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

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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.

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References

  1. Barrett, A. M., Lucero, M. A., Le, T., Robinson, R. L., Dworkin, R. H., & Chappell, A. S. (2007). Epidemiology, public health burden, and treatment of diabetic peripheral neuropathic pain: A review. Pain Medicine, 8(Suppl 2), S50–S62. doi:10.1111/j.1526-4637.2006.00179.x.

    Article  PubMed  Google Scholar 

  2. 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.

    Google Scholar 

  3. 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.

    Article  PubMed  Google Scholar 

  4. Cole, B. E. (2007). Diabetic peripheral neuropathic pain: Recognition and management. Pain Medicine, 8(Suppl 2), S27–S32. doi:10.1111/j.1526-4637.2007.00349.x.

    Article  PubMed  Google Scholar 

  5. 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.

    Article  CAS  PubMed  Google Scholar 

  6. Brod, M., Pohlman, B., Blum, S. I., Ramasamy, A., & Carson, R. (2014). Burden of illness of diabetic peripheral neuropathic pain: A qualitative study. Patient, doi:10.1007/s40271-014-0093-9.

    PubMed Central  Google Scholar 

  7. Armstrong, D. G., Chappell, A. S., Le, T. K., Kajdasz, D. K., Backonja, M., D’Souza, D. N., et al. (2007). Duloxetine for the management of diabetic peripheral neuropathic pain: Evaluation of functional outcomes. Pain Medicine, 8(5), 410–418. doi:10.1111/j.1526-4637.2007.00276.x.

    Article  PubMed  Google Scholar 

  8. Boulton, A. J. (2010). What you can’t feel can hurt you. Journal of Vascular Surgery, 52(3 Suppl), 28S–30S. doi:10.1016/j.jvs.2010.06.005.

    Article  PubMed  Google Scholar 

  9. 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.

    Article  CAS  PubMed  Google Scholar 

  10. Benbow, S. J., Wallymahmed, M. E., & MacFarlane, I. A. (1998). Diabetic peripheral neuropathy and quality of life. QJM, 91(11), 733–737.

    Article  CAS  PubMed  Google Scholar 

  11. 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.

    Article  CAS  PubMed  Google Scholar 

  12. 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.

    Article  PubMed  Google Scholar 

  13. Tolle, T., Xu, X., & Sadosky, A. B. (2006). Painful diabetic neuropathy: A cross-sectional survey of health state impairment and treatment patterns. Journal of Diabetes and Its Complications, 20(1), 26–33. doi:10.1016/j.jdiacomp.2005.09.007.

    Article  PubMed  Google Scholar 

  14. 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.

    Article  Google Scholar 

  15. Zelman, D. C., Brandenburg, N. A., & Gore, M. (2006). Sleep impairment in patients with painful diabetic peripheral neuropathy. Clinical Journal of Pain, 22(8), 681–685. doi:10.1097/01.ajp.0000210910.49923.09.

    Article  PubMed  Google Scholar 

  16. 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.

    Article  CAS  PubMed  Google Scholar 

  17. 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.

    Article  PubMed  Google Scholar 

  18. 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.

    Article  PubMed  Google Scholar 

  19. Gore, M., Brandenburg, N. A., Hoffman, D. L., Tai, K. S., & Stacey, B. (2006). Burden of illness in painful diabetic peripheral neuropathy: The patients’ perspectives. Journal of Pain, 7(12), 892–900. doi:10.1016/j.jpain.2006.04.013.

    Article  PubMed  Google Scholar 

  20. 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.

    Google Scholar 

  21. IndINeP Study Group. (2008). Burden of neuropathic pain in Indian patients attending urban, specialty clinics: Results from a cross sectional study. Pain Practice, 8(5), 362–378. doi:10.1111/j.1533-2500.2008.00208.x.

    Article  Google Scholar 

  22. 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.

    Article  PubMed  Google Scholar 

  23. 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. 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.

    Article  PubMed  Google Scholar 

  25. 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.

