The impact of COVID-19 on clinical practice and research: perspective from the RECOVERY trial
Anisa Jafar, an NIHR Academic Clinical Lecturer at HCRI, is directly managing COVID-19 patients as an emergency medicine doctor but also as part of her involvement in the recruitment of the Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial at the Manchester Royal Infirmary Emergency Department.
We asked Anisa about how COVID-19 has affected her work in clinical practice and research, and her involvement in the RECOVERY trial.
How has the COVID-19 crisis affected your work?
As lock-down was put into place in the UK, my new role, split 50% clinically and 50% research, was just about to start. Within the 24 hours prior, academic roles were suspended in favour of clinical staff offering their whole time back to the NHS front-line.
Can you tell us about the RECOVERY trial you are involved in?
The Manchester Royal Infirmary (MRI), part of Manchester Foundation Trust (MFT), is one of many hospitals across the country recruiting patients to the RECOVERY trial. This is a little unusual as clinical trials go, because it has had to adapt quickly to a changing clinical landscape. Faced with a poorly understood coronavirus, theories of pathophysiology, potential treatments and evolving data on those at most risk, research has needed to be pragmatic and quick but also ethical.
Patients with suspected COVID-19 infection in hospital have the potential to be recruited into the trial which randomly allocates them to standard treatment alone (which at present is supportive and includes oxygen and ventilatory support if the illness becomes more severe) or to additionally receive one of the trial treatments. It is a clever design, because if patients have reasons why one or more of the treatments would not work for them, they can be randomly allocated to any other of the treatments, or standard care.
Is there any evidence so far that the trial will treat patients with COVID-19?
At present, there is no convincing evidence that any of these treatments which currently include lopinavir-ritonavir, dexamethasone, hydroxychloroquine, azithromycin or tocilizumab (used in a variety of other medical conditions such as inflammation and HIV) are useful for treating COVID-19 in humans, and they do have potential side effects. Therefore, it is exactly the right thing to do to investigate whether they are useful rather than blanket administer one or more of them to all patients. Already more than 9000 patients have been recruited and so we have a good chance of getting some reliable answers.
What challenges have there been in the process of the trial?
It has not been straightforward to consent patients. This is for several reasons: avoiding moving paperwork from an infected patient bedside has meant that we have needed to note witnessed consent rather than written consent, and then again, to reduce patient contact, sometimes this witnessing has needed to be done via phone through the ward door/window. Layered on top of this has been the need to do multiple consents one after the other if patients are in the same bay, again to reduce the amount of entering and leaving the clinical area. So meticulous attention to detail and cross-checking has been paramount, especially given that ward set-ups have been modified and staff are often unfamiliar with bay and bed numbering in that environment.
In this setting it feels almost like you have one shot and need to really get it right first time and so it is a little time consuming to prepare, especially for the dedicated team of research nurses. Because this trial has been rolled out widely, it will recruit large numbers of patients fairly quickly and hopefully we’ll begin to get answers as to whether any of the treatments are better than the standard of care alone. It has felt quite a privilege join the team at the MFT who are recruiting patients into the trial at such a crucial time and are amongst the highest recruiting units in the country.
Do you feel your involvement has made an impact on COVID-19 recovery efforts?
Whilst the RECOVERY trial was a way for me to feel like I was contributing to the bigger picture, there was more to be done in providing clear and concise information about COVID-19 for the public and the medical profession.
At one stage I’d wondered about and discussed a single-safe-space approach for emergency medicine, somewhere you’d be able to access everything you might need, all up to date, from government documents, to clinical updates, to local updates. However it became clear that the avalanche of new information, websites and articles would be so challenging to control that any such initiative would just add to the noise.
As a side-step from that, a combination of those involved in the Emergency Medicine/Critical Care educational platform called St. Emlyn’s and the RCEM Learning team, developed an initiative to help emergency care providers to be able to digest and translate some of the scientific literature around COVID-19. Via webinars and weekly updates, we have been able to help bridge some of the gap between a mountain of literature and what it means for clinical practice.
How do you feel your previous experience in humanitarian research connects to your current role?
It is hard to pin-point the precise answer to this question, but equally I am aware that the skill-set I have been fortunate to develop is playing a role. The biggest lesion I have learned from my research has been combining pragmatism and transparency. There is no point to research which is so precise and perfectly designed that the answers it produces simply cannot translate into a real-world setting. At the same time, research which covers up its flaws is dangerous because it does not allow practitioners to take an informed decision as to how appropriate it is to let its conclusions influence practice. Seeking that balance is something which has become very much part of my approach.
In many ways this is what makes the RECOVERY trial such an exciting prospect: it has tested some of the traditional ways of thinking about this type of research and instead needed to adopt practical solutions whilst being open about how this may influence the research outcomes. The other aspect which my previous research has inspired is the speed of translation. Clearly some empirical research will take years to have its practical effect felt. However for other research we need to really visualize and communicate a pathway to output and impact, otherwise lots of time and resource can be spent with very little to show for it. Stakeholder engagement is one way to accelerate this process and ensure that research outcomes, whether negative or positive, keep adding to the overall picture of “what next?”.
Could you tell us a bit about your research into data collection by emergency medical teams (EMTs) in sudden onset disasters?
It all started because of a research question I was thinking about during my NIHR Academic Clinical Fellowship during which I spent a year at the HCRI. My supervisors and I were playing around with questions which would involve data from sudden onset disasters. As I dug around further I realised there is such non-standardised data collecton by EMTs, that it would be almost impossible to answer any research questions with the available information. This led to my involvement in the WHO working group on a minimum data set for EMTs and then my PhD project.
I focused on the implementation of standardised documentation within the UK EMT and practitioner approaches to EMT documentation. It really opened my eyes to the idea of data integrity and the translation of data into information. So much of the research we interpret is based on data, however if we don’t truly understand the size and meaning of the data gaps and its journey to becoming information we can be led to conclusions which are far from what is actually happening. This can have serious consequences if we then base our subsequent interventions upon these conclusions. In many ways, the COVID-19 pandemic has brought me back to the same way of thinking as we watch live, the almost immediate dissemination of information, which is not always based on truly robust data or accurate conclusions.
What do you feel are the main challenges for society in recovering from COVID-19?
There is an awful lot going on behind the COVID-19 scenes. In healthcare we are unfortunately aware that people are avoiding hospitals, which is resulting in serious consequences for their immediate and longer-term health.
There is also uncertainty over what will happen to foreign aid budgets being drastically cut as its numerically logical (if not morally questionable) for a nation state to “protect its own”. Yet those suffering the harshest lives often find themselves in circumstances which mean that the western development sector has disappointingly become their only lifeline. Furthermore, the serious economic impacts will be felt for many, many years especially within weaker health systems as the inescapable cuts to public spending will directly target the most vulnerable.
Indeed some NHS colleagues who have had experience in resource-poor settings, have been trying to approach this in a very different way by aligning some common working practices and useful resources, demonstrating the benefit of working across different environments when tackling COVID-19. This mutual benefit may be yet another way to keep an eye outward so that when, one day, UK life does seem to have normalised, whether it is next year or in 5 or 10 years time, no matter the losses we will face, we’ll still far and away be amongst the lucky ones.
Anisa completed her PhD in 2019 at HCRI in the area of medical-record keeping in sudden onset disasters. Her academic clinical training in Emergency Medicine has taken place mainly in North West England. She has also studied/worked in London (UK), Pakistan, France and KwaZulu-Natal (South Africa).