BMJ Surgery Interventions Health Technologies最新文献

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The impact of adjuvant antibiotic hydrogel application on the primary stability of uncemented hip stems. 应用辅助抗生素水凝胶对非骨接合髋关节柄主要稳定性的影响。
IF 2.1
BMJ Surgery Interventions Health Technologies Pub Date : 2024-10-18 eCollection Date: 2024-01-01 DOI: 10.1136/bmjsit-2024-000307
Georgios Orfanos, Ivan Zderic, Boyko Gueorguiev, Pamela Nylund, Matteo D'Este, Peter Varga, Tosan Okoro
{"title":"The impact of adjuvant antibiotic hydrogel application on the primary stability of uncemented hip stems.","authors":"Georgios Orfanos, Ivan Zderic, Boyko Gueorguiev, Pamela Nylund, Matteo D'Este, Peter Varga, Tosan Okoro","doi":"10.1136/bmjsit-2024-000307","DOIUrl":"10.1136/bmjsit-2024-000307","url":null,"abstract":"<p><strong>Objectives: </strong>To assess the effect of adjuvant antibiotic-loaded hydrogel application on the primary stability of implanted uncemented hip stems.</p><p><strong>Design: </strong>Biomechanical study.</p><p><strong>Setting: </strong>An electro-mechanic material test system (#5866, Instron, Norwood, MA, USA) equipped with a 10-kN load cell was used. A staircase loading protocol was applied via quasi-static ramped compression loading at 0.005 mm/s and six different load levels between 500 N and 3000 N in 500 N intermittent load increase steps.</p><p><strong>Participants: </strong>12 artificial femora were prepared and received a collarless uncemented standard offset stem (Corail; DePuy Synthes, Zuchwil, Switzerland).</p><p><strong>Interventions: </strong>The two groups were prepared with or without the antibiotic-loaded hydrogel.</p><p><strong>Main outcome measures: </strong>Construct stiffness was determined from the recorded load-displacement curves and stem subsidence was measured via motion tracking.</p><p><strong>Results: </strong>Construct stiffness (control: 4176±240 N/mm; intervention: 4588±448 N/mm) was not significantly different between the groups (p=0.076). Stem subsidence increased significantly over the increasing load levels in each separate group (p≤0.002) and remained not significantly different between the groups (p=0.609).</p><p><strong>Conclusions: </strong>The application of antibiotic-loaded hydrogel was associated with non-inferior performance in terms of primary uncemented hip stem stability. This finding makes the prospect of adjuvant antibiotic-loaded hydrogel application potentially feasible; however, it requires further investigations prior to translation in the clinical practice.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"6 1","pages":"e000307"},"PeriodicalIF":2.1,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11492958/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142476440","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}
引用次数: 0
Prospective randomized evaluation of the sustained impact of assistive artificial intelligence on anesthetists' ultrasound scanning for regional anesthesia. 辅助人工智能对麻醉师区域麻醉超声扫描持续影响的前瞻性随机评估。
IF 2.1
BMJ Surgery Interventions Health Technologies Pub Date : 2024-10-16 eCollection Date: 2024-01-01 DOI: 10.1136/bmjsit-2024-000264
Chao-Ying Kowa, Megan Morecroft, Alan J R Macfarlane, David Burckett-St Laurent, Amit Pawa, Simeon West, Steve Margetts, Nat Haslam, Toby Ashken, Maria Paz Sebastian, Athmaja Thottungal, Jono Womack, Julia Alison Noble, Helen Higham, James S Bowness
{"title":"Prospective randomized evaluation of the sustained impact of assistive artificial intelligence on anesthetists' ultrasound scanning for regional anesthesia.","authors":"Chao-Ying Kowa, Megan Morecroft, Alan J R Macfarlane, David Burckett-St Laurent, Amit Pawa, Simeon West, Steve Margetts, Nat Haslam, Toby Ashken, Maria Paz Sebastian, Athmaja Thottungal, Jono Womack, Julia Alison Noble, Helen Higham, James S Bowness","doi":"10.1136/bmjsit-2024-000264","DOIUrl":"10.1136/bmjsit-2024-000264","url":null,"abstract":"<p><strong>Objectives: </strong>Ultrasound-guided regional anesthesia (UGRA) relies on acquiring and interpreting an appropriate view of sonoanatomy. Artificial intelligence (AI) has the potential to aid this by applying a color overlay to key sonoanatomical structures.The primary aim was to determine whether an AI-generated color overlay was associated with a difference in participants' ability to identify an appropriate block view over a 2-month period after a standardized teaching session (as judged by a blinded assessor). Secondary outcomes included the ability to identify an appropriate block view (unblinded assessor), global rating score and participant confidence scores.