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


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.

SUBMITTER: Gates A 

PROVIDER: S-EPMC6267313 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Publications

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

Gates Allison A   Caldwell Patrina P   Curtis Sarah S   Dans Leonila L   Fernandes Ricardo M RM   Hartling Lisa L   Kelly Lauren E LE   Williams Katrina K   Woolfall Kerry K   Dyson Michele P MP  

BMJ paediatrics open 20181126 1


<h4>Objectives</h4>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.<h4>Methods</h4>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 re  ...[more]

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