WS16: Designing a proper case-control study to assess causality of unwanted drug effects (workshop SIG Pharmacoepidemiology)

Katoo Muylle, Vrije Universiteit Brussel
Pieter Cornu, Vrije Universiteit Brussel

Background:

Pharmacoepidemiology is the scientific discipline that applies epidemiologic knowledge, methods and reasoning to study both beneficial and adverse effects of pharmaceuticals in human populations. Pharmacoepidemiology operates at the interface of clinical pharmacy and clinical epidemiology. The major focus in this field is the quantification of the risk of uncommon and often unexpected adverse events or reactions relative to one or several alternatives. Especially in causal research case-control studies have proven their potential in identifying and quantifying risks of drugs. However, this design is often referred to as “quick and dirty” because it is sensitive to several biases (e.g. selection bias and recall bias) and confounding.

Target audience:

This workshop aims to demonstrate the rationale, basic principles, weaknesses and strengths of a case-control study. We will discuss and offer solutions for methodological problems specific to this design using real-world examples. Subsequently, we will apply this knowledge to interactively design a case-control study to assess causality of unwanted drug effects.

Learning Objectives:

After the workshop, the participant should be able to overcome the pitfalls of a case-control study and be able to design a proper case-control study.

Content and Structure:

First, we will start with an introduction of the rationale and the principles of case-control studies and discuss the methodological issues specific to this study design. We will discuss the selection of cases and controls, how to identify confounders and how to control for them in both the design stage and the analysis stage. We will discuss the typical data analysis and briefly touch the issue of missing data. In the second part of the workshop, we will design a case-control study interactively step by step. At each step, several possibilities will be discussed and the best option will be chosen. We will use the app “Poll Everywhere” to ensure active participation and active learning.

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