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Development and validity testing of the neuropathy total symptom score-6: questionnaire for the study of sensory symptoms of diabetic peripheral neuropathy.
Clin Ther. 2005 Aug; 27(8):1278-94.CT

Abstract

OBJECTIVE

The aim of this study was to develop and validate a neuropathy sensory symptom scale, the Neuropathy Total Symptom Score-6 (NTSS-6), which evaluates individual neuropathy sensory symptoms in patients with diabetes mellitus (DM) and diabetic peripheral neuropathy (DPN) in clinical trials, with the intent of distinguishing a response to therapy.

METHODS

The NTSS-6 questionnaire was developed to evaluate the frequency and intensity of individual neuropathy sensory symptoms identified frequently by patients with DPN (ie, numbness and/or insensitivity; prickling and/or tingling sensation; burning sensation; aching pain and/or tightness; sharp, shooting, lancinating pain; and allodynia and/or hyperalgesia). The NTSS-6 was administered 8 times over a 1-year period to DPN patients. The NTSS-6's reliability (determined by internal consistency and test-retest reproducibility), construct validity, convergent validity, and minimally clinically important differences (MCIDs) were determined.

RESULTS

The NTSS-6 was administered to a total of 205 patients at 10 centers in the United States, Canada, Belgium, Germany, Hungary, Croatia, Slovenia, and the United Kingdom. Internal consistency was demonstrated at all 8 visits (Cronbach's alpha > 0.7). Test-retest reproducibility (intraclass correlation coefficient >0.9) was observed during the baseline period and at end point. Construct validity was demonstrated by statistically significant correlations between the NTSS-6 total score and the Neuropathy Symptoms and Change (NSC) score (r = 0.773-0.885, P < 0.001). Convergent validity was demonstrated by statistically significant correlations between the change in NTSS-6 total scores and the following: change in NSC scores (r = 0.519-0.708, P < 0.001); change in Neuropathy Impairment Score of the Lower Limbs and composite nerve function scores (r = 0.188-0.202, P < 0.007), and categories of the Clinical Global Impressions (r = 0.402, P < 0.001). The within- and between-groups MCIDs for the total NTSS-6 total scores were -1.26 and 0.97 points, respectively. The mean (SD) within-group MCID for all patients who improved on the Clinical Global Impression was -2.29 (3.4) points.

CONCLUSIONS

The NTSS-6 provided a valid assessment of neuropathy sensory symptoms in this sample of patients with DM and DPN, which suggests that it may be useful for symptom evaluation in clinical trials and practice. The NTSS-6 showed internal consistency, test-retest reliability, and construct validity. There was also convergent validity of the scores, indicating that the NTSS-6 may be a suitable questionnaire for clinical trials that evaluate symptoms of DPN in this well-defined patient population.

Authors+Show Affiliations

Lilly Research Laboratories, Indianapolis, Indiana, 46285, USA. ejbIII@lilly.comNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

16199253

Citation

Bastyr, Edward J., et al. "Development and Validity Testing of the Neuropathy Total Symptom Score-6: Questionnaire for the Study of Sensory Symptoms of Diabetic Peripheral Neuropathy." Clinical Therapeutics, vol. 27, no. 8, 2005, pp. 1278-94.
Bastyr EJ, Price KL, Bril V, et al. Development and validity testing of the neuropathy total symptom score-6: questionnaire for the study of sensory symptoms of diabetic peripheral neuropathy. Clin Ther. 2005;27(8):1278-94.
Bastyr, E. J., Price, K. L., & Bril, V. (2005). Development and validity testing of the neuropathy total symptom score-6: questionnaire for the study of sensory symptoms of diabetic peripheral neuropathy. Clinical Therapeutics, 27(8), 1278-94.
Bastyr EJ, et al. Development and Validity Testing of the Neuropathy Total Symptom Score-6: Questionnaire for the Study of Sensory Symptoms of Diabetic Peripheral Neuropathy. Clin Ther. 2005;27(8):1278-94. PubMed PMID: 16199253.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development and validity testing of the neuropathy total symptom score-6: questionnaire for the study of sensory symptoms of diabetic peripheral neuropathy. AU - Bastyr,Edward J,3rd AU - Price,Karen L, AU - Bril,Vera, AU - ,, PY - 2005/07/05/accepted PY - 2005/10/4/pubmed PY - 2006/7/22/medline PY - 2005/10/4/entrez SP - 1278 EP - 94 JF - Clinical therapeutics JO - Clin Ther VL - 27 IS - 8 N2 - OBJECTIVE: The aim of this study was to develop and validate a neuropathy sensory symptom scale, the Neuropathy Total Symptom Score-6 (NTSS-6), which evaluates individual neuropathy sensory symptoms in patients with diabetes mellitus (DM) and diabetic peripheral neuropathy (DPN) in clinical trials, with the intent of distinguishing a response to therapy. METHODS: The NTSS-6 questionnaire was developed to evaluate the frequency and intensity of individual neuropathy sensory symptoms identified frequently by patients with DPN (ie, numbness and/or insensitivity; prickling and/or tingling sensation; burning sensation; aching pain and/or tightness; sharp, shooting, lancinating pain; and allodynia and/or hyperalgesia). The NTSS-6 was administered 8 times over a 1-year period to DPN patients. The NTSS-6's reliability (determined by internal consistency and test-retest reproducibility), construct validity, convergent validity, and minimally clinically important differences (MCIDs) were determined. RESULTS: The NTSS-6 was administered to a total of 205 patients at 10 centers in the United States, Canada, Belgium, Germany, Hungary, Croatia, Slovenia, and the United Kingdom. Internal consistency was demonstrated at all 8 visits (Cronbach's alpha > 0.7). Test-retest reproducibility (intraclass correlation coefficient >0.9) was observed during the baseline period and at end point. Construct validity was demonstrated by statistically significant correlations between the NTSS-6 total score and the Neuropathy Symptoms and Change (NSC) score (r = 0.773-0.885, P < 0.001). Convergent validity was demonstrated by statistically significant correlations between the change in NTSS-6 total scores and the following: change in NSC scores (r = 0.519-0.708, P < 0.001); change in Neuropathy Impairment Score of the Lower Limbs and composite nerve function scores (r = 0.188-0.202, P < 0.007), and categories of the Clinical Global Impressions (r = 0.402, P < 0.001). The within- and between-groups MCIDs for the total NTSS-6 total scores were -1.26 and 0.97 points, respectively. The mean (SD) within-group MCID for all patients who improved on the Clinical Global Impression was -2.29 (3.4) points. CONCLUSIONS: The NTSS-6 provided a valid assessment of neuropathy sensory symptoms in this sample of patients with DM and DPN, which suggests that it may be useful for symptom evaluation in clinical trials and practice. The NTSS-6 showed internal consistency, test-retest reliability, and construct validity. There was also convergent validity of the scores, indicating that the NTSS-6 may be a suitable questionnaire for clinical trials that evaluate symptoms of DPN in this well-defined patient population. SN - 0149-2918 UR - https://www.unboundmedicine.com/medline/citation/16199253/Development_and_validity_testing_of_the_neuropathy_total_symptom_score_6:_questionnaire_for_the_study_of_sensory_symptoms_of_diabetic_peripheral_neuropathy_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149-2918(05)00150-5 DB - PRIME DP - Unbound Medicine ER -