8 Integrating and cross-referring to other guidance
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8 Integrating and cross-referring to other guidance
This chapter describes how other NICE guidance on the topic area and guidance from other developers are integrated into a guideline or cross-referred from it while it is being developed.
NICE guidelines, guidance on health technologies and guidance from other developers with content that is relevant to or overlaps with a guideline (referred to as 'related guidance') should be identified while defining the scope of a guideline (see the chapter on the scope), or when checking if a guideline needs updating (see the chapter on ensuring that guidelines are current and accurate). This includes identifying any related guidance or guidelines in development, as well as those that are published.
When a guideline topic covers guidance on health technologies that is published or in development, staff with a quality assurance role (see section on who is involved in the chapter on introduction) work closely with the health technologies team to agree the approach to take.
8.1 Related NICE technology appraisal guidance
A guideline committee cannot usually make recommendations on health technologies that contradict recommendations made in NICE health technologies guidance that is published. In rare cases, technology appraisal guidance will be updated in the guideline (see the section on updating technology appraisal guidance in a guideline).
Technology appraisal being developed or updated alongside the guideline
When it is known before development starts that a guideline and related technology appraisal will be developed at the same time
When a technology appraisal is developed at the same time as a related NICE guideline, development should ideally be coordinated so that the appraisal recommendations are published in time to be integrated into the guideline consultation draft. This is not always possible (for example, if the technology has not yet received a marketing authorisation). In this case, the guideline consultation draft will cross-refer to the appraisal consultation document.
If guideline committee members wish to comment on the appraisal, they do this through the guideline developer (see the NICE health technology evaluations manual).The guideline committee chair and developer may attend relevant appraisal committee meetings as advisers, but cannot take part in the formal technology appraisal decision-making.
New technology appraisal referral during guideline development
When a new, related technology is referred to NICE for appraisal after NICE has started developing a guideline, the technology appraisal team inform the developer and staff with a responsibility for quality assurance. The related technology appraisal guidance is developed alongside the guideline.
Updating technology appraisal guidance in a guideline
When to update a technology appraisal guidance in a guideline
If there is new evidence on a technology that has been appraised by NICE, the related NICE technology appraisal can be updated within the context of a guideline, during guideline development. For example, the guideline may place technologies in order of preference because of new cost-effectiveness evidence, or to account for additional considerations for some subgroups of the population covered by the technology appraisal.
This cannot be done for highly specialised technologies (HSTs), or technologies recommended for managed access. Managed access technology appraisals would only be considered for inclusion in a guideline after the managed access period has completed and a positive technology appraisal recommendation has been published.
See our process and methods manual on NICE health technology evaluations for more information on how NICE technology appraisals are developed.
Process for updating technology appraisal guidance in a guideline
Early planning is essential to identify how the developer will update technology appraisal guidance within a guideline. The developer considers whether there are any data not in the public domain that are likely to be useful. If so, they call for evidence from registered stakeholders, using the procedures described in the appendix on call for evidence and expert witnesses.
If significant new evidence has arisen or costs have changed since the technology appraisal guidance was published, the developer assesses effectiveness and cost effectiveness (performs an economic analysis) to enable the committee to determine whether the technology appraisal guidance recommendations should be considered for change.
Approach to economic analysis
In exceptional circumstances, it may not be clear that an economic analysis is needed until the evidence is reviewed and discussed by the committee. Nevertheless, the developers start planning for any economic analysis at an early stage. The intended approach to cost-effectiveness (economic) analysis for technology appraisal updates is included in the guideline economic plan and discussed with the committee and a member of staff with responsibility for quality assurance.
The approach should follow the principles described in the chapter on incorporating economic evaluation and be similar to that used in the technology appraisal. Any differences must be justified by changes in the evidence or decision context (for example, a broader range of comparators in the guideline).
