NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Health and social care directorate. Quality standards and indicators.

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1 NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Health and social care directorate Quality standards and indicators Briefing paper Quality standard topic: Heavy menstrual bleeding Output: Prioritised quality improvement areas for development. Date of Quality Standards Advisory Committee meeting: 15 February 2013 Contents 1 Overview Summary of suggestions Suggested improvement area: History, examination and investigations for HMB Suggested improvement area: Pharmaceutical treatments for HMB Suggested improvement area: Non-hysterectomy surgery for HMB Suggested improvement area: Treatment follow-up Suggested improvement area: Settings dedicated HMB clinics Suggested improvement area: Settings hysteroscopy clinic Suggested improvement area: Awareness Suggested improvement area: Outcomes Suggested improvement area: Scope Suggested improvement area: Review of evidence for pharmaceutical treatments Suggested improvement area: Education and information provision, choice and further interventions for uterine fibroids associated with HMB Appendix 1 Pathway diagram Appendix 2 Pharmaceutical treatment Appendix 3 Surgical and radiological treatments Appendix 4 Key priorities for implementation recommendations Appendix 5 Glossary Appendix 6 Suggestions from stakeholder engagement exercise QSAC briefing paper: Heavy menstrual bleeding 1 of 59

2 Introduction This briefing paper presents a structured overview of potential quality improvement areas for heavy menstrual bleeding. It provides the Committee with a basis for discussion and prioritising quality improvement areas for developing quality statements and measures, which will be drafted for public consultation. Structure This includes a brief overview of the topic followed by a summary of each of the suggested quality improvement areas followed with supporting information. Where relevant, guideline recommendations selected from the key development source below are presented to aid the Committee when considering specific aspects for which statements and measures should be considered. Development source The key development source referenced in this briefing paper is: Heavy Menstrual Bleeding: Investigation and treatment. NICE clinical guideline 44 (2007). Where relevant, guideline recommendations from the key development source are presented alongside each of the suggested areas for quality improvement within the main body of the report. 1 Overview 1.1 Focus of quality standard This quality standard will cover the care of women of reproductive age with heavy menstrual bleeding as a result of cyclical ovarian activity, as the major complaint. This may be associated with uterine fibroids, because heavy menstrual bleeding is commonly the major presenting symptom, or dysfunctional uterine bleeding in the absence of visible pathology. 1.2 Definition Heavy menstrual bleeding (HMB) is defined as excessive menstrual blood loss which interferes with the woman's physical, emotional, social and material quality of life, and which can occur alone or in combination with other symptoms. HMB should be recognised as having a major impact on a woman's quality of life, and any intervention should aim to improve this rather than focusing on menstrual blood loss. QSAC briefing paper: Heavy menstrual bleeding 2 of 59

3 Evidence presented in the full guideline for NICE clinical guideline 44 shows that the presence of uterine fibroids, increased age and racial group are linked to the likelihood of women having HMB (although these factors may themselves be related). Evidence also shows that psychological wellbeing factors are likely to moderate an individual woman s response to her menstrual blood loss. However, for many of these factors, their role in causality and the effect of modifying them has yet to be elucidated. 1.3 Incidence and prevalence Heavy menstrual bleeding (HMB) is a common condition affecting 20 30% of women of reproductive age. There are various treatments available for women with HMB and for some women the condition can be effectively managed within primary care. However, medical therapies may not be tolerated or prove ineffective, and it is estimated that HMB is the fourth most common reason women are referred to gynaecology services. In England and Wales, each year about women with HMB are referred for the first time to secondary care and approximately undergo surgical treatment 1. The majority of women with HMB have no histological abnormality that can be implicated in causing HMB. Uterine fibroids (approximately 30% of women) and polyps (approximately 10% of women) are the most common form of pathology found. It is rare for a woman who has presented with HMB and has undergone investigations to have an underlying pre-malignant or malignant condition Management In the early 1990s it was estimated that at least 60% of women presenting with HMB would have a hysterectomy to treat the problem, often as a first line. However, things have changed and the number of hysterectomies is decreasing rapidly 2. Alternative effective treatments to hysterectomy are now available for women with HMB and these include pharmaceutical and non-hysterectomy surgical treatments. Given the range of treatment options, women need to be given the opportunity to review and agree their treatment options and this includes the provision of adequate time and information on which to base this decision. Ultrasound scan (USS) is the first-line diagnostic tool for identifying structural abnormalities. Imagining should be undertaken for women with HMB in whom their uterus is palpable abdominally, or a vaginal examination reveals a pelvic mass of uncertain origin or in whom pharmaceutical treatments have failed. For women in whom the USS confirms fibroids greater than 3cm diameter uterine artery 1 Prevalence data has been taken from the National Heavy Menstrual Bleeding Audit (RCOG, 2011). 2 National Collaborating Centre for Women s and Children s Health (January 2007) Full guideline for heavy menstrual bleeding. QSAC briefing paper: Heavy menstrual bleeding 3 of 59

