A Comparison of Neuropathy Quality of Life Tools: Norfolk QOL-DN, PN-QOL-97, and NeuroQOL-28
Main Article Content
Abstract
Aims To explore the effectiveness of the Norfolk QOL-DN (QOL-DN), PN-QOL-97, and NeuroQOL-28 as tools for early detection of diabetic peripheral neuropathy in overweight, obese, and inactive (OOI), prediabetes (PD), and type 2 diabetes (T2D) individuals.
Methods Thirty-four adults were divided by A1C [(10 OOI, 13 PD, and 11 T2D] and the sural nerves were tested bilaterally via NC-Stat DPN Check, conducting a sural nerve conduction study (NCS). Participants were individually timed, filling out questionnaires (QOL-DN, NeuroQOL-28, and PN-QOL-97) at a self-selected pace. Data were analyzed and compared to NCS findings to determine the best instrument for early neuropathy detection, usability in screening settings, and application for individuals with OOI, PD, and T2D.
Results Abnormal NCS results were obtained from 27 individuals, of which 25 were bilateral and symmetrical. Confirmed DSPN criteria were met for 24, and 1 case met criteria for subclinical neuropathy. Normal NCS findings, reported symptoms, and reduced bilateral sensation were found in 7 cases. The QOL-DN and NeuroQOL-28 significantly predict neuropathy criteria in OOI, PD, and T2D subjects. Analyses revealed the QOL-DN as the quickest for completion (M=5.17; SD=1.83), followed by the NeuroQOL-28 (M=5.58; SD=3.56), and the PN-QOL-97 (M=13.23; SD=3.606).
Conclusions The QOL-DN and NeuroQOL-28 are valid early screening measures for DPN detection. Time completion studies revealed that the QOL-DN and NeuroQOL-28 may be used as excellent short screening measures, completed in approximately 6 minutes or less, with reasonable scoring for both. The NeuroQOL-28 is a better fit for immediate feedback, time constraints, or limited staff. Future investigations should evaluate these tools for detection in DPN-prone individuals and in subclinical populations screenings.
Keywords:
Quality of Life, QOL-DN, PN-QOL-97, NeuroQOL-28, Overweight Obese Inactive
Article Details
How to Cite
BROWN, Jennifer Joy et al.
A Comparison of Neuropathy Quality of Life Tools: Norfolk QOL-DN, PN-QOL-97, and NeuroQOL-28.
Medical Research Archives, [S.l.], v. 9, n. 11, nov. 2021.
ISSN 2375-1924.
Available at: <https://esmed.org/MRA/mra/article/view/2556>. Date accessed: 23 apr. 2024.
doi: https://doi.org/10.18103/mra.v9i11.2556.
Section
Research Articles
The Medical Research Archives grants authors the right to publish and reproduce the unrevised contribution in whole or in part at any time and in any form for any scholarly non-commercial purpose with the condition that all publications of the contribution include a full citation to the journal as published by the Medical Research Archives.
References
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4. Vinik AI, Nevoret M-L, Casellini C, Parson H. Diabetic Neuropathy. Endocrinology and Metabolism Clinics of North America. 12// 2013;42(4):747-787. doi:http://dx.doi.org/10.1016/j.ecl.2013.06.001
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8. Sloan G, Shillo P, Selvarajah D, et al. A new look at painful diabetic neuropathy. Diabetes research and clinical practice. 2018;144:177-191.
9. Luscombe FA. Health‐Related Quality of Life Measurement in Type 2 Diabetes. Value in Health. 2000;3(s1):15-28.
10. International Diabetes Federation. IDF Diabetes Atlas, 9th Edition. 2019.
11. Saeedi P, Petersohn I, Salpea P, et al. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9(th) edition. Diabetes Res Clin Pract. Nov 2019;157:107843. doi:10.1016/j.diabres.2019.107843
12. Bredfeldt C, Altschuler A, Adams AS, Portz JD, Bayliss EA. Patient reported outcomes for diabetic peripheral neuropathy. Article. Journal of Diabetes and Its Complications. 8/20 2015;doi:10.1016/j.jdiacomp.2015.08.015
13. Smith S, Lamping D, Maclaine G. Measuring health-related quality of life in diabetic peripheral neuropathy: A systematic review. Diabetes Research and Clinical Practice. 2012;96(3):261-270.
