Rasch-built Overall Disability Scale for patients with chemotherapy-induced peripheral neuropathy (CIPN-R-ODS)

Binda, Davide; Vanhoutte, Els K.; Cavaletti, Guido; Cornblath, David R.; Postma, T.J.; Frigeni, Barbara; Alberti, Paola; Bruna, Jordi; Velasco, Roser; Argyriou, Andreas A.; Kalofonos, Haralabos P.; Psimaras, Dimitri; Ricard, Damien; Pace, Andrea; Galiè, Edvina; Briani, Chiara; Torre, Chiara Dalla; Lalisang, Roy I.; Boogerd, W.; Brandsma, Dieta; Koeppen, Susanne; Hense, J.; Storey, Dawn J; Kerrigan, Simon; Schenone, Angelo; Fabbri, Sabrina; Rossi, Emanuela; Valsecchi, Maria Grazia; Faber, Catharina G.; Merkies, Ingemar S. J.; Galimberti, Stefania; Lanzani, Francesca; Mattavelli, Laura; Piatti, M.; Bidoli, Paolo; Cazzaniga, M.; Cortinovis, Diego; Lucchetta, Marta; Campagnolo, Marta; Bakkers, Mayienne; Brouwer, Brigitte A.; Grant, Robin; Reni, Lizia; Piras, Bruno; Pessino, A.; Padua, Luca; Granata, Giuseppe; Leandri, Massimo; Ghignotti, I.; Plasmati, R.; Pastorelli, Francesca; Heimans, Jan J.; Eurelings, M.; Meijer, Ronaldus Jacobus; Grisold, Wolfgang; pozza, E. Lindeck; Mazzeo, Anna; Toscano, Antonio; Russo, Massimo; Tomasello, Chiara; Altavilla, Giuseppe; Prado, Mara; Domínguez‐González, Cristina; Dorsey, Susan G.

doi:10.1016/j.ejca.2013.04.004

Cited by 38 publications

(29 citation statements)

References 19 publications

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“…This secondary analysis was performed in order to test the criterion validity of each self‐reported item selected by neurologists with long‐lasting experience in the assessment of CIPN among a list of questions used to create a new, Rasch‐built CIPN questionnaire currently under validation. Since answers to simple questions, such as those used in this study and those forming the basis for PRO instruments, are likely to be influenced by several, convergent events/conditions, possible misinterpretations may occur when a patient reports daily life impairment to the treating oncologist.…”

Section: Discussionmentioning

confidence: 52%

Patients' and physicians' interpretation of chemotherapy‐induced peripheral neurotoxicity

Cavaletti

Cornblath

Merkies

et al. 2019

J Peripheral Nervous Sys

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To test if and how chemotherapy‐induced peripheral neurotoxicity (CIPN) is perceived differently by patients and physicians, making assessment and interpretation challenging. We performed a secondary analysis of the CI‐PeriNomS study which included 281 patients with stable CIPN. We tested: (a) the association between patients' perception of activity limitation in performing eight common tasks and neurological impairment and (b) how the responses to questions related to these daily activities are interpreted by the treating oncologist. To achieve this, we compared patients' perception of their activity limitation with neurological assessment and the oncologists' blind interpretation. Distribution of the scores attributed by oncologists to each daily life maximum limitation (“impossible”) generated three groups: Group 1 included limitations oncologists attributed mainly to motor impairment; Group 2 ones mainly attributed to sensory impairment and Group 3 ones with uncertain motor and sensory impairment. Only a subset of questions showed a significant trend between severity in subjective limitation, reported by patients, and neurological impairment. In Group 1, neurological examination confirmed motor impairment in only 51%‐65% of patients; 76%‐78% of them also had vibration perception impairment. In Group 2, sensory impairment ranged from 84% to 100%; some degree of motor impairment occurred in 43%‐56% of them. In Group 3 strength reduction was observed in 49%‐50% and sensory perception was altered in up to 82%. Interpretation provided by the panel of experienced oncologists was inconsistent with the neurological impairment. These observations highlight the need of a core set of outcome measures for future CIPN trials.

