Objective:To summarize the practical experience of constructing an intelligent quality control system for electronic medical record (EMR) in clinical trials, providing reference for continuously improving the quality of clinical trials.Methods:Quality control rules for clinical trial EMR were established, and an intelligent quality control platform was developed to enable dynamic monitoring, interception, early warning, and evaluation. A hybrid quality control system integrating real-time and terminal quality control was constructed, alongside a three-dimensional linkage mechanism encompassing training, quality control, and evaluation.Results:Through the extensive application of information technology and the implementation of a multi-level quality control network, a quality control loop characterized by ″Efficient machine screening and precise human decision-making″ was achieved to enhance management quality and efficiency. However, challenges such as the standardization of quality control rules, data security and privacy protection, and system interface heterogeneity were persistent.Conclusions:The development of an intelligent quality control system for clinical trial EMR represents a critical step in advancing clinical trial quality management. Nevertheless, ongoing optimization of technical solutions is essential to address existing challenges and further improve system performance.

Objective:To evaluate the effectiveness of a patient-family-centered visiting model in improving caregivers'beliefs and attitudes toward visiting patients with mental disorders.Methods:A total of 140 caregivers of inpatients diagnosed with mental disorders according to the ICD-10 were randomly assigned to an intervention group(n=71)and a control group(n=69).The intervention group participated a patient-family-centered visiting model for 4 weeks,while the control group followed routine visitation.Caregivers' beliefs and attitudes were assessed using the Beliefs and Attitudes toward Visitation in ICU Questionnaire(BAVIQ)was used to assess the improvement in caregivers' beliefs and attitudes before the intervention and at the end of the 1st,2nd,3rd,and 4th weeks after the intervention.Results:Repeated measures ANOVA showed that the belief score and attitude score of the BAVIQ questionnaire in the intervention group were significantly higher than those in the control group(Ps＜0.05)across time points.Chi-square test further confirmed that the improvement in the intervention group were significantly bet-ter than in the control group(Ps＜0.05).Conclusion:The patient-family-centered visiting model is more effective than routine visiting model in improving the caregivers' visiting beliefs and attitudes in mental health settings.

Objective To meet the clinical need for dynamic monitoring on lactate metabolism in septic shock pa-tients,a time-series prediction model based on a long short-term memory(LSTM)network was developed to predict 24-hour lactate clearance rate at admission.Methods A multi-stage retrospective cohort design was adopted to en-roll septic shock patients admitted to the department of critical care medicine of a hospital from January 2018 to Sep-tember 2024.By conducting univariate analysis and LASSO combined feature screening,predictive factors were extracted from multidimensional clinical data.An end-to-end LSTM framework(two-layer 64/32 units,dropout rate=0.3)was constructed.A sliding window strategy(six-hour step size)was adopted for dynamic prediction and compared with traditional logistic model in terms of three dimensions:calibration(Brier score),discrimination(area under the curve[AUC]of time-dependent receiver operating characteristic[ROC]),and clinical practicality(deci-sion curve analysis).Consistency between model prediction result and actual lactate clearance rate was analyzed,and the accuracy of prediction was evaluated.Results A total of 112 septic shock patients were enrolled in the analysis,including 65 males and 47 females,with an average age of(67.35±7.28)years.65 patients were assigned in the lactate good clearance rate group(lactate good clearance rate≥10％)and 47 in the lactate poor clearance rate group(lactate good clearance rate＜10％);78 patients were in the training set and 34 in the validation set.Time-depen-dent AUC analysis revealed that the predictive performance of the LSTM model in the time windows of 6,12,and 24 hours were 0.89(0.85-0.93),0.91(0.88-0.95),and 0.92(0.89-0.96),respectively,superior to the logistic regression model(ΔAUC=0.085,P＜0.01).The core predictive factors included APACHE Ⅱ score(OR=1.38),lactate level at admission(OR=1.65),vasoactive drug dosage(OR=1.42),and 6-hour fluid resuscitation dosage(OR=1.35).The Pearson correlation coefficient between the predicted value of the model and the actual 24-hour lactate clearance rate was 0.83(P＜0.001),with an average absolute error of 8.2％.Decision curve analysis confirmed that when the threshold probability was 15％-60％,the LSTM model could increase clinical net benefits by 27.3％.The validation of each subgroup showed that the model maintained the optimal predictive performance(AUC=0.87)in the lung infection subgroup(n=16).Conclusion The LSTM-based dynamic prediction model for predicting 24-hour lactate clearance rate through integrating early admission indicators demonstrates excellent pre-dictive performance and clinical application value,which can provide important reference for individualized treatment decisions in septic shock patients.

