title: Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Standard Reporting and Evaluation Guidelines: Results of a National Institutes of Health Working Group.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Department of Dermatology, University of California, Davis, Sacramento.
authors.forename: Emanual
authors.initials: E
authors.lastname: Maverakis
authors.affiliation: Department of Dermatology, University of California, Davis, Sacramento.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Wang
authors.affiliation: Department of Dermatology, University of California, San Francisco.
authors.forename: Kanade
authors.initials: K
authors.lastname: Shinkai
authors.affiliation: Medical Genetics Center, Medical Life Sciences Institute, Department of Medical Sciences, Ministry of Public Health, Nonthaburi, Thailand.
authors.forename: Surakameth
authors.initials: S
authors.lastname: Mahasirimongkol
authors.affiliation: Department of Dermatology, University of Pennsylvania, Philadelphia.
authors.forename: David J
authors.initials: DJ
authors.lastname: Margolis
authors.affiliation: Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Mark
authors.initials: M
authors.lastname: Avigan
authors.affiliation: Department of Dermatology, Drug Hypersensitivity Clinical and Research Center, Chang Gung Memorial Hospital, Taipei, Linko and Keelung.
authors.forename: Wen-Hung
authors.initials: WH
authors.lastname: Chung
authors.affiliation: Department of Pediatrics, UMKC School of Medicine, Kansas City, Missouri.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Goldman
authors.affiliation: Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Lois
authors.initials: L
authors.lastname: La Grenade
authors.affiliation: Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, England.
authors.forename: Munir
authors.initials: M
authors.lastname: Pirmohamed
authors.affiliation: Division of Dermatology, Department of Medicine, Sunnybrook Health Sciences Center and University of Toronto, Toronto, Ontario, Canada.
authors.forename: Neil H
authors.initials: NH
authors.lastname: Shear
authors.affiliation: Department of Pharmacology, Khon Kaen University, Khon Kaen 40002, Thailand.
authors.forename: Wichittra
authors.initials: W
authors.lastname: Tassaeeyakul
authors.affiliation: Department of Dermatology, University of Zurich, Gloriastrasse 31, 8091 Zurich, Switzerland.
authors.forename: Wolfram
authors.initials: W
authors.lastname: Hoetzenecker
authors.affiliation: Division of Allergy and Clinical Immunology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
authors.forename: Jettanong
authors.initials: J
authors.lastname: Klaewsongkram
authors.affiliation: Allergy Immunology and Rheumatology Division, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
authors.forename: Ticha
authors.initials: T
authors.lastname: Rerkpattanapipat
authors.affiliation: Division of Allergy, Immunology, and Rheumatology, Department of Pediatrics, Mahidol University, Bangkok, Thailand.
authors.forename: Wiparat
authors.initials: W
authors.lastname: Manuyakorn
authors.affiliation: Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Sally Usdin
authors.initials: SU
authors.lastname: Yasuda
authors.affiliation: Department of Dermatology, University of California, Davis, Sacramento.
authors.forename: Victoria R
authors.initials: VR
authors.lastname: Sharon
authors.affiliation: Department of Dermatology, University of California, Davis, Sacramento.
authors.forename: Andrea
authors.initials: A
authors.lastname: Sukhov
authors.affiliation: Department of Dermatology, University of Pennsylvania, Philadelphia.
authors.forename: Robert
authors.initials: R
authors.lastname: Micheletti
authors.affiliation: National Human Genome Research Institute, Rockville, Maryland.
authors.forename: Jeff
authors.initials: J
authors.lastname: Struewing
authors.affiliation: Department of Dermatology, University of Zurich, Gloriastrasse 31, 8091 Zurich, Switzerland.
authors.forename: Lars E
authors.initials: LE
authors.lastname: French
authors.affiliation: Department of Dermatology, University of California, Davis, Sacramento.
authors.forename: Michelle Y
authors.initials: MY
authors.lastname: Cheng
mesh_terms: D032921:Consensus; D003625:Data Collection / Q000379:methods / Q000592:standards*; D003697:Delphi Technique; D004282:Documentation / Q000379:methods / Q000592:standards*; D006801:Humans; D007391:International Cooperation; D009316:National Institutes of Health (U.S.); D017410:Practice Guidelines as Topic; D013262:Stevens-Johnson Syndrome; D014481:United States