Contents
47.1 Scope . . . . 893
47.2 Information Databases . . . . 894
47.2.1 Information on Allergens . . . . 894
47.2.2 Product Databases . . . . 895
47.2.3 Other Information . . . . 896
47.3 Patient Management Systems . . . . 897
47.4 Epidemiological Tools . . . . 898
47.4.1 Epidemiological (Multicenter) Surveillance . 898 47.4.2 Good Clinical Practice in Patch Testing . . . 899
47.5 Further Applications and Perspectives . . . . 900
References . . . . 900
47.1 Scope
Within a few decades, we have witnessed an over- whelming increase in the rate of technological progress concerning computers. In fact, computers of various kinds have become indispensable in both everyday and professional life. Not only has their sheer number increased, but also their quality in terms of computing power, user-friendliness and versatility. Consequently, the scope of computer ap-
plications has become broader and broader, includ- ing worldwide connectivity via the Internet. This general trend also applies to the field of medicine.
Electronic health records have principal advantages and potential problems, which is an important issue (reviewed in [1]) but one that we will not be address- ing here in detail; some important aspects are sum- marized in Table 1. This chapter will focus on elec- tronic data processing (EDP) applications that can aid the management of patients with contact derma- titis. For instance, computers can be used to retrieve information, such as scientific publications, product compositions or allergen characteristics to aid the diagnostic process and help to advise the patient (see Sect. 47.2, Information Databases). Furthermore, an- amnestic and patch test data, along with other clini- cal or administrative data, can be stored in a struc- tured, computer-based documentation system (see Sect. 47.3, Patient Management Systems). Using such
“computerized” patient data, epidemiological and other studies may be performed, again using com- puters together with appropriate software as a re- search tool (see Sect. 47.4, Epidemiological Tools).
Moreover, computers are increasingly being used in basic research, such as image analysis and bioengi- neering, and in a variety of other situations (see Sect. 47.5, Further Applications and Perspectives).
Computers in the Management of Contact Dermatitis
W. Uter, D. Orton, D. Perrenoud, A. Schnuch
쐽 Disclaimer. No liability is accepted for the continued correctness of URLs. Moreover, the authors disclaim responsibility for the contents of the webpages mentioned, and for the contents of other websites possibly linked to the sites referenced here.
47
Table 1.Some specific potential advantages and dangers of electronic health records
Advantages Hazards
Availability (in more than one place at a time) Authenticity as a medical document
Flexible display and report functions Unauthorized access to data during storage or transfer
Uniform structure Suitability as a long-term archive (for example, in view of changing data formats)
Readability of written information Incompatibility of electronic formats in critical situations Alerts and other dynamic functions Potentially unclear responsibilities for contents
Rapid communication possible
47.2 Information Databases
This section refers to data that are not directly relat- ed to specific patients, such as allergen and product information, but that may be combined into a data- base. General considerations regarding all types of databases like this are:
쐽 How precise and how current is the informa- tion (is the database updated regularly)?
쐽 Who is responsible for the content, as there could be a conflict of interest impairing the validity of data and hence their usefulness?
쐽 Are statements supported by scientific refer- ences?
쐽 Is there restricted access to information (ac- cess incurs a fee, or only open to user groups) and, if so, is the use of this site cost-effective?
47.2.1 Information on Allergens
Information on the chemical nature of a particular allergen, its biological properties, sources of contact and the clinical pattern of contact dermatitis caused by it is traditionally found in textbooks. In such books, experts in their fields give “state of the art re- views” based on their own results and all relevant lit- erature, thus not only reviewing current information, but also giving a balanced view on potentially con- flicting data. The results of such a process could be transferred from print media to electronic media very easily, and indeed more and more textbooks ap- pear in CD-ROM format. Ideally, however, such elec- tronic media should be more than just a copy of the book, enabling users (not termed “readers” anymore) to navigate efficiently through the contents with in- telligent tools, such as hyperlink technology, or met- athesaurus-based search facilities [2].
