Conducting ethical review of investigator-initiated trials （IIT） is one of the important links to ensure the quality of research projects. Currently， the quality of ethical review for IIT projects is greatly influenced by the personal factors of committee members， which to some extent affects the ethical review committee’s judgments of research risks and benefits. Based on the previously developed Risk-Benefit Assessment Scale for Clinical Research， this paper established an ethical review decision-making pathway based on risk-benefit assessment， that is， proposed the “four-step method” for ethical review risk-benefit assessment， including evaluating the research benefits， assessing the research risks， constructing a risk-benefit matrix， and establishing an ethical review pathway. The “four-step method” helps to reduce the impact of committee members’ subjective/intuitive judgments on the quality of ethical review， assists in promoting the implementation of multi-center ethical review policy， narrows the gap in the quality of ethical review among different medical institutions， and provides clearer guidance for the risk judgments of scientific research management and ethical review departments.

Background Mindful parenting is related to the physical and mental health of adolescents,but only few empirical studies have been conducted on the mindful parenting and none has addressed on the impact and actor-partner effects of mindful parenting on adolescents' aggressive behaviors via parenting stress.Objective To explore the impact and actor-partner effects of mindful parenting on adolescents' aggressive behaviors via parenting stress,so as to provide references for improvements in family education and interventions on behavioral problems in adolescents.Methods A sample of 907 subjects(including family members and students)from three classes in each of five grades from grade 5 in elementary school to grade 9 in junior high school in Mianyang,Sichuan Province were selected from September 8 to 15,2023.Parents were assessed with Mindfulness In Parenting Questionnaire(MIPQ)and Parenting Stress Index-Short Form(PSI-SF),and students were required to fulfill aggressive behavior scale of Youth Self-Report(YSR).Pearson correlation analysis was utilized to examine the correlation among the above scales.The actor-partner interdependence model was used to analyze the impact of mindful parenting on their own and their spouses' parenting stress,as well as the impact on adolescents' aggressive behaviors via parenting stress.Results A total of 472 families completed the effective questionnaires.Both father and mother's mindful parenting exhibited an actor effect on adolescents' aggressive behaviors via their own parenting stress,with the effect size of-0.018(P=0.002)and-0.026(P=0.012).The partner effect sizes of father's mindful parenting and mother's mindful parenting on adolescents' aggressive behaviors via their spouse's parenting stress were-0.006(P=0.026)and-0.007(P=0.012),respectively.Conclusion Mindful parenting has been proven to have specific indirect impact on adolescents' aggressive behaviors through their own and their spouse's parenting stress,and the actor effect and partner effect are found both significant.

OBJECTIVE To construct an evaluation index system for the effectiveness of cough and wheeze pharmaceutical care clinic （CWPC） among asthma patients， and to provide assessment tools and a theoretical basis for improving the control level of asthma patients and standardizing pharmaceutical care. METHODS Literature analysis and semi-structured interviews were used to establish the evaluation index system for the effectiveness of CWPC among asthma patients. Delphi method was used to conduct two rounds of expert correspondence consultation， and the index weights were determined by the analytic hierarchy process. The reliability and validity of the constructed index system were analyzed by questionnaire. RESULTS Totally 29 experts from three disciplines of medicine， pharmacy and nursing were selected from the third-grade class A hospitals in Henan province. After two rounds of expert correspondence consultation， the effectiveness evaluation index system of CWPC asthma patients （including 9 sub- dimensions， such as lung function， symptoms； 35 measurement items， such as wheezing and respiratory rate） was finally determined from three core dimensions of structure level， function level and literacy management level， and the weight value of each dimension index was determined. The results of the reliability and validity analysis confirmed the scientific rationality of the index system. CONCLUSIONS The constructed CWPC effectiveness evaluation index system for asthma patients has a high degree of recognition， reliability and validity， and can be used as a measurement tool for the effectiveness evaluation of asthma patients.

