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

被引:3
作者
Gu, Zhancheng [1 ,2 ]
Chen, Chen [2 ,3 ]
Gu, Jialin [2 ,4 ]
Song, Ziwei [2 ,4 ]
Wei, Guoli [4 ,5 ]
Cai, Guoxiang [6 ]
Shu, Qijin [7 ]
Zhu, Lingjun [8 ]
Zhu, Weiyou [8 ]
Deng, Haibin [9 ]
Li, Sheng [10 ]
Chen, Aifei [11 ]
Yin, Yue [8 ]
Wu, Qiulan [4 ]
Zhu, Hongyu [12 ]
Li, Guochun [13 ]
Dai, Anwei [1 ]
Huo, Jiege [4 ,5 ]
机构
[1] Kunshan Hosp Tradit Chinese Med, Dept Oncol, Suzhou 215399, Peoples R China
[2] Nanjing Univ Chinese Med, Clin Med Coll 3, Nanjing 210046, Peoples R China
[3] Nanjing Univ Chinese Med, Yancheng TCM Hosp, Dept Oncol, Yancheng 224005, Peoples R China
[4] Nanjing Univ Chinese Med, Affiliated Hosp Integrated Tradit Chinese & Wester, Dept Oncol, Nanjing 210028, Peoples R China
[5] Jiangsu Prov Acad Tradit Chinese Med, Nanjing 210028, Peoples R China
[6] Fudan Univ, Shanghai Canc Ctr, Dept Colorectal Surg, Shanghai 200032, Peoples R China
[7] Zhejiang Prov Hosp TCM, Dept Oncol, Hangzhou 310003, Peoples R China
[8] Jiangsu Prov Hosp, Dept Oncol, Nanjing 210029, Peoples R China
[9] Shanghai Univ Tradit Chinese Med, Longhua Hosp, Dept Oncol, Shanghai 350122, Peoples R China
[10] Jiangsu Canc Hosp, Dept Med Oncol, Nanjing 210009, Peoples R China
[11] Huaian Hosp Tradit Chinese Med, Dept Oncol, Huaian 223005, Peoples R China
[12] Fujian Med Univ, Sch Nursing, Fuzhou 350122, Peoples R China
[13] Nanjing Univ Chinese Med, Sch Med & Holist Integrat Med, Nanjing 210046, Peoples R China
关键词
Oxaliplatin-induced peripheral neuropathy (OIPN); Assessment tool; Reliability and validity analysis; Sensitivity; Patient-reported outcome; CANCER; QUESTIONNAIRE; PREVENTION; MANAGEMENT; DIAGNOSIS; CRITERIA; TRIAL; PAIN; CIPN;
D O I
10.1186/s12885-023-11541-7
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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 alpha 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.Resul tA 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 alpha 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.
引用
收藏
页数:12
相关论文
共 49 条
[1]   COMPREHENSIVE CRITERIA FOR ASSESSING THERAPY-INDUCED TOXICITY [J].
AJANI, JA ;
WELCH, SR ;
RABER, MN ;
FIELDS, WS ;
KRAKOFF, IH .
CANCER INVESTIGATION, 1990, 8 (02) :147-159
[2]   Clinical pattern and associations of oxaliplatin acute neurotoxicity [J].
Argyriou, Andreas A. ;
Cavaletti, Guido ;
Briani, Chiara ;
Velasco, Roser ;
Bruna, Jordi ;
Campagnolo, Marta ;
Alberti, Paola ;
Bergamo, Francesca ;
Cortinovis, Diego ;
Cazzaniga, Marina ;
Santos, Cristina ;
Papadimitriou, Konstantinos ;
Kalofonos, Haralabos P. .
CANCER, 2013, 119 (02) :438-444
[3]   Composite grading algorithm for the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [J].
Basch, Ethan ;
Becker, Claus ;
Rogak, Lauren J. ;
Schrag, Deborah ;
Reeve, Bryce B. ;
Spears, Patricia ;
Smith, Mary Lou ;
Gounder, Mrinal M. ;
Mahoney, Michelle R. ;
Schwartz, Gary K. ;
Bennett, Antonia, V ;
Mendoza, Tito R. ;
Cleeland, Charles S. ;
Sloan, Jeff A. ;
Bruner, Deborah Watkins ;
Schwab, Gisela ;
Atkinson, Thomas M. ;
Thanarajasingam, Gita ;
Bertagnolli, Monica M. ;
Dueck, Amylou C. .
CLINICAL TRIALS, 2021, 18 (01) :104-114
[4]   Pain in oxaliplatin-induced neuropathy - Sensitisation in the peripheral and central nociceptive system [J].
Binder, Andreas ;
Stengel, Maike ;
Maag, Rainer ;
Wasner, Gunnar ;
Schoch, Robert ;
Moosig, Frank ;
Schommer, Bernhard ;
Baron, Ralf .
EUROPEAN JOURNAL OF CANCER, 2007, 43 (18) :2658-2663
[5]   Psychometric evaluation of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (Fact/GOG-Ntx) questionnaire for patients receiving systemic chemotherapy [J].
Calhoun, EA ;
Welshman, EE ;
Chang, CH ;
Lurain, JR ;
Fishman, DA ;
Hunt, TL ;
Cella, D .
INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER, 2003, 13 (06) :741-748
[6]   Management of Oxaliplatin-Induced Peripheral Sensory Neuropathy [J].
Cavaletti, Guido ;
Marmiroli, Paola .
CANCERS, 2020, 12 (06)
[7]   Oxaliplatin-associated neuropathy: A review [J].
Cersosimo, RJ .
ANNALS OF PHARMACOTHERAPY, 2005, 39 (01) :128-135
[8]   Total neuropathy score - Validation and reliability study [J].
Cornblath, DR ;
Chaudhry, V ;
Carter, K ;
Lee, D ;
Seysedadr, M ;
Miernicki, M ;
Joh, T .
NEUROLOGY, 1999, 53 (08) :1660-1664
[9]   Recommendations for Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy [J].
Derman, Benjamin A. ;
Davis, Andrew M. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2021, 326 (11) :1058-1059
[10]   Chemotherapy-Induced Peripheral Neuropathy [J].
Desai, Nidhi ;
Arora, Nivedita ;
Gupta, Arjun .
JAMA INTERNAL MEDICINE, 2022, 182 (07) :766-767