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Evaluation of the psychometric properties of the EORTC chemotherapy-induced peripheral neuropathy questionnaire (QLQ-CIPN20)

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Abstract

Purpose

To investigate the scale structure and psychometrics of the EORTC chemotherapy-induced peripheral neuropathy module (QLQ-CIPN20).

Methods

Using confirmatory factor analyses (CFA), we tested two hypothesized scale structure models of the QLQ-CIPN20 in 473 patients with non-small cell lung cancer, 281 patients with heterogeneous cancer diagnoses, and 500 patients with colorectal cancer. We also modeled the two hypothesized models as bi-factor models. These included a general factor, in addition to the specific domain factors. Additional models were investigated with exploratory factor analysis (EFA). Known groups validity was evaluated where justified.

Results

CFA could not confirm the two hypothesized models (Model 1: CFI < 0.926; TLI < 0.914; RMSEA > 0.077 and Model 2: CFI < 0.906; TLI < 0.887; RMSEA > 0.105) in any of the three samples. Including a general factor to these two hypothesized models to produce a bi-factor model also did not yield satisfactory results. Using EFA, we identified four different factor structures in the three samples that were unstable due to cross loadings of the items. When scoring the QLQ-CIPN20 as a simple, additive checklist evidence was found for known groups validity in the first two samples based on Common Toxicity Criteria (CTC-AE), and in the third sample based on exposure to CIPN-inducing chemotherapy.

Conclusions

Neither CFA nor EFA yielded support for a stable subscale structure for the QLQ-CIPN20. Scoring the questionnaire as a simple additive checklist results in acceptable validity.

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References

  1. Riaz, S. S., & Tomlinson, D. R. (1996). Neurotrophic factors in peripheral neuropathies: Pharmacological strategies. Progress in Neurobiology, 49(2), 125–143.

    Article  CAS  PubMed  Google Scholar 

  2. Miltenburg, N. C., & Boogerd, W. (2014). Chemotherapy-induced neuropathy: A comprehensive survey. Cancer Treatment Reviews, 40(7), 872–882.

    Article  CAS  PubMed  Google Scholar 

  3. Grisold, W., Cavaletti, G., & Windebank, A. J. (2012). Peripheral neuropathies from chemotherapeutics and targeted agents: Diagnosis, treatment, and prevention. Neuro-Oncology, 14(Suppl 4), iv45–iv54.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  4. Mols, F., Beijers, T., Lemmens, V., van den Hurk, C. J., Vreugdenhil, G., & van de Poll-Franse, L. V. (2013). Chemotherapy-induced neuropathy and its association with quality of life among 2- to 11-year colorectal cancer survivors: Results from the population-based PROFILES registry. Journal of Clinical Oncology, 31(21), 2699–2707.

    Article  PubMed  Google Scholar 

  5. Mols, F., Beijers, T., Vreugdenhil, G., & van de Poll-Franse, L. (2014). Chemotherapy-induced peripheral neuropathy and its association with quality of life: A systematic review. Supportive Care in Cancer, 22(8), 2261–2269.

    Article  PubMed  Google Scholar 

  6. Trotti, A., Colevas, A. D., Setser, A., Rusch, V., Jaques, D., Budach, V., et al. (2003). CTCAE v3.0: Development of a comprehensive grading system for the adverse effects of cancer treatment. Seminars in Radiation Oncology, 13(3), 176–181.

    Article  PubMed  Google Scholar 

  7. Cornblath, D. R., Chaudhry, V., Carter, K., Lee, D., Seysedadr, M., Miernicki, M., et al. (1999). Total neuropathy score: Validation and reliability study. Neurology, 53(8), 1660–1664.

    Article  CAS  PubMed  Google Scholar 

  8. 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  CAS  PubMed  Google Scholar 

  9. Basch, E., Iasonos, A., McDonough, T., Barz, A., Culkin, A., Kris, M. G., et al. (2006). Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: Results of a questionnaire-based study. Lancet Oncol, 7(11), 903–909.

    Article  PubMed  Google Scholar 

  10. Alberti, P., Rossi, E., Cornblath, D. R., Merkies, I. S. J., Postma, T. J., Frigeni, B., et al. (2014). Physician-assessed and patient-reported outcome measures in chemotherapy-induced sensory peripheral neurotoxicity: two sides of the same coin. Annals of Oncology, 25(1), 257–264.

