SIGN 50: A guideline developer's handbook - Section 3: Selection of guideline topics

Section 3: Selection of guideline topics

3.1 THE SIGN PROGRAMME

The experience of SIGN and other guideline developers has shown that selection of appropriate topics for guideline development is crucial. Guidelines should address a specific healthcare need and there should be an expectation that change is possible and desirable and that, if the guidelines are followed, there is potential to improve the quality of care and/or patient outcomes. There must also be robust evidence of effective practice on which to base guideline recommendations.

SIGN has limited resources for guideline development. As a result it is important to identify topics which are most amenable to guideline development. Likewise, when a published guideline is due for review it must be judged against potential new topics for inclusion in the SIGN programme.

3.2 CRITERIA FOR SELECTION OF TOPICS

Guideline topics selected for inclusion in the SIGN programme are chosen on the basis of the burden of disease, the existence of variation in practice, and the potential to improve outcome. The following criteria are considered by SIGN in selecting and prioritising topics for guideline development:

Areas of clinical uncertainty as evidenced by wide variation in practice or outcomes.
Conditions where effective treatment is proven and where mortality or morbidity can be reduced.
Iatrogenic diseases or interventions carrying significant risks.
Clinical priority areas for NHSScotland: presently these are coronary heart disease and stroke, cancer, and mental health. The strategic aims of NHSScotland are also considered. These are improving health and tackling inequalities, especially with regard to children and young people, developing primary and community care and reshaping hospital services.
The perceived need for the guideline, as indicated by a network of relevant stakeholders.

For information on the current SIGN programme, see the SIGN website: www.sign.ac.uk

3.3 TOPIC SELECTION PROCESS

Any group or individual may propose a guideline topic to SIGN. In addition, the five SIGN specialty subgroups (SSGs) may suggest new topics for consideration (see Chapter 2.1.4 for details of the SSGs).

The Chair of each SSG represents SIGN Council on the Guideline Programme Advisory Group (GPAG), which oversees development of proposals for new guidelines or for reviewing existing guidelines. This ensures that there is appropriate communication and interaction between the specialty subgroups, as most topics are relevant to more than one specialty. The Group also has representatives from other parts of NHS Quality Improvement Scotland. This should ensure that, wherever possible, SIGN’s programme and the programmes of clinical standards and health technology assessments will be complementary. GPAG will also consider the work programme of other guideline developers, in particular guidelines that have been commissioned by NICE (the National Institute for Health and Clinical Excellence) in England and Wales, to avoid potential duplication of effort.

Specialty subgroups consider all new proposals, prioritise them using a suitability screening and scoring tool and submit their prioritised lists of potential guideline topics to the Guideline Programme Advisory Group. The suitability screening tool identifies the extent to which the proposal fulfils the criteria listed in chapter 3.2, makes an assessment of the extent of evidence on which to base the guideline and considers whether the benefits that were likely to accrue from successful implementation of the guideline recommendations would outweigh the efforts required to develop it.

GPAG will look at the combined scores from each SSG and using this information, together with the professional judgment of the group, and taking into account SIGN’s work capacity, will make recommendations to SIGN Council about which proposals should be accepted onto the work programme and which should be rejected. Topics ranked highest are included in SIGN’s proposed programme, depending on capacity. Proposals which are not ranked sufficiently highly to be accepted on to the programme will be reconsidered at the next topic prioritisation meeting alongside new and review topics. If the proposal still receives a low ranking on its second reading it will be returned to the SIGN specialty subgroup for reconsideration or revision.

SIGN Council dedicates one meeting each year to approving guideline topic proposals that have been recommended by GPAG as suitable candidates for the SIGN guideline development programme. Council is presented with fully worked up guideline proposals and a summary of the suitability screening results and the subsequent discussions of the Guideline Programme Advisory Group.

The final step is for the resulting topics to be forwarded to NHS Quality Improvement Scotland for approval for inclusion in the work programme before incorporation into the SIGN programme.

