Viewpoint - How useful are clinical guidelines?

Dr Tim Stokes and Professor Peter Littlejohns of NICE argue the case with GPSI Dr Kathryn Griffith.

Professor Ruth Chambers
Professor Ruth Chambers

FOR: Guidelines are crucial to consistent patient care

By Dr Tim Stokes and Professor Peter Littlejohns

Ever since doctors have been treating patients, guidance has existed aimed at directing professional practice, but the move to a more formalised approach to producing guidelines can be traced back about 20 years.

Guidelines have now become an established tool to improve the quality of healthcare for patients in both general practice and specialist settings in the UK and internationally.

The aim of guidelines
Clinical guidelines have a number of aims. They are intended to improve healthcare outcomes for patients and drive up the quality of patient care; to reduce inappropriate variation in practice; to promote efficient use of resources; to summarise research findings and make clinical decisions more transparent; to enable patients to make informed choices about care; to identify gaps in existing research and prioritise what new research is needed; and to support clinical audit and quality indicator activity.

Clinical guidelines have been criticised for leading to 'cook book' medicine, where the clinician slavishly follows a 'recipe' without taking account of the needs of the patient in the consulting room. This is incorrect.

Guidelines are not intended to replace clinical decision making, but rather to assist it. They are not intended to provide guidance that covers all circumstances and all patients; or to be a textbook that provides in-depth clinical knowledge on a topic.

Guideline development
There are a large number of clinical guidelines available to GPs developed by a range of bodies, from medical specialist societies, the royal colleges and national organisations such as the NICE and SIGN.

NICE clinical guidelines are developed by its seven National Collaborating Centres (NCCs), hosted mostly by the royal colleges and by an internal Short Clinical Guidelines team.

NICE clinical guidelines set out the clinical care that is suitable for most patients with a specific condition in the NHS in England and Wales.

Key aspects of NICE's guidelines are that they assess clinical and cost-effectiveness and ways of managing a particular condition, and are developed by a rigorous and transparent process.1

NICE and its NCCs view the involvement of GPs in guideline development groups as essential. A key aspect of modern clinical guideline development groups is that they should be multi-disciplinary and any guideline that deals with a topic of relevance to general practice should have at least one GP on the panel.

Implementation
Guidelines, no matter how rigorously developed, will not improve the quality of patient care if they are not implemented. While there is evidence that guidelines can improve the quality of care, it also clear that there is no single preferred way of achieving this.

NICE has a separate Implementation Directorate that leads activity in this area and which has become increasingly successful in delivering a range of implementation support tools and embedding NICE guidelines within relevant NHS systems.

One way of thinking about implementation is to split it into what steps need to be taken before, during and after a healthcare consultation. This approach can be illustrated by the NICE epilepsy guideline.2

It is important that clinical guidelines link with relevant educational activities so that GPs have the necessary knowledge and skills to be able to use a clinical guideline. This has been achieved with the epilepsy guideline, which has a NICE-sponsored educational learning package on epilepsy based on the clinical guideline. 3

Most GPs have access to the internet during consultations and could access the various versions of the NICE epilepsy guideline during a consultation with a patient to check recommended actions - for example, when to refer to a specialist and what should be considered when reviewing and changing antiepileptic medication.

However, such a process is cumbersome and slow. In future, it is intended that clinicians will be able to access information from NICE guidance much more quickly and simply - for example, by clicking on a care pathway in a clinical decision support system.

Rather than viewing complete guideline documents as PDFs, information can be accessed as xml 'knowledge fragments'. This Electronic Guidance Access Project is well advanced.4

Lastly, clinical guidelines need to be the basis for the development of audit support tools and inform clinical indicator development.

The quality framework has clinical indicators on epilepsy informed by the NICE guideline.

The framework provides the clinical components of an annual review of the care of patients with epilepsy and rewards the recording of seizure frequency or, a key health outcome, being seizure free for the past 12 months. GPs with quality framework support software will also get prompts to record such data when patients attend - another way of ensuring that clinical guidelines are acted on.

To conclude, not only are clinical guidelines here to stay, but they are crucial to improving health outcomes for patients in UK general practice.