    Article  CAS  PubMed  Google Scholar 

  11. Hershman, D. L., Lacchetti, C., Dworkin, R. H., Lavoie Smith, E. M., Bleeker, J., Cavaletti, G., et al. (2014). Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: American Society of Clinical Oncology Clinical Practice Guideline. Journal of Clinical Oncology, 32(18), 1941–1967.

    Article  CAS  PubMed  Google Scholar 

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

    Article  CAS  PubMed  Google Scholar 

  13. Shimozuma, K., Ohashi, Y., Takeuchi, A., Aranishi, T., Morita, S., Kuroi, K., et al. (2009). Feasibility and validity of the Patient Neurotoxicity Questionnaire during taxane chemotherapy in a phase III randomized trial in patients with breast cancer: N-SAS BC. Support Care Center, 17(12), 1483–1491.

    Article  Google Scholar 

  14. Land, S., Kopec, J., Cecchini, R., Ganz, P., Wieand, H. S., Colangelo, L., et al. (2007). Neurotoxicity from oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: NSABP C-07. Journal of Clinical Oncology, 25(16), 2205–2211.

    Article  CAS  PubMed  Google Scholar 

  15. Cella, D., Peterman, A., Hudgens, S., Webster, K., & Socinski, M. (2003). Measuring the side effects of taxane therapy in oncology. Cancer, 98(4), 822–831.

    Article  CAS  PubMed  Google Scholar 

  16. Kopec, J. A., Land, S. R., Cecchini, R. S., Ganz, P. A., Cella, D., Costantino, J., et al. (2006). Validation of a self-reported neurotoxicity scale in patients with operable colon cancer receiving oxaliplatin. Journal of supportive oncology, 4, W1–W8.

    Google Scholar 

  17. Driessen, C. M. L., Kleine-Bolt, K. M. E., Vingerhoets, A. J. J. M., Mols, F., & Vreugdenhil, G. (2012). Assessing the impact of chemotherapy-induced peripheral neurotoxicity on the quality of life of cancer patients. Supportive Care in Cancer, 20(4), 877–881.

    Article  CAS  PubMed  Google Scholar 

  18. 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  CAS  PubMed  Google Scholar 

  19. Sprangers, M. A. G., Cull, A., Groenvold, M., Bjordal, K., Blazeby, J., & Aaronson, N. K. (1998). The European organization for research and treatment of cancer approach to develo** questionnaire modules: An update and overview. Quality of Life Research, 7(4), 291–300.

    Article  CAS  PubMed  Google Scholar 

  20. Cavaletti, G., Bogliun, G., Marzorati, L., Zincone, A., Piatti, M., Colombo, N., et al. (2003). Grading of chemotherapy-induced peripheral neurotoxicity using the Total Neuropathy Scale. Neurology, 61(9), 1297–1300.

    Article  CAS  PubMed  Google Scholar 

  21. Wolf, S., Barton, D., Qin, R., Wos, E., Sloan, J., Liu, H., et al. (2012). The relationship between numbness, tingling, and shooting/burning pain in patients with chemotherapy-induced peripheral neuropathy (CIPN) as measured by the EORTC QLQ-CIPN20 instrument, N06CA. Supportive Care in Cancer, 20(3), 625–632.

    Article  PubMed  Google Scholar 

  22. Lavoie Smith, E., Barton, D., Qin, R., Steen, P., Aaronson, N., & Loprinzi, C. (2013). Assessing patient-reported peripheral neuropathy: the reliability and validity of the European Organization for Research and Treatment of Cancer QLQ-CIPN20 Questionnaire. Quality of Life Research, 22(10), 2787–2799.

    Article  PubMed  PubMed Central  Google Scholar 

  23. Cavaletti, G., Cornblath, D. R., Merkies, I. S. J., Postma, T. J., Rossi, E., Frigeni, B., et al. (2013). The chemotherapy-induced peripheral neuropathy outcome measures standardization study: From consensus to the first validity and reliability findings. Annals of Oncology, 24(2), 454–462.

    Article  CAS  PubMed  Google Scholar 

  24. Hausheer, F. H., Kanter, P., Cao, S., Haridas, K., Seetharamulu, P., Reddy, D., et al. (1998). Modulation of platinum-induced toxicities and therapeutic index: mechanistic insights and first- and second-generation protecting agents. Seminars in Oncology, 25(5), 584–599.

