Using Studies Within A Trial (SWATs) to increase the evidence-base for trial process decisions: how to select, design and run them

Speaker: Catherine Arundel, Peter Bower, Declan Devane, Katie Gillies, Karen Innes, Adwoa Parker, David Torgerson, Shaun Treweek

This is a pre-conference workshop at the International Clinical Trials Methodology Conference (ICTMC), Brighton, UK, 6th – 9th October 2019.  Venue is the Hilton Brighton Metropole.

Time: approx 9.00 to 12.30, 6th October

Introduction 

Randomised trials are at the heart of clinical guidelines affecting the care of millions of people around the world and are central to evidence-based health care systems.  It is odd then that the evidence available to trial teams to inform their own decisions about trial design, conduct and dissemination is so sparse.  This is true for trial processes from choice of research question through to the dissemination of results.  

This interactive workshop will give a brief overview of the trial process evidence problem and then devote the rest of the time to a key tool in the methods evaluation armoury– the Study Within A Trial (SWAT).  The workshop will give practical, hands-on advice about how to select, design, run and report SWAT studies.  Moreover, we will explain the need for coordinated and collaborative work so that high quality evidence is generated in a few years not decades as is currently the case.  

Structure of the workshop

Part 1 (105 mins)

1. Introduction and learning about participants and what they want from the workshop.  We will use this list later in the workshop (Shaun Treweek, 20 mins)
2. A tool to increase the evidence base for trial processes: the Study Within A Trial (SWAT) (Adwoa Parker, 10 mins).
3. Small group work #1.  We will divide participants into small groups of around 4-8 people.  We will give participants two SWAT examples (one qualitative, one quantitative), which they can use as the focus for considering the following questions (25 mins):
   • What are the challenges and problems I would face if I wanted to embed these SWATs in my trials?
   • What would reduce these challenges and problems?
4. Feedback from each group – A representative of each group will give feedback on the group’s discussions and other groups will be invited to comment (15 mins).
5. A Trials Unit’s experience of running SWATs (David Torgerson/Catherine Arundel, 15 mins).
6. Case studies (20 mins):
   • • The Christmas card SWAT (Karen Innes)
     • Case study from Liverpool (TBC)
     • Experience from the MRC START study (Peter Bower)
     • Post It Note SWATs (Catherine Arundel)

Break (15 mins)

Part 2 (90 mins)

1. Why would a trial chief investigator be interested in SWATs? (David Torgerson, 10 mins).
2. The ethics of SWATs (Catherine Arundel/others, 15 mins)
3. The PRIORITY prioritisation projects for recruitment and retention (Declan Devane/Katie Gillies, 10 mins)
4. Small group work #2.  The two PRIORITY projects came up with a list of priority unanswered questions in trial recruitment and retention.  In small groups, participants should consider the priority questions coming from PRIORITY 1 (recruitment) and PRIORITY 2 (retention) and suggest concrete SWATs they would like to see done under some of these headings (25 mins).
5. Discussion and open Q&A (25 mins).  This will:

• • Get feedback from small group work #2
  • Discuss the things raised in Part 1, #1  

6. Summing up (approx 5 mins).

Total time: around 3 hours 45 mins.

Target audience

Anyone interested in improving the evidence base for trial process decision-making.

Goals of the session

Participants a) gain an overview of the lack of trial process evidence and the harm it does b) learn about SWATs as a way of increasing trial process evidence c) have a hands-on session to discuss issues around designing and running SWATs in participants’ own fields and institutions.