The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE).
The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE).
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DOI：
10.1136/bmj.k3532
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发表时间：
2018-11-14
期刊：
影响因子：
--
通讯作者：
Benchimol EI
中科院分区：
文献类型：
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作者：
Langan SM;Schmidt SA;Wing K;Ehrenstein V;Nicholls SG;Filion KB;Klungel O;Petersen I;Sorensen HT;Dixon WG;Guttmann A;Harron K;Hemkens LG;Moher D;Schneeweiss S;Smeeth L;Sturkenboom M;von Elm E;Wang SV;Benchimol EI
在药物流行病学中，从电子健康记录（包括初级保健数据库、登记和行政医疗索赔）中常规收集的数据是评价药物在真实的世界中的有效性和安全性的研究资源。目前使用非随机、常规收集的数据报告研究的可用指南-特别是使用观察性非随机收集的健康数据进行的研究报告（RECORD）和加强流行病学中观察性研究报告（STROBE）声明-没有捕获药物流行病学研究的复杂性。因此，我们扩展了RECORD声明，以包括药物流行病学研究的特定报告指南（RECORD-PE）。本文包括RECORD-PE检查表（也可在www.record-statement.org上获得），并通过良好报告的示例解释每个检查表项目。我们预计，研究人员越来越多地使用RECORD-PE指南，期刊编辑的认可和遵守将提高使用常规收集的数据进行的药物流行病学研究的报告标准。这种透明度的提高将有利于研究界、病人护理，并最终改善公共卫生。
In pharmacoepidemiology, routinely collected data from electronic health records (including primary care databases, registries, and administrative healthcare claims) are a resource for research evaluating the real world effectiveness and safety of medicines. Currently available guidelines for the reporting of research using non-randomised, routinely collected data—specifically the REporting of studies Conducted using Observational Routinely collected health Data (RECORD) and the Strengthening the Reporting of OBservational studies in Epidemiology (STROBE) statements—do not capture the complexity of pharmacoepidemiological research. We have therefore extended the RECORD statement to include reporting guidelines specific to pharmacoepidemiological research (RECORD-PE). This article includes the RECORD-PE checklist (also available on www.record-statement.org) and explains each checklist item with examples of good reporting. We anticipate that increasing use of the RECORD-PE guidelines by researchers and endorsement and adherence by journal editors will improve the standards of reporting of pharmacoepidemiological research undertaken using routinely collected data. This improved transparency will benefit the research community, patient care, and ultimately improve public health.