  • Dr Stokes is a sessional GP in Leicester, associate director at the Centre for Clinical Practice, NICE and an honorary senior lecturer, National Primary Care Research and Development Centre, University of Manchester
  • Professor Littlejohns is professor of Public Health at St Georges, University of London and clinical and public health director, NICE

AGAINST: Too many guidelines confuse GPs

By Dr Kathryn Griffith

GPs care for their patients from 'top to toe' and 'cradle to grave.' Patients are not pre-selected. This is one of the satisfying parts of the profession.

The variety of the case mix of general practice causes enormous problems in keeping up to date with developments in such a diverse number of clinical areas. It is also the reason why GPs need clear guidance to help manage problems in the most effective way possible, both for the sake of the patient and within the limits of a stretched NHS.

My view is that this guidance should be accessible easily, simple and clear. It should be also apparent who has produced the guidance and what their motivation was.

Guidance needs to be evidence-based and as up to date as possible.

Too many guidelines
The problem is that there is too much guidance, and this quantity means that it fails to achieve its purpose.

There are national, European and local guidelines and it is not clear which should be followed. Should NICE guidelines be given priority, or should we trust the advice given by learned societies more than that from the DoH?

We know that members of learned societies may have been sponsored by pharmaceutical companies, but it often appears that NICE is swayed largely by financial motives. This does not necessarily fit well when GPs are seeking to do their best for an individual patient.

Confusing
Confusion is created when comparing guidelines. There are at least five national and international guidelines for the management of type-2 diabetes. There are at least three BP targets and HbA1c levels to treat to.

Rather than simple and clear, this becomes confusing for the practitioner and the patient.

Cardiovascular risk management is another contentious area. We are all keen to follow prime ministerial demands to seek out those patients who may be at high risk of cardiovascular events and offer them appropriate interventions to reduce their risk.

The problem is whether we follow European, Joint British Societies, NICE, SIGN or local protocols. Which method do we use to calculate their risk?

All recommend different factors and weighting for risk and can potentially calculate different scores. We now need guidance on which guideline to use.

Complicated
NICE produces lots of guidance. In the first eight months of 2008 there were 69 publications. In June 2008 NICE published 12 appraisals - seven Technology Appraisals and five Interventional Procedure appraisals.

May was a quieter month with only eight publications; two of these were major documents on type-2 diabetes and lipid modification. Both of these are extremely important for primary care but have fallen under the radar for many practitioners.

In an attempt to be comprehensive guidelines can become over-long and complicated and often difficult to follow.

For example, the full NICE guideline 'Urinary Tract Infection in Children' covers 178 pages, which refers to 'Feverish Illness in Children' for support; this itself is 170 pages long.

The ability to access quickly fragments of guidance online would be welcomed.

Out of date
My final concern with guidelines is that almost as soon as they are written they become out of date. Rimonabant guidelines lasted from June to October 2008.

It is difficult to take account of new research evidence. A study published on 16 October 2008 in the BMJ demonstrated that aspirin was of no benefit in preventing cardiovascular events in people with type-2 diabetes without symptomatic cardiovascular disease.5 This goes against all current guidance but is based on evidence from a double-blind placebo-controlled trial. Should GPs wait for guidelines to change or follow this evidence?

Another dilemma has been produced by the results of the JUPITER trial on rosuvastatin.6 This demonstrated a staggering reduction of 47 per cent in the combined endpoint of heart attack, stroke and cardiovascular death. This is greater than any other statin study, even for secondary prevention of events.

How long can we hide behind NICE guidelines that allow us to use simvastatin 80mg as our 'high-intensity statin', when we have patients clutching their newspaper cuttings requesting the most effective agent?

Please provide guidelines to primary care. Make them clear, easy to use, up to date and enable us to provide our patients with the best clinical care. A consensus should be reached by those providing the advice so GPs are not confused and crushed by the weight of paper and advice.

  • Dr Griffith is a GPSI in cardiology and kidney disease in York

References

1. Developing NICE clinical guidelines.

2. The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care. NICE CG 20.

3. BMJ Learning.

4. Electronic guidance access project.

5. Belch J et al. POPAD trial. BMJ 2008; 337: a1840.

6. JUPITER Study Group. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 2008; 359: 2,195-207.

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