Process and methods

5 Development process

5.1 Equality and diversity considerations

All good practice guidance is developed in accordance with the NICE equality scheme.

5.2 Process and timescales

Table 1 shows the key steps in the development of the good practice guidance.

Table 1 Production process outline and timetable

Stage

Week

Preliminary literature search, development of scope and project plan

In advance of start of process

Literature search, review and gap analysis

Weeks 0–7

GDG recruitment

Weeks 1–9

Produce proposed structure (based on literature search and scope)

Weeks 8–12

1st GDG meeting

Week 13

Identification of any additional evidence

Week 13

Request for and receipt of written evidence (if required)

Weeks 13–17

Authoring of 1st draft

Weeks 13–16

2nd GDG meeting (face to face)

Week 17

Authoring of 2nd draft

Weeks 17–25

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

Week 21

Authoring subgroup (if required)

Week 23

4th GDG meeting

Week 26

Authoring of 3rd draft and preparation for consultation

Weeks 26–28

Consultation phase

Weeks 29–32

Authoring of 4th draft

Weeks 33–37

Collate consultation comments and produce consultation response table

Weeks 32–43

5th GDG meeting – validation. Review of comments and amendment of final draft

Weeks 38

Internal document production process

Weeks 39–43

Guidance Executive

Week 44

Publication

Week 46

Note: The exact length and timing of each stage of the process will vary dependent on topic and scheduling conflicts. The number of Guidance Development Group (GDG) meetings may vary according to the needs of the good practice guidance being developed. The overall length of the process will normally be between 36 and 52 weeks.

5.3 Evidence gathering and appraisal

5.3.1 Literature search

Searching for evidence

A literature search is undertaken based on the scope.

Sifting and selecting the evidence

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

The sift of evidence includes relevant primary research that addresses the systems and processes for the safe handling and use of the medicines. If 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.

Appraising and categorising the prioritised evidence

The NICE project team appraises the evidence using a technique appropriate for the type of evidence.

5.3.2 Gap analysis

Following the appraisal of the published literature, the project team determines if there is sufficient published evidence to address the issues identified within the scope of the good practice guidance. This is documented in the form of a gap analysis. A summary of the published evidence and the gap analysis is provided to the GDG.

5.3.3 Additional evidence

The GDG reviews the evidence, its critical appraisal by the NICE project team, and the project team's gap analysis. If appropriate, the GDG determines 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 informs the drafting of, and mechanisms for, appropriate communications.

Any additional evidence received is appraised by the NICE project team in conjunction with the GDG using the same exclusion and inclusion criteria for published evidence. All evidence received is documented and assessed.

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

5.4 Framework for good practice guidance

The NICE project team drafts the good practice guidance using a standard framework, which includes as a minimum the following:

  • title and contents page

  • date and version control information

  • good practice recommendations

  • introduction

  • policy context

  • legislation and regulatory requirements

  • methodology

  • evidence

  • appendices:

    • glossary

    • search strategy

    • evidence selection process and criteria

    • GDG and project team members.

5.5 Reviews of drafts

A draft of the good practice guidance is circulated to the GDG for comments at appropriate stages of the process according to the project schedule.

A draft is also made available for stakeholders to comment on during a scheduled consultation period (see table 1 and section 5.7) after stakeholder registration.

External expert reviewers may be identified by the NICE project team to review part or all of the good practice guidance. This may take place during guidance development or during the consultation phase for the draft guidance. If external advisers comment during consultation, their comments are responded to in the same way as comments from registered stakeholders, and are published in the consultation table on the NICE website under 'expert advisers'.

5.6 Quality assurance

Quality assurance of the good practice guidance is undertaken by the NICE project team. The NICE Publishing team also reviews the good practice guidance and recommends further revisions as necessary.

5.7 Consultation

The draft good practice guidance is posted on NICE's website for a 4-week public consultation period (see table 1). All registered stakeholders receive notification when consultation starts. Only registered stakeholders or experts selected by the NICE project team are able to comment during consultation. The NICE project team logs and collates all stakeholder comments. These are considered by the GDG and responses documented. The GDG agrees the final draft guidance and recommendations. Consultation comments and responses are made available on NICE's website.

Feedback that may delay the publication of the guidance is escalated to the NICE Medicines and Prescribing Centre Programme Director.

5.8 Sign off and publication

The final draft is signed off by the Centre for Clinical Practice Director, Medicines and Prescribing Centre Programme Director and Medicines Advice Associate Director. The draft guidance is then taken to the NICE Guidance Executive for approval for publication.

The final good practice guidance is uploaded to the NICE website.