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Reliability and validity of a point-of-care sural nerve conduction device for identification of diabetic neuropathy.
PLoS One. 2014; 9(1):e86515.Plos

Abstract

BACKGROUND

Confirmation of diabetic sensorimotor polyneuropathy (DSP) relies on standard nerve conduction studies (NCS) performed in specialized clinics. We explored the utility of a point-of-care device (POCD) for DSP detection by nontechnical personnel and a validation of diagnostic thresholds with those observed in a normative database.

RESEARCH DESIGN AND METHODS

44 subjects with type 1 and type 2 diabetes underwent standard NCS (reference method). Two nontechnical examiners measured sural nerve amplitude potential (SNAP) and conduction velocity (SNCV) using the POCD. Reliability was determined by intraclass correlation coefficients (ICC [2], [1]). Validity was determined by Bland-Altman analysis and receiver operating characteristic curves.

RESULTS

The 44 subjects (50% female) with mean age 56 ± 18 years had mean SNAP and SNCV of 8.0 ± 8.6 µV and 41.5 ± 8.2 m/s using standard NCS and 8.0 ± 8.2 µV and 49.9 ± 11.1 m/s using the POCD. Intrarater reproducibility ICC values were 0.97 for SNAP and 0.94 for SNCV while interrater reproducibility values were 0.83 and 0.79, respectively. Mean bias of the POCD was -0.1 ± 3.6 µV for SNAP and +8.4 ± 6.4 m/s for SNCV. A SNAP of ≤6 µV had 88% sensitivity and 94% specificity for identifying age-and height-standardized reference NCS values, while a SNCV of ≤48 m/s had 94% sensitivity and 82% specificity [corrected].. Abnormality in one or more of these thresholds was associated with 95% sensitivity and 71% specificity for identification of DSP according to electrophysiological criteria.

CONCLUSIONS

The POCD demonstrated excellent reliability and acceptable accuracy. Threshold values for DSP identification validated those of published POCD normative values. We emphasize the presence of measurement bias--particularly for SNCV--that requires adjustment of threshold values to reflect those of standard NCS.

Authors+Show Affiliations

Division of Endocrinology and Metabolism, Department of Medicine, University of Toronto, Ontario, Canada.Division of Endocrinology and Metabolism, Department of Medicine, University of Toronto, Ontario, Canada.Division of Endocrinology and Metabolism, Department of Medicine, University of Toronto, Ontario, Canada.Division of Neurology, Department of Medicine, University of Toronto, Ontario, Canada.Division of Neurology, Department of Medicine, University of Toronto, Ontario, Canada.Division of Endocrinology and Metabolism, Department of Medicine, University of Toronto, Ontario, Canada.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24466129

Citation

Lee, Justin A., et al. "Reliability and Validity of a Point-of-care Sural Nerve Conduction Device for Identification of Diabetic Neuropathy." PloS One, vol. 9, no. 1, 2014, pp. e86515.
Lee JA, Halpern EM, Lovblom LE, et al. Reliability and validity of a point-of-care sural nerve conduction device for identification of diabetic neuropathy. PLoS One. 2014;9(1):e86515.
Lee, J. A., Halpern, E. M., Lovblom, L. E., Yeung, E., Bril, V., & Perkins, B. A. (2014). Reliability and validity of a point-of-care sural nerve conduction device for identification of diabetic neuropathy. PloS One, 9(1), e86515. https://doi.org/10.1371/journal.pone.0086515
Lee JA, et al. Reliability and Validity of a Point-of-care Sural Nerve Conduction Device for Identification of Diabetic Neuropathy. PLoS One. 2014;9(1):e86515. PubMed PMID: 24466129.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Reliability and validity of a point-of-care sural nerve conduction device for identification of diabetic neuropathy. AU - Lee,Justin A, AU - Halpern,Elise M, AU - Lovblom,Leif E, AU - Yeung,Emily, AU - Bril,Vera, AU - Perkins,Bruce A, Y1 - 2014/01/22/ PY - 2013/10/04/received PY - 2013/12/14/accepted PY - 2014/1/28/entrez PY - 2014/1/28/pubmed PY - 2014/11/5/medline SP - e86515 EP - e86515 JF - PloS one JO - PLoS One VL - 9 IS - 1 N2 - BACKGROUND: Confirmation of diabetic sensorimotor polyneuropathy (DSP) relies on standard nerve conduction studies (NCS) performed in specialized clinics. We explored the utility of a point-of-care device (POCD) for DSP detection by nontechnical personnel and a validation of diagnostic thresholds with those observed in a normative database. RESEARCH DESIGN AND METHODS: 44 subjects with type 1 and type 2 diabetes underwent standard NCS (reference method). Two nontechnical examiners measured sural nerve amplitude potential (SNAP) and conduction velocity (SNCV) using the POCD. Reliability was determined by intraclass correlation coefficients (ICC [2], [1]). Validity was determined by Bland-Altman analysis and receiver operating characteristic curves. RESULTS: The 44 subjects (50% female) with mean age 56 ± 18 years had mean SNAP and SNCV of 8.0 ± 8.6 µV and 41.5 ± 8.2 m/s using standard NCS and 8.0 ± 8.2 µV and 49.9 ± 11.1 m/s using the POCD. Intrarater reproducibility ICC values were 0.97 for SNAP and 0.94 for SNCV while interrater reproducibility values were 0.83 and 0.79, respectively. Mean bias of the POCD was -0.1 ± 3.6 µV for SNAP and +8.4 ± 6.4 m/s for SNCV. A SNAP of ≤6 µV had 88% sensitivity and 94% specificity for identifying age-and height-standardized reference NCS values, while a SNCV of ≤48 m/s had 94% sensitivity and 82% specificity [corrected].. Abnormality in one or more of these thresholds was associated with 95% sensitivity and 71% specificity for identification of DSP according to electrophysiological criteria. CONCLUSIONS: The POCD demonstrated excellent reliability and acceptable accuracy. Threshold values for DSP identification validated those of published POCD normative values. We emphasize the presence of measurement bias--particularly for SNCV--that requires adjustment of threshold values to reflect those of standard NCS. SN - 1932-6203 UR - https://www.unboundmedicine.com/medline/citation/24466129/Reliability_and_validity_of_a_point_of_care_sural_nerve_conduction_device_for_identification_of_diabetic_neuropathy_ L2 - https://dx.plos.org/10.1371/journal.pone.0086515 DB - PRIME DP - Unbound Medicine ER -