Detailed disclosure to Saudi Arabian patients on risks related to an invasive procedure.

OBJECTIVES: To measure the effect of providing a detailed description of coronary angiography risks on obtaining informed consent from Saudi Arabian patients.

METHODS: This randomized controlled trial was conducted at King Khalid University Hospital, Riyadh, Saudi Arabia from August 2006 to June 2007. Patients were randomized to either an information sheet containing brief information on procedure-related risks (brief sheet), or full disclosure of risks (detailed sheet). Both groups completed a brief questionnaire following exposure to either sheet. Primary endpoint was refusal to consent to coronary angiography. Secondary endpoints were anxiety following exposure to the detailed sheet and appropriateness of the amount of risk disclosure contained in both information sheets.

RESULTS: One hundred and six Saudi patients were enrolled, 6 patients were later excluded. Mean age was 58 years; 45 patients (45%) were illiterate. Fifty-three patients were randomized to the brief sheet, and 47 to the detailed sheet. Only one patient (1.8%) given the brief sheet refused consent, compared to 5 patients (10.6%) given the detailed sheet (p=0.06, 95% confidence interval 1.2 to 2.8). Ninety-four patients responding to the questionnaire felt that the information given was enough, including all of the patients randomized to the brief sheet. Twenty-two patients randomized to the detailed sheet indicated increased anxiety after hearing procedure-related risks.

CONCLUSIONS: We found no significant difference in consent status between the detailed and brief disclosure of procedure-related risk groups. Most patients did not require detailed risk disclosure.