The OnyCOE-t™ Questionnaire for Toenail Onychomycosis
Author Information
Author(s): Lori P. Potter, Susan D. Mathias, Monika Raut, Farid Kianifard, Amir Tavakkol
Primary Institution: Ovation Research Group
Hypothesis
To confirm the validity and reliability and to assess the responsiveness and clinical meaningfulness of the OnyCOE-t™, a questionnaire specifically designed to measure patient-reported outcomes associated with toenail onychomycosis.
Conclusion
The OnyCOE-t™ questionnaire is a unique, toenail-specific PRO questionnaire that can be used with confidence in future studies of toenail onychomycosis.
Supporting Evidence
- The OnyCOE-t™ was shown to be reliable and valid.
- Internal consistency reliability of multi-item scales was demonstrated by Cronbach's alpha > .84.
- Responsiveness was good, with the Treatment Satisfaction and Symptom Frequency scales demonstrating the most responsiveness.
Takeaway
The OnyCOE-t™ is a special questionnaire that helps doctors understand how toenail fungus affects patients' lives, and it works well to show if treatments are helping.
Methodology
Patients completed the OnyCOE-t™ at baseline and at weeks 6, 12, 24, and 48 during a trial where they received terbinafine with or without toenail debridement.
Potential Biases
Potential bias due to the subjective nature of patient-reported outcomes and the blinding of clinical assessments.
Limitations
The study was limited to the target nail, which may not reflect the overall clinical status of patients with multiple affected nails.
Participant Demographics
Patients were between 18 and 75 years old, with a mean age of 48.5 years, predominantly Caucasian (63.5%) and male (61.3%).
Statistical Information
P-Value
p<0.001
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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