New editions of such print media usually appear only every few years, and the production time, in- cluding the editing process, is relatively long. There- fore, current knowledge on, in this case, allergens, cannot be incorporated. To access current literature, the clinician (and researcher) must resort to litera- ture databases and retrieval services, the most well known of which is probably Medline, maintained by the US National Library of Medicine. The immediate benefit from consulting Medline on patient care has already been documented [3]; consultation with such databases is part of the structured approach of “Evi- dence Based Medicine,” including “Evidence Based Dermatology” (http://www.ebderm.org). Direct on- line access to Medline is presently possible free of
charge via http://www.ncbi.nlm.nih.gov/entrez/. Cur- rent Contents and Science Citation Index, published by the Institute for Scientific Information (ISI) (http://www.isinet.com/) and EMBASE (http://www.
embase.com) are also popular literature databases, which are also partly available as CD-ROM and as other subscription services. Some of these (commer- cial) services allow selected entries to be downloaded (which is generally not considered to be a violation of copyright, in contrast to downloading a whole data- base or major parts of it), which can then be pro- cessed further using various commercial reference manager systems. As smaller national journals are sometimes not indexed in the literature databases mentioned, and “gray literature” may be interesting for collection, too, the compilation of an in-house database (examples: [4, 5]) could be considered to be a supplement to external databases such as the ones mentioned. Additional databases dedicated to scien- tific literature concerning allergens include COSME, INFAL und CDRF [6], which have been recently made available online [7].
If literature databases are used, information on al- lergens will only be retrieved indirectly (the original paper must be retrieved, if the abridged format of the abstract is not sufficiently informative). Allergen databases that directly present details such as syno- nyms, INCI names, CAS number, chemical formulae, potential sources of contact, and so on, may also be accessed with a computer. For these databases, the is- sues of constant revision and maintenance raised above are particularly crucial. Table 2 contains a col- lection of potentially useful websites.
A British website with information on plants rele- vant to dermatology is still available and has been updated recently [http://bodd.cf.ac.uk/BoDDHom- ePage.html, R.J. Schmidt (ed.)]. In the course of time this site may disappear, as other valuable sites have, and other sites may be implemented due to the fast pace of development in this field of electronic pub- lishing. The same may hold true for allergen manu- facturers that have a presence on the Internet. One manufacturer also offers allergen information in a dictionary format. However, this information is lim- ited and only available in the German language (Her- mal/Trolab, Reinbek, Germany, http://www.haut- stadt.de/hs/pages/infozentrum_allergie/kontaktal- lergene.php). Consulting the homepages of national contact dermatitis groups is therefore recommended for advice on allergen sources (see Chapter 48). In- formation may also be derived using Internet search facilities such as Google (http://www.google.com), Altavista (http://www.altavista.com), Hotbot (http://
www.hotbot.com), Yahoo (http://www.yahoo.com) and others.
47
The Allergen Bank was established in Denmark.
Special test materials are stocked in the Bank and made available for dermatologists on request (in- cluding plant chemicals, acrylates, animal feed addi- tives, and so on). The Bank’s computer system regis- ters several hundred contact allergens in appropriate patch test concentrations as well as patch test results [8]. With a similar aim of supporting patch testing with “uncommon” allergens – in this case cosmetic ingredients – the “IDOK” was established in Germa- ny in November 1997 [9]. Sometimes information on allergenic potential is only available from animal ex- periments; results from these have previously been compiled in the database “INPRET” [10].
쐽 Online (Internet) information resources on allergens differ greatly in terms of the variety of substances covered, the degree of detail, and how current the information is.
Their correctness and cost-effectiveness (in case of restricted or paid access) should be evaluated carefully before relying on the information presented.
47.2.2 Product Databases
Many compilations of the ingredients of products are available in print and on electronic media, mostly CD-ROM. For topical drugs, traditional national and international formularies can be regarded as the pre-
cursor of modern, computer-based product lists.
Since products, or at least brand names, are often specific to a certain country, such lists are primarily of national interest. One example available via the Internet (intended only for Swiss dermatologists) is a Swiss database on the ingredients of topicals [11].
