1.Construction of key performance indicator system of clinical quality control for ECMO equipment based on Delphi method
Xuebin CHEN ; Jing ZHAO ; Zhangxi ZHU ; Zhanguo LI ; Yong CUI
China Medical Equipment 2025;22(6):103-107
Objective:To construct a quality control indicator system for the performance of extracorporeal membrane oxygenation(ECMO)equipment during clinical use,and to improve scientific evaluation ability for the reliability of clinical application of ECMO products,so as to provide guarantees for ECMO technical specifications and its reliability in clinical application.Methods:The ECMO industry standard specifications,relative research literature and ECMO equipment operation manuals were retrieved,and the quality control indicators of ECMO performance parameters were summarized and organized.The items of indicators were analyzed through individual interviews and group discussions.Three rounds of expert inquiries were conducted using the Delphi method to construct indicator library of ECMO performance parameters.And then,a key performance indicator system of clinical quality control for ECMO equipment was constructed through analyzed the weight of each indicator.Results:The key performance indicator system of clinical quality control for ECMO equipment included 3 key components(primary indicators)(centrifugal pump,air oxygen mixer,and water tank of variable temperature),6 performance parameters(secondary indicators)(flow rate of blood pump,blood pump speed,oxygen concentration,temperature,pressure pre operating pump,and pressure post operating pump),and 6 performance testing ranges(tertiary indicators),all of which were indicators of quality control for ECMO performance.Conclusion:This research organized an indicator system of clinical quality control for ECMO equipment through analyzed the key performance indicators of ECMO equipment,and constructed quality control template for ECMO in clinical application,and conducted beneficial explorations for the management of quality control for ECMO equipment in clinical application.
2.Establishment and Validation of a Risk Prediction Model for Non-complete Procedural Success in Patients Undergoing Transvenous Lead Extraction
Xinxin ZHANG ; Feng ZE ; Xuebin LI ; Haicheng ZHANG ; Jiangbo DUAN ; Dandan YANG ; Ding LI ; Long WANG ; Jinshan HE
Chinese Circulation Journal 2025;40(8):806-812
Objective:To screen the risk factors for non-complete procedural success of transvenous lead extraction(TLE),and to establish a prediction model based on the results and evaluate its predictive efficacy.Methods:A total of 1 029 patients who underwent TLE in Peking University People's Hospital from January 2014 to December 2020 were enrolled and divided into training set(n=720)and validation set(n=309)using the random number method.There were no statistically significant differences among the variables in the training set and the validation set.The training set was divided into the complete procedural success(CPS)group(n=664)and the non-CPS group(n=56).Univariate analysis was employed to screen the relevant indicators of non-CPS,followed by binary logistic regression analysis to identify the independent risk factors of non-CPS.Subsequently,a predictive model and nomogram were constructed.The receiver operating characteristic(ROC)curve analysis was applied to evaluate the ability of the model to distinguish non-CPS from TLE patients in the training set and validation set.The Hosmer-Lemeshow goodness-of-fit test was used to assess the consistency between the predicted risk and the actual risk of the model.Results:Univariate analysis showed that the relevant variables with P<0.1 including the age at the first implantation of the lead,the number of leads extracted,the oldest dwell time of lead extracted,the presence of abandoned leads,non-manual traction for lead extracted,the number of extracted leads>3,bilateral lead implantation,and the indications for TLE.The binary logistic regression analysis revealed that the presence of abandoned leads(OR=2.252,95%CI:1.111-4.564,P=0.024),the oldest dwell time of the extracted leads(OR=1.009,95%CI:1.005-1.012,P<0.001),and the number of extracted leads>3(OR=3.177,95%CI:1.306-7.733,P=0.011)were independent risk factors for non-CPS of TLE.ROC curve analysis revealed that the area under the ROC curve(AUC)of the training set was 0.80(95%CI:0.75-0.85,P<0.001).The AUC of the validation set was 0.81(95%CI:0.72-0.90,P<0.001).The Hosmer-Lemeshow goodness-of-fit test indicated that the P values of both the training set(P=0.089)and the validation set(P=0.136)were greater than 0.05.Conclusions:The presence of abandoned leads,the oldest dwell time of lead extracted,and the number of extracted leads>3 are independent risk factors for non-CPS in patients undergoing TLE.The nomogram model based on the above factors has satisfactory predictive ability.
