By John Pearce, TOFS Volunteer & TOAST representative.
For several years now, I have been the TOFS representative to the TOAST (Treating Oesophageal Atresia to prevent Stricture study), a major UK medical research exercise. After an awful lot of planning, and some setbacks, the study is expected to get going in earnest in autumn 2025.
The study aims to enable an eventual improvement in the lives of future OA/TOF babies by finding out whether it’s a good idea to give all OA/TOF babies a gastric acid suppression drug such as omeprazole for a year after their surgery. The study involves a “gold standard” randomised controlled trial, which will — once fully up and running — take place via many of the UK’s leading paediatric surgical centres. The trial aims to offer the chance to take part (it is voluntary, of course) to the parents of the majority of newborn OA/TOF babies in the UK, and it will be completed in seven years’ time.
There is no suggestion of denying anti-reflux or acid suppression treatment to those who are suffering with reflux and clearly need it, by the way. The key question being addressed is: is it a good idea to give all OA/TOF babies (whether there is reason to believe any given individual may be suffering reflux, or not) acid suppression treatment, essentially on a “just in case” basis.
The fact that this is even a question will surprise the casual observer. But there is no “gold standard” evidence anywhere in the world which shows that giving anti-reflux drugs to all OA/TOF babies (after their surgery) is beneficial, and some research which indicates it may well cause problems. The international guideline (ESPGHAN / NASPGHAN, 2016) recommends this universal anti-reflux treatment, but also says that this recommendation is based on “expert opinion” with a very low level of evidence, and it suggests that further research could result in changes.
TOFS is the patient and public participation partner for the study. About 20 TOFS members took part in detailed interviews as part of the feasibility study stage, and TOFS members make up the study’s Parent Advisory Group, which meets periodically.
I attended my first meeting about what was to become TOAST in 2019, and have been attending the study’s Project Management Group meetings for the last few years. Recognising our contribution, TOFS has even received a small amount of money from the project’s budget!
As you would expect, we at TOFS have made numerous suggestions to try to make the detail of the study (and the patient-facing language describing it) as patient-friendly as possible. One specific point is that in response to our concerns, the study team developed a “Symptomatic reflux treatment pathway”. This is intended to ensure that babies who take part in the trial and who develop what might be symptoms of reflux do indeed get treated, including if necessary with omeprazole. This pathway is shown, written in parent-friendly language, in the trial’s Parent Information Leaflet.
Quite a lot of work has already been done; the feasibility study stage started in spring 2021 and was completed during 2022. This has been published in an article in the prestigious journal BMJ Open, and it has been presented at international surgical conferences. The wider TOAST study has also been presented at several key professional conferences in the UK, Europe and beyond.
Please note that this article is deliberately written in everyday language. The detailed documents about TOAST (and there are loads) are written in appropriately precise scientific/medical terms.
