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Development and validation of the chemotherapy-induced peripheral neuropathy integrated assessment – oxaliplatin subscale: a prospective cohort study

BACKGROUND: Current chemotherapy-induced peripheral neuropathy (CIPN) assessment tools mostly have poor sensitivity and weak anti-interference, so that it is sometimes difficult to provide substantive guidance for clinical intervention. This study aimed to develop an assessment tool dedicated for ox...

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Autores principales: Gu, Zhancheng, Chen, Chen, Gu, Jialin, Song, Ziwei, Wei, Guoli, Cai, Guoxiang, Shu, Qijin, Zhu, Lingjun, Zhu, Weiyou, Deng, Haibin, Li, Sheng, Chen, Aifei, Yin, Yue, Wu, Qiulan, Zhu, Hongyu, Li, Guochun, Dai, Anwei, Huo, Jiege
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10648311/
https://www.ncbi.nlm.nih.gov/pubmed/37964212
http://dx.doi.org/10.1186/s12885-023-11541-7
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author Gu, Zhancheng
Chen, Chen
Gu, Jialin
Song, Ziwei
Wei, Guoli
Cai, Guoxiang
Shu, Qijin
Zhu, Lingjun
Zhu, Weiyou
Deng, Haibin
Li, Sheng
Chen, Aifei
Yin, Yue
Wu, Qiulan
Zhu, Hongyu
Li, Guochun
Dai, Anwei
Huo, Jiege
author_facet Gu, Zhancheng
Chen, Chen
Gu, Jialin
Song, Ziwei
Wei, Guoli
Cai, Guoxiang
Shu, Qijin
Zhu, Lingjun
Zhu, Weiyou
Deng, Haibin
Li, Sheng
Chen, Aifei
Yin, Yue
Wu, Qiulan
Zhu, Hongyu
Li, Guochun
Dai, Anwei
Huo, Jiege
author_sort Gu, Zhancheng
collection PubMed
description BACKGROUND: Current chemotherapy-induced peripheral neuropathy (CIPN) assessment tools mostly have poor sensitivity and weak anti-interference, so that it is sometimes difficult to provide substantive guidance for clinical intervention. This study aimed to develop an assessment tool dedicated for oxaliplatin to address these limitations. METHODS: This study screened 445 OIPN-related literatures for producing a symptom list, and developed the questionnaire module through expert supplement, item generation, content correlation analysis, pre-testing, and item improvement. The validation phase used a Chinese population-based prospective cohort study from June 2021 to July 2022. Patients were requested to complete the tested questionnaire, QLQ-CIPN20 and the CTCAE grading one day before cycles 2–6 of chemotherapy. Cronbach’s α coefficient and intraclass correlation coefficient (ICC) were calculated for the internal consistency and stability analysis, respectively. Exploratory factor analysis was conducted to investigate the construct validity. The correlations among the tested questionnaire, QLQ-CIPN20 and CTCAE were compared for the criterion validity analysis. Wilcoxon signed-rank sum test was utilized to compare the sensitivity between the tested questionnaire and QLQ-CIPN20. RESULT: A 20-item CIPN assessment tool named chemotherapy-induced peripheral neuropathy integrated assessment – oxaliplatin subscale (CIPNIA-OS) was developed. The validation phase included 186 patients. Cronbach's α coefficient of CIPNIA-OS was 0.764 (> 0.7), and ICC was 0.997 (between 0.9 and 1). The structure of CIPNIA-OS containing seven factors was examined. The correlation coefficient between CIPNIA-OS and CTCAE was 0.661 (95%CI 0.623 to 0.695), which was significantly higher than that between QLQ-CIPN20 and CTCAE (0.417, 95%CI 0.363 to 0.469, p < 0.01). Besides, the total score of CIPNIA-OS was mostly higher than QLQ-CIPN20, with an average difference of 2.189 (CI 95% 2.056 to 2.322), and the difference gradually expanded with the progress of chemotherapy (p < 0.05). CONCLUSION: This study developed an original CIPN questionnaire which was dedicated for OIPN assessment. It was a comprehensive tool that covered acute OIPN symptoms and integrated features from several proven CIPN assessment tools. The validation results supported that CIPNIA-OS had satisfactory reliability, stability, construct, criterion validity, and was more accuracy and sensitive than QLQ-CIPN20 in the evaluation of OIPN. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12885-023-11541-7.
