基于德尔菲法进行药物临床试验受试者日记卡使用现状调研问卷的构建
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摘要
目的:采用德尔菲法构建受试者日记卡使用现状调研问卷。方法:通过文献评价法和专家头脑风暴法结合初步拟定问卷的专家咨询表,采用德尔菲法进行多轮次专家咨询,计算专家积极性情况、专家权威程度、专家意见集中程度和协调程度,并计算高优、低优指标的界值,根据结果调整问卷,最终形成科学完善的受试者日记卡现状调查问卷,用于后续的调查和研究。结果:通过两轮专家咨询,问卷的肯德尔协调系数的假设检验结果P=0.000,具有显著性统计学意义,各项指标满足要求,最终形成受试者日记卡使用现状调研问卷,调研问卷由A卷和B卷组成,A卷包括日志卡来源、日志卡溯源性、和日志卡问题,设置3个一级指标共30个二级指标;B卷包括11个二级指标。结论:借鉴德尔菲法构建受试者日记卡使用现状调研问卷,具有较高可靠性,对受试者日记卡使用现状调查和日记卡后续内容优化具有现实意义。
OBJECTIVE To construct the questionnaire of current status of subject diary card by Delphi method. METHODS Through the literature evaluation method and the expert brainstorm method combined with the preliminary questionnaire of the expert consultation form, the Delphi method was used for multiple rounds of expert consultation to calculate positivity, the authority coefficient, the opinion concentration and the concordance correlation coefficient of the experts and the high priority and low priority indicators boundary value for adjustment of the questionnaire. The final edition was scientifically formed for subsequent use. RESULTS Through two rounds of expert consultation, the hypothesis test result of the Kendall coordination coefficient of the questionnaire was P=0.000. Each indicator met the requirements. Finally, the investigation questionnaire on the status of subject diary card use was formed. The investigation questionnaire was composed of Volume A and Volume B. Volume A included the source of diary card, traceability of diary card, and problems of diary card, in which a total of 30 secondary indicators of three primary indicators were set; Volume B included 11 secondary indicators. CONCLUSION The constructed questionnaire on the current status of subject diary by Delphi method is highly reliable. The questionnaire is significant for the investigation of subject diaries' current status and the subsequent optimization of the subject diary.
OBJECTIVE To construct the questionnaire of current status of subject diary card by Delphi method. METHODS Through the literature evaluation method and the expert brainstorm method combined with the preliminary questionnaire of the expert consultation form, the Delphi method was used for multiple rounds of expert consultation to calculate positivity, the authority coefficient, the opinion concentration and the concordance correlation coefficient of the experts and the high priority and low priority indicators boundary value for adjustment of the questionnaire. The final edition was scientifically formed for subsequent use. RESULTS Through two rounds of expert consultation, the hypothesis test result of the Kendall coordination coefficient of the questionnaire was P=0.000. Each indicator met the requirements. Finally, the investigation questionnaire on the status of subject diary card use was formed. The investigation questionnaire was composed of Volume A and Volume B. Volume A included the source of diary card, traceability of diary card, and problems of diary card, in which a total of 30 secondary indicators of three primary indicators were set; Volume B included 11 secondary indicators. CONCLUSION The constructed questionnaire on the current status of subject diary by Delphi method is highly reliable. The questionnaire is significant for the investigation of subject diaries' current status and the subsequent optimization of the subject diary.
引文
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[7] Wang AN,Li JM,Qian X,et al.Analysis of good clinical practice inspections conducted by the European Union from 2008 to 2015[J].Chin J New Drugs Clin Rem(中国新药与临床杂志),2017,36(4):196-202.
[8] Zhou PX,Lin QN,Chen Y,et al.Using Delphi method to develop the recommendations included in the Rapid Advice Guideline for Intravenous Azithromycin in Pediatrics[J].Chin Hosp Pharm J(中国医院药学杂志),2018,38(12):1273-1276.
[9] Guan CY,Liu YL,Huang H,et al.Outpatient Experience of Human Caring Scale (OEHC-Scale):Improvement by Delphi Method[J].CURR MED SCI,2018,38(2):360-371.
[10] Bauer SM,Fusté A,Andrés A,et al.The Barcelona Orthorexia Scale (BOS):development process using the Delphi method[J].Eat Weight Disord (2018).https://doi.org/10.1007/s40519-018-0556-4.
[11] Liu Y,Bian Y,Yan JF.Establishment of pediatric trigger for drug adverse events based on global trigger tool[J].Chin J New Drugs Clin Rem(中国新药与临床杂志),2018,37(7):432-438.
