Developing NICE guidelines: the manual

Major changes since publication

January 2024: Major changes from the 2023 guidelines manual are as follows:

Chapter 2: The scope

We included details of scopes for topic suites, added additional details on NICE's updated approach to considering health inequalities, information on consultation time of scopes was changed to 2 to 4 weeks (except for small updates), simplified the process for scopes for updates and streamlined the chapter including the removal of operational detail.

Chapter 5: Identifying the evidence: literature searching and evidence submission

We added information outlining living evidence surveillance, search sources were updated, more information was added on real world data and NICE's updated approach to considering equalities and health inequalities was added.

Chapter 9: Interpreting the evidence and writing the guideline

We added a table outlining 'topic areas we do not usually make recommendations on', the chapter was restructured to provide a more logical flow and NICE's updated approach to considering equalities and health inequalities was added.

Chapter 11: Finalising and publishing the guideline recommendations

We added NICE's updated approach to considering equalities and health inequalities, clarified the information around embargoed release of guideline recommendations and sections on promoting awareness of guidelines were updated to match current practice.

Chapter 12: Support for putting the guideline recommendations into practice

We have added emphasis on partnership working and supporting implementation, updated the section on tools and resources to reflect current practice, added additional detail on assessing, and measuring the use of guidance, and using that system intelligence in the guideline lifecycle and removed details on endorsement.

Appendix L: Process and methods for guidelines developed in response to health and social care emergencies

We removed duplicate information which repeated content in the main guideline manual and added additional text on how recommendations on medicines are dealt with in partnership with CHTE.

December 2023: We added a new appendix P on updating guideline recommendations, which includes information on types of update, identification of topics, full updates and routine editorial maintenance.

November 2023: We added a new appendix O on interim principles for monitoring approaches of guideline recommendations through surveillance. We also added information on how we will consolidate and streamline our guideline content to appendix M.

August 2023: Major changes from the 2022 guidelines manual are shown below.

Chapter 1: Introduction

We have described the future approach to developing guidelines, including producing digital living guideline recommendations for some topics. We have also made changes to reflect updated processes and methods covered in chapters 4, 6 and 7, and added information on our approach to reducing inequalities.

Chapter 4: Developing review questions and planning the evidence review

We have added a new section on considering health inequalities when preparing review questions, and signposted our real-world evidence framework.

We have added details on writing review protocols to support mixed-methods reviews, qualitative methods and other newer evidence review methods, and on considering medicines safety information and antimicrobial stewardship in protocols.

Chapter 6: Reviewing evidence

We have added details of our approach to equalities and health inequalities when developing recommendations, and signposted our real-world evidence framework. We have also included advice on reusing existing systematic reviews or recommendations from non-NICE producers in evidence reviews to reduce the time and cost of developing recommendations.

We have added details on mixed-methods reviews, qualitative methods and other newer methods, and on considering medicines safety information and antimicrobial stewardship.

Chapter 7: Incorporating economic evaluation

We have made changes to align with the Centre for Health Technology Evaluation methods and processes. The exception is the severity modifier. We are exploring approaches to applying the severity modifier in NICE guidelines.

We have signposted our real-world evidence framework, and added information about a tool to explore providing quantitative estimates of the impact of guideline recommendations on health inequalities. We encourage guideline developers to pilot this tool.

Appendices: We have made minor changes to appendices B, H, I, J and K, to make them accessible, and add examples of additional consultation (appendix B) and expert testimony (appendix J).

January 2022: Major changes from the 2018 guidelines manual are shown below.

Chapter 1: introduction

We have put more emphasis on addressing health inequalities.

Chapter 2: the scope

We have added a new shorter process for scoping, with more emphasis on addressing health inequalities.

Chapter 4: Developing review questions and planning the evidence review

We have added more information on mixed methods reviews and prediction models.

Chapter 5: Identifying the evidence: literature searching and evidence submission

We have added an option for the use of RCT classifiers, and removed OpenGrey as a potential source.

Chapter 6: Reviewing evidence

We have made searching for conference abstracts 'optional' and made it an option for there to be no distinction between 'critical' or 'important' outcomes. We have specified that data extraction for complex analyses (such as network meta-analyses) should be checked by 2 reviewers. We have added instructions for mixed methods reviews. Example evidence statements have been removed (apart from prognostic examples).

