Skip to main content
Top
Gepubliceerd in: Quality of Life Research 12/2015

12-06-2015

Development and validation of the Diabetic Peripheral Neuropathic Pain Impact (DPNPI) measure, a patient-reported outcome measure

Auteurs: Meryl Brod, Steven I. Blum, Donald M. Bushnell, Abhilasha Ramasamy

Gepubliceerd in: Quality of Life Research | Uitgave 12/2015

Log in om toegang te krijgen
share
DELEN

Deel dit onderdeel of sectie (kopieer de link)

  • Optie A:
    Klik op de rechtermuisknop op de link en selecteer de optie “linkadres kopiëren”
  • Optie B:
    Deel de link per e-mail

Abstract

Purpose

Diabetic peripheral neuropathy (DPN) occurs in 26–47 % of diabetes patients and may have negative impacts on physical functioning, sleep, well-being, and quality of life. The Diabetic Peripheral Neuropathic Pain Impact measure (DPNPI) was developed to measure disease impacts and treatment effects. Presented are the DPNPI conceptual development and validation findings.

Methods

The DPNPI was developed following the FDA Guidance for Industry on patient-reported outcome (PRO) measures. Concept elicitation (CE) included literature review, clinical expert interviews, and patient interviews/focus groups. Qualitative data were analyzed following grounded theory principles, and draft items were cognitively debriefed. The measure underwent psychometric validation, and an a priori statistical analysis plan assessed the measurement model, reliability, and validity. Simultaneous analyses of item functioning were conducted using Rasch measurement theory (RMT). All tests were performed for the total score and each domain.

Results

Twenty-five patients and three clinical experts participated in CE which resulted in a 27-item validation ready measure. In the validation study (N = 124), nine draft items were dropped due to high missing data and/or high correlations between items. Factor analysis revealed three domains: physical functioning/mobility, sleep, and daily activities. RMT confirmed adequate item fit and placement within domains. Internal consistency ranged from 0.91 to 0.96 and test–retest from 0.84 to 0.91. All prespecified hypotheses for convergent and discriminant validity were met.

