AIM:To evaluate the application effec-tiveness of a Bayesian mixture model based on the principal stratum strategy for estimating the com-plier average causal effect(CACE)in clinical trials with non-compliance.METHODS:Using a non-infe-riority randomized controlled trial investigating a novel drug for primary type 2 diabetes mellitus(non-inferiority margin:-0.4)as a case study,the primary analysis applied a Bayesian mixture model under the monotonicity assumption to estimate CACE of between-group differences in glycated he-moglobin(HbA1c)changes within the compliant stratum,followed by non-inferiority testing.Sensi-tivity analyses included a Bayesian mixture model relaxing the monotonicity assumption and compar-ing results with per-protocol set(PPS)analysis.RE-SULTS:In the primary analysis,the posterior mean of CACE for HbA1c change in the compliant stratum was 0.081％,with a one-sided 97.5％credible inter-val lower bound of-0.124,exceeding the non-infe-riority margin(-0.4％),supporting the non-inferiori-ty efficacy of the novel drug in the compliant stra-tum(P(H1|Data)=1).Consistent findings were ob-served in PPS analyses(estimated effect:0.136％;one-sided 97.5％credible interval lower bound:-0.069％),further validating methodological robust-ness.CONCLUSION:In clinical trials with noncom-pliance as an intercurrent event,the Bayesian mix-ture model under the principal stratum strategy ef-fectively adjusts for compliance-related bias and yields conservative,robust estimates of causal ef-fects,supporting its value in efficacy evaluation un-der complex compliance scenarios.

To investigate the antimicrobial resistance of Enterococci isolated from 596 anal swabs,feces and environmental samples were collected from pig,cattle,chicken and quail farms in Chang-sha,Hunan Province,Enterococci were isolated and identified by mass spectrometry.The minimum inhibitory concentrations(MICs)of 10 antimicrobial agents were determined by AGAR diffusion method.Whole genome sequencing(WGS)was used to detect the distribution of multilocus se-quence typing(ST),drug resistance genes and virulence genes.A total of 272 strains of Enterococ-cus were isolated(45.6％).The isolates were resistant to cefoxitin(68.9％)and cefotiofur(58.5％),followed by trimethoprim/sulfamethoxazole(52.2％),vancomycin(4.4％),and linezolid(13.6％).In this study,six linezolid highly resistant Enterococci isolates were analyzed by whole genome sequencing to explore the transmission mechanism of linezolid resistance because linezolid is forbidden to be used in aquaculture.ST403(4/6),ST16(1/6)and ST476(1/6)were the most common ST types,which all originated from the same farm.Three oxazolidinone resistance genes(cfr,poxtA and optrA)were found in all 21 strains.One strain(Ecc60)carried all three oxazo-lidinone resistance genes,but none of them were located on the plasmid.tet(M),aph(3')-Ⅲ,and lsa(A)were found in all six Enterococcus isolates.Interestingly,the present study is the first to i-dentify enterococci carrying the optrA gene in quail fecal samples.The analysis of the genetic envi-ronment of oxazolidinone resistance genes showed that the genetic environment of cfr(D),poxtA and optrA of isolates from the same farm was similar.A total of 19 virulence genes were detected in 6 isolates,of which 12 genes(ElrA,SrtA,ace,agg,cCF10,cOB1,cad,camE,ebpA,ebpC,efaAfs,tpx)were carried by all 6 isolates,and the types of virulence genes in strains from the same farm were extremely similar.The results showed that the drug resistance of Enterococci iso-lated from the fish farms in Changsha was serious,and the resistance rate to linezolid,which was prohibited in the fish farms,was high.The oxazolidinone resistance gene loci were accompanied by other resistance genes,especially the florfenicol resistance gene(FexA),which may be related to the abuse of florfenicol in the fish farms.

