Background:: Immunomodulators and biologics are effective treatments for children with Crohn's disease (CD). The challenge of communicating the anticipated disease course with and without therapy to patients and parents is a barrier to the timely use of these agents. The aim of this project was to develop a tool to graphically display the predicted risks of CD and expected benefits of therapy.
Methods:: Using prospectively collected data from 796 pediatric CD patients we developed a model using system dynamics analysis (SDA). The primary model outcome is the probability of developing a CD‐related complication. Input variables include patient and disease characteristics, magnitude of serologic immune responses expressed as the quartile sum score (QSS), and exposure to medical treatments.
Results:: Multivariate Cox proportional analyses show variables contributing a significant increase in the hazard ratio (HR) for a disease complication include female gender, older age at diagnosis, small bowel or perianal disease, and a higher QSS. As QSS increases, the HR for early use of corticosteroids increases, in contrast to a decreasing HR with early use of immunomodulators, early or late biologics, and early combination therapy. The concordance index for the model is 0.81. Using SDA, results of the Cox analyses are transformed into a simple graph displaying a real‐time individualized probability of disease complication and treatment response.
Conclusions:: We have developed a tool to predict and communicate individualized risks of CD complications and how this is modified by treatment. Once validated, it can be used at the bedside to facilitate patient decision making. (Inflamm Bowel Dis 2011;)
1Dartmouth‐Hitchcock Inflammatory Bowel Disease Center, Dartmouth‐Hitchcock Medical Center, Lebanon, New Hampshire
2Siegel Environmental Dynamics, LLC, Hanover, New Hampshire
3Department of Pediatrics, Connecticut Children's Medical Center, Hartford, Connecticut
4Children's Healthcare of Atlanta, Emory University, Atlanta, Georgia
5Schneider Children's Hospital, New Hyde Park, New York
6Department of Pediatrics, Morristown Memorial Hospital, Morristown, New Jersey
7Department of Pediatrics, Hasbro Children's Hospital, Providence, Rhode Island
8Department of Pediatrics, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada
9Department of Pediatrics, Nationwide Children's Hospital, Columbus, Ohio
10Department of Pediatrics, Nemours Children's Clinic, Jacksonville, Florida
11Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
12Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada
13Department of Pediatrics, Johns Hopkins Hospital, Baltimore, Maryland
14Department of Pediatrics, IBD Center, Cedars‐Sinai Medical Center, Los Angeles, California
15Department of Pediatrics, Alberta Children's Hospital, Calgary, Alberta, Canada
16Department of Pediatrics, Seattle Children's Hospital, Seattle, Washington
17California Pacific Medical Center, San Francisco, California
18Department of Pediatrics, Phoenix Children's Hospital, Phoenix, Arizona
19Gastrointestinal Unit, MGH Crohn's and Colitis Center, Massachusetts General Hospital, Boston, Massachusetts
Reprints: Inflammatory Bowel Disease Center, Section of Gastroenterology and Hepatology, Dartmouth‐Hitchcock Medical Center, Lebanon, NH 03756
Received 12 May 2010; Accepted 17 May 2010
Grant sponsor: CCFA career development award; Grant Number: K23DK078678; Grant sponsor: National Institute of Diabetes and Digestive and Kidney Diseases; Grant sponsor: Abe and Claire Levine Chair in Pediatric IBD; Grant Number: K23DK066248; Grant sponsor: National Institute of Diabetes and Digestive and Kidney Diseases.
Dr. Siegel is supported by a CCFA career development award and by Grant Number K23DK078678 from the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Dubinsky is supported by the Abe and Claire Levine Chair in Pediatric IBD, and Grant Number K23DK066248 from the National Institute of Diabetes and Digestive and Kidney Diseases. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Diabetes and Digestive and Kidney Diseases or the National Institutes of Health. Dr. Ghassan is supported in part by the Truman Katz Foundation.