1.Deconstruction and measurement of the public welfare connotation of public hospitals based on the theory of equal rights and responsibilities
Ye MA ; Mingzhu JIANG ; Linan WANG ; Xiaohua YING
Chinese Journal of Hospital Administration 2025;41(4):268-275
This study started from the connotation of public welfare and, from the perspective of equal rights and responsibilities, interpreted the public welfare responsibilities and entitlements of hospitals. It developed corresponding quantitative measurement tools and constructed a Public Welfare Rights and Responsibilities Index. Public welfare responsibilities were reflected in the provision of equitable, accessible, appropriate, and reasonable basic medical and public health services. These responsibilities were quantified using the market price of basic medical services, the average cost per case-mix index unit, and public service expenditures. Entitlements were reflected in financial subsidies, tax exemptions, and land policy support. Based on this framework, the study applies the Public Welfare Rights and Responsibilities Index to evaluate 147 public hospitals in City S from 2019 to 2021. The results show that the overall level of public welfare among public hospitals in City S was relatively high (with an average index of 2.39), but showed a slight downward trend. Differences were observed across hospital grades and types, with secondary-level hospitals and general hospitals demonstrating relatively higher levels of public welfare. This study could provide a practical and quantifiable method for measuring hospital public welfare within an equal rights and responsibilities framework, offering a novel analytical tool and empirical evidence to support policy formulation and performance evaluation.
2.Changes in Esophageal Cancer Survival: A Global Review of Survival Analysis from Cancer Registration Data over the Past Three Decades.
Zhuo Jun YE ; Dan Ni YANG ; Yu JIANG ; Yu Xuan XIAO ; Zhuo Ying LI ; Yu Ting TAN ; Hui Yun YUAN ; Yong Bing XIANG
Biomedical and Environmental Sciences 2025;38(5):571-584
OBJECTIVE:
To describe survival trends and global patterns of esophageal cancer (EC) using survival data from population-based cancer registries.
METHODS:
We systematically searched PubMed, EMBASE, Web of Science, SEER, and SinoMed databases for articles published up to 31 December 2023. Eligible EC survival estimates were evaluated according to country or region, period, sex, age group, pathology, and disease stage.
RESULTS:
After 2010, Jordan exhibited the highest age-standardized 5-year relative survival rates (RSRs)/net survival rates (NSRs) at 41.1% between 2010 and 2014, while India had the lowest, at 4.1%. Survival rates generally improved with diagnostic age across most countries, with significant increases in South Korea and China, of 12.7% and 10.5% between 2000 and 2017, respectively. Survival was higher among women compared to men, ranging from 0.4%-10.9%. Survival rates for adenocarcinoma and squamous cell carcinoma were similar, differing by about 4%. In China, the highest age-standardized RSRs/NSRs was 33.4% between 2015 and 2017. Meanwhile, the lowest was 5.3%, in Qidong (Jiangsu province) between 1992-1996.
CONCLUSION
Global EC survival rates have improved significantly in recent decades, but substantial geographical, sex, and age disparities still exist. In Asia, squamous cell carcinoma demonstrated superior survival rates compared to adenocarcinoma, while the opposite trend was observed in Western countries. Future research should clarify the prognostic factors influencing EC survival and tailor prevention and screening strategies to the changing EC survival patterns.
