In December 2005, Professor (now Sir) Ian Wilmut, the first director of Edinburgh University's Centre for Regenerative Medicine, called for stem cell treatments to be offered to people with terminal illnesses. He argued that the benefits of offering such treatments before they had been properly evaluated might outweigh the risks, saying, ‘if we wait until things are totally tested and analysed in animals, it will deny some people treatment’ (BBC News, 2005).
This ran counter to the prevailing medical culture of evidence-based medicine (EBM), one definition of which is ‘…the conscientious explicit and judicious use of current best evidence in making decisions about the care of individual patients' (Sackett et al, 1996). EBM has not been universally lauded by the medical profession. For example, the not altogether tongue-in-cheek Clinicians for the Restoration of Autonomous Practice (CRAP) Writing Group (2002) derided the reverence extended towards the randomised controlled trial (RCT) as a pillar of EBM.
Reverting to an RCT rather than common sense seems too tempting for some. For example, one might infer that much time and money were expended by Czorlich et al (2016) in the course of their research which concluded ‘a parachute is an effective tool to prevent major trauma when falling from a great height.’
Encompassing all things from parachutes to assisted repro duction, a recent piece by Evers (2017) asks ‘Do we need an RCT for everything?’ His answer is ‘no’. Evers points out, for example, that caesarean section for obstructed labour was introduced without an RCT, yet nobody doubts its effectiveness, and that in vitro fertilisation (IVF) was introduced in 1977 without an RCT. Evers also cites an RCT undertaken by Bhattacharya et al (2001), who compared IVF with intra-cytoplasmic sperm injection (ICSI) for 415 couples attending UK centres. Bhattacharya et al (2001) not only found that ICSI offered no advantage over IVF in terms of clinical outcome in cases of non-male-factor infertility, they stated ‘assisted reproduction has been technologically-driven rather than evidence-based. Treatment tends to be empirical, and existing evidence can be ignored in favour of novel interventions.’
‘Reverting to an RCT rather than common sense seems too tempting for some’
So, should researchers in assisted reproduction cling to RCTs? Griffin and Sheldon (2017) consider this in relation to pre-implantation genetic screening (PGS), in which IVF embryos are tested for chromosomal abnormalities and embryos with a normal chromosome complement are selectively transferred. Noting ‘that convincing randomised trial data from about 2007 onwards suggested that PGS was ineffective or even harmful’, Griffin and Sheldon (2017) reject the ‘mountain model’ of EBM, at the summit of which is the flag of a placebo-controlled clinical trial, asserting that in the PGS context such a trial is near impossible to achieve. Instead of a ‘mountain model’ they prefer a ‘gentler hill’ as a way of ‘visualising EBM for PGS and reproductive medicine generally’, arguing that this ‘gives more weight to retrospective analyses and case reports to gain a bigger picture of the evidence base.’
However, despite acknowledging that an RCT is not needed for everything, Evers (2017) opposes the ‘gentler hill’ approach. ‘What we should definitely not do is aim for a party-political trade-off (“In a reasonable world, we may not always agree, but we would try to find common ground”), and lower the gold standard of evidence-based medicine, as for example recently proposed for PGS by Griffin and Sheldon (2017).’
Given these differences of opinion, one might wonder how an evidence-based approach to midwifery can progress, yet not lose an element of innovation or creative thinking. If such thinking is to flourish, then the extent to which it may do so could be restricted by parameters determined by the EBM context in which midwives work. Might such a tension risk leading to a relative decline in creative work?
Maybe we need an RCT to find out.