193

Original Articles

Registries in Clinical Epidemiology:

the European Surveillance System
on Contact Allergies (ESSCA)
W. Uter1; A. Schnuch2; M. Wilkinson3; A. Dugonik4; B. Dugonik5; T. Ganslandt6
1Department

of Medical Informatics, Biometry and Epidemiology, Friedrich-Alexander University Erlangen-Nrnberg,

Erlangen, Germany;
2Information Network of Departments of Dermatology, Georg-August University of Gttingen, Gttingen, Germany;
3Department of Dermatology, Leeds Teaching Hospitals NHS Trust, Leeds, UK;
4Department of Dermatology, University Medical Centre Maribor, Maribor, Slovenia;
5Faculty of Electrical Engineering and Computer Science at the University of Maribor, University of Maribor,
Maribor, Slovenia;
6Medical Center for Information & Communication Technology, Erlangen University Hospital, Erlangen, Germany

Keywords
Registry, dermatitis, allergic contact dermatitis, epidemiologic surveillance

Summary
Background: Disease registries rely on
consistent electronic data capturing (EDC)
pertinent to their objectives; either by using
existing electronic data as far as available,
or by implementing specific software solutions.
Objectives: To describe the current practice
of an international disease registry (European Surveillance System on Contact Allergies, ESSCA, www.essca-dc.org) against different state of the art approaches for EDC.
Methods: Since 2002, ESSCA is collecting
data, currently from 53 departments in 12
countries. Departmental EDC software
Correspondence to:
Wolfgang Uter
Department of Medical Informatics, Biometry and
Epidemiology
Friedrich-Alexander University Erlangen-Nrnberg
Waldstr. 4 6
91054 Erlangen
Germany
E-mail: wolfgang.uter@fau.de

1. Introduction
Disease registries used as a basis for scientific analyses rely on consistently collected
data pertinent to their objectives. The
extraction of relevant information from
electronic patient record systems in terms

ranges from spreadsheets to comprehensive

patch test software based on a relational
database. In the Erlangen data centre, such
diverse data is imported, converted to a
common format, quality checked and pooled
for scientific analyses.
Results: Feed-back to participating departments for quality control is provided by
standardised reports. Varying author teams
publish scientific analyses addressing the objective of contact allergy surveillance.
Conclusions: Although ESSCA represents a
historically grown, heterogeneous network
and not one unified approach to EDC, some
of its features have contributed to its viability
in the last 12 years and may be useful to
consider for similar investigator-initiated
networks.

Methods Inf Med 2016; 55: 193199

http://dx.doi.org/10.3414/ME15-01-0099
received: July 27, 2015
accepted: February 1, 2016
epub ahead of print: February 24, 2016

of routine data for purposes of a registry,

or also for an ad-hoc clinical study, is an
important field of medical information
science research and service [1]. However,
if the scope of such available data does not
fully suffice to meet the respective research
needs, study- or registry-specific data has

to be collected in addition, and merged to

the existing data. For some research topics,
virtually no routine data may be available
beyond basic patient characteristics such
as age and sex. This was the case almost
30 years ago, and is still the case nowadays,
according to the best of our knowledge,
concerning data used for the clinical surveillance of contact allergy [2]. Such data is
generated during the diagnostic work-up
of patients with suspected allergic contact
dermatitis by means of the so-called patch
test [3].
The following article addresses the
evolution and the current practice of the
European contact allergy surveillance network ESSCA (www.essca-dc.org). The
technical details (standard operating procedures, structure of central data pool) are
presented briefly, but shown in detail in
a web document (www.essca-dc.org/doc/
essca_central_SOPs_online.pdf, last accessed 2016-01-27). The ESSCA data
centre may serve as an example of the
technical difficulties, and possible solutions, which are encountered when trying
to collect consistent clinical data from a
heterogeneous multinational environment,
specifically, in the absence of funding
beyond an initial start-up period funded
by the EU (QLK4-CT-2001-00343)
20022004 which would otherwise enable implementation of a more uniform
and efficient structure along the lines of
concepts discussed below. Some characteristics of ESSCA will be discussed which are
believed to contribute to sustainability and
notable scientific output even from such a

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non-supportive background and may be of

value also for other research networks.

