Interventional procedures programme manual

  • NICE process and methods
  • PMG28
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4 Producing a scope for interventional procedures

A scope defines the issues of interest surrounding the procedure and, for the purposes of the assessment, sets the boundaries for the work to be done. This is done by defining the procedure and indications that will be used to identify relevant evidence. Advice can be sought from relevant committee members and experts when preparing the scope.

4.1 Content of the scope

The scope sets out the following information relevant to the procedure (depending on the contents of the notification and the procedure, some sections may not be relevant):

  • notified procedure title, and proposed procedure title (if a different title is thought necessary)

  • proposed lay description

  • proposed procedure description, using a generic (non‑proprietary) description

  • notified indication

  • proposed indication and different indications if these are thought necessary

  • key ongoing trials

  • suggested search terms for the intervention and indication

  • epidemiology of the condition(s) for which the procedure is indicated, particularly when this relates to NICE's equalities duties

  • established alternative interventions for the condition

  • safety and efficacy outcomes

  • category of notifier

  • disease area(s)

  • specialty area(s)

  • professional organisations to approach for experts

  • professional organisations to be informed that NICE is assessing the procedure

  • patient organisations to be informed that NICE is assessing the procedure

  • related NICE guidance

  • special issues relating to the procedure (NICE may be made aware of these by experts).

The scope also includes details of other considerations that could form part of the assessment of the procedure. These may include:

  • details of specific patient subgroups

  • highlighting when procedures are notified for more than 1 indication

  • procedures that can be done with more than 1 device

  • information about the timing of regulatory approval of any devices involved in the procedure

  • identification of issues about the available evidence base (for example, emerging key trials)

  • related policy developments.

4.2 Complex notifications

Sometimes a notification cannot be accepted in its original form, but the scope can suggest how useful guidance could be developed. For example:

  • NICE is notified about a procedure with an imprecise name, or 1 that is atypical in UK practice. Because there is no universally recognised nomenclature for interventional procedures, the NICE team may rename the notified procedure on the advice of experts or a committee member. NICE aims to make the names of the procedures it assesses relevant to the clinicians who carry them out and it consults with experts when considering changes to procedure names.

  • NICE is notified about a procedure with a name that is device‑specific (for example, 'device X for indication Y', instead of 'procedure Z for indication Y'). Because the assessment for interventional procedures does not evaluate devices, the name of the procedure is revised to avoid reference to specific devices or trade names.

  • NICE is notified about a procedure for an imprecise or atypical indication. For example, the indication might be a symptom of a disease (such as pruritus), rather than the disease itself (chronic liver disease). The NICE team may revise the pairing of the procedure and indication to produce appropriate guidance.

  • NICE is notified about a procedure for more than 1 distinct indication. In this case, the procedure may be 'split' to produce 1 piece of guidance for each indication, for example when the safety or efficacy profiles are likely to be different.

Scopes involving complex notifications are likely to take longer to prepare than standard scopes.