Patient and Public Involvement in designing a clinical trial for the surgical management of persistent Post-Infectious Olfactory Dysfunction
Year: 2026
Type: preprint
Abstract: ABSTRACT 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.
Source: medRxiv
Language: English
Subfield: General Health Professions
Field: Health Professions
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7212189716