An AI-based patient-specific clinical decision support system for OA patients choosing surgery or not: study protocol for a single-centre, parallel-group, non-inferiority randomised controlled trial
| Autor: | Nanna Kastrup, Helene H. Bjerregaard, Mogens Laursen, Jan B. Valentin, Søren P. Johnsen, Cathrine E. Jensen |
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| Rok vydání: | 2023 |
| Předmět: |
Randomised controlled trial
Adult Artificial intelligence Patient-reported outcomes Cost-Benefit Analysis Total hip replacement Medicine (miscellaneous) Clinical decision support system Decision Support Systems Clinical Knee Joint/surgery Total knee replacement Machine learning Osteoarthritis Humans Cost-effectiveness Pharmacology (medical) Randomized Controlled Trials as Topic |
| Zdroj: | Kastrup, N, Bjerregaard, H H, Laursen, M, Valentin, J B, Johnsen, S P & Jensen, C E 2023, ' An AI-based patient-specific clinical decision support system for OA patients choosing surgery or not : study protocol for a single-centre, parallel-group, non-inferiority randomised controlled trial ', Trials, vol. 24, 24 . https://doi.org/10.1186/s13063-022-07039-5 |
| ISSN: | 1745-6215 |
| DOI: | 10.1186/s13063-022-07039-5 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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