Read all about it – Tips for TEBM
July 24, 2018
A tip for teaching evidence-based medicine – ‘Read all about it’
I have developed a habit for spotting stories that might be useful in my teaching – this felt like one.
To give or not to give adrenaline? It’s a question I’ve been asking to learners on my module for the MSc in Evidence-Based Health Care for the past three years. For it was three years ago whilst on my usual train commute to the office that a story in a discarded newspaper caught my eye. The tagline went: “Paramedics to give dummy drug for heart attacks: Controversial trial will see patients given placebo instead of adrenaline when their heart has stopped”
I have developed a habit for spotting stories that might be useful in my teaching and this felt like one. Turns out I was right. During my week-long module, learners are taught about different study designs in health research and the types of clinical questions the different study designs are best fit to answer.
“Does this intervention help?” type questions bring us to randomised controlled trials (RCT). I’m often looking for examples where the question indicates an RCT is the best study design to answer it but there are also interesting ethical issues. Childhood brain cancer and mobile phone masts is a good one. And then I found the study on adrenaline.
The ethical issue here was that unlike typical RCTs, people who would be eligible to be included in the trial (i.e. anyone whose heart had stopped) wouldn’t be able to give informed consent prior to being enrolled (because they would be unconscious). People would be asked to consent once they had regained consciousness, or their next of kin would be asked if the patient died. This is a rare study type known as a ‘Zelen’s design’.
However, the need for high-quality evidence to answer an important question – we started giving adrenaline as routine practice for cardiac arrest in the 1960’s, without it ever being properly tested in a trial – was deemed necessary despite the challenging ethical issues.
After what seems like ages, the trial has been published in the New England Journal of Medicine. I was asked by the Science Media Centre (SMC) to comment on the study prior to its release. My response in full is below, parts of which were quoted in the Times, the Guardian and by the BBC. I can now add this to my teaching portfolio and look forward to the discussions it will generate in the next iteration of my module.
When it comes to material for teaching the key concepts of EBM, my advice is to ‘read all about it’ and keep an eye on news stories for everyday examples.
Response to the SMC
“Every now and then scientific research produces landmark findings. This is one of those occasions.
“At the core of evidence-based practice is ensuring the treatments we give to patients provide more benefit than harm. It may come as a surprise that for many treatments we simply do not know whether they do more good than harm. One such treatment is the practice of giving adrenaline to patients whose hearts have stopped.
“The need to do this research was underpinned by a serious concern that although using adrenaline might help restart the heart in the short term, it may cause severe brain damage leading to death a few hours or days later.
“There are challenging ethical issues in performing a clinical trial of this nature because patients in cardiac arrest are unable to consent to participating before being enrolled. However, given the uncertainty of the evidence and the life-threatening nature of the condition being treated, it is important that we have the best evidence we can to provide the best treatment possible.
“Despite some limitations, this is a well-conducted study providing the highest-quality evidence about a long standing yet untested treatment in medical practice. The study found that if we give adrenaline to 1000 people whose hearts have stopped, 9 more people will be alive after 30 days. However, the risk of serious brain damage in people who are able to return home is almost doubled if they are given adrenaline. We now have a decision to make about the small survival benefit versus the large increased risk of debilitating brain damage when giving adrenaline.
“The funders, researchers, health professionals and participants (and their families) who gave consent should all be praised for their roles in this important research. The practice of giving adrenaline to someone in cardiac arrest has been the standard of care for nearly 60 years. Make no mistake, the results of this landmark trial will change the way people are treated if, unfortunately, their heart should stop.”
Want to learn more about how we teach everyday EBM and other key topics in Evidence-Based Health Care then join us at our annual teaching course 10 – 13 September 2018. More details here.