Quality of informed consent for invasive procedures

Abstract Objective. To assess quality of informed consent among patients undergoing procedures and patient's preferences about decision-making. Design. Cross-sectional survey of hospitalized patients about informed consent before surgery or other procedures. Preference for decision-making was elicited in hospitalized and ambulatory patients. Setting. Large academic general hospital and 10 general clinics, over the years 2002 -04. Intervention. Data of initial survey were presented at staff meetings, recommending asking patients to restate what was explained to them. Main outcome measures. Rate of patient's recall for explanations on risks and alternative options; rate of patients preferring shared, autonomous and paternalistic modes of decision-making; degree of satisfaction from the decision-making. Results. Half of the patients did not recall receiving explanations about risks and two-third did not remember discussion of alternative options. The intervention failed, ,10% of patients being asked to re-state what was explained to them. Expectations about decision varied: 60% favored shared decision, nearly 20% preferred autonomous decision and the remainder wanted physicians to make decisions. Satisfaction was rated as good or very good by 80% of patients. Conclusions. Most patients do not remember receiving explanations about risks or alternatives for procedures, and physicians resist attempts to improve informed consent. Tools should be developed to measure the quality of consent. Since patients significantly differ in their preferred mode of decision-making, the informed consent should be patient-specific. Keywords: informed consent, quality of care Informed consent of patients undergoing procedures is important not only for ethical and legal reasons [1] but also for the quality of care: patient's understanding allows cooperation, improves results and satisfaction and also helps preventing errors Since the informed consent is culture-dependent and we were unaware of clinical research on its implementation in our country, we set about to evaluate some aspects of this process at our institution. Rather than looking at the quantity of information remembered by patients, we wished to look at some qualitative aspects of this exchange: Was the patient satisfied with decision-making? Could the patient recall any mention of risks or alternatives? Had she or he wished to receive more information? What is the preferred mode of decision-making: autonomous, shared or paternalistic? Had the patient signed an informed consent? Had she or he been asked to repeat the explanations? Although the necessary legal requirements for informed consent have been reviewed in great detail [15], we were more interested in examining and framing the issues from the viewpoint of quality of care. We prospectively surveyed patients surrounding invasive procedures, exploring gaps between perceived and preferred modes of decision, attempting to construct a basis for a standard for the quality of the informed consent. Address reprint requests to: Maye