1.Break the domestic public hospital clinical research evaluation system under the background of"five only"
Xiaowen CHEN ; Yongkai ZHU ; Yingyan ZHENG ; Yuhui LIN ; Peng SHI ; Liyuan HAN ; Pin JIA ; Rui DONG
Modern Hospital 2024;24(3):465-468,492
Objective The purpose of this article is to summarize and review the current status of the construction of clinical research evaluation systems in domestic public hospitals,identify existing problems in the evaluation system,and propose development strategies and suggestions.Methods Retrieved relevant articles,dissertations and policies from the past five years(2018-2022),screened the titles,viewed the full texts of 52 selected papers and their references,and summarized them.Results The"five-only"indicators have long been an important indicator for evaluating clinical research in public hospitals,but in today's scientific research environment and policy environment,the"five-only"evaluation system has revealed its utilitarian draw-backs and gradually evolved into a hindrance to scientific research.It is urgent to break through the"five-only"orientation and establish a clinical research evaluation system oriented towards"transforming and applying transformation of scientific research achievements".Conclusion The evaluation system for clinical research should break the previous"five-only"evaluation model based on quantity-oriented scientific research evaluation.We can draw on the framework of the research output,influence,and environment indicators in the UK's REF Excellence Framework model,combine the American APT system and the Chinese STEM indicator dimensions,explore multi-outcome evaluation,integrate developmental indicators,and continuously improve the indica-tor system and application methods in practice to promote the development of clinical research in public hospitals.
2.Incidence of postoperative complications in Chinese patients with gastric or colorectal cancer based on a national, multicenter, prospective, cohort study
Shuqin ZHANG ; Zhouqiao WU ; Bowen HUO ; Huining XU ; Kang ZHAO ; Changqing JING ; Fenglin LIU ; Jiang YU ; Zhengrong LI ; Jian ZHANG ; Lu ZANG ; Hankun HAO ; Chaohui ZHENG ; Yong LI ; Lin FAN ; Hua HUANG ; Pin LIANG ; Bin WU ; Jiaming ZHU ; Zhaojian NIU ; Linghua ZHU ; Wu SONG ; Jun YOU ; Su YAN ; Ziyu LI
Chinese Journal of Gastrointestinal Surgery 2024;27(3):247-260
Objective:To investigate the incidence of postoperative complications in Chinese patients with gastric or colorectal cancer, and to evaluate the risk factors for postoperative complications.Methods:This was a national, multicenter, prospective, registry-based, cohort study of data obtained from the database of the Prevalence of Abdominal Complications After Gastro- enterological Surgery (PACAGE) study sponsored by the China Gastrointestinal Cancer Surgical Union. The PACAGE database prospectively collected general demographic characteristics, protocols for perioperative treatment, and variables associated with postoperative complications in patients treated for gastric or colorectal cancer in 20 medical centers from December 2018 to December 2020. The patients were grouped according to the presence or absence of postoperative complications. Postoperative complications were categorized and graded in accordance with the expert consensus on postoperative complications in gastrointestinal oncology surgery and Clavien-Dindo grading criteria. The incidence of postoperative complications of different grades are presented as bar charts. Independent risk factors for occurrence of postoperative complications were identified by multifactorial unconditional logistic regression.Results:The study cohort comprised 3926 patients with gastric or colorectal cancer, 657 (16.7%) of whom had a total of 876 postoperative complications. Serious complications (Grade III and above) occurred in 4.0% of patients (156/3926). The rate of Grade V complications was 0.2% (7/3926). The cohort included 2271 patients with gastric cancer with a postoperative complication rate of 