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- Development of RCOG Green-top Guidelines Policies and Processes
Clinical Governance Advice No. 1a Revised November 2006
This is the second edition of Clinical governance Advice No. 1. It replaces the first edition, entitled Guidance for the Development of RCOG Green-top Guidelines published in January 2000. This second edition has been separated into four documents:
Clinical Governance Advice No. 1a: Policies and Processes.
Clinical Governance Advice No. 1b: Producing a Scope.
Clinical Governance Advice No. 1c: Producing a Clinical Practice Guideline.
Clinical Governance Advice No. 1d: Adaptation and Implementation
The Royal College of Obstetricians and Gynaecologists (RCOG) produces a series of clinical Green-top Guidelines. The procedure for developing these guidelines has evolved from being one of informal consensus opinion to being evidence based. Clinical guidelines are an increasingly familiar part of clinical practice. Their principal aim is to improve the effectiveness and efficiency of clinical care through the identification of good clinical practice and desired clinical outcomes. This guidance has been updated in line with the methodology used in the development of the national guidelines produced by the National Institute for Health and Clinical Excellence (NICE)1 and the Scottish Intercollegiate Guideline Network (SIGN).2
Green-top Guidelines provide systematically developed recommendations which assist clinicians and patients in making decisions about appropriate treatment for specific conditions. They are concise documents, providing specific practice recommendations on focused areas of clinical practice.
This document outlines the policies and processes used in the production of Green-top Guidelines. It covers the following topics:
- selection of guideline topics
- selection of guideline lead developers
- guideline development
- guideline criteria
- consumer involvement
- peer review process
- support structure for guideline lead developers
- parallel patient information
The aim of this series of four documents is to assist and guide those developing Green-top Guidelines and support implementation.
2. Guidelines versus statements
The RCOG currently produces guidelines and statements.
Guidelines provide recommendations derived from researched clinical questions that are directly pertinent to clinical practice in obstetrics and gynaecology, such as the management of tubal pregnancy.
Statements provide an overview of relevant evidence in areas that have some influence or effect on day-to-day clinical practice, such as birth in water, but do not provide specific recommendations.
3. Selection of guideline topics
The Guidelines and Audit Committee (GAC) aims to develop a structured agenda for guideline development. There is a wide range of subjects that lend themselves to guideline development. To formalise this process, a subject map is constructed and updated at regular intervals of the entire specialty (in progress, October 2006). The results of this subject-mapping exercise will be the preferred method of guideline topic selection and hence is a move away from self-volunteered topics. In addition, this subject map will provide the core of the overall syllabus central to lifelong learning and professional development within the specialty.
The mapping process will be coordinated by GAC, which is made up of clinicians, both generalists and subspecialists. A proportion of these clinicians are members of specialist societies. Specialist societies, other Royal Colleges, the RCOG Consumers’ Forum and other relevant stakeholders will be invited to suggest guideline topics in the relevant subspecialty areas. This list will be augmented by GAC. The identified areas will be mapped to existing guidance to allow the work programme of both new guidelines and revisions to be planned more efficiently. Part of this process will involve close links with relevant groups within the Cochrane Collaboration to map planned guideline development with ongoing systematic reviews. This process will be reactive enough to adapt to new evidence as and when it becomes available.
Topics, once suggested, will be assessed against the following criteria. For topics to be suitable for guideline development they need to satisfy all or most of the following criteria.
- Areas where there are high rates of mortality, morbidity or disability.
- Areas where improved standards of care would reduce rates of mortality, morbidity or disability.
- Areas where there is uncertainty, as evidenced by a wide variation in clinical practice and service delivery.
- Areas where new high-quality clinical evidence has been published.
- Areas where there are resource implications: either high cost and low turnover or low cost and high turnover.
- Areas where there are implications across the primary–secondary care interface.
- Areas where there is a frequent chance of litigation.
3.1 New guidance
Once the guideline topic has been approved by GAC and the RCOG Standards Board, the guideline lead developers will be selected and a scope requested. Topics are expected to have a narrower remit than NICE clinical guidelines. Hence, it may be necessary for some guideline topics to be divided (and in some circumstances combined) at the scoping phase to give suitably concise advice. Equally, some guideline topics may be better suited to publication as NICE guidelines and these topics will be fed through the NICE topic selection process. Guidelines that fall into this category may include wider topic areas that lend themselves to a single review, such as intrapartum care, or areas where the volume of evidence to be reviewed is too large to allow for two or three developers to deal with. During this initial phase there will be consultation with NICE, Department of Health (DH) and specialist societies and other Royal Colleges to ensure that there is no avoidable overlap in the work planned.