Since Swiss legislation does not require that all ingre- dients of topical preparations are listed, this database was developed to fill that void. To obtain cooperation from manufacturers in revealing proprietary infor- mation, it was agreed that the database would be cen- tralized and accessible only by duly authorized der- matologists. Since computers were used to develop the database and to produce a printed card-file, it was easy to migrate to an on-line file. This was done in 1998 with password protection. Thus all Swiss der- matologists can perform multiple criteria Boolean searches online, including formulations, therapeutic uses and allergenic groups.
In Germany, the compositions of drugs, including topicals, are compiled and available in an almost complete electronic list that is updated yearly (“Rote Liste” [12]). Additional lists were available in the past, such as a compilation of cosmetic products and topi- cals [13] or ingredients of UV filter-containing cos- metics [14]. Similar databases for local or general use were compiled and reported on quite early in several other countries (for example [4, 15–17]). In the UK, refer to http://www.medicines.org.uk, which lists the excipients of many topical and some oral medicines.
Databases on the ingredients of products can be used to compile a list of products [4] that a patient with a certain contact sensitization can and cannot use – as long as the ingredients are fully (qualitative- ly) declared. The usefulness of such information has been demonstrated by Edman [16]. Once full declar-
Table 2.Selected Internet resources regarding information on allergens
URL Description Access
http://www.haz-map.com/allergic.htm A relational database of hazardous chemicals Free and occupational seases with a description
of “chemicals that cause contact allergy”
http://pharmacos.eudra.org/F3/cosmetic/cosm_inci_ Inventory of INCI names and fragrance Free
index.htm compounds
http://chemfinder.cambridgesoft.com/ Information on a broad range of chemicals Partially Free http://www.rifm.org/ and http://www.ifraorg.org Fragrance materials Free http://www3.interscience.wiley.com/cgi-bin/mrwhome/ List of MAK and BAT values (German regula- Restricted
104554790/HOME tions) for chemicals with scientific statement
http://bodd.cf.ac.uk/BoDDHomePage.html Botanical names and further information on Free, but
plants support
appreciated
Core Message
ation using a controlled vocabulary regarding ingre- dients is established – even for only a specific group of products such as cosmetics, as with the INCI dec- laration [18] – such lists will become unnecessary for patients, although they will still be helpful when esti- mating the amount of exposure to allergens on the respective market [19]. For other products, such as industrial work materials, full declaration will prob- ably be hard to achieve. In this situation, the mainte- nance of a central national database containing such information confidentially, with the possibility of ac- cessing a relevant part of it for individual patients, seems a reasonable alternative. The Danish Product Register (PROBAS) is an example of such a database.
It is updated on a daily basis and contains informa- tion on more than 75,000 (mostly industrial) prod- ucts, and is notified or updated by producers or im- porters [20]; however, it is not freely accessible. This database can be used to estimate the extent of expo- sure in the workplace [21].
One more example of product-related data are systems which monitor adverse effects of, say, cos- metics. Examples of such systems are “IDOK” [9] or the French “Cosmetovigilance” [22].
쐽 Freely available (online) information on the ingredients of most types of products in terms of potential contact allergens is still scarce, with the exception of informa- tion on cosmetics and medicaments.
47.2.3 Other Information
Apart from data on allergens and products, other in- formation may be useful for the management of pa- tients with contact dermatitis.
Protective gloves are a mainstay of primary and secondary prevention of contact dermatitis. While information on the gloves, such as material, size and intended use, is usually readily available from the re- spective manufacturers or importers, permeability and chemical composition data are often hard to ob- tain. Different institutions, partly commercial, have tried to meet the need for comprehensive informa- tion on gloves by providing EDP databases, although usually without (free) online access:
쐽 In Sweden, Mellström has compiled a database on protective gloves [23]
쐽 In the US, a commercial database is available containing information on 321 brands of gloves and protective clothing, tested with 835 different chemicals (“Gloves and CPC Data- base”, compiled by Forsberg and Keith, avail- able from Digital Liaisons, Austin, TX 78731)
쐽 In Germany, databases concerning the gloves of the respective manufacturer only (KCL, D-36124 Eichenzell, Germany), and another database (“GloSaDa”) with 34,000 measure- ment data on the effects of different chemicals on the six most important glove materials [24], are currently available. A few years ago, a freely accessible online list of potential aller- gens in protective gloves was created by the occupational liability insurance entity of the construction industry (http://www.gisbau.de:
“Aktuelles”, in the German language only [25]).
