Consent and recruitment: the reporting of paediatric trials published in 2012. Issue 1 (26th November 2018)

• Record Type: Journal Article
• Authors: Gates, Allison; Caldwell, Patrina; Curtis, Sarah; Dans, Leonila; Fernandes, Ricardo M; Hartling, Lisa; Kelly, Lauren E; Williams, Katrina; Woolfall, Kerry; Dyson, Michele P
• Is Part Of: BMJ paediatrics open. Volume 2:Issue 1(2018)
• Publication Date: 2018-11-26
• Subjects: data collection -- general paediatrics; Pediatrics -- Periodicals; Children -- Health and hygiene -- Periodicals; 618.920005
• DOI: 10.1136/bmjpo-2018-000369
• Languages: English
• ISSNs: 2399-9772

Abstract

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.