3.2 Revision of existing guidelines
During the subject mapping exercise outlined above, existing guidelines will be incorporated. They will either be archived or modified in line with the new process. Guideline leads of revisions will be expected to resubmit a further scope.
4. Selection of guideline lead developers
Previous Green-top Guideline lead developers have been proposed by members of GAC or have been self-nominated. This process in itself may introduce an element of bias into the guideline’s development. The involvement of relevant specialist societies and Royal Colleges in the selection of guideline topics will be extended to proposed guideline leads.
Guideline lead developers should have an interest in the field as well as appropriate methodological expertise in guideline development and should have credibility with stakeholders within the area of the guideline. Their selection will need to be approved by GAC and the Standards Board. Additional secondary developers may be proposed by the guideline lead, although they will require approval by GAC. The responsibility for both the content and production of the guideline will remain with the guideline lead, who will draft the guideline within the expected time frame. Agreement will also be sought on the proposed order of developers in the published documents and this should reflect the individual’s contribution to the guideline process. A ‘conflict of interests’ form is completed by all developers and GAC members.
Some clinical experts may lack the necessary skills for drafting guidelines. GAC and the RCOG will provide in-house support to allow future and existing guideline leads to develop these skills.
This process applies mainly to new guidelines. Existing guidelines due for updating will need to have the current guideline leads approved in the same manner. If the current guideline leads decline to update, or are not able to review, or are thought to be inappropriate by either the specialist society or GAC, then new or additional guideline leads will be sought.
5. Guideline development
The development of guidelines involves more than the collation and reviewing of evidence. Even with high-quality data from systematic reviews of randomised controlled trials, a value judgement is needed when comparing one therapy with another. This will therefore introduce the need for consensus.
RCOG Green-top Guidelines are drafted by nominated developers, in contrast to other guideline groups such as NICE and SIGN, who use larger guideline development groups. Equally, in contrast to other guideline groups, the topics chosen for development as Green-top Guidelines are concise enough to allow development by a smaller group of individuals.
In agreeing the precise wording of evidence-based guideline recommendations and in developing consensus-based ‘good practice points’, GAC will employ an informal consensus approach through group discussion. In line with current methodologies, the entire development process will follow strict guidance and be both transparent and robust. The RCOG acknowledges that formal consensus methods have been described3–5 but these require further evaluation in the context of clinical guideline development.6 It is envisaged that this will not detract from the rigor of the process but prevent undue delays in development.
6. Guideline criteria
Guidelines produced by the RCOG will satisfy the basic criteria laid out in the Appraisal of Guidelines for Research and Evaluation in Europe (AGREE) guidelines.2 The key features of such guidelines are:
- a multidisciplinary working group
- a well-described systematic review of the literature
- graded recommendations with explicit links to the evidence
- quality control; for example, input by an independent advisory board or by independent peer review.
Further guidance is available from the SIGN website.2
7. Consumer involvement
As outlined above, the selection of topics via the subject mapping exercise will have a significant input from consumers. This will mainly be via the RCOG Consumers’ Forum.
The remaining stages of guideline development will also require extensive consumer input. This will entail consultation over the development of the scope and will include an overview of the clinical area to be examined. Once the guideline has been finalised, there will be further peer review by consumers through the Consumers’ Forum and other relevant stakeholder organisations.
8. Peer review process
The peer review process must be transparent and robust. This demands that there is a broad and unbiased range of peer reviewers and that comments received are dealt with systematically.
The peer review process will occur after an initial review by GAC. The guideline will be sent out for formal and open peer review. The peer review process will be via the RCOG website and, in addition, the guideline will be sent to a wide range of individual peer reviewers.
In line with many journal peer review processes, the peer reviewing of RCOG Green-top Guidelines will be open. Peer reviewers who are unhappy for the guideline leads to know who has commented on the guideline will not be accepted. It is anticipated that, where possible, peer reviewers will aim to be constructive with their comments.
