Digital Twin–Assisted Risk Disclosure in Adults Undergoing Elective Bronchoscopy: Multicenter Randomized Controlled Trial
Journal of Medical Internet Research ·
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; <.001) and APAIS total anxiety score (β=−6.77, SE 0.98, 95% CI −8.71 to −4.83; <.001). Similar effects were observed for APAIS procedure-related anxiety (β=−4.25, 95% CI −5.47 to −3.02; <.001) and APAIS outcome-related anxiety (β=−2.52, 95% CI −3.46 to −1.59; <.001). Clinically meaningful improvement occurred more often in the digital-twin group for VAS (30/61, 49.2% vs 4/61, 6.6%) and APAIS (33/61, 54.1% vs 6/61, 9.8%; both <.001). Satisfaction was higher in the digital-twin group (mean 16.89, SD 2.08 vs mean 14.38, SD 1.89; <.001). All participants completed bronchoscopy without complications or adverse conditions. 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. Trial Registration: ClinicalTrials.gov NCT06441149; https://clinicaltrials.gov/study/NCT06441149
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; <.001) and APAIS total anxiety score (β=−6.77, SE 0.98, 95% CI −8.71 to −4.83; <.001). Similar effects were observed for APAIS procedure-related anxiety (β=−4.25, 95% CI −5.47 to −3.02; <.001) and APAIS outcome-related anxiety (β=−2.52, 95% CI −3.46 to −1.59; <.001). Clinically meaningful improvement occurred more often in the digital-twin group for VAS (30/61, 49.2% vs 4/61, 6.6%) and APAIS (33/61, 54.1% vs 6/61, 9.8%; both <.001). Satisfaction was higher in the digital-twin group (mean 16.89, SD 2.08 vs mean 14.38, SD 1.89; <.001). All participants completed bronchoscopy without complications or adverse conditions. 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. Trial Registration: ClinicalTrials.gov NCT06441149; https://clinicaltrials.gov/study/NCT06441149