3.Application and effectiveness verification of three-dimensional fracture map construction technology in Pilon fracture typing and surgical planning
Changhui LI ; Lianxin SONG ; Yang LUO ; Tianhua DONG ; Biao NING ; Xuebin ZHANG
Journal of Capital Medical University 2025;46(5):784-790
Objective To explore the clinical value of three-dimensional(3D)fracture mapping in improving the consistency of Arbeitsgemeinschaft für Osteosynthesefragen(AO)/the Orthopaedic Trauma Association(OTA)classification and optimizing preoperative surgical planning for Pilon fractures.Methods This single-center retrospective cohort study included 60 Pilon fracture patients admitted to the Trauma Emergency Center of the Third Hospital of Hebei Medical University between January 2022 and December 2024.All patients underwent preoperative computed tomography(CT)scans.Image standardization and expert manual segmentation/annotation of fracture lines and fragments were performed with 3D Slicer software.3D fracture lines extracted from gold-standard models were registered to a unified standard tibial model.A 3D probability heatmap was constructed by counting spatial fracture frequency,with high-incidence zones analyzed via spatial clustering algorithms.Three orthopedic surgeons independently completed AO/OTA classification and preoperative planning with the assistance of conventional CT only and CT with 3D fracture mapping.Accuracy,time consumption,inter-observer consistency(Cohen's κ),planning time,plan modification frequency,and subjective scores were evaluated.Results The 3D fracture heatmap revealed that fracture lines predominantly concentrated in the anterolateral and posteromedial regions of the distal tibia,with an average of(4.2±1.1)hotspots,a coverage rate of(78.3±5.6)%,and(3.5±1.0)clustering areas.With 3D fracture mapping assistance,classification accuracy was improved to(88.0±5.0)%compared to(75.0±8.0)%with conventional CT(P=0.001);classification time reduced to(10.4±2.5)min from(15.2±3.1)min(P<0.001);and Cohen's κ increased from 0.68±0.05 to 0.82±0.03(P=0.002).For preoperative planning,the average planning time was(15.8±3.2)min in the 3D mapping-assisted group,which was significantly shorter than that of conventional CT group(22.5±4.3)min(P<0.001);the number of plan modifications was(1.5±0.7)times,lower than that of conventional CT group(3.2±1.1)times(P<0.001),and the subjective score was 8.9±0.9,higher than that of conventional CT group(6.8±1.2)(P<0.001).Conclusion The 3D fracture mapping accurately characterizes spatial distribution patterns of Pilon fractures,significantly improves classification accuracy,inter-observer consistency,and preoperative planning efficiency,and thus holds substantial clinical value.
4.Management for Redundant Lead:Current Status and Future Perspectives
Chinese Circulation Journal 2025;40(4):397-401
With the increasing numbers of implanted cardiovascular implantable electronic devices(CIED),the issue of lead management has become increasingly prominent.Currently,there is controversy on the management of redundant lead.In clinical practices such as CIED device upgrades,choosing to abandon redundant leads can avoid the risks associated with lead extraction.However,the strategy may increase the risks of future CIED infections,venous occlusions,and the risks of future lead extraction.On the other hand,choosing to remove redundant leads might expose patients to risks associated with lead extraction.Therefore,the management regarding redundant lead need to balance the risks of abandonment and extraction strategies.This article discusses the current strategies for redundant lead management and their potential risks.
5.Research on Lightweight Large Language Models for Ancient Traditional Chinese Medicine Texts Based on Lora Fine-Tuning
Jingxian CHAI ; Xufeng LANG ; Hongyan LI ; Zuojian ZHOU ; Yun LING ; Libin ZHAN ; Kongfa HU ; Xuebin QIAO
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(3):823-831
Objective To address the challenges of constructing large language models for traditional Chinese medicine(TCM)classics,which are complex and expensive to fine-tune,this study explores a lightweight fine-tuning method for such models,aiming to develop a question-answering model centered on TCM classics,particularly various editions of Shang Han Lun through the ages.Methods Dataset construction involved designing prompts to guide GPT-4 in generating Q&A pairs based on Shang Han Lun and integrating them with the ShenNong_TCM_Dataset and cMedQA2 datasets.Five general-purpose large models were selected for Lora fine-tuning.The best model was chosen through evaluation,and the performance of multiple quantized versions was validated.Results After fine-tuning,the BLEU,ROUGE-1,ROUGE-2,and ROUGE-L metrics for the Qwen-7B-Chat model improved by 17.61,19.63,14.3,and 21.4,respectively,compared to the base model.Conclusion The selected model in this study is capable of effectively understanding and utilizing professional terms and concepts from TCM classics,such as Shang Han Lun,to provide accurate answers to user queries.Compared to similar models,it requires lower fine-tuning costs and computational power,contributing to the dissemination of TCM knowledge and the development of intelligent systems.
