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As an additional option to the text below, you might like to watch the following short video from Helen Hughes, Patient Safety Learning's Chief Executive. Using our voice to help create awareness and change Part of how we work towards our goals at Patient Safety Learning is by responding to official reports, using our independent voice for patient safety to help raise awareness of key issues and make the case for change. In July, we set out our analysis of the Cumberlege Review, a week after it was first published. We considered the review’s findings and highlighted the key patient safety themes running throughout, many of which were consistent with those found in other patient safety scandals in the last 20 years. We looked at what needs to change to prevent these issues from recurring and made the case that patients should not be asked to ‘join the dots’ for patient safety, concluding that it is “the responsibility of healthcare leaders who must seize this opportunity to drive the changes needed for safer care”. We also published two shorter blogs on our patient safety platform, the hub, looking in more detail at the patient safety issues around informed consent and patient complaints, highlighted by the review. In August, Helen Hughes commented on the Cumberlege Review as part of our ‘2-minute Tuesdays’ series. She said that it identifies the scale and severity of harm to thousands of women and shows patient safety themes going back decades, including those found in the Paterson Report, “another report that is yet to be responded to by the Government”. Helen highlighted that the report not only highlights patient safety issues but also: “equality issues” because women claimed the issues they raised were dismissed as ‘women’s issues’ “issues of failed leadership” with Baroness Cumberlege commenting that the healthcare system, including the NHS, private providers, regulators and professional bodies, pharmaceutical and device manufacturers, and policymakers, are “disjointed, siloed, unresponsive and defensive”. Taking steps to ensure action is taken Like many others, we want to see a government response to this report, resulting in actions that will help to create a future where all patients receive safe healthcare. To help make this happen, we have been widely sharing our insights on implications for patient safety raised by this report and are seeking to work with others to ensure that its recommendations are kept on the Government’s agenda. Looking forward We will continue to use the hub to expose health inequalities, provide a public platform to those who have been harmed or dismissed and encourage people to speak up. We will use what we learn to inform the concerns we voice and the actions we take.

As an additional option to the text below, you might like to watch the following video from Stephanie O'Donohue, Content and Engagement Manager of Patient Safety Learning's the hub: Sharing patients’ experiences on the hub In February this year, we heard from the Campaign Against Painful Hysteroscopy (CAPH) about the high numbers of women experiencing painful hysteroscopies. This prompted us to start a new Community discussion on our patient safety platform, the hub, titled ‘Painful hysteroscopy’, asking members to share their experiences with us. This has, by far, been the most popular discussion on the hub. To date, there have been close to 100 comments made, over 30 members have contributed to the discussion, and the conversation itself has received nearly 6,000 page views, with people viewing the discussion daily. Engaging with patients, clinicians, researchers and leaders Through our contact with CAPH and hearing from patients, clinicians and researchers on the hub, we’ve identified the main patient safety issues to be around consent, access to pain relief and implementation of guidance. Since identifying these issues, we have written to key political stakeholders, including Nadine Dorries MP, Minister for Patient Safety, Suicide Prevention and Mental Health, and Jeremy Hunt MP, Chair of the Health and Social Care Select Committee. More recently, we have made a request for data from the National Reporting and Learning System (the central NHS database for patient safety incident reports) to understand whether the experiences we are hearing about are being accurately captured. We believe patients’ experiences of hysteroscopy should be proactively gathered and used to evidence and inform improvements. Looking forward In 2021, we will continue calling for patients’ experiences of hysteroscopy, and their concerns about this procedure, to be heard and responded to. We want to see systems put in place to support patient safety, and evidence-based conversations occurring between clinicians and patients before procedures take place. These conversations should aim to ensure patients are well-informed of the benefits, risks and alternatives of the procedure, as well as what impact it will have on them if they choose not to proceed. You can read more about the action we believe is needed to address the patient safety issues around painful hysteroscopies.

