A collaboration between NHS Blood and Transplant, The University of Cambridge, Cambridge University Hospitals Trust & Thinklusive.
Working with the research team, alongside expert-by-experience patient representatives, the Thinklusive team created an easy-read Participant Information Sheet.
The production of this booklet was funded by the NIHR Efficacy and Mechanism Evaluation Programme (NIHR161200) as part of the CLOTBUST-L Trial (ISRCTN73484674).
In addition to the Participant Information Sheet, an illustrated ‘easy-read’ information sheet was co-produced and reviewed by the REC.
This offered a supplementary guide to what the study involved, and what it meant for patients to take part.
The booklet is core to the patient information material used to ensure informed consent in participant decisions to join the study, or not. It provides an accessible information format suitable for all participants, not only those who find complex information difficult to assess. Especially, when eligible participants are in a stressful clinical circumstance.
The easy-read guide was reviewed by an independent research ethics committee (North West – Greater Manchester South Research Ethics Committee) and the Medicines and Healthcare Products Regulatory Agency (MHRA).
Praised by the wider research community, this project is an excellent example of how details of a very complex study can be communicated in a novel way to patients and their families.
This project (NIHR161200) is funded by the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership. The views expressed in this publication are those of the authors and not necessarily those of the MRC, NIHR or the Department of Health and Social Care.