Abstract
BackgroundHand eczema is the most frequently recognized occupational disease in Denmark with an incidence of approximately 0.32 per 1000 person-years. Consequences of hand eczema include chronic severe eczema, prolonged sick leave, unemployment, and impaired quality of life. New preventive strategies are needed to reduce occupational hand eczema.Methods/DesignWe describe the design of a randomised clinical trial to investigate the effects of classification of hand eczema plus individual counselling versus no intervention. The trial includes health-care workers with hand eczema identified from a self-administered questionnaire delivered to 3181 health-care workers in three Danish hospitals. The questionnaire identifies the prevalence of hand eczema, knowledge of skin-protection, and exposures that can lead to hand eczema. At entry, all participants are assessed regarding: disease severity (Hand Eczema Severity Index); self-evaluated disease severity; number of eruptions; quality of life; skin protective behaviour, and knowledge of skin protection. The patients are centrally randomised to intervention versus no intervention 1:1 stratified for hospital, profession, and severity score. The experimental group undergoes patch and prick testing; classification of the hand eczema; demonstration of hand washing and appliance of emollients; individual counselling, and a skin-care programme. The control group receives no intervention. All participants are reassessed after six months. The primary outcome is observer-blinded assessment of disease severity and the secondary outcomes are unblinded assessments of disease severity; number of eruptions; knowledge of skin protection; skin-protective behaviour, and quality of life.Trial registrationThe trial is registered in ClinicalTrials.Gov, NCT01012453.
Highlights
Hand eczema is the most frequently recognized occupational disease in Denmark with an incidence of approximately 0.32 per 1000 person-years
The HET trial is the first trial on secondary prevention that is individually randomised and stratified according to hospital, profession, and Hand Eczema Severity Index (HECSI) score
The trial focuses on Hand eczema (HE) among nurses and nursing aids who account for almost 25% of recognized Occupational hand eczema (OHE) in Denmark
Summary
Hand eczema (HE) is a long-lasting disease with a point prevalence of 9.7% in the background population [1] and an incidence reported to be 5.5 to 8.8 per 1000 person-years [2,3]. In a Danish study on patients with OHE, irritant contact dermatitis was found to occur more frequently than allergic contact dermatitis [34] This was found in a recent German study on geriatric nurses from nursing homes and home care facilities [35] and in a study on 1301 health-care workers from 1995 [36]. The effect of a prevention programme consisting of a combination of classification of HE and individual, work-related counselling in skin protective behaviour, has not yet been investigated in Denmark. The HET trial is the first trial on secondary prevention that is individually randomised and stratified according to hospital (the three different hospitals involved), profession (physicians compared to nurses, nursing aids, and biotechnicians), and Hand Eczema Severity Index (HECSI) score
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