Process and methods
2 The scope
The scope sets out what a NICE guideline 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 research evidence, and incorporating economic evaluation).
The scope 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:
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 key issues that will be considered and lists the draft questions
describes the economic perspective(s) to be used.
The scope also includes:
a brief description of the guideline topic (for example, a description of the condition or disease, health or social care services, organisation of services, or areas of public health practice)
a brief overview of the context (current policy and practice) in which the guideline will be developed
a summary of why the guideline is needed and where it will add value, including how the relationship between commissioners and providers may affect outcomes and costs
how the guideline will build on, rather than simply reproduce, the actions required by legislation and statutory guidance
a draft outline of the NICE Pathway (everything NICE says on a topic in an interactive flowchart)
potential equality issues among groups sharing protected characteristics and how these will be considered
health inequalities associated with socioeconomic factors and with inequities in access for certain groups to healthcare and social care, and opportunities to improve health.
The title of the guideline (as given in the scope) should accurately reflect the content of the scope. Occasionally, it may be necessary when preparing the scope to seek clarification from the commissioning body (see the section on choice of guideline topics in the introduction chapter) 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).
When a guideline is being updated or replaced, the scope of the existing guideline may be used unchanged, the scope of the existing guideline may be modified or a new scope developed. The scope lists which sections will be updated, and any that will be removed, for example, because they are now covered by other NICE guidance or by legislation or other sources of advice, or are no longer current practice.
The draft scope is prepared by the developer or by a team at NICE, with other input depending on the guideline topic. Topic‑specific expertise may be provided by members of the committee (if early appointment is appropriate) and the topic adviser if there is one (see the section on topic-specific committees in the chapter on decision-making committees). Lay expertise may be provided by 1 or more lay people recruited specifically to support scope development, or 1 or more lay members of the committee if early recruitment is appropriate.
When several related guidelines are being developed simultaneously, cross-representation of expertise on each scoping group may also be considered.
The following are usually involved:
a lead from NICE's Pathways team
a lead from NICE's public involvement programme
a lead from NICE's resource impact assessment team
the developer's information specialist, systematic reviewer and economist
NICE staff with responsibility for quality assurance.
The draft scope is signed off by a senior NICE staff member with responsibility for quality assurance.
The scope is developed in 7 stages:
stage 2: understanding the context
stage 3: identifying the population and key issues
stage 6: consulting on the draft scope
stage 7: finalising the scope after consultation.
To support scope development a scoping search is undertaken. The sources searched will depend on the topic, the type of questions the guideline will seek to address and the type(s) 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. Topic advisers or committee members may also identify relevant sources and evidence.
The search for evidence to support scope development should identify any appropriate:
NICE guidance and guidance from other developers
policy and legislation
information on current practice, including costs and resource use and any safety concerns
audits, surveys and registries
types of interventions that may be appropriate and their safety
statistics (for example, on epidemiology or service configuration), national prevalence data and data on the natural history of the condition
information on the views and experiences of people using services, their family members or carers, or the public.
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 indicate whether there is sufficient evidence to answer the draft questions. At this stage, tools that cluster search results into topics can be helpful. The search should focus on identifying secondary sources, such as reviews of the evidence. If there is insufficient review‑level information, the scoping search should be extended to identify relevant primary studies and data sources (including those sources that might not be identified using traditional search strategies). When searching for systematic reviews, it may be efficient to limit any searches of databases that are sources for DARE (Database of Abstracts of Reviews of Effects) on the Centre for Reviews and Dissemination website to studies indexed after December 2014, when the searches to identify studies for DARE ceased.
In some cases, a scoping search for economic evidence may be conducted (see the section on reviewing economic evaluations in the chapter on incorporating economic evaluation).
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.
For a guideline that is an update of existing NICE guidance, and for which the scope of the existing guideline is being modified, the developer can use any background information (including briefing papers and searches undertaken as part of the process for reaching an update decision) to inform the searches at the scoping stage. (See the chapters on ensuring that published guidelines are current and accurate and updating guidelines for information on updating guidelines.)
