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The Harmonizing outcome measures for Eczema (HOME) initiative
Posted by 28 Jun 2011 at 07:33 GMTon
The study by Rehal and Armstrong1 investigated the trends in outcome measures used to assess the severity of atopic eczema (synonymous with atopic dermatitis or AD) in randomized controlled trials (RCTs) published between 1985 and 2010. The authors identified 20 different disease-severity instruments and explored the frequency of use of these different instruments. While some instruments (SCORAD, EASI, IGA, and SASSAD) have been frequently applied in eczema trials, others have been rarely used.
The report published in PLOSone adds to a growing body of literature that indicates that the current use of various non-comparable, frequently non-validated scales for the severity of eczema are a significant threat to evidence-based dermatology practice and research. The report was a novel and useful exercise in that it identified which outcomes have been used most frequently for atopic dermatitis trials over time, which provides some rationale basis for future research into outcomes.
We wish to make some additional points which were perhaps not picked up sufficiently in the paper. The first is make the authors and PLOSone readers aware of the GREAT (Global Resource for Eczema Trials) database which has systematically searched for and summarised all randomized controlled trials of atopic dermatitis/eczema since the year 20002 when another detailed and open access systematic review of all eczema RCTs had been done3. The GREAT database contains comprehensive information on all included trials and was produced in the hope of saving researchers from unnecessary duplication of effort in trying to identify eczema/AD trials for different purposes. The database is free in the public domain and it also includes non/English RCTs. Had the authors used this database or been made aware of it, they might have saved themselves a lot of work in whittling down the 791 possible RCTs identified to the 382 included studies.
Second, in their objectives, the authors state that they aimed to “provide a useful summary of the dimensions and validation studies for the most commonly used measures” in eczema trials.1 However, the frequency of application of scales must not be confused with the validity of scales. Whilst the authors did provide a useful description of the identified scales and their components, they did not systematically identify, assess, or critically appraise the validation studies of eczema scales, and in that sense the published report did not quite meet the objectives as stated in the abstract.
In 2007, two of us performed a systematic review concerning the validity, reliability, and ease of use of all published named measures to assess the severity of atopic eczema. Our review indicates, that out of 20 scales introduced, only the SCORAD, EASI, and POEM have been adequately validated to recommend their use.4 Although frequently used, the SASSAD and IGA have been less thoroughly validated highlighting that widespread use does not necessarily correspond to validity. Interestingly, the Patient-oriented eczema measure (POEM), which measures the symptoms of atopic eczema has not been identified by the review, probably because studies that have used it have appeared since 20105;6, Our systematic review indicates that it is adequately validated to recommend its use.4
The identified scales are divided into severity instruments and quality of life measurements. It might be interesting to group the different scales in signs, symptom, quality of life and composite scales. In this way the core domains -constructs studied thus far in atopic dermatitis can be detected.
Aiming to standardize outcome measures for eczema trials we recently undertook an international Delphi consensus exercise to define core sets of outcome domains for clinical trials and for recordkeeping in routine care.7 A total of 46 individuals from four stakeholder groups (consumers, clinical experts, regulatory agency representatives, and journal editors) representing 11 countries participated in the study. Consensus was achieved for inclusion of symptoms, physician-assessed clinical signs, and a measurement for long-term control of flares in the core set of outcome domains for eczema trials.7 Following the positive feedback from the research community we founded the harmonizing outcome measures for eczema (HOME) initiative8 (www.homeforeczema.org) which is linked with other international outcome measures initiatives such as COMET and OMERACT. The HOME II meeting was held on June 7th and 8th in Amsterdam9, including also pharmaceutical company representatives and methodologists and endorsed the domains identified in the international Delphi exercise and which will now proceed with a series of project to identify which measures are best suited to measure such domains. We are delighted that the senior author of this report has agreed to join the HOME initiative to address the multiplicity of scales that hampers current comparability of trials of atopic dermatitis/eczema between countries and over time.
Autors: Jochen Schmitt1, Phyllis Spuls2, Hywel Williams3
1 Department of occupational and social medicine, Medical Faculty Carl Gustav Carus, Technische Universität Dresden, Germany
2 Department of Dermatology, Academic Medical Center, University of Amsterdam, the Netherlands
3 Centre of Evidence Based Dermatology, Nottingham University Hospitals NHS Trust, Queen's Medical Centre Nottingham, UK
1. Rehal B,.Armstrong AW. Health outcome measures in atopic dermatitis: a systematic review of trends in disease severity and quality-of-life instruments 1985-2010. PLoS.One. 2011;6:e17520.
2. Nankervis H, Maplethorpe A, Williams HC. Mapping randomized controlled trials of treatments for eczema - The GREAT database (The Global Resource of Eczema Trials: a collection of key data on randomized controlled trials of treatments for eczema from 2000 to 2010). BMC.Dermatol 2011;11:10.
3. Hoare C, Li Wan PA, Williams H. Systematic review of treatments for atopic eczema. Health Technol.Assess. 2000;4:1-191.
4. Schmitt J, Langan SM, Williams HC. What are the best outcome measurements for atopic eczema? – A systematic review . J Allergy Clin Immunol 2007;120:1389-98.
5. Thomas KS, Dean T, O'Leary C, Sach TH, Koller K, Frost A et al. A randomised controlled trial of ion-exchange water softeners for the treatment of eczema in children. PLoS.Med 2011;8:e1000395.
6. Schram ME, Roekevisch E, Leeflang MM, Bos JD, Schmitt J, Spuls PI. A randomized trial of methotrexate versus azathioprine for severe atopic eczema. J Allergy Clin Immunol 2011.
7. Schmitt J, Langan S, Stamm T, Williams HC. Core outcome domains for controlled trials and clinical recordkeeping in eczema: international multiperspective delphi consensus process. J Invest Dermatol 2011;131:623-30.
8. Schmitt J,.Williams HC. Harmonising Outcome Measures for Eczema (HOME). Report from the first international consensus meeting (HOME 1), 24 July 2010, Munich, Germany. Br.J.Dermatol. 2010;163:1166-8.
9. Harmonizing Outcome Measures for Eczema. Programme of the HOME II meeting, June 5th and 6th 2011, Amsterdam . http://www.homeforeczema.... (accessed 20h June 2011) . 2011.