Who's afraid of informed consent?

Abstract

To test the assumption that patients will become unduly anxious if they are given detailed information about the risks of surgery in an attempt to obtain fully informed consent. Preoperative anxiety assessed before and after patients were randomly allocated an information sheet containing either simple or detailed descriptions of possible postoperative complications. Four surgical wards at two Sheffield hospitals. 96 men undergoing elective inguinal hernia repair under general anaesthesia. Change in anxiety level observed after receiving information about potential complications. Detailed information did not increase patient anxiety (mean Spielberger score at baseline 33.7 (95% confidence interval 31.3 to 36.2), after information 34.8 (32.1 to 37.5); p = 0.20, paired t test). A simple explanation of the facts provided a statistically significant degree of reassurance (mean score at baseline 34.6 (31.5 to 37.6), after information 32.3 (29.8 to 34.9); p = 0.012), although this small effect is likely to be clinically important only in those whose baseline anxiety was high (r = 0.27, p = 0.05). In men undergoing elective inguinal hernia repair a very detailed account of what might go wrong does not increase patient anxiety significantly and has the advantage of allowing patients a fully informed choice before they consent to surgery, thus reducing the potential for subsequent litigation.