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In a recent editorial, Fiorella et al1 marvel at the recent maturation of the neurointerventional surgical field, which they attribute to what they claim are ‘two seemingly diametrically opposed factors’: industry-driven research and evidence-based practice (emphasis ours).1 The thesis of the editorial is that, if randomized controlled trials (RCTs) are the gold standard, they are not feasible in many circumstances.
Here is the list of situations for which RCTs are allegedly not ‘feasible’: ‘At the introduction of a new device’; ‘When devices are designed to treat diseases that have a poor natural history with standard management’; ‘When no suitable control group exists’; ‘When iterative technologies emerge to compete with existing technology’; ‘When the disease is insufficiently prevalent for an RCT to be completed’; ‘When there is no market to support an industry-sponsored trial’; and ‘When treatment is proven for the same disease in a different patient population’.1
Are there any indications left? When should our community properly test innovative treatments against the standard management that has existed up until then? If not at the introduction of the innovation, when uncertainty is maximal; if not later in the process, when clinicians are ‘accumulating critical case experience’, and not even when a second iteration emerges, then when? According to the authors, it is too late when ‘equipoise no longer exists’. Thus we are invited to consider innovative solutions. Unfortunately, the small case series with historical comparisons that the authors propose can hardly qualify as innovative: they are the very methods which have previously misled us and that …
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