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

BackgroundComparative, 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)

Itching in Patients with Chronic Hand Eczema: Data from the CARPE Registry

Background: Itching is a leading symptom of chronic hand eczema (CHE) having a great impact on patients. The determinants of itching in CHE are unclear. Objective: We performed a cross-sectional analysis investigating factors associated with the presence and severity of itch in CHE patients from the CARPE registry. Methods: We present baseline data on itch in relationship with sociodemographic factors, severity of CHE, atopy, contact allergy, treatment and patient- reported outcomes including health-related quality of life (HRQoL). Results: Of 1,051 patients with CHE, 78.1% reported itching. Significant positive associations with itching were observed for younger age groups (17-25 and 26-45 years), for moderate, severe and very severe CHE and for small/moderate impairment in HRQoL. Atopic skin diathesis, hardly being able to realize treatment recommendations and very or extremely large impairments in HRQoL were associated with itch severity. Conclusion: Taking the identified variables into account may help identify vulnerable groups most affected by (severe) itch

Protocol for the development of a core domain set for hand eczema trials

Background Clinical hand eczema trials measure a variety of outcome domains to determine the success of interventions. This considerably limits the comparability and overall confidence in the study results, and thereby the strength of recommendations for clinical practice. Objectives The Hand Eczema Core Outcome Set (HECOS) initiative aims to develop a core outcome set (COS) for the standardized evaluation of interventions in future hand eczema trials and reviews. This COS will define the minimum that should be measured and reported in controlled and randomized-controlled trials of therapeutic hand eczema interventions. The objective of this protocol is to specify the methods to develop a core domain set. Methods In Phase 1, a list of candidate domains will be derived from a systematic literature review concerning previously measured outcomes in hand eczema trials, from qualitative patient interviews and from expert interviews. In Phase 2, a consensus study about core domains will be conducted by an online 3-round Delphi survey and a face-to-face meeting, applying predefined consensus criteria. HECOS involves hand eczema and methods experts as well as patients and further stakeholders with an interest in the initiative. Outlook When a set of core domains has been defined, HECOS is going to identify appropriate outcome measurement instruments in a development process that will be detailed in another protocol. The COS will considerably enhance the methodological quality, comparability and usefulness of hand eczema trials for clinical decision-making and the development of new therapeutic options for hand eczema, and also reduce the effort of planning, conducting, and reporting individual hand eczema studies, reviews and meta-analyses

Measurement properties of patient-reported outcome measures (PROMs) for women with Genitourinary Syndrome of Menopause: a systematic review

Background: Genitourinary Syndrome of Menopause (GSM) is a chronic and usually progressive skin disease which affects up to 50% of postmenopausal women. Symptoms, such as vaginal dryness, itching and burning have negative impacts on the women's sexual activity and often come along with urinary problems. Furthermore, these consequences influence the women's quality of life (QoL). Patient‐reported outcome measures can be used to measure the impact of GSM. Objectives: We aimed to identify all existing PROMs that were developed and/or validated for measuring patient‐reported outcomes in women with GSM or vulvovaginal symptoms during menopause and assess the quality of these PROMs in a transparent and structured way. Methods: We performed a systematic literature search in MEDLINE, EMBASE, Web of Science and smaller data bases, and hand‐searched reference lists of included studies. Only studies in English, German, French or Italian aiming at the evaluation of measurement properties, the development of a PROM, or the evaluation of the interpretability of the PROMs of interest were eligible. The methodological quality of eligible studies was evaluated with the COnsensus‐based Standards for the selection of health Measurement INstruments (COSMIN) risk of bias checklist. Quality criteria for good measurement properties were applied and the quality of evidence was graded using a GRADE approach. Information on interpretability and feasibility was extracted as well. PROMs were then categorized into three categories. PROMs of category A had evidence for sufficient content validity and at least low quality evidence for sufficient internal consistency, PROMs of category C had high‐quality evidence for an insufficient measurement property, and PROMs of category B could not be categorized in A or C. Results: Eight studies, two of which were found by reference list screening, were included. These studies reported on four PROMs. All of the included PROMs showed sufficient content validity. Two of the PROMs, the Vaginal Symptoms Questionnaire (VSQ) and the Day‐to‐Day Impact of Vaginal Aging (DIVA) showed moderate‐to‐high quality of evidence for sufficient structural validity and internal consistency, and were categorized as A. They can be therefore recommended for future use. The UGAQoL still has the opportunity to be recommended for use, but further validation is needed. The overall rating was often indeterminate since structural validity or important reliability parameters were not reported. The Urogenital symptom scale cannot be recommended for use since there was high quality of evidence for insufficient structural validity and internal consistency. Conclusion: Currently, two PROMs for women with GSM or vulvovaginal symptoms can be recommended. Nevertheless, those PROMs do not cover the urinary component of GSM. Future validation research should try to confirm and extend the measurement properties of those PROMs to strengthen this recommendation. PROSPERO registration CRD42018092384

