NICE process and methods
12 Developing recommendations
12 Developing recommendations
The principles outlined in chapter 9 of 'The guidelines manual' should be used when developing service guidance recommendations. The link between the evidence on clinical and cost effectiveness and the recommendations should be clearly presented in the full guidance, and the Committee should assess the strength of recommendations (see section 9.2 of 'The guidelines manual'). The Committee will, however, have to consider additional factors when developing recommendations for service guidance.
Recommendations on service guidance could have a potentially significant impact on all aspects of care and resources. It is therefore important that the recommendations are underpinned by a clear and comprehensive review of the evidence, results from validated models, and documented and explicit considerations of the Committee to justify what may be a highly disruptive and expensive reorganisation of the service with potentially irrecoverable costs. This includes ensuring that recommendations will remain relevant into the future (usually for at least 5 years).
Although the aim of service guidance is to reduce variability in outcomes of and access to services, there may be circumstances when the Committee wants to ensure that local customisation is possible. Therefore the Committee may recommend a list of preferred options so that decision makers can choose appropriate models for their local circumstances. However, there needs to be an overarching statement about the objective of the recommendations.
Potential areas that the Committee could address or refer to include the following:
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The resources required for delivering clinically and cost effective services. These could include minimum specifications that a service must be able to deliver.
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Where patients should be treated or referred for treatment.
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How NHS staff should be organised.
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Designating staff who should be responsible for the provision and delivery of services.
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How services should interact and the sharing of information between services.
The Committee should identify potential areas for disinvestment. Development and drafting of these recommendations should follow the same process, including consideration of the evidence and model development, as that followed for recommendations that lead to an increase in resources. However, the Committee should consider the potential impact of the withdrawal of a service on the health of the population, taking into account equalities considerations (for example, whether withdrawal might affect some groups more than others), as well as any other potential negative effects, and so the Committee should also consider how these effects may be mitigated.
NHS England will be the primary audience for service guidance. The Committee should not attempt to ensure that recommendations are directly relevant to the rest of the UK, as this will be the responsibility of the devolved administrations. Recommendations should meet the needs of both patients and decision makers. Therefore consideration should be given to aiming recommendations at specific audiences, such as commissioners and/or providers. This might include highlighting who is responsible for implementing recommendations.
The advice on the wording of recommendations in clinical guidelines (see section 9.2 of 'The guidelines manual') will not always be appropriate for service guidance. This is because recommendations about service guidance are not referring to a clinician's individual decision to offer or consider using a treatment. Therefore alternative wording should be explored by the Committee and discussed with NICE – in particular, the NICE editor.
In general, the wording of recommendations should be agreed by the Committee, and should:
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focus on the services that needs to be delivered, and where appropriate, who needs to provide these
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include what readers need to know
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reflect the strength of the recommendation
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emphasise the involvement of people using services, carers where appropriate, and the public in making decisions
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use plain English where possible and avoid vague language and jargon
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use language and terms that NICE has agreed to ensure consistency across guidelines and other products
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follow NICE's standard advice on recommendations about waiting times and ineffective interventions.
The recommendations should (wherever possible and if not obvious from the context of the guideline) clearly detail the intended audience for the recommendation (who is responsible for implementing it), the intended population, the setting (if relevant), what specifically should be done, and, where relevant, what the timeframe is for doing it.
12.1 Economic evidence and recommendations
When a cost per QALY can be obtained, the principles outlined in chapter 7 of 'The guidelines manual' should be followed. Additional considerations include the potential effects of identified factors that impact on the ICER, including the possible implications of legal and equity issues. If these factors have not been incorporated into the ICER, they need to be considered by the Committee.
The approach adopted by the Committee for interpreting cost-effectiveness or cost–benefit results, including the relative weight given to certain outcomes, should be clearly described in the evidence to recommendations sections of the guidance. The Committee should aim to maximise efficiency while maintaining the quality of services, and the considerations used should be outlined in the evidence to recommendations sections.
When there is no evidence of differences between different options, a cost-minimisation approach can be used. However, the Committee must be convinced that the 2 options do not differ for all relevant outcomes.
12.2 Research recommendations
Research recommendations will be vitally important to improve the available evidence base for health services. These should be formulated using the principles outlined in section 9.5 of 'The guidelines manual'.