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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 Q2 SURGERY 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

Objectives: To address the lack of nerve and blood supply after labial salivary gland transplantation (LSGT) resulting in glandular atrophy. We designed a modified LSGT, called insular infraorbital neurovascular pedicle LSGT, and evaluated the postoperative efficacy.

Design: This is a prospective, single-centre, self-contained study.

Setting: The research was conducted at Beijing Tongren Hospital, Capital Medical University from July 2019 to March 2024.

Participants: Eight patients (nine eyes) with severe dry eye disease (DED) were enrolled in this study.

Interventions: All patients underwent insular infraorbital neurovascular pedicle LSGT and were followed up for at least 6 months postoperatively.

Main outcome measure: Key evaluation indices were best-corrected visual acuity (BCVA), Ocular Surface Disease Index (OSDI) score, tear break-up time (TBUT), Corneal Fluorescence Staining (CFS) score, and Schirmer I test (SIT).

Results: With a mean follow-up of 17.56±11.72 months, BCVA improved in four eyes and stabilized in five. OSDI score decreased from 59.33±14.37 to 26.27±10.14 (p<0.001). SIT improved from 0.00±0.00 mm to 5.44±2.01 mm (p<0.0001). TBUT increased from 0.23±0.48 s to 5.48±4.67 s (p=0.008). CFS scores decreased from 12.56±2.65 to 7.56±3.09 (p<0.001). All glands remained viable with good blood supply, and no serious complications were observed.

Conclusion: Insular infraorbital neurovascular pedicle LSGT for severe DED is a feasible and effective treatment, maintaining good secretory capacity and blood supply long-term.

Trial registration number: ChiCTR2200056015.

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引用次数: 0
Benefits, problems, and optimal timing of administration of indocyanine green fluorescence cholangiography in laparoscopic cholecystectomy.
IF 2.1 Q2 SURGERY Pub Date : 2025-01-06 eCollection Date: 2025-01-01 DOI: 10.1136/bmjsit-2024-000310
Shinichi Kinami, Kaori Maruyama, Yuta Sannomiya, Hitoshi Saito, Hiroyuki Takamura

Objectives: The advantages of indocyanine green (ICG) fluorescence cholangiography have been emphasized, but its disadvantages remain unclear. This study investigated the advantages and disadvantages of this modality, particularly the optimal timing of administration of ICG fluorescence.

Design: This was a retrospective analysis of prospectively collected patient data.

Setting: Data were gathered from a single institution.

Participants: 69 patients scheduled for cholecystectomy were included.

Interventions: We administered intravenous ICG injections at three different times: preoperatively (5 mg/body weight (BW), 15 min before incision), morning of the surgery (12.5 mg/BW 4 hours before surgery), and on the day before the surgery (25 mg/BW, 20 hours before surgery). The PINPOINT or SPY-PHI (Stryker) systems were used for fluorescence imaging.

Main outcome measures: The course of the common bile and cystic ducts was identified using fluorescence imaging. The visualization quality was graded on a three-point scale: good, poor, and unobservable.

Results: There were 17 patients for preoperative administration, 14 on the morning of the surgery, and 38 on the day before the surgery. The cystic duct could not be visualized in five patients because of insufficient dose, impacted gallstones, cystic duct stones, after endoscopic retrograde biliary drainage (ERBD), and severe cholecystitis. The observations were poor in 14 patients. The reasons for the poor visualization were cholecystitis after ERBD and a low signal-to-noise ratio due to intense light emission from the liver, which is a characteristic of preoperative administration.

Conclusion: The cystic and common bile ducts were well visualized using ICG fluorescence cholangiography, except in patients with impacted gallstones, cystic duct stones, ERBD, and severe cholecystitis. The most effective timing for ICG administration was the day before the surgery. ICG fluorescence cholangiography is not a substitute for intraoperative cholangiography or preoperative biliary imaging; however, it would be desirable in all patients who undergo cholecystectomy.

