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Arian Ranjbar,1 Eilin Wermundsen Mork,1 Jesper Ravn,1 Helga Brøgger,2 Per Myrseth,2 Hans Peter Østrem,3 Harry Hallock2 1Medical Technology and E-Health, Akershus University Hospital, Lørenskog, Norway; 2Group Research and Development, DNV AS, Høvik, Norway; 3Business Assurance, DNV AS, Høvik, NorwayCorrespondence: Arian Ranjbar, Akershus University Hospital, Sykehusveien 25, 1478, Lørenskog, Norway, Tel +46700436768, Email arian.ranjbar@medisin.uio.noAbstract: Artificial intelligence (AI) provides a unique opportunity to help meet the demands of the future healthcare system. However, hospitals may not be well equipped to handle safe and effective development and/or procurement of AI systems. Furthermore, upcoming regulations such as the EU AI Act may enforce the need to establish new management systems, quality assurance and control mechanisms, novel to healthcare organizations. This paper discusses challenges in AI implementation, particularly potential gaps in current management systems (MS), by reviewing the harmonized standard for AI MS, ISO 42001, as part of a gap analysis of a tertiary acute hospital with ongoing AI activities. Examination of the industry agnostic ISO 42001 reveals a technical debt within healthcare, aligning with previous research on digitalization and AI implementation. To successfully implement AI with quality assurance in mind, emphasis should be put on the foundation and structure of the healthcare organizations, including both workforce and data infrastructure.Keywords: artificial intelligence, management systems, quality assurance, risk management, implementation

Background: The aim of this study was to evaluate the outcome after nondisplaced and stable Lisfranc injuries., Methods: 26 patients with injuries to the Lisfranc joint complex detected on CT scans, but without displacement were tested to be stable using a fluoroscopic stress test. The patients were immobilized in a non-weightbearing short leg cast for 6 weeks. The final follow-up was 55 (IQR 53-60) months after injury., Results: All the Lisfranc injuries were confirmed to be stable on follow-up weightbearing radiographs at a minimum of 3 months after injury. Median American Foot and Ankle Society (AOFAS) midfoot score at 1-year follow-up was 89 (IQR 84-97) and at final follow-up 100 (IQR 90-100); The AOFAS score continued to improve after 1-year (P=.005). The median visual analog scale (VAS) for pain was 0 (IQR 0-0) at the final follow-up. One patient had radiological signs of osteoarthritis at 1-year follow-up., Conclusion: Stable Lisfranc injuries treated nonoperatively had an excellent outcome in this study with a median follow-up of 55 months. The AOFAS score continued to improve after 1 year., (Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: In Lisfranc injuries the stability of the tarsometatarsal joints guides the treatment of the injury. Determining the stability, especially in the subtle Lisfranc injuries, can be challenging. The purpose of this study was to identify incidence, mechanisms of injury and predictors for instability in Lisfranc injuries., Methods: Eighty-four Lisfranc injuries presenting at Oslo University Hospital between September 2014 and August 2015 were included. The diagnosis was based on radiologically verified injuries to the tarsometatarsal joints. Associations between radiographic findings and stability were examined., Results: The incidence of Lisfranc injuries was 14/100,000 person-years, and only 31% were high-energy injuries. The incidence of unstable injuries was 6/100,000 person-years, and these were more common in women than men (P = 0.016). Intraarticular fractures in the two lateral tarsometatarsal joints increased the risk of instability (P = 0.007). The height of the second tarsometatarsal joint was less in the unstable injuries than in the stable injuries (P = 0.036)., Conclusion: The incidence of Lisfranc injuries in the present study is higher than previously published. The most common mechanism of injury is low-energy trauma. Intraarticular fractures in the two lateral tarsometatarsal joints, female gender and shorter second tarsometatarsal joint height increase the risk of an unstable injury., Level of Evidence: Level III, cross-sectional study., (Copyright © 2019 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.)

Background: Assessment of degenerative changes of the cartilage is important in knee cartilage repair surgery. Magnetic Resonance Imaging (MRI) T2 mapping and delayed Gadolinium Enhanced MRI of Cartilage (dGEMRIC) are able to detect early degenerative changes. The hypothesis of the study was that cartilage surrounding a focal cartilage lesion in the knee does not possess degenerative changes., Methods: Twenty-eight consecutive patients included in a randomized controlled trial on cartilage repair were evaluated using MRI T2 mapping and dGEMRIC before cartilage treatment was initiated. Inclusion was based on disabling knee problems (Lysholm score of ≤ 75) due to an arthroscopically verified focal femoral condyle cartilage lesion. Furthermore, no major malalignments or knee ligament injuries were accepted. Mean patient age was 33 ± 9.6 years, and the mean duration of knee symptoms was 49 ± 60 months. The MRI T2 mapping and the dGEMRIC measurements were performed at three standardized regions of interest (ROIs) at the medial and lateral femoral condyle, avoiding the cartilage lesion, Results: The MRI T2 mapping of the cartilage did not demonstrate significant differences between condyles with or without cartilage lesions. The dGEMRIC results did not show significantly lower values of the affected condyle compared with the opposite condyle and the contra-lateral knee in any of the ROIs. The intraclass correlation coefficient (ICC) of the dGEMRIC readings was 0.882., Conclusion: The MRI T2 mapping and the dGEMRIC confirmed the arthroscopic findings that normal articular cartilage surrounded the cartilage lesion, reflecting normal variation in articular cartilage quality., Study Identifier: NCT00885729 , registered April 17 2009.

Background: Despite an extensive literature on treatment interventions for patients with knee osteoarthritis, studies comparing the efficacy of different exercise interventions and living the life as usual on quality of life, cartilage quality and cost-effectiveness are lacking. The aim of the present study is to compare the efficacy of two different exercise programs compared to a control group in individuals with established radiographic and symptomatic knee osteoarthritis on self-reported knee-related quality of life, knee pain, physical function, and cartilage quality., Methods/design: A three-armed randomized controlled trial involving two exercise interventions and a control group of individuals doing as they usually do is described. The patients will have mild to moderate radiographic osteoarthritis according to the Kellgren and Lawrence classification (grade 2-3), and fulfill the American College of Rheumatology clinical criteria, be aged between 45 and 65 years, and have no other serious physical or mental illnesses. The patients will be randomly allocated to a strength exercise group; a cycling group, or a control group. The primary outcome is the Knee injury and Osteoarthritis Outcome Score knee-related quality of life subscale. Secondary outcomes include all five Knee Injury and Osteoarthritis Outcome Score subscales, morphological evaluation of cartilage including focal thickness, subchondral bone marrow edema, proteoglycan content and collagen degradation (measured using magnetic resonance imaging clinical sequences, T2 mapping and T1ρ), specific serum biomarkers, isokinetic muscle strength, maximal oxygen uptake, quality of life (EuroQol 5D), and self-efficacy (Arthritis Self-Efficacy Scale). A sample size calculation on the primary outcome showed that 207 individuals, 69 in each group, is needed to detect a clinically relevant difference of 10 points with 80% power and a significance level of 5%. Assessments will be conducted at baseline, 14 weeks, 1 year and 2 years post-randomization. The interventions will be a 14 weeks exercise program., Discussion: Although exercise therapy has been found to be effective in knee osteoarthritis, the knowledge of the underlying mechanisms for why exercise works is lacking. This study will contribute with knowledge on the efficacy of strength exercise versus cycling on patient-reported outcomes, cartilage quality and cost-effectiveness., Trial Registration: Clinicaltrial.gov Identifier: NCT01682980.