基于德尔菲法构建《中国妊娠期药物风险评估专家共识》

“Expert Consensus on Risk Assessment of Drugs in Pregnancy in China” Based on the Delphi Method

目的:基于德尔菲法构建《中国妊娠期药物风险评估专家共识》,为进一步开展妊娠期药物风险评估研究提供方法学基础。方法:参考妊娠期药物风险评估研究相关文献,撰写《中国妊娠期药物风险评估专家共识》,并设计专家咨询问卷。选取北京、上海等省市51名专家,应用德尔菲法进行两轮专家咨询,对《中国妊娠期药物风险评估专家共识》的内容进行修改。结果:两轮问卷回收率为100%,专家权威系数(Cr)为0.80±0.10,专家意见的变异系数(CV)第1轮为0.15±0.04,第2轮为0.13±0.03,专家意见的协调系数(Kendall-W)第1轮为0.170,第2轮为0.493,两轮专家意见协调系数的χ^(2)检验结果显示差异均具有统计学意义(P<0.001),最终确定《中国妊娠期药物风险评估专家共识》。结论:应用德尔菲法构建《中国妊娠期药物风险评估共识》,为开展中国妊娠期药物风险评估提供了方法学基础。

OBJECTIVE: To establish the “Expert Consensus on Risk Assessment of Drugs in Pregnancy in China” based on the Delphi method, so as to provide methodological basis for further studies on drug risk assessment in pregnancy. METHODS: By referring to the literature related to drug risk assessment in pregnancy, the “Expert Consensus on Risk Assessment of Drugs in Pregnancy in China” was established, and the expert consultation questionnaire was designed. Fifty-one experts from Beijing, Shanghai and other provinces and cities were selected to apply the Delphi method for two rounds of expert consultation to revise the content of the “Expert Consensus on Risk Assessment of Drugs in Pregnancy in China”. RESULTS: The recovery rates of the two rounds of questionnaire were 100%. The expert authority coefficient(Cr) was 0.80±0.10, the coefficient of variation(CV) of expert opinion was 0.15±0.04 in the first round and 0.13±0.03 in the second round, and the coordination coefficient of expert opinion(Kendall-W) was 0.170 in the first round and 0.493 in the second round.In both rounds, Chi-square test showed statistically significant differences(P<0.001). Finally, the “Expert Consensus on Risk Assessment of Drugs in Pregnancy in China” was determined. CONCLUSIONS: The Delphi method is used to establish the “Expert Consensus on Risk Assessment of Drugs in Pregnancy in China”, which provides methodological basis for the risk assessment of drugs during pregnancy in China.