In order for the NHS to change the way it treats patients, there needs to be a significant body of evidence that the change will be a positive one. Oesophageal cancer is considered very deadly, as it is so hard to detect in early stages. In 2009 Professor Rebecca Fitzgerald at Cambridge University set out to design a screening test for pre-cancerous condition Barrett’s Oesophagus. The Cytosponge is now used in Scottish NHS cancer screening services and will soon come to the rest of the UK. From idea to implementation has taken 11 years.
Here’s a look at how we got there:
The first step was to pilot the device, testing safety, accuracy and how acceptable participants find it. This stage guides any modifications needed to improve the device before proceeding. There was not just the device collecting the sample to consider, but the accompanying test which would identify Barrett’s Oesophagus if present. The team went through several iterations before concluding that the sample should be stained for the biomarker TFF3. BEST1 tested people in 12 UK GP practices who had prescriptions for acid suppressants, an indicator of long-term acid reflux.
The next step was to efficacy and acceptability of the test with people who would be using the test in a real-life setting. BEST2 tested people with a diagnosis of chronic gastro-oesophageal reflux disease, (which can lead to Barrett’s Oesophagus) in 11 UK hospitals. This trial showed that people with the condition found the test acceptable, and that the test itself was both sensitive and accurate.
The randomised controlled trial BEST3 tested a larger population to see if the Cytosponge test picked up more cases of Barrett’s Oesophagus than the standard care of surveillance and periodic endoscopy. One of the advantages of the Cytosponge test is that it can be administered by a nurse in a GP practice, making it very convenient, quick and inexpensive. The trial showed that the Cytosponge found more cases of Barrett’s Oeasophagus than the standard care used in the NHS.
One thing the BEST trial teams have always focussed on is the experience of the patients themselves. From comments received from participants they developed of a video of a test taking place. Participants who saw the video commented “He looked very relaxed, surprisingly… I think I'm sort of happier now, after watching the video” and “He didn’t show any gagging or anything. He was absolutely fine.” It’s this dedication to the patients that has no doubt contributed to the enormous success of this new device.