2. Background
2.1 General Options for Setting
Up a Disease Registry
Electronic data capture (EDC) solutions in
a registry network can be categorised according to the following two dimensions:
Data hosting: Locally installed (uniform
or diverse) software, potentially incurring significant manual efforts to export, transfer and harmonise datasets
for central pooling and maintaining
multi-site software installations versus
one centralized EDC solution collecting
data in a central data repository. Many
successful implementations of such
EDC platforms in the context of disease
registries have been reported [4 6].
Level of integration into departmental
routines: A minimal add-on strategy
minimising the amount of data entered
additionally for the research purpose,
e.g. by collecting only aggregated or
a priori selected patient information,
with potential limitations concerning
the future use of data versus a replacement strategy, by which the research
EDC instrument shall cover all departmental documentation needs, thus
eliminating the necessity for additional
(paper) routine documentation [7, 8].
However, regardless of whether locally installed software or a centralized EDC platform is used, these approaches still require
data entry into a dedicated research platform, which may duplicate documentation
requirements of the actual patient care
work-flow. The replacement strategy described above aims towards using the dedicated research platform to also cover local
departmental needs, but it may be difficult
to cover all such needs encountered in a
multinational research network in one
single software solution. Some requirements may be impossible to address (e.g.
legally mandated documentation in local
billing or quality control systems); implementation of interfaces such as HL7 may
provide some limited integration in this
situation.

Concerning research topics other than

contact allergy where this is feasible, a secondary use strategy could be implemented, which relies on data which is already routinely documented in the electronic health record (EHR), made available
for research use. The use of routine data
could be regarded as following a minimal
add-on strategy, in terms of adding no additional burden of documentation on the
local staff. Data collected in such a way can
either be made available through exports
and pooling as described above, or through
federated approaches e.g. using the Shared
Health Research Network (SHRINE) platform [9], in which data resides locally and
is queried remotely. Applicability of this
approach, however, relies on the overlap
between routine documentation and research needs, which depends on both research focus and routine documentation
requirements. Also, the re-use of existing
documentation items implies that data
elements and value sets have to be taken
as is and cannot easily be harmonized to
better meet research requirements.
A more comprehensive approach would
be to implement a single source documentation strategy, in which all data elements required both for routine care as
well as associated research projects are entered in the EHR, and research data is consecutively extracted [10, 11]. As such, the
single source strategy would mostly be a
replacement (of a previous, less comprehensive and flexible EHR) strategy, while
trying to minimise documentation efforts
by providing a single all-purpose EHR,
without, however, restricting the scope of
data a priori as a minimal add-on strategy necessarily would. The advantage of
this approach is that documentation can be
optimized to meet the needs of both routine care as well as research, and that those
data elements and value sets can potentially
be harmonized across sites. Also, federated
approaches like SHRINE [9] can be used in
a single source context. However, single
source approaches may be the most difficult to put into practice, requiring an EHR
platform that can be adapted to local and
dynamically changing documentation
needs as well as support from local routine
IT departments and/or vendors to implement the respective data entry forms and

work-flows. Harmonizing this integration

of clinical care and research documentation across multiple sites creates additional challenges both concerning differences in local work-flows and semantic
issues [12].

