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"

Just how bad is Cancer care in the UK?

The UK has poor cancer care compared with our neighbours. This fact is used as a stick to beat GPs especially, and has led to a huge investment in hospital cancer care in the last five years. But can we trust the stats, and has the investment been a good idea?

First of all we need to examine whether we really are making fair comparisons, and what factors other than quality of care affect the results. We generally compare survival figures such as the percentage of patients alive 5 years after diagnosis of a particular disease. There is an obvious problem with this approach if the patients in one country differ at the outset from those in another. This happens in various ways.

First of all, cancer of any particular organ is not one disease but a collection of different mutated cell types that have changed in a way that allows them to evade the immune system and invade other tissues. Some cancers are much more deadly than others and some countries may suffer deadlier subtypes more than others. For example, one type of lung cancer, so called small cell, is never curable by surgery, and has a 5 year survival near zero. A high proportion of this type among lung cancers will adversely affect overall lung cancer survival. Cancer types do vary between European countries, so this a significant problem.

Another problem is so called incidentalomas.  These are true cancers under the microscope, but do not behave as cancers, and rarely pose a threat to life. These are not rare, with kidney cancer, thyroid cancer, skin cancer, and so called Ductal Carcinoma of the breast being well known examples. In countries where more formal or ad hoc screening scans are done, a proportion of 5 year survivors are not surviving because of good treatment, but because they would have been alive anyway because their ‘cancers’ were never a threat to life.

Then there is so called 'lead time bias'. If patients are diagnosed earlier, they are more likely to survive for 5 years, even if there is no effective treatment, simply because the diagnosis is made earlier in the natural course of the disease. This problem is well known but it is difficult for experts to allow for it.

A useful example is Prostate Cancer compared between the US and the UK. The death rate of this condition has remained similar and very stable in both countries for many years. But the survival figures have improved dramatically in the U.S. The general interpretation is that U.S. Patients are getting a diagnosis, which is of more harm than benefit, and that treatment is largely useless at least in terms of postponing death.

Then there is the issue of cancer registries and death certification, especially of elderly patients who are likely to have advanced cancer, but who are frail and generally sick. These patients and their families may choose not to have scans or operations and they may therefore never be included in the statistics. This tendency is likely to vary between countries. A large proportion of patients are certified as dying of 'old age', some of who surely in reality died of cancer. Some countries have much higher rates of post mortem examinations than others. In those countries the true cancerous diagnosis will be recorded, thus adversely affecting survival statistics.

Then there is patient behaviour, which varies significantly. For example, lung cancer survival is strongly affected by whether smokers stop the habit. Other variables, such as Vitamin D blood levels are also known to have a major effect (so if you get cancer, move somewhere sunny). Behaviour in terms of the way patients seek medical advice is also important. Anecdotally, there seem to be 2 main types of patients in the UK, the 'worriers'-those who listen attentively to the health info publicity, and seek advice for every skin blemish or headache because it might be cancer,- and a significant number of 'deniers' who ignore symptoms like weeing blood. If a country has a higher level of health literacy, and more sensible behaviour, then it is likely to result in earlier diagnosis and better survival.

Another relevant variable factor is the extent to which patients accept definite harms in the hope of an improved chance of long term survival. For example, patients with early localised breast cancer may be offered drugs and radiation with the aim of mopping up cells that may have spread, even though that may be relatively unlikely, so that only a small minority of patients are likely to benefit. Patients and their doctors in some countries will conclude that it is worth taking the small risk of not having the treatments,  in order to avoid the certainty of months of feeling ill, losing hair etc. This will worsen the statistics for that country but does that mean that the standard of care is worse?

Taking the survival figures at face value has led to various actions in the UK. Cancer patients are now treated by so called MDT's, where the surgeons, oncologists, X-ray specialists etc. discuss patients and decide on treatment. This has been done in order to improve survival. But this ignores one of the most important principles of medical ethics, which is patient autonomy, the freedom to make ones own choices with ones body. It also commonly leads to severe communication failures, for example patients attending for follow up appointments at which the doctor that sees them assumes incorrectly that the patient has already been given some bad news, for example that a cancer has spread. This seems unbelievable but I personally have encountered this several times in the last 3 years just among my own patients.  

