Consent and recruitment: the reporting of paediatric trials published in 2012.

Gates, Allison, Caldwell, Patrina, Curtis, Sarah, Dans, Leonila, Fernandes, Ricardo M, Hartling, Lisa, Kelly, Lauren E, Williams, Katrina, Woolfall, Kerry ORCID: 0000-0002-5726-5304 and Dyson, Michele P (2018) Consent and recruitment: the reporting of paediatric trials published in 2012. BMJ Paediatr Open, 2 (1). e000369-e000369.

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Abstract

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.

Item Type:	Article
Uncontrolled Keywords:	data collection, general paediatrics
Depositing User:	Symplectic Admin
Date Deposited:	20 Dec 2018 10:40
Last Modified:	19 Jan 2023 01:08
DOI:	10.1136/bmjpo-2018-000369
Related URLs:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3030291