18.1% (412/2271) and serious complication rate of 4.7% (106/2271); and 1655 with colorectal cancer, with a postoperative complication rate of 14.8% (245/1655) and serious complication rate of 3.0% (50/1655). The incidences of anastomotic leakage in patients with gastric and colorectal cancer were 3.3% (74/2271) and 3.4% (56/1655), respectively. Abdominal infection was the most frequently occurring complication, accounting for 28.7% (164/572) and 39.5% (120/304) of postoperative complications in patients with gastric and colorectal cancer, respectively. The most frequently occurring grade of postoperative complication was Grade II, accounting for 65.4% (374/572) and 56.6% (172/304) of complications in patients with gastric and colorectal cancers, respectively. Multifactorial analysis identified (1) the following independent risk factors for postoperative complications in patients in the gastric cancer group: preoperative comorbidities (OR=2.54, 95%CI: 1.51-4.28, P<0.001), neoadjuvant therapy (OR=1.42, 95%CI:1.06-1.89, P=0.020), high American Society of Anesthesiologists (ASA) scores (ASA score 2 points:OR=1.60, 95% CI: 1.23-2.07, P<0.001, ASA score ≥3 points:OR=0.43, 95% CI: 0.25-0.73, P=0.002), operative time >180 minutes (OR=1.81, 95% CI: 1.42-2.31, P<0.001), intraoperative bleeding >50 mL (OR=1.29,95%CI: 1.01-1.63, P=0.038), and distal gastrectomy compared with total gastrectomy (OR=0.65,95%CI: 0.51-0.83, P<0.001); and (2) the following independent risk factors for postoperative complications in patients in the colorectal cancer group: female (OR=0.60, 95%CI: 0.44-0.80, P<0.001), preoperative comorbidities (OR=2.73, 95%CI: 1.25-5.99, P=0.030), neoadjuvant therapy (OR=1.83, 95%CI:1.23-2.72, P=0.008), laparoscopic surgery (OR=0.47, 95%CI: 0.30-0.72, P=0.022), and abdominoperineal resection compared with low anterior resection (OR=2.74, 95%CI: 1.71-4.41, P<0.001). Conclusion:Postoperative complications associated with various types of infection were the most frequent complications in patients with gastric or colorectal cancer. Although the risk factors for postoperative complications differed between patients with gastric cancer and those with colorectal cancer, the presence of preoperative comorbidities, administration of neoadjuvant therapy, and extent of surgical resection, were the commonest factors associated with postoperative complications in patients of both categories.
3.Analysis on the development strategy of clinical research in children's specialized hospital based on SWOT model
Yuhui LIN ; Xiaowen CHEN ; Yingyan ZHENG ; Yongkai ZHU ; Pin JIA ; Rui DONG
Modern Hospital 2024;24(6):965-969
Objective To provide strategies and suggestions for the development of clinical research in children's spe-cialized hospitals.Methods With a Class A tertiary children's specialty hospital in Shanghai as an example,the SWOT model is used to analyze the strengths,weaknesses,opportunities,and threats of clinical research development in the hospital,and to propose corresponding strategies and suggestions.Results The hospital has distinguished disciplinary advantages,tremendous strength in scientific research,a strong team of talents,and steady progress in the construction of clinical research center.The weaknesses include imperfect clinical research management system,imperfect informatization construction,and insufficient allo-cation of full-time management personnel.There are now opportunities of high policy support,increasing funding support,the shift in clinical demand,and good prospects for development of investigator-initiated trials(IIT).The hospital is also faced with the threat of difficulty in conducting pediatric clinical research and fierce competition among similar hospitals.Conclusion We could promote the development of pediatric clinical research by incentivizing the conduction of clinical research,strengthening the construction of clinical research system,improving the clinical research capabilities,and building a collaborative network for ped-iatric multicenter clinical research.
