How not to harm patients (and control antibiotic use while you're about it)

So I am often asked, as a microbiologist, what I would do if it were me, or my kids, with a sore throat/sinusitis/cough and so on. People seem surprised when I say I would have some paracetamol (maybe with a little whisky and lemon obviously). As though I know that antibiotics are really what's needed, for an individual patient, but that I put public health concerns above this when advising others. Taking this approach, as a doctor I would have to weigh up the benefits of giving an antibiotic (24 hours less symptoms perhaps) but then try to factor in some professional responsibility to 'do the right thing', even if that is in direct conflict with what the patient might want.

But of course a patient wants more than just to get better. They also don't want to be exposed to potential harm. And antibiotic use is not benign. Data presented at ECCMID shows that there are high rates of colonisation with resistant organisms after antibiotic treatment. Clinically relevant? Who knows... But as a patient I might like to know that it might happen. People know that MRSA is not a good thing to have on your skin. And of course there are myriad other risks. From drug reactions to irreversibly altered gut flora (with who knows what consequences).

So looked at this way, over prescribing is not patient centred medicine triumphing over the paternalism of population health. Rather it is a complete failure on behalf of the medical profession to properly consent patients for the things we do to them. So let's start sharing our uncertainties with patients in more honest and open ways.

I was thinking of an analogy. You are driving from A to B. You could do so very fast, breaking the law, increasing the chance of death to you and others; or you could do so more sedately, arriving a bit later, but safely. We might normally do the second, but in some situations, say if time is tight, we might do the first. To make that choice requires 'consent' by considering all consequences, both short and long term, and weighing them up. The answer we get to may not always be rational to others, but perhaps by focusing on rationality we lose the argument? So perhaps the answer to problems of antibiotic stewardship is purely designing ways of sharing risks and benefits with patients and then letting them make the call with us as their impartial advisors.

Designing pathology services through studying demand

So I'm here at ECCMID2015 in lovely Copenhagen. It is clear that the predicted shift from culture to molecular is gaining pace. This will have a major impact on how we organise our laboratories and support clinical medicine. Many people see this as the death knell for local services. I will argue the contrary. For the first time, we have the tools in microbiology (beyond simple microscopy) to deliver results in a time frame that impacts on empirical decisions. In order to work, these tools need to be as near to the decision point as possible, as inevitably transport and other logistical issues will come to dominate the time taken to get a result. We will move from batch processing, to random access or point of care testing. These are things that local services can deliver, but that centralised reference laboratories cannot provide. The irony may be that it is reference labs that will remain the bastion of culture based methods (and perhaps non time critical molecular tests, such as viral load).

So that is all good. But in order to do this we need to change our thinking. We cannot replicate what we do with culture and just do it faster. We need to reconsider the questions we are asking and think about how the results we produce inform action. Just because you can do a test does not mean that you should. We heard today about how highly accurate molecular tests for tuberculosis actually perform poorly in low probability settings. So without considering exactly what test results mean, when applied to a specific setting, we run a real risk of doing more harm than good. And the mystique of molecular makes the risk of blind acceptance of results even greater. I will suggest that we need to go back to studying demand, and by that I mean asking what questions a patient would want to ask, and thinking about how we can answer them. So the question is not 'how can molecular do what I now do faster/better?' Rather it is, 'what clinical decisions can I now support using molecular?'.

And even more importantly, we need to be careful that we don't substitute good clinical assessment for the false security of a test result. Test results can only ever be interpreted in the context of the prior probability that flows from the extraction of clinically relevant information. We need to find ways that help us to resist the siren call of false reassurance, and back our clinical judgement when it is appropriate to do so.

The other concern I have is that small laboratories lack the skills with which to appraise these new technologies. It is easy to be bamboozled by reps promising sensitivities and specificities in excess of 99%, with business cases ready to pull from the shelf. What we need are experts who have a deep understanding of the emerging platforms, with attendant risks and benefits, and perhaps more importantly how they can be fitted together into a coherent package. We need advice on optimum staffing to run these services.

But these are certainly exciting times to be an infection specialist.

Pathology in a system : Wound swabs as an example of how pathology can spot system failures

Pathology in a system: The identification of system failures by Darunee Whiting

Systems theories have been used to describe and help predict how systems behave. It has been used for space projects, financial systems and can also be applied to the healthcare system. Key system concepts are that actors within systems are interdependent but may be disparate. There may be a time lag between actions and effects within systems, so that the effect of an action is not immediately felt and thus the root cause of a problem often goes unrecognised. This can be especially so when actors, actions and effects are in different parts of the system. Systems have feedback processes that can be accelerate growth/decline or rebalance. We see pathology tests as key decision points in a networked system of decision making with the aim of supporting patients, and those helping patients, to make good and timely decisions about their care.

