Shared decision making using augmented reality a multicentre pilot randomised controlled trial in orthognathic...

Effective patient education is critical for informed consent. Augmented Reality (AR) offers a novel approach to improving patient understanding and satisfaction, although current evidence is limited and of low quality. This study evaluated the added value of AR compared to traditional monitor-based 3D models for patient education and decision making for orthognathic surgery. A multicentre randomised controlled trial was conducted between August 2023 and June 2024 at three university medical centres in north-west Europe. Sixty referred patients were randomised to either the intervention group or the control group. Patient satisfaction and knowledge were assessed using two questionnaires. The study was registered at ClinicalTrials.gov(NCT06140043). Patient satisfaction was significantly higher in the control group (p = 0.04). No significant differences were found in knowledge acquisition (p = 0.74). Women showed a significant preference for the monitor-based consultation (p = 0.01), while men did not show a significant difference in satisfaction. Despite some centre heterogeneity, no clear added benefit of AR in satisfaction or knowledge was visible. Observed effect sizes (d = 0.76) and post-hoc power estimates (84%) are provided for context but should be interpreted cautiously. In the absence of clear evidence a monitor remain the most practical option for patient education.