ObjectiveTo review the characteristics of registered industry-sponsored clinical trials of pediatric drugs and vaccines in China and to provide references for promoting the development of new pediatric drugs. MethodsWe searched ClinicalTrials.gov and the Chinese Clinical Trial Registry for completed registered industry-sponsored clinical trials of pediatric drugs and vaccines from the database inception to September 11, 2022. Data including the date the trial was first posted, product type (drug or vaccine), sample size, and other information to describe the general characteristics of pediatric clinical trials were collected. The studies were divided into 2 phases based on the trial posted date, 2005―2010 and 2011―2022, reflecting the enactment of pediatric drug clinical trial policies in recent years. The quality of trial registration and the main characteristics of interventional trials in the 2 phases were then compared. Exploring the results attached to industry and non-industry sponsored clinical trials. ResultsData for 145 trials were collected, and the largest proportion (63.4%) involved vaccines. Randomized control trial (RCT) was the study type with the highest percentage (68.3%). The average report completion rate for registered interventional trials was 81.0%. Compared with 2005―2010, the percentage of average report completions, pediatric drug clinical studies, multicenter, RCTs, and double-blinded registered trials increased in 2011―2022. The proportion of positive outcomes in pediatric clinical trials sponsored by industries was higher than those sponsored by non-industry. ConclusionThe majority of completed pediatric clinical trials sponsored by industries are for vaccines, in line with the promotion of pediatric policies. The quality of trial registration has improved, but not significantly, and some characteristics of trial design have changed. The proportion of positive outcomes in pediatric clinical trials sponsored by industries is higher. And further promotion of pediatric clinical trials is needed.
ObjectiveTo evaluate the robustness of pediatrics clinical evidence-based evidence using fragility index and to explore the factors influencing fragility index. MethodsWe searched the PubMed, Embase, and Scopus databases to collect relevant literature on systematic reviews and meta-analyses in the field of pediatrics, and calculated the fragility index. The rank sum test was used to compare differences between groups with different outcome types, different levels of statistical significance, and different sample sizes. Spearman correlation analysis was used to explore the association between the fragility index and sample size, as well as the year of publication. ResultsA total of 152 systematic reviews, including 573 meta-analyses, were included, with a median fragility index of 6 (3, 10). Most meta-analyses chose the risk ratio (RR) as the effect measure (387/573, 67.5%), the Mantel-Haenszel method (412/573, 71.9%) as the synthesis method, and the fixed-effect model (300/573, 57.4%) as the assumed model. The Mann-Whitney test showed no statistically significant difference in the fragility index between meta-analyses with safety outcomes and those with efficacy outcomes (P=0.397), and no statistically significant difference between meta-analyses with significant results and those with non-significant results (P=0.520). The Kruskal-Wallis test found a statistically significant difference in sample size among groups with different fragility indices (P<0.001). Spearman correlation analysis found a positive correlation between the fragility index and sample size (ρ=0.39, P<0.001), but no statistically significant correlation with the year of publication (P=0.235). ConclusionThe fragility index of systematic review and meta-analysis published in pediatrics journals is generally low, and the robustness of the results is not high, so it is necessary to be cautious when making evidence-based decisions. Furthermore, the larger the sample size included in the meta-analysis, the higher the fragility index, and incorporating more trials and populations can facilitate the increase in the robustness of the meta-analysis results.