Key decision points trigger actions within the system which can help patients on a path to better health, or in some cases lead them off this path! Tests are placed at key decision points. In primary care, within a clinical consultation there are four key decision points/ actions: these are whether or not to

1. Support the patient
2. Test
3. Prescribe or
4. Refer.

Systems can have patterns of behaviour. To help identify root causes of problems- these patterns of behaviour- system archetypes- have been identified. Our work on wound swabs in lower leg wound care demonstrates one of these archetypes and shows how primary care pathology can identify the root causes of health system failures, as pathology tests/ actions are placed at key decision points in care. Pathology can deliver value here and better health for patients by reducing system failures, through testing decision support and the optimisation of testing.

Lower leg wounds are common. They can become chronic in patients with underlying diseases such as venous or arterial insufficiency, diabetes and anaemia. The majority, approximately 80%, are due to venous insufficiency and require compression dressings to heal in optimal time. The remainder are made up of arterial and mixed arterial/ venous ulcers. It is important to perform a doppler ABPI (ankle brachial pressure index) test on all leg wounds to help decide the likely aetiology of an ulcer and subsequent dressing/ treatment. This is a key decision point. A venous ulcer treated with compression dressings should heal within 3 months. An arterial ulcer would deteriorate with compression dressings which constrict the circulation further. A doppler test can help differentiate between venous and arterial ulcers- and places a patient on the right path to quick healing.

What we did:

1) Identification of high volume/ low value test requesting= Lower leg wound swabs from primary care to the lab. Why was this? A clinical conversation between microbiology and tissue viability suggested that wound care in primary care was not optimal- as suggested by inappropriate tissue viability referrals for patients who hadn't received good primary treatment.

2) Go See: What was happening in primary care: The lab led a collaborative multidisciplinary meeting with microbiology/ vascular surgeon/ tissue viability/ practice nurse/ podiatrist/ GP. It was important to look jointly at the problems with the views of all healthcare professionals involved in the system.

3) Audit of patients with wound swabs/ lower leg wounds in primary care

4) Mapping of key decision points

5) Audit of patients vs mapped decision points

Findings:

Doppler tests not being done routinely or in a timely fashion- due to the lengthy time taken to do the test (30-40 minutes, not enough time was given in nurse timetables for this) This led to patients with venous ulcers not being put into compression dressings for a long time and consequently very very long heal times, and patients with arterial ulcers being referred very late to vascular surgeons for healing interventions This led to more nurse appointments for lower leg wounds that were not healing....which in turn made it more difficult to offer extended nurse appointments for doppler tests... (the system here was accelerating decline) When wounds were not healing, clinicians would often take a wound swab to look for infection. They would find bacteria colonising the wound, not causing infection, and often give unnecessary antibiotics. This demonstrates the 'Quick fix' systems archetype and often led to 'repeated quick fixes- fixes that fail to treat the underlying cause' It is much easier to take a swab, which takes seconds, and believe that this is the right decision, than to take the time to do a doppler (which the system also makes difficult to do in practice)

Here is a systems diagram showing this 'quick fix'

So, the root cause of the problem is in primary care: Wrong action: Doppler tests not being done Consequences of this action are felt throughout the system. Consequences for primary care: more nurse appointments. Consequences for pathology lab: More wounds swabs of low value Consequences for secondary care: Late vascular referrals- how much of this is contributing to high SARS rate for amputations? Consequences for patients: Unnecessary antibiotics, very long heal times/ morbidity Consequences for the health economy: cost

Pathology identified the route cause: a test which was a quick fix (wound swab) used instead of another test (doppler) at a key decision point- the root cause that would fix the whole system failures. The next step was to support primary care decision making and the optimisation of testing. Less wounds swabs- more doppler tests. We showed the key decision points and audit data. It was important to tell the story of how the system was not working and how this impacted on patients. The story for GP practices was that if they prioritised time for a lengthly doppler test, they would actually free up more time later through reduced nurse appointments and quicker heal rates. Addressing the root cause here would also reduce whole system failures- which is the patients story.... which was also important to tell. And the story for pathology? How many other times are tests used as quick fixes that lead to systems failures? Lets Go See!

What matters to patients about diagnostics?

What matters to patients about pathology results? Two talks over recent days have brought this question into sharp focus. First Joan Saddler talked from the perspective of a patient representative. Patients need to know

• why is a test being done (or not done)
• when will the result be available?
• what does the result mean?

So for me we have to think about the consent process (do patients /their carers understand the point of a test? Have they thought about what they will do with a result? Were other actions at this requesting decision point considered/correct?)

In terms of result availability, we need to think about whether necessary information available at time of key decisions. Was this information error free? Was there a predictable flow?

In terms of results there is a lot to do! We need to think about how we convey information in a way that informs decisions. (Was an appropriate action taken as a consequence of receiving the result?) This will include much more thought as to how we define and then convey inherent uncertainties in test results - if these are important when assessing options for action. If there is a 10% variability in creatinine measurement, how do we relay this? How do we deal with variation between laboratories? We cannot transfer uncertainty without considering how patients want this to be done. It will almost certainly be different for different patients.