4 embolisation (UAE), hysteroscopic myomectomy, myomectomy and hysterectomy (first line vaginal, second line abdominal) are surgical treatment options. For women with HMB without structural abnormalities including fibroids less than 3cm diameter, pharmaceutical options, initiated largely in primary care should be considered. Pharmaceutical treatment options include levonorgestrel-releasing intrauterine system (LNG-IUS) provided long-term (at least 12 months) use is anticipated, tranexamic acid, non-steroidal anti-inflammatory drugs (NSAIDs), combined oral contraceptives (COCs), norethisterone (15 mg) daily from days 5 to 26 of the menstrual cycle and injected long-acting progestogens. For women with HMB with or without fibroids less than 3cm diameter in whom pharmaceutical treatments have failed or are not suitable, endometrial ablation and hysterectomy (first line vaginal, second line abdominal) are surgical options. NICE CG44 recommends that hysterectomy is not used as a first-line treatment solely for HMB and should only be considered when other treatment options have failed, are contraindicated or are declined by the woman, there is a wish for amenorrhoea, the woman (who has been fully informed) requests it or the woman no longer wishes to retain her uterus and fertility. See appendices 1-5 for patient pathway, algorithms and key priority for implementation recommendations from NICE clinical guideline 44 and the glossary. 1.5 National Heavy Menstrual Bleeding Audit The RCOG is conducting the National Heavy Menstrual Bleeding Audit (HQIP funded), which began on 1 st February The findings of this audit are presented in the current practice sections, if they relate to a quality improvement area. The overall aims of this 4-year audit are to describe the care received by women with HMB referred to NHS outpatient clinics in England and Wales and to assess women s outcomes and experience of care. The audit consists of two components; an organisational audit and a prospective audit of patient-reported outcomes. The findings of the organisational audit of acute NHS trusts in England and Wales are available in the first annual report. The organisational audit describes the organisation of hospital gynaecological services, current referral patterns and local protocols with reference to the management of HMB. All NHS acute trusts with outpatient gynaecology departments in England and Wales were sent a questionnaire on issues related to the availability of facilities, local treatment protocols and patterns of care in both primary and secondary care. Responses were received from 221 hospitals (100% response). The findings of the first year of the prospective audit of patient-reported outcomes are available in the second annual report. It focuses on women who attended outpatient gynaecology clinics with HMB symptoms for the first time between 1 QSAC briefing paper: Heavy menstrual bleeding 4 of 59

5 Public Health Outcomes Framework NHS Outcomes Framework February 2011 and 31 January 2012, describing their symptoms and the care received prior to referral. The report is based on the analysis of questionnaires meeting the inclusion criteria. 1.6 National Outcome Frameworks The table below shows the indicators from the frameworks that the quality standard could contribute to: Domain 3: Helping people to recover from episodes of ill health or following injury. Domain 4: Ensuring people have a positive experience of care. Domain 5: Treating and caring for people in a safe environment and protect them from avoidable harm. 3b Emergency readmissions within 30 days of discharge from hospital 4a Patient experience of primary care (i) GP services 4b Patient experience of hospital care 4.c Friends and Family Test (placeholder) 4.1 Patient experience of outpatient services 4.2 Responsiveness to in-patients personal needs 4.4i Access to GP services 5a Patient safety incidents reported 5b Safety incidents involving severe harm or death 5c Hospital deaths attributable to problems in care (placeholder) 2.19 Cancer diagnosed at stage 1 and Emergency readmissions within 30 days of discharge from hospital QSAC briefing paper: Heavy menstrual bleeding 5 of 59

6 2 Summary of suggestions 2.1 Responses In total nine stakeholders submitted suggestions for quality improvement as part of the engagement exercise (17/12/12 4/01/13). For this topic the engagement exercise was extended beyond the usual 2-week period to allow for the holiday period. Table 1 Summary of suggested quality improvement areas Stakeholders were asked to suggest up to 5 areas for quality improvement. These have been merged and summarised in the table below for further consideration by the Committee. The full detail of the suggestions is provided in appendix 6 for information. Suggested area for improvement History, examination and investigations for HMB Diagnostic investigations - USS The diagnostic process should be thorough and where appropriate include referral for pelvic ultrasound scan (first-line investigation). The outcome of diagnostic investigations will inform the subsequent treatment and management options. Diagnostic - physical examination Physical examination should be carried out in all patients presenting with HMB to include an internal examination as appropriate. Presence of an enlarged uterus makes diagnosis of fibroids or adenomyosis more likely. Diagnostic investigations biopsy HMB alone is not a useful marker for endometrial cancer or atypical hyperplasia (NCC-WCH). Inappropriate testing can cause unnecessary anxiety and use of resources (NCC-WCH). Competency standards required for endometrial biopsy in primary care (SCM). Diagnostic investigations quantifying blood loss Use of quantitative tests of menstrual bleeding loss is inappropriate. Stakeholder (see table 2 for abbreviations) RCR NCC-WCH FEmISA RCR NCC-WCH SCM NCC-WCH QSAC briefing paper: Heavy menstrual bleeding 6 of 59

