Process and methods
3 The guidance development processes
The key stages in the development of public health guidance are:
Publication and dissemination.
The process usually takes between 14 and 18 months from publishing the final scope on the NICE website to approval of the final guidance by the NICE Guidance Executive (see chapter 10). The time taken at each stage may vary slightly, for example to take account of public holidays.
Whether to develop the guidance using a standard (18 months) or short (14 months) process is decided following formal referral of a public health guidance topic to NICE by the Department of Health. The Centre for Public Health Excellence (CPHE) senior team considers the subject of the referral, including:
whether it covers single or multiple interventions
whether the intervention is delivered at one level or in one setting, or across multiple levels and settings
sensitivities or complexities unique to the topic.
The topic is then allocated to one of the Public Health Advisory Committees (PHACs). The choice of PHAC depends on timing and resources. It may also depend on expertise on the topic among standing members of the PHAC, although in most cases topic expert members will be recruited to the PHAC for the duration of each topic, or co-opted for specific meetings.
All the issues specified in the referral from the Department of Health are addressed in the scope. Occasionally, it may be necessary to seek clarification from the Department of Health on the remit for guidance, although this will usually be addressed during the topic selection process.
The scope sets out the need for the guidance and defines what will and will not be covered, so that the guidance stays within the area indicated through the topic development and selection process, and the referral from the Department of Health. The scope describes:
the policy context and the need for the guidance
the populations and groups to be included (for example, socially disadvantaged young people) or excluded (for example, certain age groups or people with certain clinical conditions)
the settings to be included and excluded (for example, primary healthcare, education or community)
the types of interventions to be included and excluded (for example, education, preventive care, environmental design, mass media, community support, lifestyle advice and information); the scope is as specific as possible about the type of interventions the guidance is intended to cover
the main outcomes that will be considered
links with other relevant NICE guidance (see chapter 9).
The draft scope is edited and then published on the NICE website for a 4-week period of consultation. Comments are invited from registered stakeholder organisations (see chapter 4).
Once consultation has closed, the CPHE team consider and respond to all comments from stakeholders, and revise the scope in the light of comments received. This final scope is published on the NICE website, with a table of all the stakeholder comments and NICE's responses to them, which documents the actions taken.
The scoping stage normally takes around 7 months for both standard and short guidance, although it may take longer for some complex areas of guidance.
Once the final scope has been agreed, a contractor is appointed to form the review team that works with the CPHE project team (see chapter 7) to develop a protocol for carrying out the evidence reviews. The protocol sets out detailed research questions, based on the scope. It also specifies how and where evidence will be searched for and identified, and the planned methods for appraisal and synthesis. The protocol is refined and agreed by the CPHE project team with the support of the NICE information services team, which is responsible for checking the quality and accuracy of the search strategy (see Methods for the development of NICE public health guidance – third edition , chapters 3, 4 and 5).
If resources and expertise are available, the CPHE senior team may occasionally decide to develop search strategies or evidence reviews in house. When in-house evidence searches or reviews are undertaken, the CPHE senior team and the NICE information services team will allocate an independent quality assurance lead within the wider team, who will check that all searches and reviews are developed according to NICE processes and standards.
Studies identified by the searches are reviewed for relevant and appropriate evidence, which is then interpreted and synthesised in order to address the review questions. If sufficient evidence of cost effectiveness is not available from published studies, further economic analysis and modelling is carried out (see Methods for the development of NICE public health guidance – third edition , chapter 6).
In addition to evidence identified through formal searches, the CPHE project team may invite registered stakeholders to submit evidence at any point during development, although this usually occurs early in the development process. When a call for evidence is made, registered stakeholders are invited to submit additional published or unpublished evidence that is relevant to the scope questions.
If evidence is weak or absent, key programmes or interventions are in progress and not fully evaluated, or evidence about specific practice issues is needed, the PHAC may invite one or more expert witnesses to give testimony. Expert testimony – spoken evidence, based on a summary paper – from professional or community experts may be considered by the PHAC during the development of the guidance.
The Chairs and members of the PHAC then consider the evidence and other relevant issues such as equality, implementation and commissioning issues. Based on their deliberations, the CPHE project team formulates draft recommendations for providers, practitioners and commissioners of public health interventions and programmes, as well as recommendations for further research, to be discussed at the next PHAC meeting.
The development stage normally takes around 13 months for standard guidance and 9 months for short guidance.
The draft guidance (containing the recommendations and research recommendations, and details of how they were developed) is issued for a 6-week consultation with stakeholders. Stakeholders can comment on the evidence reviews that the draft guidance is based on.
At the same time as the consultation, the draft recommendations may be tested in fieldwork with professionals, practitioners, commissioners or end users of the guidance to gather more information on their views on the draft recommendations, including the feasibility of putting the recommendations into practice. Fieldwork is carried out only if there are complexities or issues with the guidance topic or recommendations that require in-depth consideration with stakeholders.
Once the consultation and any fieldwork are complete, the CPHE team and PHAC consider all responses, and agree changes to the guidance. The draft guidance is then revised accordingly (see chapters 4 and 8 and Methods for the development of NICE public health guidance – third edition ). A full table of consultation comments, including responses and actions taken by the CPHE project team (see chapter 7), is published alongside the final guidance.
The guidance is submitted to NICE's Guidance Executive – a committee made up of NICE's executive directors, guidance centre directors, and the communications director – for approval before publication (see chapter 10).
The validation stage normally takes around 5 months for both standard and short guidance.
The guidance will normally be published on the NICE website within 6 weeks of approval by the Guidance Executive, on the fourth Wednesday of the month.
The guidance includes sections on:
recommendations for practice and for research
relevant policy and practice
considerations that informed the recommendations and interpretation of evidence
appendices, including details of reviews, methodology, economic analysis, other sources of evidence and fieldwork, PHAC members and CPHE project team (see chapter 7) members
related NICE guidance
The following guidance products are also produced:
NICE Pathway, an online tool that provides a graphic representation of the guidance recommendations, and links to key information about development and implementation, and to related NICE products
supporting documents, including evidence reviews, other sources of evidence (for example, expert testimony), economic analysis and fieldwork reports (see chapter 8)
stakeholder consultation comments and responses, for scope and guidance consultations.