As with the selection of guideline topics and guideline leads, it is anticipated that the specialist societies and Royal Colleges will propose peer reviewers. In addition, clinicians who have published within the subject area may be approached. Owing to the large number of peer reviewers required, self-nominated reviewers will also be accepted (following approval by GAC). In addition, other relevant stakeholders will be identified, together with the relevant patient or user groups. All peer reviewers will be expected to commit formally to the process. This will include acknowledgement of the time frame expected for return of comments and that although all comments will be considered not all proposed changes will be accepted.
All comments will be collated by the RCOG and tabulated for consideration by the guideline leads. Each comment will require discussion. Where comments are rejected then justification will need to be made. Following review of the comments, the document will be updated and GAC will review the revised draft and the table of comments.
A list of peer reviewers, together with the guideline developers, will be included in the published document.
9. Support structure for guideline lead developers
As mentioned previously, future Green-top Guidelines will be supported by RCOG staff. Support will include performing the main literature search and distributing relevant papers.
GAC and the RCOG are also keen to assist guideline lead developers in producing guidelines. To this end, individual Green-top Guideline topics will be assigned to specific members of GAC. The guideline lead will be encouraged to consult with these GAC members and the Guidelines Research Fellow if there are concerns over the scope or methodology. Furthermore, it is hoped that both GAC and the RCOG will be able to assist potential developers to enhance the requisite skills to be able to develop future guidelines.
10. Parallel patient information
GAC will make recommendations on the need for parallel patient information during the guideline development process. The Patient Information Subgroup (PISG) will develop this information for consideration by GAC. This will occur through the Chair of the PISG, who is a member of GAC, and the patient representative.
Once guidelines have been published they will be available in both paper and electronic versions. When a guideline is updated or replaced, all previous versions will be archived. Copies of archived versions will be available through the RCOG website and the RCOG library.
An example of a Green-top Guideline citation is given below:
Royal College of Obstetricians and Gynaecologists. The Management of Ovarian Hyperstimulation Syndrome. Green-top Guideline No. 5. London: RCOG; 2006.
- National Institute for Health and Clinical Excellence. The Guidelines Manual. London: NICE; 2006 [www.nice.org.uk/page.aspx?o=308639]; replaces Guideline Development Methods (2005). London: NICE [www.nice.org.uk/page.aspx?o=308552].
- Scottish Intercollegiate Guidelines Network. SIGN 50: A Guideline Developer’s Handbook. Edinburgh: 2001, updated May 2004 [www.sign.ac.uk/guidelines/fulltext/50/index.html]. Accessed 11 October 2006.
- Bayley EW, Richmond T, Noroian EL, Allen LR. A Delphi study on research priorities for trauma nursing. Am J Crit Care 1994;3:208–16.
- Delbecq, Van de Ven A. A group process model for problem identification and program planning. J Appl Behav Sci 1971;7:467–92.
- Brook RH. The RAND/UCLA appropriateness method. In: McCromick KA, More SR, Siegel RA, editors. Clinical Practice Guideline Development: Methodology Perspectives. Rockville, MD: Public Health Services, US Department of Health and Human Services; 1994. p. 59–70.
- Raine R, Sanderson C, Black N. Developing clinical guidelines: a challenge to current methods. BMJ 2005;331:631–3.
This Clinical Governance Advice was produced on behalf of the Guidelines and Audit Committee of the Royal College of Obstetricians and Gynaecologists by:
Mr AJ Kelly MRCOG, Brighton
Peer reviewed by:
British Fertility Society; British Society for Colposcopy and Cervical Pathology; British Gynaecological Cancer Society; Mr J Clark MRCOG, Birmingham; Cochrane Pregnancy and Childbirth Group; Family Planning Association; Mr R Foy, Clinical Senior Lecturer in Primary Care, Centre for Health Services Research, Newcastle; Mr DI Fraser MRCOG, Norfolk; Dr SIMF Ismail MRCOG, Yeovil; Professor P Littlejohns, Clinical and Public Health Director, National Institute for Health and Clinical Excellence, London; London School of Hygiene and Tropical Medicine; Ms J Kavanagh, Research Officer, Social Science Research Unit, Institute of Education, University of London, London; Dr GC Penney FRCOG, Aberdeen; RCOG Consumers’ Forum; RCOG Patient Information Subgroup.
The GAC lead reviewer was Professor DJ Murphy MRCOG, Dublin, Ireland.
The final version is the responsibility of the Guidelines and Audit Committee of the RCOG
Valid until November 2009 unless otherwise indicated