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A new evidence-based guideline was released by the National Institute for Health and Clinical Excellence (NICE) in June 2006 for the management of patients with atrial fibrillation. Although there have been several (mostly expert consensus) guidelines and systematic reviews of atrial fibrillation published over the past few years with varying degrees of focus,1–4 this is the first time that a full national guideline has been produced for the management of this important condition, using the rigorous guideline development methods used by NICE for all of its clinical guidelines.5,6 Full details of this process can be found on the NICE website (www.nice.org.uk), but it is relevant to highlight some key components of this method in order to appreciate fully the strengths and the limitations of the guideline.
A WELL DEFINED SCOPE
Firstly, and perhaps most importantly, it must be accepted that the guideline is not intended to be a fully comprehensive manual dealing with every possible aspect of the investigation and management of atrial fibrillation, but that it has been developed in response to a well-defined scope. The full scope is shown as an appendix to the guideline, and this specifies those aspects of atrial fibrillation which were to be included, and those which were excluded. The scope, as with other aspects of the guideline development process, was subjected to consultation with a large number of registered stakeholders, which included the major bodies representing healthcare professionals (Royal Colleges, specialist societies, etc), national patient or carer organisations, healthcare providers and commissioners, various statutory organisations, research bodies and companies with valid commercial interests. Although the guideline is designed to cover most atrial fibrillation cases, it does not require highly specialised areas such as paediatric or gestational atrial fibrillation, nor does it consider topics of public health screening or health service delivery. The remit was a highly practical, pragmatic and applicable guideline which would be relevant for the majority patients with atrial fibrillation.
The actual development of the guideline was undertaken by the National Collaborating Centre for Chronic Conditions (NCC-CC) based at the Royal College of Physicians, England, which is one of the national centres established to support the production of national guidelines commissioned by NICE. The NCC-CC convened a Guideline Development Group (GDG), using nominations received from relevant professional bodies and patient carer groups, which met in July 2004 to agree on the questions that would form the basis of the guideline development process. It then met on 13 more further occasions at approximately monthly intervals between September 2004 and December 2005 to consider the evidence base and formulate recommendations.
The GDG was supported by a technical team of guideline specialists employed by the NCC-CC, which included a clinical adviser (a cardiologist with special knowledge and expertise in atrial fibrillation), a GDG chairman (who was not a cardiologist and would be seen as totally unbiased), an information scientist (who would retrieve, assess and organise sources of evidence), a health services research fellow (who reviewed and graded the evidence), a health economist and a project manager.
AN EVIDENCE-BASED GUIDELINE
The extremely rigorous methods used to formulate questions, to identify, locate and select studies, to assess study quality, to extract and analyse data, and to interpret results, are all detailed in the NICE technical manual (also available on the NICE website). Once all the evidence had been identified and assessed, the GDG had to consider the implications for clinical practice, and then make explicit and systematic judgements about the recommendations that emerged. All of the recommendations were graded from A to D, reflecting the strength of their supporting evidence. This entire process guaranteed that the final guideline is, wherever possible, truly evidence-based and that there is documented linkage between any recommendation and its evidence base.
Not surprisingly, there were significant areas where there was little, or no, good quality evidence on which to base recommendations, and in these circumstances good practice points were developed on the basis of the GDG’s experience. Clearly, this is one of the important limitations of evidence-based guidelines—namely, that they may be perceived as having ‘low-quality’ evidence for some of the recommendations. However, this would not imply that the recommendation is unimportant; indeed, some of the most clinically relevant recommendations fall into this category. The lack of good quality evidence in some areas has highlighted the need for further research.
One of the most important features of the GDG was the active involvement of patient-carer representatives, who had direct experience of atrial fibrillation and its consequences. They were invaluable in helping to identify areas in which patient preference and choice needed to be acknowledged, and we believe that one of the major strengths of this guideline is the inclusion, in many of the recommendations, of the need to discuss with patients the advantages and disadvantages of various treatment options.
The initial draft of the guideline was made available in October 2005 to all stakeholders for their comments, as a result of which important modifications to the guideline were agreed upon by the GDG. A second and final round of stakeholder consultation was held in January 2006, and we really hope that the final version of the guideline will now achieve its stated aims: (1) to be a user-friendly, clinically relevant, evidence-based guideline that offers best clinical advice; (2) to be based on best published evidence and expert consensus; (3) to take into account patient choice and informed decision making; and (4) to detail areas of uncertainty or controversy requiring further research.
This mini-symposium, containing six articles written by members of the GDG and their colleagues, highlights some of the key issues, and we hope that this will be seen as an important contribution to the overall need to publicise and implement the guideline, and thereby ensure that more of our patients with atrial fibrillation, in both primary and secondary care settings, receive the best possible management.
The guideline is available from the National Institute for Health and Clinical Excellence webpage (http://www.nice.org.uk/page.aspx?o=cg36). The guideline is also published in full as follows. National Collaborating Centre for Chronic Conditions. Atrial fibrillation: national clinical guideline for management in primary and secondary care. London: Royal College of Physicians, 2006 (http://rcplondon.ac.uk/pubs/books/af/index.asp)
This is a guest editorial for heart mini-symposium on behalf of the Guidelines Development Group for the NICE clinical guideline for the management of atrial fibrillation.
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