Humans
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Esophageal Neoplasms/mortality*
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Registries
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Male
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Female
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Survival Analysis
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Middle Aged
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Survival Rate
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Aged
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Global Health
3.Optimization and preliminary efficacy of postoperative radiotherapy target volume delineation for adenoid cystic carcinoma of head and neck
Ying XIAO ; Wen JIANG ; Shengjin DOU ; Lulu YE ; Shengwen LIU ; Guopei ZHU
Chinese Journal of Radiation Oncology 2025;34(1):49-56
Objective:To analyze the efficacy of delineating the clinical target volume (CTV) following the trajectory of trigeminal nerve branches and elective neck irradiation (ENI) in postoperative intensity-modulated radiotherapy (IMRT) for adenoid cystic carcinoma of head and neck (ACCHN).Methods:In this study, the data of ACCHN patients without distal metastasis who received postoperative radiotherapy after radical surgery at the Ninth People's Hospital of Shanghai Jiaotong University School of Medicine from January 2016 to December 2022 were retrospectively analyzed. Postoperative radiotherapy target zone and intensity-modulated radiotherapy plan for ACCHN were formulated according to the site of primary focus, whether nerve invasion and pathological staging. Kaplan-Meier method was applied to perform survival analysis, while assessing the tumor local control rate and locoregional recurrence pattern under this target zone outlining principle.Results:A total of 309 ACCHN patients were included. With a median follow-up of 49 months, the 5-year local control rate was 93.2%, the 5-year overall survival rate, locoregional recurrence-free survival rate, and distant metastasis-free survival rate were 90.8%, 90.6%, 66.3%, respectively. Twenty-three patients developed locoregional recurrence, including 14 with primary tumor recurrence alone, 5 with regional lymph node recurrence alone, and 4 with both primary and regional lymph node recurrence. Among the patients with primary tumor recurrence, 11 had recurrence related to the trigeminal nerve branches,and 7 had recurrence in the tumor bed or surgical bed region, with no out-of-field recurrence. Among the 9 patients with lymph node recurrence, none had undergone neck dissection.Conclusions:Delineating the CTV following the trigeminal nerve branches in postoperative radiotherapy for ACCHN achieves excellent local control. Elective neck irradiation avoids irradiation of the entire neck lymphatic drainage area with a low regional recurrence rate.
4.Analysis of key prognostic factors for postoperative radiotherapy for adenoid cystic carcinoma of the head and neck
Ying XIAO ; Wen JIANG ; Shengjin DOU ; Lulu YE ; Lin ZHANG ; Jiang LI ; Shengwen LIU ; Guopei ZHU
Chinese Journal of Radiation Oncology 2025;34(4):326-333
Objective:To evaluate the impact of surgical margin status and pathological subtypes on the prognosis of patients with adenoid cystic carcinoma of the head and neck (ACCHN) who underwent postoperative radiotherapy.Methods:A retrospective analysis was conducted on 309 patients with initially treated, non-metastatic ACCHN who completed postoperative radiotherapy at Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine from January 2016 to December 2022. All patients underwent curative (non-palliative) surgery followed by postoperative radiotherapy, with a median dose of 66 Gy (range: 54-70 Gy). The Kaplan-Meier method was used to compare 5-year local recurrence-free survival (LRFS) between R0 (negative margin) and non-R0 resections in patients with initially resectable (T 1-T 4a stage) and initially unresectable (T 4b stage) disease. Univariate and multivariate Cox proportional hazards models were employed to analyze risk factors for local recurrence, with a focus on surgical margin status and pathological subtypes. Results:The median follow-up was 48 months. Of the 309 patients included in the study, 133 were males and 176 were females, with a median age of 51 years (range: 18-77 years). Primary tumors were located in the major salivary glands in 135 cases (including 42 in the parotid gland, 65 in the submandibular gland, and 28 in the sublingual gland) and in the minor salivary glands in 174 cases. The 5-year overall survival, locoregional recurrence-free survival, distant metastasis-free survival, and progression-free survival rates were 91.5%, 90.8%, 66.1%, and 63.9%, respectively. Non-R0 resection was achieved in 177 patients (57.3%). Among initially resectable patients ( n=253), the non-R0 resection rate was 49.0% ( n=124), with only 6 cases (2.4%) experiencing local recurrence (all non-R0 resections). In initially unresectable patients ( n=56), the non-R0 resection rate was as high as 95% ( n=53), with 13 cases (23%) experiencing local recurrence (2 cases in non-R0 resection and 1 case in R0 resection). For initially resectable patients, non-R0 resection significantly reduced the 5-year LRFS rate to 95.2%, compared to 100% in R0 resection patients ( P=0.014). However, multivariate analysis revealed that the solid pathological subtype was an independent risk factor for 5-year LRFS ( HR=7.40, 95% CI: 2.81-19.52, P<0.001), while the surgical margin status was not an independent factor. Conclusions:The combined strategy of surgery and postoperative radiotherapy provides high local control rates for ACCHN patients. Achieving R0 resection is crucial for initially resectable patients, while a comprehensive treatment strategy involving surgery and postoperative radiotherapy remains essential for initially unresectable patients. The solid pathological subtype is the most significant risk factor for local recurrence.
