1.Establishment and validation of a model for femoral head necrosis after internal fixation of femoral neck fracture using logistic regression and SHAP analysis
Long LIAO ; Zepeng ZHAO ; Zongyuan LI ; Qinglong YU ; Tao ZHANG ; Jinyuan TANG ; Nan YE ; Han XU ; Bo SHI
Chinese Journal of Tissue Engineering Research 2026;30(3):626-633
BACKGROUND:The most common complication of traumatic femoral neck fractures after internal fixation is femoral head necrosis.Currently,many studies have reported on the risk factors that affect the occurrence and development of postoperative femoral head necrosis,but there is still a lack of tools to predict the risk of femoral head necrosis after internal fixation of femoral neck fractures.OBJECTIVE:To develop a predictive model that estimates the risk of femoral head necrosis shortly after patients with femoral neck fractures receive cannulated screw internal fixation.METHODS:A retrospective analysis reviewed clinical records of 172 patients who underwent cannulated screw internal fixation for femoral neck fractures at Department of Orthopedics of Mianyang Central Hospital from January 2013 to June 2023.Patients were categorized into two groups based on the presence or absence of femoral head necrosis within one year post-operation:the necrosis group and the non-necrosis group.Univariate analysis,Lasso regression,and multivariate Logistic regression techniques were employed to identify the determinants of femoral head necrosis.A nomogram prediction model was constructed using R language's"rms"package,version 4.0.The receiver operating characteristic curve was used to evaluate the discriminatory ability of the model.The Hosmer-Lemeshow test was used to evaluate the goodness of fit of the model,and the decision curve analysis was used to determine its clinical application benefits.Internal validation of the study was conducted using the Bootstrap method,involving 1 000 repeated samplings.To delve deeper into the primary factors influencing femoral head necrosis post-internal fixation of the femoral neck,this paper employed the SHAP method for data set analysis.RESULTS AND CONCLUSION:(1)The risk factors leading to femoral head necrosis in the short term after cannulated screw fixation of femoral neck fractures include:smoking,diabetes,Garden classification,fracture line location,reduction quality,age,and operation time.(2)The prediction model demonstrated robust performance,evidenced by an area under the curve of 0.940(95%Confidence Interval:0.903 to 0.977),indicating a high level of prediction accuracy.The model achieved a sensitivity of 90.2%and a specificity of 87.6%,indicating that its diagnostic performance was stable.The Hosmer-Lemeshow goodness-of-fit test yielded a chi-square value of 6.593 with a P-value of 0.581,confirming that the model's predictions closely align with the observed outcomes.(3)The calibration curve of the model also performed well,and its overall trend was very close to the ideal curve,further proving the high accuracy of the model.(4)The internal validation was carried out by the Bootstrap method with 1 000 repeated samplings,and the area under the curve of the model internal validation was still as high as 0.939,proving that the model had good stability.(5)Through the decision curve,it is found that within the probability threshold range of 1%to 92%,the model can obtain the maximum net benefit value.(6)The SHAP analysis results show that among the risk factors analyzed in this study,the location of the fracture line serves as the most significant predictor of femoral head necrosis following internal fixation with cannulated screws in femoral neck fractures,and subcapital fractures are extremely prone to femoral head necrosis after surgery.(7)It is concluded that the validated prediction model demonstrates strong discriminative power and reliability,offering practical clinical utility.It serves as a useful reference tool for short-term risk assessment of femoral head necrosis following internal fixation of femoral neck fractures.
