Objective:This study aims to construct a quality evaluation index system for specialized disease databases. Through systematic assessment and optimization, it seeks to comprehensively enhance the quality and standardization of specialized disease cohort data. This initiative will provide more precise and reliable data support for disease research, the development of innovative drugs and medical devices, as well as policy formulation.Methods:By conducting a thorough analysis of domestic and international literature and policies related to clinical research data quality evaluation systems, preliminary quality evaluation indicators for specialized disease databases were established. Utilizing the Delphi method in two rounds, a quality evaluation system for specialized disease databases was constructed. The Analytic Hierarchy Process (AHP) and YAAHP 7.5 software were then employed to calculate the relative weights of indicators at various levels and their composite weights.Results:The two rounds of expert consultation achieved a 100.00% valid response rate, with an expert authority coefficient of 0.81 in both rounds. In the second round, the Kendall′s coordination coefficients for the first-level and second-level indicators reached 0.311 and 0.218, respectively ( P<0.05), indicating a good level of consensus among experts. The final specialized disease database quality evaluation system consists of 3 first-level indicators, 10 second-level indicators, and 32 third-level indicators. The first-level indicators include database construction, data quality, and cohort development, with weight coefficients of 31.82%, 41.49%, and 26.69%, respectively. The scientific validity of the indicator system was confirmed through reliability and validity analyses. When applied to assessing 58 specialized disease database projects from 36 medical institutions in a certain city, the results showed significant improvements in scores for database construction, data quality, and cohort development, with the most notable improvement observed in database construction. Conclusions:This study successfully developed a scientific, practical, and rationally weighted quality evaluation system for specialized disease databases, demonstrating high expert consensus and broad applicability.Validation studies have shown that this system effectively enhances the standardization and data quality of databases, providing robust technical support and assurance for specialized disease research and data resource sharing.

Objective:This study aims to construct a quality evaluation index system for specialized disease databases. Through systematic assessment and optimization, it seeks to comprehensively enhance the quality and standardization of specialized disease cohort data. This initiative will provide more precise and reliable data support for disease research, the development of innovative drugs and medical devices, as well as policy formulation.Methods:By conducting a thorough analysis of domestic and international literature and policies related to clinical research data quality evaluation systems, preliminary quality evaluation indicators for specialized disease databases were established. Utilizing the Delphi method in two rounds, a quality evaluation system for specialized disease databases was constructed. The Analytic Hierarchy Process (AHP) and YAAHP 7.5 software were then employed to calculate the relative weights of indicators at various levels and their composite weights.Results:The two rounds of expert consultation achieved a 100.00% valid response rate, with an expert authority coefficient of 0.81 in both rounds. In the second round, the Kendall′s coordination coefficients for the first-level and second-level indicators reached 0.311 and 0.218, respectively ( P<0.05), indicating a good level of consensus among experts. The final specialized disease database quality evaluation system consists of 3 first-level indicators, 10 second-level indicators, and 32 third-level indicators. The first-level indicators include database construction, data quality, and cohort development, with weight coefficients of 31.82%, 41.49%, and 26.69%, respectively. The scientific validity of the indicator system was confirmed through reliability and validity analyses. When applied to assessing 58 specialized disease database projects from 36 medical institutions in a certain city, the results showed significant improvements in scores for database construction, data quality, and cohort development, with the most notable improvement observed in database construction. Conclusions:This study successfully developed a scientific, practical, and rationally weighted quality evaluation system for specialized disease databases, demonstrating high expert consensus and broad applicability.Validation studies have shown that this system effectively enhances the standardization and data quality of databases, providing robust technical support and assurance for specialized disease research and data resource sharing.

Objective To explore the value of transesophageal echocardiography(TEE)for surgical therapy of pediatric atrioventricular valve diseases.Methods Data of 273 children with atrioventricular valve diseases who underwent surgical operation under extracorporeal circulation were retrospectively analyzed.Transthoracic echocardiography(TTE)was performed within 1 week before,while TEE was performed before and after surgical operation.Whether TTE diagnosis should be adjusted were evaluated according to findings of TEE,so were the effects of surgical treatments,and the ultrasonic diagnostic coincidence rate before operation were compared taken surgical findings as standards.Results TEE was successfully completed in all 273 children.The diagnostic coincidence rate of preoperative TTE was 83.88％(229/273).After adjustment or supplement according to TEE in 44 cases(44/273,16.12％),the ultrasonic diagnostic coincidence rate reached 100％(273/273),higher than that of preoperative TTE alone(P＜0.001).Residual shunt was found in 5 cases,while no obvious improvement of valvular regurgitation was noticed in 3 cases with post operative TEE,and after corresponding treatments,re-examination of TEE showed satisfactory efficacy in all the above cases.Conclusion TEE could be used to accurately diagnose pediatric atrioventricular valve diseases before and evaluate the efficacy after surgical treatments,having important clinical application value.