2.2 Definition of Contact Allergy

and Its Clinical Surveillance
Contact allergy is an acquired immunological alteration resulting in allergic reactions of the skin (allergic contact dermatitis) after contact with a sufficient amount
of the allergen in those who became sensitised (allergic) during an earlier exposure
to the specific trigger. Allergens comprise
natural as well as man-made substances
and abound in the (work) environment
[13]. However, those affected by allergic
contact dermatitis only partly consult the
medical system [14]. Affected persons surfacing as patients are either treated (without further specialised and specific diagnostics) at the level of primary care, or are
referred for diagnosis and treatment to a
dermatologist, who may also be directly
consulted, depending on the health system.
The availability of services for cutaneous
allergy will depend on the wealth and degree of development of a country and society. Normally dermatologist will perform
a so-called patch test to identify the allergen, or sometimes the multiple allergens,
causing the presumptive allergic contact
dermatitis. At this particular point of medical care clinical and demographic data are
collected which are relevant for contact allergy surveillance. A necessary set of variables has been defined as minimal dataset
by the European network ESSCA (www.
essca-dc.org), consensualised at a general
assembly in 2003, described in Table 1.
Morbidity data are collected in patients,
and not in population samples. This
implies, as in other clinical surveillance
systems, that the relative frequency of diagnosed contact allergies cannot be interpreted in terms of prevalence at the population level. Indeed, prevalence is expected
to be higher to a varying degree, due to
morbidity-driven patient selection [15]
which may also vary between countries
and departments, respectively [16]. The resulting considerations involved in the use

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W. Uter et al.: Registries in Clinical Epidemiology: the European Surveillance System on Contact Allergies (ESSCA)

and interpretation of the clinical epidemiology of contact allergy are beyond the
scope of the present paper and have been
discussed elsewhere [2, 17]. Some examples
of contact allergy surveillance will be
briefly presented in the results section.

3. Methods
3.1 Electronic Data Capturing
Software for Contact Allergy
As mentioned, only a minute part of the
minimal dataset for contact allergy is potentially covered by data collected routinely, as we are aware of. This covers
mostly just basic demographic and clinical
data, and possibly the patch test series applied however, no detailed results. Hence,
all local EDC software solutions have specifically been developed for the purpose of
documenting patch test results and the associated demographic and other clinical
data ( Table 1). At present, both the
minimal add-on and the replacement
strategies are being followed, depending on
the preferences and scope of the respective
research networks. The varying degree of
flexibility (and complexity) of the patch
test software used and the consequences
for data analysed is described in [18].
Briefly, the following options are being
used by contributors of the ESSCA network, ordered by increasing complexity
(and: flexibility, usefulness and need for IT
support):
Use of an electronic spreadsheet, following a minimal add-on strategy. In this
spreadsheet the rows usually represent
single consultations of patients. The columns list different attributes of this patient, such as age, gender, occupation,
and patch test reactions. Only one or, at
maximum, two patch test reading results per allergen are usually included,
covering just the baseline series applied
routinely to every patient, but no
specialised test series.
A relational database used as a backend, with workflow-oriented screen
forms as a front end, programmed e.g.
with MS-Access, as used by the British
Society of Cutaneous Allergy (http://
www.cutaneousallergy.org/, last accessed 20150609). This potentially

Table 1 Demographic and clinical data relevant for contact allergy surveillance, according to the
ESSCA minimal dataset
Variable

Significance/Comment

Country, department

Identifier for benchmarking, comparisons

Date (year) of test

Seasonal effects, time trends

Patient identifier

Anonymous; link of multiple consultations by one patient

Consultation identifier

Anonymous; individual primary key for one consultation

Age, gender

Important gross exposure surrogates, used for direct standardisation

(age usually dichotomised into < 40 and > 39

Occupation (job title)

Exposure surrogate; ISCO-88 (starting 2014 in ESSCA: ISCO-08),

partly aggregated to major/sub-major groups

Anatomical site(s)

Indicator of contact with allergen

Incriminated product

One or more product categories considered as cause of dermatitis;

can be used as exposure surrogate

Allergens tested

Array of substances patch tested during consultation (multiple reading

times of the test). The baseline series tested in virtually all patients
typically comprises 25 to 30 allergens, which are read 2 or 3, sometimes
4 times. Hence the matrix has 120 elements; considerably more if more
allergens, such as up to 100, are being tested.

