NICE process and methods

1 Introduction

1 Introduction

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

The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance on promoting good health and preventing and treating ill health. NICE guidance is developed using the expertise of the NHS and the wider healthcare community, including healthcare and other professionals, patients, service users and carers[1], the academic world and the healthcare industry.

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 that represent patients and carers

  • national health and social care professional organisations

  • the NHS

  • organisations that fund or carry out research

  • companies that have an interest in the guidance being developed.

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. The document Positively equal: a guide to addressing equality issues in developing NICE clinical guidelines provides further guidance on how equality issues are considered during guideline development.

All NICE guidance, and the procedures 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 manual is for

This guidelines manual explains how NICE develops and updates clinical guidelines. It provides advice on the technical aspects of clinical guideline development and the methods used. It is aimed primarily at staff at the National Collaborating Centres (NCCs) and the Internal Clinical Guidelines Programme within the Centre for Clinical Practice (CCP) at NICE[2] that are commissioned by NICE to develop NICE clinical guidelines, and at members of the Guideline Development Groups (GDGs) that develop the individual guidelines (see table 1.1). It is also likely to be useful and of interest to a broader audience, including all guideline developers.

The advice in this manual draws on international guideline development methodology, and the experience and expertise of the clinical guidelines team in the CCP at NICE and the NCCs. It is based on internationally acceptable criteria of quality, as detailed in the Appraisal of Guidelines Research and Evaluation (AGREE II) instrument.

The structure of this manual follows the development of a NICE clinical guideline from inception through to publication. The clinical guideline development process is summarised in section 1.4.2, and an overview of the process for stakeholders, the public and the NHS is provided in appendix N. There is also information on the support provided by NICE to aid implementation of the guideline.

1.3 NICE clinical guidelines

NICE clinical guidelines are recommendations, based on the best available evidence, for the care of people by healthcare and other professionals. They are relevant to clinicians, health service managers and commissioners, as well as to patients and their families and carers.

Good clinical guidelines change the process of healthcare, improve outcomes for patients and ensure efficient use of healthcare resources. They can be used to develop standards for assessing the clinical practice of healthcare professionals, to educate and train healthcare professionals, to help patients make informed decisions, and to improve communication and shared decision-making between patients and healthcare professionals.

NICE clinical guidelines:

  • set out the care that is suitable for most patients with a specific condition in the NHS in England and Wales[3]

  • aim to improve the quality of care

  • assess the clinical and cost effectiveness of treatments and ways of managing a particular condition

  • are developed using a process that takes account of the views of those who might be affected by the guideline (including healthcare and other professionals, patients and their carers, health service managers, NHS trusts, the public, government bodies and the healthcare industry)

  • are based on the best available research evidence and expert consensus

  • are developed using recognised methods that are robust and transparent

  • may be used to inform the development of NICE quality standards.

Healthcare and other professionals are expected to take NICE clinical guidelines fully into account when exercising their clinical judgement. However, the guidance does not override the responsibility of healthcare professionals and others to make decisions appropriate to the circumstances of each patient, in consultation with the patient and/or their guardian or carer.

1.3.1 Standard versus short clinical guidelines

Most NICE clinical guidelines are standard clinical guidelines, which cover broad aspects of clinical care and the management of specific conditions.

NICE short clinical guidelines address a smaller part of a care pathway. They allow the rapid development of guidance on aspects of care for which the NHS requires urgent advice.

The development of short clinical guidelines differs in some ways from that of standard clinical guidelines. Whereas an NCC oversees the development of most standard clinical guidelines, most short clinical guidelines are overseen by the Internal Clinical Guidelines Programme within CCP at NICE. Occasionally, NICE commissions an NCC to develop a short guideline. In all cases, a GDG is responsible for formulating the recommendations.

Implementation support is also provided for short clinical guidelines, following the same procedure as for standard clinical guidelines.

This manual describes the methods and processes used for developing standard clinical guidelines. Any differences between this and the process for developing short clinical guidelines are described in 'Guide to the short clinical guideline process' (appendix M).

1.3.2 Service guidance

Sometimes the Department of Health or the NHS Commissioning Board asks NICE to develop service guidance as part of the clinical guidelines programme. This service guidance is developed primarily for service commissioners rather than healthcare professionals, and focuses on the broad configuration and provision of clinical services. It addresses only interventions that are likely to have implications for the configuration of services (for example, the Cancer service guidance series).

