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药品不良反应/事件病例报告质量评价指标体系实证研究

陈立勋 姜玲 沈爱宗 魏伟

中国药房2011,Vol.22Issue(2):162-164,3.
中国药房2011,Vol.22Issue(2):162-164,3.

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

陈立勋 1姜玲 2沈爱宗 1魏伟2

作者信息

  • 1. 安徽医科大学临床药理研究所/抗炎免疫药理学省部共建教育部重点实验室,合肥市,230032
  • 2. 安徽医科大学附属省立医院药剂科,合肥市,230001
  • 折叠

摘要

Abstract

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 reflect the quality of ADR/ADE case reports.

关键词

药品不良反应/药品不良事件/指标体系/信度/效度/综合评价

分类

医药卫生

引用本文复制引用

陈立勋,姜玲,沈爱宗,魏伟..药品不良反应/事件病例报告质量评价指标体系实证研究[J].中国药房,2011,22(2):162-164,3.

基金项目

安徽省科技厅2009年度软科学计划项目(09030503074) (09030503074)

中国药房

OACSCDCSTPCD

1001-0408

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