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. 2024 Mar 15:458:122907.
doi: 10.1016/j.jns.2024.122907. Epub 2024 Jan 30.

Qualitative interviews to support development of a patient-reported companion measure to the Glucocorticoid Toxicity Index

Timothy A Howell  1 , Louis S Matza  1 , John H Stone  2 , Deborah Gelinas  3 , Martha N Stone  4 , Vijayaraghava T S Rao  5 , Glenn A Phillips  3
Affiliations

Qualitative interviews to support development of a patient-reported companion measure to the Glucocorticoid Toxicity Index

Timothy A Howell et al. J Neurol Sci. .

Abstract

Introduction: Glucocorticoids (GCs) are associated with multiple toxicities that have substantial impact on patients. We conducted qualitative interviews with patients to identify the toxicities that are most relevant from their perspective, with the goal of creating a patient-reported companion measure to the Glucocorticoid Toxicity Index (GTI), a clinician-facing instrument.

Methods: Thirty-one patients with recent or current GC use participated in concept elicitation interviews. Participants received GC treatment for myasthenia gravis, chronic inflammatory demyelinating polyradiculoneuropathy, vasculitis, or systemic lupus erythematosus. Transcripts were coded following a thematic analysis approach.

Results: Participants reported more than 100 toxicities they believed to be associated with their GC medications. Common toxicities included weight gain (87%), increased appetite (84%), insomnia/sleep problems (77%), cognitive impairment/brain fog (71%), easy bruising (68%), anxiety (65%), irritability/short temper (65%), and osteoporosis (39%). These toxicities often centered on self-esteem, neuropsychiatric effects, skin toxicities, and musculoskeletal function. They can be categorized into domains such emphasizing neuropsychiatric, metabolic/endocrine, musculoskeletal, and dermatological effects, highlighting aspects of GC toxicity that patients are uniquely positioned to appreciate and report.

Conclusion: Our results confirm that the toxicities associated with GCs are pervasive and diverse, with substantial impact on patients' lives. These data will be used to inform the development of a patient-reported outcome measure assessing GC toxicity. This patient-reported instrument will be designed to complement the clinician-reported GTI, facilitating a more detailed understanding of the nuances of change in GC toxicity.

Keywords: GC toxicity; GTI; Glucocorticoid toxicity index; Glucocorticoids; Patient-reported outcome.

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Conflict of interest statement

Declaration of competing interest TAH and LSM are employed by Evidera, a company that received funding from argenx for time spent conducting this research. MNS is the CEO of Steritas, LLC, which holds the licensing rights to the Glucocorticoid Toxicity Index, and reports owning stock in Steritas (the intellectual property of the GTI is owned by the Massachusetts General Hospital). MNS is a co-founder of Steritas. JHS reports consulting fees from ChemoCentryx, Amgen, Roche/Genentech, Sanofi, Bristol-Myers Squib, AbbVie, InflaRx, Kyverna, Novartis, Q32Bio, Steritas, Zenas, Horizon, argenx, Spruce, PPD; owning stock in Steritas; commercial research grants from Roche/Genentech, Sanofi, Bristol-Myers Squib; royalties from UpToDate; non-commercial research grants from NIH/NIAID. JHS is a co-founder of Steritas and serves as the unpaid chair of the Scientific Advisory Board. He has no fiduciary responsibility at the company. GAP, VR, and DG are employees of argenx, who sponsored the study.

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