NICE process and methods

1 Introduction

1 Introduction

The National Institute for Health and Care Excellence (NICE) is a non-departmental public body that provides national guidance and advice to improve health and social care in England. Decisions on how NICE guidelines apply in other UK countries are made by ministers in the Welsh Government, Scottish Government and Northern Ireland Executive.

This manual explains the processes and methods used to develop and update NICE guidelines, the guidance that NICE develops covering topics across clinical care (in primary, secondary and community care settings), social care and public health. For more information on the other types of NICE guidance and advice (including technology appraisal guidance), see about NICE.

1.1 NICE guideline recommendations

NICE guidelines make evidence-based recommendations on a wide range of topics, from preventing and managing specific conditions, improving health, and managing medicines in different settings, to providing social care and support to adults and children, and planning broader services and interventions to improve the health of communities. Guidelines promote individualised care and integrated care (for example, by covering transitions between children's and adult's services and between health and social care).

Guideline recommendations set out:

  • the care and services that are suitable for:

    • most people with a specific condition or need

    • particular populations, groups or people in particular circumstances or settings (for example, when being discharged from hospital)

  • ways to promote and protect good health or prevent ill health

  • the configuration and provision of health and social care services and/or

  • how national and local public sector organisations and partnerships can improve the quality of care and services (for example, how the NHS and social care services work together).

Many guideline recommendations are for individual health and social care professionals, who should use them in their work together with their own judgement and discussion with people using services. Some recommendations are for local authorities, commissioners and managers, and cover planning, commissioning and improving services; others are for providers (organisations providing services), schools, and local and national organisations and partnerships in the public, private and voluntary sectors. Guideline recommendations are also useful for people who use health and social care services (including people who purchase their own social care), their families and carers, and organisations representing their interests.

In addition to the recommendations, guidelines also summarise the evidence behind the recommendations and explain how the recommendations were derived from the evidence.

1.2 Information about this manual

This manual explains the processes and methods NICE uses for developing, maintaining and updating NICE guidelines. It is primarily for:

  • NICE staff involved in developing guidelines

  • organisations contracted by NICE (such as those doing evidence reviews, economic analysis and other engagement work)

  • members of the committees that develop the guidelines (see the section on who is involved).

It is also likely to be of interest to a broader audience, including developers of other guidance, stakeholders and users of NICE guideline recommendations.

The processes and methods described in this manual are based on internationally recognised standards, and the experience and expertise of the teams at NICE, the contractors that work with NICE, NICE committee members and stakeholders. They are based on internationally accepted criteria of quality, as detailed in the AGREE Enterprise's Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument, and primary methodological research and evaluation undertaken by the NICE teams.

As NICE changes its processes and methods in line with the NICE strategy for 2021 to 2026, a key focus is on delivering digital living guideline recommendations. This means that in future, we will update some recommendations as soon as new evidence becomes available to provide useful and useable content to users. This manual describes how we develop new guidelines and update our existing guideline recommendations. It includes information on referral (for new guidelines) and development through to publication and implementation, as well as checking the need for an update, and the updating process.

This manual covers methods and processes for clinical, public health and social care topics, and service guidance (see the appendix on service delivery – developing review questions, evidence reviews and synthesis).

NICE uses a different process for producing guidelines relating to health and social care emergencies. This process is covered in the appendix on process and methods for guidelines developed in response to health and social care emergencies.

NICE is piloting a different process for producing digital living guideline recommendations. The principles are covered in the appendix on interim principles for methods and processes for supporting digital living guideline recommendations and the appendix on surveillance decision framework and multi-criteria decision framework for deciding whether to develop or update recommendations and which methods to use.

1.3 Key principles for developing NICE guideline recommendations

We develop guideline recommendations according to our principles that guide the development of NICE guidance and standards.

Using the best available evidence to develop recommendations

NICE guideline recommendations are based on the best available evidence. We use a wide range of different types of evidence and other information – from scientific research using a variety of methods, to testimony from practitioners and people using services.

Review questions guide the search for evidence, and the type of evidence used depends on the type of question (see the chapter on developing review questions and planning the evidence review).

Whatever evidence is used, it is selected and quality assessed using clear, consistent and appropriate methods (see the chapters on identifying the evidence: literature searching and evidence submission, reviewing evidence and incorporating economic evaluation).

Involving people affected by the guideline

When developing guideline recommendations, we involve people who might be affected by the guideline recommendations in a collaborative and transparent way. This includes commissioners, practitioners and others involved in providing services. People using health and care services, carers and the public also contribute to ensure that guidelines address issues relevant to them, reflect their views, and meet their health and social care needs.

