BMJ Surgery Interventions Health Technologies最新文献

{"title":"Exploring procedure duration and risk for serious adverse events during congenital cardiac catheterization.","authors":"Mary J Yeh,&nbsp;Elizabeth Lydon,&nbsp;Kimberlee Gauvreau,&nbsp;Kathy J Jenkins,&nbsp;David Slater,&nbsp;Lisa Bergersen","doi":"10.1136/bmjsit-2022-000142","DOIUrl":"https://doi.org/10.1136/bmjsit-2022-000142","url":null,"abstract":"<p><strong>Objectives: </strong>While procedure length is considered an important metric for cardiothoracic surgical procedures, the relationship between procedure length and adverse events (AEs) in congenital cardiac catheterizations has little published data available. Furthermore, most existing congenital cardiac catheterization risk prediction models are built on logistic regression models. This study aimed to characterize the relationship between case length and AE occurrence in congenital cardiac catheterization while adjusting for known risk factors and to investigate the potential role of non-linear analysis in risk modeling.</p><p><strong>Design: </strong>Age, case type, and procedure duration were evaluated for relationships with the primary outcome using logistic regression. Non-linearity of the associations with continuous risk factors was assessed using restricted cubic spline transformations.</p><p><strong>Setting and participants: </strong>All diagnostic and interventional congenital cardiac catheterization cases performed at Boston Children's Hospital between January 1, 2014 and October 31, 2019 were analyzed.</p><p><strong>Main outcome measure: </strong>The primary outcome was defined as the occurrence of any clinically significant (level 3/4/5) AE.</p><p><strong>Results: </strong>A total of 7011 catheterization cases met inclusion criteria, with interventional procedures accounting for 68% of cases. Median case duration was 97 min. A multivariable model including age, procedure type, and case duration showed a significant relationship between case duration and AE occurrence (OR 1.07 per 10 min increase, 95% CI 1.06 to 1.09, p<0.001).</p><p><strong>Conclusions: </strong>This study demonstrated the importance of procedure duration as a potential frontier for procedure risk management. Better understanding of the role of procedure duration in cardiac catheterizations may provide opportunities for quality improvement in patient safety and resource planning.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"5 1","pages":"e000142"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/ec/e3/bmjsit-2022-000142.PMC9835933.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10535595","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Computer-assisted simulated workplace-based assessment in surgery: application of the universal framework of intraoperative performance within a mixed-reality simulation.","authors":"Philipp Stefan,&nbsp;Michael Pfandler,&nbsp;Aljoscha Kullmann,&nbsp;Ulrich Eck,&nbsp;Amelie Koch,&nbsp;Christoph Mehren,&nbsp;Anna von der Heide,&nbsp;Simon Weidert,&nbsp;Julian Fürmetz,&nbsp;Ekkehard Euler,&nbsp;Marc Lazarovici,&nbsp;Nassir Navab,&nbsp;Matthias Weigl","doi":"10.1136/bmjsit-2022-000135","DOIUrl":"https://doi.org/10.1136/bmjsit-2022-000135","url":null,"abstract":"<p><strong>Objectives: </strong>Workplace-based assessment (WBA) is a key requirement of competency-based medical education in postgraduate surgical education. Although simulated workplace-based assessment (SWBA) has been proposed to complement WBA, it is insufficiently adopted in surgical education. In particular, approaches to criterion-referenced and automated assessment of intraoperative surgical competency in contextualized SWBA settings are missing.Main objectives were (1) application of the universal framework of intraoperative performance and exemplary adaptation to spine surgery (vertebroplasty); (2) development of computer-assisted assessment based on criterion-referenced metrics; and (3) implementation in contextualized, team-based operating room (OR) simulation, and evaluation of validity.</p><p><strong>Design: </strong>Multistage development and assessment study: (1) expert-based definition of performance indicators based on framework's performance domains; (2) development of respective assessment metrics based on preoperative planning and intraoperative performance data; (3) implementation in mixed-reality OR simulation and assessment of surgeons operating in a confederate team. Statistical analyses included internal consistency and interdomain associations, correlations with experience, and technical and non-technical performances.</p><p><strong>Setting: </strong>Surgical simulation center. Full surgical team set-up within mixed-reality OR simulation.</p><p><strong>Participants: </strong>Eleven surgeons were recruited from two teaching hospitals. Eligibility criteria included surgical specialists in orthopedic, trauma, or neurosurgery with prior VP or kyphoplasty experience.</p><p><strong>Main outcome measures: </strong>Computer-assisted assessment of surgeons' intraoperative performance.