Development and validation of the Rome IV diagnostic questionnaire for adults

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 S.C. Rao, Ami Sperber, Brennan Spiegel, Jan Tack, Stephen Vanner, Lynn S. Walker, Peter Whorwell, Yunsheng Yang

Research output: Contribution to journalArticlepeer-review

385 Scopus citations


The Rome IV Diagnostic Questionnaires were developed to screen for functional gastrointestinal disorders, serve as inclusion criteria in clinical trials, and support epidemiologic surveys. Separate questionnaires were developed for adults, children and adolescents, and infants and toddlers. For the adult questionnaire, we first surveyed 1162 adults without gastrointestinal disorders, and recommended the 90th 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 5931 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 three-fourths of patients after 1 month. Validation of the pediatric questionnaires is ongoing.

Original languageEnglish
Pages (from-to)1481-1491
Number of pages11
Issue number6
StatePublished - 1 May 2016
Externally publishedYes


  • Functional Constipation
  • Functional Dyspepsia
  • Functional Gastrointestinal Disorder
  • Irritable Bowel Syndrome
  • Sensitivity
  • Specificity


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