Validation of the Toronto Clinical Scoring System for diabetic polyneuropathy.

OBJECTIVE The aim of the current study was to determine the validity of the Toronto Clinical Scoring System (CSS) in reflecting the presence and severity of diabetic peripheral sensorimotor polyneuropathy (DSP) as determined by myelinated fiber density (FD) on sural nerve biopsy. RESEARCH DESIGN AND METHODS Eighty-nine patients with both type 1 and type 2 diabetes, ascertained from a large therapeutic randomized controlled trial, were included in this cross-sectional, observational cohort study. Morphological severity of DSP was expressed as the FD in the sural nerve biopsy. The Toronto CSS was applied to all patients to determine a clinical neuropathy score. General linear regression models were used to assess the relationship between the morphological severity of DSP and the Toronto CSS. RESULTS The Toronto CSS showed a significant negative correlation with sural nerve FD (R(2) = 0.256, P < 0.0001). The Toronto CSS was lower in those with better glycemic control (HbA(1c) </=8%). Sural nerve FD and the Toronto CSS showed strong correlations with electrophysiology, by both summed amplitude and summed conduction velocity values. CONCLUSIONS The Toronto CSS is a valid instrument to reflect the presence and severity of DSP as measured by sural nerve morphology and electrophysiology. The results of the current study underscore the interrelationships between clinical deficits, electrophysiological findings, and morphological changes in DSP. This evidence suggests that the Toronto CSS may prove useful in documenting and monitoring DSP in the clinic and in clinical research trials.