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Sense and readability: Participant information sheets for research studies

  • Liam Ennis (a1) and Til Wykes (a2)
Abstract
Background

Informed consent in research is partly achieved through the use of information sheets. There is a perception however that these information sheets are long and complex. The recommended reading level for patient information is grade 6, or 11–12 years old.

Aims

To investigate whether the readability of participant information sheets has changed over time, whether particular study characteristics are related to poorer readability and whether readability and other study characteristics are related to successful study recruitment.

Method

We obtained 522 information sheets from the UK National Institute for Health Research Clinical Research Network: Mental Health portfolio database and study principal investigators. Readability was assessed with the Flesch reading index and the Grade level test.

Results

Information sheets increased in length over the study period. The mean grade level across all information sheets was 9.8, or 15–16 years old. A high level of patient involvement was associated with more recruitment success and studies involving pharmaceutical or device interventions were the least successful. The complexity of information sheets had little bearing on successful recruitment.

Conclusions

Information sheets are far more complex than the recommended reading level of grade 6 for patient information. The disparity may be exacerbated by an increasing focus on legal content. Researchers would benefit from clear guidance from ethics committees on writing succinctly and accessibly and how to balance the competing legal issues with the ability of participants to understand what a study entails.

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Copyright
Corresponding author
Til Wykes, Psychology Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, Denmark Hill, London SE5 8AF, UK. Email: Til.Wykes@kcl.ac.uk
Footnotes
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This study was funded by the NIHR Biomedical Research Centre and the NIHR: CRN Mental Health. The funders had no part in the decision to publish this manuscript.

Declaration of interest

None.

Footnotes
References
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Sense and readability: Participant information sheets for research studies

  • Liam Ennis (a1) and Til Wykes (a2)
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