Silvio Danese1, Gionata Fiorino2, Jean-Yves Mary3, Peter L Lakatos4, Geert D'Haens5, Lorenzo Moja6, André D'Hoore7, Julian Panes8, Walter Reinisch9, William J Sandborn10, Simon P Travis11, Séverine Vermeire12, Laurent Peyrin-Biroulet13, Jean-Fréderic Colombel14. 1. IBD Center, Humanitas Research Hospital, Rozzano, Milan, Italy sdanese@hotmail.com. 2. IBD Center, Humanitas Research Hospital, Rozzano, Milan, Italy. 3. Inserm U1153 - SBIM Hôpital Saint-Louis, Paris, France. 4. 1st Department of Medicine, Semmelweis University, Budapest, Hungary. 5. IBD Unit, Gastroenterology, Amsterdam Medical Center, Amsterdam, The Netherlands. 6. Department of Biomedical Sciences for Health, University of Milan, Milan, Italy Unit of Clinical Epidemiology, IRCCS Galeazzi Orthopedic Institute, Milan, Italy. 7. Abdominal Surgery, UZ Leuven, Leuven, Belgium. 8. Gastroenterology Department, Hospital Clinic of Barcelona, IDIPABS, CIBERehd, Barcelona, Spain. 9. Medizinische Universität Wien, Klinische Abt. Gastroenterologie & Hepatologie, AKH Wien, Austria. 10. Division of Gastroenterology, UC San Diego Health System, La Jolla, CA, USA. 11. Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford, UK. 12. Department of Gastroenterology, University Hospitals Leuven, Leuven, Belgium. 13. Department of Hepato-Gastroenterology and Inserm U954, Nancy University Hospital, Lorraine University, Vandoeuvre-lès-Nancy, France. 14. Department of Gastroenterology, Icahn Medical School at Mount Sinai, New York, NY, USA.
Abstract
BACKGROUND AND AIMS: Diagnostic delay is frequent in patients with Crohn's disease (CD). We developed a tool to predict early diagnosis. METHODS: A systematic literature review and 12 CD specialists identified 'Red Flags', i.e. symptoms or signs suggestive of CD. A 21-item questionnaire was administered to 36 healthy subjects, 80 patients with irritable bowel syndrome (non-CD group) and 85 patients with recently diagnosed (<18 months) CD. Patients with CD were asked to recall symptoms and signs they experienced during the 12 months before diagnosis. Multiple logistic regression analyses selected and weighted independent items to construct the Red Flags index. A receiver operating characteristic curve was used to assess the threshold that discriminated CD from non-CD. Association with the Red Flags index relative to this threshold was expressed as the odds ratios (OR). RESULTS: Two hundred and one subjects, CD and non-CD, answered the questionnaire. The multivariate analysis identified eight items independently associated with a diagnosis of CD. A minimum Red Flags index value of 8 was highly predictive of CD diagnosis with sensitivity and specificity bootstrap estimates of 0.94 (95% confidence interval 0.88-0.99) and 0.94 (0.90-0.97), respectively. Positive and negative likelihood ratios were 15.1 (9.3-33.6) and 0.066 (0.013-0.125), respectively. The association between CD diagnosis and a Red Flags index value of ≥8 corresponds to an OR of 290 (p < 0.0001). CONCLUSIONS: The Red Flags index using early symptoms and signs has high predictive value for the diagnosis of CD. These results need prospective validation prior to introduction into clinical practice.
BACKGROUND AND AIMS: Diagnostic delay is frequent in patients with Crohn's disease (CD). We developed a tool to predict early diagnosis. METHODS: A systematic literature review and 12 CD specialists identified 'Red Flags', i.e. symptoms or signs suggestive of CD. A 21-item questionnaire was administered to 36 healthy subjects, 80 patients with irritable bowel syndrome (non-CD group) and 85 patients with recently diagnosed (<18 months) CD. Patients with CD were asked to recall symptoms and signs they experienced during the 12 months before diagnosis. Multiple logistic regression analyses selected and weighted independent items to construct the Red Flags index. A receiver operating characteristic curve was used to assess the threshold that discriminated CD from non-CD. Association with the Red Flags index relative to this threshold was expressed as the odds ratios (OR). RESULTS: Two hundred and one subjects, CD and non-CD, answered the questionnaire. The multivariate analysis identified eight items independently associated with a diagnosis of CD. A minimum Red Flags index value of 8 was highly predictive of CD diagnosis with sensitivity and specificity bootstrap estimates of 0.94 (95% confidence interval 0.88-0.99) and 0.94 (0.90-0.97), respectively. Positive and negative likelihood ratios were 15.1 (9.3-33.6) and 0.066 (0.013-0.125), respectively. The association between CD diagnosis and a Red Flags index value of ≥8 corresponds to an OR of 290 (p < 0.0001). CONCLUSIONS: The Red Flags index using early symptoms and signs has high predictive value for the diagnosis of CD. These results need prospective validation prior to introduction into clinical practice.
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