应用Delphi法建立药品上市后风险评价指标体系的研究
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摘要
研究目的
本研究旨在通过Delphi专家咨询法建立一套科学的、实用的、适合我国医疗卫生发展现状的药品上市后风险评价指标体系。合理地对药品上市后的风险进行综合评价,为临床合理用药提供理论依据,也为相关政策的制定提供参考。
研究方法
由于药品风险具有多源性,本研究将与人体、疾病、药品等因素有关的风险称为内在风险,或固有风险。与不合理用药、药品质量、政策法规、医务人员等因素有关的风险称为外在风险,或不定风险。本研究拟定的药品上市后风险评价指标体系主要分为内在风险评价指标和外在风险评价指标两部分进行研究。通过查阅大量文献和征求有关专家意见的基础上,从影响药品风险的因素进行考虑。先将与药品风险有关的指标收集起来,然后再小范围征询相关专家的意见和建议,构建了指标体系的框架。选择全国范围内具有副高级及以上职称,相关专业工作10年以上的临床医学、药学、流行病学和管理学专家26名,采用Delphi专家咨询法进行两轮咨询。运用SPSS16.0统计软件进行数据分析,指标筛选以同时满足算术平均值>3.50分,满分频率>0.20,变异系数<0.25为标准,并根据专家对各指标的赋值情况,运用百分权重法确定各指标的权重,最终确立药品上市后风险评价指标体系。
研究结果
本研究共进行了两轮专家咨询。第一轮专家咨询发出问卷26份,回收问卷22份,回收率为84.62%；第二轮专家咨询发出问卷22份,回收问卷21份,回收率为95.45%。两轮专家的权威程度分别为0.74和0.75,经过两轮咨询后,最终确定药品上市后风险评价指标体系为内在风险指标29项和外在风险指标36项。内在风险评价指标中一级指标3项,分别为人体、药物、疾病,其权重系数分别为0.3348、0.3867、0.2784；二级指标26项,其中人体包括6个,药物包括17个,疾病包括3个。在二级指标中相对重要的指标有药品剂量、给药途径、肾功不全、肝功不全、疾病严重程度等。专家重要程度和可操作性的协调系数分别为0.330、0.326,有显著性差异(P<0.01)。外在风险评价指标中一级指标4项,分别为患者、药品质量、医务人员、政策法规,其权重系数分别为0.2336、0.2907、0.2734、0.2022。二级指标32项,其中患者包括3个,药品质量有6个,医务人员17个,政策法规6个。在二级指标中相对重要的指标有药品质量合格率、药物贮藏合格率、药师发药准确率、患者服药依从率、药品不良反应监测和报告制度等。专家重要程度和可操作性的协调系数分别为0.326、0.143,有显著性差异(P<0.01)。
结论
本研究建立的指标体系覆盖面较广,所选取的指标具有代表性。专家的代表性较强、积极性较高、权威性、协调性较好。初步建立了药品上市后风险评价指标体系,内在风险评价指标中一级指标3项,二级指标26项,外在风险评价指标中一级指标4项,二级指标32项。
Objective This study was aimed to establish an evaluating indicator system by Delphi method. This indicator system would be scientific, practical and suitable for the Chinese medical situation. It could reasonably evaluate the risk of post-marketing drugs, and provide some theoretical basis for clinical medication and reference for the relevant drug policy.
Methods Since drug risk is from various aspects, it might be classified as internal risk and external risk in this paper. The internal risk is related to human body, drug and disease while external risk is related to irrational use of drug, drug quality, policy and regulations, medical professional and so on. Based on review of literatures, opinions of some experts and factors of drug risk, the prototype of the indicator system was established. A total of 26 national experts who have experiences on clinical, pharmacology, epidemiology and management, and have engaged in related specialty for more than ten years and specialized technical title above assistant professor academic rank were selected. The indicator system was filtered by Delphi method in two rounds of expert consultation. The data was analyzed by SPSS 16.0 statistical software. Experts valuations of each indicator could meet to the average>3.50, full marks ratio>0.20, and coefficient of variability<0.25, the final evaluation indicator system on the risk of post-marketing drugs was constructed. According to valuation of experts about each indicator, the weight of each indicator was identified with percentile.