5.Sonodynamic therapy promotes luminal gain in carotid and femoral atherosclerotic plaques: a single-center prospective clinical study
Yu WANG ; Yihan SUN ; Ying LIU ; Jingxue FAN ; Yuanqi WANG ; Yongxing JIANG ; Hui WANG ; Jiemei YANG ; Liuying WANG ; Shuyuan GUO ; Wei WANG ; Ye TIAN
Chinese Journal of Cardiology 2025;53(11):1216-1224
Objective:To preliminarily evaluate the lumen gain of sonodynamic therapy (SDT) mediated by sinoporphyrin sodium at carotid and femoral atherosclerotic plaque sites, and to assess whether concomitant statin use, lesion location, plaque echogenicity/type, and baseline stenosis severity modify the therapeutic response.Methods:This single-center, prospective, exploratory pilot clinical study enrolled patients with peripheral artery disease who attended the outpatient cardiology clinic of the First Affiliated Hospital of Harbin Medical University between February and September 2016. All enrolled patients received optimized oral medical therapy in combination with a single session of SDT. Vascular evaluation was performed using color Doppler ultrasound before treatment and 1 and 4 weeks after treatment. The primary efficacy endpoint was the percent change from baseline in luminal diameter stenosis at the site of the atherosclerotic plaque (%Δ) at week 4, while the secondary efficacy endpoint was %Δ at week 1. Subgroup analyses were conducted according to prior statin use, plaque location, plaque characteristics, and baseline degree of luminal stenosis.Results:A total of 24 patients, aged (70.7±2.2) years were enrolled. There were 20 (83%) males. Compared to baseline, luminal diameter stenosis at the plaque site reduced by week 4 ((50.1±1.2)% vs. (57.2±1.1)%, P<0.001), %Δ was(12.32±1.05)%; and luminal diameter stenosis also reduced by week 1 ((51.7±1.2)% vs. (57.2±1.1)%, P<0.001)), %Δ was(9.61±0.85)%. In subgroup analyses, the treatment effect on diameter stenosis was independent of prior statin use; SDT reduced stenosis in both carotid and femoral plaques; with superior efficacy observed in hypoechoic and mixed-echo plaques; and efficacy was observed across mild, moderate, and severe baseline stenosis categories (all P<0.05). Conclusion:In this single-center pilot study, SDT demonstrates therapeutic efficacy across mild, moderate, and severe stenoses, as well as in hypoechoic and mixed-echo plaques, showing potential to rapidly promote luminal gain at carotid and femoral atherosclerotic plaque sites.