3.3.1 APPLICATION PROCEDURE

SIGN uses a two-stage application procedure. The initial application is made using a short, single-page application form. When a group or individual proposes a guideline topic to SIGN, their suggestion is discussed initially by the SIGN Senior Management Team (SMT). SMT use a set of defined criteria to assess whether or not the topic is an appropriate one for a SIGN guideline. If the proposed topic has the potential to meet the selection criteria the proposer is asked to complete a second, more detailed, application form.

As part of the preparatory work done before a guideline proposal is considered by the SSGs and submitted to the Guideline Programme Advisory Group, a scoping search is carried out. This is a very broad search of the literature relevant to the condition that is to be the topic of the guideline. No attempt is made to focus on specific questions at this stage. The intention is only to establish the general extent of the literature in the clinical area to see if there is likely to be sufficient good quality evidence to make an evidence based guideline feasible.

Firstly, a check is made to see if any other good quality guidelines have been produced on the subject by searching the following websites:

Guidelines International Network (www.g-i-n.net)

National Library for Health Guidelines finder (www.library.nhs.uk/guidance/)

National Guideline Clearinghouse (www.guideline.gov)

National Institute for Clinical Excellence (www.nice.org.uk)

In addition, a search for existing systematic reviews is carried out. This covers reviews produced by the Cochrane Collaboration and those covered by the databases of the Centre for Reviews and Dissemination at the University of york (www.crd.york.ac.uk/crdweb/)

From this scoping search a report is prepared summarising the available evidence, emphasising the outcomes from systematic reviews and whether these have been positive or have identified significant work that remains to be done.

SIGN’s standard guideline application form requests the following information:

A summary of the clinical problems and outcomes to be addressed.
Details of the group(s) or institution(s) supporting the proposal.
A brief background to the clinical topic which will be addressed by the proposed guideline.
Evidence of variation in practice in the management of the condition.
An indication of the benefits likely to arise from the development and successful implementation of the guideline.
A definition of the patient group to which the guideline will apply. This should include consideration of whether any specific social groups or minorities are likely to be particularly affected, either favourably or adversely, by changes in healthcare provision in the topic area under consideration.
A definition of the aspects of management of the clinical condition which the proposed guideline will address and an indication as to whether the guideline will apply to primary or secondary care, or both.
An indication of the healthcare professionals potentially involved in developing the guideline.
An indication of the size and strength of the evidence base which is available to support recommendations on effective practice, citing key supporting papers.
Details of any existing guidelines or systematic reviews in the field.

The procedure for selection of new topics for SIGN guidelines is illustrated in Figure 5. The application form to request consideration by SIGN of a specific guideline topic and the full guideline proposal form are available from the SIGN Executive or can be downloaded from the SIGN website: www.sign.ac.uk

[Figure 5: Selection of new topics for SIGN guideline development]

3.4 UPDATING PUBLISHED GUIDELINES

3.4.1 SCHEDULED UPDATES

SIGN has made a commitment to consider whether or not published guidelines need to be reviewed after a period of three years and all SIGN guidelines carry a statement indicating that they will be considered for review three years after publication. A full review of a guideline after a fixed time period is not always appropriate as new evidence is published at different rates in different fields. It also imposes a workload for future years that may not be achievable in practice. A further factor that will influence the decision on whether and how to review a guideline is the emergence of any evidence of inequality in access to services between different social groups that can be addressed through guideline recommendations.

3.4.2 UPDATE PROPOSALS

[Figure 6: Selection of guidelines for updating]

When a guideline is considered for updating, there are four possible outcomes:

the guideline, as it stands, will be revalidated for a further year
the guideline will undergo a complete review
the guideline will undergo a partial or selective review
the guideline will be withdrawn.

A fifth option, which is likely to be applicable in only a small number of cases, is to make the guideline into a ‘living guideline’. This option involves keeping the evidence under constant review and updating the guideline on a regular basis. A three year trial project using this process for the asthma guideline (produced in conjunction with the British Thoracic Society) is nearing completion, and evaluation of this project will influence the extent of future use of this approach to guideline updating.

As a first step, an update search is carried out looking for evidence based guidelines, HTAs, and systematic reviews produced since publication of the last version of a guideline. These searches are based on the key questions and search strategies used in the original guideline.

