NICE Recommendations for Hyperglycaemia in ACS
NICE Recommendations for Hyperglycaemia in ACS
The guideline was produced in accordance with NICE's short clinical guideline process using the methodology set out in the NICE Guideline Manual (2009). For those without experience of developing NICE guidance, a brief review of this process may help in understanding not only how NICE produces its recommendations, but also why they are drafted the way they are, particularly if the guidance may be considered controversial. The guideline topic is referred to NICE by the Department of Health. National organisations representing patients and carers, and also health professionals involved in their care can register as stakeholders. Stakeholders are consulted throughout the guideline development process. The 'scope' of the guideline is then established. The Internal Clinical Guideline Team commissioned to develop the guideline prepares the scope. This document sets out what the guideline will—and will not—cover. NICE, and registered stakeholders, can both contribute to the development of the scope. The NICE development team will then undertake a methodical and exhaustive literature search according to strict criteria, to identify the data that will allow the research questions derived from the scope to be answered objectively. A multi-disciplinary guideline development group (GDG) then reviews this evidence according to the GRADE system. Key features of the GRADE approach are the objectivity and transparency with which the evidence is reviewed, and the way in which the derived evidence statements will lead seamlessly into guideline recommendations. The overall quality of the evidence (ranging from high to very low) is assessed according to the type of study conducted, and whether it suffered from any limitations, inconsistency, indirectness, imprecision or other considerations, such as reporting bias or large treatment effects. Meta-analysis of randomised controlled trials is assumed to start as high-quality evidence, but may be downgraded if any of the above factors are present. For example, the DIGAMI study, although it is a randomised controlled trial, could be downgraded from high to moderate to low quality on lack of blinding (limitation) and relatively small patient numbers with wide confidence intervals (CI) (imprecision). Observational studies, such as the report on treatment strategy and outcomes in hyperglycaemic patients without previous diabetes from the Myocardial Ischaemia National Audit Project (MINAP), can also be considered by GRADE, but they start as low-quality evidence and are usually rapidly downgraded further on the basis of factors, such as limitations and inconsistencies, unless they have markedly positive features, such as adequate statistical control of potential confounders, a dose-response gradient and large treatment effects (all of which can upgrade the evidence quality). An inevitable consequence of this approach is that the strength of the recommendations made will be directly proportional to the quality of the evidence available (which will be explicitly stated in the guideline document). The draft guideline is then produced, whereby the group assesses such available evidence and makes recommendations. The guideline undergoes a consultation period which allows registered stakeholders to comment on the draft recommendations. These comments are then collated and considered. The GDG then finalises the recommendations in light of stakeholder comments. NICE formally approves the final guideline and issues its guidance to the NHS.
Methodology
The guideline was produced in accordance with NICE's short clinical guideline process using the methodology set out in the NICE Guideline Manual (2009). For those without experience of developing NICE guidance, a brief review of this process may help in understanding not only how NICE produces its recommendations, but also why they are drafted the way they are, particularly if the guidance may be considered controversial. The guideline topic is referred to NICE by the Department of Health. National organisations representing patients and carers, and also health professionals involved in their care can register as stakeholders. Stakeholders are consulted throughout the guideline development process. The 'scope' of the guideline is then established. The Internal Clinical Guideline Team commissioned to develop the guideline prepares the scope. This document sets out what the guideline will—and will not—cover. NICE, and registered stakeholders, can both contribute to the development of the scope. The NICE development team will then undertake a methodical and exhaustive literature search according to strict criteria, to identify the data that will allow the research questions derived from the scope to be answered objectively. A multi-disciplinary guideline development group (GDG) then reviews this evidence according to the GRADE system. Key features of the GRADE approach are the objectivity and transparency with which the evidence is reviewed, and the way in which the derived evidence statements will lead seamlessly into guideline recommendations. The overall quality of the evidence (ranging from high to very low) is assessed according to the type of study conducted, and whether it suffered from any limitations, inconsistency, indirectness, imprecision or other considerations, such as reporting bias or large treatment effects. Meta-analysis of randomised controlled trials is assumed to start as high-quality evidence, but may be downgraded if any of the above factors are present. For example, the DIGAMI study, although it is a randomised controlled trial, could be downgraded from high to moderate to low quality on lack of blinding (limitation) and relatively small patient numbers with wide confidence intervals (CI) (imprecision). Observational studies, such as the report on treatment strategy and outcomes in hyperglycaemic patients without previous diabetes from the Myocardial Ischaemia National Audit Project (MINAP), can also be considered by GRADE, but they start as low-quality evidence and are usually rapidly downgraded further on the basis of factors, such as limitations and inconsistencies, unless they have markedly positive features, such as adequate statistical control of potential confounders, a dose-response gradient and large treatment effects (all of which can upgrade the evidence quality). An inevitable consequence of this approach is that the strength of the recommendations made will be directly proportional to the quality of the evidence available (which will be explicitly stated in the guideline document). The draft guideline is then produced, whereby the group assesses such available evidence and makes recommendations. The guideline undergoes a consultation period which allows registered stakeholders to comment on the draft recommendations. These comments are then collated and considered. The GDG then finalises the recommendations in light of stakeholder comments. NICE formally approves the final guideline and issues its guidance to the NHS.