Quality assessment of paediatric randomized controlled trials published in China from 1999 to 2022: a cross-sectional study

作者全名：Huo, Bennian; Xu, Song; Liu, Yao; Su, Lin; Jia, Yuntao; Ai, Maolin; Yin, Nange; Song, Lin

作者地址：[Huo, Bennian; Su, Lin; Jia, Yuntao; Ai, Maolin; Yin, Nange; Song, Lin] Chongqing Med Univ, Natl Clin Res Ctr Child Hlth & Disorders, Chongqing Key Lab Pediat, Minist Educ,Key Lab Child Dev & Disorders,Chongqin, Chongqing, Peoples R China; [Xu, Song] Bishan Tradit Chinese Med Hosp, Dept Orthoped, Chongqing 400014, Peoples R China; [Liu, Yao] Army Med Univ, Daping Hosp, Dept Pharm, Chongqing, Peoples R China

通信作者：Song, L (通讯作者)，Chongqing Med Univ, Natl Clin Res Ctr Child Hlth & Disorders, Chongqing Key Lab Pediat, Minist Educ,Key Lab Child Dev & Disorders,Chongqin, Chongqing, Peoples R China.

来源：BMC PEDIATRICS

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:001232854300001

JCR分区：Q2

影响因子：2

年份：2024

卷号：24

期号：1

开始页：　

结束页：　

文献类型：Article

关键词：Paediatric; Randomized controlled trial; Characteristics; Quality assessment; China

摘要：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.Conclusion 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.

基金机构：Chongqing Science and Health Joint Medical Research Project

基金资助正文：The authors are indebted to Jian-Wen Xiao from Children's Hospital of Chongqing Medical University for his helpful advice on protocol design and to the information centre engineers for their help in creating the figure of the manuscript.