Harmonising Outcome Measures For Eczema Research Articles

How to use the Harmonising Outcome Measures for Eczema Core Outcome Set for atopic dermatitis trials: ausers' guide.

The Harmonising Outcome Measures for Eczema (HOME) initiative has agreed upon the Core Outcome Set (COS) for use in atopic dermatitis (AD) clinical trials, but additional guidance is needed to maximize its uptake. To provide answers to some of the commonly asked questions about using the HOME COS; to provide data to help with the interpretation of trial results; and to support sample size calculations for future trials. We provide practical guidance on the use of the HOME COS for investigators planning clinical trials in patients with AD. It answers some of the common questions about using the HOME COS, how to access the outcome measurement instruments, what training/resources are needed to use them appropriately and clarifies when the COS is applicable. We also provide exemplar data to inform sample size calculations for eczema trials and encourage standardized data collection and reporting of the COS. By encouraging adoption of the COS and facilitating consistent reporting of outcome data, it is hoped that the results of eczema trials will be more comprehensive and readily combined in meta-analyses and that patient care will subsequently be improved.

Reporting of Harmonising Outcome Measures for Eczema (HOME) core outcome set instruments in randomized clinical trials for systemic treatments in atopic dermatitis.

The HOME initiative has successfully completed a core outcome set for atopic dermatitis (AD) trials, and most trials now include the core set instruments. However, to enable evidence synthesis of all relevant trials, reporting must also be standardized. In this study, we evaluated the reporting of the core outcome set instruments in AD systemic treatment trials included in a living systematic review and network meta-analysis. We found that although the core instruments were measured in most trials, they were often not reported sufficiently to enable inclusion in network meta-analysis.

Implementation of the HOME core outcome set for clinical trials of atopic eczema-barriers and opportunities: the HOME IX meeting report.

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 24h), 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 2days (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.

605 Uptake and reporting of the harmonising outcome measures for eczema (HOME) core outcome set in randomized clinical trials for systemic treatments for atopic dermatitis

605 Uptake and reporting of the harmonising outcome measures for eczema (HOME) core outcome set in randomized clinical trials for systemic treatments for atopic dermatitis

Vitiligo International Task force for an Agreed List of core data (VITAL): study protocol of a vitiligo core outcome set (COS) and contextual factors for clinical trials, registries, and clinical practice

BackgroundThere is a lack of consensus related to the collection of standardized data for individuals with vitiligo enrolled in clinical trials and registries as well as those seen in clinical practice which causes difficulty in accurately interpreting, comparing, and pooling of data.Several years ago, efforts to initiate work on developing core outcome sets were performed and a consensus was reached in 2015 on the first core domain set for vitiligo clinical trials.Methods/designThis project aims to further develop a core outcome set for vitiligo clinical trials as well as create internationally agreed-upon core outcome sets for registries and clinical practice. These core outcome sets will include a core domain set and a core measurement instruments set and will be supplemented by contextual factors, including baseline and treatment-related characteristics. In a preparatory exercise, the 2015 core domain set will be re-evaluated and will serve as the basis for the list of outcome domains used to initiate the consensus process. This project will consist of two parts. Part 1 will focus on the selection of a core domain set, or “what to measure” and contextual factors, for each setting based on electronic surveys (e-Delphi technique) and a conclusive consensus meeting by a large group of international stakeholders. Part 2 will include selection of core measurement instruments, or “how to measure,” and measurement details (e.g., scale and timing) for the core domain sets and contextual factors agreed upon in part 1. Part 2 will be based on consensus meetings with stakeholders involved in part 1 and will be guided by C3 (CHORD-COUSIN Collaboration), Harmonising Outcome Measures for Eczema (HOME), COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN), and Outcome Measures in Rheumatology (OMERACT) recommendations including information on measurement properties of available instruments (systematic review and expert/patient opinion). At the end of part 2, all stakeholders involved will be invited to participate in a final meeting in which the ultimate core data sets (core outcome sets and contextual factors) will be presented and the dissemination plan and implementation goals will be defined.DiscussionThis project will harmonize data collection between clinical trials, registries, and clinical practices, facilitating new insights in vitiligo.Trial registrationThis study is registered in the Core Outcome Measures for Effectiveness Trials (COMET) database and on the C3 (CHORD-COUSIN Collaboration) website.

Atopic Dermatitis in Latin America: A Roadmap to Address Data Collection, Knowledge Gaps, and Challenges.

