I qualified as a doctor almost 35 years ago. Looking back it seemed to be a period of relative innocence. Time and blurred memory makes the reality of medical care then fade, but I am sure that we didn’t use the word guideline much then. There were some clinical “rules” of course, but the vast number of guidelines didn’t exist then. There was much more variation in the care that was delivered, with the doctors personal preferences going relatively unchallenged.
Since then of course, the technical care of patients has become much more standardised, and this has undoubtedly led to improvements in the outcomes for patients. The concept of clinical audit developed in the 1980s, and we started measuring how many of our patients got the standard of care that had been outlined by the relevant guidelines. Where audit results were poor we started improving to ensure that almost all patients who could benefit were treated according to the most up to date guideline.
There followed a period where guidelines began to multiply, and many of the most experienced doctors nurses and pharmacists found themselves sifting through clinical evidence from trials and spending long hours developing guidelines. They were published by a vast number of groups and soon there were also local guidelines in each Health Board.
SIGN (The Scottish Intercollegiate Guideline Network) was born in an attempt to give more authoritative and unbiased guidance to clinicians. This was a world leader (and probably still is), publishing guidelines that tended to be much clearer than others, and also included an assessment of how strong the evidence supporting each bit of the guideline was, allowing the clinician to have confidence in interpreting the guidance that was presented. SIGN was, I recall, ground-breaking in that patient groups were invited to join the guideline development panels.
SIGN guidelines are published in glossy booklets that were sent out to all GPs. They had a wonderful smell of fresh ink, and although the format was largely standardised each had a different coloured cover so that you could rapidly find the one that you wanted in the pile of papers and magazines that lay in the corner of your room. When they arrived in the post I would glance through them: Some were not really relevant to general practice (I was a GP in the Scottish Borders then), but they were to be revered, and not to be discarded. On busy days I saved them for later reading. A pile of them grew steadily in the corner of my consulting room, sadly neglected, and tending to stick to one another as the once sweet smelling ink dried and stuck them together. When I left general practice I had over 100 of them. I couldn’t throw them out, but left them in a neat chronologically ordered row for my successor who would no doubt wonder if I had lived up to the standards espoused by the guidelines.
Guidelines began to interest lawyers. Around about 2000, failure to follow a SIGN guideline was discussed by a Sherriff in Glasgow who was hearing a fatal accident inquiry into the death of a patient from epilepsy. The SIGN guideline was clear in saying that General Practices should have distinct clinics for patients with epilepsy to assist a practice in providing structured, proactive care. The sheriff was extremely critical of the practice in not having such a clinic. He noted that they had failed to follow authoritative opinion in their provision of care, and were therefore guilty of a significant failure. Inevitably lawyers and doctors began to view guidelines in a different light. Lawyers would read and understand guidelines when dealing with medical negligence cases, and doctors would worry about ensuring that they were following them, and keeping up to date with them.
Guidelines have been incorporated into the Quality and Outcomes Framework of the GP contract since 2004, and the payment to GPs is significantly determined by their compliance with guidelines in a number of diseases- giving another incentive for GPs to follow guidelines, even if they hadn’t already felt compelled to do so by potential litigation.
But I sense that there is growing concern about some aspects of guidelines, and I share those concerns. This is difficult to say as a professional (still less a Medical Director) “How can you possibly want to ignore guidelines and bring back substandard care” others would say. Des Spence, a regular (and somewhat irreverent) contributor to the back pages of the BMJ talks of the “tyranny of guidelines” and the difficulties of railing against what now sound like compulsory edicts rather than helpful guidance. And sadly there is increasing evidence that there are commercial interests hovering around the production of guidelines: Guidelines can help sell vast volumes of medications.
Let me try to explain some of the concerns I have about guidelines.
Firstly they are so often misquoted. If you go back to the original guideline they often say something along the lines of “Drug X should be considered for ….”. The cool and sophisticated pharmaceutical company representative who comes to see you will, slightly challengingly, suggest to you that the guideline says “Drug X should always be used”, and, not actually having read the guideline in detail yourself you feel obliged to consider changing your clinical practice in the face of what you believe to be incontrovertible evidence. And of course the pharmaceutical rep (if you are unwise enough to see them) will have selected a particular guideline – there may be others that disagree.
Secondly, they are often unarguably correct when first developed, but over time they become extrapolated. A guideline may, for example, say, quite correctly, that patients with moderate to severe asthma should be given a steroid inhaler. This is absolutely correct. But gradually this message is reshaped in practice, and the principle is applied to patients with less and less troublesome asthma, until the patient with only occasional mild wheeze is given a steroid inhaler with “doctor’s orders” to take them on a regular twice daily basis. Taking a medication to prevent symptoms is of course more profitable for a drug company than only taking medicines when you are ill.
