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改良德尔菲法研究北京市药品生产企业重点监测指导原则
Using Modified Delphi Method to Establish Guidance for Drug Intensive Monitoring by Pharmaceutical Enterprises in Beijing
  
DOI:
中文关键词:  改良德尔菲法  重点监测  药品生产企业  指导原则
英文关键词:Modified Delphi method  Intensive monitoring  Pharmaceutical enterprises  Guidance
基金项目:
作者单位
闫盈盈 邢丽秋 焦立公 陈恳①③ 张婷 杨毅恒 翟所迪 ①北京大学第三医院药剂科(北京 100191)②北京市药品不良反应监测中心③北京大学药学院药事管理与临床药学系。 
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中文摘要:
      摘 要 目的:初步建立北京市药品生产企业重点监测指导原则。方法:采用改良的德尔菲法,事先拟定专家库,通过三轮专家咨询,收集专家意见,采用SPSS17.0对专家的权威程度、专家的积极系数、专家意见的集中程度、专家意见的协调程度进行计算,依据“该项问题是否应该涵盖在指导原则中”以及“该部分内容的撰写符合实际需求并具有可行性”两个维度,明确预先准备好的18项关键问题的修订方向。结果:共遴选出11位专家,专家的权威程度为0.80±0.13。三轮问卷专家积极系数均较高,超过90%。前后两轮的专家意见的协调系数范围为0.230~0.383,第三轮问卷的协调系数经χ2检验后表明专家的意见趋于一致(P<0.05)。在三轮问卷后,在指导原则中须涵盖:重点监测适用范围、研究流程、推荐进行药品安全性循证评价、专家小组的组成原则、实施团队的组成原则、重点监测的质量保证、伦理学、研究方法、样本量、记录形式。结论:本研究采用改良的德尔菲法,专家的权威性、积极性均较好,初步明确了北京市药品生产企业药品重点监测的关键内容,初步构建了相关指导性文件。
英文摘要:
      ABSTRACT Objective: To establish guidance for drug intensive monitoring by pharmaceutical enterprises in Beijing. Methods:Expert panel were set up as a heterogeneous group of experts before. Eighteen items of structured questionnaires were designed involving necessity and feasibility in each items. After questionnaires were completed in 3 rounds, we collected the experts’ opinions and determined directions to revise 18 items. Parameters including experts’ positive coefficient, authority coefficient, and coordination degree towards experts’ opinion were calculated using SPSS 17.0. Results:Eleven experts were selected and experts’ authority coefficient was 0.80±0.13. In the first and third round, experts’ positive coefficient were over 90%, and the range of coordination coefficient was 0.230-0.383. Group consensus was reached after the third round (P<0.05). The elements as follows should be involved in the guidance: scope and process of the intensive monitoring, recommendation of evidence based safety evaluation before intensive monitoring, principles when establishing science committee and implementation group, quality control, ethics, methodology, sample size, and form of records. Conclusion:With well authority and high rate of response in experts, this study defined key contents of guidance for drug intensive monitoring by pharmaceutical enterprises through modified Delphi method.
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