乳腺癌化疗患者心脏毒性风险评估量表的编制和信效度检验  

Development and Reliability and Validity Test of Cardiotoxicity Risk Assessment Scale for Breast Cancer Patients Undergoing Chemotherapy

作　　者：姚珊珊 马珠月 史妍妍 吴雨晴 张柳柳[3] 陈明霞[2] 吴冰[3] 程芳[1] YAO Shanshan;MA Zhuyue;SHI Yanyan;WU Yuqing;ZHANG Liuliu;CHEN Mingxia;WU Bing;CHENG Fang(Department of Breast Surgery,Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Prevention and Treatment/Cancer Hospital Affiliated to Nanjing Medical University,Nanjing 210009,China;School of Nursing,Nanjing Medical University,Nanjing 211166,China;Nursing Department,Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Prevention and Treatment/Cancer Hospital Affiliated to Nanjing Medical University,Nanjing 210009,China)

机构地区：[1]江苏省肿瘤医院、江苏省肿瘤防治研究所、南京医科大学附属肿瘤医院乳腺外科,江苏省南京市210009 [2]南京医科大学护理学院,江苏省南京市211166 [3]江苏省肿瘤医院、江苏省肿瘤防治研究所、南京医科大学附属肿瘤医院护理部,江苏省南京市210009

出　　处：《中国全科医学》2024年第27期3428-3434,共7页Chinese General Practice

基　　金：国家自然科学基金青年项目(82203171);江苏省卫生健康委员会医学科研项目(M2021114);江苏高校哲学社会科学研究课题(2020SJA0312)。

摘　　要：背景乳腺癌化疗患者心脏毒性是乳腺癌幸存者及患者死亡的主要原因,而早期风险评估发现心脏毒性对临床预防和治疗心脏毒性具有重要意义,但目前国内缺乏公认的乳腺癌化疗患者心脏毒性风险评估工具。目的编制乳腺癌化疗患者心脏毒性风险评估量表,并检验其信效度。方法通过查阅国内外相关文献构建条目池,采用目的抽样法,于2022年9—10月在江苏省肿瘤医院选取医护人员进行半结构式访谈,初步形成乳腺癌化疗患者心脏毒性风险评估条目池,并选取江苏省肿瘤医院就诊的乳腺癌化疗患者进行预调查与量表的信效度检验,将所有乳腺癌化疗患者心脏毒性风险评分进行排序,以前27%为低分组,后27%为高分组。采用Cronbach'sα系数评价量表的内部一致性,采用条目水平的内容效度指数(I-CVI)与量表水平的内容效度指数(S-CVI)进行效度检验,运用探索性因子分析的方法对量表的结构效度进行评价,绘制受试者工作特征曲线(ROC曲线),计算ROC曲线下面积(AUC)确定预测效度。结果半结构式访谈纳入医护人员9名,经过2轮专家函询后,形成19个条目的乳腺癌化疗患者心脏毒性风险评估量表。本研究患者低分组共79例,高分组共83例,两组吸烟史、内分泌治疗史、免疫治疗史临界比值比较,差异无统计学意义(P>0.05)。相关性分析结果显示,吸烟史、免疫治疗史与总分无相关性(P>0.05)。最终删除“吸烟史”“内分泌治疗史”“免疫治疗史”3个条目,形成含有16个条目的量表。量表的Cronbach'sα系数为0.739;重测信度为0.983;评定者间信度为0.984。本量表内容效度结果示:I-CVI为0.83~1.00;S-CVI为0.98。预测效度结果示:量表的AUC为0.887(95%CI=0.827~0.947,P<0.001),截断值为32.50分,约登指数为0.649,特异度为89.1%,灵敏度为75.9%。探索性因子分析结果显示,KMO值为0.700,Bartlett's球形检验的χ^(2)值为1037.898(df=120,P<0.Background Cardiotoxicity is a leading cause of mortality among breast cancer patients treated with chemotherapy.Therefore,an early risk assessment is vital for the clinical prevention and treatment of cardiotoxicity in breast cancer patients treated with chemotherapy,although a recognized tool is scant in our country.Objective To develop a cardiotoxic risk assessment scale for breast cancer patients undergoing chemotherapy and to test its reliability and validity.Methods Through reviewing relevant domestic and international literatures,a pool involving items to assess the risk of cardiotoxicity in breast cancer patients treated with chemotherapy was created.Semi-structured interviews with healthcare providers at Jiangsu Cancer Hospital from September to October 2022 were performed by purposive sampling,thus primarily forming a tool of items for the cardiotoxic risk assessment scale.In addition,breast cancer patients treated with chemotherapy in Jiangsu Cancer Hospital were randomly selected for a pre-survey and validation of the reliability and validity of the scale.Ranked by the score of the cardiotoxic risk assessment scale,the top 27% of participants were assigned into the high-score group,and the remaining were in the lowscore group.Cronbach'sαcoefficient was used to evaluate the internal consistency of the scale.Validity of the scale was verified by measuring the item-level content validity index(I-CVI)and scale-level content validity index(S-CVI).Exploratory factor analysis was performed to assess the structural validity.Receiver operating characteristic(ROC)curves were plotted,and the area under tcurve(AUC)was calculated to determine the predictive validity.Results Twenty healthcare providers were included in the semi-structured interviews.After two rounds of expert consultations,a 19-item cardiotoxic risk assessment scale in breast cancer patients treated with chemotherapy was developed.In this study,there were 79 patients in the low-score group and 83 in the high-score group.No significant differences

关 键 词：乳腺肿瘤 化疗反应 心脏毒性 质性研究 信效度检验 

分 类 号：R737.9[医药卫生—肿瘤]