Conclusions

CE and psychometric results provide evidence that the final, 18-item DPNPI is a reliable and valid PRO measure of disease impacts and treatment for DPNP. Further validation work should include responsiveness assessment.
Literatuur
2.
go back to reference Tesfaye, S., Vileikyte, L., Rayman, G., Sindrup, S., Perkins, B., Baconja, M., et al. (2011). Painful diabetic peripheral neuropathy: Consensus recommendations on diagnosis, assessment and management. Diabetes/Metabolism Research and Reviews,. doi:10.1002/dmrr.1225. Tesfaye, S., Vileikyte, L., Rayman, G., Sindrup, S., Perkins, B., Baconja, M., et al. (2011). Painful diabetic peripheral neuropathy: Consensus recommendations on diagnosis, assessment and management. Diabetes/Metabolism Research and Reviews,. doi:10.​1002/​dmrr.​1225.
3.
go back to reference Argoff, C. E., Cole, B. E., Fishbain, D. A., & Irving, G. A. (2006). Diabetic peripheral neuropathic pain: Clinical and quality-of-life issues. Mayo Clinic Proceedings, 81(4 Suppl), S3–S11.CrossRefPubMed Argoff, C. E., Cole, B. E., Fishbain, D. A., & Irving, G. A. (2006). Diabetic peripheral neuropathic pain: Clinical and quality-of-life issues. Mayo Clinic Proceedings, 81(4 Suppl), S3–S11.CrossRefPubMed
5.
go back to reference Galer, B. S., Gianas, A., & Jensen, M. P. (2000). Painful diabetic polyneuropathy: Epidemiology, pain description, and quality of life. Diabetes Research and Clinical Practice, 47(2), 123–128.CrossRefPubMed Galer, B. S., Gianas, A., & Jensen, M. P. (2000). Painful diabetic polyneuropathy: Epidemiology, pain description, and quality of life. Diabetes Research and Clinical Practice, 47(2), 123–128.CrossRefPubMed
9.
go back to reference Baron, R., Brunnmuller, U., Brasser, M., May, M., & Binder, A. (2008). Efficacy and safety of pregabalin in patients with diabetic peripheral neuropathy or postherpetic neuralgia: Open-label, non-comparative, flexible-dose study. European Journal of Pain, 12(7), 850–858. doi:10.1016/j.ejpain.2007.12.004.CrossRefPubMed Baron, R., Brunnmuller, U., Brasser, M., May, M., & Binder, A. (2008). Efficacy and safety of pregabalin in patients with diabetic peripheral neuropathy or postherpetic neuralgia: Open-label, non-comparative, flexible-dose study. European Journal of Pain, 12(7), 850–858. doi:10.​1016/​j.​ejpain.​2007.​12.​004.CrossRefPubMed
10.
go back to reference Benbow, S. J., Wallymahmed, M. E., & MacFarlane, I. A. (1998). Diabetic peripheral neuropathy and quality of life. QJM, 91(11), 733–737.CrossRefPubMed Benbow, S. J., Wallymahmed, M. E., & MacFarlane, I. A. (1998). Diabetic peripheral neuropathy and quality of life. QJM, 91(11), 733–737.CrossRefPubMed
11.
go back to reference Currie, C. J., Poole, C. D., Woehl, A., Morgan, C. L., Cawley, S., Rousculp, M. D., et al. (2006). The health-related utility and health-related quality of life of hospital-treated subjects with type 1 or type 2 diabetes with particular reference to differing severity of peripheral neuropathy. Diabetologia, 49(10), 2272–2280. doi:10.1007/s00125-006-0380-7.CrossRefPubMed Currie, C. J., Poole, C. D., Woehl, A., Morgan, C. L., Cawley, S., Rousculp, M. D., et al. (2006). The health-related utility and health-related quality of life of hospital-treated subjects with type 1 or type 2 diabetes with particular reference to differing severity of peripheral neuropathy. Diabetologia, 49(10), 2272–2280. doi:10.​1007/​s00125-006-0380-7.CrossRefPubMed
12.
go back to reference Jensen, T. S., Backonja, M. M., Hernandez Jimenez, S., Tesfaye, S., Valensi, P., & Ziegler, D. (2006). New perspectives on the management of diabetic peripheral neuropathic pain. Diabetes and Vascular Disease Research, 3(2), 108–119. doi:10.3132/dvdr.2006.013.CrossRefPubMed Jensen, T. S., Backonja, M. M., Hernandez Jimenez, S., Tesfaye, S., Valensi, P., & Ziegler, D. (2006). New perspectives on the management of diabetic peripheral neuropathic pain. Diabetes and Vascular Disease Research, 3(2), 108–119. doi:10.​3132/​dvdr.​2006.​013.CrossRefPubMed
