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 🙂