How to use the HOME Core Outcome Set for atopic dermatitis trials - a users' guide

The Harmonizing Outcome Measures for Eczema (HOME) initiative has agreed upon the core outcome set for use in atopic dermatitis (AD) clinical trials, but additional guidance is needed to maximise uptake of the core set. This article provides answers to some of the commonly asked questions about using the HOME core outcome set. It also provides data to aid interpretation of trial results and to support sample size calculations for future trials. By encouraging adoption of the core outcome set and facilitating consistent reporting of outcome data, we hope that results of eczema trials will be more comprehensive and readily combined in meta-analyses and patient care will be improved

Standardized reporting of the Eczema Area and Severity Index (EASI) and the Patient-Oriented Eczema Measure (POEM): a recommendation by the Harmonising Outcome Measures for Eczema (HOME) Initiative

Several organizations from multiple fields of medicine are setting standards for clinical research including protocol development,1 harmonization of outcome reporting,2 statistical analysis,3 quality assessment4 and reporting of findings.1 Clinical research standardization facilitates the interpretation and synthesis of data, increases the usability of trial results for guideline groups and shared decision‐making, and reduces selective outcome reporting bias. The mission of the Harmonising Outcome Measures for Eczema (HOME) initiative is to establish an agreed‐upon core set of outcomes to be measured and reported in all clinical trials of atopic dermatitis (AD)

A qualitative study of the impact of severe asthma and its treatment showing that treatment burden is neglected in existing asthma assessment scales

Background People with severe asthma experience significant respiratory symptoms and suffer adverse effects of oral corticosteroids (OCS), including disturbed mood and physical symptoms. OCS impacts on health-related quality of life (HRQoL) have not been quantified. Asthma HRQoL scales are valid as outcome measures for patients requiring OCS only if they assess the deficits imposed by OCS. Aims The aim of this study was to compare the burden of disease and treatment in patients with severe asthma with items in eight asthma-specific HRQoL scales. Methods Twenty-three patients with severe asthma recruited from a severe asthma clinic were interviewed about the impact of their respiratory symptoms and the burden of their treatment. The domains from a thematic analysis of these interviews were compared with the items of eight asthma-specific HRQoL scales. Results In addition to the burden caused by symptoms, ten domains of OCS impact on HRQoL were identified: depression, irritability, sleep, hunger, weight, skin, gastric, pain, disease anxiety, and medication anxiety. Some patients experienced substantial HRQoL deficits attributed to OCS. Although all HRQoL scales include some OCS-relevant items, all eight scales fail to adequately assess the several types of burden experienced by some patients while on OCS. Conclusion The burden of OCS in severe asthma is neglected in policy and practice because it is not assessed in outcome studies. Existing asthma HRQoL scales provide an overly positive estimation of HRQoL in patients with frequent exposure to OCS and underestimate the benefit of interventions that reduce OCS exposure. Changes to existing measurement procedures are needed

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