Rome IV Diagnostic Questionnaires and Tables for Investigators and Clinicians

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

doi:10.1053/j.gastro.2016.02.014

Rome IV Diagnostic Questionnaires and Tables for Investigators and Clinicians

Gastroenterology. 2016 Feb 13:S0016-5085(16)00180-3. doi: 10.1053/j.gastro.2016.02.014. Online ahead of print.

Authors

Olafur S Palsson¹, William E Whitehead², Miranda A L van Tilburg³, Lin Chang⁴, William Chey⁵, Michael D Crowell⁶, Laurie Keefer⁷, Anthony J Lembo⁸, Henry P Parkman⁹, Satish Sc Rao¹⁰, Ami Sperber¹¹, Brennan Spiegel¹², Jan Tack¹³, Stephen Vanner¹⁴, Lynn S Walker¹⁵, Peter Whorwell¹⁶, Yunsheng Yang¹⁷

Affiliations

¹ Bioinformatics Building Room 4111, Campus Box 7080, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599-7080.
² Bioinformatics Building Room 4112, Campus Box 7080, University of North Carolina at Chapel Hill, Chapel Hill, NC.
³ Bioinformatics Building Room 4008 Campus Box 7080 University of North Carolina at Chapel Hill Chapel Hill, NC 27599-7080.
⁴ Center for Neurobiology of Stress, David Geffen School of Medicine, UCLA Los Angeles,California.
⁵ Division of Gastroenterology, University of Michigan Health System, Ann Arbor, Michigan.
⁶ Mayo Clinic, Scottsdale, Arizona.
⁷ Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
⁸ Harvard Medical School, Boston, Massachusetts.
⁹ Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania.
¹⁰ Director, Digestive Health Center, Medical College of GeorgiaGeorgia Regents University, Augusta, Georgia.
¹¹ Kibbutz Farod, House 86, D.N. Bikat Bet Hakerem, 2010000, Israel.
¹² Mt. Sinai Medical Center, Los Angeles, California.
¹³ K. U. Leuven, Center for GI Research, Herestraat 49, Leuven 3000, Belgium.
¹⁴ Division of Gastroenterology, Kingston General Hospital, Ontario, Canada.
¹⁵ Department of Pediatrics, Adolescent Division, Vanderbilt University Medical Center, 2146 Belcourt Ave, Nashville TN 37212.
¹⁶ University Hospital of South Manchester, United Kingdom.
¹⁷ Chinese PLA General Hospital Beijing, China.

PMID: 27144634
DOI: 10.1053/j.gastro.2016.02.014

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.

Keywords: Functional constipation; Functional dyspepsia; Functional gastrointestinal disorder; Irritable bowel syndrome; Sensitivity; Specificity; Validation.