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Development of a Novel Index: The Glucocorticoids Toxicity Index (GTI)

June 9 2016 11:29 AM ET via RheumReports RheumReports

Glucocorticoids (GC) were first discovered by Philip S. Hench in 1949 and the initial trial for GCs was on patients with RA. Nowadays, GCs are the cornerstone of treatment for several rheumatic diseases including SLE. 

In the literature, there is confusion between the use of the terms glucocorticoids, corticoids, glucocorticosteroids and corticosteroids. In addition, the use of the term steroids is too broad and can be misleading. Thus, Buttgereit et al. proposed the use of the term glucocorticoids (ARD 2002) to avoid this confusion.

GCs are associated with several adverse effects that can occur in a short period and/or after long exposure. More importantly, GCs are considered  a major confounder in lupus drug trials. Unfortunately, "No reliable instrument exists to measure GCs toxicity" in drug trials, said JH Stone. The main objective of his research team was to develop an instrument that can separate High from Low GC users according to toxicity incurred.

In preparation to the development of a new index, the team held several meetings to identify a list of items to be included in the index. Using a multi-criteria decision analysis method called the 1000Minds software approach, items reduction was accomplished and the final version of the GCs Toxicity Index along with the weighted scores for each item were achieved. 

The GTI underwent an initial validation phase which included the participation of external raters and the results were promising. The composite GTI includes nine common domains (bone, glucose intolerance, lipids and others) and 31 items. The total score ranges between -36 to +439. Currently, the GTI is undergoing further validated.

The use of GCs is associated with a number of complications in SLE. The development of this novel index, GTI, is mainly intended for use in controlled trials and research studies to separate high from low GCs users according to toxicity incurred.

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About the Author

Dr. Zahi Touma
Dr. Zahi Touma

Dr. Touma is a clinical epidemiologist and an Assistant Professor of Medicine in the Division of Rheumatology at the University of Toronto, and Staff Physician and Clinician Scientist in the Division of Rheumatology, Toronto Western Hospital and Mount Sinai Hospital. In 2012 he completed his PhD in Clinical Epidemiology and subsequently completed one year of post-doctoral work in Measurement in Clinical Research.

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