In this post, we interview Irene Debiram-Beecham, clinical coordinator for the BEST3 trial. Irene is a Senior Research Sister in Professor Rebecca’s Fitzgerald’s group and ensures that patients are accurately recruited into the BEST trials. In addition, she trains new staff on the use of the Cytosponge, and is a point of contact for patients, ensuring their appointments and results are organised and delivered on time.
What were patients initial reactions to the Cytosponge?
Most patients were curious in the first instance and because of their symptoms thought it was a great opportunity to get it checked out. I guess because it was linked to their GP practice they also felt that if the GP recommended them to have the procedure then it was worth doing it. Some of them just wanted to give something back to society by helping with research. Initially when they saw the pill most patients said they could manage it. For some patients the idea of having something pulled back up their oesophagus was not appealing but because of their symptoms and possible family history they agreed to do it anyway.
The acceptability score as you know from the paper was quite good and out of 1464 patients most patients rated the Cytosponge as a score of 5 and above. The median score was 9 overall with 10 being completely acceptable.
BEST3 involved 13,000 people from 109 different GP surgeries across England. What advice would you give to anyone setting up a trial of this size in the future?
I think the main thing is that there are so many facets to this project.
My initial advice is to get all the help you can and make sure that resources are in place and the study is funded appropriately. If it is a primary care/ secondary care based study link in with the CRN early as far back as the funding stage. They will ensure that you cost your project up appropriately. It is a huge undertaking and requires a lot of commitment and dedication. Beth Muldrew the project manager and myself worked tirelessly in making sure we met the timelines for this study. We also had a very supportive and engaged CI Professor Rebecca Fitzgerald who we met with regularly. Use Docmail where you can and it saves a lot of time and effort when posting study info and having different mail out at different times.
It also worth considering running the study via a trials unit as they would have the infra structure and possible expertise in place to support a study of this magnitude such building a bespoke database, CRF development, sample collection procedures and templates for documents ( SOPs etc) so that you are not having to start everything from scratch. You need to make sure that your study and time lines are planned taking into account areas where you would get bottle necks in the project such as protocol development and ethics submission. Engaging with a multitude of CRNs and health care professionals across the country and keeping everyone engaged so that they deliver on the study. We did a lot of publicity by presenting at GP forums and various meeting to build an interest and profile for the study. Be prepared to travel and engage with your sites. With a study of this magnitude you are dealing with a number of individuals and different skill mix and therefore you need to be prepared to support the teams where there are gaps otherwise recruitment and data collection will suffer. Also don’t forget to engage with the legal team to make sure that the relevant contracts are in place for Training, Staff working in different settings, Data transfer and sharing agreements.
In terms of our finance, tracking reimbursements for this project was also a key element and we needed to ensure that practices were reimbursed in a timely and appropriate manner. Make sure you have a good system and someone in post to track that all practices and secondary care institutions are reimbursed promptly and accurately.
Biggest challenge faced in this trial?
Getting all the nurses trained up to administer the cytosponge and to carry out their clinics independently. Supporting these clinics until the nurses felt competent and we were able to sign them off. We also had to support endoscopy teams in making sure that the endoscopy was carried out according to study protocol and samples were taken and reported appropriately. Running the searches correctly, and making sure that the list of patients we had was accurate and labelled correctly presented some challenges too? Finally, I’d say that keeping practices and hospital and teams engaged and delivering results on time was difficult- but this was something we strived to achieve, to make sure hospitals felt they were always kept in the loop.
What’s next for you in the BEST trials?
Well I think for the moment the name has taken a different turn and we are now about to start a project called DELTA (integrateD diagnostic solution for EarLy deTection of oesophageal cAncer) which is funded by innovate UK grant where we aim to implement the Cytosponge as a diagnostic tool into clinical practice. We see the cytosponge being used as an option via the dyspepsia service and for some of our BE surveillance patients. We are working with Medtronic in the commercial role out to secondary care in the first instance and then to Primary care. We recently did a pilot study in Tanzania and we hope that a much bigger study will emerge as the pilot showed a need for a simple and easy test like this used for early detection of Ca of oesophagus particularly Sq cell carcinoma due to a higher incidence in these countries. We are also working with colleagues in India and Poland in setting up similar projects using the device in a commercial setting. The device is simple and safe and the results are accurate in comparison to an endoscopy as shown in the recent BEST3 trial. We hope that with emerging interest and also as a result of COVID 19 many Gastroenetrologist are looking for alternative to diagnosing patients with upper GI symptoms. Hence it has spun quite a lot of interest in the UK and Scotland.
We look forward to working with these various different teams in getting this device commissioned into clinical practice.
The views expressed are those of the author. Posting of the blog does not signify that the Cancer Prevention Group endorse those views or opinions.