title: Sense and readability: participant information sheets for research studies.
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.
  
  
  OBJECTIVE
  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.
authors.affiliation: Liam Ennis, BSc, MSc, Health Services and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London; Til Wykes, DPhil, Psychology Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.
authors.forename: Liam
authors.initials: L
authors.lastname: Ennis
authors.affiliation: Liam Ennis, BSc, MSc, Health Services and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London; Til Wykes, DPhil, Psychology Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK Til.Wykes@kcl.ac.uk.
authors.forename: Til
authors.initials: T
authors.lastname: Wykes
mesh_terms: D035843:Biomedical Research; D032882:Comprehension; D032962:Consent Forms / Q000592:standards*; D016208:Databases, Factual; D006801:Humans; D007258:Informed Consent; D010353:Patient Education as Topic; D010358:Patient Participation; D013664:Teaching Materials / Q000592:standards*