Developing NICE guidelines: the manual

Aims of monitoring

The aim of monitoring is to check that guideline recommendations in prioritised topic areas are up to date. This is done by exploring if there is any new evidence or intelligence to contradict, reinforce (for example, increase the strength of recommendation) or clarify recommendations. Monitoring may also identify new interventions, innovations or topic areas that may need to be considered in a guideline or a suite of guideline recommendations. Finally, it explores changes in context that may mean modifications are needed, for example, changes in policy, infrastructure, legislation or costs.

Proactive monitoring

NICE has more than 350 published guidelines, so the volume of monitoring is considerable. Some topic areas change frequently, which impacts on how up to date the guideline recommendations are. Topic areas are prioritised for monitoring and NICE takes a proactive approach to identify key events that may impact guideline recommendations at any time after publication (for example, a safety alert, publication of a key study, or publication of new related guidance by NICE or other organisations).

NICE identifies events that can affect prioritised guideline recommendations through constant intelligence gathering as recommendations are developed and after they are published. For example, events are identified through:

This approach means that NICE can quickly identify changes in the evidence base and current context, and assess the impact on guideline recommendations and the need for any changes.

Events that could affect guideline recommendations include:

This list is not exhaustive and individual events will be considered on a case-by-case basis. To make the most efficient use of resources, events are:

Equality and health inequalities issues should be fully considered during proactive monitoring. A new Equality and Health Inequalities Assessment (EHIA) should be prepared, or the existing EHIA should be updated, as appropriate.

Information from topic experts

We usually invite topic experts (including members of NICE's Expert Advisers Panel) to provide their expert views about how an event affects the recommendations, and their knowledge of recent developments in the topic area. For some topic areas, we may seek further specialist input from other experts, if needed. This could include other government organisations, or representatives from a Quality Standards Advisory Committee.

System monitoring from intelligence gathering

If needed, we may seek additional intelligence. This might include:

Evidence monitoring from literature searching

If needed, to support a decision on whether to update any recommendations, published evidence or related guidance is identified by searching a range of bibliographic databases relevant to the topic, generally by using the same databases that were used during the development of the original guideline recommendations. The sources searched may vary depending on the topic. In general, MEDLINE, MEDLINE in Process, Embase, Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials (CENTRAL) could be considered.

Stakeholder consultation, quality assurance and sign-off

Consultations on proposed decisions will only be held if there is value in doing so, for example, if there is uncertainty about the proposed actions. The consultation period would usually be 2 weeks.

Quality assurance on the assessment process of an event and rationales for proposed actions will be done to ensure the final decision is robust and fit for approval by NICE's Centre for Guidelines director or Guidance Executive.

If it is decided that the guideline recommendations need updating, registered stakeholders are informed of the planned approach and the decision is published on the NICE website.

Updates involving a change of scope

Follow the scoping process in the chapter on the scope for updates that involve multiple topic areas within a guideline or across a suite of guidelines (for example, those with complex health and care pathways, complex analysis or new health economic modelling) and for which existing scopes need to be substantially changed. Depending on the complexity and information required for the update, not all steps in the scoping process are needed. Rationales for any deviation from the scoping process should be clearly documented and signed off by NICE staff with responsibility for quality assurance.

Updates with separate small update scopes

For small updates (usually up to 3 review questions) or distinct updates (topic areas already identified as key priority areas), a separate small update scope will usually be produced as an addendum to the original scope. The small update scope will be incorporated into the original scope after publication of the update. The small update scope includes:

How the process for defining topic areas differs for small updates

This section details how the process for defining topic areas for updates with unchanged or small update scopes differs from the scope development process for new guidelines or full updates (see the chapter on the scope).

Updates of recommendations or topic areas in guidelines

NICE will prioritise the update of recommendations or topic areas to implement dynamic living guidelines in line with NICE's 5-year strategy. Updating recommendations or topic areas may involve existing topic-specific committees or a newly recruited topic-specific committee.

