Only one in ten current critical care treatments are based on the best quality evidence, partially due to the challenges of conducting research trials in emergency situations. Wales is leading the way in this area, finding better ways of involving patients and families in studies vital for improving care for critically ill patients, long into the next 70 years of the NHS.
Working out what medical treatments work or do not bring patient benefit is difficult. Clinical trials need to compare new treatments with existing ones in a way that avoids bias. These “double blind” trials need both the patient and the clinical team to be unaware of which treatment option each patient involved in a trial is receiving.
As most patients that are critically ill are unconscious, formally describing the process of a clinical trial is often impossible. The immediacy of treatments also means that having time to discuss this with very ill people or family members, many of which may be very distressed, is rare. There is little opportunity therefore for using the standard process of “informed consent” used in trials of conscious patients who are not critically ill. Therefore, unlike many other areas of medicine, critical illness has a limited number of treatments with a strong evidence base.
As the NHS celebrates 70 years and looks forward to its next 70, it is a great opportunity to reflect on our international leadership in this challenging area of care and research.
World-leading critical care research
Here in Wales, a number of teams are leading the way in this area, helping to shape the future of emergency and critical care that will see more lives saved and better lives led after acute injury or illness.
“We’re one of the biggest recruiters into critical care research in the UK,” said Dr Matt Morgan, Head of Research and Development at the Cardiff Critical Care Research Department.
“We’ve recruited around 1500 patients into trials over the last 5 years, published multiple papers as a result of that, which impact on national and international guidelines.”
The department, led by consultants Matt Wise, Matt Morgan and clinical nurse specialist, Jade Cole, strongly believes that involving the most critically ill patients in research is vital for improving emergency care and saving more lives.
Challenging decades of practice
In 2013 the department led the UK’s contribution to the world’s largest cardiac arrest study, the TTM Trial (Targeted Temperature Management).
Cooling patients following cardiac arrest to 33 degrees formed a core part of international guidelines. The TTM Trial demonstrated that in fact there was no difference in patient outcomes when cooling to 36 degrees with many of the risks associated with using the lower temperature avoided.
After challenging this concept which had been around for decades, the results now inform every international guideline on cooling after cardiac arrest.
Appropriate, sensitive consent 24/7
“Critical illness is unpredictable and can occur at any time,” said Jade. “We provide a 24/7 service that enables us to enrol patients into research studies outside of the standard working hours of Monday to Friday, 9 to 5.
“This 24/7 recruitment model means that not only are we able to enrol patients into research studies at any time of the day or night, but we are also available to the patients’ relatives and representatives to discuss our research studies, provide information and support and most importantly find out what the patient’s wishes would be. Other critical care research teams can struggle with recruitment because they are only available during standard working hours.
“In addition we use a deferred, emergency consent model. This carefully regulated process, with overview from a professional ethics committee and members of the public, allows unconscious patients who cannot give consent, to still contribute towards medical research. As soon as it is appropriate, we speak with their family or legal representative to ensure that participating in research is something that their relative would want to do. Most importantly, when the patient has recovered sufficiently we seek their consent to continue in the study.
“Without this deferred consent model, improving the care of critically ill patients through research is simply not possible. “
The TTM II study starts later in 2018 and will now compare cooling with no cooling at all to understand if the additional risks and resources of cooling can be avoided completely. Once again, Cardiff will be the lead UK site for this global study of huge importance to patients.
Better care at-the-scene
Wales is also taking a leading role in care before patients even reach A&E, with the Welsh Ambulance Service NHS Trust (WAST) central to a number of major paramedical care research studies. One such study, PARAMEDIC, led by the University of Warwick, compared survival rates of people suffering cardiac arrest after receiving CPR from paramedics by either a mechanical chest compression device or hands-on chest compressions.
Named Trial of the Year 2014 by the Society for Clinical Trials, PARAMEDIC showed no difference between methods in the number of people alive one month after cardiac arrest. It also found no improvement to NHS ambulance paramedics’ high quality overall care through use of the device, all of which indicated that such devices represented unnecessary cost to the NHS.
And WAST continue to contribute to better care through PARAMEDIC’s successor trial, challenging over 50 years of potentially harmful cardiac arrest treatment. Despite near-universal use of adrenaline to help rapidly restart the heart in cardiac arrests, there exists evidence it may lower patients’ survival rates and increase their chances of brain damage. That’s why The International Liaison Committee for Resuscitation has called for a definitive answer on the safety and benefits of adrenaline; something a current trial WAST is a key part of, PARAMEDIC-2, aims to provide.
Cutting needless overdose deaths
The Wales Centre for Primary and Emergency Care Research (PRIME), funded by Health and Care Research Wales, is a leading centre focusing on research that can help provide the evidence base needed to improve care and treatment in GP surgeries, hospitals and A&E departments.
They are now working with WAST on their UK-wide study assessing feasibility of paramedics issuing heroin users with take-home heroin antidote kits at the scene of 999 overdose call-outs.
A report released last year by the European Monitoring Centre for Drugs and Drug Addiction showed the UK accounted for 2,655 (31%) of overdose deaths in Europe, with heroin or morphine mentioned in 1,200 deaths in England and Wales – a 26% increase on the previous year
That makes the Take home Naloxone Intervention Multicentre Emergency setting feasibility (TIME) study a critical piece of work to cut tragic deaths amongst a highly vulnerable group.
“Critical care research hasn’t necessarily produced a ‘wonder-drug’,” concluded Matt Morgan, “but it has updated treatments to prevent harm and to deliver more prudent healthcare.
“Thanks to research, staff now know that the best patient outcomes can be gained where certain treatments are used in a more focused manner. For example, fewer blood transfusions take place, they use less oxygen and fluids, and less volume on a ventilator.
“All of these changes have come about through research and now save lives.”