Trial registration number: jRCTs041180006.

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引用次数: 0
Initial experience of parenchyma-sparing liver resection with systematic selective hepatic vein reconstruction for colorectal metastases. 保留实质肝切除加系统性选择性肝静脉重建治疗结肠转移瘤的初步经验。
IF 2.1 Q2 SURGERY Pub Date : 2024-12-12 eCollection Date: 2024-01-01 DOI: 10.1136/bmjsit-2024-000302
Yevhenii Trehub, Åsmund Avdem Fretland, Artem Zelinskyi, Dzmitrii Kharkov, Oleksii Babashev, Dmytro Chieverdiuk, Artem Shchebetun, Kyrylo Khyzhniak, Maksym Pavlovskii, Andrii Strokan, Sergii Zemskov

Objectives: This study aims to assess the feasibility and short-term and intermediate-term technical success rate of the concept of systematic selective hepatic vein (HV) reconstruction for parenchyma-sparing hepatectomies (PSHs) in patients with colorectal liver metastases (CRLM) in accordance with stage 2a of the IDEAL framework.

Design: The prospective case series of patients deemed eligible and operated on according to the concept.

Setting: All patients were treated by a single surgical team in three hospitals in Ukraine from June 2022 to November 2023.

Participants: The study included nine cases of resectable CRLM with at least one lesion located in the hepatocaval confluence with HV(s) invasion, for whom reconstruction of the HV(s) allowed for additional parenchyma preservation, being an alternative to major or extended hepatectomy.

Interventions: Liver resections with different types of HVs reconstruction (primary closure, patching, end-to-end anastomosis with or without grafting) were performed after a thorough evaluation of the future liver remnant volume, volume of potentially additionally preserved parenchyma and possibility of future repeat hepatectomies.

Main outcome measures: Postoperative morbidity, short-term and long-term patency of the reconstructed vessels, and the volume of additionally preserved parenchyma were the focus.

Results: Segmental resection was performed in four cases, two with graft interposition. Patch reconstruction was performed for three HVs and two inferior vena cava resections. Two cases required primary closure. No mortality was observed, while the major morbidity rate was 33%. The short-term and long-term patency of the reconstructed HVs was 88.9% and 66.7%, respectively. HV reconstructions allowed the preservation of additional parenchyma (mean 495.4 mL, 95% CI 350.2 to 640.7). A decision-making algorithm to be used within the described approach is proposed.

Conclusions: Selective HV reconstruction is a feasible approach for PSH for CRLM. Further studies are needed to compare this approach to convenient major hepatectomies.

研究目的本研究旨在评估根据IDEAL框架第2a阶段对结直肠肝转移(CRLM)患者进行系统性选择性肝静脉(HV)重建保肝切除术(PSHs)的可行性和中短期技术成功率:前瞻性病例系列:根据该理念对符合条件并接受手术的患者:所有患者均于2022年6月至2023年11月期间在乌克兰的三家医院由一个手术团队进行治疗:研究包括9例可切除的CRLM,至少有一个病灶位于肝腔汇合处,且有HV(s)侵犯,对这些患者而言,重建HV(s)可额外保留实质,是大肝切除术或扩大肝切除术的替代方案:干预措施:在对未来残肝体积、可能额外保留的肝实质体积以及未来再次进行肝切除术的可能性进行全面评估后,采用不同类型的肝静脉重建(原发性闭合、修补、带或不带移植的端对端吻合)进行肝切除术:主要结果指标:术后发病率、重建血管的短期和长期通畅情况以及额外保留的实质组织体积:结果:四例病例进行了分段切除,其中两例进行了移植物插植。对三条高压血管和两条下腔静脉切除术进行了补片重建。两个病例需要进行初次闭合。无死亡病例,主要发病率为 33%。重建后高压静脉的短期和长期通畅率分别为 88.9% 和 66.7%。HV 重建可保留额外的实质组织(平均 495.4 mL,95% CI 350.2 至 640.7)。结论:选择性 HV 重建是一种可行的方法:结论:选择性 HV 重建是 CRLM PSH 的一种可行方法。结论:选择性 HV 重建是 CRLM PSH 的一种可行方法,需要进一步研究将这种方法与便捷的大肝切除术进行比较。
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引用次数: 0
Leveraging data science and AI to democratize global surgical expertise. 利用数据科学和人工智能实现全球外科专业知识的民主化。
IF 2.1 Q2 SURGERY Pub Date : 2024-11-29 eCollection Date: 2024-01-01 DOI: 10.1136/bmjsit-2024-000334
Samy Cheikh Youssef, Prokar Dasgupta, May Haram, Nadine Hachach-Haram
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引用次数: 0
Financial incentives and motivational intervention to improve gastric cancer screening in China: a randomized controlled trial study protocol. 中国改善胃癌筛查的经济激励和动机干预:随机对照试验研究方案。
IF 2.1 Q2 SURGERY Pub Date : 2024-11-24 eCollection Date: 2024-01-01 DOI: 10.1136/bmjsit-2024-000300
Quan Wang, Chao Gong, Yumeng Lv, Yiyang Tan, Siqi Liu, Li Yang