Objective To systematically review the risk factors of tic disorder (TD) in children. Methods Databases including PubMed, EMbase, The Cochrane Library, Web of Science, CNKI, CBM, VIP, and WanFang Data were electronically searched to collect observational studies on children with TD from inception to June 29th 2021. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of the included studies. Meta-analysis was then performed using RevMan 5.3 software. Results A total of 32 studies involving 556 560 children were included. The results of meta-analysis showed that the risk factors for TD were as follows: male (OR=2.23, 95%CI 1.08 to 4.61, P=0.03), premature delivery (OR=1.66, 95%CI 1.04 to 2.64, P=0.03), low birth weight (OR=1.27, 95%CI 1.07 to 1.50, P=0.005), history of neonatal jaundice (OR=7.46, 95%CI 1.15 to 48.42, P=0.04), other adverse factors in the perinatal period (OR=2.74, 95%CI 1.89 to 3.98, P<0.000 01), poor eating habits (OR=2.11, 95%CI 1.52 to 2.93, P<0.000 01), long-term viewing of electronic products (OR=2.22, 95%CI 1.31 to 3.75, P=0.003), history of febrile convulsions (OR=2.43, 95%CI 1.21 to 4.86, P=0.01), recurrent respiratory infection (OR=2.63, 95%CI 1.49 to 4.64, P=0.000 8), chronic tonsillitis (OR=2.01, 95%CI 1.31 to 3.09, P=0.001), rhinopathy (OR=1.77, 95%CI 1.35 to 2.31, P<0.000 1), attention deficit hyperactivity disorder (ADHD) (OR=5.32, 95%CI 3.77 to 7.51, P<0.000 01), decreased blood iron content (OR=3.68, 95%CI 1.56 to 8.67, P=0.003), family history of TD (OR=6.33, 95%CI 3.20 to 12.53, P<0.000 01), family history of mental illness (OR=2.39, 95%CI 2.03 to 2.83, P<0.000 01), maternal mental disorder during pregnancy (OR=2.49, 95%CI 1.99 to 3.11, P<0.000 01), alcohol drinking during pregnancy (OR=1.40, 95%CI 1.09 to1.79, P=0.007), smoking or passive smoking during pregnancy (OR=1.84, 95%CI 1.68 to 2.01, P<0.000 01), and corporal punishment (OR=3.57, 95%CI 1.52 to 8.34, P=0.003). Parity (second birth and above) (OR=0.41, 95%CI 0.25 to 0.68, P=0.000 6) was a protective factor for tic disorder. Conclusions Current evidence shows that the incidence of TD is related to gender, family history of mental illness, maternal life habits during pregnancy, perinatal history, chronic respiratory diseases, abnormal trace elements, and strict education methods, etc. Moreover, parity is a protective factor for the occurrence of TD. Due to the limited quantity and quality of included studies, more high-quality studies are required to verify the above conclusions.
Objective To explore the use of ChatGPT (Chat Generative Pre-trained Transformer) in pediatric diagnosis, treatment and doctor-patient communication, evaluate the professionalism and accuracy of the medical advice provided, and assess its ability to provide psychological support. Methods The knowledge databases of ChatGPT 3.5 and 4.0 versions as of April 2023 were selected. A total of 30 diagnosis and treatment questions and 10 doctor-patient communication questions regarding the pediatric urinary system were submitted to ChatGPT versions 3.5 and 4.0, and the answers to ChatGPT were evaluated. Results The answers to the 40 questions answered by ChatGPT versions 3.5 and 4.0 all reached the qualified level. The answers to 30 diagnostic and treatment questions in ChatGPT 4.0 version were superior to those in ChatGPT 3.5 version (P=0.024). There was no statistically significant difference in the answers to the 10 doctor-patient communication questions answered by ChatGPT 3.5 and 4.0 versions (P=0.727). For prevention, single symptom, and disease diagnosis and treatment questions, ChatGPT’s answer scores were relatively high. For questions related to the diagnosis and treatment of complex medical conditions, ChatGPT’s answer scores were relatively low. Conclusion ChatGPT has certain value in assisting pediatric diagnosis, treatment and doctor-patient communication, but the medical advice provided by ChatGPT cannot completely replace the professional judgment and personal care of doctors.
Objective To investigate the off-label prescriptions in pediatrics in West China Second University Hospital and to analyze the reasons and performance, so as to provide the baseline data for improving the rationality drug use in pediatrics in China. Methods The prescriptions of pediatrics outpatient department were randomly selected from May 2008 to April 2009; and the off-label use was analyzed according to the package inserts in the following aspects, the types of off-label use, the rate of off-label use in different age groups and categories of medicine. Results Of the total 2 400 prescriptions, 1 398 (58.25%) involving off-label use. All sample prescriptions contained 6028 records, 1 923 (31.90%) involving off-label use. The problems such as dosage (45.98%), frequency (21.17%) and age (18.19%) were the top-three types of off-label use. The rate in different age groups ranked as the top-three were school-age (61.56%), followed by preschool (60.77%) and infants (57.56). The top-five categories of medicines in off-label use were anti-allergy drugs (49.45%), digestive system drugs (49.32%), externally applied drugs (41.49%), Chinese patent drugs (34.60%) and nervous system drugs (33.78%). Conclusion The off-label drug use is widespread in pediatrics outpatient department. It is an effective approach to reduce off-label use and improve drug safety through strictly abiding by the instruction of usage and dosage as well as selecting a suitable dosage form.