Results This study conducted two rounds of expert consultation.26 questionnaires were dispatched in first round of expert consultation, and 22 questionnaires were returned. The response rates was 84.62%; 22 questionnaires were dispatched in second round of expert consultation, and 21 questionnaires were returned, the response rates was 95.45%. The means of two rounds authorities were 0.74 and 0.75, respectively. After twice investigation,29 internal risk indicators and 36 external risk indicators remained in the final evaluation indicator system on the risk of post-marketing drugs. The internal risk indicators included 3 indicators of first grade. The weight coefficient of the first grade indicators, human, drug and disease was 0.3348,0.3867,0.2784, respectively. The internal risk indicators included 26 indicators of second grade. The human body was composed of 6 indicators; the drug was composed of 17 indicators; the disease was composed of 3 indicators. In the second grade indicators, drug dose, administration route, poor renal function, poor liver function, disease severity are more important. The harmonious coefficients of importance and feasibility were 0.330,0.326, respectively, and had statistic significance (P＜0.01). The external risk indicators included 4 indicators of first grade. The weight coefficient of the first grade indicators, patients, drug quality, medical professional, policy and regulations were 0.2336,0.2907,0.2734,0.2022, respectively. The external risk indicators included 32 indicators of second grade. The patient was composed of 3 indicators; the drug quality was composed of 6 indicators; the medical professional was composed of 17 indicators; the policy and regulations was composed of 6 indicators. In the second grade indicators, passing rate of drug quality, passing rate of drug storage, pharmacists dispensing accuracy, medication compliance rate of patients, adverse drug reaction monitoring and reporting system were more important. The harmonious coefficients of importance and feasibility were 0.326,0.143, respectively, and had statistic significance (P<0.01).
Conclusion In the research, the scope covered by the indicator system is broad; the constructed indicators are representative; the enthusiasm, authority and harmony of experts are good. Initial indicator system of evaluating the risk of post-marketing drugs has been established. The internal risk indicators included 3 indicators of first grade and 26 indicators of second grade. The external risk indicators included 4 indicators of first grade and 32 indicators of second grade.
本研究旨在通过Delphi专家咨询法建立一套科学的、实用的、适合我国医疗卫生发展现状的药品上市后风险评价指标体系。合理地对药品上市后的风险进行综合评价,为临床合理用药提供理论依据,也为相关政策的制定提供参考。
研究方法
由于药品风险具有多源性,本研究将与人体、疾病、药品等因素有关的风险称为内在风险,或固有风险。与不合理用药、药品质量、政策法规、医务人员等因素有关的风险称为外在风险,或不定风险。本研究拟定的药品上市后风险评价指标体系主要分为内在风险评价指标和外在风险评价指标两部分进行研究。通过查阅大量文献和征求有关专家意见的基础上,从影响药品风险的因素进行考虑。先将与药品风险有关的指标收集起来,然后再小范围征询相关专家的意见和建议,构建了指标体系的框架。选择全国范围内具有副高级及以上职称,相关专业工作10年以上的临床医学、药学、流行病学和管理学专家26名,采用Delphi专家咨询法进行两轮咨询。运用SPSS16.0统计软件进行数据分析,指标筛选以同时满足算术平均值>3.50分,满分频率>0.20,变异系数<0.25为标准,并根据专家对各指标的赋值情况,运用百分权重法确定各指标的权重,最终确立药品上市后风险评价指标体系。
研究结果
本研究共进行了两轮专家咨询。第一轮专家咨询发出问卷26份,回收问卷22份,回收率为84.62%；第二轮专家咨询发出问卷22份,回收问卷21份,回收率为95.45%。两轮专家的权威程度分别为0.74和0.75,经过两轮咨询后,最终确定药品上市后风险评价指标体系为内在风险指标29项和外在风险指标36项。内在风险评价指标中一级指标3项,分别为人体、药物、疾病,其权重系数分别为0.3348、0.3867、0.2784；二级指标26项,其中人体包括6个,药物包括17个,疾病包括3个。在二级指标中相对重要的指标有药品剂量、给药途径、肾功不全、肝功不全、疾病严重程度等。专家重要程度和可操作性的协调系数分别为0.330、0.326,有显著性差异(P<0.01)。外在风险评价指标中一级指标4项,分别为患者、药品质量、医务人员、政策法规,其权重系数分别为0.2336、0.2907、0.2734、0.2022。二级指标32项,其中患者包括3个,药品质量有6个,医务人员17个,政策法规6个。在二级指标中相对重要的指标有药品质量合格率、药物贮藏合格率、药师发药准确率、患者服药依从率、药品不良反应监测和报告制度等。专家重要程度和可操作性的协调系数分别为0.326、0.143,有显著性差异(P<0.01)。
结论
本研究建立的指标体系覆盖面较广,所选取的指标具有代表性。专家的代表性较强、积极性较高、权威性、协调性较好。初步建立了药品上市后风险评价指标体系,内在风险评价指标中一级指标3项,二级指标26项,外在风险评价指标中一级指标4项,二级指标32项。
Objective This study was aimed to establish an evaluating indicator system by Delphi method. This indicator system would be scientific, practical and suitable for the Chinese medical situation. It could reasonably evaluate the risk of post-marketing drugs, and provide some theoretical basis for clinical medication and reference for the relevant drug policy.
