Abstract
Background: Osteoarthritis (OA) affects 20% of the adult Danish population, and the financial burden to society amounts to DKK 4.6 billion annually. Research suggests that up to 75% of surgical patients could have postponed an operation and managed with physical training. ERVIN.2 is an artificial intelligence (AI)-based clinical support system that addresses this problem by enhancing patient involvement in decisions concerning surgical knee and hip replacement. However, the clinical outcomes and cost-effectiveness of using such a system are scantily documented. Objective: The primary objective is to investigate whether the usual care is non-inferior to ERVIN.2 supported care. The second objective is to determine if ERVIN.2 enhances clinical decision support and whether ERVIN.2 supported care is cost-effective. Methods: This study used a single-centre, non-inferiority, randomised controlled in a two-arm parallel-group design. The study will be reported in compliance with CONSORT guidelines. The control group receives the usual care. As an add-on, the intervention group have access to baseline scores and predicted Oxford hip/knee scores and HRQoL for both the surgical and the non-surgical trajectory. A cost-utility analysis will be conducted alongside the trial using a hospital perspective, a 1-year time horizon and effects estimated using EQ-5D-3L. Results will be presented as cost per QALY gain. Discussion: This study will bring knowledge about whether ERVIN.2 enhances clinical decision support, clinical effects, and cost-effectiveness of the AI system. The study design will not allow for the blinding of surgeons. Trial registration: ClinicalTrials.gov NCT04332055. Registered on 2 April 2020.
Original language | English |
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Article number | 24 |
Journal | Trials |
Volume | 24 |
ISSN | 1745-6215 |
DOIs | |
Publication status | Published - 12 Jan 2023 |
Bibliographical note
© 2023. The Author(s).Keywords
- Artificial intelligence
- Clinical decision support system
- Cost-effectiveness
- Machine learning
- Osteoarthritis
- Patient-reported outcomes
- Randomised controlled trial
- Total hip replacement
- Total knee replacement
- Knee Joint/surgery
- Humans
- Artificial Intelligence
- Decision Support Systems, Clinical
- Randomized Controlled Trials as Topic
- Cost-Benefit Analysis
- Adult