K S Thomas1, C A Apfelbacher2, J R Chalmers1, E Simpson3, P I Spuls4, L A A Gerbens4, H C Williams1, J Schmitt5, M Gabes6, L Howells1, B L Stuart7, E Grinich8, T Pawlitschek8, T Burton9, L Howie10, A Gadkari11, L Eckert12, T Ebata13, M Boers14, H Saeki15, T Nakahara16, N Katoh17. 1. Centre of Evidence Based Dermatology, School of Medicine, Nottingham, UK. 2. Institute of Social Medicine and Health Systems Research (ISMHSR), Otto von Guericke University Magdeburg, Magdeburg, Germany. 3. Department of Dermatology, Oregon Health & Science University, Portland, OR, USA. 4. Department of Dermatology, Amsterdam Public Health, Infection and Immunity, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands. 5. Center for Evidence-based Healthcare, Medical Faculty Carl Gustav Carus, Dresden, Germany. 6. Medical Sociology, Department of Epidemiology and Preventive Medicine, University of Regensburg, Regensburg, Germany. 7. Primary Care, Population Sciences and Medical Education, Faculty of Medicine, University of Southampton, Southampton, UK. 8. School of Medicine (Department of Dermatology), Oregon Health & Science University, Portland, OR, USA. 9. Patient representative (independent), Nottingham, UK. 10. Global Parents for Eczema Research, Brisbane, Australia. 11. Health Economics and Outcomes Research, Boehringer Ingelheim Inc., Ingelheim, Rheinland-Pfalz, Germany. 12. Global Dupixent Business Partner, sanofi GHEVA, 1 av. Pierre Brossolette, Chilly-Mazarin, 91380, France. 13. Chitofuna Dermatology Clinic, Tokyo, Japan. 14. Department of Epidemiology and Data Science, Amsterdam Rheumatology and Immunology Center, Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands. 15. Department of Dermatology, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan. 16. Department of Dermatology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. 17. Department of Dermatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Abstract
BACKGROUND: The Harmonising Outcome Measures for Eczema (HOME) initiative has established a core outcome set of domains for atopic eczema (AE) clinical trials. Previous consensus meetings have agreed on preferred instruments for clinician-reported signs (Eczema Area and Severity Index, EASI) and patient-reported symptoms (Patient-Oriented Eczema Measure, POEM). This paper reports consensus decisions from the HOME VII meeting. OBJECTIVES: To complete the core outcome set for AE by agreeing on core outcome instruments for the domains of quality of life (QoL), long-term control and itch intensity. METHODS: A face-to-face consensus meeting was held in Tokyo, Japan (8-10 April 2019) including 75 participants (49 healthcare professionals/methodologists, 14 patients, 12 industry representatives) from 16 countries. Consensus decisions were made by presentations of evidence, followed by whole and small group discussions and anonymous voting using predefined consensus rules. RESULTS: It was agreed by consensus that QoL should be measured using the Dermatology Life Quality Index (DLQI) for adults, the Children's Dermatology Life Quality Index (CDLQI) for children and the Infant's Dermatology Quality of Life Index (IDQoL) for infants. For long-term control, the Recap of Atopic Eczema (RECAP) instrument or the Atopic Dermatitis Control Test (ADCT) should be used. Consensus was not reached over the frequency of data collection for long-term control. The peak itch numerical rating scale (NRS)-11 past 24 h was recommended as an additional instrument for the symptom domain in trials of older children and adults. Agreement was reached that all core outcome instruments should be captured at baseline and at the time of primary outcome assessment as a minimum. CONCLUSIONS: For now, the core outcome set for clinical trials in AE is complete. The specified domains and instruments should be used in all new clinical trials and systematic reviews of eczema treatments.
BACKGROUND: The Harmonising Outcome Measures for Eczema (HOME) initiative has established a core outcome set of domains for atopic eczema (AE) clinical trials. Previous consensus meetings have agreed on preferred instruments for clinician-reported signs (Eczema Area and Severity Index, EASI) and patient-reported symptoms (Patient-Oriented Eczema Measure, POEM). This paper reports consensus decisions from the HOME VII meeting. OBJECTIVES: To complete the core outcome set for AE by agreeing on core outcome instruments for the domains of quality of life (QoL), long-term control and itch intensity. METHODS: A face-to-face consensus meeting was held in Tokyo, Japan (8-10 April 2019) including 75 participants (49 healthcare professionals/methodologists, 14 patients, 12 industry representatives) from 16 countries. Consensus decisions were made by presentations of evidence, followed by whole and small group discussions and anonymous voting using predefined consensus rules. RESULTS: It was agreed by consensus that QoL should be measured using the Dermatology Life Quality Index (DLQI) for adults, the Children's Dermatology Life Quality Index (CDLQI) for children and the Infant's Dermatology Quality of Life Index (IDQoL) for infants. For long-term control, the Recap of Atopic Eczema (RECAP) instrument or the Atopic Dermatitis Control Test (ADCT) should be used. Consensus was not reached over the frequency of data collection for long-term control. The peak itch numerical rating scale (NRS)-11 past 24 h was recommended as an additional instrument for the symptom domain in trials of older children and adults. Agreement was reached that all core outcome instruments should be captured at baseline and at the time of primary outcome assessment as a minimum. CONCLUSIONS: For now, the core outcome set for clinical trials in AE is complete. The specified domains and instruments should be used in all new clinical trials and systematic reviews of eczema treatments.
Authors: Brett A King; Maryanne M Senna; Manabu Ohyama; Antonella Tosti; Rodney D Sinclair; Susan Ball; Justin M Ko; Marc Glashofer; Rodrigo Pirmez; Jerry Shapiro Journal: Dermatol Ther (Heidelb) Date: 2022-03-31
Authors: I van Ee; E Deprez; A Egeberg; M Augustin; C Conrad; V Corazza; L Donati; J Lambert; R Lăpădatu; A Meyer; C Paul; R Penzer-Hick; K Stephen; J van der Zon; A Bewley Journal: J Eur Acad Dermatol Venereol Date: 2021-12-27 Impact factor: 9.228