Preciosa M. Coloma

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BACKGROUND & AIMS Concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs) and low-dose aspirin increases the risk of upper gastrointestinal bleeding (UGIB). Guidelines suggest avoiding certain drug combinations, yet little is known about the magnitude of their interactions. We estimated the risk of UGIB during concomitant use of nonselective(More)
PURPOSE In this proof-of-concept paper we describe the framework, process, and preliminary results of combining data from European electronic healthcare record (EHR) databases for large-scale monitoring of drug safety. METHODS Aggregated demographic, clinical, and prescription data from eight databases in four countries (Denmark, Italy, Netherlands, the(More)
PURPOSE Data mining on electronic health records (EHRs) has emerged as a promising complementary method for post-marketing drug safety surveillance. The EU-ADR project, funded by the European Commission, is developing techniques that allow mining of EHRs for adverse drug events across different countries in Europe. Since mining on all possible events was(More)
PURPOSE To provide estimates of the number and types of drugs that can be monitored for safety surveillance using electronic healthcare databases. METHODS Using data from eight European databases (administrative claims, medical records) and in the context of a cohort study, we determined the amount of drug exposure required for signal detection across(More)
BACKGROUND Drug safety monitoring relies primarily on spontaneous reporting, but electronic health care record databases offer a possible alternative for the detection of adverse drug reactions (ADRs). OBJECTIVES To evaluate the relative performance of different statistical methods for detecting drug-adverse event associations in electronic health care(More)
The EU-ADR project aims to exploit different European electronic healthcare records (EHR) databases for drug safety signal detection. In this paper we report the preliminary results concerning the comparison of signal detection between EU-ADR network and two spontaneous reporting databases, the Food and Drug Administration and World Health Organization(More)
INTRODUCTION There is growing interest in whether social media can capture patient-generated information relevant for medicines safety surveillance that cannot be found in traditional sources. OBJECTIVE The aim of this study was to evaluate the potential contribution of mining social media networks for medicines safety surveillance using the following(More)
OBJECTIVE To evaluate the accuracy of disease codes and free text in identifying upper gastrointestinal bleeding (UGIB) from electronic health-care records (EHRs). STUDY DESIGN AND SETTING We conducted a validation study in four European electronic health-care record (EHR) databases such as Integrated Primary Care Information (IPCI), Health Search/CSD(More)
BACKGROUND The growing interest in using electronic healthcare record (EHR) databases for drug safety surveillance has spurred development of new methodologies for signal detection. Although several drugs have been withdrawn postmarketing by regulatory authorities after scientific evaluation of harms and benefits, there is no definitive list of confirmed(More)
The safety profile of a drug evolves over its lifetime on the market; there are bound to be changes in the circumstances of a drug's clinical use which may give rise to previously unobserved adverse effects, hence necessitating surveillance postmarketing. Postmarketing surveillance has traditionally been carried out by systematic manual review of(More)