TY - JOUR
T1 - Effectiveness of antenatal corticosteroids at term
T2 - Can we trust the data that ‘inform’ us?
AU - Mol, Ben W.
AU - Li, Wentao
AU - Lai, Shimona
AU - Stock, Sarah
N1 - Funding Information:
Ben W Mol is supported by a NHMRC Investigator grant ( GNT1176437) . Sarah Stock is supported by a Wellcome Trust Clinical Career Development Fellowship for research into antenatal corticosteroids. The other authors have no competing interests to declare.
Publisher Copyright:
© 2021
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/6
Y1 - 2021/6
N2 - Randomized controlled trials (RCTs) are a cornerstone for the assessment of the effectiveness of interventions. Appropriate randomization, design, sample size, statistical analyses, and conduct that reduces the risk of bias, enhance the chance they will deliver true research findings. The credibility of RCTs is difficult to assess without objective evidence of compliance with Good Clinical Practice standards. Remarkably, no mechanisms are in place both in the initial peer review process and during meta-analysis to assess these, and little guidance on how to assess data where research integrity cannot be confirmed (e.g. where data originated from a setting without established infrastructure or an era preceding current standards). We describe the case of the use of antenatal steroids. When these drugs are used in early preterm birth, their benefits outweigh the harms. However, later in pregnancy, and specifically at term, this balance is less clear. We describe that the four randomised clinical trials that inform clinical practice through the Cochrane meta-analysis, for various reasons, lack clear governance which makes it difficult to verify provenance and reliability of the data. We conclude that transparency and assessment of data credibility need to be inbuilt both at the time of publication and at the time of meta-analysis. This will drive up standards and encourage appropriate interpretation of results and the context from which they were derived.
AB - Randomized controlled trials (RCTs) are a cornerstone for the assessment of the effectiveness of interventions. Appropriate randomization, design, sample size, statistical analyses, and conduct that reduces the risk of bias, enhance the chance they will deliver true research findings. The credibility of RCTs is difficult to assess without objective evidence of compliance with Good Clinical Practice standards. Remarkably, no mechanisms are in place both in the initial peer review process and during meta-analysis to assess these, and little guidance on how to assess data where research integrity cannot be confirmed (e.g. where data originated from a setting without established infrastructure or an era preceding current standards). We describe the case of the use of antenatal steroids. When these drugs are used in early preterm birth, their benefits outweigh the harms. However, later in pregnancy, and specifically at term, this balance is less clear. We describe that the four randomised clinical trials that inform clinical practice through the Cochrane meta-analysis, for various reasons, lack clear governance which makes it difficult to verify provenance and reliability of the data. We conclude that transparency and assessment of data credibility need to be inbuilt both at the time of publication and at the time of meta-analysis. This will drive up standards and encourage appropriate interpretation of results and the context from which they were derived.
KW - Antenatal corticosteroids
KW - Data integrity
UR - http://www.scopus.com/inward/record.url?scp=85105833609&partnerID=8YFLogxK
U2 - 10.1016/j.ejogrb.2021.04.031
DO - 10.1016/j.ejogrb.2021.04.031
M3 - Article
C2 - 33940424
AN - SCOPUS:85105833609
VL - 261
SP - 144
EP - 147
JO - European Journal of Obstetrics & Gynecology and Reproductive Biology
JF - European Journal of Obstetrics & Gynecology and Reproductive Biology
SN - 0301-2115
ER -