TRE atment of AT opic eczema ( TREAT ) Registry Taskforce: consensus on how and when to measure the core dataset for atopic eczema treatment research registries

Abstract

Summary 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).

Effectiveness of dupilumab treatment in 95 patients with atopic dermatitis: daily practice data

“…The TREAT Registry Taskforce (http://treat-registry-taskforce.org/ ) is an international network of national registries that aim to collect such data . Such registries intend to gather observational real‐world data of paediatric and adult patients with AD and receiving phototherapy and systemic therapy, using a harmonized dataset including time points . The TREAT NL registry is the Dutch TREAT registry, and data from this registry were used for the current study.…”

“…Patients visited the outpatient clinic at baseline, week 4 and after either 12 (Amsterdam University Medical Center) or 16 (Erasmus University Medical Center) weeks of treatment. In one of the centres, data were collected according to the harmonized dataset of the TREAT Registry Taskforce …”

“…In one of the centres, data were collected according to the harmonized dataset of the TREAT Registry Taskforce. [16][17][18] Treatment A 600-mg loading dose of dupilumab was injected subcutaneously at baseline, followed by an injection of 300 mg dupilumab every other week. 19 Patients either discontinued systemic immunosuppressive treatment before starting dupilumab treatment or continued the immunosuppressant during dupilumab treatment, on the basis of a shared decision.…”

The European TREatment of ATopic eczema (TREAT) Registry Taskforce survey: prescribing practices in Europe for phototherapy and systemic therapy in adult patients with moderate‐to‐severe atopic eczema*

“…Large, well‐designed prospective patient cohorts (for real‐life data) or (living) network meta‐analyses24 might provide the data that are needed, and might provide guidance on the treatment of subgroups, for example. The TREAT Registry Taskforce25 has developed a core dataset that can aid in gathering comparable data26,27 and that is already used in many national research registries (https://treat-registry-taskforce.org/).…”

Patient engagement with the BJD : why and how?

“…But their tone suggests that the ground has already been prepared for this particular seed to germinate. After all, we already have patients involved in developing new models of healthcare; research grant applications; research teams’ presentations to research ethics committees; clinical trial steering committees; producing clinical guidelines; writing and reviewing Cochrane systematic reviews; coauthoring original articles, editorials, commentaries, guidelines and other academic papers; and teaching our students. Indeed, best practice in all of these examples requires that we engage with and support patients to become active team members who can help to shape our endeavours.…”