NICE process and methods
2 The scope
The scope sets out what a NICE guideline or topic suite will and will not cover. Preparing the scope is the first step in developing a guideline. The scope is used to create a framework for the development work (see the chapters on developing review questions and planning the evidence review, identifying the evidence: literature searching and evidence submission, reviewing evidence, and incorporating economic evaluation).
The scope of a guideline sets boundaries that ensure the work stays within the referral and the resulting guideline can support any relevant quality standard (see the section on choice of guideline topics in the introduction chapter). The scope for each guideline:
defines the population(s) and setting(s) that will and will not be covered
describes what the guideline will and will not consider
identifies the activities, services or aspects of care that will be considered and lists the draft questions
describes the economic perspective(s) to be used
identifies potential equality and health inequality issues among groups sharing protected characteristics and how these will be considered.
Occasionally, it may be necessary when preparing the scope to seek clarification on the referral (for example, to clarify how the NICE guideline will add value in relation to existing non‑NICE guidance or to specify the boundaries and the extent of the work) from the commissioning body (see the section on choice of guideline topics in the introduction chapter).
When we identify that recommendations need updating, the guideline scope is updated to reflect this. It lists:
the sections that will be updated and
any changes from the current guideline.
A separate scope for a topic suite identifies:
the guidelines included in the topic suite
the areas being actively monitored
the areas being updated.
The draft scope is prepared by the development team.
Topic-specific expertise may be provided by members of the committee. Independent quality assurance is done throughout the scoping process by staff with responsibility for quality assurance.
When several related guidelines or guidelines within a topic suite are being developed simultaneously, cross-representation of expertise on each scoping group may also be considered.
The draft scope is signed off by a senior member of staff with responsibility for quality assurance.
The scope is developed in stages. Stages 1 to 6 apply to new guidelines and stage 7 is for updates to the guideline:
stage 2: identifying the population, settings and activities, services or aspects of care
stage 5: consulting on the draft scope
stage 6: finalising the scope after consultation
stage 7: updates to the guideline.
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 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.
whether there is any risk of unlawful discrimination arising from the guideline
whether the guideline offers any opportunities for advancing equality or reducing inequalities and health inequalities
whether there might need to be reasonable adjustments to a recommendation to avoid putting any group of people covered by the scope at a substantial disadvantage
whether, and to what extent, particular equality issues should be included in the scope.
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.
Before the draft scope is signed off for consultation, an equality and health inequalities assessment is completed by the development team and the committee chair to show which equality issues have been identified and considered during scoping, and to provide assurance that risks of adverse impacts on equality of any exclusions from the scope have been assessed and can be justified. The equality and health inequalities assessment is signed off by a member of staff with responsibly for quality assurance, and published on the NICE website with the draft scope. The assessment is updated by the development team and the committee chair after the scope consultation.
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 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, staff with responsibility for social care should be asked about appropriate stakeholders.
After consultation, the development team finalises the scope based on the comments received ensuring that the scope stays in line with the referral for the guideline.
Sometimes registered stakeholders ask for the scope of a guideline to be broadened. If the development team considers that a request to expand the scope would mean the guideline could not be completed on schedule, this should be discussed with staff with responsibility for quality assurance. Sometimes lower‑priority areas are removed from the scope to keep the development work manageable. This is done in collaboration with the lead for any related quality standards. Suggestions that are clearly outside the original referral should not be included.
All comments from registered stakeholders, and the actions taken by the development team in response to each comment, are clearly documented by the development team in a 'scope consultation table'. The process for responding to comments from registered stakeholders should follow the principles described in the section on principles of responding to stakeholder comments in the chapter on the validation process for draft guidelines, and dealing with stakeholder comments. Comments received from unregistered stakeholders and individuals are reviewed by the development team and staff with responsibly for quality assurance. We do not formally respond to these comments and do not publish them.
We reserve the right to summarise and edit comments received during consultations, or not to publish them at all, if we consider the comments are too long, or publication would be unlawful or otherwise inappropriate.
The final scope is signed off by a senior member of staff with responsibility for quality assurance. Once the final scope has been published no changes should be made to it unless the guideline is being updated or there are exceptional circumstances (see the section on amending the final scope after publication on the NICE website).
The final scope, the scope consultation table with comments from registered stakeholders and responses to these comments, and the equality and health inequalities assessment are published on the NICE website.
When we identify that recommendations need updating, we add to the guideline scope to reflect this. It lists:
the sections that will be updated and
any changes from the current guideline.
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.
There can be exceptional circumstances when the final scope may need amending after it has been signed off and published on the NICE website. For example, amendments may be needed in the light of policy changes, the withdrawal of a medicine, or to include a NICE technology appraisal in development (see the section on related NICE technology appraisal guidance in the chapter on linking to other guidance). The decision on whether to amend the scope is made by a senior member of staff with responsibility for quality assurance, based on advice from the committee or development team as appropriate.
If a final scope is amended after publication, registered stakeholders are informed and the revised scope is published on the NICE website. Further consultation on the scope would not usually be done.
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