Objective To addresses the challenges arising from the rapid expansion of pharmaceutical clinical trials and the growing demands for quality management,this paper investigates the application of low-code technology in project management.Its goals are to enhance the operational efficiency and execution capabilities of clinical trial institutions,ensure trial quality and safety,and accelerate the translation of pharmaceutical scientific achievements.Methods A brainstorming session was conducted to analyze the technical and functional requirements for managing pharmaceutical clinical trial projects.Utilizing the ＂template design＂ and ＂decision analysis＂ functionalities of low-code technology,the study adopted a modular and visually driven data management approach to develop a system compliant with Good Clinical Practice(GCP)standards.This system integrates key functionalities,including project progress management,funding management,drug inventory management,and quality control.Its effectiveness was evaluated through real-world operation and performance validation.Results The system had demonstrated stable operation with substantial improvements in practical application.Compared with conventional management approaches,it significantly enhanced project management efficiency:the time required for project schedule management was reduced by 80%,the efficiency of financial processing increased by 95%,drug inventory management efficiency improved by 75%,and the time spent on quality control was shortened by 60%.Conclusion The pharmaceutical clinical trial project management system developed using low-code technology offers substantial advantages and promising application potential.It represents a critical practice in applying digital and intelligent tools to advance pharmaceutical productivity in the medical and healthcare sectors.

Objective To addresses the challenges arising from the rapid expansion of pharmaceutical clinical trials and the growing demands for quality management,this paper investigates the application of low-code technology in project management.Its goals are to enhance the operational efficiency and execution capabilities of clinical trial institutions,ensure trial quality and safety,and accelerate the translation of pharmaceutical scientific achievements.Methods A brainstorming session was conducted to analyze the technical and functional requirements for managing pharmaceutical clinical trial projects.Utilizing the ＂template design＂ and ＂decision analysis＂ functionalities of low-code technology,the study adopted a modular and visually driven data management approach to develop a system compliant with Good Clinical Practice(GCP)standards.This system integrates key functionalities,including project progress management,funding management,drug inventory management,and quality control.Its effectiveness was evaluated through real-world operation and performance validation.Results The system had demonstrated stable operation with substantial improvements in practical application.Compared with conventional management approaches,it significantly enhanced project management efficiency:the time required for project schedule management was reduced by 80%,the efficiency of financial processing increased by 95%,drug inventory management efficiency improved by 75%,and the time spent on quality control was shortened by 60%.Conclusion The pharmaceutical clinical trial project management system developed using low-code technology offers substantial advantages and promising application potential.It represents a critical practice in applying digital and intelligent tools to advance pharmaceutical productivity in the medical and healthcare sectors.

Objective:To explore the effect of the treatment of tendinous mallet finger deformity by the minimally invasive percutaneous quantitative suture technique eight times.Methods:A retrospective analysis was performed on patients with fresh tendinous mallet fingers who underwent surgery in the Department of Hand and Foot Microsurgery of Nanjing Jiangbei Hospital from April 2021 to April 2022. During the procedure, the extensor digitalis tendon in the zone Ⅰ was sutured percutaneous with 3-0 thread monofilament sutures in the "quantitative 8-stitch method" according to the pre-marked number sequence of 1 to 8, and fixed at the base of the distal phalanx via a constructed bone tunnel. Removal of the Kirschner wire 8 weeks, the brace was used to fix the affected finger in the dorsal extension. The flexion and extension of the affected finger were gradually strengthened. The function of the affected finger was evaluated according to the Crawford standard after operation and follow-up: the active flexion and extension range of motion of each joint of the affected finger and the contralateral healthy finger was measured, and the total active ranges of motion of the finger were recorded. Finger function was evaluated according to the total active range of motion (TAM) system of the American Association of Hand Surgeons.Results:A total of 10 patients (10 digits) were enrolled, including 7 males and 3 females, and the age ranged from 20 to 52 years old, with an average age of 36.5 years old. The distance of tendon break was ≤10 mm. The operation time of the patients was 20-30 min, with an average of 24.5 min. The intraoperative blood loss was minimal. All 10 cases were followed up and the follow-up period was 6 to 12 months, with an average of 7 months. Mallet finger deformities were all corrected postoperatively, dorsal skin of fingers without a scar, there were no knot exposure, skin necrosis and other complications. At the last follow-up, the mean active range of motion of the distal interphalangeal joint was 84.4° and the mean TAM of the injured finger was 265.6°. According to TAM system assessment criteria: 8 cases were excellent, and 2 cases were good.Conclusions:Satisfactory therapeutic outcome for the treatment of tendinous mallet finger deformity can be achieved by the minimally invasive percutaneous quantitative suture technique eight times. It is a simple, safe, and effective method with minimal invasion.

