The National Collaborating Centre for Primary Care (NCC-PC) is one of six collaborating centres set up by NICE.1 It is a professionally led organisation with the expertise, experience and resources required to develop clinical guidelines and audit for the NHS. Although based at the RCGP, the NCC-PC is best seen as a 'virtual' organisation, with its two academic partners - the Clinical Governance Research and Development Unit (CGRDU) at the University of Leicester, and the School of Health and Related Research (ScHARR) at the University of Sheffield 2 - delivering a programme of work commissioned by NICE.
The CGRDU came into existence on 1 April 1999 and is directed by Professor Richard Baker. Its principal function is research and development within the field of clinical governance.3 Research interests include methods of developing protocols for audit, implementing change in clinical practice, patient involvement, and monitoring of outcomes.
CGRDU staff have contributed to the preparation of Principles for Best Practice in Clinical Audit,4 NICEÍs guide to undertaking audit in the NHS in England and Wales, and suggestions for clinical audit contained in its publication Referral Advice.5
The NCC-PC Leicester was set up in December 2001 and has recently published its first audit protocol for NICE on the management of patients post-MI in primary care.6 It is currently developing two national evidence-based guidelines: Epilepsy: the diagnosis and management of epilepsy in children and adults and Referral guidelines for suspected cancer. Both of these guidelines will address important issues for primary care and should be published in 2004.
Epilepsy is a common neurological disorder characterised by recurring seizures. Optimal management can improve health outcomes and can also help to minimise the conditionÍs detrimental impact on patientsÍ education, employment and social activities.
The cancer referral guideline will address the initial symptoms and signs that should lead the clinician to suspect cancer. Cancer was responsible for a quarter of all deaths in England and Wales in 1997,7 and delays in suspecting cancer, arranging referral, and specialist assessment for diagnosis and treatment can lead to poor outcomes.
Guidelines are developed according to methods set out by NICE in its manual, Guideline Development Process - Information for National Collaborating Centres and Guideline Development.8 This draws on the review of guidelines methodology carried out by Eccles and Mason.9
The NICE guidelines programme has three important features:
- A strong commitment to patient involvement in the guideline development process; each guideline development group should include at least two patient/carer organisation representatives who will be supported by the Patient Involvement Unit funded by NICE.
- A need to address the cost-effectiveness of recommendations by considering health economic data during the guideline development process.
- An extensive consultation process for scoping and validation, involving a large number of stakeholders. The central unit of the NCC-PC based at the RCGP plays an important role in facilitating this process.
There are five key steps in guideline development.
Identifying and refining the subject area of a guideline
Given the resource implications of developing guidelines, particularly at national level, they should tackle clinical areas in which there is most potential for health gain:
- The condition should be a major cause of morbidity, mortality or disability;
- Effective interventions to improve clinical outcomes should exist;
- There should be evidence of unacceptable variation in clinical practice.
It is also important to refine the subject area of the guideline before the evidence is appraised so that searching can address specific questions relating to diagnosis, prognosis and treatment. This can be achieved by:
- Ensuring that it is focused and achievable;
- Constructing a disease care pathway to identify the common paths of patients as the disease runs its course, key intervention points and key outcomes that are affected by these interventions;
- Identifying key clinical questions.
Convening and running guideline development groups
The guideline development groupÍs job is to turn the evidence into recommendations for clinical practice. An important feature of the group is that membership should be multidisciplinary and represent all key stakeholders. This is important to ensure adequate discussion of the evidence when developing the recommendations.
The development of each guideline is supported by a methodology team based at the NCC-PC Leicester, consisting of a project lead, systematic reviewer, information specialist and health economist.
Obtaining and assessing the evidence
When a particular clinical question has been identified, the following four tasks must be undertaken to arrive at a summary of the evidence to be presented to the guideline development group:
- The clinical question is turned into one or more evidence-based questions. For example, the clinical question, ïWhat is the role of the epilepsy nurse specialist?Í becomes, ïIs there evidence for the effectiveness of specialist epilepsy nurses compared with routine care?Í
- Electronic databases are searched to identify relevant primary and secondary studies. All secondary studies (systematic reviews and meta-analyses) relating to the guideline topic are identified, and if they cannot provide valid or up-to-date answers to particular clinical questions, new searches are conducted.
- The identified studies are critically appraised.