6.Guideline for Adult Weight Management in China
Weiqing WANG ; Qin WAN ; Jianhua MA ; Guang WANG ; Yufan WANG ; Guixia WANG ; Yongquan SHI ; Tingjun YE ; Xiaoguang SHI ; Jian KUANG ; Bo FENG ; Xiuyan FENG ; Guang NING ; Yiming MU ; Hongyu KUANG ; Xiaoping XING ; Chunli PIAO ; Xingbo CHENG ; Zhifeng CHENG ; Yufang BI ; Yan BI ; Wenshan LYU ; Dalong ZHU ; Cuiyan ZHU ; Wei ZHU ; Fei HUA ; Fei XIANG ; Shuang YAN ; Zilin SUN ; Yadong SUN ; Liqin SUN ; Luying SUN ; Li YAN ; Yanbing LI ; Hong LI ; Shu LI ; Ling LI ; Yiming LI ; Chenzhong LI ; Hua YANG ; Jinkui YANG ; Ling YANG ; Ying YANG ; Tao YANG ; Xiao YANG ; Xinhua XIAO ; Dan WU ; Jinsong KUANG ; Lanjie HE ; Wei GU ; Jie SHEN ; Yongfeng SONG ; Qiao ZHANG ; Hong ZHANG ; Yuwei ZHANG ; Junqing ZHANG ; Xianfeng ZHANG ; Miao ZHANG ; Yifei ZHANG ; Yingli LU ; Hong CHEN ; Li CHEN ; Bing CHEN ; Shihong CHEN ; Guiyan CHEN ; Haibing CHEN ; Lei CHEN ; Yanyan CHEN ; Genben CHEN ; Yikun ZHOU ; Xianghai ZHOU ; Qiang ZHOU ; Jiaqiang ZHOU ; Hongting ZHENG ; Zhongyan SHAN ; Jiajun ZHAO ; Dong ZHAO ; Ji HU ; Jiang HU ; Xinguo HOU ; Bimin SHI ; Tianpei HONG ; Mingxia YUAN ; Weibo XIA ; Xuejiang GU ; Yong XU ; Shuguang PANG ; Tianshu GAO ; Zuhua GAO ; Xiaohui GUO ; Hongyi CAO ; Mingfeng CAO ; Xiaopei CAO ; Jing MA ; Bin LU ; Zhen LIANG ; Jun LIANG ; Min LONG ; Yongde PENG ; Jin LU ; Hongyun LU ; Yan LU ; Chunping ZENG ; Binhong WEN ; Xueyong LOU ; Qingbo GUAN ; Lin LIAO ; Xin LIAO ; Ping XIONG ; Yaoming XUE
Chinese Journal of Endocrinology and Metabolism 2025;41(11):891-907
Body weight abnormalities, including overweight, obesity, and underweight, have become a dual public health challenge in Chinese adults: overweight and obesity lead to a variety of chronic complications, while underweight increases the risks of malnutrition, sarcopenia, and organ dysfunction. To systematically address these issues, multidisciplinary experts in endocrinology, sports science, nutrition, and psychiatry from various regions have held multiple weight management seminars. Based on the latest epidemiological data and clinical evidence, they expanded the guideline to include assessment and intervention strategies for underweight, in addition to the core content of obesity management. This guideline outlines the etiological mechanisms, evaluation methods, and multidimensional management strategies for overweight and obesity, covering key areas such as diagnosis and assessment, medical nutrition therapy, exercise prescription, pharmacological intervention, and psychological support. It is intended to provide a scientific and standardized approach to weight management across the adult population, aiming to curb the rising prevalence of obesity, mitigate complications associated with abnormal body weight, and improve nutritional status and overall quality of life.
7.Deconstruction and measurement of the public welfare connotation of public hospitals based on the theory of equal rights and responsibilities
Ye MA ; Mingzhu JIANG ; Linan WANG ; Xiaohua YING
Chinese Journal of Hospital Administration 2025;41(4):268-275
This study started from the connotation of public welfare and, from the perspective of equal rights and responsibilities, interpreted the public welfare responsibilities and entitlements of hospitals. It developed corresponding quantitative measurement tools and constructed a Public Welfare Rights and Responsibilities Index. Public welfare responsibilities were reflected in the provision of equitable, accessible, appropriate, and reasonable basic medical and public health services. These responsibilities were quantified using the market price of basic medical services, the average cost per case-mix index unit, and public service expenditures. Entitlements were reflected in financial subsidies, tax exemptions, and land policy support. Based on this framework, the study applies the Public Welfare Rights and Responsibilities Index to evaluate 147 public hospitals in City S from 2019 to 2021. The results show that the overall level of public welfare among public hospitals in City S was relatively high (with an average index of 2.39), but showed a slight downward trend. Differences were observed across hospital grades and types, with secondary-level hospitals and general hospitals demonstrating relatively higher levels of public welfare. This study could provide a practical and quantifiable method for measuring hospital public welfare within an equal rights and responsibilities framework, offering a novel analytical tool and empirical evidence to support policy formulation and performance evaluation.
