Objective: To investigate the epidemiological characteristics of varicella outbreaks in primary and middle schools, and to establish a risk predictive model, so as to provide scientific guidance for the prevention of varicella outbreaks in schools. Methods: Based on a nested case-control study, primary and middle schools in 4 districts of Shanghai (Yangpu District and Jingan District) and Hangzhou (Xiaoshan District and Linping District) from January to December 2023 were selected to observe the status of varicella outbreaks. Associated factors of varicella outbreaks were investigated and used for establishing the predictive model, which was evaluated by the Hosmer-Lemeshow(H-L) goodness of fit test, receiver operating characteristic (ROC) curve, Calibration curve, decision curve analysis (DCA). Results: A total of 98 varicella outbreaks were included, with 195 schools without varicella outbreaks during the same period as controls. Eight factors, including the availability of warm water in restroom, availability of hand soap in restroom, average class size, duration of student attendance at school per day, presence of a fulltime school doctor, hesitancy of the school principal towards varicella vaccination, and rates of first and second doses of varicella vaccination, were identified as potential factors for school varicella outbreaks, with statistically significant differences (χ2/Z=10.01, 20.49, 17.43, 9.74, 32.17, 6.60, 2.20, 3.39, P<0.05). The 8 variables above were employed to construct a risk predictive model, and Hosmer-Lemeshow goodness of fit test yielded a χ2 value of 5.863 (P>0.05); the area under the ROC curve (AUC) was 0.846 (95%CI=0.799-0.893); Calibration curve analysis indicated good consistency between predicted and actual values of the model. DCA demonstrated favorable predictive performance of the model over a wide range. Conclusions The predictive model for school varicella outbreaks demonstrates satisfactory accuracy and efficacy. It suggested to make good use of this prediction model and take relevant measures to reduce the risk of varicella transmission in schools.

Objective:To investigate the current status of vocational training for pediatric clinical research coordinators (CRC), and discuss the construction of base-based pediatric CRC training, and to promote the ability of pediatric CRCs.Methods:From July 25 to October 16, 2023, an anonymous self-designed questionnaire survey was conducted through the Wenjuanxing platform to investigate the current situation of pediatric CRC vocational training and base training needs. The data were collated using Excel. Categorical data were described as numbers and percentages.Results:A total of 328 usable questionnaires were returned. Only 7.62% (25 people) believed that existing CRC training was sufficient and could meet actual work needs; 4.88% (16 people) responded that there was no training; 46.34% (152 people) believed that the training was insufficient to support actual work needs; 87.50% (287 people) believed that continuous CRC training was needed; 46.95% (154 people) preferred experienced CRCs for teaching, who should have at least 3 years of CRC work experience; and 46.95% (154 people) preferred a duration of 3 months for CRC training. The preferred training methods were: practice under the direction of experienced CRCs (90.85%, 298 people), step-by-step teaching of practical skills (88.41%, 290 people), case analysis and discussion (87.20%, 286 people), process simulation (83.23%, 273 people), and lecture-based teaching (76.52%, 251 people). The preferred post-training assessment methods were: case analysis (76.52%, 251 people), operation simulation (74.09%, 243 people), process simulation (73.17%, 240 people), written examination (66.16%, 217 people), and interview (63.72%, 209 people).Conclusions:The current pediatric CRC training is not enough to meet actual work needs. It is urgent to develop and promote a CRC training system that can meet work needs, laying the foundation for the construction of pediatric clinical research ecology in China.