Objective:To prevent postoperative myocardial oedema or other causes of acute heart failure in congenital cardiac disease,anticipating delay sternal closure may reduce the number of children requiring cardiopulmonary resuscitation after surgery.The aim of this study was to describe the rate of delay sternal closure after surgery for congenital cardiac disease and to analyse the risk factors that may be associated with it.Methods:We retrospectively reviewed all surgeries with extracorporeal circulation in the cardiothoracic surgery intensive care unit of Shanghai Children's Medical Center in the past five years,from September 2014 to December 2018.The study cohort was divided into the delay sternal closure group (n=418) and the control group (routine chest closure,n=12 188) according to whether a delay sternal closure was applicated.Risk factors associated with delay sternal closure were identified by multivariate Logistic regression analysis.Results:A total of 12 606 cases were eligible,of which 418 (3.32%) were in the delayed sternal closure group.The most common cardiac diagnosis in the delayed sternal group was transposition of the great arteries (26.8%,112/418),whereas the most common cardiac diagnosis in the control group was ventricular septal defect (45.9%,5 599/12 188).All-cause mortality in children in the delayed sternal closure group was 3.3% (14/418) compared with 0.4% (46/12 188) in the control group,with a statistically significant difference ( P<0.05).Multivariate Logistic regression analysis showed that the need for delayed sternal closure were associated with age ( OR 0.164,95% CI 0.079-0.338, P<0.001),positive intropic support before surgery ( OR 0.42,95% CI 0.252-0.699, P=0.001),sex（ OR 0.742，95% CI 0.648-1.098， P<0.05），mean body weight（ OR 1.192，95% CI 1.078-1.318， P<0.001），positive intropic support before surgery（ OR 0.370，95% CI 0.252-0.699， P<0.001），complicated surgery ( OR 0.241,95% CI 0.159-0.367, P<0.001) and extracorporeal circulation diversion time ( OR 6.412,95% CI 4.339-9.475, P<0.001). Conclusion:Delayed sternal closure is an important management strategy for congenital cardiac surgery in infants and children.Delayed sternal closure is associated with age，sex,mean body weight at the time of surgery,positive intropic support before surgery，complicated surgery and extracorporeal circulation diversion time.

Objective To observe the value of MRI texture features combined with apparent diffusion coefficient(ADC)for differentiating uterine sarcoma(US)and cellular uterine leiomyoma(CUL).Methods Pelvic MRI data of 27 US patients(US group)and 34 CUL patients(CUL group)were retrospectively analyzed.The texture features of lesions were extracted from T2WI and diffusion weighted imaging(DWI),the ADC value were measured,and the average ADC value(ADCmean),the minimum ADC value(ADCmin)and standard ADC value(ADCst)were recorded.Then logistic regression(LR)models were constructed based on ADC value,optimal texture features alone and their combination,respectively,including LRADC,LRtexture and LRADC+texture models.Receiver operating characteristic curves were drawn,and the area under the curves(AUC)were calculated to evaluate the efficacy of each model for differentiating US and CUL.Results The ADCmean,ADCmin and ADCst in US group were all lower than those in CUL group(all P＜0.05).A total of 3 750 texture features were extracted from pelvic T2WI and DWI,5 optimal features were finally obtained,and the constructed LRADC+texture model and LRtexture model had similar efficacy of differentiating US and CUL(AUC=0.921,0.887;P＞0.05),which were both higher than that of LRADC model(AUC=0.696;both P＜0.05).The calibration curve of LRADC+texture model was basically consistent with the ideal curve,which had better clinical benefits than LRADC and LRtexture models.Conclusion MRI texture features combined with ADC value could improve efficacy for differentiating US and CUL.

Objective To explore potential predictors of macrolide-resistant Mycoplasma pneumoniae pneumonia(MRMP)to severe Mycoplasma pneumoniae pneumonia(SMPP)in early stage.Methods A retrospective analysis was conducted on 117 cases of MRMP that were hospitalized in the First People's Hospital of Huzhou between January 2023 and January 2024.The children were divided into severe group and mild group based on the severity of their disease.A comparison of the clinical characteristics between two groups was conducted,along with an analysis of the risk factors contributing to the occurrence of SMPP.Results Among 117 children with MRMP,there were 63 in severe group and 54 in mild group.The duration of fever,cough,white blood cell count,C-reactive protein(CRP),and lactate dehydrogenase(LDH)in severe group were all higher than those in mild group(P＜0.05).Logistic regression analysis showed that the duration of fever,CRP,and LDH were independent risk factors for the development of SMPP from MRMP.Area under the curve of the three combined tests was 0.963(95％CI:0.935-0.991,P＜0.001).Conclusion The probability of MRMP developing into SMPP can be predicted based on the duration of fever,CRP,and LDH levels at the first visit of the patient,thereby achieving early diagnosis and treatment.

