Developing NICE guidelines: the manual

Stage 1: the scoping search

To support scope development a scoping search is done (see the chapter on identifying the evidence: literature searching and evidence submission). 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 held (see stage 4: checking the population and selected activities, services or aspects of care with stakeholders).

Stage 2: identifying the population, settings and activities, services or aspects of care

Stage 2 includes identifying the population and settings, then considering the activities, services or aspects of care, including main outcomes, for inclusion in the scope. These may have emerged during preliminary work, or may be identified by the scoping search, by considering any health inequalities and impacts on equality, or by consulting experts.

Guidelines do not usually include activities, services or aspects of care that are covered by other arms-length or government bodies such as the Department of Health and Social Care, NHS England, UK Health Security Agency and the Office for Health Improvement and Disparities. For details on areas where we do not usually make recommendations see table 1 in the chapter on interpreting the evidence and writing the guideline.

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

Identifying related NICE guidance (both published and in development) is a key element of scoping. This helps to see where and how the guideline recommendations are likely to relate to existing recommendations in other guidance.

This process should aim to identify any gaps where new recommendations would be of value, and areas where recommendations already exist (see the chapter on linking to other guidance).

Stage 4: checking the population and selected activities, services or aspects of care with stakeholders

NICE values the views of stakeholders on whether the population group(s) and activities, services or aspects of care identified are relevant and appropriate. Stakeholders include organisations representing health and care professionals such as Royal Colleges and professional associations, 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 activities, services or aspects of care in the scope, and discuss any other issues as needed. A workshop may be held if the referral is in a new area, there is a new audience for NICE guidelines, or a guideline topic or an area of practice has unique complexities. Following discussions with the development team, staff with responsibility for quality assurance decide whether, and when, to hold a scoping workshop, and document the reasons for the decision.

If a scoping workshop has been held, the development team (with input from other teams) considers the issues raised and refines the scope after the workshop.

Stage 5: consulting on the draft scope

For new guidelines or for updates where consultation is required, the draft scope is signed off for consultation by a senior member of staff with responsibility for quality assurance. It is published on the NICE website for a 2- to 4-week consultation, and registered stakeholders are notified. Information and prompts to support stakeholder input are posted with the draft scope. The purpose of these prompts is to seek their views on activities, services or aspects of care (such as whether the identified outcome measures are in line with what matters to people with the condition or people using services) and to ask what should be included or excluded. We ask stakeholders to suggest areas where cost savings could be achieved.

Comments are invited from registered stakeholders. The NICE website explains how to register as a stakeholder and how to contribute to the development of a guideline. In particular circumstances, comments will also be requested 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 within the guideline or when advice is required on regulations related to medicines.

Registered stakeholders comment on the draft scope (and later on the draft guideline; see the section on what happens during consultation in the chapter on the validation process for draft guidelines, and dealing with stakeholder comments). Comments should be constructed as reasoned arguments and be submitted for the purpose of improving the draft scope. We reserve the right not to respond to comments that are hostile or inappropriate. Accepting late comments and responding to them is at the discretion of the development team.

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

The development team, staff responsible for quality assurance and the people and communities team (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, staff with responsibility for social care should be asked about appropriate stakeholders.

Stage 6: finalising the scope after consultation

Stage 7: updates to the guideline

When we identify that recommendations need updating, we add to the guideline scope to reflect this. It lists:

Small updates to the guideline scope are not usually subject to consultation with stakeholders. For larger updates, or where areas are added to the guideline, consultation with stakeholders may take place. The decision to consult with stakeholders is made by staff with responsibility for quality assurance. For all updates, the scope is published on the NICE website and stakeholders are informed.