Developing a core outcome set for clinical trials in olfactory disorders: a COMET initiative

Area of Science:

• Olfactory research
• Clinical trial methodology
• Patient-centered outcomes

Background:

• Evaluating olfactory dysfunction (OD) treatments is hindered by inconsistent outcome reporting in clinical trials.
• A Core Outcome Set (COS) standardizes outcome measurement, facilitating meta-analyses and systematic reviews for OD interventions.

Approach:

• A comprehensive list of potential outcomes was compiled from literature reviews, stakeholder analyses, and existing Patient-Reported Outcome Measures (PROMs).
• An iterative e-Delphi process engaged patients and healthcare practitioners to prioritize outcomes based on importance.

Key Points:

• The developed COS includes subjective assessments (visual analogue scales), quality of life metrics, and psychophysical testing for smell and taste.
• It also incorporates evaluation of side effects, investigational treatments, and patient symptom logs.

Conclusions:

• Implementing this COS in future trials will enhance the value and comparability of research on OD interventions.
• Further work is needed to refine and validate the selected outcome measures for olfactory dysfunction research.