Consent and recruitment: The reporting of paediatric trials published in 2012

Allison Gates, Patrina Caldwell, Sarah Curtis, Leonila Dans, Ricardo M. Fernandes, Lisa Hartling, Lauren E. Kelly, Katrina Williams, Kerry Woolfall, Michele P. Dyson

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7 Citations (Scopus)


Objectives We evaluated 300 paediatric trials to determine: the consent and recruitment strategies used, who trial information was targeted to, how incentives were used and if they achieved their recruitment targets. Methods For this cross-sectional evaluation, we searched the Cochrane Central Register of Controlled Trials for paediatric trials published in 2012 and randomly selected 300 that reported on outcomes for participants aged ≤21 years. We collected data on consent and recruitment procedures for each trial and undertook descriptive analyses in SPSS statistics V.23. Results All but one trial (99.7%) used a standard recruitment strategy. Most (92%) trials reported that consent was obtained but only 13% reported who obtained consent. Two-thirds (65%) of trials included school-aged participants, and of these 68% reported obtaining assent. Half (50%) of the trials reported who the trial information was targeted to. Most trials (75%) of school-aged participants targeted information towards children or children and their parents. Fourteen per cent of trials reported using incentives, half (50%) of which were in the form of compensation. Only 48% of trials reported sufficient data to determine if their recruitment targets were achieved. Of these, 70% achieved their targets. Conclusions Notable reporting shortcomings included: how families were recruited into the trial, who obtained consent and/or assent and how, who trial information was directed to, whether incentives were used and sufficient data to determine if the recruitment target was achieved. Forthcoming paediatric-specific reporting standards may improve reporting in this priority area. Our data provide a baseline for ongoing monitoring of the state of the research.

Original languageEnglish
Article numbere000369
Number of pages8
JournalBMJ Paediatrics Open
Issue number1
Publication statusPublished - 1 Nov 2018
Externally publishedYes


  • data collection
  • general paediatrics

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