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


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.


CONCLUSIONS
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.
Department of Neuroscience and Biomedical Technologies, University of Milano-Bicocca, Monza, Italy. Electronic address: guido.cavaletti@unimib.it.
G
G
Cavaletti
Department of Neurology, Johns Hopkins University, School of Medicine, Baltimore, MD, USA.
D R
DR
Cornblath
Department of Neurology, Spaarne Hospital, Hoofddorp/Maastricht, University Medical Center, Maastricht.
I S J
ISJ
Merkies
Department of Neurology, VU University Medical Center, Amsterdam, The Netherlands.
T J
TJ
Postma
Center of Biostatistics for Clinical Epidemiology, Department of Clinical Medicine and Prevention, University of Milano-Bicocca, Monza, Italy.
E
E
Rossi
Department of Neuroscience and Biomedical Technologies, University of Milano-Bicocca, Monza, Italy.
B
B
Frigeni
Department of Neuroscience and Biomedical Technologies, University of Milano-Bicocca, Monza, Italy.
P
P
Alberti
Unit of Neuro-Oncology, Department of Neurology, University Hospital of Bellvitge, L'Hospitalet, Spain.
J
J
Bruna
Unit of Neuro-Oncology, Department of Neurology, University Hospital of Bellvitge, L'Hospitalet, Spain.
R
R
Velasco
Division of Clinical Oncology, Department of Medicine, University Hospital of Patras, Patras, Greece.
A A
AA
Argyriou
Division of Clinical Oncology, Department of Medicine, University Hospital of Patras, Patras, Greece.
H P
HP
Kalofonos
Service de Neurologie Mazarin, Hôpital de la Pitié-Salpêtrière, AP-HP, Paris.
D
D
Psimaras
Service de Neurologie, Hôpital du Val-de-Grâce, Service de Santé des Armées, Paris, France.
D
D
Ricard
Neurology Unit, National Cancer Institute Regina Elena, Rome.
A
A
Pace
Neurology Unit, National Cancer Institute Regina Elena, Rome.
E
E
Galiè
Department of Neurosciences, University of Padova, Padova, Italy.
C
C
Briani
Department of Neurosciences, University of Padova, Padova, Italy.
C
C
Dalla Torre
Department of Neurology, Spaarne Hospital, Hoofddorp/Maastricht, University Medical Center, Maastricht.
C G
CG
Faber
Division of Medical Oncology, Department of Internal Medicine, GROW-School of Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht.
R I
RI
Lalisang
Department of Neuro-oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.
W
W
Boogerd
Department of Neuro-oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.
D
D
Brandsma
Department of Neurology and West German Cancer Center, University of Essen, Essen, Germany.
S
S
Koeppen
Department of Neurology and West German Cancer Center, University of Essen, Essen, Germany.
J
J
Hense
Edinburgh Centre for Neuro-Oncology and Edinburgh Cancer Research Centre, Western General Hospital, Edinburgh, UK.
D
D
Storey
Edinburgh Centre for Neuro-Oncology and Edinburgh Cancer Research Centre, Western General Hospital, Edinburgh, UK.
S
S
Kerrigan
Department of Neurosciences, Ophthalmology and Genetic, Center of Excellence for Biomedical Research, University of Genova, Genova, Italy.
A
A
Schenone
Department of Neurosciences, Ophthalmology and Genetic, Center of Excellence for Biomedical Research, University of Genova, Genova, Italy.
S
S
Fabbri
Center of Biostatistics for Clinical Epidemiology, Department of Clinical Medicine and Prevention, University of Milano-Bicocca, Monza, Italy.
M G
MG
Valsecchi
A
A
Mazzeo
A
A
Pace
A
A
Pessino
A
A
Schenone
A
A
Toscano
A A
AA
Argyriou
B
B
Brouwer
B
B
Frigeni
B
B
Piras
C
C
Briani
C
C
Dalla Torre
C
C
Dominguez Gonzalez
C G
CG
Faber
C
C
Tomasello
D
D
Binda
D
D
Brandsma
D
D
Cortinovis
D
D
Psimaras
D
D
Ricard
D
D
Storey
D R
DR
Cornblath
E
E
Galiè
E
E
Lindeck Pozza
E
E
Rossi
E K
EK
Vanhoutte
F
F
Lanzani
F
F
Pastorelli
G
G
Altavilla
G
G
Cavaletti
G
G
Granata
H P
HP
Kalofonos
I
I
Ghignotti
I S J
ISJ
Merkies
J
J
Bruna
J
J
Hense
J J
JJ
Heimans
L
L
Mattavelli
L
L
Padua
L
L
Reni
M
M
Bakkers
M
M
Boogerd
M
M
Campagnolo
M
M
Cazzaniga
M
M
Eurelings
M
M
Leandri
M
M
Lucchetta
M
M
Penas Prado
M
M
Russo
M G
MG
Valsecchi
M L
ML
Piatti
P
P
Alberti
P
P
Bidoli
R
R
Grant
R
R
Plasmati
R
R
Velasco
R I
RI
Lalisang
R J
RJ
Meijer
S
S
Fabbri
S G
SG
Dorsey
S
S
Galimberti
S
S
Kerrigan
S
S
Koeppen
T J
TJ
Postma
W
W
Boogerd
W
W
Grisold
D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D003430:Cross-Sectional Studies; D006304:Health Status; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D017063:Outcome Assessment, Health Care; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced*; D011788:Quality of Life; D016896:Treatment Outcome
D000970:Antineoplastic Agents