Dr Sarah Gray shows how NICE care pathways can help GPs to offer effective, individualised care and treatment for women with heavy menstrual bleeding
H eavy menstrual bleeding (HMB) is a common condition, affecting 20%–30% of women of reproductive age,1 who frequently present in primary care. Historical data indicate that in the early 1990s, as many as 60% of women were treated with hysterectomy for this condition, and some were offered no treatment at all.2 Both treating and not treating HMB leads to significant costs and implications for the patient herself (e.g. sanitary protection, bedding, prescription costs, and time off work for treatment), as well as for the national health economy.
NICE clinical guideline on heavy menstrual bleeding
In January 2007, NICE published Heavy menstrual bleeding, Clinical Guideline (CG) 44; (see www.nice.org.uk/guidance/CG44).2 This guideline redefined HMB as ‘excessive menstrual blood loss which interferes with a woman’s physical, social, emotional, and/or material quality of life. It can occur alone or in combination with other symptoms.’2 The inclusion of the concept of ‘quality of life’ has moved diagnosis of HMB significantly forward from the time when, up until the 1990s, excessive blood loss was statistically quantified in research settings but never properly assessed in clinical practice. Clinical Guideline 44 acknowledged that the impact HMB has depends on the subjective experience of the woman, and that any interventions should aim to improve the woman’s quality of life.2
NICE CG44 on HMB has been widely implemented through primary and secondary care. The Royal College of Obstetricians and Gynaecologists (RCOG) has since audited referral patterns, protocols, and practices in hospital settings.1 A survey has also been carried out of patients referred to secondary care for HMB, aimed at understanding their symptoms and reported outcomes following referral.3,4 In order to complete the audit cycle and to allow evaluation of the primary care elements of the pathway, a quality standard on HMB was needed.
Quality standard on heavy menstrual bleeding
NICE Quality Standard (QS) 47 on Heavy menstrual bleeding, developed by NICE with the assistance of specialist committee members, was published in September 2013.5 This quality standard was developed as part of a wider initiative by the Government, in partnership with NICE, to drive up standards in key clinical areas and improve quality of care.
NICE QS47 on HMB is intended to support NICE CG44, as it:
- provides patients with information on what they should expect from their healthcare provider if they present with HMB
- will be used to assess healthcare provision and performance in the clinical setting, both of individuals and organisations
- will inform the process of commissioning, and contribute to the delivery of NHS Outcomes Framework 2013/14??6 and Public Health Outcomes Framework for England 2013–2016.7
In the context of NICE QS47 (see Table 1, below), ‘women’ refers to all women of reproductive age (that is, from onset to cessation of menstruation); it does not exclude those under 18 years of age, so young women should have the same options offered to them as older women. NICE clinical guidelines are advisory, and clinical judgement remains important.
Healthcare professionals should be aware that the likelihood of pathology and acceptability of management options by the woman will be significantly influenced by many factors, including but not limited to:
- capacity to consent
- concomitant medical conditions
- sexual practice
- contraceptive need.
It is vitally important to perform a thorough assessment and to provide sufficient information to allow informed choice and a management plan tailored to the needs of the individual woman.2
|1||Women presenting with symptoms of heavy menstrual bleeding have a detailed history and a full blood count taken.|
|2||Women with heavy menstrual bleeding in whom a structural or histological abnormality is suspected have a physical examination before referral for further investigations.|
|3||Women with heavy menstrual bleeding without suspected structural or histological abnormalities are offered drug treatment at the initial assessment.|
|4||Women with heavy menstrual bleeding who are undergoing further investigations or awaiting definitive treatment are offered tranexamic acid or non-steroidal anti-inflammatory drugs at the initial assessment.|
|5||Women with heavy menstrual bleeding and a normal uterus or small uterine fibroids who choose surgical intervention have a documented discussion about endometrial ablation as a preferred treatment to hysterectomy.|
|6||Women with heavy menstrual bleeding related to large uterine fibroids who choose surgical or radiological intervention have a documented discussion about uterine artery embolisation, myomectomy and hysterectomy.|
|NICE (2013) QS47. Quality standard for heay menstrual bleeding. Available at: publications.nice.org.uk/heavy-menstrual-bleeding-qs47|
Initial assessment—statement 1
The initial consultation in primary care should give an opportunity to reflect whether the woman’s blood loss is within the range of normal. Understanding her concern may be sufficient for her to accept that the degree of blood loss does not represent either a concern to be investigated or demand active management. Satisfaction with any intervention offered is also subjective, as partial improvement may be enough to allow the woman to cope with her bleeding.2
When taking a detailed history from a woman with HMB, the clinician should ask about and record:
- the nature of the bleeding problem
- when it started
- its impact on the woman’s life.
