Process and methods

4 Production

4.1 Equality and diversity considerations

Key therapeutic topics are developed in accordance with the NICE equality and diversity policy.

4.2 Process and timescales

Key therapeutic topics are not formal NICE guidance and therefore are not subject to the same intensity of process as other NICE products.

Table 1 shows the key steps in the annual update of key therapeutic topics.

Table 1 Key steps for annual development of key therapeutic topics with timelines

Key Step

Timescale

Topic identification, prioritisation and selection

NHS England Medicines Optimisation Intelligence Group identifies potential key therapeutic topics to be retained, retired or added, to produce draft list of topics

June

NHS England Medicines Optimisation Intelligence Group prioritise topics and amend draft list of topics as appropriate

June

Draft list of topics to be retained, retired or added published on NICE website for feedback

July

Feedback on draft list of topics to be retained, retired or added ends

Early August

NHS England Medicines Optimisation Intelligence Group considers feedback, NICE Medicines and Prescribing Team produce final list of topics to be agreed by NICE Guidance Executive

August

Final list of topics to be retained, retired or added published on NICE website

September

Table of comments and responses to feedback on draft list of topics to be retained, retired or added published on NICE website

September

Production

NICE Medicines and Prescribing Team scope individual key therapeutic topic content

July

NICE Medicines and Prescribing Team senior advisers author content

August/September

NICE Medicines and Prescribing Team senior advisers technical check of content

October

Check of content by NICE Medicines and Prescribing Team associate director and programme director

October/November

Draft content of key therapeutic topics published on NICE website for feedback

Late November

Feedback on draft content of key therapeutic topics ends

December

NICE Medicines and Prescribing Team revise draft as appropriate

January

NICE Medicines and Prescribing Team senior advisers editorial check of content

January

Final check of content by NICE Medicines and Prescribing Team associate director and programme director

January

NICE Publication Executive sign off

February

Final key therapeutic topics published on NICE website

Early March

Table of comments and responses to feedback on draft content of key therapeutic topics published on NICE website

Early March

4.3 Scoping of selected key therapeutic topics

The NICE Medicines and Prescribing Team holds an internal meeting to scope the content for each selected key therapeutic topic (either an existing topic or a new topic) to:

  • Identify and review important, 'high-level', therapeutic evidence for each key therapeutic topic, such as NICE guidance, recommendations from the Medicines and Healthcare products Regulatory Agency (MHRA), or NICE Medicines and Prescribing Team outputs.

  • Identify relevant prescribing metrics for each key therapeutic topic.

  • Agree the content for each key therapeutic topic, to ensure current best practice and prescribing issues for each topic are up to date.

  • Agree if any key therapeutic topic requires a literature search. A literature search is only considered if national guidance, advice or policy is not available. For most topics a literature search will not be required.

4.4 Authoring of key therapeutic topics

NICE Medicines and Prescribing Team advisers draft the content of each key therapeutic topic using a standard template, which includes sections relating to the following:

  • foreword

  • for each key therapeutic topic:

    • options for local implementation

    • evidence context

    • prescribing data, metrics or supporting resources.

4.5 Review of key therapeutic topics

The draft content of each key therapeutic topic is made available on the NICE website, and comments invited for a 4-week period. Key groups involved in the production of key therapeutic topics, such as the NHS England Medicines Optimisation Intelligence Group, the Department of Health, NHS Digital and internal key NICE teams including clinical guidelines and technology appraisals, are sent an email inviting them to comment. Any comments received are considered within the production of the revised draft. Feedback is collated by NICE Medicines and Prescribing Team staff and responses produced for each element of feedback. A table detailing these comments and responses is published on the NICE website when the final content of the key therapeutic topics is published.

4.6 Quality assurance of key therapeutic topics

NICE Medicines and Prescribing Team advisers quality assure the content of each key therapeutic topic to a checklist. This involves a detailed check to ensure the content of each topic contains statements and conclusions that are fair and balanced. They must accurately reflect the evidence reviewed and be substantiated by an explicit and appropriate source of evidence. A further check for clarity, grammar, spelling and style is also undertaken. All drafts and any changes to drafts are recorded for audit purposes.

The NICE Medicines and Prescribing Team, in conjunction with the NICE publishing team, produce a near-final draft. Once sign-off is received from the Programme Director of the NICE Medicines and Prescribing Team, NICE Publication Executive reviews the key therapeutic topics and if appropriate approves them for publication, ensuring that due process has been followed in its development.

4.7 Publication of key therapeutic topics

The final key therapeutic topics are uploaded and made available online through the Medicines and Prescribing Team Key Therapeutic Topics page of the NICE website.

The NICE Communications team develops a communications plan for the key therapeutic topics, together with the Associate Director within the Medicines and Prescribing Team, and is responsible for disseminating the key therapeutic topics once they have been published.