7 Pharmaceutical treatments for HMB Variation in the access to pharmaceutical treatments Women are referred into secondary care without having tried appropriate first-line pharmaceutical therapies Unable to ascertain what percentage of women are offered LNG- IUS before being treated surgically and variation in the availability of outpatient facilities for the insertion of LNG-IUS. LNG-IUS is a cost-effective treatment option for women where use is anticipated for at least 12 months. Competency standards required for fitting and LNG-IUS. Non-hysterectomy surgery for HMB Variations in the types of surgical interventions available to women Need to standardise availability of non-hysterectomy surgery Three stakeholders (RCOG, FEmISA and Schering Health Care Ltd) highlight variations in the use and availability of uterine artery embolisation and this is supported by data from National HMB audit. Need to define place of uterine artery embolisation in the treatment pathway in relationship to other treatments for fibroids Treatment follow-up Women should be offered at least one follow-up apt and a contact number. Settings dedicated HMB clinic There should be dedicated HMB clinics to ensure consistent treatment by staff with specialised skills. Settings hysteroscopy clinics Hysteroscopy for women with HMB should to be carried out in outpatient setting and this would reduce unnecessary general anaesthetics. Awareness Simple media messages for women on HMB, to encourage greater awareness and enable women to seek help sooner. Outcomes Providers should publish comparable intervention rates and associated outcomes, to enable women to be better informed. Scope The scope should include teenagers and young women with HMB. Review of evidence for pharmaceutical treatments Review of evidence regarding new hormonal therapies. Education and information provision, choice and further interventions for uterine fibroids associated with HMB Stakeholders report inequity in the availability of pharmaceutical and surgical treatments, and that women require written information about the full range of treatment options which should be available to them. RCOG RCN (+SCM) Cam Uni Hosp Tr Schering HC Ltd NCC-WCH SCM RCOG RCN (+SCM) FEmISA Cam Uni Hosp Tr Schering HC Ltd NCC-WCH RCR RCN (+SCM) RCOG RCN (+SCM) Cam Uni Hosp Tr Cam Uni Hosp Tr RCN (+SCM) FEmISA RCPCH SCM Schering HC Ltd RCN (+SCM) FEmISA SCM QSAC briefing paper: Heavy menstrual bleeding 7 of 59

8 This includes information about which treatment options are not available through their local provider. Table 2 Stakeholder details (abbreviations) The details of stakeholder organisations who submitted suggestions are provided in the table below. Abbreviation RCN (+SCM) NCC-WCH RCR FEmISA Schering HC Ltd RCOG Cam Uni Hosp Tr RCPCH SCM Full name Royal College of Nursing including a Specialist Committee Member National Collaborating Centre for Women and Children's Health Royal College of Radiologists Fibroid Embolisation: Information, Support & Advice Schering Health Care Ltd (Bayer) Royal College of Obstetricians and Gynaecologists Cambridge University Hospital Trust Royal College of Paediatrics and Child Health Specialist Committee Member QSAC briefing paper: Heavy menstrual bleeding 8 of 59

9 3 Suggested improvement area: History, examination and investigations for HMB 3.1 Summary of suggestions Stakeholders highlighted the importance of the woman receiving a full diagnosis, including the presence or absence of structural abnormalities. It was highlighted that diagnosing the cause of the woman s HMB impacts on the woman s treatment and management options. The following areas were suggested as important aspects of the diagnostic pathway: a) Diagnostic investigations - USS Ultrasound scan was suggested by stakeholders as an appropriate first-line investigation with should be made available to women with a suspected structural abnormality (RCR, NCC-WCH, FEmISA) b) Diagnostic investigations physical examination A physical examination should be carried out for all women presenting with HMB, note that this is not fully supported by CG44 recommendation (RCR) c) Diagnostic investigations biopsy A woman should only undergo an endometrial biopsy where she has specific risk factors for endometrial cancer or atypical hyperplasia (NCC-WCH). A competency standard is required for those undertaking this procedure in primary care (SCM). d) Diagnostic - quantifying blood loss Diagnosis of HMB should be made on the woman s assessment of the impact on her quality of life and quantifying menstrual blood loss should not be used as a tool to aid diagnosis (NCC-WCH). 3.2 Selected recommendations 3 from development source Recommendations from the development source relating to the suggested improvement areas have been provisionally selected and are presented below to inform QSAC discussion. 3 Note that there is an error in the recommendation numbers which appear on the web-version of CG44 and this is being rectified. This briefing paper refers to the recommendation numbers listed in the pdf version of the guidance. QSAC briefing paper: Heavy menstrual bleeding 9 of 59

10 NICE CG 44 History, examination and investigations for HMB Recommendations 1.2.3, 1.2.4, 1.2.5, 1.2.6, (KPI), , (KPI). a) Diagnostic investigations - USS History If the history suggests HMB without structural or histological abnormality, pharmaceutical treatment can be started without carrying out a physical examination or other investigations at initial consultation in primary care, unless the treatment chosen is levonorgestrel-releasing intrauterine system (LNG-IUS) (see recommendation 1.2.6) If the history suggests HMB with structural or histological abnormality, with symptoms such as intermenstrual or postcoital bleeding, pelvic pain and/or pressure symptoms, a physical examination and/or other investigations (such as ultrasound) should be performed. Structural and histological investigations Imaging should be undertaken in the following circumstances: The uterus is palpable abdominally. Vaginal examination reveals a pelvic mass of uncertain origin. Pharmaceutical treatment fails (KPI) Ultrasound is the first-line diagnostic tool for identifying structural abnormalities. b) Diagnostic investigations physical examination History If the history suggests HMB without structural or histological abnormality, pharmaceutical treatment can be started without carrying out a physical examination or other investigations at initial consultation in primary care, unless the treatment chosen is levonorgestrel-releasing intrauterine system (LNG-IUS) (see recommendation 1.2.6) If the history suggests HMB with structural or histological abnormality, with symptoms such as intermenstrual or postcoital bleeding, pelvic pain and/or pressure symptoms, a physical examination and/or other investigations (such as ultrasound) should be performed. QSAC briefing paper: Heavy menstrual bleeding 10 of 59

