Quality of randomised controlled trials, systematic reviews and
meta-analyses in paediatric surgery: a cross-sectional analysis
Abstract
Background: There are few randomised controlled trials (RCTs) in
paediatric surgery, and the risk of bias of these studies is unknown.
There is also little known about the methodological or reporting quality
of systematic reviews and meta-analyses in paediatric surgery. We aimed
to determine the risk of bias and reporting quality of recent RCTs,
systematic reviews and meta-analyses in paediatric surgery, and the
associations with study characteristics. Methods: We searched MEDLINE,
Embase, Cochrane Library, JBI EBP Database, Centre for Reviews and
Dissemination, Web of Science and high-impact journals for all RCTs,
systematic reviews and meta-analyses in paediatric surgery published in
2021. 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
PRISMA tools. Findings: We identified 82 RCTs and 289 systematic reviews
or meta-analyses in paediatric surgery 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 4 (1%)
systematic reviews and meta-analyses were adequately reported. We found
that lower risk of bias and higher reporting quality in RCTs, systematic
reviews, and meta-analyses were associated with the presence of a
published protocol. For systematic reviews and meta-analyses, a higher
PRISMA score was associated with being a Cochrane review. Surprisingly,
we found that more than half of systematic reviews and meta-analyses
(n=162, 56.1%) had no risk of bias assessments. Conclusions: Recently
published RCTs, systematic reviews, and meta-analyses in paediatric
surgery are at high risk of bias and have poor reporting quality. We
suggest strategies for how trialists, systematic reviewers and other
stakeholders across the research lifecycle can design, conduct and
report higher quality research in paediatric surgery.