Also, patients seem to be being pushed into treatment with drugs which reduce their quality of life, when the prospects of extending their lives seem very poor. it seems that the imperative to improve the stats is once again going against standard medical ethical principles.

One suggestion made by our Health Minister on this issue, has been to 'name and shame' individual GPs who fail to refer patents within the first couple of consultations, or if their patients are diagnosed after being admitted to hospital as an emergency. This is a naive idea. First of all measuring this statistic per individual GP would be tricky, as defining which consultations counted would not be obvious. Also each doctor will only refer a handful of patients every year who are found to have cancer, and there would be a lot of random variation. But the main problem is that once again cancer is a mixed bag and certain types (pancreatic cancer for example), are very difficult to diagnose, while others are easy.  Once again there is a big risk of comparing apples and pears.

There is however one very obvious factor that is associated with better survival rates, which is short waiting times for 'routine' scans and specialist appointments. Results for the UK and Denmark, which both rely on GPs as gatekeepers to assign priority to patients, are poor.

The reason is that medicine is a difficult art, and a large proportion of patients in all countries are diagnosed with cancer after routine investigation of vague complaints rather than so called red flag symptoms. Reducing waiting times for these patients, and loosening the tick box restrictions on urgent referrals would certainly improve performance, but at a huge cost and of course not within the tenure of any particular minister.  Blaming GPs is easier.

  

So should we ignore the figures? No of course we should not, but like all statistics they should be examined carefully and suspiciously and kept away from politicians and never used as soundbites.

 

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How to solve the NHS financial crisis at a stroke, (painless for nearly everyone).

The total cost of meeting successful personal injury claims made by patients treated by the NHS is rising fast, as is its proportion of the total budget. See the NHS Litigation Authority Annual Report
Payments in 2014/15 were £1.1bn and are predicted to rise by almost 30% next year. The projected current ‘debt’ for damages for the NHS is £28bn, around one fifth of total NHS expenditure and over £300 per head of the UK population. Around one third of the cost ends up being paid to lawyers who are entitled to claim payment of high hourly fees as well as a percentage of the payment to the patient. For claims under £10,000, lawyers fees are typically three or four times the amount claimed.

The amount of compensation is worked out on the basis that care of a patient disabled by bad treatment is provided on a private basis, ignoring the existence of the NHS. Loss of earnings compensation is bases on current earnings, so that high earners are entitled to larger payouts. Payment for mental distress can be judged to be many times that paid out for physical injury, such as loss of a limb. The NHS cannot normally recover its costs in cases that it wins, unless the claim is judged to be particularly vexatious. Cases are judged on the so called ' balance of probabilities’, (rather than beyond reasonable doubt as in criminal cases), and the natural sympathy towards a ‘victim’ is a big factor which can affect judgements. Compensation sums are now often greater than in the U.S. However if the poor result of medical treatment is judged to be due to bad luck rather than someone's fault, then the payment is nothing. On top of this the legal process takes several very stressful years, and patients often gets nothing during life, so that it is only the heirs that benefit.

As well as the direct costs to the NHS, there are huge indirect costs. Hospitals will have their own risk management departments whose salaries are not met centrally.  Expensive time is spent by doctors on elaborate multi page consent forms which patients can rarely understand. Huge effort is expended checking patient identities multiple times, which is tiresome and distracts attention from more important issues.

GPs pay for their own indemnity insurance, and those who do a lot of weekend work are having to pay five figure sums for their insurance. The total GP cost is around £300million per year. This cost is indirectly borne by the NHS as these costs are taken into account when pay is adjusted.

But the major costs are in terms of tests and scans that are not done because the doctor thinks they are likely to benefit the patient, but just to reduce the likelihood of being sued. So as well as the huge costs, patients suffer unnecessary and possibly harmful tests, and have to worry about harms of treatment even when there is no realistic alternative. Just because of the very small possibility of litigation. On average a GP will be sued only twice in his or her whole career.

So the present system is an expensive disaster, that is good for no one except lawyers.

But why should patients who are treated at no direct cost to themselves, be entitled to make claims?

The standard argument is that the threat of being sued helps drive up quality of care. Unfortunately, all the research done in this area shows that there is no correlation between being sued and medical competence. 