Manufacturers of gloves and other protective materi- als partly maintain websites, though these mostly contain general and order information only.
Other databases may offer more indirect benefits, such as webpages announcing forthcoming meetings such as those offered by several institutions: for ex- ample, the ESCD (http://dermis.multimedica.de/in- dex_e.htm), the Swiss Contact Dermatitis Research Group (http://www.dermacom.ch), the British Con- tact Dermatitis Society (BCDS) (http://www.bad.
org.uk/groups/bcds/), the German Contact Derma- titis Group (http://www.ivdk.gwdg.de/dkg) and oth- ers (see Chap. 48). Links to other relevant sites are of- ten included. In the US, DERM-INFONET has pro- vided such facilities with a broad scope for AAD members for many years ([26]; http://www.derm- infonet.com).
Many publishers of scientific journals and books maintain websites of various scopes, which may be used, say, for submitting manuscripts, retrieving arti- cles (sometimes available in full text, for free or on a subscription basis), to get information on products, and so on. Currently, several commercial online pro- viders offer information on scientific facts, pharma- ceutical products, political issues in the field of med- icine and communication facilities, including closed newsgroups. These services may or may not be re- garded as helpful by the individual physician. Bene- fits and costs should be evaluated before subscribing to any such service; however, a comprehensive in- depth review of these facilities is beyond the scope of this chapter.
47
Core Message
쐽 General or detailed information on various issues pertaining to occupational derma- tology and contact dermatitis is available, that is sometimes only relevant on a national level. Hence, (national) contact dermatitis societies could establish and maintain online lists of links useful to their members in order to support patient management.
47.3 Patient Management Systems
As already mentioned, electronic patient records are an important area for computer applications (see al- so Table 1). Despite financial constraints (in some countries) or the conservative attitudes of physi- cians, computer systems are increasingly used by dermatologists’ offices. The potential role of comput- er systems extends far beyond common applications such as automated billing and other clerical purpos- es [27], and includes:
쐽 Immediate access to well-structured patient data
쐽 Reports for economical or scientific analyses and auditing quality control – both external and internal
쐽 Output of selected data, for example for medi- cal letters
쐽 Integration of information databases and communication facilities, as well as transfer of patient data and networking with other offices or health centers.
In the field of contact dermatitis, any computer sys- tem needs to store not only the patient’s history, but also patch test results. Over the last two decades, dif- ferent patch test computer systems have been devel- oped in various centers – some of them used locally [28–33], some in national networks of different size [4, 6, 34–38] or in an international network [39]. This list of references is not complete, as many developers and users have not published on their computer sys- tem, especially in recent years, during which the use of computers has begun to change from an exception to a rule. The scope of data recorded is mainly deter- mined by local demands, and may range from a
“maximum”, with the aim of complete, highly indi-
vidualized documentation of a case, to a “minimum”, containing only data considered essential for epi- demiological analyses.
In October 1996, the ESSCA working group of the ESCD was established with the aim of continuous international (European) collaboration concerning the collection and analysis of patch test data [40]. As a prerequisite for this, a list of items that should be recorded, in the sense of a “minimal dataset”, was first compiled and agreed upon by ESSCA partici- pants. This contained demographic (“patient”) data, including date of birth, sex and an identifier (with names stored only on the local system), case data (data which must be recorded for every new consul- tation because it may change), and actual test data, in other words substances (along with concentration, vehicle and manufacturer) that the “case” had been tested with and all reactions (including doubtful, ir- ritant, and so on) to these allergen preparations, to- gether with a statement as to clinical relevance (cur- rent, past or unknown) in the case of allergic reac- tions. This “minimal dataset” has subsequently been amended and is accessible to the public at http://
www.ivdk.gwdg.de/essca/doc/minidat8_2003_06.pdf.
The document contains the current consensus of the ESSCA network regarding essential and optional data items to be recorded by any patch test software.
