TY - JOUR
T1 - An AI-based patient-specific clinical decision support system for OA patients choosing surgery or not
T2 - study protocol for a single-centre, parallel-group, non-inferiority randomised controlled trial
AU - Kastrup, Nanna
AU - Bjerregaard, Helene H.
AU - Laursen, Mogens
AU - Valentin, Jan B.
AU - Johnsen, Søren P.
AU - Jensen, Cathrine E.
N1 - © 2023. The Author(s).
PY - 2023/1/12
Y1 - 2023/1/12
N2 - 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.
AB - 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.
KW - Artificial intelligence
KW - Clinical decision support system
KW - Cost-effectiveness
KW - Machine learning
KW - Osteoarthritis
KW - Patient-reported outcomes
KW - Randomised controlled trial
KW - Total hip replacement
KW - Total knee replacement
KW - Knee Joint/surgery
KW - Humans
KW - Artificial Intelligence
KW - Decision Support Systems, Clinical
KW - Randomized Controlled Trials as Topic
KW - Cost-Benefit Analysis
KW - Adult
UR - http://www.scopus.com/inward/record.url?scp=85146271340&partnerID=8YFLogxK
U2 - 10.1186/s13063-022-07039-5
DO - 10.1186/s13063-022-07039-5
M3 - Journal article
C2 - 36635747
AN - SCOPUS:85146271340
SN - 1745-6215
VL - 24
JO - Trials
JF - Trials
M1 - 24
ER -