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

Introduction: Informed 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. Methods: Participants 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. Results: In 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). Conclusion: Our 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. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT05717465 ### Funding Statement This study did not receive any funding ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: University College London Research Ethics Committee gave ethical approval for this work I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors