Abstract: Background　Cardiotoxicity is a leading cause of mortality among breast cancer survivors and patients，making early risk assessment vital for the clinical prevention and treatment of cardiac toxicity. However，there is currently a lack of recognized tools for assessing the risk of cardiotoxicity in breast cancer chemotherapy patients in China. Objective　To develop a cardiotoxic risk assessment scale for breast cancer patients undergoing chemotherapy and test its reliability and validity. Methods　To develop a risk assessment scale for cardiotoxicity in breast cancer chemotherapy patients and to test its reliability and validity. Results　Twenty medical staff experts were included in the semi-structured interviews. After two rounds of expert consultations，a 19-item risk assessment scale for cardiotoxicity in breast cancer chemotherapy patients was developed. In this study，there were 79 patients in the low-score group and 83 in the high-score group. Comparisons of endocrine treatment history and immunotherapy history showed no statistically significant differences between the two groups（P>0.05）. Correlation analysis showed that smoking history and immunotherapy history were not significantly correlated with total scores（P>0.05）. Eventually，three items-"smoking history，"endocrine treatment history" and "immunotherapy history"-were removed，resulting in a 16-item scale. The scale's Cronbach's alpha coefficient was 0.739; test-retest reliability was 0.983; inter-rater reliability was 0.984. The content validity results showed: I-CVI ranged from 0.83 to 1.00; S-CVI was 0.98. Predictive validity results showed: the scale's AUC was 0.887（95%CI=0.827-0.947，P<0.001），with a cut-off value of 32.50 points，Youden's index was 0.649，specificity was 89.1%，and sensitivity was 75.9%. Exploratory factor analysis results showed a KMO value of 0.700，and Bartlett's test of sphericity χ2value was 1037.898（df=120，P<0.001）. The study extracted five common factors with a cumulative variance contribution rate of 61.991%. Risk stratification results indicated scores of 32-38 points as low risk，39-56 points as medium risk，and ≥ 57 points as high risk. Conclusion　The cardiotoxicity risk assessment scale for breast cancer patients undergoing chemotherapy has good reliability and validity，which can better predict the high-risk population of cardiotoxicity and provide an effective assessment tool for clinicians and nurses to effectively identify the high-risk population of breast cancer patients undergoing chemotherapy.

Key words: Breast neoplasms, Chemotherapy side effects, Cardiotoxicity, Qualitative research, Reliability and validity test

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's α 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来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专家 20 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's α 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 χ2 值为 1 037.898（df=120，P<0.001）。本研究共提取 5 个公因子、累计方差贡献率为 61.991%。危险程度分级结果显示，得分为 32~38 分为低危，39~56 分为中危，≥ 57 分为高危。结论 乳腺癌化疗患者心脏毒性风险评估量表具有良好的信效度，能够较好预测心脏毒性的高危人群，可为临床医生护士有效识别乳腺癌化疗患者心脏毒性高风险人群提供有效的评估工具。

关键词: 乳腺肿瘤, 化疗反应, 心脏毒性, 质性研究, 信效度检验