Objective:To explore the effect of the treatment of tendinous mallet finger deformity by the minimally invasive percutaneous quantitative suture technique eight times.Methods:A retrospective analysis was performed on patients with fresh tendinous mallet fingers who underwent surgery in the Department of Hand and Foot Microsurgery of Nanjing Jiangbei Hospital from April 2021 to April 2022. During the procedure, the extensor digitalis tendon in the zone Ⅰ was sutured percutaneous with 3-0 thread monofilament sutures in the "quantitative 8-stitch method" according to the pre-marked number sequence of 1 to 8, and fixed at the base of the distal phalanx via a constructed bone tunnel. Removal of the Kirschner wire 8 weeks, the brace was used to fix the affected finger in the dorsal extension. The flexion and extension of the affected finger were gradually strengthened. The function of the affected finger was evaluated according to the Crawford standard after operation and follow-up: the active flexion and extension range of motion of each joint of the affected finger and the contralateral healthy finger was measured, and the total active ranges of motion of the finger were recorded. Finger function was evaluated according to the total active range of motion (TAM) system of the American Association of Hand Surgeons.Results:A total of 10 patients (10 digits) were enrolled, including 7 males and 3 females, and the age ranged from 20 to 52 years old, with an average age of 36.5 years old. The distance of tendon break was ≤10 mm. The operation time of the patients was 20-30 min, with an average of 24.5 min. The intraoperative blood loss was minimal. All 10 cases were followed up and the follow-up period was 6 to 12 months, with an average of 7 months. Mallet finger deformities were all corrected postoperatively, dorsal skin of fingers without a scar, there were no knot exposure, skin necrosis and other complications. At the last follow-up, the mean active range of motion of the distal interphalangeal joint was 84.4° and the mean TAM of the injured finger was 265.6°. According to TAM system assessment criteria: 8 cases were excellent, and 2 cases were good.Conclusions:Satisfactory therapeutic outcome for the treatment of tendinous mallet finger deformity can be achieved by the minimally invasive percutaneous quantitative suture technique eight times. It is a simple, safe, and effective method with minimal invasion.

Objective: To study the role of virtual gastroscopy simulator in the examination of clinical practice skills of gastrointestinal specialists. Methods: A multi-center empirical study was carried out. In June 2018, ninety participants from three tertiary care teaching hospitals in China, including Zhongshan Hospital of Fudan University, Shanghai Tongji Hospital and Xiangya Hospital of Central South University, took part in the examination. Participants were selected as follows: 30 specialists without any experience of gastroscopy exams, 30 with basic knowledge (gastroscopy exams <500 cases) and 30 with good skill (gastroscopy exams ≥500 cases). These 90 students participated in this empirical study after theoretical study and simulator training. Among them, 50 (55.6%) were undergraduates, 25 (27.8%) masters, and 15 (16.7%) doctors; 42 (46.7%) were residents, 39 (43.3%) attending physicians, and 9 (10.0%) deputy chief physicians. The assessment was divided into two parts. The first part was to use the simulator (GI mentor II) for ballooning within 10 minutes, with a total score of 40 points. The second part was a complete gastroscopy exam on the simulator, including preparation before gastroscopy exam, gastroscopy exam, post - exam management and related knowledge quiz. The difficulty and discrimination of the assessment plan were evaluated by the extreme grouping method parameters (difficulty P definition: <0.3 was difficult, 0.3 to 0.7 was medium, ≥0.7 was easy; discrimination degree D definition: <0 was poor, 0 to 0.2 was medium, ≥0.2 was good), and by comparing the virtual gastroscopy assessment scores of different experience, academic, and professional title groups. The score analysis of the student group was expressed using the mastering rate (the average score divided by the total score). The data of the normal distribution was represented by (mean±SD) (range), and the data of the nonnormal distribution was represented by M (P25, P75). Kruskal-Wallis non-parametric test was used for comparison between groups. Results: The total score of 90 students was (82.9±10.9) (55.8 to 99.0), and the mastering rate was 82.9%. The overall difficulty of the first and the second parts were 0.78 and 0.76, respectively, and the difficulty level was easy. The overall discrimination of the first and the second parts were 0.70 and 0.67, respectively, and the discrimination was good. The stratified analysis was performed according to the professional title. The median score was 83.2 (75.5, 89.0) in the residents, 82.5 (71.7, 93.6) in the attending physicians, and 93.5 (88.5, 99.0) in the deputy chief physicians, and the difference was statistically significant (H=6.213, P=0.045). According to the stratification analysis of academic qualifications, the median score was 81.7 (73.0, 87.5) in participants with undergraduate degree, 91.0 (79.0, 95.0) in those with master degree and 88.0 (81.7, 93.5) in those with doctor degree, whose difference was statistically significant (H=9.233, P=0.010). The stratified analysis of the second part showed that the median scores of the "operational process" part of the low, medium and high basis group were 33.0 (30.5, 36.5), 34.0 (32.0, 36.0) and 37.0 (35.0, 37.5), respectively, whose difference was statistically significant (H=7.603, P=0.022). The median scores of the "operational process" section of the resident, attending physician, and deputy chief physician were 33.0 (30.5, 35.0) points, 36.0 (34.0, 37.5) points and 37.0 (37.0, 37.5) points, respectively, whose difference was statistically significant (H=18.563, P=0.001). Conclusions The virtual gastroscopy simulator can reflect the true level of gastroscopy exam skills of the students. The examination questions are moderately difficult, and there is a good discrimination of the exam.