    CAS  PubMed  Google Scholar 

  25. Reilly, R. T. (2004). BNP-7787 (BioNumerik/Baxter Oncology/Grelan). IDrugs, 7(1), 64–69.

    CAS  PubMed  Google Scholar 

  26. Trotti, A., Byhardt, R., Stetz, J., Gwede, C., Corn, B., Fu, K., et al. (2000). Common toxicity criteria: version 2.0. an improved reference for grading the acute effects of cancer treatment: impact on radiotherapy. International Journal of Radiation Oncology * Biology *Physics, 47(1), 13–47.

    Article  CAS  Google Scholar 

  27. Muthén, L. K., & Muthén, B. O. (1998–2010). Mplus User’s Guide (6th ed.). Los Angeles, CA: Muthén & Muthén.

  28. Muthen, B., du Toit, S., & Spisic, D. (1997). Robust inference using weighted least squares and quadratic estimating equation in latent variable modeling with categorical and continuous outcomes. Retrieved January 8, 2015, from http://www.statmodel.com/bmuthen/articles/Article_075.pdf

  29. Flora, D., & Curran, P. (2004). An empirical evaluation of alternative methods of estimation for confirmatory factor analysis with ordinal data. Psychological Methods, 9(4), 466.

    Article  PubMed  PubMed Central  Google Scholar 

  30. Reise, S. P., Morizot, J., & Hays, R. D. (2007). The role of the bifactor model in resolving dimensionality issues in health outcomes measures. Quality of Life Research, 16(Suppl 1), 19–31.

    Article  PubMed  Google Scholar 

  31. Reise, S. P., Moore, T. M., & Haviland, M. G. (2010). Bifactor models and rotations: Exploring the extent to which multidimensional data yield univocal scale scores. Journal of Personality Assessment, 92(6), 544–559.

    Article  PubMed  PubMed Central  Google Scholar 

  32. Schermelleh-Engel, K., Moosbrugger, H., & Muller, H. (2003). Evaluating the fit of structural equation models: Tests of significance and descriptive goodness-of-fit measures. Methods of Psychological Research-Online, 8, 23–74.

    Google Scholar 

  33. Ferguson, E., & Cox, T. (1993). Exploratory factor analysis: A users’guide. International Journal of Selection and Assessment, 1(2), 84–94.

    Article  Google Scholar 

  34. Cattell, R. B., & Vogelmann, S. (1977). A comprehensive trial of the scree and kg criteria for determining the number of factors. Multivariate Behavioral Research, 12(3), 289–325.

    Article  CAS  PubMed  Google Scholar 

  35. Fayers, P. M., Aaronson, N. K., Bjordal, K., Groenvold, M., Curran, D., Bottomley, A., on behalf of the EORTC Quality of Life Group and of the Quality of Life Unit. (2001). EORTC QLQ-C30 Scoring Manual (3rd ed.). Brussels EORTC.

  36. Šidák, Z. (1967). Rectangular confidence regions for the means of multivariate normal distributions. Journal of the American Statistical Association, 62(318), 626–633.

    Google Scholar 

  37. Cersosimo, R. (2005). Oxaliplatin-associated neuropathy: A review. The Annals of Pharmacotherapy, 39(1), 128–135.

    Article  CAS  PubMed  Google Scholar 

  38. Cohen, J. (1977). Statistical power analysis for the behavioural sciences (revised ed.). New York: Academic Press

  39. Norman, G. R., Sloan, J. A., & Wyrwich, K. W. (2003). Interpretation of changes in health-related quality of life: The remarkable universality of half a standard deviation. Medical Care, 41(5), 582–592.

    PubMed  Google Scholar 

  40. Egan, M., Burke, E., Meskell, P., MacNeela, P., & Dowling, M. (2015). Quality of life and resilience related to chemotherapy-induced peripheral neuropathy in patients post treatment with platinums and taxanes. Journal of Research in Nursing. doi:10.1177/1744987115574296.

    Google Scholar 

  41. Loprinzi, C. L., Qin, R., Dakhil, S. R., Fehrenbacher, L., Flynn, K. A., Atherton, P., et al. (2014). Phase III randomized, placebo-controlled, double-blind study of intravenous calcium and magnesium to prevent oxaliplatin-induced sensory neurotoxicity (N08CB/Alliance). Journal of Clinical Oncology, 32(10), 997–1005.