The developer may sometimes consider that cost effectiveness can best be assessed by modifying or building on an existing economic analysis model used when developing the technology appraisal, taking into account any third-party agreements that may be needed (for example when a model is owned by another organisation). If so, this is discussed with a member of staff with responsibility for quality assurance when developing the economic plan.
Referring to technology appraisals in recommendations
When related technology appraisal guidance is identified, the usual approach is for a guideline to state that the technology appraisal recommendations should be followed and cross-refer to the technology appraisal recommendations. If needed, a brief explanation agreed with the technology appraisals team can be included in the guideline to cover information such as the sequencing of treatments recommended in technology appraisals.
In some cases, technology appraisal recommendations may be integrated into the guideline, for example, if this is essential for readability or there is a need to highlight specific recommendations.
Sometimes a guideline covers a medicine for which NICE technology appraisal guidance exists, but for a different population or indication (condition). In these cases, the committee developing the guideline recommendations considers evidence of effectiveness using methods described in this manual. The guideline recommendations may be different from the technology appraisal recommendations if there is evidence of differing safety, effectiveness or cost effectiveness for the population or indications covered by the guideline.
New medicines
Evaluations of new medicines and significant new indications will be carried out in line with section 3.17 of the 2019 voluntary scheme for branded medicines pricing and access published on the GOV.UK website.
8.2 Related interventional procedures guidance
Interventional procedures guidance differs from other NICE guidance in that it addresses the safety and efficacy of interventions, but not their effectiveness, cost effectiveness, or cost-savings. (For more details see the NICE interventional procedures programme manual.)
Any related published interventional procedures guidance is identified when defining the scope of a guideline or checking whether the guideline needs updating. The approach depends on whether the recommendation in the interventional procedures guidance is for the procedure to be used with 'standard' (previously known as 'normal') or with 'special' arrangements for clinical governance, consent, and audit or research. Because guidelines focus on placing established treatments in the care pathway, they will generally only include interventional procedures guidance that recommends 'standard' arrangements.
If NICE starts developing interventional procedures guidance on procedures related to a guideline during guideline development, the interventional procedures team send the finalised brief for the procedures to staff with responsibility for quality assurance of the guideline, to enable timelines to be co-ordinated where possible.
Interventional procedures guidance with recommendations for 'standard' arrangements
The scoping group for a guideline decides whether there are any procedures for which NICE interventional procedures guidance recommends 'standard' arrangements that are related to the guideline. If there are, they then decide whether they need to include a review question.
Review question is not needed
If a review question is not needed, the guideline should cross-refer to the related interventional procedures guidance and provide a context for doing so.
The developer does not search for new evidence on procedures that are not covered by a review question. However, if during evidence searches for the guideline, the developer finds new relevant evidence on that procedure, they inform staff with responsibility for quality assurance of the guideline who discuss it with the interventional procedures team to agree on the proposed approach to manage this (see other approaches).
Review question is needed
If a guideline is being updated and the surveillance review identifies that, when updating the guideline, it is likely that a review question will be needed on a procedure for whose use interventional procedures guidance recommends 'standard' arrangements, this is highlighted in the surveillance report.
Similarly, if the scoping group for a new guideline has decided that a guideline review question is needed for a procedure for whose use interventional procedures guidance recommends 'standard' arrangements, this is highlighted in the guideline scope. For example, comparisons of clinical and cost effectiveness could be included in a review question if there is interventional procedures guidance covering several procedures for the same condition. While defining the guideline scope, the staff with responsibility for guideline quality assurance contact the interventional procedures team to ask for their input on the proposed approach (see other approaches).
If the procedure is included in the final guideline scope, the developer considers its effectiveness using standard methods for guideline development (see the chapters on reviewing research evidence and incorporating economic evaluation).
Because interventional procedures guidance relates to the efficacy and safety of a procedure, while guidelines cover clinical and cost effectiveness, interventional procedures guidance and guidelines address different questions. As a result, unless the interventional procedures and staff with a responsibility for guideline quality assurance have identified reasons it should not, interventional procedures guidance remains active even if:
a review question in a guideline relates to the same procedure as the interventional procedures guidance
its recommendations are supplemented by a guideline recommendation on the effectiveness of a procedure for 1 or more indications.