Objective To study the role of virtual gastroscopy simulator in the examination of clinical practice skills of gastrointestinal specialists. Methods A multi?center empirical study was carried out. In June 2018, ninety participants from three tertiary care teaching hospitals in China, including Zhongshan Hospital of Fudan University, Shanghai Tongji Hospital and Xiangya Hospital of Central South University, took part in the examination. Participants were selected as follows: 30 specialists without any experience of gastroscopy exams, 30 with basic knowledge (gastroscopy exams <500 cases) and 30 with good skill (gastroscopy exams ≥500 cases). These 90 students participated in this empirical study after theoretical study and simulator training. Among them, 50 (55.6%) were undergraduates, 25 (27.8%) masters , and 15 (16.7%) doctors; 42 (46.7%) were residents, 39 (43.3%) attending physicians, and 9 (10.0%) deputy chief physicians. The assessment was divided into two parts. The first part was to use the simulator (GI mentor II) for ballooning within 10 minutes, with a total score of 40 points. The second part was a complete gastroscopy exam on the simulator, including preparation before gastroscopy exam, gastroscopy exam, post ? exam management and related knowledge quiz. The difficulty and discrimination of the assessment plan were evaluated by the extreme grouping method parameters (difficulty P definition: <0.3 was difficult, 0.3 to 0.7 was medium,≥0.7 was easy; discrimination degree D definition: <0 was poor, 0 to 0.2 was medium, ≥0.2 was good), and by comparing the virtual gastroscopy assessment scores of different experience, academic, and professional title groups. The score analysis of the student group was expressed using the mastering rate (the average score divided by the total score). The data of the normal distribution was represented by (mean ± SD) (range), and the data of the nonnormal distribution was represented by M (P25, P75). Kruskal?Wallis non?parametric test was used for comparison between groups. Results The total score of 90 students was (82.9±10.9) (55.8 to 99.0), and the mastering rate was 82.9%. The overall difficulty of the first and the second parts were 0.78 and 0.76, respectively, and the difficulty level was easy. The overall discrimination of the first and the second parts were 0.70 and 0.67, respectively, and the discrimination was good. The stratified analysis was performed according to the professional title. The median score was 83.2 (75.5, 89.0) in the residents, 82.5 (71.7, 93.6) in the attending physicians, and 93.5 (88.5, 99.0) in the deputy chief physicians, and the difference was statistically significant (H=6.213, P=0.045). According to the stratification analysis of academic qualifications, the median score was 81.7 (73.0, 87.5) in participants with undergraduate degree, 91.0 (79.0, 95.0) in those with master degree and 88.0 (81.7, 93.5) in those with doctor degree, whose difference was statistically significant (H=9.233, P=0.010). The stratified analysis of the second part showed that the median scores of the "operational process" part of the low, medium and high basis group were 33.0 (30.5, 36.5), 34.0 (32.0, 36.0) and 37.0 (35.0, 37.5), respectively, whose difference was statistically significant (H=7.603, P=0.022). The median scores of the "operational process" section of the resident, attending physician, and deputy chief physician were 33.0 (30.5, 35.0) points, 36.0 (34.0, 37.5) points and 37.0 (37.0, 37.5) points, respectively, whose difference was statistically significant (H=18.563, P=0.001). Conclusions The virtual gastroscopy simulator can reflect the true level of gastroscopy exam skills of the students. The examination questions are moderately difficult, and there is a good discrimination of the exam.

