Second opinion: Who needs guidelines?
In a distant corner of my office stands a bulging file labelled 'Guidelines'. Its contents started arriving about five years ago in the form of a few loosely bound photocopied sheets summarising the consensus approach to some condition agreed by a small group of local GPs, often in collaboration with the relevant hospital specialist. I used to read them to see where my practice conformed with or diverged from that of respected colleagues.
Though I sometimes picked up useful tips from these early guidelines, I soon found that they gathered dust. While they tend to start from a clear-cut diagnosis such as diabetes or asthma, many patients have complaints which cannot be readily understood in terms of any recognised disease state. Some patients have more than one diagnosis - for example, diabetes, high blood pressure and coronary heart disease - and their management involves integrating several sets of guidelines.
Other patients may be resistant to changing treatments started in hospital or by other colleagues, even if recommended by the guidelines. Others still are convinced that recommended treatments may be harmful - for example, the use of inhaled steroid 'preventers' rather than inhaled bronchodilator 'relievers' in asthma. The fact that this is generally regarded as sound therapeutics does little to allay patients' fears that it will either erode their bones or boost their muscles to olympic proportions.
Some people will not take anything in a capsule because of their concerns about the transmission of mad cow disease through gelatin; others will only take medicines in liquid form - the occasional visitor insists on suppositories. In short, guidelines provide a limited guide to the real world of medical practice.
Yet the guidelines keep on coming. A recent survey reveals that more than 2000 sets of guidelines have been produced. One mysterious trend I have noticed in Hackney is that as the guidelines have proliferated - in numbers and length - their authors have produced summaries reduced to two sides of A4 paper and laminated with plastic. The result is suitable for use as a table mat for a hurried lunch; but I have not found this form of guideline any more useful in treating patients.
A more ominous trend is towards the replacement of friendly local guidelines with guidelines issued from the newly established National Institute of Clinical Excellence (NICE). In a recent article in the Lancet, NICE supremo Professor Sir Michael Rawlings indicated that he expected that doctors would follow his guidelines, advising rather menacingly that 'health professionals would be wise to record their reason for non-compliance in patients' medical records' (1999, 353: 1079). Guidelines as a form of internal and informal professional quality control are being transformed into an instrument of managerial authority over medical practice: the enforcement arm of NICE is to be known as the Commission for Health Improvement (CHI, or CHIMP).
A symposium held at the Royal College of Physicians in London in September on the theme 'Enabling excellence or imposing control' heard a number of critics of the government reforms. Though the debate was diminished by the refusal of NICE to participate, the discussion was of a high quality.
Anaesthetist Neville Goodman challenged the reliance of NICE on the dogmas of 'evidence-based medicine' (EBM). As he explained, the basic error of this approach arises from the fact that 'epidemiological data do not provide the information necessary to treat individual patients'. People drawing up guidelines put too much faith in randomised controlled trials - the 'gold standard' of EBM - in which the patients and the circumstances may be quite different from those of clinical practice.
This has become clear to me since many of our patients have been involved in a large trial of different treatments for high blood pressure. Those who are chosen to participate tend to be in better health and better motivated than those who are not. Furthermore, they enjoy the greater attention they get from the young and enthusiastic research team - and they take their tablets more regularly and generally behave themselves much better in matters such as smoking, drinking, exercise, etc. In short, they are in many ways a different population from the rest of our patients and the treatment that works for them may not work so well for others.
Proponents of EBM try to overcome the deficiencies of individual trials by conducting 'meta-analyses', pooling the results of several trials. This may, however, compound their errors instead of reinforcing their conclusions. There are considerable disagreements among statisticians about how such analyses should be conducted - and different techniques yield different results. A recent American survey has revealed significant discrepancies in the results of large randomised controlled trials and the results of meta-analyses published earlier on the same topic (New England Journal of Medicine, 21 August 1997).
Professor Bruce Charlton emphasised that NICE was not a scientific body, but a managerial hierarchy. He drew a striking parallel between the manipulation of science through a centralised bureaucracy in the Soviet Union under Stalin (the system which produced the degradation of biology symbolised by Lysenko) and the establishment of NICE by New Labour in Britain. He anticipated that NICE would produce recommendations excused by science and use its administrative power to enforce them on doctors and patients - in the way that has already happened with Viagra.
It is not surprising that a government already notorious for its authoritarian instincts should be keen on 'clinical governance' legitimised through EBM and enforced through NICE and CHIMP. Dr Michael Loughlin, a philosopher at the symposium, argued that if the conceptual underpinnings of NICE were not explained, it would be experienced as a form of oppression and resisted. The unfortunate fact is that outside this symposium the assumptions behind NICE are barely questioned and, such is the abject state of the medical profession, doctors widely welcome the advent of clinical governance. The interests of doctors and patients alike now depend on the further development of the critique of the guideline mentality in all its manifestations.
Dr Michael Fitzpatrick
Reproduced from LM issue 124, October 1999