Benefits and risks of treatments are only interpretable in the context of treated patients with a given disease. In this year’s series of master classes, we start by showcasing pharmacoepidemiology challenges and methods in specific diseases and finish by the popular meta-analysis course.
Format: Brief overview lectures followed by hands-on exercises and group work rooted in real studies.
Prerequisites: basic training in epidemiology and biostatistics is assumed.
Equipment: Laptop. All participants will get a short-course STATA license for the duration of the course, which needs to be installed on laptop.
DAY 1
Get real: crash course in pharmacoepi-methods (half day)
Epidemiologic study design, prescription data, and sources of bias in pharmacoepidemiology. Confounding by indication, healthy user effects.
Sugar, statins and other stories (half day)
Brief overview of diabetes/obesity/cardiovascular disease epidemiology and treatment. Studying comparative effectiveness and drug safety.
Instructor:
Reimar W. Thomsen, MD, PhD, Aarhus University
DAY 2
Cancer epidemiology in the era of precision medicine (half day)
Treatment patterns and recurrence, immortal time bias, targeted therapies.
Instructors:
Deirdre Cronin-Fenton, PhD, Aarhus University
Mette Nørgaard, MD, PhD, Aarhus University
Drugs and biomarkers in renal diseases (half day)
Longitudinal data, defining outcomes using laboratory values, longitudinal data with repeated measurements.
Instructor:
Christian Fynbo Christiansen, MD, PhD, Aarhus University
DAY 3
Perinatal pharmacoepidemiology (half day)
Design, analysis, and biaas as applied to studies of drug treatment in pregnancy.
DUS and Don’ts (half day)
Drug utilization and risk minimization studies. Interrupted time series regression. Validation studies of routinely collected data.
Instructors:
Irene Petersen, PhD, University College London and Aarhus University
Vera Ehrenstein, MPH, DSc, Aarhus University
DAY 4
Meta-analysis (part 1)
The course 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 observational studies. Core elements will also be covered in hands-on practical sessions. These sessions will be provided in R and STATA. After the course, the students should be able to perform a standard meta-analysis by themselves.
Instructors:
Olaf M. Dekkers, MD, PhD, Leiden University Medical Center
Saskia le Cessie, PhD, Leiden University Medical Center
DAY 5
Meta-analysis (part 2)
The course 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 observational studies. Core elements will also be covered in hands-on practical sessions. These sessions will be provided in R and STATA. After the course, the students should be able to perform a standard meta-analysis by themselves.
Instructors:
Olaf M. Dekkers, MD, PhD, Leiden University Medical Center
Saskia le Cessie, PhD, Leiden University Medical Center
The 2021 Pharmacoepidemiology Summer School was cancelled due to COVID-19. See the 2020 program below.
DAY 1
Get real: crash course in pharmacoepi-methods (half day)
Epidemiologic study design, prescription data and sources of bias in pharmacoepidemiology. Confounding by indication, healthy user effects.
Sugar, statins and other stories (half day)
Brief overview of diabetes/obesity/cardiovascular disease epidemiology and treatment. Studying comparative effectiveness and drug safety.
Instructor:
Reimar W. Thomsen, MD, PhD, Aarhus University
DAY 2
Cancer epidemiology in the era of precision medicine (half day)
Treatment patterns and recurrence, immortal time bias, targeted therapies.
Instructors:
Deirdre Cronin-Fenton, PhD, Aarhus University
Mette Nørgaard, MD, PhD, Aarhus University
Drugs and biomarkers in renal diseases (half day)
Longitudinal data, defining outcomes using laboratory values, longitudinal data with repeated measurements.
Instructor:
Christian Fynbo Christiansen, MD, PhD, Aarhus University
DAY 3
Bone disease and device safety (half day)
Measuring adherence and persistence of long-acting agents. Health Technology Assessment. Safety of devices.
Instructor:
Alma B. Pedersen, MD, PhD, DMSc, Aarhus University
DUS and Don’ts (half day)
Drug utilization and risk minimization studies. Interrupted time series regression. Validation studies of routinely collected data.
Instructors:
Irene Petersen, PhD, University College London and Aarhus University
Vera Ehrenstein, MPH, DSc, Aarhus University
DAY 4
Meta-analysis (part 1)
The course will give a broad 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, differences between meta-analysis of randomized trials and meta-analysis observational studies. Core elements will also be covered in hands-on practical sessions (risk of bias analysis, statistical analysis). After the course, the students should be able to perform a standard meta-analysis by themselves. The course will briefly cover some more advanced topics (network meta-analysis, combining different metrics).