There are 2 main ways to get involved:

  • organisations can register as a stakeholder

  • individuals can apply to join a committee that works on developing guideline recommendations or individuals may be asked to advise a committee as co-opted experts on a particular issue.

There is more information about stakeholders and committee members in the section on who is involved and in our guide for stakeholders and the public on how to get involved in developing NICE guidelines.

The Public Involvement Programme at NICE provides advice and support to committees and NICE staff about involving the public in developing NICE guidelines.

The Guidelines International Network Public Toolkit includes our best practice examples on how to involve patients and the public in guideline development.

Practitioners and people who use health and care services, family members, carers and the public may also be involved as:

Advancing equality and diversity, and upholding NICE principles

We are committed to ensuring that our guideline development process:

  • fully meets duties under the Equality Act (2010) to have due regard to the need to eliminate discrimination, foster good relations and advance equality of opportunity in relation to people who share the protected characteristics of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex, and sexual orientation, including the public sector equality duty to tackle discrimination and provide equality of opportunity for all

  • enables us to meet requirements under the Human Rights Act (1998)

  • fully meets duties under the Health and Social Care Act 2012 to consider the degree of a person's need for health services or social care in England.

NICE's equality objectives and equality programme (2020 to 2024) summarises our legal and other equality obligations and describes our approach to meeting them. In addition, NICE's strategy for 2021 to 2026 reaffirms our commitment to identifying and reducing health inequalities through our work.

Reducing health inequalities

Health inequalities arise because of the conditions in which we are born, grow, live, work and age. Health inequalities can be considered across 4 dimensions:

  • socio-economic status and deprivation (for example, unemployment, poor housing, poor education, low income or people living in deprived areas)

  • protected characteristics defined in the Equality Act 2010

  • vulnerable groups of society, or 'inclusion health' groups (for example, vulnerable migrants, people who are homeless, sex workers, and Gypsy, Roma and Travellers)

  • geography (for example, urban or rural areas, coastal areas).

Health inequalities can be measured through examining differences in 5 domains:

  • health status (for example, life expectancy and prevalence of health conditions)

  • behavioural risks to health (for example, smoking, diet and physical activity)

  • wider determinants of health (for example, income, education and access to green spaces)

  • access to care (for example, availability of treatments)

  • quality and experience of care (for example, levels of patient satisfaction).

Having due consideration for groups that may be affected by equality and health inequalities issues is an aspect of our compliance with both general public law requirements to act fairly and reasonably, and human rights obligations. It is also aligned to duties placed on the integrated care systems as outlined in the Health and Care Act 2022. We also have a moral, leadership and strategic duty to address health inequalities given our reputational role in delivering robust, independent and trusted advice to the UK health and care system.

Approaches to reducing health inequalities

We use evidence-based approaches to help identify and address equality and health inequalities issues throughout the guideline development process by:

  • systematically identifying population groups that may experience health inequalities using an equality and health inequalities assessment form, which considers the 4 dimensions of health inequalities

  • building on the key principles of co-design, co-production and community engagement to include diverse voices and perspectives that can help identify health inequalities and inform actions to reduce them

  • proactively considering whether recommendations can be made to advance equality and reduce health inequalities.

1.4 Choice of guideline topics

We may develop guideline recommendations on new topic areas or update existing guideline recommendations. Decisions on which new topics to develop recommendations on will be based on the NICE-wide topic prioritisation process. This process ensures that NICE guidance reflects national priorities.

Further details on this process are available in the NICE-wide topic prioritisation: the manual. Briefly this process involves:

  • The identification of national priorities for the health and care system.

  • Consideration of whether a new topic area or update of an existing area addresses and national priority and meets the eligibility criteria of being within NICE's remit and there is either a gap in the existing NICE portfolio or there is significant and unwarranted variation in practice.

  • Where these criteria are met there is a further assessment via the prioritisation framework (alongside the NICE strategic principles for public health, social care and rare disease, if relevant).

  • The prioritisation board will make decisions on if the topic should be prioritised for further development and what type(s) of guidance the topic is likely to be best addressed by. This decision alongside brief rationale/s is published on the NICE website.

There are updates that do not require assessment by the prioritisation board, these are usually:

  • Related to a safety alert that NICE must respond to (for example an MHRA safety alert).

  • An alignment of guidance of content already approved by the prioritisation board (for example an update to an incorporated technology appraisal recommendation/s).

NICE guidelines are a key source for the development of NICE quality standards. Therefore, any new guidelines we develop are usually agreed with the relevant body (NHS England or the Department of Health and Social Care).