2.Establishment and validation of a model for femoral head necrosis after internal fixation of femoral neck fracture using logistic regression and SHAP analysis
Long LIAO ; Zepeng ZHAO ; Zongyuan LI ; Qinglong YU ; Tao ZHANG ; Jinyuan TANG ; Nan YE ; Han XU ; Bo SHI
Chinese Journal of Tissue Engineering Research 2026;30(3):626-633
BACKGROUND:The most common complication of traumatic femoral neck fractures after internal fixation is femoral head necrosis.Currently,many studies have reported on the risk factors that affect the occurrence and development of postoperative femoral head necrosis,but there is still a lack of tools to predict the risk of femoral head necrosis after internal fixation of femoral neck fractures.OBJECTIVE:To develop a predictive model that estimates the risk of femoral head necrosis shortly after patients with femoral neck fractures receive cannulated screw internal fixation.METHODS:A retrospective analysis reviewed clinical records of 172 patients who underwent cannulated screw internal fixation for femoral neck fractures at Department of Orthopedics of Mianyang Central Hospital from January 2013 to June 2023.Patients were categorized into two groups based on the presence or absence of femoral head necrosis within one year post-operation:the necrosis group and the non-necrosis group.Univariate analysis,Lasso regression,and multivariate Logistic regression techniques were employed to identify the determinants of femoral head necrosis.A nomogram prediction model was constructed using R language's"rms"package,version 4.0.The receiver operating characteristic curve was used to evaluate the discriminatory ability of the model.The Hosmer-Lemeshow test was used to evaluate the goodness of fit of the model,and the decision curve analysis was used to determine its clinical application benefits.Internal validation of the study was conducted using the Bootstrap method,involving 1 000 repeated samplings.To delve deeper into the primary factors influencing femoral head necrosis post-internal fixation of the femoral neck,this paper employed the SHAP method for data set analysis.RESULTS AND CONCLUSION:(1)The risk factors leading to femoral head necrosis in the short term after cannulated screw fixation of femoral neck fractures include:smoking,diabetes,Garden classification,fracture line location,reduction quality,age,and operation time.(2)The prediction model demonstrated robust performance,evidenced by an area under the curve of 0.940(95%Confidence Interval:0.903 to 0.977),indicating a high level of prediction accuracy.The model achieved a sensitivity of 90.2%and a specificity of 87.6%,indicating that its diagnostic performance was stable.The Hosmer-Lemeshow goodness-of-fit test yielded a chi-square value of 6.593 with a P-value of 0.581,confirming that the model's predictions closely align with the observed outcomes.(3)The calibration curve of the model also performed well,and its overall trend was very close to the ideal curve,further proving the high accuracy of the model.(4)The internal validation was carried out by the Bootstrap method with 1 000 repeated samplings,and the area under the curve of the model internal validation was still as high as 0.939,proving that the model had good stability.(5)Through the decision curve,it is found that within the probability threshold range of 1%to 92%,the model can obtain the maximum net benefit value.(6)The SHAP analysis results show that among the risk factors analyzed in this study,the location of the fracture line serves as the most significant predictor of femoral head necrosis following internal fixation with cannulated screws in femoral neck fractures,and subcapital fractures are extremely prone to femoral head necrosis after surgery.(7)It is concluded that the validated prediction model demonstrates strong discriminative power and reliability,offering practical clinical utility.It serves as a useful reference tool for short-term risk assessment of femoral head necrosis following internal fixation of femoral neck fractures.
3.Analyses of causes of death among hepatitis C patients in Hongkou District, Shanghai, 2012‒2024
Zuping GUO ; Jiaru LONG ; Chen ZHANG ; Jinghong YE ; Yi HUANG
Shanghai Journal of Preventive Medicine 2026;38(4):284-288
ObjectiveTo systematically analyze the epidemiological characteristics and cause-of-death distribution among death cases with hepatitis C in Hongkou District of Shanghai, and to provide a scientific basis for optimizing healthcare resources allocation and targeted hepatitis C prevention and control measures. MethodsA retrospective cross-sectional study was conducted by integrating historical surveillance data from China Information System of Disease Prevention and Control and Shanghai Hongkou District Death Medical Registration System. Data on demographic characteristics, hepatitis C-related clinical and management records, and underlying causes of death for cases with hepatitis C between 2012 and 2024 in Hongkou District of Shanghai, were collected. Descriptive analyses were performed to analyze the epidemiological characteristics and cause-of-death distribution of death cases, and comparative analyses were conducted across different subgroups. ResultsA total of 204 hepatitis C-related deaths were identified in Hongkou District, Shanghai, from 2012 to 2024. The average age at death was (69.49±12.75) years The majority decedents were males (71.57%) and retired (73.53%). The top three underlying causes of death were malignant tumors (45.10%), cerebrovascular diseases (15.20%) and cardiovascular diseases (12.25%), collectively accounting for 72.55% of all deaths. Deaths attributed to hepatitis C accounted for 9.80% (20/204), with a mean age at death of (63.41±11.81) years. No statistically significant differences were observed in the proportion of hepatitis C-attributed deaths across different subgroups (all P>0.05). The proportion of premature deaths was 55.88% (114/204), with a mean age at death of (60.02±6.89) years. The proportion of premature deaths was higher among males (60.27%), laboratory-diagnosed patients (62.69%), patients with other liver diseases (72.06%), and those non-compliant with follow-up (70.97%) compared to their respective counterparts (all P<0.05). Additionally, homemakers /unemployed patients (100.00%) and employed patients (88.89%) had a significantly higher proportion of premature deaths compared to retired patients (42.67%) (P<0.001). There was a statistically significant difference in the distribution of causes of death between the premature death group and the non-premature death group (χ2=14.93, P=0.048). The top three causes of premature deaths were malignant tumors (50.00%), hepatitis C (12.28%) and cerebrovascular diseases (10.53%). Regarding the proportion of deaths occuring prematurely, other viral hepatitis had the highest percentage (75.00%), followed by diabetes mellitus (71.43%) and hepatitis C (70.00%). ConclusionThe majority of death cases with hepatitis C were males and retirees in Hongkou District, Shanghai. The leading cause of death was malignant tumors, while hepatitis C ranked as the fourth underlying cause, as well as served as the second leading cause of premature death following malignant tumors. Premature death was closely associated with gender, occupation, diagnostic classification, presence of other liver diseases, and follow-up compliance, highlighting the importance of enhanced health management and targeted interventions among high-risk groups.