</p><p><strong>Results: </strong>Performance scores were associated with surgeons' experience, observational assessment (Objective Structured Assessment of Technical Skill) scores and overall pass/fail ratings. Results provide strong evidence for validity of our computer-assisted SWBA approach. Diverse indicators of surgeons' technical and non-technical performances could be quantified and captured.</p><p><strong>Conclusions: </strong>This study is the first to investigate computer-assisted assessment based on a competency framework in authentic, contextualized team-based OR simulation. Our approach discriminates surgical competency across the domains of intraoperative performance. It advances previous automated assessment based on the use of current surgical simulators in decontextualized settings. Our findings inform future use of computer-assisted multidomain competency assessments of surgeons using SWBA approaches.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"5 1","pages":"e000135"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/4e/be/bmjsit-2022-000135.PMC9853221.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10544506","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pathway map development for medical device event reporting in operating theatres: a human factors approach to improving the existing system.","authors":"Arkeliana Tase,&nbsp;Massimo Micocci,&nbsp;Peter Buckle,&nbsp;Melody Ni,&nbsp;George Hanna","doi":"10.1136/bmjsit-2022-000155","DOIUrl":"https://doi.org/10.1136/bmjsit-2022-000155","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to develop the actual pathway to reporting and information transfer in operating theatres in relation to medical technology malfunction/failure. This with the aim of understanding the differences with the pathway published by NHS Improvement and identification of points for improvement.</p><p><strong>Design: </strong>This is a qualitative study involving stakeholder interviews with doctors, nurses, manufacturers, medical device safety officer and Medicines and Healthcare products Regulatory Agency.</p><p><strong>Setting: </strong>Data were collected on reporting pathway used in operating theatres. Clinical staff who took part worked in different trusts throughout UK while manufacturers provided devices in UK and EU/USA.</p><p><strong>Participants: </strong>Semistructured interviews were completed with 15 clinicians and 13 manufacturers. Surveys were completed by 38 clinicians and 5 manufacturers. Recognised methods of pathway development were used. The Lean Six Sigma principles adapted to healthcare were used to develop suggestions for improvement.</p><p><strong>Main outcome measures: </strong>To identify the differences between the set pathway to reporting and information transfer to what is occurring on a day-to-day basis as reported by staff. Identify points in the pathway where improvements could be applied.</p><p><strong>Results: </strong>The developed pathway demonstrated great complexity of the current reporting system for medical devices. It identified numerous areas that give rise to problems and multiple biases in decision making. This highlighted the core issues leading to under-reporting and lack of knowledge on device performance and patient risk. Suggestions for improvement were deduced based on end user requirements and identified problems.</p><p><strong>Conclusions: </strong>This study has provided a detailed understanding of the key problem areas that exist within the current reporting system for medical devices and technology. The developed pathway sets to address the key problems to improve reporting outcomes. The identification of pathway differences between 'work as done' and 'work as imagined' can lead to development of quality improvements that could be systematically applied.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"5 1","pages":"e000155"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/2c/94/bmjsit-2022-000155.PMC9980347.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10837173","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Developing the foundation for assessment of devices used for Acute Ischemic Stroke Interventions (DAISI) using a Coordinated Registry Network.","authors":"","doi":"10.1136/bmjsit-2021-000113corr1","DOIUrl":"https://doi.org/10.1136/bmjsit-2021-000113corr1","url":null,"abstract":"[This corrects the article DOI: 10.1136/bmjsit-2021-000113.].","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"5 1","pages":"e000113corr1"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/77/5b/bmjsit-2021-000113corr1.PMC10030792.