Observational Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Diabetes. Apr 15, 2023; 14(4): 435-446
Published online Apr 15, 2023. doi: 10.4239/wjd.v14.i4.435
Validity and reliability of the Polish version of the Michigan Neuropathy Screening Instrument
Edyta Sutkowska, Dominik Marciniak, Magdalena Koszewicz, Edyta Dziadkowiak, Slawomir Budrewicz, Karolina Biernat, Natalia Kuciel, Justyna Mazurek, Katarzyna Hap
Edyta Sutkowska, Karolina Biernat, Natalia Kuciel, Justyna Mazurek, Katarzyna Hap, University Rehabilitation Centre, Wroclaw Medical University, Wroclaw 50-556, Poland
Dominik Marciniak, Department of Drugs Form Technology, Wroclaw Medical University, Wroclaw 50-556, Poland
Magdalena Koszewicz, Edyta Dziadkowiak, Slawomir Budrewicz, Department of Neurology, Wroclaw Medical University, Wroclaw 50-556, Poland
Author contributions: Sutkowska E designed the study, prepared the article and was major in substantial contributions to conception and design of the work; Sutkowska E, Marciniak D, and Hap K contributed to the data analysis and interpretation; Sutkowska E, Koszewicz M, Dziadkowiak E, Budrewicz S, Biernat K, Kuciel N, and Mazurek J were involved in the acquisition and analysis of data for the work investigation; Koszewicz M and Dziadkowiak E participated in the interpretation of data for the work investigation; Marciniak D, Koszewicz M, Dziadkowiak E, Budrewicz S, Biernat K, Kuciel N, and Mazurek J revised the work critically for important intellectual content; Sutkowska E and Hap K drafted the work; and all authors approved the final version to be published and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Supported by the Ministry of Health Subvention from the IT Simple System of the Wroclaw Medical University by Wroclaw Medical University, No. SUBZ.C310.22.075; and the MCDTR grant from the National Institute of Diabetes and Digestive and Kidney Diseases, No. P30DK092926.
Institutional review board statement: Our cross-sectional study was conducted at the University Rehabilitation Centre at Wroclaw Medical University in collaboration with the Department of Neurology. The study was approved by the Wroclaw Medical University’s ethics committee (Approval No: 1007/2021).
Informed consent statement: All patients included in the study were provided written informed consent to participate in the study.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: The data that support the findings of this study are available from the corresponding author upon reasonable request.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Katarzyna Hap, Doctor, University Rehabilitation Centre, Wroclaw Medical University, Borowska Street 213, Wroclaw 50-556, Poland. katarzyna.hap@umw.edu.pl
Received: November 8, 2022
Peer-review started: November 8, 2022
First decision: November 27, 2022
Revised: December 11, 2022
Accepted: January 9, 2023
Article in press: January 9, 2023
Published online: April 15, 2023
Processing time: 154 Days and 1.1 Hours
Abstract
BACKGROUND

Diabetic sensorimotor polyneuropathy is an important risk factor for foot ulceration and amputation. Thus, patients with diabetes should be screened for this disorder according to local guidelines. An obstacle to the diagnosis of this disease may be the lack of unified diagnostic criteria due to the lack of properly validated scales used for assessment.

AIM

To validate both sections (A and B) of the Michigan Neuropathy Screening Instrument (MNSI) in Polish (PL) patients with diabetes.

METHODS

A cross-sectional study using a test (A1, B1) and re-test (A2, B2) formula was performed in 80 patients with diabetes. The gold standard used for neuropathy detection was a nerve conduction study (NCS) which was performed in all participants. Reliability of the MNSI-PL was assessed using the Cronbach’s alpha, Kuder-Richardson formula 20 (KR-20), split-half reliability, the Gottman split-half tests, and correlation between first and second half was accessed. Stability was assessed using an intraclass correlation coefficient (ICC). For external validation, we used simple linear correlation, binomial regression, and agreement between two different tools using a Bland-Altman plot analysis.

RESULTS

The scale was internally consistent (Cronbach’s alpha for the full scale: 0.81 for A and 0.87 for B). MNSI-PL scores in test/retest showed high stability (ICC = 0.73 for A and ICC = 0.97 for B). The statistically important correlations between MNSI-PL and NCS were found for B1, B2, and A1 (P < 0.005). The cut-off points of ≥ 3 for section A (sensitivity of 90%-100%; specificity of 33%-40%) and ≥ 2 for section B (sensitivity of 81%-84%; specificity of 60%-70%) were obtained during neuropathy detection.

CONCLUSION

The MNSI-PL is a reliable and valid instrument in screening for diabetic neuropathy.

Keywords: Michigan Neuropathy Screening Instrument; Validity; Reliability; Diabetic neuropathy; Chronic complications

Core Tip: The Michigan Neuropathy Screening Instrument (MNSI) is a collective tool for assessing the peripheral nervous system in patients with diabetes mellitus and is widely used to evaluate patients in many countries. In Poland, the MNSI has not yet been validated, thus is a problem when using it in daily practice and for research purposes. We concluded that the Polish MNSI is a reliable and accurate screening tool for peripheral neuropathy, and we hope that it can be used by our colleagues in their studies. We also proposed cutoff points of both scales for patients and for physicians, hoping that MNSI can be used by other authors from different countries