Clinical research informs the guidelines and recommendations that underpin delivery of clinical care. Undertaking research is a priority for a trust constantly seeking to improve and develop patient care. Patients benefit from potentially receiving novel treatments before they become part of the recommended guidelines and staff benefit from contributing to the evidence on which new guidelines are based.
The research team in SCAS is responsible for overseeing all clinical research projects undertaken by the Trust. We are a small team, and we have been involved in large scale research trials including PARAMEDIC (the Prehospital Randomised Assessment of a Mechanical Device In Cardiac arrest). SCAS was one of four ambulance trusts which took part in this national study, which received the prestigious accolade of ‘Trial of the Year 2014’ awarded by The Society for Clinical Trials.
We have strong links with our neighbouring acute trusts through the local research network and with the other UK ambulance services via national networks. This enables us to hear about the latest research projects and get involved from the early stages.
Performance in initiating and delivering clinical research documents
- SCAS Performance in Initiating and Delivering clinical research Q1 (April to June) 2017
- SCAS Performance in Initiating and Delivering clinical research Q2 (July to Sept) 2017
- SCAS Performance in Initiating and Delivering clinical research Q3 (October to December) 2017
- SCAS Performance in Initiating and Delivering clinical research Q4 (Jan – Mar) 2018
- SCAS Performance in Initiating and Delivering clinical research Q1 (April – June) 2018
Documents to follow
SCAS started a small pilot study of this trial in February 2015, followed by wider implementation in August 2015. The last patient was enrolled in October 2017 and no more patients will now be included. SCAS ambulance staff now provide standard care to patients suffering cardiac arrest. Trial results are expected to be published in the latter half of 2018.
This trial, led by the University of Warwick, aimed to improve the outcome for patients suffering cardiac arrest (when the heart stops beating) outside of the hospital environment. Of the 30,000 people experiencing this catastrophic event each year, no more than 7% survive to hospital discharge.
Although the drug “adrenaline” has been used as part of the standard treatment of cardiac arrest since the 1950s, there have never been any trials to show whether it is of benefit or not. This trial looked at whether adrenaline, which can be administered during resuscitation, improved a person’s chance of survival to hospital discharge. It had been assumed that by stimulating the heart, adrenaline may improve the chances of successful resuscitation. However, some recent studies have suggested that although adrenaline may indeed help ‘restart’ the heart, the chances of survival in patients given adrenaline may actually be worse. This may be because when adrenaline stimulates the heart it increases the amount of oxygen required by the heart which may, in turn, reduce the amount of oxygen available to the brain.
How the trial worked
The International Liaison Committee on Resuscitation, European Resuscitation Council and Resuscitation Council (UK) which all set the current resuscitation guidelines, identified the urgent need for a clinical trial to look at whether current adrenaline therapy is safe and effective.
The only way to do this is by a type of research study called a randomised trial comparing adrenaline with a placebo (saline), in which neither the clinician nor the patient is aware of the group into which they have been randomised. Adult patients who suffer cardiac arrest, and where advanced life support is given, were eligible for the study. Those who were pregnant, suffering from anaphylaxis or where adrenaline had been given prior to ambulance arrival were not enrolled in the trial.
At a cardiac arrest where adrenaline is indicated, clinicians were supplied with a pack of trial medicines, which were used in place of standard adrenaline syringes. Patients have been followed up in hospital and the study investigators will compare what happens to the two groups of patients (those who received adrenaline and those who received placebo).
Members of the public who did not wish to be enrolled in the PARAMEDIC2 Trial could choose to opt-out by requesting a stainless steel bracelet which has the words ‘NO STUDY’ engraved on it.
Local paramedics were trained to look for these bracelets in the same way they do for other medical ID bands. This meant that, in the event that you have a cardiac arrest, you received standard treatment which may have included adrenaline. This system is used successfully in North America for a number of trials.
The trial, funded by the National Institute for Health Research and.co-ordinated by the University of Warwick in collaboration with the University of Surrey, received Research Ethics Committee approval and Medicines & Healthcare products Regulatory Authority (MHRA) approval. It involved five ambulance trusts (South Central Ambulance Service, London Ambulance Service, West Midlands Ambulance Service, Welsh Ambulance Service and North East Ambulance Service) and aimed to recruit a total of 8,000 patients: the number needed to be sure that any benefit or harm from adrenaline can be detected. The data was analysed at stages as the trial progressed so that had a difference been detected sooner, the trial could be stopped.
