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

ABSTRACT:

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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, s

SUBMITTER: Ilowite NT 

PROVIDER: S-EPMC3520770 | biostudies-literature | 2012 Aug

REPOSITORIES: biostudies-literature