肿瘤预防与治疗2025，Vol.38Issue(3)：191-200,10.DOI:10.3969/j.issn.1674-0904.2025.03.003
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
摘要
Abstract
Objective:To develop a scale for assessing cancer patients'willingness to voluntarily participate in drug clin-ical 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 con-cerns,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.Con-clusion:The scale developed in this study to assess cancer patients'willingness to participate in drug clinical trials demon-strates 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Key words
Cancer patients/Drug clinical trials/Scale development/Reliability/Validity分类
医药卫生引用本文复制引用
陈彩娥,张晋昕,宋其骏,曾银朵,张颢严,田晶,李济宾,叶穗雯,丁林潇潇,次仁罗布..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[J].肿瘤预防与治疗,2025,38(3):191-200,10.基金项目
广东省自然科学基金(编号:2023A151501195) This study was supported by Natural Science Foundation of Guangdong Province(No.2023A1515011951). （编号:2023A151501195）