Chapter 7: Incorporating economic evaluation

We have removed the end-of-life modifier section as this was a technology appraisal policy applied to NICE guidelines, which the Centre for Health Technology Evaluations (CHTE) have now withdrawn. NICE guidelines will also discontinue its application.

Chapter 8: Linking to other guidance

We have added information on updating NICE technology appraisals in guidelines.

Chapter 9: Interpreting the evidence and writing the guideline

We have added clarification for 'offer', 'consider' and 'do not offer' recommendations. We have given more details on medicines, including dosing information and therapeutic monitoring. We have added options for not making a recommendation when there is insufficient evidence.

Chapter 10: The validation process for draft guidelines, and dealing with stakeholder comments

We have added an option for a 2-week consultation for a small update of 1 or 2 review questions, and added information to differentiate between additional consultation and commissioned primary research.

Chapter 11: Support for putting the guideline recommendations into practice

We have added information about press launches of guidelines.

Chapter 13: Ensuring that published guidelines are current and accurate

We have emphasised proactive surveillance, and removed 5-year routine surveillance.

Appendix B: Approaches to additional consultation and commissioned primary research

We have added information and guidance on additional consultation and commissioned primary research, and given more information on the differences between these 2 processes.

Appendix G: Sources for evidence reviews

We have added sources of primary or real-world data.

Appendix H: Appraisal checklists, evidence tables, GRADE and economic profiles

We have added a checklist for mixed methods reviews.

Appendix J: Call for evidence and expert witnesses

We have added more guidance on conducting a call for evidence and involving expert witnesses.

Appendix L: Process and methods for guidelines developed in response to health and social care emergencies

We have provided a new process and methods for guidelines developed in response to health and social care emergencies.

January 2021: We amended the text on assessing new medicines and significant new indications to clarify that this will be carried out in line with the 2019 voluntary scheme for branded medicines pricing and access published on the GOV.UK website.

October 2020: We amended the text on topic-specific committees to indicate that they may work on multiple guidelines within a topic area, with membership subject to renewal for a total period of up to 10 years.

July 2020: We added process and methods for guidelines developed in response to health and social care emergencies (appendix L).

October 2018: Major changes from the 2014 guidelines manual are shown below.

Service delivery

Methods for developing recommendations on service delivery have been incorporated into the manual, with information added to the chapters on scoping, searching, evidence submission and economics. We have added a new appendix (appendix A) with detailed advice on developing review questions in this area.

Primary data analytics

NICE is currently exploring the place of primary data analytics in our work and further advice will be shared as this develops.

Chapter 2 – the scope

We encourage developers to list areas where evidence is lacking and details of stakeholders who might provide information in a call for evidence or who might identify expert witnesses.

We are clear that guidelines don't usually include key issues covered by bodies such as the Department of Health and Social Care, NHS England or Public Health England.

We remind developers that guidelines don't usually cover training requirements. However, recommendations may cover the need for specific knowledge and skills for a particular aspect of care.

Chapter 3 – decision-making committees

We encourage developers to think about other related NICE guidance in development and promote cross-representation across committees when topics are closely related.

We include advice for developers about seeking expert testimony from children and vulnerable groups, including use of video recording and giving testimony in private session.

We have made changes to ensure consistency with the updated code of practice for declaring and dealing with conflicts of interest. We have also clarified the involvement of tobacco companies as respondents rather than stakeholders.

Chapter 4 – developing review questions and planning the evidence review

We indicate that core outcome sets (one source is the COMET database) should be used if suitable based on quality and validity. We give standards for assessing the suitability of core outcome sets.

We include review questions that assess diagnostic prediction models and prognostic prediction models and link to external sources of further advice.

We have included a standard template for review protocols as an appendix (appendix I). Registration of the review protocol on the PROSPERO database is now mandatory.

Chapter 5 – identifying the evidence

We have included new sources, tools and approaches to searching, as well as a new prompt for identifying MHRA safety information.