4.Incidence of postoperative complications in Chinese patients with gastric or colorectal cancer based on a national, multicenter, prospective, cohort study
Shuqin ZHANG ; Zhouqiao WU ; Bowen HUO ; Huining XU ; Kang ZHAO ; Changqing JING ; Fenglin LIU ; Jiang YU ; Zhengrong LI ; Jian ZHANG ; Lu ZANG ; Hankun HAO ; Chaohui ZHENG ; Yong LI ; Lin FAN ; Hua HUANG ; Pin LIANG ; Bin WU ; Jiaming ZHU ; Zhaojian NIU ; Linghua ZHU ; Wu SONG ; Jun YOU ; Su YAN ; Ziyu LI
Chinese Journal of Gastrointestinal Surgery 2024;27(3):247-260
Objective:To investigate the incidence of postoperative complications in Chinese patients with gastric or colorectal cancer, and to evaluate the risk factors for postoperative complications.Methods:This was a national, multicenter, prospective, registry-based, cohort study of data obtained from the database of the Prevalence of Abdominal Complications After Gastro- enterological Surgery (PACAGE) study sponsored by the China Gastrointestinal Cancer Surgical Union. The PACAGE database prospectively collected general demographic characteristics, protocols for perioperative treatment, and variables associated with postoperative complications in patients treated for gastric or colorectal cancer in 20 medical centers from December 2018 to December 2020. The patients were grouped according to the presence or absence of postoperative complications. Postoperative complications were categorized and graded in accordance with the expert consensus on postoperative complications in gastrointestinal oncology surgery and Clavien-Dindo grading criteria. The incidence of postoperative complications of different grades are presented as bar charts. Independent risk factors for occurrence of postoperative complications were identified by multifactorial unconditional logistic regression.Results:The study cohort comprised 3926 patients with gastric or colorectal cancer, 657 (16.7%) of whom had a total of 876 postoperative complications. Serious complications (Grade III and above) occurred in 4.0% of patients (156/3926). The rate of Grade V complications was 0.2% (7/3926). The cohort included 2271 patients with gastric cancer with a postoperative complication rate of 18.1% (412/2271) and serious complication rate of 4.7% (106/2271); and 1655 with colorectal cancer, with a postoperative complication rate of 14.8% (245/1655) and serious complication rate of 3.0% (50/1655). The incidences of anastomotic leakage in patients with gastric and colorectal cancer were 3.3% (74/2271) and 3.4% (56/1655), respectively. Abdominal infection was the most frequently occurring complication, accounting for 28.7% (164/572) and 39.5% (120/304) of postoperative complications in patients with gastric and colorectal cancer, respectively. The most frequently occurring grade of postoperative complication was Grade II, accounting for 65.4% (374/572) and 56.6% (172/304) of complications in patients with gastric and colorectal cancers, respectively. Multifactorial analysis identified (1) the following independent risk factors for postoperative complications in patients in the gastric cancer group: preoperative comorbidities (OR=2.54, 95%CI: 1.51-4.28, P<0.001), neoadjuvant therapy (OR=1.42, 95%CI:1.06-1.89, P=0.020), high American Society of Anesthesiologists (ASA) scores (ASA score 2 points:OR=1.60, 95% CI: 1.23-2.07, P<0.001, ASA score ≥3 points:OR=0.43, 95% CI: 0.25-0.73, P=0.002), operative time >180 minutes (OR=1.81, 95% CI: 1.42-2.31, P<0.001), intraoperative bleeding >50 mL (OR=1.29,95%CI: 1.01-1.63, P=0.038), and distal gastrectomy compared with total gastrectomy (OR=0.65,95%CI: 0.51-0.83, P<0.001); and (2) the following independent risk factors for postoperative complications in patients in the colorectal cancer group: female (OR=0.60, 95%CI: 0.44-0.80, P<0.001), preoperative comorbidities (OR=2.73, 95%CI: 1.25-5.99, P=0.030), neoadjuvant therapy (OR=1.83, 95%CI:1.23-2.72, P=0.008), laparoscopic surgery (OR=0.47, 95%CI: 0.30-0.72, P=0.022), and abdominoperineal resection compared with low anterior resection (OR=2.74, 95%CI: 1.71-4.41, P<0.001). Conclusion:Postoperative complications associated with various types of infection were the most frequent complications in patients with gastric or colorectal cancer. Although the risk factors for postoperative complications differed between patients with gastric cancer and those with colorectal cancer, the presence of preoperative comorbidities, administration of neoadjuvant therapy, and extent of surgical resection, were the commonest factors associated with postoperative complications in patients of both categories.