Allergens with (allergic) Subset of above, various reactions possible during the multiple reading
reactions
times, usually aggregated to positive (allergic) vs. non-positive
(not allergic) for common analyses. The complement has a negative
result (not allergic).
Relevance of positive
reactions

All allergic patch test reactions must at the final reading be assessed
concerning their (unequivocal or probable) significance for current or
past (occupational or non-occupational) allergic contact dermatitis

Final diagnosis/-es

Allergic or irritant contact dermatitis, dermatitis of other or unknown

aetiology, other types of allergic reactions, other dermatological
diagnoses.

Occupational factors

Global statement whether current contact dermatitis is at least partially

related to occupational exposures

more flexible way to collect patch test

data allows for the inclusion of (different versions of) several test series applied to a patient. Some standardised reports of the locally collected data are
available (e.g., results with a certain test
series in a defined period). Data can be
exported for central pooling, covering
defined periods.
As another example of a software based
on a relational database, the multilingual WinAlldat software [19] is used by
several departments of the European
Surveillance System on Contact Allergies (ESSCA; www.essca-dc.org) network, enabled by start-up funding
by the EU (QLK4-CT-200100343;
20022004). The software allows administration of centre-specific test series

and individualised series with patients

own materials, linking between different consultations of one patient (n:1),
network integration, an interface to hospital information systems and, most recently, a data mining tool to examine
the contents of the database with a set of
freely definable filters (replacement
strategy). Anonymised export into csv
files is provided. However, WinAlldat/
ESSCA is locally installed, which
implies performing any updates in each
participating department, and dependence on local IT support.
The obvious alternative to locally distributed EDC systems use of a central
database server accessed via the Internet
with browser software, employing hier-

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archically controlled access to data has

hitherto not been implemented for contact
allergy research in terms of a productive
system, to the best of our knowledge. In
other fields, with possibly less pronounced
historical roots (which are definitely an obstacle for a uniform, consistent EDC solution), e.g. [6] , this option has proven useful and viable.
The development and maintenance of
locally installed software or a centrally
hosted database necessitates specialised
personnel and appropriate resources on a
departmental and a central level, respectively. Hence, only (larger, adequately
funded) networks will possibly be in a
position to invest in such an undertaking.
Single centres or smaller groups are advised to join existing networks after carefully checking evidence of previous productivity (list of publications using the
system) and indicators of future viability.

3.2 ESSCA Data Centre

ESSCA became fully operational in 2002,
with start-up funding by the EU not only
for i) the data centre, but also ii) the development of the WinAlldat/ESSCA software
[19] intended for consortium members not
yet using a patch test software, or wanting
to upgrade, and iii) local export interfaces
for those network participants who continued to use their existing software. Initially, 17 departments from 9 countries
were included, whereas the latest reporting
period comprises 53 departments from 12
European countries [16, 19]. Since 2004,
several new contributors to the ESSCA network have joined, necessitating (in lieu of
export interfaces) the development of import scripts and mapping procedures upon
receiving local data in their original shape
in the data centre. The standard operating
procedures of the ESSCA data centre are
described in detail at http://www.esscadc.org/doc/essca_central_SOPs_online.pdf
(last accessed 2016-01-27). In brief, the following successive tasks are performed (at
present, by one staff part-time):
1. Structured archiving of all incoming
data in its original form, import as is
into R using functions as appropriate.
2. Transformation into the central format
of data storage, and mapping to cen-

