title: Rome IV Diagnostic Questionnaires and Tables for Investigators and Clinicians.
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 90thpercentile 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.
authors.affiliation: Bioinformatics Building Room 4111, Campus Box 7080, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599-7080.
authors.forename: Olafur S
authors.initials: OS
authors.lastname: Palsson
authors.affiliation: Bioinformatics Building Room 4112, Campus Box 7080, University of North Carolina at Chapel Hill, Chapel Hill, NC.
authors.forename: William E
authors.initials: WE
authors.lastname: Whitehead
authors.affiliation: Bioinformatics Building Room 4008 Campus Box 7080 University of North Carolina at Chapel Hill Chapel Hill, NC 27599-7080.
authors.forename: Miranda A L
authors.initials: MA
authors.lastname: van Tilburg
authors.affiliation: Center for Neurobiology of Stress, David Geffen School of Medicine, UCLA Los Angeles,California.
authors.forename: Lin
authors.initials: L
authors.lastname: Chang
authors.affiliation: Division of Gastroenterology, University of Michigan Health System, Ann Arbor, Michigan.
authors.forename: William
authors.initials: W
authors.lastname: Chey
authors.affiliation: Mayo Clinic, Scottsdale, Arizona.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Crowell
authors.affiliation: Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
authors.forename: Laurie
authors.initials: L
authors.lastname: Keefer
authors.affiliation: Harvard Medical School, Boston, Massachusetts.
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Lembo
authors.affiliation: Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania.
authors.forename: Henry P
authors.initials: HP
authors.lastname: Parkman
authors.affiliation: Director, Digestive Health Center, Medical College of GeorgiaGeorgia Regents University, Augusta, Georgia.
authors.forename: Satish Sc
authors.initials: SS
authors.lastname: Rao
authors.affiliation: Kibbutz Farod, House 86, D.N. Bikat Bet Hakerem, 2010000, Israel.
authors.forename: Ami
authors.initials: A
authors.lastname: Sperber
authors.affiliation: Mt. Sinai Medical Center, Los Angeles, California.
authors.forename: Brennan
authors.initials: B
authors.lastname: Spiegel
authors.affiliation: K. U. Leuven, Center for GI Research, Herestraat 49, Leuven 3000, Belgium.
authors.forename: Jan
authors.initials: J
authors.lastname: Tack
authors.affiliation: Division of Gastroenterology, Kingston General Hospital, Ontario, Canada.
authors.forename: Stephen
authors.initials: S
authors.lastname: Vanner
authors.affiliation: Department of Pediatrics, Adolescent Division, Vanderbilt University Medical Center, 2146 Belcourt Ave, Nashville TN 37212.
authors.forename: Lynn S
authors.initials: LS
authors.lastname: Walker
authors.affiliation: University Hospital of South Manchester, United Kingdom.
authors.forename: Peter
authors.initials: P
authors.lastname: Whorwell
authors.affiliation: Chinese PLA General Hospital Beijing, China.
authors.forename: Yunsheng
authors.initials: Y
authors.lastname: Yang
keywords: Functional constipation; Functional dyspepsia; Functional gastrointestinal disorder; Irritable bowel syndrome; Sensitivity; Specificity; Validation