Why Doctors should not follow Guidelines

There are large variations between different doctors in terms of prescribing, use of tests, and referrals to specialists. Some of this difference is clearly explained by doctor’s ignorance, and their failure to apply the lessons of medical research. A proportion of patients who suffer for example internal bleeding from stomach ulcers do so partly because doctors prescribe anti inflammatory drugs to high risk patients, such as those taking antidepressants, or patients with poor kidney function etc.

In order to prevent these harms, various institutions including NICE (the National Institute for Clinical Excellence), the Royal Colleges of various specialties, and various special interest societies such as the British Heart Foundation have systematically examined the research on many topics, and produced guidelines on the management of many conditions, which are widely disseminated and taught to doctors. Statistics are collected comparing the performance of doctors in complying with this guidance, and doctors who perform badly may be penalised in various ways. Reports from pathology labs, for example when they grow bugs in swabs, often only report whether the bug is sensitive to 'approved' antibiotics even though they are also tested against other drugs. The results supplied to the requesting doctors are restricted in order to nudge the doctors to use the treatments advocated by the microbiologist.

Surely this is a good idea, and likely to benefit patients?

I am not so sure for several reasons. 

One major problem is that the evidence on which they are based is insufficient or even biased, and is usually applied to groups of patients (such as the elderly), who were not included in the original research. Almost all research trials exclude patients over a certain age, or on other medication. Trials are conducted by the drug industry. They usually control all the data, and numerous cases of manipulation and fraud have been revealed. However, this possibility tends to be ignored by the relevant committees. For example, Guidelines advising the use of clot busting in stroke were issued in 2007 and hospital services have been reorganised to facilitate the use of this treatment. However, in a poll of emergency doctors, most said they did not believe the treatment to be beneficial, and in 2014 the MHRA launched a review of the treatment after reanalysis of the trial data showed glaring inconsistencies and a lack of benefit to patients in the majority of the hospitals taking part.

Similarly, after heart attacks patients are now treated with a new expensive clot preventer. The trial on which this advice is based showed a remarkable lack of significant benefit in some countries in the trial, with very large benefits in others. This could be a statistical blip, but it does seem suspicious, and surely the issue needs further research before it becomes official guidance.

Research is also biased in the sense that very little research is done into drug harms, so that guidelines are biased towards recommending medication. NICE guidance on using Statins in all over 80's is an example. Some of the results of Statin trials are probably misrepresented, there has been very little research in this age group, and there is a lot of uncertainty about harms, with huge numbers of patient reports of muscle pain, falls, memory problems, diabetes, cataracts, and nerve damage. Experts (some of whom are likely to have a conflict of interest) are sceptical, and say that the harms are exaggerated, and these problems are ignored by NICE.

Similarly, NICE advises medication for patients with brittle bones, although there are fears of these drugs causing cancer of the oesophagus. The Quality and Outcomes Framework target that makes up a large amount of GP pay promotes long term use, although the pharmacology of the drugs suggests that it is pointless using the treatment for more than 5 years. GPs are also paid for hitting targets for controlling blood sugar in patients with diabetes, although the evidence that this prevents deaths and complications is lacking. GPs are thereby encouraged to use new drugs that have no proven long term benefit, and are likely to have harms. This problem has lead to some embarrassing u turns by NICE, for example after the so called Cox2 selective anti-inflammatory drugs came out they advised their exclusive use in over 65's. However soon afterwards it became clear that these drugs caused heart attacks, and that they were particularly dangerous in the very patient group that NICE had recommended them for.