As far as possible, the catalogs (the lists to choose particular items from, such as allergen names or oc- cupations) should be compatible with international- ly used nomenclatures or code numbers. For occupa- tions, the ISCO 88 standard [41], established by the International Labour Organization, should prefer- ably be used [42]. The full details of this 4-digit hier- archical catalogue can be partially collapsed (for var- ious “office workers” for example) or extended by ad- ditions to a 5-digit level, as deemed necessary (see http://www.ivdk.gwdg.de/essca/doc/occup_ESSCA_
01-02.pdf.
The database used to store this data would be best conceived as a relational database, following the principle of normalization to achieve maximum data integrity, integration of standardized catalogs with well-defined entries, update flexibility and minimum storage requirements [36]. The actual patch test soft- ware used to enter and retrieve data should generally be evaluated against the following criteria:
쐽 How well does the structure and user inter- face of the computer program follow the step- wise procedures in an allergy department?
This is critical for acceptability during routine use.
Core Message
쐽 Is it possible to integrate the computer pro- gram into local networks, and into hospital in- formation systems (electronic records) [1] in particular, at least in terms of upgrade flex- ibility? This may become necessary due to ad- ministrative demands. Would it furthermore be possible to integrate data held within the system into a meta-database with health records, for example by employing standard- ized formats for data exchange such as HTML or XML [43]?
쐽 Is there at least one person in the department or office responsible for daily maintenance, such as back-up, program updates, routine reports?
쐽 Is confidentiality guaranteed (such as pass- word protection)?
쐽 How easily can the program be adapted to local demands, including integration of sup- plementary anamnestic items and test series and supplementary entries into pre-existing picklists?
쐽 Is historical correctness guaranteed: will it be possible to reconstitute the full and correct set of case data even if the compositions of test series or catalogs have changed in the mean- time?
쐽 Can free text be entered where categorical data is inadequate, to individualize documen- tation?
쐽 How easily can data be exported in a format that can be read by common application pro- grams, or in a “standard” format such as ASCII? This issue might be relevant if more complex analyses are going to be performed locally, or if data is to be passed to a network such as ESSCA.
쐽 Are there any report functions (not just sim- ple download of table contents) to analyze col- lected data and to print test results, case sum- maries, and so on, for a given patient? Do these queries require specific knowledge, for example of the structured query language (SQL), or is there a fairly extensive set of pre- defined reports that only require a few param- eters to be entered (such as a time frame, the name of an allergen)? Is there continuous sup- port allowing for the inclusion of new queries?
This aspect seems particularly important if export for further analysis into standard ap- plication programs is difficult or even impos- sible.
쐽 Will the computer program be supported by its developers, and if so, how long after initial
installation? Is there a hotline for installation or runtime problems? Does the computer pro- gram depend on the installation of third party programs or hardware components, and is their function and (future) availability guar- anteed?
쐽 Software used for the electronic registration of patch test results should (1) fulfill certain general quality criteria and (2) include a set of basic data to allow meaningful analyses.
47.4 Epidemiological Tools
The use of a computer program to record patch test results and selected parts of the patient’s medical his- tory may be worthwhile for the sake of compact structured storage, and the generation of test results and medical letters. With online documentation there may even be minimal or no extra work, com- pared to conventional records. However, a second, and probably predominant motivation for the use of a computer system – beyond a limited study context – is the ability to analyze the continually growing pool of data, which would not otherwise be possible.
This analysis might be retrospective, or prospective, following a certain study objective. Therefore, the re- port functions mentioned in the above checklist must be deemed essential. This potential has been well recognized for decades [34], and it has been ex- ploited not only for local, but also for multicenter projects and analyses. The special considerations re- garding such analyses in terms of clinical epidemiol- ogy of contact allergy are outlined in Chapter 10. By continually collecting and analyzing patch test data, a surveillance system for monitoring trends in contact allergies will be established. Additionally, quality control is both a prerequisite for, and an outcome of, such a system [44].
47.4.1 Epidemiological (Multicenter) Surveillance
The monitoring of trends over time, and in particu- lar an increase in the prevalence of sensitization to an allergen, may act as a “sentinel event”, serving as a
47
Core Message
starting point for either targeted research or preven- tative action. The amalgamation of a large amount of multicenter data allows for more rapid recognition of such trends than the analysis of local data only. This holds especially true for intrinsically small sub- groups, such as persons working in a certain occupa- tion [44]. International comparison (within ESSCA for example) may give valuable clues towards deter- minants of sensitization – if presumed differences in exposure or population characteristics are taken into account. Clearly, a sufficient degree of standardiza- tion is a prerequisite for such a task and guidelines for such surveillance systems should be considered [45].
