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JAMA Dermatol. 2017 Jun 1;153(6):587-592. doi: 10.1001/jamadermatol.2017.0160.

Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Standard Reporting and Evaluation Guidelines: Results of a National Institutes of Health Working Group.

Author information

1
Department of Dermatology, University of California, Davis, Sacramento.
2
Department of Dermatology, University of California, San Francisco.
3
Medical Genetics Center, Medical Life Sciences Institute, Department of Medical Sciences, Ministry of Public Health, Nonthaburi, Thailand.
4
Department of Dermatology, University of Pennsylvania, Philadelphia.
5
Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
6
Department of Dermatology, Drug Hypersensitivity Clinical and Research Center, Chang Gung Memorial Hospital, Taipei, Linko and Keelung.
7
Department of Pediatrics, UMKC School of Medicine, Kansas City, Missouri.
8
Food and Drug Administration, Silver Spring, Maryland.
9
Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, England.
10
Division of Dermatology, Department of Medicine, Sunnybrook Health Sciences Center and University of Toronto, Toronto, Ontario, Canada.
11
Department of Pharmacology, Khon Kaen University, Khon Kaen 40002, Thailand.
12
Department of Dermatology, University of Zurich, Gloriastrasse 31, 8091 Zurich, Switzerland.
13
Division of Allergy and Clinical Immunology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
14
Allergy Immunology and Rheumatology Division, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
15
Division of Allergy, Immunology, and Rheumatology, Department of Pediatrics, Mahidol University, Bangkok, Thailand.
16
National Human Genome Research Institute, Rockville, Maryland.

Erratum in

Abstract

Importance:

Toxic epidermal necrolysis (TEN) and Stevens-Johnson Syndrome (SJS) are rare, acute, life-threatening dermatologic disorders involving the skin and mucous membranes. Research into these conditions is hampered by a lack of standardization of case reporting and data collection.

Objective:

To establish a standardized case report form to facilitate comparisons and maintain data quality based on an international panel of SJS/TEN experts who performed a Delphi consensus-building exercise.

Evidence Review:

The elements presented for committee scrutiny were adapted from previous case report forms and from PubMed literature searches of highly cited manuscripts pertaining to SJS/TEN. The expert opinions and experience of the members of the consensus group were included in the discussion.

Findings:

Overall, 21 out of 29 experts who were invited to participate in the online Delphi exercise agreed to participate. Surveys at each stage were administered via an online survery software tool. For the first 2 Delphi rounds, results were analyzed using the Interpercentile Range Adjusted for Symmetry method and statements that passed consensus formulated a new case report form. For the third Delphi round, the case report form was presented to the committee, who agreed that it was "appropriate and useful" for documenting cases of SJS/TEN, making it more reliable and valuable for future research endeavors.

Conclusions and Relevance:

With the consensus of international experts, a case report form for SJS/TEN has been created to help standardize the collection of patient information in future studies and the documentation of individual cases.

PMID:
28296986
DOI:
10.1001/jamadermatol.2017.0160
[Indexed for MEDLINE]
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