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Abstract
BackgroundThis research was conducted 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 (PRO) associated with toenail onychomycosis.Methods504 patients with toenail onychomycosis randomized to receive 12 weeks of terbinafine 250 mg/day with or without target toenail debridement in the IRON-CLAD® trial completed the OnyCOE-t™ at baseline, weeks 6, 12, 24, and 48. The OnyCOE-t™ is composed of 6 multi-item scales and 1 single-item scale. These include a 7-item Toenail Symptom assessment, which comprises both Symptom Frequency and Symptom Bothersomeness scales; an 8-item Appearance Problems scale; a 7-item Physical Activities Problems scale; a 1-item Overall Problem scale; a 7-item Stigma scale; and a 3-item Treatment Satisfaction scale. In total, 33 toenail onychomycosis-specific items are included in the OnyCOE-t™. Clinical data, in particular the percent clearing of mycotic involvement in the target toenail, and OnyCOE-t™ responses were used to evaluate the questionnaire's reliability, validity, responsiveness, and the minimally clinical important difference (MCID). ResultsThe OnyCOE-t™ was shown to be reliable and valid. Construct validity and known groups validity were acceptable. Internal consistency reliability of multi-item scales was demonstrated by Cronbach's alpha > .84. Responsiveness was good, with the Treatment Satisfaction, Symptom Frequency, Overall Problem, and Appearance Problem scales demonstrating the most responsiveness (Guyatt's statistic of 1.72, 1.31, 1.13, and 1.11, respectively). MCID was evaluated for three different clinical measures, and indicated that approximately an 8.5-point change (on a 0 to 100 scale) was clinically meaningful based on a 25% improvement in target nail clearing.ConclusionThe OnyCOE-t™ questionnaire is a unique, toenail-specific PRO questionnaire that can be used with confidence in future studies of toenail onychomycosis. MCID was evaluated for three different clinical measures, and indicated that approximately a 7-point change (on a 0 to 100 scale) was clinically meaningful based on a 12.5% improvement in target nail clearing.
Highlights
This research was conducted to confirm the validity and reliability and to assess the responsiveness and clinical meaningfulness of the OnyCOE-tTM, a questionnaire designed to measure patient-reported outcomes (PRO) associated with toenail onychomycosis
Validity and reliability Strong correlations exist between items measuring toenail symptom frequency, and bothersomeness
Under the 25% difference scenario, most of the individual minimally clinical important difference (MCID) estimates were consistent of the estimated MCID at 12.5%; the exceptions were Symptom Frequency and Treatment Satisfaction
Summary
This research was conducted to confirm the validity and reliability and to assess the responsiveness and clinical meaningfulness of the OnyCOE-tTM, a questionnaire designed to measure patient-reported outcomes (PRO) associated with toenail onychomycosis. Onychomycosis is a common, chronic fungal infection of the keratinized tissue of the nail bed and nail plate that may impact patients' quality of life. Patients often experience pain and discomfort, and normal tactile functions can be impaired or lost. Toenail dystrophy can interfere with walking, standing, exercise, or proper shoe fit. Like other visible dermatologic imperfections, onychomycosis has both psychosocially and physically detrimental effects [1]. Patients report concerns about nail appearance, embarrassment, reduced self-esteem, and social withdrawal. Patients may fear injury and spreading the infection to others [2]
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