</p><p><strong>Design: </strong>Randomized, partially blinded, prospective cross-over study.</p><p><strong>Setting: </strong>Simulation scans on healthy volunteers. Initial assessments on 29 November 2022 and 30 November 2022, with follow-up on 25 January 2023 - 27 January 2023.</p><p><strong>Participants: </strong>57 junior anesthetists undertook initial assessments and 51 (89.47%) returned at 2 months.</p><p><strong>Intervention: </strong>Participants performed ultrasound scans for six peripheral nerve blocks, with AI assistance randomized to half of the blocks. Cross-over assignment was employed for 2 months.</p><p><strong>Main outcome measures: </strong>Blinded experts assessed whether the block view acquired was acceptable (yes/no). Unblinded experts also assessed this parameter and provided a global performance rating (0-100). Participants reported scan confidence (0-100).</p><p><strong>Results: </strong>AI assistance was associated with a higher rate of appropriate block view acquisition in both blinded and unblinded assessments (p=0.02 and <0.01, respectively). Participant confidence and expert rating scores were superior throughout (all p<0.01).</p><p><strong>Conclusions: </strong>Assistive AI was associated with superior ultrasound scanning performance 2 months after formal teaching. It may aid application of sonoanatomical knowledge and skills gained in teaching, to support delivery of UGRA beyond the immediate post-teaching period.</p><p><strong>Trial registration number: </strong>www.clinicaltrials.govNCT05583032.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"6 1","pages":"e000264"},"PeriodicalIF":2.1,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11487881/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142476439","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}
引用次数: 0
Clinical effectiveness of a modified muscle sparing posterior technique compared with a standard lateral approach in hip hemiarthroplasty for displaced intracapsular fractures (HemiSPAIRE): a multicenter, parallel-group, randomized controlled trial. 在髋关节半关节成形术治疗移位的囊内骨折中,改良的肌肉疏松后路技术与标准侧路相比的临床效果(HemiSPAIRE):一项多中心、平行组、随机对照试验。
BMJ Surgery Interventions Health Technologies Pub Date : 2024-06-17 eCollection Date: 2024-01-01 DOI: 10.1136/bmjsit-2023-000251
Susan Ball, Alex Aylward, Emma Cockcroft, Aisling Corr, Elizabeth Gordon, Alison Kerridge, Amy McAndrew, Sarah Morgan-Trimmer, Roy Powell, Anna Price, Shelley Rhodes, Andrew John Timperley, Jayden van Horik, Robert Wickins, John Charity
{"title":"Clinical effectiveness of a modified muscle sparing posterior technique compared with a standard lateral approach in hip hemiarthroplasty for displaced intracapsular fractures (HemiSPAIRE): a multicenter, parallel-group, randomized controlled trial.","authors":"Susan Ball, Alex Aylward, Emma Cockcroft, Aisling Corr, Elizabeth Gordon, Alison Kerridge, Amy McAndrew, Sarah Morgan-Trimmer, Roy Powell, Anna Price, Shelley Rhodes, Andrew John Timperley, Jayden van Horik, Robert Wickins, John Charity","doi":"10.1136/bmjsit-2023-000251","DOIUrl":"10.1136/bmjsit-2023-000251","url":null,"abstract":"<p><strong>Objectives: </strong>Assess the effect of a modified muscle sparing posterior approach; SPAIRE (Save Piriformis and Internus, Repairing Externus), in hip hemiarthroplasty for displaced intracapsular fractures on postoperative mobility and function compared with a standard lateral approach.</p><p><strong>Design: </strong>Pragmatic, superiority, multicenter, parallel-group, randomized controlled trial (with internal pilot). Participants, ward staff, and research staff conducting postoperative assessments were blinded to allocation. A CTU allocated treatments centrally using computer-generated lists.</p><p><strong>Setting: </strong>Six hospitals in Southwest England, recruiting November 25, 2019-April 25, 2022.</p><p><strong>Participants: </strong>244 adults (≥60 years) requiring hip hemiarthroplasty (122 allocated to each approach). 90 and 85 participants allocated to SPAIRE and lateral, respectively, had primary outcome data within the prespecified data collection window.