1 Introduction and overview

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. This manual explains the processes and methods used to develop and update NICE guidelines. For more information on the other types of NICE guidance and advice (including technology appraisal guidance), see about NICE on the NICE website.

1.1 NICE guidelines

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. They aim to promote individualised care and integrated care (for example, by covering transitions between children's and adult 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

  • the care and services suitable for 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 practitioners, who should use them in their work in conjunction 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.

NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government and Northern Ireland Executive.

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

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

  • members of the committees that develop the guidelines (see section 1.5).

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

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 Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument, and primary methodological research and evaluation undertaken by the NICE teams. They draw on the Guideline Implementability Appraisal tool to ensure that recommendations are clear and unambiguous, making them easier to implement.

This manual describes the development of NICE guidelines from referral through to publication, implementation, checking the need for an update and updating. The guideline development process is summarised in section 1.6. There is also information in chapter 12 on the support NICE provides to help organisations use each guideline.

This manual covers methods and processes for clinical, public health and social care topics, and service guidance (see appendix A). The best approach may vary depending on the topic; this manual gives alternatives and examples to help choose which approach to follow. Options should be considered from the outset, and the approach discussed and agreed with NICE staff with responsibility for quality assurance. The chosen approach should be documented in the methods for the guideline or the individual evidence review, together with the reasons for the choice. Decisions will be reviewed for consistency. In exceptional circumstances, significant deviations from the methods and process described in this manual may be needed; in these cases, NICE's senior management team must approve the approach before guideline development begins.

All guidelines produced using this manual are known as NICE guidelines.

1.3 Choice of guideline topics

NICE guidelines are a key source for the development of NICE quality standards and therefore new guidelines developed by NICE are usually chosen from a library of topics for quality standards and then agreed with the relevant commissioning body (NHS England or the Department of Health and Social Care).

Decisions on which library topics to develop guidelines on, and in what order, are based on factors such as:

  • whether there is existing NICE-accredited guidance on which to base a quality standard that encompasses the whole of the topic

  • the priority given to the topic by commissioners and professional organisations, and organisations for people using services, their families and carers

  • the health and care burden, and the potential to improve outcomes and quality of life.

A topic selection oversight group at NICE considers topics for guideline development, taking these factors into account. NICE then discusses topics identified in this way with NHS England, the Department of Health and Social Care, and Public Health England, and a prioritised list is agreed by these 3 bodies.

Topics are then formally referred to NICE and scheduled into NICE's guideline development plans.

1.4 Key principles for developing guidelines

NICE develops guidelines according to the following core principles:

  • Guidance is based on the best available evidence of what works, and what it costs.

  • Guidance is developed by independent and unbiased committees of experts.

  • All our committees include at least 2 lay members (people with personal experience of using health or care services, including carers, or from a community affected by the guideline).

  • Regular consultation allows organisations and individuals to comment on our recommendations.

  • Once published, all NICE guidance is regularly checked, and updated in the light of new evidence or intelligence if necessary.

  • We are committed to advancing equality of opportunity and ensuring that the social value judgements we make reflect the values of society.

  • We ensure that our processes, methods and policies remain up‑to‑date.

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 chapter 4). For example, a randomised controlled trial is often the most appropriate type of study to assess the efficacy or effectiveness (including cost effectiveness) of an intervention. However, a range of other non-randomised evidence, such as observational evidence (including that derived from the analysis of primary data sources such as patient registries), experimental and qualitative evidence, may also be used to inform assessments of effectiveness, or aspects of effectiveness. This evidence may include ways of delivering services, or the experience of people using services and how this contributes to outcomes. For some topics, there is little evidence from scientific studies, or the evidence is weak or contradictory. In these cases, we look for evidence from other sources to see if it agrees or differs ('triangulation'). When there is little or no evidence, the committee may also use expert testimony, make consensus recommendations using their knowledge and experience, or make recommendations for further research.

Whatever evidence is used, it is selected and quality assessed using clear and appropriate methods (see chapters 5, 6 and 7).

Involving people affected by the guideline

When developing guidelines, NICE involves 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 and individuals can join (or advise) a committee that works on guidelines. There is more information about stakeholders and committee members in section 1.5 and in our guide for stakeholders and the public (Developing NICE guidelines: how to get involved).

The public involvement programme at NICE provides advice and support to committees, developers and NICE staff, about involving the public in developing NICE guidelines. A public involvement adviser is allocated to each topic.

