PT  - JOURNAL ARTICLE
AU  - Fiona James
AU  - Michelle S Y Goh
AU  - Effie Mouhtouris
AU  - Sara Vogrin
AU  - Kyra Y L Chua
AU  - Natasha E Holmes
AU  - Andrew Awad
AU  - Ana-Maria Copaescu
AU  - Joseph F De Luca
AU  - Celia Zubrinich
AU  - Douglas Gin
AU  - Heather Cleland
AU  - Abby Douglas
AU  - Johannes S Kern
AU  - Constance H Katelaris
AU  - Francis Thien
AU  - Sara Barnes
AU  - James Yun
AU  - Winnie Tong
AU  - William B Smith
AU  - Andrew Carr
AU  - Tara Anderson
AU  - Amy Legg
AU  - Jack Bourke
AU  - Laura K Mackay
AU  - Ar Kar Aung
AU  - Elizabeth J Phillips
AU  - Jason Trubiano
TI  - Study protocol: Australasian Registry of Severe Cutaneous Adverse Reactions (AUS-SCAR)
AID  - 10.1136/bmjopen-2021-055906
DP  - 2022 Aug 01
TA  - BMJ Open
PG  - e055906
VI  - 12
IP  - 8
4099  - http://bmjopen.bmj.com/content/12/8/e055906.short
4100  - http://bmjopen.bmj.com/content/12/8/e055906.full
SO  - BMJ Open2022 Aug 01; 12
AB  - Introduction Severe cutaneous adverse reactions (SCAR) are a group of T cell-mediated hypersensitivities associated with significant morbidity, mortality and hospital costs. Clinical phenotypes include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP). In this Australasian, multicentre, prospective registry, we plan to examine the clinical presentation, drug causality, genomic predictors, potential diagnostic approaches, treatments and long-term outcomes of SCAR in Australia and New Zealand.Methods and analysis Adult and adolescent patients with SCAR including SJS, TEN, DRESS, AGEP and another T cell-mediated hypersensitivity, generalised bullous fixed drug eruption, will be prospectively recruited. A waiver of consent has been granted for some sites to retrospectively include cases which result in early mortality. DNA will be collected for all prospective cases. Blood, blister fluid and skin biopsy sampling is optional and subject to patient consent and site capacity. To develop culprit drug identification and prevention, genomic testing will be performed to confirm human leukocyte antigen (HLA) type and ex vivo testing will be performed via interferon-γ release enzyme linked immunospot assay using collected peripheral blood mononuclear cells. The long-term outcomes of SCAR will be investigated with a 12-month quality of life survey and examination of prescribing and mortality data.Ethics and dissemination This study was reviewed and approved by the Austin Health Human Research Ethics Committee (HREC/50791/Austin-19). Results will be published in peer-reviewed journals and presented at relevant conferences.Trial registration number Australian New Zealand Clinical Trials Registry (ACTRN12619000241134).