</p><p><strong>Interventions: </strong>Surgery using SPAIRE or standard lateral approach. Follow-up 3 days and 120 days postoperation.</p><p><strong>Main outcome measure: </strong>Oxford Hip Score (OHS), via telephone at 120 days. Secondary outcomes: function and mobility (3 days), pain (3 days, 120 days), discharge destination, length of hospital stay, complications and mortality (within 120 days), quality of life and place of residence (120 days).</p><p><strong>Results: </strong>Participants' mean age was 84.6 years (SD 7.2); 168 (69%) were women. Primary outcome: little evidence of a difference in OHS at 120 days; adjusted mean difference (SPAIRE-lateral) -1.23 (95% CI -3.96 to 1.49, p=0.37). Secondary outcomes: indication of lower participant-reported pain at 3 days in SPAIRE arm; no differences between arms for remaining outcomes.</p><p><strong>Conclusions: </strong>Participants' mobility and function are similar in the short term (3 days) and longer term (120 days), whether receiving the SPAIRE or lateral approach. Neither approach confers benefit over the other in terms of length of hospital stay, return to prefracture residence, survival within 120 days, or quality of life at 120 days. Participants receiving SPAIRE approach may experience less pain in the early postoperative period. Modifying the posterior approach in hip hemiarthroplasty to the SPAIRE approach gives equivalent patient outcomes to the lateral approach within 120 days.</p><p><strong>Trial registration number: </strong>NCT04095611.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"6 1","pages":"e000251"},"PeriodicalIF":0.0,"publicationDate":"2024-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11184196/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141421205","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}
引用次数: 0
IDEAL evaluation for global surgery innovation. 全球手术创新 IDEAL 评估。
BMJ Surgery Interventions Health Technologies Pub Date : 2024-06-12 eCollection Date: 2024-01-01 DOI: 10.1136/bmjsit-2024-000297
Peter McCulloch, Janet Martin
{"title":"IDEAL evaluation for global surgery innovation.","authors":"Peter McCulloch, Janet Martin","doi":"10.1136/bmjsit-2024-000297","DOIUrl":"10.1136/bmjsit-2024-000297","url":null,"abstract":"","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"6 1","pages":"e000297"},"PeriodicalIF":0.0,"publicationDate":"2024-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11177697/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141331934","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}
引用次数: 0
No frugal innovation without frugal evaluation: the Global IDEAL Sub-Framework. 没有节俭的评估,就没有节俭的创新:全球 IDEAL 子框架。
BMJ Surgery Interventions Health Technologies Pub Date : 2024-06-12 eCollection Date: 2024-01-01 DOI: 10.1136/bmjsit-2023-000248
William S Bolton, Noel K Aruparayil, Bonnie Cundill, Peter McCulloch, Jesudian Gnanaraj, Ibrahim Bundu, Peter R Culmer, Julia M Brown, Julian Scott, David G Jayne
{"title":"No frugal innovation without frugal evaluation: the Global IDEAL Sub-Framework.","authors":"William S Bolton, Noel K Aruparayil, Bonnie Cundill, Peter McCulloch, Jesudian Gnanaraj, Ibrahim Bundu, Peter R Culmer, Julia M Brown, Julian Scott, David G Jayne","doi":"10.1136/bmjsit-2023-000248","DOIUrl":"10.1136/bmjsit-2023-000248","url":null,"abstract":"<p><strong>Objective: </strong>The Global IDEAL Sub-Framework Study aimed to combine the intended effects of the 2009/2019 IDEAL (Idea, Development, Exploration, Assessment, Long-term study) Framework recommendations on evaluating surgical innovation with the vision outlined by the 2015 Lancet Commission on Global Surgery to provide recommendations for evaluating surgical innovation in low-resource environments.</p><p><strong>Design: </strong>A mixture of methods including an online global survey and semistructured interviews (SSIs). Quantitative data were summarized with descriptive statistics and qualitative data were analyzed using the Framework Method.</p><p><strong>Participants: </strong>Surgeons and surgical researchers from any country.</p><p><strong>Main outcome measures: </strong>Findings were used to suggest the nature of adaptations to the IDEAL Framework to address the particular problems of evaluation in low-resource settings.