Published: 27 April 2021
Professor Ramesh Arasaradnam and clinical trial coordinator Chris Bradley of the University Hospital Coventry and Warwickshire (UHCW) reflect on the challenges COVID-19 has brought to NHS research. In this blog, they stress the importance of continuing to make research happen.
Since the start of the pandemic, COVID research has been prioritised in NHS trusts across the UK. A three tier system was implemented by the NIHR in order to accelerate the setup and delivery of nationally prioritised COVID-19 urgent public health (UPH) studies (tier 1), with most other research falling into the lowest tier 3. Since the implementation many NHS trusts have reassigned most research staff to support tier 1 studies, often leading to research categorised into tiers 2 and 3 to be paused, delayed or abandoned.
In order to progress non-COVID patient care, it was evident that solutions were required to circumvent these challenges in an effort to deliver research for all. The RECEDE study is one such example that has had to evolve and adapt to successfully continue recruitment in a COVID world.
REducing Colonoscopies in patients without significant bowEl DiseasE - The RECEDE study - is seeking to find alternative diagnostic tools for people who present with bowel symptoms. Currently, almost all patients presenting with bowel symptoms are offered a colonoscopy – a camera examination of the large bowel. This procedure is invasive and can be very uncomfortable for the patient. In the majority of cases, no significant findings are found. RECEDE is investigating whether a simple urine and stool sample from a participant can accurately rule out any serious bowel conditions and, in doing so, avoid the need for a colonoscopy entirely.
The stool is assessed for the quantity of haemoglobin (blood) within a sample using faecal immunochemical testing (FIT), whereas the urine is tested for the composition of volatile organic compounds (VOC) produced from the sample. Preliminary evidence suggests that by combining these two tests, the accuracy for detecting bowel cancer and other serious bowel conditions is similar to that of a colonoscopy.
Impact of COVID-19
RECEDE was purposefully designed to be a simple study which required only one stool and one urine sample from participants before their colonoscopy. However, as with all research at the time, the COVID-19 pandemic required us to rethink and re-plan how this study would be conducted – particularly as there was reduced patient contact. Consequently the study adopted a completely remote recruitment plan to allow continued delivery of the project without any increased risk of transmission for the participants or research staff. Consultation and consenting participants moved from face-to-face to over the phone. Study information and sample collection kits could be posted out to participants instead of being handed to them, and they could be returned either by post or dropped off at their clinic on the day of their colonoscopy.
Though it was important when writing the protocol that both remote and face-to-face recruitment options were included, due to the uncertain nature of the pandemic we wanted the flexibility to tailor the flow of recruitment to the ever changing national situation, without the need to continually make amendments which would then require regulatory review and inherent delays.
Naturally the team faced some teething issues when the study opened, as previously all research activity would have been conducted face-to-face within a clinic. The primary issue to present itself was finding an effective way of transporting samples that patients dropped off on the day of their appointment to the correct location. Colonoscopy patients at UHCW can have their examination at multiple locations across different sites. So a system had to be established whereby each department knew what to do with the incoming samples. Through multiple telephone calls, emails and the use of posters in sample drop-off ‘hotspots’, we have established an effective line of communication and transportation to ensure all samples arrive in the correct location.
Through adopting a remote approach, the sponsor and other external sites have been able to deliver the RECEDE study throughout the second wave of COVID-19, despite being on the lowest tier in terms of research prioritisation. As more sites begin to open up again to non-COVID research, this spring we are hopeful that the successful delivery of the project throughout the waves of infection will provide reassurance that the study can be delivered in the COVID-19 era. We are looking to extend the study into 2022, so hopefully it will prove an attractive prospect to sites who may be looking at setting up their first non-COVID study of the year.
Although not possible for all studies, RECEDE has shown us that some studies can be successfully run entirely remotely. This method will likely be utilised in future research at the NHS trust as this can save nursing capacity and reduce the number of visits into hospitals for participants for research purposes.
Although COVID-19 research has proved immensely important over the last 12 months, it is important to remember that this public health crisis will not last forever. Research into other areas of healthcare remains vitally important to the improvement of patient care within the NHS moving forward. Studies like RECEDE show that research can be adapted and continue to run in these challenging times. As COVID cases decline across the country in parallel with increased vaccination uptake, it is critical that we take this opportunity to begin to open up and deliver non-COVID research again.
Professor Ramesh Arasaradnam and clinical trial coordinator Chris Bradley of the University Hospital Coventry & Warwickshire
Find out more about the RECEDE study on the NIHR Funding & Awards website and on the NHS University Hospitals Coventry and Warwickshire website.