It is more than 20 years since the Scottish Intercollegiate Guidelines Network started developing clinical guidelines and a dozen years or more since NICE took on a similar role. Between them, these national bodies have produced clinical guidelines covering around 80% of clinical practice. While they are not meant to be followed slavishly, uptake is as high as the more heavily mandated NICE technology appraisals and deliberate deviance has to be recorded with reasons.
The NICE guideline portfolio now numbers more than 170. It is likely to exceed 200 in 2015 and will continue to rise more slowly thereafter. Almost all the major clinical areas are covered (screening and HIV guidelines are produced by other Department of Health bodies) and guideline updates are extending the scope of original documents. Maintaining the currency (and therefore the relevance) of such a large portfolio has become the major challenge, and more frequent reviews and updates have been introduced to ensure that NICE guidance remains the default for the National Health Service in England.
Recent changes in NICE’s remit have extended the scope of guidance to cover social care and the (sometimes complex) interfaces between clinical, public health and social care requirements of people receiving support. The change in NICE’s name (from Health and Clinical Excellence to Health and Care Excellence) is more than just semantics. It converts what has generally been a tightly focused, disease-based genre into a much more holistic and person directed approach to guidance, in line with the current obsession with choice. This may be of only passing interest to most clinicians but it is changing the way NICE thinks about how it develops its guidance and for whom. Increasingly, guidance is being developed not only for the professions but also for the public, empowering people to make choices and challenge ‘judgements’ made on their behalf by others.
While we are gradually running out of diseases on which to produce guidance, there seems no limit to the number of conditions with which people are surviving. Although most of the evidence on which guidance is based comes from controlled environments, usually with the exclusion of people with multiple morbidity, the majority of people for whom the guidance applies would not have been eligible for entry to the sentinel studies because of co-morbidity.
In most cases, treatments that work in a person with single system disease will also work in people with multiple morbidity but the actual benefits may be different: higher in conditions with multiplicative effects (such as hypertension, raised lipids and smoking) but lower in others where the attributable gains are highly dependent on expectation of life (such as prostate cancer). Furthermore, it is doubtful whether some of these conditions are worth treating, given the clinical risk factors, if the person is much more likely to die of something else first. In addition, calculation of cost effectiveness is massively influenced by ability to benefit and, at the macro level, that is significantly affected by co-morbidities and life expectancy. These are not easy to account for in health economic models although we are going to have a jolly good try!
This challenge lies at the heart of the transition now taking place in the guidance development centres in NICE with an increasing focus on managing the patient/person rather than the disease. The trick is to make healthcare more simple; it is very easy to make it appear more complex (than single disease management) but many guidelines are already too complicated for the ten-minute consultation.
The other major concern that NICE harbours with regard to its guidelines is the apparent over-dependence on them by many (mostly younger) clinicians. NICE guidelines are not intended to be comprehensive, do not set out to cover all clinical situations and do not remove the clinical responsibility from the clinicians for the decisions they make. Despite this, increasingly, stupid clinical decisions are blamed on NICE guidance, either erroneously or where adherence to the guidance is neither required nor appropriate. This unnecessary dependence on guidance is not good clinical practice but merely unthinking practice. Indeed, there is mounting concern that the growing portfolio of guidance is creating a generation of clinicians who no longer have the confidence (or even the ability) to make clinical decisions. As a result, guidance becomes disabling, the exact opposite of its intended purpose.
Most clinicians, especially in specialist settings, do a few things often and well. For unusual or uncommon presentations, they might seek advice from guidelines, the British National Formulary or textbooks (and, of course, web-based sources). The purpose of guidelines is to support and inform practice, not to dictate it. Many commissioners do not seem to understand this and treat all NICE outputs as of equal status, which they determinedly are not. What is more disturbing is that some clinicians are becoming equally undiscriminating. The golden rules of clinical practice are that decisions made regarding a patient’s treatment must be relevant to the person receiving the treatment, based on the best available evidence and agreed with the patient, especially when there are options (including conservative management). NICE guidelines are designed to support these rules but not to rewrite them.
It is, of course, always helpful when one’s management of a patient is challenged to be able to point to the fact that guidance from a national organisation is being followed; it is a pretty sound defence in court! However, failure to make sensible decisions in the person’s own interests is not helpful, even if guidance is being followed.
We need to redress the balance. This is not an encouragement to ignore NICE’s guidelines; that would be self-defeating. Nevertheless, it is time for clinicians to re-own the responsibility for the decisions they make, not just if guidance is to be departed from but also if it is to be adhered to. Guidelines are not law and they should not be treated as law. They should, however, be treated with respect, especially when developed through a process as transparent and reliable as that of NICE, but the responsibility for clinical decisions must rest with the clinician.