The HOME Core outcome set for clinical trials of atopic dermatitis
Core outcome sets are critically important outcomes that should be measured in clinical trials. Their absence in atopic dermatitis is a form of research waste and impedes combining evidence to inform patient care. Here, we articulate the rationale for core outcome sets in atopic dermatitis and revie...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Journal Article |
| Language: | English |
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2022
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| Online Access: | https://hdl.handle.net/10356/162611 |
| _version_ | 1824456719795748864 |
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| author | Williams, Hywel C. Schmitt, Jochen Thomas, Kim S. Spuls, Phyllis I. Simpson, Eric L. Apfelbacher, Christian Chalmers, Joanne R. Furue, Masutaka Katoh, Norito Gerbens, Louise A. A. Leshem, Yael A. Howells, Laura Singh, Jasvinder A. Boers, Maarten |
| author2 | Lee Kong Chian School of Medicine (LKCMedicine) |
| author_facet | Lee Kong Chian School of Medicine (LKCMedicine) Williams, Hywel C. Schmitt, Jochen Thomas, Kim S. Spuls, Phyllis I. Simpson, Eric L. Apfelbacher, Christian Chalmers, Joanne R. Furue, Masutaka Katoh, Norito Gerbens, Louise A. A. Leshem, Yael A. Howells, Laura Singh, Jasvinder A. Boers, Maarten |
| author_sort | Williams, Hywel C. |
| collection | NTU |
| description | Core outcome sets are critically important outcomes that should be measured in clinical trials. Their absence in atopic dermatitis is a form of research waste and impedes combining evidence to inform patient care. Here, we articulate the rationale for core outcome sets in atopic dermatitis and review the work of the international Harmonising Outcome Measures for Eczema group from its inception in Munich, 2010. We describe core domain determination (what should be measured), to instrument selection (how domains should be measured), culminating in the complete core outcome measurement set in Tokyo, 2019. Using a "road map," Harmonising Outcome Measures for Eczema includes diverse research methods including Delphi and nominal group techniques informed by systematic reviews of properties of candidate instruments. The 4 domains and recommended instruments for including in all clinical trials of atopic dermatitis are patient symptoms, measured by Patient-Oriented Eczema Measure and peak Numerical Rating Scale 11 for itch intensity over 24 hours, clinical signs measured using the Eczema Area and Severity Index, quality of life measured by the Dermatology Life Quality Index series for adults, children, and infants, and long-term control measured by either Recap of atopic eczema or Atopic Dermatitis Control Tool. |
| first_indexed | 2025-02-19T03:58:35Z |
| format | Journal Article |
| id | ntu-10356/162611 |
| institution | Nanyang Technological University |
| language | English |
| last_indexed | 2025-02-19T03:58:35Z |
| publishDate | 2022 |
| record_format | dspace |
| spelling | ntu-10356/1626112023-03-05T16:51:01Z The HOME Core outcome set for clinical trials of atopic dermatitis Williams, Hywel C. Schmitt, Jochen Thomas, Kim S. Spuls, Phyllis I. Simpson, Eric L. Apfelbacher, Christian Chalmers, Joanne R. Furue, Masutaka Katoh, Norito Gerbens, Louise A. A. Leshem, Yael A. Howells, Laura Singh, Jasvinder A. Boers, Maarten Lee Kong Chian School of Medicine (LKCMedicine) Science::Medicine Atopic Dermatitis Eczema Core outcome sets are critically important outcomes that should be measured in clinical trials. Their absence in atopic dermatitis is a form of research waste and impedes combining evidence to inform patient care. Here, we articulate the rationale for core outcome sets in atopic dermatitis and review the work of the international Harmonising Outcome Measures for Eczema group from its inception in Munich, 2010. We describe core domain determination (what should be measured), to instrument selection (how domains should be measured), culminating in the complete core outcome measurement set in Tokyo, 2019. Using a "road map," Harmonising Outcome Measures for Eczema includes diverse research methods including Delphi and nominal group techniques informed by systematic reviews of properties of candidate instruments. The 4 domains and recommended instruments for including in all clinical trials of atopic dermatitis are patient symptoms, measured by Patient-Oriented Eczema Measure and peak Numerical Rating Scale 11 for itch intensity over 24 hours, clinical signs measured using the Eczema Area and Severity Index, quality of life measured by the Dermatology Life Quality Index series for adults, children, and infants, and long-term control measured by either Recap of atopic eczema or Atopic Dermatitis Control Tool. Published version Details of funding for each of the consensus meetings is outlined in the published meeting reports. The following additional funding sources contributed to facilitating the HOME COS development: National Institute for Health and Care Research Senior Investigator award to Prof Hywel Williams (RE 2374) funded travel costs to enable UK patients to participate in HOME meetings; National Institute for Health and Care Research Programme Grant for Applied Research RP-PG-0407-10177 ‘‘Setting Priorities and Reducing Uncertainties for the Prevention and Treatment of Skin Disease (SPRUSD)’’ was used to support completion of the some of the systematic reviews, the cost of meetings and patient and public involvement (Prof Kim Thomas); NIH NIAMS A Community-based Assessment of Skin Care, Allergies, and Eczema: The CASCADE Trial grant number 5 R01 AR071057-05 and Oregon Clinical and Translational Research Institute (OCTRI) assisted with outcome evaluations and associated travel costs (Prof Eric Simpson); Laura Howells received a PhD studentship from the British Skin Foundation (Ref: 8016) for studies that informed this work. 2022-11-01T03:07:57Z 2022-11-01T03:07:57Z 2022 Journal Article Williams, H. C., Schmitt, J., Thomas, K. S., Spuls, P. I., Simpson, E. L., Apfelbacher, C., Chalmers, J. R., Furue, M., Katoh, N., Gerbens, L. A. A., Leshem, Y. A., Howells, L., Singh, J. A. & Boers, M. (2022). The HOME Core outcome set for clinical trials of atopic dermatitis. Journal of Allergy and Clinical Immunology, 149(6), 1899-1911. https://dx.doi.org/10.1016/j.jaci.2022.03.017 0091-6749 https://hdl.handle.net/10356/162611 10.1016/j.jaci.2022.03.017 35351441 2-s2.0-85129445332 6 149 1899 1911 en Journal of Allergy and Clinical Immunology © 2022 The Authors. Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). application/pdf |
| spellingShingle | Science::Medicine Atopic Dermatitis Eczema Williams, Hywel C. Schmitt, Jochen Thomas, Kim S. Spuls, Phyllis I. Simpson, Eric L. Apfelbacher, Christian Chalmers, Joanne R. Furue, Masutaka Katoh, Norito Gerbens, Louise A. A. Leshem, Yael A. Howells, Laura Singh, Jasvinder A. Boers, Maarten The HOME Core outcome set for clinical trials of atopic dermatitis |
| title | The HOME Core outcome set for clinical trials of atopic dermatitis |
| title_full | The HOME Core outcome set for clinical trials of atopic dermatitis |
| title_fullStr | The HOME Core outcome set for clinical trials of atopic dermatitis |
| title_full_unstemmed | The HOME Core outcome set for clinical trials of atopic dermatitis |
| title_short | The HOME Core outcome set for clinical trials of atopic dermatitis |
| title_sort | home core outcome set for clinical trials of atopic dermatitis |
| topic | Science::Medicine Atopic Dermatitis Eczema |
| url | https://hdl.handle.net/10356/162611 |
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