It is usual practice to obtain informed consent from patients to participate in research studies. Inevitably, there are ethical challenges and concerns involved in a trial where patients are unconscious and cannot give their agreement to take part. This has been a concern for researchers working in the pre-hospital setting for some time and has recently been highlighted in the press. It has been suggested that if patients are unable to give consent, either because they are in an emergency situation or are unconscious, they should not be included in a research trial. However, this would severely reduce the opportunities for improving the care of patients suffering conditions such as cardiac arrest. A number of years ago this was debated at the highest level in the UK Government and the European Union. A new law was drawn up that allowed researchers in specific emergency situations to enrol patients in a study without obtaining consent (waiver of consent) so long as consent was obtained as soon as reasonably possible after the patient was able to make a decision. The law regarding informed consent in an emergency situation is set out in Statutory Instrument 2006 No. 2984, The Medicines for Human Use (Clinical Trials) Amendment (No2) Regulation 2006. With appropriate regulatory control, studies of this group of patients are the best way to improve outcomes for those suffering such conditions in future.
The British Heart Foundation Medical Director, Professor Peter Weissberg, said: “It is important to remember that whilst adrenaline is routinely used to treat a cardiac arrest, we don’t actually know whether this is a safe and effective practice. The concern is it could be doing patients more harm than good. The only way to answer this crucially important question is to do a well-designed clinical trial. It is always difficult to conduct a trial in situations where people are too ill to give their consent. But there are well established ethical guidelines for undertaking such studies. What is unacceptable is to continue giving a treatment that could be doing more harm than good. Only by undertaking difficult studies of this kind can we be sure that patients are receiving the highest possible standard of care and have the best chance of a good outcome.”
Frequently Asked Questions
Q. Why was my relative entered into this trial without anyone’s permission or knowledge?
A. We are aware of the sensitive nature of the circumstances in which patients will be part of the trial and of distress that relatives will be in at such a difficult time. We have given careful consideration to the need for a compassionate approach to relatives, to reduce further distress, and have discussed this in detail with both the ethics committee and with our patient/service user advisers for the trial. The trial was designed and conducted according to the legal and ethical requirements, and was independently monitored to ensure that patients’ rights, dignity and safety were paramount.
When a person is unconscious due to their cardiac arrest we can’t ask permission about their treatment. Due to the urgent need for treatment we are not able to ask a relative or friend, should there be anyone else on scene. Research like the PARAMEDIC2 Trial is considered lawful and ethical, provided it has been scrutinised and reviewed by several regulatory organisations including an ethics committee (which is a panel of medical, scientific and legal experts, as well as representatives of the public) who review the research in terms of its importance to clinical practice and assess the risks and benefits of doing such a trial. The trial is then reviewed regularly by two independent monitoring committees, made up of representatives of the public and very experienced medical and scientific experts in the field.
The research team, headed by an intensive care consultant who works in NHS hospitals as well as being a professor at the University Clinical Trials Unit, and other doctors, nurses, paramedics and scientists, were required to keep these organisations informed of the progress of the trial, and to report to an independent monitoring committee who had the authority to stop the research if there were major concerns about patient safety. Without research like this we would not be able to make improvements in patient care in the emergency setting.
Q. My relative died after being enrolled in this trial. I want to know what treatment my relative had.
A. If you decide you do want to know about the treatment your relative received we can tell you this, but we would like to meet with you to do this to be able to explain fully what the information means in order for it to be of help to you, and to offer you support at what we recognise will be a difficult time for you. A person who has a cardiac arrest in the community rather than in hospital, has less than a 10% chance of survival. Current treatments for cardiac arrest include basic life support (particularly chest compressions), defibrillation (an electric shock) and a range of medicines including adrenaline. Adrenaline has never been formally tested in humans with sufficient numbers to inform us reliably whether it is helpful or harmful, and recent studies have created substantial concern amongst doctors, nurses, paramedics and patients that adrenaline may be harmful when used as a treatment for cardiac arrest. To look at the effectiveness of adrenaline we need to collect data on 8,000 patients. However, it is very difficult to examine an individual patient’s treatment and decide if part of the treatment lead to the death.
Further frequently asked questions, additional information and other relevant documentation about the PARAMEDIC2 Trial can be found here: www2.warwick.ac.uk/fac/med/research/hscience/ctu/trials/critical/paramedic2/faqs/
If you have any queries about the involvement of a relative, please contact our Patient Experience Team on 0300 123 9280 ov via email@example.com
Funding Acknowledgement: This project was funded by the National Institute for Health Research Health Technology Assessment programme (project number 12/127/126)
South Central Ambulance Service NHS Foundation Trust (SCAS) is among 8 ambulance trusts in the UK taking part in vital research to address questions that clinicians and researchers have about the use of a medicine called glyceryl trinitrate (GTN) in the early phase of stroke.
A growing body of scientific evidence suggests that GTN may be beneficial to patients suffering stroke by lowering blood pressure and that the earlier this can be given the better. A patch, which is cheap and readily available, could be a simple new way for paramedics to routinely treat patients in an ambulance following a suspected stroke.