Reliability and validity of the modified Toronto Clinical Neuropathy Score in diabetic sensorimotor polyneuropathy

Abstract

IntroductionA reliable and valid clinical tool to capture symptoms and signs of diabetic sensorimotor polyneuropathy (DSP) for use in clinical research trials is urgently needed. The validated Toronto Clinical Neuropathy Score (TCNS) was modified to improve sensitivity to early DSP changes. We aimed to assess the reproducibility of this modified tool, the mTCNS and to determine its validity relative to the precursor TCNS.MethodsSixty-five patients (six Type 1, 59 Type 2 diabetes) with diabetes duration 13 ± 8 years were accrued from four study sites and examined on 2 days for internal consistency and inter- and intra-rater reliability of the mTCNS. In the absence of a single quantitative gold-standard measure for DSP, results of the mTCNS were compared with the precursor TCNS for the purpose of estimating validity.ResultsInternal consistency of the two domains within the mTCNS was good (Cronbach's alpha 0.78). Very good inter-rater reliability for the mTCNS was demonstrated by an intra-class correlation coefficient for the mTCNS of 0.87 (95% confidence interval, 0.79–0.91), which was similar in magnitude to that of the TCNS (0.83; 95% confidence interval, 0.75–0.89). Intra-rater reliability testing of the mTCNS showed moderate to good correlation for individual symptoms and sensory tests (Cohen's kappa values of 0.54–0.73). The mTCNS shared moderate correlation with the precursor TCNS (Pearson correlation coefficient, 0.58).DiscussionThe mTCNS, a clinical score with higher face validity for tracking mild to moderate DSP, has sufficient reliability and validity relative to its precursor TCNS for use in clinical research.

Sudoscan is an effective screening method for asymptomatic diabetic neuropathy in Chinese type 2 diabetes mellitus patients

“…Conventional screening methods for DSPN consist of different questionnaires including the Michigan Neuropathy Screening Instrument, Neurological Symptom Score (NSS), Neuropathy Disability Score (NDS), Neuropathy Impairment Score–Lower Limb, Utah Early Neuropathy Scale and so on10, 11, 12, 13, 14. Each of these questionnaires emphasizes different clinical manifestations, and proves to be quite time‐consuming in everyday clinical use.…”

Useful Application of the Neuropad Test for Assessment of Diabetic Polyneuropathy

“…Evaluation of DPN was based on clinical examinations using the modified mTCNS, as described previously (11). It consists of graded symptoms (foot pain, numbness, tingling, weakness, ataxia and upper limb symptoms) and a sensory test (pinprick, temperature, light touch, vibration and position sense) score associated with DPN in the judgment of the examiner.…”

“…On the other hand, several instruments (9,10) have developed for use in clinical practice because clinical evaluation of DPN is complex. The modified Toronto Clinical Neuropathy Score (mTCNS) (11) has recently proven to have sufficient reliability and validity to capture mild to moderate symptoms and signs of DPN. The aim of this study was to evaluate clinical usefulness of Neuropad test for assessment of DPN diagnosed through mTCNS.…”

Distal Sensorimotor Neuropathy: Improvements in Diagnosis

“…Importantly, it remains one of the few scores that have been validated against morphometry, with a significant negative correlation with sural nerve fiber density (r 2 = -0.256, p < 0.0001). Subsequently, the authors published a modification, the mTCNS, to better capture the early sensory abnormalities of DSPN, and to eliminate muscle reflex tests which are notoriously variable between raters [19]. In a recent study comparing seven neuropathy composite scores in individuals with impaired glucose tolerance and symptomatic early neuropathy of less than 2 years' duration, mTCNS was the strongest discriminant, with an AUC of 0.99 (p = 0.006) for all subjects with neuropathy [20].…”