BMJ Surgery Interventions Health Technologies最新文献

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Early clinical evaluation of the Hugo robotic-assisted surgery (RAS) for performing radical prostatectomy: an IDEAL stage 2 study.
IF 2.1
BMJ Surgery Interventions Health Technologies Pub Date : 2025-04-05 eCollection Date: 2025-01-01 DOI: 10.1136/bmjsit-2024-000360
Andrew Shepherd, Ata Jaffer, Angus Bruce, Daniel Chia, Prokar Dasgupta, Ben Challacombe
{"title":"Early clinical evaluation of the Hugo robotic-assisted surgery (RAS) for performing radical prostatectomy: an IDEAL stage 2 study.","authors":"Andrew Shepherd, Ata Jaffer, Angus Bruce, Daniel Chia, Prokar Dasgupta, Ben Challacombe","doi":"10.1136/bmjsit-2024-000360","DOIUrl":"https://doi.org/10.1136/bmjsit-2024-000360","url":null,"abstract":"<p><strong>Objectives: </strong>To assess the feasibility and safety of the new Hugo robotic-assisted surgery (RAS) system for robotic-assisted radical prostatectomy (RARP), describing iterative changes in our operative technique-IDEAL stage 2.</p><p><strong>Design: </strong>Prospective, single-centre series.</p><p><strong>Setting: </strong>Tertiary urological unit in London, UK.</p><p><strong>Participants: </strong>Male patients diagnosed with clinically localised prostate cancer and suitable for RARP from February 2023 to May 2024.</p><p><strong>Main outcome measures: </strong>The primary outcome was to assess the safety of using the device without converting to the existing robotic platform (da Vinci), laparoscopy or open. Secondary outcomes assessed surgical (operative time, blood loss, time to catheter removal, complications), oncologic (surgical pathology and margin status) and early functional (continence) outcomes.</p><p><strong>Results: </strong>50 patients were included in the study. No cases required conversion to an existing robotic platform, laparoscopy or open, and there were no intraoperative surgical complications. Mean age was 60 years and mean prostate-specific antigen was 12.2 ng/mL. The mean operative time was 148 min and estimated blood loss was 168 mL. Mean length of stay was 1.5 days and mean length of catheter duration was 13 days. On final pathology, 18 patients (36%) had T3 disease and four had positive surgical margins (8%). The mean International Consultation on Incontinence Questionnaire-Urinary Incontinence score for urinary continence at 3 months was 7. There were six Clavien-Dindo grade 2 complications and two Clavien-Dindo 3a complications. There were four instances of recoverable, temporary device failure. Iterative improvements were made to docking setup, use of robotic instruments and reduction in robotic arm collisions.</p><p><strong>Conclusions: </strong>We demonstrated feasibility and the safe introduction of the Hugo RAS for RARP into an experienced robotic urological programme. Perioperative, early oncological and functional outcomes were similar to other early series. Further studies will aim to describe the learning curve with this robot and optimisation of surgical quality.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"7 1","pages":"e000360"},"PeriodicalIF":2.1,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11973793/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143804438","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
Patient perspectives on AI-based decision support in surgery.
