基于问卷调研法构建《口服组胺H1受体拮抗剂在儿童中合理应用的临床实践指南》的核心内容  

Questionnaire surveying for developing core content of a Clinical Practice Guideline on the Rational Use of Oral H Receptor Antagonists in Children

作　　者：周鹏翔[1,2] 郑思骞 程吟楚 周薇 翟所迪[1,2] ZHOU Peng-xiang;ZHENG Si-qian;CHENG Yin-chu;ZHOU Wei;ZHAI Suo-di(Department of Pharmacy,Peking University Third Hospital,Beijing 100191,China;Institute for Drug Evaluation,Peking UniversityHealth Science Center,Beijing 100191,China;Department of Pediatrics,Peking University Third Hospital,Beijing 100191,China)

机构地区：[1]北京大学第三医院药剂科,北京100191 [2]北京大学医学部药物评价中心,北京100191 [3]北京大学第三医院儿科,北京100191

出　　处：《中国医院药学杂志》2021年第15期1562-1568,共7页Chinese Journal of Hospital Pharmacy

基　　金：十三五国家科技重大专项:儿科常见病示范性新药临床评价技术平台建设(编号:2017ZX09304029-005-02)。

摘　　要：目的:构建《口服组胺H1受体拮抗剂在儿童中合理应用的临床实践指南》的疾病、药物、临床问题与结局指标,为同类指南核心内容的构建提供方法学参考与实践经验。方法:对指南专家组、医务人员与患者家属进行半开放式问卷调研,主要包括口服组胺H1受体拮抗剂、儿童变态反应性疾病、临床问题与结局指标4个部分。采用Likert法(5分制或9分制)对每个部分进行定量评估,同时可进行定性补充。统计参与者的基本信息,根据评分结果和变异系数,纳入平均分不小于3.0分且变异系数不大于35%的内容,其余内容与补充内容则通过德尔菲法专家咨询法形成共识。采用Wilcoxon符号秩检验或Friedam检验对组间进行差异评估,对补充的问题进行描述性分析。结果:共回收242份有效问卷,包括指南专家组成员27份、医务人员163份和患者家属62份,参与调研者的各方面基本信息均有一定分布,代表性良好。指南拟纳入的疾病、药物、临床问题与结局指标在通过第一轮调研后纳入44条,专家组、医务人员和患者家属的大部分评估结果的差异不具有统计学意义(P<0.05),少数内容的差异体现在专家组与患者家属之间,患者家属评估分数更高。专家组通过两轮德尔菲法问卷,对10条未达成共识的内容和8条有效的补充内容进行了投票,拟纳入其中的10条。最终,指南确定了14种疾病、10个药物、11个临床问题和19个结局指标作为核心内容。结论:本研究采用了问卷调研法构建了指南的核心内容,以定量评估结合定性补充的方法,合理反馈了利益相关群体的意愿,为同类指南的核心内容构建提供了方法学参考和实践经验。OBJECTIVE To determine the diseases,medications,clinical problems and outcome indicators to be included into a clinical practice guideline on rational use of oral H1 receptor antagonists in children and provide methodological references and practical experiences for constructing the core content of similar guidelines.METHODS A questionnaire survey with semi-open-ended questions was conducted among the guideline expert group,medical professionals and patients’family members.The specific content included four major sections:oral H1 receptor antagonists,allergic diseases in children,clinical problems and outcome indicators.The Likert method(5/9-point scoring system)was utilized for evaluating each section quantitatively while qualitative analysis could be made as supplementary.Basic information of participants was recorded and the items with an average score of no less than 3.0 and a coefficient of variation(CV)of no more than 35%were included.Consensus was reached on the remaining items as well as the supplement using Delphi method.Wilcoxon or Friedam test was employed for evaluating the difference between groups and descriptive analysis performed on the supplementary questions.RESULTS A total of 242 valid questionnaires were collected from guideline experts(n=27),medical professionals(n=163)and patients’family members(n=62).The participants were representative due to a decent distribution of their basic profiles.After surveying,44 items on diseases,medications,clinical problems and outcome indicators were included.No significant difference existed among the evaluation results of experts,medical professionals and patients’family members(P<0.05)for the most items.The difference of a few items was reflected between experts and patients’family members and the score of patient’s family members was higher.Two rounds of Delphi questionnaire were then conducted among experts to vote on 10 items for reaching a consensus and 8 valid supplementary items.Ten additional items were chosen for inclusion.As a result,14

关 键 词：组胺H1受体拮抗剂 变态反应性疾病 儿童 临床实践指南 问卷调研 

分 类 号：R969.3[医药卫生—药理学]