11 Examination A physical examination should be carried out before all: LNG-IUS fittings[1] investigations for structural abnormalities investigations for histological abnormalities. c) Diagnostic investigations biopsy Structural and histological investigations (KPI) If appropriate, a biopsy should be taken to exclude endometrial cancer or atypical hyperplasia. Indications for a biopsy include, for example, persistent intermenstrual bleeding, and in women aged 45 and over treatment failure or ineffective treatment. Competencies - Maintenance Maintenance of surgical, imaging or radiological skills requires a robust clinical governance framework including audit of numbers, decision making, casemix issues and outcomes of all treatments at both individual operator and organisational levels. These data should be used to demonstrate good clinical practice. d) Diagnostic - quantifying blood loss History Measuring menstrual blood loss either directly (alkaline haematin) or indirectly ('Pictorial blood loss assessment chart') is not routinely recommended for HMB. Whether menstrual blood loss is a problem should be determined not by measuring blood loss but by the woman herself. 3.3 Current UK practice National Heavy Menstrual Bleeding Audit The findings of the organisational audit of acute NHS trusts in England and Wales are available in the first annual report. The following findings relate to this quality improvement area: a) Diagnostic investigations USS The majority of hospitals (177 of 221, 80%) reported having access to ultrasound within outpatient gynaecology clinics. QSAC briefing paper: Heavy menstrual bleeding 11 of 59

12 b) Diagnostic investigations physical examination Respondents were asked what investigations are considered at the initial consultation in their clinic for women with HMB being referred for the first time. An abdominal and pelvic examination was considered mostly or always by almost all hospitals (data not shown in the report) to be an investigation considered at the initial consultation in their clinic for women with HMB being referred for the first time. c) Diagnostic investigations biopsy The majority of hospitals (216 of 221, 97.7%) reported the availability of endometrial biopsy within outpatient gynaecology clinics and 210 hospitals (95.0%) reported that they had available day care diagnosis, which is inpatient-based hysteroscopy plus endometrial biopsy. d) Diagnostic - quantifying blood loss An objective measure of blood loss was considered never or rarely in most hospitals (data not shown in the report) to be a relevant investigation at the initial consultation in their clinic for women with HMB being referred for the first time. Patient information and choice survey a) Diagnostic investigations USS The findings of a small scale study which received responses from 120 women who completed an online survey found that in this cohort of women 94.8% reported having received an ultrasound test as a diagnostic investigation. Women who completed the survey had been in contact with the UK based charity (Fibroid Embolisation: Information, Support & Advice) and therefore the sample may not reflect the wider population. The survey ran from March to September 2011 and respondents ages ranged from 20 to over 60, with many women being in the age ranges (60%) and (23%). Numbers of fibroids ranged from 1 to more than 5 with over 82% of women reporting fibroids larger than 3cm. The majority of women (59%) did not want a future pregnancy, although 26% did and 14% were undecided. When asked Which diagnostic tests did you have? the following responses were received: QSAC briefing paper: Heavy menstrual bleeding 12 of 59

13 Table taken from FemiSA Patient information and choice survey (2012) QSAC briefing paper: Heavy menstrual bleeding 13 of 59

14 4 Suggested improvement area: Pharmaceutical treatments for HMB 4.1 Summary of suggestions Stakeholders highlighted that there is inequity in the provision of pharmaceutical therapies, which for some women should be first-line treatment. Stakeholders highlighted that these therapies are usually initiated within a primary care setting and that some women are referred into secondary care without having tried appropriate first-line pharmaceutical therapies. This leads to delayed treatment and an inefficient use of secondary care services. Variation in the availability of outpatient facilities for the insertion of LNG-IUS is cited by one stakeholder (RCOG) as a possible cause of variation in surgical interventions. This stakeholder suggested that establishing a national database which records the offer of LNG-IUS prior to surgical treatment as a quality improvement area. Another stakeholder highlighted the importance of competency standards for the fitting of LNG-IUS in primary care. The NCC-WCH highlighted that the LNG-IUS is a cost-effective treatment option for women where use is anticipated for at least 12 months. 4.2 Selected recommendations from development source Recommendations from the development source relating to the suggested improvement areas have been provisionally selected and are presented below to inform QSAC discussion. NICE CG 44 Recommendations & 1.5.3(KPI). Pharmaceutical treatments for HMB Pharmaceutical treatment should be considered where no structural or histological abnormality is present, or for fibroids less than 3 cm in diameter which are causing no distortion of the uterine cavity (KPI) If history and investigations indicate that pharmaceutical treatment is appropriate and either hormonal or non-hormonal treatments are acceptable, treatments should be considered in the following order: a) levonorgestrel-releasing intrauterine system (LNG-IUS) provided long-term (at least 12 months) use is anticipated b) tranexamic acid or non-steroidal anti-inflammatory drugs (NSAIDs) or combined oral contraceptives (COCs) QSAC briefing paper: Heavy menstrual bleeding 14 of 59

