Patient and Public Involvement in designing a clinical trial for the surgical management of persistent Post-Infectious Olfactory Dysfunction

Introduction: Persistent post-infectious olfactory dysfunction (PIOD) has limited effective treatments. In developing a randomized controlled trial (RCT) to evaluate a novel surgical intervention for persistent PIOD, embedding Patient and Public Involvement (PPI), a core NIHR requirement in research, was essential. Objectives: To outline the PPI programme for our proposed RCT, in line with UK Standards for Public Involvement. The objective of the PPI programme was to design a patient-centred, inclusive, and ethically sound trial. Methods: The PPI programme included an online survey, online discussion forums, and focus groups. Results: 63 survey responses, 2 online discussion forums, and 2 focus groups provided PPI input on control arm acceptability, participant recruitment and retention strategies, participation burden, and trial outcome selection, directly shaping the trial protocol. Conclusions: This study demonstrates how robust PPI in trial design ensures that clinical trials remain responsive to the true priorities of the patient by aligning scientific rigor with lived experience.