Publication Explainer: Trial Forge Guidance 1: what is a Study Within A Trial (SWAT)?

This is the third in my ‘Publication Explainer’ series, read the first and second here and here. As I have said previously, these explainers are a place for me to answer some of the most common questions I’ve been asked by the people around me (usually my boyfriend, friends, or colleagues that haven’t been involved with the project).

This post focusses on the paper below: Trial Forge Guidance 1: what is a Study Within A Trial (SWAT)? Read the full paper here.

What is a SWAT?

A SWAT is a Study Within A Trial – i.e. a self-contained research study that is taking place within a clinical trial. Usually SWATs focus on a methodological aspect of a trial, e.g. evaluation of: an intervention that is designed to improve the recruitment of participants to trials; an intervention that is designed to keep participants engaged with the trial (i.e. retention of participants); or an intervention that is designed to find out more about the way that data is collected (e.g. online versus paper). Often

Why are you trying to encourage people to do SWATs?

It is important that we encourage people to do SWATs because they are so often underpowered. Statisticians can calculate the sample size needed for the results to enable us to see a difference between the two interventions; if we hit that target sample size (i.e. recruit enough participants) then the result is less likely to be down to pure chance. As sample size calculations are done for the host trial, and not the SWAT, it’s likely that the SWAT will be ‘underpowered’ – meaning that the effect that we see in the results may not be a real effect; it could be down to chance. That’s ok though, because SWATs are designed to enable the data from them to be pooled with the same SWATs that have been done in other host studies.

What are you aiming to do in this paper?

This paper is the result of a huge amount of discussion, much of which started at a face to face event that was held in Aberdeen last year, the group of authors on this papers is pretty big, and that reflects everyone that took part in that event and the discussions that came after it. As a group, we are very conscious that SWATs are one of the most obvious (and arguably, easiest) ways for us to improve the way that trials are designed and conducted; so it’s important that we encourage people to do them. It is not realistic to think that trial methodologists can do all of the SWATs that we need; there just isn’t enough of us, and we need trialists to help us. By writing and publishing this piece of guidance, we aimed to produce a one-stop paper where people could go to find out what a SWAT is easily.

Within the last few days, we’ve submitted ‘Trial Forge Guidance 2: How to decide if a further Study Within A Trial (SWAT) is needed’ to the same journal, Trials. Trials journal is currently taking part in a pilot along with a number of other journals that fall under the BioMed Central umbrella, when authors submit their papers for publication they have the option of publishing a pre-print of their work. This pre-print edition is published online within about a week, meaning that the peer review process can run along side, but the research is being disseminated more more quickly. Once that pre-print is available, I’ll share it on the blog so you can read that too 🙂

Studies Within A Trial (SWAT) Workshop – Aberdeen, 23rd March 2017

I realised earlier in the week that I haven’t talked a huge amount about the other projects I’m involved with aside from my PhD work, so this week’s post is about a project linked, but not central to, my own research project.

Studies Within A Trial (SWATs) are smaller studies embedded within a host trial, largely they have the aim of investigating some methodological aspect of the way we conduct the trial. There are currently 46 SWATs listed on the SWAT repository, which mainly look at recruitment and retention of participants; the two most difficult parts of the trial process.

These types of study are notoriously difficult to get funding for, they’re often poorly understood by approvals and ethics bodies, and they tend to be the first thing to fall off the list of priorities for trial teams as they’re an ‘add-on’ – a bonus that’s not central to the aims of the overarching trial. On Thursday last week I attended a SWAT workshop led by my PhD Supervisor in Aberdeen. Other attendees included representatives from pharma, the National Institute for Health Research (NIHR), the Health Research Authority (HRA), researchers, clinicians, trial managers, patients and directors of UK Clinical Trials Units.

Our discussion was lively, wide-ranging and incredibly useful. We tackled the tricky aspects of how to gain approvals, how to get funding, and how to galvanise the trials community to embed the use SWATs in routine practice.

One thing that I found really valuable was the discussion with patient representatives; we had 2 ladies join us to give their opinions. They drew our attention to topics I hadn’t necessarily thought of before, and helped us work through how we might (or might not) explain this additional study to trial participants both at the beginning and end of the study.

Throughout the day I took lots of notes – scribbling away whilst different people were talking to ensure I didn’t miss key points. We ended up discussing how to make SWATs easier to do for around 6 hours so my pile of notes was pretty huge! Once I’d got home I read over my notes whilst the discussion was fresh in my head, and consolidated them into one side of A5.

I find this a really useful thing to do after a day at a conference or workshop – it helps me to summarise topics in my head and ensures I don’t just push my pile of notes to the back of my desk drawer to be forgotten about.
Does anyone else do this or is it just an excuse I’m making to get the best use out of my unhealthily large stationery collection…?

Getting involved with additional projects outside of the PhD has been so valuable for me – it’s helped to improve my time management skills, expanded my knowledge of health services research more generally, but most importantly it’s helped me build confidence. I really enjoyed the day, and found it useful to speak to people outside of my own little research group; we tend to agree on a lot of things so it’s refreshing to get a new perspective and be challenged on points I’d previously taken at face value.