Pharmacoepidemiology and Drug Safety · 2011 · 199 citations · 8 references
MedicineHealth InformaticsPharmacologyClinical Data ManagementClinical PharmacologyPharmacovigilanceDrug DatabasesDrug Information ResourcesClinical Drug DatabasesDatabase AcquisitionPharmacy DatabasesPrescription Drug DatabasesStudy Population Definition
The use of healthcare databases in research provides advantages such as increased speed, lower costs and limitation of some biases. However, database research has its own challenges as studies must be performed within the limitations of resources, which often are the product of complex healthcare systems. The primary purpose of this document is to assist in the selection and use of data resources in pharmacoepidemiology, highlighting potential limitations and recommending tested procedures. This guidance is presented as a detailed text with a checklist for quick reference and covers six areas: selection of a database, use of multiple data resources, extraction and analysis of the study population, privacy and security, quality and validation procedures and documentation.
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Erik von Elm, Douglas G. Altman, Matthias Egger et al. · PLoS Medicine · 2007 · 21.6K citations · Full text
Public Health, Public Health Practice, Epidemiologic Methods +10
Marc L. Berger, Muhammad Mamdani, David C. Atkins et al. · Value in Health · 2009 · 410 citations
Guidelines for good pharmacoepidemiology practices (GPP)
ISPE · Pharmacoepidemiology and Drug Safety · 2007 · 346 citations
Distributed Health Data Networks
Jeffrey S. Brown, John H. Holmes, Kiran Shah et al. · Medical Care · 2010 · 218 citations · Full text