Evidence generation from healthcare databases: recommendations for managing change

Alison Bourke; Andrew Bate; Brian C Sauer; Jeffrey S Brown; Gillian C Hall

doi:10.1002/pds.4004

Evidence generation from healthcare databases: recommendations for managing change

Pharmacoepidemiol Drug Saf. 2016 Jul;25(7):749-54. doi: 10.1002/pds.4004. Epub 2016 May 17.

Authors

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

Affiliations

¹ IMS Health, London, UK.
² Pfizer, Tadworth, UK.
³ University of Utah School of Medicine, Salt Lake City, UT, USA.
⁴ Harvard Medical School, Boston, MA, USA.
⁵ Grimsdyke House, London, UK.

PMID: 27183900
DOI: 10.1002/pds.4004

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.

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

Publication types

Review

MeSH terms

Biomedical Research / methods*
Databases, Factual*
Humans
Pharmacoepidemiology / methods*
Research Design
Time Factors