Gastric cancer (GC) remains a significant global health challenge, with high mortality rates, particularly in low- and middle-income countries, like China. Early detection through screening is crucial for improving prognosis and reducing mortality. However, uptake of GC screening remains suboptimal, highlighting the need for effective interventions to promote screening participation. This study employs an experimental design to evaluate the effectiveness of two interventions, financial incentives and motivational interventions, in promoting GC screening uptake at the individual level. A large sample size will be recruited from high GC-burden provinces in China, and participants will be randomly assigned to intervention and control groups. Statistical analyses, including the χ² test and interrupted time series analysis, will be used to assess the impact of interventions on screening uptake and adherence. The research protocol was reviewed by the ethical review committee of the Peking University Health Science Center (2024097) and registered at the ClinicalTrials.gov. Findings from this study will be disseminated through peer-reviewed publications, conference presentations, and engagement with stakeholders to inform evidence-based strategies for improving GC screening and reducing GC-related morbidity and mortality.

胃癌(GC)仍然是全球健康面临的一项重大挑战,死亡率很高,尤其是在中国等中低收入国家。通过筛查及早发现对于改善预后和降低死亡率至关重要。然而,胃癌筛查的接受率仍不理想,这凸显了采取有效干预措施促进筛查参与率的必要性。本研究采用实验设计,以评估经济激励和动机干预这两种干预措施在促进个人接受 GC 筛查方面的效果。研究人员将从中国肺癌高发省份招募大量样本,并将参与者随机分配到干预组和对照组。研究将采用χ²检验和间断时间序列分析等统计分析方法来评估干预措施对筛查接受率和坚持率的影响。研究方案已通过北京大学医学部伦理审查委员会的审查(2024097),并在 ClinicalTrials.gov 上注册。本研究的结果将通过同行评议出版物、会议演讲和与利益相关者的接触进行传播,为改善GC筛查和降低GC相关发病率和死亡率的循证策略提供信息。
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引用次数: 0
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 Q2 SURGERY 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

Objectives: To assess the effect of adjuvant antibiotic-loaded hydrogel application on the primary stability of implanted uncemented hip stems.

Design: Biomechanical study.

Setting: 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.

Participants: 12 artificial femora were prepared and received a collarless uncemented standard offset stem (Corail; DePuy Synthes, Zuchwil, Switzerland).

Interventions: The two groups were prepared with or without the antibiotic-loaded hydrogel.

Main outcome measures: Construct stiffness was determined from the recorded load-displacement curves and stem subsidence was measured via motion tracking.

Results: 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).

Conclusions: 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.

