Skip to main content

Advertisement

SpringerLink
Log in

Assessing patient-reported peripheral neuropathy: the reliability and validity of the European Organization for Research and Treatment of Cancer QLQ-CIPN20 Questionnaire

  • Published:
Quality of Life Research Aims and scope Submit manuscript

Abstract

Purpose

This clinimetric analysis was conducted to evaluate the reliability, validity, and responsiveness to changeover time of the QLQ-CIPN20 when used to quantify patient-reported chemotherapy-induced peripheral neuropathy (CIPN).

Methods

Participants recruited to four cooperative group trials were pooled to create two groups (n = 376, 575): those who did versus did not receive neurotoxic chemotherapy. QLQ-CIPN20 internal consistency reliability was assessed using Cronbach’s alpha coefficients. Instrument validity was assessed using factor analysis, by evaluating score correlations with other CIPN and pain measures, and by comparing scores between contrasting groups. Cohen’s d was used to assess responsiveness to change.

Results

Alpha coefficients for the sensory, motor, and autonomic scales were 0.88, 0.88, and 0.78, respectively. However, autonomic scale and hearing loss items exhibited low item–item correlations (r ≤ 0.30) and thus were deleted. Moderate correlations were found between QLQ-CIPN20 and Brief Pain Inventory pain severity items (r 0.30–0.57, p ≤ .0001). Correlation between the QLQ-CIPN20 sensory and toxicity grading scale scores was low (r = .20; p ≤ .01). Mean scores were higher (worse) (p ≤ 0.0001) in individuals who did versus did not receive neurotoxic chemotherapy. The sensory and motor scales exhibited moderate-high responsiveness to change (Cohen’s d = 0.82 and 0.48, respectively). Factor analysis indicated that the 16-item version formed distinct factors for lower and upper extremity CIPN, delineating typical distal to proximal CIPN progression.

Conclusions

Results provide support for QLQ-CIPN20 sensory and motor scale reliability and validity. The more parsimonious and clinically relevant 16-item version merits further consideration.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  1. Hausheer, F. H., Schilsky, R. L., Bain, S., Berghorn, E. J., & Lieberman, F. (2006). Diagnosis, management, and evaluation of chemotherapy-induced peripheral neuropathy. Seminars in Oncology, 33(1), 15–49.

    Article  PubMed  CAS  Google Scholar 

  2. Argyriou, A. A., Bruna, J., Marmiroli, P., & Cavaletti, G. (2012). Chemotherapy-induced peripheral neurotoxicity (CIPN): An update. Critical Reviews in Oncology-Hematology, 82(1), 51–77.

    Article  Google Scholar 

  3. Stubblefield, M. D., Burstein, H. J., Burton, A. W., Custodio, C. M., Deng, G. E., Ho, M., et al. (2009). NCCN task force report: Management of neuropathy in cancer. Journal of the National Comprehensive Cancer Network, 7(Suppl 5), S1–S26.

    PubMed  Google Scholar 

  4. Argyriou, A. A., Zolota, V., Kyriakopoulou, O., & Kalofonos, H. P. (2010). Toxic peripheral neuropathy associated with commonly used chemotherapeutic agents. Journal of B.U.On, 15(3), 435–446.

    Google Scholar 

  5. Paice, J. A. (2009). Clinical challenges: Chemotherapy-induced peripheral neuropathy. Seminars in Oncology Nursing, 25(2 Suppl 1), S8–S19.

    Article  PubMed  Google Scholar 

  6. Loprinzi, C. L., Reeves, B. N., Dakhil, S. R., Sloan, J. A., Wolf, S. L., Burger, K. N., et al. (2011). Natural history of paclitaxel-associated acute pain syndrome: Prospective cohort study NCCTG N08C1. Journal of Clinical Oncology, 29(11), 1472–1478.

    Article  PubMed  CAS  Google Scholar 

  7. Visovsky, C., & Daly, B. J. (2004). Clinical evaluation and patterns of chemotherapy-induced peripheral neuropathy. Journal of the American Academy of Nurse Practitioners, 16(8), 353–359.