Background Sleep disturbances in children and adolescents have become a global public health concern,with pronounced issues in the Western China.Despite this,research on the prevalence of insomnia and its influencing factors among children and adolescents in Chongqing is still lacking.Objective To understand the prevalence of insomnia and analyze its influencing factors among children and adolescents in Chongqing,so as to provide references for clinical interventions and preventive strategies of insomnia.Methods A stratified random sampling method was used to select 9 969 children and adolescents in Chongqing from November to December 2021.Insomnia Severity Index(ISI)and a self-designed questionnaire on awareness of core mental health knowledge were administered.Binary Logistic regression analysis was used to identify the influencing factors of insomnia in this population.Results A total of 3 578 children and adolescents(35.89％)were found to have insomnia symptoms.There were statistically significant differences in the detection of insomnia symptoms among gender,ethnicity,education level,domicile,only-child status,parental education level,introversion/extroversion,parental relationship,average monthly per capita income,family history of mental illness,medical insurance coverage,living situation and understanding of mental health knowledge(P<0.05 or 0.01).Binary Logistic regression analysis identified several risk factors for insomnia,including female gender(OR=1.301,95％CI:1.192～1.419),ethnic minority status(OR=1.163,95％CI:1.015～1.333),junior high school for education level(OR=1.985,95％CI:1.774～2.220),senior high school for education level(OR=3.085,95％CI:2.749～3.462),non-only-child status(OR=1.127,95％CI:1.013～1.253),degree of harmony between parents is not high or not harmonious[(OR=1.846,95％CI:1.669～2.041 for relatively harmonious;OR=2.524,95％CI:2.214～2.877 for generally harmonious;OR=2.452,95％CI:1.999～3.007 for not very harmonious;OR=2.926,95％CI:2.307～3.710 for very discordant)]and incomplete medical insurance coverage(OR=1.218,95％CI:1.093～1.358).Protective factors included an extroverted personality(OR=0.838,95％CI:0.766～0.917),absence of family history of mental illness(OR=0.719,95％CI:0.549～0.941),junior high school for mother's education level(OR=0.822,95％CI:0.734～0.920),senior high school or secondary specialized school for mother's education level(OR=0.862,95％CI:0.752～0.988),college and above for mother's education level(OR=0.748,95％CI:0.633～0.884)and knowledge of mental health(OR=0.854,95％CI:0.778～0.937).Conclusion The problem of insomnia among children and adolescents in Chongqing is quite serious.Risk factors for insomnia include female gender,ethnic minority status,higher education levels,being a non-only child,poor family relationships and incomplete medical insurance.Conversely,an extroverted personality,absence of family history of mental illness,higher maternal education and knowledge of mental health serve as protective factors against insomnia.

Objective:To investigate the accuracy of resting energy expenditure(REE)prediction formulas and to develop a new REE prediction formula suitable for hospitalized older adults.Methods:Older adults hospitalized in the Department of Geriatrics from October 1, 2022, to November 31, 2022, were included in the study.The predicted values of REE(pREE)were estimated using 13 commonly employed formulas that incorporate parameters related to resting energy expenditure, such as gender, age, body mass index(BMI), and body weight.Indirect calorimetry measurements(mREE)served as the gold standard for comparison.Group differences between pREE and mREE, the coefficient of concordance( ICC), and accuracy(defined as±10% of the mREE values)were utilized to evaluate the performance of the formulas.The ten-fold cross-validation method was employed to identify valid variables and to construct a new prediction formula.The performance of this new formula was compared to mREE, the Harris-Benedict formula, the European Society of Clinical Nutrition and Metabolism(ESPEN)formula, and the Chinese Society of Clinical Nutrition and Metabolism(CSPEN)formula. Results:A total of 223 hospitalized participants aged 60 to 98 years(mean age 79.5±8.2 years)were included in the study.Among these participants, 49.3%(110 cases)were male, and the prevalence of frailty was approximately 84.3%(188 cases).The median difference between pREE and mREE ranged from 9.1 to 232.1 kcal/d.The predictions from the Harris-Benedict, ESPEN, and CSPEN equations differed significantly from mREE(all P<0.05), with respective accuracies of 30.9%, 31.4%, and 24.7%.A new equation was developed: pREE=794.847+ 8.661×body weight -7.976 × age+ 14.757 ×grip strength+ 5.037 × heart rate, with an ICC of 0.6(95% CI: 0.5-0.7), and the accuracy reached 56.3%. Conclusions:Existing equations demonstrate low accuracy in predicting REE among hospitalized older adults.The newly developed equation shows improved performance compared to previous models and can serve as a reference method for predicting REE in this demographic.