Written Questions are a parliamentary mechanism by which Members of the Senedd can table questions specifically for a written answer by the Welsh Government or the Senedd Commission. Laura Anne Jones MS asked what progress had been made in Wales in implementing the findings of the Cumberlege Review (The Independent Medicines and Medical Devices Review). This review examined how the healthcare system in England responds to reports about the harmful side effects from medicines and medical devices and consider how it could respond to them more quickly and effectively in the future. Vaughan Gething MS, Minister for Health and Social Services, responded as follows: The Cumberlege recommendations are primarily focused on England but they have implications for Wales. I issued a written statement on 15 July about the Cumberlege review: https://gov.wales/written-statement-baroness-cumberleges-announcement-use-surgical-mesh In that statement, I said the principle of high vigilance to ensure mesh use is restricted until the same conditions Baroness Cumberlege identified in her report are met should also apply in Wales. Her recommendations were consistent with those made by the review panel, which I set up at the end of 2019. It is my expectation that sufficient levels of clinical governance, including consent, audit and research are in place in health boards in Wales to ensure all women can be confident that all possible safeguards are in place. The evidence we have already of a significant reduction in the use of vaginal mesh procedures in Wales suggests a “pause” is already largely in place, driven by a change in clinical decision making during recent years. However, it is my expectation that these additional restrictions will be the case until the requirements for increased safeguards can be met. Action has already been taken on some of the recommendations. Specialist mesh centres have been identified in Swansea and Cardiff and work is underway in establishing a UK-wide medical device information system. In addition, the Women’s Health Implementation Group will be tasked with considering many of the recommendations of the Cumberlege review as they pertain to mesh, as this is consistent with work the group is already doing in this area. My officials are examining the other recommendations which relate to Wales and are working with the other UK governments to look at those recommendations with a UK remit. The Medicines and Medical Devices Bill, currently before the House of Lords, will also impact in relevant areas. I will issue a further statement when officials have completed their assessment of the options available and their implications for the future effectiveness of Wales’ healthcare service.

Radio 2 episode (1h:09m:42s into the episode) Further reading: BMJ: Vaginal examinations, consent and COVID-19 (May 2020) Birthrights: How to run a safe and rights respecting maternity service during a pandemic

Patients, campaign groups and politicians have raised serious safety concerns around outpatient hysteroscopy for several years, arguing that women are suffering avoidably. Some women have described how the lack of forewarning, coupled with the trauma of the experience itself, left them feeling that both their body and trust had been violated. Many received little or no pain relief and were not given the information needed to make an informed choice about their own care and their own bodies. Those voices need to be heard and hysteroscopy processes reviewed accordingly to ensure the safest delivery of care, reflective of lived experience. Helen Hughes, Chief Executive of Patient Safety Learning, says: “There are clear diagnostic benefits of having a hysteroscopy, and a small number of women may not feel any pain. This is not, however, a good enough reason to dismiss the significant number of women who have reported unbearable levels of pain when undergoing the procedure as an outpatient. These experiences warrant urgent attention if future harm is to be prevented.” Patient Safety Learning supports the call for: National guidance for outpatient hysteroscopy to be consistently applied Women to be provided with information and advice to inform their consent Women to be offered and provided with pain relief Significant pain to be considered an adverse event and recorded and reported as such Research to assess the scale of unsafe care and pain, the extent to which women are suffering, the implementation of national guidelines and the appropriateness of financial incentives without proper safeguards. Baroness Cumberlege reported in her recent review[2] that patients “should not have to join the dots of patient safety”. Patient Safety Learning considers that this is another example where women’s rights to safe services are being compromised, and seeks an urgent response from healthcare leaders to address this significant patient safety issue. Pain during hysteroscopy Recent research, published in the British Journal of Anaesthesia, shows that 17.6% of women rate their pain during hysteroscopy as greater than 7/10, and only 7.8% report no pain at all[3]. Another study estimates the number of women reporting intense or intolerable pain to be much higher at around 25%.