{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,12]],"date-time":"2026-01-12T21:14:42Z","timestamp":1768252482885,"version":"3.49.0"},"reference-count":28,"publisher":"BMJ","issue":"8","license":[{"start":{"date-parts":[[2022,8,17]],"date-time":"2022-08-17T00:00:00Z","timestamp":1660694400000},"content-version":"unspecified","delay-in-days":16,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2022,7,27]]},"published-print":{"date-parts":[[2022,8]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>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-\u03b3 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>Australian New Zealand Clinical Trials Registry (ACTRN12619000241134).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-055906","type":"journal-article","created":{"date-parts":[[2022,8,17]],"date-time":"2022-08-17T11:05:13Z","timestamp":1660734313000},"page":"e055906","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":9,"title":["Study protocol: Australasian Registry of Severe Cutaneous Adverse Reactions (AUS-SCAR)"],"prefix":"10.1136","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0469-5666","authenticated-orcid":false,"given":"Fiona","family":"James","sequence":"first","affiliation":[{"name":"Centre for Antibiotic Allergy & Research, Department of Infectious Diseases, Austin Health, Heidelberg, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michelle S Y","family":"Goh","sequence":"additional","affiliation":[{"name":"Department of Dermatology, St Vincent's Hospital Melbourne Pty Ltd, Fitzroy, Victoria, Australia"},{"name":"Department of Dermatology, Alfred Health, Melbourne, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Effie","family":"Mouhtouris","sequence":"additional","affiliation":[{"name":"Centre for Antibiotic Allergy & Research, Department of Infectious Diseases, Austin Health, Heidelberg, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sara","family":"Vogrin","sequence":"additional","affiliation":[{"name":"Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kyra Y L","family":"Chua","sequence":"additional","affiliation":[{"name":"Centre for Antibiotic Allergy & Research, Department of Infectious Diseases, Austin Health, Heidelberg, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Natasha E","family":"Holmes","sequence":"additional","affiliation":[{"name":"Centre for Antibiotic Allergy & Research, Department of Infectious Diseases, Austin Health, Heidelberg, Victoria, Australia"},{"name":"Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Awad","sequence":"additional","affiliation":[{"name":"Centre for Antibiotic Allergy & Research, Department of Infectious Diseases, Austin Health, Heidelberg, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9183-5032","authenticated-orcid":false,"given":"Ana-Maria","family":"Copaescu","sequence":"additional","affiliation":[{"name":"Centre for Antibiotic Allergy & Research, Department of Infectious Diseases, Austin Health, Heidelberg, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6541-5512","authenticated-orcid":false,"given":"Joseph F","family":"De Luca","sequence":"additional","affiliation":[{"name":"Centre for Antibiotic Allergy & Research, Department of Infectious Diseases, Austin Health, Heidelberg, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Celia","family":"Zubrinich","sequence":"additional","affiliation":[{"name":"Allergy, Asthma & Clinical Immunology, Alfred Health, Melbourne, Victoria, Australia"},{"name":"School of Public Health and Preventive Medicine, Monash University, Clayton, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Douglas","family":"Gin","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Alfred Hospital, Melbourne, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Heather","family":"Cleland","sequence":"additional","affiliation":[{"name":"Victorian Adult Burns Service, Alfred Hospital, Melbourne, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abby","family":"Douglas","sequence":"additional","affiliation":[{"name":"Infectious Diseases and Infection Control, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Johannes S","family":"Kern","sequence":"additional","affiliation":[{"name":"Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia"},{"name":"Dermatology Department, The Royal Melbourne Hospital, Melbourne, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Constance H","family":"Katelaris","sequence":"additional","affiliation":[{"name":"Department of Immunology, Campbelltown Hospital, Campbelltown, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francis","family":"Thien","sequence":"additional","affiliation":[{"name":"Eastern Health Clinical School, Monash University, Clayton, Victoria, Australia"},{"name":"Department of Respiratory and Sleep Medicine, Eastern Health, Box Hill, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sara","family":"Barnes","sequence":"additional","affiliation":[{"name":"Monash Lung Sleep Allergy and Immunology, Monash