Instructor:
Olaf M. Dekkers, MD, PhD, Leiden University Medical Center
DAY 5
Meta-analysis (part 2)
Instructor:
Olaf M. Dekkers, MD, PhD, Leiden University Medical Center
Advanced topics in pharmacoepidemiology (2 days)
Professor M. Alan Brookhart
University of North Carolina at Chapel Hill
Self-controlled study designs (1 day)
Professor Ian Douglas
London School of Hygiene and Tropical Medicine
Perinatal and reproductive pharmacoepidemiology (1 day)
Professor Irene Petersen
University College London and Aarhus University
Professor Vera Ehrenstein
Aarhus University
Reporting our research using routinely-collected health data better- introducing STROBE, RECORD and RECORD-PE (half day)
Professor Sinead Langan
London School of Hygiene and Tropical Medicine
Pharmacoepidemiology and Comparative Effectiveness Research (2 days)
Professor Til Stürmer & Assistant Professor Jennifer Lund
University of North Carolina at Chapel Hill
Meta-Analysis (2 days)
Professor Olaf M. Dekkers
Leiden University Medical Center and Aarhus University
Group Work: Designing a Pharmacoepidemiologic Study (half day)
Professor Irene Petersen
University College London and Aarhus University
Professor Vera Ehrenstein
Aarhus University
Advanced Topics in Pharmacoepidemiology (2 days)
Professor Alan Brookhart, BA, MAMS, MA, PhD
University of North Carolina
Dr. Leah Sirkus McGrath, BS, MHS, PhD
NoviSci, LLC
Missing Data Issues (1 day)
Professor Irene Petersen, MSc, PGCert, P. Grad Dip, PhD
University College London and Aarhus University
Self-controlled Designs (1 day)
Associate Professor Ian Douglas, BSc, MSc, PhD
London School of Hygiene and Tropical Medicine
Perinatal and Reproductive Pharmacoepidemiology (half day)
Professor Irene Petersen, MSc, PGCert, P. Grad Dip, PhD
University College London and Aarhus University
Professor Vera Ehrenstein, MPH, DSc
Aarhus University
Introduction to Pharmacoepidemiology (half day)
Professor John Acquavella
Aarhus University, Aarhus, Denmark
Questions to Consider Regarding the Application of the Results of a RCT of the Efficacy of Therapy to the Management of Patients (half day)
Professor Noel Weiss
University of Washington, Seattle, USA
Pharmacoepidemiology and Comparative Effectiveness Research (2 days)
Professor Til Stürmer & Assistant Professor Jennifer Lund
University of North Carolina, Chapel Hill, USA
Meta-Analysis (2 days)
Professor Olaf M. Dekkers
Leiden University Medical Center, Leiden, The Netherlands and Adjunct Professor at Aarhus University, Aarhus, Denmark
Introduction to Pharmaceutical Risk Management (half day)
Visiting Professor John Acquavella
Aarhus University, Denmark
Pruning the Research Question (half day)
Professor Jan P. Vandenbroucke
Leiden University Medical Center, The Netherlands and Aarhus University, Denmark
Pharmacoepidemiology and Comparative Effectiveness Research (2 days)
Professor Til Stürmer & Assistant Professor Jennifer Lund
University of North Carolina, USA
Visiting Professor and Visiting Scientist, respectively, at Aarhus University, Denmark
Systematic Review and Meta-Analysis (2 days)
Associate Professor Olaf M. Dekkers
Leiden University Medical Center, The Netherlands and Honorary Professor at Aarhus University, Denmark
Issues in study design (2 days)
Randomized clinical trials
Associate professor Vera Ehrenstein, MPH, DMS
Power and sample size calculation
Associate professor Anders H. Riis, MSc
Cohort studies
Clinical associate professor Christian Fynbo Christiansen, MD, PhD
Issues in randomization and hypothesis testing
Consultant Søren Paaske Johnsen, MD, PhD
Case-control studies
Associate professor Deirdre Cronin-Fenton, BSc, PhD
Clinical associate professor Mette Nørgaard, MD, PhD
Cross-sectional studies
PhD student Morten Schmidt, MD
Drug safety (1 day)
Professor Tom MacDonald, BSc, MD, FRCPE, FRCPSG, FESC, FISPE, FBPharmacolS
Systematic review and meta-analysis (2 days)
Associate professor Olaf M. Dekkers, MD, MSc, MA, PhD