Hand eczema (HE) is a common skin disease characterized by itch, pain and visible skin changes such as fissures, erythema and vesicles. It is not yet clear which outcome domains are most important for patients. The Hand Eczema Core Outcome Set (HECOS) initiative is developing a consented set of core domains and suitable measurement instruments for the future application in all HE trials. This includes an online Delphi survey about core domains, which requires a ‘Long List’ of all domains that might be important to measure.
To compile a ‘Long List’ of candidate outcome domains for therapeutic HE trials with suggestions from patients and experts.
First, 60 patients with chronic HE were interviewed at seven study sites in Croatia, Denmark, Germany, the Netherlands and Spain. Patients were asked about domains that were important from their perspectives. Second, 185 HE experts were invited by email to complete an online survey. With an open question, they were asked to suggest up to six domains.
Suggestions were provided by 58 patients and 82 experts. Most patients and experts suggested to measure the domains ‘signs’, ‘symptoms’ and ‘HE-related quality of life’. Specifically, >25% of patients said that less itch, pain or fissures indicated a successful treatment. Among experts, >25% suggested ‘itch’ and ‘ability to work’ as core sub-domains. Further outcomes from the domains ‘HE control over time’, ‘patient-reported treatment experience’ and ‘skin barrier function’ were mentioned.
‘Itch’ was rated high among patients with HE and professional HE experts. While patients emphasized fissures as important, experts underlined the ability to work. This investigation allowed us to define a ‘Long List’ of 7 candidate outcome domains with 58 sub-domains. From this list, a panel of stakeholders will select core domains during an online Delphi survey.
Therefore, the aims of the present investigation were to (1) explore the views of both patients and professionals regarding outcomes of im-portance for HE clinical trials, and (2) to use this evidence together with the findings from our systematic review8 to generate a ‘Long List’ of outcomes for the upcoming consen-sus process towards a core domain set for HE.Contributors
Henriette Rönsch, Frederike Schiffers, Robert Ofenloch, Elke Weisshaar, Anna- Sophie Buse, Andreas Hansen, Swen Malte John, Ana M. Giménez Arnau, David Pesqué, Tove Agner, Line Brok Nørreslet, Laura Loman, Geertruida L. E. Romeijn, Marie L. A. Schuttelaar, Adrijana Košcec Bjelajac, Jelena Macan, Andrea Bauer, Christian J. Apfelbacher
- Patient perspectives
Patient interviews and an expert survey were combined to one ‘Long List’ of candidates for core do-mains in therapeutic HE trials.