15 c) norethisterone (15 mg) daily from days 5 to 26 of the menstrual cycle, or injected long-acting progestogens. Competencies - Maintenance Maintenance of surgical, imaging or radiological skills requires a robust clinical governance framework including audit of numbers, decision making, casemix issues and outcomes of all treatments at both individual operator and organisational levels. These data should be used to demonstrate good clinical practice. 4.3 Current UK practice National Heavy Menstrual Bleeding Audit The findings of the first year of the prospective audit of patient-reported outcomes are available in the second annual report. The following findings relate to this quality improvement area Patient characteristics and clinical symptoms The median age of women who completed the questionnaires was 44 years and 87.8% were of white ethnicity. Nearly half (48.1%) of all women included in the analyses had known fibroids, endometriosis and/or uterine polyps together with their HMB condition. Analyses focusing on clinical symptoms showed the following: 74.0% of women had symptoms for over 1 year before being referred to secondary care; 71% of women with only HMB (i.e. without fibroids, polyps and/or endometriosis) had symptoms for over 1 year. 54.2% of women reported severe or very severe pain at their first outpatient visit; this was considerably higher for those with endometriosis (75.8%) and for those with fibroids and endometriosis (66.0%). 83.5% of women would feel unhappy or terrible if their symptoms persisted over the next 5 years. Primary Care While the majority of women were seen in primary care before referral to secondary care, 6.5% of women had not been seen by their general practitioner (GP) in the year prior to their first outpatient appointment. The proportion of women with more than four GP visits was higher among those of younger age, of non-white ethnicity and with longer duration of symptoms. Of those in severe or very severe pain, 21.3% had more than four GP visits, compared with 11.0% of those in moderate pain. Women with other comorbidities QSAC briefing paper: Heavy menstrual bleeding 15 of 59

16 such as depression, high blood pressure and thyroid disorder were also more likely to have a greater number of GP visits. In relation to initial treatment in primary care prior to referral to secondary care: 31.1% of women had received no initial treatment in primary care and this percentage increased with older age (24.3% of those under 35 years compared with 36.6% of those over 50 years) women of non-white ethnicity, those who had fewer GP visits, those with HMB alone and those with HMB with fibroids (as opposed to those with HMB with endometriosis) were more likely to have had no previous treatment 26.0% of women in severe or very severe pain had had no previous treatment. Among those who had received initial treatment, the most frequent treatment received was medication (other than the pill) (32.6%) and the pill (15.3%). Figure taken from Second Annual Report: National Heavy Menstrual Bleeding Audit (RCOG, 2011), page 24. There was no significant difference among trusts in the medical care that women had received at primary care, or in the clinical symptoms seen in women before referral to secondary care. In particular, there was little evidence to suggest that differences in the proportion of patients with no GP visits or no previous treatment varied at trust level. QSAC briefing paper: Heavy menstrual bleeding 16 of 59

17 Patient information and choice survey In the Patient information and choice survey (FEmISA, 2012) the responses to the question Which treatment options did your GP tell you about when your fibroids were diagnosed? suggest that in this small sample of women conversations with GPs were swayed towards hysterectomy. Table taken from FemiSA Patient information and choice survey (2012) QSAC briefing paper: Heavy menstrual bleeding 17 of 59

18 5 Suggested improvement area: Non-hysterectomy surgery for HMB 5.1 Summary of suggestions Stakeholders reported considerable variations in the types of surgical interventions available to women and the need to standardise availability of non-hysterectomy surgery. The NICE guideline recommends that for women requiring surgical intervention who have fibroids >3cm that hyseterctomy, myomectomy and uterine artery embolisation are surgical options which should be made available to women. However stakeholders report that non-hysterectomy surgical interventions are not always available or offered to women. The RCOG highlight the absence of a standardised protocol on the surgical management of women and note the three fold difference in surgical intervention rates reported in the National HMB audit. Specifically three stakeholders (RCOG, FEmISA and Schering HC Ltd) highlight variations in the use and availability of uterine artery embolisation. One stakeholder highlighted the need to define place of uterine artery embolisation in the treatment pathway in relationship to other treatments for fibroids. This is covered in CG44 recommendations Selected recommendations from development source Recommendations from the development source relating to this suggested improvement area have been provisionally selected and are presented below to inform QSAC discussion. NICE CG 44 Recommendations 1.6.1, 1.6.4, (KPI), 1.7.1, 1.7.2, 1.7.3, Non-hysterectomy surgery for HMB (Endometrial ablation) Endometrial ablation should be considered where bleeding is having a severe impact on a woman s quality of life, and she does not want to conceive in the future Endometrial ablation may be offered as an initial treatment for HMB after full discussion with the woman of the risks and benefits and of other treatment options Endometrial ablation should be considered in women with HMB who have a normal uterus and also those with small uterine fibroids (less than 3 cm in diameter) (KPI) In women with HMB alone, with uterus no bigger than a 10-week pregnancy, endometrial ablation should be considered preferable to hysterectomy. QSAC briefing paper: Heavy menstrual bleeding 18 of 59