</p><p><strong>Results: </strong>The online survey yielded 66 responses representing experience from 40 countries, and nine individual SSIs were conducted. Most respondents (n=49; 74.2%) had experience evaluating surgical technologies across a range of life cycle stages. Innovation was most frequently adopted based on colleague recommendation or clinical evaluation in other countries. Four themes emerged, centered around: frugal innovation in technological development; evaluating the same technology/innovation in different contexts; additional methodologies important in evaluation of surgical innovation in low/middle-income countries; and support for low-income country researchers along the evaluation pathway.</p><p><strong>Conclusions: </strong>The Global IDEAL Sub-Framework provides suggestions for modified IDEAL recommendations aimed at dealing with the special problems found in this setting. These will require validation in a stakeholder consensus forum, and qualitative assessment in pilot studies. From assisting researchers with identification of the correct evaluation stage, to providing context-specific recommendations relevant to the whole evaluation pathway, this process will aim to develop a comprehensive and applicable set of guidance that will benefit surgical innovation and patients globally.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"6 1","pages":"e000248"},"PeriodicalIF":0.0,"publicationDate":"2024-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11177672/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141331935","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}
引用次数: 0
Decompressive craniectomy to cranioplasty: a retrospective observational study using Hospital Episode Statistics in England. 从颅骨减压切除术到颅骨成形术:利用英格兰医院病例统计资料进行的回顾性观察研究。
BMJ Surgery Interventions Health Technologies Pub Date : 2024-06-03 eCollection Date: 2024-01-01 DOI: 10.1136/bmjsit-2023-000253
Harry Mee, J M Harris, T Korhonen, F Anwar, A J Wahba, Michael Martin, G Whiting, E Viaroli, I Timofeev, A Helmy, Angelos G Kolias, Peter J Hutchinson
{"title":"Decompressive craniectomy to cranioplasty: a retrospective observational study using Hospital Episode Statistics in England.","authors":"Harry Mee, J M Harris, T Korhonen, F Anwar, A J Wahba, Michael Martin, G Whiting, E Viaroli, I Timofeev, A Helmy, Angelos G Kolias, Peter J Hutchinson","doi":"10.1136/bmjsit-2023-000253","DOIUrl":"10.1136/bmjsit-2023-000253","url":null,"abstract":"<p><strong>Objectives: </strong>To investigate the longitudinal trends of decompressive craniectomy (DC) following traumatic brain injury (TBI) or stroke and explore whether the timing of cranial reconstruction affected revision or removal rates using Hospital Episode Statistics (HES) between 2014 and 2019.</p><p><strong>Design: </strong>Retrospective observational cohort study using HES. The time frame definitions mirror those often used in clinical practice.</p><p><strong>Setting: </strong>HES data from neurosurgical centres in England.</p><p><strong>Participants: </strong>HES data related to decompressive craniectomy procedures and cranioplasty following TBI or stroke between 2014 and 2019.</p><p><strong>Main outcome measures: </strong>The primary outcome was the timing and rate of revision/removal compared with cranioplasty within <12 weeks to ≥12 weeks.</p><p><strong>Results: </strong>There were 4627 DC procedures, of which 1847 (40%) were due to head injury, 1116 (24%) were due to stroke, 728 (16%) were due to other cerebrovascular diagnoses, 317 (7%) had mixed diagnosis and 619 (13%) had no pre-specified diagnoses. The number of DC procedures performed per year ranged from 876 in 2014-2015 to 967 in 2018-2019. There were 4466 cranioplasty procedures, with 309 (7%) revisions and/or removals during the first postoperative year. There was a 33% increase in the overall number of cranioplasty procedures performed within 12 weeks, and there were 1823 patients who underwent both craniectomy and cranioplasty during the study period, with 1436 (79%) having a cranioplasty within 1 year. However, relating to the timing of cranial reconstruction, there was no evidence of any difference in the rate of revision or removal surgery in the early timing group (6.5%) compared with standard care (7.9%) (adjusted HR 0.93, 95% CIs 0.61 to 1.43; p=0.75).</p><p><strong>Conclusions: </strong>Overall number of craniectomies and the subsequent requirements for cranioplasty increased steadily during the study period. However, relating to the timing of cranial reconstruction, there was no evidence of an overall difference in the rate of revision or removal surgery in the early timing group.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"6 1","pages":"e000253"},"PeriodicalIF":0.0,"publicationDate":"2024-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11149159/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141248854","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}
