The drugs we are using for the trial were chosen collaboratively with input from patients and UK-based clinicians in 2019 and 2022. Since then, we’ve worked with our Patient and Public Involvement members to develop and improve patient-facing documents and trial methods.
Trial Development
Two members of the public were members of our trial development group: one with lived experience as a patient taking blood-thinning tablets for blocked leg arteries, and one with lived experience as a carer for their parents.
We held two PPI focus groups during the development of the trial. The first group included 8 patients taking blood-thinning tablets for arterial disease: all agreed the trial design was acceptable and confirmed they would be willing to take part in principle. The second group of 6 patients helped us to develop the trial methods, for example having an emphasis on preventing amputation as a result of blocked arteries and reducing the number of patient questionnaires. |
Oversight Groups
The CLARITY trial has PPI representation on the Trial Management Group (TMG) and Trial Steering Committee (TSC). PPI representatives will review patient-facing materials and provide feedback throughout the trial to refine the methodology and support the dissemination of activities and results.
|
Patient Advisory Group
An advisory group of 9 members with experience of chronic limb-threatening ischaemia (CLTI) has been set up. The group will meet 3-4 times to discuss and provide feedback on various aspects of the trial, including co-producing and reviewing patient-facing documents and data collection materials, discussing any recruitment issues, inputting into the analysis of patient interviews, and helping with results reporting.
|
