In 1996 the Royal College of Obstetricians and Gynaecologists (RCOG) embarked on the development of evidence-based guidelines in menorrhagia, infertility and sterilisation, with funding provided by the NHS Executive, as part of its Clinical Effectiveness initiative.
The topics were commissioned from within a broad framework of priority clinical areas. They satisfy the criteria for guideline development of addressing a topic with high morbidity or disability, dealing with treatments of established potential, in an area with wide variation in practice, where the services concerned are resource intensive.
A multidisciplinary guideline group was convened for each topic under the overall direction of a guideline steering group. This ensured that the methodology and appearance were the same for each set of guidelines. For menorrhagia the guideline group con-sisted of specialists, a GP, a purchaser, a nurse and a patient representative.
Menorrhagia or heavy menstrual bleeding has an impact on many women's lives. One in 20 women aged 30-49 years consult their GP each year with menorrhagia. Once referred to a gynaecologist, surgical intervention is highly likely.
One in five women in the UK will have a hysterectomy before the age of 60. In at least half of those who undergo hysterectomies, menorrhagia is the main presenting problem. About half of all women who have a hysterectomy for menorrhagia have a normal uterus removed.
A systematic review1 had shown that there are wide variations in:
- the drugs prescribed in general practice for the management of menorrhagia
- referral patterns for this condition
- population-based rates of hysterectomy.
Such variation in the management of a common complaint is an indication for guideline development.
The RCOG Menorrhagia Guideline Development Group decided that the guidelines covering menorrhagia should be split into two: one set covering initial management in primary care2and one covering further management after hospital referral.
Menorrhagia is defined, for the purpose of these guidelines, as a complaint of heavy cyclical menstrual bleeding over several consecutive cycles. The management of any other abnormalities of the menstrual cycle, such as irregular bleeding, is not covered.
The aim of the first set of guidelines (the second set is about to go to the printers) is to provide recommendations to aid GPs and gynaecologists in the initial management of menorrhagia, whether this be initiated in a primary care setting or after referral to the hospital outpatient department.
The treatment objective in menorrhagia is to alleviate heavy menstrual flow and consequently improve quality of life. Iron deficiency anaemia must also be prevented.
A comprehensive literature search was performed to identify relevant evidence on which to base recommendations. MEDLINE, EMBASE, The Cochrane Library and reference lists of review articles were searched up to December 1997. Published systematic reviews or meta-analyses were used if available.
Otherwise relevant randomised controlled trials or other experimental studies were obtained. If there were no published randomised controlled trials or randomised controlled trials were not appropriate for a particular clinical question, other appropriate experimental or observational studies were sought.
Identified articles were assessed methodologically and the evidence was synthesised using qualitative methods. These involved summarising the content of identified papers into brief statements that accurately reflected the relevant evidence.
Meta-analyses, apart from those published, were not performed, owing to time constraints and the difficulty of combining studies of various designs.
Recommendations were derived using informal consensus methods. Where there were areas without evidence, consensus was again used.
The recommendations were then graded according to the level of evidence upon which they were based. The grading used was formulated by the Clinical Outcomes Group (COG) and recommended by the NHS Executive.
- A – based on randomised controlled trials
- B – based on other robust experimental or observational studies
- C – based on more limited evidence but the advice relies on expert opinion and is endorsed by respected authorities.
It is accepted that randomised controlled trials are not the most appropriate study design to investigate diagnostic tests, so the use of this grading system means that no recommendations concerning diagnostic tests will receive an A grade.
Similarly there may be clinical questions that cannot easily be answered by experimental design but nevertheless represent good practice. Such recommendations will automatically be graded C. Other C recommendations may also be questionable as they are not based on incontrovertible evidence.
However, the views of the guideline group combined with comments from an extensive peer review suggest that the recommendations with a C grading are acceptable to a wide body of expert opinion pending the results of future research.
Thirteen recommendations were formulated based on the evidence found with the search strategy outlined above. These have been summarised into two clinical algorithms, shown in Figures 1 and 2 (below).
|Figure 1: Algorithm for the evaluation of menorrhagia, taken from the RCOG guidelines|
|Figure 2: Algorithm for the medical management of menorrhagia, taken from the RCOG guidelines|
Like all RCOG guidelines funded by the NHS Executive, they were sent to the Health Care Evaluation Unit at St George's Hospital Medical School for independent peer review and assessment.
The guidelines will be reviewed by the RCOG no later than the year 2002. A similar methodology will be used and the process will involve updating the literature searches and reviews for each topic to take into account any new developments in the area.
This programme of regular review will ensure that new research is reflected in the guidelines and that, where necessary, recommendations are changed or re-graded.
The main emphasis in these guidelines is on the provision of effective medical treatment for menorrhagia before recourse to hospital referral. Extensive investigation is not recommended.
As it is essentially the subjective complaint of menorrhagia that is being treated, emphasis is also placed on sharing the decision making process with the woman.
We hope that this national guideline will form the basis for the development of local primary care protocols which will take into account local service provision and the needs and preferences of the local population. If local adaptation takes place, it should occur within a similar multidisciplinary group.
Each year around £7m is spent in the UK on primary care prescribing to treat menorrhagia. A small survey of GPs' prescribing habits for menorrhagia3 showed that the majority of GPs used oral progestogens, an ineffective treatment for menorrhagia, while less than 2% used tranexamic acid, one of the most effective treatments.
A more recent survey showed that awareness of tranexamic acid had increased, although progestogens were still commonly prescribed.4
In producing similar guidelines in New Zealand,5 it was anticipated that their introduction would lead to savings, mainly by reducing the number of hysterectomies.
There may be cost savings associated with a reduction in unnecessary tests, or with the avoidance of inappropriate surgical intervention. This may offset the initially higher costs of drug therapy.
It is anticipated that there will be health benefits for women complaining of menorrhagia in the form of effective investigation of their presenting problem without delay, more information provision, and more effective initial medical management with appropriate referral to a specialist if necessary.
The full guidelines and guidelines summary can be obtained from the RCOG bookshop (020-7772 6275, email: firstname.lastname@example.org). A laminated chart containing both algorithms is available with the full guidelines for easy reference during the consultation.
Alternatively the guidelines summary can be downloaded from the RCOG website (http://www.rcog.org.uk) .
- Coulter A, Kelland J, Long A. The Management of Menorrhagia. Effective Health Care Bull 1995;9.
- Royal College of Obstetricians and Gynaecologists. The Initial Management of Menorrhagia. Evidence-based Clinical Guidelines No.1. 1998. ISBN: 1 900364 14 X.
- Coulter A, Kelland J, Peto V, Rees MC. Treating menorrhagia in primary care. An overview of drug trials and a survey of prescribing practice. Int J Technol Assess Health Care 1995; 11 456-71.
- Taskforce to Improve the Management of Menorrhagia. GP Survey on Menorrhagia. London: Meditex, 1997. (Available from the Secretariat to the Taskforce to Improve the Management of Menorrhagia, 35 Findon Road, London W12 9PP.)
- Working Party of the National Health Committee NZ. Guidelines for the Management of Heavy Menstrual Bleeding. 1998. Available from The Ministry of Health, 133 Molesworth Street, PO Box 5013, Wellington, New Zealand.