目的 研发中医药临床研究的知情同意质量评价工具，以实现对中医药临床研究知情同意过程质量的简 易、方便、客观的评价。方法 采用横断面调查设计，利用前期制定的中医药临床试验知情同意质量评价问 卷，对河北、山西、江苏、广东等地区符合纳入标准的参加过中医药临床试验的研究参与者进行现场问卷调 查。收集、整理问卷数据，进一步分析并对问卷的可行性、信度和效度等测量学特性进行评价。结果 符合纳 入标准的研究参与者198例，共197份问卷纳入分析，问卷回收率100%，完成率99.5%。填写问卷花费的平均 时间约 14.8 min。问卷的重测信度为 0.892，分半信度为 0.892，克朗巴赫 ɑ系数为 0.879，各领域的克朗巴赫 ɑ 系数在 0.486~0.956之间，说明问卷总的信度较好。采用探索性因子分析来评价结构效度，共提取出 5个公因 子，累积贡献率为70.831%。经方差正交旋转后，第1因子反映了理解程度和总体评价领域；第2、5因子主要 反映的是自愿选择领域；第3因子主要反映的是沟通满意度领域；第4因子反映了告知信息完整性领域。除了 自愿选择领域外，其他领域相对来说比较集中，且因子载荷均在0.5以上。结论 中医药临床试验知情同意过 程质量评价问卷具有较好的可行性、良好的信度和一定的效度，可作为评价中医药临床试验知情同意质量的有效、 可靠、简便的工具，有助于促进中医药领域临床研究水平的提高，以及更好地保护研究对象的权益和健康。

Objective To develop a quality evaluation tool for informed consent in clinical research of traditional Chinese medicine（TCM）， and to realize the simple， convenient and objective evaluation for quality of informed consent process in clinical research of TCM. Methods A cross-sectional method was adopted. Using the quality evaluation questionnaire of informed consent in clinical research of TCM，which had been previously formulated，we conducted a questionnaire survey of 198 participants， who met the inclusion criteria and participated in TCM clinical trials in 4 different regions of China，including Hebei，Shanxi，Jiangsu and Guangdong. The questionnaire data were collected， organized and further analyzed. The measurement characteristics such as feasibility， reliability， and validity of the questionnaire were also evaluated. Results A total of 198 participants were enrolled， and 197 questionnaires were included in the analysis. The questionnaire response rate was 100%，and the completion rate was 99.5%. The average time to finish the questionnaire was about 14.8 min. The test-retest reliability of the questionnaire was 0.892. The splithalf reliability was 0.892. The Cronbach 􀆳s coefficient alpha was 0.879，and the Cronbach 􀆳s coefficient alpha of each domain was between 0.486-0.956，indicating that the overall reliability of the questionnaire is good. Exploratory factor analysis was adopted to evaluate construct validity in this study. Five common factors were extracted. The cumulative contribution rate was 70.831%. After orthogonal rotation， the first factor reflected the domain of comprehension and general evaluation，the second factor and the fifth factor mainly reflected the domain of voluntariness，the third factor mainly reflected communication satisfaction，and the fourth factor reflected the domain of completeness of information. Except for the domain of voluntariness，other domains were all concentrated，and the factor loadings were all above 0.5. Conclusion The quality evaluation questionnaire of informed consent process in clinical trials of TCM showed good feasibility，reliability and validity. It is expected to be used as an effective，reliable and simple tool for evaluation of quality of the informed consent for trials of TCM. It helps to promote the improvement of the level in TCM clinical research，as well as better protects the rights and health of research subjects.

R285.6；R-052

广东省中医院中医药科学技术研究专项（YN2019ML09）；国家工业和信息化部 2023 年产业基础再造和制造业高质量发展专项 （TC2308068）