引用次数: 0
Theory and evidence-base for a digital platform for the delivery of language tests during awake craniotomy and collaborative brain mapping. 在清醒开颅手术和协作脑图绘制过程中进行语言测试的数字平台的理论和证据基础。
BMJ Surgery Interventions Health Technologies Pub Date : 2024-05-13 eCollection Date: 2024-01-01 DOI: 10.1136/bmjsit-2023-000234
Damjan Veljanoski, Xin Yi Ng, Ciaran Scott Hill, Aimun A B Jamjoom
{"title":"Theory and evidence-base for a digital platform for the delivery of language tests during awake craniotomy and collaborative brain mapping.","authors":"Damjan Veljanoski, Xin Yi Ng, Ciaran Scott Hill, Aimun A B Jamjoom","doi":"10.1136/bmjsit-2023-000234","DOIUrl":"https://doi.org/10.1136/bmjsit-2023-000234","url":null,"abstract":"<p><strong>Objectives: </strong>Build the theoretical and evidence-base for a digital platform (map-OR) which delivers intraoperative language tests during awake craniotomy and facilitates collaborative sharing of brain mapping data.</p><p><strong>Design: </strong>Mixed methodology study including two scoping reviews, international survey, synthesis of development guiding principles and a risk assessment using failure modes and effects analysis.</p><p><strong>Setting: </strong>The two scoping reviews examined the literature published in the English language. International survey was completed by members of awake craniotomy teams from 14 countries.</p><p><strong>Main outcome measures: </strong>Scoping review 1: number of technologies described for language mapping during awake craniotomy. Scoping review 2: barriers and facilitators to adopting novel technology in surgery. International survey: degree of language mapping technology penetration into clinical practice.</p><p><strong>Results: </strong>A total of 12 research articles describing 6 technologies were included. The technologies required a range of hardware components including portable devices, virtual reality headsets and large integrated multiscreen stacks. The facilitators and barriers of technology adoption in surgery were extracted from 11 studies and mapped onto the 4 Unified Theory of Acceptance and Use of Technology constructs. A total of 37 awake craniotomy teams from 14 countries completed the survey. Of the responses, 20 (54.1%) delivered their language tests digitally, 10 (27.0%) delivered tests using cards and 7 (18.9%) used a combination of both. The most commonly used devices were tablet computers (67.7%; n=21) and the most common software used was Microsoft PowerPoint (60.6%; n=20). Four key risks for the proposed digital platform were identified, the highest risk being a software and internet connectivity failure during surgery.</p><p><strong>Conclusions: </strong>This work represents a rigorous and structured approach to the development of a digital platform for standardized intraoperative language testing during awake craniotomy and for collaborative sharing of brain mapping data.</p><p><strong>Trial registration number: </strong>Scoping review protocol registrations in OSF registries (scoping review 1: osf.io/su9xm; scoping review 2: osf.io/x4wsc).</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"6 1","pages":"e000234"},"PeriodicalIF":0.0,"publicationDate":"2024-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11097893/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140959265","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}
引用次数: 0
Post-trial access to implantable neural devices: an exploratory international survey. 植入式神经设备试用后的使用情况:一项探索性国际调查。
BMJ Surgery Interventions Health Technologies Pub Date : 2024-04-17 eCollection Date: 2024-01-01 DOI: 10.1136/bmjsit-2024-000262
Nathan Higgins, John Gardner, Anna Wexler, Philipp Kellmeyer, Kerry O'Brien, Adrian Carter
