Eli M Miloslavsky1, Ray P Naden2, Johannes W J Bijlsma3, Paul A Brogan4, E Sherwood Brown5, Paul Brunetta6, Frank Buttgereit7, Hyon K Choi8, Jean-Francois DiCaire9, Jeffrey M Gelfand10, Liam G Heaney11, Liz Lightstone12, Na Lu13, Dedee F Murrell14, Michelle Petri15, James T Rosenbaum16, Kenneth S Saag17, Murray B Urowitz18, Kevin L Winthrop19, John H Stone20. 1. Rheumatology, Allergy and Immunology Division, Massachusetts General Hospital, Boston, Massachusetts, USA. 2. Maternal-Fetal Medicine, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada. 3. Department of Rheumatology, UMCUtrecht, Utrecht, Netherlands. 4. Institute of Child Health, University College London, UCL Inst of Child Health, London, UK. 5. Department of Psychiatry, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA. 6. Late Stage Immunology Product Development, Genentech, Inc., South San Francisco, USA. 7. Department of Rheumatology and Immunology, Charité University Medicine Berlin, Berlin, Germany. 8. Department of Rheumatology, Harvard Medical School, Boston, Massachusetts, USA. 9. Pinnacle, Inc., Montreal, Quebec, Canada. 10. University of California-San Francisco, San Francisco, USA. 11. Queen's University of Belfast, Belfast, UK. 12. Section of Renal Medicine and Vascular Inflammation, Division of Immunology and Inflammation, Department of Medicine, Imperial College London, Imperial College London, London, UK. 13. Department of Rheumatology, Massachusetts General Hospital, Boston, USA. 14. University of New South Wales, Sydney, New South Wales, Australia. 15. Department of Rheumatology, Johns Hopkins University, Baltimore, Maryland, USA. 16. Casey Eye Institute, Oregon Health and Science University, Portland, Oregon, USA. 17. UAB Division of Clinical Immunology/Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA. 18. Center for Prognosis Studies in the Rheumatic Diseases, Toronto Western Hospital, University of Toronto, Lupus Clinic, Toronto, Canada. 19. Oregon Health Sciences University, Portland, Oregon, USA. 20. Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Rheumatology Clinic, Boston, Massachusetts, USA.
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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
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 GTItoxicities 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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
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