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9170242","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Iterative evaluation of novel access techniques for small bowel obstruction: combining image guided, percutaneous, and endoscopic methods.","authors":"Kentaro Matsuo,&nbsp;Shinya Urakawa,&nbsp;Matthew Symer,&nbsp;Art Sedrakyan,&nbsp;Bradley Pua,&nbsp;Jeffrey Milsom","doi":"10.1136/bmjsit-2022-000150","DOIUrl":"https://doi.org/10.1136/bmjsit-2022-000150","url":null,"abstract":"<p><strong>Objective: </strong>To avoid the need for extensive adhesiolysis in patients with small bowel obstruction (SBO). We evaluated the feasibility of using advanced imaging, percutaneous access, and endoscopy as alternative therapies for SBO.</p><p><strong>Design: </strong>Retrospective case series (IDEAL [Idea, Development, Exploration, Assessment, and Long-term Study Collaborative] stages 1 and 2a).</p><p><strong>Setting: </strong>Single tertiary referral center.</p><p><strong>Participants: </strong>Twelve adults with chronic SBO resulting from inflammatory bowel disease, disseminated cancer, radiation, and/or adhesive disease. Participants were included if they underwent one of three novel access procedures. There were no exclusion criteria. The median age of participants was 67.5 years (range 42-81); two-thirds were women; and median American Society of Anesthesiology class was 3.</p><p><strong>Interventions: </strong>All participants underwent one of three novel access methods, followed by wire-guided balloon dilation of a narrowed area of small bowel. These methods combined endoscopic, fluoroscopic, and surgical techniques. The techniques were (1) a purely endoscopic approach aided by an over-the-scope double-balloon device, (2) a combined endoscopic and percutaneous approach, and (3) a cut-down approach.</p><p><strong>Main outcome measures: </strong>Procedural success (defined as successful access to the small bowel and successful balloon dilation of the stenotic area). Secondary outcomes included major complications, recurrence, length of stay, and procedure time.</p><p><strong>Results: </strong>Procedural success was achieved in 10 of 12 patients (83%). At the time of median follow-up of 10 months, recurrence of SBO was observed in two patients. In only one patient, the novel method did not change the treatment plan. No major complications occurred. Conventional operative intervention was avoided in all patients who achieved technical success with one of the novel approaches. The median postprocedure length of hospital stay was 4 days. Median procedure time was 135 min.</p><p><strong>Conclusions: </strong>Novel minimally invasive approaches to SBO represent feasible alternatives to surgical procedures in select patients. Further study should compare these approaches to standard ones as new methods are refined.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"5 1","pages":"e000150"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/cd/91/bmjsit-2022-000150.PMC10201263.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9510058","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safe implementation of surgical innovation: a prospective registry of the Versius Robotic Surgical System.","authors":"Ilias Soumpasis,&nbsp;Samer Nashef,&nbsp;Joel Dunning,&nbsp;Paul Moran,&nbsp;Mark Slack","doi":"10.1136/bmjsit-2022-000144","DOIUrl":"https://doi.org/10.1136/bmjsit-2022-000144","url":null,"abstract":"<p><strong>Objectives: </strong>To describe a new, international, prospective surgical registry developed to accompany the clinical implementation of the Versius Robotic Surgical System by accumulating real-world evidence of its safety and effectiveness.</p><p><strong>Interventions: </strong>This robotic surgical system was introduced in 2019 for its first live-human case. With its introduction, cumulative database enrollment was initiated across several surgical specialties, with systematic data collection via a secure online platform.</p><p><strong>Main outcome measures: </strong>Pre-operative data include diagnosis, planned procedure(s), characteristics (age, sex, body mass index and disease status) and surgical history. Peri-operative data include operative time, intra-operative blood loss and use of blood transfusion products, intra-operative complications, conversion to an alternative technique, return to the operating room prior to discharge and length of hospital stay. Complications and mortality within 90 days of surgery are also recorded.</p><p><strong>Results: </strong>The data collected in the registry are analyzed as comparative performance metrics, by meta-analyses or by individual surgeon performance using control method analysis. Continual monitoring of key performance indicators, using various types of analyses and outputs within the registry, have provided meaningful insights that help institutions, teams and individual surgeons to perform most effectively and ensure optimal patient safety.</p><p><strong>Conclusions: </strong>Harnessing the power of large-scale, real-world registry data for routine surveillance of device performance in live-human surgery from first use will enhance the safety and efficacy outcomes of innovative surgical techniques. Data are crucial to driving the evolution of robot-assisted minimal access surgery while minimizing risk to patients.</p><p><strong>Trial registration number: </strong>CTRI/2019/02/017872.