Abstract
BACKGROUND AND AIMS: Informed consent is a vital preprocedural step for endoscopy but there are substantial variations in its delivery. We therefore sought to assess a multifaceted intervention to improve the consent process. METHODS: Gastroenterologists at a tertiary center were educated on the recommended components of informed consent. Following this, 3 cohorts of patients undergoing colonoscopy were surveyed before and after consent. In one cohort, the effect of optimized verbal consent alone was assessed. In the second and third groups, the effects of the addition of either a handout or a video describing colonoscopy and its risks were evaluated. The primary outcomes were the changes between preconsent and postconsent survey responses regarding confidence in understanding the procedure's purpose, likelihood of adverse events, and levels of anxiety. RESULTS: In total, 240 patients were included with 79 to 81 patients per group. There were no significant differences among the groups' survey responses. Compared with patients receiving verbal consent alone, fewer patients in the handout and video groups increased their perceived risk of adverse events following consent, but this difference did not reach significance (P=0.08). Examining all groups together, anxiety levels changed significantly after consent (P=0.003), with 31% of patients reducing their anxiety level, 8% increasing it, and 62% having no change. CONCLUSIONS: The consent process appears to decrease patient anxiety about colonoscopy. When used in conjunction with a high-quality verbal consent, written or video educational adjuncts provided on the day of colonoscopy likely have no effect on patient perceptions.