With sufficient structure and process quality, mul- ticenter surveillance may offer considerable benefits:
“We still cling to a traditional research paradigm based on ad hoc studies … despite well recognised limitations (e.g.) … small samples restrict the scope for subgroup analyses and thus the practical value of the results. High quality clinical databases offer an al- ternative approach, with the potential to bring re- search closer to practice and audit. The advantages in- clude wide ownership and high generalisability through the participation of many clinicians; relative- ly low cost for each study, as the expense of data col- lection is spread over a range of research, audit, and administrative uses; the ability to generate large sam- ples rapidly; the opportunity to study rare conditions or interventions” [46].
While it is relatively difficult to relate the preva- lence of allergen sensitization found in a subgroup of patch-tested patients to the general population (see Chap. 10), the relative importance of allergens (such as the preservatives used in cosmetics) can be evalu- ated based on pooled data, because the average expo- sure profile can be regarded as reasonably represen- tative (not influenced by local or regional prescrip- tions or consumer habits or industries). If exposure to different substances (such as preservatives in cos- metics) could be estimated (in this subgroup of test patients), true risk assessment would be possible.
However, an estimation of the “exposure denomina- tor” is probably even more difficult than the approxi- mation of a “disease numerator” – except in just a few instances: hairdressers have been exposed both to
“alkaline” and “acid” perms (ammonium thioglyco- late and glyceryl thioglycolate) quite homogeneously.
While the former is apparently a very rare allergen, the latter is known to be one of the most aggressive allergens, with a much higher risk of sensitization under usual working conditions.
47.4.2 Good Clinical Practice in Patch Testing
International groups such as the ICDRG or the ESCD, and many national groups, have devoted much work to the improvement of patch testing. Active partici- pation in such a group must be regarded as essential for participation in a scientific network on contact allergy, such as the IVDK or ESSCA. However, similar to the experience of the NACDG [37], considerable differences (even between members of such special- ist groups) were noted upon first analyses of pooled data concerning the interpretation of test reactions;
these differences would otherwise not have come to light. As an educational consequence, regular patch test training sessions should be instituted [44].
Furthermore, the composition of patch test series should constantly be adapted to trends in allergen exposure; eliminating allergens which are no longer important, or always cross-react, and introducing new potential allergens. The analysis of a large amount of data greatly supports such decisions, and the addition of allergens presumed to be important (such as bufexamac [47] or hydroxymethyl pentylcy- clohexene carboxaldehyde [48] in Austria and Ger- many) to the standard series for a limited period of time allows rapid estimation of the prevalence of a particular sensitization in the clinical population of patch-tested patients [49]. The analysis of cross-reac- tivity [50–52] improves when using a large set of data, because statistical estimates such as kappa val- ues, positive predictive values, and so on, are more precise.
쐽 With little extra effort compared to con- ventional record keeping (and in the case of primary online documentation, without even incurring additional costs), the com- puterized registration of patch test data, along with selected demographic data, can be exploited for medical letter writing, quality auditing, and clinical epidemiology research.
Core Message
47.5 Further Applications and Perspectives Beyond the current use of computers in the manage- ment of contact dermatitis, the following applica- tions are conceivable, partially realized in experi- mental settings:
쐽 Composition of a panel of allergens for patch testing according to a certain demographic and occupational profile [53] or even on an individual basis (instead of using standard and other series), based on a rule-generating system [54] – commonly termed an “expert system” [55].
쐽 Telemedical applications such as graphical or text-based consultation systems on contact allergies to support daily practice
쐽 Use for image analysis of, for example, ultrasound [56], histological or clinical [57]
pictures
쐽 Conception of lecture or self-learning educa- tional material in the field of contact allergy [27]
쐽 Further advances in the use of computers in the search for quantitative structure-activity relationships [58–60].
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