Luto produces information for Clinical Trials, such as Patient Information Sheets (PIS) and Informed Consent Forms (ICF) that participants can understand – our research demonstrates that better informed participants make better treatment decisions. These participants are also more likely to demonstrate improved adherence to participation in Clinical Trials. We are able to provide a complete training package for your clinical trial and deliver training to Clinical Trial sites on your behalf.
Our service on PIS and ICF brings together our experience in patient information, through application of the best principles of Information Design and applying User Testing methodology. The result is a PIS or ICF that is enhanced in both content and format where the key points and safety messages can be shown to be understood by the target patient cohort.
We are able to redesign, refine and align various PIS and ICF materials. Alongside this, Luto can facilitate consultations with target patient or healthcare professional groups to ensure that the material is legible, clear and easy to use. We can test participants’ interpretations of the purpose of the materials, their understanding of the key messages and their behavioural intention, self-efficacy and confidence.
Luto can produce a full report that explains our methodology and the results of the applied User Test.
Studies that have informed our approach
Research commissioned by the University of Leeds and undertaken by Luto assessed the readability of four clinical trial PIS. The research applied the method of User Testing but showed that each PIS did not perform as expected. This was particularly surprising given that the PIS had already received research ethics approval.
Patients in the research showed difficulty in finding information in the PIS relating to several key points 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.
Results of the research showed that amending the layout and wording of the information for the four PIS led to significant performance improvements.
Contact us today to discuss your requirements for Clinical Trials.