19 Further interventions for uterine fibroids associated with HMB For women with large fibroids and HMB, and other significant symptoms such as dysmenorrhoea or pressure symptoms, referral for consideration of surgery or uterine artery embolisation (UAE) as first-line treatment can be recommended UAE, myomectomy or hysterectomy should be considered in cases of HMB where large fibroids (greater than 3 cm in diameter) are present and bleeding is having a severe impact on a woman s quality of life When surgery for fibroid-related HMB is felt necessary then UAE, myomectomy and hysterectomy must all be considered, discussed and documented. Hysterectomy Hysterectomy should not be used as a first-line treatment solely for HMB. Hysterectomy should be considered only when: other treatment options have failed, are contraindicated or are declined by the woman there is a wish for amenorrhoea the woman (who has been fully informed) requests it the woman no longer wishes to retain her uterus and fertility. 5.3 Current UK practice National Heavy Menstrual Bleeding Audit Availability of surgical interventions The findings of the organisational audit of acute NHS trusts in England and Wales are available in the first annual report. The following findings relate to this quality improvement area: Almost all hospitals reported that abdominal and vaginal hysterectomy were available surgical options at their hospitals (97.3%and 95.9%, respectively); laparoscopic-assisted hysterectomy was available at 82.4% of hospitals. Most hospitals (93.7%) offered one or more second generation ablation technique, of these various techniques, fluid-filled thermal balloon ablation was the most commonly available. Over 70% of hospitals still offered the firstgeneration rollerball ablation technique, but only 5% of hospitals offered this as their only ablation option. QSAC briefing paper: Heavy menstrual bleeding 19 of 59

20 The availability of myomectomy (72.9%) and uterine artery embolisation (49.4%) was also assessed in the survey as these surgeries are sometimes performed in the treatment of fibroids. Figure taken from First Annual Report: National Heavy Menstrual Bleeding Audit (RCOG, 2011), page 15. Patterns of surgical treatment over time An analysis of Hospital Episode Statistics (HES) is presented in the first annual report of the National HMB audit which considered trends and regional variations in treatment. This analysis focused on the surgical treatments of hysterectomy and endometrial ablation (note recommendations and 1.7.3) in women aged between 25 and 59 years at the time of surgery and in whom the diagnosis field was indicative of HMB. Between April 1997 and December 2009, women were admitted to hospital with HMB as their primary diagnosis. Of these women, women (37.7%) received surgical treatment. There were a total of vaginal QSAC briefing paper: Heavy menstrual bleeding 20 of 59

21 hysterectomies, abdominal hysterectomies and endometrial ablations between April 1997 and December The number of endometrial ablations increased significantly in the last decade, accounting for 65% of all procedures for HMB in 2009 compared with only 22% in 1997/98. About 25% of all hysterectomies were vaginal hysterectomies, with the proportion decreasing slightly over time from 27% in 1997/98 to 24% in Figure taken from First Annual Report: National Heavy Menstrual Bleeding Audit (RCOG, 2011), page 7. Overall, between 1997 and 2009, the rate of surgery decreased in women less than 40 years of age, falling by around 50% in women under 35 years of age. By contrast, rates of surgery among older women have been increasing. Women living in the most deprived areas of England were more likely to have hysterectomies than women living in the least deprived areas, while women in the least deprived areas were more likely than women in more deprived areas to have endometrial ablations. Regional variations in surgical treatment This HES analysis demonstrated that between 1 April 2006 and 31 December 2009: The age-standardised annual rate of surgery for HMB in English NHS trusts was 152 procedures/ women. This was a slight increase from the QSAC briefing paper: Heavy menstrual bleeding 21 of 59

22 previous 3-year period, which mainly reflected an increase in the rate of endometrial ablation. Surgical rates across the ten strategic health authorities varied significantly from 70 to 255/ women. There was also wide variation in rates within primary care trusts, ranging from 14 to 392 procedures/ women. Between April 2003 and March 2006, the proportion of women having surgery who underwent endometrial ablation ranged from 46% to 75% within the 10 SHAs. After April 2006, endometrial ablation accounted for more than 60% of all procedures across the 10 SHAs. Nonetheless, the proportions varied from 64% (East Midlands) to 82% (North East). Patient information and choice survey In the Patient information and choice survey (FEmISA, 2012) the small sample of women were asked the following question Which treatment options did your gynaecologist tell you about and which were you offered to you? Some treatment options may not have been appropriate for all the women, but despite this 73% of the sample of women reported they were told about hysterectomy as a treatment option and 52% were offered hysterectomy. Source FemiSA Patient information and choice survey (2012) QSAC briefing paper: Heavy menstrual bleeding 22 of 59

23 6 Suggested improvement area: Treatment follow-up 6.1 Summary of suggestions One stakeholder reported that women should be offered at least one review appointment following treatment (face to face or telephone) and a dedicated helpline / support mechanism of a specialised team for advice and to optimise treatment compliance. 6.2 Selected recommendations from development source No recommendations to support this suggested quality improvement area. 6.3 Current UK practice No data identified. QSAC briefing paper: Heavy menstrual bleeding 23 of 59

