Developing Clinical Guidelines for both Primary and Secondary Care

Development of the guideline

What is a guideline?

Our clinical guidelines provide recommendations for the care of individuals with specific clinical conditions or circumstances. Recommendations can cover prevention and self-care, primary and secondary care treatments and interventions, and more specialised services. We base our clinical guidelines on the best available research evidence, with the aim of improving the quality of healthcare. Predetermined and systematic methods are used to identify and evaluate the evidence relating to specific clinical questions.

Clinical guidelines can:

  • provide recommendations for the treatment and care of people by health professionals
  • be used to develop standards to assess the clinical practice of individual health professionals 
  • be used in the education and training of health professionals
  • help patients to make informed decisions
  • improve communication between patient and health professional.

While guidelines assist the practice of healthcare professionals, they do not replace their knowledge and skills.

Developing clinical guidelines

The following provides a brief summary of how we develop clinical guidelines. For more detailed information please refer to the NICE guidelines manual.

1. The guideline topic is referred

The Department of Health refers clinical guideline topics to NICE, which commissions one of its specialist Centres to produce the clinical guidelines. Topics relating to general, chronic and acute conditions are referred to the NCGC; other NICE funded Centres specialise in topics relating to cancer, mental health, and women's and children's health. Read more about how guideline topics are chosen on the NICE website.

2. Stakeholders register an interest  

Stakeholders are usually: 

  • national organisations representing patients and carers and/or healthcare professionals
  • companies that manufacture medicines or devices related to the guideline topic
  • providers and commissioners of health services
  • statutory organisations
  • research organisations that have produced nationally recognised research related to the guideline topic.

Read more about stakeholder registration on the NICE website. Stakeholders are consulted throughout the guideline development process.

3. The scope is prepared by the NCGC

The NCGC prepares the scope. This document sets out what the guideline will and will not cover. NICE, registered stakeholders and an independent guideline review panel all contribute to the development of the scope.

4. The guideline development group is established

The NCGC establishes the guideline development group (GDG) through an open recruitment process. The GDG consists of healthcare professionals, patient and carer representatives and technical experts.

5. A draft guideline is produced

The GDG searches for and assesses the best available evidence according to the methodology set by NICE (see NICE guidelines manual) and makes recommendations.

6. Consultation on the draft guideline

There is at least one public consultation period for registered stakeholders to comment on the draft guideline. An independent guideline review panel ensures that stakeholder comments have been responded to appropriately and taken into account.

7. The final guideline is produced

Once the stakeholder comments have been considered and the guideline updated, the NCGC produces the final guideline.

8. The Guidance is issued

NICE formally approves the final guideline and issues its guidance to the NHS.

The NCGC and NICE produce a number of versions of this guideline:

  • the full guideline contains all the recommendations, plus details of the methods used and the underpinning evidence
  • the NICE guideline presents the recommendations from the full version in a format suited to implementation by health professionals and NHS bodies
  • the Quick Reference Guide (QRG) presents recommendations in a suitable format for health professionals
  • Understanding NICE guidance (UNG) is information for the wider public and is written using suitable language for people without specialist medical knowledge.