Atopic dermatitis (AD) is a systemic, multifactorial disease that causes significant morbidity and health care burden in Latin America (LA). Data on AD are scarce in LA. Lack of disease registries and non-standardized study methodologies, coupled with region-specific genetic, immunological, and environmental factors, hamper data collection. A panel of LA experts in AD was given a series of relevant questions to address before a conference. Each narrative was discussed and edited through numerous rounds of deliberation until achieving consensus. Identified knowledge gaps in AD research were updated prevalence, adult-disease epidemiology, local phenotypes and endotypes, severe-disease prevalence, specialist distribution, and AD public health policy. Underlying reasons for these gaps include limited funding for AD research, from epidemiology and public policy to clinical and translational studies. Regional heterogeneity requires that complex interactions between race, ethnicity, and environmental factors be further studied. Informed awareness, education, and decision making should be encouraged.

HOME VII consensus decisions for measuring eczema control, quality of life and itch intensity

British Journal of DermatologyVolume 185, Issue 1 p. e11-e11 Plain Language Summary HOME VII consensus decisions for measuring eczema control, quality of life and itch intensity First published: 02 July 2021 https://doi.org/10.1111/bjd.20449AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinked InRedditWechat Abstract Linked Article: Thomas et al. Br J Dermatol 2021; 185:139–146. The Harmonising Outcome Measures for Eczema (HOME) initiative is an international collaboration involving people with eczema, health professionals, researchers, regulators and industry representatives. The collaboration is working globally to agree a defined list of aspects of eczema that should be measured in all future eczema clinical trials and systematic reviews. At previous international consensus meetings, collaborators have agreed what aspects of eczema (also called dermatitis) are important to capture, and how clinical signs of eczema and eczema symptoms should be measured. The HOME VII consensus meeting, held in Japan in April 2019, involved 74 participants from around the world and aimed to agree how best to measure quality of life, long-term eczema control and itch intensity. Following whole and small group discussions and anonymous keypad voting over 3 days, agreement was reached on the preferred measurement instruments to be used to capture patient-reported outcomes of quality of life, eczema control and itch intensity. For now, the core outcome set for clinical trials in atopic eczema is complete and can be used by researchers around the world to improve consistency in clinical trial design and allow evidence to be combined from different studies more easily. This should help ensure that clinical care is based on the best available evidence. Volume185, Issue1July 2021Pages e11-e11 RelatedInformation

Measurement properties of patient-reported outcome measures for eczema control: a systematic review.

Atopic eczema (herein referred to as 'eczema') is a skin disease characterized by remitting and relapsing symptoms. The Harmonising Outcome Measures for Eczema (HOME) initiative was developed to establish a core outcome set (COS) for eczema to be measured for all future eczema trials. The core outcome set for atopic eczema clinical trials includes the domain for patient-reported eczema control, but a review of the validation of available eczema control instruments was lacking. We aimed to review the literature and systematically assess the measurement properties of validated patient-reported outcome instruments that capture eczema control. PubMed and Ovid EMBASE were searched up to 24 January 2020 for any study that reported on PROM instrument development or validation. The COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) criteria were used to assess the quality of eligible studies. We screened 12036 titles and abstracts and 58 full texts. A total of 12 papers were included, reporting on seven PROMS. These were assessed with respect to development, reliability, construct validity and responsiveness. Two instruments, Recap of Atopic Eczema (RECAP) and the Atopic Dermatitis Control Tool (ADCT), have been developed and validated to a sufficient standard to support their recommendation as patient-reported outcome instruments for measuring control of atopic eczema as part of the HOME Core Outcome Set.

Recommended core outcome instruments for health-related quality of life, long-term control and itch intensity in atopic eczema trials: results of the HOME VII consensus meeting.

SummaryBackgroundThe 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.ObjectivesTo 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.MethodsA 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.ResultsIt 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.ConclusionsFor 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.

17030 IGA×BSA: A simple practice-friendly alternative to the Eczema Area and Severity Index for assessing severity of pediatric atopic dermatitis

Background: The Harmonizing Outcome Measures for Eczema (HOME) initiative recommends the Eczema Area and Severity Index (EASI) for reporting disease severity in atopic dermatitis (AD) trials. However, scoring can be complicated and difficult to administer in clinical settings. The product of the Physician Global Assessment and body surface area (PGA×BSA) is a simple outcome measure for psoriasis severity but has not been applied to AD.

Recommended core outcome instruments for health-related quality of life, long-term control and itch intensity in atopic eczema trials: results of the HOME VII consensus meeting.

