[Development of standards for quality management in interventional cardiology]

Standardization is one of the fundamental methods for quality management. Standards describe first requirements for adequate delivery of diagnostic and therapeutic services (e.g. in the format of guidelines and protocols), second they define core data sets for documentation of real clinical outcome and of process and structure quality or third they define normal values (standards in the strict sense) or thresholds for critical parameters. This standardization is increasingly performed by the professional societies in international collaboration. We report on the parallel development of methodology. Presently standards for documentation and guidelines are being developed for the areas of cardiac interventional and surgical therapy. Three main methods are described. First, the common approach to guideline definition becomes more formalized as exemplified by the consensus approaches of the RAND group and of physicians in The Netherlands. Second, the definition of core data sets for quality assurance is increasingly based on the statistical evaluation of large interventional databases with the goal of developing predictive models of outcome. Since some of these methods are not yet fully reliable, it is still necessary to combine the results of predictive modelling with consensus on clinical practice. Figure 1 describes one of these approaches to data standards definition. These methods are currently developed within the new Cardiovascular Data Standards Initiative of the American College of Cardiology (ACC) that is open for international collaboration. Figure 2 describes a parallel approach for standardization of digital image communication in angiocardiography. As shown in Figure 3, these data set standards and imaging standards will be applied not only in quality assurance, but also in shared care. Third, the PRESTIGE project of the European Commission is developing computerized tools that support terminology support, guideline authoring, guideline dissemination and protocol-directed care. We show that the elements described can be put to use within the unifying framework depicted in Figure 4. This guideline approach that is fully integrated into daily care delivery provides the physician with instant feedback from the guideline and, in addition, with periodic quality reports based on a comparison of the local clinical reality with the recommendations from the guideline. In our extended concept, these deviations are in addition symmetrically used to trigger, where necessary, the process of evaluation of the guideline. The often poor acceptance of guidelines should be improved both by integrating them into daily practice and by providing a feedback to the guideline authoring committee. We conclude that standardization activities are now entering into a new era due to increased involvement of physicians, international collaboration, integrated approaches to quality management, and improved computerized tools.