It may be helpful to consider the changes and grade of sanitary protection required. Regularity of periods, cycle length, and number of bleeding days are also relevant. It is important to ask specifically about:
- post-coital bleeding
- intermenstrual bleeding
- general pelvic discomfort.
The above-listed four symptoms are ‘red-flag’ symptoms that demand further investigation and may warrant additional treatment outside of the care pathway (see Figure 1, below).8
The GP should review the woman’s general health, contraceptive method, and any medication taken: an intrauterine device (IUD), hormonal contraception, or anticoagulants will alter the analysis. Additionally, a family history may reveal a pattern (e.g. daughters often follow a similar pattern to their mothers).
The diagnosis of HMB is made on the basis of the history provided by the woman. If a diagnosis of HMB is made, the woman should be offered a full blood count to determine whether she has an iron-deficiency anaemia requiring treatment. Thyroid function testing is not required unless some other element of the history suggests there may be reason to suspect an anomaly.2
Physical examination—statement 2
In some women, post-coital bleeding, intermenstrual bleeding, pain, or symptoms of pelvic pressure may be caused by a structural anomaly (e.g. a cervical or endometrial polyp, fibroid, cervical ectropion, ovarian mass). The causes of these symptoms should be considered and investigated to exclude histological anomalies, such as:
- cervical malignancy
- endometrial hyperplasia
The likelihood of these potential causes is determined through a detailed history and by:
- physical examination to view the vulva, vagina, and cervix
- bimanual palpation of the pelvic organs.
Swabs to exclude sexually transmitted infection should be taken if indicated, but a sample for cervical cytology is only needed if scheduled on the NHS cervical screening programme. Information gained from the examination should be recorded and included in any referral request. It is not acceptable to refer the woman for investigations without having first conducted a preliminary examination in primary care. This does not need to be at the initial consultation: a request for a female clinician to perform the examination should be respected and a chaperone offered, if necessary at a later appointment.9
Drug treatment—statements 3—4
In most cases there is no pathological explanation for the HMB. Women who have no ‘red-flag’ symptoms or other features requiring investigation should be informed of the pharmaceutical treatment options available for HMB8 (see Table 2, here), which CG44 states should be considered in the following order:2
- levonorgestrel intrauterine system (LNG-IUS)
- antifibrinolytics (tranexamic acid), non-steroidal anti-inflammatory drugs (NSAIDs), or combined hormonal contraception
- high-dose progestogens.
The order in which CG44 recommends treatments is based on efficacy and long-term, rather than acquisition, cost.
The discussion with the woman should also include a summary of the available surgical options, together with an indication of when these might be considered. Women should be informed, using appropriate language/media, about:
- how the methods work
- how well and how soon they work, including their side-effect profile
- what would be required of the woman to achieve the best effect.
It is quite feasible to do this in the context of a 10-minute GP consultation. Drug treatments can be discussed and offered at the initial consultation (i.e. in primary care) without physical examination or other investigations, unless the treatment chosen is LNG-IUS.
It is common for the woman initially to choose a method that she has been advised may be less effective, while she considers more effective alternatives.It is not envisaged that a LNG-IUS would be offered and provided at first presentation. The woman should be aware that an examination would be needed at fitting of the device, and what this would involve. It is important to be reasonably certain that she is not pregnant at the time of fitting, and this is a further factor determining timing, and requiring discussion.
Quality statement 4 recommends that women who are undergoing further investigation, or awaiting definitive treatment in secondary care, should be offered NSAIDs or tranexamic acid in an attempt to ease their distress. It is not acceptable to recognise that there is a problem and yet offer nothing to help.
|Pharmaceutical treatment||How it works||Is it a contraceptive?||Will it impact on future fertility?||Potential unwanted outcomes experienced by some women§|
|* The evidence for effectiveness can be found in the full guideline.
