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National Collaborating Centre for Chronic Conditions (UK). Type 2 Diabetes: National Clinical Guideline for Management in Primary and Secondary Care (Update). London: Royal College of Physicians (UK); 2008. (NICE Clinical Guidelines, No. 66.)

2Methodology

2.1. Aim

The aim of the National Collaborating Centre for Chronic Conditions (NCC-CC) is to provide a user-friendly, clinical, evidence-based guideline for the NHS in England and Wales that:

  • offers best clinical advice for the management of Type 2 diabetes
  • is based on best published clinical and economic evidence, alongside expert consensus
  • takes into account patient choice and informed decision making
  • defines the major components of NHS care provision for Type 2 diabetes
  • details areas of uncertainty or controversy requiring further research
  • provides a choice of guideline versions for differing audiences.

2.2. Scope

The guideline was developed in accordance with a scope, which detailed the remit of the guideline originating from the Department of Health (DH) and specified those aspects of Type 2 diabetes care to be included and excluded. The application of the guideline to children has not been excluded but we were not able to specifically search for paediatric literature due to volume of work. When health carers are applying these guidelines to children they need to use their clinical judgement in doing so. For further assistance with applying this guideline to children please refer to the British National Formulary (BNF) for children.6

Prior to the commencement of the guideline development, the scope was subjected to stakeholder consultation in accordance with processes established by the National Institute for Health and Clinical Excellence (NICE).1 The full scope is shown in appendix B. Available at www.rcplondon.ac.uk/pubs/brochure.aspx?e=247

2.3. Audience

The guideline is intended for use by the following people or organisations:

  • all healthcare professionals
  • people with Type 2 diabetes and their parents and carers
  • patient support groups
  • commissioning organisations
  • service providers.

2.4. Involvement of people with Type 2 diabetes

The NCC-CC was keen to ensure the views and preferences of people with Type 2 diabetes and their carers informed all stages of the guideline. This was achieved by:

  • having two people with Type 2 diabetes as patient representatives on the GDG
  • consulting the Patient and Public Involvement Programme (PPIP) housed within NICE during the pre-development (scoping) and final validation stages of the guideline project
  • the inclusion of patient groups as registered stakeholders for the guideline.

2.5. Guideline limitations

The guideline has the following limitations.

  • NICE clinical guidelines usually do not cover issues of service delivery, organisation or provision (unless specified in the remit from the DH).
  • NICE is primarily concerned with health services and so recommendations are not provided for social services and the voluntary sector. However, the guideline may address important issues in how NHS clinicians interface with these other sectors.
  • Generally, the guideline does not cover rare, complex, complicated or unusual conditions.
  • Where a meta-analysis was available, generally the individual papers contained within were not appraised.
  • It is not possible in the development of a clinical guideline to complete an extensive systematic literature review of all pharmacological toxicity, although NICE expect their guidelines to be read alongside the summaries of product characteristics (SPCs).

2.6. Other work relevant to the guideline

The guideline will update the following NICE technology appraisals (TAs) but only in relation to Type 2 diabetes:

Related NICE public health guidance:

  • ‘Smoking cessation services, including the use of pharmacotherapies, in primary care, pharmacies, local authorities and workplaces, with particular reference to manual working groups, pregnant smokers and hard to reach communities’, Public health programme guidance no. PH010 (February 2008)
  • ‘Physical activity guidance for the Highways Agency, local authorities, primary care, pharmacists, health visitors and community nurses, schools, workplaces, the leisure and fitness industry and sports clubs’, Public health programme guidance no. PH008 (January 2007).

Related NICE clinical guidelines:

  • ‘Cardiovascular risk assessment: the modification of blood lipids for the primary and secondary prevention of cardiovascular disease’ (expected date of publication May 2008)
  • ‘Diabetes in pregnancy: management of diabetes and its complications from preconception to the postnatal period’, NICE clinical guideline no. 63 (2008)
  • ‘Hypertension: management of hypertension in adults in primary care’ (partial update of NICE CG18), NICE clinical guideline no. 34 (2006)
  • ‘Obesity: the prevention, identification, assessment and management of overweight and obesity in adults and children’, NICE clinical guideline no. 43 (2006)
  • Type 1 diabetes: diagnosis and management of type 1 diabetes in children, young people and adults’, NICE clinical guideline no. 15 (2004, to be reviewed 2008)
  • Type 2 diabetes: prevention and management of foot problems’, NICE clinical guideline no. 10 (2004).

