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Program

Assessing risks and benefits of treatments: Methodological issues


Format: Lectures, group work, and exercises.

Prerequisites: Basic training in epidemiology and biostatistics is assumed.

Equipment: Laptop. All participants will get a short-course STATA license, which needs to be installed on the laptop.


Monday, 10 June & Tuesday, 11 June 2024


All day (9.00 am - 4.00 pm)

Pharmacoepidemiology and comparative effectiveness research

The aims of this class are to understand the unique research challenges and opportunities presented when conducting non-experimental studies of medical interventions and identify the specific tools required to design, analyze, and evaluate the validity of these studies. This course will cover a variety of topics central to the conduct of pharmacoepidemiology (PE) and comparative effectiveness research (CER), including (but not limited to): a review of commonly used healthcare databases for PE/CER, an overview of the major methodological challenges in evaluating the benefit and harm of medical interventions using non-experimental methods, an introduction to the study design and analytic solutions to address these challenges (including the target trial emulation framework), and other special topics. The participants will work in groups through a series of structured breakout sessions that will address the full spectrum of issues relevant to the conduct of a PE or CER study from research question development/feasibility assessment through the analytic approach and presentation of results. 


Instructors

Til Stürmer, MD, MPH, PhD
University of North Carolina at Chapel Hill

Jennifer Lund, PhD
University of North Carolina at Chapel Hill


Wednesday, 12 June & Thursday, 13 June 2024


All day (9.00 am - 4.00 pm)

Meta-analysis

This class will give a comprehensive overview of topics in meta-analysis. Most standard topics in meta-analysis will be covered, such as risk of bias analysis, fixed versus random effect models, heterogeneity, meta-regression, and differences between meta-analysis of randomized trials and meta-analysis of observational studies. Core elements will also be covered in hands-on practical sessions. These sessions will be taught in R and STATA. After the class, the participants should be able to perform a standard meta-analysis by themselves.


Instructors

Olaf M. Dekkers, MD, PhD
Leiden University Medical Center

Saskia le Cessie
Leiden University Medical Center


Friday, 14 June 2024


Morning (9.00 am - 12.00 noon)

Design of pharmacoepidemiological studies

In this class, the participants will be asked to design a specific pharmacoepidemiologic study, address strengths and limitations of the proposed design, and present the results in the forum.

The participants will randomly be assigned to a group, and each group will complete its project and lead the discussion on its specific aspects.


Instructor
Irene Petersen, MSc, PGCert, P. Grad Dip, PhD
University College London and Aarhus University