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

被引:229
作者
Cavaletti, G. [1 ]
Cornblath, D. R. [2 ]
Merkies, I. S. J. [3 ]
Postma, T. J. [4 ]
Rossi, E. [5 ]
Frigeni, B. [1 ]
Alberti, P. [1 ]
Bruna, J. [6 ]
Velasco, R. [6 ]
Argyriou, A. A. [7 ]
Kalofonos, H. P. [7 ]
Psimaras, D. [8 ]
Ricard, D. [9 ]
Pace, A. [10 ]
Galie, E. [10 ]
Briani, C. [11 ]
Dalla Torre, C. [11 ]
Faber, C. G. [3 ]
Lalisang, R. I. [12 ]
Boogerd, W. [13 ]
Brandsma, D. [13 ]
Koeppen, S. [14 ,15 ]
Hense, J. [14 ,15 ]
Storey, D. [16 ]
Kerrigan, S. [16 ]
Schenone, A. [17 ]
Fabbri, S. [17 ]
Valsecchi, M. G. [5 ]
机构
[1] Univ Milano Bicocca, DNTB, I-20900 Monza, MB, Italy
[2] Johns Hopkins Univ, Sch Med, Dept Neurol, Baltimore, MD 21205 USA
[3] Spaarne Hosp, Univ Med Ctr, Dept Neurol, Maastricht, Netherlands
[4] Vrije Univ Amsterdam Med Ctr, Dept Neurol, Amsterdam, Netherlands
[5] Univ Milano Bicocca, Dept Clin Med & Prevent, Ctr Biostat Clin Epidemiol, I-20900 Monza, MB, Italy
[6] Univ Hosp Bellvitge, Dept Neurol, Unit Neurooncol, Lhospitalet De Llobregat, Spain
[7] Univ Hosp Patras, Div Clin Oncol, Dept Med, Patras, Greece
[8] Hop La Pitie Salpetriere, AP HP, Serv Neurol Mazarin, Paris, France
[9] Hop Val de Grace, Serv Neurol, Serv Sante Armees, Paris, France
[10] Natl Canc Inst Regina Elena, Neurol Unit, Rome, Italy
[11] Univ Padua, Dept Neurosci, Padua, Italy
[12] Maastricht Univ, Med Ctr, GROW Sch Oncol & Dev Biol, Div Med Oncol,Dept Internal Med, Maastricht, Netherlands
[13] Netherlands Canc Inst, Dept Neurooncol, Amsterdam, Netherlands
[14] Univ Essen Gesamthsch, Dept Neurol, Essen, Germany
[15] Univ Essen Gesamthsch, W German Canc Ctr, Essen, Germany
[16] Western Gen Hosp, Edinburgh Ctr Neurooncol, Edinburgh EH4 2XU, Midlothian, Scotland
[17] Univ Genoa, Ctr Excellence Biomed Res, Dept Neurosci Ophthalmol & Genet, Genoa, Italy
关键词
assessment; chemotherapy; clinimetrics; peripheral neuropathy; reliability; validity; QUALITY-OF-LIFE; GRADUATED TUNING FORK; CLINICAL-TRIALS; EORTC; TOXICITY; NEUROTOXICITY; QLQ-C30; SCALE; SCORE; RESPONSIVENESS;
D O I
10.1093/annonc/mds329
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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.
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收藏
页码:454 / 462
页数:9
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