5.Development and validity test of alcohol-related cognitive scale among adolescents based on health belief model
Xiao-Tao YAN ; Wen-Jie GUO ; Cai-Fang SHEN ; Zi-Yi CUI ; Jia-Qian WU ; Ling FANG ; Yu-Chen ZHAO ; Chen-Yu QIAN ; Yan-Qiu YU ; Pin-Pin ZHENG
Fudan University Journal of Medical Sciences 2024;51(4):465-472
Objective To develop a health belief model(HBM)based adolescent alcohol-related cognition scale to measure adolescent alcohol-related cognition and test its reliability and validity.Methods The adolescents'alcohol-related cognitive scale was developed based on HBM model.By using purposive sampling,three general high schools in Qingpu District,Shanghai were selected.One-third of the classes from grades 10 and 11 in each school were randomly selected,and the students from these classes were surveyed as the research subjects.Exploratory factor analysis and confirmatory factor analysis were used to analyze its reliability(internal consistency reliability and combination reliability)and validity(structural validity,convergent validity,discriminative validity and criterion validity).Results A total of 970 questionnaires were collected,of which 948 were valid,with an effective rate of 97.7%.The adolescents'alcohol-related cognitive scale contained 22 items.Five common factors were extracted from exploratory factor analysis,including perceived susceptibility,perceived severity,perceived benefits,perceived obstacles,and self-efficacy.The cumulative variance contribution rate reached 83.89%.The results of confirmatory factor analysis confirmed the overall fit of the model.The average variance extracted value(AVE)of each dimension was greater than 0.5,and the convergent validity of the model was ideal.The AVE square root of each dimension of the scale was greater than its correlation coefficient,indicating good discrimination validity.Cronbach's α coefficient of the total volume table was 0.892,indicating good overall reliability.Conclusion The adolescents'alcohol-related cognitive scale developed in this study has good reliability and validity,which can be used to measure adolescents'alcohol-related perceptions.
6.Risk prediction models for pancreatic fistula in patients after pancreaticoduodenectomy: a systematic review
Shuting ZHU ; Lanping ZHENG ; Pin ZHANG ; Lihui LI ; Zhenqi LU
Chinese Journal of Hepatobiliary Surgery 2024;30(9):691-698
Objective:To evaluate the risk of bias and applicability of the risk prediction models for pancreatic fistula after pancreaticoduodenectomy (PD).Methods:The relevant studies were systematically searched from Chinese database (Chinese medical journals database, CNKI, Wanfang, Weipu, Sinomed) and English databases (PubMed, Embase, Web of Science, Cochrane Library, CINAHL Database) and the retrieval time limit was from the establishment of the database to December 31, 2023. Based on the risk of bias assessment tool of the predictive model study, the risk of bias and applicability of the model were evaluated, and the predictors with high repetition rate in the model were meta-analyzed by RevMan 5.4 software.Results:A total of 23 studies involving 30 models were included. The incidence of pancreatic fistula was 11.4%-41.7%. nineteen studies reported the discrimination index of model construction and/or validation, and the area under the curve (AUC) was 0.62-0.94. The other four studies reported the consistency index (c-index). The predictive performance of the 23 studies is good, but there is a high risk of bias. The main reasons are that the sample size is not saturated, the research object from the appropriate source is not selected, the continuous variables are not properly processed, and the predictive factors are screened by single factor analysis. Eight studies were rated as " high risk" for applicability due to inconsistencies between the included study subjects and outcome measures and the systematic review study questions. The meta-analysis results showed that the dilation of main pancreatic duct (>3 mm) ( OR=0.70, 95% CI: 0.65-0.76), soft pancreas texture ( OR=5.18, 95% CI: 3.90-6.88), and body mass index ≥25 kg/m 2 ( OR=1.12, 95% CI: 1.07-1.17) were effective predictors of postoperative pancreatic fistula (POPF). Conclusion:The existing predictive models for pancreatic fistula risk in patients undergoing PD both domestically and internationally have good predictive performance, but there is a certain risk of bias and some models have poor applicability. Predictors such as dilation of main pancreatic duct, soft pancreas texture, and body mass index≥25 kg/m 2 should be more emphasized in future predictive models.
7.Three cases of neonatal pericardial effusion related to umbilical venous catheterization
Pu YANG ; Xia WANG ; Junwen ZHENG ; Pin LIU ; Shuwen FENG ; Cong WEI ; Bingyan HE ; Dongchi ZHAO
Chinese Journal of Applied Clinical Pediatrics 2023;38(3):226-229
A retrospective case review was conducted of 3 cases with umbilical venous catheterization(UVC) related pericardial effusions in the Neonatal Intensive Care Unit of Zhongnan Hospital of Wuhan University from December 2020 to April 2022.All 3 cases were preterm infants with gestational ages of 33 + 4, 31 and 27 + 6 weeks, respectively.UVC was inserted routinely in 24 hours after birth.Three neonates developed tachycardia or bradycardia, dyspnea, decreased oxygen saturation and muffled heart sound at the 1 st to 4 th day after catheterization.Echocardiography indicated pericardial effusion, so the 3 neonates underwent pericardiocentesis and drainage.Among the 3 neonates, 2 cases improved and have good prognosis, 1 case died.UVC can cause pericardial effusion, which occurs mostly in the early stage after catheterization.Pericardial effusion and tamponade should be considered when patients show unexplained sudden clinical deterioration after catheterization, such as dyspnea, cyanosis, tachycardia or bradycardia, etc.Once diagnosed, umbilical vein catheter should be removed in time and pericardiocentesis and drainage should be performed for decompression.Early diagnosis and intervention can effectively improve the prognosis.