目的评估应用抗生素水凝胶辅助剂对植入式非骨水泥髋关节柄主要稳定性的影响:设计:生物力学研究:使用装有 10 千牛称重传感器的电子机械材料测试系统(5866 号,Instron,Norwood,MA,USA)。采用阶梯加载协议,以 0.005 毫米/秒的速度进行准静态斜坡压缩加载,并以 500 牛顿的间歇加载步长在 500 牛顿到 3000 牛顿之间施加六个不同的加载水平:准备了12个人工股骨,并接受了无领非骨水泥标准偏置柄(Corail;DePuy Synthes,瑞士Zuchwil):干预措施:两组分别使用或不使用抗生素水凝胶:根据记录的载荷-位移曲线确定结构刚度,通过运动跟踪测量骨干下沉:结果:结构刚度(对照组:4176±240 N/mm;干预组:4588±448 N/mm)在组间无显著差异(p=0.076)。在各组中,随着负荷水平的增加,茎杆下沉明显增加(p≤0.002),但组间仍无明显差异(p=0.609):结论:在初级非骨水泥髋关节干稳定性方面,应用抗生素水凝胶的效果并不差。这一发现使得应用抗生素水凝胶辅助治疗具有潜在的可行性,但在应用于临床实践之前还需要进一步的研究。
{"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 Q2 SURGERY 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

Objectives: 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.

Design: Randomized, partially blinded, prospective cross-over study.

Setting: 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.

Participants: 57 junior anesthetists undertook initial assessments and 51 (89.47%) returned at 2 months.

Intervention: 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.

Main outcome measures: 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).

Results: 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).

Conclusions: 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.

Trial registration number: www.clinicaltrials.govNCT05583032.

目的:超声引导区域麻醉(UGRA)依赖于获取和解释适当的声像解剖视图。主要目的是确定人工智能生成的颜色叠加是否与参与者在标准化教学课程结束后两个月内识别适当阻滞视图的能力差异有关(由盲人评估员评判)。次要结果包括识别适当块状视图的能力(无盲评估员)、总体评分和参与者信心分数:随机、部分盲法、前瞻性交叉研究:对健康志愿者进行模拟扫描。初始评估时间为 2022 年 11 月 29 日和 2022 年 11 月 30 日,随访时间为 2023 年 1 月 25 日至 2023 年 1 月 27 日:57名初级麻醉师进行了初步评估,51人(89.47%)在2个月后返回:干预措施:参与者进行六次周围神经阻滞的超声扫描,其中一半阻滞由人工智能协助随机完成。主要结果测量:盲法专家评估获得的阻滞视图是否可接受(是/否)。非盲法专家也对这一参数进行评估,并给出总体性能评分(0-100)。参与者报告扫描信心(0-100):结果:在盲法和非盲法评估中,人工智能辅助与更高的适当区块视图获取率相关(p=0.02),结论:在盲法和非盲法评估中,人工智能辅助与更高的适当区块视图获取率相关(p=0.02):辅助人工智能与正式教学 2 个月后的超声扫描性能优越有关。它可以帮助应用在教学中获得的超声解剖学知识和技能,支持在教学结束后立即进行 UGRA。试验注册号:www.clinicaltrials.govNCT05583032。
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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。
Q2 SURGERY 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

Objectives: 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.

Design: 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.

Setting: Six hospitals in Southwest England, recruiting November 25, 2019-April 25, 2022.

Participants: 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.

Interventions: Surgery using SPAIRE or standard lateral approach. Follow-up 3 days and 120 days postoperation.

Main outcome measure: 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).

Results: 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.

Conclusions: 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.

Trial registration number: NCT04095611.