The Harmonising Outcome Measures for Eczema (HOME) initiative has established a core outcome set of domains for atopic eczema clinical trials. Previous consensus meetings have agreed upon 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. To complete the core outcome set for atopic eczema by agreeing upon core outcome instruments for the domains of quality of life, long-term control and itch intensity. Face-to-face consensus meeting held in Tokyo, Japan (8th to 10th April, 2019) including 74 participants (47 healthcare professionals/methodologists, 14 patients, 13 industry representatives), from 16 countries. Consensus decisions were made by presentations of evidence, followed by whole and small group discussions and anonymous voting using pre-defined consensus rules. It was agreed by consensus that quality of life 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 hours 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. For now, the core outcome set for clinical trials in atopic eczema is complete. The specified domains and instruments should be used in all new clinical trials and systematic reviews of eczema treatments.

Les scores d’évaluation de la dermatite atopique: Outcome measures for atopic dermatitis

Scores evaluating the severity of atopic dermatitis are less well known and less used in daily practice of dermatologists than those for psoriasis, but things are changing. Indeed, the numerous trials and therapeutic advances in the field of eczema have also imposed the use of scales to objectively assess the severity of the disease and its improvement with treatment. The scores were initially numerous and poorly validated, but there is currently a trends towards simplification and standardization, with the work in particular of the Harmonizing Outcome Measures for Eczema (HOME) group. Scores for objective clinical signs, patient-reported symptoms, quality of life, and long-term disease control are now considered to be the core outcome set. The most used scores are detailed in this article. © 2020 Elsevier Masson SAS. All rights reserved.

IDQoL, CDLQI and the 45-item CADIS received a sufficient content validity rating during the HOME VII meeting in Japan: a group discussion study.

The Harmonising Outcome Measures for Eczema (HOME) initiative has agreed that quality of life should be measured in all atopic eczema clinical trials. Various candidate instruments exist for this domain but their content validity in atopic eczema is largely unclear. To assess the content validity of quality-of-life candidate instruments for atopic eczema in infants, children and adults in order to aid the decision on what instrument to include in the core outcome set for the quality-of-life domain. Six group discussions were conducted at the HOME VII Meeting in Tokyo. Each group was composed of 8-12 patients or parents of patients, clinicians, methodologists and pharmaceutical industry delegates and discussed one or two candidate instruments. The COSMIN criteria on relevance, comprehensiveness and comprehensibility were used to determine the overall content validity rating per instrument. Content validity of the Infant's Dermatitis Quality of Life Index, Children's Dermatology Life Quality Index and the Childhood Atopic Dermatitis Impact Scale (CADIS) long-form was rated as sufficient (+). Results for the CADIS short-form, DLQI and Skindex were inconsistent (±). DISABKIDS, Infants and Toddlers Dermatology Quality of Life and ABS-A were classified as having insufficient content validity. The content validity rating allowed for a comparison of all candidate instruments and informed the consensus-seeking process regarding the core instrument for the quality-of-life domain.

Assessing uptake of the Harmonising Outcome Measures for Eczema (HOME) Core Outcome Set and recommended instruments

Assessing uptake of the Harmonising Outcome Measures for Eczema (HOME) Core Outcome Set and recommended instruments

Measuring atopic eczema symptoms in clinical practice: The first consensus statement from the Harmonising Outcome Measures for Eczema in clinical practice initiative

Measuring patient-centered outcomes in clinical practice is valuable for monitoring patients and advancing real-world research. A new initiative from the Harmonising Outcome Measures for Eczema (HOME) group aims to recommend what might be recorded for atopic eczema patients in routine clinical care. Prioritize outcome domains to measure atopic eczema in clinical practice and select valid and practical outcome measurement instruments for the highest-priority domain. An online survey of HOME members identified and ranked 21 possible health domains. Suitable instruments were then selected for the top-prioritized domain at the HOME VI meeting, using established consensus processes informed by systematic reviews of instrument quality. Patient-reported symptoms was the top-prioritized domain. In accordance with psychometric properties and feasibility, there was consensus that the recommended instruments to measure atopic eczema symptoms in clinical practice are the POEM, the PO-SCORAD index, or both. The numeric rating scale for itch received support pending definition and validation in atopic eczema. Following the first step of the HOME Clinical Practice initiative, we endorse using the POEM, the PO-SCORAD index, or both for measuring atopic eczema symptoms in clinical practice. Additional high-priority domains for clinical practice will be assessed at subsequent HOME meetings.

