1 Introduction and overview

The National Institute for Health and Care Excellence (NICE) is an independent public body that provides national guidance and advice to improve health and social care in England. NICE guidance offers evidence-based recommendations made by independent Committees on a broad range of topics. 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 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 fieldwork)

  • 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 other developers of guidance, stakeholders and users of NICE guidelines.

The processes and methods described in this manual are based on internationally recognised guideline development methodology, and the experience and expertise of the teams at NICE, the contractors that work with NICE, NICE Committee members and stakeholders. The processes and methods 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. They are also designed to fulfil the requirements of the NICE accreditation scheme.

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 is the first edition of the manual that covers all NICE guidelines. Previously, guidelines were developed using 4 sets of processes and methods:

These manuals were based on the same over‑arching core principles common to all NICE guidance. However, they had evolved to include some procedural and/or methodological differences, depending on the areas and the evidence base that they covered. This manual brings together methods and processes for developing guidelines on the whole range of topics, with the aim of achieving consistency of approach, and rationalising differences where appropriate. In some cases 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 evidence review or guideline, together with the rationale for the choice. The use of, and rationale for, the approach agreed for each guideline will also be documented by NICE staff with responsibility for quality assurance. 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. In the short-term the Interim methods guide for developing service guidance will stand. These interim methods will be incorporated in this manual at its next revision.

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).

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.

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 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 same core principles we use for all our guidance:

  • 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, 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 light of new evidence 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.

NICE also considers dissemination and implementation when developing guidelines.

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 that gives the best 'fit' 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, other study designs (including observational, experimental or qualitative) may also be used to assess effectiveness, or aspects of effectiveness. These 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 concurs or differs ('triangulation').

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.

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 insufficient (for example, when the topic covers a population group that is not part of the Committee, such as children or people 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).

A statement from NICE's Board summarises NICE's legal and other obligations and describes NICE's approach to meeting them, particularly the process of equality analysis. 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). Identification of 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 (see the entry on social value judgements in our Glossary).

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 and the public informed of progress by email and by adding information to the guideline page on the NICE website. The schedule for the guideline, the scope and details of the Committee and teams involved are also available on the guideline page.

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, may provide evidence, and support implementation of the guideline. NICE formally responds to all comments from registered stakeholders, and these responses are published on the NICE website.

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

  • 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 respond 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.

NICE is established as an England‑only body, and acknowledges that its 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 with an interest in a particular guideline topic can register to comment on the draft scope and the draft guideline. Their comments are carefully considered and are made public with those of registered stakeholders. However, the term 'respondent' rather than 'stakeholder' is used for a tobacco company to acknowledge NICE's commitment to Article 5.3 of the WHO Framework Convention on Tobacco Control. This sets out an obligation to protect the development of public health policy from any vested interests of the tobacco industry.

NICE staff and contractors who work with the Committee

The Committees are assisted by teams whose work covers quality assurance, guideline development, evidence review and support.

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 the process has 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. Quality assurance takes place throughout guideline development; key tasks are referred to in relevant sections of this manual.

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 Associate Director 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 Associate Director also advises the Committee Chair and the Developer on matters of method and process. For some guidelines, guideline commissioners help them with this.

The technical lead is responsible for ensuring the technical quality of the non‑economic evidence reviews. They also commission, coordinate and quality assure any fieldwork and quality assure any additional consultation with people affected by the guideline.

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

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 writing the guideline in accordance with the Committee's discussions and decisions.

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.

Evidence review

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. This team may be within NICE, or an organisation contracted by NICE.

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 tables and writes brief summaries (evidence statements) 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 communications team

The press team and communications lead support Committee members, the Developer, and NICE staff with responsibility for guideline quality assurance, on all aspects of communications, including contacts with the media and managing any issues, throughout guideline development and after publication.

NICE Adoption and Impact Programme

The resource impact assessment team from the Adoption and Impact Programme work with the Committee, and NICE staff carrying out quality assurance, to provide information on the resource impact of recommendations. Final cost estimates are available to support the implementation of the guideline. 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.

Field team

Implementation consultants from the field team work with local organisations to promote the guideline.

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, including the NICE Pathway (which brings together everything NICE says on a topic in an interactive flowchart), are written and presented in a way that is clear and accessible to a range of different audiences.

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

Stages of guideline development

1.7 Publication and implementation of the guideline

Guidelines are published on the NICE website alongside the summarised evidence and resources to help users implement the guideline. In addition, the guideline is included in NICE Pathways – an online tool that brings together everything NICE says on a topic in an interactive flowchart. Pathways are structured and sign-posted so users can find relevant recommendations quickly and easily.

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, Dieppe P, McIntyre S et al. on behalf of the MRC (2008) Developing and evaluating complex interventions: new guidance. London: Medical Research Council

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

Flay BR (1986) Efficacy and effectiveness trials (and other phases of research) in the development of health promotion programs. Preventive Medicine 15: 451–74

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

Kelly MP, Morgan A, Bonnefoy J et al. (2007) The social determinants of health: developing an evidence base for political action. Final report to the World Health Organization Commission on the Social Determinants of Health, from the Measurement and Evidence Knowledge Network. London: National Institute of Health and Clinical Excellence

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

Nutbeam D (1998) Evaluating health promotion – progress, problems and solutions. Health Promotion International 13: 27–44

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

Weightman A, Ellis S, Cullum A et al. (2005) Grading evidence and recommendations for public health interventions: developing and piloting a framework. London: Health Development Agency

Weiss CH (1995) Nothing as practical as good theory: exploring theory‑based evaluation for comprehensive community initiatives for children and families. In: Connell JP, Kubisch A, Schorr LB et al., editors New approaches to evaluating community initiatives: concepts, methods and context. Washington DC: Aspen Institute