The term “pragmatic attitude,” was introduced by Daniel Schwartz and Joseph Lellouch [J Chron Dis 1967;20:637-48] to designate a trial architecture designed to answer the practical question of whether offering an intervention in routine healthcare setting does more good than harm. Pragmatic trials have been receiving increasing attention as patients, clinicians, organizers and payers for health services are increasingly searching for answers (e.g., the burgeoning programs of “Comparative Effectiveness” research). However, this increasing attention has exposed considerable confusion and disagreement about whether pragmatic trials are “less perfect experiments” than efficacy [explanatory] trials, whether permitting non-compliance and cross-overs is a “problem,” whether knowing one’s treatment and telling examiners how one feels creates “bias,” and whether other departures from the explanatory architecture are good use of limited resources to answer burning questions about the benefits and harms of interventions. This 3-hour course will cover the following objectives:
- To describe what a pragmatic trial is, and how it is different from an explanatory trial;
- To know the pros and cons of pragmatic trials;
- To be familiar with the PRECIS tool for the design of pragmatic trials;
- To learn how to analyze and report pragmatic trials using the CONSORT extension to pragmatic trials; and
- To understand the common controversies and criticisms of pragmatic trials, and how to address them in design and analysis.
Schedule:
Lehana Thabane (McMaster University) (9:00-10:20)
Coffee break: (10:20-10:40)
Kevin Thorpe (University of Toronto) (10:40-12:00)
lunch break: (12:00-13:30)