Objective:To summarize the surgical strategies and to evaluate the clinical outcomes of up-per urinary tract reconstruction in patients with stone-related ureteral strictures.Methods:This retro-spective study included 71 patients diagnosed with ureteral strictures secondary to urinary stones who un-derwent upper urinary tract reconstructive surgery at Peking University First Hospital between March 2014 and November 2023.Patient data were collected,including demographic characteristics,clinical presen-tation,laboratory results,imaging findings,surgical procedures,and follow-up outcomes.Ureteral stric-tures were classified according to anatomical location into upper,middle,lower,or multiple segments.Surgical procedures were carried out depending on the stricture characteristics.Surgical success was de-fined as resolution or improvement of clinical symptoms,radiographic improvement or stabilization of hy-dronephrosis,and maintenance of normal and stable renal function.Results:Among the 71 patients,36(50.7％)had strictures in the upper ureter,9(12.7％)in the middle ureter,15(21.1％)in the lower ureter,and 11(15.5％)had multifocal ureteral strictures.The median stricture length was 5.0 cm(interquartile range:3.0-15.0 cm).Surgical approach selection was individualized based on the location and extent of the stricture.For upper ureteral strictures,the most frequently employed techniques were oral mucosal graft ureteroplasty(13/36,36.1％)and appendiceal flap ureteroplasty(8/36,22.2％).Other options included ureteroureterostomy and ileal ureter replacement for longer or more complex strictures.In middle ureteral strictures,treatment was stratified by length:balloon dilation(1/9,11.1％)and ureteroureterostomy(1/9,11.1％)were applied in shorter strictures,while oral mucosal graft ureteroplasty(3/9,33.3％)and ileal ureter replacement(4/9,44.4％)were reserved for longer segments.For lower ureteral strictures,ureteral reimplantation into the bladder was the most common approach(10/15,66.7％),often combined with a psoas hitch or Boari flap when necessary.All the patients with multiple segmental strictures underwent ileal ureter replacement due to the extensive nature of the disease.The median follow-up period was 14.2 months(range:6.1-107.1 months).During follow-up,69 of 71 patients(97.2％)achieved surgical success.Conclusion:Stone-related ure-teral strictures present with considerable heterogeneity in terms of anatomical location,length,and com-plexity.Careful preoperative evaluation and individualized surgical planning are critical to successful re-construction.With appropriate selection of surgical methods,favorable long-term clinical outcomes can be achieved in the majority of patients.

Objective:To explore the effect of hospital-community continuous management based on mobile health and dyadic coping intervention in ileostomy patients and their spouses.Methods:This was a randomized controlled trial. Patients with rectal cancer who underwent ileostomy at Taizhou People′s Hospital between August 2018 and August 2023, along with their spouses, were enrolled. Patient-spouse dyads were randomly assigned to either the intervention group or the control group using a random number table method. Baseline demographic data were collected from both groups. The control group received routine care, whereas the intervention group was given a hospital-community transitional care program based on mHealth (mobile health) and a dyadic coping model. Stoma adaptation, family functioning, and dyadic coping capacity were evaluated at 1 week, 1 month, and 3 months postoperatively. Sedentary behavior time and exercise compliance were also assessed at 1 month and 3 months after surgery.Results:A total of 47 patient-spouse dyads were included in the control group and 48 dyads in the intervention group. There were no statistically significant differences in baseline characteristics between the two groups (all P>0.05). Similarly, no significant differences were found in the age, sex or education level of the spouses (all P>0.05). At 1 week postoperatively, there were no significant differences in family cohesion and adaptability scores between the two groups (all P>0.05). However, at 1 and 3 months postoperatively, the intervention group had significantly higher family cohesion and adaptability scores than the control group (all P<0.05). With regard to dyadic coping capacity, no significant differences were observed in any of the subscale scores of the dyadic coping questionnaire at 1 week postoperatively (all P>0.05). At 1 and 3 months postoperatively, the intervention group scored significantly higher than the control group on stress communication, supportive coping, delegated coping, and joint coping ( P<0.05), but lower on negative coping ( P<0.05). In terms of stoma adaptation, no significant difference was found between the two groups at 1 week postoperatively ( P>0.05). At 1 and 3 months postoperatively, the intervention group showed significantly higher stoma adaptation and exercise compliance scores, as well as shorter sedentary behavior time, compared to the control group (all P<0.05). Conclusions:The hospital-community transitional care program developed by the research team effectively improves family functioning, dyadic coping capacity in ileostomy patient-spouse dyads, and postoperative stoma adaptation and rehabilitation outcomes.

