Our Research

Recent research commissioned by the University of Leeds and undertaken by luto assessed the readability of four trial patient information sheets (PIS). The research applied the method of User Testing to show that the four PIS performed less well than expected. This is particularly surprising since the sheets had received research ethics approval.

Participants in the research had difficulty in finding information in the PIS relating to several key aspects, including:

  • the placebo group,
  • seeing their own GP, and
  • what they should do if they felt unwell after discharge from the clinic.

They were also unable to show understanding of several aspects of the trials, including:

 
  • common side effects of trial drugs,
  • pre-trial dietary restrictions, and
  • the number of return clinic visits.

The University of Leeds research showed that amending the layout and the wording of the PIS for four trials led to significant performance improvements.