Assessing patient-reported peripheral neuropathy: the reliability and validity of the European Organization for Research and Treatment of Cancer QLQ-CIPN20 Questionnaire
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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).
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.
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.
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.
KeywordsChemotherapy Peripheral neuropathy EORTC QLQ-CIPN20 Reliability Validity
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.
- 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
- 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
- 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.PubMedCrossRefGoogle 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.CrossRefGoogle 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
- 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
- 28.Cohen, J. (1988). Statistical power analysis for the behavioral sciences. Hillsdale, New Jersey: Lawrence Earlbaum and Associate.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