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spelling pubmed-106483112023-11-14 Development and validation of the chemotherapy-induced peripheral neuropathy integrated assessment – oxaliplatin subscale: a prospective cohort study Gu, Zhancheng Chen, Chen Gu, Jialin Song, Ziwei Wei, Guoli Cai, Guoxiang Shu, Qijin Zhu, Lingjun Zhu, Weiyou Deng, Haibin Li, Sheng Chen, Aifei Yin, Yue Wu, Qiulan Zhu, Hongyu Li, Guochun Dai, Anwei Huo, Jiege BMC Cancer Research BACKGROUND: Current chemotherapy-induced peripheral neuropathy (CIPN) assessment tools mostly have poor sensitivity and weak anti-interference, so that it is sometimes difficult to provide substantive guidance for clinical intervention. This study aimed to develop an assessment tool dedicated for oxaliplatin to address these limitations. METHODS: This study screened 445 OIPN-related literatures for producing a symptom list, and developed the questionnaire module through expert supplement, item generation, content correlation analysis, pre-testing, and item improvement. The validation phase used a Chinese population-based prospective cohort study from June 2021 to July 2022. Patients were requested to complete the tested questionnaire, QLQ-CIPN20 and the CTCAE grading one day before cycles 2–6 of chemotherapy. Cronbach’s α coefficient and intraclass correlation coefficient (ICC) were calculated for the internal consistency and stability analysis, respectively. Exploratory factor analysis was conducted to investigate the construct validity. The correlations among the tested questionnaire, QLQ-CIPN20 and CTCAE were compared for the criterion validity analysis. Wilcoxon signed-rank sum test was utilized to compare the sensitivity between the tested questionnaire and QLQ-CIPN20. RESULT: A 20-item CIPN assessment tool named chemotherapy-induced peripheral neuropathy integrated assessment – oxaliplatin subscale (CIPNIA-OS) was developed. The validation phase included 186 patients. Cronbach's α coefficient of CIPNIA-OS was 0.764 (> 0.7), and ICC was 0.997 (between 0.9 and 1). The structure of CIPNIA-OS containing seven factors was examined. The correlation coefficient between CIPNIA-OS and CTCAE was 0.661 (95%CI 0.623 to 0.695), which was significantly higher than that between QLQ-CIPN20 and CTCAE (0.417, 95%CI 0.363 to 0.469, p < 0.01). Besides, the total score of CIPNIA-OS was mostly higher than QLQ-CIPN20, with an average difference of 2.189 (CI 95% 2.056 to 2.322), and the difference gradually expanded with the progress of chemotherapy (p < 0.05). CONCLUSION: This study developed an original CIPN questionnaire which was dedicated for OIPN assessment. It was a comprehensive tool that covered acute OIPN symptoms and integrated features from several proven CIPN assessment tools. The validation results supported that CIPNIA-OS had satisfactory reliability, stability, construct, criterion validity, and was more accuracy and sensitive than QLQ-CIPN20 in the evaluation of OIPN. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12885-023-11541-7. BioMed Central 2023-11-14 /pmc/articles/PMC10648311/ /pubmed/37964212 http://dx.doi.org/10.1186/s12885-023-11541-7 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Gu, Zhancheng
Chen, Chen
Gu, Jialin
Song, Ziwei
Wei, Guoli
Cai, Guoxiang
Shu, Qijin
Zhu, Lingjun
Zhu, Weiyou
Deng, Haibin
Li, Sheng
Chen, Aifei
Yin, Yue
Wu, Qiulan
Zhu, Hongyu
Li, Guochun
Dai, Anwei
Huo, Jiege
Development and validation of the chemotherapy-induced peripheral neuropathy integrated assessment – oxaliplatin subscale: a prospective cohort study
title Development and validation of the chemotherapy-induced peripheral neuropathy integrated assessment – oxaliplatin subscale: a prospective cohort study
title_full Development and validation of the chemotherapy-induced peripheral neuropathy integrated assessment – oxaliplatin subscale: a prospective cohort study
title_fullStr Development and validation of the chemotherapy-induced peripheral neuropathy integrated assessment – oxaliplatin subscale: a prospective cohort study
title_full_unstemmed Development and validation of the chemotherapy-induced peripheral neuropathy integrated assessment – oxaliplatin subscale: a prospective cohort study
title_short Development and validation of the chemotherapy-induced peripheral neuropathy integrated assessment – oxaliplatin subscale: a prospective cohort study
title_sort development and validation of the chemotherapy-induced peripheral neuropathy integrated assessment – oxaliplatin subscale: a prospective cohort study
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10648311/
https://www.ncbi.nlm.nih.gov/pubmed/37964212
http://dx.doi.org/10.1186/s12885-023-11541-7
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