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

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

G Cavaletti  1 , D R Cornblath  2 , I S J Merkies  3 , T J Postma  4 , E Rossi  5 , B Frigeni  6 , P Alberti  6 , J Bruna  7 , R Velasco  7 , A A Argyriou  8 , H P Kalofonos  8 , D Psimaras  9 , D Ricard  10 , A Pace  11 , E Galiè  11 , C Briani  12 , C Dalla Torre  12 , C G Faber  3 , R I Lalisang  13 , W Boogerd  14 , D Brandsma  14 , S Koeppen  15 , J Hense  15 , D Storey  16 , S Kerrigan  16 , A Schenone  17 , S Fabbri  17 , M G Valsecchi  5 ; 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
Multicenter Study

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

G Cavaletti et al. Ann Oncol. 2013 Feb.

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.

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Figures

Figure 1
Figure 1
Flowchart of the study describing the time points of each examination and the outcome measures used to assess chemotherapy-induced peripheral neuropathy (CIPN) in our study population. NCI-CTCs+m, National Cancer Institute-Common Toxicity Criteria sensory and motor subscales; TNSc, Total Neuropathy Score clinical version; mISS, modified INCAT sensory sum score; NCS, nerve conduction studies; VAS, visual analog pain scale; PI-NRS, 11-point pain-intensity numerical rating scale; preliminary RODS-CIPN, preliminary Rasch-built linearly weighted overall disability scale; QLQ-C30, European Organization for Research and Treatment of Cancer (EORTC) 30-item questionnaire for cancer patients; QLQ-CIPN20, EORTC 20 items CIPN-specific quality-of-life questionnaire.
Figure 2
Figure 2
Results obtained by the examiners and visits using the National Cancer Institute-Common Toxicity Criteria sensory and motor subscales.
Figure 3
Figure 3
Results obtained by the examiners and visits using the Total Neuropathy Score clinical and the modified INCAT sensory sumscore.
Figure 4
Figure 4
European Organization for Research and Treatment of Cancer QLQ C30 global health status at visits 1 and 2 (0 = worst quality of life, 100 = best quality of life).
See this image and copyright information in PMC

References

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