The guidelines manual

Figure M1 Short clinical guideline process timeline

2.3.1 Drafting the scope

2.3.1.1 A draft scope, which defines the areas the guideline will and will not cover, is prepared by the Internal Clinical Guidelines Programme technical team at NICE. It is based on the remit from the Department of Health or the NHS Commissioning Board, input from relevant experts, patients, service users and carers^[1], and a preliminary search of the literature to identify existing clinical practice guidelines, key systematic reviews and other relevant publications. The literature search facilitates an overview of the issues likely to be covered by the guideline – the clinical need for the guideline and the clinical management of the condition – and helps define key clinical issues. It also informs the technical team of the volume of literature likely to be available in the topic area, and therefore the amount of work required. The draft scope is tightly focused, covering a small number of key clinical issues. Review questions, which specify in some detail the particular interventions to be compared and the health outcomes of interest (see chapter 4 of The guidelines manual), may be included in the scope.

2.3.1.2 Comparison with the standard clinical guideline process. The process for drafting the scope follows that outlined for standard clinical guidelines (see chapter 2 of The guidelines manual).

2.3.2 The scope consultation process

2.3.2.1 Stakeholders are invited to register at the time of formal referral of the guideline topic by the Department of Health or the NHS Commissioning Board. Contact with stakeholders is important to ensure that they are included in the development of the guideline and support it.

2.3.2.2 The draft scope is presented at a stakeholder scoping workshop to a relevant group of stakeholders and professional groups. Attendees are identified by inviting all registered stakeholder organisations to offer suggestions of possible workshop attendees; one person from each registered stakeholder organisation may attend. The scoping search is used to identify UK-based individuals who have led on recent national published guidelines and/or recent key reviews in the topic area. Workshop attendees, including representatives of relevant patient and carer organisations, should have specific knowledge or experience in the topic area. The workshop consists of presentations and facilitated parallel-running working groups. The aim is to obtain detailed feedback on the draft scope and agree core areas of care to be covered in the guideline, to seek input about the composition of the GDG and to raise awareness that NICE is publicly advertising for applications for GDG membership.

2.3.2.3 The draft scope is amended to address and/or include issues raised in the workshop. The scope is then subject to a 4-week consultation with stakeholders. Stakeholder comments are reviewed by the Internal Clinical Guidelines Programme technical team, the GDG Chair and the Clinical Adviser (if one is appointed; see section 2.4.1.1 below). A revised scope is prepared, which is signed off by the CCP lead for the guideline at NICE. Stakeholders are notified once the final version of the scope is available on the NICE website.

2.3.2.4 Comparison with the standard clinical guideline process. The process for consulting on the scope follows that outlined for standard clinical guidelines (see chapter 2 of The guidelines manual).

2.4.1 Forming and running the short clinical guideline GDG

2.4.1.1 Each short clinical guideline is developed by a unique GDG consisting of 8–12 members, supported by the Internal Clinical Guidelines Programme technical team at NICE. Each GDG has a Chair, healthcare professional members and a minimum of two patient and carer members. Co-opted expert advisers are recruited as appropriate. A Clinical Adviser, who has specific content expertise and additional responsibilities, may be appointed depending on the topic. Recruitment of the GDG Chair and members is carried out in accordance with NICE's policy Appointments to guidance producing bodies advisory to NICE (November 2006). The development phase of the guideline takes 4–6 months, and the GDG meets approximately every 4–6 weeks.

2.4.1.2 NICE reserves the option of selecting the GDG Chair from a pool of suitable members. This pool is recruited through a formal advertisement and recruitment process to act as standing members for each guideline. They are appointed on 3-year rolling contracts.

2.4.1.3 Healthcare professional members and patient and carer members of the GDG are recruited using the standard process (see section 3.1 of The guidelines manual).

2.4.1.4 The GDG makes its decisions using the best available evidence presented to it at GDG meetings by technical team. The use of formal consensus methods within the GDG will be considered on a case-by-case basis (see section 3.5 of The guidelines manual). However, formal consensus methods that seek the views of groups outside the GDG are unlikely to be used in the short clinical guideline process because of the short timeframe.

2.4.1.5 Comparison with the standard clinical guideline process. The process of forming and running the GDG outlined here is consistent with that for the standard clinical guideline programme (see chapter 3 of The guidelines manual). However, the development phase takes 4–6 months, compared with up to 18 months in the standard process. The process outlined in here is an adaptation of standard methods.

2.4.2 Developing review questions

2.4.2.1 A short clinical guideline has a narrow scope and covers only part of a care pathway. It addresses approximately three subject areas covering clinical management. This will result in a small number of key clinical issues (listed in the scope). These are broken down into a defined number of review questions – usually one or two per clinical management area. The exact number will be dictated by the size of the short clinical guideline remit and the amount of development time available. As with the standard clinical guideline programme, it is feasible to present a maximum of two systematic reviews per day at a GDG meeting. These review questions are formulated and structured according to the process for standard clinical guidelines (see chapter 4 of The guidelines manual).

2.4.2.2 Comparison with the standard clinical guideline process. The tightly focused scope and short development phase (4–6 months) mean that between three and six review questions are considered, compared with 15–20 review questions in the standard clinical guideline process.

2.4.3 Identifying the evidence

2.4.3.1 The short clinical guideline process follows the standard process for identifying evidence (see chapter 5 of The guidelines manual). However, there is no requirement to re-run searches for short clinical guidelines (as in section 5.9 of The guidelines manual).

2.4.4 Reviewing the evidence

2.4.4.1 The short clinical guideline process follows the standard process for assessing and summarising the evidence (see chapter 6 of The guidelines manual).

2.4.5 Incorporating health economics in the guideline and assessing health-economic impact

2.4.5.1 The short clinical guideline process in general follows the standard process for incorporating health economics in the guideline and assessing health-economic impact (see chapter 7 of The guidelines manual). However, given the short overall timeframe, it will be necessary to consider identifying relevant topics for health-economic analysis during the scoping phase.

2.4.6 Creating guideline recommendations

2.4.6.1 The short clinical guideline process follows the standard process for creating guideline recommendations (see section 9.1 of The guidelines manual).

2.4.6.2 The smaller number of review questions results in a smaller number of guideline recommendations. The number of recommendations in each short clinical guideline is likely to be between 5 and 20.

2.4.6.3 Research recommendations are formulated for short clinical guidelines. Their number is dependent on the size of the short clinical guideline remit.

2.4.6.4 Comparison with the standard clinical guideline process. The short clinical guideline process broadly follows the standard process for creating guideline recommendations and formulating research recommendations (see chapter 9 of The guidelines manual).

2.4.7 Writing the guideline

2.4.7.1 There are four versions of short clinical guidelines (see chapter 10 of The guidelines manual for further details):

2.4.7.2 The full guideline is written by the Internal Clinical Guidelines Programme technical team, following the principles in chapters 9 and 10 of 'The guidelines manual'. The NICE guideline, NICE pathway and 'Information for the public' are written by NICE editors.

2.4.7.3 In cases where an NCC is commissioned by NICE to develop a short clinical guideline, the full guideline is produced by the NCC.