ObjectiveTo explore the appropriate intervention measures to reduce the influence of drug repercussion by pediatric hospital inpatients on nursing work. MethodBetween March 1st and 28th, 2014, statistical analysis on the characteristics of pediatric drug-return by drug repercussion questionnaires was carried out. ResultsEach drug repercussion took much time of the nurses (median of 5.00 minutes per time). The frequency of drug repercussion in the internal medicine department was more than that in the surgical department; the most drug repercussions were found in the respiratory medicine department, reaching 26.84%. The main category of drug repercussion was aerosolized medication (39.32%). The drug repercussion mainly resulted from lack of patients' education and doctor-related administration, which had a proportion of 31.44% and 27.19%, respectively. ConclusionsThe wards which have more drug repercussions should be under the supervision according to the analysis of drug repercussion. Meanwhile, improving patients' education and training of medical staff can reduce the pediatric hospital inpatients' drug repercussion and also may reduce the bad effects on nursing work.
ObjectiveTo carry out a retrospective study of the reporting quality and current situation of the systematic reviews (SRs)/meta-analyses (MAs) in pediatric field in China, as well as compliance with the PRISMA and MOOSE guidelines. MethodsSeven core Chinese pediatric journals were hand-searched. Two reviewers extracted data independently using predesigned data extraction form, crosschecked data, and discussed to solve discrepancy. The PRISMA and MOOSE guidelines were used to assess the reporting quality respectively, and subgroup analysis was conducted by different total cites and different published time. SPSS 22.0 was used to for statistical analysis. Percentage was used to describe categorical data and Chi-square test was used to compare the difference among groups. ResultsA total of 157 SRs/MA were included. The proportion of SRs/MA related to interventions was the biggest (61.1%, 96 SRs/MA). (1) The coincidence rate of SRs/MA related to interventions in the PRISMA checklist was better:the coincidence rate of twenty entries was above 50%; (2) The coincidence rate of observational SRs/MA in the MOOSE guidelines was not so good:the coincidence rate of 15 entries was less than 50%, even some of them were less than 20%. There were no significant difference between different total cites (≤5 vs. > 5) in PRISMA and MOOSE guidelines. (3) The coincidence rate of SRs/MA related to interventions had been improved to some extent in most of items after the PRISMA guidelines published, and the differences were statistically significant respectively in No. 8, 19, 20, and 23 (P≤0.05). ConclusionsThe number of SRs/MA published in the pediatric journals in China is increasing generally, the coincidence rate of SRs/MAs related to interventions have been obviously improved after the PRISMA guidelines published, and it's better than the coincidence rate of observational SRs/MAs in MOOSE guidelines. In a word, we should pay more attention to the quality of SRs/MAs, but not just the number.