Chapter 6 – reviewing the evidence

We now recommend GRADE as the first approach to quality assessment for all guidelines, including those covering public health and social care topics. We recommend GRADE-CERQual for qualitative evidence.

Results of the analysis and confidence in the evidence should now be presented as GRADE profiles. Evidence statements should be presented when the GRADE approach is not used.

We now have preferred 'checklists' for assessing the quality of the evidence (see appendix H). Use of any other checklist should be agreed in advance with NICE staff with a quality assurance role.

We now indicate that an agreed proportion of papers should be sifted by 2 analysts (not less than 10%) because duplicate sifting of all papers is time consuming and there are other ways of ensuring that relevant papers aren't missed. We have included details of using a machine learning algorithm for priority screening.

We include advice on the minimum outputs and reporting standards for network meta-analyses (see appendix K) and how these apply to developing NICE guidelines.

Chapter 7 – economic evaluation

For base-case analysis, we recommend a cost–utility analysis using a cost per QALY. This will allow more consistent decisions related to costs.

We have clarified that the same levels of evidence and considerations should be used for disinvestment and investment decisions.

We have added information on end of life criteria in line with technology appraisal methods.

Chapter 8 – linking to other guidance

We advise linking to technology appraisal recommendation in the NICE Pathway rather than incorporating TA recommendations verbatim in a guideline.

We have removed the details on updating technology appraisals within a guideline and have added a link to the policy from the Department of Health and Social Care.

We include advice for developers on what to do when similar review questions are covered in other guidelines. Options include linking to the recommendations in the other guideline, using the evidence review to make new recommendations or doing a new systematic review.

Chapter 9 – Interpreting the evidence and writing the guideline

We have simplified advice on writing guidelines, and a separate writing guide with more details and examples will be coming soon.

The section on supporting shared decision-making has been clarified, and includes information on when a separate decision aid could be produced. The writing guide includes more detail on summarising evidence in the guideline to support a professional's discussion with the person making the decision.

We have added new advice on what to do when recommendations are made for the use of CE-marked devices outside their instructions for use. This includes standard footnote wording.

We have clarified advice on recommendations on the off-label use of medicines.

Chapter 10 – validation

We have defined the types of 'additional consultation' that can inform development. There is more information about the changes in appendix B.

Chapter 12 – implementation

Information on how we work and the tools we produce has been updated. A new section on how we work with other organisations, including endorsing resources, has also been added.

We highlight the role of the new Guideline Recommendations Implementation Panel.

Chapter 13 – surveillance

We have focused the process on event-driven checks of guidelines as well as a standard check every 5 years.

We plan themed surveillance of guidelines covering similar populations or settings to ensure that the process is efficient.

We have revised the process for considering whether to remove a guideline from the static list.

We have indicated that we may refresh some recommendations following an event-driven or standard check.

We have added information about the quality assurance of the surveillance process.

Chapter 14 – updating guidelines

We have added a new section on refreshing recommendations, to make minor changes to improve the usability of recommendations without the need for an evidence review or committee input.

Minor changes since publication

April 2024: We added a sentence to the section on off-label use of licensed medicines to say that we clearly state when a medicine is being used for off-label use.

September 2023: We added details about the responsibilities of suite faculties to appendix M.

July 2023: We amended appendices M and N to separate, and clarify, surveillance tasks from topic prioritisation tasks.

June 2023: We amended the definition of quality assurance to remove mention of commissioning the developer.

May 2023: We published our NICE interim principles for methods and processes for supporting digital living guideline recommendations (appendix M) and surveillance decision framework and multi-criteria decision framework (appendix N) for deciding whether to develop or update recommendations and which methods to use.

March 2023: We added text in section 4.5 to say that the review questions are published on our website 6 weeks before consultation.

October 2022: We added information to the introduction in relation to the consultation on updating this manual.

September 2022: We added text to section 2.4 to clarify that some small updates will not have a consultation.

November 2020: We aligned the publication of declarations of interest for members of independent advisory panels with process and methods for standard guideline development.

January 2020: A statement was added to the introduction and overview section to reflect the publication of our list of NICE principles. They succeed our social value judgements document which was first published in 2005.

ISBN: 978-1-4731-5692-0