European Surveillance System on Contact Allergies (ESSCA)


Objectives

Contact allergy is a frequent condition (with up to 20% of the general population affected), and its clinical manifestation - allergic contact dermatitis (incidence approximately 7 per 1000 per year)- has considerable socioeconomic impact. Recommendations concerning primary prevention must be founded on sound scientific knowledge concerning occurrence of allergen exposures in the population. To provide such data on a European scale, ESSCA-DC, a co-ordinating data centre for the expert network ESSCA, has been conceived.

A first, technical objective is to develop Electronic Data Processing (EDP) infrastructure according to the different needs of participating departments. Once this has been achieved, the ultimate aim of ESSCA-DC can be pursued: the continuous analysis (surveillance) of pooled data for different purposes. These include internal quality control, which is both a prerequisite, and an outcome of this multicentre activity. Furthermore, inter-national comparisons which reflect the effects of a wider than strictly national allergen exposure variation, time-trend analyses, and subgroup analyses will be performed, including the possible occurrence of known allergens in new exposure contexts. These analyses, which will be duly reported not only to the scientific community, but also to (EU) regulatory institutions and - suitably prepared - to industry and to the general public, shall provide a valuable starting point for lowering the incidence of contact allergies. For industry, such analyses can serve the purpose of post marketing surveillance of product safety; thus, a considerable interest in funding ESSCA-DC beyond the initial period of three years is expected and has, indeed, been indicated at the conceptual stage already.

Scientific approach

The ESSCA-DC work plan can be divided into a technical part - an application of medical informatics - and a scientific part. The former includes the following work packages:

•Implementation of local interfaces for export of uniformly structured data for pooled analysis in those departments which will continue to use their existing - heterogeneous - software.

•Adaptation of an existing computer program (developed for the German network ”IVDK”) to ESSCA requirements, including national adaptation (e.g., translation, special test programs).

•A one-time conversion of old databases of similar scope into the newly developed structure in those departments who already used patch test software, but wanted to, or had to, switch to a system fulfilling current requirements (user-friendliness, flexibilty, speed).

•Integration of the new software to be (further) developed into a hospital information system environment with very strict conformity requirements, which makes the implementation of additonal database interfaces necessary

•Set up of a co-ordinating data centre

The scientific work packages include first communal analyses of pooled data (beyond a limited study context, i.e., in terms of the intended continuous surveillance), internal reporting and discussion of data during a first workshop (with two more workshops with a similar purpose scheduled in the 2 nd and the 3 rd year, respectively), publication of these results in peer-reviewed scientific journals, launch of an Internet site with a description of ESSCA-DC and selected results which are of public interest. The final work package is devoted to ensuring adequate funding beyond the period of 3 years contributed by the EU; interested parties have already been identified, namely manufacturers of cosmetics and household goods which often act on an international (European) scale rather than a strictly national market, and are thus interested in post marketing surveillance of product safety adapted to this market.