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Abstract：
BACKGROUND: Randomized controlled trials (RCTs) are usually the basis of evidence-based medicine, but whether the results of RCTs can be correctly translated into clinical practice depends on the quality of the literature reported. In this study, we evaluated the general characteristics and quality of paediatric RCTs published in China to provide evidence for the reporting of paediatric RCTs and their application in clinical practice.
METHODS: We conducted a cross-sectional observational study of paediatric RCTs published in paediatric journals in China between January 1, 1999, and December 30, 2022. All RCTs that included children (younger than 18 years old) were retrieved, and the general characteristics of the RCTs were extracted and analysed. The quality of the RCTs was assessed by the Cochrane quality assessment protocol.
RESULTS: After screening 20 available paediatric journals, 3545 RCTs were included for analysis. The average annual growth rate of the number of published paediatric RCTs from 1999 to 2022 was 7.8% (P = 0.005, R2 = 0.311). Most of the studies were carried out in East China [1148 (32.4%]; the centres of the RCTs were mainly single-centre [3453 (97.4%], and the interventions were mainly medication [2442 (68.9%)]. Comparing RCTs published in 2017-2022 with RCTs published in 1999-2004, the quality of RCTs significantly improved in terms of random sequence generation, allocation concealment, blinding participants and personnel, incomplete outcome data and selective outcome reporting. RCTs published in multiple centres from the Chinese Science Citation Database were identified, and the approval of the ethics committee was of better quality for all the analysed risk of bias items.
CONCLUSIONS: The number and quality of paediatric RCTs reported in China have improved in recent years, but the overall quality was relatively low. Special attention should be given to allocation concealment and blinding outcome assessment, and dropouts, adverse effects and sample size calculations should be reported. Promoting government policies, strengthening the standardization of journal publishing and advancing the registration of clinical trials are feasible measures.
METHODS: We conducted a cross-sectional observational study of paediatric RCTs published in paediatric journals in China between January 1, 1999, and December 30, 2022. All RCTs that included children (younger than 18 years old) were retrieved, and the general characteristics of the RCTs were extracted and analysed. The quality of the RCTs was assessed by the Cochrane quality assessment protocol.
RESULTS: After screening 20 available paediatric journals, 3545 RCTs were included for analysis. The average annual growth rate of the number of published paediatric RCTs from 1999 to 2022 was 7.8% (P = 0.005, R2 = 0.311). Most of the studies were carried out in East China [1148 (32.4%]; the centres of the RCTs were mainly single-centre [3453 (97.4%], and the interventions were mainly medication [2442 (68.9%)]. Comparing RCTs published in 2017-2022 with RCTs published in 1999-2004, the quality of RCTs significantly improved in terms of random sequence generation, allocation concealment, blinding participants and personnel, incomplete outcome data and selective outcome reporting. RCTs published in multiple centres from the Chinese Science Citation Database were identified, and the approval of the ethics committee was of better quality for all the analysed risk of bias items.
CONCLUSIONS: The number and quality of paediatric RCTs reported in China have improved in recent years, but the overall quality was relatively low. Special attention should be given to allocation concealment and blinding outcome assessment, and dropouts, adverse effects and sample size calculations should be reported. Promoting government policies, strengthening the standardization of journal publishing and advancing the registration of clinical trials are feasible measures.
摘要：
背景：随机对照试验（RCT）通常是循证医学的基础，但RCT结果能否正确转化为临床实践取决于文献报道的质量.在这项研究中,我们评估了中国发表的儿科随机对照试验的一般特征和质量,为儿科随机对照试验的报告及其在临床实践中的应用提供证据.
方法：我们对1999年1月1日至2022年12月30日在中国儿科期刊上发表的儿科随机对照研究进行了横断面观察研究。所有包括儿童（18岁以下）的RCT都被检索到，提取和分析RCT的一般特征。通过Cochrane质量评估方案评估随机对照试验的质量。
结果：在筛选了20种可用的儿科期刊后，纳入3545个RCT用于分析。1999年至2022年发表的儿科随机对照试验数量的年均增长率为7.8%(P=0.005,R2=0.311)。大部分研究在华东地区进行[1148(32.4%];随机对照试验的中心主要是单中心[3453(97.4%],干预措施以药物为主[2442(68.9%)]。将2017-2022年发布的RCT与1999-2004年发布的RCT进行比较，RCT的质量在随机序列生成方面显着提高，分配隐藏，致盲参与者和人员，不完整的结果数据和选择性结果报告。确定了在中国科学引文数据库中多个中心发表的RCT，对于所有分析的偏倚风险项目,伦理委员会的批准质量更高.
结论：近年来，中国报道的儿科随机对照试验的数量和质量有所提高，但总体质量相对较低。应特别注意隐藏分配和盲目性结果评估，和辍学，应报告不利影响和样本量计算。推动政府政策,加强期刊出版标准化和推进临床试验注册是可行的措施。
方法：我们对1999年1月1日至2022年12月30日在中国儿科期刊上发表的儿科随机对照研究进行了横断面观察研究。所有包括儿童（18岁以下）的RCT都被检索到，提取和分析RCT的一般特征。通过Cochrane质量评估方案评估随机对照试验的质量。
结果：在筛选了20种可用的儿科期刊后，纳入3545个RCT用于分析。1999年至2022年发表的儿科随机对照试验数量的年均增长率为7.8%(P=0.005,R2=0.311)。大部分研究在华东地区进行[1148(32.4%];随机对照试验的中心主要是单中心[3453(97.4%],干预措施以药物为主[2442(68.9%)]。将2017-2022年发布的RCT与1999-2004年发布的RCT进行比较，RCT的质量在随机序列生成方面显着提高，分配隐藏，致盲参与者和人员，不完整的结果数据和选择性结果报告。确定了在中国科学引文数据库中多个中心发表的RCT，对于所有分析的偏倚风险项目,伦理委员会的批准质量更高.
结论：近年来，中国报道的儿科随机对照试验的数量和质量有所提高，但总体质量相对较低。应特别注意隐藏分配和盲目性结果评估，和辍学，应报告不利影响和样本量计算。推动政府政策,加强期刊出版标准化和推进临床试验注册是可行的措施。
