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Ongoing Projects
The STROBE systematic review
Dr Sinéad Langan and four of the other steering group members have completed a systematic review on the quality of reporting of epidemiological studies in dermatology on behalf of the European Dermatoepidemiology Network (EDEN). The aim of this review was to determine how well observational studies published over a three year period from 2004 to 2007 in four leading dermatology journals comply with the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) checklists. This study was published in the Archives of Dermatology. The list of studies relevant to this research study is available using the link below. This body of work is now complete.
This work has led to the adoption of the STROBE checklists by the British Journal of Dermatology and it is hoped other dermatology journals will encourage the use of these checklists in the near future to improve the quality of reporting.
A French group, led by Prof. Sylvie Bastuji-Garin, a Steering group member is now undertaking further research to determine the impact of STROBE on the quality of reporting following its introduction (observational studies published over a seven year period from 2004 to 2010).
Reference:
von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for Reporting Observational Studies. PLoS Medicine Vol. 4, No. 10, e296 doi:10.1371/journal.pmed.0040296
Langan S, et al. The reporting of observational research studies in dermatology journals - A literature-based study. Arch Dermatol 2010; 146(5):534-41.
Langan SM, Schmitt J, Coenraads PJ, Svensson A, von Elm E, Williams HC; European Dermato-Epidemiology Network (EDEN). STROBE and reporting observational studies in dermatology. Br J Dermatol. 2011;164(1):1-3
Team:
L Naldi, A Svensson, TL Diepgen, HC Williams, JN Bouwes Bavinck, P Elsner, PJ Coenraads, JJ Grob
Aim:
To identify published therapeutic trials of psoriasis treatments over a 23 year period, to explore study design and quality issues in these publications, and to make recommendations for good clinical trial design and reporting for psoriasis trials.
Method:
Combination of hand-searching and electronic searching for psoriasis treatment trials in medical journals published in English, German, French, Italian and Dutch language.
Distribution of eligible publications among an expert panel. Assessment of quality in pairs, using a standard data extraction form.
Analysis of the data generated by the data extraction form.
The EDEN psoriasis project is an ongoing survey of RCTs of psoriasis published in 14 leading medical and dermatological journals. A first analysis was done on studies published from 1977 to 2000, showing major problems with reporting and clinical relevance. A further update was done with analysis of studies published from January 2001 up to December 2006. Recent trials in psoriasis tend to be larger, longer, more likely to include PASI and quality of life measures, more likely to be sponsored by the pharmaceutical industry, and more likely to adopt a placebo control arm. There is an urgent need for comparative RCTs in psoriasis, especially to address longer term issues such as duration and maintenance of remission using different therapeutic options.
Future: EDEN is considering setting up a project group to continue with this project.
References:
Naldi L, Svensson A, Diepgen T, Elsner P, Grob JJ, Coenraads PJ, Bavinck JN, Williams H; European Dermato-Epidemiology Network. Randomized clinical trials for psoriasis 1977-2000: the EDEN survey. J Invest Dermatol. 2003;120(5):738-41.
Naldi L, Svensson A, Zenoni D, Diepgen T, Elsner P, Grob JJ, Coenraads PJ, Bouwes Bavinck JN, Maccagni A, Linder D, Williams H. Comparators, study duration, outcome measures and sponsorship in therapeutic trials of psoriasis: update of the EDEN Psoriasis Survey 2001-2006. Br J Dermatol 2010 Feb 1;162(2):384-9. Epub 2009 Sep 24.
Team:
PJ Coenraads, HC Williams, TL Diepgen, A Svensson, L Naldi
Aim:
1. To explore study design and quality issues in published clinical trials of interventions for hand-eczema over the past 25 years.
- To describe the range of interventions and comparators
- To describe and comment on the suitability of the main study design types
- To critically appraise the use of disease definitions
- To describe the quality of reporting
- To explore how the abovementioned factors have changed of the 25 year study period
- To make recommendations for improving design and reporting
2. To build a register of published clinical trials on hand-eczema for use in a Cochrane review
Method:
Combination of hand-searching and electronic searching for hand-eczema intervention trials in medical journals published in English, German, French, Italian and Dutch language.
Distribution of eligible publications among an expert panel. Assessment of quality in pairs, using a standard data extraction form.
Analysis of the data generated by the data extraction form.
The work is being continued as a Cochrane systematic review.