The other claim is that the law of tort allows claims to be made against anyone who has harmed us. But when we go out horse riding or mountain biking we are used to making contracts in which we absolve other parties of responsibility for predictable adverse outcomes.

So why can we not make such a contract a condition of NHS treatment, and release so many billions that can be used for patient care, and at the same time improve care by ending the 'cover my ass' culture. We could also easily pay for a no fault compensation scheme as in New Zealand.

It would however be a major blow to the legal industry, and with hundreds of lawyers in parliament I don't think it has much chance.

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The story of an honest man

This man is now 70 years old. He was born into a family of peasant farmers in South India. He did well at school as well as helping on the farm, so he went to secondary school where he loved history.  His teacher told him that science was a better choice in terms of bettering his lot in life and that of his family, and with the help of a charitable foundation he was supported to go to university and study to be a doctor. There he met his wife to be, from a slightly more privileged background. After qualification, like most of his fellow students he emigrated. He was going to go to Australia but could not since he, like most of his village, had not had his birth registered, and had no birth certificate. The UK was not so fussy then, and there was a shortage of junior doctors in the 1970's so he found work as a junior hospital doctor in the Manchester area. In those days even in A&E, the working week was Monday to Friday, and then on top of that there was overtime. The on call rota would be usually every second or third evening and night on, and ditto weekends. This overtime was paid in so called UMT's or units of medical time. The assumption was that only a third or a quarter of hours on duty were actually worked so the pay was set at about a quarter of the standard hourly pay rate. Not surprisingly busy jobs such as A&E were shunned by anyone who could get anything less arduous. However, he had been brought up on a peasant farm, and working all the hours there were was not unusual. So he accepted the conditions, thinking that he was after all getting good experience. In the apprenticeship like system that existed in those days he learned some valuable lessons.

Eventually he and his wife got the chance to try General Practice.  Initially he was exploited as a salaried assistant, but it did not take long before the opportunity arose of taking over a practice in a central and somewhat deprived area of a northern industrial town.

They started of course with no appointment system and a very small staff, but they worked very hard and he augmented his income with work as a police surgeon. Gradually, they developed the practice and after the GP reforms of the 1980's they built a purpose designed surgery. His life was his work, and his work became his life. He gradually recruited a team of helpers to whom he was devoted and they became devoted to him. He continued to work a seven day week, and his wife brought up their 2 children mostly unaided.

The practice went well. He resented the cost of employing locums for his holidays so he seldom took any. His patients appreciated the way that the surgery was always available in a way that is almost inconceivable nowadays, and continuity of care was excellent. He loved working as a GP in the NHS because he made an adequate income doing what he was most interested in, with none of the commercial pressure, conflicts of interest, and outright corruption that he was all too aware was endemic in Indian medicine. He earned enough to help his family in India build houses and to support a school, thus giving back to the society that had helped him and to which he felt a debt of gratitude. He spent a large part of his spare time going to educational medical meetings, generally on proper clinical bedside doctoring rather than practice organisation.

He did have some problems of course. Being so accessible meant that he was not well protected against patients who wished to manipulate him, and some patients interpreted his wish to help them as weakness. He prescribed diazepam and similar drugs as GPs did in those days, and then when he refused to continue the prescriptions because of possible abuse and the danger of addiction, patients sometimes complained. When his police surgeon job was reorganised away from his town he started to replace that work by doing a lot of weekend shifts for what was then an out of hours GP cooperative. He often did 20 hours at a weekend, and he received the appropriate share of patient complaints. Asian doctors get many more complaints than English doctors. The reasons are not totally clear but there is no doubt that communication difficulties and racist attitudes in some patients play a significant role.

The first big problem however, started with the 2004 GP contract. It brought in Quality payments for GPs (QOF), which made computerised records essential, at least for those aspects like recording Blood Pressures and smoking status. Computers were provided free by the NHS but there was little in the way of training and no funding for the huge task of inputting handwritten data.  For a doctor in his late 50's this was a challenge. For several years he continued to use hand written records from which his staff extracted the information to ‘feed the QOF beast’.  This gradually became less workable after the lab stopped sending paper reports, and he then used a dual system with major illness, prescriptions, lab data on the computer, and consultation notes and hospital letters still filed on paper. Many doctors went through the same process of gradual transition, but he was one of the hindmost.

