Who's afraid of informed consent?

OBJECTIVE: 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.

DESIGN: Preoperative anxiety assessed before and after patients were randomly allocated an information sheet containing either simple or detailed descriptions of possible postoperative complications.

SETTING: Four surgical wards at two Sheffield hospitals.

SUBJECTS: 96 men undergoing elective inguinal hernia repair under general anaesthesia.

MAIN OUTCOME MEASURE: Change in anxiety level observed after receiving information about potential complications.

RESULTS: 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).

CONCLUSIONS: 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.