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 that provides national guidance on the promotion of good health and the prevention and treatment of ill health. NICE also produces quality standards that set out what high-quality care in the NHS should look like, and support tools for providers and commissioners in the NHS and local authorities. From 2013, NICE will produce quality standards for social care, as part of its expanding remit.

Box 1. Developing NICE public health guidance

This is the process manual for public health guidance produced by the Centre for Public Health Excellence (CPHE) at NICE. The process manual is about how guidance is produced, and explains the stages of guidance development, the different activities, roles and responsibilities of different groups of people involved at different stages.

The CPHE methods manual, which has been produced alongside this process manual, explains the methods for appraising the evidence and economic modelling, and how these are presented to the committees and used to develop guidance.

1.1 Background

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 involving stakeholders in a transparent and collaborative manner. Stakeholders include national organisations that represent the public, patients and carers, practitioners, community interests and companies that have an interest in the guidance in development.

NICE guidance is:

  • based on a rigorous assessment of the evidence base

  • developed by independent advisory bodies, with input from the public, patients, carers, service users, health professionals and other professional groups

  • developed using a transparent process and methods

  • subject to a consultation with stakeholders

  • regularly reviewed.

This guide details the processes that the Centre for Public Health Excellence (CPHE) at NICE uses to produce public health guidance. It is the third edition, and includes changes to the previous (2009) edition that were consulted on with stakeholders and agreed with the NICE Board between 2011 and 2012. Information on the methods used for appraising the evidence and developing recommendations can be found in Methods for the development of NICE public health guidance – third edition (2012).

1.2 Equality and social value judgements

NICE is committed to promoting equality, eliminating unlawful discrimination and considering the implications of its guidance for human rights. It aims to comply fully with all legal obligations to:

  • promote race and disability equality and equality of opportunity between men and women

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

NICE's revised equality scheme sets out how it is meeting these obligations on equality and discrimination and what it still needs to do. In line with NICE's equalities scheme, this manual includes explicit consideration of how the development of guidance will consider equalities issues at the scoping, development, and validation stages, and how an audit trail of this activity will be maintained.

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).

1.3 Who is this overview for?

From 2006 to 2013, NICE produced guidance on public health using 2 processes. The 'intervention guidance process' was used to produce guidance on clearly defined topics for particular population groups or settings, and the 'programme guidance process' was used for guidance on wider topics that required action by many different groups in a range of settings. Further information on these methods and processes can be found in the first and second editions of Methods for the development of NICE public health guidance and The NICE public health guidance development process: an overview for stakeholders including public health practitioners, policy makers and the public (second edition).

Following stakeholder consultation in 2011, and Board approval in 2012, the CPHE adopted a single guidance development process. This document gives an overview of the new single process. It also describes the role of stakeholders, the Public Health Advisory Committees (PHACs), and the roles of the evidence review teams, other contractors and the staff of CPHE.

This overview is for stakeholder organisations, staff at NICE and the evidence review teams, other contractors, and members of the PHACs that develop guidance. It is also likely to be useful and of interest to national and international groups responsible for the development of guidance for health improvement.

The guidance development process and this guide have been developed by drawing on the expertise of the staff of CPHE and other guidance development centres at NICE, and the experience of members of our independent advisory committees. This guide is based on knowledge acquired during the first 7 years of producing NICE public health guidance.

1.4 Public health guidance

NICE public health guidance makes recommendations for England on what is known from research and practice about the effectiveness and cost effectiveness of interventions and broader programmes, including the systems in which they are delivered, and the methods used to deliver them.

NICE public health guidance is relevant to health professionals working in clinical and community settings, and commissioners, managers and team leaders with responsibility for health improvement in the NHS, local authorities, schools, and public, private and voluntary sectors. It is also relevant to people interested in improving their own health or the health of their children or other people they care for, and to the wider community.

NICE public health guidance can:

  • Help NHS organisations and local authorities (including social care and children's services) to meet standards for public health (for example, the Public Health Outcomes Framework, 2012), and work towards the requirements of national planning and commissioning frameworks.

  • Enable national and local public sector organisations and partnerships to improve health and reduce health inequities.

  • Support local authorities and schools in fulfilling their duty to promote the wellbeing of communities.

The implementation of public health guidance can help all those involved in delivering public health improvement to benefit from identified cost savings, and from opportunities for re-directing resources.

