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 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

doi:10.1093/annonc/mds329

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

Ann Oncol. 2013 Feb;24(2):454-462. doi: 10.1093/annonc/mds329. Epub 2012 Aug 21.

Authors

G Cavaletti¹, D R Cornblath², I S J Merkies³, T J Postma⁴, E Rossi⁵, B Frigeni⁶, P Alberti⁶, J Bruna⁷, R Velasco⁷, A A Argyriou⁸, H P Kalofonos⁸, D Psimaras⁹, D Ricard¹⁰, A Pace¹¹, E Galiè¹¹, C Briani¹², C Dalla Torre¹², C G Faber³, R I Lalisang¹³, W Boogerd¹⁴, D Brandsma¹⁴, S Koeppen¹⁵, J Hense¹⁵, D Storey¹⁶, S Kerrigan¹⁶, A Schenone¹⁷, S Fabbri¹⁷, M G Valsecchi⁵; 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

Affiliations

¹ Department of Neuroscience and Biomedical Technologies, University of Milano-Bicocca, Monza, Italy. Electronic address: [email protected].
² Department of Neurology, Johns Hopkins University, School of Medicine, Baltimore, MD, USA.
³ Department of Neurology, Spaarne Hospital, Hoofddorp/Maastricht, University Medical Center, Maastricht.
⁴ Department of Neurology, VU University Medical Center, Amsterdam, The Netherlands.
⁵ Center of Biostatistics for Clinical Epidemiology, Department of Clinical Medicine and Prevention, University of Milano-Bicocca, Monza, Italy.
⁶ Department of Neuroscience and Biomedical Technologies, University of Milano-Bicocca, Monza, Italy.
⁷ Unit of Neuro-Oncology, Department of Neurology, University Hospital of Bellvitge, L'Hospitalet, Spain.
⁸ Division of Clinical Oncology, Department of Medicine, University Hospital of Patras, Patras, Greece.
⁹ Service de Neurologie Mazarin, Hôpital de la Pitié-Salpêtrière, AP-HP, Paris.
¹⁰ Service de Neurologie, Hôpital du Val-de-Grâce, Service de Santé des Armées, Paris, France.
¹¹ Neurology Unit, National Cancer Institute Regina Elena, Rome.
¹² Department of Neurosciences, University of Padova, Padova, Italy.
¹³ Division of Medical Oncology, Department of Internal Medicine, GROW-School of Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht.
¹⁴ Department of Neuro-oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.
¹⁵ Department of Neurology and West German Cancer Center, University of Essen, Essen, Germany.
¹⁶ Edinburgh Centre for Neuro-Oncology and Edinburgh Cancer Research Centre, Western General Hospital, Edinburgh, UK.
¹⁷ Department of Neurosciences, Ophthalmology and Genetic, Center of Excellence for Biomedical Research, University of Genova, Genova, Italy.

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.

Publication types

Multicenter Study
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

Antineoplastic Agents / adverse effects*
Antineoplastic Agents / 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

Substances

Antineoplastic Agents

Grants and funding

P30 NR011396/NR/NINR NIH HHS/United States