NICE will routinely identify and contact relevant individuals and organisations at planned points in the topic prioritisation process. Additionally, there is a proforma for topic suggestions (topics@nice.org.uk).

1.5 Who is involved

The committee

The committee is the independent advisory group that considers the evidence and develops the recommendations, taking into account the views of stakeholders (see the chapter on decision-making committees). Committee members include practitioners (both specialists in the topic and generalists), service or care providers or commissioners, and others working in the area covered by the guideline for example researchers and academics. In addition, at least 2 members of every committee are people using services, their family members or carers, or members of the public and community or voluntary sector with relevant experience (lay members).

If needed for a topic, the committee can co-opt members with specific expertise to contribute to developing some of the recommendations.

Registered stakeholders

Registered stakeholders are organisations that have registered with us because they have an interest in the guideline topic, or they represent people whose practice or care may be directly affected by the guideline. They play an important role in developing and advocating for, or implementing, NICE guidelines. During guideline development, we keep registered stakeholders informed of progress by email. We also add information on progress to the guideline page on the NICE website. The plan for the development of guideline recommendations and details of the committee are also available on the NICE website.

Stakeholder organisations are encouraged to get involved in guideline development in a range of ways. The NICE website explains how to register as a stakeholder and how to contribute to the development of a guideline. Registered stakeholders comment on the draft scope (depending on the process followed) and draft guideline recommendations, and they may be invited to provide evidence during guideline development. We formally respond to comments from registered stakeholders, and these responses are published on the NICE website. We may work with key stakeholders to support implementation of published guideline recommendations.

Stakeholders include:

  • national organisations for people who use health and social care services, their families and carers, and the public

  • local Healthwatch organisations and local organisations that have no national group to participate on their behalf

  • national organisations that represent health and social care practitioners and other relevant professionals whose practice may be affected by the guideline, or who can influence uptake of the guideline recommendations

  • public sector providers and commissioners of care or services (for example, GP practices)

  • private, voluntary sector and other independent providers of care or services

  • groups who produce evidence reviews and guidelines

  • companies that manufacture medicines, devices, equipment or adaptations, and commercial industries relevant to public health (excluding the tobacco industry)

  • organisations that fund or carry out research

  • government departments and national statutory agencies

  • overseas agencies with a remit covering England.

Individuals cannot register as stakeholders but we encourage anyone with an interest in the topic to express their views to a registered stakeholder listed on the guideline page on the NICE website. Although we will consider comments on the draft scope and guideline from individuals, we do not have the resources to write responses to these comments.

Local or regional professional or practitioner groups, and local or regional groups for people who use health and social care services cannot register as stakeholders unless there is no national organisation that represents the group's specific interests.

Although we are established as an England-only body, our guideline recommendations are used in other countries in the UK. We want our recommendations to be useful in these countries, so encourage individuals and stakeholders from anywhere in the UK to take part in developing them.

Tobacco companies and those who speak for them or are funded by them (collectively referred to as 'tobacco organisations') cannot register as stakeholders and are simply referred to as 'respondents'.

NICE staff and contractors who work with the committee

The committees are assisted by teams whose work covers evidence review and support, health economic evaluation, guideline recommendation development and quality assurance.

These teams are represented at committee meetings and contribute to discussions. They are not committee members, do not contribute to the quorum of the committee or the development of recommendations during meetings, and do not hold voting rights.

Quality assurance

Staff not involved in developing the guideline carry out independent quality assurance of the guideline to ensure that processes have been followed appropriately, and that the methods are clear and transparent. This includes ensuring that the reviews of the evidence and any economic analysis are up-to-date, credible, robust and relevant. They also check that there is a valid link between the evidence and the recommendations.

The centre director is responsible for ensuring that the guideline is produced in accordance with this manual. The centre director is also responsible for appointing the committee chair and committee members.

The guideline lead is responsible for the development and quality assurance of the guideline (including the scope), and has delegated responsibility for approving the consultation draft, the final guideline, and other documents, before final approval by NICE's guidance executive. The guideline lead also advises the chair of the committee and the developer on matters of method and process. Guideline commissioning managers help them with this.

The clinical, public health or social care adviser is responsible for providing advice during all stages of guideline development.

The technical lead is responsible for the technical quality assurance of the evidence reviews and other work undertaken by the developer. The technical lead commissions, coordinates and quality assures any fieldwork.

The economic lead is responsible for ensuring the technical quality of the economic evidence and any economic analysis.

Quality assurance takes place throughout development and during checks of the guideline recommendations after publication (surveillance). Independent quality assurance takes place in line with methods and processes set out in this manual, which are informed by the AGREE criteria. We do not routinely invite peer review but may occasionally use external expert peer review (see the section on external expert peer review in the chapter on the validation process for draft guidelines, and dealing with stakeholder comments).

