Scientific Publications by FDA Staff

JAMA Dermatol 2017 Jun 1;153(6):587-92

Stevens-Johnson Syndrome and toxic epidermal necrolysis standard reporting and evaluation guidelines: results of a National Institutes of Health working group.

Maverakis E, Wang EA, Shinkai K, Mahasirimongkol S, Margolis DJ, Avigan M, Chung WH, Goldman J, La Grenade L, Pirmohamed M, Shear NH, Tassaeeyakul W, Hoetzenecker W, Klaewsongkram J, Rerkpattanapipat T, Manuyakorn W, Yasuda SU, Sharon VR, Sukhov A, Micheletti R, Struewing J, French LE, Cheng MY

IMPORTNACE: 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.