    Article  CAS  PubMed  Google Scholar 

  42. Fayers, P., & Hand, D. (2002). Causal variables, indicator variables and measurement scales: An example from quality of life. Journal of the Royal Statistical Society: Series A (Statistics in Society), 165(2), 233–253.

    Article  Google Scholar 

  43. Kieffer, J., Verrips, E., & Hoogstraten, J. (2009). Model specification in oral health-related quality of life research. European Journal of Oral Sciences, 117(5), 481–484.

    Article  PubMed  Google Scholar 

  44. Fayers, P. M., & Hand, D. J. (1997). Factor analysis, causal indicators and quality of life. Quality of Life Research, 6(2), 139–150.

    Article  CAS  PubMed  Google Scholar 

  45. Sprangers, M. A. G., te Velde, A., & Aaronson, N. K. (1999). The construction and testing of the EORTC colorectal cancer-specific quality of life questionnaire module (QLQ-CR38). European Journal of Cancer, 35(2), 238–247.

    Article  CAS  PubMed  Google Scholar 

  46. Fayers, P. M., Hand, D. J., Bjordal, K., & Groenvold, M. (1997). Causal indicators in quality of life research. Quality of Life Research, 6(5), 393–406.

    Article  CAS  PubMed  Google Scholar 

  47. Velikova, G., Booth, L., Smith, A. B., Brown, P. M., Lynch, P., Brown, J. M., et al. (2004). Measuring quality of life in routine oncology practice improves communication and patient well-being: A randomized controlled trial. Journal of Clinical Oncology, 22(4), 714–724.

    Article  PubMed  Google Scholar 

  48. Hilarius, D. L., Kloeg, P. H., Gundy, C. M., & Aaronson, N. K. (2008). Use of health-related quality-of-life assessments in daily clinical oncology nursing practice: A community hospital-based intervention study. Cancer, 113(3), 628–637.

    Article  PubMed  Google Scholar 

  49. Ruland, C. M., Holte, H. H., Røislien, J., Heaven, C., Hamilton, G. A., Kristiansen, J., et al. (2010). Effects of a computer-supported interactive tailored patient assessment tool on patient care, symptom distress, and patients’ need for symptom management support: a randomized clinical trial. Journal of the American Medical Informatics Association, 17(4), 403–410.

    Article  PubMed  PubMed Central  Google Scholar 

  50. Kluetz, P. G., Slagle, A., Papadopoulos, E., Johnson, L. L., Donoghue, M., Kwitkowski, V. E., et al. (2016). Focusing on core patient-reported outcomes in cancer clinical trials: Symptomatic adverse events, physical function, and disease-related symptoms. Clinical Cancer Research, 22(7), 1553–1558.

    Article  CAS  PubMed  Google Scholar 

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Acknowledgements

We would like to express our gratitude to the many individuals who provided the data used in these analyses, to Chad Gundy (deceased) who played a key role in the development of the QLQ-CIPN20 module, to BioNumerik Pharmaceuticals for providing non-proprietary CIPN and clinical data, and to Inc. Schering-Plough International that provided initial support during the developmental phase of the QLQ-CIPN20.

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Authors and Affiliations

Authors

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Corresponding author

Correspondence to Jacobien M. Kieffer.

Ethics declarations

Conflict of interest

JM Kieffer, TJ Postma, L van de Poll-Franse, F Mols, JJ Heimans, G Cavaletti, and NK Aaronson declare not to have any commercial associations that might pose a conflict of interest in connection with this manuscript. BioNumerik provided us with access to non-proprietary data and had no influence on the conduct of the analyses or interpretation of the results.

Humans and animal rights

This study involved secondary data analyses where all data were de-identified to ensure the anonymity of the patients.

Informed consent

Informed consent was not required as all analyses were secondary in nature and were performed on de-identified data.

Additional information

Jacobien M. Kieffer and Tjeerd J. Postma—Shared first authorship.

Collaborators of the CI-PeriNomS Groups are listed in “Appendix”.

Appendix—The CI-PeriNomS study group

Appendix—The CI-PeriNomS study group

Steering Committee

  • G. Cavaletti, Department of Neurosciences and Biomedical Technologies, University of Milano-Bicocca, Monza, Italy;

  • D.R. Cornblath, Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA;

  • I.S.J. Merkies, Department of Neurology, Spaarne Hospital, Hoofddorp & Maastricht University Medical Center, Maastricht, The Netherlands; and

  • T.J. Postma, Department of Neurology, VU University Medical Center, Amsterdam, The Netherlands.