IF 2.1
BMJ Surgery Interventions Health Technologies Pub Date : 2025-04-02 eCollection Date: 2025-01-01 DOI: 10.1136/bmjsit-2024-000365
Sara Ben Hmido, Houssam Abder Rahim, Corrette Ploem, Saskia Haitjema, Olga Damman, Geert Kazemier, Freek Daams
{"title":"Patient perspectives on AI-based decision support in surgery.","authors":"Sara Ben Hmido, Houssam Abder Rahim, Corrette Ploem, Saskia Haitjema, Olga Damman, Geert Kazemier, Freek Daams","doi":"10.1136/bmjsit-2024-000365","DOIUrl":"10.1136/bmjsit-2024-000365","url":null,"abstract":"<p><strong>Background: </strong>Predictive machine learning in healthcare, especially in surgical decisions, is advancing swiftly. Yet, literature on patient views regarding predictive machine learning, specifically its use throughout the clinical course, is scarce. Views among patients who underwent colorectal surgery (CRS) on the use of intra-operative predictive machine learning (IPML) by surgeons, particularly those aiming to predict colorectal anastomotic leakage (CAL), were explored in this study.</p><p><strong>Objective: </strong>This study investigated the views of patients who previously underwent CRS on the implementation of IPML models. Domains of interest were perceptions of IPML, perceived role in decision-making and information provided in the clinical encounter.</p><p><strong>Methods: </strong>A qualitative research design was employed, using focus groups and semi-structured interviews with patients who had undergone CRS. Descriptive thematic analysis was used to analyse data and identify prevailing themes and attitudes. The associations in the code tree were established based on a co-occurrence table. The patient sample size was determined using a saturation analysis.</p><p><strong>Results: </strong>A study with n=19 participants across four focus groups and seven interviews found a generally positive perception regarding the use of IPML models in CRS. Participants recognised their potential to enhance surgical decision-making but stressed the surgeon's role as the primary decision-maker, suggesting IPML models act as advisory tools, with surgeons able to override recommendations. Personalised communication and consideration of quality of life were emphasised, highlighting the need for a balanced integration of IPML models to support clinical judgement and the construction of patient preferences.</p><p><strong>Conclusion: </strong>IPML in CRS is well-received by participants, provided that surgeons retain the ability to override model recommendations and document their decisions transparently. Trust in the surgeon remains a key factor in patient acceptance of IPML, reinforcing the need for clear explanations during consultation sessions. Regardless of the use of IPML, tailoring patient communication and addressing the quality-of-life impacts of anastomosis vs stoma are also critical.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"7 1","pages":"e000365"},"PeriodicalIF":2.1,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11966983/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143781538","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
Middle meningeal artery embolization for chronic subdural hematoma.
IF 2.1
BMJ Surgery Interventions Health Technologies Pub Date : 2025-03-28 eCollection Date: 2025-01-01 DOI: 10.1136/bmjsit-2024-000290
Malgorzata Maciaszek, Brendan Steinfort, Timothy Harrington, Ken Faulder, Nazih Assaad, Mark Dexter, Alice Ma
{"title":"Middle meningeal artery embolization for chronic subdural hematoma.","authors":"Malgorzata Maciaszek, Brendan Steinfort, Timothy Harrington, Ken Faulder, Nazih Assaad, Mark Dexter, Alice Ma","doi":"10.1136/bmjsit-2024-000290","DOIUrl":"10.1136/bmjsit-2024-000290","url":null,"abstract":"<p><strong>Objectives: </strong>To assess recurrence rates, procedural outcomes and patient outcomes following middle meningeal artery (MMA) embolization for the treatment of chronic subdural hematomas (cSDH).</p><p><strong>Design: </strong>Retrospective case series.</p><p><strong>Setting: </strong>Two tertiary neurosurgical referral centers in Sydney, Australia.</p><p><strong>Participants: </strong>13 adult patients (mean age±SD, 68.5±9.5 years, 11 male) with 17 cSDHs (measuring 13.8±4.5 mm) undergoing MMA embolization alone (8/13) or with surgical evacuation (5/13) for cSDH. There were no exclusion criteria.</p><p><strong>Interventions: </strong>Embolization was performed via femoral access, using either liquid embolic, polyvinyl alcohol particles, coils, or a combination of agents. Embolization was done either as the sole treatment or with surgical evacuation.</p><p><strong>Main outcome measures: </strong>Primary outcomes were recurrence or increase in hematoma size requiring surgical evacuation. Secondary outcomes included procedural complications, hematoma size at follow-up, and patient clinical outcomes.</p><p><strong>Results: </strong>No procedural complications occurred. 12 patients were discharged home at baseline neurological function, and one was discharged to an aged care facility with significant disability. At follow-up (mean=8.7 weeks), combined embolization with surgical evacuation led to hematoma size reduction (14.3±2.6 mm to 5.7±6.5 mm, p<0.01), while embolization alone showed a stable hematoma size (13.3±5.7 mm to 10.0±8.8 mm, p=0.20). Recurrence or increase in hematoma size requiring surgical evacuation occurred in 2/13 (15.4%) patients, one of whom received only unilateral embolization, and the other received partial coiling due to the presence of dangerous collaterals.</p><p><strong>Conclusions: </strong>MMA embolization is a safe procedure that may reduce recurrence rates of cSDH when used as an adjunct to surgery or as a sole treatment. Possible reasons for treatment failure may include unilateral embolization, partial coiling, and absence of distal penetration of embolic agent. Large randomized control trials are currently in progress to assess the safety and efficacy of MMA embolization for this purpose.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"7 1","pages":"e000290"},"PeriodicalIF":2.1,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11956281/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143754736","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
Effects of visual guidance and instrument choice on symptom recurrence following adenoidectomy: a systematic review of randomized controlled trials.