    Article  PubMed  Google Scholar 

  26. Atlas.ti. Qualitative Data Analysis. (2014). Retrieved from http://www.atlasti.com/index.html.

  27. Corbin, J. M., & Strauss, A. L. (2008). Basics of qualitative research: Techniques and procedures. Los Angeles, CA: Sage.

    Google Scholar 

  28. 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.

    Article  PubMed Central  PubMed  Google Scholar 

  29. Sheehan, D. V. (1983). The Anxiety Disease. New York, NY: Charles Scribner and Sons.

  30. 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.

    CAS  PubMed  Google Scholar 

  31. Ware, J. E, Jr. (2000). SF-36 health survey update. Spine (Phila Pa 1976), 25(24), 3130–3139.

    Article  Google Scholar 

  32. 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.

    Google Scholar 

  33. 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.

    Article  CAS  PubMed  Google Scholar 

  34. RUMM2030, RUMM Laboratory Pty Ltd. (2014). Retrieved from http://www.rummlab.com.au/.

  35. Lai, J.-S., & Eton, D. T. (2002). Clinically Meaningful Gaps. Rasch Measurement Transactions, 15(4), 850.

    Google Scholar 

  36. 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.

    Google Scholar 

  37. de Vet, H. C. W., Terwee, C. B., Mokkink, L. B., & Knol, D. L. (2011). Measurement in medicine. New York: Cambridge University Press.

    Book  Google Scholar 

  38. Fayers, P. M., & Machin, D. (2007). Quality of life: The assessment, analysis and interpretation of patient-reported outcomes. Chichester, England: Wiley.

    Book  Google Scholar 

  39. 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.

    Article  Google Scholar 

  40. Floyd, F. J., & Widaman, K. F. (1995). Factor analysis in the development and refinement of clinical assessment instruments. Psychological Assessment, 7(3), 286–299.

    Article  Google Scholar 

  41. 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.

    Google Scholar 

  42. 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.

    Article  PubMed  Google Scholar 

  43. 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.

    Article  PubMed  Google Scholar 

  44. Hobara, M. (2005). Beliefs about appropriate pain behavior: Cross-cultural and sex differences between Japanese and Euro-Americans. European Journal of Pain, 9(4), 389–393. doi:10.1016/j.ejpain.2004.09.006.

    Article  PubMed  Google Scholar 

  45. Lasch, K. E. (2000). Culture, pain, and culturally sensitive pain care. Pain Management Nursing, 1(3 Suppl 1), 16–22.

    Article  CAS  PubMed  Google Scholar 

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Acknowledgments

This study was funded by Forest Research Institute Inc. a subsidiary of Actavis plc. We would like to acknowledge and thank Juliana Setyawan and Robyn Carson for their contributions during the qualitative development stage of the project.

Conflict of interest

Dr. Brod and Mr. Bushnell are paid advisors/consultants to Forest Research Institute. Ms. Ramasamy is an employee of Actavis, Inc., and Mr. Blum is a former employee of Forest Research Institute, who is now employed by GlaxoSmithKline.

Ethical standard

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Institutional Review Board approval was granted by Copernicus Group IRB: #TBG1-11-483.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Author information

Authors and Affiliations

  1. The Brod Group, 219 Julia Avenue, Mill Valley, CA, 94941, USA

    Meryl Brod

  2. GlaxoSmithKline, 2301 Renaissance Blvd., King of Prussia, PA, 19406, USA

    Steven I. Blum

  3. Health Research Associates, Inc., 6505 216th Street SW, Suite 105, Mountlake Terrace, WA, 98043, USA

    Donald M. Bushnell

  4. Actavis, Inc., Harborside Financial Center, Plaza V, Jersey City, NJ, 07311, USA

    Abhilasha Ramasamy

Authors
  1. Meryl Brod
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  2. Steven I. Blum
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  4. Abhilasha Ramasamy
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Correspondence to Meryl Brod.

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Brod, M., Blum, S.I., Bushnell, D.M. et al. Development and validation of the Diabetic Peripheral Neuropathic Pain Impact (DPNPI) measure, a patient-reported outcome measure. Qual Life Res 24, 3001–3014 (2015). https://doi.org/10.1007/s11136-015-1037-0

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