The passing of ethical review is a necessary conditions and prerequisite for the development of life science and medical research involving humans. At present, some medical and health institutions have no or insufficient ethical review capabilities. The lack of ethical review ability has become a bottleneck restricting the development of life science and medical research involving humans. According to documents such as Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices, Opinions on Strengthening the Ethical Governance of Science and Technology, institutions can entrust competent institutional ethics review committees or regional ethics review committees in writing to conduct ethical review. Entrustment ethical review provides a viable solution for institutions that need to carry out life science and medical research involving humans but do not have an ethics (review) committee or the ethics (review) committee is not competent to review. To conduct the entrustment ethical review, the entrustment between the principal and the trustee is required. According to The Measures for Ethical Review of Life Sciences and Medical Research Involving Humans, if medical and health institutions and their ethical review committees do not accept the formal entrustment to provide the ethical review opinions for other institutions, the local health authorities at or above the county level will impose administrative penalties and sanctions on the relevant institutions and personnel in accordance with the law. Signing the entrustment ethical review contract, implementing legal compliance entrusted ethical review to protect the rights and interests of the trustee and the principal, and protect the research participants.

Nonalcoholic fatty liver disease (NAFLD) has become the most common chronic liver disease, and liver fibrosis is closely associated with the prognosis in NAFLD; therefore, accurate assessment of liver fibrosis is of great importance. Liver biopsy is the gold standard for the diagnosis of NAFLD, but its clinical application is limited by invasiveness. Elastography technique based on ultrasound and magnetic resonance imaging has gradually been applied in the diagnosis of liver fibrosis associated with NAFLD. This article elaborates on the principles of the two techniques, compares their respective advantages and disadvantages, and introduces the advances in application in combination with artificial intelligence.

OBJECTIVE To establish a method for the determination of polymyxin B concentration in plasma and apply it to clinical practice. METHODS After precipitated with 5% trichloroacetic acid solution， using polymyxin E2 as internal standard， the concentrations of polymyxin B1 and B2 in plasma sample were determined by UPLC-MS/MS. The determination was performed on BEH C18 chromatographic column with water （0.1% formic acid）-acetonitrile （0.1% formic acid） as mobile phase （gradient elution） at the flow rate of 0.5 mL/min. The sample size was 10 µL. The detection was accomplished with electrospray ionization operated in positive ion scanning by multi-reaction monitoring mode. The ion pairs for quantitative analysis were m/z 603.2→101.2 （polymyxin B1）， m/z 595.7→101.1 （polymyxin B2） and m/z 578.5→101.1 （internal standard）. The plasma concentration of polymyxin B in 79 critically ill patients was measured by the above method， the occurrence of acute renal injury （AKI） was recorded and the relationship of polymyxin B concentration in plasma with AKI was analyzed. RESULTS The linear ranges of polymyxin B1 and polymyxin B2 were 200-20 000， 50-5 000 ng/mL （r＞0.995）， and the lower limits of quantification were 200 and 50 ng/mL， respectively. RSDs of intra‐day and inter‐day precision tests were not higher than 12.06%， the average extraction recovery was 103.04%-117.44%， and RSDs of matrix effect test and stability test were all not higher than 7.42%. Steady state trough and peak plasma concentration were （2.54±2.52） and （8.17±5.20） mg/L for 79 clinical patients using polymyxin B. Eighteen patients out of 27 included patients developed AKI， with an incidence of 66.67%. The peak concentration of polymyxin B of patients without AKI was significantly lower than that of patients with AKI （P＜0.05）， but there was no significant difference in the trough concentration between two groups （P＞0.05）. CONCLUSIONS The established UPLC-MS/MS has the advantages of simple operation and high sensitivity， and can be used to monitor the plasma concentration of polymyxin B in patients. The occurrence of AKI is correlated with the peak concentration of polymyxin B.

Objective:With the rapid increase in the number of real world studies, especially the use of health data in medical institutions, ethical issues such as the use of patient health data and the protection of patient′s privacy rights and the right to know have been gradually exposed. To strike a good balance between promoting data sharing and maintaining subjects′ personal privacy, the mode of informed consent appears to be crucial. This paper provided guidance for the selection of informed consent models for real world research health data utilization.Methods:The authors extensively studied the relevant laws and regulations of health data utilization worldwide, conducted extensive searches in Chinese and English databases, sorted out and analyzed various alternative informed consent models, and summarized their characteristics and applications.Results:At present, five alternative informed consent models were used to conduct real world research based on health data utilization. Researchers can choose informed consent models according to the research purpose, research design, research risk, operability of informed consent, and vulnerable groups.Conclusions:Different alternative informed consent models have varied characteristics. Researchers need to choose informed consent models based on the above factors to ensure the maximum protection of patients' privacy rights while using health data.