[4] This data is supported by the countless testimonials from women who say they have been left feeling in shock, violated and traumatised following very high levels of pain.[5] “I began to hyperventilate with the pain, I was sweating and shaking and I believe I had gone into shock.”[6] Despite the evidence that women can experience unbearable pain, in surveying patients, the Campaign Against Painful Hysteroscopy (CAPH) found that the risk of significant pain is very rarely communicated to women beforehand. Instead, the advice given is usually to take over the counter painkillers and that any discomfort should be minimal. “I was reassured that for most women it is just like period pain and just asked to take paracetamol. Three hours later I found myself screaming from my guts, to stop! Please stop!”[7] Is there informed consent? The principle of consent is an important part of medical ethics and international human rights law. Failure to obtain informed consent can lead to avoidable patient harm, as highlighted by Nadine Montgomery’s story.[8] This led to a landmark ruling, stating that doctors must ensure patients are aware of any risks involved in a proposed treatment, and of reasonable alternatives. The NHS defines informed consent as: The person must be given all of the information about what the treatment involves, including the benefits and risks, whether there are reasonable alternative treatments, and what will happen if treatment does not go ahead. There are a growing number of women who were not given sufficient information and therefore do not feel they gave informed consent before their hysteroscopy procedure. Many were not told about the risk of high levels of pain or given an opportunity to discuss the pros and cons of all the available options (such as general anaesthetic or sedation). “I am a midwife myself and spoke to the consultant explaining how anxious I felt regarding the procedure, as I had had a very painful / difficult removal of Mirena coil previously and been told I had a cervical stenosis. I asked could I have sedation and was declined saying it would only be ‘brief discomfort’ and to just take painkillers a couple of hours before”.[9] Speaking to the House of Commons in September, Lyn Brown MP, called for urgent action to improve hysteroscopy processes and patient safety, highlighting the fact that this issue had been brought to Parliament eight times in total. In her statement, she read aloud the words of patients, illustrating the physical and psychological trauma experienced by many and the impact of not being fully informed. One account came from Rebecca, who was given no information before her appointment, received no warnings about severe pain and was not offered sedation. “The procedure seemed to go on and on. It was barbaric and, as I hadn’t been given any warning, I felt panicked and unsafe.”[10] The CAPH has surveyed many women who have reported experiences to similar Rebecca’s.[11] Particularly alarming is that we are also hearing of women whose procedures were not paused to re-obtain consent, despite clear expressions of distress and extreme pain. The responses collected by the CAPH and patient forums[12] also highlight the damaging impact that these traumatic experiences can have on a patient’s relationship with the healthcare system. A lack of forewarning of the risks, or information about the choices available, have left some mistrustful and fearful of accessing healthcare services again. Many have described feeling violated. Some have reported long-lasting trauma and have been diagnosed with Post Traumatic Stress Disorder (PTSD). “I would dream that I was back in hospital having the procedure and racked with pain. Some nights I would wake up screaming, sweating and with my heart racing. Then, during the day, I started getting flashbacks of the examination.” [13] Listening to and engaging with patients There is clearly a huge disconnect between the information given beforehand and the actual lived experience of many women who have an outpatient hysteroscopy. Research indicates there is also a substantial disconnect between patient and clinician understanding of the pain experienced during the procedure, and that clinician perception of a patient’s pain during hysteroscopy is not a reliable assessment method. [14] Listening to patients is therefore vital to understanding what is happening and how these gaps can be bridged to prevent future harm. The CAPH has been challenging the processes around hysteroscopy procedures for several years. They have engaged with hundreds of patients to understand the extent of the issue and to identify common themes. In October they wrote