What is a pragmatic trial and how do I do a good one?

Conference: 
SAPC ASM 2019 - Exeter
Talk Code: 
6F.1
Presenter: 
Sandra Eldridge and Sally Kerry
Author institutions: 
Queen Mary University London and University of London

AIM AND INTENDED OUTCOME/EDUCATIONAL OBJECTIVES 

The aim of this workshop is to give participants a better understanding of pragmatic trials. It is intended that participants leave the workshop with a clearer understanding of the definition of pragmatic trials, the key ways that these trials differ from explanatory trials, and the aspects of these trials that need to be thought through carefully in order to avoid some of the common pitfalls. 

Objectives: 

1.                To provide a clear definition of pragmatic trials 

2.             To introduce participants to the idea of a spectrum between explanatory and pragmatic trials and the PRECIS-2 tool that can be useful in understanding where on the spectrum trials are 

3.             To consider some specific aspects of pragmatic trials on which investigators need to make decisions  

FORMAT 

A.      An introduction to the workshop and objectives 1 & 2 will be covered. Slides will be used for objectives 1 and 2.  

B.      Small group discussions. Participants will consider some specific aspects of pragmatic trials in small groups, thinking about how they might make decisions about these aspects. Introductory scenarios will be provided for groups to discuss, but if participants have brought examples of their own trials these can also be discussed.  

C.      Whole group discussion. Feedback on small group discussions. 

D.      Quiz to determine participants views on aspects of pragmatic trials at the end of the workshop, and conclusion.

The workshop will cover definitions of pragmatic trials; the PRECIS-2 tool which has nine domains representing different aspects of trials that can be rated on a pragmatic-explanatory spectrum including, for example, how flexible an intervention is, how intensive  follow-up is, how much additional resource is necessary to implement the intervention. We will also cover how to define the intervention, current regulatory frameworks and pragmatic trials, how important are pilot studies, bias and blinding, and what sort of designs can be used.   

INTENDED AUDIENCE 

The workshop is designed for anyone - those who know nothing about pragmatic trials as well as those who are more experienced and are conducting, have conducted or plan to conduct, such trials.