Process and methods

4 Scope

Topics for new good practice guidance (GPG) are identified using the topic consultation, selection and prioritisation process (see section 2). The topic selection documentation identifies the broad areas to be covered by the GPG, which is then translated into the scope for the GPG. The scope is agreed during the preliminary work stage of the development process and cannot be changed once the project plan has been signed off.

4.1 Purpose of the scope

The purpose of the scope is to:

  • provide an overview of what the GPG will include and will not include

  • identify the key issues and most important aspects of care that should be included

  • define the breadth and depth of the GPG

  • set the boundaries of the development work and provide a clear framework to enable the work to stay within the agreed priorities

  • inform the development of the detailed literature search (see section 8) from the key issues

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

  • ensure that the GPG can be developed within the specified time period.

The scope provides a framework within which to conduct the guidance development work.

4.2 Content of the scope

The title of the GPG is considered carefully by the NICE project team to ensure it adequately reflects the content of the scope. The scope briefly defines:

  • the high-level systems and processes that the GPG will and will not cover

  • an indication of how much detail will be provided for each system or process – for example, the breadth and depth of the GPG

  • the healthcare setting – for example, NHS-commissioned services, care homes or independent hospitals

  • the audience for the GPG – for example, health and social care professionals.

The scope may also include, for clarification when necessary:

  • populations to be included or excluded – for example, specific age groups

  • geographical relevancy.

4.3 Scope development

The scope is prepared by the NICE project team using the following stages of development:

  • Stage 1: Identification of key areas for inclusion

  • Stage 2: Preparation of first draft

  • Stage 3: Expert and/or stakeholder review

  • Stage 4: Finalisation of scope

  • Stage 5: Sign off and publication.

4.4 Stage 1: Identification of key areas for inclusion

This stage involves considering any relevant remit from the NICE senior management team (including GPG topic selection), the Department of Health and/or NHS England to identify key areas for inclusion. This remit 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. Identification of these key areas informs the preliminary literature search and helps to identify the systems and processes to be covered by the GPG.

4.4.1 Preliminary literature search

A high-level preliminary literature search is undertaken to inform both the draft scope and the scoping workshop. The search is developed using a broad PICO (population, intervention, comparator and outcomes) framework and is based on the key areas for inclusion. Each search is divided into 4 components:

  • population

  • intervention

  • comparators

  • outcome.

Box 4.1 Features of a well-formulated, high-level search using the PICO framework

Population: Which populations of patients are we interested in? How can they be best described? Are there subgroups that need to be considered?

Intervention: Which intervention, system or processes are, or should be, used?

Comparators: What are the main alternatives to compare with the interventions, systems or processes being considered?

Outcome: What is really important for the patients? Which outcomes should be considered?

The overarching themes are identified from the preliminary search and are used to identify the overarching themes, systems and processes which, along with the scoping process, identify the review questions for the GPG and refine the PICO framework for the main literature search.

4.5 Stages 2 and 3: Draft scope preparation and review

The draft scope is prepared by the NICE project team after review of the literature search results. It is then reviewed and revised. This involves:

  • a scoping workshop

  • liaison with experts.

4.5.1 Scoping workshop

A scoping workshop is held. An email alert is sent inviting people with specific knowledge and experience relevant to the topic to submit an expression of interest in attending the event. Delegates are chosen by the NICE project team to ensure the group provides the correct mix of backgrounds and experience to inform the scope. The scoping workshop is also used to identify key stakeholders and help inform the composition of the Guidance Development Group (GDG).

4.5.2 Liaison with relevant experts

The proposed scope is written by the NICE project team, which is reviewed, clarified and validated by relevant experts and delegates from the scoping workshop.

4.6 Stages 4 and 5: Finalising, sign off and publication

After review, the draft scope is finalised by the NICE project team and signed off by the Centre for Clinical Practice Director and Programme Director. It is published on the NICE website within the 'Terms of Reference' of the GDG.