14. Vickrey BG, Hays RD, Beckstrand M. Development of a health-related quality of life measure for peripheral neuropathy. Neurorehabilitation and Neural Repair. 2000;14(2):93-104.
15. Vileikyte L, Peyrot M, Bundy C, et al. The development and validation of a neuropathy- and foot ulcer-specific quality of life instrument. Diabetes Care. Sep 2003;26(9):2549-55.
16. Marrero D, Pan Q, Barrett-Connor E, et al. Impact of diagnosis of diabetes on health-related quality of life among high risk individuals: The Diabetes Prevention Program outcomes study. Article. Quality of Life Research. 2014;23(1):75-88. doi:10.1007/s11136-013-0436-3
17. Pop-Busui R, Boulton AJ, Feldman EL, et al. Diabetic neuropathy: A position statement by the American Diabetes Association. Diabetes Care. 2017;40(1):136-154.
18. Grisold A, Callaghan BC, Feldman EL. Mediators of diabetic neuropathy: Is hyperglycemia the only culprit? Current Opinion in Endocrinology, Diabetes and Obesity. 2017;24(2):103-111.
19. Brown JJ, Pribesh SL, Baskette KG, Vinik AI, Colberg SR. A Comparison of Screening Tools for the Early Detection of Peripheral Neuropathy in Adults with and without Type 2 Diabetes. Journal of diabetes research. 2017;2017
20. Papanas N, Ziegler D. Prediabetic neuropathy: Does it exist? Curr Diab Rep. Aug 2012;12(4):376-83. doi:10.1007/s11892-012-0278-3
21. Kasznicki J. Advances in the diagnosis and management of diabetic distal symmetric polyneuropathy. Archives of Medical Science: AMS. 2014;10(2):345-354. doi:10.5114/aoms.2014.42588
22. Selwaness M, van den Bouwhuijsen QJA, Verwoert GC, et al. Blood Pressure Parameters and Carotid Intraplaque Hemorrhage as Measured by Magnetic Resonance Imaging: The Rotterdam Study. Hypertension. January 1, 2013 2013;61(1):76-81. doi:10.1161/hypertensionaha.112.198267
23. Miscio G, Guastamacchia G, Brunani A, Priano L, Baudo S, Mauro A. Obesity and peripheral neuropathy risk: A dangerous liaison. Journal of the Peripheral Nervous System. 2005;10(4):354-358. doi:10.1111/j.1085-9489.2005.00047.x
24. Vinik EJ, Vinik AI, Paulson JF, et al. Norfolk QOL‐DN: Validation of a patient reported outcome measure in transthyretin familial amyloid polyneuropathy. Journal of the Peripheral Nervous System. 2014;19(2):104-114.
25. Obici L, Berk JL, González-Duarte A, et al. Quality of life outcomes in APOLLO, the phase 3 trial of the RNAi therapeutic patisiran in patients with hereditary transthyretin-mediated amyloidosis. Amyloid. 2020;27(3):153-162.
26. Vonica CL, Gâvan NA, Cosma DT, et al. Factors influencing quality of life over a 4‐year period of time in Romanian patients with diabetes mellitus. International Journal of Clinical Practice. 2021:e14076.
27. Maxwell SK, Kokokyi S, Breiner A, Ebadi H, Bril V, Katzberg HD. Characteristics of muscle cramps in patients with polyneuropathy. Neuromuscular Disorders. 2014;24(8):671-676.
28. Degu H, Wondimagegnehu A, Yifru YM, Belachew A. Is health related quality of life influenced by diabetic neuropathic pain among type II diabetes mellitus patients in Ethiopia? PloS one. 2019;14(2):e0211449.
