Digital Twin-Assisted Risk Disclosure in Adults Undergoing Elective Bronchoscopy: Multicenter Randomized Controlled Trial.

Background: Risk disclosure before bronchoscopy should provide sufficient information for informed consent, but detailed text-based risk disclosure may increase procedural anxiety. Patient-specific visualization with a digital twin-based bronchoscopy simulator may help patients understand bronchoscopy and its risks in a more individualized manner. Objective: This study evaluated whether digital twin-assisted risk disclosure reduces prebronchoscopy anxiety and improves postbronchoscopy satisfaction compared with conventional risk disclosure in adults scheduled for elective bronchoscopy. Methods: We conducted a multicenter, parallel-group randomized controlled trial. Adults aged 18 years or older scheduled for elective bronchoscopy under local anesthesia were included. Participants were randomized to either a digital-twin informed-consent group, which received standard written information plus a physician-led oral explanation supported by a patient-specific simulator visualization, or a conventional informed-consent group, which received the same written information plus a standard physician-led oral explanation without simulator visualization. Owing to the nature of the intervention, participants and physicians were not blinded. The primary outcome was the change in self-reported anxiety after risk disclosure, measured using the visual analog scale (VAS) and the modified Amsterdam Preoperative Anxiety and Information Scale (APAIS). Linear mixed models with a group-by-time interaction were used for the main analysis. The secondary outcome was postbronchoscopy satisfaction. Results: Of 150 patients assessed for eligibility, 122 were randomized and analyzed, with 61 participants in each group. Compared with conventional risk disclosure, digital twin-assisted disclosure produced greater reductions in anxiety on the VAS (group by time β=-15.89, SE 3.08, 95% CI -21.99 to -9.78; Conclusions: Patient-specific digital twin-visualization during physician-led risk disclosure reduced short-term self-reported anxiety and modestly improved satisfaction. The innovation lies in using each patient's computed tomography-derived airway and lesion anatomy during consent rather than standardized text, audiovisual content, or graphic narratives evaluated previously. This multicenter trial extends digital-twin technology from bronchoscopy training to individualized risk communication. In clinical practice, the approach could supplement physician-led consent in units with computed tomography and simulator infrastructure; however, time-matched studies should establish objective benefits, workflow burden, cost-effectiveness, accessibility, and applicability to highly anxious or resource-limited populations before wider adoption.