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RECOVERY RS - Addressing Clinical Equipoise in Research

Dr Dichard Innes Header

“We just don’t know” Richard Innes, Consultant in Intensive Care at Somerset NHS Foundation Trust and Clinical Research Speciality Lead for Critical Care, says when describing the context for the RECOVERY-RS Study. The study looks to shed light on the most suitable form of ventilation to use when treating the patients worst affected by COVID-19. 

Navigating the unknown

Clinical research, and those working to devise and deliver it, embrace and navigate unknowns to further our understanding and improve practice and treatments for the benefit of patients and staff. At the very heart of this process is the concept of ‘clinical equipoise,’ the idea that for a randomised control trial (RCT) to go ahead ethically, there needs to be genuine uncertainty within the expert medical community over which treatment will be most beneficial. This idea sits at the heart of every randomised control trial and is fundamental to generating a meaningful research question with the potential to readdress our understanding. RECOVERY-RS is no different.

RECOVERY-RS stands for ‘RECOVERY-Respiratory Support: Respiratory Strategies in COVID-19; CPAP, High-flow, and standard care.’ Patients admitted to hospital with COVID-19 with low levels of oxygen will need assistance to stop their condition from deteriorating and they will require more help with their breathing. The study compares the use of three interventions that are commonly used in the NHS; continuous positive airway pressure (CPAP), high flow nasal oxygen (HFNO) and standard care: standard treatment will involve oxygen delivered via a normal face mask or tubes in the nose. There is some disagreement among professionals about which offers the most effective treatment, this is why research is being conducted in this area.

Working together

Due to the serious condition patients will be in, this study is delivered in the acute care setting, an area in which Richard specialises in. He describes how a research culture is vital to creating an environment receptive to research.

“We don’t work in isolation and we need all clinicians to be on board. This is a study that we all need to support, it’s of crucial importance.” 

He continues: “Looking at a different example, the results from the RECOVERY Study to show [that] steroids do work in the treatment of COVID-19, a treatment that most clinicians would have said would not work because past studies in similar but different conditions showed steroids didn’t work. Steroids have been shown to have a positive impact [in treating COVID-19] and work in a massive fashion. This would have come as a surprise to most clinicians.”

The need for debate

Richard states that the question of equipoise is as much a philosophical one as it is clinical.

“Changing your mind is difficult and it’s hard to change your mind or your ways. You can think one thing but the results from research show something else. This issue needs discussion and an open debate.

“We must try to learn the lessons from COVID-19. I changed my mind about RECOVERY-RS when I read the protocol. When I reflected on it, I agreed that the evidence isn’t there, which is why the study exists. It doesn’t matter what people think of you; if you change your mind it’s not a sign of weakness.”

The COVID-19 pandemic has put research at the forefront of clinical practice and public attention but we must capitalise on this to ensure the work has a positive impact on how research is perceived in the long term.

Creating a research culture

Richard finishes by saying: “An attitude change is needed so that research feels important to every institution and professional. It’s a cultural issue and one that’s only addressed with education. We need to challenge our assumptions and use an evidence base.”