INCLEN Diagnostic Tool for Epilepsy (INDT-EPI) for primary care physicians: development and validation.

OBJECTIVE: To evaluate the diagnostic accuracy of a new diagnostic instrument for epilepsy - INCLEN Diagnostic Tool for Epilepsy (INDT-EPI) - with evaluation by expert pediatric neurologists. STUDY DESIGN: Evaluation of diagnostic test. SETTING: Tertiary care pediatric referral centers in India. METHODS: Children aged 2-9 years, enrolled by systematic random sampling at pediatric neurology out-patient clinics of three tertiary care centers were independently evaluated in a blinded manner by primary care physicians trained to administer the test, and by teams of two pediatric neurologists. OUTCOMES: A 13-item questionnaire administered by trained primary care physicians (candidate test) and comprehensive subject evaluation by pediatric neurologists (gold standard). RESULTS: There were 240 children with epilepsy and 274 without epilepsy. The candidate test for epilepsy had sensitivity and specificity of 85.8% and 95.3%; positive and negative predictive values of 94.0% and 88.5%; and positive and negative likelihood ratios of 18.25 and 0.15, respectively. CONCLUSIONS: The INDT-EPI has high validity to identify children with epilepsy when used by primary care physicians.