NICE process and methods

2 The scope

Preparing the scope is the first step in developing social care guidance. It determines the details of the review work (see section 6). The scope is conducted in 4 stages:

  • stage 1: selecting key issues and drafting the scope (section 2.3)

  • stage 2: checking the selected key issues with stakeholders (section 2.4)

  • stage 3: consulting on the draft scope (section 2.5)

  • stage 4: finalising the scope after consultation (section 2.6).

This section describes what the scope is, the role of the scoping group and the process used at each stage to develop the scope.

2.1 Purpose of the scope

The purpose of the scope is to:

  • provide a brief overview of the policy and practice context in which the guidance will be developed

  • provide an overview of what the social care guidance will include and what will not be covered

  • identify the key issues that need to be included

  • set the boundaries of the development work so that it informs the quality standard

  • ensure equality issues are identified and considered

  • set parameters for the development of detailed review questions (see section 4.2) and the search strategy (see section 5) from the key issues

  • provide information to the social care sector, stakeholders and the public about the expected content of the guidance

  • ensure the guidance can be developed within the specified time period and within the available resources.

The scope provides a framework within which to conduct the guidance development work. The title of the guidance (as given in the scope) needs to be considered very carefully so that it adequately reflects the content of the scope.

The scope briefly describes the topic, current services, level of need and aspects of care or service provision that the guidance will cover in terms of the following:

  • Populations to be included or excluded. For example, different age groups or people with certain types of condition or specific needs or at specific stages of care. Or groups that may merit specific consideration (for example, people from particular ethnic groups or with learning disabilities).

  • Service setting – for example, care homes.

  • Types of approaches and aspects of service delivery. For example, assessment processes, support services, rehabilitation, re-ablement, information and support. It is important that the scope is as specific as possible about the activities that the guidance aims to cover.

  • Topic-specific information and support for service users and carers.

  • The main outcomes that will be considered.

  • Links with other NICE guidance, including guidance to be updated or incorporated within the new guidance.

  • Links to other related guidance, such as statutory guidance (see section 8).

  • NICE pathways that relate to the guidance topic.

  • Links with relevant quality standards.

2.2 The scoping group

The scope is prepared by a scoping group. The composition of this group will depend on the guidance topic, but should include NICE Collaborating Centre for Social Care (NCCSC) representatives, the Guidance Development Group (GDG) chair (once appointed), the GDG social care topic adviser (if there is one) and NICE representatives.

NCCSC representatives should include a director or senior member of staff (chair of scoping group), a project manager, an information specialist, a systematic reviewer and an economist. NICE representatives should include a technical lead, a programme lead, a Public Involvement Programme lead for the guidance and the Quality Programme lead for social care (or equivalent).

The role of the scoping group is to:

  • identify key issues and draft the scope, based on information from any pre-scoping work

  • revise the draft scope after the stakeholder scoping workshop (see section 2.4.1)

  • prepare the draft scope for consultation

  • respond to stakeholder comments

  • finalise the scope after consultation.

2.3 Stage 1: identifying key issues and drafting the scope

Stage 1 includes considering the key issues for inclusion in the scope, which may have emerged in a pre-scoping meeting, searching the literature, considering any equalities issues and consulting experts.

2.3.1 Identifying the key issues

Identifying the most important aspects of care or service provision that the guidance will cover is a critical part of the process because it determines the breadth and depth of the work. It ensures the guidance focuses on areas where providers and commissioners of social care most need advice.

This process should ensure that a range of care or services for the topic is considered for inclusion in the scope and could be used in the subsequent NICE quality standard.

Review questions may be included in the scope; these specify in more detail the particular approaches and aspects of service delivery to be compared and the outcomes of interest (see section 4). Key issues should be as specific as possible, indicating the relevant population and the alternative strategies that are being considered. Examples of key issues are shown in box 2.

