Process and methods

2 The scope

Topics for new clinical guidelines are referred to NICE by the Department of Health or the NHS Commissioning Board, and will usually be related to a topic in the library of quality standards for the NHS. The referral gives a remit that identifies the broad areas to be covered by the guideline, which is then translated into the scope for the guideline. Preparing the scope is the first step in developing a clinical guideline, and determines the shape of the review work. It is conducted in four stages:

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

  • Stage 2: checking the selected key clinical 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 chapter describes what the scope is, the role of the scoping group and the process used to develop the scope at each stage.

2.1 Purpose of the scope

The purpose of the scope is to:

  • provide an overview of what the clinical guideline will include, and what will not be covered

  • identify the key clinical issues that must be included

  • set the boundaries of the development work and provide a clear framework to enable the work to stay within the priorities agreed by NICE and the National Collaborating Centre (NCC) or the NICE Internal Clinical Guidelines Programme[4] and the remit from the Department of Health or the NHS Commissioning Board

  • ensure that equality issues are identified and considered

  • inform the development of the detailed review questions (see chapter 4) and the search strategy (see chapter 5) from the key clinical issues

  • provide information to healthcare and other professionals, stakeholders and the public about the expected content of the guideline

  • ensure that the guideline will be of a reasonable size so that it can be developed within the specified time period.

The scope provides a framework within which to conduct the guideline development work. The title of the guideline (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 epidemiology relevant to the disease or condition, and defines the aspects of care that the guideline will cover in terms of the following:

  • Populations to be included or excluded – for example, age groups or people with certain types of disease or condition. Equality groups that may merit specific consideration (for example, specific ethnic groups or people with learning disabilities) are identified.

  • Healthcare setting – for example, primary, secondary or tertiary care.

  • The different types of interventions and treatments to be included and excluded – for example, diagnostic tests, surgical treatments, medical and psychological therapies, rehabilitation and lifestyle advice. It is important that the scope is as specific as possible about the interventions the guideline is intended to cover.

  • Topic-specific information and support for patients and carers.

  • The main outcomes that will be considered.

  • Defining links with other relevant NICE guidance, including guidance to be updated, guidance to be incorporated and other related guidance (see chapters 8 and 14).

2.2 The scoping group

The scope is prepared by a scoping group, led by the NCC with input from the Guideline Development Group (GDG) Chair (and the GDG Clinical Adviser or topic specialist if there is one; see section 3.1.3) and NICE (including the Patient and Public Involvement Programme [PPIP] lead for the guideline). Box 2.1 shows the membership of the scoping group. The role of the group is to:

  • identify the key clinical issues for inclusion and draft the scope

  • revise the draft scope after the stakeholder scoping workshop

  • prepare the draft scope for consultation

  • respond to stakeholder comments

  • finalise the scope after consultation.

Box 2.1 Members of the scoping group

NCC

  • Director or senior staff member (Chair of scoping group)

  • Project manager

  • Information specialist

  • Systematic reviewer

  • Health economist

GDG

  • Chair

  • Clinical Adviser or topic specialist (if there is one)

NICE

  • Guidelines Commissioning Manager (Centre for Clinical Practice [CCP]), plus staff providing technical support as necessary

  • PPIP lead for the guideline

The scoping group meets (either face to face or by teleconference) before the stakeholder scoping workshop (see below), and again after the workshop to refine the draft scope for consultation. It also discusses and responds to comments received during consultation and finalises the scope for sign off by NICE.

2.3 Stage 1: selecting key clinical issues and drafting the scope

This stage includes considering the remit from the Department of Health or the NHS Commissioning Board, identifying the key clinical issues for inclusion in the scope, searching the literature, considering any equalities issues and consulting with experts.

2.3.1 Considering the remit

The remit received by NICE forms the basis of the scope, and all issues specified by the remit are addressed in the scope. The remit may also be intended to support the subsequent development of a NICE quality standard. Sometimes NICE may request clarification on the remit and the topic. This may involve redefining the remit in order to specify the boundaries and the extent of the work.

2.3.2 Identifying the key clinical issues from the care pathway

This is a critical part of the process, because it determines the breadth and depth of the work. It involves identifying the most important aspects of care that the clinical guideline will cover. This ensures that the guideline focuses on areas in which the NHS most needs advice. Key clinical issues relate to the effectiveness and cost effectiveness of interventions or tests that are being considered for a given population.

To ensure that areas from the whole patient pathway for the condition are considered for inclusion in the scope, so that the guideline can inform the subsequent development of a NICE quality standard, a care pathway or similar analytical framework should be used. Draft review questions, which specify in some detail the particular interventions to be compared and the health outcomes of interest (see chapter 4), may be included in the scope. Key clinical issues should be as specific as possible, indicating the relevant population and the alternative strategies that are being considered. Examples of key clinical issues are shown in box 2.2.