29. Dixit S, Maiya A. Diabetic peripheral neuropathy and its evaluation in a clinical scenario: A review. Journal of Postgraduate Medicine. 2014;60(1):33. doi:10.4103/0022-3859.128805
30. Lenters-Westra E, Slingerland RJ. Six of eight hemoglobin A1c point-of-care instruments do not meet the general accepted analytical performance criteria. Clinical Chemistry. Jan 2010;56(1):44-52. doi:10.1373/clinchem.2009.130641
31. Selvin E, Steffes MW, Gregg E, Brancati FL, Coresh J. Performance of A1C for the classification and prediction of diabetes. Diabetes Care. 2011;34(1):84-89. doi:10.2337/dc10-1235
32. Mustafa E, Alemam A, Hamid E. Subclinical peripheral neuropathy in prediabetics; Correlation with glycosylated hemoglobin and C-reactive protein. 2012;
33. Mannarino M, Tonelli M, Allan GM. Tools for practice: Screening and diagnosis of type 2 diabetes with HbA1c. Canadian Family Physician Medecin de Famille Canadien. Jan 2013;59(1):42.
34. Lee JA, Halpern EM, Lovblom LE, Yeung E, Bril V, Perkins BA. Reliability and validity of a point-of-care sural nerve conduction device for identification of diabetic neuropathy. Plos One. 2014;9(1):e86515-e86515. doi:10.1371/journal.pone.0086515
35. Perkins BA, Grewal J, Ng E, Ngo M, Bril V. Validation of a novel point-of-care nerve conduction device for the detection of diabetic sensorimotor polyneuropathy. Diabetes Care. Sep 2006;29(9):2023-7. doi:10.2337/dc08-0500
36. Pambianco G, Costacou T, Strotmeyer E, Orchard TJ. The assessment of clinical distal symmetric polyneuropathy in type 1 diabetes: A comparison of methodologies from the Pittsburgh Epidemiology of Diabetes Complications Cohort. Article. Diabetes Research and Clinical Practice. 5/1/May 2011 2011;92:280-287. doi:10.1016/j.diabres.2011.02.005
37. Sharma S, Vas PR, Rayman G. Assessment of Diabetic Neuropathy Using a Point-of-Care Nerve Conduction Device Shows Significant Associations With the LDIFLARE Method and Clinical Neuropathy Scoring. Journal of Diabetes Science and Technology. 2015;9(1):123-131.
38. Binns‐Hall O, Selvarajah D, Sanger D, Walker J, Scott A, Tesfaye S. One‐stop microvascular screening service: An effective model for the early detection of diabetic peripheral neuropathy and the high‐risk foot. Diabetic Medicine. 2018;35(7):887-894.
39. Hamasaki H, Hamasaki Y. Diabetic neuropathy evaluated by a novel device: Sural nerve conduction is associated with glycemic control and ankle–Brachial Pressure index in Japanese Patients with Diabetes. Frontiers in Endocrinology. 2017;8:203.
40. Veresiu AI, Bondor CI, Florea B, Vinik EJ, Vinik AI, Gâvan NA. Detection of undisclosed neuropathy and assessment of its impact on quality of life: A survey in 25,000 Romanian patients with diabetes. Article. Journal of Diabetes and Its Complications. 7/1/July 2015 2015;29:644-649. doi:10.1016/j.jdiacomp.2015.04.001
41. Herrera-Rangel A, Aranda-Moreno C, Mantilla-Ochoa T, Zainos-Saucedo L, Jáuregui-Renaud K. The influence of peripheral neuropathy, gender, and obesity on the postural stability of patients with type 2 diabetes mellitus. Journal of Diabetes Research. 2014;2014
42. Vinik EJ, Hayes RP, Oglesby A, et al. The Development and Validation of the Norfolk QOL-DN, a New Measure of Patients' Perception of the Effects of Diabetes and Diabetic Neuropathy. Diabetes Technology & Therapeutics. 2005/06/01 2005;7(3):497-508. doi:10.1089/dia.2005.7.497
43. Tesfaye S, Boulton AJ, Dyck PJ, et al. Diabetic neuropathies: Update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. Oct 2010;33(10):2285-93. doi:10.2337/dc10-1303
44. Papanas N, Vinik AI, Ziegler D. Neuropathy in prediabetes: Does the clock start ticking early? Nat Rev Endocrinol. Nov 2011;7(11):682-90. doi:10.1038/nrendo.2011.113
45. Marcovecchio ML, Lucantoni M, Chiarelli F. Role of chronic and acute hyperglycemia in the development of diabetes complications. Diabetes Technology & Therapeutics. Mar 2011;13(3):389-94. doi:10.1089/dia.2010.0146
46. Smith AG, Singleton JR. Obesity and hyperlipidemia are risk factors for early diabetic neuropathy. Journal of Diabetes and Its Complications. Sep-Oct 2013;27(5):436-42. doi:10.1016/j.jdiacomp.2013.04.003
47. Farhan S, Jarai R, Tentzeris I, et al. Comparison of HbA1c and oral glucose tolerance test for diagnosis of diabetes in patients with coronary artery disease. Clinical Research in Cardiology: Official Journal of the German Cardiac Society. Aug 2012;101(8):625-30. doi:10.1007/s00392-012-0435-3
2. Guo J, Whittemore R, Jeon S, et al. Diabetes self-management, depressive symptoms, metabolic control and satisfaction with quality of life over time in Chinese youth with type 1 diabetes. Journal of Clinical Nursing. 2015;24(9/10):1258-1268 11p. doi: doi: 10.1111/jocn.12698.
