NICE process and methods

5 Development process for good practice guidance

5 Development process for good practice guidance

5.1 Equality and diversity considerations

All good practice guidance is developed in accordance with the NICE equality scheme (available from http://www.nice.org.uk/aboutnice/howwework/niceequalityscheme.jsp).

5.2 Process and timescales

Table 2 shows the key steps in the development of the good practice guidance.

Table 2: Production process outline and timetable

Stage

Week

Preliminary literature search, development of scope

In advance of start of process

Literature search and review

Week 1

GDG recruitment

Weeks 0–6

1st GDG meeting

Week 6

Identification of any additional evidence

Week 6

Request for and receipt of written evidence (if required)

Weeks 6–8

Authoring of 1st draft

Weeks 9–10

2nd GDG meeting (face to face)

Week 11

Authoring of 2nd draft

Weeks 11–15

Consideration of oral testimony (if required)/3rd GDG meeting

Week 15

Authoring of 3nd draft - preparation for consultation

Weeks 16–20

Consultation phase

Weeks 20–24

4th GDG meeting - validation. Review of comments and amendment of final draft

Weeks 24–25

Internal document production process

Weeks 25–28

Guidance Executive

Week 29

Publication

Week 30

Note: the number of GDG meetings may vary according to the needs of each good practice guidance.

5.3 Evidence gathering and appraisal

5.3.1 Literature search and appraisal

Searching for evidence

A literature search will be undertaken based on the scope.

Sifting and selecting the evidence

The NICE Medicines and Prescribing Centre project team will sift the search results using the title and abstract of each article, applying first exclusion and then inclusion criteria. These criteria include the basic criteria as set out below.

First sift

This process removes evidence based on the following exclusion criteria:

  • articles of poor relevance against search terms

  • non-English language abstracts or non-English language articles with English abstract.

Second sift

This sift of evidence includes relevant primary research that addresses the systems and processes for the safe handling and use of the medicines. Where robust randomised controlled trials or systematic reviews are available, they form the basis of the review. However, given the nature of the topics, the best available evidence on which to produce the good practice guidance may include evidence other than randomised controlled trials.

The project team will record the reasons for non-inclusion based on the second sift as well as a 'long list' of those articles that are excluded from the first sift.

Appraising and categorising the prioritised evidence

The NICE Medicines and Prescribing Centre project team will critically appraise the evidence, recording decisions in an evidence log. The full text of the prioritised evidence will be appraised using a technique appropriate for the type of evidence.

5.3.2 Gap analysis

Following the appraisal of the published literature the project team will determine if there is sufficient published evidence to address the issues identified within the scope of the generic medicines advice. This will be documented in the form of a gap analysis. A summary of the published evidence and the gap analysis will be provided to the GDG.

5.3.3 Additional evidence

The GDG will review the evidence, its critical appraisal by the NICE Medicines and Prescribing Centre project team, and the project team's gap analysis. The GDG will, if appropriate, determine the most appropriate method for sourcing further evidence identified from the gap analysis. This may be in the form of a call for evidence from service providers and commissioners. The GDG will inform the drafting of and mechanisms for appropriate communications.

Any additional evidence received will be appraised by the NICE Medicines and Prescribing Centre project team in conjunction with the GDG using the same exclusion and inclusion criteria for published evidence. All evidence received will be documented and assessment of the validity of the evidence recorded within the evidence log.

The GDG will review the relevant evidence gathered through this method together with evidence from published sources and determine if further evidence is required to address issues within the scope where there is still an evidence gap or further information relating specific issues is required.

5.4 Framework for good practice guidance

The project team will draft the good practice guidance using a standard framework, which includes as a minimum the following sections:

  • Title and contents page

  • Date and version control information

  • Good practice recommendations

  • Introduction

  • Policy context

  • Methodology

  • Evidence

  • References

  • Appendices:

    • Search strategy

    • Evidence selection process and criteria.

5.5 Reviews of drafts

Draft documents will be circulated to the GDG for comments at appropriate stages of the process according to the project schedule.

A draft will be made available for stakeholders to comment on during a scheduled consultation period (See table 2 and section 5.7).

5.6 Quality assurance

Quality assurance of the good practice guidance will be undertaken by the NICE Medicines and Prescribing Centre project team. The NICE Editorial team will also review and recommend further revisions as necessary.

5.7 Consultation

The draft document will be posted on NICE's website for a 4 week public consultation period (see table 2). When the consultation document is uploaded, all interested parties who have registered as stakeholders will receive an automatic email to alert them of the start of the consultation. Comments will be collated by the NICE Medicines and Prescribing Centre project team for consideration by the GDG. The GDG will agree the final recommendations. Consultation comments and responses will be made available on NICE's website.

5.8 Sign off and publication

The final draft will be signed off by the NICE Medicines and Prescribing Centre Programme Director, and sent to the NICE Guidance Executive for approval for publication.

The good practice guidance is uploaded to the Medicines and Prescribing Centre pages of the NICE website.