首页|基于改良德尔菲法构建盐城市《医疗机构药物警戒工作指南》

基于改良德尔菲法构建盐城市《医疗机构药物警戒工作指南》

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目的:构建地方标准《医疗机构药物警戒工作指南》(以下简称《指南》),为盐城市医疗机构药物警戒工作提供指导。方法:在文献分析法和半结构访谈法的基础上,制定专家咨询问卷。采用改良德尔菲法开展3轮专家咨询,确定《指南》的三级条目。结果:第2和3轮均有30名专家参加咨询,问卷有效回收率为100%,专家权威系数分别为0。89和0。92,肯德尔和谐系数为0。309(P<0。001)和0。404(P<0。001),各条目变异系数均小于0。25,Cronbach α系数分别为0。96和0。98。最终确定了《指南》条目包括一级条目9个,二级条目23个,三级条目21个。结论:《指南》条目的确立科学、可靠,对医疗机构构建药物警戒质量管理体系具有较高的指导意义。
Constructing Pharmacovigilance Guidelines for Medical Institutions Based on Modified Delphi Method
Objective:To construct a local standard of"Pharmacovigilance Guidelines for Medical Insti-tutions"and provide guidance for pharmacovigilance work in medical institutions in Yancheng.Methods:The expert consultation questionnaire was developed by literature analysis and semi-structured interview.Modified Delphi method was used to perform three rounds of consultation for determining the three-level indicators of the guideline.Results:Thirty experts participated in the consultation in the second and third rounds of the consultation questionnaire,the effective recovery rate was 100%,the authority coefficient of experts were 0.89 and 0.92,the Kendall harmony coefficient were 0.309(P<0.001)and 0.404(P<0.001),and the coefficient of variation of each indicator was smaller than 0.25,Cronbach α coefficients were 0.96 and 0.98,respectively.A guideline,including 9 primary indicators,23 secondary indicators and 21 tertiary indicators was determined.Conclusion:The method is scientific and reliable,and it has a good guiding significance for GVP in medical institutions to build pharmacovigilance quality practice.

PharmacovigilanceMedical institutionsModified Delphi methodGuideline

姚立娟、邓晓文、顾萍辰、刘丽丽

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盐城市食品药品监督检验中心,盐城 224000

药物警戒 医疗机构 改良德尔菲法 工作指南

盐城市自然科学软课题(2022)

yckxrkt2022-47

2024

药学与临床研究
江苏省药学会

药学与临床研究

CSTPCD
影响因子:0.95
ISSN:1673-7806
年,卷(期):2024.32(2)
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