IMPORTANCE Onychomycosis is the most common disease of the nail in adults. International guidelines urge health care professionals to perform confirmatory diagnostic testing before initiating systemic therapy. This approach was determined to be cost-effective in studies from the late 1990s but has not been evaluated more recently. The effect of testing on the costs of efinaconazole, 10%, topical solution treatment is unknown.OBJECTIVE To evaluate the cost and potential harm associated with 3 approaches to onychomycosis evaluation before treatment with oral terbinafine or efinaconazole, 10%.
DESIGN, SETTING, AND PARTICIPANTSA decision analysis that compared the costs of 3 onychomycosis management algorithms based on recently published data of test statistics, disease prevalence, and relevant costs: (1) empirical therapy without confirmatory testing, (2) pretreatment confirmatory testing with potassium hydroxide (KOH) stain followed by periodic acid-Schiff (PAS) evaluation if KOH testing is negative, and (3) pretreatment testing with PAS. There was no direct patient evaluation. Selection of included studies was based on outcome variables and the quality of study design. The study was conducted from April 1, 2014, to September 1, 2015.
MAIN OUTCOMES AND MEASURESPrimary outcomes included direct cost of onychomycosis testing and therapy and cost to avoid harm when treating patients with oral terbinafine.RESULTS At a disease prevalence of 75%, per-patient cost savings of empirical terbinafine therapy without confirmatory testing was $47 compared with the KOH screening model and $135 compared with PAS testing. The cost of testing necessary to prevent a single case of clinically relevant liver toxic effects related to
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Although onychomycosis can be diagnosed clinically, many guidelines still recommend pathologic confirmation of the diagnosis prior to initiation of systemic treatment. We retrospectively reviewed results from 541 toenail clippings (160 by dermatologists, 198 by podiatrists, and 183 by other provider types) sent to the Brigham and Women's Department of Dermatopathology between January 2000 and December 2013 for confirmatory periodic acid-Schiff (PAS) testing of clinically diagnosed onychomycosis. Of these, 93 (58.1%), 125 (63.1%), and 71 (38.8%) were sent for confirmation of onychomycosis (as opposed to diagnosis of onychodystrophy) by dermatologists, podiatrists, and other provider types, respectively. Confirmatory PAS stains were positive in 70 (75.3%), 101 (80.8%), and 47 (66.2%) of samples ordered by dermatologists, podiatrists, and other providers, respectively. Our study demonstrates that clinical diagnosis of onychomycosis in the appropriate clinical setting is accurate across specialties. Further prospective investigation on the accuracy of clinical diagnosis of onychomycosis may be beneficial.
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