Objective To observe the value of MR lymphangiography(MRL)radiomics for evaluating central conducting lymphatic anomaly(CCLA).Methods Sixty-one patients with complex lymphatic anomaly,including 41 CCLA(group A),20 non-CCLA(generalized lymphatic anomaly and Gorham-Stout disease)and 20 subjects with normal thoracic duct(group B,n=38)were retrospectively enrolled.Cervical and thoracic(combined with abdominal if necessary)MRL was acquired using three-dimensional heavily T2W fast spin echo sequence.ROI was delineated along overall thoracic duct,and radiomics features were extracted.Data sets of group A and B were divided into K subsets using 5-fold cross-validation.The union of(K-1)subset was always used as training set,while the other subsets were used as validation set.Radiomics model was constructed based on support vector machine(SVM)algorithm.Receiver operating characteristic curve was drawn,the area under the curve(AUC)was calculated to evaluate the efficacy of SVM model for assessing CCLA.Results The proportions of bifurcation,cystoid change and extension of main thoracic duct,and extension of terminal thoracic duct in group A were all higher,while of normal main and terminal thoracic duct in group A were both lower than those in group B(all P＜0.05).No significant difference of proportions of multiple thoracic ducts,dextral thoracic duct,part of thoracic duct invisible,multiple terminal thoracic ducts,cystoid change of terminal thoracic duct nor terminal thoracic duct pampiniform was found between groups(all P＞0.05).The sensitivity,specificity,accuracy,positive predictive,negative predictive and AUC of SVM model for evaluating CCLA in training set was 78.95％,97.56％,88.61％,96.77％,83.33％and 0.920,respectively,which in validation set was 78.95％,83.57％,82.28％,83.33％,81.40％and 0.833,respectively.Conclusion MRL radiomics could be used to effectively evaluate CCLA.

Objective To observe the incidence of pericardial tamponade(PT)after left atrial appendage closure(LAAC)in patients with non-valvular atrial fibrillation(NVAF),and to explore its related factors and outcomes.Methods NVAF patients who were hospitalized and treated with LAAC in Department of Cardiology of our hospital from August 2014 to March 2023 were selected for the study.The general clinical data,preoperative transthoracic echocardiography and transesophageal echocardiography data,results of routine preoperative laboratory tests,intraoperative data and follow-up data of the patients were collected through the hospital medical record management system.The enrolled patients were classified into the non-PT group(n=8)and the PT group(n =1184)according to whether PT occurred after LAAC or not.The incidence of PT,related risk factors and outcomes were statistically analyzed.Results This study included 639 males(53.6%)and 553 females(46.4%),with an average age of 68.1±9.65 years.The CHA2 DS2-VASc score was 4.51±1.72,and the HAS-BLED score was 3.36±1.09.PT occurred in 8 cases(0.67%),among them,6 cases occurred 1 to 33 h after LAAC,and 2 cases occurred on day 19 and day 27 after LAAC.As for the results of transesophageal echocardiography(TEE)and LAA angiography,compared with the non-PT group,the PT group had the significantly larger maximum caliber of the LAA(P=0.025,P=0.015),smaller maximum depth of the LAA(P=0.028,P=0.031),and lower success rate of one-time placement of the occluder(P=0.031);The occluder compression rate of the PT group was significantly greater than that of the non-PT group(P=0.046).Multivariate analysis showed that larger maximum diameter of LAA,smaller average effective depth of LAA and larger compression rate of occluder were the main risk factors for PT.All the 8 PT patients were cured by stopping antithrombotic drugs,pericardiocentesis or surgical drainage.During a mean follow-up of 39±27 months,there were no device-related thrombosis(DRT),ischemic stroke,systemic embolism and other complications in the PT group.Conclusion The incidence of PT after LAAC is low,which is related to the large diameter of LAA,the relatively insufficient depth of the LAA and the large compression rate of the occlude.PT can be cured by stopping antithrombotic drugs and pericardiocentesis/surgical drainage.

Objective:To constructe an evaluation index system for clinical research innovation in medical institutions, for references for enhancing the research and innovation capabilities of medical institutions and formulating policies related to clinical research innovation.Methods:From March 2022 to May 2023, relevant literature and policies on the evaluation system of scientific and technological innovation at home and abroad were analyzed to establish the preliminary screening clinical research innovation indicators. Two rounds of Delphi method were used to construct a clinical research innovation index evaluation system, analytic hierarchy process was used to calculate the weights of each indicator.Results:The effective response rates of the two rounds of consultation questionnaires were both 100.00%, with expert authority coefficients of 0.95 and Kendall coordination coefficients of 0.85 and 0.87, respectively. The clinical research innovation index evaluation system ultimately established 4 primary indicators, 13 secondary indicators, and 42 tertiary indicators. The first level indicators included infrastructure construction, innovation support environment, clinical research activity, and innovation effectiveness, with weight coefficients of 18.00%, 21.00%, 30.00%, and 31.00%, respectively.Conclusions:The clinical research innovation evaluation index system constructed in this study covered the investment, environment, and output aspects of research innovation, and could comprehensively and objectively reflect the clinical research innovation ability of medical institutions.