3. Zhao F-F, Suhonen R, Katajisto J, Leino-Kilpi H. The association of diabetes-related self-care activities with perceived stress, anxiety, and fatigue: A cross-sectional study. Patient Preference and Adherence. 2018;12:1677.
4. Vinik AI, Nevoret M-L, Casellini C, Parson H. Diabetic Neuropathy. Endocrinology and Metabolism Clinics of North America. 12// 2013;42(4):747-787. doi:http://dx.doi.org/10.1016/j.ecl.2013.06.001
5. Dal Canto E, Ceriello A, Rydén L, et al. Diabetes as a cardiovascular risk factor: An overview of global trends of macro and micro vascular complications. European journal of preventive cardiology. 2019;26(2_suppl):25-32.
6. Valencia WM, Florez H. How to prevent the microvascular complications of type 2 diabetes beyond glucose control. BMJ. 2017;356
7. Lu Y, Xing P, Cai X, et al. Prevalence and Risk Factors for Diabetic Peripheral Neuropathy in Type 2 Diabetic Patients From 14 Countries: Estimates of the INTERPRET-DD Study. Front Public Health. 2020;8:534372. doi:10.3389/fpubh.2020.534372
8. Sloan G, Shillo P, Selvarajah D, et al. A new look at painful diabetic neuropathy. Diabetes research and clinical practice. 2018;144:177-191.
9. Luscombe FA. Health‐Related Quality of Life Measurement in Type 2 Diabetes. Value in Health. 2000;3(s1):15-28.
10. International Diabetes Federation. IDF Diabetes Atlas, 9th Edition. 2019.
11. Saeedi P, Petersohn I, Salpea P, et al. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9(th) edition. Diabetes Res Clin Pract. Nov 2019;157:107843. doi:10.1016/j.diabres.2019.107843
12. Bredfeldt C, Altschuler A, Adams AS, Portz JD, Bayliss EA. Patient reported outcomes for diabetic peripheral neuropathy. Article. Journal of Diabetes and Its Complications. 8/20 2015;doi:10.1016/j.jdiacomp.2015.08.015
13. Smith S, Lamping D, Maclaine G. Measuring health-related quality of life in diabetic peripheral neuropathy: A systematic review. Diabetes Research and Clinical Practice. 2012;96(3):261-270.
14. Vickrey BG, Hays RD, Beckstrand M. Development of a health-related quality of life measure for peripheral neuropathy. Neurorehabilitation and Neural Repair. 2000;14(2):93-104.
15. Vileikyte L, Peyrot M, Bundy C, et al. The development and validation of a neuropathy- and foot ulcer-specific quality of life instrument. Diabetes Care. Sep 2003;26(9):2549-55.
16. Marrero D, Pan Q, Barrett-Connor E, et al. Impact of diagnosis of diabetes on health-related quality of life among high risk individuals: The Diabetes Prevention Program outcomes study. Article. Quality of Life Research. 2014;23(1):75-88. doi:10.1007/s11136-013-0436-3
17. Pop-Busui R, Boulton AJ, Feldman EL, et al. Diabetic neuropathy: A position statement by the American Diabetes Association. Diabetes Care. 2017;40(1):136-154.
