Linee guida in oncologia: strumento educativo, giuridico, regolatorio?

Abstract

In the clinical practice, the oncological decision is based rather on the experience than on the analytical evaluation of prospective studies. Therefore the definition of practice guidelines, based on validity, reproducibility, representativity, clinical feasibility, with clear definition of evidence levels and recommendations strength is mandatory. Thus many scientific societies and national or international authorities have worked out clinical guidelines. They show significant differencies about the number of considered neoplastic pathologies, the adopted model, frequency of upgrade, method of distribution. The oncologists carefully pay attention to these guidelines, and they follow them if guidelines are well structured, so their behaviour is modified. In the legal context, guidelines have the value of non-mandatory recommendations, without a specific power, nevertheless they can help the judges in the interpretation of clinical controversies. Oncologists are not forced to adopt literally recommendations and guidelines in the clinical field. The decision to follow them or not is generally on individual basis and it takes into account the specific characteristics of each patient. In this context, also who hopes the employment of guidelines as indicators of the quality of medical behaviour, is in agreement with the fact that an exclusively administrative approach could generate conflicts and it does not reflect the complexity of the clinical practice. This statement has been largely approved in clinical oncology and it suggests caution concerning an exclusively regulatory approach to guidelines and recommendations.