EBM in critically unwell patients
Evidence based medicine (EBM) was undoubtedly one of the major medical advances of the last century. EBM is at its best when it changes daily clinical practice and challenges well-established norms, but this only really happens every now and then. Two recent New England Journal papers about management of critically unwell patients have done just that.
Since medical school, doctors learn that the optimal treatment of patients with severe infection (sepsis) and low blood pressure (shock) is to pour in intravenous fluids. Not something that is up for debate, you would think. There are much more pressing things like drug-eluting stents to take to clinical trials. Well, think again. A paper by Maitland and colleagues reports a trial in Africa where over 3000 children with severe sepsis and shock were randomised to receive either boluses of fluid (albumin and saline) or no bolus in the early stages of treatment. Children with malnutrition or gastroenteritis were excluded. Amazingly, any bolus treatment led to an increase of 45% in the risk of mortality at 48 hours (relative risk 1.45; 95% CI, 1.13 to 1.86; P=0.003). The results were consistent across all subgroups of patients, and now researchers and clinicians all over the world are scratching their heads to understand whether what they have been doing since they were medical students is actually wrong and too much fluid is a bad thing in septic patients.
Intensive care, like surgery, is often cited as a difficult area of medicine for EBM to infiltrate. The traditional mantra is to give ITU patients nutritional support as soon as possible. In a trial of nearly 5000 patients, the two arms were either early initiation of intravenous (also known as parenteral) nutrition on days 1 and 2 of ITU admission, or late initiation of parenteral nutrition after day 7. Late initiation was associated with reduced complications and faster recovery. So EBM is possible in the ITU and it does change practice. What other areas of treatment of the critically unwell do we need to test?
The gaps between evidence, quality and policy
Microcredit is an idea that has won the brains behind it, Professor Muhammad Yunus, a Nobel Peace Prize, and has received billions of dollars in terms of global funding. The idea was simple: very small loans could make a disproportionate difference to a poor person, and so the Grameen Bank and many similar institutions like it have opened around the world. However, only one randomised control trial has ever been done for this intervention in Hyderabad and actually showed no benefit. So what we are saying is that billions of dollars have been spent with potentially no effect. Shouldn’t this study have been done earlier?
It got me thinking that regardless of the arena, whether policy, clinical practice, healthcare or economic, lack of the right kind of evidence can lead to the wrong intervention. As large-scale NHS reforms are upon us, this is particularly important.
Quality improvement is something which all adaptive organisations should be doing as part of their daily work, but it turns out that this fairly new discipline is gaining huge popularity because this vital component of clinical practice has been neglected.
In JAMA this week, the results of an RCT of a multi-centre, multi-component intervention to improve quality of intensive care were published. Like Atul Gawande’s surgical checklist, the authors took 6 quality measures that have been proven to improve patient outcomes(prevention of ventilator-associated pneumonia (VAP), prophylaxis for deep venous thrombosis (DVT), daily spontaneous breathing trials, prevention of catheter-related bloodstream infections, early enteral feeding, and prevention of decubitus ulcers) and looked at over 9000 ITU (intensive therapy unit) admissions across 15 Canadian hospitals.
ITUs were randomised to receive an intensive programme (including audit, video-conferencing and expert-led education) to increase adherence to these 6 measures or to continue normal practice. The authors found that the adoption of the 6 target measures was twice as likely in the intervention group, compared with the control group.
In an accompanying editorial, the urgent need for high quality science such as this complex trial, in quality improvement is highlighted. If it can be done in critical care medicine, then it can be done in any area of healthcare or policy. The fact that it was funded by a healthcare organisation as opposed to a central funding agency is also seen as a positive aspect, since all stakeholders have a part to play in improving quality and reducing costs. Those parties that argue that evidence is too difficult or takes too long might end up making costly mistakes.