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

  • expert witnesses invited to give testimony to the committee (see section 3.5)

  • members of a reference group, focus group or other advisory group set up when standard involvement and consultation processes are likely to be insufficient (for example, when the topic covers a population group that is not part of the committee, such as children, or adults with a learning disability (see section 10.1).

Advancing equality and making social value judgements

NICE is committed to ensuring that its 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 it to meet requirements under the Human Rights Act (1998).

NICE's equality objectives and equality programme 2016–2020 summarises NICE's legal and other equality obligations and describes NICE's approach to meeting them, particularly the process of equality impact assessment. NICE uses this approach to consider not just equality in relation to groups sharing the characteristics protected by the Equality Act (2010) but also health inequalities arising from socioeconomic factors or associated with the shared circumstances, behaviours or conditions of particular groups (for example, looked‑after children, people who are homeless, people who misuse drugs and people in prison). Identifying such groups is an aspect of NICE's compliance with both general public law requirements to act fairly and reasonably, and human rights obligations.

NICE guidelines, and the procedures NICE uses to develop them, also take account of NICE's principles on social value judgements.

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. It may be a standing committee working on many guideline topics, or a topic-specific committee put together to work on a specific guideline (see chapter 3). 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 (see chapter 3). 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 (see sections 3.3 and 3.4).

Registered stakeholders

Registered stakeholders are organisations that have registered with NICE 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 NICE keeps registered stakeholders informed of progress by email. NICE also adds information on progress to the guideline page on the NICE website. The schedule for the guideline, the scope 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 and draft guideline, and they may be invited to provide evidence during guideline development. NICE formally responds to comments from registered stakeholders, and these responses are published on the NICE website. Stakeholders support implementation of the guideline once it is published.

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

  • 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 NICE encourages 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 NICE 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 NICE is established as an England‑only body, our guidelines are used in other countries in the UK. We want our guidelines to be useful in these countries, so encourage 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. This is in line with NICE's obligation under Article 5.3 of the WHO Framework Convention on Tobacco Control (FCTC) to protect public health policies from the commercial and other vested interests of the tobacco industry. Tobacco organisations are simply referred to as 'respondents'. Any comments received during consultation from respondents are reviewed for factual inaccuracy claims and are made public along with any responses.

NICE staff and contractors who work with the committee

The committees are assisted by teams whose work covers guideline development, evidence review and support, 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 by NICE

NICE staff carry out 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. These staff may also be responsible for commissioning the developer. Staff with responsibility for quality assurance must declare any interests, which are managed in line with NICE's policy on declaring and managing interests for board members and employees. Quality assurance takes place throughout development and during checks of the guideline after publication (surveillance). The responsibilities of NICE staff involved in guideline quality assurance are summarised below:

  • The NICE 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 NICE 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 and the final guideline, before approval by NICE's Guidance Executive. The guideline lead also advises the committee chair and the developer on matters of method and process. Guideline commissioning managers help them with this.

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

  • The NICE technical lead is responsible for ensuring the technical quality of the non-economic evidence reviews.

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

Quality assurance of guideline surveillance reflects quality assurance of guideline development. The NICE associate director – surveillance is responsible for ensuring that processes are followed and that decisions to update or not update guidelines are robust and fit for approval by NICE's Guidance Executive. The NICE technical adviser – surveillance ensures the technical quality of the surveillance review, and the NICE clinical, public health or social care adviser provides advice at all stages.

Development

The developer may be a team within NICE, or in an organisation contracted by NICE to develop guidelines. The developer 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) identifies, reviews and summarises the evidence, and undertakes economic analyses. Sometimes developers may commission other organisations to review the evidence.

The information specialist identifies relevant literature to answer the review questions (see chapter 5), 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 chapter 6). 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 chapter 7).

Support

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

NICE media relations team

The media relations team supports committee members, the developer, and NICE 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.

NICE resource impact assessment team

The resource impact assessment team works with the committee, and NICE staff carrying out 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.

NICE adoption and impact team

The adoption and impact team produces tools and signposts to other support that can help organisations put guideline recommendations into practice. The implementation support team works with external organisations on selected priority areas, which depend on the interests of our partner organisations and resources.

NICE 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. The NICE endorsement and shared learning programmes also support implementation with external resources and implementation case study examples.