Objective To compare the clinical efficacy of resecting epiglottic cysts using low-tem-perature plasma scalpel versus ultrasonic scalpel under suspension laryngoscopy.Methods A total of 120 patients with epiglottic cysts were selected and divided into plasma group and ultrasonic scalpel group,with 60 cases in each group.The plasma group underwent resection of epiglottic cysts with low-temperature plasma scalpel under suspension laryngoscopy,while the ultrasonic scalpel group was trea-ted with ultrasonic scalpel under suspension laryngoscopy.The operation time,the time from postoper-ation to complete wound healing,and the amount of bleeding during treatment were recorded.Pain levels at 1,3,and 5 d after treatment,as well as the effectiveness of treatment and complication rates one month later were compared between the two groups.Results The operation time and blood loss in the plasma group were lower or shorter than those in the ultrasonic scalpel group(P＜0.05).The wound healing time in the plasma group was shorter,postoperative pain was less,and the incidence of complications was lower in the ultrasonic scalpel group compared to the ultrasonic scalpel group(P＜0.05).Conclusion Under suspension laryngoscopy,the low-temperature plasma scalpel is more ef-fective in treating epiglottic cysts than the ultrasonic scalpel,which can shorten operation time and re-duce blood loss,alleviate pain,and decrease the rate of complications.

Objective:To evaluate the effectiveness of a patient-family-centered visiting model in improving caregivers'beliefs and attitudes toward visiting patients with mental disorders.Methods:A total of 140 caregivers of inpatients diagnosed with mental disorders according to the ICD-10 were randomly assigned to an intervention group(n=71)and a control group(n=69).The intervention group participated a patient-family-centered visiting model for 4 weeks,while the control group followed routine visitation.Caregivers' beliefs and attitudes were assessed using the Beliefs and Attitudes toward Visitation in ICU Questionnaire(BAVIQ)was used to assess the improvement in caregivers' beliefs and attitudes before the intervention and at the end of the 1st,2nd,3rd,and 4th weeks after the intervention.Results:Repeated measures ANOVA showed that the belief score and attitude score of the BAVIQ questionnaire in the intervention group were significantly higher than those in the control group(Ps＜0.05)across time points.Chi-square test further confirmed that the improvement in the intervention group were significantly bet-ter than in the control group(Ps＜0.05).Conclusion:The patient-family-centered visiting model is more effective than routine visiting model in improving the caregivers' visiting beliefs and attitudes in mental health settings.

