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.

ObjectiveTo analyze the quality and status of technical service items of radiation health technical service institutions (RHTSI) in China. Methods A total of 608 and 622 RHTSIs with radiation health technical service qualifications from 31 provinces, autonomous regions, and municipalities in the years of 2021 and 2022 were selected as the research subjects. The data of quality monitoring of radiological health technology services, comparison of radiological health testing capabilities, and investigation of the current status of technical support institutions were collected to analyze the status of technical service items which was conducted by RHTSIs from 2021 to 2022. Results A total of 622 RHTSIs in China obtained technical service institution qualifications in 2022, an increase of 14 from 608 in 2021. While a total of 404 of 622 RHTSIs conducted radiological health technology services, a decrease of 11.4% from 456 in 2021. A total of 241 804 technical service items were conducted in 2022, an increase of 39.7% from 173 064 in 2021. The median number of technical service items by non-health system RHTSIs was higher than that of the health system RHTSIs in 2021 and 2022, (203 vs 40 items, 215 vs 55 items, all P<0.01). The number of technical service institutions and technical service items conducted in different regions from high to low were the eastern, central, and western regions in 2021. The number of technical service institutions in different regions was highest in the eastern region, followed by the central and western regions, while the number of technical service items from high to low were the eastern, western, and central regions in 2022. The number of provincial, municipal, and county-level health system RHTSIs decreased by 6.5%, 26.3%, and 27.3%, respectively, in 2022 compared with 2021. The number of technical service items conducted by provincial health system RHTSIs increased by 48.6%, while those conducted by municipal and county-level health system RHTSIs decreased by 13.8% and 21.3%, respectively. Conclusion Although the number of RHTSI conducting technical services decreases in 2022 compared with 2021, the number of technical service items conducted increases. Non-medical RHTSI undertake the majority of technical service items. Within the medical institutes, the number of technical service items conducted by provincial RHTSI is higher than that of municipal and county-level RHTSI.

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.

Objective To observe the effect of Huayu Xiaozheng Granules on angiogenesis and invasion in trophoblast cells with overexpression of miR-210 and under hypoxia.Methods HTR-8/SVneo cells were cultured in vitro,a miR-210 overexpression model was established by transfection,and a chemical hypoxia model was established by CoCl2 method.The blank group,miR-210 overexpression group,miR-210 overexpression-negative group,miR-210 overexpression+Chinese medicine group,hypoxia+Chinese medicine group and Chinese medicine group in experiment were set up.Western Blot method was used to detect protein expressions of hypoxia-inducible factor 1α(HIF-1α),vascular endothelial growth factor(VEGF),and invasion-associated factors[matrix metalloproteinase 9(MMP-9)and tissue inhibitors of matrix metalloproteinase 1(TIMP-1)]in HTR-8/SVneo cells.Results Compared with the blank group,the protein expression levels of HIF-1α,VEGF,MMP-9,TIMP-1 and MMP-9/TIMP-1 ratio were increased in the miR-210 overexpression group(P＜0.05);compared with the miR-210 overexpression group,the HIF-1α,VEGF,MMP-9,TIMP-1 protein expression levels and MMP-9/TIMP-1 ratio in the miR-210 overexpression-negative group,miR-210 overexpression+Chinese medicine group,hypoxia+Chinese medicine group and Chinese medicine group were all decreased(P＜0.05),and the decrease effects in Chinese medicine group was especially obvious;compared with the miR-210 overexpression+Chinese medicine group,the protein expression levels of HIF-1α,VEGF,MMP-9,TIMP-1 and MMP-9/TIMP-1 ratio in hypoxia+Chinese medicine group and Chinese medicine group were all decreased(P＜0.05);compared with the hypoxia+Chinese medicine group,the above indicators were decreased in the Chinese medicine group(P＜0.05).Conclusion Huayu Xiaozheng Granules can negatively regulate the increased angiogenesis and invasion of trophoblast cells with miR-210 overexpression and under hypoxia,which may be one of the action mechanisms of its treatment for tubal pregnancy.

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.

