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

BACKGROUND: Comparative, 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. OBJECTIVES: To 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. METHODS: Proposals 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. RESULTS: A 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. CONCLUSIONS: This 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).

[Health services research: the example of hand eczema]. / Versorgungsforschung am Beispiel des Handekzems.

Hand eczema is one of the most frequent skin diseases with a lifetime prevalence of up to 15% and a median incidence rate of 6 cases per 1000 person-years. Female gender, contact allergy, atopic eczema and wet work have been identified as the most important associated risk factors. Hand eczema has a high public health and socio-economic significance, since the vast majority of occupational skin disease is hand eczema. Hand eczema is often chronic, chronically relapsing or persisting. It entails substantial impairment of health-related quality of life for the affected individual. The cost-of-illness of hand eczema is estimated to be in the range of moderate to severe psoriasis and even higher than that of atopic eczema. Although various therapeutic options to treat hand eczema exist, an assessment of these options in randomized, controlled clinical trials to build up an evidence base is mostly lacking. The investigation of the treatment of chronic hand eczema under everyday conditions in dermatological clinics and private practices has only just begun. The first register of patients with chronic hand eczema (acronym: carpe) is expected to yield substantial insights in the effectiveness and safety of different therapeutic measures. A related task is the assessment of the quality of care in the light of the guidelines for the management of chronic hand eczema.