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"5 1","pages":"e000144"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/64/91/bmjsit-2022-000144.PMC9972451.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9186113","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploring unique device identifier implementation and use for real-world evidence: a mixed-methods study with NESTcc health system network collaborators.","authors":"Sanket S Dhruva,&nbsp;Jennifer L Ridgeway,&nbsp;Joseph S Ross,&nbsp;Joseph P Drozda,&nbsp;Natalia A Wilson","doi":"10.1136/bmjsit-2022-000167","DOIUrl":"https://doi.org/10.1136/bmjsit-2022-000167","url":null,"abstract":"<p><strong>Objectives: </strong>To examine the current state of unique device identifier (UDI) implementation, including barriers and facilitators, among eight health systems participating in a research network committed to real-world evidence (RWE) generation for medical devices.</p><p><strong>Design: </strong>Mixed methods, including a structured survey and semistructured interviews.</p><p><strong>Setting: </strong>Eight health systems participating in the National Evaluation System for health Technology research network within the USA.</p><p><strong>Participants: </strong>Individuals identified as being involved in or knowledgeable about UDI implementation or medical device identification from supply chain, information technology and high-volume procedural area(s) in their health system.</p><p><strong>Main outcomes measures: </strong>Interview topics were related to UDI implementation, including barriers and facilitators; UDI use; benefits of UDI adoption; and vision for UDI implementation. Data were analysed using directed content analysis, drawing on prior conceptual models of UDI implementation and the Exploration, Preparation, Implementation, Sustainment framework. A brief survey of health system characteristics and scope of UDI implementation was also conducted.</p><p><strong>Results: </strong>Thirty-five individuals completed interviews. Three of eight health systems reported having implemented UDI. Themes identified about barriers and facilitators to UDI implementation included knowledge of the UDI and its benefits among decision-makers; organisational systems, culture and networks that support technology and workflow changes; and external factors such as policy mandates and technology. A final theme focused on the availability of UDIs for RWE; lack of availability significantly hindered RWE studies on medical devices.</p><p><strong>Conclusions: </strong>UDI adoption within health systems requires knowledge of and impetus to achieve operational and clinical benefits. These are necessary to support UDI availability for medical device safety and effectiveness studies and RWE generation.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"5 1","pages":"e000167"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d0/47/bmjsit-2022-000167.PMC9872505.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9177873","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Systematic review of preoperative n-3 fatty acids in major gastrointestinal surgery.","authors":"Jason George,&nbsp;Daniel White,&nbsp;Barbara Fielding,&nbsp;Michael Scott,&nbsp;Timothy Rockall,&nbsp;Martin Brunel Whyte","doi":"10.1136/bmjsit-2022-000172","DOIUrl":"https://doi.org/10.1136/bmjsit-2022-000172","url":null,"abstract":"<p><strong>Objectives: </strong>Perioperative nutrition aims to replenish nutritional stores before surgery and reduce postoperative complications. 'Immunonutrition' (including omega-3 fatty acids) may modulate the immune system and attenuate the postoperative inflammatory response. Hitherto, immunonutrition has overwhelmingly been administered in the postoperative period-however, this may be too late to provide benefit.</p><p><strong>Design: </strong>A systematic literature search using MEDLINE and EMBASE for randomized controlled trials (RCTs).</p><p><strong>Setting: </strong>Perioperative major gastrointestinal surgery.</p><p><strong>Participants: </strong>Patients undergoing major gastrointestinal surgery.</p><p><strong>Interventions: </strong>Omega-3 fatty acid supplementation commenced in the preoperative period, with or without continuation into postoperative period.</p><p><strong>Main outcome measures: </strong>The effect of preoperative omega-3 fatty acids on inflammatory response and clinical outcomes.</p><p><strong>Results: </strong>833 studies were identified. After applying inclusion and exclusion criteria, 12 RCTs, involving 1456 randomized patients, were included. Ten articles exclusively enrolled patients with cancer. Seven studies used a combination of EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) as the intervention and five studies used EPA alone. Eight out of 12 studies continued preoperative nutritional support into the postoperative period.Of the nine studies reporting mortality, no difference was seen. Duration of hospitalisation ranged from 4.5 to 18 days with intervention and 3.5 to 23.5 days with control. Omega-3 fatty acids had no effect on postoperative C-reactive protein and the effect on cytokines (including tumor necrosis factor-α, interleukin (IL)-6 and IL-10) was inconsistent. Ten of the 12 studies had low risk of bias, with one study having moderate bias from allocation and blinding.