AIM To explore the clinical effects of Shuilu Erxian Pills combined with Modified Didang Decoction on patients with early and middle stage diabetic nephropathy.METHODS Eighty-three patients were randomly assigned into control group(42 cases)for 12-week administration of Irbesartan Tablets,and observation group(41 cases)for 12-week administration of Shuilu Erxian Pills,Modified Didang Decoction and Irbesartan Tablets.The changes in clinical effects,TCM syndrome scores,blood glucose indices(FBG,HbA1c),blood lipid indices(TC,TG),renal function indices(BUN,Scr,24 h UTP,eGFR),inflammatory factors(IL-1β,hs-CRP,IL-6,TNF-α,IL-18,TGF-β1),immune function indices(lymphocyte,neutrophil,CD8+,CD3+,CD4+,CD4+/CD8+)and incidence of adverse reactions were detected.RESULTS The observation group demonstrated higher total effective rate than the control group(P＜0.05).After the treatment,the observation group displayed decreased TCM syndrome scores,blood glucose indices,blood lipid indices,BUN,Scr,24 h UTP,inflammatory factors,CD8+(P＜0.05),reduced lymphocyte,neutrophil(P＜0.05),and increased eGFR,CD3+,CD4+,CD4+/CD8+(P＜0.05),which were more obvious than those in the control group(except for HbA1c,TG,SCr,24 h UTP,lymphocyte,neutrophil)(P＜0.05).No significant difference in incidence of adverse reactions was found between the two groups(P＞0.05).CONCLUSION For the patients with early and middle stage diabetic nephropathy,Shuilu Erxian Pills combined with Modified Didang Decoction can safely and effectively improve clinical symptoms,whose mechanism may contribute to the reduction of inflammatory levels and improvement of immune functions.

[Objective]To investigate the optimal ratio of Shuji Decoction for the treatment of dystonia in Parkinson's disease(PD)rats.[Methods]The model of PD dystonia was prepared by induction of 6-hydroxydopamine,and the experiment was designed by the orthogonal experimental design,and randomly divided into model group(equal volume of 0.9%sodium chloride solution),Shuji Decoction group 1～16[dosing ratio according to L16(215)orthogonal test table],and sham operation group(equal volume of 0.9%sodium chloride solution)as control,which was administered once/d for 28 d.The stepping test,suspension test and abnormal involuntary movement(AIM)were used to detect the degree of muscular rigidity.Ultrastructural changes of the neuromuscular junctions of the phrenic nerve were observed by transmission electron microscope.The expression level of tyrosine hydroxylase(TH)in brain tissue was measured by immunohistochemistry.[Results]The results of the orthogonal test showed that the best combination of Shuji Decoction was Shuji Decoction group 4,i.e.,Magnoliae Officinalis Cortex:Clematis chinensis Osbeck:Stephania tetrandra S.Moore:Cyclea barbata Miers:Lobelia sessilifolia Lamb in the ratio of 1:1:2:2:1.Compared with sham operation group,there was significantly decreased number of adjusting steps whereas increased latency and AIM scores of rats in model group(P<0.01);compared with model group,the number of adjusting steps was significantly increased,while latency and AIM scores of rats in Shuji Decoction groups were significantly reduced(P<0.01),among which the effect of No.4 Shuji Decoction group was the most obvious(P<0.01).The electron microscopic examination revealed that Shuji Decoction could reduce the number of presynaptic membrane vesicles,mitochondria and postsynaptic membrane folds,and relieve the structural damage of neurons.Immunohistochemistry showed that compared with model group,the expression level of TH was significantly increased in Shuji Decoction groups(P<0.05),and the expression level of TH in Shuji Decoction group 4 was highest(P<0.01).[Conclusion]The optimal ratio of Shuji Decoction for the treatment of dystonia in rats with PD is 1:1:2:2:1 for Magnoliae Officinalis Cortex:Clematis chinensis Osbeck:Stephania tetrandra S.Moore:Cyclea barbata Miers:Lobelia sessilifolia Lamb.