Interventional procedures guidance may also contain more detailed information than the guideline, that may help practitioners and people considering having the procedure.
Importantly, the interventional procedures guidance may also specify conditions for procedure use. For example, it may specify that the surgeon should have training, or that the procedure should be carried out within the context of a multidisciplinary team.
In such cases, the guideline cross-refers to the interventional procedures guidance.
If new evidence is identified during the guideline development process that may impact an interventional procedure recommendation, the interventional procedure team is contacted by NICE staff with responsibility for guideline quality assurance to agree the proposed approach (see other approaches).
Other approaches
If NICE staff with responsibility for guideline quality assurance and the interventional procedures team agree that a different approach is needed, the teams agree a solution, which is signed-off by NICE's Guidance Executive. Decisions to take other approaches are made on a case-by-case basis. Examples include:
Evidence appraisal indicates that a procedure with interventional procedures guidance is not effective, and the guideline recommends that it should not be used.
There is considerable uncertainty about the clinical or cost effectiveness of a procedure.
There has been a considerable change in the evidence whereby efficacy or safety may have changed and new evidence identified during a guideline's development suggests interventional procedure guidance may need updating.
The guideline committee makes a 'research only' recommendation for a procedure for whose use interventional procedures guidance recommends 'standard' arrangements.
Interventional procedures guidance with recommendations for 'special' arrangements
If a guideline committee considers that a procedure for whose use NICE has published recommendations for 'special' arrangements has become part of NHS practice and falls into the remit of a guideline review question, the interventional procedures team is notified for potential review of the interventional procedures guidance:
If the guidance is updated and the procedure's status is changed to 'standard' arrangements, the developer considers the procedure's effectiveness and cost effectiveness.
If the procedure retains its 'special' arrangements status, the guideline cross-refers to the interventional procedures guidance.
Interventional procedures guidance with recommendations for 'research only' or 'do not use'
Sometimes interventional procedures guidance recommends that a procedure should only be carried out in research, or that it should not be used:
A recommendation not to use a procedure is made when the evidence suggests that a procedure has no efficacy or poses unacceptable safety risks.
A 'research only' recommendation is made if the evidence shows that there are important uncertainties.
In these cases the evidence usually reflects the fact that they are not established procedures and they would not normally be covered by a guideline review question.
For more information see Main types of recommendations made by the committee in the interventional procedures programme manual.
Developing a guideline and interventional procedures guidance at the same time
When NICE has been asked to assess an interventional procedure, a scope has been defined for this work, and it has been agreed that it will be assessed by the interventional procedures team. If the procedure is related to a guideline in development, the interventional procedures team informs the developer and staff with responsibility for guideline quality assurance to enable timelines to be co-ordinated where possible. The guideline can cross-refer to the interventional procedures guidance when it is published.
8.3 Related NICE guidelines
Related NICE guidelines or recommendations, either published or in-development, may be identified:
when checking if a guideline needs updating (see the chapter on ensuring that published guidelines are current and accurate)
while defining the scope of the guideline (see chapter on scoping) or
during guideline development.
Similar review question covered in another guideline
Once related recommendations from a published guideline have been identified, they can be:
excluded from the scope of the guideline in development (see [link to relevant section of scoping chapter]) or
considered for integration in the guideline.
To decide whether to integrate these existing recommendations, the developer and committee should document whether:
the review question in the guideline in development is similar enough to the question addressed in the published guideline
the evidence underpinning any recommendations is unlikely to have changed significantly since the publication of the related guideline
the evidence review for the review question in the published guideline is relevant to the question in the guideline in development.
The guideline in development will integrate the recommendations from the published guideline if:
the committee agree that the evidence review is relevant for the guideline in development AND
the committee are happy to accept the intent and exact wording of the recommendations, and understand that any future changes (for example, as part of an update) would also apply to their guideline.
