Process and methods

1 Introduction

This is not the current manual. From January 2015, guidelines were developed using Developing NICE guidelines: the manual.

From February 2014, good practice guidance became known as medicines practice guidelines. This is to bring the guideline naming in line with other NICE products. This is purely a name change, the processes and methods used to develop the guidelines remains the same.

The National Institute for Health and Care Excellence (NICE) is a non-departmental public body responsible for providing national guidance and advice to improve health and social care. NICE guidance is developed using the expertise of the NHS, social care, local authorities, and others in the public, private, academic and voluntary sectors, including patients andcarers, service users and the public. Further details about NICE and its work programmes are available from What we do.

1.1 NICE guidance

NICE develops guidance across a number of different areas and on a range of topics.

  • All types of NICE guidance are developed using the best available evidence, and by involving stakeholders in a transparent and collaborative manner. Stakeholders include: national organisations representing patients and carers

  • national health and social care professional organisations

  • the NHS

  • other public and private sector organisations that have an interest in the guidance being developed.

This interim methods guide is based on the general principles and methods included in other methods guides for developing NICE guidance. It can be used in conjunction with the Good practice guidance: integrated process statement. This interim methods guide will be considered during the wider NICE methods manual review.

1.1.1 Equality and social value judgements

NICE is committed to promoting equality, eliminating unlawful discrimination and actively considering the implications of its guidance for human rights. It aims to comply fully with the public sector equality duty as outlined in the Equality Act (2010) to:

  • eliminate unlawful discrimination on the grounds of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex or sexual orientation (the 'protected characteristics') in the way it carries out its functions and in its employment policies and practices and

  • advance equality of opportunity between people who share a protected characteristic and people who do not share it and

  • foster good relations between people who share a protected characteristic and people who do not share it.

NICE's revised equality scheme 2010–2013 sets out how it is meeting these obligations on equality and discrimination and what it still needs to do. Further guidance on how equality issues are considered during the development of NICE guidance is provided in Positively equal: a guide to addressing equality issues in developing NICE clinical guidelines.

All NICE guidance, and the processes NICE uses to develop its guidance, follow the principles set out in Social value judgements: principles for the development of NICE guidance (second edition).

1.2 Who this methods guide is for?

This methods guide explains how NICE develops and updates good practice guidance (GPG). It provides advice on the technical aspects of developing the GPG and the methods used. It is aimed primarily at:

  • the NICE project team within the Centre for Clinical Practice (CCP)

  • other NICE teams who may be involved in producing the GPG

  • members of the Guidance Development Groups (GDGs) that support the development of individual guidance

  • stakeholders.

It is also likely to be useful and of interest to a broader audience, including all guidance developers.

The structure of this interim methods guide follows the development of NICE GPG from inception to publication. The GPG development process is summarised in section 1.4.1, and the process for including stakeholders and the public is provided in section 5.

1.3 NICE good practice guidance

NICE GPG provides recommendations for good practice for those individuals and organisations involved in governing, commissioning, prescribing and decision-making about medicines. The outputs have a wide range of audiences across both health and social care environments.

The content of the GPG is developed according to the best available evidence, taking into consideration legislation, current processes and systems relating to the guidance topic. The outputs aim to be thorough, effective, relevant and balanced, while remaining appropriate to the target audience with an emphasis on the implications for national practice.

The outputs can be used to develop quality standards when reviewing systems and processes relating to the use of medicines in different care settings and within provider and commissioning organisations.

NICE GPG:

  • assesses the processes involving the use of medicines in care settings and organisations

  • sets out the processes of care that are suitable for service users who are accessing medicines

  • aims to improve the safety and quality of care

  • takes account of the views of people who might be affected by the guidance (including health and social care and other professionals, patients and their carers, health service managers, NHS trusts, the public, government bodies and the health and social care industry)

  • is based on the best available evidence and expert consensus

  • is developed using recognised methods (see section 8) that are robust and transparent.

The production of good practice guidance is commissioned by the Department of Health. As a non-departmental public body, we are accountable to our sponsor department, the Department of Health, but operationally we are independent of government. The good practice guidance and its recommendations are made by independent committees.

1.4 Development process overview

The development time for NICE GPG (from start of scoping to publication) is between 9 and 12 months. The exact length and timing of each stage of the process will vary depending on the topic and scheduling conflicts. The number of GDG meetings may vary according to the needs of the GPG being developed and will be determined by the NICE project team.

1.4.1 Summary of the good practice guidance development process

Potential topics for NICE GPG will be identified from a review of existing GPG, referral from NHS England and the Department of Health, and formal consultation with stakeholders (see section 2). The key stages in developing the GPG are summarised in figure 1.1.

Figure 1.1 NICE good practice guidance development process

Figure 1.1 NICE good practice guidance development process

The authoring of GPG is an iterative process that is ongoing throughout the development and consultation phases.

1.4.2 Who is involved?

The various individuals and groups involved in developing GPG, and their key tasks during guidance development, are listed in table 1.1.

For each topic selected (see section 2), the NICE Programme Director and the NICE project lead identifies a project team responsible for working with the GDG (see section 6) to deliver the output.

