TY - JOUR
T1 - The Harmonising Outcome Measures for Eczema (HOME) implementation roadmap
AU - Leshem, Yael A.
AU - Simpson, Eric L.
AU - Apfelbacher, Christian
AU - Spuls, Phyllis I.
AU - Thomas, Kim S.
AU - Schmitt, Jochen
AU - Howells, Laura
AU - Gerbens, Louise A. A.
AU - Jacobson, Michael E.
AU - Katoh, Norito
AU - Williams, Hywel C.
N1 - Funding Information: Conflicts of interest Y.A.L. has received honoraria or fees from AbbVie, Sanofi, Genentech, Regeneron, Pfizer and Dexcel Pharma, an independent research grant from AbbVie and has – without personal compensation – provided investigator services for Eli Lilly, Pfizer and AbbVie, all unrelated to this study. E.L.S. reports personal fees from Advances in Cosmetic Medical Derm Hawaii, AbbVie, Amgen, AOBiome, Arcutis Biotherapeutics, Arena Pharmaceuticals, Aslan Pharma, Boehringer Ingelheim USA, Boston Consulting Group, Bristol Myers Squibb, Collective Acumen (CA), CorEvitas, Dermira, Eli Lilly, Evelo Biosciences, Evidera, ExcerptaMedica, FIDE, Forte Bio RX, Galderma, GlaxoSmithKline, Incyte, Janssen, Johnson & Johnson, Kyowa Kirin Pharmaceutical Development, LEO Pharma, Medscape, Merck, MauiDerm, MLG Operating, MJH Holding, Pfizer, Physicians World, PRImE, Regeneron, Revolutionizing Atopic Dermatitis, Roivant, Sanofi-Genzyme, Trevi Therapeutics, Valeant, Vindico Medical Education and WebMD. He also reports grants (or serves in a Principal Investigator role for) from AbbVie, Acrotech Biopharma, Amgen, Arcutis, Aslan, Castle Biosciences, CorEvitas, Dermavant, Dermira, Eli Lilly, Incyte, Kymab, Kyowa Kirin, National Jewish Health, LEO, Pfizer, Regeneron, Sanofi and Target RWE. These potential conflicts of interest have been reviewed and managed by Oregon Health & Science University. C.A. has received institutional funding from the Dr Wolff Group and Bionorica, and consultancy fees or honoraria from the Dr Wolff Group, Bionorica, Sanofi, LEO Pharma and RHEACELL. He was also involved in the development and testing of one of the HOME core outcome instruments [Recap of atopic eczema (RECAP)]. P.I.S. has received departmental independent research grants for the TREAT NL registry from pharma since December 2019; is involved in performing clinical trials with many pharmaceutical industries that manufacture drugs used for the treatment of, for example, psoriasis and atopic dermatitis, for which financial compensation is paid to the department/hospital; is Chief Investigator of the systemic and phototherapy atopic eczema registry (TREAT NL) for adults and children; and was involved in the development of one of the HOME core outcome instruments (RECAP). K.S.T. was involved in the development and testing of one of the HOME core outcome instruments (RECAP). J.S. reports institutional grants for investigator-initiated research from the German Federal Joint Committee (G-BA), the Federal Ministry of Health (BMG), Federal Ministry of Research and Education (BMBF), European Union, Federal State of Saxony, Novartis, Sanofi, ALK and Pfizer. He has also participated in advisory board meetings as a paid consultant for Sanofi, Eli Lilly and ALK. L.H. has received consultation fees from the University of Oxford on an educational grant funded by Pfizer, unrelated to the submitted work, and was involved in the development of the RECAP instrument. N.K. has received honoraria as a speaker/consultant for Sanofi, Maruho, AbbVie, Eli Lilly Japan, Mitsubishi Tanabe Pharma, Janssen Pharma, Taiho Pharmaceutical, Torii Pharmaceutical, Kyowa Kirin, Celgene Japan and LEO Pharma; and has received grants as an investigator from Maruho, Eli Lilly Japan, Sun Pharma, Taiho Pharmaceutical, Torii Pharmaceutical, Boehringer Ingelheim Japan, Kyowa Kirin, Jansen Pharma, Boehringer Ingelheim Japan, A2 Healthcare, AbbVie and LEO Pharma. H.C.W. chaired the HOME core outcome set initiative from 2008 to 2021 and was involved in the development of the Patient Oriented Eczema Measure (POEM). H.C.W., K.S.T. and L.H. are employed at the research centre where the POEM was developed. The University of Nottingham owns copyright to license POEM – chargeable for commercial users. L.A.A.G. and M.E.J. declare no conflicts of interest. Publisher Copyright: © The Author(s) 2023.