4.Deep learning model based on fundus images for detection of coronary artery disease with mild cognitive impairment
Yi YE ; Wei FENG ; Yao-dong DING ; Qing CHEN ; Yang ZHANG ; Li LIN ; Tong MA ; Bin WANG ; Xian-gang CHANG ; Zong-yuan GE ; Xiao-yi WANG ; Long-jun CAI ; Yong ZENG
Chinese Journal of Interventional Cardiology 2025;33(6):303-311
Objective To develop a deep learning model based on fundus retinal images to improve the detection rate of mild cognitive impairment(MCI)in patients with coronary heart disease,achieve early intervention and improve prognosis.Methods The study was a single-center cross-sectional study that retrospectively included patients diagnosed with coronary heart disease(CHD)by coronary angiography(≥50% stenosis of at least one coronary vessel)from Beijing Anzhen Hospital between November 2021 and December 2022.The whole data set was randomly divided into the training set and the testing set according to the ratio of 8∶2 for model development.After that,the patient data of the same center from January 2023 to April 2023 were included in the time verification method to verify the model.The diagnostic criteria for MCI were MMSE<27 or MoCA<26.Four kinds of convolutional neural network(CNN)architectures were used to train fundus images,and a comprehensive vision model of MCI detection was established through model integration.The area under the curve(AUC),sensitivity and specificity of the receiver operating curve(ROC)were used to evaluate the performance of the AI model.Results We collected 5 880 eligible fundus images from 3 368 CHD patients.Based on the results of the MMSE scale,the algorithm was labeled,including 2 898 males and 527 MCI patients.The AUC of the deep learning model in the test group is 0.733(95%CI 0.688-0.778),and the sensitivity of the algorithm in the test group is 0.577(95%CI 0.528-0.625)by using the operating point with the maximum sum of sensitivity and specificity.With a specificity of 0.758(95%CI 0.714-0.802),corresponding to a validated AUC of 0.710(95%CI 0.601-0.818).Based on the results of the MoCA scale,the algorithm labels 2 437 males and 1 626 MCI patients.The AUC of the deep learning model in the test group was 0.702(95%CI 0.671-0.733).The operating point with the maximum sum of sensitivity and specificity was selected,and the sensitivity of the algorithm was 0.749(95%CI 0.719-0.778)and the specificity was 0.561(95%CI 0.527-0.595),corresponding to the AUC value of the verification group was 0.674(95%CI 0.622-0.726).Conclusions The deep learning algorithm model based on fundus images has good diagnostic performance,and may be used as a new non-invasive,convenient and rapid screening method for MCI in CHD population.
