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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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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