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Development and Evaluation of the Reliability and Validity of Knowledge, Attitude, and Practice Questionnaire regarding Clinical Adverse Event Reporting
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摘要:目的 编制不良事件上报知信行问卷, 并评价其信度和效度。方法 采用知信行理论为问卷构架, 在文献阅读、医护人员和专家访谈的基础上初步编制不良事件上报知信行问卷; 随机抽取北京协和医院医护人员进行问卷调查。以Cronbach'α系数检验内部一致性信度, 以内部相关系数(intraclass correlation coefficient, ICC)检验重测信度, 以内容效度指数(content validity index, CVI)检验内容效度, 探索因子分析检验结构效度, 以问卷得分的高分组和低分组之间的独立样本t检验评价区分效度。结果 回收有效问卷130份; 各维度及总问卷的Cronbach'α系数均 > 0.6;各条目ICC系数均 > 0.75;各维度CVI系数均 > 0.9;因子分析共提取5个公因子, 累计方差贡献率61.8%, 各条目的共性方差均>0.4;高分组和低分组得分差异具有统计学意义(P < 0.01)。结论 《临床不良事件上报知信行问卷》具有理想的信度和效度, 可作为不良事件上报现状的调研工具。Abstract:Objective To develop a knowledge, attitude, and practice (KAP) questionnaire regarding clinical adverse event reporting and to evaluate its reliability and validity.Methods The questionnaire was developed following KAP theory, based on literature review and interview of experts and medical practitioners. Doctors and nurses in Peking Union Medical College Hospital were selected by random sampling and surveyed. Cronbach's α coefficient was used to test the internal consistency reliability, and intraclass correlation coefficient (ICC) to test retest reliability. Content validity index (CVI), exploratory factor analysis, and independent t-test between high-score and low-score groups were used to test the content validity, construct validity, and discrimination validity, respectively.Results 130 questionnaires were collected. Cronbach's α coefficient of each dimension and total questionnaire was all > 0.6. ICC of each item was > 0.75 and CVI of each dimension was > 0.9. Five principal factors were extracted, the cumulative contribution rate was 61.8%, and the common variance of each item was > 0.4. There were statistically significant differences between the high-score and low-score groups(P < 0.01).Conclusions The KAP questionnaire regarding clinical adverse eventreporting is a reliable and valid tool for evaluating the status of adverse event reporting.
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表 1 问卷重测信度检验结果
条目 内部相关系数 P值 K1 0.774 0.007 K2 0.789 0.007 K3 0.766 0.008 K4 0.803 0.007 K5 0.751 0.008 K6 0.857 0.004 K7 0.767 0.008 K8 0.828 0.006 A1 0.833 0.006 A2 0.902 0.001 A3 0.880 0.003 A4 0.873 0.003 A5 0.853 0.004 P1 0.810 0.007 P2 0.845 0.004 P3 0.849 0.004 
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表 2 问卷结构效度检验结果
公因子 特征根 方差贡献率(%) 累计贡献率(%) 相关条目 负荷范围 F1 4.009 25.1 25.1 A1、A2、A3、A4、A5 0.812~0.909 F2 2.032 12.7 37.8 K1、K2、K3、K4、K5 0.538~0.698 F3 1.424 8.9 46.7 P1、P2 0.477~0.693 F4 1.268 7.9 54.6 K6、K7 0.496~0.658 F5 1.152 7.2 61.8 K8 0.503~0.623
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