Methods Since drug risk is from various aspects, it might be classified as internal risk and external risk in this paper. The internal risk is related to human body, drug and disease while external risk is related to irrational use of drug, drug quality, policy and regulations, medical professional and so on. Based on review of literatures, opinions of some experts and factors of drug risk, the prototype of the indicator system was established. A total of 26 national experts who have experiences on clinical, pharmacology, epidemiology and management, and have engaged in related specialty for more than ten years and specialized technical title above assistant professor academic rank were selected. The indicator system was filtered by Delphi method in two rounds of expert consultation. The data was analyzed by SPSS 16.0 statistical software. Experts valuations of each indicator could meet to the average>3.50, full marks ratio>0.20, and coefficient of variability<0.25, the final evaluation indicator system on the risk of post-marketing drugs was constructed. According to valuation of experts about each indicator, the weight of each indicator was identified with percentile.
Results This study conducted two rounds of expert consultation.26 questionnaires were dispatched in first round of expert consultation, and 22 questionnaires were returned. The response rates was 84.62%; 22 questionnaires were dispatched in second round of expert consultation, and 21 questionnaires were returned, the response rates was 95.45%. The means of two rounds authorities were 0.74 and 0.75, respectively. After twice investigation,29 internal risk indicators and 36 external risk indicators remained in the final evaluation indicator system on the risk of post-marketing drugs. The internal risk indicators included 3 indicators of first grade. The weight coefficient of the first grade indicators, human, drug and disease was 0.3348,0.3867,0.2784, respectively. The internal risk indicators included 26 indicators of second grade. The human body was composed of 6 indicators; the drug was composed of 17 indicators; the disease was composed of 3 indicators. In the second grade indicators, drug dose, administration route, poor renal function, poor liver function, disease severity are more important. The harmonious coefficients of importance and feasibility were 0.330,0.326, respectively, and had statistic significance (P＜0.01). The external risk indicators included 4 indicators of first grade. The weight coefficient of the first grade indicators, patients, drug quality, medical professional, policy and regulations were 0.2336,0.2907,0.2734,0.2022, respectively. The external risk indicators included 32 indicators of second grade. The patient was composed of 3 indicators; the drug quality was composed of 6 indicators; the medical professional was composed of 17 indicators; the policy and regulations was composed of 6 indicators. In the second grade indicators, passing rate of drug quality, passing rate of drug storage, pharmacists dispensing accuracy, medication compliance rate of patients, adverse drug reaction monitoring and reporting system were more important. The harmonious coefficients of importance and feasibility were 0.326,0.143, respectively, and had statistic significance (P<0.01).
Conclusion In the research, the scope covered by the indicator system is broad; the constructed indicators are representative; the enthusiasm, authority and harmony of experts are good. Initial indicator system of evaluating the risk of post-marketing drugs has been established. The internal risk indicators included 3 indicators of first grade and 26 indicators of second grade. The external risk indicators included 4 indicators of first grade and 32 indicators of second grade.
