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目的:对建立的药品不良反应/事件(ADR/ADE)病例报告质量评价指标体系进行实证研究,评价其信度、效度及综合评价模型的可靠性。方法:随机抽取我院2002-2009年每年100份ADR/ADE病例报告,对其质量进行综合评价,根据调查结果对指标体系的内在信度、内容效度进行评价,运用加权TOPSIS法和综合指数法对其综合评价模型进行验证,通过方差分析、相关性分析对综合评价模型等级分类的可行性和3种综合评价方法结果进行分析。结果:评价指标体系总体上具有较好的信度(总的克朗巴赫α系数为0.894、折半信度r为0.998);指标体系符合专家的共识和认同,具有较好的内容效度;确立了区分不同评分等级的界限,且各等级之间比较差异有统计学意义(F=32.28,P=0.001)。综合评价模型评分结果与加权TOPSIS法和综合指数法评价结果的Spearman相关系数分别为0.786(P=0.021)和0.905(P=0.002),且呈正相关,评价结果较为可靠。结论:建立的ADR/ADE病例报告质量评价指标体系具有较好的内在信度和效度,能较为全面地反映病例报告的质量水平,具有较好的科学性、可行性和可靠性。
OBJECTIVE: To establish an empirical study on the quality evaluation index system of ADR / ADR cases and evaluate the reliability, validity and reliability of the comprehensive evaluation model. Methods: A total of 100 cases of ADR / ADE cases were randomly selected in our hospital from 2002 to 2009, and their quality was evaluated comprehensively. According to the survey results, the intrinsic reliability and the content validity of the index system were evaluated. The weighted TOPSIS method and the comprehensive index Method to verify its comprehensive evaluation model. Through the analysis of variance and correlation analysis, the feasibility of the classification of the comprehensive evaluation model and the results of three kinds of comprehensive evaluation methods are analyzed. Results: The evaluation index system generally has good reliability (the total Cronbach α coefficient is 0.894 and the half reliability r is 0.998). The index system accords with the consensus and recognition of experts and has good content validity. Differentiation between different grading levels, and the differences between the grades were statistically significant (F = 32.28, P = 0.001). The Spearman correlation coefficients of the evaluation results of the comprehensive evaluation model and the weighted TOPSIS method and the comprehensive index method are 0.786 (P = 0.021) and 0.905 (P = 0.002), respectively, which are positively correlated and the evaluation results are more reliable. Conclusion: The established quality evaluation index system for ADR / ADE cases has good internal reliability and validity, and can fully reflect the quality of case reports. It has good scientific, feasibility and reliability.