Background: Introduction of digital animations to explain medical procedures before consent to treatment (animation-supported consent) has been shown to improve patient-reported understanding of a procedure's benefits, risks and alternatives. Aim: We examined whether introduction of animation-supported consent is associated with a change in the incidence of complaints and serious incidents due to failure to inform. Methods: Multi-language animations explaining 10 cardiac procedures, in coronary intervention, electrophysiology and cardiac surgery, (www.explainmyprocedure.com ) were introduced at a London cardiac centre from April 2019. Complaints and serious incidents due to failure to inform were identified from the hospital Datix database for the two years before introducing animation-supported consent (no animation group) and the two years afterwards (animation group), together with the total number of procedures and major complications recorded during these periods. We compared the incidence of complaints and serious incidents, expressed as a proportion of the number of major complications, recorded during each period. Results: There were 580 complications among 21 855 procedures performed in the no animation group and 411 complications among 18 254 procedures in the animation group. There were 14 complaints or serious incidents due to failure to inform in the no animation group and 3 in the animation group; rates of 2.41 (14/580) and 0.73 (3/411), respectively (P < 0.001 for difference). Conclusion: In this observational comparison, introduction of animation-supported consent was associated with a 70 reduction in complaints or serious incidents due to failure to inform before consent. This has significant quality and cost implications for improving consent pathways in clinical practice.
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