Tosan Okoro, Sebastian Tomescu, J Michael Paterson, Bheeshma Ravi
{"title":"Analysis of the relationship between surgeon procedure volume and complications after total knee arthroplasty using a propensity-matched cohort study.","authors":"Tosan Okoro, Sebastian Tomescu, J Michael Paterson, Bheeshma Ravi","doi":"10.1136/bmjsit-2020-000072","DOIUrl":"https://doi.org/10.1136/bmjsit-2020-000072","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to identify a threshold in annual surgeon volume associated with increased risk of revision (for any cause) and deep infection requiring surgery following primary elective total knee arthroplasty (TKA).</p><p><strong>Design: </strong>A propensity score matched cohort study.</p><p><strong>Setting: </strong>Ontario, Canada.</p><p><strong>Participants: </strong>169 713 persons who received a primary TKA between 2002 and 2016, with 3-year postoperative follow-up.</p><p><strong>Main outcome measures: </strong>Revision arthroplasty (for any cause), and the occurrence of deep surgical infection requiring surgery.</p><p><strong>Results: </strong>Based on restricted cubic spline analysis, the threshold for increased probability of revision and deep infection requiring surgery was <70 cases/year. After matching of 51 658 TKA recipients from surgeons performing <70 cases/year to TKA recipients from surgeons with greater than 70 cases/year, patients in the former group had a higher rate of revision (for any cause, 2.23% (95% Confidence Interval (CI) 1.39 to 3.07) vs 1.70% (95% CI 0.85 to 2.55); Hazard Ratio (HR) 1.33, 95% CI 1.21 to 1.47, p<0.0001) and deep infection requiring surgery (1.29% (95% CI 0.44 to 2.14) vs 1.09% (95% CI 0.24 to 1.94); HR 1.33, 95% CI 1.17 to 1.51, p<0.0001).</p><p><strong>Conclusions: </strong>For primary TKA recipients, cases performed by surgeons who had performed fewer than 70 TKAs in the year prior to the index TKA were at 31% increased relative risk of revision (for any cause), and 18% increased relative risk for deep surgical infection requiring surgery, at 3-year follow-up.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"3 1","pages":"e000072"},"PeriodicalIF":0.0,"publicationDate":"2021-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1136/bmjsit-2020-000072","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39838726","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}
Camilla Fleetcroft, Peter McCulloch, Bruce Campbell
{"title":"IDEAL as a guide to designing clinical device studies consistent with the new European Medical Device Regulation.","authors":"Camilla Fleetcroft, Peter McCulloch, Bruce Campbell","doi":"10.1136/bmjsit-2020-000066","DOIUrl":"10.1136/bmjsit-2020-000066","url":null,"abstract":"","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"3 1","pages":"e000066"},"PeriodicalIF":0.0,"publicationDate":"2021-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/a3/b6/bmjsit-2020-000066.PMC8647605.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39834976","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}
Jiajie Yu, Fei Shan, Allison Hirst, Peter McCulloch, Youping Li, Xin Sun
{"title":"Identifying research waste from surgical research: a protocol for assessing compliance with the IDEAL framework and recommendations.","authors":"Jiajie Yu, Fei Shan, Allison Hirst, Peter McCulloch, Youping Li, Xin Sun","doi":"10.1136/bmjsit-2020-000050","DOIUrl":"https://doi.org/10.1136/bmjsit-2020-000050","url":null,"abstract":"<p><strong>Introduction: </strong>Approximately £1130 billion was invested in research worldwide in 2016, and 9.6% of this was on biomedical research. However, about 85% of biomedical research investment is wasted. The Lancet published a series to identify five categories relating to research waste and in 2014. Some categories of research waste in surgery are avoidable by complying with the Idea, Development, Exploration, Assessment, Long-term follow-up (IDEAL) framework for it enables researchers to design, conduct and report surgical studies robustly and transparently. This review aims to examine the extent to which surgical studies adhered to the IDEAL framework and estimate the amount of overall research waste that could be avoided if compliance was improved.</p><p><strong>Methods: </strong>We will search for potential studies published in English and between 1 January 2018 and 31 December 2018 via PubMed. Teams of paired reviewers will screen titles, abstracts and full texts independently. Two researchers will extract data from each paper. Data will be collected about general information and specialised information in each stage, and our IDEAL Compliance Appraisal tool will be used to analyse included studies. Descriptive statistics and χ<sup>2</sup> or Fisher's exact tests for comparisons will be presented.