</p><p><strong>Conclusions: </strong>There is insufficient evidence to support routine preoperative omega-3 fatty acid supplementation for major gastrointestinal surgery, even when this is continued after surgery.</p><p><strong>Prospero registration number: </strong>CRD42018108333.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"5 1","pages":"e000172"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/18/3d/bmjsit-2022-000172.PMC10314636.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9745798","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Predicting total knee replacement at 2 and 5 years in osteoarthritis patients using machine learning.","authors":"Khadija Mahmoud,&nbsp;M Abdulhadi Alagha,&nbsp;Zuzanna Nowinka,&nbsp;Gareth Jones","doi":"10.1136/bmjsit-2022-000141","DOIUrl":"https://doi.org/10.1136/bmjsit-2022-000141","url":null,"abstract":"<p><strong>Objectives: </strong>Knee osteoarthritis is a major cause of physical disability and reduced quality of life, with end-stage disease often treated by total knee replacement (TKR). We set out to develop and externally validate a machine learning model capable of predicting the need for a TKR in 2 and 5 years time using routinely collected health data.</p><p><strong>Design: </strong>A prospective study using datasets Osteoarthritis Initiative (OAI) and the Multicentre Osteoarthritis Study (MOST). OAI data were used to train the models while MOST data formed the external test set. The data were preprocessed using feature selection to curate 45 candidate features including demographics, medical history, imaging assessments, history of intervention and outcome.</p><p><strong>Setting: </strong>The study was conducted using two multicentre USA-based datasets of participants with or at high risk of knee OA.</p><p><strong>Participants: </strong>The study excluded participants with at least one existing TKR. OAI dataset included participants aged 45-79 years of which 3234 were used for training and 809 for internal testing, while MOST involved participants aged 50-79 and 2248 were used for external testing.</p><p><strong>Main outcome measures: </strong>The primary outcome of this study was prediction of TKR onset at 2 and 5 years. Performance was evaluated using area under the curve (AUC) and F1-score and key predictors identified.</p><p><strong>Results: </strong>For the best performing model (gradient boosting machine), the AUC at 2 years was 0.913 (95% CI 0.876 to 0.951), and at 5 years 0.873 (95% CI 0.839 to 0.907). Radiographic-derived features, questionnaire-based assessments alongside the patient's educational attainment were key predictors for these models.</p><p><strong>Conclusions: </strong>Our approach suggests that routinely collected patient data are sufficient to drive a predictive model with a clinically acceptable level of accuracy (AUC>0.7) and is the first such tool to be externally validated. This level of accuracy is higher than previously published models utilising MRI data, which is not routinely collected.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"5 1","pages":"e000141"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/18/4d/bmjsit-2022-000141.PMC9933661.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10772204","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Market competition among manufacturers of novel high-risk therapeutic devices receiving FDA premarket approval between 2001 and 2018.","authors":"Vinay K Rathi,&nbsp;James L Johnston,&nbsp;Sanket Dhruva,&nbsp;Joseph Ross","doi":"10.1136/bmjsit-2022-000152","DOIUrl":"https://doi.org/10.1136/bmjsit-2022-000152","url":null,"abstract":"© Author(s) (or their employer(s)) 2023. Reuse permitted under CC BYNC. No commercial reuse. See rights and permissions. Published by BMJ. INTRODUCTION The US Food and Drug Administration (FDA) regulates highrisk medical devices through the premarket approval (PMA) pathway, which requires clinical evidence assuring safety and effectiveness for approval. After approval, manufacturers may face barriers to successful commercialization, such as uncertainties about reimbursement or limited market exclusivity. 3 These clinical, financial and operational hurdles may discourage market entry by manufacturers, thereby limiting competitive innovation. We sought to evaluate the extent of market entry by manufacturers of firstinclass devices and subsequent competitors.","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"5 1","pages":"e000152"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/75/ac/bmjsit-2022-000152.PMC9923248.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9522194","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}