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Development of a Glucocorticoid Toxicity Index (GTI) using multicriteria decision analysis
  1. Eli M Miloslavsky1,
  2. Ray P Naden2,
  3. Johannes W J Bijlsma3,
  4. Paul A Brogan4,
  5. E Sherwood Brown5,
  6. Paul Brunetta6,
  7. Frank Buttgereit7,
  8. Hyon K Choi8,
  9. Jean-Francois DiCaire9,
  10. Jeffrey M Gelfand10,
  11. Liam G Heaney11,
  12. Liz Lightstone12,
  13. Na Lu13,
  14. Dedee F Murrell14,
  15. Michelle Petri15,
  16. James T Rosenbaum16,
  17. Kenneth S Saag17,
  18. Murray B Urowitz18,
  19. Kevin L Winthrop19,
  20. John H Stone20
  1. 1Rheumatology, Allergy and Immunology Division, Massachusetts General Hospital, Boston, Massachusetts, USA
  2. 2Maternal-Fetal Medicine, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada
  3. 3Department of Rheumatology, UMCUtrecht, Utrecht, Netherlands
  4. 4Institute of Child Health, University College London, UCL Inst of Child Health, London, UK
  5. 5Department of Psychiatry, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA
  6. 6Late Stage Immunology Product Development, Genentech, Inc., South San Francisco, USA
  7. 7Department of Rheumatology and Immunology, Charité University Medicine Berlin, Berlin, Germany
  8. 8Department of Rheumatology, Harvard Medical School, Boston, Massachusetts, USA
  9. 9Pinnacle, Inc., Montreal, Quebec, Canada
  10. 10University of California-San Francisco, San Francisco, USA
  11. 11Queen's University of Belfast, Belfast, UK
  12. 12Section of Renal Medicine and Vascular Inflammation, Division of Immunology and Inflammation, Department of Medicine, Imperial College London, Imperial College London, London, UK
  13. 13Department of Rheumatology, Massachusetts General Hospital, Boston, USA
  14. 14University of New South Wales, Sydney, New South Wales, Australia
  15. 15Department of Rheumatology, Johns Hopkins University, Baltimore, Maryland, USA
  16. 16Casey Eye Institute, Oregon Health and Science University, Portland, Oregon, USA
  17. 17UAB Division of Clinical Immunology/Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA
  18. 18Center for Prognosis Studies in the Rheumatic Diseases, Toronto Western Hospital, University of Toronto, Lupus Clinic, Toronto, Canada
  19. 19Oregon Health Sciences University, Portland, Oregon, USA
  20. 20Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Rheumatology Clinic, Boston, Massachusetts, USA
  1. Correspondence to Dr John H Stone, Rheumatology Clinic, Yawkey 2, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114, USA; jhstone{at}mgh.harvard.edu

Abstract

Objectives To develop a Glucocorticoid Toxicity Index (GTI) to assess glucocorticoid (GC)-related morbidity and GC-sparing ability of other therapies.

Methods Nineteen experts on GC use and outcome measures from 11 subspecialties participated. Ten experts were from the USA; nine from Canada, Europe or Australia. Group consensus methods and multicriteria decision analysis (MCDA) were used. A Composite GTI and Specific List comprise the overall GTI. The Composite GTI reflects toxicity likely to change during a clinical trial. The Composite GTI toxicities occur commonly, vary with GC exposure, and are weighted and scored. Relative weights for items in the Composite GTI were derived by group consensus and MCDA. The Specific List is designed to capture GC toxicity not included in the Composite GTI. The Composite GTI was evaluated by application to paper cases by the investigators and an external group of 17 subspecialists.

Results Thirty-one toxicity items were included in the Composite GTI and 23 in the Specific List. Composite GTI evaluation showed high inter-rater agreement (investigators κ 0.88, external raters κ 0.90). To assess the degree to which the Composite GTI corresponds to expert clinical judgement, participants ranked 15 cases by clinical judgement in order of highest to lowest GC toxicity. Expert rankings were then compared with case ranking by the Composite GTI, yielding excellent agreement (investigators weighted κ 0.87, external raters weighted κ 0.77).

Conclusions We describe the development and initial evaluation of a comprehensive instrument for the assessment of GC toxicity.

  • Corticosteroids
  • Outcomes research
  • Treatment

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