Consensus statements on pediatric atopic dermatitis from dermatology and pediatrics practitioners in Japan: Goals of treatment and topical therapy

BackgroundPediatric atopic dermatitis (PAD) is a pluricausal disease and is frequently seen in dermatological and pediatric practice. Therefore, it is important to find common views in clinical practice and to promote consensus among practitioners. Aiming to obtain common views among dermatologists and pediatricians and to disseminate them widely in clinical practice, we held the PAD Consensus Forums described herein. MethodsQuestionnaire surveys of treatment goals and drug therapy were conducted to prepare topics for discussion at the PAD Consensus Forums. Reaching consensus was defined as agreement among at least 70% of the participants. ResultsAs a result of discussion among 24 dermatologists and 25 pediatricians, consensus was obtained on 7 topics. These topics configure 3 consensus of treatment goals (Attainment targets were divided into the short/medium term and the long term. Attainment targets were associated with the primary evaluation domains of the Harmonising Outcome Measures for Eczema (HOME) roadmap, etc.) and 4 consensus of drug therapy (The number of applications of topical anti-inflammatory drugs in the acute phase and selection and ideal intervals between applications of topical anti-inflammatory drugs in proactive therapy, etc.). ConclusionsThe consensus is expected to help practitioners set appropriate treatment goals in clinical practice and facilitate the choice of drugs for treatment.

Consensus on measurement of core dataset for AE treatment research registries

Moderate‐to‐severe atopic eczema (AE) is often treated with phototherapy (light treatment) or systemic therapy (medication that works throughout the whole body). Long‐term data on effectiveness and safety of these treatments is currently missing. To address this issue, data on paediatric and adult patients who use or used these treatments in a real‐life setting should be collected in national research registries. Ideally, these national registries should be compatible, so that data can be combined and analysed from as many patients as possible (which is needed to find rare side‐effects, for example). Therefore, every country needs to collect the same data in the same way. For this purpose the international TREatment of ATopic eczema (TREAT) Registry Taskforce has been established. It has already standardised which items need to be measured (e.g. disease severity, side effects). This study addresses the two remaining issues: how and when to measure these items. To determine how to measure the items (i.e. which measurement instruments to use), the authors used the recommendations from the Harmonising Outcome Measures for Eczema (HOME) initiative, relevant literature (published scientific studies), an already existing AE registry in Germany, and expert opinions. The proposals were discussed at multiple meetings and via email. This resulted in agreement (consensus) on how to measure the already standardised item‐set. The issue of when to measure the items, the follow‐up frequency, was resolved with an online survey. Consensus was reached on a minimum follow‐up frequency of 4 weeks after starting treatment, then every 3 months whilst on treatment and every 6 months whilst off treatment. A complete core dataset is now available that will help with the standardised collection of data of paediatric and adult AE patients on photo‐ and systemic therapies. This will help, in time, answer questions on the long‐term effectiveness and safety of these treatments and improve care for moderate‐to‐severe AE patients.

TREatment of ATopic eczema (TREAT) Registry Taskforce: consensus on how and when to measure the core dataset for atopic eczema treatment research registries.

SummaryBackgroundComparative, real‐life and long‐term evidence on the effectiveness and safety of phototherapy and systemic therapy in moderate‐to‐severe atopic eczema (AE) is limited. Such data must come from well‐designed prospective patient registries. Standardization of data collection is needed for direct comparisons and data pooling.ObjectivesTo reach a consensus on how and when to measure the previously defined domain items of the TREatment of ATopic eczema (TREAT) Registry Taskforce core dataset for research registries for paediatric and adult patients with AE.MethodsProposals for the measurement instruments were based on recommendations of the Harmonising Outcome Measures for Eczema (HOME) initiative, the existing AE database of TREATgermany, systematic reviews of the literature and expert opinions. The proposals were discussed at three face‐to‐face consensus meetings, one teleconference and via e‐mail. The frequency of follow‐up visits was determined by an expert survey.ResultsA total of 16 experts from seven countries participated in the ‘how to measure’ consensus process and 12 external experts were consulted. A consensus was reached for all domain items on how they should be measured by assigning measurement instruments. A minimum follow‐up frequency of initially 4 weeks after commencing treatment, then every 3 months while on treatment and every 6 months while off treatment was defined.ConclusionsThis core dataset for national AE research registries will aid in the comparability and pooling of data across centres and country borders, and enables international collaboration to assess the long‐term effectiveness and safety of phototherapy and systemic therapy used in patients with AE. What's already known about this topic? Comparable, real‐life and long‐term data on the effectiveness and safety of phototherapy and systemic therapy in patients with atopic eczema (AE) are needed.There is a high diversity of outcomes and instruments used in AE research, which require harmonization to enhance comparability and allow data pooling. What does this study add? Our taskforce has reached international consensus on how and when to measure core domain items for national AE research registries.This core dataset is now available for use by researchers worldwide and will aid in the collection of unified data. What are the clinical implications of this work? The data collected through this core dataset will help to gain better insights into the long‐term effectiveness and safety of phototherapy and systemic therapy in AE and will provide important information for clinical practice.Standardization of such data collection at the national level will also allow direct data comparisons and pooling across country borders (e.g. in the analysis of treatment‐related adverse events that require large patient numbers).

