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TOFS involved in another big research project!

TOFS involved in another big research project!

In 2021, the feasibility study stage of a major UK research programme – called TOAST (Treating Oesophageal Atresia to Prevent Stricture) – will get underway. The intention is to run a “gold standard” randomised controlled trial to establish whether or not the routine use of antacid drugs with OA/TOF babies is helpful to them. The multi-year programme is expected to involve most of the 26 UK surgical centres where OA/TOF babies are initially treated.

TOFS is now asking for members to be interviewed by the TOAST feasibility study team, as part of a consultation about the detailed design of the trial.

The researchers are now ready to recruit approximately 25 parents/legal guardians to take part in an interview to discuss the details of the envisaged trial, so as to ensure that patients’ interests are built in from the start. An information leaflet will be sent prior to interview so you can see how they are proposing to run the trial.

The team is looking for people whose OA/TOF baby was born within the last 3 years. The volunteers need to include a mixture of those:

  • whose babies did and did not receive routine antacids (e.g., omeprazole) for most or all of their first year, and;
  • whose babies did and did not develop a stricture in that time;
  • whose babies underwent their surgery at a variety of UK paediatric surgical hospitals.

The researchers would conduct (approximately 45 minute) interviews by Zoom or telephone with interested parents/guardians. It is hoped that the interviews will begin in June 2021.

An Amazon voucher will be offered as a token of thanks.

More details are available via:

Background to the Study

It is thought that around half of the UK’s OA/TOF babies are routinely given antacids. Indeed, the 2016 North American Society For Pediatric Gastroenterology, Hepatology & Nutrition/ European society for paediatric gastroenterology, hepatology and nutrition (NASPGHAN / ESPGHAN) guidelines suggest this, but only on the basis of expert opinion, backed by a low level of evidence: this is a signal that more research would be welcome. Research done around the World to date has been limited with no major controlled trials and it has not so far been clearly established that routine use of antacids with OA/TOF babies is beneficial.

This TOAST research programme will be the biggest trial of its type in the World, and will be a major UK contribution to knowledge about how best to treat OA/TOF babies. We anticipate that its outcomes will make it possible to strengthen or alter the ESPGHAN/NASPGHAN guidelines.

TOFS is involved in this project as “Patient and Public Involvement” partner, trying to ensure that the interest and concerns of patients are built in from the start.

For more information, please see the official project press release.

Notes: In 2016 a set of guidelines for the care of those born with OA were published, under the banner of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition, jointly with the North American society of the same name. Our international federation of OA/TOF support groups (EAT) reviewed the guidelines before publication. TOFS has drawn members’ attention to these guidelines a number of times in Chew. And we are asking the British body BSPGHAN what we need to do to have such guidelines formally adopted in the UK.

In a typical randomised controlled trial, a randomly-chosen half of the participants are given the medication being trialled, and the other half an identical – seeming placebo. If the medication is effective, the outcomes for the two groups of participants are notably different.

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