The chemotherapy-induced peripheral neuropathy outcome measures standardization study: from consensus to the first validity and reliability findings

G. Cavaletti*, D. R. Cornblath, I. S. J. Merkies, T. J. Postma, E. Rossi, B. Frigeni, P. Alberti, J. Bruna, R. Velasco, A. A. Argyriou, H. P. Kalofonos, D. Psimaras, D. Ricard, A. Pace, E. Galie, C. Briani, C. Dalla Torre, C. G. Faber, R. I. Lalisang, W. BoogerdD. Brandsma, S. Koeppen, J. Hense, D. Storey, S. Kerrigan, A. Schenone, S. Fabbri, M. G. Valsecchi

*Corresponding author for this work

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Chemotherapy-induced peripheral neuropathy (CIPN) is a debilitating and dose-limiting complication of cancer treatment. Thus far, the impact of CIPN has not been studied in a systematic clinimetric manner. The objective of the study was to select outcome measures for CIPN evaluation and to establish their validity and reproducibility in a cross-sectional multicenter study. After literature review and a consensus meeting among experts, face/content validity were obtained for the following selected scales: the National Cancer Institute-Common Toxicity Criteria (NCI-CTC), the Total Neuropathy Score clinical version (TNSc), the modified Inflammatory Neuropathy Cause and Treatment (INCAT) group sensory sumscore (mISS), the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, and CIPN20 quality-of-life measures. A total of 281 patients with stable CIPN were examined. Validity (correlation) and reliability studies were carried out. Good inter-/intra-observer scores were obtained for the TNSc, mISS, and NCI-CTC sensory/motor subscales. Test-retest values were also good for the EORTC QLQ-C30 and CIPN20. Acceptable validity scores were obtained through the correlation among the measures. Good validity and reliability scores were demonstrated for the set of selected impairment and quality-of-life outcome measures in CIPN. Future studies are planned to investigate the responsiveness aspects of these measures.
Original languageEnglish
Pages (from-to)454-462
JournalAnnals of Oncology
Issue number2
Publication statusPublished - Feb 2013


  • assessment
  • chemotherapy
  • clinimetrics
  • peripheral neuropathy
  • reliability
  • validity

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