药物临床试验中研究者对药物不良事件上报的意向性态度分析

发布时间：2018-06-08 01:01

本文选题：药物不良事件 + 不良事件上报　；参考：《中国新药杂志》2015年10期

【摘要】：目的:评估临床研究者对发生药物不良事件(Adverse Drug Event,ADE)上报机构伦理委员会的意向性态度与实践,旨在促进ADE及时上报。方法:本研究为一项预试验(pilot study),采用问卷调查的形式,共计37个问卷条目对我院临床主要研究者分别从4个方面进行问卷回馈调查,即"将ADE上报伦委会的意愿与态度"(13条目)、"每次遇到ADE发生并作处理的态度"(4条目)、"影响ADE上报伦委会的因素"(11条目)及"AE发生及其上报的相关知识"(9条目)。数据获取后通过SPSS 18.0进行分析。结果:我院临床专业组中29个主要研究者(问卷调查回馈率95%),当发生ADE时有79.3%反馈将"竭尽全力"(intend to)上报,89.6%"设法"(try to)上报,86.3%"打算"(plan to)上报;研究者觉得上报ADE是"有价值的"(5.5±1.7),"有意义的"(3.3±2.2)、"可以让更多人受益"(5.5±1.7)。部分研究者觉得上报ADE存有消极影响,会"增加医疗事故风险","引发与其他医师的关系紧张/妥协","破坏与患者之间的信任","扰乱正常的工作流程"及"耗费时间";不少研究者对AE上报缺乏相关知识。结论:进行试验的研究者针对所发生的ADE有很强的意识或意愿上报伦理委员会,可基于自身知识不足或经验缺乏,需加强机构内部培训。基于本研究预试验其方法学等限制,在今后仍需在临床中纳入采用大样本、多中心、设计严谨的试验予以进一步验证。
[Abstract]:Objective: to evaluate the intention and practice of clinical researchers to report ADE to the institutional ethics committee in order to promote the timely reporting of ADE. Methods: in this study, a pilot study was conducted in a pilot study. A total of 37 questionnaire entries were used to investigate the major clinical researchers in our hospital from four aspects. That is, "the intention and attitude of reporting ADE to the commission" (13 items), "the attitude of occurrence and treatment of ADE every time", "factors affecting ADE report to the commission" (11 entries) and "AE occurrence and related knowledge reported" (9 entries). The data were analyzed by SPSS 18.0. Results: 29 major researchers in our clinical specialty group (questionnaire feedback rate 95%, when ADE occurred, 79.3% of the feedback reported "do your best" intend to report 89.6% "try to try") to report "plan to" 86.3% "plan to" report); The researchers found that reporting ADE was "valuable" (5.5 卤1.7), "meaningful" (3.3 卤2.2) and "beneficial to more people" (5.5 卤1.7). Some researchers feel that there is a negative impact on reporting ADE. It will "increase the risk of medical malpractice", "cause tension / compromise with other doctors", "destroy trust with patients", "disrupt normal work flow" and "waste time". Many researchers lack relevant knowledge of AE reports. Conclusion: the researchers involved in the experiment have strong awareness or willingness to report to the ethics committee in view of the occurrence of ADE, which can be based on their own lack of knowledge or experience, so the internal training should be strengthened. Based on the limitations of its methodology in this study, large sample, multi-center, and well-designed trials are still needed to be further validated in clinical practice in the future.
【作者单位】：广州中医药大学临床药理研究所;广东省中医院;广州中医药大学第二临床医学院;世界中医药学会联合会伦理审查委员会;中国医学科学院药用植物研究所;
【基金】：国家自然科学基金(81473698) 教育部博士点基金项目(20124425110004) 广东省财政厅项目([2014]157号) 2014年省级优博培育项目(广中医研[2014]55号)
【分类号】：R969

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