East Lancashire team makes flying restart on reproductive health study
The Women and Children's Health Research Team at East Lancashire Hospitals NHS Trust (ELHT) were able to recruit their first patient within days of re-opening an NIHR Clinical Research Network Portfolio study during the coronavirus outbreak.
The team, who are based in CRN Greater Manchester, initially had to pause recruitment to C-STICH due to the COVID-19 pandemic.
C-STICH is an interventional, randomised controlled trial taking place at multiple sites, including ELHT’s Lancashire Women and Newborn Centre at Burnley General Teaching Hospital.
The study is investigating the most suitable thread-type to use when stitching the cervix in cases where it has opened in the early months of pregnancy.
Despite having to pause initially, the team at Burnley were able to safely re-open the study during lockdown and recruit a participant in just two days.
Bev Hammond, ELHT Team Leader for Reproductive Health, explains how a practical approach and an excellent working relationship between the Principal Investigator and the research team allowed them to restart C-STICH promptly.
Bev says: “We are in the enviable position where COVID-19 did not have a significantly negative impact on the Women and Children's Health Research Team at ELHT. While other trust colleagues were redeployed to other service areas, we were fortunate to retain our staff and could therefore maintain continuity for our existing workload.
“The trust has played an integral role in delivering Urgent Public Health (UPH) COVID-19 studies under the leadership of our new Director for Research and Innovation, Dr Srikanth Chukkambotla. Our team has predominantly supported those UPH studies within Reproductive Health and Childbirth but also made a wider contribution alongside our multidisciplinary colleagues. We felt, however, that in addition to these studies, we still had capacity to deliver some of our existing portfolio.
“Prior to the pandemic, we had recently welcomed Mr Yen Eit Liew Liew as our new Principal Investigator (PI) for C-STICH and, with his support, assessed how to efficiently move forward with C-STICH. As part of this, we evaluated whether there had been any changes in clinical practice that would affect recruitment to the study.
“We have historic, strong relationships with our clinicians, and have always had excellent support from them in relation to C-STICH. Within our pre-term labour clinic, developed shortly before the pandemic, this cohort of patients was still being seen clinically.
“To discuss how we could move forward during COVID-19, I had a video call with the PI to discuss what would be required from both a clinical and research perspective. Mr Liew’s priority was the safety of the research team and reducing footfall in clinical areas.
“This enabled us to complete a Trust-developed risk assessment, and we decided on the best strategy for recruitment. We agreed clinicians would be responsible for identifying, approaching patients and counselling regarding the study once the decision for cerclage [cervical stitch] was made, rather than our team increasing unnecessary presence in clinics.
“Once the risk assessment was completed, it was evident that the study would continue to fit in with current clinical practice and our R&D department were happy for us to re-open the study.
“Upon the green light to resume recruitment, we identified a patient who was booked for cerclage. She had already been approached by clinicians about the study and was happy for further information. As part of the direct clinical team, I phoned the lady, discussed the rationale, and she confirmed her willingness to participate. The consent forms were signed when she was admitted and subsequently randomised in an effective manner, ensuring a minimal amount of time on the wards.
“It was a great achievement to have our first portfolio study back up-and-running, as we have put a lot of time and effort into C-STICH over the years, and we were delighted to be able to offer this important study to our patients again.”
Michelle Stephens, Head of Research and Innovation at ELHT, says: “The sponsor contacted the research team at the beginning of May to let us know that the study had restarted recruitment, subject to clinical capacity at Investigator Sites. The women who are eligible for this study continued to attend hospital for clinical care throughout COVID-19, so it was really important to us that we restart recruitment into this important study and offer women the opportunity to join the research as an option for their care.
“At the start of the outbreak we formed a dedicated COVID-19 research team with other members of our Research Delivery Team re-deployed to clinical services or taking responsibility for caring for existing participants in non-COVID-19 research. Thanks to the generosity of our patients we’ve entered 1,412 patients into COVID-19 research, an endeavour which continues and places us in the top 20 Trusts nationally.
“Our local restart process is for Research Team Leaders to liaise with PIs and clinical service leaders to assess the feasibility for restarting research studies. We have a proforma which captures information to ensure all essential requirements for patient and staff safety can be met, that the study is still viable and feasible within the clinical and research services and that we fulfil our contractual obligations. The Research Support Office is in regular contact with Team Leads throughout the process and we provide a rapid review and response to requests to restart studies.
“To date we’ve restarted 17 research studies with work ongoing to restart many more. We are delighted to re-establish our usual service, bringing high-quality research to as many East Lancashire patients as possible."