Reporting of interventions and “standard of care” control arms in pediatric clinical trials: a quantitative analysis

Abstract

Background: In pediatric medicine, the usual treatment received by children (“standard of care”) varies across centers. Evaluations of new treatments often compare to the existing “standard of care” to determine if a treatment is more effective, has a better safety profile, or costs less. The objective of our study was to evaluate intervention and “standard of care” control arms reported in published pediatric clinical trials. Methods: Pediatric clinical trials, published in 2014, reporting the use of a “standard of care” control arm were included. Duplicate assessment of reporting completeness was done using the 12-item TIDieR (Template for Intervention Description and Replication) checklist for both the “standard of care” control arms and intervention arms within the same published study. Results: Following screening, 214 pediatric trials in diverse therapeutic areas were included. Several different terms were used to describe “standard of care.” There was a significant difference between the mean reported TIDieR checklist items of “standard of care” control arms (5.81 (SD 2.13) and intervention arms (8.45 (SD 1.39, p < 0.0001). Conclusions: Reporting of intervention and “standard of care” control arms in pediatric clinical trials should be improved as current “standard of care” reporting deficiencies limit reproducibility of research and may ultimately contribute to research waste.