This is at least possible to remedy, but other difficulties seem insoluble. One big problem is that inferring actions from evidence needs value judgements about the pros and cons of the harms and benefits of treatment. NICE have attempted to deal with the cost effectiveness issue by adopting a cut off of £30k per year of quality life gained (This is of course extremely tricky to calculate in practice, and often the assumptions used are heroic), but there are lots of other harms and costs that defy mathematical solutions. The risk of stroke for patients with an irregular heart rhythm, so called AF, is roughly 1 in 20 per year and can be halved by blood thinning treatment. But the patient will have put up with various harms, including large increases in risks of surgery and accidents, not being able to have many other medications that upset the blood  thinning treatment, the need for frequent blood tests, which can make travel very difficult, a large increase in the risk of dangerous internal bleeding etc. The GP QOF system based on NICE Guidelines presently penalises doctors when patients are not being prescribed this treatment, and it is common to meet patients who have been prescribed blood thinners for this reason in hospitals without a detailed discussion of pros and cons. But balancing the reduced risk of stroke against for example the increased difficulty of overseas travel is surely a value judgement that only the individual patient can make. Even taking a daily pill is a cost that will vary between patients., some see it as depressing evidence of poor health, while others are not bothered.

Guidelines from different countries varies hugely because of this value issue, despite being based on the same evidence. For example, high blood pressure is the commonest reason for the use of long term medication and there have been countless research trials into its treatment, which often requires several different medications used in sequence. Despite this, comparisons of guidelines from the US, Canada, Denmark, and the UK shows that there is no agreement even on the most basic issue of which drug to start with. Most countries advise starting treatment with a diuretic (which makes the kidneys excrete more salt and water), but this treatment is only step 3 in the UK Guidance.

The AF guidance focuses on preventing strokes without paying a lot of attention to harms. Other guidelines focusing on a particular problem can have unintended harmful consequences in other areas. GPs are monitored on how much they prescribe certain antibiotics that increase the risk of the superbug Clostridium difficile, usually by looking at the percentage of prescriptions for 2 particular classes. One of the main types that is encouraged are so called macrolides, like clarithromycin. However, it is now clear that these drugs have a dangerous effect on the heart in some patients and significantly increase the risk of sudden death.

But the biggest problem with guidelines is that they completely fail to take account of the fact that most patients have more than one long term condition, and many have several. Does it matter? Yes of course it does. How well do the various drugs go together? We often do not know. If a patient has very poor kidney function, does that affect his diabetes treatment? Well obviously. If a patient has dementia, are we keen to start treatment aimed at preventing sudden death? Well, maybe not. There has been an attempt to assess how many guidelines may be relevant to the treatment of typical illnesses in typical patients. For a particular elderly patient with a broken hip it was calculated that 75 guidelines were relevant. Simply to read them all would have taken several weeks.

So how can this situation be ameliorated?

First of all, the advice that is usually buried somewhere in the small print, that the guidelines need to be interpreted in the context of the individual patient, and that it may be entirely correct to ignore them occasionally, needs to be printed in bold on every page. Along with this, most targets that incentivise treatments should be removed. Removing doctors conflicts of interest in this way would also improve patients trust in doctors.

A recent research study BMC Cancer 2015; 15;734  looked at patients treated for breast cancer in Germany comparing results for patients whose treatment adhered to guidelines, with those whose treatment diverged from the guidance.  The latter group showed a significant improvement in survival! The authors conclude in a somewhat Teutonic formulation “This is an indicator for the appropriate application of guidelines. A maximization of guideline-based decisions instead of the ubiquitous demand of guideline adherence maximization is advocated.” i.e. patients may benefit when doctors do not adhere to guidelines.

Secondly, NICE etc. need to be more rigorous with examining all the data and ignoring any trials with a whiff of fraud. They should cease to extrapolate to patients for whom there is no direct  evidence. They also need to commission research into the harms of treatments because no one else is doing it. Conflicts of interest among members of NICE and other guideline producers need to be rigorously policed.

Thirdly there needs to be a big effort to make guidance appropriate to real patients, with multiple conditions.

Last of all but most importantly, it needs to be emphasised that good medical care is a matter of well educated doctors evaluating evidence together with patients and making appropriate decisions together, or in the words of Glasgow GP Des Spence “A doctor’s role is not ….. to follow guidelines but to interpret, and often ignore, them—that is, to short circuit the mechanised medical machine for the benefit of patients. Otherwise what is the point of doctors: any idiot can follow a guideline"