NICE process and methods

2 Background

2 Background

These interim process and methods aim to address concerns about the previous process (for example, the resource intensity of focused literature searching) while retaining best practice (for example, involving technical and methodological analysts and subject content experts from guideline development groups [GDGs]). In this interim surveillance process, there is a change in the frequency and type of surveillance evidence reviews from full reviews every 3 years to alternate rapid and full reviews every 2 years.

Clinical guidelines developed by NICE are published with the expectation that they will be regularly reviewed and updated as necessary. Any decision to update a guideline must balance the need to reflect changes in the evidence against the need for stability, because frequent changes to guideline recommendations would make implementation difficult. There are inherent risks that a new and less exhaustive surveillance methodology (for the 2-year, 6-year and 10-year reviews; see section 4) might have a lower sensitivity to determine which guidelines need updating, although these risks will be balanced against a new surveillance process that will allow decisions to be revisited more frequently.

The purpose of the guideline surveillance process is to maintain a clinically relevant library of guideline topics, because advances in medicines and technologies may lead to guideline recommendations becoming obsolete. There is little published evidence about guideline surveillance or review methodology, but a recent analysis found that 14% of NICE clinical guidelines need a substantial update 3 years after their publication; by 5 years this increases to approximately 50%. However, it has also been found that, although a guideline may not need a substantial update, there are often small discrete areas that could be updated, but previously NICE has not had the capacity or processes to deal with these. This is being addressed through a separate pilot programme for conducting rapid updates.

The process and methods described here do not affect reviews of published guidelines that arise as a result of exceptional circumstances (safety concerns, withdrawal of drugs or interventions, significant changes to legislation, etc.), as described in section 14.4 of the NICE guidelines manual 2012. These will continue to be assessed on a case-by-case basis without the need for a formal guideline surveillance review.