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: approximately 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.