It’s an emergency: should we ‘rescue’ vulnerable emergency care patients from research?

 pulpfiction

Kate Sahan, The Ethox Centre, Nuffield Department of Population Health, University of Oxford

A current emergency medicine trial, Paramedic2, which randomizes patients to adrenaline versus saline in cardiac arrest has put emergency medicine research (EMR) back under the spotlight. There are concerns that a ‘totally useless placebo’ will be more harmful than the standard adrenaline shot given during the resuscitation protocol. However, the history of EMR has taught us that some emergency interventions rest on an insufficiently-explored and updated evidence base[1]. For example, up until the early 2000s, corticosteroids were given to tens of thousands of severe head trauma patients in the belief they were medically beneficial. But it took a systematic, placebo-controlled research study of their use called CRASH to make an unwholesome discovery: steroids had no benefit, and caused actual harm by killing or severely brain-damaging more patients than placebo.

Generally we accept that doing research confirms whether health treatments work and can save lives. And this is not to say EMR is not being done, and has not wrought advances in acute care[2],[3] and (to some extent) intensive care[4]. But its doing raises ethical questions which have not been settled, despite regulatory efforts over the last 30 years to solve the EMR ‘problem’. These have ranged from: banning some EMR over fears about lack of informed consent; through ‘waiving’ informed consent; to the requiring of prospective consultation of relevant communities about the research. Nonetheless, the body of work remains under-supported and prone to regular bouts of bad PR.

We need to understand better why we draw back from researching emergency care patients.

One thought, with its origins in issues of research risk, is that emergency patients have a special status which forbids research. Though calling this status vulnerability[5] may miss the mark[6], the emergency patient’s extreme condition heightens our protective instinct towards them. This instinct includes two concerns. Firstly, we worry that EMR, uniquely, will risk harm to the patient which is undeserved given their state. This incorporates an assumption that EMR is especially risky or deadly[7]. But it’s more than just not accepting risk analysis. After all, mortality outcomes are common to other types of research. Leading to our second concern: that we are not dealing with just any life-threatened group eg terminal cases. Instead the emergency is immediate, the person’s experience immediately reversed from life to near-death, and this leads us into the territory of urgency. Urgency encourages an urge to ‘rescue’ such patients, inviting comparisons with rule of rescue arguments. This develops an antipathy to the cold calculations, not of clinical cost effectiveness bean-counters, but of research. Shelving the research becomes an acceptable cost to society in order for us to ‘express concern for the value of [identifiable, individual] human life’ in immediate peril[8]. We’re in a unique, more perturbing version of the statistical vs individual benefit trope[9].

While an alternative case for EMR can be made, it should not ignore what such unique perturbations to society contribute. In this vein, if you will, I’ll in(ter)ject a thought about adrenaline itself, a.k.a. the ‘emergency hormone’ whose side effects impressively include a ‘fear of impending doom’. Research like Paramedic2 may prove it the poster child for the dramatic, ‘do something’, but ultimately misplaced rescuing of emergency cardiac patients. Perhaps the reality of research also has a part to play in the rescue. I’ll (spoiler alert) close with a link to the debunking of another famous role for adrenaline in the film Pulp Fiction.

[1] I’m not saying the EM evidence base is barren; nor that gold standard research designs, like RCTs, are the only way to form that base. The problem is not that research can’t be done, or isn’t being done. It’s about how it sits with standards of research ethics and our own intuitions of the right thing to do with respect to emergency care patients.

[2]ISIS trials testing different drugs for heart attacks including clot-busting drugs, ACE inhibitors and aspirin.

[3] Mechanical chest compression trial

[4] NICE-SUGAR study investigating intensive vs conventional glucose control

[5] Though some regulations stop short of calling emergency patients a vulnerable research group, risk thresholds for research on emergency patients are comparable with those groups eg prisoners, terminal cases, pregnant women or children

[6] Vulnerability has struggled for conceptual clarity as it is easy to label us all as vulnerable in some way. See F. Luna. Also, social context plays a large part in defining vulnerable groups and researcher duties towards them, see Lange, M. M. et al. In emergency patients, it’s hard to take account of that social context, unless group is prospectively identifiable eg population areas of high gun crime.

[7] Though EMR must be in clinical equipoise.

[8] See McKie and Richardson about valuing rule of rescue versus other ways of valuing healthcare such as cost effectiveness analysis.

[9] See eg Wendler

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It’s an emergency: should we ‘rescue’ vulnerable emergency care patients from research?

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