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Ongoing Projects
The STROBE systematic review
Four of the steering group members are currently carrying out 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 is 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. <
Reference:
The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for Reporting Observational Studies von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, et al. PLoS Medicine Vol. 4, No. 10, e296 doi:10.1371/journal.pmed.0040296
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.
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.
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.
References:
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.
Request:
Have we missed any trials ?
In List1 you can find all the trials 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:
To determine the prevalence and severity of contact dermatitis in the general population in Europe and to assess the rate of sensitisation to fragrances, 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 being 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. Preparations are now made for the full study. Meanwhile, medical-ethical committees gave their approval.
Dear colleague,
I am Ignacio Garcia-Doval, a Spanish dermatologist with special interest in epidemiology, and MSc in research methodology. I am writing you to invite you to participate in a moderated e-mail discussion list about clinical research methodology in dermatology. This will take place with the priceless support of the European Dermato-Epidemiology Network (EDEN).
What is the aim of this Forum?
Clinical research means a lot of work. It is done in very different settings: optimally in a well structured group with methodological support from experts, but sometimes it is done in a less adequate environment.
Wherever you work, good planning is very important in research. Even small and simple studies should be based on a written protocol. The worst possible scenario is discovering, after a lot of time and effort, that your study has a fatal flaw and is not useful. The main aim of this forum is that we all learn research methodology by reviewing research protocols (or parts of them). It is a sort of friendly peer-review system for protocols, before the research work is done. We hope that it will improve our knowledge on the subject, as well as the quality of the research protocols used as examples.
How can I participate?
If you join the forum you will receive occasional e-mails with research protocols for review. You can send your comments on them. You will lately receive another e-mail with a summary of these comments. Your participation in the discussion will always be welcome.
How can I send a proposal for discussion?
If you are planning some research, all of us would be very grateful if you could send us a structured protocol (when you join the forum you will receive some instructions). We will distribute it in the forum, and try to ask some experts. We will learn from it and will give you all the feed-back with the aim of improving your protocol.
We would also be glad to receive parts of a protocol, such as questionnaires, data collection forms, or others.
How can I send a comment to the Forum?
Apart form the above-mentioned main subject of the forum, we would be glad to receive other types of comments on the subject of dermatological clinical research (general comments or about books, software, courses, and the like.)
How to subscribe?
Would you like to try? Just send me your e-mail to edenforum@aedv.es. I would be thankful if you could also send me a few lines on your background and experience in research, to help me organize discussions.
Please feel free to invite other colleagues with interest in research methodology applied to dermatology, either dermatologists, epidemiologists, statisticians or interested people with other background.
And last, I will do my best to avoid causing you any inconvenience such as spam inoculation (your e-mail will be hidden, and will not be used with any other aim or offered to anyone) or virus dissemination (all e-mails will be virus checked, and we will avoid risks such as HTML coding).
I am looking forward to hearing from you,
Ignacio Garcia-Doval
Dermatology Department
Complexo Hospitalario de Pontevedra
Pontevedra
Spain
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