Process and methods

16 Updating or correcting published good practice guidance

Good practice guidance (GPG) is published with the expectation that it will be reviewed and updated as necessary. Any decision to update GPG must balance the need to reflect changes in the evidence against the need for stability, because frequent changes to GPG recommendations would make implementation difficult. This section describes the process and methods for reviewing the need to update NICE GPG and for producing updated GPG.

It is the responsibility of the NICE project team who originally developed the GPG to update it.

When scheduling updates of GPG into its work programme, NICE prioritises topics according to the topic consultation, selection and prioritisation process.

16.1 Process and method for reviewing the need to update published guidance

NICE GPG is updated as needed to ensure recommendations take into account important new information. The NICE project team checks for new evidence 2 and 4 years after publication, to decide whether all or part of the GPG needs updating. If important new evidence is published at other times, the NICE project team may decide to undertake a more rapid update of some recommendations.

The NICE project team will not actively seek new evidence, unless it has been identified in the GPG that important new information is likely to emerge before the 2‑year scheduled review that may result in the need for an exceptional update or amendment (see section 16.4). Ways in which new evidence can emerge are from:

  • regular foraging activities for identifying new information

  • queries or comments received by NICE after publication

  • feedback about guidance implementation

  • evidence submitted by other stakeholders.

The review includes the following key stages and methods:

16.1.1 Stage 1

  • Collect any new information relevant to the GPG from members of the Guidance Development Group (GDG) that developed the original GPG (including patient, service user and carer members) using a questionnaire. See table 16.1 for criteria.

  • Collate other types of information, including the results of a re-run of the original search used for the scope of the published GPG (see section 4), post-publication comments and feedback about guidance implementation (for example, feedback gathered by the NICE field team of implementation consultants and associates and local and national audit data, where relevant).

  • Conduct a broad search for relevant ongoing clinical trials.

  • Conduct a high-level search for evidence such as relevant systematic reviews and randomised controlled trials (RCTs) using MEDLINE, MEDLINE In‑Process, Embase and Cochrane (CDSR and Central only), with PsycINFO as an optional database for specific mental health topics.

  • Assesses the relevance of, and summarises the evidence identified in the high-level search, see section 8).

  • Collate all information and evidence identified so far to assess the need to conduct further focused searches on specific areas in the GPG and/or new areas that may be important for an update of the GPG.

  • Confirm with the GDG chair of the original GPG, and other GDG members if necessary, the decisions on further focused searches and discuss developing PICO (population, intervention, comparator and outcome) frameworks for the focused searches.

16.1.2 Stage 2

  • Conduct further focused searches based on the relevant PICO frameworks using MEDLINE, MEDLINE In‑Process, Embase and Cochrane (CDSR and Central only), plus 2 optional extra databases: PsycINFO (for mental health and psychological interventions questions only) and NHS EED (for health economics and cost-effectiveness questions only).

  • Assesses the relevance of, and summarises the evidence identified in the high-level search, see section 8.

  • Assess and summarise all information and evidence collected in stages 1 and 2, and develop a draft review decision on the need to update the GPG.

  • Confirm with the GDG chair of the original GPG, and other GDG members if necessary, that they agree with the draft review decision before consultation with stakeholders.

16.1.3 Stage 3

  • Check the stakeholder list for the original GPG to ensure that stakeholder details are up to date.

  • Consult stakeholders on the draft review decision for 2 weeks.

  • Consider (and if necessary revise) the draft review decision, taking into account the stakeholders' comments, and decide on the advice for NICE's Guidance Executive (see table 1.1).

  • NICE Guidance Executive makes the final review decision.

16.2 Deciding whether to update good practice guidance

The Programme Director and Centre for Clinical Practice Director consider the draft review decision in the light of evidence and information identified during the review process and stakeholders' comments.

The Centre for Clinical Practice Director advises NICE's Guidance Executive on whether:

  • a full update is needed

  • an update of particular areas is needed

  • no update is needed

  • the GPG should be transferred to a 'static list'

  • the GPG should be withdrawn.

