The National Collaborating Centre for Primary Care (NCC-PC), hosted by the RCGP, is one of six centres created by NICE to develop clinical guidelines. Guideline development for the NCC-PC is carried out at the two provider partners: the School of Health and Related Research (ScHARR) at the University of Sheffield and the Clinical Governance Research and Development Unit at the University of Leicester. This continues the RCGPÍs tradition of outsourcing much of its academic work, including that of clinical effectiveness.
At ScHARR, as well as developing guidelines, we also undertake work on technology appraisals for NICE. This has created a critical mass of people with the relevant skills and experience to draw upon.
For several years ScHARR housed the RCGP clinical effectiveness programme, funded by the Department of Health. Much of the work of this programme, under the directorship of Professor Allen Hutchinson, was concerned with the development of evidence-based guidelines, audit programmes and implementation issues.
Considerable experience and expertise was built through this programme, which included developing guidelines for acute low back pain,1 national standards for the management of glue ear and methods of review criteria through the Clinical Practice Evaluation Programme.
A major programme of work was the development of evidence-based guidelines for type 2 diabetes. The initial guideline in the series, for foot care, was published by the RCGP in 20002 and subsequent guidelines in the series have been published by NICE as part of their inherited guidelines work programme.3
The advent of NICE has brought a more explicit, transparent and uniform approach to guideline development, which most guideline developers
had not previously employed. The methods to be used for developing NICE guidelines are outlined in their development manuals.4
The phases in the NICE process are summarised in Figure 1 (below). The provider partners are involved during all five stages, but primarily in the guideline development.
|Figure 1: The phases of the NICE guideline development process|
The guidelines developed previously in Sheffield used much of the methodology now required by NICE, the main differences being in the following areas:
- Consultation is now much wider than the peer review processes previously used
- Patient involvement is more extensive and brings a valuable perspective to the development process.
- Previously, consideration of cost effectiveness was often very limited but it is now a central aspect of guideline development.
The key stages in developing a guideline are summarised in Box 1 (below).
|Box 1: Key stages in developing a guideline|
NICE guidelines are aimed at health professionals in different sectors of the NHS. The task therefore involves developing guidelines that are useful and relevant to a wide range of professionals and across the sectors.
The composition of the guideline development groups reflects this mix, with representatives from a range of professions across the sectors as well as representatives of patient organisations. The development of each guideline is supported by a methodologist, a researcher/reviewer, an information specialist and a health economist.
One of the most time consuming tasks is that of the evidence review. Despite the overwhelming amount of research literature, there is often little evidence to answer the key clinical questions.
Guidelines in development
The Sheffield programme is currently developing guidelines on:
- Familial breast cancer: classification and care of women at risk of familial breast cancer
- Anxiety: management of generalised anxiety disorder and panic disorder (with or without agoraphobia)
Both of these areas are important to primary care, with implications for effective management, including referral.
The guideline looking at familial breast cancer concerns a group of women who are perceived as being at risk of developing that condition, and this differs from most guidelines where the starting point is the diagnosis of a particular disease or condition.
In the familial breast cancer guideline we are addressing not only what might be effective interventions, and who should be referred for genetic testing, for example, but also how to assess the level of risk for women with a family history of breast cancer and how best to describe that level of risk.
The anxiety guideline will cover both pharmacological and psychological interventions, as well as diagnosis.
An update of the guideline for foot care in type 2 diabetes will begin shortly, to be published by NICE late next year.
With a central unit based in London at the RCGP and two provider units, a certain degree of coordination and sharing of management responsibilities naturally ensues.
The provider partners have responsibility for the day-to-day management of the guideline development processes. We report regularly to the board of the NCC-PC and thus to NICE. The central unit provides considerable key support to the provider partners to help ensure that the NICE process is followed. In particular, the central unit plays a vital role in identifying stakeholders and nominees from the stakeholder organisations, and ensuring that the validation of the guidelines goes as smoothly as possible.
Our experience with the inherited type 2 diabetes guidelines is that many comments received during the consultation phases concern process issues rather than those of clinical and cost effectiveness. The central unit is better placed to deal with these, allowing us to concentrate on comments about the content of the guideline.
The central unit also facilitates the connections with other collaborating centres, guideline developers and NICE itself. The provider partners of the NCC-PC share expertise with each other as well as more widely with those developing NICE guidelines in the other collaborating centres. The collaborating centre, through its professional partnerships, ensures that the guidelines are not only methodologically rigorous but also professionally relevant.
The NICE guideline development processes are new to us all and are still evolving, as are the structures created to deliver the guidelines. Improving patient care, however, remains the goal of our work.
Although implementation is not part of the NICE remit, it is of central importance, not least to members of guideline development groups. Thus the guidelines we develop should be realistic and clinically relevant as well as rigorous and ambitious. Improved patient care depends on the ability of the provider partners to deliver high quality guidelines that can be rolled out through the NCC-PC and its professional partners.
|SHEFFIELD EVIDENCE BASED GUIDELINES PROGRAMME|
|1 April 2001|
|Objectives:||To develop high quality evidence-based guidelines and undertake research into guideline methods|
|Key personnel:||Director:||Professor Allen Hutchinson|
|Deputy Director:||Aileen McIntosh|
|Reviewers:||Clare Shaw (familial breast cancer) Tracy Elliott (anxiety)|
|Health economist:||Allan Wailoo|
|Information scientist:||Catherine Beverley|
|Administrative support:||Karen Beck|
Sheffield Evidence Based Guidelines Programme,
|Tel:||0114 222 0795|
|Fax:||0114 222 0791|
This work is undertaken by ScHARR, University of Sheffield which received funding from the Royal College of General Practitioners on behalf of the National Institute for Clinical Excellence. The views expressed in this article are those of the authors and not necessarily those of either the RCGP or NICE.
- Waddell G, McIntosh A, Hutchinson A, Feder G, Lewis M. Acute Low Back Pain Guidelines and Evidence Review. London: Royal College of General Practitioners, 1999. www.rcgp.org.uk
- Hutchinson A, McIntosh A, Feder G, Home P et al. Clinical Guidelines and Evidence Review for Type 2 Diabetes: Prevention and Management of Foot Problems. London: Royal College of General Practitioners, 2000.
- Type 2 diabetes guidelines series, available on www.nice.org.uk
- NICE. Guideline Development Process 3 – Information for Collaborating Centres and Guideline Development Groups London: NICE, 2001.