IF 2.1
BMJ Surgery Interventions Health Technologies Pub Date : 2025-03-27 eCollection Date: 2025-01-01 DOI: 10.1136/bmjsit-2024-000370
Martin Mølhave, Therese Ovesen, Adnan Madzak
{"title":"Effects of visual guidance and instrument choice on symptom recurrence following adenoidectomy: a systematic review of randomized controlled trials.","authors":"Martin Mølhave, Therese Ovesen, Adnan Madzak","doi":"10.1136/bmjsit-2024-000370","DOIUrl":"10.1136/bmjsit-2024-000370","url":null,"abstract":"<p><strong>Objectives: </strong>To assess the impact of visual guidance and instrument choice on obstructive sleep apnea (OSA) and otitis media with effusion (OME) symptom recurrence and reoperation rates following adenoidectomy in pediatric patients.</p><p><strong>Design: </strong>Systematic review of randomized controlled trials (RCTs).</p><p><strong>Setting: </strong>A comprehensive literature search was conducted in Embase, PubMed/Medline, the Cochrane Library, and Scopus, with the final search on September 23, 2024. Reference lists were also screened.</p><p><strong>Participants: </strong>Eligible studies included RCTs published from 2000 onwards, with ≥25 pediatric patients undergoing adenoidectomy for OSA or OME. Comparisons included visually guided versus blinded and cold versus hot adenoidectomy techniques. Studies involving concurrent procedures, craniofacial abnormalities, or non-primary adenoidectomy cases were excluded.</p><p><strong>Main outcome measures: </strong>The primary outcomes were OSA and OME symptom recurrence and reoperation rates following adenoidectomy. Risk of bias was assessed using Cochrane Risk of Bias tool, and evidence quality was evaluated using Grading of Recommendations Assessment, Development and Evaluation.</p><p><strong>Results: </strong>Of 2302 screened articles, 35 underwent full-text review, and 4r studies (373 participants) met inclusion criteria. All studies compared hot and cold techniques, with hot techniques being visually guided. Only one study directly compared both hot and cold techniques under visual guidance, reporting lower OSA recurrence rates with the hot technique, though with a high risk of bias. Other studies found no significant differences, and none reported reoperation rates. Study heterogeneity prevented meta-analysis. Overall risk of bias and evidence quality were moderate.</p><p><strong>Conclusions: </strong>There is insufficient evidence to determine whether visual guidance reduces symptom recurrence following adenoidectomy. Further high-quality RCTs are needed to provide more sound conclusions.</p><p><strong>Prospero registration number: </strong>CRD42024513408.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"7 1","pages":"e000370"},"PeriodicalIF":2.1,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11956394/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143754834","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
At the cutting edge: the potential of autonomous surgery and challenges faced.