NICE's Guidance Executive decides which of these options is most appropriate.

The decision is based on predefined criteria, as listed in table 16.1. The decision takes into account the competing priorities of other GPG topics and the capacity to schedule the work within the GPG programme.

If Guidance Executive determines that the GPG requires review, this is included in the next topic consultation process (see section 2).

Table 16.1 Criteria for deciding whether to update good practice guidance

Update decision

Criteria

Actions

Full update

Major sections of the GPG need updating

Many of the recommendations are no longer necessary

New good practice areas have been identified

Prepare a new scope after a scoping workshop

Partial update

Some recommendations need updating in the light of new evidence, or because they are unclear or new good practice areas have been identified that need to be covered in the GPG

Prepare a new scope after a scoping workshop

No update

No new evidence has been identified that would overturn any of the recommendations

There is no evidence from clinical practice to indicate that any of the recommendations need changing

There is no evidence from clinical practice that the original scope needs changing

The GPG is not updated

The GPG is reviewed after a further 2 years to determine its update status

Transfer to the 'static list'

The recommendations are unlikely to change in the foreseeable future

No further update planned

May be reviewed if new evidence emerges

Withdraw the GPG

The GPG no longer applies

Consult with stakeholders

16.3 Next steps

16.3.1 Conducting an update (full and partial)

If the entire GPG requires a full update, the NICE project team prepares a new scope, after the process described in section 4.

Recruitment of GDG members follows the usual process (see section 6.1). The NICE project team should inform members of the original GDG that they are recruiting a new GDG, but the composition of the GDG should be tailored to the requirements defined by the new scope. The time required for development of the GPG is agreed between with the Centre for Clinical Practice Director and the NICE project team. The GPG is developed using the same process as for new GPG and is subject to the normal 4‑week consultation period (see section 13). The usual process for finalising and publishing the GPG is also followed (see section 14).

If the GPG requires a partial update, there are 2 possible scenarios:

  • some recommendations need to be updated and/or

  • new areas have been identified that require new recommendations.

For both of these scenarios, a new scope is prepared through the usual process (see section 4). The scope will make clear exactly which sections of the GPG are and are not being updated. The scope will also make clear that all recommendations in the original GPG, including those that have not been otherwise reviewed, will be checked to ensure that they comply with NICE's equality duties.

The NICE project team recruits a new GDG to undertake the work, using the usual recruitment process (see section 6.1). The time needed to undertake the update is agreed between the Centre for Clinical Practice Director and the NICE project team.

16.3.2 No update

If it is decided that the GPG does not need to be updated, the GPG will be reviewed after a further 2 years. The same process for deciding whether an update is needed will be followed.

16.3.3 The 'static list'

There may be circumstances in which the areas covered in a GPG do not need to be considered for updating. This may be the case, for example, if the evidence base is so poor that it is unlikely that any of the recommendations will change in the foreseeable future. In this case, the GPG will be transferred to a 'static list' and no further update will be required. When GPG has been placed on the static list, this will be made clear on the home page for the GPG on the NICE website. GPGs on the static list may be transferred back to the 'active list' for further review if new evidence or information becomes available that is likely to mean that changes to the recommendations are required.

16.3.4 Withdrawing the good practice guidance

It may be decided that recommendations in GPG no longer apply, but that the GPG is not of sufficiently high priority for updating. In this case, the GPG will be withdrawn. This decision will be consulted on with stakeholders.

16.4 Exceptional updates

Exceptionally, significant new evidence may emerge that necessitates an update of GPG before the 2‑year review. This might be a single piece of evidence, an accumulation of evidence or other published NICE guidance (such as other clinical guidelines or technical appraisal guidance). This evidence must be sufficiently robust to make it likely that:

  • 1 or more recommendations in the GPG will need updating in a way that will change practice significantly or

  • patient safety issues need to be addressed

  • identification of errors in the GPG after publication.

Examples of such evidence include significant changes in legislation or major changes in systems and processes, such as national organisational changes. Exceptional updates may also be triggered by the identification of errors in the GPG after publication (see section 16.4).