To explore the application of sequential analysis in post-market safety dynamic surveillance of vaccines. Under the dynamic monitoring data of vaccines post-market approval, this research introduces the fundamental principles of maximizing sequential probability ratio test (MaxSPRT) and Bayesian sequential analysis, employing R software. Through an example of dynamic safety monitoring data of vaccines post-market approval, we analyze using the MaxSPRT and Bayesian sequential analysis. The MaxSPRT identified a safety signal in week 4 ( P<0.05), while Bayesian sequential analysis indicated that the 95% highest density interval for the RR value at week 4 is 1.13-3.27, suggesting the first appearance of a safety signal at week 4. The MaxSPRT and Bayesian sequential analysis effectively leverage continuously accumulating dynamic monitoring data, thereby serving as a valuable method for post-market safety surveillance of vaccines.

Objective:Based on data from the Global Burden of Disease Study 2021 (GBD 2021), this study aims to analyze the epidemiological trends of inflammatory bowel diseases (IBD) in China from 1990 to 2021 and to assess the projected disease burden.Methods:Data on incidence, prevalence, mortality, and disability-adjusted life years (DALY) for IBD in China from 1990 to 2021 were extracted from the GBD 2021 database. Annual percent change (EAPC) and Bayesian age-period-cohort (BAPC) analyses were employed to evaluate these trends. Additionally, predictions for the disease burden over the next 25 years were made.Results:The age-standardized incidence rate of IBD in China rose from 0.74 per 100 000 in 1990 to 1.40 per 100 000 in 2021, an 89.19% increase. The age-standardized prevalence rate increased from 5.59 per 100 000 in 1990 to 9.16 per 100 000 in 2021, marking a 63.86% rise. Conversely, the age-standardized case fatality rate decreased from 0.75 per 100 000 in 1990 to 0.33 per 100 000 in 2021, a reduction of 56.00%. The total DALYs decreased from 162 186 in 1990 to 136 932 in 2021, a decline of 15.57%, while the age-standardized DALY rate fell from 18.38 per 100 000 in 1990 to 7.68 per 100 000 in 2021, a decrease of 58.22%. Analysis by age group revealed that the age-standardized incidence rate for the 35-39 years cohort increased most significantly, with an EAPC of 3.23%. The age-standardized prevalence rate for the 50-54 years cohort increased most significantly, with an EAPC of 2.85%. Gender analysis indicated that from 1990 to 2021, the age-standardized prevalence rate was higher among females than males, but the age-standardized case fatality rate rate was higher among males. From 2004 to 2021, the age-standardized DALY rate declined for both sexes, though it remained higher in males. By 2046, the number of new cases is projected to be slightly higher in males, while case fatality rate and DALYs are expected to remain low for both genders.Conclusions:Over the past three decades, the disease burden of IBD in China has increased significantly, particularly in terms of incidence and prevalence. Despite a general decrease in case fatality rates, the burden of IBD may increase in the elderly population due to aging demographics. Therefore, effective preventive measures, early screening, and aggressive treatment are crucial, especially for the elderly.