18. Grisold A, Callaghan BC, Feldman EL. Mediators of diabetic neuropathy: Is hyperglycemia the only culprit? Current Opinion in Endocrinology, Diabetes and Obesity. 2017;24(2):103-111.
19. Brown JJ, Pribesh SL, Baskette KG, Vinik AI, Colberg SR. A Comparison of Screening Tools for the Early Detection of Peripheral Neuropathy in Adults with and without Type 2 Diabetes. Journal of diabetes research. 2017;2017
20. Papanas N, Ziegler D. Prediabetic neuropathy: Does it exist? Curr Diab Rep. Aug 2012;12(4):376-83. doi:10.1007/s11892-012-0278-3
21. Kasznicki J. Advances in the diagnosis and management of diabetic distal symmetric polyneuropathy. Archives of Medical Science: AMS. 2014;10(2):345-354. doi:10.5114/aoms.2014.42588
22. Selwaness M, van den Bouwhuijsen QJA, Verwoert GC, et al. Blood Pressure Parameters and Carotid Intraplaque Hemorrhage as Measured by Magnetic Resonance Imaging: The Rotterdam Study. Hypertension. January 1, 2013 2013;61(1):76-81. doi:10.1161/hypertensionaha.112.198267
23. Miscio G, Guastamacchia G, Brunani A, Priano L, Baudo S, Mauro A. Obesity and peripheral neuropathy risk: A dangerous liaison. Journal of the Peripheral Nervous System. 2005;10(4):354-358. doi:10.1111/j.1085-9489.2005.00047.x
24. Vinik EJ, Vinik AI, Paulson JF, et al. Norfolk QOL‐DN: Validation of a patient reported outcome measure in transthyretin familial amyloid polyneuropathy. Journal of the Peripheral Nervous System. 2014;19(2):104-114.
25. Obici L, Berk JL, González-Duarte A, et al. Quality of life outcomes in APOLLO, the phase 3 trial of the RNAi therapeutic patisiran in patients with hereditary transthyretin-mediated amyloidosis. Amyloid. 2020;27(3):153-162.
26. Vonica CL, Gâvan NA, Cosma DT, et al. Factors influencing quality of life over a 4‐year period of time in Romanian patients with diabetes mellitus. International Journal of Clinical Practice. 2021:e14076.
27. Maxwell SK, Kokokyi S, Breiner A, Ebadi H, Bril V, Katzberg HD. Characteristics of muscle cramps in patients with polyneuropathy. Neuromuscular Disorders. 2014;24(8):671-676.
28. Degu H, Wondimagegnehu A, Yifru YM, Belachew A. Is health related quality of life influenced by diabetic neuropathic pain among type II diabetes mellitus patients in Ethiopia? PloS one. 2019;14(2):e0211449.
29. Dixit S, Maiya A. Diabetic peripheral neuropathy and its evaluation in a clinical scenario: A review. Journal of Postgraduate Medicine. 2014;60(1):33. doi:10.4103/0022-3859.128805
30. Lenters-Westra E, Slingerland RJ. Six of eight hemoglobin A1c point-of-care instruments do not meet the general accepted analytical performance criteria. Clinical Chemistry. Jan 2010;56(1):44-52. doi:10.1373/clinchem.2009.130641
31. Selvin E, Steffes MW, Gregg E, Brancati FL, Coresh J. Performance of A1C for the classification and prediction of diabetes. Diabetes Care. 2011;34(1):84-89. doi:10.2337/dc10-1235
32. Mustafa E, Alemam A, Hamid E. Subclinical peripheral neuropathy in prediabetics; Correlation with glycosylated hemoglobin and C-reactive protein. 2012;
33. Mannarino M, Tonelli M, Allan GM. Tools for practice: Screening and diagnosis of type 2 diabetes with HbA1c. Canadian Family Physician Medecin de Famille Canadien. Jan 2013;59(1):42.