24 7 Suggested improvement area: Settings dedicated HMB clinics 7.1 Summary of suggestions There should be dedicated HMB clinics to ensure consistent treatment by staff with specialised skills. One stakeholder felt a dedicated service may streamline services, improve waiting times and has the potential to improve patient satisfaction. 7.2 Selected recommendations from development source There are no recommendations within the evidence source (NICE CG44) to support this suggested quality improvement area. However the RCOG (2008) Standards for Gynaecology includes a recommendation but this is not a NICE Accredited Evidence source. 7.3 Current UK practice National Heavy Menstrual Bleeding Audit The findings of the organisational audit of acute NHS trusts in England and Wales are available in the first annual report. Eighty-four hospitals (38.4%) reported that they ran a dedicated menstrual bleeding clinic (two hospitals did not respond to this question). Of these 84 hospitals, 72 described the clinic as a one-stop clinic (a clinic that provides both diagnosis and treatment plan at the same appointment). QSAC briefing paper: Heavy menstrual bleeding 24 of 59

25 8 Suggested improvement area: Settings hysteroscopy clinic 8.1 Summary of suggestions One stakeholder reported that hysteroscopy for women with HMB should to be carried out in outpatient setting and this would reduce unnecessary general anaesthetics. 8.2 Selected recommendations from development source No recommendations to support this suggested quality improvement area. 8.3 Current UK practice No data identified. QSAC briefing paper: Heavy menstrual bleeding 25 of 59

26 9 Suggested improvement area: Awareness 9.1 Summary of suggestions One stakeholder reported that Simple media messages for women about HMB, would encourage greater awareness and enable women to seek help sooner. 9.2 Selected recommendations from development source No recommendations to support this suggested quality improvement area. 9.3 Current UK practice No data identified. QSAC briefing paper: Heavy menstrual bleeding 26 of 59

27 10 Suggested improvement area: Outcomes 10.1 Summary of suggestions One stakeholder suggested that providers should publish comparable intervention rates and associated outcomes, to enable women to be better informed Selected recommendations from development source No recommendations to support this suggested quality improvement area Current UK practice No data identified. QSAC briefing paper: Heavy menstrual bleeding 27 of 59

28 11 Suggested improvement area: Scope 11.1 Summary of suggestions This stakeholder commented that the scope should include teenagers and young women with HMB. The scope includes all women of reproductive age with HMB, and therefore includes teenagers and young women Selected recommendations from development source No recommendations to support this suggested quality improvement area Current UK practice No data identified.. QSAC briefing paper: Heavy menstrual bleeding 28 of 59

29 12 Suggested improvement area: Review of evidence for pharmaceutical treatments 12.1 Summary of suggestions One stakeholder highlighted the need to review the evidence regarding new hormonal therapies Selected recommendations from development source No recommendation, outside the remit of the quality standard development process to review new evidence Current UK practice No data identified. QSAC briefing paper: Heavy menstrual bleeding 29 of 59

30 13 Suggested improvement area: Education and information provision, choice and further interventions for uterine fibroids associated with HMB Summary of suggestions Stakeholders highlighted the importance of women being able to make an informed decision about their treatment plan. Stakeholders report that there is inequity in the availability of pharmaceutical and surgical treatments, and that women require written information about the full range of treatment options which should be available to them. This includes information about which treatment options are not available through their local provider. One stakeholder (RCN + SCM) suggests there should be a directory of services and treatments available. Two stakeholders highlight that the patient information leaflet which supplements CG44 is not ideal as it is too simplistic (FEmISA) and requires updating (SCM). One stakeholder (FEmISA) suggests that where a provider or commissioner does not make available the full range of treatment options recommended in the NICE guidance, that this should be published on the provider or commissioner website Selected recommendations from development source Recommendations from the development source relating to these suggested improvement areas have been provisionally selected and are presented below to inform QSAC discussion. NICE CG 44 Recommendations (KPI), 1.4.1, Education and information provision (KPI) A woman with HMB referred to specialist care should be given information before her outpatient appointment. The Institute s information for patients ( Understanding NICE guidance ) is available from Choice A woman with HMB should be given the opportunity to review and agree any treatment decision. She should have adequate time and support from healthcare professionals in the decision-making process. QSAC briefing paper: Heavy menstrual bleeding 30 of 59

31 1.7 Further interventions for uterine fibroids associated with HMB When surgery for fibroid-related HMB is felt necessary then UAE, myomectomy and hysterectomy must all be considered, discussed and documented Current UK practice National Heavy Menstrual Bleeding Audit The findings of the organisational audit of acute NHS trusts in England and Wales are available in the first annual report. Responses were received from 221 hospitals (100% response) and 76.0% of hospitals reported providing a HMB-specific information leaflet for women, 8.3% referred women to a website for information and 19.8% did not provide written information. Patient information and choice survey In the Patient information and choice survey (FEmISA, 2012) the responses to the question What additional information would you liked to have been given? suggests that women in this small sample felt they had not been provided with sufficient information on which to base treatment decisions. QSAC briefing paper: Heavy menstrual bleeding 31 of 59

32 Appendix 1 Pathway diagram (CG44) Pathway diagram taken from NICE CG44: Heavy menstrual bleeding: quick reference guide. QSAC briefing paper: Heavy menstrual bleeding 32 of 59

33 Appendix 2 Pharmaceutical treatment (CG44: Quick reference guide) Continued.. QSAC briefing paper: Heavy menstrual bleeding 33 of 59

34 QSAC briefing paper: Heavy menstrual bleeding 34 of 59

35 Appendix 3 Surgical and radiological treatments (CG44: Quick reference guide) QSAC briefing paper: Heavy menstrual bleeding 35 of 59

