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Springer, International Journal of Clinical Pharmacy, 2016

DOI: 10.1007/s11096-016-0285-6

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Medication safety research by observational study design

Journal article published in 2016 by Kim S. J. Lao, S. Lao, Celine S. L. Chui, Slc Chui ORCID, Kenneth K. C. Man, Wallis C. Y. Lau, Cy Lau, Esther W. Chan, Ian C. K. Wong
This paper is made freely available by the publisher.
This paper is made freely available by the publisher.

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Abstract

Observational studies have been recognised to be essential for investigating the safety profile of medications. Numerous observational studies have been conducted on the platform of large population databases, which provide adequate sample size and follow-up length to detect infrequent and/or delayed clinical outcomes. Cohort and case-control are well-accepted traditional methodologies for hypothesis testing, while within-individual study designs are developing and evolving, addressing previous known methodological limitations to reduce confounding and bias. Respective examples of observational studies of different study designs using medical databases are shown. Methodology characteristics, study assumptions, strengths and weaknesses of each method are discussed in this review.