According to survey research, onychomycosis, a fungal infection of the toen
ail or fingernail, affects quality of life including physical and social fu
nctioning and emotional health. We developed an onychomycosis disease-speci
fic questionnaire (ODSQ) that sensitively assessed symptom distress, functi
onal impact, and social stigma associated with the disease. Samples of pati
ents enrolled in a randomized controlled clinical trial were used for the p
sychometric evaluations. The multi-item scales were internally consistent (
alpha greater than or equal to 0.80) and reproducible (ICC > 0.85). Intersc
ale correlations between the ODSQ and generic scales were moderate and cons
istent with the hypothesized magnitude and directions. Construct validation
, employing known groups analysis, supported the hypothesized impact of ony
chomycosis on three domains of quality of life: physical functioning, emoti
onal health, and social functioning. Significant differences were found bet
ween clinically "cured", "improved", or "failed" patients, and between myco
logically "eradicated" and "persistent" patients. The ODSQ was responsive t
o clinical change and more sensitive than derived Medical Outcomes Study Sh
ort Form-36 scales. The ODSQ provides reliable, validated and responsive in
formation about the consequences of onychomycosis and its treatment.