16.4.1 Determining the need for an exceptional update

The NICE project team advises NICE's Guidance Executive on the following questions:

  • Is the update necessary?

  • Is there any other evidence (published, unpublished or from ongoing studies) that is relevant to the newly identified evidence?

  • Which recommendations need to be reviewed in the light of the new evidence?

Guidance Executive then decides on the need for an update based on the answers to these questions. If an exceptional update is necessary, the Centre for Clinical Practice Director liaises with the NICE project team to carry out the work. Stakeholders are informed at this point by the NICE project team.

The aim of an exceptional update is to be responsive to new evidence, so it is imperative that changes to recommendations are published quickly. The process for developing exceptional updates should be the same as that for conducting an update, except that the original scope is used (see section 16.4).

16.5 Presenting updates

If a decision is made to fully update the GPG, the process is as for new guidance, except that the previous version of the GPG is available for comparison. The Centre for Clinical Practice Director and NICE project team agree as early as possible how the full updated GPG will be presented for consultation.

When presenting partially updated GPG, the aim is to ensure that there is a single set of publications that bring together relevant information from all previous versions of the GPG and the updated information. In this way, readers of the updated GPG will be able to easily identify which recommendations were made when. Usually, the updated sections will be integrated into a single document with the existing GPG. The rest of this section covers general principles to be used when part of a GPG has been updated.

16.5.1 Consultation draft

The consultation draft is signed off by the project lead, Programme Director and Centre for Clinical Practice Director before consultation. The following are checked before sign off:

  • Sections of GPG have been updated as agreed at the scoping stage.

  • The GPG includes standard text at the beginning, setting out which sections have been updated, how these are marked in the consultation draft and which sections are open for comment during consultation.

  • The GPG includes updated sections (including the evidence and recommendations) which are clearly marked with paragraph borders, preferably a strip down the right hand side of the relevant pages bearing the word 'updated' and the year of the update. This will allow stakeholders to easily identify what they can comment on. The text that is superseded is placed in an appendix.

  • The recommendations have been marked up as described in box 16.1.

  • Recommendations from sections not being updated have been checked to determine whether any changes are essential.

  • Changes in recommendations from sections that have not been updated are kept to a minimum.

  • There is an appendix in the GPG containing a table summarising the proposed changes to the original recommendations (see below for more information).

  • All current recommendations (new, updated and unchanged) have been assessed with respect to NICE's equality duties.

Box 16.1 Labelling and rewording recommendations

In both the consultation and final published versions of the GPG, label all recommendations so that it is clear when the evidence was reviewed and whether the recommendation is new. The example below is of a clinical guideline first published in 2008 with an update published in 2012.

Sections where the evidence has been updated

  • New recommendations, either an additional good practice area for the GPG or changed because of new evidence – add [new 2012] to the end of the recommendation.

  • Unchanged recommendations where the evidence has been reviewed for the 2012 update but the recommended action is the same as in the 2008 guideline – add [2012]. Reword these recommendations into the direct style (see section 12.2), but check with the GDG that rewording has not changed the meaning.

Sections where the evidence has not been reviewed

  • For the consultation, add a grey background tint to recommendations that are not being updated, to indicate that they are not being consulted on.

  • Unchanged recommendations from 2008, where the evidence has not been reviewed for the 2012 update – add [2008] to the end of the recommendation.

  • Changes to recommendation wording that change the meaning (for example, because of equalities duties or a change in legislation) – add [2008, amended 2012] to the end of the recommendation, mark the change with yellow highlighting for the consultation and add a footnote explaining the reason for the change. This also applies if part of a recommendation (for example, a bullet point) has been deleted because it has been updated by other NICE guidance.

  • Evidence has not been reviewed, but there have been minor changes in 2012 to the wording of a 2008 recommendation that do not affect the meaning, for specific reasons such as changes in terminology – add [2008]. For the consultation, mark small changes in these recommendations with yellow highlighting. Include a general note about these changes in the appendix table.

  • Recommendation is incorporated from other published guidance – use the label to show when that other guidance was published, for example [2006]

Explaining the proposed changes in the consultation version

Standard text at the beginning of the guidance

The NICE project team will use a standard template for the good practice guidance template.

