Information required to provide informed consent for endoscopy: an observational study of patients' expectations.

BACKGROUND AND STUDY AIMS

The aim of this study was to determine how much information patients require about the risk of complications in order to provide informed consent to undergo endoscopy.

PATIENTS AND METHODS

Endoscopic complications and their consequences were discussed with consecutive patients who had undergone endoscopy. The patients were asked how common each complication would have to be for them to require information about the complication before providing adequately informed consent.

RESULTS

Data were obtained from 150 gastroscopy patients (51% male, median age 55.5 years) and 150 colonoscopy patients (60% male, median age 54.4 years). Patients in both groups were more likely to want to know about major rather than minor complications at a lower level of risk (P < 0.001 at a risk greater than one in 1000). Similar proportions of gastroscopy patients (n = 29, 19%) and colonoscopy patients (n = 21, 14 %) wanted to know about all possible complications, no matter how inconsequential or rare. Colonoscopy patients were less likely to want no information about any complications than gastroscopy patients (n = 1, 0.7% and n = 15, 10%, respectively; P < 0.001).

CONCLUSIONS

The information patients require in order to provide informed consent is very variable. Many appear to make a judgement about the need for information depending on the perceived severity of the complication, but some want information about all complications, irrespective of risk and severity. The level of risk at which they require this information is likely to be higher than the level used by doctors who are obtaining consent from patients. The process may be improved by providing procedure-specific information leaflets that offer information regarding common and serious complications.