Total neuropathy score - Validation and reliability study

Total neuropathy score - Validation and reliability study
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DOI:
10.1212/wnl.53.8.1660
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发表时间:
1999-11-10
期刊:
影响因子:
9.9
通讯作者:
Joh, T
Joh, T
中科院分区:
医学1区
文献类型:
--
作者:
Cornblath, DR;Chaudhry, V;Joh, T

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目的:确定神经病变总评分(TNS)在正常受试者和糖尿病多发性神经病变受试者中的有效性和可靠性。背景:周围神经病变的临床研究需要经过验证的结果指标。临床试验中使用了多种结局指标,包括症状指标、功能量表、定量临床检查、神经传导研究、计算机化感觉检查和神经活检。这些措施各有优缺点。在之前的两项化疗药物中毒性神经病研究中,作者使用TNS作为结局指标。TNS结合了从症状分级、体征、神经传导研究和定量感觉测试中获得的信息,并提供了量化神经病变的单一测量。研究方法:作者测量了TNS的内部和内部可靠性,并在5名健康对照受试者和30名患有不同严重程度的糖尿病多发性神经病的个体中,使用马约诊所的神经病变、神经病变症状评分(NSS)和神经功能缺损评分(NIS)指标对TNS及其子量表进行了横断面验证研究。结果:TNS的信度为0.966,内信度为0.986,具有良好的信度。横断面验证研究显示,神经病变的所有措施之间的良好相关性。结论:总神经病变评分是周围神经功能的有效指标,可用作周围神经病变临床试验的终点。
Objective: To determine the validity and reliability of the total neuropathy score (TNS) in normal subjects and in subjects with diabetic polyneuropathy. Background: Clinical research in peripheral neuropathy requires validated outcome measures. Multiple outcome measures have been used in clinical trials, 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 information obtained from grading of symptoms, signs, nerve conduction studies, and quantitative sensory tests, and provides a single measure to quantify neuropathy. 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 symptom score (NSS), and the neurologic impairment score (NIS) in five healthy control subjects and 30 individuals with varying severities of diabetic polyneuropathy. Results: Inter- and intrarater reliability of the TNS was excellent (0.966 and 0.986 respectively). The cross-sectional validation study showed excellent correlations among all measures of neuropathy. Conclusions: The total neuropathy score is a validated measure of peripheral nerve function and could be used as an end point for clinical trials of peripheral neuropathy.