{"title":"Post-trial access to implantable neural devices: an exploratory international survey.","authors":"Nathan Higgins, John Gardner, Anna Wexler, Philipp Kellmeyer, Kerry O'Brien, Adrian Carter","doi":"10.1136/bmjsit-2024-000262","DOIUrl":"https://doi.org/10.1136/bmjsit-2024-000262","url":null,"abstract":"<p><strong>Objectives: </strong>Clinical trials of innovative neural implants are rapidly increasing and diversifying, but little is known about participants' post-trial access to the device and ongoing clinical care. This exploratory study examines common practices in the planning and coordination of post-trial access to neurosurgical devices. We also explore the perspectives of trial investigators on the barriers to post-trial access and ongoing care, as well as ethical questions related to the responsibilities of key stakeholder groups.</p><p><strong>Design setting and participants: </strong>Trial investigators (n=66) completed a survey on post-trial access in the most recent investigational trial of a surgically implanted neural device they had conducted. Survey respondents predominantly specialized in neurosurgery, neurology and psychiatry, with a mean of 14.8 years of experience working with implantable neural devices.</p><p><strong>Main outcome measures: </strong>Outcomes of interest included rates of device explantation during or at the conclusion of the trial (pre-follow-up) and whether plans for post-trial access were described in the study protocol. Outcomes also included investigators' greatest 'barrier' and 'facilitator' to providing research participants with post-trial access to functional implants and perspectives on current arrangements for the sharing of post-trial responsibilities among key stakeholders.</p><p><strong>Results: </strong>Trial investigators reported either 'all' (64%) or 'most' (33%) trial participants had remained implanted after the end of the trial, with 'infection' and 'non-response' the most common reasons for explantation. When asked to describe the main barriers to facilitating post-trial access, investigators described limited funding, scarcity of expertise and specialist clinical infrastructure and difficulties maintaining stakeholder relationships. Notwithstanding these barriers, investigators overwhelmingly (95%) agreed there is an ethical obligation to provide post-trial access when participants individually benefit during the trial.</p><p><strong>Conclusions: </strong>On occasions when devices were explanted during or at the end of the trial, this was done out of concern for the safety and well-being of participants. Further research into common practices in the post-trial phase is needed and essential to ethical and pragmatic discussions regarding stakeholder responsibilities.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"6 1","pages":"e000262"},"PeriodicalIF":0.0,"publicationDate":"2024-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11029395/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140858169","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}
引用次数: 0
PROJECT PREVENT: a randomized controlled trial of preoperative vaginal metronidazole to decrease patient issues and infections after hysterectomy PREVENT 项目:术前阴道用甲硝唑减少患者问题和子宫切除术后感染的随机对照试验
BMJ Surgery Interventions Health Technologies Pub Date : 2024-04-01 DOI: 10.1136/bmjsit-2023-000241
Tana Pradhan, Helen Zhang, Amanda Kadesh, Ama Buskwofie, Sonali Patankar, Sharifa Menon, Timothy Ryntz, Cara L. Grimes
{"title":"PROJECT PREVENT: a randomized controlled trial of preoperative vaginal metronidazole to decrease patient issues and infections after hysterectomy","authors":"Tana Pradhan, Helen Zhang, Amanda Kadesh, Ama Buskwofie, Sonali Patankar, Sharifa Menon, Timothy Ryntz, Cara L. Grimes","doi":"10.1136/bmjsit-2023-000241","DOIUrl":"https://doi.org/10.1136/bmjsit-2023-000241","url":null,"abstract":"Objectives To evaluate if vaginal metronidazole for 5 days before hysterectomy decreases postoperative infections and patient issues. Design This randomized trial compared vaginal metronidazole for 5 days before a scheduled hysterectomy to no intervention. Sample size calculation was based on a 20% difference in issues and infection (30% incidence and 10% in the intervention arm) with 80% power and an alpha error of 0.05 and indicated 62 subjects needed in each arm. Setting Outpatient gynecology clinics at a single academic institution. Participants 154 subjects were screened for eligibility between July 2020 and September 2022. 