Defining and measuring 'eczema control': an international qualitative study to explore the views of those living with and treating atopic eczema.

BackgroundAtopic eczema (also known as eczema) is a chronic, inflammatory skin condition that often afflicts patients’ health and well‐being. The Harmonising Outcome Measures for Eczema (HOME) initiative recommends that ‘long‐term control of eczema’ is measured in all clinical trials 3 months or longer in duration. However, little has been published on what eczema control means to those living with or treating atopic eczema.ObjectivesTo (i) develop understanding of what eczema control means to patients, carers and clinicians and (ii) explore the feasibility and acceptability of different ways of measuring eczema control in the long term.MethodsOnline focus groups explored patients/carers experiences in the UK, the United States, the Netherlands, France, Sweden and Japan, and an international online survey gathered views of clinicians. The framework method was used to analyse the focus groups, and thematic analysis was used to analyse survey data. All findings were integrated into a theoretical framework to create overarching themes that cut across these diverse groups.ResultsEight focus groups with patients (16 years+) and eight groups with carers of children took place (N = 97). Sixty‐two people took part in the survey. Eczema control was described as a multifaceted construct involving changes in disease activity, the treatment and management of the condition and psychological, social and physical functioning. Patient/carer measurement allows personal accounts and frequent measurement, whilst clinician measurement was deemed less subjective. The burden on patients/carers and issues for analysing and interpreting data should be considered.ConclusionsThis study formed the basis of judging the content validity and feasibility of measurement instruments/methods to assess control of eczema in clinical trials. This online approach to an international qualitative study is an example of how core outcome set developers with limited resources can engage with multiple stakeholder groups on an international basis to inform consensus meeting discussions.

Abstracts of the 10th George Rajka International Symposium on Atopic Dermatitis, 11-13 April 2018, Utrecht, the Netherlands

The Harmonising Outcome Measures for Eczema (HOME) initiative is a multidisciplinary, evidence-based international group developing a core outcome set for atopic eczema trials. HOME has previously recommended four essential domains to be measured; signs, symptoms, quality of life and long-term control, with Eczema Area and Severity Index (EASI) and Patient-Oriented Eczema Measure (POEM) as the instruments to measures signs and symptoms, respectively. The aim of the current study was to define the domain of long-term control, and achieve consensus on what instrument(s) should be used to measure it. Two qualitative studies were conducted by the long-term control working group: online focus groups involving patients and carers, and an online qualitative survey of the HOME membership. These were analysed thematically and combined to provide evidence on what long-term control of atopic eczema means to patients, carers and clinicians. A face-to-face consensus meeting (HOME V) was held on 12-14 June 2017 in Nantes, France, involving moderated small interactive groups and whole-group discussions with anonymous voting. The HOME roadmap and COSMIN and COMET guidelines on outcome measurement instrument selection were followed. Discussions and voting on the definition of long-term control and the face validity and feasibility of different ways of measuring long-term control were informed by these two international qualitative studies and other published evidence (systematic reviews and validation studies). Focus groups involving 99 patients and carers were conducted in the U.K., the U.S.A., the Netherlands, France, Sweden and Japan. The HOME survey included 62 responses, mainly clinicians, representing 16 countries. Patients, carers and clinicians considered long-term control to involve several related concepts: level of disease activity, impact on daily life, and treatment required (such as reducing treatment or using only maintenance treatment). Issues highlighted to consider when measuring long-term control included capturing the perspective of patients, carers and clini-cians, burden of data collection, interpretability and including an objective assessment. The consensus meeting in Nantes was attended by 81 participants from 13 countries. There was consensus (91% of participants voted in favour) that the long-term-control domain consists of repeated measures of the agreed core domains [clinician-reported signs, patient-reported symptoms (including itch intensity) and quality of life] plus a patient global assessment. Pending further discussions, the existing recommended instruments for signs and symptoms (EASI and POEM) should be used. HOME recommends that long-term control of atopic eczema is captured in trials by repeated measures of the existing core domains plus a patient global assessment. Further work is required on the timing of assessments and to determine the patient global assessment instrument.