Health, Clayton, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James","family":"Yun","sequence":"additional","affiliation":[{"name":"Immunology and Rheumatology, Nepean Hospital, Penrith, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Winnie","family":"Tong","sequence":"additional","affiliation":[{"name":"HIV & Immunology, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia"},{"name":"School of Clinical Medicine, St Vincent's Healthcare Clinical Campus, Faculty of Medicine and Health, UNSW, Sydney, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William B","family":"Smith","sequence":"additional","affiliation":[{"name":"Clinical Immunology and Allergy, Royal Adelaide Hospital, Adelaide, South Australia, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Carr","sequence":"additional","affiliation":[{"name":"HIV & Immunology, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tara","family":"Anderson","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases, Royal Hobart Hospital, Hobart, Tasmania, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amy","family":"Legg","sequence":"additional","affiliation":[{"name":"Pharmacy Department, Royal Darwin Hospital, Casuarina, Northern Territory, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jack","family":"Bourke","sequence":"additional","affiliation":[{"name":"Department of Immunology, Fiona Stanley Hospital, Murdoch, Western Australia, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura K","family":"Mackay","sequence":"additional","affiliation":[{"name":"Department of Microbiology and Immunology, The University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ar Kar","family":"Aung","sequence":"additional","affiliation":[{"name":"Department of General Medicine, Alfred Hospital, Melbourne, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elizabeth J","family":"Phillips","sequence":"additional","affiliation":[{"name":"Institute for Immunology and Infectious Diseases, Murdoch University, Murdoch, Western Australia, Australia"},{"name":"Departments of Medicine, Dermatology, Pathology, Microbiology, Immunology and Pharmacology, Vanderbilt University Medical Center, Nashville, Tennessee, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5111-6367","authenticated-orcid":false,"given":"Jason","family":"Trubiano","sequence":"additional","affiliation":[{"name":"Centre for Antibiotic Allergy & Research, Department of Infectious Diseases, Austin Health, Heidelberg, Victoria, Australia"},{"name":"Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia"},{"name":"National Centre for Infections in Cancer, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2022,8,17]]},"reference":[{"key":"2025121422425460000_12.8.e055906.1","doi-asserted-by":"crossref","first-page":"561","DOI":"10.1097\/QCO.0000000000000323","article-title":"Old dog Begging for new tricks: current practices and future directions in the diagnosis of delayed antimicrobial hypersensitivity","volume":"29","author":"Konvinse","year":"2016","journal-title":"Curr Opin Infect Dis"},{"key":"2025121422425460000_12.8.e055906.2","doi-asserted-by":"crossref","first-page":"1996","DOI":"10.1016\/S0140-6736(16)30378-6","article-title":"Severe cutaneous adverse reactions to drugs","volume":"390","author":"Duong","year":"2017","journal-title":"Lancet"},{"key":"2025121422425460000_12.8.e055906.3","doi-asserted-by":"crossref","first-page":"1187","DOI":"10.1016\/j.jaip.2016.04.026","article-title":"A comparative analysis between Antibiotic- and Nonantibiotic-Associated delayed cutaneous adverse drug reactions","volume":"4","author":"Trubiano","year":"2016","journal-title":"J Allergy Clin Immunol Pract"},{"key":"2025121422425460000_12.8.e055906.4","doi-asserted-by":"crossref","first-page":"575","DOI":"10.1111\/j.1365-4632.2012.05743.x","article-title":"Stevens-Johnson syndrome and toxic epidermal necrolysis in sub-Saharan Africa: a multicentric study in four countries","volume":"52","author":"Saka","year":"2013","journal-title":"Int J Dermatol"},{"key":"2025121422425460000_12.8.e055906.5","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciu126"},{"key":"2025121422425460000_12.8.e055906.6","doi-asserted-by":"crossref","first-page":"1339","DOI":"10.1111\/ijd.12118","article-title":"Severe cutaneous adverse reactions in a local hospital setting: a 5-year retrospective study","volume":"53","author":"Su","year":"2014","journal-title":"Int J Dermatol"},{"key":"2025121422425460000_12.8.e055906.7","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.12501"},{"key":"2025121422425460000_12.8.e055906.8","first-page":"15","article-title":"Testing for drug hypersensitivity syndromes","volume":"34","author":"Rive","year":"2013","journal-title":"Clin Biochem Rev"},{"key":"2025121422425460000_12.8.e055906.9","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)32218-9"},{"key":"2025121422425460000_12.8.e055906.10","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2018.10.030"},{"key":"2025121422425460000_12.8.e055906.11","doi-asserted-by":"crossref","first-page":"1341","DOI":"10.1016\/j.jaip.2018.09.014","article-title":"The