Total neuropathy score - Validation and reliability study

Objective: To determine the validity and reliability of the total neuropath y score (TNS) in normal subjects and in subjects with diabetic polyneuropat hy. Background: Clinical research in peripheral neuropathy requires validat ed outcome measures. Multiple outcome measures have been used in clinical t rials, including symptom measures, functional scales, quantitative clinical examinations, nerve conduction studies, computerized sensory examinations, and nerve biopsy. Each of these measures has its strengths and weaknesses. In two previous studies of toxic neuropathy from chemotherapeutic agents, the authors used the TNS as the outcome measure. The TNS combines informati on obtained from grading of symptoms, signs, nerve conduction studies, and quantitative sensory tests, and provides a single measure to quantify neuro pathy. Methods: The authors measured the inter- and intrarater reliability of the TNS and preformed a cross-sectional validation study of the TNS and its subscales with the Mayo Clinic measures of neuropathy, neuropathy sympt om score (NSS), and the neurologic impairment score (NIS) in five healthy c ontrol subjects and 30 individuals with varying severities of diabetic poly neuropathy. Results: Inter- and intrarater reliability of the TNS was excel lent (0.966 and 0.986 respectively). The cross-sectional validation study s howed excellent correlations among all measures of neuropathy. Conclusions: The total neuropathy score is a validated measure of peripheral nerve func tion and could be used as an end point for clinical trials of peripheral ne uropathy.