Development of RCOG Green-top Guidelines: Producing a Scope (Clinical Governance Advice 1b)

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Development of RCOG Green-top Guidelines: Producing a Scope Clinical Governance Advice No. 1b

Development of RCOG Green-top Guidelines: Producing a Scope

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.

1. Introduction

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.

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 defines the processes used in producing a scope for the development of a Greentop Guideline.

2. Content of the scope

Following the selection of a topic, the development of a scope is the first stage of the guideline development process. The purpose of the scope is to provide the following:

the background epidemiology relevant to the condition or disease
a clear outline of the aspects of care that the guideline will cover in terms of:
- population to be included or excluded
- healthcare setting
- interventions and treatments to be included and excluded
an overview of the clinical questions to be addressed.

The overview of the clinical questions involves identification of the broad areas to be examined and, from these, the focused clinical questions can be developed (see Clinical Governance Advice No. 1c: Producing a Clinical Practice Guideline).

3. Identification of the evidence

A part of the scoping process may involve a preliminary review of the literature. This will aim to identify any guidelines and systematic reviews relevant to the guideline. However, it is not anticipated that the scope will be referenced.

4. Stakeholder involvement

It is anticipated that GAC will work closely with the relevant specialist societies, other Royal Colleges, NICE, SIGN, the RCOG Consumers’ Forum, the Cochrane Collaboration and other stakeholders when planning its guideline development programme. This may involve the development of joint guidance for specific topics. However, for the purpose of the development of RCOG guidelines, the scope will only require approval by GAC prior to the formal development phase.

In specific circumstances, where systematic reviews of randomised controlled trials would help to inform the clinical questions posed, it may be appropriate to commission a review if one is not found during the initial literature searches. This may be performed by the guideline lead developers or commissioned through one of the groups of the Cochrane Collaboration, such as the Pregnancy and Childbirth Group. Equally, as part of the preliminary searches, a search of published protocols on the Cochrane Library must also be carried out.

5. Approval of the scope

Following submission of the scope to GAC, all committee comments will be collated and tabulated. The guideline leads will be expected to amend the scope in line with these comments and submit a final draft of the scope to the RCOG for the Chairman’s approval. Once approval is given, no changes to the scope should be made by the guideline leads without consultation with GAC. The first draft of the guideline submitted to GAC will be cross-referenced to the final scope.

6. An example of a scope

An abridged example of a proposed guideline scope is outlined below. It should be noted that this is a hypothetical example based on RCOG Green-top Guideline The Management of Tubal Pregnancy.

The Management of Tubal Pregnancy Scope

Background epidemiology
The incidence of ectopic pregnancy has remained static in recent years (11.1/1000 pregnancies) and nearly 32 000 ectopic pregnancies are diagnosed in the UK within a 3-year period. There were 13 maternal deaths resulting from ectopic pregnancy in the UK during the period 1997–99. Tubal pregnancy can be managed by laparotomy, operative laparoscopy, medically and, occasionally, by observation alone. Management must be tailored to the clinical conditions and future fertility requirements of the woman.

Population to be studied and setting
Pregnant women with suspected tubal pregnancy managed within a secondary care setting, including outpatient management.
The guideline will not cover the diagnosis of tubal pregnancy.

Interventions to be studied
Comparison of conservative, all surgical and medical treatments for the management of tubal pregnancy.

Clinical areas to be examined
Q: Which surgical technique is preferable (laparotomy or laparoscopy) for the management of tubal pregnancy?
Q: Which surgical technique is preferable (laparotomy or laparoscopy) for the management of tubal pregnancy in the woman who is haemodynamically unstable?
Q: Should salpingectomy or salpingotomy/salpingostomy be used for the management of a confirmed tubal pregnancy in the presence of a normal contralateral tube? Which method should be used when the contralateral tubal is damaged/absent?
Q: Which medical treatment should be offered for the management of suspected tubal pregnancy and in which patient group should it be used? Q: Is expectant management of women with suspected tubal pregnancy appropriate and if so in which patient groups should it be used

Preliminary review of evidence
Several systematic reviews of randomised controlled trials comparing various treatments are available, as well as a small number of high-quality cohort studies. Outcomes considered include future pregnancy and fertility rates, recurrence of ectopic pregnancy and operative complications. There are notable gaps in the evidence base (no direct comparison of laparoscopic salpingectomy to salpingotomy), resulting in the need for indirect comparisons. This will make the drawing of firm conclusions difficult.

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