Guest Blog: Democratising diagnostics

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Democratisation of healthcare access is a significant development in the arena of medicine. Dr Mark Davies, European medical director at MedeAnalytics, considers some of the professional and ethical implications.

Technological progress has made services available to the general public that were previously the preserve of professionals. Travel agents, financial services, insurance comparisons; there are examples where the shift to a more self-service model has fundamentally changed the consumer’s ease of access. Those industries have had to respond or risk being left behind.

The same is also true of healthcare, where there is a keen interest in the transformation that health tech may provide. A sure indication of the need to embrace this shift is the amount of venture capital and tech start-up activity in the sector. The possibilities being offered to patients by new sensors, big data analytics, the processing power of mobile phones and more affordable biochemical processes, make direct use a reality. The capacity problems in our healthcare services are driving this emergence of a new industry of direct to consumer (DTC) diagnostics.  Companies like 23andMe, Thriva and WebMD are starting to fill the access gap that the public perceive. Some diagnostic tests have been about for a long time, e.g. high street pregnancy tests, so in many ways this is just the logical progression into a broader range of clinical areas. If doctors and nurses order these tests to get a diagnosis, then surely people should be able to cut to the chase, cut out the middle man and get their own tests.

This democratisation of healthcare access is a significant development in the arena of medicine, and the implications need to be considered carefully. On one hand it brings huge benefits. It encourages people to take more responsibility for their own health. It makes access to some diagnostics more convenient and may lead to earlier diagnoses being made. There are also strong arguments about assisting health service capacity. However, when disrupting any industry with technology, and even more so in health, it is important to consider the personal, ethical and professional implications of what we are doing.

The DTC medical investigations market is growing rapidly. A BCC research paper  in 2014 estimated that the global market for point of care diagnostics being $19.3bn by 2018 – annual growth of 4.5%. Health tests are being increasingly sold directly to consumers or provided as part of a health screen such as in an occupational health scheme. There are perhaps three main groups of consumers interested in DTC diagnostics. There are those wanting to understand risk and their propensity to develop disease, for example genotype information, lipids profiles and certain kinds of antibody biomarkers. Then there are those with symptoms who want more information to decide what they are going to do about their symptoms e.g. thyroid function tests for tiredness. Then those who are curious and want as much information about their bodies as possible. This last group are often triggered by a health scare or a relative that has developed a serious illness.

In the case of risk-assessment testing this makes sense, although it is important that the result is backed up with the information and advice needed to make sense of the results they receive. There is a duty of care and ethical responsibility to these individuals in these circumstances. The same is true of the symptomatic and the curious, but in these circumstances the problem is more complex. When healthcare professions order diagnostics, those tests are part of a clinical process.  An evaluation of a patient’s story, a physical examination and knowledge of that particular person’s risks and previous medical events guides the choice of investigation. The clinical process typically generates a number of hypotheses, known professionally as differential diagnoses. The test is then used to help narrow down the options and possible diagnoses. Starting the process at the end point is a very different proposition. There is risk of false reassurance delaying diagnosis or patients embarking on an erratic, illogical pursuit of answers resulting in a journey of anxiety and confusion.

Evidence and experience tells the professionals what these tests mean in the context of a particular clinical presentation, the challenge is that we are less clear how to interpret them in the general population. Most blood test results are normally distributed in statistical terms, an abnormal test is usually two standard deviations from the mean. Being outside the normal range doesn’t mean its abnormal or pathological – it means its unusual. For example, if a blood test was a height measurement, we would be running around telling all the women over 5ft 11 that they are diseased. The interpretation of the result needs to be made in the context of the clinical background and an understanding of normal variation in the population. This isn’t limited to blood tests, so although there is limited direct access currently, the potential for lung age assessment for smokers using spirometry or liver elastography measurements for people worried about alcohol related liver disease is significant.

There is a danger that DIY diagnostics are seen as an alternative to a proper assessment. Investigations are generally at the end of the assessment process when the likely hypothesis is being tested, so are often seen as the main source of the answer/diagnosis. This sometimes leads people to exaggerate their importance, leading to false reassurance or concern. In a clinical context, the most valuable part of the diagnostics process is what the patient tells you – the story. The art of listening and questioning to effectively obtain this ‘story’, called ‘taking the patient history’, forms one of the largest parts of medical training. I remember as a medical student, being told ‘if you don’t have a good idea what the diagnosis is by the time you have taken the history, you are unlikely to find it with examination and tests’. However, there is not the theatre or mystery in just ‘the story’, so the blood test (which is usually much less helpful) can appear more tangible, scientific and therefore more credible.

Consumer-targeted investigations have enormous value in helping people understand their own risk of disease, and in taking more interest in their bodies and taking more responsibility and control of their health.  Particularly in the context of symptoms, we need to ensure that people have the right support to make sense of what the test is telling them and ensuring the decisions they make on the back of these results make sense. Direct to consumer diagnostics is an important and inevitable development in sharing power in healthcare. However, we need to tread carefully and guard against the illusion of certainty that an isolated diagnostic test gives.

The future is here and self-ordered results will increasingly form a valid part of the patient story. There is a challenge to the health profession that, whilst embracing the benefits this may bring, we ensure we are prepared to explain these results for the patient and incorporate them into our mainstream records.

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