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

Research output: Contribution to journalArticle

115 Scopus citations

Abstract

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 (US)
Pages (from-to)1481-1491
Number of pages11
JournalGastroenterology
Volume150
Issue number6
DOIs
StatePublished - May 1 2016

Keywords

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

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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    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. (2016). Development and validation of the Rome IV diagnostic questionnaire for adults. Gastroenterology, 150(6), 1481-1491. https://doi.org/10.1053/j.gastro.2016.02.014