What is your role?
I work as a consultant in respiratory medicine at North Tees and Hartlepool NHS Foundation Trust. Since the COVID-19 pandemic started, I have been our Trust’s principal investigator for the RECOVERY Trial.
What are your normal duties?
Normally, I alternate between working on the inpatient wards and in the outpatient clinics. During ward-based weeks, I spend the mornings reviewing and treating hospital patients, then carry out clinical duties in the afternoons. For weeks when I am based in the outpatient clinic, my tasks generally involve assessing patients with respiratory symptoms and carrying out diagnostic tests or surgical procedures.
What I particularly love about respiratory medicine is that it is such a broad speciality because so many diseases affect our breathing system. It is also a very patient-focused speciality, where traditional physical examination and history taking remain the cornerstone of assessment, which requires direct, face-to-face interaction with patients. But at the same time, we get to use some very high-tech kit, such as cutting-edge ultrasound machines.
What happened when COVID-19 first arrived in the UK?
Because we are based in the North East, we had some advance warning about what was coming by watching what was happening in London. So from mid-March onwards, our efforts were focused on planning and preparing. As a respiratory specialist, I was naturally heavily involved in this. We knew we didn’t have enough capacity for respiratory support within our immediate team alone, so we had to rapidly train staff from other clinical areas.
Over one two-week period, our specialist nursing team trained over 300 staff to manage respiratory failure and use continuous positive airway pressure (CPAP) machines.
When the first wave of COVID-19 patients hit, it was hugely challenging and upsetting, as the mortality rate was so high then. Our intensive care unit (ICU) was overwhelmed, and had to expand into other hospital areas. One of the first COVID-19 patients was a local GP who sadly didn’t make it. This caused a lot of staff to worry about their own risks.
Given the burden you were under, why did you think it was important to take part in the RECOVERY trial?
In the early days of the pandemic, there was a very strong feeling that if there was any evidence at all that a drug might possibly help COVID-19 patients, we should just give it to them. But we knew that such an ad hoc approach would mean that we wouldn’t be any wiser about what actually worked or not. It was fantastic to hear that there was going to be a trial that would test promising medicines in a systematic fashion. As a clinician, it really eases the burden.
When you have a patient who is desperately ill with a condition you don’t know how to treat, and you have many drugs that might potentially work – how do you choose which one to try? RECOVERY provided the structure we needed to make a decision that we knew was in the patient’s best interest.
You have been one of the most successful trusts for recruitment, having recruited over 900 COVID-19 patients to RECOVERY so far. How did you do this?
It was a real team effort, across all clinical grades and levels. Even before the pandemic, we had strong inter-departmental relationships as we are a medium-sized hospital trust, so different units tend to be integrated on the front line, rather than tucked away. We also had top-down support from our medical director and board of governors, who emphasised that RECOVERY was the right thing to do for our patients. A key decision our trust made was to not redeploy our research nurses into clinical roles, as many were elsewhere. This meant they could fully support RECOVERY, besides the other COVID-19 related trials we were participating in.
Right from the planning stage, we were very proactive in making sure that RECOVERY was fully integrated into the standard care for all COVID-19 patients. Our clinical teams were briefed so that they knew to mention the trial to COVID-19 patients at the first opportunity, rather than waiting for a few days. This meant patients were pre-alerted by the time they saw a consultant, and had already had time to consider taking part.
All the staff were exceptional and really motivated. It was the first time many of the junior doctors had been involved in proper research, so they felt a particularly strong sense of ownership. Before, clinical trials were just something they read about.
We made sure that we recognised and rewarded their enthusiasm; for instance, the research nurses gave out little prizes when we reached key recruitment milestones, and we engaged with local and national press to champion how our staff were fighting back against COVID-19. It created a positive cycle: the more successful we were in recruitment, the more motivated staff became.
What were the highlights?
When the RECOVERY Trial leaders announced that the study had found the world’s first proven COVID-19 treatment, the steroid dexamethasone, it was a really positive moment. Everybody realised that all our hard work had paid off. Before the pandemic, I had been involved in various clinical trials, and normally it takes several years before you see any results. So it was brilliant to contribute to this discovery, made within three months of the trial’s launch and in time to make a real difference to patient care and survival worldwide.
In addition, our hospital was particularly quick off the mark when new treatments were added to RECOVERY, thanks to our strong interdepartmental communication and a really switched-on pharmacy team. We were the first hospital trust to recruit patients to the dimethyl fumarate, tocilizumab and monoclonal antibodies (Ronapreve) arms of the study. Until Ronapreve entered the trial, RECOVERY had only tested pre-existing treatments for other conditions, so it felt particularly exciting to be the first to offer an entirely new, ‘designer’ treatment that specifically targeted COVID-19.
What is the situation now?
Things are a lot better now compared with the peaks at the beginning of the pandemic and last winter. The worst period was after Christmas last year, when we reached a high of 220 COVID-19 inpatients at one time. Although we have a relatively small number of COVID-19 patients now, they are still coming. But the treatments discovered through the RECOVERY trial have definitely made a difference. Inpatient mortality from COVID-19 has markedly reduced and fewer people reach the point where they require intensive care and mechanical ventilation. The challenge now is to manage their care whilst also keeping the other clinical areas fully open, many of which are having to deal with a huge backlog of patients. Now that the focus isn’t solely on COVID-19, we have patients with a wide range of conditions, and we have to keep them all safe.
What lessons do you hope will be applied from RECOVERY to clinical research in the future?
I’m really hopeful that the pandemic will make clinicians remember the role that research plays in driving forward improvements in patient care, and that this doesn’t need to be done in an external place. Instead it can be integrated within front line clinical care. Also, I hope patients and the public will be more aware of how clinical trials help us answer important questions about healthcare, and how important it is that people take part.
What the RECOVERY trial has demonstrated in particular is that clinical research doesn’t necessarily have to be done according to a single, set model. Undoubtedly, a crucial element of RECOVERY’S success was its simplicity – from the protocol and training tools, to how patients were recruited and randomly allocated a treatment. For instance, the online training videos for clinicians were quick and easy to understand. If every clinician had to complete a training programme similar in length to those for conventional trials (which usually take up a whole day), we would never have recruited the volume of patients that we did.