M.E. Schram

Diagnostic criteria for atopic dermatitis: a systematic review

Background  Atopic dermatitis (AD) has a wide spectrum of dermatological manifestations and despite various validated sets of diagnostic criteria that have been developed over the past decades, there is disagreement about its definition. Nevertheless, clinical studies require valid diagnostic criteria for reliable and reproducible results.

EASI, (objective) SCORAD and POEM for atopic eczema: responsiveness and minimal clinically important difference

To cite this article: Schram ME, Spuls PI, Leeflang MMG, Lindeboom R, Bos JD, Schmitt J. EASI, (objective) SCORAD and POEM for atopic eczema: responsiveness and minimal clinically important difference. Allergy 2012; 67: 99–106.

Towards global consensus on outcome measures for atopic eczema research: results of the HOME II meeting

The use of nonstandardized and inadequately validated outcome measures in atopic eczema trials is a major obstacle to practising evidence‐based dermatology. The Harmonising Outcome Measures for Eczema (HOME) initiative is an international multiprofessional group dedicated to atopic eczema outcomes research. In June 2011, the HOME initiative conducted a consensus study involving 43 individuals from 10 countries, representing different stakeholders (patients, clinicians, methodologists, pharmaceutical industry) to determine core outcome domains for atopic eczema trials, to define quality criteria for atopic eczema outcome measures and to prioritize topics for atopic eczema outcomes research. Delegates were given evidence‐based information, followed by structured group discussion and anonymous consensus voting. Consensus was achieved to include clinical signs, symptoms, long‐term control of flares and quality of life into the core set of outcome domains for atopic eczema trials. The HOME initiative strongly recommends including and reporting these core outcome domains as primary or secondary endpoints in all future atopic eczema trials. Measures of these core outcome domains need to be valid, sensitive to change and feasible. Prioritized topics of the HOME initiative are the identification/development of the most appropriate instruments for the four core outcome domains. HOME is open to anyone with an interest in atopic eczema outcomes research.

Is there a rural/urban gradient in the prevalence of eczema? A systematic review.

Background  Eczema affects approximately 10% of all schoolchildren in the western world and has shown an increase over the past decades in ‘developing’ countries. Numerous factors have been suggested that might contribute to the increasing prevalence of eczema. A plausible explanation is the role of environmental factors. As part of the ‘hygiene hypothesis’ it has been thought that eczema is more common in urban than in rural communities, but such a notion has never been assessed systematically.

Report from the third international consensus meeting to harmonise core outcome measures for atopic eczema/dermatitis clinical trials (HOME)

This report provides a summary of the third meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in San Diego, CA, U.S.A., 6–7 April 2013 (HOME III). The meeting addressed the four domains that had previously been agreed should be measured in every eczema clinical trial: clinical signs, patient‐reported symptoms, long‐term control and quality of life. Formal presentations and nominal group techniques were used at this working meeting, attended by 56 voting participants (31 of whom were dermatologists). Significant progress was made on the domain of clinical signs. Without reference to any named scales, it was agreed that the intensity and extent of erythema, excoriation, oedema/papulation and lichenification should be included in the core outcome measure for the scale to have content validity. The group then discussed a systematic review of all scales measuring the clinical signs of eczema and their measurement properties, followed by a consensus vote on which scale to recommend for inclusion in the core outcome set. Research into the remaining three domains was presented, followed by discussions. The symptoms group and quality of life groups need to systematically identify all available tools and rate the quality of the tools. A definition of long‐term control is needed before progress can be made towards recommending a core outcome measure.

Off-label Use of Azathioprine in Dermatology: A Systematic Review

OBJECTIVE To summarize evidence regarding the effectiveness, efficacy, and safety of off-label azathioprine use in dermatology. DATA SOURCES We searched the MEDLINE (1950-2009), EMBASE (1980-2009), and CENTRAL (1996-2009) databases on October 9, 2009. The main search terms were azathioprine and its synonyms. No restrictions were imposed regarding publication date. Only articles in English, French, German, or Dutch were included. STUDY SELECTION Randomized controlled trials, cohorts, and case series concerning the use of azathioprine in an off-label dermatologic setting were independently assessed for eligibility by 2 coauthors. The search retrieved 3870 articles, and 148 articles were selected for detailed review. DATA EXTRACTION Forty-three articles matching the inclusion and exclusion criteria were reviewed for methodologic quality by 2 reviewers independently, including an evaluation of components associated with biased estimates of treatment effect. DATA SYNTHESIS High-quality evidence (level A) was found for a moderate therapeutic effect in severe atopic dermatitis. Evidence of moderate quality (level B) was found for efficacy in parthenium dermatitis (an airborne plant allergen contact dermatitis), bullous pemphigoid, chronic actinic dermatitis, and leprosy type 1 reaction. Furthermore, favorable therapeutic effects existed for erythema multiforme, lichen planus, and pityriasis rubra pilaris, although the quality of evidence was low (level C). CONCLUSIONS A strong clinical recommendation was given for azathioprine in atopic dermatitis. Conclusions regarding safety in an off-label setting could not be reached because of scarce and incomplete data (level C evidence). Long-term registries and prospective studies could add to the existing evidence and provide legal support for off-label drug use in dermatology.

Atopic eczema or atopiform dermatitis

Please cite this paper as: Atopic eczema or atopiform dermatitis. Experimental Dermatology 2010.

Validation and refinement of the Millennium Criteria for atopic dermatitis

There is no gold standard for a definite diagnosis of atopic dermatitis. For the time being, several lists of diagnostic criteria have been proposed, some of them in actual use. The Millennium Criteria have been proposed to diagnose atopic dermatitis and to differentiate it from atopiform dermatitis. Our aim was to further refine the Millennium Criteria into a manageable set that can differentiate between atopic and atopiform dermatitis and other entities. The hereby refined Millennium Criteria will be compared with the UK Working Party Criteria and the Hanifin & Rajka Criteria. Data of 210 included patients were used. After multiple logistic regression, a minimum set of five criteria was identified as best discriminators: (i) typical morphology; (ii) early age of onset; (iii) Dennie–Morgan fold; (iv) historical and (v) actual flexural involvement. The refined Millennium Criteria were constituted from these criteria. When comparing the different list for validity in diagnosing atopic dermatitis, the refined Millennium Criteria showed a sensitivity of 81.8% and a specificity of 98.8% compared to a sensitivity of 97.7% and specificity of 72.9% of the UK Criteria and a sensitivity of 100% and specificity of 48.8% of the Hanifin & Rajka Criteria. This refinement and validity study shows that the refined Millennium Criteria are a valid tool to diagnose atopic and atopiform dermatitis in a hospital‐based setting and therefore could be incorporated in clinical practice and trials.

Response to a randomized trial of methotrexate vs. azathioprine for severe atopic eczema: a critical appraisal

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Relationship and probabilistic stratification of Eczema Area and Severity Index and objective Scoring Atopic Dermatitis severity scores for atopic dermatitis

The Harmonizing Outcome Measures for Eczema (HOME) recommended the Eczema Area and Severity Index (EASI) as the core outcome instrument for measuring the clinical signs of atopic dermatitis (AD). However, EASI may not have been used in previous clinical trials, and other scores, e.g. SCORAD (SCORing Atopic Dermatitis), the objective component of SCORAD (oSCORAD) and the Investigator Global Assessment (IGA), remain widely used. It is useful to establish a method to convert these scores into EASI to compare the results from different studies effectively. Indeed, EASI and oSCORAD have been found to be strongly correlated (rSpearman =0.92)7 , suggesting a possibility to find a relationship between the two scores. This article is protected by copyright. All rights reserved.