5.Efficacy of Ureteral Dilation Versus Ureteral Reimplantation for Primary Obstructed Megaureter in Children
Jiabin JIANG ; Yin ZHANG ; Ye ZHANG ; Xiang FANG ; Daolong LI ; Peng TANG ; Tengyun LONG ; Min CHAO
Journal of Sun Yat-sen University(Medical Sciences) 2025;46(4):686-692
[Objective]To evaluate the efficacy of ureteral dilation versus ureteral reimplantation in treating pediatric primary obstructive megaureter(POM).[Methods]A retrospective analysis was conducted on clinical data of 53 pediatric patients with POM treated in the Department of Urology,Anhui Provincial Children's Hospital from April 2019 to September 2023.The cohort included 37 boys and 16 girls with 5 bilateral and 48 unilateral cases.The age ranged from 1 to 157 months,with a median age of 17.00(5.50-48.00)months.Patients were assigned to 3 groups based on the management of the ureteral stricture segment:dilation group(18 cases,19 sides),Cohen group(20 cases,24 sides),and Lich-Gregoir group(15 cases,15 sides).The duration of the operations,postoperative hospital stays,postoperative indwelling catheters,postoperative D-J stents;changes in renal pelvis anteroposterior diameter and ureteral diameter;and postoperative complications were compared to evaluate the therapeutic effects.[Results]All 53 patients successfully underwent surgery.The dilation group showed significantly shorter operative time,postoperative hospital stay,and postoperative catheterization duration compared to the Cohen and Lich-Gregoir groups(P<0.05).However,the postoperative D-J stent time was longer in the dilation group than in the other 2 groups(P<0.05).Upon follow-ups for 6-12 months after stent removal,all groups demonstrated statistically significant reductions in renal pelvis anteroposterior diameter and ureteral diameter compared to preoperative values(P<0.05).No significant differences were observed among the 3 groups in hydronephrosis resolution rates(P>0.05).Additionally,the incidence of postoperative complications(urinary tract infection,vesicoureteral reflux,and reoperation for restenosis)did not differ significantly among the groups(P>0.05).[Conclusions]Ureteral dilation demonstrated non-inferior short-term clinical efficacy compared to ureteral reimplantation in managing POM in pediatric patients.With reduced operative time,minimal invasiveness,and technical simplicity,ureteral dilation may be considered a preferential treatment option for children with POM.
6.Construction of hyperuricemic mouse model with Uox gene knockout based on CRISPR/Cas9 system
Yiwei ZHANG ; Weihu LONG ; Donghong TANG ; Shengtao FAN ; Peng WANG ; Chenyun WANG ; Zheli LI ; Zhangqiong HUANG ; Yousong YE
Acta Laboratorium Animalis Scientia Sinica 2025;33(3):411-419
Objective To construct a uricase-deficient mouse model with stable inheritance using the CRISPR/Cas9 system,and evaluate its ability to simulate the disease characteristics of patients with hyperuricemia.Methods Double single guide RNAs(sgRNAs)were designed on both sides of exon 2~4 of the Uox gene.sgRNA and Cas9 mRNA for gene knockout were microinjected into the fertilized eggs of mice.After culture for 2~4 h,the embryos were transferred to surrogate mother mice to produce an F0 generation.Uox-knockout mice were identified by polymerase chain reaction and sequencing analysis.Positive mice were then mated with wild-type(WT)mice to produce an F1 generation,and heterozygous female and male F1 mice were then selected to obtain homozygous F2 mice.Serum and urine levels of uric acid,creatinine,and urea,and serum alanine aminotransferase(ALT)and aspartate aminotransferase(AST)levels were detected and compared between homozygous and wild-type mice.Pathological changes in kidney and liver tissues were observed by hematoxylin and eosin and Masson staining.Results Urine levels of serum uric acid(male:(4116.8±1928.1)μmol/L,P<0.001;female:(2998.0±547.7)μmol/L,P<0.01)and serum levels of uric acid(male:(478.4±114.6)μmol/L,P<0.001;female:(507.7±129.6)μmol/L,P<0.001),creatinine((91.8±55.6)μmol/L,P<0.001),urea((28.6±13.9)mmol/L,P<0.05),ALT((53.3±23.3)U/L,P<0.01),and AST((203.3±70.3)U/L,P<0.001)were significantly increased in Uox-/-mice compared with WT mice.Histopathological examination showed moderate hepatocyte degeneration in the liver,moderate-to-severe tubular cystic dilation,degeneration,and fibrosis in the kidney,glomerular hypertrophy and hyperplasia,small-vessel dilation and congestion,and infiltration of stromal monocytes and lymphocytes in Uox-/-mice.Conclusions We successfully established a homozygous uricase-deficient mouse strain using CRISPR/Cas9 technology,as a suitable animal model for research in the field of hyperuricemia.
