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

Janet Holt,Peter Knapp,Simon Gilbody,Brian Parkinson,Yvonne Birks,Jonathan Silcock,Natasha Mitchell,David K Raynor

doi:10.1186/1745-6215-12-s1-a123

Janet Holt, Peter Knapp + Show 6 more

Open Access

https://doi.org/10.1186/1745-6215-12-s1-a123

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Abstract

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).

Highlights

Assess effects on interest in participation and recruitment
The comprehensibility of the National Research Ethics Service (NRES)-approved standard sheet was assessed by asking cohorts of 10 older adults to take part in individual user testing interviews
In a nested RCT, potential CASPER participants will be posted either the ‘standard’ or ‘enhanced’ sheet, to Results Despite it being approved by NRES, testing of the standard CASPER trial sheet revealed limitations in document organisation and writing, resulting in difficulty understanding such issues as trial benefits, sources of patient data and trial withdrawal

Summary

Open Access

Can we improve recruitment to trials and informed consent by improving participant information sheets? - A nested RCT. Can we improve recruitment to trials and informed consent by improving participant information sheets? Peter Knapp1*, Natasha Mitchell, David K Raynor, Jonathan Silcock, Brian Parkinson, Janet Holt, Yvonne Birks, Simon Gilbody. Objectives Develop a more readable participant information sheet (PIS) for an ongoing trial (CASPER) through re-writing, graphic design and user testing; and. Assess the impact of the enhanced sheet on trial recruitment and informed consent. 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 conduct 2 focus groups with participants to explore the role of the sheet in their decision to participate (or not)

Methods

Results

Conclusions