6.Application and effectiveness verification of three-dimensional fracture map construction technology in Pilon fracture typing and surgical planning
Changhui LI ; Lianxin SONG ; Yang LUO ; Tianhua DONG ; Biao NING ; Xuebin ZHANG
Journal of Capital Medical University 2025;46(5):784-790
Objective To explore the clinical value of three-dimensional(3D)fracture mapping in improving the consistency of Arbeitsgemeinschaft für Osteosynthesefragen(AO)/the Orthopaedic Trauma Association(OTA)classification and optimizing preoperative surgical planning for Pilon fractures.Methods This single-center retrospective cohort study included 60 Pilon fracture patients admitted to the Trauma Emergency Center of the Third Hospital of Hebei Medical University between January 2022 and December 2024.All patients underwent preoperative computed tomography(CT)scans.Image standardization and expert manual segmentation/annotation of fracture lines and fragments were performed with 3D Slicer software.3D fracture lines extracted from gold-standard models were registered to a unified standard tibial model.A 3D probability heatmap was constructed by counting spatial fracture frequency,with high-incidence zones analyzed via spatial clustering algorithms.Three orthopedic surgeons independently completed AO/OTA classification and preoperative planning with the assistance of conventional CT only and CT with 3D fracture mapping.Accuracy,time consumption,inter-observer consistency(Cohen's κ),planning time,plan modification frequency,and subjective scores were evaluated.Results The 3D fracture heatmap revealed that fracture lines predominantly concentrated in the anterolateral and posteromedial regions of the distal tibia,with an average of(4.2±1.1)hotspots,a coverage rate of(78.3±5.6)%,and(3.5±1.0)clustering areas.With 3D fracture mapping assistance,classification accuracy was improved to(88.0±5.0)%compared to(75.0±8.0)%with conventional CT(P=0.001);classification time reduced to(10.4±2.5)min from(15.2±3.1)min(P<0.001);and Cohen's κ increased from 0.68±0.05 to 0.82±0.03(P=0.002).For preoperative planning,the average planning time was(15.8±3.2)min in the 3D mapping-assisted group,which was significantly shorter than that of conventional CT group(22.5±4.3)min(P<0.001);the number of plan modifications was(1.5±0.7)times,lower than that of conventional CT group(3.2±1.1)times(P<0.001),and the subjective score was 8.9±0.9,higher than that of conventional CT group(6.8±1.2)(P<0.001).Conclusion The 3D fracture mapping accurately characterizes spatial distribution patterns of Pilon fractures,significantly improves classification accuracy,inter-observer consistency,and preoperative planning efficiency,and thus holds substantial clinical value.
7.Management for Redundant Lead:Current Status and Future Perspectives
Chinese Circulation Journal 2025;40(4):397-401
With the increasing numbers of implanted cardiovascular implantable electronic devices(CIED),the issue of lead management has become increasingly prominent.Currently,there is controversy on the management of redundant lead.In clinical practices such as CIED device upgrades,choosing to abandon redundant leads can avoid the risks associated with lead extraction.However,the strategy may increase the risks of future CIED infections,venous occlusions,and the risks of future lead extraction.On the other hand,choosing to remove redundant leads might expose patients to risks associated with lead extraction.Therefore,the management regarding redundant lead need to balance the risks of abandonment and extraction strategies.This article discusses the current strategies for redundant lead management and their potential risks.