34. Lee JA, Halpern EM, Lovblom LE, Yeung E, Bril V, Perkins BA. Reliability and validity of a point-of-care sural nerve conduction device for identification of diabetic neuropathy. Plos One. 2014;9(1):e86515-e86515. doi:10.1371/journal.pone.0086515
35. Perkins BA, Grewal J, Ng E, Ngo M, Bril V. Validation of a novel point-of-care nerve conduction device for the detection of diabetic sensorimotor polyneuropathy. Diabetes Care. Sep 2006;29(9):2023-7. doi:10.2337/dc08-0500
36. Pambianco G, Costacou T, Strotmeyer E, Orchard TJ. The assessment of clinical distal symmetric polyneuropathy in type 1 diabetes: A comparison of methodologies from the Pittsburgh Epidemiology of Diabetes Complications Cohort. Article. Diabetes Research and Clinical Practice. 5/1/May 2011 2011;92:280-287. doi:10.1016/j.diabres.2011.02.005
37. Sharma S, Vas PR, Rayman G. Assessment of Diabetic Neuropathy Using a Point-of-Care Nerve Conduction Device Shows Significant Associations With the LDIFLARE Method and Clinical Neuropathy Scoring. Journal of Diabetes Science and Technology. 2015;9(1):123-131.
38. Binns‐Hall O, Selvarajah D, Sanger D, Walker J, Scott A, Tesfaye S. One‐stop microvascular screening service: An effective model for the early detection of diabetic peripheral neuropathy and the high‐risk foot. Diabetic Medicine. 2018;35(7):887-894.
39. Hamasaki H, Hamasaki Y. Diabetic neuropathy evaluated by a novel device: Sural nerve conduction is associated with glycemic control and ankle–Brachial Pressure index in Japanese Patients with Diabetes. Frontiers in Endocrinology. 2017;8:203.
40. Veresiu AI, Bondor CI, Florea B, Vinik EJ, Vinik AI, Gâvan NA. Detection of undisclosed neuropathy and assessment of its impact on quality of life: A survey in 25,000 Romanian patients with diabetes. Article. Journal of Diabetes and Its Complications. 7/1/July 2015 2015;29:644-649. doi:10.1016/j.jdiacomp.2015.04.001
41. Herrera-Rangel A, Aranda-Moreno C, Mantilla-Ochoa T, Zainos-Saucedo L, Jáuregui-Renaud K. The influence of peripheral neuropathy, gender, and obesity on the postural stability of patients with type 2 diabetes mellitus. Journal of Diabetes Research. 2014;2014
42. Vinik EJ, Hayes RP, Oglesby A, et al. The Development and Validation of the Norfolk QOL-DN, a New Measure of Patients' Perception of the Effects of Diabetes and Diabetic Neuropathy. Diabetes Technology & Therapeutics. 2005/06/01 2005;7(3):497-508. doi:10.1089/dia.2005.7.497
43. Tesfaye S, Boulton AJ, Dyck PJ, et al. Diabetic neuropathies: Update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. Oct 2010;33(10):2285-93. doi:10.2337/dc10-1303
44. Papanas N, Vinik AI, Ziegler D. Neuropathy in prediabetes: Does the clock start ticking early? Nat Rev Endocrinol. Nov 2011;7(11):682-90. doi:10.1038/nrendo.2011.113
45. Marcovecchio ML, Lucantoni M, Chiarelli F. Role of chronic and acute hyperglycemia in the development of diabetes complications. Diabetes Technology & Therapeutics. Mar 2011;13(3):389-94. doi:10.1089/dia.2010.0146
46. Smith AG, Singleton JR. Obesity and hyperlipidemia are risk factors for early diabetic neuropathy. Journal of Diabetes and Its Complications. Sep-Oct 2013;27(5):436-42. doi:10.1016/j.jdiacomp.2013.04.003
47. Farhan S, Jarai R, Tentzeris I, et al. Comparison of HbA1c and oral glucose tolerance test for diagnosis of diabetes in patients with coronary artery disease. Clinical Research in Cardiology: Official Journal of the German Cardiac Society. Aug 2012;101(8):625-30. doi:10.1007/s00392-012-0435-3