Quality of randomized controlled trials and systematic reviews in pediatric surgery: A cross-sectional meta-research study

Cochrane Evidence Synthesis and Methods Pub Date : 2024-02-04 DOI:10.1002/cesm.12042

Wilson Jiang, Bill Wang, Sandro Sperandei, Aidan Christopher Tan

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Abstract

Background

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.

Methods

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.

Findings

We found 82 RCTs and 289 systematic reviews/meta-analyses published in 2021. More than half (n = 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 (n = 40, 49%) of RCTs and just over a quarter (n = 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 (n = 162, 56.1%), had no risk of bias assessment.

Conclusions

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.

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小儿外科随机对照试验和系统综述的质量：横断面荟萃研究

背景儿科手术中的随机对照试验（RCT）很少，其偏倚风险也不明。关于小儿外科系统综述（含或不含荟萃分析）的方法或报告质量也知之甚少。因此，我们进行了一项横断面荟萃研究，以确定小儿外科 RCT、系统综述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。方法我们检索了 MEDLINE、Embase、Cochrane 图书馆、JBI EBP 数据库、Centre for Reviews and Dissemination 和 Web of Science 中 2021 年发表的所有小儿外科 RCT 和系统综述。我们还检索了2021年高影响力小儿外科期刊的索引。我们分别使用 RoB 2 和 CONSORT 工具评估了 RCT 的偏倚风险和报告质量。我们使用 ROBIS 和系统综述和荟萃分析首选报告项目工具评估了系统综述和荟萃分析的相同参数。研究结果我们发现，2021 年共发表了 82 篇 RCT 和 289 篇系统综述/荟萃分析。半数以上（n = 46，56%）的研究性试验和几乎所有（n = 278，96%）的系统综述和荟萃分析存在高偏倚风险。只有一项（1%）研究性试验和四项（1%）系统综述和荟萃分析得到了充分报告。不到一半的研究性试验（n = 40，49%）和略高于四分之一的系统综述和荟萃分析（n = 77，27%）有注册协议。令人惊讶的是，我们发现一半以上的系统综述和荟萃分析（n = 162，56.1%）没有进行偏倚风险评估。结论近期发表的小儿外科 RCT 和系统综述存在较高的偏倚风险，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更高质量的研究，并制定降低偏倚风险的策略。然而，高偏倚和低报告的研究并不一定没有价值。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Cochrane Evidence Synthesis and Methods

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