13/12/2011 Medicine Psychology
DOI: 10.1186/1745-6215-12-S1-A123 SemanticScholar ID: 20335357 MAG: 2022260521

Can we improve recruitment to trials and informed consent by improving participant information sheets? – A nested RCT

Publication Summary

Methods CASPER is a UK NIHR-funded trial of Collaborative Care to prevent depression in adults aged 75+. During the CASPER set-up phase we produced an information sheet compliant with National Research Ethics Service (NRES) guidance (the ‘standard sheet’). We decided to try to enhance recruitment by improving the PIS (the ‘enhanced sheet’). The nested study comprises: first, development and testing of an ‘enhanced sheet’; second, comparison of the ‘standard’ and ‘enhanced’ versions in a nested RCT. The comprehensibility of the NRES-approved standard sheet was assessed by asking cohorts of 10 older adults to take part in individual user testing interviews. After reading the sheet, participants were asked to find answers in the sheet to 18 factual questions and show their understanding of found information. The sheet was then re-written, re-structured and re-designed, drawing on graphics and writing expertise and the user testing data. The ‘enhanced sheet’ was user-tested on further cohorts of 10 people and amended according to the data obtained. In a nested RCT, potential CASPER participants will be posted either the ‘standard’ or ‘enhanced’ sheet, to assess effects on interest in participation and recruitment. Responders will be asked to complete an abbreviated version of the Joffe Quality of Informed Consent measure [1]. We will also conduct 2 focus groups with participants to explore the role of the sheet in their decision to participate (or not).

CAER Authors

Avatar Image for Simon Gilbody

Prof. Simon Gilbody

University of York - Director of the Mental Health and Addictions Research Group

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