Stevens-Johnson syndrome and toxic epidermal necrolysis standard reporting and evaluation guidelines: Results of a National Institutes of Health working group

Emanual Michael Maverakis, Elizabeth A. Wang, Kanade Shinkai, Surakameth Mahasirimongkol, David J. Margolis, Mark Avigan, Wen Hung Chung, Jennifer Goldman, Lois La Grenade, Munir Pirmohamed, Neil H. Shear, Wichittra Tassaeeyakul, Wolfram Hoetzenecker, Jettanong Klaewsongkram, Ticha Rerkpattanapipat, Wiparat Manuyakorn, Sally Usdin Yasuda, Victoria R. Sharon, Andrea Sukhov, Robert MichelettiJeff Struewing, Lars E. French, Michelle Y. Cheng

Research output: Contribution to journalArticle

13 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)587-592
Number of pages6
JournalJAMA Dermatology
Volume153
Issue number6
DOIs
StatePublished - Jun 1 2017

Fingerprint

Stevens-Johnson Syndrome
National Institutes of Health (U.S.)
Guidelines
Exercise
Manuscripts
Expert Testimony
PubMed
Documentation
Mucous Membrane
Software
Skin
Research

ASJC Scopus subject areas

  • Dermatology

Cite this

Stevens-Johnson syndrome and toxic epidermal necrolysis standard reporting and evaluation guidelines : Results of a National Institutes of Health working group. / Maverakis, Emanual Michael; Wang, Elizabeth A.; Shinkai, Kanade; Mahasirimongkol, Surakameth; Margolis, David J.; Avigan, Mark; Chung, Wen Hung; Goldman, Jennifer; La Grenade, Lois; Pirmohamed, Munir; Shear, Neil H.; Tassaeeyakul, Wichittra; Hoetzenecker, Wolfram; Klaewsongkram, Jettanong; Rerkpattanapipat, Ticha; Manuyakorn, Wiparat; Yasuda, Sally Usdin; Sharon, Victoria R.; Sukhov, Andrea; Micheletti, Robert; Struewing, Jeff; French, Lars E.; Cheng, Michelle Y.

In: JAMA Dermatology, Vol. 153, No. 6, 01.06.2017, p. 587-592.

Research output: Contribution to journalArticle

Maverakis, EM, 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 2017, 'Stevens-Johnson syndrome and toxic epidermal necrolysis standard reporting and evaluation guidelines: Results of a National Institutes of Health working group', JAMA Dermatology, vol. 153, no. 6, pp. 587-592. https://doi.org/10.1001/jamadermatol.2017.0160
Maverakis, Emanual Michael ; Wang, Elizabeth A. ; Shinkai, Kanade ; Mahasirimongkol, Surakameth ; Margolis, David J. ; Avigan, Mark ; Chung, Wen Hung ; Goldman, Jennifer ; La Grenade, Lois ; Pirmohamed, Munir ; Shear, Neil H. ; Tassaeeyakul, Wichittra ; Hoetzenecker, Wolfram ; Klaewsongkram, Jettanong ; Rerkpattanapipat, Ticha ; Manuyakorn, Wiparat ; Yasuda, Sally Usdin ; Sharon, Victoria R. ; Sukhov, Andrea ; Micheletti, Robert ; Struewing, Jeff ; French, Lars E. ; Cheng, Michelle Y. / Stevens-Johnson syndrome and toxic epidermal necrolysis standard reporting and evaluation guidelines : Results of a National Institutes of Health working group. In: JAMA Dermatology. 2017 ; Vol. 153, No. 6. pp. 587-592.
@article{383ec34470e4438fb6ad05cd29e4f404,
title = "Stevens-Johnson syndrome and toxic epidermal necrolysis standard reporting and evaluation guidelines: Results of a National Institutes of Health working group",
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.",
author = "Maverakis, {Emanual Michael} and Wang, {Elizabeth A.} and Kanade Shinkai and Surakameth Mahasirimongkol and Margolis, {David J.} and Mark Avigan and Chung, {Wen Hung} and Jennifer Goldman and {La Grenade}, Lois and Munir Pirmohamed and Shear, {Neil H.} and Wichittra Tassaeeyakul and Wolfram Hoetzenecker and Jettanong Klaewsongkram and Ticha Rerkpattanapipat and Wiparat Manuyakorn and Yasuda, {Sally Usdin} and Sharon, {Victoria R.} and Andrea Sukhov and Robert Micheletti and Jeff Struewing and French, {Lars E.} and Cheng, {Michelle Y.}",
year = "2017",
month = "6",
day = "1",
doi = "10.1001/jamadermatol.2017.0160",
language = "English (US)",
volume = "153",
pages = "587--592",
journal = "JAMA Dermatology",
issn = "2168-6068",
publisher = "American Medical Association",
number = "6",

}

TY - JOUR

T1 - Stevens-Johnson syndrome and toxic epidermal necrolysis standard reporting and evaluation guidelines

T2 - Results of a National Institutes of Health working group

AU - Maverakis, Emanual Michael

AU - Wang, Elizabeth A.

AU - Shinkai, Kanade

AU - Mahasirimongkol, Surakameth

AU - Margolis, David J.

AU - Avigan, Mark

AU - Chung, Wen Hung

AU - Goldman, Jennifer

AU - La Grenade, Lois

AU - Pirmohamed, Munir

AU - Shear, Neil H.

AU - Tassaeeyakul, Wichittra

AU - Hoetzenecker, Wolfram

AU - Klaewsongkram, Jettanong

AU - Rerkpattanapipat, Ticha

AU - Manuyakorn, Wiparat

AU - Yasuda, Sally Usdin

AU - Sharon, Victoria R.

AU - Sukhov, Andrea

AU - Micheletti, Robert

AU - Struewing, Jeff

AU - French, Lars E.

AU - Cheng, Michelle Y.

PY - 2017/6/1

Y1 - 2017/6/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85020705080&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85020705080&partnerID=8YFLogxK

U2 - 10.1001/jamadermatol.2017.0160

DO - 10.1001/jamadermatol.2017.0160

M3 - Article

C2 - 28296986

AN - SCOPUS:85020705080

VL - 153

SP - 587

EP - 592

JO - JAMA Dermatology

JF - JAMA Dermatology

SN - 2168-6068

IS - 6

ER -