Objective To meet the clinical need for dynamic monitoring on lactate metabolism in septic shock pa-tients,a time-series prediction model based on a long short-term memory(LSTM)network was developed to predict 24-hour lactate clearance rate at admission.Methods A multi-stage retrospective cohort design was adopted to en-roll septic shock patients admitted to the department of critical care medicine of a hospital from January 2018 to Sep-tember 2024.By conducting univariate analysis and LASSO combined feature screening,predictive factors were extracted from multidimensional clinical data.An end-to-end LSTM framework(two-layer 64/32 units,dropout rate=0.3)was constructed.A sliding window strategy(six-hour step size)was adopted for dynamic prediction and compared with traditional logistic model in terms of three dimensions:calibration(Brier score),discrimination(area under the curve[AUC]of time-dependent receiver operating characteristic[ROC]),and clinical practicality(deci-sion curve analysis).Consistency between model prediction result and actual lactate clearance rate was analyzed,and the accuracy of prediction was evaluated.Results A total of 112 septic shock patients were enrolled in the analysis,including 65 males and 47 females,with an average age of(67.35±7.28)years.65 patients were assigned in the lactate good clearance rate group(lactate good clearance rate≥10％)and 47 in the lactate poor clearance rate group(lactate good clearance rate＜10％);78 patients were in the training set and 34 in the validation set.Time-depen-dent AUC analysis revealed that the predictive performance of the LSTM model in the time windows of 6,12,and 24 hours were 0.89(0.85-0.93),0.91(0.88-0.95),and 0.92(0.89-0.96),respectively,superior to the logistic regression model(ΔAUC=0.085,P＜0.01).The core predictive factors included APACHE Ⅱ score(OR=1.38),lactate level at admission(OR=1.65),vasoactive drug dosage(OR=1.42),and 6-hour fluid resuscitation dosage(OR=1.35).The Pearson correlation coefficient between the predicted value of the model and the actual 24-hour lactate clearance rate was 0.83(P＜0.001),with an average absolute error of 8.2％.Decision curve analysis confirmed that when the threshold probability was 15％-60％,the LSTM model could increase clinical net benefits by 27.3％.The validation of each subgroup showed that the model maintained the optimal predictive performance(AUC=0.87)in the lung infection subgroup(n=16).Conclusion The LSTM-based dynamic prediction model for predicting 24-hour lactate clearance rate through integrating early admission indicators demonstrates excellent pre-dictive performance and clinical application value,which can provide important reference for individualized treatment decisions in septic shock patients.

Objective:To summarize the practical experience of constructing an intelligent quality control system for electronic medical record (EMR) in clinical trials, providing reference for continuously improving the quality of clinical trials.Methods:Quality control rules for clinical trial EMR were established, and an intelligent quality control platform was developed to enable dynamic monitoring, interception, early warning, and evaluation. A hybrid quality control system integrating real-time and terminal quality control was constructed, alongside a three-dimensional linkage mechanism encompassing training, quality control, and evaluation.Results:Through the extensive application of information technology and the implementation of a multi-level quality control network, a quality control loop characterized by ″Efficient machine screening and precise human decision-making″ was achieved to enhance management quality and efficiency. However, challenges such as the standardization of quality control rules, data security and privacy protection, and system interface heterogeneity were persistent.Conclusions:The development of an intelligent quality control system for clinical trial EMR represents a critical step in advancing clinical trial quality management. Nevertheless, ongoing optimization of technical solutions is essential to address existing challenges and further improve system performance.

Objective The amplitude of low-frequency fluctuation(ALFF)resting state functional magnetic resonance imaging(rs-fMRI)was used to investigate the signals image in the brain functional areas of overactive bladder(OAB)patients.Methods OAB patients treated in 3 participating hospitals during Mar.2021 and Mar.2023 were selected as the OAB group(n=14).Healthy subjects matching the gender,age and years of education of the patients in the OAB group were collected as the control group(NC group,n=14).Changes in the over active bladder symptom score(OABSS),quality of life scale(QoL),self-rating depression scale(SDS),self-rating anxiety scale(SAS)were analyzed.All subjects underwent rs-fMRI to collect blood oxygen level dependent magnetic resonance signals,which were then processed with ALFF.Two-sample t-test was conducted on the results to obtain the different brain regions.Results The OABSS[(8.07±0.37)vs.(1.21±0.18)],QoL[(4.85±0.21)vs.(0.64±0.13)],SAS[(60.14±1.40)vs.(37.64±1.57)]and SDS[(52.50±1.29)vs.(36.14±0.34)]scores of the OAB group were higher than those of the NC group,with significant differences(P＜0.05).The brain regions with significant differences in ALFF were located in the left supplementary motor area,left medial superior frontal gyrus and right anterior central gyrus(P＜0.000 1).Conclusion The abnormal spontaneous activity and coordination ability of the brain in resting state may lead to OAB symptoms,which are displayed in the abnormal functions of the left supplementary motor area,left medial superior frontal gyrus and right anterior central gyrus.