7.Relationship between frailty and acute kidney injury after hip fracture surgery in the elderly
Shu-Jun YE ; Kai-Hong ZHANG ; Xiao-Man SUN ; Huan-Kai ZHANG ; Zhi-Liang HUANG ; Duo YANG ; Long-Sheng ZHANG
Medical Journal of Chinese People's Liberation Army 2025;50(7):831-838
Objective To analyze the relationship between frailty and acute kidney injury(AKI)after hip fracture surgery in the elderly.Methods A total of 405 elderly patients who underwent hip fracture surgery in Jieyang People's Hospital from August 2021 to January 2023 were retrospectively analysed.According to the modified frailty index(mFI),they were divided into frail group(mFI≥0.27,n=112)and non-frail group(mFI<0.27,n=293).Postoperative AKI was defined according to the Kidney Disease:Improving Global Outcomes(KDIGO)criteria.After 1:1 propensity score matching(PSM),100 cases in each group were successfully matched.Univariable and multivariable logistic regression models,propensity score adjustment,PSM,inverse probability of treatment weighting(IPTW),standardized mortality ratio weighting(SMRW),pairwise algorithm(PA)weighting,and overlap weighting(OW)methods were used to analyze the relationship between frailty and postoperative AKI.Stratified analyses were performed according to age(≥80 or<80 years),gender,whether angiotensin-converting enzyme inhibitors(ACEI)/angiotensin Ⅱreceptor antagonists(ARB)were used,and whether intraoperative hypotension occurred.Results After PSM,there were no significant differences between the two groups in age,sex,surgical type,ACEI/ARB,blood urea nitrogen,serum creatinine,intraoperative blood loss,and intraoperative hypotension[standardized mean difference(SMD)<0.1].In both the original cohort and the matched cohort,the incidence of AKI was higher in frail group than in non-frail group(25.9%vs.8.9%,P<0.001;28.0%vs.11.0%,P=0.002).Analysis of the risk of postoperative AKI in elderly hip fracture patients in frail group found that compared with the non-frail group,in the univariate logistic regression model the odds ratio(OR)and a 95%confidence interval(CI)for the frail group was 3.59(2.00-6.43),P<0.001,and in the multivariable logistic regression model,the OR(95%CI)for frail group was 3.04(1.55-5.95),P=0.001.After adjustment for propensity score,the OR(95%CI)for frail group was 2.85(1.52-5.34),P=0.001,and the OR(95%CI)for frail group after PSM was 3.15(1.47-6.75),P=0.003.After IPTW,SMRW,PA weighting,and OW,the OR(95%CI)for frail group were 2.48(1.37-4.50),2.43(1.41-4.19),2.63(1.25-5.54),and 2.69(1.07-6.78),respectively,with P<0.05.The interaction tests were not statistically significant for age,sex,use of ACEI/ARB,and intraoperative hypotension(P>0.05).Conclusion In elderly patients with hip fractures,preoperative frailty may be a risk factor for postoperative AKI.
8.RODENT DENSITY IN THE GARRISONS OF LANZHOU CITY DURING 2014-2022
Jun GAN ; Jing ZUO ; Lin WANG ; Wei WANG ; Xing MENG ; Yong-Long ZHANG ; Qing-Ming SHI ; Xiao-Lei YE
Acta Parasitologica et Medica Entomologica Sinica 2025;32(1):34-38
Objective To investigate the density,species composition,and seasonal prevalence of domestic rodents in different habitats within Lanzhou garrisons,providing basic information for rodent prevention and control.Methods A total of 12 monitoring sites were sampled across urban,suburban,and rural residential areas from 2014 to 2022.Rodent density was monitored using the night-trapping method in the middle of odd-numbered months.Results From 2014 to 2022,346 domestic rodents were captured using 122 035 effective traps,with an average domestic rodent density of 0.28%.The highest domestic rodent density was 0.63%in 2016,and the lowest was 0.07%in 2020,showing significant differences across years,with an overall trend of initially decreasing and then increasing(χ2=136.555,P<0.001).The dominant species was Rattus norvegicus,accounting for 83.24%of the total rodents captured.Rattus norvegicus accounted for a relatively high proportion across different years,with a statistically significant difference in species composition(χ2=20.931,P<0.05).Rodent densities and species composition also varied significantly among the monitored habitats(P<0.001),with the highest densities observed in rural residential areas and the lowest in urban areas.Seasonal variation in rodent densities showed a bimodal pattern,with smaller peaks in January or March and a larger peak in July.Conclusions Domestic rodent density in Lanzhou garrisons has shown an upward trend in the past few years.Rodent control measures should focus on barracks in rural residential areas,with targeted interventions to reduce the risk of rodent-borne diseases.