However, with the considerable help from his staff, they managed quite well. Patient surveys were good, which was a huge achievement in a poor area, prescription statistics were good, and the QOF points were at least up to average. He had yearly appraisals, during which hints would be dropped about rather the old fashioned record system and prescribing out of fashion drugs like antihistamines to kids with colds, but no serious problems emerged.

Then around 2008, Blair appointed Arai Darzi, a highly specialised London Surgeon, to sort out the problems of general practice!, which in London were largely about inadequate buildings without other services, and lack of GPs in deprived areas. As a result, all the local areas in the NHS were told they had to build a new multipurpose medical centre, and the career prospects of NHS administrators depended on the success of the scheme. Unfortunately, many towns had plenty of doctors and pretty good premises already often with other services like district nurses on site, so filling a new building with patients was a challenge. The obvious answer was to persuade existing practices to move to the new building.

As a result, an NHS administrator (a former car salesman) visited the practice. When the doctor learned that his patients would have to travel 2 miles without a good bus route or free parking, he refused to move. The manager told him that he would not take no for an answer, and that if he did not comply he would eventually get the practice closed down.

Things settled for a while as the 15 million pound surgery building took a long time to build, and then it didn't work as they had failed to build an adequate sewage system. Then matters took a turn for the worse when the NHS implemented the new Conservative Health Bill, which no one had either read or understood. Many NHS managers took redundancy, and were then re-employed in the new NHS administration. The manager who had made the threat to close our man down ended up moving sites and sharing an office with the "Performance Review Department".

So it happened that in May 2014, the doctor was notified that he was to be visited by a Doctor and assistant as part of a Performance review. The inspecting team came and inspected 4 sets of case notes and asked a few questions in an aggressive manner, and concluded by saying that they would be back for a further visit. He had by now got the wind up a bit, and asked if he could have representation at a future visit. It was agreed that a doctor from the local medical committee (which represents local doctors) would be present for the next visit, scheduled for early July.

Despite several requests and the passage of over 6 weeks, no report from the first visit was sent to the doctor until the day before the second visit, giving the doctor no time to respond. 

During the second inspection visit, done by the same doctor as the first visit, 3 more patient records were examined.  The LMC doctor was only able to be present for the first hour.

After the records were examined, the doctor was told that they had found severe deficiencies, which would be reported to the performance review panel meeting that was scheduled for within the next 10 days. At this stage no other evidence of performance had been examined (although a lot of statistics are collected routinely by the NHS ), no one else had been interviewed, and no consultations had been observed.

It was thought to be adequate that the opinion of one doctor, who only examined 7 patient records was sufficient to end the career of a man who everyone agrees is dedicated to his patients. Given that judgements of this sort are well known to be highly subjective, and prone to a host of biases, and that racist bias was an obvious possibility, this is astonishing.

After the inspecting doctor had left, the other member of the team spoke to the practice manager and suggested that it would be better for the doctor to hand in his license to practice in order to avoid publicity and shame. As he relied heavily on her advice he did as suggested, surrendering his licence to practise to the GMC, and resigning from the local performers list. Within 2 working days the authorities wrote letters to all the patients informing them that the practice was closing, and informing them of nearby practices that they could register with. On the front side of this list were 2 practices which were both located in the new building, while all the other practices were listed over the page. The obvious conclusion was that the inspection and its results were pre-planned by the manager who shared the office with the Performance review team.

In the following days and weeks the doctor discussed the situation with colleagues, who examined the report of the first visit and found it to be both ill informed and unfair. They were horrified at the way that the procedure contravened natural justice. Several weeks after the second visit no report of that visit was supplied. When it did come it was seen to be even less fit for purpose than the first. He and his colleagues complained to the performance review authorities who promised to look into it.

However, the review procedure turned out to be no more than a rubber stamp and a delaying tactic. They admitted that the delay in writing and sending the reports was a serious flaw, but insisted that the process and the 'decision' was valid.

So, can we trust British ' Justice' ?  Maybe, but Not in the health service at any rate.