BackgroundOnychomycosis, the most common cause of nail dystrophy, is generally diagnosed by clinical examination. Current guidelines for Dutch general practice advise confirmatory testing only in cases of doubt or insufficient response to treatment. However, making a correct diagnosis can be challenging given the wide variety of clinical features and differential diagnosis.AimTo establish accuracy of clinical diagnosis of onychomycosis by GPs.Design & settingA diagnostic accuracy study based on GPs' clinical diagnosis of primary care patients suspected of onychomycosis.MethodUsing 137 complete datasets from the Onycho Trial, diagnostic accuracy of clinical diagnosis as the index test was compared with confirmatory testing as the reference test. A sensitivity analysis was performed to determine diagnostic values for different combinations of index and reference test. Logistical regression was used to assess which clinical characteristics were associated with the positive predictive value (PPV) of the index test.ResultsClinical accuracy, that is the PPV of the index test, was 74.5%. Sensitivity analysis showed no significant difference in diagnostic values. Male sex and a history of any previous treatment significantly increased clinical accuracy with an odds ratio (OR) of 3.873 (95% confidence interval [CI] = 1.230 to 12.195,P= 0.021) and OR 4.022 (95% CI = 1.075 to 15.040,P= 0.039), respectively.ConclusionThe study demonstrated that the GPs' clinical diagnosis of onychomycosis was insufficiently accurate to initiate treatment without confirmatory testing. Further research is needed to investigate how to increase clinical accuracy and reduce potentially unnecessary exposure to treatment.