to Matt Hancock MP, Secretary of State for Health and Social Care and Nadine Dorries MP, Minister for Patient Safety, Suicide Prevention and Mental Health. [15] In their letter, they used both empirical data and the personal stories of women to illustrate the prevalence and seriousness of the issue. Lyn Brown has also retold the stories of women to parliamentary peers, calling for urgent action in response and yet the issues raised have still not been addressed. The Cumberlege Review illustrates the devastating and long-lasting consequences that can occur when patients are not listened to. We know the dismissal of patient voices provides space for harm to persist and causes further psychological distress to those involved. With growing concerns and evidence of harm, it is imperative that hysteroscopy patients are actively encouraged to provide feedback and that they are listened to at all stages of the process. Current guidance The CAPH have been working with the Royal College of Obstetricians and Gynaecologists (RCOG) and others to develop and promote good practice guidance.[16] Collaborative approaches are key to resolving patient safety issues and Patient Safety Learning welcomes and supports this work. However, it is clear that guidance is not being consistently adhered to, leaving women susceptible to alarmingly varied standards of hysteroscopy care. This raises important questions. Why are good practice guidelines that already exist not being effectively communicated to clinicians and patients, and implemented? How are examples of excellence being shared between clinical colleagues so that all patients can benefit and receive safer care? What are the barriers? Finding the answers to these questions will be key to improving hysteroscopy processes for all women. Currently, the NHS Best Practice Tariff financially incentivises hysteroscopy procedures being performed under outpatient services. Patient Safety Learning believes this framework has created unintended consequence of avoidable harm and requires urgent review. The safety of patients must be prioritised.[17] Responding to concerns about this in a recent House of Commons debate, Nadine Dorries indicated that NHS England and NHS Improvement will shortly be looking at policy proposals for the 2021-22 national tariff, which would remove this incentive.[18] What action is needed? So, if we know that there is a significant problem, why is it not being addressed? Why are NHS leaders not listening to women, to MPs or to clinicians? Why have effective clinical procedures not been applied safely to thousands of women over many years? Patient Safety Learning believes that the reasons for this are well reflected in the Cumberledge Review. We eagerly await the government’s response to its recommendations, but we must act urgently to address painful hysteroscopies. Both the CAPH and Lyn Brown have made several recommendations to the government for improving hysteroscopy processes.[19-20] Recently, pain researcher and co-author of Pain-free day surgery? Evaluating pain and pain assessment during hysteroscopy, Dr Richard Harrison, has highlighted his own concerns: "The dangers of advertising hysteroscopy as a mildly painful procedure are many. Firstly, this stands to put women off engaging with a very useful diagnostic test for the identification of serious medical conditions, such as ovarian cancer or endometriosis. But secondly, it is highly plausible that the resulting prediction error stands to make the experience even more painful than if patients were appropriately warned."[21] On social media, clinicians are also questioning why women are not warned of the risk of pain involved in gynaecological procedures, and why medical education describes these procedures as being only mildly discomforting for women.[22] This touches on a much wider debate around gender pain bias in healthcare[23]. Drawing on all these insights and recommendations, Patient Safety Learning believes that we need to consider the following: Designing and delivering for patient safety o National guidance for outpatient hysteroscopy should be consistently applied o There should be a clear requirement to prevent unsafe care and painful hysteroscopies; this should be embedded in commissioning guidance o There should be the removal of perverse financial incentives o Women should be offered and provided with pain relief o Patient feedback needs to be routinely collected and made publicly available in order to inform the delivery of safer care and respond appropriately in the event of harm o Significant pain should be considered an adverse event, being recorded, reported and responded to appropriately o Research should be undertaken to assess the scale of unsafe care and pain, the extent to which women are suffering, the implementation of national guidelines and the appropriateness of financial incentives and proper safeguards. Patient information, advice, and consent