8.Prognostic analysis of local excision in 153 cases of locally advanced low rectal cancer following neoadjuvant therapy
Hongfeng PAN ; Jiahong YE ; Heyuan ZHU ; Xiaojie WANG ; Yanwu SUN ; Zhifen CHEN ; Zongbin XU ; Shenghui HUANG ; Weizhong JIANG ; Pan CHI ; Ying HUANG
Chinese Journal of Gastrointestinal Surgery 2025;28(11):1250-1259
Objective:To evaluate the short-term and long-term outcomes of patients with locally advanced low rectal cancer who achieved clinical complete response (cCR) or near-clinical complete response (near-cCR) after neoadjuvant chemoradiotherapy (nCRT) and then underwent local excision.Methods:This was a descriptive case series study. Clinical data of patients with low rectal cancer who received neoadjuvant therapy, achieved cCR or near-cCR, underwent local excision, and had complete postoperative follow-up data were retrospectively analyzed. The study period was from May, 2015 to October, 2024, and the patients were treated at Fujian Medical University Union Hospital. Indications for local excision in this study were as follows: pathologically confirmed rectal adenocarcinoma, with the lower edge of the tumor ≤ 6 cm from the anal verge; maximum diameter of the lesion ≤ 2 cm after nCRT; no regional lymph node metastasis detected by transrectal endoscopic ultrasound (ERUS), pelvic magnetic resonance imaging (MRI), or positron emission tomography-computed tomography (PET-CT) after nCRT; MRI showing fibrosis of the primary lesion with a small amount of high signal on diffusion-weighted imaging (DWI), consistent with ymrT0-1 stage; serum carcinoembryonic antigen level within the normal range (< 5 μg/L) after nCRT; complicated with severe underlying diseases such as cardiovascular and cerebrovascular diseases and assessed as unable to tolerate radical surgery through comprehensive evaluation; and signed informed consent for local excision. The contraindications were: colonoscopic pathology indicating poorly differentiated adenocarcinoma or signet ring cell carcinoma; suspected lateral lymph node metastasis before neoadjuvant therapy; patients with residual lesions exceeding 3 cm in range after treatment. A total of 153 patients were included in this study, including 84 males and 69 females. The median age was 62 years, and the median distance from the tumor to the anal verge after neoadjuvant therapy was 4.0 cm. The short-term efficacy indicators of this study included postoperative complications of local excision and postoperative pathological results, and the long-term efficacy indicators included oncological prognosis (3-year cumulative local recurrence rate, 3-year cumulative distant metastasis rate, 3-year progression-free survival, and 3-year overall survival) and anal function at 1 year after surgery evaluated using the Low Anterior Resection Syndrome (LARS) scale where the total score is 42 points such that 0-20 points indicate no LARS, 21-29 points indicate mild LARS, and 30-42 points indicate severe LARS.Results:Postoperative pathology showed 122 cases (79.7%) of ypT0 stage, 10 cases (6.5%) of ypT1 stage, 18 cases (11.8%) of ypT2 stage, and 3 cases (2.0%) of ypT3 stage. The incidence of surgery-related complications was 42.5% (65/153), and the main complications included perianal pain (39.9%, 61/153), intestinal wall incision dehiscence (21.6%, 33/153), and intestinal wall incision infection (18.3%, 28/153). The proportion of patients who received hypofractionated radiotherapy before surgery and developed intestinal wall incision dehiscence was 65.2% (15/23), which was higher than that in the conventional long-course (13.6%, 16/118) and short-course radiotherapy groups (16.7%,2/12) (χ 2=30.55, P<0.001); of the 20 patients who received additional immunotherapy before surgery, 13 developed intestinal wall incision dehiscence was 65.0%, which was higher than that in the group without additional immunotherapy [15.0%(20/133),χ 2=25.66, P<0.001]. The median follow-up time of the entire group was 35.4 months. During the follow-up period, there were 9 cases of postoperative local recurrence, with a 3-year cumulative local recurrence rate of 7.9% and 5 cases of distant metastasis, with a 3-year cumulative distant metastasis rate of 5.0%. The 3-year progression-free survival rate was 89.0%, and the 3-year overall survival rate was 95.9%. At 1 year after surgery, 10 cases (10.5%, 10/95) had severe anal dysfunction, and the median LARS score of the entire group was 5.0 (range: 0-41.0) points. Conclusions:For patients with locally advanced low rectal cancer who achieve cCR or near-cCR after neoadjuvant therapy, local excision results in favorable oncological prognosis and anal function preservation effects; however, the incidence of complications is relatively high.
