NICE process and methods

5 Developing a patient decision aid

5 Developing a patient decision aid

5.1 Equality and diversity

NICE decision aids are developed in line with NICE's equality scheme and declaration of interests policy.

5.2 Process overview and timelines

The key steps in developing a NICE decision aid

Timeline

Process overview

Weeks 1 to 3

Confirm the project aim and specification, including liaison with any external commissioner or partner

Weeks 1 to 3

Form the scoping group – identify clinical and patient experts

Weeks 4 to 6

Scope the decision aid with the scoping group

Additional 4 to 7 weeks

Evidence update completed between these steps if needed.

Weeks 7 to 8

Confirm project group and produce first draft

Weeks 9 to 10

Project group review and amend draft decision aid to reflect project group comments

Week 11

Project group meeting

Weeks 12 to 14

Amend draft after project group meeting, further project group review and amends made

Weeks 14 to 17

Technical accuracy check. Decision aid produced in InDesign format ready for stakeholder review

Weeks 18 to 21

Stakeholder review and user testing

Weeks 22 to 24

Amendments following stakeholder review and user testing made and reviewed by project group. Decision aid updated and prepared for sign-off

Week 25

Internal team sign-off

Weeks 26 to 28

Executive sign off and publication

5.3 Scoping

The development team agrees the aim and specifications of the decision aid with the relevant NICE team and the commissioner or partner (as appropriate). This includes agreeing the aim (user need) and the MoSCoW criteria.

The user need is stated as:

As [specify the population, for example 'an adult newly diagnosed with chronic primary pain'] facing the decision about [specify options, including the option of having no treatment or not changing what the person is currently doing], I need clear, understandable information about what the options involve and the associated possible risks, benefits and consequences; so that I can make an informed choice knowing which of those matter most to me.

The MoSCoW criteria specify content that:

  • Must be included: omitting any of these would constitute project failure

  • Should be included: things that would ideally be included but are not essential in the same way as must-haves and the need for which may be met in a different way

  • Could be included: things that are desirable but not necessary, things that would improve the user experience

  • Will Not be included: things that are out of scope.

The project group then defines the detailed content (for example, which possible harms, benefits and consequences to cover), and advises on other information that the writers need, such as language to use. All NICE-produced decision aids are consistent with relevant NICE guidance.

5.4 Evidence for use in NICE decision aids

NICE decision aids are based on the best available evidence. The primary evidence source is normally the evidence review or submission used in developing the relevant NICE guidance. Where necessary, individual studies included in evidence reviews or submissions may be examined for further data. Studies excluded by the guidance development process are not used. Additional information may be taken from other NICE guidance and advice, and from standard reference sources including the NHS website (www.nhs.uk), NICE Clinical Knowledge Summaries (CKS) and (for information on adverse effects, monitoring requirements and similar matters relating to medicines) manufacturers' summaries of product characteristics (SPCs) and the BNF.

In exceptional circumstances a targeted literature search is undertaken by NICE's information services. This step will be considered only if:

  • evidence to address an essential component of the scope has not been identified within the evidence reviews or submission used in the development process for the guidance, or

  • the relevant part of the guidance was last updated more than 3 years previously or more recent evidence has been highlighted to NICE's guideline surveillance process, or

  • the topic for an externally commissioned decision aid has not been the subject of NICE guidance published in the previous 3 years.

The process for searching for and selecting the evidence is described in appendix A: Searching for and selecting evidence for use in NICE decision aids. The rationale for including or excluding evidence is recorded. All evidence used in the decision aid is agreed with the project group. NICE decision aids use only evidence that is in the public domain.