引文
[1]陈易新.对实施药品风险管理的思考[J].中国药房,2010,21(2):97-100
[2]詹思延,药物流行病学研究的迫切性和特殊性,中华流行病学杂志,2001；22(6)：403-404
[3]Haramburu F, Pouyanne P, Imbs JL, etc. Incidence and prevalence of adverse drug reactions, Presse Med.2000, Jan 22; 29(2):111-114
[4]Einarson TR, Drug-related hospital admissions. Ann Pharmacother.1993,27(7-8):832-40
[5]Juntti-Patinen L, Neuvonen PJ, Drug-related deaths in a university central hospital. Eur J Clin Pharmacol.2002,58(7):479-82
[6]Lazarou J, Pomeranz BH, Corey PN, Incidence of adverse drug reactions in hospitalized patients:a meta-analysis of prospective studies. JAMA.1998,279(15):1200-1205
[7]姜远英.临床药物治疗学.北京：人民卫生出版社,2006.37
[8]吴延琉.风险—效益评估的概念[J].药物流行病学杂志,1997,6(3):188-189
[9]杨依晗,马爱霞.效益风险评价的国内外研究进展[J].中国执业药师,2009,6(3)： 21-30
[10]夏芸,李昕雪,刘建平.国际Cochrane协作网有关药品安全性评价的证据概括[J].中国药物警戒,2010,7(4)：208-210
[11]柯惠新,沈浩.调查研究中的统计分析方法[M].北京：北京传媒大学出版社,2005.324
[12]Precidential & Congressional Commission on Risk Assessment and Risk M anagement, Final Report:Framework for Environmental Health Risk M anagement Voll; Risk Assessment and Risk Managment in Regulatory decision-Making Vol 2, Posted in Risk World on March 1997,27
[13]Heriz DB et al, Risk Analysis and Its Application, New York:John Wiley and sons,1983
[14]杨依晗,马爱霞.效益风险评价概述[J].上海医药,2009,30(1):35-36
[15]平卫伟,谭红专.Delphi法的研究进展及其在医学中的应用.疾病控制杂志,2003,7(3)：243-246
[16]李铁映.预测决策方法[M]. 沈阳：辽宁科学技术出版社,1984.30-44
[17]任佰玲,胡志,周新发.住院医师规范化培训基地评价指标体系的研究[J].继续医学教育,2004,24(9)：418-50
[18]曾光主编.现代流行病学方法与应用[M].北京：北京医科大学中国协和医科大学联合出版社,1994:250-270
[19]齐小华,高福安.预测理论与方法[M].北京广播学院出版社,1994:57-97
[20]关勋强,李瑞兴,刘运成.医学研究生教育评价研究与实践[M].北京：军事医学科学出版社,2000:82
[21]刘晓红,段志光.本科护理学专业教材质量评价指标体系的构建[J].护理研究,2008,22(10)：2609-2611
[22]丁申慧,蔡辉,祁新辉,等.卫生服务评价中权重系数的测量[J].交通医学,2001,15(5)：484-486
[23]责智强,曹晓斌,阙文进.百分权重法在评价食品卫生工作质量中的应用[J].江苏预防医学,2004,15(3)：50-51
[24]UMA G. GUPTA and Robert E. Clarke. The theory and applications of Delphi Technique:A Bibliography(1975-1994). Technological Forecasting and Social Change,1996,53:185-211
[25]苏建军,钱卫国,彭伟,等.Delphi法在医学重点学科绩效评价指标体系构建中的应用[J].中国卫生经济,2009,28(5)：73-74
[26]孔越,陈娟.特尔菲法在社区卫生服务利用者满意度指标筛选中的应用[J].中国初级卫生保健,2007,21(5)：33
[27]丁昌慧,祁新辉,蔡辉.卫生服务评价中权重系数的测量[J].交通医学,2001,15(5)：484-486
[28]倪少凯.7种确定评估指标权重方法的比较[J].华南预防医学,2002,28(6):54-62
[29]贲智强.应用密切值法评价创建卫生县城前后不同年度食品卫生工作质量[J].数理医药学杂志,2001,14(1)：81
[30]贲智强,章燕,阙文进,等.应用层次分析法评价创建卫生县城前后食品卫生工作质量[J].交通医学,2001,15(5):475-476
