Relative importance of informational items in Participant Information Leaflets for trials: a Q-Methodology approach

Karen Anne Innes, Seonaidh Cotton, Marion K. Campbell, Jim Elliott, Kate Gillies

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Objectives To identify which information items potential participants and research nurses rank as the most important, and the reasons for this, when considering participation in a randomised controlled trial.

Design Q-methodology approach alongside a think-aloud process. Using a vignette outlining a hypothetical trial, participants were asked to rank statements about informational items usually included in a participant information leaflet (PIL) on a Q-grid, while undertaking a real-time think-aloud process to elicit the underpinning decision processes. Analysis of quantitative data was conducted using descriptive statistics and qualitative data was coded using content analysis.

Participants 20 participants (10 potential trial participants and 10 research nurses).

Setting UK-based participants.

Results Ten research nurses and 10 potential trial participants provided data for the study. Both stakeholder groups ranked similar statements in their top three most important statements, with ‘What are the possible disadvantages and risks of taking part?’ featuring in both. However, considerable variability existed between the groups with regard to their ranking of statements of least importance. Participants identified that sufficient information to make a decision was secured using around 14 items. Participants also identified other items of importance not routinely included in PILs.

Conclusions This study has provided a unique insight into how and why different trial stakeholder groups rank informational items currently contained within PILs. These results have implications for those developing future PILs and those who develop guidance on their content; PILs should focus most on the information items that potential trial participants want and need to make an informed choice about trial participation.
Original languageEnglish
Article numbere023303
Number of pages13
JournalBMJ Open
Issue number9
Early online date5 Sept 2018
Publication statusPublished - Sept 2018

Bibliographical note

Acknowledgements: The authors would like to thank the stakeholders who
participated in the study for their time.

Funding: This work was supported by personal fellowship award (to KG) from
the Medical Research Council Strategic Skills Methodology Fellowship (MRC MR/
L01193X/1). KI and SC were supported by awards from the National Institute for
Health Research Health Technology Assessment Programme (HTA ref 14/192/71, HTA ref 11/58/15). The Health Services Research Unit is supported by a core grant from the Chief Scientist Office of the Scottish Government Health and Social Care Directorates.


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