9.Diagnostic value of a combined clinical-radiomics model based on MRI for the assessment of renal fibrosis in chronic kidney disease
Chaogang WEI ; Ying ZENG ; Qing MA ; Zhicheng JIN ; Yilin XU ; Ye ZHU ; Xiaojing LI ; Junkang SHEN ; Zhen JIANG
Chinese Journal of Radiology 2025;59(10):1163-1169
Objective:To explore the diagnostic value of a clinical-radiomics model based on the T 1 mapping and apparent diffusion coefficient (ADC)-based radiomics, and the clinical indicator for renal fibrosis (RF) caused by chronic kidney disease (CKD). Methods:This cross-sectional study prospectively and consecutively enrolled 122 patients with CKD at the Second Affiliated Hospital of Soochow University from September 2021 to December 2023 who were randomly allocated to a training set ( n=85) or a validation set ( n=37) in an approximate 7∶3 ratio using simple random sampling. Patients underwent T 1 mapping and diffusion-weighted imaging scans. Renal biopsy was performed within 3 days after the MRI scans. Patients were categorized into three groups based on the degree of RF: no RF ( n=25), mild RF ( n=55), and moderate to severe RF ( n=42). To differentiate the presence of RF (no RF vs. any RF) and the severity of RF (mild RF vs. moderate to severe RF), univariate and multivariate logistic regression were used to optimize the independent clinical predictor, which constituted the clinical model. Radiomics features were extracted from regions of interest delineated within the renal parenchyma of the right kidney on T 1 mapping and ADC maps. Features were selected using least absolute shrinkage and selection operator regression to build the radiomics model. A clinical-radiomics model was subsequently constructed by integrating the independent clinical predictors with the selected radiomics features. Model diagnostic performance was evaluated using the area under the receiver operating characteristic curve (AUC). Calibration curve was plotted to assess model calibration, and decision curve analysis was performed to evaluate clinical net benefit. Results:Univariate logistic regression analysis revealed that estimated glomerular filtration rate (eGFR), serum creatinine, and blood urea nitrogen exhibited statistically significant differences ( P0.05) in distinguishing both the presence and severity of RF. Multivariate analysis identified eGFR as an independent clinical predictor for both the presence of RF ( OR=0.939, 95% CI 0.898-0.982, P=0.006) and RF severity ( OR=0.956, 95% CI 0.917-0.997, P=0.037). From the MRI images, 7 radiomics features were selected to build the radiomics model for distinguishing the presence of RF, and 8 features were selected for the model assessing RF severity. These radiomics models were then combined with eGFR to construct the clinical-radiomics models. The clinical-radiomics models demonstrated the highest diagnostic performance, with an AUC of 0.935 (95% CI 0.859-0.977) for RF presence and 0.967 (95% CI 0.891-0.995) for RF severity in the training set, and 0.914 (95% CI 0.774-0.981) and 0.908 (95% CI 0.748-0.981) in the validation set. Calibration curves and decision curve analysis confirmed that the clinical-radiomics models exhibited excellent calibration and provided the highest clinical net benefit for assessing RF in CKD patients. Conclusion:The clinical-radiomics model integrating T 1 mapping and ADC-based radiomics and eGFR can effectively improve the diagnostic performance for RF in CKD patients.
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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