目的 构建中国妊娠用药登记专家共识,为进一步开展妊娠用药登记研究提供方法学基础。方法 检索国内外妊娠用药登记相关文献,设计专家咨询问卷。选取北京、上海等23个省市26名医院药学专家,应用德尔菲法进行两轮专家咨询,对中国妊娠用药登记专家共识内容进行修改。结果 两轮问卷回收率为100%,专家权威系数(Cr)为(0.86±0.1),变异系数(CV)第一轮为(0.13±0.06),第二轮为(0.12±0.02),协调系数(Kendall-W)第一轮为0.235,第二轮为0.605,均具有统计学意义(P<0.001),最终制定涵盖妊娠用药登记原则及方法、基本信息及妊娠相关信息、妊娠用药登记条目、妊娠结局、登记药历5部分72条目的妊娠用药登记专家共识。结论 初步建立了中国妊娠用药登记专家共识,为开展中国妊娠用药登记研究提供了方法学基础。
Abstract
OBJECTIVE To build up the consensus of experts on pregnancy drug registry in China based on Delphi method, and to provide a methodological basis for further studies. METHODS Based on studies of pregnancy drug registry, the manuscript of the consensus of experts on pregnancy drug registry in China was made, the questionnaire was designed. Twenty-six experts from different provinces of China were selected to conduct two rounds of expert consultation with Delphi method, and the content of experts on pregnancy drug registry in China was revised. RESULTS The recovery rates of the two rounds of questionnaire were 100%. The expert authority coefficient(CR) was(0.86±0.1), and the CV of expert opinion was( 0.13±0.06) in the first round,(0.12±0.02) in the second round. The coordination coefficient of expert opinion(Kendall-W) was 0.235 in the first round and 0.605 in the second round. The chi square test was statistically significant (P<0.001). Finally, the expert consensus on pregnancy drug registry in China was determined. CONCLUSION Building up the consensus of experts on pregnancy drug registry in China based on Delphi method, a methodological basis for studies of pregnancy drug registry in China could be provided.
关键词
德尔菲法 /
妊娠用药登记 /
专家共识 /
登记方法 /
登记内容
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Key words
Delphi method /
pregnancy drug registry /
expert consensus /
registration method /
registration content
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中图分类号：
R95
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参考文献
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脚注
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基金
北京市医院管理中心临床医学发展专项经费资助(ZYLX202119);北京市属医院科研培育项目资助(PZ2021028);首都医科大学附属北京妇产医院中青年学科骨干培养专项资助(FCYY201819);北京药理学会智慧药学专项资助(320.6750.2020-08-48)
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