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

Abstract

BACKGROUND:

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.

PATIENTS AND METHODS:

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.

RESULTS:

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.

CONCLUSION:

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.

• Authors: 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 Galiè, C Briani, C Dalla Torre, C G Faber, R I Lalisang, W Boogerd, D Brandsma, S Koeppen, J Hense, D Storey, S Kerrigan, A Schenone, S Fabbri, M G Valsecchi, CI-PeriNomS Group, A Mazzeo, A Pace, A Pessino, A Schenone, A Toscano, A A Argyriou, B Brouwer, B Frigeni, B Piras, C Briani, C Dalla Torre, C Dominguez Gonzalez, C G Faber, C Tomasello, D Binda, D Brandsma, D Cortinovis, D Psimaras, D Ricard, D Storey, D R Cornblath, E Galiè, E Lindeck Pozza, E Rossi, E K Vanhoutte, F Lanzani, F Pastorelli, G Altavilla, G Cavaletti, G Granata, H P Kalofonos, I Ghignotti, I S J Merkies, J Bruna, J Hense, J J Heimans, L Mattavelli, L Padua, L Reni, M Bakkers, M Boogerd, M Campagnolo, M Cazzaniga, M Eurelings, M Leandri, M Lucchetta, M Penas Prado, M Russo, M G Valsecchi, M L Piatti, P Alberti, P Bidoli, R Grant, R Plasmati, R Velasco, R I Lalisang, R J Meijer, S Fabbri, S G Dorsey, S Galimberti, S Kerrigan, S Koeppen, T J Postma, W Boogerd, W Grisold
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 24 Issue 2 Pg. 454-462 (Feb 2013) ISSN: 1569-8041 [Electronic] England
• PMID: 22910842 (Publication Type: Journal Article, Multicenter Study, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents

Topics

• Antineoplastic Agents (adverse effects, therapeutic use)
• Cross-Sectional Studies
• Health Status
• Humans
• Neoplasms (drug therapy)
• Outcome Assessment, Health Care
• Peripheral Nervous System Diseases (chemically induced)
• Quality of Life
• Treatment Outcome