Recently there has been much talk about "practice guidelines", "best practice guidelines" and "clinical standards". What does this mean for the renal patient?
Some 2000 or more guidelines have been constructed in the past ten years, which concern almost every aspect of medical practice, and renal medicine has been no exception. 1995 and 1997 saw the publication of the 1st and 2nd editions of the Renal Association's Standards and Audit document, and the 3rd edition is scheduled for 2001. In 1997 the American National Kidney Foundation DOQI guidelines were published (see link on Links page ). Finally, in March this year, the European best practice guidelines for the management of anaemia in chronic renal failure were published and other European documents on dialysis and transplantation are on the way.
Medical treatment aims to improve the survival and quality of life of patients suffering illness. However, many clinical management strategies currently in use world-wide are not only far from ideal but may even be useless and, in a few instances, even damaging. Despite this, a body of evidence already exists in many areas of medicine to permit the evolution of optimum management strategies. Yet in many areas no clear advice that is truly evidence-based is available to guide physicians towards best practice. In addition, not all doctors keep abreast of developments to the same extent and so are not aware of optimum practice. Finally, even though best management may be identified and widely known, for financial or organisational reasons this is not put into practice.
Best practice guidelines aim to fill this void: they suggest practices which appear to offer optimum outcomes for the majority of patients [1-4]. This does not - of course - deny the individual needs of individual patients, and so your doctor needs to identify whether the strategy should be applied to you. What is most important is that these recommendations are made in the light of all the available evidence, critically and systematically reviewed by experts both in medicine, and in how to acquire and analyse information. They are not static and once-for-all: as we shall see, once formulated guidelines and standards are under continual review as new evidence accumulates, as with the Renal Association's standards document.
Best practice guidelines have two components:
UK National Health Service Executive recommendations [3] suggest that clinical practice guidelines are particularly relevant where:
It is obvious that many aspects of renal care fulfil most or all of these conditions.
No individual physician can undertake a full critical analysis of every area of practice with which he or she is concerned nor would it be an efficient use of time to do so. Clinical practice guidelines help individual physicians - and physicians as a group - to improve the overall clinical performance and thus raise standards of patient care towards an optimum. They may also help to ensure that all institutions provide an equally good 'baseline' standard of care. This is owed to every patient.
The current momentum towards developing clinical practice guidelines across a wide range of specialities has been and is, to an extent, 'market driven', with various forms of managed care increasingly playing a role in the delivery of health-care world-wide. As well as being useful to clinicians, best practice guidelines offer purchasers of medical care an indication of the health profession's views on what standards that can and should be attained, and thus help them to make purchasing decisions. Best clinical practice guidelines constructed by health professionals (nurses, doctors, technicians, social workers etc) provide protection against the tendency of price to drive out quality in health care (ie for the cheapest, but not necessarily most satisfactory, option to be purchased). Previous experience suggests that purchasers welcome well-researched and clearly-written guidelines generated by health professionals, and will use them and apply them.
Thus clinical practice guidelines are constructed by health professionals and not imposed by government bodies, with increasing patient involvement; for example, the Renal Association committee consulted the National Patients' Federation on the first two editions of their standards document. Now, there is a patients' representative as full member of the sub-committee for the 3rd edition.
As the evolution of the Renal Association document illustrates - they are not static, but continuously under review and being updated. In the near future this is likely to be done online using the world wide web to avoid the long delay time in publication and dissemination.
Another thing that best practice guidelines can do is to highlight areas of ignorance, and facilitate good studies to fill them in. Just writing down what we know illustrated how much of our daily clinical behaviour is based on little or no evidence.
Naturally, there is a down-side to guidelines and standards. Many physicians are suspicious that best practice guidelines represent an erosion of clinical freedom and that guidelines will be (mis)used by purchasers of health care simply to limit choice and contain costs. It is correct that guidelines suggest a selection of only those options which can be justified by evidence-based outcomes. However, both in practice and law, the physician remains the only person who can decide what is best for individual patients at a particular point in their illness. Best clinical practice guidelines provide information, but do not alter this relationship. Best Practice guidelines have been characterised as epitomising:
"appropriate care based on scientific evidence and broad consensus, leaving room for justifiable variations in practice [4] "
Another worry has been that guidelines will lead to rigid standardised management protocols applied blindly to every patient, and stifle the introduction of new and potentially beneficial treatments. This will have to be watched, although the presence of guidelines do not in any way affect the ability to carry out properly designed, prospective trials of potential new treatments compared with the best available current treatment. This will be OK - provided money is available to pay for these trials from research rather than clinical budgets, a topic which is outside our remit today.