Objective:To compare the surgical efficacy of pericardial soft ring tricuspid valvuloplasty with DeVega and artificial valvuloplasty.Methods:227 patients undergoing tricuspid valvuloplasty due to rheumatic heart disease complicated with functional tricuspid valve insufficiency were retrospectively analyzed and divided into 3 groups according to tricuspid valvuloplasty dynamic cohort(pericardial ring group, 89 cases; the artificial flap ring group, 61 cases, and the DeVega group, 77 cases) were matched 1∶1 for propensity score(match A: pericardial ring group and artificial flap ring group; match B: pericardial ring group and DeVega group), the successful matching was included in follow-up and data collection, and cases with incomplete case data during follow-up were removed from the study cohort in pairs according to matching conditions. The results of follow-up 1 month, 6 months and 24 months after surgery were compared.Results:1 month after operation: the tricuspid valve regurgitant in all groups was significantly reduced or even disappeared compared with that before operation, and the right atrium and right ventricle were also smaller than that before operation, with statistical significance( P<0.05). 6 months after surgery: There was no statistical significance in the area of tricuspid regurgitation and right atrial/indoor diameter between all groups compared with the results one month after surgery( P>0.05), and there was no statistical significance in the recurrence rate of tricuspid regurgitation between all groups( P>0.05). 24 months after surgery: There were no significant differences in the recurrence rate of tricuspid regurgitation, area of tricuspid regurgitation and right atrial/indoor diameter between the two groups in matching A( P>0.05). There was no statistical significance in the right atrial/indoor diameter between the matched pericardial ring group and the Devega group, but the tricuspid valve regurgentation area of the Devega group at 24 months after surgery was higher than that of the Devega group at 1 month after surgery, and the difference was statistically significant( P<0.05). The regurgitation area and recurrence rate of tricuspid valve were significantly higher than those of pericardium-TVP group( P<0.05). Conclusion:Pericardial soft ring tricuspid valvuloplasty can effectively correct functional tricuspid valvuloplasty and reverse right heart remodeling, which is an effective tricuspid valvuloplasty.

Objective::Data comparing the outcomes of MiStent (Micell Technologies, Durham, North Carolina, USA) microcrystalline biodegradable polymer (BP) drug-eluting stent (DES) and those of another post-marketing BP-DES, TIVOLI (EssenTech, Beijing, China) are rare. This study sought to compare the angiographic efficacy and clinical outcomes of the microcrystalline BP sirolimus-eluting stent (SES) system MiStent and those of TIVOLI BP-SES.Methods::The DESSOLVE-C trial was a prospective, single-blinded, multicenter, randomized trial (NCT02448524), which randomly assigned patients with de novo coronary lesions to receive MiStent or TIVOLI BP-SES by a 1:1 ratio. The primary endpoint was a non-inferiority comparison of in-stent late lumen loss (LLL) by quantitative coronary angiography at 9 months. The secondary endpoint was device-related clinical cardiovascular composite events (target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction (MI), and clinically driven target lesion revascularization) and 1-year outcomes. Results::A total of 428 patients (216 patients in the MiStent group and 212 patients in the TIVOLI group) were enrolled and included in an intention-to-treat analysis. MiStent was not only non-inferior but superior to TIVOLI for in-stent LLL at 9 months ((0.23 ± 0.37) mm vs. (0.34 ± 0.48) mm, P for non-inferiority <0.001, P for superiority = 0.02). Although without significant difference, the rate of TLF in MiStent was quantitatively lower than that in TIVOLI (3.70% vs. 6.60%; P = 0.17). Conclusion::Compared with TIVOLI BP-SES, the MiStent system was superior in in-stent LLL at 9 months and had a comparable clinical benefit at 1 year in de novo coronary lesions.