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目的:初步建立北京市药品生产企业重点监测指导原则。方法:采用改良的德尔菲法,事先拟定专家库,通过三轮专家咨询,收集专家意见,采用SPSS17.0对专家的权威程度、专家的积极系数、专家意见的集中程度、专家意见的协调程度进行计算,依据“该项问题是否应该涵盖在指导原则中”以及“该部分内容的撰写符合实际需求并具有可行性”两个维度,明确预先准备好的18项关键问题的修订方向。结果:共遴选出11位专家,专家的权威程度为0.80±0.13。三轮问卷专家积极系数均较高,超过90%。前后两轮的专家意见的协调系数范围为0.230~0.383,第三轮问卷的协调系数经χ~2检验后表明专家的意见趋于一致(P<0.05)。在三轮问卷后,在指导原则中须涵盖:重点监测适用范围、研究流程、推荐进行药品安全性循证评价、专家小组的组成原则、实施团队的组成原则、重点监测的质量保证、伦理学、研究方法、样本量、记录形式。结论:本研究采用改良的德尔菲法,专家的权威性、积极性均较好,初步明确了北京市药品生产企业药品重点监测的关键内容,初步构建了相关指导性文件。
Objective: To initially establish the guiding principle for key monitoring of pharmaceutical manufacturers in Beijing. Methods: The modified Delphi method was used to draw up an expert database in advance. Through three rounds of expert consultation, experts ’opinions were collected. The authority of experts, the experts’ positive factors, the concentration degree of experts ’opinions and the coordination degree of experts’ opinions were analyzed using SPSS17.0 Calculated on the basis of “whether the issue should be covered by the Guiding Principles” and “the content of the part should be prepared in a practical and viable manner” and “two dimensions” to clarify the revision of the 18 key issues prepared in advance direction. Results: A total of 11 experts were selected and the expert’s authority was 0.80 ± 0.13. Three rounds of questionnaire experts positive coefficient are higher, more than 90%. The coordination coefficients of two rounds of experts ’opinions ranged from 0.230 to 0.383. The coordination coefficients of the third round of questionnaires showed that experts’ opinions tended to be consistent (χ ~ 2) after the χ ~ 2 test (P <0.05). After three rounds of questionnaires, the guidelines should cover: application of key monitoring scope, research flow, recommended evidence-based evaluation of drug safety, composition of expert groups, composition of implementation team, quality assurance of key monitoring, ethics , Research methods, sample size, record form. Conclusion: The improved Delphi method was used in this study. The authoritativeness and enthusiasm of experts were good. The key contents of drug key monitoring in pharmaceutical manufacturing enterprises in Beijing were initially identified and the relevant guidance documents were initially constructed.