Objective:To investigate the accuracy of resting energy expenditure(REE)prediction formulas and to develop a new REE prediction formula suitable for hospitalized older adults.Methods:Older adults hospitalized in the Department of Geriatrics from October 1, 2022, to November 31, 2022, were included in the study.The predicted values of REE(pREE)were estimated using 13 commonly employed formulas that incorporate parameters related to resting energy expenditure, such as gender, age, body mass index(BMI), and body weight.Indirect calorimetry measurements(mREE)served as the gold standard for comparison.Group differences between pREE and mREE, the coefficient of concordance( ICC), and accuracy(defined as±10% of the mREE values)were utilized to evaluate the performance of the formulas.The ten-fold cross-validation method was employed to identify valid variables and to construct a new prediction formula.The performance of this new formula was compared to mREE, the Harris-Benedict formula, the European Society of Clinical Nutrition and Metabolism(ESPEN)formula, and the Chinese Society of Clinical Nutrition and Metabolism(CSPEN)formula. Results:A total of 223 hospitalized participants aged 60 to 98 years(mean age 79.5±8.2 years)were included in the study.Among these participants, 49.3%(110 cases)were male, and the prevalence of frailty was approximately 84.3%(188 cases).The median difference between pREE and mREE ranged from 9.1 to 232.1 kcal/d.The predictions from the Harris-Benedict, ESPEN, and CSPEN equations differed significantly from mREE(all P<0.05), with respective accuracies of 30.9%, 31.4%, and 24.7%.A new equation was developed: pREE=794.847+ 8.661×body weight -7.976 × age+ 14.757 ×grip strength+ 5.037 × heart rate, with an ICC of 0.6(95% CI: 0.5-0.7), and the accuracy reached 56.3%. Conclusions:Existing equations demonstrate low accuracy in predicting REE among hospitalized older adults.The newly developed equation shows improved performance compared to previous models and can serve as a reference method for predicting REE in this demographic.

【Objective:】 To analyze and explore the key points of the ethical review of real-world research in pediatric population, and to provide reference for ethical review of real-world research in pediatric population. 【Methods:】 According to the characteristics of real-world research and pediatric clinical trials, the review points of real-world research in pediatric population were analyzed and discussed in comparison with the principles and focus of ethical review in general clinical research. 【Results:】 The ethics committee should pay particular attention to the review of informed consent, privacy protection, risk benefit assessment, cost and compensation, and should also take into account the research design, data governance, research conflicts of interest, research registration and publication, etc., and conduct scientific and reasonable ethical review of real-world research in pediatric population. 【Conclusion:】 Clinical trials in pediatric population should have stricter and scientific ethical review, which can not only protect the interests of vulnerable groups of minors, but also standardize real-world research in pediatric population and promote the healthy development of pediatric clinical research, so as to better protect children and promote their health.

Objective:To understand the current situation and problems of pediatric drug clinical trials in China, and provide reference for the healthy development of pediatric drug clinical trials.Methods:Such keywords as " pediatrics" " children" " annual reports" " children′s drug research and development" " policies" were used, to search for information on China′s pediatric drug research and development policies and regulations, pediatric drug clinical trial institutions and pediatric drug clinical trial professional registration status, as well as pediatric drug clinical trial project registration status as of October 2023 on the drug clinical trial institution registration management information platforms and relevant government department websites. Then descriptive analysis was made on the collected information.Results:China has released 9 policies and regulations on pediatric drug research and development, supporting the development of new varieties, dosage forms, and specifications of pediatric drugs that meet the physiological characteristics of children, and giving priority review and approval to pediatric drugs. 477 drug technology guiding principles have been released, but only 14 of them were specifically designed for pediatric populations. As of March 20, 2023, there were a total of 272 registered pediatric drug clinical trial institutions, accounting for 20.72% of the total number of registered institutions. The top 5 provinces for their number of registered institutions were Guangdong province (34), Henan province (21), Zhejiang province (20), Beijing (20), and Jiangsu province (18); A total of 26 clinical trial specialties for pediatric drugs have been registered, with the largest number of registrations being pediatric respiratory (143), pediatric hematology (72), pediatrics other (71), pediatric endocrinology (68), and pediatric neurology (64). From 2020 to 2022, the proportion of pediatric drug clinical trial registration projects in newly registered drug clinical trials was 8.8% (129/1 473), 8.3% (168/2 033), and 8.3% (164/1 974), respectively, while clinical trials conducted only in the pediatric population accounted for 2.2% (33/1 473), 3.0% (61/2 033), and 3.2% (64/1 974), respectively.Conclusions:The policies and regulations on pediatric drug research and development in China still need further improvement. The number of registered pediatric drug clinical trial institutions and pediatric specialties is lower than that of adults and distributed unevenly. Clinical trial registration projects for pediatric drugs, especially those conducted in the pediatric population, account for a relatively small proportion. It is recommended to further improve the policy system for drug research and development in the pediatric population, optimize the layout of pediatric drug clinical trial institutions and specialties in the country.