Statistical analysis

  • M.G Valsecchi, S. Galimberti, E. Rossi, Clinical Epidemiology and Biostatistic Research Center, Department of Clinical Medicine and Prevention, University of Milano-Bicocca, Monza, Italy

Participating centers and researchers

  • Department of Neurosciences and Biomedical Technologies, University of Milan-Bicocca and Department of Oncology, S. Gerardo Hospital, Monza, Italy (Cavaletti G, Frigeni B, Lanzani F, Mattavelli L, Piatti ML, Alberti P, Binda D, Bidoli P., Cazzaniga M, Cortinovis D)

  • Unit of Neuro-Oncology, Department of Neurology, University Hospital of Bellvitge, L’Hospitalet, Spain. (Bruna J, Velasco R)

  • Division of Clinical Oncology-Department of Medicine, University Hospital of Patras, Patras, Greece (Argyriou AA, Kalofonos HP)

  • Service de Neurologie Mazarin, Hôpital Pitié-Salpêtrière, Paris, France (Psimaras D)

  • Service de Neurologie, Hôpital du Val-de-Grâce, Paris, France (Ricard D)

  • Neurology Unit, National Cancer Institute Regina Elena, Rome, Italy (Pace A, Galiè E)

  • Department of Neurosciences, University of Padova, Padova, Italy (Briani C, Lucchetta M, Campagnolo M, Dalla Torre C)

  • Department of Neurology, Spaarne Hospital, Hoofddorp/Maastricht University Medical Center, Maastricht, The Netherlands (Faber CG, Merkies ISJ, Vanhoutte EK, Bakkers M, Brouwer B, Boogerd M)

  • Division of Medical Oncology, Department of Internal Medicine, GROW-School of Oncology and Developmental Biology, Maastricht University Medical Centre, The Netherlands (Lalisang RI)

  • Department of Neuro-oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands (Boogerd W, Brandsma D)

  • Department of Neurology, University of Essen, Germany (Koeppen S)

  • West German Cancer Center, University of Essen, Germany (Hense J)

  • Edinburgh Centre for Neuro-Oncology and Edinburgh Cancer Research Centre, Western General Hospital, Edinburgh, UK (Grant R, Storey D, Kerrigan S)

  • Department of Neurosciences, Ophthalmology and Genetic, Center of Excellence for Biomedical Research, University of Genova, Genova, Italy (Schenone A, Reni L, Piras B)

  • Department of Neurosciences, Ophthalmology and Genetic, University of Genova, Genova, Italy (Fabbri S)

  • Medical Oncology Division, University Hospital San Martino-IST, Genoa, Italy (Pessino A)

  • Department of Neurosciences Cattolica University, Rome, Don C. Gnocchi Foundation, Italy (Padua L, Granata G)

  • Interuniversity Centre for Pain Neurophysiology at the University of Genova (Leandri M, Ghignotti I)

  • I.R.C.C.S. of Neurological Sciences, Bellaria Hospital, Bologna, Italy (Plasmati R., Pastorelli F)

  • Department of Neurology, VU University Medical Center, Amsterdam, the Netherlands (Postma TJ, Heimans JJ).

  • Department of Neurology, Spaarne Hospital, Hoofddorp, the Netherlands (Eurelings M, Meijer RJ)

  • Department of Neurology, Kaiser Franz Josef Hospital, Vienna, Austria (Grisold W, Lindeck Pozza E)

  • Department of Neurosciences, Psychiatry and Anesthesiology, AOU “G. Martino”, Messina, Italy (Mazzeo A, Toscano A, Russo M)

  • Department of Medical Oncology, University of Messina, Messina, Italy (Tomasello C, Altavilla G)

  • Servicio de Neurologia, Hospital Universitario Doce de Octubre, Madrid, Spain (Penas Prado M, Dominguez Gonzalez C)

  • University of Maryland School of Nursing and Marlene and Stewart Greenebaum Cancer Center, Baltimore, MD, USA (Dorsey SG)

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Kieffer, J.M., Postma, T.J., van de Poll-Franse, L. et al. Evaluation of the psychometric properties of the EORTC chemotherapy-induced peripheral neuropathy questionnaire (QLQ-CIPN20). Qual Life Res 26, 2999–3010 (2017). https://doi.org/10.1007/s11136-017-1626-1

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