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

Norman T. Ilowite*, Christy I. Sandborg, Brian M. Feldman, Alexi Grom, Laura E. Schanberg, Edward H. Giannini, Carol A. Wallace, Rayfel Schneider, Kathleen Kenney, Beth Gottlieb, Philip J. Hashkes, Lisa Imundo, Yukiko Kimura, Bianca Lang, Michael L Miller, Diana Milojevic, Kathleen M. O'Neil, Marilynn Punaro, Natasha Ruth, Nora G. Singer & 4 others Richard K. Vehe, James Verbsky, Amy Woodward, Lawrence Zemel

*Corresponding author for this work

Research output: Contribution to journalArticle

11 Citations (Scopus)

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.

Original languageEnglish (US)
Article number31
JournalPediatric Rheumatology
Volume10
DOIs
StatePublished - Aug 29 2012

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Juvenile Arthritis
Adrenal Cortex Hormones
Macrophage Activation Syndrome
Research Personnel
Pleurisy
Pericarditis
Myocarditis
Rheumatology
Peritonitis
Anemia
Appointments and Schedules
Fever
Steroids
Placebos
Clinical Trials

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Rheumatology
  • Immunology and Allergy

Cite this

Ilowite, N. T., Sandborg, C. I., Feldman, B. M., Grom, A., Schanberg, L. E., Giannini, E. H., ... Zemel, L. (2012). Algorithm development for corticosteroid management in systemic juvenile idiopathic arthritis trial using consensus methodology. Pediatric Rheumatology, 10, [31]. https://doi.org/10.1186/1546-0096-10-31
Ilowite, Norman T. ; Sandborg, Christy I. ; Feldman, Brian M. ; Grom, Alexi ; Schanberg, Laura E. ; Giannini, Edward H. ; Wallace, Carol A. ; Schneider, Rayfel ; Kenney, Kathleen ; Gottlieb, Beth ; Hashkes, Philip J. ; Imundo, Lisa ; Kimura, Yukiko ; Lang, Bianca ; Miller, Michael L ; Milojevic, Diana ; O'Neil, Kathleen M. ; Punaro, Marilynn ; Ruth, Natasha ; Singer, Nora G. ; Vehe, Richard K. ; Verbsky, James ; Woodward, Amy ; Zemel, Lawrence. / Algorithm development for corticosteroid management in systemic juvenile idiopathic arthritis trial using consensus methodology. In: Pediatric Rheumatology. 2012 ; Vol. 10.
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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.",
author = "Ilowite, {Norman T.} and Sandborg, {Christy I.} and Feldman, {Brian M.} and Alexi Grom and Schanberg, {Laura E.} and Giannini, {Edward H.} and Wallace, {Carol A.} and Rayfel Schneider and Kathleen Kenney and Beth Gottlieb and Hashkes, {Philip J.} and Lisa Imundo and Yukiko Kimura and Bianca Lang and Miller, {Michael L} and Diana Milojevic and O'Neil, {Kathleen M.} and Marilynn Punaro and Natasha Ruth and Singer, {Nora G.} and Vehe, {Richard K.} and James Verbsky and Amy Woodward and Lawrence Zemel",
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Ilowite, NT, Sandborg, CI, Feldman, BM, Grom, A, Schanberg, LE, Giannini, EH, Wallace, CA, Schneider, R, Kenney, K, Gottlieb, B, Hashkes, PJ, Imundo, L, Kimura, Y, Lang, B, Miller, ML, Milojevic, D, O'Neil, KM, Punaro, M, Ruth, N, Singer, NG, Vehe, RK, Verbsky, J, Woodward, A & Zemel, L 2012, 'Algorithm development for corticosteroid management in systemic juvenile idiopathic arthritis trial using consensus methodology', Pediatric Rheumatology, vol. 10, 31. https://doi.org/10.1186/1546-0096-10-31

Algorithm development for corticosteroid management in systemic juvenile idiopathic arthritis trial using consensus methodology. / Ilowite, Norman T.; Sandborg, Christy I.; Feldman, Brian M.; Grom, Alexi; Schanberg, Laura E.; Giannini, Edward H.; Wallace, Carol A.; Schneider, Rayfel; Kenney, Kathleen; Gottlieb, Beth; Hashkes, Philip J.; Imundo, Lisa; Kimura, Yukiko; Lang, Bianca; Miller, Michael L; Milojevic, Diana; O'Neil, Kathleen M.; Punaro, Marilynn; Ruth, Natasha; Singer, Nora G.; Vehe, Richard K.; Verbsky, James; Woodward, Amy; Zemel, Lawrence.

In: Pediatric Rheumatology, Vol. 10, 31, 29.08.2012.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Algorithm development for corticosteroid management in systemic juvenile idiopathic arthritis trial using consensus methodology

AU - Ilowite, Norman T.

AU - Sandborg, Christy I.

AU - Feldman, Brian M.

AU - Grom, Alexi

AU - Schanberg, Laura E.

AU - Giannini, Edward H.

AU - Wallace, Carol A.

AU - Schneider, Rayfel

AU - Kenney, Kathleen

AU - Gottlieb, Beth

AU - Hashkes, Philip J.

AU - Imundo, Lisa

AU - Kimura, Yukiko

AU - Lang, Bianca

AU - Miller, Michael L

AU - Milojevic, Diana

AU - O'Neil, Kathleen M.

AU - Punaro, Marilynn

AU - Ruth, Natasha

AU - Singer, Nora G.

AU - Vehe, Richard K.

AU - Verbsky, James

AU - Woodward, Amy

AU - Zemel, Lawrence

PY - 2012/8/29

Y1 - 2012/8/29

N2 - 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.

AB - 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.

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