[Patterns of information and informed consent procedures. Study of the Ethical Commission of the ANMCO]. / Modalità di informazione ed acquisizione del consenso informato. Indiagine della Commissione Etica dell'ANMCO.

A survey on patterns of information and informed consent procedures during daily clinical practice has been performed by the Ethical Commission of ANMCO. A structured questionnaire (38 questions) was sent to the 653 cardiological units of the National Health Service in Italy. Four hundred and eighty (73.5%) were received. The following variables were considered to evaluate differences in the answers from the various cardiological units: geographical site, presence or absence of an in-patient department, a cath-lab, and of cardiac surgery facilities. Independent predictors of returning questionnaires were: geographical site (Northern Italy vs Central and Southern) and the presence of a cath-lab. Informed consent forms were provided in 53% of instances, while in 40% a free comment about the topic of informed consent was sent. Statistically significant differences in the answers were found about physicians' and nurses' role, ways of information, qualitative and quantitative risk estimates, other persons' role, models of consent forms and procedures of obtaining consent. Free comments and informed consent forms did not allow a statistical analysis. However, they still provided sufficient material to identify specific patterns of how cardiologists deal with the informed consent process. The distinction between the two phases of information and consent was rarely clear. Information or educational material was often mixed with consent forms. While some still showed a paternalistic approach, or else considered informed consent as a formal act, others demonstrated a deep understanding of the significance of the concept of informed consent. A widespread need of guidelines and standard patterns resulted.

[Evaluation of the appropriateness of prescribing non-invasive cardiologic tests]. / La valutazione dell'appropriatezza della prescrizione dei test cardiologici non invasivi.

BACKGROUND: We evaluated the appropriateness of the prescription of echocardiography, exercise testing, Holter monitoring and vascular sonography for ambulatory patients, performed during 4 weeks in 21 outpatient laboratories in Tuscany and Umbria, Italy. METHODS: We collected the following data: the appropriateness of the prescription (according to the guidelines of the Italian Federation of Cardiology), the prescribing physician (cardiologist vs noncardiologist), the synthetic result (normal vs abnormal) and the clinical utility (useful vs useless) of each exam. RESULTS: We evaluated 5614 prescriptions (patients: 3027 males, 2587 females; mean age 63 years, range 14-96 years). The indication to the test was of class I (appropriate) in 45.3%, of class II (doubtfully appropriate) in 34.8% and of class III (inappropriate) in 19.9% of the cases. The test was abnormal in 58.3% of class I exams vs 17% of class III exams (p < 0.05). The test was useful in 72.4% of class I exams vs 17.1% of class III exams (p < 0.05). The test was prescribed by a cardiologist in 1882 cases (33.5%). Cardiologist-prescribed exams were of class I in 57.3%, of class II in 32.4% and of class III in 10.3% of the cases vs 39.2, 36.1 and 24.7% of non-cardiologist-prescribed exams (p < 0.05). Cardiologist-prescribed exams were abnormal in 53.4% of the cases vs 39% of those of non-cardiologists' (odds ratio 1.76, 95% confidence interval 1.58-1.97; p < 0.05). Cardiologist-prescribed exams were useful in 64.7% of the cases vs 44.4% of those of non-cardiologists' (odds ratio 2.26, 95% confidence interval 2.02-2.53; p < 0.05). CONCLUSIONS: In Tuscany and Umbria, Italy, less than half of the prescriptions for non-invasive diagnostic tests are appropriate: appropriately prescribed exams more often provide abnormal and useful results; cardiologist-prescribed exams are more often appropriate, abnormal and useful.