Section 2: Organisation of guideline development

2.1 THE SCOTTISH INTERCOLLEGIATE GUIDELINES NETWORK

The Scottish Intercollegiate Guidelines Network (SIGN) was established in 1993 by the Conference (later, the Academy) of Royal Colleges and their Faculties in Scotland, to develop evidence based clinical guidelines for the National Health Service in Scotland.2 This followed the publication of a report by the Clinical Resource and Audit Group (CRAG) which highlighted the need for national, evidence based clinical guidelines to be developed by “the Royal Colleges, the specialist associations of the healthcare professionals and relevant educational bodies”.1

SIGN has evolved significantly since 1993 but remains a collaborative initiative - a network of clinicians, patients’ representatives and other healthcare professionals, including all the medical specialties, nursing, pharmacy, dentistry, professions allied to medicine, and NHS management. Patients are represented on SIGN by Voluntary Health Scotland and lay representation. The current membership of SIGN Council is noted on the website: www.sign.ac.uk

2.1.1 SIGN COUNCIL

SIGN Council is the policy making body for SIGN with overall responsibility for topic selection, methodology, and editorial policy. Members of SIGN Council are nominated by a particular Royal College or other professional organisation or committee, but also represent their specialty or discipline in a wider sense and consult widely with other specialist societies in their field. SIGN also works closely with other parts of its parent body, NHS Quality Improvement Scotland, as well as other relevant national groupings and agencies within NHSScotland.

Members of SIGN Council determine the overall direction of SIGN’s development and play a key role in shaping the SIGN guideline programme. Some are also actively involved in aspects of the guideline development process - as members of Advisory Groups, or on the editorial group for specific guidelines, or as chairs or members of individual guideline development groups - and all provide input into the selection of topics for guideline development and the composition of guideline development groups (see Chapters 4 and 5).

The structure of SIGN is illustrated in Figure 2

[Figure 2: The structure of SIGN]

2.1.2 STRATEGY GROUP

The Strategy Group is chaired by the Vice-Chair of SIGN Council and provides a strategic monitoring and advisory role for SIGN. Among the specific functions of the group are:

Membership of the group is made up of five elected voting members of SIGN Council, (one of whom must be a lay representative and at least two current holders of medical or dental qualifications and are members of Royal Colleges or their Faculties in Scotland) plus representation from other parts NHS Quality Improvement Scotland. Meetings are also attended by the Chair of SIGN, Executive Secretary to SIGN Council, and members of the SIGN Senior Management Team.

2.1.3 GUIDELINE PROGRAMME ADVISORy GROUP (GPAG)

GPAG oversees the guideline development programme. Specific functions include:

Membership of the group consists of:

Meetings are also attended by the Executive Secretary to SIGN Council.

2.1.4 SPECIALTY SUBGROUPS (SSGS)

There are five specialty subgroups of SIGN Council, one in each of the NHS priority areas (cancer, children, cardiovascular disease, mental health) plus one covering primary care. The role of each subgroup is to advise on the selection of new topics, to support implementation of guidelines in their topic area, and to network with others to promote guideline use. Membership of each group is made up of members of SIGN Council (who are asked to volunteer for the group closest to their subject interest) plus one or two representatives from other organisations with a particular interest in the topic of the SSG. All groups should include a patient representative.

2.1.5 METHODOLOGY DEVELOPMENT GROUP (MDG)

The Methodology Development Group advises the SIGN Executive on the most appropriate ways of developing the SIGN guideline development methodology and provides advice and methodological support for guideline development groups. Methods of meeting these objectives include:

All decisions or proposals from the Methodology Development Group must be ratified by SIGN Council before they are fully implemented.

Membership of the Methodology Development Group consists of:

Meetings of the Committee are attended by the Executive Secretary to SIGN Council.

2.1.6 SIGN EXECUTIVE

The SIGN Executive are the staff employed to run the organisation. They are responsible for the implementation of decisions taken by SIGN Council and its subgroups, and for delivering the guideline programme to time and on budget. All staff are employees of NHS Quality Improvement Scotland and as such are also required to work closely with other parts of that organisation, and to comply with their policies and procedures with the specific exception of those areas where responsibility has been retained by SIGN Council (see Chapter 2.1.1). A staff tree of the current SIGN staff is shown in Figure 3.

Figure 3: Staff tree, SIGN Executive[SIGN Organisational Structure]

Professional healthcare qualifications are not a requirement for any SIGN staff positions, and there is an extensive mix of skills among the Executive staff, including:

Day to day management is the responsibility of the Senior Management Team (SMT). This team is made up of the three Directors, plus the Chair and Vice-Chair of SIGN Council. SMT meets regularly to resolve problems and to discuss the allocation of resources to the different parts of the guideline development programme.

2.2 FUNDING FOR GUIDELINE DEVELOPMENT

Funding from NHS Quality Improvement Scotland supports the SIGN Executive, expenses associated with individual guideline development projects (eg online search costs, library and copyright fees to obtain copies of articles for review, guideline development group meeting expenses), and the costs of printing and distributing published SIGN guidelines.

As of April 2007, the funding for SIGN was around £1 million. It is important to note that this funding does not include the majority of the professional time involved in guideline development. Members of SIGN guideline development groups do not receive any payment for their participation, although General Medical and Dental Practitioners are partially reimbursed through locum payments and travel expenses to enable them to attend guideline development group meetings. The expenses of other members of SIGN guideline development groups are met by their employing NHS Boards and universities, which make an important contribution to the SIGN initiative in this way. The expenses of any members of guideline development groups who are unable to reclaim these from their employers for any reason (eg patient representatives) are met by SIGN.

Additional sources of income for the SIGN initiative are the sale of guidelines to individuals and organisations outwith NHSScotland and a small amount made from training courses and consultancy work in the UK and overseas.

2.3 TIMESCALE FOR GUIDELINE DEVELOPMENT

The time taken to develop a SIGN guideline varies widely according to the scope of the topic under consideration, the volume of relevant literature to be critically appraised, the amount of feedback received during the consultative phases of development and, most importantly, the competing pressures on the time of members of guideline development groups. The average time taken by recent guideline development groups is illustrated in Figure 2.3 (see also Figure 9).

[Figure 4: Average timescale for SIGN guideline development]

2.4 INFLUENCE OF FINANCIAL AND OTHER INTERESTS

It has been recognised for some time that financial interests in, or close working relationships with pharmaceutical companies has an influence on the interpretation of evidence from clinical studies. This can affect both guideline developers and guideline users.

It is not possible to completely eliminate any possible bias from this source, nor even to quantify the degree of bias with any certainty. Despite some doubts as to how effective an answer it is, most organisations have chosen to address this problem by asking those involved in producing clinical guidelines to declare any financial or other interests related to their work on the guideline. By being explicit about the influences to which the authors are subjected, guideline producers acknowledge the risk of bias and make it possible for guideline users or reviewers to assess for themselves how likely it is that the conclusions and guideline recommendations are based on a biased interpretation of the evidence.

SIGN has taken the view that all those involved in the work of guideline development should declare all financial interests, whether direct or indirect, annually for as long as they are actively working with the organisation. An example of the form to be completed by all concerned is presented in Annex A to this document.

These forms are completed annually by all members of the following groups.

Signed copies are retained by the SIGN Executive and can be inspected by any interested party at the SIGN offices.

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