title: Medication safety research by observational study design.
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.
authors.affiliation: Department of Pharmacology and Pharmacy, Centre for Safe Medication Practice and Research, Li Ka Shing Faculty of Medicine, The University of Hong Kong, 2/F Laboratory Block, 21 Sassoon Road, Pok Fu Lam, Hong Kong SAR, China.
authors.forename: Kim S J
authors.initials: KS
authors.lastname: Lao
authors.affiliation: Department of Pharmacology and Pharmacy, Centre for Safe Medication Practice and Research, Li Ka Shing Faculty of Medicine, The University of Hong Kong, 2/F Laboratory Block, 21 Sassoon Road, Pok Fu Lam, Hong Kong SAR, China.
authors.forename: Celine S L
authors.initials: CS
authors.lastname: Chui
authors.affiliation: Department of Pharmacology and Pharmacy, Centre for Safe Medication Practice and Research, Li Ka Shing Faculty of Medicine, The University of Hong Kong, 2/F Laboratory Block, 21 Sassoon Road, Pok Fu Lam, Hong Kong SAR, China.
authors.forename: Kenneth K C
authors.initials: KK
authors.lastname: Man
authors.affiliation: Department of Pharmacology and Pharmacy, Centre for Safe Medication Practice and Research, Li Ka Shing Faculty of Medicine, The University of Hong Kong, 2/F Laboratory Block, 21 Sassoon Road, Pok Fu Lam, Hong Kong SAR, China.
authors.forename: Wallis C Y
authors.initials: WC
authors.lastname: Lau
authors.affiliation: Department of Pharmacology and Pharmacy, Centre for Safe Medication Practice and Research, Li Ka Shing Faculty of Medicine, The University of Hong Kong, 2/F Laboratory Block, 21 Sassoon Road, Pok Fu Lam, Hong Kong SAR, China.
authors.forename: Esther W
authors.initials: EW
authors.lastname: Chan
authors.affiliation: Department of Pharmacology and Pharmacy, Centre for Safe Medication Practice and Research, Li Ka Shing Faculty of Medicine, The University of Hong Kong, 2/F Laboratory Block, 21 Sassoon Road, Pok Fu Lam, Hong Kong SAR, China. I.wong@ucl.ac.uk.|School of Pharmacy, University College London, 29-39 Brunswick Square, London, WC1N 1AX, UK. I.wong@ucl.ac.uk.
authors.forename: Ian C K
authors.initials: IC
authors.lastname: Wong
mesh_terms: D062313:Databases, Pharmaceutical; D006801:Humans; D064887:Observational Studies as Topic / Q000379:methods*; D017891:Pharmacoepidemiology / Q000379:methods*; D012107:Research Design
keywords: Methodology; Observational study; Pharmacoepidemiology