TY - JOUR
T1 - Implementation of the HOME core outcome set for clinical trials of atopic eczema—barriers and opportunities
T2 - the HOME IX meeting report
AU - Jacobson, M. E.
AU - Thomas, K. S.
AU - Apfelbacher, C. J.
AU - Leshem, Y. A.
AU - Williams, H. C.
AU - Gerbens, L. A. A.
AU - Spuls, P. I.
AU - Schmitt, J.
AU - Howells, L.
AU - On behalf of the Harmonising Outcome Measures for Eczema (HOME) Initiative
AU - Katoh, N.
AU - Simpson, E. L.
N1 - Funding Information: MEJ reports no conflicts to disclose. KST reports institutional royalties for the licensing of the Patient-Oriented Eczema Measure and employment at the research center where it was developed and was a developer of the Recap of Atopic Eczema instrument. CJA reports grants from Bionorica and the Dr. Wolff Grop, consulting fees from the Dr. Wolff Group, Bionorica, Sanofi-Aventis Germany, and LEO Pharma, support for attending meetings and/or travel from the Dr. Wolff Group, and participation on a Dr. Wolff Group data safety monitoring board and the advisory board of TREAT registry Germany. CJA is the Co-Chair of the Harmonising Outcomes Measures for Eczema initiative. YAL reports a grant from AbbVie, consulting fees from AbbVie, Sanofi, and Pfizer, honoraria from AbbVie, Sanofi, Pfizer, and Janssen, support for attending meetings and/or travel from AbbVie and Sanofi, Participation on Data Safety Monitoring/Advisory Boards of AbbVie, Sanofi, Regeneron Pharmaceuticals, Pfizer, and Dexcel Pharma. HCW was a developer of the Patient-Oriented Eczema Measurement and reports institutional royalties for the licensing of the instrument. LAAG reports an honorarium from Janssen-Cilag. PIS reports institutional royalties for the licensing of the Patient-Oriented Eczema Measure and was a developer of the Recap of Atopic Eczema instrument. PS is the Chief Investigator of the systemic and phototherapy atopic eczema registry (TREAT NL) for adults and children and receives departmental independent research grants for TREAT NL registry from industry. JS reports institutional grants for investigator-initiated research from the German GBA, the BMG, BMBF, EU, Federal State of Saxony, Novartis, Sanofi, ALK, and Pfizer, and participated in advisory board meetings as a paid consultant for Sanofi, Lilly, and ALK. LH reports institutional royalties for the licensing of the Patient-Oriented Eczema Measure and employment at the research center where it was developed and was a developer of the Recap of Atopic Eczema instrument. LH received consultation fees from the University of Oxford on an educational grant funded by Pfizer, unrelated to submitted work. NK reports institutional grants from Mitsubishi Tanabe Pharma, Taiho Pharmaceutical, Torii Pharmaceutical, Maruho. Kyowa Kirin, Eli Lilly Japan, Sanofi, Jansen Pharma, Eisai, A2 Healthcare, Leo Pharma, Boehringer Ingelheim Japan, and AbbVie and honoraria from Maruho, AbbVie, Eli Lilly Japan, Sanofi, Mitsubishi Tanabe Pharma, Jansen Pharma, Taiho Pharmaceutical, Leo Pharma, Torii Pharmaceutical, Kyowa Kirin, and Celgene Japan. NH participated in data safety monitoring and advisory boards and received payments from Leo Pharma, Eli Lilly Japan, AbbVie, and Sanofi. ELS is the Co-Chair of the Harmonising Outcomes Measures for Eczema initiative. KST, CJA, YL, HCW, LAAG, PS, JS, LH, NK, and ELS are members of the HOME Executive Committee. Publisher Copyright: © 2023, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.
PY - 2023/11
Y1 - 2023/11
N2 - The Harmonising Outcome Measures for Eczema (HOME) initiative established a core outcome set (COS) for atopic eczema (AE) clinical trials in 2019. This set encompasses four core outcome domains and corresponding measurement instruments: clinical signs (EASI), patient-reported symptoms (POEM and NRS 11 point for worst itch over the last 24 h), quality of life (DLQI/CDLQI/IDQoLI), and long-term control (Recap or ADCT). Following its roadmap, the HOME initiative is now focused on supporting implementation of the COS. To identify barriers and facilitators to implementation of the COS, and to guide the effort to promote COS uptake, a virtual consensus meeting was held over 2 days (September 25–26, 2021) attended by 55 participants (26 healthcare professionals, 16 methodologists, 5 patients, 4 industry representatives, and 4 students). Implementation themes were identified by a pre-meeting survey distributed to HOME members, presentations, and whole-group discussion. Participants were divided into five multi-professional small groups which ranked their top 3 most important themes, followed by whole-group discussion and anonymous consensus voting (consensus criteria: < 30% disagreement). Three most important implementation themes were identified and agreed upon: (1) awareness and stakeholder engagement, (2) universal applicability of the COS, and (3) ensuring minimum administrative burden. Working groups to address these issues are now a priority for the HOME initiative. The results from this meeting will inform the development of a HOME Implementation Roadmap in an effort to support other COS groups planning for effective implementation of their core sets.
AB - The Harmonising Outcome Measures for Eczema (HOME) initiative established a core outcome set (COS) for atopic eczema (AE) clinical trials in 2019. This set encompasses four core outcome domains and corresponding measurement instruments: clinical signs (EASI), patient-reported symptoms (POEM and NRS 11 point for worst itch over the last 24 h), quality of life (DLQI/CDLQI/IDQoLI), and long-term control (Recap or ADCT). Following its roadmap, the HOME initiative is now focused on supporting implementation of the COS. To identify barriers and facilitators to implementation of the COS, and to guide the effort to promote COS uptake, a virtual consensus meeting was held over 2 days (September 25–26, 2021) attended by 55 participants (26 healthcare professionals, 16 methodologists, 5 patients, 4 industry representatives, and 4 students). Implementation themes were identified by a pre-meeting survey distributed to HOME members, presentations, and whole-group discussion. Participants were divided into five multi-professional small groups which ranked their top 3 most important themes, followed by whole-group discussion and anonymous consensus voting (consensus criteria: < 30% disagreement). Three most important implementation themes were identified and agreed upon: (1) awareness and stakeholder engagement, (2) universal applicability of the COS, and (3) ensuring minimum administrative burden. Working groups to address these issues are now a priority for the HOME initiative. The results from this meeting will inform the development of a HOME Implementation Roadmap in an effort to support other COS groups planning for effective implementation of their core sets.
KW - Atopic eczema
KW - Core outcome set implementation
KW - Core outcome sets
KW - Harmonising outcome measures for eczema initiative
UR - http://www.scopus.com/inward/record.url?scp=85164779138&partnerID=8YFLogxK
U2 - https://doi.org/10.1007/s00403-023-02647-w
DO - https://doi.org/10.1007/s00403-023-02647-w
M3 - Article
C2 - 37432466
SN - 0340-3696
VL - 315
SP - 2617
EP - 2622
JO - Archives of Dermatological Research
JF - Archives of Dermatological Research
IS - 9
ER -