Objective:To summarize the surgical strategies and to evaluate the clinical outcomes of up-per urinary tract reconstruction in patients with stone-related ureteral strictures.Methods:This retro-spective study included 71 patients diagnosed with ureteral strictures secondary to urinary stones who un-derwent upper urinary tract reconstructive surgery at Peking University First Hospital between March 2014 and November 2023.Patient data were collected,including demographic characteristics,clinical presen-tation,laboratory results,imaging findings,surgical procedures,and follow-up outcomes.Ureteral stric-tures were classified according to anatomical location into upper,middle,lower,or multiple segments.Surgical procedures were carried out depending on the stricture characteristics.Surgical success was de-fined as resolution or improvement of clinical symptoms,radiographic improvement or stabilization of hy-dronephrosis,and maintenance of normal and stable renal function.Results:Among the 71 patients,36(50.7％)had strictures in the upper ureter,9(12.7％)in the middle ureter,15(21.1％)in the lower ureter,and 11(15.5％)had multifocal ureteral strictures.The median stricture length was 5.0 cm(interquartile range:3.0-15.0 cm).Surgical approach selection was individualized based on the location and extent of the stricture.For upper ureteral strictures,the most frequently employed techniques were oral mucosal graft ureteroplasty(13/36,36.1％)and appendiceal flap ureteroplasty(8/36,22.2％).Other options included ureteroureterostomy and ileal ureter replacement for longer or more complex strictures.In middle ureteral strictures,treatment was stratified by length:balloon dilation(1/9,11.1％)and ureteroureterostomy(1/9,11.1％)were applied in shorter strictures,while oral mucosal graft ureteroplasty(3/9,33.3％)and ileal ureter replacement(4/9,44.4％)were reserved for longer segments.For lower ureteral strictures,ureteral reimplantation into the bladder was the most common approach(10/15,66.7％),often combined with a psoas hitch or Boari flap when necessary.All the patients with multiple segmental strictures underwent ileal ureter replacement due to the extensive nature of the disease.The median follow-up period was 14.2 months(range:6.1-107.1 months).During follow-up,69 of 71 patients(97.2％)achieved surgical success.Conclusion:Stone-related ure-teral strictures present with considerable heterogeneity in terms of anatomical location,length,and com-plexity.Careful preoperative evaluation and individualized surgical planning are critical to successful re-construction.With appropriate selection of surgical methods,favorable long-term clinical outcomes can be achieved in the majority of patients.

Objective:To evaluate the ability of ENDOANGEL artificial intelligence system to predict invasion depth and differentiation status of early gastric cancer using more diverse multi-center videos, and to test the performance of the new system upgraded from ENDOANGEL.Methods:Based on the completed 2020 man-machine competition for early gastric cancer diagnosis using single-center videos, the second man-machine competition was conducted in 2022, involving 30 endoscopists from 30 hospitals across 10 Chinese provinces. A multi-center video cohort was retrospectively collected from 12 institutions in 8 provinces/municipalities in China. The study proceeded in 3 stages. First, the ENDOANGEL was re-tested on multi-center videos, its performance on single and multi-center videos was compared, then the ENDOANGEL was upgraded to ENDOANGEL-2022. Second, the second man-machine competition was conducted between ENDOANGEL-2022 and 30 endoscopists using multi-center videos, and the performance between ENDOANGEL-2022, ENDOANGEL and endoscopists on multi-center videos were compared. Third, the ENDOANGEL-2022 was re-tested on the single-center videos previously collected in 2020, its performance on single and multi-center videos was also compared.Results:Compared with the performance on single-center videos, the sensitivity of ENDOANGEL for predicting submucosal invasion of early gastric cancer decreased significantly [18.18% (2/11) VS 70.00% (7/10), P=0.030], but demonstrated comparable ability to predict undifferentiated type of early gastric cancer ( P>0.05). On multi-center videos, in the respect of predicting submucosal invasion of early gastric cancer, the sensitivity of ENDOANGEL-2022 was higher than that of ENDOANGEL [40.00% (4/10) VS 18.18% (2/11), P=0.361], but inferior to that of 30 endoscopists [40.00% VS 52.04% (95% CI: 43.70%-60.38%), P<0.001]. The specificity of ENDOANGEL-2022 was lower than that of ENDOANGEL [82.86% (29/35) VS 100.00% (34/34), χ2=4.41, P=0.036] and higher than that of 30 endoscopists [82.86% VS 68.97% (95% CI: 60.83%-77.11%), P=0.018], the accuracy of ENDOANGEL-2022 was lower than that of ENDOANGEL [73.33% (33/45) VS 80.00% (36/45), χ2=0.56, P=0.455] and higher than that of 30 endoscopists [73.33% VS 65.30% (95% CI: 60.61%-69.99%), P=0.018]. In the respect of predicting undifferentiated type of early gastric cancer, the sensitivity of ENDOANGEL-2022 was higher than that of ENDOANGEL [71.43% (5/7) VS 57.14% (4/7), P>0.999] and 30 endoscopists [71.43% VS 63.11% (95% CI: 55.58%-70.64%), P=0.031], the specificity of ENDOANGEL-2022 was lower than that of ENDOANGEL [76.32% (29/38) VS 78.95% (30/38), χ2=0.08, P=0.783] and higher than that of 30 endoscopists [76.32% VS 65.27% (95% CI: 59.10%-71.44%), P=0.004],the accuracy of ENDOANGEL-2022 was similar to that of ENDOANGEL [75.56% (34/45) VS 75.56% (34/45), χ2=0.00, P>0.999] and higher than that of 30 endoscopists [75.56% VS 65.10% (95% CI: 59.96%- 70.24%), P<0.001]. Compared with performance in single center videos, the sensitivity [40.00% VS 60.00%(6/10), P=0.656], specificity [82.86% VS 93.75% (15/16), χ2=0.37, P=0.542] and accuracy [73.33% VS 80.77% (21/26), χ2=0.50, P=0.479] of ENDOANGEL-2022 for predicting submucosal invasion of early gastric cancer decreased; in predicting undifferentiated type of early gastric cancer, the sensitivity of ENDOANGEL-2022 increased [71.43% VS 37.50% (3/8), P=0.315], while the specificity [76.32% VS 100.00% (18/18), χ2=3.48, P=0.062] and accuracy [75.56% VS 80.77% (21/26), χ2=0.26, P=0.612] decreased. Conclusion:Multi-center cases introduce greater heterogeneity that may reduce artificial intelligence prediction accuracy, but the artificial intelligence system still outperforms endoscopists.

