Background: Few interventions in paediatric surgery are supported by well-conducted randomised controlled trials (RCTs), and most clinical research in paediatric surgery consists of retrospective studies, half of which are case series. It is imperative that the few RCTs in paediatric surgery, and the systematic reviews and meta-analyses which include them, are of high quality.
Objectives: To determine the risk of bias and reporting quality of RCTs, systematic reviews and meta-analyses in paediatric surgery.
Methods: This was a cross-sectional study of RCTs, systematic reviews and meta-analyses in paediatric surgery which were published in full text in 2021. Studies were identified by searching MEDLINE, Embase, Cochrane Library, JBI EBP Database, Centre for Reviews and Dissemination and Web of Science, and the 2021 indexes of high-impact paediatric surgery journals. For RCTs, risk of bias was assessed with the RoB (Risk of Bias) 2 tool and reporting quality was assessed with the CONSORT (CONsolidated Standards Of Reporting Trials) 2010 statement. For systematic reviews and meta-analyses, risk of bias was assessed with the ROBIS (Risk Of Bias In Systematic reviews) tool and reporting quality was assessed with the PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) 2020 statement. Risk of bias was assessed as high, unclear or low, and reporting quality was assessed as adequate if ≥75% of items in the reporting guideline were reported. All studies were screened and assessed in duplicate by two independent investigators.
Results: We identified 82 RCTs and 268 systematic reviews or meta-analyses in paediatric surgery which were published in full text in 2021. More than half of the RCTs (n=46, 56%) (see Figure 1) and almost all of the systematic reviews and meta-analyses (n=258, 96%) (see Figure 2) were at high risk of bias. Only one RCT (1%) and only four (1%) systematic reviews and meta-analyses were adequately reported. Less than half of RCTs (n=40, 49%) and only a quarter of systematic reviews and meta-analyses (n=68, 25%) had a registered protocol.
Conclusions: Recently published RCTs, systematic reviews and meta-analyses in paediatric surgery are at a high risk of bias and have poor reporting quality.
Patient, public and/or healthcare consumer involvement: None.