Objective To determine the extent of off-label drug use in pediatric outpatients of West China Second University Hospital in 2010, and to analyze its possible risk factors, so as to provide baseline data for getting acquainted with the extent of off-label drug use in pediatrics in China and developing policy of off-label drug use. Methods The stratified random sampling was conducted to select prescriptions of children aged 0 to 18 years in pediatric outpatients of the West China Second University Hospital in 2010. According to drug instructions, off-label drug use of prescriptions of all selected children was analyzed in the following aspects, the category of off-label drug use, age, category of drugs. In addition, an analysis was conducted to check the relationship between off-label use and following possible risk factors: age, sex, essential medicines and over-the-counter drugs. Results A total of 2 640 prescriptions with 8 588 medical advices involving 329 drugs were extracted and analyzed, with incidence rates of off-label drug use accounting for 76.59%, 40.88% and 83.89%, respectively. The main categories of off-label drug use were no pediatric information (35.57%), indication (25.44%), and dosage (25.31%). The top 2 age groups with highest incidence rate of off-label drug were neonates (54.35%) and adolescents (49.64%). The top 4 drugs with highest incidence rate of off-label drug were respiratory system medicines (48.12%), Chinese patent medicines (48.12%), digestive and metabolic system medicines (33.36%), and systemic anti-infectives (16.27%). The off-label use risks in all age groups in the hospital were indifferent, and the essential medicines and prescription medicines were likely to present higher risks of drug off-label. Conclusion Off-label drug use in pediatric outpatients is common with growth trend in pediatric outpatients of the West China Second University Hospital. On the one hand, drug instructions lack pediatric information, and on the other hand, it’s badly in need of developing relevant legislation, regulations or guidelines to regulate off-label drug use, providing more evidence by conducting clinical trials on pediatric drugs, encouraging the development and production of the applicable drugs and dosage forms for children, and establishing the children essential medicine list, so as to avoid doctor’s professional risk and ensure the safety of pediatric drug use.
ObjectiveTo analyze the perdictive value of Screening Tool for the Assessment of Malnutrition in Pediatrics (STAMP) for malnutrition or postoperative complications in children with critical congenital heart disease (CHD).MethodsA total of 875 children with critical CHD who were hospitalized in West China Hospital, Sichuan University form August 2019 to February 2021, including 442 males and 433 females with a median age of 30 (12, 48) months, were assessed by STAMP in Health Information System. Clinical data of postoperative complications were collected.Results(1) Based on World Health Organization Z-score as gold standard, 24.5% had malnutrition risk, and 34.3% were diagnosed with malnutrition. According to STAMP, the children were with medium malnutrition risk of 37.9% and high malnutrition risk of 62.1%. There was a statistical difference of incidence rate of malnutrition and detection rate of STAMP malnutrition risk in gender, age, ICU stay or length of mechanical ventilation (P<0.05); (2) with the optimal cut-off point of 5.5 in STAMP for malnutrition, the sensitivity, specificity, positive predictive value, negative predictive value and area under the curve (AUC) were 68.3%, 84.3%, 48.1%, 88.3% and 0.82, respectively; (3) 12.0% of the children were with postoperative complications; (4) with the optimal cut-off point of 5.5 in STAMP for postoperative complications, the sensitivity, specificity, positive predictive value, negative predictive value and AUC were 83.8%, 73.1%, 18.8%, 99.1% and 0.85, respectively.ConclusionChildren with critical CHD have a higher incidence of malnutrition risk and postoperative complications. STAMP has a good perdictive value for malnutrition or postoperative complications, however, the sensitivity and specificity of STAMP are affected by the gold standard or the cut-off point.
ObjectiveTo systematically evaluate the efficacy and safety of anatomical landmark method (ALM) versus ultrasound (US)-guided internal jugular vein (IJV) catheterization in pediatric patients. MethodsDatabases including PubMed, EMbase, The Cochrane Library (Issue 10, 2016), CNKI, CBM, WanFang Data and CNKI were searched from inception to October 2016 to collect randomized controlled trials (RCTs) of landmark-guided versus ultrasound-guided IJV catheterization in pediatric patients who underwent elective surgery. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies. Then RevMan 5.3 software was used to perform meta-analysis. ResultsA total of 13 RCTs involving 1 026 pediatric patients were included. The results of meta-analysis showed that, the overall success rate (RR=1.21, 95%CI 1.09 to 1.34, P=0.000 5) and arterial puncture rate (RR=0.19, 95%CI 0.07 to 0.50, P=0.000 7) of US-guided IJV catheterization were both significantly superior to the ALM group. Whereas there was no significant difference between two groups as for the incidence of hematoma formation (RR=0.35, 95%CI 0.09 to 1.31, P=0.12). ConclusionCurrent evidence shows that, for IJV catheterization of pediatric patients, both the effectiveness and safety of ultrasound-guided technique are better than the landmark-guided. Since the quantity and quality of included studies are limited, the conclusion of this study needs more high quality studies to verify.