PY - 2023/12
Y1 - 2023/12
N2 - BACKGROUND: Core outcome sets (COS) are consensus-driven sets of minimum outcomes that should be measured and reported in all clinical trials. COS aim to reduce heterogeneity in outcome measurement and reporting, and selective outcome reporting. Implementing COS into clinical trials is challenging. Guidance to improve COS uptake in dermatology is lacking. OBJECTIVES: To develop a structured practical guide to COS implementation. METHODS: Members of the Harmonising Outcome Measurement for Eczema (HOME) executive committee developed an expert opinion-based roadmap founded on a combination of a review of the COS implementation literature, the Core Outcome Measures in Effectiveness Trials (COMET) initiative resources, input from HOME members and experience in COS development and clinical trials. RESULTS: The data review and input from HOME members was synthesized into themes, which guided roadmap development: (a) barriers and facilitators to COS uptake based on stakeholder awareness/engagement and COS features; and (b) key implementation science principles (assessment-driven, data-centred, priority-based and context-sensitive). The HOME implementation roadmap follows three stages. Firstly, the COS uptake scope and goals need to be defined. Secondly, during COS development, preparation for future implementation is supported by establishing the COS as a credible evidence-informed consensus by applying robust COS development methodology, engaging multiple stakeholders, fostering sustained and global engagement, emphasizing COS ease of use and universal applicability, and providing recommendations on COS use. Thirdly, incorporating completed COS into primary (trials) and secondary (reviews) research is an iterative process starting with mapping COS uptake and stakeholders' attitudes, followed by designing and carrying out targeted implementation projects. Main themes for implementation projects identified at HOME are stakeholder awareness/engagement; universal applicability for different populations; and improving ease-of-use by reducing administrative and study burden. Formal implementation frameworks can be used to identify implementation barriers/facilitators and to design implementation strategies. The effect of these strategies on uptake should be evaluated and implementation plans adjusted accordingly. CONCLUSIONS: COS can improve the quality and applicability of research and, so, clinical practice but can only succeed if used and reported consistently. The HOME implementation roadmap is an extension of the original HOME roadmap for COS development and provides a pragmatic framework to develop COS implementation strategies.
AB - BACKGROUND: Core outcome sets (COS) are consensus-driven sets of minimum outcomes that should be measured and reported in all clinical trials. COS aim to reduce heterogeneity in outcome measurement and reporting, and selective outcome reporting. Implementing COS into clinical trials is challenging. Guidance to improve COS uptake in dermatology is lacking. OBJECTIVES: To develop a structured practical guide to COS implementation. METHODS: Members of the Harmonising Outcome Measurement for Eczema (HOME) executive committee developed an expert opinion-based roadmap founded on a combination of a review of the COS implementation literature, the Core Outcome Measures in Effectiveness Trials (COMET) initiative resources, input from HOME members and experience in COS development and clinical trials. RESULTS: The data review and input from HOME members was synthesized into themes, which guided roadmap development: (a) barriers and facilitators to COS uptake based on stakeholder awareness/engagement and COS features; and (b) key implementation science principles (assessment-driven, data-centred, priority-based and context-sensitive). The HOME implementation roadmap follows three stages. Firstly, the COS uptake scope and goals need to be defined. Secondly, during COS development, preparation for future implementation is supported by establishing the COS as a credible evidence-informed consensus by applying robust COS development methodology, engaging multiple stakeholders, fostering sustained and global engagement, emphasizing COS ease of use and universal applicability, and providing recommendations on COS use. Thirdly, incorporating completed COS into primary (trials) and secondary (reviews) research is an iterative process starting with mapping COS uptake and stakeholders' attitudes, followed by designing and carrying out targeted implementation projects. Main themes for implementation projects identified at HOME are stakeholder awareness/engagement; universal applicability for different populations; and improving ease-of-use by reducing administrative and study burden. Formal implementation frameworks can be used to identify implementation barriers/facilitators and to design implementation strategies. The effect of these strategies on uptake should be evaluated and implementation plans adjusted accordingly. CONCLUSIONS: COS can improve the quality and applicability of research and, so, clinical practice but can only succeed if used and reported consistently. The HOME implementation roadmap is an extension of the original HOME roadmap for COS development and provides a pragmatic framework to develop COS implementation strategies.
UR - http://www.scopus.com/inward/record.url?scp=85177102833&partnerID=8YFLogxK
U2 - https://doi.org/10.1093/bjd/ljad278
DO - https://doi.org/10.1093/bjd/ljad278
M3 - Article
C2 - 37548315
SN - 0007-0963
VL - 189
SP - 710
EP - 718
JO - British Journal of Dermatology
JF - British Journal of Dermatology
IS - 6
ER -