Christian Apfelbacher

Towards global consensus on outcome measures for atopic eczema research: results of the HOME II meeting

The use of nonstandardized and inadequately validated outcome measures in atopic eczema trials is a major obstacle to practising evidence‐based dermatology. The Harmonising Outcome Measures for Eczema (HOME) initiative is an international multiprofessional group dedicated to atopic eczema outcomes research. In June 2011, the HOME initiative conducted a consensus study involving 43 individuals from 10 countries, representing different stakeholders (patients, clinicians, methodologists, pharmaceutical industry) to determine core outcome domains for atopic eczema trials, to define quality criteria for atopic eczema outcome measures and to prioritize topics for atopic eczema outcomes research. Delegates were given evidence‐based information, followed by structured group discussion and anonymous consensus voting. Consensus was achieved to include clinical signs, symptoms, long‐term control of flares and quality of life into the core set of outcome domains for atopic eczema trials. The HOME initiative strongly recommends including and reporting these core outcome domains as primary or secondary endpoints in all future atopic eczema trials. Measures of these core outcome domains need to be valid, sensitive to change and feasible. Prioritized topics of the HOME initiative are the identification/development of the most appropriate instruments for the four core outcome domains. HOME is open to anyone with an interest in atopic eczema outcomes research.

The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials.

The lack of core outcome sets for atopic eczema (AE) is a major obstacle for advancing evidence-based treatment. The global Harmonising Outcome Measures for Eczema (HOME) initiative has already defined clinical signs, symptoms, quality of life, and long-term control of flares as core outcome domains for AE trials. This article deals with the standardization of measurement instruments to assess clinical signs of AE. To resolve the current lack of standardization of the assessment of clinical signs of AE, we followed a structured process of systematic reviews and international consensus sessions to identify 1 core outcome measurement instrument for assessment of clinical signs in all future AE trials. Systematic reviews indicated that from 16 different instruments identified to assess clinical signs of AE, only the Eczema Area and Severity Index (EASI) and the objective Scoring Atopic Dermatitis (SCORAD) index were identified as extensively validated. The EASI has adequate validity, responsiveness, internal consistency, and intraobserver reliability. The objective SCORAD index has adequate validity, responsiveness, and interobserver reliability but unclear intraobserver reliability to measure clinical signs of AE. In an international consensus study, patients, physicians, nurses, methodologists, and pharmaceutical industry representatives agreed that the EASI is the preferred core instrument to measure clinical signs in all future AE trials. All stakeholders involved in designing, reporting, and using clinical trials on AE are asked to comply with this consensus to enable better evidence-based decision making, clearer scientific communication, and improved patient care.

Pruritus as a leading symptom: clinical characteristics and quality of life in German and Ugandan patients.

Background  Pruritus is the most frequent and distressing symptom associated with dermatoses and various internal and neurological diseases.

The Harmonizing Outcome Measures for Eczema (HOME) Roadmap: A Methodological Framework to Develop Core Sets of Outcome Measurements in Dermatology

Core outcome sets (COSs) are consensus-derived minimum sets of outcomes to be assessed in a specific situation. COSs are being increasingly developed to limit outcome-reporting bias, allow comparisons across trials, and strengthen clinical decision making. Despite the increasing interest in outcomes research, methods to develop COSs have not yet been standardized. The aim of this paper is to present the Harmonizing Outcomes Measures for Eczema (HOME) roadmap for the development and implementation of COSs, which was developed on the basis of our experience in the standardization of outcome measurements for atopic eczema. Following the establishment of a panel representing all relevant stakeholders and a research team experienced in outcomes research, the scope and setting of the core set should be defined. The next steps are the definition of a core set of outcome domains such as symptoms or quality of life, followed by the identification or development and validation of appropriate outcome measurement instruments to measure these core domains. Finally, the consented COS needs to be disseminated, implemented, and reviewed. We believe that the HOME roadmap is a useful methodological framework to develop COSs in dermatology, with the ultimate goal of better decision making and promoting patient-centered health care.

Prevalence, Correlates and Characteristics of Chronic Pruritus: A Population-based Cross-sectional Study

Pruritus is the most frequent symptom in dermatology. Its impact on quality of life is substantial. Epidemiological data on chronic pruritus (>6 weeks) at the population level is sparse, but is important in order to understand the burden and risk factors of this distressing symptom. The aim of this population-based cross-sectional study was to estimate the point, 12-month and lifetime prevalence of chronic pruritus, assessing its association with sociodemographic variables and describing its characteristics. A validated postal questionnaire was sent to 4,500 individuals in from the German General population. Three contact attempts were made. The response rate was 57.8% (n=2,540). The point prevalence of chronic pruritus was 13.5% (95% confidence interval (95% CI) 12.2-14.9%), 12-month prevalence 16.4% (15.0-17.9%) and lifetime prevalence 22.0% (20.4-23.7%). Multivariate analyses found only ethnic origin independently associated with chronic pruritus. The impact of chronic pruritus on quality of life and emotional well-being appears to depend on severity rather than on the presence of the symptom alone. This is the first study to investigate various prevalence estimates of chronic pruritus at the population level. Despite its limitations (self-report and potential self-selection) this study indicates a high burden of chronic pruritus in society.

Low vitamin D serum level is inversely associated with eczema in children and adolescents in Germany.