safety of antibiotic skin testing in severe T-cell-mediated hypersensitivity of immunocompetent and immunocompromised hosts","volume":"7","author":"Trubiano","year":"2019","journal-title":"J Allergy Clin Immunol Pract"},{"key":"2025121422425460000_12.8.e055906.12","doi-asserted-by":"crossref","first-page":"1287","DOI":"10.1016\/j.jaip.2017.09.004","article-title":"The Combined Utility of Ex Vivo IFN-\u03b3 Release Enzyme-Linked ImmunoSpot Assay and In Vivo Skin Testing in Patients with Antibiotic-Associated Severe Cutaneous Adverse Reactions","volume":"6","author":"Trubiano","year":"2018","journal-title":"J Allergy Clin Immunol Pract"},{"key":"2025121422425460000_12.8.e055906.13","doi-asserted-by":"crossref","first-page":"38","DOI":"10.1016\/j.jaip.2017.11.023","article-title":"SJS\/TEN 2017: building multidisciplinary networks to drive science and translation","volume":"6","author":"White","year":"2018","journal-title":"J Allergy Clin Immunol Pract"},{"key":"2025121422425460000_12.8.e055906.14","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0706135"},{"key":"2025121422425460000_12.8.e055906.15","doi-asserted-by":"publisher","DOI":"10.4049\/jimmunol.1302306"},{"key":"2025121422425460000_12.8.e055906.16","doi-asserted-by":"publisher","DOI":"10.1111\/j.1398-9995.2007.01553.x"},{"key":"2025121422425460000_12.8.e055906.17","doi-asserted-by":"crossref","DOI":"10.3390\/ijms18081737","article-title":"In vitro assays in severe cutaneous adverse drug reactions: are they still research tools or diagnostic tests already?","volume":"18","author":"Porebski","year":"2017","journal-title":"Int J Mol Sci"},{"key":"2025121422425460000_12.8.e055906.18","doi-asserted-by":"crossref","first-page":"228","DOI":"10.1016\/j.jaip.2018.07.011","article-title":"Prevention and diagnosis of severe T-cell-mediated adverse drug reactions: are we there yet?","volume":"7","author":"Redwood","year":"2019","journal-title":"J Allergy Clin Immunol Pract"},{"key":"2025121422425460000_12.8.e055906.19","doi-asserted-by":"crossref","first-page":"219","DOI":"10.1016\/j.jaip.2018.05.004","article-title":"Analysis of HLA-B allelic variation and IFN-\u03b3 ELISpot responses in patients with severe cutaneous adverse reactions associated with drugs","volume":"7","author":"Klaewsongkram","year":"2019","journal-title":"J Allergy Clin Immunol Pract"},{"key":"2025121422425460000_12.8.e055906.20","doi-asserted-by":"crossref","unstructured":"Pichler WJ . Drug hypersensitivity: Karger publishers, 2007.","DOI":"10.1159\/isbn.978-3-318-01454-9"},{"key":"2025121422425460000_12.8.e055906.21","doi-asserted-by":"crossref","first-page":"2010","DOI":"10.1016\/j.jaip.2020.12.052","article-title":"The Role of In Vivo and Ex Vivo Diagnostic Tools in Severe Delayed Immune-Mediated Adverse Antibiotic Drug Reactions","volume":"9","author":"Copaescu","year":"2021","journal-title":"J Allergy Clin Immunol Pract"},{"key":"2025121422425460000_12.8.e055906.22","doi-asserted-by":"crossref","DOI":"10.3389\/fphar.2020.573573","article-title":"An updated review of the diagnostic methods in delayed drug hypersensitivity","volume":"11","author":"Copaescu","year":"2020","journal-title":"Front Pharmacol"},{"key":"2025121422425460000_12.8.e055906.23","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.12501"},{"key":"2025121422425460000_12.8.e055906.24","doi-asserted-by":"crossref","first-page":"929","DOI":"10.1016\/j.jaip.2020.09.011","article-title":"Korean severe cutaneous adverse reactions Consortium. A nationwide study of severe cutaneous adverse reactions based on the multicenter registry in Korea","volume":"9","author":"Kang","year":"2021","journal-title":"J Allergy Clin Immunol Pract"},{"key":"2025121422425460000_12.8.e055906.25","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.i5239"},{"key":"2025121422425460000_12.8.e055906.26","doi-asserted-by":"publisher","DOI":"10.1038\/kisup.2012.1"},{"key":"2025121422425460000_12.8.e055906.27","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2011.58"},{"key":"2025121422425460000_12.8.e055906.28","doi-asserted-by":"crossref","first-page":"330","DOI":"10.1016\/j.anai.2010.12.014","article-title":"Development and validation of the drug hypersensitivity quality of life questionnaire","volume":"106","author":"Baiardini","year":"2011","journal-title":"Ann Allergy Asthma Immunol"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2021-055906","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T06:43:07Z","timestamp":1765780987000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2021-055906"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,8]]},"references-count":28,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2022,8,17]]},"published-print":{"date-parts":[[2022,8]]}},"alternative-id":["10.1136\/bmjopen-2021-055906"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2021-055906","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,8]]}}}