    Article  PubMed  Google Scholar 

  8. Wampler, M. A., Miaskowski, C., Hamel, K., Byl, N., Rugo, H., & Topp, L. S. (2006). The modified total neuropathy score: A clinically feasible and valid measure of taxane-induced peripheral neuropathy in women with breast cancer. Supportive Oncology, 4(8), W9–W16.

    Google Scholar 

  9. Bakitas, M. A. (2007). Background noise: The experience of chemotherapy-induced peripheral neuropathy. Nursing Research, 56(5), 323–331.

    Article  PubMed  Google Scholar 

  10. Smith, E. M. L., Bakitas, M. A., Homel, P., Piehl, M., Kingman, L., Fadul, C. E., et al. (2011). Preliminary assessment of a neuropathic pain treatment and referral algorithm for patients with cancer. Journal of Pain and Symptom Management, 42(6), 822–838.

    Article  PubMed  Google Scholar 

  11. Griffith, K., Merkies, I. S. J., Hill, E., & Cornblath, D. (2010). Measures of chemotherapy-induced peripheral neuropathy: A systematic review of psychometric properties. Journal of the Peripheral Nervous System, 15(4), 314–325.

    Article  PubMed  Google Scholar 

  12. Cavaletti, G., Frigeni, B., Lanzani, F., Mattavelli, L., Susani, E., Alberti, P., et al. (2010). Chemotherapy-Induced Peripheral Neurotoxicity assessment: A critical revision of the currently available tools. European Journal of Cancer, 46(3), 479–494.

    Article  PubMed  CAS  Google Scholar 

  13. Postma, T. J., Aaronson, N. K., Heimans, J. J., Muller, M. J., Hildebrand, J. G., Delattre, J. Y., et al. (2005). The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: The QLQ-CIPN20. European Journal of Cancer, 41(8), 1135–1139.

    Article  PubMed  CAS  Google Scholar 

  14. Cleeland, C. S., & Ryan, K. M. (1994). Pain assessment: Global use of the brief pain inventory. Annals of the Academy of Medicine, Singapore, 23(2), 129.

    PubMed  CAS  Google Scholar 

  15. Common Terminology Criteria for Adverse Events Version 4.02 (CTCAE). (2009). U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute. http://evs.nci.nih.gov/ftp1/CTCAE/About.html. Accessed 7 January, 2010.

  16. Barton, D. L., Wos, E. J., Qin, R., Mattar, B. I., Green, N. B., Lanier, K. S., et al. (2011). A double-blind, placebo-controlled trial of a topical treatment for chemotherapy-induced peripheral neuropathy: NCCTG trial N06CA. Supportive care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer, 19(6), 833–841.

    Article  Google Scholar 

  17. Reeves, B. N., Dakhil, S. R., Sloan, J. A., Wolf, S. L., Burger, K. N., Kamal, A., et al. (2012). Further data supporting that the paclitaxel-associated acute pain syndrome is associated with the development of peripheral neuropathy: NCCTG Trial N08C1. Cancer, 118(20), 5171–5178.

    Google Scholar 

  18. Ferketich, S. (1991). Focus on psychometrics: Aspects of item analysis. Research in Nursing & Health, 14(2), 165–168.

    Article  CAS  Google Scholar 

  19. Boehmer, S., & Luszczynska, A. (2006). Two kinds of items in quality of life instruments: ‘Indicator and causal variables’ in the EORTC qlq-c30. Quality of Life Research, 15(1), 131–141.

    Article  PubMed  Google Scholar 

  20. Fayers, P. M. (2004). Quality-of-life measurement in clinical trials—the impact of causal variables. Journal of Biopharmaceutical Statistics, 14(1), 155–176.

    Article  PubMed  Google Scholar 

  21. Pett, M. A., Lackey, N. R., & Sullivan, J. L. (2003). Making sense of factor analysis: The use of factor analysis for instrument development in health care research. Thousand Oaks: Sage Publications.

    Google Scholar 

  22. Barrett, P. P. (2007). Structural equation modeling: Adjudging model fit. Personality and Individual Differences, 42(5), 815–824.

    Article  Google Scholar 

  23. Flora, D. D. B. (2004). An empirical evaluation of alternative methods of estimation for confirmatory factor analysis with ordinal data. Psychological Methods, 9(4), 466–491.