Rats ; Animals ; Urinary Bladder Neck Obstruction/pathology* ; Survivin/genetics* ; Urinary Bladder/pathology* ; Fibrosis

The feasibility and safety of intracardiac echocardiography (ICE)-guided catheter ablation for atrial fibrillation (AF) using a minimal/zero-fluoroscopy approach have recently been reported. This approach helps to reduce ionizing radiation exposure and orthopedic complications resulting from using lead aprons. The objectives of this planned prospective, multicenter randomized controlled trial (RCT) (paroxysmal AF (PAF)-ICE trial; ChiCTR2000033624) are to evaluate the efficacy and safety of ICE-guided minimal-fluoroscopy ablation in patients with PAF and the impact on occupational hazards among lab staff.Patients will be randomized in a 1:1 ratio to 2 groups: minimal fluoroscopy group ( n = 216) and traditional approach group ( n = 216). In the minimal fluoroscopy group, an ICE catheter will be used for geometry/anatomic construction, transseptal puncture, catheter tracking, and effusion monitoring. Pulmonary vein isolation (PVI) will be performed using an open-irrigated radiofrequency SmartTouch Surround Flow or SmartTouch catheter (Biosense Webster, Diamond Bar, California, USA), and confirmed by a multipolar Lasso or PentaRay catheter (Biosense Webster). In the traditional approach group, an ICE catheter will not be used. Transseptal puncture will be performed under fluoroscopic guidance, with all geometries constructed by mapping the catheters. The primary efficacy endpoint is freedom from AF recurrence (without antiarrhythmic medications) at 12 months after ablation. Other endpoints include duration of lead apron use, measures of intra-procedural efficiency, and peri-procedural complications. This RCT will evaluate the efficacy and safety of ICE-guided minimal-fluoroscopy ablation in patients with PAF, also evaluate the benefits to lab staff (regarding reducing occupational hazards) related to this "minimal/zero-fluoroscopy" and "leadless" mode.

The feasibility and safety of intracardiac echocardiography (ICE)-guided catheter ablation for atrial fibrillation (AF) using a minimal/zero-fluoroscopy approach have recently been reported. This approach helps to reduce ionizing radiation exposure and orthopedic complications resulting from using lead aprons. The objectives of this planned prospective, multicenter randomized controlled trial (RCT) (paroxysmal AF (PAF)-ICE trial; ChiCTR2000033624) are to evaluate the efficacy and safety of ICE-guided minimal-fluoroscopy ablation in patients with PAF and the impact on occupational hazards among lab staff.Patients will be randomized in a 1:1 ratio to 2 groups: minimal fluoroscopy group ( n = 216) and traditional approach group ( n = 216). In the minimal fluoroscopy group, an ICE catheter will be used for geometry/anatomic construction, transseptal puncture, catheter tracking, and effusion monitoring. Pulmonary vein isolation (PVI) will be performed using an open-irrigated radiofrequency SmartTouch Surround Flow or SmartTouch catheter (Biosense Webster, Diamond Bar, California, USA), and confirmed by a multipolar Lasso or PentaRay catheter (Biosense Webster). In the traditional approach group, an ICE catheter will not be used. Transseptal puncture will be performed under fluoroscopic guidance, with all geometries constructed by mapping the catheters. The primary efficacy endpoint is freedom from AF recurrence (without antiarrhythmic medications) at 12 months after ablation. Other endpoints include duration of lead apron use, measures of intra-procedural efficiency, and peri-procedural complications. This RCT will evaluate the efficacy and safety of ICE-guided minimal-fluoroscopy ablation in patients with PAF, also evaluate the benefits to lab staff (regarding reducing occupational hazards) related to this "minimal/zero-fluoroscopy" and "leadless" mode.

The lung is the second most common site of neuroendocrine tumors (NETs). Typical and atypical carcinoids are low-grade NETs of the lung. These rare tumors have received little attention and education is needed for treating physicians. The article describes the classifcation of lung NETs, the epidemiology and pathological characteristics. When lung NETs are diagnosed at an early stage, surgical intervention is often curative. For advanced lung NETs patients, different treatment methods including chemotherapy, somatostatin analogs, m-TOR inhibition, peptide receptor radioligand therapy, and biologic systemic therapy are discussed. The conclusions are generally extrapolated from the outcome of extra-pulmonary carcinoids. Prospective randomized well-designed trials are urgently needed to inform current recommendations on systemic treatment.
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Disease-Free Survival ; Drug Therapy ; methods ; Humans ; Lung ; drug effects ; radiation effects ; surgery ; Lung Neoplasms ; pathology ; surgery ; therapy ; Neoplasm Grading ; Neuroendocrine Tumors ; pathology ; surgery ; therapy ; Outcome Assessment (Health Care) ; Radiotherapy ; methods