NICE process and methods

Summary of main changes from the 2009 guidelines manual

Summary of main changes from the 2009 guidelines manual






This update of 'The guidelines manual' incorporates changes to the process of guideline development that were discussed at the NICE Board meeting in September 2011.

Other changes are small clarifications and minor adjustments to methods to reflect, for example, greater experience in the use of GRADE, and organisational issues such as the expanding remit to include development of social care guidance and the new work programmes within NICE, and changes in names of teams (for example, the Short Clinical Guidelines Team is now called the Internal Clinical Guidelines Programme).



Minor revisions throughout this chapter, including:

  • referring people to the NICE website for details of NICE's other activities rather than detailing them in the manual, to allow for anticipated changes in NICE's functions over the next few years.

  • reflecting the Equality Act 2010.


The scope

Revisions throughout the chapter to reflect process changes approved previously by the NICE Board.

Editorial changes to emphasise the role of clinical guidelines in informing the subsequent development of quality standards.


The Guideline Development Group

Revisions to reflect changes in the wider NHS environment.


Developing review questions and planning the systematic review

Minor revisions throughout, including updating the examples of review questions.


Identifying the evidence: literature searching and evidence submission

Minor revisions, including:

  • updating links to webpages for databases and other information

  • removing text from section 5.5 referencing particular suppliers of reference management software.


Reviewing the evidence

Minor revisions, including to:

  • reflect further minor changes in GRADE

  • describe the possible use of indirect and mixed treatment comparisons

  • reference the update to the AGREE tool.


Assessing cost effectiveness

Minor revisions, including to:

  • emphasise the involvement of the health economist within the guideline team at all stages

  • clarify the use of and methods for reviews of economic studies

  • clarify the requirements for some aspects of the analysis and reporting of new economic analyses conducted for the guideline, particularly around sensitivity analyses and reporting of all outcomes

  • refer to the Guide to the methods of technology appraisal for additional considerations (for example, life-extending treatments) that GDGs should take into account when developing recommendations.


Linking clinical guidelines to other NICE guidance

Changes to reflect new work programmes within NICE and changes to policy on the appropriate route for appraising significant new medicines within NICE.


Developing and wording guideline recommendations

Minor revisions, including to:

  • clarify and revise examples around the interpretation of the strength of evidence, and wording of recommendations

  • update the text about off-label prescribing (in consultation with the MHRA)

  • reflect the NICE research recommendations manual

  • emphasise the potential role of key priorities for implementation for informing subsequent development of quality standards.


Writing the clinical guideline and the role of NICE editors

Minor revisions, including to:

  • reflect developments in the templates

  • remove the requirement to present an algorithm in the NICE guideline

  • add details about NICE pathways

  • reflect the name change from 'Understanding NICE guidance' to 'Information for the public'.


The consultation process and dealing with stakeholder comments.

Revisions to reflect:

  • changes to validation processes agreed by the NICE Board

  • removal of commissioned expert peer review.


Finalising and publishing the guideline

Revisions to reflect:

  • changes to processes agreed by the NICE Board

  • changes in the documents produced by NICE.


Implementation support for clinical guidelines

Revisions to reflect the evolving role of implementation support.


Updating clinical guidelines and correcting errors

Revisions to reflect:

  • the evolution of the methods and process used to assess the need to update guidelines

  • the way updates to guidelines are presented for consultation and publication

  • the updated NICE process for handling errors.

An interim clinical guideline surveillance process and methods guide was published by NICE in August 2013, which replaces sections 14.1 and 14.2 in this guidelines manual. This interim process applies to guidelines being considered for updating from August 2013 onwards.

Appendix A

Agreements and advice for Guideline Development Group members

Minor revisions.

Appendix B

Study design checklist


Appendix C

Methodology checklist: systematic reviews and meta-analyses

Title change: now appendix B; no change to content.

Appendix D

Methodology checklist: randomised controlled trials

Title change: now appendix C; no change to content.

Appendix E

Methodology checklist: cohort studies

Title change: now appendix D.

Minor revisions to the supporting notes.

Appendix F

Methodology checklist: case–control studies

Title change: now appendix E; no change to content.

Appendix G

Methodology checklist: the QUADAS tool for studies of diagnostic test accuracy

Title change: now appendix F.

Existing QUADAS checklist replaced by new QUADAS-2 checklist.

Appendix H

Methodology checklist: economic evaluations

Title change: now appendix G.

Minor revisions.



Methodology checklist: qualitative studies

Title change: now appendix H.

Rewording of some of the current criteria to be more in line with guideline development terminology, and to be more user friendly.

Removal of some criteria that are not applicable to guideline development.

Appendix J

Methodology checklist: prognostic studies

Title change: now appendix I; no change to content.


Evidence tables

Title change: now appendix J.

New examples of tables included.

Appendix L

Modified GRADE profile

Title change: now appendix K.

Deletion of the word 'Modified'.

Example replaced by a GRADE profile generated by GRADE pro version 3.6.

Appendix M

Abbreviations and glossary

Title change: now appendix L.

Removal of terms that are incorporated within the main NICE glossary.

Appendix N

Guide to the short clinical guideline process

Title change: now appendix M.

Minor revisions to reflect changes to the process.

Appendix O

How NICE clinical guidelines are developed: an overview for stakeholders, the public and the NHS

Title change: now appendix N.

Changes to reflect changes in manual chapters.

Removal of the 'Proposing and selecting topics for clinical guidelines' section (note that NICE's Senior Management Team has decided to remove the clinical guideline topic suggestion facility from the NICE website until future prioritising arrangements can be agreed with the Department of Health and the NHS Commissioning Board).

Change in description of 'statutory' stakeholder organisations to 'standing' stakeholder organisations.