Development and Validation of Consensus Clinical Criteria Inclen Diagnostic Tool Kits for Neuro-Motor Impairment (INDT-NMI) and Epilepsy (INDT-EPI)

Background: A structured, validated diagnostic instrument for identifying children with neuro-motor impairment and epilepsy was needed for easy and standardized assessment by the primary care physicians in resource constraint environments, and for collecting epidemiological information for decision makers and scientists.

Objectives: To validate diagnostic toolkits for Neuromotor Impairments (INDT-NMI) and Epilepsy (INDT-EPI) for use by the primary care physician.  

Methods: For INDT-NMI, standardized instrument comprising three sections (Section 1: triage questions: to elicit information on developmental milestones, Section 2: observations: by the physician in terms of hand function, gait and muscle weakness, Section 3: neurological examination: for confirmation of neuromotor impairments) and in INDT-EPI, precision-based 10-question evaluation form was developed. The study was conducted on children aged 2-9 years by systematic random selection at the general pediatrics out-patient clinics of three tertiary care pediatric facilities. The assessment of study subjects were done twice. In step-1 the INDT-NMI and INDT-EPI was administered by primary care graduate physician and in step-2 diagnosis established by consensus of two Pediatric Neurologists each with at least three years experience in diagnosis and management of children (team diagnosis). The team diagnosis was taken as the reference standard.

Results: A total of 454 children 2-9 years age (mean age 60.4 ± 1.1 months) in INDT-NMI and 514 children (mean age was 60.1 ± 1.0 months) in INDT-EPI were enrolled in the study. The diagnostic evaluation was adapted to the local vernacular language, required 15- 20 minutes in an office-setting and allowed for additional time for family counseling. The diagnostic tool-kit INDT-NMI demonstrated psychometric properties with sensitivity and specificity of 85.8% and 95.3 %, positive and negative predictive values of 94 % and 88.5 %, and positive and negative likelihood ratios of 18.25 and 0.15 respectively when compared to the expert evaluation. INDT-EPI was also observed to have good psychometric properties, with sensitivity and specificity of 85.6% and 93.5%, positive and negative predictive values of 88.5% and 91.7%, and positive and negative likelihood ratios of 13.2 and 0.15 respectively when compared to expert evaluation.

Conclusions: A validated structured and intuitive toolkit for point-of-care diagnosis (INDT-NMI) and (INDT-EPI) in children by primary care physicians has been developed and would promote early treatment and timely, targeted referrals for expert evaluation, particularly in resource constraint environments.