Results are presented in the form of summaries of the findings of the papers that have been identified.

These searches include an element of horizon scanning to see if there are new treatments or technologies that should be considered as part of the update.

The search results are incorporated into a report that summarises the new evidence and looks at how it will impact on the recommendations made in the existing guideline. This report will also note any new areas or key questions that have emerged since the previous publication.

The review report is then widely circulated for comment within NHSScotland, to Royal Colleges and other professional bodies (through their representatives on SIGN Council), to relevant patient organisations, and to other organisations providing guidance or advice to the NHS in any part of the UK. Responses to this consultation are gathered and presented to the Guideline Programme Advisory Group. On the basis of these reports combined with input from their professional networks GPAG then makes recommendations to SIGN Council on which guidelines should be updated, and whether a full or selective update is appropriate.

At their November meeting, SIGN Council will agree which guidelines are to be updated and prioritise the updates along with new guideline proposals for addition to the SIGN guideline programme.

Information on the status of guidelines due for updating, or currently being updated, is provided on the SIGN website: www.sign.ac.uk

3.4.3 SELECTIVE UPDATE PROCEDURE

When a guideline has been accepted for a selective update, the process for carrying out the update will be largely the same as that described elsewhere in this manual. The principal difference is that the update will focus on those chapters of the original guideline that have been identified as being in need of updating. The same methodological principles apply, though the nature of the chapters being reviewed may necessitate a slightly different composition from the original guideline group. If a chapter on surgical interventions is a major part of an update, for example, the guideline group is likely to include more surgeons and theatre staff than (say) pharmacists or home care workers.

The process begins with a review of the patient literature. This will feed into a review of patient issues (see Chapter 4) that seeks to establish whether any new issues have emerged since the last version of the guideline.

Unlike new topics, where the main literature searches do not get underway until the key questions have been established by the guideline group, literature searches for systematic reviews and randomised controlled trials are started while the guideline group is being assembled. These searches are based on the recommendations in the chapters of the guideline that have been identified as being in need of updating. They seek to update and build on the evidence base used in the original guideline. The only new questions that may be addressed are any arising from the patient issues search, or that arose from new developments identified during the process of authorising the update.

Once searches are completed, the Information Officer working with the guideline group will carry out a preliminary sift to remove irrelevant material. The Chair or a designated alternative from the new guideline group will carry out a second sift to remove any further papers seen as clinically irrelevant or inappropriate. The remaining papers will be obtained for review and shared among guideline group members for critical appraisal. The Information Officer will extract relevant data from those papers deemed acceptable by the group, and produce evidence tables.

From this point the processes used will be the same as those used for a new guideline. A possible exception is the need for a national meeting. Here the guideline group may decide whether or not the proposed changes are sufficiently far reaching as to justify such wide consultation. If a national meeting is not held, the first draft of the guideline is published on the SIGN website for a fixed period, during which time potentially interested parties will be alerted to its presence and invited to submit comments.

3.4.4 WITHDRAWING GUIDELINES

From time to time it is necessary to consider withdrawing guidelines which are outdated or no longer relevant. Proposals to withdraw guidelines are submitted initially to the Guideline Programme Advisory Group and if it agrees with the proposal it is submitted to SIGN Council for final approval. Once it has been agreed to withdraw a guideline, all versions of the text and any associated material will be removed from the SIGN website. The list of published guidelines will be amended to show the guideline as withdrawn, with a note of the reason for withdrawal and reference to any alternative sources of advice. Guidelines may be withdrawn for any of the following reasons.

Superceded by a more recent or more comprehensive guideline
Evidence that the guideline is fully complied with by NHSScotland, and has become accepted practice
Emergence of new treatments or preventive measures that render the guideline irrelevant.

3.4.5 MONITORING AND INTERIM UPDATES

All comments received on published SIGN guidelines, or information on important new evidence in the field, or evidence of impacts on equality groups are fed back to the guideline development group, either for immediate response or for more detailed consideration on review of the guideline. Any updates to the guideline which might be required in the interim period prior to review are noted on the SIGN website.