Andrew Carr

The National Health Service (NHS) in the UK is currently facing a significant waiting list backlog following the disruption of the COVID-19 pandemic, with millions of patients waiting for elective surgical procedures. Effective treatment prioritisation has been identified as a key element of addressing this backlog, with NHS England's delivery plan highlighting the importance of ensuring that those with ‘the clinically most urgent conditions are diagnosed and treated most rapidly’. Indeed, we describe how the current clinical guidance on prioritisation issued by The Federation of Surgical Specialty Associations serves this aim. However, whilst there are strong reasons to prioritise elective surgery in accordance with clinical need, we argue that it would be a mistake to assume that prioritisation in accordance with clinical need requires only a clinical or scientific judgement. The understanding of clinical need that we choose to employ in a prioritisation system will be grounded by some key ethical judgements. Moreover, we may also have to make trade-offs between addressing clinical need, safeguarding equality, and achieving other benefits. As the UK faces up to the backlog, it is important that surgical prioritisation guidelines enshrine a broad range of values that we believe ought to determine access to care in non-emergency circumstances. Our analysis suggests that the current approach to prioritisation is not a sufficiently nuanced way of balancing the different moral values that are operative in this context.

Use of a placebo control in surgical trials is a divisive issue. We argue that, in principle, placebo controls for surgery are necessary in the same way as for medicine. However, there are important differences between these types of trial, which both increase justification and limit application of surgical studies. We propose that surgical randomised placebo-controlled trials are ethical if certain conditions are fulfilled: the presence of equipoise, defined as a lack of unbiased evidence for efficacy of an intervention; clinically important research question; the risk to patients is minimised and reasonable; there is uncertainty about treatment allocation rather than deception; there is preliminary evidence for efficacy, which justifies a placebo-controlled design; and ideally, the placebo procedure should have some direct benefit to the patient, for example, as a diagnostic tool. Placebo-controlled trials in surgery will most often be justified when surgery is performed to improve function or relieve symptoms and when objective outcomes are not available, while the risk of mortality or significant morbidity is low. In line with medical placebo-controlled trials, the surgical trial should be sufficiently powered and standardised so that its results are valid, consent should be valid, the standard treatment or rescue medication should be provided if possible, and after the trial, the patients should be told which treatment they received and there should be provision for post-trial care if the study may result in long-term negative effects. We comment and contrast our guidelines with those of the American Medical Association.