Recent studies have yielded heterogeneous results regarding the relationship between vitamin D and atopic conditions. The aim of this study was to investigate the association between serum vitamin D level and the prevalence of eczema in German children and adolescents.

Report from the fourth international consensus meeting to harmonize core outcome measures for atopic eczema/dermatitis clinical trials (HOME initiative)

This article is a report of the fourth meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in Malmö, Sweden on 23–24 April 2015 (HOME IV). The aim of the meeting was to achieve consensus over the preferred outcome instruments for measuring patient‐reported symptoms and quality of life for the HOME core outcome set for atopic eczema (AE). Following presentations, which included data from systematic reviews, consensus discussions were held in a mixture of whole group and small group discussions. Small groups were allocated a priori to ensure representation of different stakeholders and countries. Decisions were voted on using electronic keypads. For the patient‐reported symptoms, the group agreed by vote that itch, sleep loss, dryness, redness/inflamed skin and irritated skin were all considered essential aspects of AE symptoms. Many instruments for capturing patient‐reported symptoms were discussed [including the Patient‐Oriented SCOring Atopic Dermatitis index, Patient‐Oriented Eczema Measure (POEM), Self‐Administered Eczema Area and Severity Index, Itch Severity Scale, Atopic Dermatitis Quickscore and the Nottingham Eczema Severity Score] and, by consensus, POEM was selected as the preferred instrument to measure patient‐reported symptoms. Further work is needed to determine the reliability and measurement error of POEM. Further work is also required to establish the importance of pain/soreness and the importance of collecting information regarding the intensity of symptoms in addition to their frequency. Much of the discussion on quality of life concerned the Dermatology Life Quality Index and Quality of Life Index for Atopic Dermatitis; however, consensus on a preferred instrument for measuring this domain could not be reached. In summary, POEM is recommended as the HOME core outcome instrument for measuring AE symptoms.

Report from the third international consensus meeting to harmonise core outcome measures for atopic eczema/dermatitis clinical trials (HOME)

This report provides a summary of the third meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in San Diego, CA, U.S.A., 6–7 April 2013 (HOME III). The meeting addressed the four domains that had previously been agreed should be measured in every eczema clinical trial: clinical signs, patient‐reported symptoms, long‐term control and quality of life. Formal presentations and nominal group techniques were used at this working meeting, attended by 56 voting participants (31 of whom were dermatologists). Significant progress was made on the domain of clinical signs. Without reference to any named scales, it was agreed that the intensity and extent of erythema, excoriation, oedema/papulation and lichenification should be included in the core outcome measure for the scale to have content validity. The group then discussed a systematic review of all scales measuring the clinical signs of eczema and their measurement properties, followed by a consensus vote on which scale to recommend for inclusion in the core outcome set. Research into the remaining three domains was presented, followed by discussions. The symptoms group and quality of life groups need to systematically identify all available tools and rate the quality of the tools. A definition of long‐term control is needed before progress can be made towards recommending a core outcome measure.

Measuring the Prevalence of Chronic Itch in the General Population: Development and Validation of a Questionnaire for Use in Large-scale Studies

Itching is the most frequent symptom in dermatology. Little is known about its occurrence and its characteristics in the general population. Instruments specifically designed to measure itch are scarce. The aim of this pilot study was to develop and validate an instrument measuring prevalence and characteristics of chronic itch in the general population. A questionnaire was developed and administered to a sample from the general population (n = 200) and a sample (n = 100) of itch-clinic patients. Life time prevalence of itch was 22.6% in non-patients and 100% in patients. Principal component, internal consist ency and correlational analyses revealed the instrument to be able to reliably and validly measure itch. Strength of itch was higher in patients and was associated with itch- related quality of life and affect in both groups. Preliminary results indicate that itch is prevalent in the general population. We intend to utilize this parsimonious and easy-to-administer questionnaire in a forthcoming population-based study.

Incidence and determinants of chronic pruritus: a population-based cohort study.

Epidemiological data on chronic pruritus (> 6 weeks) in the general population are sparse. We aimed to provide data on the incidence and prevalence of chronic pruritus, and identify its determinants based on cross-sectional and longitudinal analyses. A cohort of 1,190 participants from a cross-sectional baseline-study (response rate: 57.8%) was followed up after one year. The questionnaire assessed occurrence of chronic pruritus, medical, lifestyle and psychosocial variables. Incident chronic pruritus was defined as reported chronic pruritus at follow-up in those subjects free-of-the-symptom at baseline. Cross-sectional analyses of data from the follow-up assessments addressed potential associations of medical, lifestyle and psychosocial factors with prevalent chronic pruritus. Longitudinal analyses examined sociodemographic factors as potential predictors of incident chronic pruritus. The follow-up response rate was 83.1%. The mean age of subjects was 56 years, and 58% were female. The 12-month cumulative-incidence equalled 7.0% (95% confidence interval (95% CI) 5.2-9.2%. Lifetime prevalence was 25.5% (95% CI 21.8-27.8%). Incidence was significantly associated with age. Determinants of prevalent chronic pruritus in multi-variable analyses were: liver disease, asthma, eczema and dry skin within the medical domain, an elevated body mass index within the lifestyle domain and higher anxiety scores within the psychosocial domain. Findings suggest a considerable 12-month incidence and lifetime prevalence and provide important directions for future research.