Jiang Wilson, Wang Bill, Sperandei Sandro, Tan Aidan Christopher
School of Medicine Western Sydney University Sydney Australia.
Translational Health and Research Institute Western Sydney University Sydney Australia.
Cochrane Evid Synth Methods. 2024 Feb 4;2(2):e12042. doi: 10.1002/cesm.12042. eCollection 2024 Feb.
There are few randomized controlled trials (RCTs) in pediatric surgery, and their risk of bias is unknown. There is also little known about the methodological or reporting quality of systematic reviews (with or without meta-analyses) in pediatric surgery. Therefore, we conducted a cross-sectional meta-research study to determine the risk of bias and reporting quality of RCTs and systematic reviews and meta-analyses in pediatric surgery, and the associations between these outcomes and study characteristics.
We searched MEDLINE, Embase, Cochrane Library, JBI EBP Database, Centre for Reviews and Dissemination and Web of Science for all RCTs and systematic reviews in pediatric surgery published in 2021. We also searched the 2021 indexes of high-impact pediatric surgery journals. We assessed the risk of bias and reporting quality of RCTs using the RoB 2 and CONSORT tools respectively. We assessed the same parameters for systematic reviews and meta-analyses using the ROBIS and Preferred Reporting Items for Systematic Reviews and Meta-analyses tools.
We found 82 RCTs and 289 systematic reviews/meta-analyses published in 2021. More than half ( = 46, 56%) of RCTs and almost all (n = 278, 96%) systematic reviews and meta-analyses were at high risk of bias. Only one (1%) RCT and four (1%) systematic reviews and meta-analyses were adequately reported. Less than half ( = 40, 49%) of RCTs and just over a quarter ( = 77, 27%) of systematic reviews and meta-analyses had a registered protocol. Surprisingly, we found that more than half of systematic reviews and meta-analyse ( = 162, 56.1%), had no risk of bias assessment.
Recently published RCTs and systematic reviews in pediatric surgery are at high risk of bias and have poor reporting quality. Journals, universities, and research institutions should train authors to conduct and report higher quality studies and develop strategies to reduce risk of bias. However, research with high bias and low reporting does not necessarily lack value.
儿科手术领域的随机对照试验（RCT）较少，其偏倚风险未知。关于儿科手术系统评价（无论是否进行荟萃分析）的方法学或报告质量也知之甚少。因此，我们开展了一项横断面元研究，以确定儿科手术中RCT以及系统评价和荟萃分析的偏倚风险和报告质量，以及这些结果与研究特征之间的关联。
我们检索了MEDLINE、Embase、Cochrane图书馆、JBI循证医学数据库、综述与传播中心和科学网，查找2021年发表的所有儿科手术RCT和系统评价。我们还检索了2021年高影响力儿科手术期刊的索引。我们分别使用RoB 2和CONSORT工具评估RCT的偏倚风险和报告质量。我们使用ROBIS以及系统评价和荟萃分析的首选报告项目工具评估系统评价和荟萃分析的相同参数。
我们发现2021年发表了82项RCT和289项系统评价/荟萃分析。超过一半（n = 46，56%）的RCT以及几乎所有（n = 278，96%）的系统评价和荟萃分析存在高偏倚风险。只有1项（1%）RCT以及4项（1%）系统评价和荟萃分析报告充分。不到一半（n = 40，49%）的RCT以及略多于四分之一（n = 77，27%）的系统评价和荟萃分析有注册方案。令人惊讶的是，我们发现超过一半的系统评价和荟萃分析（n = 162，56.1%）没有偏倚风险评估。
最近发表的儿科手术RCT和系统评价存在高偏倚风险且报告质量较差。期刊、大学和研究机构应培训作者开展和报告质量更高的研究，并制定策略以降低偏倚风险。然而，高偏倚和低报告的研究不一定没有价值。