Objective To study the role of virtual gastroscopy simulator in the examination of clinical practice skills of gastrointestinal specialists. Methods A multi?center empirical study was carried out. In June 2018, ninety participants from three tertiary care teaching hospitals in China, including Zhongshan Hospital of Fudan University, Shanghai Tongji Hospital and Xiangya Hospital of Central South University, took part in the examination. Participants were selected as follows: 30 specialists without any experience of gastroscopy exams, 30 with basic knowledge (gastroscopy exams <500 cases) and 30 with good skill (gastroscopy exams ≥500 cases). These 90 students participated in this empirical study after theoretical study and simulator training. Among them, 50 (55.6%) were undergraduates, 25 (27.8%) masters , and 15 (16.7%) doctors; 42 (46.7%) were residents, 39 (43.3%) attending physicians, and 9 (10.0%) deputy chief physicians. The assessment was divided into two parts. The first part was to use the simulator (GI mentor II) for ballooning within 10 minutes, with a total score of 40 points. The second part was a complete gastroscopy exam on the simulator, including preparation before gastroscopy exam, gastroscopy exam, post ? exam management and related knowledge quiz. The difficulty and discrimination of the assessment plan were evaluated by the extreme grouping method parameters (difficulty P definition: <0.3 was difficult, 0.3 to 0.7 was medium,≥0.7 was easy; discrimination degree D definition: <0 was poor, 0 to 0.2 was medium, ≥0.2 was good), and by comparing the virtual gastroscopy assessment scores of different experience, academic, and professional title groups. The score analysis of the student group was expressed using the mastering rate (the average score divided by the total score). The data of the normal distribution was represented by (mean ± SD) (range), and the data of the nonnormal distribution was represented by M (P25, P75). Kruskal?Wallis non?parametric test was used for comparison between groups. Results The total score of 90 students was (82.9±10.9) (55.8 to 99.0), and the mastering rate was 82.9%. The overall difficulty of the first and the second parts were 0.78 and 0.76, respectively, and the difficulty level was easy. The overall discrimination of the first and the second parts were 0.70 and 0.67, respectively, and the discrimination was good. The stratified analysis was performed according to the professional title. The median score was 83.2 (75.5, 89.0) in the residents, 82.5 (71.7, 93.6) in the attending physicians, and 93.5 (88.5, 99.0) in the deputy chief physicians, and the difference was statistically significant (H=6.213, P=0.045). According to the stratification analysis of academic qualifications, the median score was 81.7 (73.0, 87.5) in participants with undergraduate degree, 91.0 (79.0, 95.0) in those with master degree and 88.0 (81.7, 93.5) in those with doctor degree, whose difference was statistically significant (H=9.233, P=0.010). The stratified analysis of the second part showed that the median scores of the "operational process" part of the low, medium and high basis group were 33.0 (30.5, 36.5), 34.0 (32.0, 36.0) and 37.0 (35.0, 37.5), respectively, whose difference was statistically significant (H=7.603, P=0.022). The median scores of the "operational process" section of the resident, attending physician, and deputy chief physician were 33.0 (30.5, 35.0) points, 36.0 (34.0, 37.5) points and 37.0 (37.0, 37.5) points, respectively, whose difference was statistically significant (H=18.563, P=0.001). Conclusions The virtual gastroscopy simulator can reflect the true level of gastroscopy exam skills of the students. The examination questions are moderately difficult, and there is a good discrimination of the exam.

Objective: To investigate the incidence and pathogen distribution of ventilator-associated pneumonia (VAP) among preterm infants admitted to level Ⅲ neonatal intensive care units (NICU) in China. Method: A prospective study was conducted in 25 level Ⅲ NICU, enrolling all preterm infants <34 weeks gestational age admitted to the participating NICU within the first 7 days of life from May 2015 to April 2016. Chi-square test, t test and Mann-Whitney U test were used for statistical analysis. Result: A total of 7 918 patients were enrolled, within whom 4 623(58.4%) were males. The birth weight was (1 639±415) g and the gestational age was (31.4±2.0) weeks; 4 654(58.8%) infants required non-invasive mechanical ventilation and 2 154(27.2%) required intubation. Of all the mechanically ventilated patients, VAP occurred in 95 patients. The overall VAP rate was 7.0 episodes per 1 000 ventilator days, varying from 0 to 34.4 episodes per 1 000 ventilator days in different centers. The incidence of VAP was 9.6 and 6.0 per 1 000 ventilator days in children′s hospitals and maternity-infant hospitals respectively, without significant differences (t=1.002, P=0.327). Gram-negative bacilli (76 strains, 91.6%) were the primary VAP microorganisms, mainly Acinetobacter baumannii (24 strains, 28.9%), Klebsiella pneumonia (23 strains, 27.7%), and Pseudomonas aeruginosa (10 strains, 12.0%). Conclusion The incidence of VAP in China is similar to that in developed counties, with substantial variability in different NICU settings. More efforts are needed to monitor and evaluate the preventable factors associated with VAP and conduct interventions that could effectively reduce the occurrence of VAP.

