenterology · doi:10.1186/s12876-025-04205-2 · Cited by 5
Global Prevalence of Functional Constipation Across All Age Groups According to Rome II–IV Criteria, 1999–2025: A Systematic Review and Meta-Analysis
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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: 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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