药品不良反应/事件病例报告质量评价指标体系实证研究

Empirical Research of Quality Evaluation Indicator System of ADR/ADE Case

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 evaluate reliability and validity of the quality evaluation indicator system of ADR/ADE case. METHODS： The quality of 100 ADR/ADE case reports per year randomly selected from our hospital during 2002-2009 was evaluated using comprehensive evaluation model. The reliability and validity of the indicator system were evaluated by adopting the TOPSIS method and synthetic indicator method based on the results of investigation. Variance analysis and correlation analysis were used to analyze the feasibility of degree classification of comprehensive evaluation model and the results of the three comprehensive evaluation methods. RESULTS： The total Cronbach＇ coefficient and Split-Half reliability were 0.894 and 0.998. The internal consistency reliability was acceptable. The established evaluation indicator system matched the consensus of experts after several rounds of iterate consultation lead to better content validity. The values of comprehensive assessment were divided into four grades by the percentiles. Verified results indicated that there were significant differences among the four grades （F=32.28, P=0.001）. The result of correlation analysis showed the spearman correlation coefficient between synthetic scored method and the TOPSIS method was 0.786 （P=0.021）, and that between the synthetic scored method and the synthetic indicator method was 0.905（P=0.002）, which meant the correlation was high and positive. The results of evaluation were reliable. CONCLUSION： The established evaluation indicator system with good reliability and validity seemed to be scientific, practical and reliable. It could comprehensively refleet the quality of ADR/ADE case reports.