IF 2.1
BMJ Surgery Interventions Health Technologies Pub Date : 2025-03-27 eCollection Date: 2025-01-01 DOI: 10.1136/bmjsit-2024-000338
Raghav Khanna, Nicholas Raison, Alejandro Granados Martinez, Sebastien Ourselin, Francesco Montorsi, Alberto Briganti, Prokar Dasgupta
{"title":"At the cutting edge: the potential of autonomous surgery and challenges faced.","authors":"Raghav Khanna, Nicholas Raison, Alejandro Granados Martinez, Sebastien Ourselin, Francesco Montorsi, Alberto Briganti, Prokar Dasgupta","doi":"10.1136/bmjsit-2024-000338","DOIUrl":"10.1136/bmjsit-2024-000338","url":null,"abstract":"","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"7 1","pages":"e000338"},"PeriodicalIF":2.1,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11956393/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143754831","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
Comparative study of ICG and non-ICG-guided laparoscopic gastrectomy for gastric cancer: a propensity score-matched analysis at a single center.
IF 2.1
BMJ Surgery Interventions Health Technologies Pub Date : 2025-03-05 eCollection Date: 2025-01-01 DOI: 10.1136/bmjsit-2024-000313
Nguyen Van Du, Nguyen Anh Tuan, Luong Ngoc Cuong
{"title":"Comparative study of ICG and non-ICG-guided laparoscopic gastrectomy for gastric cancer: a propensity score-matched analysis at a single center.","authors":"Nguyen Van Du, Nguyen Anh Tuan, Luong Ngoc Cuong","doi":"10.1136/bmjsit-2024-000313","DOIUrl":"10.1136/bmjsit-2024-000313","url":null,"abstract":"<p><strong>Abstract: </strong></p><p><strong>Objectives: </strong>To investigate the effectiveness of indocyanine green (ICG) lymphography in improving lymph nodes (LNs) harvesting during laparoscopic radical distal gastrectomy for gastric cancer.</p><p><strong>Design: </strong>Non-randomized trial, prospective study compared ICG and non-ICG group using 1:1 propensity score matching (PSM) method.</p><p><strong>Setting: </strong>Preoperative clinical characteristics, operative outcomes, and follow-up results.</p><p><strong>Participants: </strong>242 patients who underwent laparoscopic distal gastrectomy with D2 lymphadenectomy for gastric cancer between 2019 and 2023. After exclusion and PSM, 160 patients (Pts) were included, paired in two groups: ICG (80 Pts) and non-ICG (80 Pts).</p><p><strong>Interventions: </strong>Patients in the ICG group underwent ICG injection submucosal via endoscopy 1 day before surgery.</p><p><strong>Main outcome measures: </strong>Comparison of the number of retrieved LNs and complications between the ICG and non-ICG group.</p><p><strong>Results: </strong>There were no significant differences in age, sex, height, tumor size, pathological Tumor-stage, histological differentiation, and complications between the two groups. There was a shorter operative time in the ICG group compared with the non-ICG group (median: 118 mins (IQR, 105-135) vs 146 mins (IQR, 120-180), respectively). Regarding the effectiveness of LN dissection: the ICG group had a higher median of retrieved LNs than the non-ICG group (36 LNs (IQR, 29-46) vs 27 LNs (IQR, 21-31); p<0.001). The mean number of metastatic LNs in the ICG group was significantly higher than in the non-ICG group, with 2.6±5.4 LNs compared with 0.9±3.1 LNs, respectively (p=0.018). The proportion of patients with more than 25 and 30 retrieved LNs was higher in the ICG group compared with the non-ICG group, with rates of 86% and 71% versus 64% and 31%, respectively (p<0.001).</p><p><strong>Conclusions: </strong>Using ICG fluorescence-guided LNs dissection has increased both the number of total LNs and metastatic LNs dissection without increasing complications in laparoscopic distal gastrectomy for gastric cancer.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"7 1","pages":"e000313"},"PeriodicalIF":2.1,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11883552/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143574154","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
Allocation of seed-stage investments for paediatric health technology.
IF 2.1
BMJ Surgery Interventions Health Technologies Pub Date : 2025-03-05 eCollection Date: 2025-01-01 DOI: 10.1136/bmjsit-2024-000368
Juliana R Perl, Marta Arenas-Jal, Janene H Fuerch, James Kennedy Wall
{"title":"Allocation of seed-stage investments for paediatric health technology.","authors":"Juliana R Perl, Marta Arenas-Jal, Janene H Fuerch, James Kennedy Wall","doi":"10.1136/bmjsit-2024-000368","DOIUrl":"10.1136/bmjsit-2024-000368","url":null,"abstract":"","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"7 1","pages":"e000368"},"PeriodicalIF":2.1,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11883554/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143574091","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
Hidden costs of surgical complications: a retrospective cohort study.