Objective To study the effectiveness of family-integrated-care (FICare) for preterm infants with moderate to severe bronchopuhnonary dysplasia (BPD) in neonatal intensive care unit (NICU).Method Preterm infants with moderate to severe BPD in Hunan Children's Hospital from January 2015 to March 2016 were selected as the objects.These infants were assigned into two groups (FICare group and control group) in the base of whether the parents agreed to implement FICare.If the infant was enrolled into FICare group,the parents need to spend 3 hours in ward every day,and participate in nursing services under the guidance of nurses.The nursing services included bathing,cuddling,skin care,breast-feeding,and so on.If the infant was enrolled into control group,these nursing services were implemented by nurses.Oxygen exposure time,breast-feeding rate,time of begin oral feeding,time of total oral feeding,weight growth rate during hospitalization,weight of discharge,length of stay,readmission rate within 30 days,the rate of parents that mastered basic care knowledge and skills when discharge from hospital,the rate of satisfaction,and the rate of follow-up within 30 days of the two groups were compared.Result There were 106 cases in our study,54 in the FICare group and 52 in the control group.Compare the FICare group and the control group,there were statistical differences between two groups in the follow aspects (all P ＜ 0.05):oxygen exposure time [(57.1 ±20.9) d vs.(71.4 ±32.6) d],breast-feeding rate (77.8％ vs.44.2％),time of total oral feeding [(46.1 4 19.6) d vs.(59.4 ± 30.2) d,length of stay [(65.8 ± 18.4) d vs.(84.3 ±35.0) d],the rate of parents that mastered basic care knowledge and skills when discharge from hospital (96.3％ vs.82.7％),the rate of satisfaction (94.4％ vs.84.6％),the rate of follow-up within 30 days (92.6％ vs.73.1％).Conclusion FICare could significantly reduce oxygen exposure time of preterm infants with moderate to severe BPD,could improve the level of parents mastered basic care knowledge and skills of preterm infants,especially in critically ill preterm children,and could shorten length of stay of them.FICare is beneficial to the healthy growth of premature infants with BPD.

Objective To classify and grade the environments with Oncomelania hupensis snails inside embankment in marsh-land and lake areas,so as to improve the work efficiency and realize the systematic management. Methods The schistosomiasis endemic area Liaodi and Xiongdi villages in Jiangling County,Hubei Province were selected as the experiment villages,and the environments with snails in the two villages were divided into sections with a length of 500m,then the snail situation were sur-veyed by the systematic sampling method with 10m and 50m a frame respectively. The environments were classified according to the discovery of infected snails and wild fecal contamination,and the numbers of sites with snails and their areas in different class-es were recorded. Meanwhile,the data of sites with infected snails in Jingzhou City during the recent 5 years were collected and graded according to the average density of snails,so as to discuss the correlativity between the grades of environments with snails and the numbers of sites with infected snails and the occurrence rate of frames with snails. Results There were 1 967 sites with in-fected snails in Jingzhou City during the recent 5 years,and there was a positive correlation between the grades of environments with snails and the occurrence rate of frames with snails(rs=0.77,P<0.01),when the grade was 5,the constituent ratio of num-bers of sites with infected snails was 3.1%,and when the grade was 2-3,the ratio raised to 56.3%. There were 39 sites with snails in the two villages,the Class 1,2 and 3 environments included 1,18 and 20 sites,with the areas of 1 080,51 640 m2 and 41 220 m2 , respectively. There were no statistically significant difference between the grades divided by snail survey with 10m and 50m a frame(χ2=4.667,P>0.05),but the time-consuming of the former was 3 times of the latter. Conclusions The classification and grading of the environments with snails inside embankment in marshland and lake areas can master the key point of the snail survey. The subsection and setting frames at a suitable distance can save time and manpower,improve work efficiency,as well as understand the distribution of snail status of the environment with snails,which can realize the sort management of the snail envi-ronments inside embankment.