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Section: Discussionmentioning

confidence: 52%

Patients' and physicians' interpretation of chemotherapy‐induced peripheral neurotoxicity

Cavaletti

Cornblath

Merkies

et al. 2019

J Peripheral Nervous Sys

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“…The authors provide evidence supporting that the R-ODS is a valid measure of neuropathy-associated functional deficits because items not meeting Rasch model expectations (e.g., unidimensionality, threshold ordering, DIF) were removed. The same Rasch methods were used by Binda et al (2013) to retest and refine the R-ODS for use in a different population—those with CIPN [41]. When CIPN-R-ODS scores were compared to the traditional NCI-CTC grading scale scores, a measure commonly used in therapeutic oncology clinical trials, the sensory NCICTC was inferior in discriminating between various levels of neuropathy severity.…”

Section: Discussionmentioning

confidence: 99%

Rasch model-based testing of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire–Chemotherapy-Induced Peripheral Neuropathy (QLQ-CIPN20) using Alliance for Clinical Trials in Oncology (Alliance) A151408 study data

Smith

Zanville

Kanzawa-Lee

et al. 2018

Support Care Cancer

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Purpose To test the psychometric properties of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire–Chemotherapy-Induced Peripheral Neuropathy (QLQ-CIPN20) using Rasch-based methods. Methods A secondary data analysis was performed using pooled QLQ-CIPN20 data from patients (N = 1008) who had participated in any of four multi-site chemotherapy-induced peripheral neuropathy (CIPN) treatment and prevention trials. QLQ-CIPN20 responses were evaluated using a polytomous Rasch partial credit model. Data were assessed for person-item fit using the chi-square statistic, item scaling based on response proportions, threshold ordering using item characteristic curves and logit threshold locations, differential item response (DIF) (i.e., response bias) using likelihood ratio tests, and unidimensionality using cluster analysis. Results A statistically significant chi-square test indicated poor fit of the observed to the expected responses. More than 70% of the respondents reported a complete absence of six symptoms, reflecting significant floor effects and poor item scaling. Disordered/non-ordinal or narrow response thresholds were found for 11 of the 20 items. Item responses were significantly different by gender (p < 0.0001) and chemotherapy type (p < 0.0001). Cluster analysis findings suggest that the QLQ-CIPN20 is a unidimensional scale due to the absence of item clusters. Conclusions Rasch model testing revealed psychometric weaknesses that could be addressed by revising the QLQ-CIPN20’s problematic items and response options. Alternatively, perhaps the new gold standard CIPN measurement approach in future intervention trials should involve use of only the best items, which would also allow comparisons across previous trials that utilized the QLQ-CIPN20.

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“…Moreover, the increasing use of Patients Reported Outcome measures highlighted that these assessment methods report CIPN in a completely different way if compared with physician or neurophysiological assessments [63 && ,64 && ]. It is, therefore, extremely important to develop more efficient and reliable assessment methods for CIPN [65,66].…”

Section: Assessment Of Chemotherapy-induced Peripheral Neurotoxicitymentioning

confidence: 99%

Chemotherapy-induced peripheral neurotoxicity

Cavaletti

Marmiroli

2015

Current Opinion in Neurology

177

143

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Precise definition of CIPN clinical features can be obtained by only using validated outcome measures. Therefore, a major aim of clinical research is to standardize CIPN assessment, also considering that healthcare providers and patients frequently have a different perception of CIPN severity. A second major aim in clinical research is to maintain a high level of attention to the possible neurotoxicity of drugs more recently introduced into clinical practice. Preclinical studies are of pivotal importance to identify druggable targets for pharmacological intervention in order to prevent or limit CIPN.

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Rasch-built Overall Disability Scale for patients with chemotherapy-induced peripheral neuropathy (CIPN-R-ODS)

Cited by 38 publications

References 19 publications

Patients' and physicians' interpretation of chemotherapy‐induced peripheral neurotoxicity

Patients' and physicians' interpretation of chemotherapy‐induced peripheral neurotoxicity

Rasch model-based testing of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire–Chemotherapy-Induced Peripheral Neuropathy (QLQ-CIPN20) using Alliance for Clinical Trials in Oncology (Alliance) A151408 study data

Chemotherapy-induced peripheral neurotoxicity

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