1.4.1 The framework for developing public health guidance

The process of developing public health guidance is informed by a conceptual framework which explains how human behaviour and environment, social and economic factors result in patterns of preventable diseases and influence the promotion and protection of good health and wellbeing. This framework, described in more detail in chapter 1 of Methods for the development of NICE public health guidance – third edition (2012), implies the following.

  • Public health activities may be direct or indirect. They can relate to the direct provision of a health-related service, for example, contraception or smoking cessation services, or may result from the activities of wider services that affect health, for example, in education, employment and environment.

  • Public health guidance may cover a range of approaches to changing knowledge, attitudes and behaviour, including interventions delivered to individuals by public health professionals, or working with and developing communities, and local and national campaigns. Guidance may focus on health protection, health improvement, health promotion, or service provision, and on both communicable and non-communicable diseases and conditions.

  • CPHE methods and process ensure that the best available evidence is selected and assessed according to well-defined criteria, and then graded according to sound and transparent principles. Several types of evidence are considered, including evidence from practice.

  • Recommendations may be made at individual, family, group, organisational, community or population level. They may focus on an intervention itself, on the practice and system in which it is commissioned, delivered or provided, or on the skills and capabilities required to effect change.

  • Stakeholders have a central role in the development of public health guidance. Their views and experiences are actively sought throughout the development process to ensure that recommendations are realistic and appropriate.

  • The work of CPHE is based on NICE's quality assurance principles, which are designed to ensure that NICE guidance is credible, robust and relevant.

For more information about the core principles of NICE guidance development, please see our Strategic Plan (2010–2013) on the NICE website.

1.4.2 Guidance on public health interventions and programmes, 2006–2013

Between 2006 and 2013, public health guidance was produced using 2 different processes: the intervention guidance process and the programme guidance process.

Guidance produced using the intervention guidance process focused on local, clearly circumscribed and defined actions that aimed to reduce the risk of developing a disease or condition, or that helped to promote or maintain good health. Interventions were typically those delivered by front-line staff, and targeted at or limited to certain populations, communities or individuals. Examples include:

  • providing needles to prevent infection in illicit drug users

  • giving advice to help employees to stop smoking

  • promoting the social and emotional wellbeing of children in primary school.

Public health guidance produced using the programme guidance process was concerned with multiagency and multifaceted policies, services, systems and interventions. Programmes were topic-, setting- or population-based, sometimes involving changes to organisational infrastructures. Examples include:

  • Provision of smoking cessation advice and support by primary care services, pharmacies, local authorities and in the workplace for people of all ages who smoke, with a particular focus on low-income groups, pregnant women who smoke and hard-to-reach communities.

  • Promoting and creating built or natural environments that encourage and support increased levels of physical activity. This includes activities ranging from traffic management to ensuring that public open spaces, public paths and new workplaces are linked to walking and cycling networks.

  • Management of long-term sickness and incapacity for work, for primary care and employers. This includes strategies to reduce the number of employees moving from short- to long-term sickness absence and policies to help employees who have been on long-term sickness absence to return to work.

1.4.3 Public health guidance from 2012 onwards

The methods and processes used to develop NICE public health guidance are subject to regular internal review. The CPHE agreed with stakeholders and the NICE Board to remove the distinction between programme and intervention guidance for the 2012 update, and to produce public health guidance using one process. This single process would be implemented gradually across newly referred guidance topics from 2012 onwards. The single process can be completed over varying periods of time, generally between 14 and 18 months, depending on the nature and scope of the referral. (This refers to the time taken from publication of the final scope to consideration of the guidance by NICE's Guidance Executive). The Public Health Advisory Committees (PHACs) replace the Programme Development Groups (PDGs) and the Public Health Interventions Advisory Committee (PHIAC).The remainder of this guide sets out NICE's public health guidance process for guidance developed from mid-2012 onwards. Earlier versions of the guide detail past methods and processes (see Public health guidance process and methods guides on the NICE website).

1.5 Groups involved in public health guidance development

The key groups involved in developing public health guidance and their main roles and responsibilities during guidance development are listed below.

Centre for Public Health Excellence (CPHE)

  • Prepares or commissions briefings for the public health Topic Advisory Workshop (TAW) (see chapter 2).

  • Identifies, encourages and facilitates stakeholder registration (see chapter 4).