14.
go back to reference Van Acker, K., Bouhassira, D., De Bacquer, D., Weiss, S., Matthys, K., Raemen, H., et al. (2009). Prevalence and impact on quality of life of peripheral neuropathy with or without neuropathic pain in type 1 and type 2 diabetic patients attending hospital outpatients clinics. Diabetes & Metabolism, 35(3), 206–213. doi:10.1016/j.diabet.2008.11.004.CrossRef Van Acker, K., Bouhassira, D., De Bacquer, D., Weiss, S., Matthys, K., Raemen, H., et al. (2009). Prevalence and impact on quality of life of peripheral neuropathy with or without neuropathic pain in type 1 and type 2 diabetic patients attending hospital outpatients clinics. Diabetes & Metabolism, 35(3), 206–213. doi:10.​1016/​j.​diabet.​2008.​11.​004.CrossRef
16.
go back to reference Ahroni, J. H., & Boyko, E. J. (2000). Responsiveness of the SF-36 among veterans with diabetes mellitus. Journal of Diabetes and Its Complications, 14(1), 31–39.CrossRefPubMed Ahroni, J. H., & Boyko, E. J. (2000). Responsiveness of the SF-36 among veterans with diabetes mellitus. Journal of Diabetes and Its Complications, 14(1), 31–39.CrossRefPubMed
17.
go back to reference Coffey, J. T., Brandle, M., Zhou, H., Marriott, D., Burke, R., Tabaei, B. P., et al. (2002). Valuing health-related quality of life in diabetes. Diabetes Care, 25(12), 2238–2243.CrossRefPubMed Coffey, J. T., Brandle, M., Zhou, H., Marriott, D., Burke, R., Tabaei, B. P., et al. (2002). Valuing health-related quality of life in diabetes. Diabetes Care, 25(12), 2238–2243.CrossRefPubMed
18.
go back to reference Gore, M., Brandenburg, N. A., Dukes, E., Hoffman, D. L., Tai, K. S., & Stacey, B. (2005). Pain severity in diabetic peripheral neuropathy is associated with patient functioning, symptom levels of anxiety and depression, and sleep. Journal of Pain and Symptom Management, 30(4), 374–385. doi:10.1016/j.jpainsymman.2005.04.009.CrossRefPubMed Gore, M., Brandenburg, N. A., Dukes, E., Hoffman, D. L., Tai, K. S., & Stacey, B. (2005). Pain severity in diabetic peripheral neuropathy is associated with patient functioning, symptom levels of anxiety and depression, and sleep. Journal of Pain and Symptom Management, 30(4), 374–385. doi:10.​1016/​j.​jpainsymman.​2005.​04.​009.CrossRefPubMed
20.
go back to reference Lewko, J., Politynska, B., Kochanowicz, J., Zarzycki, W., Okruszko, A., Sierakowska, M., et al. (2007). Quality of life and its relationship to the degree of illness acceptance in patients with diabetes and peripheral diabetic neuropathy. Advances in Medicine and Science, 52(Suppl 1), 144–146. Lewko, J., Politynska, B., Kochanowicz, J., Zarzycki, W., Okruszko, A., Sierakowska, M., et al. (2007). Quality of life and its relationship to the degree of illness acceptance in patients with diabetes and peripheral diabetic neuropathy. Advances in Medicine and Science, 52(Suppl 1), 144–146.
22.
go back to reference Hoffman, D. L., Sadosky, A., & Alvir, J. (2009). Cross-national burden of painful diabetic peripheral neuropathy in Asia, Latin America, and the Middle East. Pain Practice, 9(1), 35–42.CrossRefPubMed Hoffman, D. L., Sadosky, A., & Alvir, J. (2009). Cross-national burden of painful diabetic peripheral neuropathy in Asia, Latin America, and the Middle East. Pain Practice, 9(1), 35–42.CrossRefPubMed
23.
go back to reference Guidance for industry: patient-reported outcome measures, use in medical product development to support labeling claims. (2009). Rockville, MD: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research: Center for Biologics Evaluation and Research : Center for Devices and Radiological Health. Guidance for industry: patient-reported outcome measures, use in medical product development to support labeling claims. (2009). Rockville, MD: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research: Center for Biologics Evaluation and Research : Center for Devices and Radiological Health.
24.
