NICE process and methods
4 Developing the decision problem (scoping)
4 Developing the decision problem (scoping)
The general principles outlined in chapter 2 of 'The guidelines manual' should be applied when developing the scope.
Assessment of the effectiveness and cost-effectiveness of service delivery interventions will consider the differences in outcomes and cost between a current model of service delivery (the intervention) with alternative current models of service delivery, new models of service delivery, and/or aspirational models of service delivery (the comparators). Ultimately the aim of a service delivery intervention is to maximise health gain, while taking into account equity considerations. Health gain may be measured directly or indirectly, through intermediate or process outcomes, often classed as performance measures. Performance measures can be categorised as follows:
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Registers (lists of included 'cases').
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Care processes indirectly linked to outcomes (for example, blood pressure measurement).
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Care processes directly linked to outcomes (for example, proportion of people with hypertension on therapy to lower blood pressure).
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Intermediate outcomes (for example, proportion of people with hypertension whose blood pressure is within target range).
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Outcomes (for example, subsequent cardiovascular event).
However, there are additional considerations for service guidance – in particular, the context in which it is being developed. The information in the following sections should be considered in addition to the information identified during standard scoping searches for effectiveness and cost-effectiveness evidence.
4.1 Policy context and constraints
Service guidance is likely to have considerable overlap with policy considerations, and a review of existing and planned policies is needed. There should be discussions with relevant policy/domain leads at NHS England, through NICE, to identify any existing policy initiatives. This may also include a review of existing government policy and other guidance, for example from the Royal Colleges.
4.2 Understanding the current service and variations
Information on current service configuration and provision is needed to inform the development of service guidance and to identify important variations in the provision and quality of services. This can usually be obtained from published sources such as reports and audits. Sources that could be considered include:
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National data sets that can identify factors such as demand, potential variation in practice, current resource use and staffing.
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National organisations.
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Royal Colleges and other professional bodies.
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NICE's QIPP (Quality, Innovation, Productivity and Prevention) collection and local practice collection.
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Specific audit data may be identifiable as useful at this point and the relevant contacts should be approached.
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Patient safety organisations, such as the Patient Safety Division of NHS England.
See appendix 1 for a list of possible sources.
Any relevant recommendations from published NICE guidance should be identified. These may include service recommendations, such as when interventions and services should be provided. NICE guidance will also include recommendations on interventions that the service(s) under consideration will be providing.
It is important that contacts within relevant national organisations, such as NHS England and the Health and Social Care Information Centre, are identified and engaged with as early as possible, because getting access to data sources may be time consuming.
4.3 Clinical and NHS engagement
There will need to be engagement with the service commissioning community to put the information gathered into clinical context. Stakeholders may also be aware of other useful data sources.
The process of identifying key areas for improvement and guidance should be informed by a combination of stakeholder input and the earlier intelligence gathering, especially if there are policy targets. For example, key areas could include addressing variation in practice or ensuring timely access to treatments.
A meeting with stakeholders could be arranged with the aims of producing an initial list of potential areas to be covered and/or developing potential hypotheses about the service. The feedback obtained could be combined with information already gathered to develop a list of priorities and initial searches to be conducted.
The areas identified should be assessed for the type of evidence that would be needed in order to develop recommendations and whether this is likely to be available: for example, a systematic review of when an intervention should be delivered, or a qualitative review to inform recommendations about behaviour change. These can then be confirmed with focused scoping searches if needed.
A key objective of this process is to develop a list of key stakeholder organisations who would be willing to provide information to support guidance development. This group of stakeholders can then be approached throughout development and asked to provide particular types of information as needed.
4.4 Involving patients, service users and carers
The views of patients, service users and carers should be actively sought. This is particularly useful for identifying the key outcomes of the service that are important to them and the relative importance of outcomes. Patient and carer organisations may also have valuable information about patients' experiences of services.
4.5 Approach to scoping
Because a number of topics will cut across clinical areas, it may be difficult to identify key areas for the guidance to focus on. Therefore various approaches to scoping may be used. In particular, consideration should be given to recruiting not only a Committee chair and topic adviser to help in developing the scope, but also additional members of the scoping group who will become Committee members. When several relevant clinical guidelines are being developed simultaneously with service guidance, there should be representation from each guideline scoping group (or Committee if established) on the service guidance scoping group.
Various methods can be used to run the stakeholder scoping workshop. It is likely that more stakeholders will need to be engaged, so the workshop may have more participants than for a clinical guideline. The workshop could be split over 2 days; for example:
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day 1: identifying the issues and developing a problem-oriented conceptual model (see section 4)
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day 2: identifying which topics should be considered for a full evidence review and which areas could be based on expert opinion alone.
However, when service delivery forms part of a clinical guideline, the stakeholder scoping workshop for the clinical aspects, as described in stage 5 in section 2.3 of 'The guidelines manual', could include service delivery considerations. In this case, specific time should be set aside to discuss the service delivery sections and identify the key issues to be addressed in the guideline.
4.6 The scoping search
A scoping search is undertaken by the Developer and is important to identify:
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related guidance from NICE and other accredited developers
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policy and legislation
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key systematic reviews
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economic evaluations
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information on current practice, including costs and resource use and variations
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types of interventions that may be appropriate
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statistics (for example, on service configuration or staffing levels)
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information on the views and experiences of people using services, their family members or carers, or the public.
The search should not aim to be exhaustive. It should be based on the need to inform the development of the draft scope and the issues to be discussed at the scoping workshop. See appendix 1 for a list of suggested sources.