36 QSAC briefing paper: Heavy menstrual bleeding 36 of 59

37 Appendix 4 Key priorities for implementation recommendations (CG44) Key priorities for implementation recommendations which have been referred to in sections 4-17 of the main body of this report are highlighted in grey. Impact on women For clinical purposes, HMB should be defined as excessive menstrual blood loss which interferes with the woman s physical, emotional, social and material quality of life, and which can occur alone or in combination with other symptoms. Any interventions should aim to improve quality of life measures. History taking, examination and investigations If appropriate, a biopsy should be taken to exclude endometrial cancer or atypical hyperplasia. Indications for a biopsy include, for example, persistent intermenstrual bleeding, and in women aged 45 and over treatment failure or ineffective treatment. Ultrasound is the first-line diagnostic tool for identifying structural abnormalities. Education and information provision A woman with HMB referred to specialist care should be given information before her outpatient appointment. The Institute s information for patients ( Understanding NICE guidance ) is available from Pharmaceutical treatment If history and investigations indicate that pharmaceutical treatment is appropriate and either hormonal or non-hormonal treatments are acceptable, treatments should be considered in the following order: levonorgestrel-releasing intrauterine system (LNG-IUS) provided long-term (at least 12-months) use is anticipated tranexamic acid or non-steroidal anti-inflammatory drugs (NSAIDs) or combined oral contraceptives (COCs) norethisterone (15 mg) daily from days 5 to 26 of the menstrual cycle, or injected long-acting progestogens. If hormonal treatments are not acceptable to the woman, then either tranexamic acid or NSAIDs can be used. QSAC briefing paper: Heavy menstrual bleeding 37 of 59

38 Non-hysterectomy surgery In women with HMB alone, with uterus no bigger than a 10-week pregnancy, endometrial ablation should be considered preferable to hysterectomy. Hysterectomy Taking into account the need for individual assessment, the route of hysterectomy should be considered in the following order: first line vaginal; second line abdominal. Competencies Maintenance of surgical, imaging or radiological skills requires a robust clinical governance framework including audit of numbers, decision making, case-mix issues and outcomes of all treatments at both individual operator and organisational levels. These data should be used to demonstrate good clinical practice. QSAC briefing paper: Heavy menstrual bleeding 38 of 59

39 Appendix 5 Glossary Endometrial ablation The endometrium is the glandular inner layer of the uterus and ablation works by destroying this glandular layer. Hysterectomy surgical removal of the uterus. Hysteroscopic myomectomy - a myomectomy may be performed using a hysterscope. Hysteroscopy is an examination of the inside of the womb (uterus) using a hysteroscope. During the procedure a biopsy may be taken for examination. Levonorgestrel - releasing intrauterine system (LNG-IUS) - a small plastic device inserted into the womb which slowly releases progestogen. Myomectomy surgical removal of fibroids. Norethisterone - a type of man-made progestogen taken in tablet form. Tranexamic acid taken in a tablet form, this medication helps blood in the uterus to clot. Uterine artery embolisation (UAE) - The uterine arteries are blocked with particles injected via the femoral and uterine arteries. This causes the fibroids to shrink, but is believed to have no permanent effect on the rest of the uterus. UAE is performed by an interventional radiologist. Uterine fibroids - Smooth-muscle tumours of the uterus, generally benign although occasionally (< 1%) malignant. They vary greatly in size from millimetres to tens of centimetres, and are associated with heavy periods, pressure symptoms and occasionally pain. They are responsive to the female hormones estrogen and progesterone, generally shrinking to a degree at the menopause. QSAC briefing paper: Heavy menstrual bleeding 39 of 59

40 Appendix 6 Suggestions from stakeholder engagement exercise Stakeholder Suggested key area for quality improvement Cambridge University Hospitals Trust Cambridge University Hospitals Trust Cambridge University Hospitals Trust Cambridge University Hospitals Trust Royal College of Radiologists Clear Referral process from primary to secondary care, with first line treatment already implemented and failed before referral Hysteroscopy for HMB patients to be carried out in Outpatient setting One-stop Menstrual Dysfunction Clinic, with treatment decision made at first visit Women offered choice of Uterine Artery Embolisation, Laparoscopic or open myomectomy and Laparoscopic or Abdominal Hysterectomy for symptomatic fibroid uterus (if clinically appropriate) Diagnosis Why is this important? To ensure patients have been appropriately treated in Primary Care, using resources in the most efficient manner Avoid unnecessary general anaesthetics Streamlined service, better patient satisfaction Patient choice, equity of access to all applicable treatment options Ultrasound as the key initial imaging investigation Why is this a key area for quality improvement? Patients are sometimes referred without having tried first-line therapy, eg Combined pill, Mirena IUS Not available in all hospitals This may shorten time to treatment Not all options available in all settings Up to half of dysfunctional uterine bleeding is due to a structural cause. Ultrasound is able to detect uterine fibroids, adenomyosis and endometrial polyps and consequently guide further investigation and management Supporting information NICE CG 44 Ongoing RCOG HMB Audit Royal Diagnostic pathway There is a need to establish a Subsequent investigations could include There is a substantial body QSAC briefing paper: Heavy menstrual bleeding 40 of 59