Related TA guidance:

2.7. Background

The development of this evidence-based clinical guideline draws upon the methods described by the NICE’s ‘Guideline development methods manual’1 and the methodology pack7 specifically developed by the NCC-CC for each chronic condition guideline (see www.rcplondon.ac.uk/clinical-standards/ncc-cc/Pages/NCC-CC.aspx). The developers’ role and remit is summarised in table 2.1.

Table 2.1. Role and remit of the developers.

Table 2.1

Role and remit of the developers.

2.8. The process of guideline development

The basic steps in the process of producing a guideline are:

  • developing clinical evidence-based questions
  • systematically searching for the evidence
  • critically appraising the evidence
  • incorporating health economic evidence
  • distilling and synthesising the evidence and writing recommendations
  • grading the evidence statements
  • agreeing the recommendations
  • structuring and writing the guideline
  • updating the guideline.

Developing evidence-based questions

The technical team drafted a series of clinical questions that covered the guideline scope. The GDG and Project Executive refine and approve these questions, which are shown in appendix A. Available at www.rcplondon.ac.uk/pubs/brochure.aspx?e=247

Searching for the evidence

The information scientist developed a search strategy for each question. Key words for the search were identified by the GDG. In addition, the health economist searched for additional papers providing economic evidence or to inform detailed health economic work (for example, modelling). Papers that were published or accepted for publication in peer-reviewed journals were considered as evidence by the GDG. Conference paper abstracts and non-English language papers were excluded from the searches.

Each clinical question dictated the appropriate study design that was prioritised in the search strategy but the strategy was not limited solely to these study types. The research fellow or health economist identified titles and abstracts from the search results that appeared to be relevant to the question. Exclusion lists were generated for each question together with the rationale for the exclusion. The exclusion lists were presented to the GDG. Full papers were obtained where relevant. See appendix A for literature search details. Available at www.rcplondon.ac.uk/pubs/brochure.aspx?e=247

Appraising the evidence

The research fellow or health economist, as appropriate, critically appraised the full papers. In general, no formal contact was made with authors; however, there were ad hoc occasions when this was required in order to clarify specific details. Critical appraisal checklists were compiled for each full paper. One research fellow undertook the critical appraisal and data extraction. The evidence was considered carefully by the GDG for accuracy and completeness.

All procedures are fully compliant with the:

Health economic evidence

Areas for health economic modelling were agreed by the GDG after the formation of the clinical questions. The health economist reviewed the clinical questions to consider the potential application of health economic modelling, and these priorities were agreed with the GDG.

The health economist performed supplemental literature searches to obtain additional data for modelling. Assumptions and designs of the models were explained to and agreed by the GDG members during meetings, and they commented on subsequent revisions.

Distilling and synthesising the evidence and developing recommendations

The evidence from each full paper was distilled into an evidence table and synthesised into evidence statements before being presented to the GDG. This evidence was then reviewed by the GDG and used as a basis upon which to formulate recommendations. The criteria for grading evidence are shown in table 2.2.

Evidence tables are available online at www.rcplondon.ac.uk/pubs/brochure.aspx?e=247

Grading the evidence statements

Table 2.2Grading the evidence statements1

Level of evidenceType of evidence
1++High-quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias.
1+Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias.
1−Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias.*
2++High-quality systematic reviews of case-control or cohort studies.
High-quality case-control or cohort studies with a very low risk of confounding, bias or chance and a high probability that the relationship is causal.
2+Well-conducted case-control or cohort studies with a low risk of confounding, bias or chance and a moderate probability that the relationship is causal.
2−Case-control or cohort studies with a high risk of confounding, bias or chance and a significant risk that the relationship is not causal.*
3Non-analytic studies (for example case reports, case series).
4Expert opinion, formal consensus.
*

Studies with a level of evidence ‘−’ are not used as a basis for making a recommendation.