  • With the agreement of the Board, appoints the Chairs and members of the PHACs (see chapter 5).

  • Prepares a draft scope for the guidance and revises the scope after stakeholder consultation (see chapters 3 and 4).

  • Manages the consultation process, compiles the responses to consultation comments on the draft scope, the evidence and the draft guidance (see chapter 3).

  • Advises and supports the Chairs, members and co-opted members of the PHACs (see chapter 5).

  • Commissions a contractor to produce reviews and economic analysis to inform the guidance (see chapter 7).

  • Quality assures the evidence reviews and economic analysis (see chapter 7).

  • Drafts the guidance and the recommendations following PHAC discussion.

  • When appropriate, commissions and manages fieldwork consultation on the draft recommendations with key local professional and practitioner groups (see chapter 8).

  • Revises the guidance in response to stakeholder comments and any fieldwork results, for approval from the PHAC (see chapter 3).

  • Advises on and supports the publication, dissemination and implementation of the guidance (see chapter 7).

  • Manages the updating of the guidance (see chapter 11).

Evidence providers

  • Develop the protocols for the evidence reviews and economic analysis, in liaison with, and for approval by CPHE (see chapter 6).

  • Prepare reviews of the evidence for consideration by the PHAC.

  • Amend draft reviews in response to comments and discussions agreed by the PHAC.

  • Assess additional evidence submitted by stakeholders.

  • Assist the CPHE project team (see chapter 7) with responses to stakeholder comments on the evidence.

  • Prepare an economic analysis, including economic modelling for consideration by the PHAC.

Public Health Advisory Committees (PHACs)

  • Consider the evidence on the guidance topic and develop recommendations for policy and practice.

  • Are collectively responsible for the development of the final guidance submitted to NICE.

  • Agree amendments to draft guidance in response to stakeholder consultation and fieldwork.

  • Work with NICE to develop the implementation tools for the guidance (see chapter 9).

Patient and Public Involvement Programme (PPIP)

  • Advises the CPHE project team on public, community, service user and carer issues (see chapter 9).

  • Identifies and approaches potential community and voluntary sector stakeholders for each public health guidance.

  • Encourages and facilitates applications from community members (people who either have direct experience of public health interventions or are members of a relevant organisation or support group) who are interested in becoming PHAC members.

  • Advises, supports and provides training for community members of PHACs.

  • Comments on the draft scope and the draft guidance from a public, community and carer perspective.

Other NICE teams and structures

  • Information services team: part of the Evidence Resources Directorate, the information services team contributes to the scoping searches, and helps to quality assure the search strategies used for the evidence reviews. From time to time, the information services team may develop and implement search strategies in-house, in collaboration with the CPHE project team (see chapter 7).

  • Press team: part of the Communications Directorate, the press team and communications lead support PHAC members and the NICE project team on all media and communications activity, and issues management, throughout the guidance development process.

  • Editors: the lead editor works with the NICE project team and the PHAC to ensure that the guidance and related products are written and presented in a way that is clear and accessible to a range of different audiences.

  • Implementation team: the implementation lead works with the PHAC and the NICE project team to identify and develop tools to support those wishing to put guidance recommendations into practice. Field consultants, part of the implementation team, work with external stakeholders to promote the guidance and may identify potential areas for new guidance.

  • Costing team: the costing lead works with the PHAC, the NICE project team and the implementation lead to develop appropriate costing tools for those wishing to implement the guidance.

  • Quality systems team: if the guidance has been identified as a topic for a quality standard, the quality systems team – part of the Health and Social Care Directorate – manage the production of the quality standard once the guidance has been developed.

1.6 Information about public health guidance

As it becomes available, the following information about each set of public health guidance can be found on the NICE website:

  • a list of registered stakeholders

  • details of the NICE (CPHE) project team

  • details of the cross-NICE leads (for example, communications, implementation)

  • details of the relevant PHAC and its membership

  • a schedule for development of the guidance

  • project history, and information on progress of the guidance

  • the consultation draft of the scope

  • the final scope

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

  • the draft guidance and the evidence for consultation

  • a table of stakeholder comments on the draft guidance and responses to the comments

  • the final published guidance

  • final versions of the evidence

  • a fieldwork report, where available

  • details of related NICE guidance

  • tools to support implementation of the guidance

  • details of scheduled updates.