</p><p><strong>Discussion: </strong>Our study will provide important information about whether compliance with the specific IDEAL Recommendations has reduced research waste in surgical and therapeutic device studies. And we will identify particular key aspects that are worse and need to focus on improving those in future education.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"3 1","pages":"e000050"},"PeriodicalIF":0.0,"publicationDate":"2021-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1136/bmjsit-2020-000050","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39834975","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}
Sejal Patel, Maroeska M Rovers, Michiel J P Sedelaar, Petra L M Zusterzeel, Ad F T M Verhagen, Camiel Rosman, Janneke P C Grutters
{"title":"How can robot-assisted surgery provide value for money?","authors":"Sejal Patel, Maroeska M Rovers, Michiel J P Sedelaar, Petra L M Zusterzeel, Ad F T M Verhagen, Camiel Rosman, Janneke P C Grutters","doi":"10.1136/bmjsit-2020-000042","DOIUrl":"https://doi.org/10.1136/bmjsit-2020-000042","url":null,"abstract":"<p><strong>Objectives: </strong>To develop an interactive tool that estimates what potential benefits are needed for the robot to provide value for money when compared with endoscopic or open surgical interventions.</p><p><strong>Design: </strong>A generic online interactive tool was developed to analyze the (health) effects needed to compensate for the additional costs of using a surgical robotic system from a healthcare perspective. The application of the tool is illustrated with a hypothetical new surgical robotic platform. A synthesis of evidence from different sources was used combined with interviews with surgeons.</p><p><strong>Setting: </strong>Flexible tool that can be adapted to flexible settings.</p><p><strong>Participants: </strong>Any hospital patient group for which robotic, endoscopic or open surgical procedures may be considered as appropriate treatment alternatives (eg, urology, gynecology, and so on).</p><p><strong>Intervention: </strong>Robotically assisted surgical interventions.</p><p><strong>Comparator: </strong>Endoscopic or open surgical interventions.</p><p><strong>Main outcome measures: </strong>Thresholds of how much (health) effect is needed for robot-assisted surgery to provide value for money and to become cost-effective.</p><p><strong>Results: </strong>The utilization rate of the surgical robotic system and a reduction in complications appeared to be important aspects in determining the value for money. To become cost-effective, it was deemed important for new surgical robotic systems to have added clinical benefit and become less costly than the current system.</p><p><strong>Conclusions: </strong>This paper and its assisting interactive tool can be used by clinicians, researchers, and policymakers to gain insight in the benefit needed to provide value for money when using a (new) surgical robotic system or, when the effects are known or can be estimated, to assess the value for money for a specific indication. For robotic surgery to provide most value for money, we recommend assessing for each indication whether the necessary effects seem achievable.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"3 1","pages":"e000042"},"PeriodicalIF":0.0,"publicationDate":"2021-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1136/bmjsit-2020-000042","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39834974","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}
Arjun Burlakoti, Jaliya Kumaratilake, David J Taylor, Maciej Henneberg
