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Algorithm development for corticosteroid management in systemic juvenile idiopathic arthritis trial using consensus methodology

Norman T Ilowite1*, Christy I Sandborg2, Brian M Feldman3, Alexi Grom4, Laura E Schanberg5, Edward H Giannini4, Carol A Wallace6, Rayfel Schneider3, Kathleen Kenney1, Beth Gottlieb7, Philip J Hashkes8, Lisa Imundo9, Yukiko Kimura10, Bianca Lang11, Michael Miller12, Diana Milojevic13, Kathleen M O’Neil14, Marilynn Punaro15, Natasha Ruth16, Nora G Singer17, Richard K Vehe18, James Verbsky19, Amy Woodward20 and Lawrence Zemel21

Author Affiliations

1 Children’s Hospital at Montefiore, Albert Einstein College of Medicine, Bronx, NY, USA

2 Stanford University School of Medicine, Palo Alto, CA, USA

3 The Hospital for Sick Children, University of Toronto, Toronto, Ontario, CA

4 Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA

5 Duke University Medical Center, Durham, NC, USA

6 Seattle Children’s Hospital, Seattle, WA, USA

7 Steven and Alexandra Cohen Children’s Medical Center of New York, New Hyde Park, NY, USA

8 Cleveland Clinic Lerner Medical School, Cleveland, OH, Shaare Zedek Medical Center, Jerusalem, Israel

9 Children’s Hospital of New York, New York, NY, USA

10 Hackensack University Medical Center, Hackensack, NJ, USA

11 IWK Health Center, Dalhousie University, Halifax, NS, USA

12 Children’s Memorial Hospital, Chicago, IL, USA

13 University of California San Francisco Medical Center, San Francisco, CA, USA

14 University of Oklahoma University Health Sciences Center, Oklahoma City, OK, USA

15 Texas Scottish Rite Hospital for Children, Dallas, TX, USA

16 Medical University of South Carolina, Charleston, SC, USA

17 University Hospitals/Case Medical Center, Cleveland, OH, USA

18 University of Minnesota, Minneapolis, MN, USA

19 Medical College of Wisconsin, Milwaukee, WI, USA

20 Vanderbilt University Medical Center, Indianapolis, IN, USA

21 Connecticut Children’s Medical Center, Hartford, CT, USA

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Pediatric Rheumatology 2012, 10:31  doi:10.1186/1546-0096-10-31

Published: 29 August 2012

Abstract

Background

The management of background corticosteroid therapy in rheumatology clinical trials poses a major challenge. We describe the consensus methodology used to design an algorithm to standardize changes in corticosteroid dosing during the Randomized Placebo Phase Study of Rilonacept in Systemic Juvenile Idiopathic Arthritis Trial (RAPPORT).

Methods

The 20 RAPPORT site principal investigators (PIs) and 4 topic specialists constituted an expert panel that participated in the consensus process. The panel used a modified Delphi Method consisting of an on-line questionnaire, followed by a one day face-to-face consensus conference. Consensus was defined as ≥ 75% agreement. For items deemed essential but when consensus on critical values was not achieved, simple majority vote drove the final decision.

Results

The panel identified criteria for initiating or increasing corticosteroids. These included the presence or development of anemia, myocarditis, pericarditis, pleuritis, peritonitis, and either complete or incomplete macrophage activation syndrome (MAS). The panel also identified criteria for tapering corticosteroids which included absence of fever for ≥ 3 days in the previous week, absence of poor physical functioning, and seven laboratory criteria. A tapering schedule was also defined.

Conclusion

The expert panel established consensus regarding corticosteroid management and an algorithm for steroid dosing that was well accepted and used by RAPPORT investigators. Developed specifically for the RAPPORT trial, further study of the algorithm is needed before recommendation for more general clinical use.