9.Construction of hyperuricemic mouse model with Uox gene knockout based on CRISPR/Cas9 system
Yiwei ZHANG ; Weihu LONG ; Donghong TANG ; Shengtao FAN ; Peng WANG ; Chenyun WANG ; Zheli LI ; Zhangqiong HUANG ; Yousong YE
Acta Laboratorium Animalis Scientia Sinica 2025;33(3):411-419
Objective To construct a uricase-deficient mouse model with stable inheritance using the CRISPR/Cas9 system,and evaluate its ability to simulate the disease characteristics of patients with hyperuricemia.Methods Double single guide RNAs(sgRNAs)were designed on both sides of exon 2~4 of the Uox gene.sgRNA and Cas9 mRNA for gene knockout were microinjected into the fertilized eggs of mice.After culture for 2~4 h,the embryos were transferred to surrogate mother mice to produce an F0 generation.Uox-knockout mice were identified by polymerase chain reaction and sequencing analysis.Positive mice were then mated with wild-type(WT)mice to produce an F1 generation,and heterozygous female and male F1 mice were then selected to obtain homozygous F2 mice.Serum and urine levels of uric acid,creatinine,and urea,and serum alanine aminotransferase(ALT)and aspartate aminotransferase(AST)levels were detected and compared between homozygous and wild-type mice.Pathological changes in kidney and liver tissues were observed by hematoxylin and eosin and Masson staining.Results Urine levels of serum uric acid(male:(4116.8±1928.1)μmol/L,P<0.001;female:(2998.0±547.7)μmol/L,P<0.01)and serum levels of uric acid(male:(478.4±114.6)μmol/L,P<0.001;female:(507.7±129.6)μmol/L,P<0.001),creatinine((91.8±55.6)μmol/L,P<0.001),urea((28.6±13.9)mmol/L,P<0.05),ALT((53.3±23.3)U/L,P<0.01),and AST((203.3±70.3)U/L,P<0.001)were significantly increased in Uox-/-mice compared with WT mice.Histopathological examination showed moderate hepatocyte degeneration in the liver,moderate-to-severe tubular cystic dilation,degeneration,and fibrosis in the kidney,glomerular hypertrophy and hyperplasia,small-vessel dilation and congestion,and infiltration of stromal monocytes and lymphocytes in Uox-/-mice.Conclusions We successfully established a homozygous uricase-deficient mouse strain using CRISPR/Cas9 technology,as a suitable animal model for research in the field of hyperuricemia.
10.Feasibility study of using clinical trial individual-level data sample bank as external control to support drug and device development:taking transcatheter aortic valve replacement device as an example
Xiao-ying LIN ; Chi-lie DANZENG ; Duo-er WANG ; Ying-xuan ZHU ; Ye LU ; Fan GAO ; Yuan-xin LI ; Meng-zhu SU ; Zi-long ZHANG ; Min CHEN ; Qi-ze LI ; Ru JIANG ; Yan-yan ZHAO ; Yang WANG
Chinese Journal of Interventional Cardiology 2025;33(8):459-466
Objective To explore the feasibility and corresponding implementation methods of constructing a sample resource bank based on individual-level data of completed clinical trials and using it to construct external controls for drug/device clinical trials.Methods Taking the pre-marketing clinical trial of transcatheter active valve replacement(TAVR)for the treatment of aortic valve stenosis as an example,the individual-level databases of multiple trials were standardized to form a sample bank.The original data of any trial in the sample bank were selected as the experimental group,and the remaining samples were selected as the control group.The potential confounding was handled by using the propensity score matching and stratification methods to clarify the process of constructing external controls based on the sample bank of individual-level data of clinical trials.Results This study included individual-level data of single-group trials of 4 TAVR devices,with a total of 569 subjects(59.2%male).The number of subjects in Trials 1 to 4 was 120,120,163,and 166,respectively.Propensity score matching enabled the matching of 113,117,125,and 147 subjects with comparable or similar characteristics from individual-level data from other trials,respectively,demonstrating a high matching success rate.The PS score distribution plot after stratification showed that the proportions of subjects in the experimental and control groups in strata 1 to 5 in scheme 1 were 4/103,11/103,22/92,32/87,and 51/64,respectively.For all constructed external controlled trials,a certain number of control samples with similar baseline characteristics to the experimental groups were distributed within each propensity score stratum.The results of the simulation test also reflected the potential differences between different devices in the 12-month all-cause mortality rate.Conclusions The sample bank constructed with individual-level data from clinical trials,as a high-quality data source,can serve as a source of external control for single-arm trials in the same field,and as a useful supplement to the external control scenario of real-world evidence to support drug and device development.At the same time,targeted research on research methods and bias control measures in related fields is also needed.

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