Process and methods

8 Producing a brief

A brief is a short internal document covering key aspects of the procedure. The interventional procedures programme team prepare a brief to initiate the assessment of the procedure. Briefs are produced in line with the NICE equality scheme.

A brief defines the issues of interest surrounding the procedure and, for the purposes of the assessment, sets the boundaries for the work to be done by the programme team and the Committee. This is done by defining the procedure and indications that will be used to identify relevant evidence. The programme team seeks advice from appropriate specialist Committee members and the programme's specialist advisers when preparing the brief.

Once the brief has been reviewed by the Committee, developing guidance on the procedure becomes part of the formal work of the programme, and NICE's website shows that guidance on the procedure is in development.

8.1 Standard approach to producing a brief

The standard brief 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

  • 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) (according to NHS classification)

  • professional organisations to approach for specialist advisers

  • 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 specialist advisers).

The brief 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.

8.2 Complex notifications

Sometimes a notification cannot be accepted in its original form, but the brief 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 programme's technical team may rename the notified procedure on the advice of specialist advisers or the specialist 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 specialist advisers 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 programme 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 programme's technical 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.

Briefs involving complex notifications are likely to take longer to prepare than standard briefs.