Literature DB >> 27183900

Evidence generation from healthcare databases: recommendations for managing change.

Alison Bourke1, Andrew Bate2, Brian C Sauer3, Jeffrey S Brown4, Gillian C Hall5.   

Abstract

There is an increasing reliance on databases of healthcare records for pharmacoepidemiology and other medical research, and such resources are often accessed over a long period of time so it is vital to consider the impact of changes in data, access methodology and the environment. The authors discuss change in communication and management, and provide a checklist of issues to consider for both database providers and users. The scope of the paper is database research, and changes are considered in relation to the three main components of database research: the data content itself, how it is accessed, and the support and tools needed to use the database.
Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Keywords:  change management; common data model; database; pharmacoepidemiology; programming; reproducibility; sustainability

Mesh:

Year:  2016        PMID: 27183900     DOI: 10.1002/pds.4004

Source DB:  PubMed          Journal:  Pharmacoepidemiol Drug Saf        ISSN: 1053-8569            Impact factor:   2.890


  4 in total

1.  Evaluation of Electronic Healthcare Databases for Post-Marketing Drug Safety Surveillance and Pharmacoepidemiology in China.

Authors:  Yu Yang; Xiaofeng Zhou; Shuangqing Gao; Hongbo Lin; Yanming Xie; Yuji Feng; Kui Huang; Siyan Zhan
Journal:  Drug Saf       Date:  2018-01       Impact factor: 5.606

2.  The Generalized Data Model for clinical research.

Authors:  Mark D Danese; Marc Halperin; Jennifer Duryea; Ryan Duryea
Journal:  BMC Med Inform Decis Mak       Date:  2019-06-24       Impact factor: 2.796

3.  Advancing a Framework for Regulatory Use of Real-World Evidence: When Real Is Reliable.

Authors:  Nancy A Dreyer
Journal:  Ther Innov Regul Sci       Date:  2018-03-19       Impact factor: 1.778

4.  Considerations when evaluating real-world data quality in the context of fitness for purpose.

Authors:  Matthew W Reynolds; Alison Bourke; Nancy A Dreyer
Journal:  Pharmacoepidemiol Drug Saf       Date:  2020-05-06       Impact factor: 2.890

  4 in total

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