NICE also agreed in 2009, as part of its programme of work to support the NHS quality and productivity agenda, to look increasingly for opportunities to make recommendations on service delivery within clinical guidelines. Broadly, these recommendations will fall into the following categories:

  • effectiveness and cost effectiveness of particular service models

  • timing of an intervention and referral

  • access to the service

  • competencies required to achieve safe, clinically effective and patient-centred interventions.

The development process for NICE service guidance is largely the same as that for clinical guidelines. There may be a few differences in the composition of the GDG and the evidence base (see sections 3.1.1 and 5.11 respectively) for service guidance and for clinical guidelines that contain recommendations about service delivery.

1.4 The development process for clinical guidelines

The development time for a NICE clinical guideline (from the start of scoping to publication) is usually between 18 and 24 months for a standard guideline, and between 11 and 13 months for a short guideline.

1.4.1 Who is involved?

The various groups and individuals involved in developing clinical guidelines, and their key tasks during guideline development, are listed in table 1.1.

Table 1.1 Groups involved in clinical guideline development

Key tasks

NICE

The Centre for Clinical Practice (CCP) at NICE commissions one of the NCCs to coordinate development of the clinical guideline

For guidelines developed 'in house', the NICE Internal Clinical Guidelines Programme within the CCP develops the guideline with a GDG and carries out the tasks listed for NCCs below

The CCP lead for the guideline (Director, Programme Director or Associate Director) signs off the scope

The CCP works with the NICE Patient and Public Involvement Programme (PPIP) to provide an induction session for the GDG Chairs

The Guidelines Commissioning Manager (GCM), technical team and CCP lead for the guideline support and advise the NCC during guideline development

The CCP coordinates consultation on the draft guideline and collates consultation comments

The GCM, technical team, CCP lead for the guideline and other NICE leads comment on the draft guideline

The CCP reviews the final draft of the guideline and the responses by the NCC to stakeholder comments

NICE's Guidance Executive approves ('signs off') the final guideline and confirms that the correct process has been followed for its development

NICE publishes the NICE version of the guideline, the NICE pathway and 'Information for the public' (see section 1.4.3)

The implementation programme at NICE develops implementation tools and may undertake a range of other activities to promote the uptake of a guideline (see section 1.4.3 and chapter 13)

National Collaborating Centre (NCC)

Prepares the draft scope and revises the scope after consultation (see chapter 2)

Prepares the workplan[a]

Helps run the stakeholder scoping workshop with the CCP at NICE (see chapter 2)

Appoints and works with the GDG to develop the guideline (see chapter 3)

Provides full technical and managerial support for the GDG (see chapter 3)

Develops the review questions with the GDG (see chapter 4)

Searches, assesses and synthesises the evidence (see chapters 3–7)

Prepares the first draft of the guideline for consultation

Compiles the responses to consultation comments on the draft guideline on behalf of the GDG

Revises the guideline in response to comments received during the consultation and in accordance with NICE's review processes (see chapter 11)

Publishes the final full guideline

Advises NICE on issues concerning publication, dissemination, implementation and updating of the guideline

Guideline Development Group (GDG)

Contributes to preparing the scope (GDG Chair and Clinical Adviser only)

Refines and agrees the review questions that will guide the search for evidence

Discusses the evidence and draws conclusions

Develops the guideline recommendations

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

Works with NICE to develop the NICE pathway, 'Information for the public' and implementation tools (see chapters 10, 12 and 13)

Supports and promotes uptake of the guideline

Patient and Public Involvement Programme (PPIP) at NICE

Advises on patient and carer issues

Identifies and approaches potential patient and carer stakeholder organisations for each clinical guideline

Provides at least one member of the scoping group – the PPIP lead for the guideline (see section 2.2)

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

Comments on the draft guideline recommendations from a patient and carer perspective

Works with NICE editors on drafting and signing off 'Information for the public'.

Stakeholders

Attend the stakeholder scoping workshop to discuss the scope of the guideline and the recruitment of GDG members

Comment on the draft scope

Respond to calls for evidence from the NCC (if they are made)

Comment on the draft guideline

Contribute to developing the implementation tools and may become involved in implementation activities

Support and promote uptake of the guideline

[a] The workplan sets out the development process for each guideline, and represents a formal agreement between the NCC and NICE. A workplan template is available on the NICE webboard for NCCs.