IF 2.1
BMJ Surgery Interventions Health Technologies Pub Date : 2025-03-03 eCollection Date: 2025-01-01 DOI: 10.1136/bmjsit-2024-000323
François-Xavier Ladant, Yann Parc, Morgan Roupret, Edward Kong, Ljubica Ristovska, Aurélia Retbi, Emmanuel Chartier Kastler, Jalal Assouad, Harry Etienne, Alain Sautet, Victor Mardon, Maxim Scrumeda, Abou Kane Diallo, Julien Hedou, Pierre Rufat, Franck Verdonk
{"title":"Hidden costs of surgical complications: a retrospective cohort study.","authors":"François-Xavier Ladant, Yann Parc, Morgan Roupret, Edward Kong, Ljubica Ristovska, Aurélia Retbi, Emmanuel Chartier Kastler, Jalal Assouad, Harry Etienne, Alain Sautet, Victor Mardon, Maxim Scrumeda, Abou Kane Diallo, Julien Hedou, Pierre Rufat, Franck Verdonk","doi":"10.1136/bmjsit-2024-000323","DOIUrl":"10.1136/bmjsit-2024-000323","url":null,"abstract":"<p><strong>Objectives: </strong>To quantify how surgical complications impact hospital revenue when their effect on the volume of admissions is considered.</p><p><strong>Design: </strong>Retrospective analysis of comprehensive administrative data.</p><p><strong>Setting: </strong>Three university hospitals in France.</p><p><strong>Participants: </strong>54 637 inpatient stays between 2017 and 2023 in 4 surgical departments (abdominal, orthopedics, thoracic, and urology).</p><p><strong>Main outcome measures: </strong>Stays were categorized by their diagnosis-related group and occurrence of one or more complications, according to International Classification of Diseases, 10th revision diagnosis codes. First, data were aggregated monthly to determine the impact of variation in the monthly mean length of stay (LOS) on the monthly volume of admissions, using an instrumental variable strategy. Second, LOS and revenue per patient were compared for patients with and without complications. Finally, an estimation of the impact of complications on total revenue was performed.</p><p><strong>Results: </strong>A total of 54 637 stays were analyzed, with 9735 (17.8%) experiencing at least one complication. The mean LOS was 8.7 days and the mean revenue per patient was €7602. The instrumental variable analysis, designed to account for unobserved confounders, showed that a decrease of 10% in the monthly mean LOS increased the monthly volume of admissions by 9% (95% CI (5.1% to 13.0%), p<0.01). Complications increased the LOS by 10.9 days (95% CI: (8.95 to 13.1), p<0.01) and revenue per patient by €7912 (95% CI: (6420 to 9087), p<0.01), but decreased daily revenue per patient by €211 (95% CI: (-384 to -83.0), p<0.01). Over the study period, the estimated potential loss induced by complications ranged from 6.6% (95% CI (6.3% to 7.0%), p<0.01) to 9.1% (95% CI (8.8% to 9.4%), p<0.01) of actual revenue. Departments with higher complication rates incurred larger potential losses.</p><p><strong>Conclusions: </strong>Surgical complications reduce total revenue by crowding out short stays that generate more daily revenue. This challenges the consensus that complications are a boon for hospital revenue, instead implying that they shrink hospital net margins (ie, revenue minus costs).</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"7 1","pages":"e000323"},"PeriodicalIF":2.1,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11877240/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143558274","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
Capacity assessment for EHR-based medical device post-market surveillance for synthetic mid-urethral slings among women with stress urinary incontinence: a NEST consortium study. 基于电子病历的医疗器械上市后监测能力评估:NEST 联合研究,针对患有压力性尿失禁的妇女的合成尿道中段吊带。
IF 2.1
BMJ Surgery Interventions Health Technologies Pub Date : 2025-02-12 eCollection Date: 2025-01-01 DOI: 10.1136/bmjsit-2023-000193