Box 2 Examples of key issues that could be included in draft scopes for consultation

Issues relating to services

  • Training to assist foster carers in managing difficult behaviour

  • Rehabilitation programmes to support people back to work

Issue relating to assessment

  • Assessment methods to establish home support needs for people living with dementia

Several criteria should be considered when identifying the key issues (see box 3).

Identifying related NICE guidance (either published or in development) is a key element of scoping. This will help to see where and how the recommendations will fit into NICE pathways. It will also help identify any instances where the guidance may update, or overlap with, recommendations made in other NICE guidance.

The scoping group should ensure that it has considered equality issues when identifying the key issues and drafting the scope (see section 2.3.3). The NCCSC (in discussion with the scoping group) should also consider the composition of the GDG at this stage (see section 3.1.1).

Box 3 Factors to consider when identifying key issues and drafting the scope

Uncertainty or disagreement on best practice

Is there:

  • variation in current care provision?

  • evidence suggesting that common practice may not be best practice?

  • debate in the literature?

Potential to improve outcomes or make better use of resources

  • How many people are affected?

  • What is the potential for improved outcomes at acceptable cost?

  • What is the potential for reducing ineffective care?

  • What is the potential for achieving cost savings with no, or limited, adverse effect on outcomes?

Potential for avoiding unlawful discrimination and reducing inequalities

  • Consider possible inequalities (see section 1.2).

  • Are exclusions listed in the scope (for example, populations, interventions or settings) justified?

  • Will inequalities in prevalence, access, outcomes or quality of care for any groups (including those with protected characteristics) be addressed in the scope?

Likelihood that the guidance could contribute to change

  • Is a new review of the evidence or an economic evaluation likely to reduce existing uncertainties?

  • How does the guidance 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 GDG and in the wider stakeholder community?

Other important factors

  • Need to update other NICE guidance.

  • How the topic relates to NICE pathways.

Main outcomes

The scope includes a section listing the main outcomes of interest. This need not be an exhaustive list, but is likely to include: quality of life, capability, functioning, effectiveness, cost effectiveness, resource use and safety. It should also include some important condition- or service-specific outcomes. Quality of life is a critical outcome and should always be included in the list. It is also desirable to specify any adverse effects of different approaches and aspects of service delivery considered in the guidance.

2.3.2 The scoping search

A scoping search of the literature is important to identify previous guidance, key systematic reviews and economic evaluations relevant to the guidance topic. This search should not aim to be exhaustive.

A scoping search should include a brief search of key sources, for example, government department, charity, and other community and voluntary sector websites to identify relevant policies and documents. A broad search of the published literature should also be undertaken using a key database, for example NHS Evidence or Social Care Online.

More information on literature searching is given in sections 5.2 and 5.3.

Further searches to identify systematic reviews and economic evaluations will be necessary once the review questions have been determined (see sections 4 and 5).

In addition to the results of the scoping search, the scoping group should consult the background documentation, if applicable. This may include briefing papers and documentation related to decisions about reviewing NICE social care guidance (see section 14).

2.3.3 Equality issues at the scoping stage

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

  • whether, and to what extent, the guidance is likely to be relevant to the promotion of equality and the elimination of unlawful discrimination

  • whether, and to what extent, it would be proportionate to include particular equality issues in the scope.

Considerations will be reflected in the equality impact assessment (see section 2.6.2).

2.4 Stage 2: checking selected key issues with stakeholders

It is essential to seek the views of experts in the field and stakeholders to confirm that the key issues identified by the scoping group are relevant and appropriate. This includes user-led organisations, and organisations that represent the interests of people with the condition or who use the services and their carers.

2.4.1 The stakeholder scoping workshop

Before the consultation on the draft scope, registered stakeholders (see section 2.5.1) are invited to a scoping workshop to talk about the key issues identified by the scoping group. One person from each registered stakeholder organisation may attend.

Organisations are permitted to nominate more than one representative in some circumstances (for example, if an organisation represents the views of both practitioners and service user groups) if space permits and with the agreement of NICE. The aim of the workshop is to have representatives from various stakeholders who can represent as wide a range of views as possible.