目标与标准侧方入路相比,评估在髋关节半关节成形术治疗移位的囊内骨折时采用改良的后方肌肉疏松入路 SPAIRE(拯救腓肠肌和内侧肌,修复外侧肌)对术后活动度和功能的影响:设计:实用性、优越性、多中心、平行组、随机对照试验(内部试点)。参试者、病房工作人员和进行术后评估的研究人员均为分配盲人。CTU使用计算机生成的名单集中分配治疗:地点:英格兰西南部六家医院,招募时间:2019年11月25日-2022年4月25日.参与者:244名需要进行髋关节半置换术的成人(≥60岁)(每种方法各分配122人)。分别有90名和85名分配到SPAIRE和侧位的参与者在预先指定的数据收集窗口内获得了主要结果数据:干预措施:采用 SPAIRE 或标准侧位方法进行手术。术后 3 天和 120 天随访:主要结果测量:牛津髋关节评分(OHS),120 天时通过电话进行。次要结果:功能和活动能力(3天)、疼痛(3天、120天)、出院目的地、住院时间、并发症和死亡率(120天内)、生活质量和居住地(120天):参与者的平均年龄为 84.6 岁(SD 7.2);168 人(69%)为女性。主要结果:几乎没有证据表明 120 天后的 OHS 存在差异;调整后的平均差异(SPAIRE-侧)为-1.23(95% CI -3.96 至 1.49,P=0.37)。次要结果:SPAIRE治疗组3天时参与者报告的疼痛程度较低;其余结果治疗组之间无差异:无论采用 SPAIRE 还是侧位方法,受试者在短期(3 天)和长期(120 天)内的活动能力和功能相似。在住院时间、恢复到骨折前的居住状态、120天内的存活率或120天后的生活质量方面,两种方法都没有优势。接受SPAIRE入路的患者在术后早期的疼痛可能较轻。将髋关节半关节置换术中的后方入路改为SPAIRE入路,120天内患者的疗效与侧方入路相当:试验注册号:NCT04095611。
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引用次数: 0
IDEAL evaluation for global surgery innovation. 全球手术创新 IDEAL 评估。
Q2 SURGERY Pub Date : 2024-06-12 eCollection Date: 2024-01-01 DOI: 10.1136/bmjsit-2024-000297
Peter McCulloch, Janet Martin
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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。
Q2 SURGERY 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

Objective: 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.

Design: 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.

Participants: Surgeons and surgical researchers from any country.

Main outcome measures: Findings were used to suggest the nature of adaptations to the IDEAL Framework to address the particular problems of evaluation in low-resource settings.

Results: 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.

Conclusions: 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.

目标:全球 IDEAL 子框架研究旨在将 2009/2019 年 IDEAL(构想、发展、探索、评估、长期研究)框架关于评估外科创新的建议的预期效果与 2015 年柳叶刀全球外科委员会概述的愿景相结合,为评估低资源环境中的外科创新提供建议:设计:采用多种方法,包括在线全球调查和半结构式访谈(SSI)。采用描述性统计对定量数据进行总结,采用框架法对定性数据进行分析:主要结果测量:主要结果测量:调查结果用于建议对 IDEAL 框架进行调整的性质,以解决低资源环境下评估的特殊问题:在线调查共收到 66 份回复,代表了来自 40 个国家的经验,并进行了 9 次个人 SSI。大多数受访者(n=49;74.2%)都有在不同生命周期阶段评估外科技术的经验。采用创新技术最常见的原因是其他国家的同行推荐或临床评估。围绕以下四个主题展开:技术开发中的节俭创新;在不同情况下评估相同的技术/创新;在中低收入国家评估外科创新的其他重要方法;以及在评估过程中为低收入国家的研究人员提供支持:全球 IDEAL 子框架为修改 IDEAL 建议提供了建议,旨在处理在这种情况下发现的特殊问题。这些建议需要在利益相关者共识论坛上进行验证,并在试点研究中进行定性评估。从协助研究人员确定正确的评估阶段,到提供与整个评估途径相关的针对具体情况的建议,这一过程旨在制定一套全面而适用的指南,使全球的外科创新和患者受益。
{"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}
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BMJ Surgery Interventions Health Technologies
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