NICE public involvement programme

The public involvement programme (PIP) advises on ways to effectively involve people who use health and care services, family members, carers and the public, and supports their participation in guideline development. PIP encourages organisations representing service user, carer and community interests to register as stakeholders. It also advertises for people using services, carers and the public to apply to join committees and supports them in their roles as committee members.

NICE publishing team

Editors from the publishing team work with the committee, the developer and NICE staff with responsibility for guideline quality assurance. They ensure that the guideline and related products are written and presented in a way that is clear and accessible to a range of different audiences. They develop the NICE Pathway (which brings together everything NICE says on a topic in an interactive flowchart) and for some topics may produce a visual summary of the recommendations.

1.6 Main stages of guideline development

The development time for guidelines is usually between 12 and 27 months (from the start of scoping to publication), depending on the size and scope of the topic. Figure 1.1 summarises the main stages.

Figure 1.1 Stages of guideline development

Figure 1.1 Stages of guideline development

1.7 Publication and implementation of the guideline

Guideline recommendations are published on the NICE website alongside the rationales for the recommendations, evidence reviews, including summaries of the committee discussions, and methods. Any resources to help users implement the guideline are also published. The guideline recommendations are also included in NICE Pathways – an online tool that brings together everything NICE says on a topic in an interactive flowchart. Pathways are structured and signposted so users can find relevant recommendations quickly and easily. They are not care pathways.

Resources to help people put the guideline into practice include tools that help users assess what needs to change. These resources inform action planning or audit, estimate costs and savings to help build a business case, or meet the education and learning needs of practitioners (see chapter 12 for information about the support available to help implement guideline recommendations).

1.8 Updating this 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 or methods of guideline development are anticipated, this interval will be reduced to 2 years.

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. Stakeholders involved in guidelines under development at the time of the change will be notified if they are affected by the change. Stakeholders of newly commissioned guidelines will be advised to consult the website at the start of the project to familiarise themselves with the updated manual.

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

Interim updates

In some situations, it may be necessary to make small changes to the manual before a formal update is due. These may be either minor, insubstantial changes or more significant changes for which formal consultation with stakeholders is necessary. 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 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 manual will be updated, and changes from the previous version of the manual will be listed.

1.9 References and further reading

Craig P, Cooper C, Gunnell D et al. on behalf of the MRC (2011) Using natural experiments to evaluate population health interventions: guidance for producers and users of evidence. London: Medical Research Council

Davidson K, Goldstein M, Kaplan RM et al. (2003) Evidence-based behavioral medicine: what it is and how do we achieve it? Annals of Behavioral Medicine 26: 161–71

Dixon‑Woods M, Agarwal S, Young B et al. (2004) Integrative approaches to qualitative and quantitative evidence. London: Health Development Agency

Graham H, Kelly MP (2004) Health inequalities: concepts, frameworks and policy. London: Health Development Agency

Kelly MP, Stewart E, Morgan A et al. (2009) A conceptual framework for public health: NICE's emerging approach. Public Health 123: e14–20

Kelly MP, Morgan A, Ellis S et al. (2010) Evidence-based public health: A review of the experience of the National Institute of Health and Clinical Excellence (NICE) of developing public health guidance in England. Social Science and Medicine 71:1056–62

Lomas J, Culyer T, McCutcheon C et al. (2005) Conceptualizing and combining evidence for health system guidance: final report. Ottawa: Canadian Health Services Research Foundation

Michie S, Berentson‑Shaw J, Pilling S et al. (2007) Turning evidence into recommendations: protocol for a study of guideline development group. Implementation Science 2: 29

Ogilvie D, Hamilton V, Egan M et al. (2005) Systematic reviews of health effects of social interventions: 1. Finding the evidence: how far should you go? Journal of Epidemiology and Community Health 59: 804–8

Ogilvie D, Egan M, Hamilton V et al. (2005) Systematic reviews of health effects of social interventions: 2. Best available evidence: how low should you go? Journal of Epidemiology and Community Health 59: 886–92

Pawson R (2006) Evidence-based policy: a realist perspective. London: Sage

Popay J, editor (2005) Moving beyond effectiveness in evidence synthesis: methodological issues in the synthesis of diverse sources of evidence. London: National Institute for Health and Clinical Excellence

Victora C, Habicht J, Bryce J (2004) Evidence-based public health: moving beyond randomized trials. American Journal of Public Health 94: 400–5