To assess the positive predictive value (PPV) of extended noninvasive prenatal testing (NIPT-plus) for fetal chromosomal abnormalities. This retrospective research enrolled 511 cases of pregnant women with positive NIPT-plus results at the Obstetrics and Gynecology Hospital of Fudan University from May 2017 to January 2021. Karyotype analysis and chromosome microarray analysis (CMA) techniques was applied for verification. All cases were followed to determine their pregnancy outcome. The Chi-square test was used in PPV. 63 out of 511 refused prenatal diagnosis after counseling, 448 pregnant women with prenatal diagnosis showed that the PPVs of NIPT-plus test for fetal trisomy 21, 18 and 13 (T21, T18, T13), sex chromosome aneuploidy (SCAs) and chromosome microdeletion/microduplication syndrome (MMS) were 86.0% (92/107), 79.5% (35/44), 54.5% (12/22), 39.5% (75/190), and 41.7% (30/72), respectively. The results revealed that the PPV was higher among older pregnant women compared to young pregnant women (77.8% vs. 51.9%, P<0.01). With increasing maternal age, the PPV of NIPT-plus presented increasing trends for T21, T13, and composite PPV except for T18 or SCAs. In addition, the termination rates for confirmed SCAs fetal karyotypes 45, X; 47, XXX; 47, XXY and 47, XYY were 11/11, 3/15, 91.7% (22/24) and 1/14, respectively. NIPT-plus can safely and effectively detect fetal chromosomal abnormalities and can be extended to MMS screening, significantly reducing the proportion of interventional prenatal diagnoses, and those with positive screening still require further confirmation.

To assess the positive predictive value (PPV) of extended noninvasive prenatal testing (NIPT-plus) for fetal chromosomal abnormalities. This retrospective research enrolled 511 cases of pregnant women with positive NIPT-plus results at the Obstetrics and Gynecology Hospital of Fudan University from May 2017 to January 2021. Karyotype analysis and chromosome microarray analysis (CMA) techniques was applied for verification. All cases were followed to determine their pregnancy outcome. The Chi-square test was used in PPV. 63 out of 511 refused prenatal diagnosis after counseling, 448 pregnant women with prenatal diagnosis showed that the PPVs of NIPT-plus test for fetal trisomy 21, 18 and 13 (T21, T18, T13), sex chromosome aneuploidy (SCAs) and chromosome microdeletion/microduplication syndrome (MMS) were 86.0% (92/107), 79.5% (35/44), 54.5% (12/22), 39.5% (75/190), and 41.7% (30/72), respectively. The results revealed that the PPV was higher among older pregnant women compared to young pregnant women (77.8% vs. 51.9%, P<0.01). With increasing maternal age, the PPV of NIPT-plus presented increasing trends for T21, T13, and composite PPV except for T18 or SCAs. In addition, the termination rates for confirmed SCAs fetal karyotypes 45, X; 47, XXX; 47, XXY and 47, XYY were 11/11, 3/15, 91.7% (22/24) and 1/14, respectively. NIPT-plus can safely and effectively detect fetal chromosomal abnormalities and can be extended to MMS screening, significantly reducing the proportion of interventional prenatal diagnoses, and those with positive screening still require further confirmation.

Objective:To evaluate the current status of the registered pediatric drug or vaccine clinical trials in China for the purpose of providing a reference for the development of pediatric clinical trials in China.Methods:We collected the data about registered pediatric clinical trials that were conducted from September 6, 2013(Mandatory registration start date) to September 6, 2019 (Cut-off date) at Chinadrugtrials.org.cn platform. The survey items included trial name and number, drug classification, sponsor′s information, current trial status, completion status, etc. The clinical trials were categorized by drug group (includes chemical medicine, traditional Chinese medicine and natural medicine, biological products) and by vaccine group.Results:During the six years 349 pediatric clinical trials were registered on the platform, including 162 pediatric drug trials and 187 vaccine trials. The numbers of chemical drugs and biological products registered in 2018 were 23 and 11, respectively, the highest in the history. The number of pediatric clinical trials of traditional Chinese medicine and natural medicine was 11 in 2014, but from 2015 to 2018 only 2 to 4 trials were registered each year. The overall completion rates of the registered drug and vaccine clinical trials were 22.8% (37/162) and 41.7%(78/187), respectively. Only 42 international multicenter pediatric clinical trial projects were registered on the platform. The numbers of drug and vaccine phase Ⅰ clinical trials were 4 and 46, respectively. Thirty-six pediatric endocrine system agent clinical trials were carried out, with the largest number of all the drug categories registered on the platform.Conclusions:In recent years the number of registered pediatric drug and vaccine clinical trials increased in China. However, the number is still very limited. It is urgent to further promote the development of pediatric clinical trials.