RCT, randomised controlled trial

Agreeing the recommendations

The GDG employed formal consensus techniques to:

  • ensure that the recommendations reflected the evidence base
  • approve recommendations based on lesser evidence or extrapolations from other situations
  • reach consensus recommendations where the evidence was inadequate
  • debate areas of disagreement and finalise recommendations.

The GDG also reached agreement on the following:

  • five recommendations as key priorities for implementation
  • five key research recommendations
  • algorithms.

In prioritising key recommendations for implementation, the GDG took into account the following criteria:

  • high clinical impact
  • high impact on reducing variation
  • more efficient use of NHS resources
  • allowing the patient to reach critical points in the care pathway more quickly.

Audit criteria for this guideline will be produced for NICE by Clinical Accountability Service Planning and Evaluation (CASPE) Research following publication in order to provide suggestions of areas for audit in line with the key recommendations for implementation.

Structuring and writing the guideline

The guideline is divided into sections for ease of reading. For each section the layout is similar and contains the following parts.

  • Clinical introduction sets a succinct background and describes the current clinical context.
  • Methodological introduction describes any issues or limitations that were apparent when reading the evidence base.
  • Evidence statements provide a synthesis of the evidence base and usually describes what the evidence showed in relation to the outcomes of interest.
  • Health economics presents, where appropriate, an overview of the cost effectiveness evidence base, or any economic modelling.
  • From evidence to recommendations sets out the GDG decision-making rationale providing a clear and explicit audit trail from the evidence to the evolution of the recommendations.
  • Recommendations provide stand alone, action-orientated recommendations.
  • Evidence tables are not published as part of the full guideline but are available online at www.rcplondon.ac.uk/pubs/brochure.aspx?e=247. These describe comprehensive details of the primary evidence that was considered during the writing of each section.

Writing the guideline

The first draft version of the guideline was drawn up by the technical team in accord with the decisions of the GDG, incorporating contributions from individual GDG members in their expert areas and edited for consistency of style and terminology. The guideline was then submitted for a formal public and stakeholder consultation prior to publication. The registered stakeholders for this guideline are detailed on the NICE website, www.nice.org.uk. Editorial responsibility for the full guideline rests with the GDG.

Table 2.3Versions of this guideline

Full versionDetails the recommendations, the supporting evidence base and the expert considerations of the GDG. Published by the NCC-CC.
Available at www​.rcplondon.ac.uk/pubs/brochure​.aspx?e=247
NICE versionDocuments the recommendations without any supporting evidence.
Available at www​.nice.org.uk
‘Quick reference guide’An abridged version.
Available at www​.nice.org.uk
‘Understanding NICE guidance’A lay version of the guideline recommendations.
Available at www​.nice.org.uk

Updating the guideline

Literature searches were repeated for all of the evidence-based questions at the end of the GDG development process allowing any relevant papers published up until 16 April 2007 to be considered. Future guideline updates will consider evidence published after this cut-off date.

Two years after publication of the guideline, NICE will ask a National Collaborating Centre to determine whether the evidence base has progressed significantly to alter the guideline recommendations and warrant an early update. If not, the guideline will be considered for update approximately 4 years after publication.

2.9. Disclaimer

Healthcare providers need to use clinical judgement, knowledge and expertise when deciding whether it is appropriate to apply guidelines. The recommendations cited here are a guide and may not be appropriate for use in all situations. The decision to adopt any of the recommendations cited here must be made by the practitioner in light of individual patient circumstances, the wishes of the patient, clinical expertise and resources.

The NCC-CC disclaims any responsibility for damages arising out of the use or non-use of these guidelines and the literature used in support of these guidelines.

2.10. Funding

The NCC-CC was commissioned by NICE to undertake the work on this guideline.

Studies with a level of evidence ‘−’ are not used as a basis for making a recommendation.

Copyright © 2008, Royal College of Physicians of London.

All rights reserved. No part of this publication may be reproduced in any form (including photocopying or storing it in any medium by electronic means and whether or not transiently or incidentally to some other use of this publication) without the written permission of the copyright owner. Applications for the copyright owner’s written permission to reproduce any part of this publication should be addressed to the publisher.

Cover of Type 2 Diabetes
Type 2 Diabetes: National Clinical Guideline for Management in Primary and Secondary Care (Update).
NICE Clinical Guidelines, No. 66.
National Collaborating Centre for Chronic Conditions (UK).

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