肿瘤患者自愿参加药物临床试验意愿量表的研制及信效度评价  

Development,Reliability and Validity Testing of a Scale to Assess the Willingness of Cancer Patients to Voluntarily Participate in Drug Clinical Trials

作　　者：陈彩娥 宋其骏 曾银朵[3] 张颢严 田晶[4] 李济宾 叶穗雯[5] 丁林潇潇[3] 次仁罗布 张晋昕[1] Chen Cai'e;Song Qijun;Zeng Yinduo;Zhang Haoyan;Tian Jing;Li Jibin;Ye Suiwen;Ding linxiaoxiao;Ciren Luobu;Zhang Jinxin(School of Public Health,Sun Yat-sen University,Guangzhou 510080,Guangdong,China;School of Mathematics and Statistics,Wuhan University,Wuhan 430072,Hubei,China;Breast Tumor Center,Sun Yat-sen Memorial Hospital,Sun Yat-sen University,Guangzhou 510120,Guangdong,China;Department of Ultrasound,Sun Yat-sen Memorial Hospital,Sun Yat-sen University,Guangzhou 510120,Guangdong,China;PhaseⅠClinical Research Center,Sun Yat-sen Memorial Hospital,Sun Yat-sen University,Guangzhou 510120,Guangdong,China;School of Financial Mathematics and Statistics,Guangdong University of Finance,Guangzhou 510521,Guangdong,China;Department of Clinical Research,Sun Yat-sen University Cancer Center,Guangzhou 510145,Guangdong,China)

机构地区：[1]中山大学公共卫生学院,广州510080 [2]武汉大学数学与统计学院,武汉430072 [3]中山大学孙逸仙纪念医院逸仙乳腺肿瘤医院,广州510120 [4]中山大学孙逸仙纪念医院超声科,广州510120 [5]中山大学孙逸仙纪念医院Ⅰ期临床研究中心,广州510120 [6]广东金融学院金融数学与统计学院,广州510521 [7]中山大学肿瘤防治中心临床研究部,广州510145

出　　处：《肿瘤预防与治疗》2025年第3期191-200,共10页Journal of Cancer Control And Treatment

基　　金：广东省自然科学基金(编号:2023A151501195)。

摘　　要：目的:编制肿瘤患者自愿参加药物临床试验意愿量表,并评价其信效度。方法:基于文献查阅、半结构式访谈和专家建议,通过2轮专家函询形成预试量表。选取418名肿瘤患者进行调查,对预试量表进行项目分析和信效度检验。结果:肿瘤患者自愿参加药物临床试验意愿的量表包含预期疗效顾虑、研究价值感知、获益考虑、拒绝参与顾虑、试验流程顾虑、探索失败顾虑6个维度,共22个条目。探索性因子分析一共提取6个公因子,累计方差贡献率为63.38%,量表整体的Cronbach’s α系数为0.82,整体的折半信度为0.86。结论:编制的肿瘤患者自愿参加药物临床试验意愿量表具有良好的信效度,可有效评估肿瘤患者自愿参加药物临床试验的意愿。Objective:To develop a scale for assessing cancer patients'willingness to voluntarily participate in drug clinical trials and to evaluate its reliability and validity.Methods:Based on literature review,semi-structured interviews,and expert recommendations,a preliminary scale was developed through two rounds of Delphi expert consultation.A total of 418 cancer patients were recruited for the study,and the pre-test scale underwent item analysis along with reliability and validity testing.Results:The scale measuring cancer patients′willingness to voluntarily participate in drug clinical trials includes 22 items across six dimensions:expected efficacy concerns,research value perception,benefit considerations,refusal concerns,trial procedure concerns,and exploratory failure concerns.Six common factors were extracted through exploratory factor analysis,accounting for 63.38%of the cumulative variance.The scale demonstrated strong reliability,with a Cronbach's α of 0.82 and a split-half reliability of 0.86.Conclusion:The scale developed in this study to assess cancer patients'willingness to participate in drug clinical trials demonstrates satisfactory reliability and validity,and effectively evaluates their willingness to voluntarily engage in such trials.

关 键 词：肿瘤患者 药物临床试验 量表研制 信度 效度 

分 类 号：R734.2[医药卫生—肿瘤]