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

• Published in: Annals of oncology Vol. 24; no. 2; pp. 454 - 462
• Main Authors: Cavaletti, G., Cornblath, D.R., Merkies, I.S.J., Postma, T.J., Rossi, E., Frigeni, B., Alberti, P., Bruna, J., Velasco, R., Argyriou, A.A., Kalofonos, H.P., Psimaras, D., Ricard, D., Pace, A., Galiè, E., Briani, C., Dalla Torre, C., Faber, C.G., Lalisang, R.I., Boogerd, W., Brandsma, D., Koeppen, S., Hense, J., Storey, D., Kerrigan, S., Schenone, A., Fabbri, S., Valsecchi, M.G., Mazzeo, A., Pessino, A., Toscano, A., Brouwer, B., Piras, B., Dominguez Gonzalez, C., Tomasello, C., Binda, D., Cortinovis, D., Lindeck Pozza, E., Vanhoutte, E.K., Lanzani, F., Pastorelli, F., Altavilla, G., Granata, G., Ghignotti, I., Heimans, J.J., Mattavelli, L., Padua, L., Reni, L., Bakkers, M., Boogerd, M., Campagnolo, M., Cazzaniga, M., Eurelings, M., Leandri, M., Lucchetta, M., Penas Prado, M., Russo, M., Piatti, M.L., Bidoli, P., Grant, R., Plasmati, R., Meijer, R.J., Dorsey, S.G., Galimberti, S., Grisold, W.
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 01.02.2013; Oxford University Press
• Subjects: Antineoplastic agents; Antineoplastic Agents - adverse effects; Antineoplastic Agents - therapeutic use; assessment; Biological and medical sciences; chemotherapy; clinimetrics; Cross-Sectional Studies; Health Status; Humans; Medical sciences; Neoplasms - drug therapy; Original; Outcome Assessment, Health Care; Peripheral Nervous System Diseases - chemically induced; peripheral neuropathy; Pharmacology. Drug treatments; Quality of Life; reliability; Treatment Outcome; validity; assessment; clinimetrics; validity; chemotherapy; peripheral neuropathy; reliability; Evaluation; Nervous system diseases; Prognosis; Standardization; Consensus; Validity; Chemotherapy; Treatment; Peripheral nerve disease; Reliability
• ISSN: 0923-7534; 1569-8041; 1569-8041
• DOI: 10.1093/annonc/mds329

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.