Publish date: 18 October 2023
Rethinking Gynaecology Pathways for Patients with Vaginal Bleeding on HRT
By Sophie Kaye, Quality Improvement Project Manager, Gynaecology Cancer Improvement Programme, Cheshire and Merseyside Cancer Alliance (CMCA)
The Cancer Alliance is working in partnership with Liverpool Women’s Hospital (LWH) and Liverpool GPs to pilot a new, innovative pathway for women on Hormone Replacement Therapy (HRT) with unscheduled vaginal bleeding. The pathway incorporates primary care management for the first six months of new treatment and a pathway for direct access ultrasound where reassurance is needed if symptoms continue after six months. CMCA will support LWH in a full evaluation of the pilot and look to implement the pathway across Cheshire and Merseyside over the next two years.
Women’s Health is a challenging area of healthcare, with a wide range of services and a complex commissioning model, split between multiple organisations across the local and national systems. Services include fertility, sexual health, menopause, general gynaecology, maternity, cancer and much more.
With widening disparities across England, a Women’s Health Strategy has been developed by the Department for Health and Social Care, setting out ambitions over 10 years for improving the health and wellbeing of women and girls across the country (Women's Health Strategy for England (Aug 2022)).
In a national consultation, menopause was the third most selected topic for inclusion in the Women’s Health Strategy with professionals raising concerns about the prescribing of HRT for menopause symptoms due to a lack of training and clear guidance, and both women and healthcare professionals reporting that the overlap of menopause symptoms and other conditions often caused confusion and mis-management.
HRT is the most prescribed drug to treat menopause symptoms in the UK;
it comes in a variety of forms such as tablets, patches, sprays and gels and is highly effective in reducing the wide range of symptoms brought on by the menopause. In 2022, the NHS Business Services Authority published new data to show a 30.5% increase in the number of patients prescribed an HRT product in 2021/22 than in the previous year.
Clinicians have widely debated the risks and benefits of HRT since it became available in the 1960s, but for many patients it offers an improved quality of life that far outweighs any negative impacts.
One common symptom of HRT is unscheduled vaginal bleeding. In the first three months of treatment, 80% of patients will experience bleeding that is not linked to their period, and whilst this usually settles by six months, 10% of patients continue to experience bleeding until one year from the start of treatment.
Unexpected vaginal bleeding is also considered a red-flag symptom for gynaecological cancers and often results in an urgent referral on to the suspected gynae cancer pathway. However, introducing HRT into the mix can muddy the waters for clinicians about what is ‘expected’ or ‘unexpected’ bleeding.
This has resulted in high numbers of referrals into rapid access clinics for new HRT users and a need for greater engagement with GPs on the clarity of risk factors.
As described previously, the majority of new HRT treatments result in unscheduled bleeding, therefore, it can be put forward that this is not ‘unexpected’ at all, at least until around six months, when the symptom has settled in 90% of cases.
Waiting lists for gynaecology are the highest of any speciality in Cheshire and Merseyside and so looking at how symptoms can be managed differently – with more joined-up and strategic pathway development – is essential, both for patients and clinicians.
At Liverpool Women’s NHS Foundation Trust, consultant gynaecologist and Rapid Access Improvement Lead, Dr Louise Wan, identified high levels of suspected cancer referrals amongst patients who had been on HRT for less than six months, with no other red flag symptoms.
consultant gynaecologist, from Liverpool Women's Hospital
Dr Wan was aware that the risk of cancer for these patients (1.2%) did not meet the NICE guidance threshold for a suspected cancer referral (>3%), and so in October 2022, with support from the Cancer Alliance, she began to draft new guidance for managing these patients outside the suspected cancer pathway with comprehensive safety netting, where they could still access support and investigations in a timely manner where needed.
Understanding the key role of primary and community care in women’s health management, Dr Wan worked alongside Dr Jill Kirkman, a Liverpool GP, who brought with her a wealth of knowledge and a network of women’s health experts to support the development of the pathway and guidance.
This collaboration between primary and secondary care was instrumental in developing a service that would not only reduce referrals into the rapid access clinic, but provide opportunity for primary care education, and improve patient experience.
Additionally, CMCA is providing project management support to fully implement and evaluate the pilot.
Patient representatives are a key stakeholder in many CMCA-led projects, including this one. Patient reps contributed to the design of new pathway documents, such as patient literature, through its Cheshire and Merseyside Cancer Voices group, and will also contribute to the evaluation, with input into the qualitative assessment of the pilot and users of the pathway asked to complete a patient experience survey.
The project team is also considering a communication strategy for local communities where English is not the main language spoken, including translated patient literature and access to translator services, alongside easy read and accessible literature for a wide range of patients who might be referred on the pathway.
The new guidance provides a two-part approach to managing patients on HRT with vaginal bleeding. Firstly, primary care management. With a growing number of patients being prescribed this type of drug to treat menopause symptoms, more and more patients are presenting to their GP with unscheduled vaginal bleeding.