    Article  PubMed  Google Scholar 

  24. Hayduk, L. L. (2007). Testing! testing! one, two, three—Testing the theory in structural equation models! Personality and Individual Differences, 42(5), 841–850.

    Article  Google Scholar 

  25. Beauducel, A. A. (2005). Simulation study on fit indexes in CFA based on data with slightly distorted simple structure. Structural Equation Modeling, 12(1), 41–75.

    Article  Google Scholar 

  26. Fan, X. X. (2005). Sensitivity of fit indexes to misspecified structural or measurement model components: Rationale of two-index strategy revisited. Structural Equation Modeling, 12(3), 343–367.

    Article  Google Scholar 

  27. Basch, E., Jia, X., Heller, G., Barz, A., Sit, L., Fruscione, M., et al. (2009). Adverse symptom event reporting by patients vs clinicians: Relationships With clinical outcomes. Journal of the National Cancer Institute, 101(23), 1624–1632.

    Article  PubMed  Google Scholar 

  28. Cohen, J. (1988). Statistical power analysis for the behavioral sciences. Hillsdale, New Jersey: Lawrence Earlbaum and Associate.

    Google Scholar 

  29. Clayton, M. F., & Pett, M. A. (2011). Modeling relationships in clinical research using path analysis Part II: Evaluating the model. Journal for Specialists in Pediatric Nursing: JSPN, 16(1), 75–79.

    Article  PubMed  Google Scholar 

  30. Hu, L. L. (1999). Cutoff criteria for fit indexes in covariance structure analysis: Conventional criteria versus new alternatives. Structural Equation Modeling, 6(1), 1–55.

    Article  Google Scholar 

  31. Zheng, Z. E. (2010). Research note–toward a causal interpretation from observational data: A new bayesian networks method for structural models with latent variables. Information Systems Research, 21(2), 365–391.

    Article  Google Scholar 

  32. Spirtes, P., Glymour, C., Scheines, R., & Tillman, R. (2010). Automated search for causal relations: Theory and practice. In R. Dechter, H. Geffner, & J. Y. Halpern (Eds.), Heuristics, probability, and causality: A tribute to judea pearl (pp. 467–506). London, UK: College Publications.

    Google Scholar 

Download references

Acknowledgments

This study was conducted as a collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic and was supported in part by Public Health Service grants CA-25224, CA-37404, CA-124477. CA-63848, CA-52352, CA-35090, CA-35101, CA-35269, CA-37417, CA-35448, CA-63844, CA-35267, CA-35272, CA-35113, CA-35103, CA-35415, and CA-35431. The content is solely the responsibility of the authors and does not necessarily represent the views of the National Cancer Institute or the National Institute of Health. A special thanks is extended to Suneetha Puttabasavaiah, BS for her assistance in data management.

Conflict of interest

The authors declare that they have no conflicts of interest.

Author information

Authors and Affiliations

  1. University of Michigan School of Nursing, 400 North Ingalls, Room 2151, Ann Arbor, MI, 48109-5482, USA

    Ellen M. Lavoie Smith

  2. Mayo Clinic Rochester, 200 First Street, SW, Rochester, MN, 55905, USA

    Debra L. Barton, Rui Qin & Charles L. Loprinzi

  3. Sanford Health/Roger Maris Cancer Center, 820 4th Street N., Fargo, ND, 58122, USA

    Preston D. Steen

  4. The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands

    Neil K. Aaronson

Authors
  1. Ellen M. Lavoie Smith
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Debra L. Barton
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Rui Qin
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Preston D. Steen
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Neil K. Aaronson
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Charles L. Loprinzi
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Ellen M. Lavoie Smith.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Lavoie Smith, E.M., Barton, D.L., Qin, R. et al. Assessing patient-reported peripheral neuropathy: the reliability and validity of the European Organization for Research and Treatment of Cancer QLQ-CIPN20 Questionnaire. Qual Life Res 22, 2787–2799 (2013). https://doi.org/10.1007/s11136-013-0379-8

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11136-013-0379-8

Keywords

Search

Navigation