More information about key groups and individuals involved in clinical guideline development is given in appendix N and on the NICE website.

1.4.2 Summary of the clinical guideline development process

Clinical guideline topics are referred from the Department of Health or the NHS Commissioning Board. The key stages in the development of NICE clinical guidelines are summarised in figure 1.1.

Figure 1.1 The clinical guideline development process

The clinical guideline development process

*The writing of the guideline is an iterative process that is ongoing throughout the development and consultation phases.

1.4.3 Publication and implementation of the clinical guideline

Four versions of each clinical guideline are published:

  • The full guideline contains all the background details and evidence for the guideline, as well as the recommendations. This document is produced by the NCC or the NICE Internal Clinical Guidelines Programme.

  • The NICE guideline contains only the recommendations from the full guideline, without the information on methods and evidence.

  • The NICE pathway is a practical online resource for healthcare and other professionals that contains all the recommendations from a guideline, as well as any other NICE guidance that is directly relevant to the topic. It also contains links to implementation tools and to related NICE guidance and pathways.

  • 'Information for the public' summarises the recommendations in the NICE guideline in everyday language for patients, their family and carers, and the wider public.

In addition to the different versions of the guideline, NICE also produces tools and may undertake a range of activities to support implementation. (See chapter 13 for further information on implementation support.)

All versions of each clinical guideline, and the associated implementation tools, are published on the NICE website.

1.4.4 Practical information

For any queries during the development of a clinical guideline, members of NCCs and GDGs should in the first instance contact the relevant Guidelines Commissioning Manager in the CCP at NICE.

NICE administers a 'webboard' for NCCs, which contains the following information and documents:

  • declaration of interests forms

  • 'The guidelines manual'

  • guidelines templates (scope, full guideline, NICE guideline and short clinical guideline)

  • writing guides

  • documents relating to the GDG (for example, job descriptions and person specifications)

  • minutes of meetings between NICE and the NCCs

  • checklist about confidential information submitted by stakeholders.

As it becomes available, the following information about each clinical guideline can be found on the NICE website:

  • the remit

  • a list of registered stakeholders

  • contact details of the NCC that is coordinating the development of the guideline

  • details of the NICE project team

  • members of the GDG

  • a schedule for development of the guideline

  • the consultation draft of the scope

  • the final scope

  • the equality impact assessment forms for the guideline completed at the scoping stage and before the guideline is signed off by NICE

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

  • project history, and information on progress of the guideline

  • health economics plan, review protocols and search strategies

  • the consultation draft of the guideline

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

  • all versions of the published guideline

  • tools to support implementation of the guideline.

1.5 Updating the guidelines manual

The formal process for updating this manual will begin 3 years after publication. In exceptional circumstances, and only if significant changes to the process of clinical guideline development are anticipated, this interval will be reduced to 2 years.

We welcome comments on the content of this manual and suggested subjects for inclusion.

1.5.1 Interim updates

In some situations it may be necessary to make small changes to the clinical guideline development process before a formal update is due. These may be either minor insubstantial changes ('bug fixes'), or more significant changes for which formal consultation with stakeholders will be necessary. For small changes to be put in place without stakeholder consultation, they must fulfil all of 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

  • no stakeholders will obviously be disadvantaged

  • the efficiency, clarity or fairness of the process or methodology will be improved.

Changes that meet all of these criteria will be published on the NICE website. 'The guidelines manual' will be updated, and changes from the previous version of the manual will be listed. Stakeholders in clinical guidelines under development at the time of the change will be notified if they are affected by the change. Stakeholders in newly commissioned guidelines will be advised to consult the website at the start of the project to familiarise themselves with the updated clinical guideline development process.


[1] When the term 'patients and carers' is used in this manual, it is intended to include all lay people involved in developing NICE clinical guidelines. This includes people with specific conditions and disabilities and their family members (including parents for children and young people under 16) and carers. It also includes employees of organisations representing the interests of patients and carers (for example, voluntary sector and non-governmental organisations). The term 'patients' is used as a general term to indicate a wide range of people who may be referred to differently elsewhere, such as service users of mental health services and healthy pregnant women. We also recognise that readers may use other terms such as 'consumer', 'user representative' or 'patient representative'.

[2] 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.

[3] NICE clinical guidelines are reviewed locally for their applicability to Northern Ireland (see The Department of Health, Social Services and Public Safety website).