Process and methods
19 Reviewing and updating interventional procedures guidance
When reviewing guidance in the interventional procedures programme, NICE finds out if there is any new evidence or information to suggest that the guidance recommendations would be likely to change. If so, NICE updates the guidance.
There are 4 main categories of recommendation within interventional procedures guidance:
standard arrangements for clinical governance, consent and audit
special arrangements for clinical governance, consent and audit or research
only in research
do not use.
The approach to reviewing guidance depends on the category of recommendation made in the guidance.
NICE does not proactively review standard arrangements guidance. It is therefore not updated unless a stakeholder or organisation alerts NICE to significant new evidence that casts doubt on the validity of the original recommendations, for example, because of emerging new safety concerns. The relevance of safety alerts issued by national or international regulators (for example, the Medicines and Healthcare products Regulatory Agency or the US Food and Drug Administration) or any other serious safety concerns brought to NICE's attention are considered, and may trigger an update of guidance.
Guidance on procedures with 'special' or 'research only' arrangements is proactively reviewed after 3 years, and the guidance is updated if important new evidence is available. This may be done sooner if there is significant new evidence or emerging new safety concerns. If the programme is made aware of a trial that is due to be published, this may also influence the timing of guidance production.
Guidance with a 'do not use' recommendation is not proactively reviewed, and so would not be updated unless there is a significant change in the evidence base.
Sometimes, guidance will contain recommendations on more than 1 group of patients, and these recommendations can differ. If there is more than 1 patient group in a piece of guidance, NICE may partially update the guidance if the evidence base changes for 1 group of patients but not the other. In these circumstances, the guidance for the group of patients in whom there has been no change in the evidence base remains current. Sometimes, where the recommendation for 1 group of patients is for standard arrangements, NICE might replace the guidance completely but only update the recommendations for any group of patients with other than standard recommendations.
In proactive reviews of guidance, the guidance information services team carries out a literature search to identify new evidence published since the literature searches were done for the original guidance. The search strategies developed for the original guidance are updated (if necessary) and rerun. Specialist advisers' opinions are obtained on the validity and relevance of any new evidence identified in this way, and they are asked if any new issues have emerged around use of the procedure. A new brief is produced for the procedure.
If it is deemed that there is sufficient new published evidence and that the opinions of specialist advisers support the reassessment of the procedure, a proposal to update the guidance is submitted to the NICE Guidance Executive for approval.
Once the NICE Guidance Executive has approved the proposal to update the guidance, the update is scheduled into the programme's work processes, and follows the standard timelines and process for guidance development.
Guidance on a procedure that is reassessed is withdrawn when the new guidance is published. While the update of the guidance is in progress, the existing guidance continues to apply. If extreme safety concerns such as reports of serious adverse events are raised, NICE will consider suspending current guidance pending publication of the updated guidance.