Most 'trials' in hand eczema are not RCTs. Internally controlled (left/right) studies were common. Based on the poor overall quality of reporting, most RCTs of hand eczema trials are not adequate to guide clinical practice. Future trials of hand eczema should be randomized, using a parallel group or self-controlled design. Research is needed to develop validated and clinically relevant outcome measures. Most of the remaining issues relating to poor quality of existing evidence can be relatively easily dealt with by following the CONSORT guidelines.
Summary Background In clinical practice or trials on hand eczema the severity of this disease can be ‘measured’ in different ways: by means of a physician‐rated clinical severity score, a patient‐rated clinical severity score or by an indicator of the burden of disease. We assume that the patient‐rated severity score corresponds more with the (change in) burden of disease than with the physician‐rated severity score. Objectives To demonstrate how physicians and patients differ in their assessment of the severity of hand eczema as seen in a physician‐rated severity score, patient‐rated severity score and a burden of disease questionnaire. Methods We used data from an open‐label randomized controlled trial which was set up in two university hospital dermatology departments in the Netherlands, specializing in hand eczema. One hundred and fifty‐eight patients with moderate to severe chronic hand eczema were included. The main outcome measures were the physician‐rated severity score, based on five visible aspects of hand eczema (desquamation, erythema, vesicles, infiltration, fissures), the patient‐rated severity score (a self‐rating scale), a burden of disease questionnaire (the Dermatology Life Quality Index, DLQI) and the correlations between these parameters, both at inclusion and over time. Results Only desquamation and infiltration were significantly correlated with patient‐rated severity score. Patient‐rated severity score correlated with seven of 10 DLQI items, but it did not correlate with the items regarding influence on clothes worn, impairment of sporting activities, and problems associated with treatment of the skin. The majority of patients showed improvement in all parameters after treatment. However, the improvement in patient‐rated severity score was not clearly correlated with changes in physician‐rated severity score. Except for DLQI item 1 (itch, soreness, pain, stinging), none of the changes in burden of disease was correlated with changes in patient‐rated severity score. For each DLQI item, change over time correlated weakly with decreases in several, but not all, components of the physician‐rated severity score. Conclusions Disease severity can be expressed by different scores; these scores are not clearly correlated, and measure different aspects. Patient satisfaction is not guaranteed when treatment is focused solely on the visible aspects of hand eczema. Instead, burden of disease has a greater impact.
Some patients with relapsing foot eczema and a shoe leather allergy, who fail to show positive results with standard series and shoe wear screening tray patch testing, do not respond to the use of hypoallergenic shoe leather. We assume that relevant allergens are present in hypoallergenic shoe leather. We described an experiment to demonstrate the presence of these allergens. Alcoholic extracts were made of green, black and undyed hypoallergenic shoe leather, and the extracts were fractioned by paper chromatography. The resulting chromatograms were cut into 16 equal paper disks and patch tests were performed with extracts and the paper chromatography fractions. Positive reactions were seen to all extracts and to fractions of all types of leather. From analysis of the pattern of positive patch tests we concluded that leather-related allergens (e.g. tanning agent) and dyes were present in hypoallergenic shoe leather. In these cases, alternatives to shoe leather should be sought, for instance wooden or plastic shoes.
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