- Summaries of the evidence are presented to the guideline development group.
This task of turning clinical questions into evidence statements is primarily the responsibility of the project team based at the NCC-PC Leicester.
Translating the evidence into recommendations
The guideline development group translates the evidence into recommendations for clinical practice using informal consensus of opinion.
Clinical areas for which there is no evidence generate more group discussion and disagreement than areas for which there is evidence.9
Where possible, these differences are resolved through informal consensus. However, the process of linking the recommendations to evidence allows an important distinction to be made between actual evidence of ineffectiveness and absence of evidence of effectiveness.
Arranging publication and external review of the guideline
Three versions of the guideline will be developed:
- A full version will be publishedÖby the NCC-PC Leicester. This will be an extensive document which will present all the summaries of the evidence used to generate the recommendations.
- A short version will be published by the Institute as the NICE guideline. This is the document for use by most ïend-usersÍ of guidelines.
- NICE will also publish a patient version of the guideline.
Quality control is clearly important in developing any guideline and this will be maintained in two ways:
- The project team will use the Appraisal of Guidelines Research and Evaluation (AGREE)10 instrument to ensure that all important aspects of guideline development are covered.
- The guideline will be sent out for external peer review. Although the guideline content remains the responsibility of the guideline evelopment group, feedback from experts in the field will provide important quality assurance.
NICE has a clear dissemination strategy to ensure that its guidelines are publicised in the media and are sent to all relevant stakeholder organisations both within and outside the NHS.
There remains the biggest challenge of all: Can we as guideline developers present evidence and recommendations in the most helpful manner, and can healthcare professionals employ the guidelines within the broader frame of clinical judgment to the benefit of individual patients?
In the next few years, NICE and SIGN will produce many new guidelines to which those working in primary care will be encouraged to respond. The challenge to primary care, where staff are already over-stretched, will be significant.
Issues such as these make the work of the primary care collaborating centre particularly important. It is essential that we at the NCC-PC and healthcare professionals in primary care work together to find the most effective and feasible ways of making the best use of guidelines.
|THE NCC-PC LEICESTER|
|Objectives||To develop clinical guidelines and audit advice for NICE, |
with particular reference to primary healthcare
|Funding||NICE. Funding is provided for infrastructure and on a project variable basis for individual guideline development groups|
|Key personnel:||Director:|| |
Professor Richard Baker
|Deputy Director:||Dr Tim Stokes|
|Systematic Reviewer:||Beth Shaw|
|Information Librarian:||Janette Camosso-Stefinovic|
|Health Economist:||Dr Allan Wailoo (ScHARR)|
|Administrative Support:||Vicki Cluley|
|Contact details:||Address: || |
National Collaborating Centre for Primary Care, Clinical Governance Research and Development Unit (CGRDU), Department of General Practice and Primary Health Care, University of Leicester, Leicester General Hospital, Leicester LE5 4PW
|Tel:||0116 258 4873|
|Fax:||0116 258 4982|
The views expressed in this article are those of the author and not necessarily those of either the Royal College of General Practitioners or the National Institute for Clinical Excellence.
- Lakhani M. The National Collaborating Centre for Primary Care. Guidelines in Practice 2002; 1: 71-3.
- McIntosh A. Sheffield Evidence Based Guidelines Programme. Guidelines in Practice 2002; 5: 64-6.
- Baker R, Lakhani M, Fraser R, Cheater F. A model for clinical governance in primary care groups. Br Med J 1999; 318: 779-83.
- National Institute for Clinical Excellence. Principles for Best Practice in Clinical Audit. Abingdon: Radcliffe Medical Press, 2002.
- National Institute for Clinical Excellence. Referral Advice -A Guide to Appropriate Referral from General to Specialist Services. London: NICE, December 2001.
- National Collaborating Centre for Primary Care. Audit of the management of post-MI patients in primary care. London: NICE, 2002. Available from: www.nice.org.uk
- Swerdlow A, Silva I, Doll R. Cancer Incidence and Mortality in England and Wales. Trends and Risk Factors. Oxford: Oxford University Press, 2002.
- National Institute for Clinical Excellence. Guideline Development Process - Information for National Collaborating Centres and Guideline Development Groups. London: NICE, 2001.
- Eccles M, Mason J. How to develop cost-conscious guidelines. Health Technol Assess 2001; 5: 1-78.