People attend the workshop from their own perspective and do not represent the views of their stakeholder organisation, but should bring as wide a perspective of views as possible. Attendees, including representatives of relevant service user and carer organisations, should have specific knowledge of, or experience in, the topic area.

The stakeholder scoping workshop is in addition to the formal consultation on the scope. Stakeholder organisations may also wish to submit comments in writing during consultation, as described in section 2.5. Depending on the needs of stakeholder groups, virtual methods, such as webinars, may be used in place of face-to-face workshops.

The objectives of the scoping workshop are to:

  • obtain feedback on the selected key issues, including highlighting any important adoption considerations

  • identify which service user or population subgroups should be specified (if any)

  • consider existing NICE Pathways and how the planned guidance topic relates to them

  • seek views on the composition of the GDG (see section 3.1.1)

  • encourage applications for GDG membership.

At the workshop, the scoping group provides details about:

  • the scope

  • the guidance development process

  • the nature of stakeholder input into the guidance (including the involvement of service users and carers)

  • the processes for recruitment to the GDG.

This is followed by a structured discussion of the key issues.

People attending the scoping workshop are sent an initial draft of the scope. This outlines the background to the guidance, groups, services and settings that will be covered, those that will not be covered and the key issues selected. This initial draft is intended as a starting point for discussion. This document is posted on the NICE website during consultation on the scope.

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

2.5 Stage 3: consulting on the draft scope

The scoping group considers the issues raised at the scoping workshop and refines the draft scope for consultation. The draft scope may be modified by NICE after discussion with the scoping group. It is then posted on the NICE website for a 4-week period of public consultation. Comments are invited from registered stakeholder organisations.

2.5.1 Stakeholder organisations

Organisations representing social care practitioners and other professionals, local authorities, the NHS and service users and carers, as well as private and independent sector organisations, or voluntary and community organisations with an interest in a particular topic, can register as stakeholders if they meet the criteria on the NICE website. For example, organisations may include those with an interest in housing, education, welfare benefits or advocacy.

Registered stakeholder organisations comment on the draft scope (and later on the draft guidance; see section 11). The NICE website contains details about how to register as a stakeholder and how to contribute to the guidance development process.

Members of the scoping group and the NCCSC's adoption support lead for the guidance (see section 13) routinely review the list of registered stakeholders to check whether any key organisations are missing. Stakeholders attending the scoping workshop are also encouraged to identify potential stakeholders who are not registered.

2.6 Stage 4: finalising the scope after consultation

2.6.1 Dealing with stakeholder comments

The scoping group finalises the scope in light of comments received.

Stakeholders may ask for additional aspects of care to be included in the guidance, but this could make the development of the guidance unmanageable within the time permitted. Therefore, the effect on overall workload needs to be considered before the scope is expanded in response to stakeholder comments. However, suggestions that might make the guidance more useful, and so improve care or services, should not be ignored. This may entail removing other 'lower-priority' areas if they do not affect the related quality standard.

Suggestions clearly outside the original remit should not be included. If the scoping group considers that a request to expand the scope would mean the guidance could not be completed on schedule, this should be discussed with NICE.

All stakeholder comments, and the actions taken by the scoping group and NICE in response to each comment, are clearly documented in a 'scope consultation table'. This is published on the NICE website with the final scope. The process for responding to stakeholder comments should follow the principles described in section 11.2.

2.6.2 Equality impact assessment

Before the scope is signed off, an equality impact assessment form is completed to show what equality issues have been identified and considered during scoping. This is published on the NICE website.

2.6.3 Signing off the final scope

The final scope is signed off by NICE. Once the scope has been signed off, the GDG should not make changes without consulting NICE (see section 2.7).

The final scope, stakeholder comments and responses to stakeholder comments are posted on the NICE website.

2.7 Amending the final scope after publication on the NICE website

In exceptional circumstances, the final scope that has been signed off and posted on the NICE website may need amending. For example, if a scope does not cover an important area of care. The decision on whether to amend the scope is made by NICE, based on advice from the NCCSC.