go back to reference Patrick, D. L., Burke, L. B., Gwaltney, C. J., Leidy, N. K., Martin, M. L., & Molsen, E., et al. (2011). Content validity—establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: Part 2—assessing respondent understanding. Value Health, 14(8), 978–988.CrossRefPubMed Patrick, D. L., Burke, L. B., Gwaltney, C. J., Leidy, N. K., Martin, M. L., & Molsen, E., et al. (2011). Content validity—establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: Part 2—assessing respondent understanding. Value Health, 14(8), 978–988.CrossRefPubMed
25.
go back to reference Patrick, D. L., Burke, L. B., Gwaltney, C. J., Leidy, N. K., Martin, M. L., & Molsen, E., et al. (2011). Content validity—establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: Part 1—eliciting concepts for a new PRO instrument. Value Health, 14(8), 967–977.CrossRefPubMed Patrick, D. L., Burke, L. B., Gwaltney, C. J., Leidy, N. K., Martin, M. L., & Molsen, E., et al. (2011). Content validity—establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: Part 1—eliciting concepts for a new PRO instrument. Value Health, 14(8), 967–977.CrossRefPubMed
27.
go back to reference Corbin, J. M., & Strauss, A. L. (2008). Basics of qualitative research: Techniques and procedures. Los Angeles, CA: Sage. Corbin, J. M., & Strauss, A. L. (2008). Basics of qualitative research: Techniques and procedures. Los Angeles, CA: Sage.
28.
go back to reference Wild, D. J., Clayson, D. J., Keating, K., & Gondek, K. (2005). Validation of a patient-administered questionnaire to measure the activity impairment experienced by women with uncomplicated urinary tract infection: The Activity Impairment Assessment (AIA). Health Quality of Life Outcomes, 3, 42. doi:10.1186/1477-7525-3-42.PubMedCentralCrossRefPubMed Wild, D. J., Clayson, D. J., Keating, K., & Gondek, K. (2005). Validation of a patient-administered questionnaire to measure the activity impairment experienced by women with uncomplicated urinary tract infection: The Activity Impairment Assessment (AIA). Health Quality of Life Outcomes, 3, 42. doi:10.​1186/​1477-7525-3-42.PubMedCentralCrossRefPubMed
29.
go back to reference Sheehan, D. V. (1983). The Anxiety Disease. New York, NY: Charles Scribner and Sons. Sheehan, D. V. (1983). The Anxiety Disease. New York, NY: Charles Scribner and Sons.
30.
go back to reference Endicott, J., Nee, J., Harrison, W., & Blumenthal, R. (1993). Quality of life enjoyment and satisfaction questionnaire: A new measure. Psychopharmacology Bulletin, 29(2), 321–326.PubMed Endicott, J., Nee, J., Harrison, W., & Blumenthal, R. (1993). Quality of life enjoyment and satisfaction questionnaire: A new measure. Psychopharmacology Bulletin, 29(2), 321–326.PubMed
31.
go back to reference Ware, J. E, Jr. (2000). SF-36 health survey update. Spine (Phila Pa 1976), 25(24), 3130–3139.CrossRef Ware, J. E, Jr. (2000). SF-36 health survey update. Spine (Phila Pa 1976), 25(24), 3130–3139.CrossRef
32.
go back to reference Hays, R. D. (1992). Sleep measures. In A. L. Stewart & J. E. Ware (Eds.), Measuring functioning and well-being: The medical outcomes study approach (pp. 235–259). Durham, NC: Duke University Press. Hays, R. D. (1992). Sleep measures. In A. L. Stewart & J. E. Ware (Eds.), Measuring functioning and well-being: The medical outcomes study approach (pp. 235–259). Durham, NC: Duke University Press.
33.
go back to reference Hann, D. M., Jacobsen, P. B., Azzarello, L. M., Martin, S. C., Curran, S. L., Fields, K. K., et al. (1998). Measurement of fatigue in cancer patients: Development and validation of the Fatigue Symptom Inventory. Quality of Life Research, 7(4), 301–310.CrossRefPubMed Hann, D. M., Jacobsen, P. B., Azzarello, L. M., Martin, S. C., Curran, S. L., Fields, K. K., et al. (1998). Measurement of fatigue in cancer patients: Development and validation of the Fatigue Symptom Inventory. Quality of Life Research, 7(4), 301–310.CrossRefPubMed
35.
