Patient-Reported Outcomes in Onychomycosis: A Review of Psychometrically Evaluated Instruments in Assessing Treatment Effectiveness.

PURPOSE: Onychomycosis is the most common nail disorder and causes morbidity and impaired quality of life (QOL). Patient-reported outcomes (PRO) are patients' assessment of their health status or treatment response. PROs help assess what is most bothersome to patients to identify targets for intervention. We sought to review the PRO instruments currently used to assess QOL and treatment response in onychomycosis patients.

PROCEDURES: A systematic review was performed by searching PubMed, Embase, CINAHL, and PsycINFO databases through December 31, 2016, to identify all English language literature on onychomycosis, PRO, and QOL.

RESULTS

Currently, 5 validated PRO instruments exist specifically for onychomycosis. Oral therapies were most extensively studied using PRO instruments. QOL data generally correlated with clinical change, although patients sometimes reported improvement without any clinically significant nail clearance. The only psychometrically validated PRO instrument used to evaluate treatment response is the OnyCOE-t™.

CONCLUSIONS

Clinicians may underestimate the impact of onychomycosis on patients. With recent initiatives from health-care management organizations to improve patient experience and the recent approval of expensive and nonsuperior topical antifungal medications, PROs will be increasingly important in onychomycosis to assess patient priorities and optimize treatment. Future research should evaluate these instruments in special populations and fingernail disease.