trally used catalogues, where necessary,

using four data frames (relations) in a
non-normalised relational database
(test series data covering all information on patch test series used in the
department, case data pertinent to one
consultation of a patient, such as age,
sex, and clinical variables, test data in
terms of all patch test results, including
negative, and relevance data indicating
the significance of a diagnosed contact
allergy for the patient). All information
is linked with appropriate keys.
3. Unless disjunct annual portions of finalised local data are provided, incoming data is incrementally added to existing data of that department, with strict
precedence of newer over older data in
case earlier data had been updated.
4. Data from one department collected in
a particular year is used to prepare an
Internal Report. The intention is to
present to the local researcher a standard descriptive analysis of all relevant
data, including the number and proportion of missing information. Should
possible errors be spotted, the import
(with new amended data and/or corrections of the import script) is re-done addressing these errors, and a new version
of the Internal Report is prepared,
until data are deemed valid and the annual portion of data can be added to the
overall pool of data. The use of quality
controlled data is believed to enhance
acceptability of results by the scientific
community. Technically, the internal report is a LaTeX file produced by the R
function Sweave(). This enables to easily
recycle a standard template, with both
in-line, tabular and graphical results
presentation and conditional commenting, using changing data portions from
different departments and different
years, respectively.
5. As soon as a sufficient body of pooled
data has accumulated, the issue of coordination of requests from among the
network participants for analyses and
publications arises, to avoid duplicate or
even competitive work. This includes a
call for co-authors by those leading a
research topic. Contributors of data not
opting for such a contribution are listed
in an acknowledgement, for which con-

sent needs to be sought for each manuscript prior to submission.

The main scientific motivation for analysing patch test data is monitoring the
frequency of contact allergy amongst patients over time, across geographical regions, or in certain subgroups or concerning certain allergens. Given sufficient size a
national network may be regarded as a
clinical sample of the national level; some
examples of surveillance are reviewed in
[8] and [9]. General good epidemiological
practice guidelines as well as guidelines
more specific for the descriptive analysis
and presentation of contact allergy research results must be considered [10 12].

4. Results
In this section, outcomes of the ESSCA
network, both on an internal level, and in
terms of informing the scientific community, are briefly presented. Another outcome, on a technical level, is the multilingual software WinAlldat/ESSCA [19]
which is available for free, after registration, from the projects website (www.
essca-dc.org). Translations into languages
other than English, Polish, Spanish and Italian can be made using a toolkit, provided
upon request to the corresponding author.
However, any (other) software solution can
be used to contribute to the ESSCA network, provided it delivers structured data
of adequate scope. The current spectrum of
EDC systems used for contribution to
ESSCA is shown in Figure 1. Presently,
only the Slovenian network and the Information Network of Departments of Dermatology (IVDK, www.ivdk.org; comprising Austrian, German and Swiss departments) contribute multi-department data
to the data centre, thereby rendering it to
a meta-network; otherwise single departments submit their data individually.
The feedback to local departments in
the standardised format of internal reports delivers a first result, as the patch
test software used locally often provides
only more limited capabilities of analysis
if these are used at all. Primarily intended
as a quality control measure, to check for
issues of data quality (missing data, plausi-

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W. Uter et al.: Registries in Clinical Epidemiology: the European Surveillance System on Contact Allergies (ESSCA)

bility), or errors in the import or mapping

process, the final internal report reflecting adequate data is appreciated as valuable
information by the local colleagues. Moreover, a comparison with the general ESSCA
results which are also provided (in the context of presentations at meetings or as publications, see below) allows some benchmarking of departmental results. Both the
IVDK and the British Society of Cutaneous
Allergy (BSCA, www.cutaneousallergy.co.
uk) have formally integrated such auditing
into their annual meetings, striving for
standardisation and high quality data.
However, the main purpose of ESSCA is
contact allergy surveillance and presentation of results at scientific congresses and
as scientific publications. So far, data from
114,330 consultations have been collected
between 2002 and 2014 from altogether
59 departments in 12 countries. Recent
examples of the latter include a comparison
of the time trend of contact allergy to
nickel in four countries [20], an overview
of the characteristics and selection of patients patch tested during the current
reporting period 20092012 [16], patch
test results in children and adolescents
across Europe [21], or identification of
high-risk occupations and important occupational allergens, respectively [22].

