In order to validate the draft guidelines there must be a stakeholder consultation process to ensure quality assurance and a robust peer review.
The draft version of the guideline (recommendations, rationales, committee discussions, evidence reviews and methods) is posted on the NICE website for consultation with registered stakeholders, alongside questions for the stakeholders. The purpose of these questions is to seek stakeholder views on factors such as the potential equality impact.
During the next stages of the process, NICE takes a larger role in coordination. Consultation is covered in more detail on page 10 of Developing NICE guidelines: the manual.
After the consultation period, the committee must discuss the stakeholders comments, propose and integrate any changes to the guideline and agree the final wording of the guideline.
The ways in which developers should respond to consultation comments is covered in this section and the same principles apply when responding to comments on the draft scope. Developers must take the following key points into account when responding to comments from registered stakeholders:
- Each comment must be acknowledged and answered as directly, fully and with as much information as possible.
- For a draft guideline, the committee must consider whether changes to the guideline are needed as a result of consultation comments; any changes to the guideline must be agreed by the committee before publication.
- If changes are made to a guideline as a result of a consultation comment, this must be made clear in the response to the comment. If no changes have been made, it should be clear from the response why not.
- Developers should maintain an audit trail of any changes made to the guideline.
Registered stakeholders who have commented on the draft guideline are sent the final guideline, and comments and responses, in confidence 2 weeks before publication. Comments and responses are made available on the NICE website when the final guideline is published.
More information is available in section 10.2 of Developing NICE guidelines: the manual
After changes agreed by the committee have been made to the guideline, it is reviewed by NICE staff with responsibility for guideline quality assurance. They check that any changes made are appropriate and that developers have responded suitably to the registered stakeholders comments. Further changes may then be needed and the developer must continue to keep an audit trail of these changes.
Guidelines are approved for publication by NICE’s Guidance Executive, made up of NICE executive directors, centre directors and the communications director. The Guideline executive does not usually comment at any stage other than during publication review.
When considering a guideline for publication, the Guidance Executive reviews a report from NICE staff with responsibility for guideline quality assurance. The report details whether the guideline:
- Addresses all the issues identified in the scope
- Is consistent with the evidence quoted
- Was developed using the agreed process and methods
- Was developed with due regard to the need to eliminate discrimination, advance equality and foster good relations
- Will lead to a resource impact when implemented.
- If any major issue is identified by the Guidance Executive it may be necessary for the committee to meet again to address the problem.
Registered stakeholders who have commented on the draft guideline are sent the final guideline, the evidence reviews and a copy of the responses to stakeholder consultation comments 2 weeks before publication. This information is confidential until the guideline is published. This step allows registered stakeholders to highlight to NICE any substantive errors, and to prepare for publication and implementation.
The guideline, including evidence reviews, methods, NICE Pathway, key messages for the public and most support tools are published on the NICE website at the same time.
For information on how to promote the guidelines after publication visit: The NICE website
For some suggested materials to aid implementation you can refer to the AGREE II document, here