The scope, small update scope or the NICE website needs to be clear about exactly which guideline recommendations are being updated and which are not, and whether any recommendations will be withdrawn (for example, if they are now covered in another guideline). Recommendations that are outside the scope of an update may be refreshed (see the section on refreshing the guideline).

Updates use the same methods and process as for a new guideline. Updates of topic areas using the scope of the published guideline use the review questions and review protocols already defined by the existing guideline. However, if the review questions and/or protocols are unavailable, need refinement, or if there is ambiguity in the published guideline, the developer may seek advice from the committee members with topic expertise before starting the evidence review.

Updates of guideline recommendations or topic areas are subject to the same level of scrutiny as full updates and new guidelines. The underlying principles of transparency of process and methodological rigour continue to hold. The draft is subject to a 4‑ or 6‑week consultation, depending on length and complexity (see the chapter on the validation process for draft guidelines, and dealing with stakeholder comments). The developer should maintain records appropriate for audit (see the section on committee meetings in the chapter on decision-making committees). The usual process for finalising and publishing the guideline is followed (see the chapter on finalising and publishing the guideline).

Full updates of guidelines

Occasionally, a full update of a guideline is needed. Either:

Sometimes an existing topic-specific committee is asked to update a guideline in their topic area. Sometimes a new topic-specific committee is set up for the update. Recruitment of committee members follows the usual process (see the chapter on decision-making committees). The composition of the committee should be tailored to new requirements if a new scope has been developed. The guideline is developed using the same methods and process as for a new guideline and the draft is subject to the normal consultation (see the chapter on the validation process for draft guidelines, and dealing with stakeholder comments). The developer should maintain records appropriate for audit (see the section on committee meetings in the chapter on decision-making committees). The usual process for finalising and publishing the guideline is followed (see the chapter on finalising and publishing the guideline).

Updates involving collaboration with other organisations

For updates involving collaboration with guideline developers from other organisations, all the above methods and processes should be discussed and agreed with the guideline developer. A collaboration plan should then be produced and signed off by the NICE Centre for Guidelines director and the responsible officer from the organisation developing the guideline.

Refreshing guideline recommendations

Refreshing guideline recommendations allows us to improve the usability of recommendations without changing the intent and therefore without the need for an evidence review or committee input.

Refreshing changes can be made to guideline recommendations even when the proactive monitoring decision is not to update the guideline. All changes to recommendations made as part of the proactive monitoring should be clearly documented in an audit trail (see the section on ensuring that published guidelines are current and accurate).

When it has been agreed which recommendations or topic areas need updating, NICE will identify recommendations that may need to be refreshed as part of the update. Occasionally during development of the update, additional recommendations that are not part of the update may be identified.

Refreshing might involve:

Refreshing changes that are made during proactive monitoring, scoping and guideline development should be agreed with NICE staff with responsibility for quality assurance.

Post-publication minor updates or changes

On rare occasions, errors or lack of clarity are found after publication of the guideline recommendations, or users may ask for clarification.

Post-publication minor updates or changes to published guideline recommendations are made if an error or lack of clarity:

Post-publication minor updates or changes are usually triggered by enquiries from the public, notifications from stakeholders, safety reports from MHRA or HSIB, and exceptional surveillance reviews. Examples of when post-publication minor updates or changes will be made include:

Post-publication minor updates or changes should only be carried out if it does not involve a change of the evidence review underpinning it. Depending on the nature of the changes, targeted topic expert engagement could be done for validation.

If an error or clarification meets the criteria for changing a published guideline recommendation, NICE's process for dealing with post-publication minor updates or changes is followed. An explanation of the decisions and actions taken is sent to the person or organisation that reported the error or requested clarification.

The guideline recommendations and resources to support implementation are amended if necessary and the changes are explained. Depending on the nature and significance of the change and the time since publication of the original guideline recommendations, registered stakeholders may also be notified.

Routine maintenance

Routine maintenance changes may also be made after publication or update of guideline recommendations. These include minor changes such as updating or fixing broken links or updating standard text in line with agreed template changes.