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 believe that there is relevant evidence not identified by the searches. In these cases, the developer should start to compile a list of the gaps 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).
In order to develop guidelines that identify and promote effective practice, it is important to understand current context. Context can include:
the reason for referral of the topic
the burden of disease
the differential impact of disease or services and outcomes (in relation to socioeconomic factors or equity issues)
how care and support is currently delivered and who is responsible for commissioning and providing it
the cost of care and support
workforce issues and variance in service organisation
use of interventions
legislative or regulatory frameworks
user experience and safety concerns.
Understanding the current context and how the guideline topic fits within this context will help to ensure that:
the guideline focuses on achieving improvement in areas where it is most needed
potential implementation issues and resource impact are identified early and used to inform the guideline and relevant resources.
The developer continues to collect contextual information during development so that the guideline can adapt to changes in context.
For some guidelines, it may be helpful to construct a topic- or question-specific conceptual framework. Two different, but interlinked, models can be used: problem-oriented and design-oriented.
A problem-oriented conceptual model can aid understanding of existing or planned interventions or services and identify areas for improvement. It provides information on how factors interact and ensures that key areas are approached in the most logical and efficient way. It helps to focus questions, as well as identifying how the discrete questions are linked and how much of the intervention or service will be covered. A problem-oriented conceptual model can be developed as part of the scoping process (for example, at the stakeholder scoping workshop) and should not be limited by what is feasible.
The problem-oriented model links to a design-oriented conceptual model (or logic model), which is used to inform the structure, assumptions and data needed for simulation models (implementation models) to assess effectiveness (including cost effectiveness). The design-oriented model can also be used to help structure the review questions and to specify the data and evidence needed to develop an economic model to inform recommendations.
Stage 3 includes identifying the population and considering the key issues 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, and consulting experts.
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 guideline focuses on areas in which providers and commissioners of care and support, or services most need advice. For example, areas in which there is unacceptable variation in practice or uncertainty about best practice, areas of unsafe practice, uncertainty around the optimal service configuration, or where new evidence suggests current practice may not be optimal. It may also be important to identify populations in which there is evidence to suggest 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.
Consideration should be given as to whether there are specific aspects of the views or experiences of people using services that need addressing. When these are identified, they should be included in the scope if they are not covered by existing guidelines and are supported as a priority area (see the chapter on developing review questions and planning the evidence review).
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, NHS England or Public Health 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.
The process should ensure that a range of care and support, or services is considered, including key areas for quality improvement, and that the resulting guideline can be used to inform the development or update of a NICE quality standard.
During development of the scope, it is important to consider and assess any equality issues to establish:
whether there is any risk of unlawful discrimination arising from the guideline
whether the guideline offers any opportunities for advancing equality
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.
Considerations should be reflected in the equality impact assessment. 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.
Box 2.1 lists the factors (including relevant equality issues) that should be considered when identifying and prioritising key issues, health inequalities and impacts on equality. At this stage, the developer (in discussion with NICE staff with responsibility for quality assurance) should also consider the composition of the committee, and the approach to be taken when key population groups are excluded from committee membership (for example, for topics covering children – see the section on forming the committee in the chapter on decision-making committees and the appendix on approaches to additional consultation).
Uncertainty or disagreement on best practice
Is there variation in current care provision and practice?
Is there variation in the level of integration of care and support for people using services or accessing care?
Is there evidence suggesting that common practice may not be best practice?
Is there debate in the literature?
Potential to improve outcomes or make better use of resources
How many people are affected and in which age groups or sectors of the population?
What is the potential for improved outcomes at acceptable cost?
What is the potential for reducing ineffective care?
What is the potential to provide care and support in a more efficient way (for example, through organisation of services to integrate care and support, or telecare)?
Are there safety concerns that need addressing?
What is the potential for achieving cost savings with acceptable outcomes?