Box 2.2 Examples of key clinical issues included in draft scopes for consultation

Issues relating to interventions

  • Antispasmodics for the management of IBS (irritable bowel syndrome)

  • Antibiotics for preventing wound infection in women who have had an elective caesarean section

  • Decision aids in prostate cancer

Issue relating to diagnosis

  • CT for identifying patients with lung cancer who are suitable for curative surgery

Several criteria should be considered when identifying the key clinical issues (see box 2.3). The scoping group should ensure that it has taken equality issues into consideration when identifying the key clinical issues and drafting the scope (see section 2.3.5). The NCC (in discussion with the scoping group) should also consider the composition of the GDG at this stage (see chapter 3).

Box 2.3 Factors to consider when identifying key clinical issues and drafting the scope

Uncertainty or disagreement on best practice

Is there:

  • variation in current practice?

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

  • debate in the literature?

Potential to improve important health outcomes and/or make better use of health resources

  • How many people are affected?

  • What is the potential for health gain at acceptable cost?

  • What is the potential for reducing ineffective practice?

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

Potential for avoiding unlawful discrimination and reducing health inequalities

  • Consider possible inequalities relating to sex and gender, gender reassignment, pregnancy and maternity, race and ethnicity, disability, age, sexual orientation, marriage and civil partnership, religion or belief, and socioeconomic status.

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

  • Are there inequalities in prevalence, risk factors, severity or likely benefit that need to be addressed in the scope?

Likelihood that the guideline could contribute to change

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

  • What is the potential for achieving consensus within the GDG and in the wider stakeholder community?

Other important factors

  • Relationship with national policy and priorities.

  • Need to update other NICE guidance.

  • The existence of 'significant new medicines' (see section 8.1.1)

  • Consideration of the licensing status of drugs (see section 9.3.6).

2.3.2.1 Main outcomes

The scope includes a section listing the main outcomes of interest for the guideline. An exhaustive list is not required, although it should be possible to include some important disease/condition-specific outcomes. Health-related 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 interventions that will be considered in the guideline. Overall survival will be an important outcome for many guidelines.

2.3.2.2 Complementary therapies

The effects of complementary and alternative therapies may be addressed in the guideline if such therapies are commonly used in the clinical area of interest. If commonly used complementary and alternative therapies are not to be covered in the guideline, this should be stated clearly in the scope.

2.3.3 The scoping search

A scoping search of the literature is important in order to identify previous clinical guidelines, health technology assessment reports, key systematic reviews and economic evaluations relevant to the guideline topic. This search should not aim to be exhaustive. It should be based on the need to reasonably inform the content of the scope as set out above. For guidelines that are updates of existing guidelines, the searches undertaken as part of the process for reaching a guideline review decision (see section 14.1) can be used to inform the searches required at the scoping stage.

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

Suggested sources for this scoping search are listed in box 2.4 (links are provided for sources that are freely available). Other sources may be used depending on the guideline topic. More information on literature searching is given in chapter 5.

Box 2.4 Suggested sources for the scoping search (listed in alphabetical order)

  • Clinical Evidence (BMJ Publishing Group)

  • Cochrane Database of Systematic Reviews – CDSR (Cochrane Reviews)a

  • COMET initiative website (agreed sets of important outcomes)

  • DUETS (UK Database of Uncertainties about the Effects of Treatments)

  • Health Technology Assessment (HTA) Database (Technology Assessments)b

  • MEDLINE/MEDLINE In-Process

  • National Guideline Clearinghouse (United States)

  • NHS Economic Evaluation Database (NHS EED) (Economic Evaluations)b and the Health Economic Evaluations Database (HEED), if subscribed to

  • NHS Evidence

  • Turning Research into Practice (TRIP database)

  • Websites of NICE and the National Institute for Health Research (NIHR) HTA Programme for guidance and HTAs in development

  • Websites of relevant professional bodies and associations that may have produced guidelines or reports (for example, British Thoracic Society for conditions relating to the lung)

For service delivery guidance:

  • Health Management Information Consortium [HMIC] database

For information about patient or service user experience (including children and young people):

Websites of relevant patient organisations that may report research on patients' views or experiences (NICE's PPIP can advise further).

a Accessible via the Cochrane Library. Database name in parentheses is that used in the Cochrane Library.

b Accessible as part of the Cochrane Library and via the Centre for Reviews and Dissemination (CRD). The CRD website hosts the most up-to-date versions of the databases. Database names in parentheses are used in the Cochrane Library.