Finally, it has been a worry that best practice guidelines might have legal implications not intended by those that construct them. This aspect has not become clear yet, although a number of law-suits have been brought, in the United States, which cites the NKF DOQI guidelines either as a weapon to demonstrate neglect, or as a protective shield, to suggest that treatment has been at least adequate.
What is the impact of guidelines for patients? The down-side is that already mentioned - namely that variations in individual treatments may become more difficult to justify and finance. A treatment in which an individual patient (and his or her doctor) may have faith and believe to be effective in a particular patient, perhaps has no good evidence to back up its use and may be excluded from guidelines.
The benefit is that practice should improve upwards as guidelines are applied. Let us look at some examples. Unless there are strong geographical reasons, almost everyone believes that at least 3 times weekly dialysis is necessary for optimum - maybe even good health. (This is even though the evidence base for 3 times a week versus twice a week is not certain. This illustrates immediately how many important issues the crucial information is lacking). The only exception is when there is still a fair amount of function in the patient's own kidneys. Yet, in the United Kingdom, a number of units practice twice weekly dialysis. The Renal Association standards, which specify thrice weekly dialysis as the norm, will strengthen both patients' demands, and their doctors', that funds necessary to perform 3 dialyses a week in all patients should be available, since the main reason for twice weekly dialysis in the UK at the moment is not geography, but lack of facilities.
Another example: The Renal Association suggests that in any unit, it should be possible to achieve a haemoglobin concentration of greater than 10g/dl in 85% of patients. In practice this means an average haemoglobin concentration of 11.5g/dl, with some patients at 13g/dl. Obviously, this has implications for the use of EPO (Erythropoietin) in units and hence on costs, iron treatment and for the adequacy of dialysis. In the first report of the UK Renal Registry (1998), only one unit of 6 already enrolled in the registry was achieving this target. If local purchasers accept the standards - which the Department of Health has done already - then the need for the Erythropoietin necessary to achieve these figures is established.
The European guidelines on the treatment of anaemia call for not only a higher minimum Hb (11g/dl, implying a mean Hb of 12.5g/dl in the population) but also management of pre-dialysis patients in a fashion identical to those already on dialysis. Whether this recommendation (which is built into the DOQI guidelines also) will be accepted in the UK remains to be seen but it has obvious major implications for the well-being and quality of life of patients in kidney failure, and possible effects in improving their outlook once they get onto dialysis.
A further set of guidelines recently issued are those of the British Transplantation Society [7] which appeared earlier this year. The renal part of the document is based closely on the Renal Association's standards, so there is no conflict between them. Apart from setting standards of success for kidney grafts using both living and cadaver donation, the document deals with other important topics such as equity in distribution of organs.
There is no doubt that clinical guidelines and standards are a part of the medical scene today, and will remain so. The new Government agency - NICE (National Centre for Clinical Excellence) - which came into operation on April 1st 1998 [8], is designed to raise standards overall and informed clinical guidelines will form a major part of their strategy. Their intention is to have a dialogue with patient organisations such as the NKF, and patients and patient organisations must play a continuing role in the generation and improvement of any guidelines which are put in place. Increasingly also, patients must have a voice in the setting of any priorities that will inevitably need to be considered; demand for quantity and quality of treatment will always run ahead of the resources available to supply them.
1. Committee to Advise the Public Health Service on Clinical Practice Guidelines, Institute of Medicine. Field MJ, Lohr KN, ed. Clinical practice guidelines: directions for a new program. National Academy Press, Washington DC: 1990.
2. American Medical Association/ Specialty Society Practice Parameters Partnership. Attributes to guide the development and evaluation of practice parameters/guidelines. American Medical Association, Chicago: 1996: 1-10.
3. NHS Executive. Good practice clinical guidelines. NHS Executive, London: 1996.
4. Thomson R, Lavender M, Madhok R. How to ensure that guidelines are effective. Br Med J 1995; 311: 237-242.
5. NKF-DOOI Work Group. NKF-DOQI clinical practice guidelines for the treatment of anaemia of chronic renal failure. Am J Kidney Disease 1997. 30 (suppl 3): S192-S240.
6. Renal Association of the United Kingdom and Royal College of Physicians of London. Treatment of adult patients with renal failure. Recommended standards and audit measures. Second edition. Royal College of Physicians, London 1997.
7. British Transplantation Society. Towards standards for organ and tissue transplantation. British Transplantation Society, Richmond, Surrey, 1998.
8. Rawlins M. In pursuit of quality: the National Institute for Clinical Excellence. Lancet 1999; 353: 1079- 1082