Appendix explaining the changes

Create a table (which will form an appendix to the GPG) summarising the proposed changes to the original recommendations, including:

  • The text and recommendation number(s) of the recommendations that have been deleted in the update (either because they are being changed significantly in light of new evidence, or because they have become redundant), and the number(s) and text of any replacement recommendations. If there is no replacement for a recommendation, explain the reasons for the deletion.

  • A general note about any small changes made to recommendations that have not been updated, such as terminology changes. (These changes are marked with yellow highlighting for the consultation.)

  • A note about every change to a recommendation that has changed the meaning without an evidence review (labelled 'amended' and marked with yellow highlighting for the consultation). Include the new text of the recommendation.

Keep explanations as short as possible – only brief details are needed.

16.5.2 Final sign off

Before final sign off, the draft GPG, should be checked for the following:

  • The recommendations are labelled as described in box 16.1.

  • Grey shading and yellow highlighting have been removed from the recommendations.

  • Footnotes explaining changes to recommendations labelled [2008, amended2012] are retained.

  • The appendix table summarising the changes to recommendations has been revised in line with the final recommendations.

  • The appendix with the superseded text is retained.

  • The standard text box at the beginning of the guidance explaining which sections have been updated has been revised.

16.5.3 Information for the public

Information for the public

When the updated GPG is published, the 'Information for the public', if available, will explain which sections have been updated, particularly if patients are likely to notice changes in their care.

16.6 Maintaining records

The NICE project team maintains records throughout the development of an updated GPG to ensure that the following information is readily available:

  • Details of the GDG membership, including declarations of interest.

  • Search strategy details, including when the most recent search was conducted.

  • Copies of the papers used.

  • Data extraction forms.

  • Evidence tables.

  • Minutes of GDG meetings.

  • Any additional information presented to the GDG.

16.7 Correcting errors in published good practice guidance

Measures are in place throughout the development of GPG to ensure that errors in the collection, synthesis, interpretation or presentation of the evidence are avoided as far as possible. However, on rare occasions errors may be found after publication of the GPG. These errors may not always warrant changes to the GPG, in which case they will be logged for consideration when the GPG is reviewed for updating. If an error is found, the following criteria and process will be used by the NICE project team to determine whether changes are necessary.

16.7.1 Criteria and process for a correction

Corrections or changes to published GPG will be made if an error:

  • puts patients at risk, or impacts on their care or

  • damages NICE's reputation or

  • significantly affects the meaning of the recommendation.

If it is necessary to correct an error in published guidance, an internal policy for dealing with errors will be followed. The individual or organisation who reported the error will be contacted in writing, and the NICE project team will explain the rationale for the decisions and actions taken.

If a correction is to be made, a notification is put on the guidance 'home' page on the NICE website. Depending on the nature and significance of the error and the time since publication of the GPG, stakeholders may also be notified in writing (usually by email). The relevant web‑based documentation is corrected, and this is also highlighted on the guidance home page on the NICE website.

16.8 Further reading

Clark E, Donovan EF, Schoettker P (2006) From outdated to updated, keeping clinical guidelines valid. International Journal for Quality in Health Care 18: 165–6

Eccles M, Rousseau N, Freemantle N (2002) Updating evidence-based clinical guidelines. Journal of Health Services Research and Policy 7: 98–103

Shekelle P, Eccles MP, Grimshaw JM et al. (2001) When should clinical guidelines be updated? British Medical Journal 323: 155–7

Shekelle PG, Ortiz E, Rhodes S et al. (2001) Validity of the Agency for Healthcare Research and Quality clinical practice guidelines: how quickly do guidelines become outdated? Journal of the American Medical Association 286: 1461–7

Shojania et al. (2007) Updating systematic reviews. Technical Review, Number 16, AHRQ Publication No. 07‑0087

Turner T, Misso M, Harris C et al. (2008) Development of evidence-based clinical practice guidelines (CPGs): comparing approaches. Implementation Science 3: 45–52