Digital Twin-Assisted Risk Disclosure in Adults Undergoing Elective Bronchoscopy: Multicenter Randomized Controlled Trial.
- Design
- Design 9 of 10
- Novelty
- Novelty 9 of 10
- Journal
- Journal 7 of 10
- Clinical
- Clinical 8 of 10
Summary
In this multicenter randomized trial, 122 adults undergoing elective bronchoscopy were assigned to conventional consent or consent supported by a patient-specific digital-twin visualization derived from computed tomography. Digital-twin-assisted disclosure produced a greater reduction in anxiety and a modest improvement in satisfaction, although participants and physicians were not blinded and workflow and cost implications remain uncertain.
Key Findings
- The multicenter trial randomized and analyzed 122 adults, with 61 participants in each group.
- Digital-twin-assisted disclosure reduced anxiety more than conventional disclosure on the visual analog scale, with a group-by-time coefficient of -15.89.
- Postbronchoscopy satisfaction improved modestly with digital-twin-assisted disclosure, but the intervention was not blinded and objective clinical benefits were not established.
Clinical Implications
Patient-specific airway and lesion visualization may be used as an adjunct to physician-led consent for bronchoscopy, particularly for patients who have difficulty understanding anatomical or procedural risks. Implementation should await assessment of consultation time, infrastructure requirements, accessibility, cost-effectiveness, and effects on objective decision quality.
Why It Matters
This study provides randomized evidence for a novel, patient-specific approach to informed consent that extends digital-twin technology from procedural training into clinical risk communication. It directly targets a common perioperative problem—anxiety—while preserving physician-led explanation.
Limitations
- Participants and physicians were not blinded, creating potential expectancy and reporting bias for subjective outcomes.
- The study did not establish effects on objective comprehension, procedural outcomes, consultation time, cost-effectiveness, or equity of access.
Future Directions
Future studies should compare time-matched consent workflows, measure objective comprehension and decisional quality, evaluate cost-effectiveness, and test implementation in highly anxious, low-literacy, and resource-limited populations. Pragmatic trials should determine whether the technology improves consent quality without delaying procedural care.
Study Information
- Study Type
- RCT
- Research Domain
- Diagnosis
- Evidence Level
- II - Multicenter randomized controlled trial with subjective primary outcomes and no participant or physician blinding.
- Study Design