NICE process and methods

10 Writing the clinical guideline and the role of the NICE editors

10 Writing the clinical guideline and the role of the NICE editors

At the end of guideline development, four versions of the guideline are published. These are:

  • the full guideline

  • the NICE guideline

  • the NICE pathway (all of the recommendations summarised in a web-based interactive pathway, with links to related guidance)

  • 'Information for the public' (for patients, carers and the public).

The National Collaborating Centre (NCC) or the NICE Internal Clinical Guidelines Programme[15], with the Guideline Development Group (GDG), writes the full guideline and the NICE guideline. The NICE editors are responsible for the NICE pathway and 'Information for the public', working with the NCC and GDG (see sections 10.3, 12.1 and 12.2 for more details).

This chapter describes the key principles for writing guidelines and what each version should include. The role of the NICE editors is also described.

10.1 Guideline structure

10.1.1 The full guideline

The full guideline contains all the recommendations, together with details of the methods used and the evidence underpinning the recommendations. It should specify the date of publication of the version of the guidelines manual that was used for developing the guideline.

The most recent version of the full guideline template and notes on how to use it are posted on the NICE webboard for NCCs. The content should include the following:

  • A title page, funding, disclaimer and copyright information, and a contents page.

  • A summary section containing:

    • GDG membership

    • a foreword (optional)

    • key priorities for implementation

    • an algorithm of the care pathway (optional)

    • a list of all the recommendations

    • a list of all the research recommendations

    • a list of the other versions of the guideline

    • if the guideline is an update, details of what has been updated (see section 14.5).

  • A short overview section discussing the need for the guideline, its aim, scope and expected audience and a section on patient-centred care.

  • A short methods section that cross-refers to the guidelines manual wherever possible and makes clear where and why there have been any deviations from the methods described in the manual.

  • If relevant to the guideline, an epidemiology chapter consisting of a formal review of epidemiology data, including data from disease registries. It should not include general background or 'scene-setting'.

  • Chapters dealing with the review questions and the evidence that led to the recommendations, each with the following content:

    • An introduction to the chapter.

    • The review question(s) in PICO (population, intervention, comparator[s] and outcome) format (see chapter 4) or a summary protocol.

    • A brief introduction to the review question if there is more than one question in the chapter (optional).

    • The clinical evidence review using summary GRADE profiles (see section and appendix K), including a summary of economic studies. If it is not possible to apply GRADE to the evidence, it may be presented in another suitable format; for example, narrative summaries.

    • The network meta-analysis (if this has been done for the review question).

    • The health economic evidence review and/or summary of the model.

    • Evidence statements (short text summaries of the evidence on clinical and cost effectiveness).

    • An 'evidence to recommendations' discussion: a structured summary of GDG discussions on the trade-off between benefits and harms, and consideration of economic evidence, in relation to policy, making clear the justification for the recommendation(s) (see section 9.1).

    • The recommendation(s).

    • The research recommendation(s) (if applicable).

  • References.

  • Glossary and abbreviations.

  • Appendices, which should include:

    • a list of the contributors

    • declarations of interest

    • the scope

    • review questions and PICO tables

    • clinical and health economic review protocols

    • details of search strategies (see chapter 5)

    • summary of numbers of studies identified

    • excluded studies

    • evidence tables (these may be presented on a CD-ROM) (see appendix J)

    • forest plots

    • full GRADE profiles

    • full economic report

    • prioritisation of research recommendations (see section 9.5)

    • if the guideline is an update, a table summarising the proposed changes to the original recommendations (see section 14.5).

    • anything else specific to the guideline, such as questionnaires, charts or examples of software.

10.1.2 The NICE guideline

The NICE guideline presents the recommendations without the evidence underpinning them. The length of the NICE guideline will therefore depend on the number of recommendations in the full guideline.

When preparing the NICE guideline, NCC staff should enter text directly into NICE's Word template. The most recent version of the NICE template and notes on how to use it are posted on the NICE webboard for NCCs.

The main information included in the NICE guideline is:

  • a brief introduction explaining why the guideline is needed and the key issues it will address, and including information about off-label drug use if applicable

  • a standard section on patient-centred care that covers general issues such as informed consent and taking into account the patient's individual needs

  • a standard section about the strength of recommendations

  • key priorities for implementation

  • the recommendations

  • brief details of the scope

  • up to five research recommendations, and an explanation of why each of these is important (see section 9.5)

  • a list of related NICE guidance

  • details of GDG membership

  • if the guideline is an update, details of what has been updated (see section 14.5).

Background information is not usually included with the recommendations in the NICE guideline. Occasionally, a brief summary may be given if the information is essential for understanding or implementing the recommendations. Any background information that is included should be in the form of a short introductory paragraph to the relevant section, not as part of the recommendations themselves. The NICE guideline should not include descriptions of GDG commentary. NCCs should liaise with the NICE lead editor if they feel that background information needs to be included in the NICE guideline.

10.2 Style

Detailed instructions for writing guideline recommendations are given in section 9.3.

When preparing the recommendations and the NICE guideline, NCC staff should follow the 'NICE style guide' and 'Writing for NICE' (both available from the NICE webboard for NCCs). It is advisable to also follow the 'NICE style guide' for the full guideline.