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 NICE clinical guideline review decisions (see section 14.1).

2.3.4 Preparing the draft scope

NICE has developed a template for preparing the draft scope that sets out the format and describes what should be included, along with notes on using the template. NCCs should use the up-to-date version of this template for preparing the scope. The template is available from NICE's webboard for NCCs and from the CCP at NICE.

References are not included in the scope, but the information specialist at the NCC should keep a detailed record of references used as a basis for the scope; these should be available on request.

2.3.5 Equality issues at the scoping stage

During development of the scope, due regard must be paid to considering and assessing any equality issues to establish:

  • whether and to what extent the guideline 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).

Further guidance on how to consider and assess equality issues at the scoping stage is given in the document Positively equal: a guide to addressing equality issues in developing NICE clinical guidelines.

2.4 Stage 2: checking the selected key clinical issues with stakeholders

It is essential to seek the views of experts in the field, stakeholders and organisations that represent the interests of people with the condition and their carers, to confirm that the key clinical issues identified by the scoping group are relevant and appropriate.

2.4.1 The stakeholder scoping workshop

Before the consultation on the draft scope, registered stakeholders are invited to a scoping workshop to discuss the key clinical issues identified by the scoping group. One person from each registered stakeholder organisation may attend. Organisations will be permitted to nominate more than one representative under some circumstances (for example, if an organisation represents the views of both professionals and patient groups) if space permits and with the prior agreement of NICE. 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 patient 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 should still submit comments in writing during consultation, as described in section 2.5.

The objectives of the scoping workshop are to:

  • obtain feedback on the selected key clinical issues

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

  • 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 timetable for guideline development, the guideline development process, the nature of stakeholder input into the guideline, and the processes for recruitment to the GDG and submission of evidence. This is followed by a structured discussion around the key clinical issues. The workshop is chaired by the CCP lead for the guideline (see table 1.1).

People attending the scoping workshop are sent an initial draft of the scope. This outlines the background to the guideline, groups and settings that will be covered, those that will not be covered, and the key clinical issues selected. This initial draft is intended as a starting point for discussion. The discussions and key themes that emerge from the scoping workshop are summarised by the NCC, with input from the GDG Chair, the Clinical Adviser (if there is one) and the Director or senior staff member of the NCC who is the Chair of the scoping group. This document is posted on the NICE website during consultation on the scope.

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 is edited by a NICE editor before consultation and 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. Comments will also be solicited from the Medicines and Healthcare products Regulatory Agency (MHRA) when the off-label use of drugs is included in the draft scope.

2.5.1 Stakeholder organisations

Organisations representing healthcare and other professionals, the NHS and patients and carers, as well as companies with an interest in a particular topic, can register as stakeholders for a particular clinical guideline. Registered stakeholder organisations comment on the draft scope (and, later, on the draft guideline – see chapter 11). Appendix N and the NICE website contain details about how to register as a stakeholder and how to contribute to the guideline development process.

Members of the scoping group and NICE's implementation adviser for the guideline (see chapter 13) routinely review the list of registered stakeholders to check whether any important organisations are missing. Stakeholders attending the stakeholder 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 the light of comments received. Stakeholders may ask for additional aspects of care to be included in the guideline, but this could make the development of the guideline unmanageable within the time permitted. Therefore the impact on overall workload needs to be considered before the scope is expanded in response to stakeholder comments. However, relevant suggestions that might make the guideline more useful, and so improve patient care, should not be ignored. This may entail removing other areas considered to be of lower priority. Suggestions clearly outside the original remit should not be included. If the scoping group considers that a request to expand the scope would mean that the guideline 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 11.1.

2.6.2 Equality impact assessment

Before the scope is signed off, an equality impact assessment (EIA) form is completed by the NCC and GDG Chair to demonstrate how equality issues have been identified and considered during scoping. The EIA form is reviewed and signed by the Chair of the scoping group (that is, the NCC Director or senior staff member) and the GDG Chair, and countersigned by the CCP lead for the guideline, before being posted on the NICE website. Further guidance on how to complete the EIA form is outlined in the document Positively equal: a guide to addressing equality issues in developing NICE clinical guidelines.

2.6.3 Signing off the final scope

Subject to any amendments agreed by NICE, the revised scope and the responses to stakeholder comments are signed off by the CCP lead for the guideline.

Once the scope has been signed off, the GDG should not make changes without consulting NICE, and this should be done only in exceptional circumstances.

The final scope 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, this might occur 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 NCC.



[4] Information throughout this manual relating to the role of the National Collaborating Centres in guideline development also applies to the Internal Clinical Guidelines Programme at NICE.