8.Research on Lightweight Large Language Models for Ancient Traditional Chinese Medicine Texts Based on Lora Fine-Tuning
Jingxian CHAI ; Xufeng LANG ; Hongyan LI ; Zuojian ZHOU ; Yun LING ; Libin ZHAN ; Kongfa HU ; Xuebin QIAO
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(3):823-831
Objective To address the challenges of constructing large language models for traditional Chinese medicine(TCM)classics,which are complex and expensive to fine-tune,this study explores a lightweight fine-tuning method for such models,aiming to develop a question-answering model centered on TCM classics,particularly various editions of Shang Han Lun through the ages.Methods Dataset construction involved designing prompts to guide GPT-4 in generating Q&A pairs based on Shang Han Lun and integrating them with the ShenNong_TCM_Dataset and cMedQA2 datasets.Five general-purpose large models were selected for Lora fine-tuning.The best model was chosen through evaluation,and the performance of multiple quantized versions was validated.Results After fine-tuning,the BLEU,ROUGE-1,ROUGE-2,and ROUGE-L metrics for the Qwen-7B-Chat model improved by 17.61,19.63,14.3,and 21.4,respectively,compared to the base model.Conclusion The selected model in this study is capable of effectively understanding and utilizing professional terms and concepts from TCM classics,such as Shang Han Lun,to provide accurate answers to user queries.Compared to similar models,it requires lower fine-tuning costs and computational power,contributing to the dissemination of TCM knowledge and the development of intelligent systems.
9.Preliminary Clinical Observation on the Implantation of AVEIR VR Single Chamber Leadless Pacemaker
Yi WEI ; Feng ZE ; Cuncao WU ; Cuizhen YUAN ; Ding LI ; Xuebin LI
Chinese Circulation Journal 2025;40(6):577-582
Objectives:To evaluate the performance of AVEIR VR single chamber leadless pacemaker(AVEIR VR)in the real world in China and the predictive factors of pacing threshold to assess the feasibility of AVEIRTM VR implantation in the domestic population.Methods:All patients who underwent AVEIR VR implantation by experienced operators from Peking University People's Hospital in multiple domestic hospitals from June 2024 to October 2024 were consecutively included,and their baseline characteristics,procedural data(including pacemaker electrical measurements at various stages),and follow-up results were observed,recorded,and statistically analyzed.Results:This study included 20 patients who met the indication for pacemaker implantation and underwent AVEIR VR implantation.Their mean age was(71.40±13.37)years,body mass index(BMI)was(23.05±3.71)kg/m2,body surface area(BSA)was(1.70±0.16)m2,all 20 patients were successfully implanted with pacemakers,there were no major complications(newly occurred pericardial effusion during the perioperative period,cardiac tamponade,poor pacemaker function,pacemaker dislocation/perforation,tricuspid valve injury,myocardial infarction,stroke,pulmonary embolism,and clinical death).One patient developed new frequent ventricular premature contractions after pacemaker release.The pacing threshold(PCT)at one week after implantation was correlated with PCT in tether mode(r=0.650,P=0.009)and PCT in release phase(r=0.596,P=0.019),but not with the sensing and impedance in each phase.Conclusions:This preliminary exploration study show that AVEIRTM VR implantation demonstrates satisfactory performance among real world patients in China,especially in elderly and low weight populations,confirming its safety.
10.Construction of key performance indicator system of clinical quality control for ECMO equipment based on Delphi method
Xuebin CHEN ; Jing ZHAO ; Zhangxi ZHU ; Zhanguo LI ; Yong CUI
China Medical Equipment 2025;22(6):103-107
Objective:To construct a quality control indicator system for the performance of extracorporeal membrane oxygenation(ECMO)equipment during clinical use,and to improve scientific evaluation ability for the reliability of clinical application of ECMO products,so as to provide guarantees for ECMO technical specifications and its reliability in clinical application.Methods:The ECMO industry standard specifications,relative research literature and ECMO equipment operation manuals were retrieved,and the quality control indicators of ECMO performance parameters were summarized and organized.The items of indicators were analyzed through individual interviews and group discussions.Three rounds of expert inquiries were conducted using the Delphi method to construct indicator library of ECMO performance parameters.And then,a key performance indicator system of clinical quality control for ECMO equipment was constructed through analyzed the weight of each indicator.Results:The key performance indicator system of clinical quality control for ECMO equipment included 3 key components(primary indicators)(centrifugal pump,air oxygen mixer,and water tank of variable temperature),6 performance parameters(secondary indicators)(flow rate of blood pump,blood pump speed,oxygen concentration,temperature,pressure pre operating pump,and pressure post operating pump),and 6 performance testing ranges(tertiary indicators),all of which were indicators of quality control for ECMO performance.Conclusion:This research organized an indicator system of clinical quality control for ECMO equipment through analyzed the key performance indicators of ECMO equipment,and constructed quality control template for ECMO in clinical application,and conducted beneficial explorations for the management of quality control for ECMO equipment in clinical application.

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