References:
Hywel C Williams, Åke A Svensson, Thomas L Diepgen, Pieter-Jan Coenraads,
Janine Blok, Uwe Matterne. Interventions for hand eczema (Protocol).
Cochrane Database of Systematic Reviews 2002, Issue 3. Art. No.: CD004055.
DOI: 10.1002/14651858.CD004055.
van Coevorden AM, Coenraads PJ, Svensson A, Bouwes Bavinck JN, Diepgen TL, Naldi L, Elsner P, Williams HC. Overview of studies of treatments for hand eczema – the EDEN hand-eczema survey. Br J Dermatol 2004; 151:446-451.
Bauer A, Schmitt J, Bennett C, Coenraads PJ, Elsner P, English J, Williams HC. Interventions for preventing occupational irritant hand dermatitis. Cochrane Database Syst Rev. 2010 Jun 16;(6):CD004414. Review.
Request:
Have we missed any trials ?
In List1 you can find the trials (not completely up to date) that were considered for assessment for the abovementioned Cochrane review. In List2 are all the publications up to the end of 2003 that were identified as possible hand-eczema trials.
You are free to use these lists with literature references, provided you acknowledge the hard work that was done by EDEN to assemble these lists.
We would appreciate it if you could notify us if you feel that we have missed a publication dealing with a hand-eczema trial.
Aim:
Team:
Naldi, Diepgen, Svensson, Elsner, Coenraads, Gonçalo, Bruze, Rossi
Aim:
To determine the prevalence and severity of contact dermatitis in the general population in Europe and to assess the rate of sensitisation to fragrances and hair-dye, as documented by standard patch test procedures in the same population. This multinational study involves several areas in five European countries (Sweden, Italy, Germany, The Netherlands, Portugal). Subsequent phases of the study are planned to include North American and Asia.
Background:
The currently available data is mostly floating numerator data derived from patch test populations with estimates based on patch test reactions as opposed to reactions that are deemed to be clinically relevant and symptomatic. A few epidemiological studies suggest that the point prevalence of contact dermatitis in the general population may vary from 5% to 10% while fragrance sensitization has an expected prevalence of about 1%
Methods:
A validated questionnaire has been developed to record demographic aspects, clinical history and product exposure. A stratified sampling design will be adopted to select a representative population sample. To collect data, a face-to-face interview will be performed by trained interviewers in the different areas. The sampled subjects will have a patch-test to detect contact allergies.
Current study design:
The pilot phase has been successfully concluded.; the feasibility of the questionnaire and the patch testing wasexamined in a pilot study involving 100 random subjects in each participating center, drawn from the general population registry. The full study in a randomly selected sample from the general population has been started in a number of centers.
References:
Rossi M, Coenraads PJ, Diepgen T, Svensson Å, Elsner P, Gonçalo M, Bruze M, Naldi L. Design and feasibility of an international study assessing the prevalence of contact allergy to fragrances in the general population: the European Dermato-Epidemiology Network Fragrance Study. Dermatology. 2010;221(3):267-75.
TREatment of severe Atopic eczema Taskforce (TREAT)
Team:
Carsten Flohr (children), Jochen Schmitt (adults), Phyllis Spuls, Ake Svensson
Anecdotally, there is wide variation in treatment approaches between clinicians in the way they treat severe atopic eczema; i.e. eczema that has not responded to conventional topical and/or light therapy. However, no survey has been conducted to confirm this impression.
The TREAT project therefore aims to gather information on how severe atopic eczema in children and adults is treated across Europe, not only to inform clinical practice but also to potentially aid the design of an intervention study with different systemic immuno-suppressive drugs.
The survey among members of Paediatric Dermatology Societies/Interest Groups in 8 countries (Germany, Netherlands, Denmark, Sweden, UK/Ireland, Spain, Italy, and France) has now been completed (n=765). Among the main results were that dermatologists are 4x more likely to use systemic immune-suppressants than paediatricians. Cyclosporin was the first choice medication overall, closely followed by corticosteroids and azathioprine, then MTX. Two publications are planned, one presenting overall European data and one with a more in-depth analysis of the UK cohort.
As a next step, Carsten Flohr is currently seeking funding for a multi-centre RCT with immune-suppressive medication in children with severe atopic eczema.
Jochen Schmitt and Carsten Flohr are still considering toconduct a similar survey re severe AE treatment in adults.
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