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Real-time tool to display the predicted disease course and treatment response for children with Crohn's disease

Siegel, Corey A. MD, MS1; Siegel, Lori S. PhD, PE2; Hyams, Jeffrey S. MD3; Kugathasan, Subra MD4; Markowitz, James MD5; Rosh, Joel R. MD6; Leleiko, Neal MD, PhD7; Mack, David R. MD8; Crandall, Wallace MD9; Evans, Jonathan MD10; Keljo, David J. MD, PhD11; Otley, Anthony R. MD, MSc12; Oliva-Hemker, Maria MD13; Farrior, Sharmayne RN, BSN18; Langton, Christine R. MSW, MPH3; Wrobel, Iwona T. MD14; Wahbeh, Ghassan MD15; Quiros, J. Antonio MD16; Silber, Gary MD17; Bahar, Ron J. MD18; Sands, Bruce E. MD, MS19; Dubinsky, Marla C. MD18

doi: 10.1002/ibd.21386
Original Clinical Articles

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

Email: corey.a.siegel@hitchcock.org

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.

© Crohn's & Colitis Foundation of America, Inc.
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