‘The Trust was keen to be innovative, and to be at the forefront of embracing new practices and technology, in order to improve the care provided to patients. While this is to be commended… the pace of innovation was too quick.’
This section of the Healthcare Commission's (2008) report of its investigation into Staffordshire Ambulance Service could arguably apply to every ambulance service. On the one hand, most people involved in prehospital care are motivated by a desire to do the best for our patients, and to be seen to be ‘ahead of the curve’ where new technologies are concerned. On the other hand, we need to ensure we protect our patients from harm— not least the risks associated with new interventions that are innovative but have not been subject to robust research to demonstrate their safety, efficacy and cost-effectiveness.
On that latter point, we have a wider duty at the ‘population level’ to safeguard taxpayer's money and not waste it on ineffective (or worse) innovations. This can be a difficult balance in an area of healthcare characterized by:
‘The uneasy balance between forces promoting early adoption, including EMS personnel and perhaps physician enthusiasm unrelated to outcomes-based demonstration of efficacy; as well as marketing efforts and business strategies, and the principle that new therapies should not be widely adopted, especially for diseases with substantial mortality and morbidity, until high-quality evidence accumulates that the new therapy is better than traditional treatments.’
Research in prehospital care is difficult to do well, and for that and other reasons, it is not unfair to describe most people working in ambulance services as research naive, particularly those on the front-line. That is not to denigrate ambulance services or personnel, it is merely a statement of fact.
Yet, things are gradually improving and if one were to take inclusion on the National Institute for Health Research (NIHR) portfolio as a marker of quality of the research, there is evidence that ambulance services are engaging with colleagues in other parts of the health system, and the higher education sector, in significant, high quality studies: on cardiac arrest, myocardial infarction, stroke and falls, for the most part.
The National Ambulance Research Steering Group, bringing colleagues together from all services in England and Wales, is playing an important coordinating and leadership role, in raising the profile and quality of prehospital research (Siriwardena et al, 2010).
Recognized uncertainty
There are many examples in prehospital care of innovations introduced with enthusiasm, but where the supporting evidence-base is lacking. To name but a few here: non-invasive pacing (Sherbino et al, 2006), mechanical chest compression devices (Brooks et al, 2011), and oxygen administered to the patient with acute myocardial infarction (Cabello et al, 2010). Evidence that benefit exceeds harm for these interventions has yet to be established in a well conducted study (high-quality research is now underway addressing most of these issues). That is not to say these interventions do not work, but there is recognized uncertainty.
Contemporary enthusiasm for mild therapeutic hypothermia (MTH) following cardiac arrest has recently been challenged (Nielsen et al, 2011) and while there is some evidence for this intervention, it is considered low-level (Walters et al, 2011); supporting this author's view that it would be premature for ambulance services to introduce MTH outside of a well-designed, ethically approved research study.
Two more examples that were published as this commentary was being written include a randomized trial of 8718 patients comparing the impedance threshold device (ITD) with a sham device (Aufderheide et al, 2011). Contrary to an earlier, non-randomized UK study (Thayne et al, 2005) suggesting that the ITD improved short-term survival, the ITD did not significantly improve survival with satisfactory function in this recent high-quality study. Moreover, another prehospital study in the same edition found no difference in outcomes with either a brief period of basic life support (BLS) compared with two minutes of BLS provided by ambulance personnel prior to first analysis of cardiac rhythm (Stiell et al, 2011) differing from more optimistic assessments from lower quality, UK observational series (Fletcher et al, 2011). These should serve as yet more reminders that robust evaluation is required before widespread adoption of innovative treatments. Using treatments before we have a robust evidence-base could be described as experimenting on patients, we need to go about it the right way through well-designed, ethically approved research that gives a fair assessment of the value of a therapeutic intervention.
It is not just about treatments either. There has been enthusiasm for introducing strategies for risk assessment in patients with suspected transient ischaemic attack (TIA), but modelling has suggested using ambulance services to expedite TIA care was unlikely to be cost effective (Mant et al, 2008). The ABCD2 score has not proven useful in the emergency department setting (Perry et al, 2011). Critical care paramedics are an attractive proposition (NHS Confederation, 2011) but there is no good evidence yet of their value to patients or the NHS, and the research underpinning the NHS Confederation report has been criticized for its poor quality (Hughes, 2011). It is possible to do such research well, see for example the work from Sheffield on paramedic practitioners (Mason et al, 2007).
The IDEAL recommendations
In surgery, a speciality where innovation is central to continuing advances and improvement in care, there is increasing recognition that the traditional approaches to evaluating a new technology, such as a novel pharmaceutical, may not be appropriate. This may particularly be the case where new devices are concerned. The IDEAL (idea, development, exploration, assessment, long-term study) recommendations set out a proposed framework for achieving improved design, conduct and reporting of research, which will need concerted action by a range of actors, from professional societies and funders through to journal editors (McCulloch et al, 2009).
Conclusion
One might argue (and this author certainly does) that the time has come for research in prehospital care to consider adopting the IDEAL recommendations as a way forward, so that we can harness the enthusiasm of paramedics and other prehospital professionals for innovation, but do so in a way that protects the rights, dignity and safety of patients—and does not squander taxpayers' money.
Prehospital care is not the only health sector where the challenges of conducting high-quality research have been recognized. In emergency medicine, the example of 195 trials that were too small to answer the question regarding the role of corticosteroids in patients with head injury, should give pause for thought. The question was answered definitively only through a very large trial (Edwards et al, 2005). In the words of a leading emergency physician and researcher:
‘It would surely be better to cooperate and discover a definitive answer to one question rather than to spend time and resources finding inconclusive results for many questions’
That goes for prehospital care too.