133 underwent hysterectomy including 68 subjects (51.1%) randomized to the metronidazole and 65 (48.9%) controls. Overall, the population was racially and ethnically diverse. There was no significant difference in characteristics between the two groups. Interventions Vaginal metronidazole for 5 days before hysterectomy. Main outcome measures Postoperative patient issues and documented postoperative infections at 4–8 weeks after surgery. Results There was no difference in the composite rate of patient-reported issues and/or documented postoperative infection (53/133 (39.8%) with no difference between groups (29/68 (42.6%) vs 24/65 (36.9%), p=0.50). There was no difference in patient-reported issues which was 51/133 (38.3%) with no difference between groups (28/68 (41.2%) vs 23/65 (33.8%), p=0.49) or in documented infections with a rate of 25/133 (18.8%) with no significant difference between groups (15/68 (22.0%) vs 10/65 (15.4%), p=0.33). In the intervention arm, the compliance rate was 73.5% for all 5 days of vaginal metronidazole, and a per-protocol analysis was performed which resulted in no significant difference between groups. Conclusions There is insufficient evidence to suggest a significant benefit of preoperative vaginal metronidazole to prevent surgical site infections and postoperative patient issues in patients undergoing hysterectomy. Trial registration number ClinicalTrials.gov, [NCT04478617][1]. Data are available upon reasonable request. The data that support the findings of this study are available from the corresponding author, TP, upon reasonable request. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04478617&atom=%2Fbmjsit%2F6%2F1%2Fe000241.atom","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"81 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140583227","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Distribution of case volumes in surgery: an analysis of the British Spine Registry 外科手术病例量的分布:英国脊柱登记处的分析
BMJ Surgery Interventions Health Technologies Pub Date : 2024-03-01 DOI: 10.1136/bmjsit-2023-000202
Chan Hee Koh, William Muirhead, Danyal Zaman Khan, Hugo Layard Horsfall, George Prezerakos, Parag Sayal, Hani J Marcus
{"title":"Distribution of case volumes in surgery: an analysis of the British Spine Registry","authors":"Chan Hee Koh, William Muirhead, Danyal Zaman Khan, Hugo Layard Horsfall, George Prezerakos, Parag Sayal, Hani J Marcus","doi":"10.1136/bmjsit-2023-000202","DOIUrl":"https://doi.org/10.1136/bmjsit-2023-000202","url":null,"abstract":"Objectives To characterize the distribution of case volumes within a surgical field. Design An analysis of British Spine Registry. Setting 295 centers in England that conducted at least one spinal operation either within the NHS or private settings between 1 May 2016 and 27 February 2021. Participants 644 surgeons. Main outcome measures Mathematical descriptions of distributions of cases among surgeons and the extent of workforce-level case-volume concentration as a surrogate marker. Results There were wide variations in monthly caseloads between surgeons, ranging from 0 to average monthly high of 81.8 cases. The curves showed that 37.7% of surgeons were required to perform 80% of all spinal operations, which is substantially less than in fields outside of healthcare. With the COVID-19 pandemic, the case volumes of surgeons with the highest volumes dropped dramatically, whereas those with the lowest case numbers remained nearly unchanged. This, along with the relatively low level of case-volume concentration within spinal surgery, may indicate an inevitability of at least some level of surgical care being provided by the relatively lower volume surgeons. Conclusions While there is a reasonable degree of workforce-level case volume concentration within spinal surgery, with high volume spinal surgeons providing a large proportion of care, it is not clear whether a further concentration of case volumes into those few hands is possible or desirable. Data may be obtained from a third party and are not publicly available. Data were obtained from the British Spine Registry for a fee. Any requests for the data must be made to the British Spine Registry, or otherwise may only be release with their permission.","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"32 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140201307","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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