Michael E Matheny, Amy M Perkins, Kimberly Rieger-Christ, Joseph S Ross, Jialin Mao, Art Sedrakyan, Nilay D Shah, Robert Winter, W Stuart Reynolds, Arthur Mourtzinos, Wade L Schulz, Victoria Bartlett, Michael Solotke, Sameer Pandya, Suvekshya Aryal, Ahra Cho, Edward A Frankenberger, Daniel Park, Danielle Bostrom, Susan Robbins, Aron Yustein, Bilal Chughtai, Emanuel C Trabuco
{"title":"Capacity assessment for EHR-based medical device post-market surveillance for synthetic mid-urethral slings among women with stress urinary incontinence: a NEST consortium study.","authors":"Michael E Matheny, Amy M Perkins, Kimberly Rieger-Christ, Joseph S Ross, Jialin Mao, Art Sedrakyan, Nilay D Shah, Robert Winter, W Stuart Reynolds, Arthur Mourtzinos, Wade L Schulz, Victoria Bartlett, Michael Solotke, Sameer Pandya, Suvekshya Aryal, Ahra Cho, Edward A Frankenberger, Daniel Park, Danielle Bostrom, Susan Robbins, Aron Yustein, Bilal Chughtai, Emanuel C Trabuco","doi":"10.1136/bmjsit-2023-000193","DOIUrl":"10.1136/bmjsit-2023-000193","url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate the feasibility for use of electronic health record (EHR) data in conducting adverse event surveillance among women who received mid-urethral slings (MUS) to treat stress urinary incontinence (SUI) in five health systems.</p><p><strong>Design: </strong>Retrospective observational study using EHR data from 2010 through 2021. Women with a history of MUS were identified using common data models; a common analytic code was executed at each site. A manual chart review was conducted in a per-site random patient subset to establish a reference standard. Automated text processing (Text Processed Integrated (TPI)) was developed and evaluated at each site to determine the surgical approach and synthetic mesh implantation. Patients were characterized and surgical outcomes were ascertained over 730 subsequent days.</p><p><strong>Setting: </strong>Five large tertiary care academic medical centers.</p><p><strong>Participants: </strong>Across five health systems, 9,906 eligible patients (mean age 57-60 per site) were identified.</p><p><strong>Main outcome measures: </strong>Determination of surgical approach, synthetic mesh implantation, and assessment of the duration of surveillance for mortality and reoperation rates following MUS implantation.</p><p><strong>Results: </strong>In the TPI cohort analysis, 3,331 patients were identified. Surgical approach per site was retropubic (42% to 77%), transobturator (6% to 44%), single incision (0% to 24%), and adjustable sling (0% to <4%). Concordance rates for TPI using chart review were 71%-90% at each site for the surgical approach and 28%-85% for synthetic mesh implantation. Patient follow-up observation rates for mortality and reoperation ranged from 22% to 36% at 90 days, 15% to 30% at 365 days, and 8% to 19% at 730 days.</p><p><strong>Conclusion: </strong>Using EHR data alone, identification of medical devices and surgical approaches was feasible among women with MUS surgery for SUI, but long-term follow-up ascertainment rates were low. Medical device surveillance using EHR data should be evaluated in the context of the clinical use case, as applicability may vary.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"7 1","pages":"e000193"},"PeriodicalIF":2.1,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11822424/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143415412","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
Insular infraorbital neurovascular pedicle labial salivary gland transplantation for the treatment of severe dry eye disease: an IDEAL stage 0, 1 and 2a study.
IF 2.1
BMJ Surgery Interventions Health Technologies Pub Date : 2025-01-07 eCollection Date: 2025-01-01 DOI: 10.1136/bmjsit-2024-000324
Ke Yang, Jing Zhou, Yinghui Wang, Yingshi Piao, Mei Li, Yun Cheng, Xiaohong Chen, Ying Jie
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