NICE process and methods
12 Finalising and publishing the guideline
Once the consultation period has ended, the Guideline Development Group (GDG) meets to consider any changes to the guideline that are required in response to the stakeholder comments received during consultation. Once the changes have been agreed, modifications are made to the full guideline and the NICE guideline. The revised versions are then sent to NICE. It is essential for the National Collaborating Centre (NCC) or the NICE Internal Clinical Guidelines Programme to keep an audit trail of what changes have been made, by whom, and for what purpose.
The final draft of the guideline and the responses to stakeholder comments are reviewed by NICE. The Guidelines Commissioning Manager (GCM) and the lead editor at NICE liaise with the NCC about any further changes that are required. After changes have been agreed, the guideline is signed off by NICE's Guidance Executive (see section 12.2).
This section summarises the main stages involved in finalising the guideline.
The guideline recommendations are edited by the NICE lead editor before the guideline is submitted by the NCC for review by NICE.
The lead editor works with the NCC to edit the guideline recommendations before submission of the revised guideline to NICE. The lead editor also revises the NICE pathway and 'Information for the public' in line with changes to the guideline recommendations.
After the revised guideline has been submitted to NICE, the editor sends the NICE guideline and the latest drafts of the NICE pathway and 'Information for the public' to the NCC and GDG to be checked and for queries to be answered. The NCC and GDG editorial nominees (see section 10.3.4) are notified in advance of the timetable for this. This check should be done initially by the NCC Director or project manager, as well as the Chair, Clinical Adviser (if there is one) and editorial nominees from the GDG. The PPIP (Patient and Public Involvement Programme) lead for the guideline at NICE also comments on 'Information for the public' from a patient and carer perspective.
It is important to check all versions carefully at this stage, because only essential changes can be made to the recommendations after sign-off. When checking the documents, the NCC and GDG members should give special attention to:
queries and comments from the editors
dosages, units, normal ranges or abnormal cut-offs (for example, for electrolytes or blood constituents)
consistency of the recommendations between the guideline, the NICE pathway and 'Information for the public'
'Information for the public' is written in language that can be understood by a lay reader. The NCC and GDG editorial nominees should check that no inaccuracies or inappropriate generalisations have been introduced, and that the use, definitions and explanations of medical terms are correct.
After this stage, the NCC and lead editor work together to resolve outstanding queries on the recommendations, including any raised by the NICE team that reviews the guideline (see section 12.1.2).
The lead editor keeps an audit trail of any changes made to the recommendation wording in the NICE guideline. The NCC is responsible for ensuring that the wording of the recommendations in the full guideline matches that in the NICE guideline.
When the revised full guideline is submitted by the NCC, a team from the Centre for Clinical Practice (CCP) at NICE (including the CCP lead for the guideline, the GCM and technical advisers) reviews both the guideline and the 'guideline consultation table' that lists stakeholder comments received during consultation and the responses by the NCC. If any outstanding issues are raised by NICE, the GCM will inform the NCC, indicating whether further changes to the full guideline should be considered.
The NCC should respond to any issues raised by NICE, indicating how it will amend the guideline. If it is not willing to make changes, the NCC should provide a detailed explanation of why not. This may lead to further dialogue between the NCC and the CCP Director and GCM at NICE.
The NCC should continue to maintain an audit trail of changes made to the full guideline. Any changes to the recommendations will be transferred to the other versions of the guideline by the lead editor.
After review of the revised guideline by NICE and liaison with the NCC to address any outstanding issues, all guideline versions will be signed off:
The full guideline is signed off by NICE's Guidance Executive.
The NICE guideline is also signed off by NICE's Guidance Executive,
'Information for the public' is signed off by the PPIP lead and the CCP lead for the guideline at NICE.
The NICE pathway is signed off by the CCP lead for the guideline and the NICE pathways group.
Once the guideline has been signed off, the lead editor sends the NICE pathway and 'Information for the public' for a final accuracy check by the NCC and GDG editorial nominees (the NICE guideline is also sent, for information). This needs to be done quickly (usually within 48 hours), so the editor will give as much notice as possible of when the check is taking place.
Once the lead editor receives final comments on 'Information for the public' and the NICE pathway from the NCC, the GDG Chair and the GDG editorial nominees, the documents are finalised.
An advance copy of the final full guideline (and a copy of the responses to stakeholder comments made during the public consultation) is made available for information purposes to registered stakeholders 2 weeks before the official publication date. This information is confidential until the guideline is published. This allows stakeholders to prepare for publication, but it is not an opportunity to comment further on the guideline.
All versions of the guideline (the full guideline, the NICE guideline, the NICE pathway and 'Information for the public') are published together. Costing tools, audit support and some other implementation tools are published at the same time (see chapter 13).
Members of the NCC and GDG work with NICE to promote awareness of the guideline, both at the point of launch and afterwards.
The communications lead at NICE will talk to the NCC and GDG about what kind of launch is appropriate for each guideline – this may be a press conference or a more targeted approach to the specialist or trade press.
If there is likely to be substantial media interest in the guideline, a press conference will be held 1 or 2 days before publication, usually at NICE's offices. This allows journalists to interview those involved in the development of the guideline and other commentators, and to prepare articles or broadcast pieces in advance. Information provided to the media is confidential until the launch date for the guideline.
Ideally, a press conference panel includes a representative from NICE (preferably the Executive Lead who is responsible for signing off the guideline), the Chair of the GDG, a healthcare professional, a patient and carer representative, and a nurse, midwife or allied healthcare professional. NICE provides training for panel members.
The NICE communications lead also ensures that relevant stakeholder organisations, such as the Royal Medical Colleges and patient organisations, are involved in the launch if appropriate.
All GDG members are encouraged to provide details of case studies that can be used to illustrate some of the guideline's key recommendations, as these are a good way of creating media interest.
The aim of the press briefing is to clearly communicate key messages about the guideline to the press and media; it is not a conference for healthcare professionals. If the NCC or GDG would like to arrange separate events at which healthcare professionals can learn more about the guideline or to showcase the guideline directly to peers, the communications team at NICE can provide support.
NICE welcomes input from GDG members on how to identify groups of healthcare professionals and specialists who should be sent details of the guideline. GDG members may also be able to identify other ways of raising awareness of the guideline – for example via newsletters, websites or training programmes of organisations they are affiliated to (particularly for patient and carer organisations), or by suggesting relevant conferences at which the guideline can be promoted.
NICE implementation services are described in section 13.6.
 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.