5. Discussion
We would not claim that the way the
ESSCA network in general, and the data
centre in particular, is organised should
serve as a model for many or even all international epidemiological disease registries.
In fact, other networks such as the German Obstetric Surveillance System [6]
which do not need to incorporate diverse,
historically grown EDC solutions, may find
quite different solutions appropriate for
their objectives. However, ESSCA has,
from the start, not tried to impose such a
one solution fits all EDC approach, but to
offer maximum accessibility by providing
locally installable software, and alternatively, also incorporating exports from
existing departmental EDC solutions. Custom formatted exports, i.e. already in the
necessary common denominator format,
had been provided in the early period of

Figure 1
ESSCA

Electronic data capturing systems currently used by local departments for contribution to

the project (20022004) enabled by EU

funding. Lately, however, exports are delivered to the data centre as is and need to
be appropriately transformed with custom
import scripts. However, with adequate
funding and input of IT knowledge (and
support on the local level) much more
consistent solutions along the lines of concepts outlined in the introduction may be
developed. Still, we believe some technical
aspects which have proven useful may
be interesting for researchers organising
a similar investigator-initiated network,
namely
a low threshold for joining the network
by acceptance of all sufficiently structured data;
responsibility for anonymisation directly at the department level and no
transmission of personal identifiers to
the data centre (the combination of age,
sex and [aggregated] occupation is
deemed insufficient to yield unique profiles within the catchment area of a department in case any central data is
stolen and misused);
structured feed-back to participating
departments in the format of internal
reports which offers an incentive for
participation in the network, in addition

to the possibility to act as (co-) author of

scientific publications;
use of the Sweave() function provided
by R which offers an elegant way of
rationalising such reports, probably superior to components of other software
packages, such as the Output Delivery
System by SAS in terms of adaptability;
a clear organisation of processes to collect, pool, analyse and publish data
which avoids uncertainties from the
side of the network participants concerning their role.

Other aspects must be viewed as weaknesses or shortcomings, such as

Some systems contributing to the
ESSCA data pool do not allow the
identification of re-consultations, i.e., a
link between different consultations of
one patient. According to data of the
IVDK contact allergy network (where
such re-identification is possible), the
proportion of re-consultations is < 1%
e.g. within a 9-year period [23] and
thus of impact only in long-term analyses, where the number of persons
tested will be slightly inflated.

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In the absence of a Europe-wide platform for re-identification of patients it

is impossible to account for re-consultations in different departments (in one
country). Cross-consultation between
different countries is probably very
limited.
A lag of availability of published results
of usually three or four years, which
does not well fit with the aim of surveillance even in the epidemiology of
contact allergy which is much less
dynamic than e.g. infectious disease epidemiology. Adequate support and funding could reduce this lag to a mostly
inevitable 1-year period, as shown by
output from the IVDK network.

Since the ESSCA data collection platform

was established, more comprehensive approaches towards decentralized data collection have been developed and published.
Record linkage tools like the TMF PID
Generator [24], the Mainzelliste [25], or
the MOSAIC E-PIX service [26] provide
methods for the centralized management
of patient pseudonyms and allow to merge
records when patients have been examined
in multiple participating centres. The deployment of such a centralized ID management service, however, raises the barrier to
entry in a distributed scenario with different data entry solutions in multiple countries that need to be integrated.
Metadata Repositories (MDRs) compliant to the ISO 11179-1 standard
(http://metadata-standards.org/11179/, last
accessed 2015-07-06) are being proposed
to provide a shared structured representation of relevant research data items that
can support the harmonisation of data
acquisition across participating centres
[27]. With open source implementations
suitable for academic use recently becoming available (e.g. https://mdr.imise.unileipzig.de/) integration of an MDR should
be considered for epidemiologic registries
[28].

6. Conclusion
The ongoing work of national networks as
well as international networks such as
ESSCA has unequivocally proven the value

of networking in this field, i) by establishing quality assurance measures (in single

centre data, no benchmarking is possible)
and ii) by providing important scientific
evidence, e.g., on the recent, dramatic increase of contact allergy prevalence to the
preservative methylisothiazolinone (e.g.
[2931]). Future solutions of (meta)network data collection in terms of disease
registries should preferentially take up the
more advanced, current solutions outlined
in the discussion. The aim is a good (economical, scientifically valid, user-acceptable) balance between the effort for data
entry locally and the scope and flexibility to
cover routine surveillance and ad hoc research topics.

10.

11.

12.

13.

14.

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