† Check the Summary of Product Characteristics for current licensed indications. Informed consent is needed when using outside the licensed indications.
‡ See World Health Organization ‘Pharmaceutical eligibility criteria for contraceptive use’ (WHOMEC), www.ffprhc.org.uk/admin/uploads/298_UKMEC_200506.pdf
§ Common: 1 in 100 chance; less common: 1 in 1000 chance; rare: 1 in 10,000 chance; very rare: 1 in 100,000 chance.
¶ The recommended dosing regimen for norethisterone is not licensed for use as a contraceptive, but may affect a woman’s ability to become pregnant while it is being taken.
NICE. Quick reference guide. Heavy menstrual bleeding. Care pathway for heavy menstrual bleeding. Clinical Guideline 44. NICE, 2007. Available at: www.nice.org.uk/nicemedia/live/11002/30403/30403.pdf. Reproduced with permission.
Access to endometrial ablation—statement 5
Some women, having been fully informed of their options, may request surgical treatment. Others may be referred because of failure of, or contraindication to, drug treatment. If they have a normal uterus or small fibroids that do not significantly distort the uterine cavity, they should be offered endometrial ablation as the preferred treatment to hysterectomy, and this discussion should be recorded.5
Access to interventions for uterine fibroids—statement 6
Women with HMB for whom investigation has demonstrated significant fibroids (larger than 3 cm) should have a documented discussion with the surgical team regarding the alternative treatments of:5
- uterine artery embolisation
Women should be provided with sufficient information to understand their suitability for these procedures and the risks, side-effects, and implications of each intervention. The woman’s opinion should be taken into consideration and her management plan negotiated and agreed.
NICE heavy menstrual bleeding pathway
NICE has developed a web-based care pathway for HMB,10 available at pathways.nice.org.uk/pathways/heavy-menstrual-bleeding#content=view-node%3Anodes-heavy-menstrual-bleeding-and-its-impact. This covers aspects of:
- support for the woman to enable her to make an informed decision about her treatment.
The initial Guideline Development Group for CG44 understood that commissioning would establish local arrangements to ensure that the proposed pathway would be implemented.
I would like to finish this article on a personal note. As a provider of women’s healthcare in primary care settings, I cannot think of another area in medicine where it is possible for very simple interventions to have such a positive effect on the lives of our patients. Women value being listened to, taken seriously, and helped to manage their problems. They are grateful when they no longer dread their periods, and wonder why they did nothing about them earlier. For the healthcare practitioner, getting it right in this situation is personally satisfying.
I have provided clinical leadership in my area for almost 20 years. There are now accredited fitters of LNG-IUS in nearly all practices in my area (in Cornwall). These accredited people in turn provide a lead for their colleagues. The local initiative was under development before the launch of NICE CG44 on HMB and has been strengthened by it. The Royal College of Gynaecologists’ 2012 audit demonstrated a lower hysterectomy rate in my geographical area than in an adjacent area with similar demographics.11 I attribute this to the educational cascade, which has resulted in greater prevalence of good primary care management of HMB. We are encouraged to audit and reflect on clinical practice. My personal view is that this new quality standard will facilitate audit of management of HMB in primary care, and as a result help even more women.
Good practice points for HMB in primary care
- When a woman presents with heavy periods, she should not be told to put up with them, or accept them as a matter of course. It is important to ask and document what effect they have on her life
- If the bleeding has an undesirable impact on her quality of life, the only recommended test is a full blood count to assess the extent of any haematological impact of the blood loss. Iron studies should follow an abnormal result, as there may be another explanation2
- Thyroid function testing is indicated only if some other element of the history provides a reason to suspect anomaly; no other tests are routinely recommended2
- Gonadotrophin tests (FSH/LH) will not inform assessment if a menstrual cycle is clearly described2
- Women with no red-flag symptoms can be offered all pharmaceutical options at their initial consultation2
- Women requiring further investigation or referral can be offered NSAIDs or tranexamic acid while these proceed2
- Women with no red-flag symptoms and a normal pelvic examination do not need to have ultrasound imaging prior to the fitting of an LNG-IUS2
- All women choosing to have an LNG-IUS fitted should have a sexual history taken with sexually transmitted infection screening where appropriate12
- Women should be counselled with respect to what they can reasonably expect from all available interventions, and be provided with sufficient information to make an informed choice.