What is the potential for improving employment outcomes among people out of work because of ill health?
Potential for avoiding unlawful discrimination, advancing equality and reducing health inequalities
Are there any health inequalities or impacts on equality?
Are there any specific access issues (for example, by population, geographical location or group sharing a protected characteristic)?
Are exclusions (for example, populations, interventions or settings, or groups sharing a protected characteristic) justified?
Have all relevant mental health issues been considered, including where topics focus on physical health problems?
Are there any specific issues for people with a learning disability?
Do inequalities in prevalence, access, outcomes or quality of care and support for any groups (particularly those sharing protected characteristics) need to be addressed by the scope?
Might there be a need to consider reasonable adjustments for a particular group when making recommendations?
Likelihood that the guideline could contribute to change
Is a new review of the evidence or an economic evaluation likely to reduce existing uncertainties?
How does the guideline fit with existing legal frameworks, statutory and professional guidance or government policies, and what is its anticipated impact?
What is the potential for achieving consensus within the committee and in the wider stakeholder community?
Other important factors
Will the guideline update or incorporate any recommendations in other published NICE guidance?
Will the guideline take into account other NICE guidance (for example, technology appraisal guidance)?
How does the topic relate to existing NICE Pathways?
Where is it proposed that the topic will fit into NICE Pathways?
Are there any particular issues about how the topic will be incorporated into NICE Pathways, or about how it should be presented in NICE Pathways?
Key issues and draft questions addressing these issues should be included in the scope. Depending on the type of guideline, whether it is an update (see the chapter on updating guidelines) and the type of question, these could be very high level or could more precisely describe the populations, interventions, or particular approaches and aspects of service delivery to be compared and the outcomes of interest (see the chapter on developing review questions and planning the evidence review). These draft questions will be used as the basis for the final review questions (see the chapter on developing review questions and planning the evidence review) in the guideline.
Examples of key issues and draft questions are shown in box 2.2.
Issues relating to services
Rehabilitation programmes to support people back to work
Integration of services to support people after a stroke
Draft questions relating to services
What types of rehabilitation programmes should be provided to support people back to work?
What types of nurses and how many are needed to provide safe care in adult intensive care units?
How can services be organised to provide integrated and coordinated support to people after a stroke?
Issues relating to interventions
Training to assist foster carers in managing behaviour that challenges
Pharmacological interventions to treat pneumonia
Digital interventions to support behaviour change
Identifying pregnant women who smoke
Draft questions relating to interventions
What training should be provided to assist foster carers in managing behaviour that challenges?
What antibiotics should be used and for how long when treating pneumonia?
What interventions (or types of interventions) are effective at identifying pregnant women who smoke?
What interventions (including art therapy) are effective in treating mild to moderate depression?
Issues relating to experience of people using services
Information and support for people with epilepsy
Coordination and integration of support for people with a learning disability
Making structural changes to homes to support independent living
Draft questions relating to experience of people using services
What are the information and support needs of people with epilepsy, and how should these be met?
How does coordinated/integrated support (or the lack of it) affect the experience of people with a learning disability?
Issues relating to health inequalities and equality
Differential access to services or treatment for different population groups, including those sharing a protected characteristic
Draft key questions relating to health inequalities and equality
How can structural interventions and aids to support independent living be delivered for people who live in rented accommodation?
The scope should include a section listing the main outcomes of interest to be used when considering the evidence. This need not be an exhaustive list, but should always include quality of life and some important condition‑ or service‑specific outcomes that are important to people receiving care and support or using services, or those providing care and support or services. Core outcome sets should be used if these are suitable based on quality and validity; one source is the COMET database. The Core Outcome Set Standards for Development (COS‑STAD) and Core Outcome Set Standards for Reporting (COS‑STAR) should be used to assess suitability. The outcome list is likely to include capability, functioning, effectiveness, cost effectiveness, resource use and safety. It is also desirable to specify any negative effects of different approaches, such as adverse effects of treatment, or aspects of service delivery considered in the guideline (see also the appendix on service delivery – developing review questions, evidence reviews and synthesis).