The guidance provides GPs with an education resource to manage patients who have recently started on HRT within their practice, and a next step for those who are still experiencing vaginal bleeding after six months on their prescribed HRT regimen.
Most patients who remain under the GP’s care for the six months will find that any bleeding will settle, and they will not need to attend a scan at all, removing the anxiety and stress around an urgent suspected cancer referral and freeing up capacity in the rapid access clinic for those with a higher risk factor.
For those whose bleeding continues after six months, the second part of the pathway will allow them timely access to an ultrasound scan at their nearest scan provider for further investigation.
The ultrasound involves a small probe being placed inside the vagina to scan the womb and surrounding area for any abnormalities. This type of ultrasound is less invasive than procedures they might receive in a cancer clinic (similar to a cervical screening test). It is expected that in most cases the scan will be reassuring, and the patient can remain under the care of their GP.
However, if the scan identifies any non-reassuring pathology, the patient can be directly upgraded to the rapid access clinic via the sonographer to ensure they are seen urgently. This part of the pathway requires some additional training for sonographers and consideration of a hospital trust’s internal process flow from radiography to the suspected/rapid access cancer clinic.
However, the benefits of this include no additional appointments or referrals in primary care (a copy of the results is provided to the referring GP) and a quicker turnaround time for the patient for additional investigations to take place.
A summarised version of the pathway is demonstrated in the diagram below. The development of a new protocol for GPs to use in their primary care system (EMIS) enables sonographers to redirect or upgrade the non-reassuring scan.
The form was developed from the existing gynae suspected cancer referral form, with input from primary care and the sonography team at LWH to ensure it is as effective as possible.
In June 2023, just eight months from the start of the pathway development, and with approval from the British Menopause Society, Cheshire & Merseyside Integrated Care Board (ICB) and the Local Medical Committee, a pilot was launched with SWAGGA Primary Care Network in South Liverpool.
Whilst the scheduled evaluation of quarter one is still to take place in October, a deep dive into the suspected cancer referrals from the live practices in July and August has given an early indication of improved management of patients on HRT within primary care.
In an audit undertaken by Dr Kirkman in late 2022, 30% of suspected gynaecological cancer referrals were for patients with vaginal bleeding on HRT. Whilst in this exercise, none of the patients referred would have been eligible for the HRT pathway, suggesting that those on HRT for less than six months were now being managed and followed up by their GP with the intention to refer for a direct access scan via the new pathway if bleeding continues.
Whilst it is early days for the pilot, and the dataset is currently small, this is a highly positive indication that the pathway is working.
A short qualitative exercise within Dr Kirkman’s surgery has shown that GPs are beginning to change their practice for these patients and gaining confidence in their management of HRT.
Dr Kirkman reported: “The guidance has helped to increase my confidence when starting patients on HRT, and with swapping preparations to manage symptoms.”
This is a really encouraging start for the pilot, as the project begins to grow, and talks with other trusts are underway.
There are already some lessons learnt, too, for example, with referrals for the Trans-Vaginal Ultrasound Scan (TVUSS) coming through more slowly than expected.
The Cancer Alliance has been able to adapt evaluation plans to capture the change in practice within primary care, and patient satisfaction after being supported by their GP, as well as the quantitative data from the scan referrals.
The early findings have been positively received by those involved, with lots of praise of Dr Wan’s pathway. Dr Wan herself said: “The creativity is not the pathway itself; it is all common sense, after all. It is the focus on shared learning, education and collegiate working across the primary-secondary care divide that will make the real difference. We are already starting to see a change in practice and, hopefully, this will help us reduce waiting times for cancer tests.”
Mr John Kirwan, Gynae-Oncology Clinical Lead at LWH and Gynaecology Cancer Improvement Programme Clinical Lead, said: “This is a fabulous piece of work…previous audits have identified 30% of rapid access referrals involve HRT, so locally and nationally this is a huge area of work. A lot of hard work has gone into this so well done to all involved.”
As we look towards the future of the project, these early findings provide confidence that we will see a reduction in suspected gynae cancer referrals into Liverpool Women’s Hospital, and that this, in turn, will enable us to accelerate the rollout across the region.
Whilst there are specific key performance indicators to achieve within the project, there is also an iterative element to it, with an agile approach to the rollout; assessing when is the right time to invite new practices or scan providers, to ensure patient safety and quality of care throughout.
The Cancer Alliance is already in discussions with other Liverpool PCNs and acute trusts, and there is hope that over the next 12 to 24 months the pathway can be thoroughly evaluated across the region.
CMCA envisions that this project will have a great contribution towards the improved management of suspected gynae cancer referrals in both primary and secondary care and enable HRT users to access the best support for them in a timely manner, improving the experience of women’s healthcare across the region.
Read the Unexpected Bleeding on HRT Guidance here.
Please note: The Unexpected Bleeding on HRT guidance (version 1.9) should be used for reference only unless your organisation is taking part in the project pilot. If you would like more information about the pilot, please email ccf-tr.admin.cmca@nhs.net