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

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.

Reliability and Validity of the Korean Version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire to Assess Chemotherapy-induced Peripheral Neuropathy

“…A patient-reported QOL questionnaire assessing CIPN (QLQ-CIPN20) was designed as an outcome instrument to supplement the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaire [2,13]. The QLQ-CIPN20 contains 3 subscales that evaluate sensory, motor, and autonomic symptoms and functioning [2].…”

“…The QLQ-CIPN20 contains 3 subscales that evaluate sensory, motor, and autonomic symptoms and functioning [2]. The validity and reliability of this instrument were verified through multisite international study [13], and numerous recent studies have used it to measure CIPN-related symptoms [14][15][16]. The QLQ-CIPN20 is valuable because it provides subjective, patient-reported information that is not captured by objective physical examinations, nerve conduction studies, or quantitative sensory testing.…”

“…The QLQ-CIPN20 has been widely translated and used to assess CIPN-related symptoms [13,14,16]. Many oncologists are also interested in CIPN-related symptoms and need a valid and reliable CIPN questionnaire [15,17,18], The EORTC QLQ-CIPN20 has been translated and back translated into Korean, but the applicability and final version of the EORTC QLQ-CIPN20 needs to be confirmed through cross-cultural validation with Korean cancer patients.…”

Voltage‐gated sodium channel polymorphisms play a pivotal role in the development of oxaliplatin‐induced peripheral neurotoxicity: Results from a prospective multicenter study

“…In addition, it focused exclusively on OXAIPN by applying prospective and detailed neurological examinations with validated grading tools such as TNSc, in addition to the National Cancer Institute Common Toxicity Criteria. 14 Finally, we tried to ensure the best-quality results by applying duplicate analysis of samples by real-time PCR and sending randomly selected samples for retesting and validation of results using DNA sequencing at an independent institution. To the best of our knowledge, the external control of pharmacogenetic results has hardly ever been performed.…”

Relationship between Chemotherapy-induced Peripheral Neuropathy and Quality of Life in Patients with Hematologic Malignancies

“…Therefore, intensive studies are currently underway to prevent and alleviate CIPN symptoms [15][16][17][18][19], and attempts are being made to standardize CIPN assessments [20]. Nevertheless, there are a limited number of studies concerning the QOL of cancer patients who experience CIPN-related symptoms [11,20,21], and studies on the CIPN-QOL relationship in patients with hematologic malignancies are rare.…”