Evidence map›Paper›PMID 35977774›Full record

ArticleBMJ open2022

Study protocol: Australasian Registry of Severe Cutaneous Adverse Reactions (AUS-SCAR).

Fiona James, Michelle S Y Goh, Effie Mouhtouris, Sara Vogrin, Kyra Y L Chua, Natasha E Holmes, Andrew Awad, Ana-Maria Copaescu, Joseph F De Luca, Celia Zubrinich and 18 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.7field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors at 18 institutions in 2 countries.

Fiona JamesCentre for Antibiotic Allergy & Research, Department of Infectious Diseases, Austin Health, Heidelberg, Victoria, Australia Fiona.JAMES@austin.org.au.ORCID 0000-0003-0469-5666
Michelle S Y GohDepartment of Dermatology, St Vincent's Hospital Melbourne Pty Ltd, Fitzroy, Victoria, Australia.
Effie MouhtourisCentre for Antibiotic Allergy & Research, Department of Infectious Diseases, Austin Health, Heidelberg, Victoria, Australia.
Sara VogrinDepartment of Medicine, The University of Melbourne, Melbourne, Victoria, Australia.
Kyra Y L ChuaCentre for Antibiotic Allergy & Research, Department of Infectious Diseases, Austin Health, Heidelberg, Victoria, Australia.
Natasha E HolmesCentre for Antibiotic Allergy & Research, Department of Infectious Diseases, Austin Health, Heidelberg, Victoria, Australia.
Andrew AwadCentre for Antibiotic Allergy & Research, Department of Infectious Diseases, Austin Health, Heidelberg, Victoria, Australia.
Ana-Maria CopaescuCentre for Antibiotic Allergy & Research, Department of Infectious Diseases, Austin Health, Heidelberg, Victoria, Australia.ORCID 0000-0002-9183-5032
Joseph F De LucaCentre for Antibiotic Allergy & Research, Department of Infectious Diseases, Austin Health, Heidelberg, Victoria, Australia.ORCID 0000-0001-6541-5512
Celia ZubrinichAllergy, Asthma & Clinical Immunology, Alfred Health, Melbourne, Victoria, Australia.
Douglas GinDepartment of Dermatology, Alfred Hospital, Melbourne, Victoria, Australia.
Heather ClelandVictorian Adult Burns Service, Alfred Hospital, Melbourne, Victoria, Australia.
Abby DouglasInfectious Diseases and Infection Control, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
Johannes S KernDepartment of Medicine, The University of Melbourne, Melbourne, Victoria, Australia.
Constance H KatelarisDepartment of Immunology, Campbelltown Hospital, Campbelltown, New South Wales, Australia.
Francis ThienEastern Health Clinical School, Monash University, Clayton, Victoria, Australia.
Sara BarnesMonash Lung Sleep Allergy and Immunology, Monash Health, Clayton, Victoria, Australia.
James YunImmunology and Rheumatology, Nepean Hospital, Penrith, New South Wales, Australia.
Winnie TongHIV & Immunology, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia.
William B SmithClinical Immunology and Allergy, Royal Adelaide Hospital, Adelaide, South Australia, Australia.
Andrew CarrHIV & Immunology, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia.
Tara AndersonDepartment of Infectious Diseases, Royal Hobart Hospital, Hobart, Tasmania, Australia.
Amy LeggPharmacy Department, Royal Darwin Hospital, Casuarina, Northern Territory, Australia.
Jack BourkeDepartment of Immunology, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.
Laura K MackayDepartment of Microbiology and Immunology, The University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
Ar Kar AungDepartment of General Medicine, Alfred Hospital, Melbourne, Victoria, Australia.
Elizabeth J PhillipsInstitute for Immunology and Infectious Diseases, Murdoch University, Murdoch, Western Australia, Australia.
Jason TrubianoCentre for Antibiotic Allergy & Research, Department of Infectious Diseases, Austin Health, Heidelberg, Victoria, Australia.ORCID 0000-0002-5111-6367
Austin Health · AUThe University of Melbourne · AUThe Alfred Hospital · AUAlfred Health · AUCamden and Campbelltown Hospitals · AUEastern Health · AUFiona Stanley Hospital · AUMonash Health · AUMurdoch University · AUNepean Hospital · AUPeter MacCallum Cancer Centre · AURoyal Adelaide Hospital · AURoyal Darwin Hospital · AURoyal Hobart Hospital · AUSt Vincent's Hospital Melbourne · AUSt Vincent's Hospital Sydney · AUThe Royal Melbourne Hospital · AUUNSW Sydney · AU

Funding

Immune Tolerance Network UM1 2023 SupplementUM1AI109565 · NIAID · BENAROYA RESEARCH INST AT VIRGINIA MASON · PI Mark S Anderson, Jane Hoyt Buckner · 2014 to 2026
$451.6M
NATIENS: A Phase III Randomized Double Blinded Study to Determine the Mechanisms and Optimal Management of Stevens-Johnson Syndrome and Toxic Epidermal NecrolysisU01AI154659 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · PI PHILLIPS, ELIZABETH · 2020 to 2025
$15.5M
Genetic risk and long-term outcomes associated with Drug-induced Stevens-Johnson syndrome and toxic epidermal necrolysis in survivorsR01HG010863 · NHGRI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI PHILLIPS, ELIZABETH · 2019 to 2022
$3.1M
Immune-mediated adverse drug reactions to HIV and TB treatments in South Africa: predict, prevent and improve long-term outcomes (IMARI SA study)R01AI152183 · NIAID · UNIVERSITY OF CAPE TOWN · PI MEINTJES, GRAEME AYTON, PHILLIPS, ELIZABETH · 2020 to 2025
$1.6M
Stevens-Johnson syndrome/toxic epidermal necrolysis 2021: Collaboration, Innovation and CommunityR13AR078623 · NIAMS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI PHILLIPS, ELIZABETH · 2021 to 2021
$33k
NHGRI NIH HHS R01 HG010863NIAID NIH HHS R01 AI152183NIAID NIH HHS U01 AI154659NIAID NIH HHS UM1 AI109565NIAMS NIH HHS R13 AR078623NIMH NIH HHS R01 AI152183
6 · The paper itself

Abstract

introductionSevere 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).

Indexed as

EosinophiliaStevens-Johnson SyndromeAdolescentAdultAustraliaHumansLeukocytes, MononuclearProspective StudiesQuality of LifeRegistriesAdverse eventsCLINICAL PHARMACOLOGYDermatological epidemiologyEPIDEMIOLOGYIMMUNOLOGYPREVENTIVE MEDICINE

Identifiers

PMID35977774
PMCPMC9389100
OpenAlexW4292103613

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.