8.The role of PIVKA-II in hepatocellular carcinoma surveillance in an Asian population.
Wai Yoong NG ; Daniel Yan Zheng LIM ; Si Yu TAN ; Jason Pik Eu CHANG ; Thinesh Lee KRISHNAMOORTHY ; Chee Hooi LIM ; Damien Meng Yew TAN ; Victoria Sze Min EKSTROM ; George Boon Bee GOH ; Mark Chang Chuen CHEAH ; Rajneesh KUMAR ; Chin Pin YEO ; Chee Kiat TAN
Annals of the Academy of Medicine, Singapore 2023;52(2):108-110
9.Vision therapy system 4D combined with stereoscopic 3D training technology for the treatment of amblyopia
Yu-Ling ZHU ; Xiao-Long LEI ; Pin-Zheng LIU ; Bo LU
International Eye Science 2023;23(9):1560-1563
AIM:To investigate the effect of vision therapy system 4D combined with stereoscopic 3D technology training for the treatment of amblyopia.METHODS: Prospective study. A total of 102 children with amblyopia who attended the clinic from January 2018 to January 2022 were selected, and they were randomly assigned into two groups by computer, with 51 cases in each group. Control group received stereoscopic 3D technology training, while observation group participated in vision therapy system 4D on the basis of control group. Then the overall effective rate, binocular visual function, spherical equivalent(SE), axial length(AL), mean corneal curvature(Km), best corrected visual acuity(BCVA)and visual evoked potential were compared between two groups.RESULTS: The overall efficacy rate was 94.1% in observation group, which was obviously higher than control group(74.5%; P<0.05). The improvement in binocular vision parameters simultaneous perception, total fusion, and stereoacuity were all more remarkable in observation group than in control group(P<0.05). The △SE, △AL and △Km yielded no statistical difference between two groups(P>0.05). The latency of two spatial frequencies(1°grid and 15'grid)showed a decline in both groups, and the decline was more notable in observation group than in control group(P<0.05). In both groups, BCVA improved, and the improvement was more significant in observation group compared with control group(P<0.05).CONCLUSION: Application of vision therapy system 4D combined with stereoscopic 3D technology training for amblyopia can effectively ameliorate the visual acuity, promote the reconstruction of simultaneous perception, total fusion, and stereoacuity without additional risk of myopic shift, and improve visual pathway function in children.
10.Cross-talk elimination in determination of gross α and gross β activities using a low-background α/β gas-flow proportional counter
Pin OU ; Yucheng LI ; Xueting ZHENG ; Huiyuan YOU
Chinese Journal of Radiological Health 2023;32(6):679-684
Objective To explore cross-talk elimination method in the determination of gross α and gross β activities using a low-background α/β gas-flow proportional counter. Methods A CLB-104 low-background α/β gas-flow proportional counter was used in this study. First, the α threshold was increased to eliminate the cross-talk counting caused by β particles in the α channel. Then, the α-β anticoincidence threshold was reduced to eliminate the cross-talk counting induced by low-energy α particles in the β channel, and β counts were corrected to eliminate the counts induced by internal convention electrons in the β channel. Finally, gross α and gross β activities of non-saline water samples with different activity levels were determined and compared with gross α and gross β activities of the same samples determined on a BH1227 low-background α/β solid scintillation counter, in order to verify effectiveness of the cross-talk elimination method. Results By eliminating the cross-talk counts of β particles in the α channel and the cross-talk counts of α particles in the β channel, and deducting the counts of internal convention electrons in the β channel, the gross α and gross β activities of the same samples determined by CLB-104 were consistent with the values determined by BH1227. Conclusion Cross-talk counts induced by low-energy α particles or β particles can be eliminated by threshold adjustment, and the counts caused by internal convention electrons in the β channel can be eliminated by correction.

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