Improving risk communication: a pilot randomised-control trial assessing the impact of visual aids for interventional consent

IntroductionInformed consent is a fundamental component in the work-up for surgical procedures. Our study aims to assess the impact of visual tools in the informed consent process of a common medical and neurosurgical procedure: a lumbar puncture. MethodsParticipants were healthy adults without any underlying cognitive impairment, and they were randomized to complete a questionnaire containing either the control video or intervention video. Both videos contained identical audio narration, however the intervention video included additional visual aids such as anatomical diagrams, icon arrays and Paling scales. Outcome measure included knowledge of the procedure (including recall of numerical risks), 5-point Likert scale questions, usability as measured by the System Usability Scale, acceptability as measured by the Acceptability of Intervention Measure and appropriateness as measured by the Intervention Appropriateness Measure. ResultsIn total, 52 participants were randomized to the control (n = 25) or intervention (n=27) group. There was no statistical difference in numerical risk recall, understanding of the procedure or its benefits. The intervention group reported better understanding of the risks (p = 0.05), felt they could more easily better explain the risks to others (p = 0.01), and felt less overwhelmed with information (p = 0.03). The intervention group was also rated as more acceptable (p = 0.02). ConclusionOur pilot study tentatively demonstrates that visual risk communication adjuncts offer several advantages over traditionally obtained surgical consent without being inferior in understanding of the procedure or recall of numerical risks.