go back to reference Lai, J.-S., & Eton, D. T. (2002). Clinically Meaningful Gaps. Rasch Measurement Transactions, 15(4), 850. Lai, J.-S., & Eton, D. T. (2002). Clinically Meaningful Gaps. Rasch Measurement Transactions, 15(4), 850.
36.
go back to reference Cappelleri, J. C., Zou, K. H., Bushmakin, A. G., Alvir, J. M. J., Alemayehu, D., & Symonds, T. (2014). Patient-reported outcomes: Measurement, implementation and interpretation. Boca Raton: CRC Press. Cappelleri, J. C., Zou, K. H., Bushmakin, A. G., Alvir, J. M. J., Alemayehu, D., & Symonds, T. (2014). Patient-reported outcomes: Measurement, implementation and interpretation. Boca Raton: CRC Press.
37.
go back to reference de Vet, H. C. W., Terwee, C. B., Mokkink, L. B., & Knol, D. L. (2011). Measurement in medicine. New York: Cambridge University Press.CrossRef de Vet, H. C. W., Terwee, C. B., Mokkink, L. B., & Knol, D. L. (2011). Measurement in medicine. New York: Cambridge University Press.CrossRef
38.
go back to reference Fayers, P. M., & Machin, D. (2007). Quality of life: The assessment, analysis and interpretation of patient-reported outcomes. Chichester, England: Wiley.CrossRef Fayers, P. M., & Machin, D. (2007). Quality of life: The assessment, analysis and interpretation of patient-reported outcomes. Chichester, England: Wiley.CrossRef
39.
go back to reference Fabrigar, L. R., Wegener, D. T., MacCallum, R. C., & Strahan, E. J. (1999). Evaluating the use of exploratory factor analysis in psychological research. Psychological Methods, 4(3), 272–299.CrossRef Fabrigar, L. R., Wegener, D. T., MacCallum, R. C., & Strahan, E. J. (1999). Evaluating the use of exploratory factor analysis in psychological research. Psychological Methods, 4(3), 272–299.CrossRef
40.
go back to reference Floyd, F. J., & Widaman, K. F. (1995). Factor analysis in the development and refinement of clinical assessment instruments. Psychological Assessment, 7(3), 286–299.CrossRef Floyd, F. J., & Widaman, K. F. (1995). Factor analysis in the development and refinement of clinical assessment instruments. Psychological Assessment, 7(3), 286–299.CrossRef
41.
go back to reference Pett, M. A., Lackey, N. R., & Sullivan, J. J. (2003). Making sense of factor analysis: The use of factor analysis for instrument development in health care research. Thousand Oaks, CA: Sage Publications. Pett, M. A., Lackey, N. R., & Sullivan, J. J. (2003). Making sense of factor analysis: The use of factor analysis for instrument development in health care research. Thousand Oaks, CA: Sage Publications.
42.
go back to reference Borsboom, D., & Cramer, A. O. J. (2013). Network analysis: An integrative approach to the structure of psychopathology. Annual Review of Clinical Psychology, 9, 91–121.CrossRefPubMed Borsboom, D., & Cramer, A. O. J. (2013). Network analysis: An integrative approach to the structure of psychopathology. Annual Review of Clinical Psychology, 9, 91–121.CrossRefPubMed
43.
go back to reference Cramer, A. O. J., Waldorp, L. J., van der Maas, H. L. J., & Borsboom, D. (2010). Comorbidity: A network perspective. Behavioral and Brain Sciences, 33, 137–150.CrossRefPubMed Cramer, A. O. J., Waldorp, L. J., van der Maas, H. L. J., & Borsboom, D. (2010). Comorbidity: A network perspective. Behavioral and Brain Sciences, 33, 137–150.CrossRefPubMed
45.
go back to reference Lasch, K. E. (2000). Culture, pain, and culturally sensitive pain care. Pain Management Nursing, 1(3 Suppl 1), 16–22.CrossRefPubMed Lasch, K. E. (2000). Culture, pain, and culturally sensitive pain care. Pain Management Nursing, 1(3 Suppl 1), 16–22.CrossRefPubMed
Metagegevens
Titel
Development and validation of the Diabetic Peripheral Neuropathic Pain Impact (DPNPI) measure, a patient-reported outcome measure
Auteurs
Meryl Brod
Steven I. Blum
Donald M. Bushnell
Abhilasha Ramasamy
Publicatiedatum
12-06-2015
Uitgeverij
Springer International Publishing
Gepubliceerd in
Quality of Life Research / Uitgave 12/2015
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-015-1037-0

Andere artikelen Uitgave 12/2015

Quality of Life Research 12/2015 Naar de uitgave