Bridging differences in outcomes of pharmacoepidemiological studies: design and first results of the PROTECT project.
Bridging differences in outcomes of pharmacoepidemiological studies: design and first results of the PROTECT project.
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DOI：
10.2174/1574884708666131111211802
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发表时间：
2014-05
影响因子：
3.2
通讯作者：
Klungel OH
中科院分区：
文献类型：
--
作者：
Abbing-Karahagopian V;Kurz X;de Vries F;van Staa TP;Alvarez Y;Hesse U;Hasford J;Dijk Lv;de Abajo FJ;Weil JG;Grimaldi-Bensouda L;Egberts AC;Reynolds RF;Klungel OH
关于药物安全性的观察性药物流行病学（PE）研究产生了不一致的结果，可能是由于设计、实施和分析的差异。欧洲联盟药物流行病学研究治疗学结局项目的药物流行病学工作包（WP 2）旨在开发、测试和传播方法标准，用于使用欧洲国家的不同数据库设计、实施和分析适用于不同安全性问题的药物流行病学研究。本文描述了安全性问题的选择和待系统研究的数据库的描述。基于两次共识会议和文献检索，我们选择了五个药物不良事件（AE）对在不同的数据库中进行评价。这一选择是根据预先确定的标准进行的，如监管和公共卫生影响，以及调查广泛的方法学问题的可能性。选定的药物-AE对为：1）吸入性长效β-2受体激动剂和急性心肌梗死; 2）抗菌剂和急性肝损伤; 3）抗抑郁药和/或苯二氮卓类药物和髋部骨折; 4）抗惊厥药和自杀/自杀企图; 5）钙通道阻滞剂和恶性肿瘤。还描述了将用于回顾性评价药物-AE对的6个欧洲数据库。将在PE研究中使用通用方案评价选定的药物-AE对。基于这些研究的差异，将制定一个指导方法选择的框架。这将增加PE研究在获益-风险评估和决策方面的有用性和可靠性。
Observational pharmacoepidemiological (PE) studies on drug safety have produced discrepant results that may be due to differences in design, conduct and analysis. The pharmacoepidemiology work-package (WP2) of the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium (PROTECT) project aims at developing, testing and disseminating methodological standards for design, conduct and analysis of pharmacoepidemiological studies applicable to different safety issues using different databases across European countries. This article describes the selection of the safety issues and the description of the databases to be systematically studied. Based on two consensus meetings and a literature search, we selected five drug-adverse event (AE) pairs to be evaluated in different databases. This selection was done according to pre-defined criteria such as regulatory and public health impact, and the potential to investigate a broad range of methodological issues. The selected drug-AE pairs are: 1) inhaled long-acting beta-2 agonists and acute myocardial infarction; 2) antimicrobials and acute liver injury; 3) antidepressants and/or benzodiazepines and hip fracture; 4) anticonvulsants and suicide/suicide attempts; and 5) calcium channel blockers and malignancies. Six European databases, that will be used to evaluate the drug-AE pairs retrospectively, are also described. The selected drug-AE pairs will be evaluated in PE studies using common protocols. Based on consistencies and discrepancies of these studies, a framework for guiding methodological choices will be developed. This will increase the usefulness and reliability of PE studies for benefit-risk assessment and decision-making.