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Published on: June 16, 2021
[Core outcome measurements in hand eczema trials : The HECOS initiative]
H Rönsch1, A Bauer2, C Apfelbacher3
1Klinik und Poliklinik für Dermatologie, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Fetscherstr. 74, 01307, Dresden, Deutschland. henriette.roensch@tu-dresden.de.
Background:
To enhance the informative value and comparability of hand eczema trials, the consensus of a set of core outcomes is necessary.
Objectives:
How is success of therapeutic and preventive interventions currently determined in hand eczema trials? Which standard should apply in the future?
Materials And Methods:
As a first step, a systematic literature review was conducted to describe the status in controlled and randomized-controlled hand eczema trials from 2000-2017 and to identify the applied outcomes. The Hand Eczema Core Outcome Set (HECOS) initiative follows the guidelines of the Cochrane Skin Group Core Outcomes Set Initiative (CS-COUSIN) so that its further process is going to ensure the validity of the proposed measurement instruments and the appropriate inclusion of patients', physicians', and researchers' perspectives.
Results:
Previous trials predominantly assessed erythema, scaling, fissures, vesicles, or pruritus as clinical signs and symptoms of hand eczema. These variables were often not reported separately but as part of a variety of scores. Only few hand eczema scores were applied in more than one trial-most commonly the Hand Eczema Severity Index (HECSI, in 10% of the trials). Overall skin condition, without mentioning specific signs or symptoms, was assessed in 51% of the trials.
Conclusions:
Although certain clinical signs and symptoms were assessed by a majority of hand eczema trials, comparability of results was not ensured because various measurement instruments were applied. HECOS is going to agree on a set of relevant and valid core outcome measurement instruments.
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