基于德尔菲法构建军队药物警戒系统指标体系的调研分析

Index System for Military Pharmacovigilance System Based on Delphi Method

目的建立一套军队药物警戒系统研究的指标体系,明确军队药物警戒系统建设的重点。方法在文献回顾与专家座谈的基础上,制定咨询问卷。采用德尔菲专家咨询法进行3轮咨询后统计分析,得出专家积极系数、专家权威程度、专家意见协调系数,构建指标体系并计算加权权重。结果共有30名专家参加咨询,3轮积极系数均为100%,专家权威程度均大于0.9,协调系数W分别为0.146、0.265、0.317(P<0.0001)。建立了由4项一级指标,14项二级指标,103项三级指标组成的指标体系。其中ADR报告质量评价、报告关联性评价、ADR监测管理系统与HIS针对性对接、ADR报告信息核对与完善、ADR报告上报数量为当前关注的重点。结论研究中构建的指标体系层次较分明且权重得当,基本涵盖了军队药物警戒的各个方面,具有较强的科学性和可操作性;该指标体系的专家权威系数、积极系数和协调系数较高,符合德尔菲法指标构建要求,结果可信度高、适用性强;为军队药物警戒系统的持续建设与完善确定了着力重点。

Objective To establish an index system for the military pharmacovigilance system and specify the priorities during its construction.Methods The consultation questionnaire was developed by literature review and expert consultation.Delphi method was used to perform three rounds of consultation.The positive coefficient,authority degree of experts,andcoordination coefficients of experts′opinions were calculated to establish the index system and the weighted weights.Results A total of 30 experts participated in the consultation.The positive coefficient of three rounds of consultation was 100%,the expert authority degree was greater than 0.9,and the coordination coefficients were 0.146,0.265 and0.317（P 〈0.0001）,respectively.An index system,including four primary indicators,14 secondary indicators and 103 tertiary indicators was established.The focuses of attention included the ADR report quality evaluation,report relevance evaluation,connection between the ADR monitoring management system and HIS,verification and improvement of ADR report information,and the number of ADR reports.Conclusion The index system constructed in this study with a clear hierarchy and proper weight covers each aspect of military pharmacovigilance at a high level of scientificity and operability.The values of expert authority coefficients,positive coefficients and coordination coefficients are very high,which can meet the requirement of Delphi method.This study highlights the key points of the construction and improvement of the military pharmacovigilance system with a good reliability and applicability.