Point of care diagnostics and treatments are starting to have a real impact, but it’s only the tip of the iceberg, as Mark Greener discovers
You can’t fault Thomas Willis’ dedication to diagnosis. The 17th-century English physician held samples of his patients’ urine to the light – then took a swig. Willis used urine’s sweet taste to distinguish diabetes from bladder stones and other infections and diseases that cause frequent urination. That’s why we still refer to ‘diabetes mellitus’, the latter word derived from the Greek for honey or sweet.
In other words, Point of Care (PoC) diagnosis is well established. Nevertheless, PoC technologies are becoming ever more important to modern healthcare. Recent advances in electronics, software and assays mean that systems that once occupied a laboratory bench, or procedures that required an entire room, can sit by the patient’s bedside or in the corner of a consulting room. Rather than needing specialist expertise, any healthcare professional can learn most PoC technologies, sometimes within a few minutes. This helps make PoC technology highly cost-effective.
A good example is a new PoC device to monitor diabetes, kidney and heart disease, and even detect markers of certain cancers developed by Professor Anthony Turner, Head of the Biosensors and Bioelectronics Centre at Linköping University, Sweden. ‘When I started electrochemistry research 30 years ago, an instrument like this would have been the size of a filing cabinet and would have cost €10,000,’ he observes. His new credit-card sized instrument could cost just €0.50. Nevertheless, realising the promise of PoC technologies means overcoming some formidable financial and attitudinal barriers.
‘The need for new, easy-to-use, home and decentralised diagnostics and other technologies is greater than ever,’ Professor Turner explains. ‘Healthcare spending is growing unsustainably. We need new solutions to cost-effectively deliver the high quality of life rightly demanded by our ever-ageing population.’
The genomic revolution further raises the stakes. ‘Personalised medicine recognises that every individual needs a tailor-made health package,’ he adds. ‘These differences can only be identified with an appropriate suite of diagnostics. In addition, PoC technologies generate consumer choice and facilitate evidence-based payment. This drives decentralisation and may result in a radical restructuring of health management nationally and internationally.’
Certainly, the range of PoC technologies is remarkable. Global healthcare company Abbott, for example, has developed a portable, hand-held device (i-Stat®) that uses two to three drops of blood to analyse troponin, a protein associated with heart injury, blood gases, coagulation, lactate, electrolytes and haematology. Within minutes, i-Stat wirelessly transmits the results to a patient’s electronic medical records.
Similarly, Alere International’s Afinion™ AS100 Analyzer allows users to perform a range of tests, including for C-reactive protein (CRP), which could help tackle the growing threat posed by antibacterial resistance. Most respiratory tract infections are viral or self-limiting bacterial infections – and so antibiotics are inappropriate. Yet GPs still seem to prescribe antibiotics to about 75 per cent of patients with lower respiratory tract infections. In turn, inappropriate antibiotic prescribing fuels resistance.
CRP ‘tags’ infected or injured cells, helping the immune system recognise and remove them as well as pathogens. CRP levels in the blood often rise to high levels in people with potentially serious bacterial infections who need antibiotics. But CRP does not usually increase to high levels during viral or self-limiting bacterial infections.
Straight to the Point, an independent report supported by Alere International, summarises the compelling evidence that CRP testing allows prescribers to target antibiotics to people that need them. Combining a PoC test for CRP with the patients’ signs, symptoms and history allows healthcare professionals to identify ‘low-risk’ patients with respiratory tract infections who do not require antibiotics and those at high risk of having a bacterial infection that do. The National Institute for Health and Care Excellence (NICE), for example, recommends CRP testing for people with suspected pneumonia. The report envisages a greater role for PoC testing for CRP as part of antimicrobial stewardship.
As a final example – and the research pipeline is bursting with many more – Professor Turner’s instrument is screen-printed on card. The user applies blood or saliva to a circle on the card, and the results are digitally displayed or sent to a mobile phone. At €5 for each card – which Professor Turner expects to fall to €0.50 – the system could provide patients and doctors in developing countries with accessible, affordable diagnostic tests. The printed card could also be part of an antibiotic’s packaging, helping to determine which drug is best for the infection, or worn like plasters or contact lenses, transmitting real-time information to mobile phones.
And PoC technologies offer much more than diagnostics. We have all had food ‘go down the wrong way’. But when patients – such as those who have suffered a stroke or are in intensive care – need feeding through a tube, food ending up in the lungs can be fatal. Feeding into a lung can drown the patient, or a misplaced tube can puncture the lung, thus trapping air and causing a potentially fatal pneumothorax. So, many patients need an x-ray to confirm that the feeding tube has been placed in the gut rather than the lungs. This delays feeding at a critical time and means moving very ill patients to a radiology suite.
A PoC technology called Cortrak®, developed by Corpak MedSystems UK, offers a bedside alternative. Cortrak uses an electromagnetic sensor to track and display the path of a feeding-tube placement. The healthcare professional can easily seewhen the tube enters the airway and can then reposition the tube, without an x-ray. A recent review suggests that Cortrak can virtually eliminate misplacement and, therefore, the risk of feeding into the lungs and pneumothoraces. Cortrak is cost-effective in a variety of settings and minimises delays in the time to start feeding, which should improve outcomes.
Richard Banham, Business Director EMEA at the Corpak MedSystems, adds that PoC technologies also ease pressure on specialist staff. ‘In some places, there is a reduced availability of specialist staff able to perform some tests and procedures, or certify results,’ he explains. ‘PoC technologies mean that a growing range of staff can perform tests or procedures that were once the sole domain of specialists. Staff training is still important. However, PoC technology is easy to use at the bedside by a wider group of people than conventional procedures. This is one reason why PoC technologies tend to be cost-effective.’
Despite their value, funding is the biggest barrier to the uptake of PoC technologies. ‘There is a widespread fear that technological innovations inevitably incur greater costs. PoC technologies, however, save money as well as patient time – but it’s not always the purchaser of the PoC that saves money. Indeed, they may incur extra costs,’ Banham explains. Straight to the Point agrees, suggesting that healthcare purchasers should explore alternative funding mechanisms to encourage uptake of diagnostics in primary care. Professor Turner argues that reimbursement should be more firmly based on evidence.
‘Despite their value, funding is the biggest barrier to the uptake of PoC technologies’
But where there is a clinical will to implement a cost-effective innovation, purchasers can generally find a way. Indeed, PoC technologies may face a more fundamental problem, which helps give rise to the financial disincentives. ‘There is a reluctance to embrace new technology by healthcare services. Across Europe, so much of what is accepted practice has very little scientific and evidence base, and still relies heavily on historical practices,’ Banham says. ‘The changes arising from PoC technologies often go to the very heart of current practice and challenge beliefs on what is and is not possible at the patient’s bedside.’ As a result, Banham says that some healthcare professionals may be reluctant to allow other staff greater autonomy. ‘There’s a lack of central leadership from the nursing and medical specialities to prioritise the implementation of PoC technologies.’
Nevertheless, the growing number of PoC technologies combined with the various growing pressures in the system, is set to force these issues higher up the political and purchasing agenda. According to Professor Turner, the implications could be profound, requiring a redesign of the healthcare structure from basic principles. ‘Until now, we have been used to going to a doctor, who endows us with some wisdom and retains our information, and then waiting to see if we get better,’ he concludes. ‘We’re on the cusp of an entirely new era for healthcare where patients have the information, while physicians provide a service.’
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