P072 A scoping review of measurement instruments of glucocorticoid toxicity

Abstract Background/Aims Glucocorticoids commonly form part of management of autoimmune rheumatic diseases (AIRDs). However, they can be associated with significant side effects, resulting in excess morbidity. Novel medicines which can be used as steroid sparing agents have the potential to reduce glucocorticoid burden. To accurately assess this, robust validated outcome measures for measuring glucocorticoid toxicity are required. The OMERACT Glucocorticoid-Related Impact Working Group aims to develop a standardised measure of glucocorticoid toxicity for use in clinical trials, including clinical measures and the patient perspective. A core domain outcome set was developed in 2021, comprising infection, bone fragility, hypertension, hyperglycaemia, weight, mood disturbance, fatigue and death. The aim of this review was to identify existing measures of glucocorticoid toxicity. Methods Medline, EMBASE, CINHAL and Cochrane Central were searched along with hand search of abstracts presented at major relevant rheumatology meetings (abstracts restricted to past 5 years (08/2019 - 08/2024) for studies referring to the use of exogenous glucocorticoids and reporting a clinician or patient reported outcome measure (PROM). Data extraction was performed in duplicate by 2 authors. Results 3694 individual records were identified and screened. 76 eligible studies were included for data extraction. 29 studies included a population with AIRD. 33 assessed non-AIRD populations, 13 were not restricted to a specific disease. Glucocorticoids were delivered systemically in 60 studies. From studies utilising clinician reported measures, bone fragility (n = 31 papers) and mood disturbance (n = 14) were frequently assessed, while fatigue (n = 0), sleep disturbance (n = 2) and appearance (n = 1) were infrequently assessed. Conversely, studies utilising PROMs more frequently assessed fatigue (n = 12), mood disturbance (n = 23), sleep disturbance (n = 16) and appearance (n = 14). 46 clinician reported measures and 25 PROMs and were identified. Of these PROMs 13 had been validated in the 5 years following publication of the included paper and were further analysed (see table 1). Conclusion We demonstrate the heterogeneity of instruments used to assess glucocorticoid toxicity, highlighting the need for a standardised measure to fully convey the burden of glucocorticoids on patients and allow comparison between studies. The next step will be to map these instruments to the core domain outcome set. Disclosure C. Shere: None. A. Terrett: None. G. Venter: None. J. Tieu: None. R.J. Black: None. S.L. Mackie: Corporate appointments; Investigator on clinical trials for Sanofi, GSK. Consultancies; Consultancy on behalf of her institution for Roche, Chugai, Sanofi. Other; Patron of the charity PMRGCAuk. C. Hill: None. J. Robson: Consultancies; Consultancy for Vifor Pharma; and speaking fees from Vifor Pharma. Consultancy for support with translation via Oxford University Innovation Ltd as co-inventor of AAVPRO, GCA PRO and Steroid PRO. Grants/research support; Steroid PRO research start-up grant from Above Steroid PRO research grant from Vifor Pharma; Steroid PRO cross-condition validation study research grant from Sanofi.