The full guideline and the NICE guideline should be written in a style that can be understood by non-specialist healthcare practitioners and by anyone who has a good knowledge of the guideline topic but is not a trained clinician (for example, a patient with the condition who has in-depth knowledge of the disease and treatment options). Plain English should be used, and unnecessary jargon avoided. The NICE editorial team can advise on this.

10.2.1 Bulleted lists

Bulleted lists are a useful way of:

  • simplifying and clarifying a series of points

  • dealing with repetition

  • dealing with complex paragraph structures.

A bulleted list should be used rather than a numbered one, unless there is a good reason to use numbers. This is because a numbered list can imply a ranking or preference that may not be intended.

10.2.2 Tables and figures in the full guideline

Tables should be easy to understand and have clear, informative titles. Footnotes should be included only if they are essential for readers to understand the table. Comparisons within the table should compare like with like.

Tables should be numbered sequentially and should be cited in the text, but information in a table should not be repeated in the text. Figures should also be numbered sequentially.

Tables or figures from another source may be reproduced only if written permission has been obtained, usually from the publisher. It must be stated in the full guideline that such permission has been received.

10.2.3 Abbreviations

Abbreviations should be used sparingly, and in accordance with the 'NICE style guide'. If a term appears only a few times, it is usually better not to abbreviate it. However, if general readers will be more familiar with the abbreviation, or if the full term is long, the abbreviation may be used throughout the guideline. All abbreviated terms should be defined at first use. The full guideline may be downloaded in sections, so abbreviations should be redefined at first use in each section. A list of abbreviations should be included in the full guideline.

10.2.4 Algorithm

The full version of the guideline may contain an algorithm that shows the care pathway and summarises the recommendations. The algorithm may form the basis of the NICE pathway (see section 10.3.2).

The algorithm should be uncluttered and follow a logical sequence. Arrows should mostly flow from top to bottom. Each decision should flow from the question that precedes it. It will usually be necessary to produce the algorithm in several sections – for example, covering diagnosis, initial management and long-term management.

If appropriate, recommendations may be summarised in other ways, such as in tables or boxes.

The algorithm should only summarise the recommendations; it must not include any information that is not in the recommendations.

10.3 The role of the NICE editors

One person from the NICE editorial team is designated as the lead editor for a particular clinical guideline, although other members of the team will also work on the guideline. The lead editor works with the NCC and members of the GDG before, during and after consultation (see also chapter 12), and has a formal responsibility for NICE's publications – that is, the NICE version of a clinical guideline, the NICE pathway and 'Information for the public'. The lead editor and other members of the editorial team work on these products to ensure that:

  • they conform to NICE's requirements in terms of style and format

  • the recommendations are unambiguous

  • the information is clear and appropriate for the intended audience.

This section summarises the main work that the editors do.

10.3.1 Editing of guideline recommendations

The lead editor advises the NCC and GDG on recommendation wording during guideline development, and carries out detailed editing of the recommendations before the consultation draft of the guideline is submitted to NICE.

After consultation, the lead editor will usually attend the GDG meeting at which stakeholder comments and changes to the guideline are discussed. They can advise on the wording of the recommendations at this meeting, and will edit the recommendations in detail after the meeting.

10.3.2 The NICE pathway

NICE pathways are a practical online resource for healthcare professionals to use on a day-to-day basis. A pathway presents recommendations from a clinical guideline in a set of interactive topic-based diagrams. It contains all the recommendations from the guideline as well as any other NICE guidance that is directly relevant to the topic (for example, quality standards and technology appraisal guidance). It also contains links to implementation tools and to related NICE guidance and pathways.

The NICE pathway is produced by the lead editor, working closely with the NCC and nominated members of GDG (see section 10.3.4).

10.3.3 'Information for the public'

'Information for the public' (formerly called 'Understanding NICE guidance') summarises the guideline recommendations in everyday language, and is aimed at patients, their families and carers, and the wider public. It does not describe the condition or interventions in detail.

It may be used by hospitals and other organisations in the NHS, and by patient and carer organisations, to develop their own information.

'Information for the public' is written by the lead editor, working closely with the NCC, nominated members of the GDG (see section 10.3.4) and the Patient and Public Involvement Programme (PPIP) lead.

10.3.4 Involvement of the GDG with the NICE pathway and 'Information for the public'

During the guideline development process, each GDG is asked to nominate two or three members who will work closely with the lead editor on the NICE pathway and 'Information for the public'. Ideally these GDG editorial nominees should include at least one clinician for the pathway, and at least one patient and carer member for 'Information for the public'. The role of the nominees is to:

  • attend an editorial meeting (see below)

  • gather the views of GDG members on key issues concerning the NICE pathway and 'Information for the public'

  • check for clinical accuracy, answer queries and check revisions on behalf of the GDG.

The editorial meeting usually takes place during consultation on the guideline. The GDG editorial nominees, the GDG Chair and at least one staff member from the NCC (such as the project manager) are invited. Also present from NICE are the lead editor, the Guidelines Commissioning Manager (who chairs the meeting) and sometimes the PPIP lead. The main aim of this meeting is to discuss drafts of the NICE pathway and 'Information for the public', which are circulated in advance. The wording of the guideline recommendations may also be discussed.

[15] Information throughout this manual relating to the role of the National Collaborating Centres in guideline development also applies to the Internal Clinical Guidelines Programme at NICE.