Metabolic dysfunction-associated fatty liver disease (MAFLD) is an increasingly common liver disease worldwide. MAFLD is diagnosed based on the presence of steatosis on images, histological findings, or serum marker levels as well as the presence of at least one of the three metabolic features: overweight/obesity, type 2 diabetes mellitus, and metabolic risk factors. MAFLD is not only a liver disease but also a factor contributing to or related to cardiovascular diseases (CVD), which is the major etiology responsible for morbidity and mortality in patients with MAFLD. Hence, understanding the association between MAFLD and CVD, surveillance and risk stratification of MAFLD in patients with CVD, and assessment of the current status of MAFLD management are urgent requirements for both hepatologists and cardiologists. This Taiwan position statement reviews the literature and provides suggestions regarding the epidemiology, etiology, risk factors, risk stratification, nonpharmacological interventions, and potential drug treatments of MAFLD, focusing on its association with CVD.

Background/Aims: Despite the high efficacy of direct-acting antivirals (DAAs), approximately 1–3% of hepatitis C virus (HCV) patients fail to achieve a sustained virological response. We conducted a nationwide study to investigate risk factors associated with DAA treatment failure. Machine-learning algorithms have been applied to discriminate subjects who may fail to respond to DAA therapy. Methods: We analyzed the Taiwan HCV Registry Program database to explore predictors of DAA failure in HCV patients. Fifty-five host and virological features were assessed using multivariate logistic regression, decision tree, random forest, eXtreme Gradient Boosting (XGBoost), and artificial neural network. The primary outcome was undetectable HCV RNA at 12 weeks after the end of treatment. Results: The training (n=23,955) and validation (n=10,346) datasets had similar baseline demographics, with an overall DAA failure rate of 1.6% (n=538). Multivariate logistic regression analysis revealed that liver cirrhosis, hepatocellular carcinoma, poor DAA adherence, and higher hemoglobin A1c were significantly associated with virological failure. XGBoost outperformed the other algorithms and logistic regression models, with an area under the receiver operating characteristic curve of 1.000 in the training dataset and 0.803 in the validation dataset. The top five predictors of treatment failure were HCV RNA, body mass index, α-fetoprotein, platelets, and FIB-4 index. The accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the XGBoost model (cutoff value=0.5) were 99.5%, 69.7%, 99.9%, 97.4%, and 99.5%, respectively, for the entire dataset. Conclusions Machine learning algorithms effectively provide risk stratification for DAA failure and additional information on the factors associated with DAA failure.

Background/Aims: Chronic hepatitis C (CHC) patients who failed antiviral therapy are at increased risk for hepatocellular carcinoma (HCC). This study assessed the potential role of metformin and statins, medications for diabetes mellitus (DM) and hyperlipidemia (HLP), in reducing HCC risk among these patients. Methods: We included CHC patients from the T-COACH study who failed antiviral therapy. We tracked the onset of HCC 1.5 years post-therapy by linking to Taiwan’s cancer registry data from 2003 to 2019. We accounted for death and liver transplantation as competing risks and employed Gray’s cumulative incidence and Cox subdistribution hazards models to analyze HCC development. Results: Out of 2,779 patients, 480 (17.3%) developed HCC post-therapy. DM patients not using metformin had a 51% increased risk of HCC compared to non-DM patients, while HLP patients on statins had a 50% reduced risk compared to those without HLP. The 5-year HCC incidence was significantly higher for metformin non-users (16.5%) versus non-DM patients (11.3%; adjusted sub-distribution hazard ratio [aSHR]=1.51; P=0.007) and metformin users (3.1%; aSHR=1.59; P=0.022). Statin use in HLP patients correlated with a lower HCC risk (3.8%) compared to non-HLP patients (12.5%; aSHR=0.50; P<0.001). Notably, the increased HCC risk associated with non-use of metformin was primarily seen in non-cirrhotic patients, whereas statins decreased HCC risk in both cirrhotic and non-cirrhotic patients. Conclusions Metformin and statins may have a chemopreventive effect against HCC in CHC patients who failed antiviral therapy. These results support the need for personalized preventive strategies in managing HCC risk.