And today listened to Bertie Squire talk about management of TB in Tanzania. A diagnosis of TB can account for 90% of a person's annual income - and this is with free access to medicine. It is important to get this right. Diagnostics may be expensive - but they are a tiny party of the system cost. This is why this work on delivering value is important. It is actually a matter of life and death.

Scripted consultation

Scripted consultations are being seen as a good way of delivering information to patients by non-experts. I suspect they are also a very good way of teaching the non-expert. They have the benefit of defining 'norms' for the non-expert, making them more confident in imparting information. Here's a draft scripted consultation draft for 'no antibiotic' consultation. Probably too long... Elicit information • What do you think is going on? (e.g. afraid it is pneumonia) • What did you want to have happen at this visit? Provide information • Your illness has the characteristics of a viral infection, so antibiotics will do nothing to help you recover, and they do not prevent complications. • We worry about using antibiotics when they are not definitely needed because : • Antibiotic use can result in the bacteria you always have in your body becoming resistant to antibiotics. Bacteria that cause disease can pick up this resistance, and this may make more serious infections (when antibiotics can be life saving) harder to treat • Resistant bacteria can spread in the community and this may put other people with life-threatening conditions at risk. • Antibiotics often cause unpleasant side effects, like diarrhoea and rashes • Some times these side effects can be very serious, like some allergic reactions. • The latest research suggests that antibiotics will kill off a lot of your friendly bugs that live in your guts, and some of these may never come back • We don’t really know what this means, but these bugs may keep us healthy in lots of ways so we need to try to look after them o They produce vitamins o They may prevent allergies o They may stop other intestinal disease, like coeliac disease o They may reduce the risk of some cancers o They may produce substances that keep our brains healthy o They may even help stop us getting fat • There is also new research that suggests antibiotics may affect the bits of our cells that produce energy. Again, we don’t know what this means to our patients, but it is another good reason to try to avoid antibiotics unless we are sure you really need them. Safety net • I have a handout here to help you manage your symptoms, and we can discuss warning signs that you might need to be reassessed. Summarise So, you understand that we won’t give you an antibiotic today? I don’t think it will help, but if you develop any of the concerning symptoms on the list we will have to reassess you. Do you have any questions?

Presenting pathology data to patients - a graphical representation of a haemoglobin result

Traditional pathology results, based on numerical values and strict reference ranges, maybe hard for both patients and doctors to understand. A lot of activity and worry is generated by tests that fall outside reference ranges. We need better ways of representing the 'normality' or otherwise of a result, so that we can have more honest dialogues with patients about meaning.

We recently saw a patient with an incidental finding of a haemoglobin of 108, with the lower end of the reference at 115. This 'low' result has caused anxiety to the GP, who must decide whether to follow guidelines for investigation of anaemia; but prinicipally to the patient, who now worries they may have cancer. 

We assumed that most haemoglobins measured in primary care are in patients with no underlying pathology. We plotted sequential results from women aged 65-75 (the demographic of our patient), to show the context of results we would be expecting. We then plotted the patients result, and used a large data point to represent the uncertainty that is inherent in any result. We added a line showing 2 standard deviations from the mean.

We think that this shows a result in a way that is instantly understandable in context. By showing the population variation as data points rather than in relation to a static mean, or between confidence limits, may give a feel for the dynamic nature of a test which is perhaps lost in traditional reports. Other background 'normal' data sets might be used if available - and this would be essential if there was a high proportion of data from patients with significant pathology.

An alternative way of presenting the data. My feeling is that this does not display the uncertainty of a test in a way that is as meaningful - it still emphasises the abnormality of the result. This may also be beacuse it uses set 'normal' ranges that may not be entirely appropriate for the popultation

Disease registers

James FalconerSmith also talked at today's RCPath day on systems, about disease registers for thyroid disease and health registers to coordinate care of those with mental illness. The general health needs of these patients may be poorly looked after, as they fall between the stools of general medicine and psychiatry. Pathology services maybe in a good place to coordinate this.

Pathology could coordinate care of many similar issues, from high risk conditions (eg lithium, DMARD monitoring, post radio iodine) to the complex (eg albuminurua in patients with diabetes, haematuria, MGUS, recurrent UTI).

These things work best when there is willingness from all stakeholders to work together. The thyroid register in Leicester was set up at the request of the endocrinologists. Labs need to be more confident in giving clinical advice.

We still need to grapple with how we commission this 'value add'. A service which is compared on test cost alone will be tempted to strip away expensive 'luxuries'  that are bundled into test contracts. One option might be for commissioners to require services to act on a certain number of system wide problems, with 'bonus' payment linked to delivery of some meaningful purpose focused measurement. For this to work well there needs to be a large degree of trust between commissioner and provider that the latter will act in the best interest of the patient. Otherwise there is a danger that the whole thing descends into management led performance monitoring of proxy measures, with perpetuation of the gaming that goes with this.