Table 1.1 Groups involved in good practice guidance development

Key tasks

NICE project team (comprising a project lead, senior advisers and project management support)

Prepares the project timeline and project plan (see section 3)

Identifies and liaises with stakeholders, manages stakeholder registration (see section 5)

Prepares the draft scope and revises the scope after review, workshop and/or consultation as needed (see section 4.3)

Runs the scoping workshop (see section 4.5.1)

Project lead signs off scope (see section 4)

Appoints and works with the GDG to develop the guidance and recommendations (see sections 11 and 12)

Provides full technical and managerial support for the GDG (see section 6)

Develops the draft review questions for the GDG (see section 7)

Arranges evidence searches, then assesses and synthesises the evidence (see sections 8 and 9)

Authors and prepares the drafts of the GPG in liaison with the GDG (see sections 6, 11 and 12)

Liaises with key national organisations and external expert advisers, as appropriate, to review specific sections, or the full content of the GPG

Circulates the draft GPG to the GDG for comments at appropriate stages of the process according to the project schedule

Prepares draft GPG for consultation

Project lead signs off draft GPG for consultation

Coordinates consultation on the draft GPG and collates consultation comments (see section 13)

Compiles the formal responses to consultation comments on the draft GPG in liaison with the GDG (see section 13)

Revises the GPG in response to comments received during the consultation and in accordance with NICE's review processes (see section 13)

Liaises with other NICE teams including those developing quality standards, clinical guidelines and technology appraisals, where relevant

NICE Centre for Clinical Practice (CCP) Director and the Programme Director

The CCP Director and Programme Director sign off:

  • the scope

  • final draft GPG for consultation

  • final GPG (following consultation) for review by the NICE Guidance Executive

NICE Guidance Executive

NICE Guidance Executive approves ('signs off') the final GPG and confirms correct processes have been followed in development

Guidance Development Group (see section 6)

Agrees the review questions with the NICE project team

Discusses the evidence and draws conclusions

Authors and advises on the draft of the GPG in liaison with the NICE project team

Develops the GPG recommendations

Responds to comments received during consultation and agrees on necessary changes to the GPG

Liaises with other NICE teams as appropriate

Supports and promotes uptake of the GPG

Stakeholders (see section 5)

Contribute evidence when needed

Comment on the draft GPG

Support and promote uptake of the GPG

Evidence resources (NICE guidance information servicesa)

Compiles the literature search based on the search terms provided by the NICE project team

Provides the NICE project team with a list of all searches and relevant literature identified (see appendix A)

NICE Implementation team

Develops implementation tools and undertakes a range of other activities to support implementation and uptake of the GPG, in collaboration with the NICE project team (see section 15)

NICE Public Involvement Programme

Advises on patient and carer issues

Identifies and approaches potential patient and carer stakeholder organisations for each GPG

Provides at least 2 patient and carer representatives for the scoping workshop (if needed)

Encourages and facilitates applications from patients and carers who are interested in becoming GDG members

Advises, supports and provides training for patient and carer members of GDGs

Topic experts

Input into scoping process (see section 4)

Review specific sections, or the full content of the GPG

NICE Publishing team

Edits the draft GPG before consultation and before final publication

Publishes the final guidance

NICE External Communications

Liaises with the NICE project team before consultation on the draft GPG and final publication

Other NICE teams (including those developing quality standards, clinical guidelines and technology appraisals)

Liaises with the NICE project team and GDG, where relevant

Abbreviations: GDG, Guidance Development Group; GPG, good practice guidance.

a Where NICE guidance information services are referred to, an externally commissioned information service may be used to provide support in this area in some cases.

1.4.3 Publication and implementation of the good practice guidance

Alongside publication of the NICE GPG, other key documents are published on the NICE website, which include:

  • the GDG terms of reference, which include:

    • members of the GDG

    • the final scope

  • a list of registered stakeholders

  • details of the NICE project team

  • a schedule for developing the GPG

  • a table of stakeholder comments on the consultation draft of the GPG and responses

  • the consultation draft of the GPG

  • tools to support implementation of the GPG.

The NICE project team also works with the implementation team to produce tools (such as slide sets, podcasts, templates) as appropriate, and undertake a range of activities to support implementation. See section 15 for further information on implementation support. Each GPG and the associated implementation tools are published on the NICE website.

1.4.4 Practical information

During GPG development, queries can be emailed to a dedicated email address for that specific guidance. The NICE project team will respond to any queries within 20 days of receipt. After publication, queries should be forwarded to nice@nice.org.uk.

1.5 Updating the methods guide

This methods guide is an 'interim methods guide'. As NICE develops the NICE methods manual, the process for developing GPG will be incorporated into this. The interim methods guide will be updated accordingly and will undergo a formal 12‑week consultation as part of the process for the NICE methods manual development.

Comments on the content of this interim methods guide can be emailed to nice@nice.org.uk.

1.5.1 Interim updates

It may be necessary to make small changes or more significant amendments to the GPG development process before the NICE methods manual is finalised. Small changes meet the following criteria:

  • No fundamental stage in the process is either added or removed.

  • No fundamental method, technique or step is either added or removed.

  • The efficiency, clarity or fairness of the process or methodology is improved.

More significant changes require approval by the Programme Director and Centre for Clinical Practice Director.