Quality assurance of guidelines and recommendations includes the following actions:

  • Ensuring that the scope and guideline are produced in accordance with this manual.

  • Approving the consultation draft and the final guideline, before approval by NICE's guidance executive.

  • Advising the committee chair and the development team on matters of method and process.

  • Providing advice on the guideline topic during all stages of guideline development.

  • Ensuring the technical quality of the non-economic and economic evidence reviews, and any related analyses.

  • Providing advice on any medicines and prescribing aspects of the guideline.

  • Ensuring that the guideline is clear and accessible to readers, and in line with NICE's style guide.

Development

The development team is responsible for scoping the guideline, supporting the committee, and documenting the recommendations, committee discussions and decisions, evidence reviews and methods.

Administrators, coordinators and project managers provide administrative and management support to the committee, planning and scheduling the work, arranging meetings, liaising with stakeholders and all individuals and organisations contributing to the development of guidelines.

The evidence review team (comprising an information specialist, systematic reviewer and, for most guidelines, an economist) works together to identify, review and summarise the evidence, and undertake economic analyses. Sometimes development teams may commission other organisations to review the evidence.

The information specialist identifies relevant literature to answer the review questions (see the chapter on identifying the evidence: literature searching and evidence submission), creates databases to manage the search results and keeps a log of search results and strategies.

The systematic reviewer critically appraises the evidence, distils it into evidence tables and writes brief summaries (including GRADE tables, GRADE-CERQual or evidence statements, if used) for presentation to the committee (see the chapter on reviewing evidence). The reviewer also summarises the main issues with the evidence for the committee and contributes to their discussions.

For most guidelines, an economist identifies potential economic issues in discussion with the committee, summarises the published economic evidence and performs additional economic analyses as needed (see the chapter on incorporating economic evaluation).

Support

Staff from other NICE teams may work on the guideline recommendations at different stages. They may attend committee meetings and comment on the guideline during consultation and at other times.

Media relations team

The media relations team supports committee members, the development team, and staff with responsibility for quality assurance, on all aspects of communications, including contacts with the media and managing any issues, throughout guideline development and after publication.

Resource impact assessment team

The resource impact assessment team works with the committee, and staff with responsibility for quality assurance, to provide information on the resource impact (costs and savings) of recommendations. Final cost estimates are available to support the implementation of the guideline.

Implementation support team

The implementation support team provide support to enable the effective use of NICE guidance. They work in close partnership with key national partners and with health and care practitioners and commissioners to consider barriers to implementation. They then develop strategies, solutions or actions on how to overcome them through things such as changes to national or local policy, resource development and signposting to other support.

Impact team

The impact team helps the health and social care system to use NICE guidance, including measuring, assessing and reporting on the uptake of guidance.

System engagement team

The system engagement team includes the field team who work with regional and local organisations to promote the guideline and help to put it into practice.

Public Involvement Programme

The Public Involvement Programme (PIP) advises on ways to effectively involve people using health and care services, carers and the public, and supports their participation in our work. The PIP team advertises for people with relevant lived experience to join committees and supports them in their roles as committee members. PIP also works with organisations for people using services, carers and the public to support their engagement with us, including encouraging organisations to register as stakeholders and contribute to guideline activities.

Medicines optimisation team

The medicines optimisation team provides advice on medicines and prescribing issues in guidelines, including medicines safety, licensing and medicines optimisation.

Publishing team

Content designers from the publishing team work with the committee, the development team and staff with responsibility for quality assurance. They ensure that the guideline and related products are written and presented in a way that is clear to a range of audiences and meets accessibility standards (see NICE's webpage on accessibility).

1.6 Publication and implementation of the guideline recommendations

Guideline recommendations are published on the NICE website alongside the rationales for the recommendations, evidence review documents that include summaries of the committee discussions, and methods. This content may also be syndicated to other organisations to incorporate into their products, for example, decision support tools. Any resources to help users implement the guideline recommendations are also published.

Updating this manual

When significant changes are made, there will be a stakeholder consultation. The updated manual will then be published, along with a list of changes from the previous version of the manual. All registered stakeholders will be invited to comment on proposed changes.

We welcome comments on the content of this manual and suggested subjects for inclusion in the next update. These should be addressed to GuidelinesManualUpdate2022@nice.org.uk.

New methods may be piloted before formal consultation, to fully assess the implications before recommending changes. 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 added or removed

  • no fundamental method, technique or step is either added or removed

  • no stakeholders will be obviously 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 manual will be updated, and changes from the previous version of the manual will be listed.