Elsevier

The Journal of Pediatrics

Volume 193, February 2018, Pages 237-244.e37
The Journal of Pediatrics

Original Articles
The Conduct and Reporting of Child Health Research: An Analysis of Randomized Controlled Trials Published in 2012 and Evaluation of Change over 5 Years

https://doi.org/10.1016/j.jpeds.2017.09.014Get rights and content
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Objectives

For child health randomized controlled trials (RCTs) published in 2012, we aimed to describe design and reporting characteristics and evaluate changes since 2007; assess the association between trial design and registration and risk of bias (RoB); and assess the association between RoB and effect size.

Study design

For 300 RCTs, we extracted design and reporting characteristics and assessed RoB. We assessed 5-year changes in design and reporting (based on 300 RCTs we had previously analyzed) using the Fisher exact test. We tested for associations between design and reporting characteristics and overall RoB and registration using the Fisher exact, Cochran-Armitage, Kruskal-Wallis, and Jonckheere-Terpstra tests. We pooled effect sizes and tested for differences by RoB using the χ2 test for subgroups in meta-analysis.

Results

The 2012 and 2007 RCTs differed with respect to many design and reporting characteristics. From 2007 to 2012, RoB did not change for random sequence generation and improved for allocation concealment (P < .001). Fewer 2012 RCTs were rated high overall RoB and more were rated unclear (P = .03). Only 7.3% of 2012 RCTs were rated low overall RoB. Trial registration doubled from 2007 to 2012 (23% to 46%) (P < .001) and was associated with lower RoB (P = .009). Effect size did not differ by RoB (P = .43)

Conclusions

Random sequence generation and allocation concealment were not often reported, and selective reporting was prevalent. Measures to increase trialists' awareness and application of existing reporting guidance, and the prospective registration of RCTs is needed to improve the trustworthiness of findings from this field.

Keywords

pediatrics
medicine
clinical studies
research design
bias

Abbreviations

CONSORT
Consolidated Standards of Reporting Trials
DMC
Data monitoring committee
RCTs
Randomized controlled trials
RoB
Risk of bias
SMD
Standardized mean difference

Cited by (0)

Funded by the Canadian Institutes of Health Research (#KRS 140989). The authors declare no conflicts of interest.