Publications by authors named "N Galwey"
Core Concepts in Pharmacoepidemiology: Quantitative Bias Analysis.
Pharmacoepidemiol Drug Saf
October 2024
Pharmacoepidemiological studies provide important information on the safety and effectiveness of medications, but the validity of study findings can be threatened by residual bias. Ideally, biases would be minimized through appropriate study design and statistical analysis methods. However, residual biases can remain, for example, due to unmeasured confounders, measurement error, or selection into the study.
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- Confounding by indication poses significant challenges in pharmacoepidemiology, particularly with time-varying confounders like infections affecting treatment and outcomes simultaneously.
- The paper introduces newly developed methods that incorporate active comparators in self-controlled study designs, specifically focusing on deriving active comparator rate ratios in self-controlled case series (SCCS).
- Through case studies on thiazolidinediones and fluoroquinolones, the authors compare different analytical approaches and provide guidelines to enhance the robustness of pharmacoepidemiological research.
Importance: Fluoroquinolone use has been associated with increased risk of uveitis and retinal detachment in noninterventional studies, but the findings have been conflicting and causality is unclear.
Objective: To estimate the association of systemic fluoroquinolone use with acute uveitis or retinal detachment, using multiple analyses and multiple databases to increase the robustness of results.
Design, Setting, And Participants: This cohort study used data from the Clinical Practice Research Datalink Aurum and GOLD UK primary care records databases, which were linked to hospital admissions data.
Importance: Fluoroquinolone use has been associated with increased hospitalization with aortic aneurysm or dissection in noninterventional studies, but the reason for this observed association is unclear.
Objective: To determine the association between fluoroquinolone use and aortic aneurysm or dissection using multiple study designs and multiple databases to increase the robustness of findings.
Design, Setting, And Participants: Cohort and case-crossover studies were conducted separately in 2 databases of UK primary care records.