o Patient information should include the risk of severe pain and the clinical factors that may make someone more susceptible (see RCOG patient leaflet developed with CAPH)[24] o Patients should be made aware of all available choices for pain management and supported in weighing up the risks and benefits o It must be clearly communicated to patients that they can stop the procedure at any point o Patients should be encouraged to bring someone with them in case they require physical or psychological support following the procedure. Staff competence and training o Only trained staff should undertake hysteroscopies o Hysteroscopy staff should receive standardised and regulated training. This should include the risks of severe pain, clinical factors that make someone more susceptible, the limitations of clinician perception to assess pain, the importance of listening to women throughout and the application of consent guidelines. How can you help? From patients to politicians, clinicians to researchers, charities to campaigners, there are many people who are working tirelessly to improve hysteroscopy processes. Patient Safety Learning want to help ‘join the dots’ and bring those insights together to work towards safer care. We will support and promote this work, using our influence to promote the action that is needed. Raise awareness We would encourage readers to share this blog widely on social media platforms to help raise awareness of the safety issues surrounding hysteroscopy and to add weight and urgency to the call for action. #share4safety The content of this blog or the CAPH open letter can also be used as a letter template for anyone wishing to call for action from their local MP. They also provide a useful briefing tool, that can be used to inform journalists, decision makers and clinical leaders of the situation. You can find out how to contact your MP here. Join the conversation Are you a healthcare worker with insights to share on this topic? Are you a patient who has had a hysteroscopy? Perhaps you are a researcher or have a different perspective to add? We are capturing insights and suggestions for action on a new area of the hub, our free learning platform for patient safety. You can join the conversation here or get in touch with us directly by emailing content@pslhub.org. Stay connected Join the Patient Safety Learning community and sign up to the hub for free. As a member, you’ll be able to join the conversation, get early access to events and receive regular news and updates about patient and staff safety. Follow us on: Twitter @ptsafetylearn Facebook Patient Safety Learning LinkedIn Patient Safety Learning References [1] NHS England and NHS Improvement, 2019/20 National Tariff Payment System – A consultation notice: Annex DtD Guidance on best practice tariffs, (2019). [2] Baroness Cumberlege, J. The Independent Medicines and Medical Devices Review. 2020. [3] Harrison, R, Kuteesa, W, Kapila, A. Pain-free day surgery? Evaluating pain and pain assessment during hysteroscopy. Journal of Anaesthesia. 2020. [4] Jansen FW, Vredevoogd, CB, Van Ulzen K, et al. Complications of hysteroscopy: a prospective, multicenter study. Obstet Gynecol. 2000; 96: 266-270. [5] Campaign Against Painful Hysteroscopy: Patient Stories. 2018. [6] Care Opinion forum, Painful Hysteroscopy. 2017. [7] Erminia. "I didn't sleep for 5 nights after this happened". Care Opinion 2018. [8] Montgomery N. Nadine’s Story: Consent. NHS Resolution 2019. [9] Campaign Against Painful Hysteroscopy. Open Letter to Matt Hancock MP and Nadine Dorries MP. [10] Hansard, House of Commons, NHS Hysteroscopy Treatment. 2020. [11] Campaign Against Painful Hysteroscopy: Patient Stories,. 2018. [12] Patient Safety Learning’s the hub, Community Forum, Painful Hysteroscopy. 2020. [13] Daily Mail, Grandmother-of-three, 67, was left with PTSD after routine NHS medical check caused pain worse than childbirth... and she’s one of thousands of women. 2020. [14] Harrison, R, Kuteesa, W, Kapila, A. Pain-free day surgery? Evaluating pain and pain assessment during hysteroscopy. Journal of Anaesthesia. 2020. [15] Campaign Against Painful Hysteroscopy. Open Letter to Matt Hancock MP and Nadine Dorries MP. [16] Royal College of Obstetricians and Gynaecologists, Outpatient Hysteroscopy. 2018. [17] NHS England and NHS Improvement, 2019/20 National Tariff Payment System – A consultation notice: Annex DtD Guidance on best practice tariffs. 2019. [18] Hansard, House of Commons, NHS Hysteroscopy Treatment. 2020. [19] Campaign Against Painful Hysteroscopy. Open Letter to Matt Hancock MP and Nadine Dorries MP. 2020. [20] Hansard. NHS Hysteroscopy Treatment. House of Commons 2020. [21] Harrison, R. "Pain-free hysteroscopy". Richard Harrison's website. 2020. [22] Twitter thread [23] Billick J. Pain Bias: The health inequality rarely discussed. BBC Future. 2018. [24] Royal College of Obstetricians and Gynaecologists, Outpatient Hysteroscopy. 2018.