Informed consent prior to coronary angiography in a real world scenario: What do patients remember?

Abstract

Background: Patients' informed consent is legally essential before elective invasive cardiac angiography (CA) and successive intervention can be done. It is unknown to what extent patients can remember previous detailed information given by a specially trained doctor in an optimal scenario as compared to standard care. Methodology/Principal Findings: In this prospective cohort study 150 consecutive in-patients and 50 out-patients were included before elective CA was initiated. The informed consent was provided and documented in in-patients by trained and instructed physicians the day before CA. In contrast, out-patients received standard information by different not trained physicians, who did not know about this investigation. All patients had to sign a form stating that enough information had been given and all questions had been answered sufficiently. One hour before CA an assessment of the patients' knowledge about CA was performed using a standard point-by-point questionnaire by another independent physician. The supplied information was composed of 12 potential complications, 3 general, 4 periprocedural and 4 procedural aspects. 95% of the patients felt that they had been well and sufficiently informed. Less than half of the potential complications could be remembered by the patients and more patients could remember less serious than life-threatening complications (27.968.8% vs. 47.1611.0%; p<0.001). Even obvious complications like local bleeding could not be remembered by 35% of in-patients and 36% of out-patients (p = 0.87). Surprisingly, there were only a few knowledge differences between in- and out-patients. Conclusions: The knowledge about CA of patients is vague when they give their informed consent. Even structured information given by a specially trained physician did not increase this knowledge. © 2010 Eran et al.