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. Because NICE Pathways bring together everything NICE says on a topic, they should be used to identify potential overlap between guidelines and to inform stakeholders of the range of relevant published NICE 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).
The publishing team at NICE develops an outline of the NICE Pathway in collaboration with the developer to support the development of the scope.
It is important to seek the views of stakeholders to confirm that the population group(s) and key issues identified by the developer 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 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 developer, NICE staff with responsibility for quality assurance decide whether, and when, to hold a scoping workshop, and document the reasons for the decision. They also arrange the workshop.
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.
The scoping workshop, if held, is in addition to the formal consultation on the draft scope. Stakeholder organisations with representatives attending the scoping workshop are also encouraged to submit comments in writing as part of the scope consultation. 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:
obtaining feedback on the selected key issues, including any important considerations for implementation
identifying whether there are specific aspects of the views or experiences of people using services that need addressing and are not covered by existing guidelines
identifying contextual issues, such as national policy or areas of care in which there is known variation in service provision
obtaining views on what should be included and what should be excluded (for example, populations, settings, interventions, main outcomes)
identifying which people using services or population subgroups should be specified for particular consideration (if any)
considering existing NICE recommendations and how the planned guideline relates to them
seeking views on the composition of the committee (see the introduction to the chapter on decision-making committees)
encouraging applications for committee membership.
People attending the scoping workshop are sent a draft of the scope, which is intended as a starting point for discussion.
At the workshop, NICE staff with responsibility for quality assurance, the developer and other teams provide details about:
the timetable and process for guideline development
the nature of stakeholder input into the guideline (including the involvement of people using services, family members and carers).
For some guidelines, they also explain the processes for recruiting committee members (see the chapter on decision-making committees).
This introduction is followed by a structured discussion of the key issues.
After the scoping workshop, the developer writes a summary of the discussions and key themes that emerged. The summary includes a list of organisations represented at the workshop. When the workshop is held before consultation on the scope, this summary is posted on the NICE website during consultation, along with the draft of the scope that was refined after the scoping workshop. 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.
If a scoping workshop has been held, the developer (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 impact assessment is completed by the developer 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 impact assessment is signed off by a member of NICE staff with responsibly for quality assurance, and published on the NICE website with the draft scope. The assessment is updated by the developer and the committee chair after the scope consultation.
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 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 key issues (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. NICE asks stakeholders to suggest areas where cost savings could be achieved.
Comments are invited from registered stakeholders. In particular circumstances, comments will also be solicited 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 and evidence; 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 argument and be submitted for the purpose of 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. 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 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.
After consultation, the developer finalises the scope in line with 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 (for example, to include additional aspects of care and support, an additional population, a wider age range or an additional setting).
If the developer considers that a request to expand the scope would mean the guideline could not be completed on schedule, this should be discussed with NICE 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 developer and NICE in response to each comment, are clearly documented by the developer in a 'scope consultation table'. This is published on the NICE website with the final scope. 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 non‑registered stakeholders and individuals are reviewed by the developer and NICE. A formal response is not given and these comments are not made available on the NICE website.
NICE reserves 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 NICE staff with responsibility for quality assurance. Once the final scope has been published no changes should be made to it except in exceptional circumstances.
The final scope, the scope consultation table with comments from registered stakeholders and responses to these comments, and the equality impact assessment are posted on the NICE website.
In exceptional circumstances, the final scope may need amending after it has been signed off and posted on the NICE website. For example, amendments may be needed in the light of policy changes, the withdrawal of a medicine, or inclusion of 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 NICE staff with responsibility for quality assurance, based on advice from the committee or developer as appropriate.
If a final scope is amended after publication, registered stakeholders are informed and the revised scope is published on the NICE website. No further consultation on the scope would usually be expected.
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