Thirdly, guidelines are often developed regarding patients who are relatively young, and who only have one particular illness. But in the real world this doesn’t happen often. As more of the population survives into older age, older patients (who metabolise drugs differently and who are more susceptible to side effects) have multiple illnesses, and so following the guidelines for each of the illnesses that they have (or are at risk of developing) results in patients facing a mountain of medication each day, often with resulting problems of confusion, falls, constipation, tiredness and the rest. So of course there are new guidelines developed on how to deal with polypharmacy – the use of large numbers of medication.
Lastly, some guidelines are found to be wrong as knowledge develops. A group of researchers some years ago reviewed all articles published in the New England Journal of Medicine in the course of 1 year, and noted that 17 (I think it was 17, I haven’t got the reference to hand) of the articles showed evidence that a basic guideline needed to be either withdrawn or significantly corrected.
But let me end with my personal evidence that guideline development may be subject to commercial pressures, and that lobby groups may push to influence clinical practice.
A letter arrived two years ago inviting me to dinner in the Scottish Parliament. The letter suggested that as an opinion leader in medicine I would be very welcome to attend a dinner in Holyrood with MSPs and doctors, hosted by the Atrial Fibrillation Association. I’m easily flattered and accepted with eager anticipation. I noted from the impressive website that the association had been recently founded to “increase awareness of atrial fibrillation” (a condition where an irregular heart beat occurs which may lead on to stroke in some patients). Cynically I wondered if the association and the website had had funding from a drug company that was soon to launch a new form of anticoagulant that could be used instead of warfarin for patients with atrial fibrillation. (Warfarin “thins” the blood and prevents stroke in atrial fibrillation). The new medicine costs almost 36 times more than warfarin and could potentially be used on thousands of patients who are currently on warfarin. While the new drug does not need regular blood tests to monitor its impact, it has only marginal improved effect in reducing stroke – and of course is not without problems itself.
The member’s dining room in Holyrood is impressive and I felt somewhat overawed as I sat at a table with MSPs some of whom I recognised from the papers. The meal was modest but accompanied by excellent wine. Half way through the meal an extraordinarily beautiful lady stood up at one of the tables and began to talk about atrial fibrillation, noting that it affects up to “one in four” of the population (in fact only about 2-3000 in Dumfries & Galloway), was associated with a “very high” risk of stroke (not an accurate representation)and was treated by a drug that was extraordinarily old-fashioned, used as a rat poison and extremely dangerous. She described in beguiling tones how the association needed support from opinion leaders such as the dinner guests to ensure that new advances in treatment could be made available to the population, along with a concerted screening problem to find patients with atrial fibrillation who had no symptoms. Her words implied an extraordinary number of patients of all ages developed strokes, and seductively implied to those present that the cost of a new medicine would be more than offset by the reduction in the number of strokes. Her talk was very slick and convincing, but at considerable variance with conventional medical evidence. Several of the MSPs asked questions, and in the answers, the presenter urged them to push their local health boards to make the new drug readily available. “This is such an important issue that it can’t be left up to clinicians to decide” seemed to be the message – “politicians need to unite to rid Scotland of its poor stroke record.”
I’ll never get invited back to Holyrood. As an “opinion leader” I stood up and said that I felt anxious that this discussion was not about raising awareness of atrial fibrillation, but about raising an appetite for a drug that would not by itself reduce the rate of stroke in Scotland significantly, and would potentially increase our drug spend in Dumfries & Galloway by £3 million pounds. I felt I was ignored and was made to feel naive: The evening ended with several of the “opinion leaders” having their photo taken with the amazingly beautiful lady, and pledging to hold their local Health Boards to account and force them to take up the new medicine.
I’m old and cynical, and I should recognise that there are good people who work with the association, and there are excellent guidelines that have shaped medicine to become safer and more effective. But sympathise with me in my belief that guidelines need to used with caution, with appreciation that there may be vested interests in their development, and that all too often they are becoming rules rather than guidance. In summary, “they should be considered” rather than followed slavishly – this is what professionalism is all about as we combine medical knowledge with sympathetic understanding of patient’s problems and preferences and provide holistic care.
I think as a doctor I shall keep out of Holyrood. And perhaps politicians should keep out of medicine.
Angus Cameron is Medical Director for NHS Dumfries and Galloway
Next week’s blog will be by Dr David Hill (@davidmhill55) Consultant Radiologist NHS Dumfries and Galloway