Objective:To explore status and influencing factors of surveillance in colorectal post-polypectomy patients.Methods:Patients who underwent colorectal polypectomy in Renmin Hospital of Wuhan University between April 1, 2019 and June 30, 2019 were retrospectively studied. The surveillance information was obtained through electronic health record and telephone call. Status and influencing factors of surveillance in colorectal post-polypectomy patients were evaluated. Logistic regression model was used for multivariate analysis to determine independent risk factors influencing surveillance.Results:A total of 268 colorectal post-polypectomy patients and their surveillance information were reviewed, of whom 153 (57.09%) patients received surveillance colonoscopy, and 115 (42.91%) patients did not. Univariate analysis showed that the source of patients (outpatients VS inpatients, χ 2=5.68, P=0.017), department (others VS department of gastroenterology, χ 2=6.64, P=0.010), and the number of polyps (1/(2~4)/≥5, χ2=7.32, P=0.026) influenced the outcome of surveillance. Logistic regression model indicated that department of gastroenterology ( P=0.039, OR=2.12, 95% CI:1.04-4.34), risk level 3 ( P=0.040, OR=1.92, 95% CI:1.03-3.58) and the number of polyps ≥5 ( P=0.016, OR=2.89, 95% CI:1.22-6.83) were independent risk factors influencing surveillance. Conclusion:Patients visit the department of gastroenterology or had a risk level 3 or ≥5 polyps are more likely to opt for surveillance following the procedure.

To explore the application of sequential analysis in post-market safety dynamic surveillance of vaccines. Under the dynamic monitoring data of vaccines post-market approval, this research introduces the fundamental principles of maximizing sequential probability ratio test (MaxSPRT) and Bayesian sequential analysis, employing R software. Through an example of dynamic safety monitoring data of vaccines post-market approval, we analyze using the MaxSPRT and Bayesian sequential analysis. The MaxSPRT identified a safety signal in week 4 ( P<0.05), while Bayesian sequential analysis indicated that the 95% highest density interval for the RR value at week 4 is 1.13-3.27, suggesting the first appearance of a safety signal at week 4. The MaxSPRT and Bayesian sequential analysis effectively leverage continuously accumulating dynamic monitoring data, thereby serving as a valuable method for post-market safety surveillance of vaccines.