EPO or not-EPO? An evidence based informed consent.

ABSTRACT

BACKGROUND: Informed consent is crucial in therapeutic choices; however, the forms presented to patients are often locally developed and information may not be homogeneous. OBJECTIVE: To prepare an evidence-based model for informed consent, applied in the case of erythropoietin therapy (EPO) as a teaching tool for medical students. METHODS: Methodological tools of Evidence-Based Medicine (EBM) were developed within the EBM Course in the Medical School of Torino, Italy, as problem solving and patient information tools (5th year students work in small groups under the supervision of statisticians, epidemiologists and experts of internal medicine--nephrology in this case). RESULTS: Methodological and ethical problems were identified in the pre-dialysis field, evidence from randomized clinical trials (RCT) is scant; how to use evidence gathered in dialysis? How to deal with implementation? How with the mass media? Do we need to discuss the drug choice with the patients? How to deal with rare and severe side effects?). The "evidence" was searched for on Medline/Embase, by using key-words and free terms. About 680 papers were retrieved and screened. Forms available on the Internet were retrieved and a general scheme was drawn it included 5 areas title, aim and targets (patients and family physicians); search strategies and updating; pros and cons of therapy; alternative options; open questions. CONCLUSIONS: EBM may offer valuable tools for systematically approaching patient information; the inclusion of this kind of exercise in the Medical School EBM courses may help enhance the awareness of future physicians of the correct communication with patients.