1 Defining topic areas for new guidelines or full updates

Stage 1: the scoping evidence search

A scoping search is done to support scope development. The sources searched will depend on the topic, the type of questions the guideline will seek to address and the types of evidence sought. Unpublished sources of data that might provide relevant high-quality evidence, such as audits and registries, should also be identified at this stage. Early committee members may also identify relevant sources and evidence.

The search for evidence to support scope development should identify any appropriate:

The search should not aim to be exhaustive. It should be based on the need to inform the development of the draft scope and the issues to be discussed at a scoping workshop (if this is held). The search can also reveal the evidence base, start to identify gaps in the evidence and show whether there is enough evidence to answer the draft questions. The search should focus on identifying secondary sources, such as reviews of the evidence. If there is not enough review‑level information, the scoping search should extend to identify relevant primary studies and data sources (including those sources that might not be identified using traditional search strategies).

In some cases, a scoping search for economic evidence may be done (see the section on reviewing economic evaluations in the chapter on incorporating economic evaluation).

When available, health inequalities briefings should be used to inform questions about equality and health inequalities issues relevant to the guideline recommendations being developed. In the absence of a briefing, a scoping search for equality and health inequalities issues may be done.

The search should be fully documented (see the section on documenting the search in the chapter on identifying the evidence: literature searching and evidence submission) and if new issues are identified at a scoping workshop, the search may be updated. The appendix on suggested sources for scoping provides a list of suggested sources for the scoping search.

More information on identifying evidence to support guideline development is provided in the chapter on identifying the evidence: literature searching and evidence submission.

When gaps in the evidence are identified, NICE staff with responsibility for quality assurance, the developer or committee members (if recruited early) may discuss areas where there may be evidence not identified by the searches. In these cases, the developer should start to compile a list of the gaps identified during scoping, along with details of stakeholders who might be able to provide information, as part of a call for evidence (see the section on calls for evidence from stakeholders in the chapter on identifying the evidence: literature searching and evidence submission) or as expert witnesses (see the section on other attendees at committee meetings in the chapter on decision-making committees).

Stage 2: identifying the population and key issues

Stage 2 involves identifying the population and the key issues for inclusion in the scope. These may have emerged during the scoping search.

Identifying the population is critical because it helps determine the breadth and depth of the work. It also means that feasible measures can be included in any related NICE quality standard.

Identifying the key issues ensures that the recommendations focus on topic areas in which providers and commissioners of care and support, or services, most need advice. It may also be important to identify populations in which there is evidence suggesting different effects from an intervention due to the intervention's mechanism of action. For example, subgroups with different responses to pharmacological interventions resulting from underlying genetic variation or different responses to cognitive or behavioural interventions due to differing levels of education, socioeconomic status, or literacy and language skills.

It should be considered whether there are specific aspects of the views or experiences of the identified population or carers that need addressing. When these are identified, they should be included in the scope if they are priority areas.

Guidelines do not usually include key issues that are covered by other arms-length or government bodies such as the Department of Health and Social Care, or NHS England. They do not usually cover training requirements, because these are the responsibility of the royal colleges and professional associations, but they may make recommendations on the need for specific knowledge and skills for a particular aspect of care.

During development of the scope, it is important to consider and assess any equality and health inequalities issues, to establish:

Considerations should be reflected in the Equality and Health Inequalities Assessment (EHIA). The draft scope should set out the groups or issues that have been identified for specific consideration – including, when relevant, a statement to indicate that no groups or issues have been identified.

Health inequalities are described and discussed in more detail in the guidance support document, Promoting, Equality, Reducing Health Inequalities.

Stage 3: identifying and making decisions on overlaps with other guidance

Scoping includes identifying related NICE guidance (both published and in development) and guidance from other organisations. This helps to explore how the topic area of the scope relates to existing recommendations in other guidance.

Related guidance should be reviewed to determine whether the guideline in development:

This process should also aim to identify:

Stage 4: checking the population and selected key issues with stakeholders

It is important to seek the views of stakeholders to confirm that the population groups and key issues identified by the draft scope are relevant and appropriate. This includes organisations led by people using services, and organisations that represent the interests of people with the condition or people using services and their family members or carers, or the public.

For some guidelines, registered stakeholders (see the section on who is involved in the introduction chapter) may be invited to a scoping workshop to talk about the key issues in the scope, and discuss any other aspects as needed. A workshop may be held if the referral is a new topic area, there is a new audience for NICE guidelines, or the guideline involves an area of practice that has unique complexities. Following discussions with the developer, NICE staff with responsibility for quality assurance decide whether, and when, to hold a scoping workshop, and document the reasons for the decision.

The workshop is usually held before the consultation on the draft scope, but may be held during or after the consultation period. Attendance is usually limited to 1 person from each registered stakeholder organisation. In some circumstances, an organisation can nominate more than 1 person (for example, if it represents the views of both practitioners and people using services) if space permits.

If there are large numbers of stakeholders, it may not be practical for all registered stakeholders to attend. NICE may specify groups or roles of stakeholders who are needed. The aim of the workshop is to include as wide a range of views as possible. Attendees, including representatives of relevant service user, carer and community organisations, should have specific knowledge of, or experience in, the topic area.

Depending on the needs of stakeholder groups, virtual workshops, such as webinars, may be held in place of face‑to‑face workshops.

The scoping workshop is chaired by a senior member of NICE staff with responsibility for guideline quality assurance.

The objectives of the scoping workshop may include:

When the workshop is held before consultation on the scope, the following are posted on the NICE website during consultation:

When the scoping workshop is held during consultation, the summary is posted on the NICE website with the final scope.

For some topics, additional meetings or specific discussions with key stakeholders may be needed. However, this is exceptional and the reasons will be documented in the guideline.

Stage 5: consulting on the draft scope

The draft scope is signed off for consultation by a senior member of NICE staff with responsibility for quality assurance. It is posted on the NICE website for a consultation period (usually 2 to 4 weeks), and registered stakeholders are notified. Information and prompts that aim to seek stakeholders' views on key issues are posted with the draft scope. NICE asks stakeholders to suggest areas where cost savings could be achieved.

In particular circumstances, comments will also be sought from the relevant regulatory organisation; for example, the Medicines and Healthcare products Regulatory Agency (MHRA), when the off‑label use of medicines is likely to be considered in the guideline, or when advice is required on regulations related to medicines.

Comments should be constructed as reasoned arguments for improving the draft scope. NICE reserves the right not to respond to comments that are hostile or inappropriate.

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'.

The developer, NICE staff responsible for quality assurance and NICE's Public Involvement Programme (see the section on who is involved in the introduction chapter) routinely review the list of registered stakeholders to check whether any key organisations are missing. Registered stakeholders are also encouraged to identify potential stakeholders who are not registered. When the guideline covers social care, the NICE team with responsibility for social care should be asked about appropriate stakeholders.

Stage 6: finalising the scope after consultation