The evaluation of clinical information systems is essential as they are increasingly used in clinical routine and may even influence patient outcome on the basis of reminder functions and decision support. Therefore we try to answer three questions in this paper: what to evaluate; how to evaluate; how to interpret the results. Those key questions lead to the discussion of goals, methods and results of evaluation studies in a common context. We will compare the objectivist and the subjectivist evaluation approach and illustrate the evaluation process itself in some detail, discussing different phases of software development and potential evaluation techniques in each phase. We use four different practical examples of evaluation studies that were conducted in various settings to demonstrate how defined evaluation goals may be achieved with a limited amount of resources. This also illustrates advantages, limitations and costs of the different evaluation methods and techniques that may be used when evaluating clinical information systems.

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This prospective, observational study of a cohort of thyroid cancer patients in Germany focusses on the "real-world" practice in the management of thyroid cancer patients. This report includes data from 2376 patients with primary differentiated thyroid carcinoma first diagnosed in the year 1996. The study reveals considerable differences in actual practice concerning surgery and radioiodine treatment. The results indicate that consensus is lacking with respect to the multimodality treatment approach for differentiated thyroid carcinoma. Our analysis represents the most current and comprehensive national assessment of presenting patient characteristics, diagnostic tests, treatment and complications for thyroid cancer.

Since 1985 a special work group involved in the coordination of hospital cancer registries in Germany (AKKK) has been collecting, storing and analysing data on tumour patients, received from cancer centres, oncological departments and specialised practices. The documentation of tumour patients is based, among other things, on information concerning localisation, histological findings and tumour spread. The data are stored in a central database administered by the work group. At present it contains data on approximately 500,000 oncological patients. In the period from 1987 to 1992, 56,013 initial entries were made concerning patients with urological tumours. Of these cases, tumours of the kidney (n = 11,424) constituted 20.4%. In 94.6% of the cases, histological investigation revealed a renal cell carcinoma-pT1: 5.8%; pT2: 53.6%, pT3: 37.2% and pT4: 3.4%. Tumours of the urinary bladder (n = 16,246) constituted 29.0% of all urological tumours. In 93.8% of the cases a transitional cell carcinoma was detected-pTis: 1.0%; pTa: 36.9%; pT1: 29.6%; pT2: 16.9%; pT3: 11.4%; pT4: 4.4%. Transitional cell carcinomas of the ureter or of the collecting system (n = 1,846) constituted 3.3% of the cases. The proportion of testicular tumours (n = 6,594) amounted to 11.8%; 53.6% of these germ-cell tumours (n = 6,281) were seminomas and 46.6% were non-seminomas. In all, 66.3% of the cases were lymph-node negative. Tumours of the prostate (n = 19,903) constituted 35.5% of the cases. In the period from 1987 to 1992, the proportion of lymph-node-positive prostate carcinomas decreased from 39.8% to 16.2%. The detailed analysis of these data shows how the hospital cancer registries can support the discussion regarding diagnosis and therapy of urological tumours.

The purpose of guidelines in clinical practice is to improve the effectiveness and efficiency of clinical care. It is known that nationally or internationally produced guidelines which, in particular, do not involve medical processes at the time of consultation, do not take local factors into account, and have no consistent implementation strategy, have limited impact in changing either the behaviour of physicians, or patterns of care. The literature provides evidence for the effectiveness of computerization of CPGs for increasing compliance and improving patient outcomes. Probably the most effective concepts are knowledge-based functions for decision support or monitoring that are integrated in clinical information systems. This approach is mostly restricted by the effort required for development and maintenance of the information systems and the limited number of implemented medical rules. Most of the guidelines are text-based, and are primarily published in medical journals and posted on the internet. However, internet-published guidelines have little impact on the behaviour of physicians. It can be difficult and time-consuming to browse the internet to find (a) the correct guidelines to an existing diagnosis and (b) and adequate recommendation for a specific clinical problem. Our objective is to provide a web-based guideline service that takes as input clinical data on a particular patient and returns as output a customizable set of recommendations regarding diagnosis and treatment. Information in healthcare is to a very large extent transmitted and stored as unstructured or slightly structured text such as discharge letters, reports, forms, etc. The same applies for facilities containing medical information resources for clinical purposes and research such as text books, articles, guidelines, etc. Physicians are used to obtaining information from text-based sources. Since most guidelines are text-based, it would be practical to use a document-based solution that preserves the original cohesiveness. The lack of structure limits the automatic identification and extraction of the information contained in these resources. For this reason, we have chosen a document-based approach using eXtensible Markup Language (XML) with its schema definition and related technologies. XML empowers the applications for in-context searching. In addition it allows the same content to be represented in different ways. Our XML reference clinical data model for guidelines has been realized with the XML schema definition. The schema is used for structuring new text-based guidelines and updating existing documents. It is also used to establish search strategies on the document base. We hypothesize that enabling the physicians to query the available CPGs easily, and to get access to selected and specific information at the point of care will foster increased use. Based on current evidence we are confident that it will have substantial impact on the care provided, and will improve health outcomes.

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