Cross-referring to the recommendations from the other guidelines is preferred to repeating recommendations in the guideline in development. In rare cases, recommendations may be copied into the guideline, for example, if this is essential for readability or there is a need to highlight specific recommendations.
If needed, a recommendation can be added to the guideline explaining anything users will need to take into account when applying the recommendations from the published guideline (for example, if some parts of a recommendation do not apply to the population or setting covered by the new guideline). The committee's discussion and decision should be clearly documented in the guideline. This includes areas of agreement and difference with the committee for the published guideline (for example, in terms of key considerations – balance of benefits and harms or costs, and interpretation of the evidence).
If however, the committee wish to draft new recommendations based on the evidence review or recommendations in the related NICE guideline, they should follow NICE's standard processes and methods, as described in this manual (see the section on reporting reviews or using recommendations from previously published NICE guidelines in the chapter on reviewing evidence).
If a NICE guideline identified during development will result in a planned evidence review not taking place developers agree an approach with staff with responsibility for quality assurance. The approach is then documented in the guideline methods.
Requesting a new or updated evidence review
If, during guideline development, the committee considers that the intent and wording of the published recommendations are not appropriate for their guideline, or:
are not prepared to agree that any updates to recommendations would also apply to their guideline, or
do not think that the related guideline review question identified during monitoring or scoping is similar enough or
do not consider the evidence review appropriate.
The committee may request that a new evidence review is conducted or that the evidence review is updated.
The new evidence review or evidence review update should follow NICE's standard processes and methods, as described in this manual (see chapters on developing review questions and planning the evidence review and reviewing evidence). The decision to update or conduct a new review should be agreed by staff with responsibility for quality assurance and documented in the guideline's methods section and evidence review.
8.4 Guidance from other organisations
Sometimes related recommendations from guidelines published by other organisations are identified, for example during guideline monitoring, defining the scope, or in the search for evidence, and may then be considered for inclusion in NICE guidelines.
All external guideline recommendations should be appraised following a 2-stage approach:
appraisal of the guideline development process used
appraisal of the recommendations themselves.
Intellectual property issues need to be considered when using content from other organisations.
Guidelines accredited by NICE are not subject to the first stage of appraisal, that is, appraisal of the guideline development process, because this has already been assessed by NICE.
Guidelines not accredited by NICE are assessed for quality using the AGREE II instrument. The AGREE II instrument may be adapted where appropriate, for example for different types of guidelines.
For guidelines accredited by NICE and those assessed to be high quality using the AGREE II instrument, the suitability of specific recommendations for inclusion in the NICE guideline should be assessed using a checklist. This checklist considers factors such as the evidence informing the recommendation and applicability to the health and care context covered by NICE guidelines. The full results of the assessment should be presented with the guideline.
Recommendations from external guidelines are only cross-referred to or integrated in a NICE guideline if both the guideline development process and recommendations have been appraised and assessed as appropriate for use within NICE guidelines. If the committee are happy to accept the exact wording of the external recommendations, and understand that any future changes (for example, as part of an update of the external guideline) would also apply to the NICE guideline, then the NICE guideline will cross-refer to or integrate the recommendations from the external guideline. If editorial revisions are needed, for example to align with NICE style or the UK context, a recommendation can be integrated into the NICE guideline without changing the intent or meaning of the source recommendation. For integrated recommendations, the external guideline should be referenced with a direct link to the source website or a full reference of the published document.
If however, the committee wish to draft new recommendations based on the evidence review or recommendations in the external guideline, they should follow NICE's standard processes and methods, as described in this manual (see the section on reporting reviews based on previously published guidance in the chapter on reviewing evidence).
References and further reading
Brouwers MC, Kho ME, Browman GP et al. (2010) AGREE II: advancing guideline development, reporting and evaluation in health care. Canadian Medical Association Journal 182: E839–42
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