{"title":"Quantifying asymmetry of anterior cerebral arteries as a predictor of anterior communicating artery complex aneurysm.","authors":"Arjun Burlakoti, Jaliya Kumaratilake, David J Taylor, Maciej Henneberg","doi":"10.1136/bmjsit-2020-000059","DOIUrl":"https://doi.org/10.1136/bmjsit-2020-000059","url":null,"abstract":"<p><strong>Objectives: </strong>The aim of this study was to establish an anatomical index for early prediction of the risk of development of aneurysms in anterior communicating arterial complex (AcomAC). The asymmetric diameter of one anterior cerebral artery (ACA) to other could alter haemodynamics and may contribute to formation of aneurysms in AcomAC and be a reliable predictor of the risk of development of aneurysms.</p><p><strong>Design and setting: </strong>This is a retrospective, observational and quantitative study, which used cerebral computed tomography angiography (CCTA) scans in South Australia.</p><p><strong>Participants: </strong>CCTA scans of 166 adult patients of both sexes were studied.</p><p><strong>Main outcome measures: </strong>The internal diameters of the proximal segments of ACAs (A1s) were measured. Position and presence or absence of aneurysms in AcomAC were determined. The ratio of A1 diameters was taken as a measure of A1 asymmetry.</p><p><strong>Results: </strong>The ratio of diameters of A1s correlated with the occurrence of AcomAC aneurysms. The risk of development of aneurysms in AcomAC was much greater (80%, OR=47.3) when one A1 segment's radius was at least 50% larger (ie, 2.25 times cross-sectional area) than the other.</p><p><strong>Conclusion: </strong>The general information on asymmetric A1 has been published previously. The present findings have significant contribution since the A1s asymmetry ratios have been categorised in ascending order and matched with the presence of AcomAC aneurysms. The asymmetry ratio of the A1 is a good predictor for the development of AcomAC aneurysms. Reconstruction of the asymmetric A1 could be done if the technology gets advanced.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"2 1","pages":"e000059"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1136/bmjsit-2020-000059","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10266682","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}
Andrea M Austin, Gouri Chakraborti, Jesse Columbo, Niveditta Ramkumar, Kayla Moore, Michelle Scheurich, Phil Goodney
{"title":"Outcomes after peripheral artery disease intervention among Medicare-Medicaid dual-eligible patients compared with the general medicare population in the Vascular Quality Initiative registry.","authors":"Andrea M Austin, Gouri Chakraborti, Jesse Columbo, Niveditta Ramkumar, Kayla Moore, Michelle Scheurich, Phil Goodney","doi":"10.1136/bmjsit-2019-000018","DOIUrl":"https://doi.org/10.1136/bmjsit-2019-000018","url":null,"abstract":"<p><strong>Objective: </strong>To determine whether patients from the Vascular Quality Initiative (VQI) registry who are Medicare-Medicaid dual-eligible have outcomes after surgical intervention with medical devices such as stents for peripheral artery disease comparable to the outcomes of those eligible for Medicare alone.</p><p><strong>Methods: </strong>The study cohort included fee-for-service Medicare beneficiaries from 2010 to 2015 who underwent peripheral vascular intervention as determined by the VQI. We performed propensity matching between the dual-eligible and non-dual-eligible cohorts. Postintervention use, including imaging, amputation and death, was determined using Medicare claims data.</p><p><strong>Results: </strong>Rates of major amputation were higher among dual-eligible patients (13.0% vs 10.5%, p<0.001), while time to amputation by disease severity was similar (p=0.443). For patients with more advanced disease (critical limb ischaemia (CLI) vs claudication), dual-eligible patients have significantly faster times to any amputation and death (p<0.001). For of postoperative imaging, 48.4% of dual-eligible patients receive at least one postoperative image, while the percentage for non-dual-eligible patients is 47.2% (p=0.187).</p><p><strong>Conclusions: </strong>Patients with mild forms of peripheral artery disease (PAD), such as claudication, demonstrated similar outcomes regardless of dual-eligibility status. However, those with severe PAD, such as CLI, who were also dual-eligible had both inferior overall survival and amputation-free survival. Minimal differences were observed in process-driven aspects of care between dual-eligible and non-dual-eligible patients, including postoperative imaging. These findings indicate that despite receiving similar care, dual-eligible patients with severe PAD have inferior long-term outcomes, suggesting the Medicaid safety net is not timely enough to benefit from long-term outcomes for these patients.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"1 1","pages":"e000018"},"PeriodicalIF":0.0,"publicationDate":"2019-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1136/bmjsit-2019-000018","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9340742","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}