| Objective This study, based on theoretical research, aims to develop a quality evaluation indicator system for assessing ADR/ADE case reports in China, and conduct an on-site study of quality of ADR/ADE case report random selected in certain Level-three A hospital in Anhui province from 2002 to 2009. Finally, to develop a comprehensive evaluation model and testify its feasibility, and thus to help related regulatory authority to improve the quality evaluation and management of ADR/ADE case reports.Method Systematic analysis, literature review and expert consultation method were conducted to establish an ADR/ADE case report quality evaluation indicator system in China. On this base, 8 years of ADR/ADE case reports from 2002 to 2009 of certain Level-there A hospital in Anhui province were randomly sampled for on-site study. SPSS (version 11.01) were used to conduct statistics analysis. Synthetic scoring method was adopted to construct the comprehensive evaluation model for comprehensively assessing the quality of ADR/ADE case reports selected from certain Level-three A hospital in Anhui province. Finally, the weighted TOPSIS method and synthetic index method were used to testify the results.Result The framework of the devised ADR/ADE case report quality evaluation indicator system includes 6 first-rank indicators: authenticity, duplication, normativity, completeness, vigilance level and reporting time frame; 18 second-rank indicators and 115 third-rank indicators.The questionnaires of this study conducted four rounds of expert's consultation. 35 questionnaires were distributed in the first round and 27 valid, rating 77.14%; 27 questionnaires were distributed in the second round and 25 valid, rating 92.59%; 25 questionnaires were distributed in the third round and 24 valid, rating 96.00%; 24 questionnaires were distributed in the fourth round and 24 valid, rating 100.00%. 27 experts were recruited to screen the indicators, the average age was 45.05±6.85, 74.07% of them were qualified the vice-senior professional titles, 85.18% of them has been working in their position for 15 years and above; 14 experts were from national and regional ADR monitoring center, 7 experts were held university research posts and 6 experts were from medical service system and multinational pharmaceutical company. The major of the panel covering pharmacovigilance (10), clinical pharmacy (6), clinical pharmacology (3), clinical medicine (3), health supervision (2), epidemiology and health statistical (2) and preventive medicine (1).After four rounds of the Delphi survey, the experts'agreement coefficient (ω) reached 0.369 (χ~2=46.14,P=0.005) for the first-rank indicators, 0.424 (χ~2=173.14, P=0.000) for the second-rank indicators, and 0.441 (χ~2=894.97,P=0.000) for the third-rank indicators.The completed ADR/ADE case report quality evaluation indicator system was used to conduct pre-investigation on the ADR/ADE case reports randomly sampled in certain Level-three A hospital. The total Cronbach's Alpha was 0.894 and structure dimension Cronbach's Alpha was 0.998.The completed evaluation system was established using several rounds of expert consultation for the conception, indicator development and screening, which indicating a good face and content validity.100 ADR/ADE case reports each year from 2002 to 2009 in certain Level-three A Hospital were randomly sampled to conduct an empirical research. The result shows that the average scoring of the quality of the 8 years was 73.22, and two years were above 75, four were 70～75 and two were lower than 70.According to the average scoring of ADR/ADE case reports each year, the years ranked by synthetical scored method are as follows: 2007, 2006, 2008, 2009, 2005, 2004, 2003, 2002; by weighted TOPSIS method: 2006, 2007, 2005, 2004, 2008, 2009, 2003, 2002; and by synthetic index method: 2006, 2007, 2005, 2008, 2009, 2004, 2003, 2002.Rank correlation analysis shows that the Spearman correlation coefficient of the results between synthetic scoring model, weighted TOPSIS method, and synthetic index method was 0.786 and 0.905, and P < 0.05, indicating it is statistically significant. The result of the synthetic scoring model and that of synthetic index method and weighted TOPSIS method displayed a positive correlation.Conclusion 1. The established ADR/ADE case report quality evaluation indicator system includes 6 first-rank indicators, 18 second-rank indicators and 115 third-rank indicators. Each indicator was weighted after four rounds Delphi survey, to quantitative measure the total quality of ADR/ADE case reports. The indicator system has met the basic requirements in feasibility and reliability in measurements, which could be used to measure the quality of ADR/ADE case report comprehensively and effectively, and seems suitable for comprehensive evaluation of ADR/ADE case report quality.2. Synthetic scoring method was adopted to establish the comprehensive evaluation model, and evaluated the total score of each year. Weighted TOPSIS method and synthetic index method were used to testify its results. The result of rank correlation analysis was the positive correlation, which indicated the constructed comprehensive evaluation model is scientific and feasible.3. The quality of ADR/ADE case report of 8 years from 2002 to 2009 randomly selected from certain Three-A level hospital ranked by synthetic scoring method are as follows: 2007, 2006, 2008, 2009, 2005, 2004, 2003, and 2002.
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