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In patients hospitalised for COVID-19 with clinical hypoxia who required either no oxygen or simple oxygen only, higher dose corticosteroids significantly increased the risk of death compared with usual care, which included low-dose corticosteroids. The RECOVERY trial continues to assess the effects of higher dose corticosteroids in patients hospitalised with COVID-19 who require non-invasive ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation.
We’re used to randomised trials in medicine. Why not apply the same rigour to policy?
Rafael Dal-Ré and Arthur L Caplan state that obtaining consent “was clearly not an issue in RECOVERY [the Randomised Evaluation of COVID-19 Therapy trial]” and use this statement to support their supposition that there is “no need” to reconsider regulations for written informed consent obtained prospectively from acutely ill patients. However, in the RECOVERY trial,1 if no family member was available, patients who lacked capacity to consent could be enrolled without providing informed consent through the involvement of a doctor (independent of the study team) who could act as the lega...