This core set has been approved by the American College of Rheumatology (ACR) Board of Directors asProvisional. This signifies that the core set has been quantitatively validated using patient data, but it has not undergone validation based on an external data set. All ACR-approved core sets are expected to undergo intermittent updates.Objective. To validate a core set of outcome measures for the evaluation of response to treatment in patients with juvenile dermatomyositis (DM). Methods. In 2001, a preliminary consensus-derived core set for evaluating response to therapy in juvenile DM was established. In the present study, the core set was validated through an evidence-based, large-scale data collection that led to the enrollment of 294 patients from 36 countries. Consecutive patients with active disease were assessed at baseline and after 6 months. The validation procedures included assessment of feasibility, responsiveness, discriminant and construct ability, concordance in the evaluation of response to therapy between physicians and parents, redundancy, internal consistency, and ability to predict a therapeutic response. Results. The following clinical measures were found to be feasible, and to have good construct validity, discriminative ability, and internal consistency; furthermore, they were not redundant, proved responsive to clinically important changes in disease activity, and were associated strongly with treatment outcome and thus were included in the final core set: 1) physician's global assessment of disease activity, 2) muscle strength, 3) global disease activity measure, 4) parent's global assessment of patient's well-being, 5) functional ability, and 6) health-related quality of life. Conclusion. The members of the Paediatric Rheumatology International Trials Organisation, with the endorsement of the American College of Rheumatology and the European League Against Rheumatism, propose a core set of criteria for the evaluation of response to therapy that is scientifically and clinically relevant and statistically validated. The core set will help standardize the conduct and reporting of clinical trials and assist practitioners in deciding whether a child with juvenile DM has responded adequately to therapy.
To investigate the frequency of Compositae sensitivity is one of the most important goals of current dermatology and allergology. We have patch tested 30 adult patients suffering from "extrinsic" atopic dermatitis with sesquiterpene lactone mix and Compositae mix including Compositae mix individual ingredients, extracts of arnica (Arnica montana), chamomile (Chamomilla recutita), tansy (Tanacetum vulgare), fever few (Tanacetum parthenium) and yarrow (Achillea millefolium) as well as with specific series for patients with atopic dermatitis. All allergens were purchased from Hermal-Trolab (Reinbek, Germany). There were 6 (20%) patients positive to Compositae mix only, and 3 (10%) patients positive to both Compositae mix and sesquiterpene lactone mix. Among 9 Compositae mix-sensitive patients 8 (88.8%) were positive to at least 1 of its individual ingredients: 5 (55.5%) to chamomile, 4 (44.4%) to arnica, 2 (22.2%) to tansy, and 2 (22.2%) to fever few. Among Compositae-sensitive patients 78.8% had other contact allergies, most often to nickel (33.3%). Since our study represents the first report on contact allergy to Compositae among patients with "extrinsic" type of atopic dermatitis, it substantiates the statement that atopy represents a risk factor for Compositae allergy. In conclusion, the overall prevalence of 30% Compositae-sensitive among patients with "extrinsic" atopic dermatitis detected in our study represents a basal sesquiterpene lactone mix detection rate of 10%, reinforced and safely supplemented by 20% by testing with the Compositae mix.
Routine patch testing with sesquiterpene lactone mix, aimed testing with Compositae extracts screening mix, Compositae plants, and with their extracts, whereas the treatment of choice is a specific allergen-immunotherapy.
Physical and physiological functioning were affected to various degrees in the studied neurodisabilities, while all groups reported similar levels of functioning and well-being in social and environmental domains.
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