Cluster randomized trials utilizing primary care electronic health records: methodological issues in design, conduct, and analysis (eCRT Study)
Cluster randomized trials utilizing primary care electronic health records: methodological issues in design, conduct, and analysis (eCRT Study)
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DOI：
10.1186/1745-6215-15-220
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发表时间：
2014-06-11
期刊：
影响因子：
2.5
通讯作者：
Dregan, Alex
中科院分区：
文献类型：
--
作者：
Gulliford, Martin C.;van Staa, Tjeerd P.;Dregan, Alex
背景：通过电子健康记录进行临床和集群随机试验的兴趣越来越大。本文报告的方法学问题，在实施过程中确定的两个集群随机试验，使用电子健康记录的临床实践研究数据链（CPRD）。方法：两项试验完成了初级保健：一个旨在减少不适当的抗生素处方急性呼吸道感染;其他旨在增加医生的依从性与二级预防干预措施后，首次中风。本文借鉴文献记录和试验数据集报告的方法论经验，研究伦理和研究治理批准，全科医生招聘和分配，样本量计算和权力，干预实施，和trial analysis.Results：我们获得了研究治理批准，从150多个初级保健组织在英格兰，威尔士和苏格兰。抗生素试验招募了104名CPRD一般实践者，中风试验招募了106名，目标数量是在六个月内招募的实践者。干预措施通过互联网远程安装到实践信息系统中。抗生素试验中每次实践的平均参与人数为5，588人，中风试验中为110人，实践规模的变异系数分别为0.53和0.56。结果指标显示干预前12个月和干预后12个月之间存在显着相关性，系数范围从舒张压的0.42到使用抗生素处方的咨询比例的0.91，需要仔细考虑定义实践和参与者分析资格。结论：使用初级保健数据库的电子健康记录，可以在英国全科实践的大样本中有效地进行群集随机试验。试验地点的地理分散给研究管理批准和干预措施的实施带来了困难。试验前数据分析应为试验设计和分析计划提供信息。
Background: There is growing interest in conducting clinical and cluster randomized trials through electronic health records. This paper reports on the methodological issues identified during the implementation of two cluster randomized trials using the electronic health records of the Clinical Practice Research Datalink (CPRD).Methods: Two trials were completed in primary care: one aimed to reduce inappropriate antibiotic prescribing for acute respiratory infection; the other aimed to increase physician adherence with secondary prevention interventions after first stroke. The paper draws on documentary records and trial datasets to report on the methodological experience with respect to research ethics and research governance approval, general practice recruitment and allocation, sample size calculation and power, intervention implementation, and trial analysis.Results: We obtained research governance approvals from more than 150 primary care organizations in England, Wales, and Scotland. There were 104 CPRD general practices recruited to the antibiotic trial and 106 to the stroke trial, with the target number of practices being recruited within six months. Interventions were installed into practice information systems remotely over the internet. The mean number of participants per practice was 5,588 in the antibiotic trial and 110 in the stroke trial, with the coefficient of variation of practice sizes being 0.53 and 0.56 respectively. Outcome measures showed substantial correlations between the 12 months before, and after intervention, with coefficients ranging from 0.42 for diastolic blood pressure to 0.91 for proportion of consultations with antibiotics prescribed, defining practice and participant eligibility for analysis requires careful consideration.Conclusions: Cluster randomized trials may be performed efficiently in large samples from UK general practices using the electronic health records of a primary care database. The geographical dispersal of trial sites presents a difficulty for research governance approval and intervention implementation. Pretrial data analyses should inform trial design and analysis plans.