[12] Zhang XG,Cao J,Wang HY,et al.Construction of geriatric nursing specialty curriculum in higher vocational education based on Delphi method[J].Chin Nurs Res(护理研究),2018,32(1):59-62.
[13] Wen RL,Li LH,Luo WT,et al.Construction on evaluation index system of ADR rapid reporting information system in hospital based on Delphi method[J].China Pharmacy(中国药房),2018,29(13):1742-1745.
[14] Wu J,Jia XY,Liu GQ.Construction of continuous care model for children with severe viral encephalitis sequela based on Delphi method[J].J Nurs Train(护理进修杂志),2018,33(12):1074-1077.
[15] Zhong MT,Han S,Zhang L,et al.Research of adjuvant drugs in medical institutions in China based on Delphi method[J].Chin Hosp Pharm J(中国医院药学杂志),2016,36(19):1621-1624.
[16] Wu YZ,Wang WJ.Effect of different response levels on the characteristics of Likert-type rating scale[J].Chin J Prev Contr Chron Dis(中国慢性病预防与控制),2010,18(2):215-217.
[2] Electronic Diaries,Part 1:What Is a Subject Diary,and How Do Regulations Apply?[EB/OL].(2002-09-01).http://www.appliedclinicaltrialsonline.com/electronic-diaries-part-1-what-subject-diary-and-how-do-regulations-apply.
[3] Announcement of China Food and Drug Administration on relevant issues regarding further the self-Inspection and verification for drug clinical trial data(国家食品药品监督管理总局关于开展药物临床试验数据自查核查工作的公告)[EB/OL].(2015-07-22).http://samr.cfda.gov.cn/WS01/CL0087/124800.html.
[4] Wang JN,Qian X,Li JM.Drug clinical trial data inspection and common problems analysis[J].Chin J New Drug(中国新药杂志),2018,27(11):1273-1276.
[5] He GL,Zeng T,Zhang W,et al.Cause analysis and controlmeasures of common problems in clinical part from drug clinical trial data inspection[J].Chin J New Drugs Clin Rem(中国新药与临床杂志),2018,37(1):24-28.
[6] Period Inspection Report on Drug Clinical Trial Data(药物临床试验数据核查阶段性报告)[EB/OL].(2017-07-21).http://www.cfdi.org.cn/resource/news/9137.html.
[7] Wang AN,Li JM,Qian X,et al.Analysis of good clinical practice inspections conducted by the European Union from 2008 to 2015[J].Chin J New Drugs Clin Rem(中国新药与临床杂志),2017,36(4):196-202.
[8] Zhou PX,Lin QN,Chen Y,et al.Using Delphi method to develop the recommendations included in the Rapid Advice Guideline for Intravenous Azithromycin in Pediatrics[J].Chin Hosp Pharm J(中国医院药学杂志),2018,38(12):1273-1276.
[9] Guan CY,Liu YL,Huang H,et al.Outpatient Experience of Human Caring Scale (OEHC-Scale):Improvement by Delphi Method[J].CURR MED SCI,2018,38(2):360-371.
[10] Bauer SM,Fusté A,Andrés A,et al.The Barcelona Orthorexia Scale (BOS):development process using the Delphi method[J].Eat Weight Disord (2018).https://doi.org/10.1007/s40519-018-0556-4.
[11] Liu Y,Bian Y,Yan JF.Establishment of pediatric trigger for drug adverse events based on global trigger tool[J].Chin J New Drugs Clin Rem(中国新药与临床杂志),2018,37(7):432-438.
[12] Zhang XG,Cao J,Wang HY,et al.Construction of geriatric nursing specialty curriculum in higher vocational education based on Delphi method[J].Chin Nurs Res(护理研究),2018,32(1):59-62.
[13] Wen RL,Li LH,Luo WT,et al.Construction on evaluation index system of ADR rapid reporting information system in hospital based on Delphi method[J].China Pharmacy(中国药房),2018,29(13):1742-1745.
[14] Wu J,Jia XY,Liu GQ.Construction of continuous care model for children with severe viral encephalitis sequela based on Delphi method[J].J Nurs Train(护理进修杂志),2018,33(12):1074-1077.
[15] Zhong MT,Han S,Zhang L,et al.Research of adjuvant drugs in medical institutions in China based on Delphi method[J].Chin Hosp Pharm J(中国医院药学杂志),2016,36(19):1621-1624.
[16] Wu YZ,Wang WJ.Effect of different response levels on the characteristics of Likert-type rating scale[J].Chin J Prev Contr Chron Dis(中国慢性病预防与控制),2010,18(2):215-217.