Patient and Public Involvement in designing a clinical trial for the surgical management of persistent Post-Infectious Olfactory Dysfunction
- 1Ear Institute, University College London
Abstract
IntroductionPersistent 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.
ObjectivesTo 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.
MethodsThe PPI programme included an online survey, online discussion forums, and focus groups.
Results63 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.
ConclusionsThis 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.
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BibTeX
@misc{khatiwada2026patient,
title = {{Patient and Public Involvement in designing a clinical trial for the surgical management of persistent Post-Infectious Olfactory Dysfunction}},
author = {A. Sharma Khatiwada and L. R. Springford and L. Corner and C. Kelly and A. L. Pendolino and P. J. Andrews},
howpublished = {medRxiv},
year = {2026},
month = sep,
doi = {10.64898/2026.09.08.26362544},
url = {https://www.medrxiv.org/content/10.64898/2026.09.08.26362544v1},
note = {CC BY},
}
RIS
TY - UNPB
TI - Patient and Public Involvement in designing a clinical trial for the surgical management of persistent Post-Infectious Olfactory Dysfunction
AU - A. Sharma Khatiwada
AU - L. R. Springford
AU - L. Corner
AU - C. Kelly
AU - A. L. Pendolino
AU - P. J. Andrews
PY - 2026
DA - 2026/09/08
PB - medRxiv
DO - 10.64898/2026.09.08.26362544
UR - https://www.medrxiv.org/content/10.64898/2026.09.08.26362544v1
AB - IntroductionPersistent 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. ObjectivesTo 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. MethodsThe PPI programme included an online survey, online discussion forums, and focus groups. Results63 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. ConclusionsThis 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.
ER -