HMB=heavy menstrual bleeding; FSH=follicle stimulating hormone; LH=luteinising hormone; NSAID=non-steroidal anti-inflammatory drug; LNG-IUS= levonorgestrel intrauterine system
- The practice can identify women presenting with HMB as a primary complaint (this requires appropriate coding for the problem)
- The proportion of women identified as having HMB:
- who have a detailed menstrual history documented at diagnosis and a full blood count result recorded within the next month
- who are offered pharmaceutical intervention at diagnosis, with the options discussed recorded
- who are referred for imaging or specialist opinion and who have a recorded speculum and pelvic examination within the previous 3 months.
- Provision of LNG-IUS in primary care is funded through enhanced service payments. In England, this enhanced service has been passed from CCGs to local authority control, along with the bulk of sexual healthcare.
- CCGs should ensure that:
- the payment is sufficient to allow provision of the service in a convenient primary care setting
- there is adequate clinical governance for the service
- local authorities do not refuse to pay for the service where contraception is not needed
- training and updating of providers includes an understanding of all relevant NICE guidance
- In areas where primary care does not provide sufficient competency-assessed fitters of the LNG IUS, CCGs should consider developing and commissioning an intermediate service to provide assessment and advice, and offer those procedures not requiring general anaesthesia
- CCGs should ensure that:
- they commission an adequate number of endometrial ablation procedures
- women with fibroids are offered myomectomy and uterine artery embolisation as alternatives to hysterectomy. They should commission these procedures in adequate numbers and ensure that they are accessible for the women involved.
- Royal College of Obstetricians and Gynaecologists. National heavy menstrual bleeding audit. First annual report. RCOG Press, 2011. Available at: www.rcog.org.uk/files/rcog-corp/NationalHMBAudit_1stAnnualReport_May2011.pdf
- NICE. Heavy menstrual bleeding. Clinical Guideline 44. NICE, 2007. Available at:publications.nice.org.uk/heavy-menstrual-bleeding-cg44
- Royal College of Obstetricians and Gynaecologists.National heavy menstrual bleeding audit. Second annual report. RCOG Press, 2012. Available at: www.rcog.org.uk/files/rcog-corp/NationalHMBAudit_2ndAnnualReport_11.07.12_forweb.pdf
- Royal College of Obstetricians and Gynaecologists. National heavy menstrual bleeding audit. Third annual report. RCOG Press, 2013. Available at: www.rcog.org.uk/files/rcog-corp/NationalHMBAudit_3rdAnnualReport_September2013.pdf
- NICE website. Heavy menstrual bleeding. NICE Quality Standard 47. www.nice.org.uk/guidance/QS47 (accessed 29 October 2013).
- Department of Health.NHS Outcomes Framework 2013/14. London: 2012. Available at:www.gov.uk/government/publications/nhs-outcomes-framework-2013-to-2014 (accessed 29 October 2013).
- Department of Health. Public heath outcomes framework 2013–16. London: DH, 2012. Available at: www.gov.uk/government/publications/healthy-lives-healthy-people-improving-outcomes-and-supporting-transparency (accessed 29 October 2013).
- NICE.Quick reference guide. Heavy menstrual bleeding. Clinical Guideline 44. NICE, 2007. Available at: www.nice.org.uk/nicemedia/live/11002/30403/30403.pdf.2007.
- General Medical Council.Intimate examinations and chaperones. GMC, 2013. Available at: www.gmc.uk.org/Intimate_examinations_and_chaperones.pdf_51449880.pdf
- NICE pathways website. Heavy menstrual bleeding. pathways.nice.org.uk/pathways/heavy-menstrual-bleeding (accessed 29 October 2013).
- Royal College of Obstetricians and Gynaecologists. National heavy menstrual bleeding audit. RCOG, 2012. Available at: www.hqip.org.uk/assets/NCAPOP-Library/NCAPOP-2012-13/Heavy-Menstrual-Bleeding-Audit-Report-published-2012.pdf
- Faculty of Sexual and Reproductive Healthcare Clinical effectiveness Unit.Intrauterine contraception. 2007. FSRH, 2007. Available at: www.fsrh.org/pdfs/CEUGuidanceintrauterineContraceptionNov07.pdf