[2]詹思延,药物流行病学研究的迫切性和特殊性,中华流行病学杂志,2001；22(6)：403-404
[3]Haramburu F, Pouyanne P, Imbs JL, etc. Incidence and prevalence of adverse drug reactions, Presse Med.2000, Jan 22; 29(2):111-114
[4]Einarson TR, Drug-related hospital admissions. Ann Pharmacother.1993,27(7-8):832-40
[5]Juntti-Patinen L, Neuvonen PJ, Drug-related deaths in a university central hospital. Eur J Clin Pharmacol.2002,58(7):479-82
[6]Lazarou J, Pomeranz BH, Corey PN, Incidence of adverse drug reactions in hospitalized patients:a meta-analysis of prospective studies. JAMA.1998,279(15):1200-1205
[7]姜远英.临床药物治疗学.北京：人民卫生出版社,2006.37
[8]吴延琉.风险—效益评估的概念[J].药物流行病学杂志,1997,6(3):188-189
[9]杨依晗,马爱霞.效益风险评价的国内外研究进展[J].中国执业药师,2009,6(3)： 21-30
[10]夏芸,李昕雪,刘建平.国际Cochrane协作网有关药品安全性评价的证据概括[J].中国药物警戒,2010,7(4)：208-210
[11]柯惠新,沈浩.调查研究中的统计分析方法[M].北京：北京传媒大学出版社,2005.324
[12]Precidential & Congressional Commission on Risk Assessment and Risk M anagement, Final Report:Framework for Environmental Health Risk M anagement Voll; Risk Assessment and Risk Managment in Regulatory decision-Making Vol 2, Posted in Risk World on March 1997,27
[13]Heriz DB et al, Risk Analysis and Its Application, New York:John Wiley and sons,1983
[14]杨依晗,马爱霞.效益风险评价概述[J].上海医药,2009,30(1):35-36
[15]平卫伟,谭红专.Delphi法的研究进展及其在医学中的应用.疾病控制杂志,2003,7(3)：243-246
[16]李铁映.预测决策方法[M]. 沈阳：辽宁科学技术出版社,1984.30-44
[17]任佰玲,胡志,周新发.住院医师规范化培训基地评价指标体系的研究[J].继续医学教育,2004,24(9)：418-50
[18]曾光主编.现代流行病学方法与应用[M].北京：北京医科大学中国协和医科大学联合出版社,1994:250-270
[19]齐小华,高福安.预测理论与方法[M].北京广播学院出版社,1994:57-97
[20]关勋强,李瑞兴,刘运成.医学研究生教育评价研究与实践[M].北京：军事医学科学出版社,2000:82
[21]刘晓红,段志光.本科护理学专业教材质量评价指标体系的构建[J].护理研究,2008,22(10)：2609-2611
[22]丁申慧,蔡辉,祁新辉,等.卫生服务评价中权重系数的测量[J].交通医学,2001,15(5)：484-486
[23]责智强,曹晓斌,阙文进.百分权重法在评价食品卫生工作质量中的应用[J].江苏预防医学,2004,15(3)：50-51
[24]UMA G. GUPTA and Robert E. Clarke. The theory and applications of Delphi Technique:A Bibliography(1975-1994). Technological Forecasting and Social Change,1996,53:185-211
[25]苏建军,钱卫国,彭伟,等.Delphi法在医学重点学科绩效评价指标体系构建中的应用[J].中国卫生经济,2009,28(5)：73-74
[26]孔越,陈娟.特尔菲法在社区卫生服务利用者满意度指标筛选中的应用[J].中国初级卫生保健,2007,21(5)：33
[27]丁昌慧,祁新辉,蔡辉.卫生服务评价中权重系数的测量[J].交通医学,2001,15(5)：484-486
[28]倪少凯.7种确定评估指标权重方法的比较[J].华南预防医学,2002,28(6):54-62
[29]贲智强.应用密切值法评价创建卫生县城前后不同年度食品卫生工作质量[J].数理医药学杂志,2001,14(1)：81
[30]贲智强,章燕,阙文进,等.应用层次分析法评价创建卫生县城前后食品卫生工作质量[J].交通医学,2001,15(5):475-476
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