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Join the British Society for Gynaecological Endoscopy for an endometriosis Q&A session with experts from across the UK. Hosted by Carla Cressy, questions can be put to the panel via the @theBSGE instagram page and the Endometriosis Foundation website. It will cover a wide range of topics from diagnosis to fertility to thoracic and adolescent endometriosis. Register

1. Bias and Biology: How the gender gap in heart disease is costing women’s lives In this briefing the British Heart Foundation highlights the stark inequalities in awareness, diagnosis and treatment of heart attacks that are leading to women needlessly dying every day in the UK. 2. Medicines, research and female hormones: a dangerous knowledge gap In this blog, Patient Safety Learning takes a look at why women have been historically underrepresented in clinical trials and medical research, and the ongoing implications this has on medication safety for women. 3. Gender bias: A threat to women’s health Sarah Graham, award winning journalist, founder of Hysterical Women and author of Rebel Bodies, talks about gender bias within healthcare. Sarah draws on research, anecdotal evidence and the Cumberlege report to highlight how widespread mistreatment of women can have a negative impact on their safety as a patient. 4. Uncharted bodies: Why we’re exploring the gender health gap A series of articles from Refinery29 UK, focusing on the gender health gap. Looking at five distinct areas in reproductive and gynaecological health they highlight how a lack of research and data is directly affecting women’s health. 5. “Brave Men” and “Emotional Women”: A Theory-Guided Literature Review on Gender Bias in Health Care and Gendered Norms towards Patients with Chronic Pain The purpose of this study, published in Pain Research and Management, was to review literature on gendered norms about men and women with pain and gender bias in the treatment of pain. 6. How can we prevent gender bias in medical AI technology? Responsibly designed artificial intelligence (AI) and machine learning algorithms have the potential to overcome gender bias in medicine. However, if machine learning methods are implemented without careful thought and consideration they can lead to the perpetuation and even accentuation of existing biases. This blog from Babylon highlights 4 key principles that can help prevent gender bias in medical AI technology. 7. Miss Diagnosed: The health handbook every woman (and man) should read This handbook published by digital healthcare provider Livi looks at some of the evidence surrounding sex-based health inequalities and how they are affecting women in the UK. Read more in the women's health section of the hub. Share your insights Have you ever felt that your sex, gender or how you identify, has impacted your experience as a patient and led to less safe care? Or perhaps you are clinician or researcher with a perspective to share on health inequities? Please leave a comments below (sign up here first for free), or contact us directly at content@PSLhub.org.

Informed consent 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.”[4] This is often broken down into the acronym BRAN (Benefits, Risks, Alternatives and doing Nothing).[5] The landmark UK Supreme Court judgment Montgomery v Lanarkshire Health Board case in 2015 reaffirmed this principle in law, setting out the legal duty of doctors to disclose information to patients about risks.[6] However, despite this legal obligation, far too often we see cases of avoidable patient harm where there has been failure of informed consent. Although this is an issue that can impact any patient, this is often particularly notable in health conditions and areas of care that predominantly affect women. In this blog, we will look at three areas where failures of informed consent have patient safety implications for women: receiving information about benefits and risks being told about alternative treatments and options, and the impact on patients after failures of informed consent. Receiving information about benefits and risks To provide informed consent, patients need to be made aware of the benefits and risks of a procedure or treatment before deciding whether to proceed. The Independent Medicines and Medical Devices Safety (IMMDS) review highlighted this as a recurring point of concern in medical interventions predominantly affecting women. This Review examined how the healthcare system responded to the harmful side effects of three medical interventions: hormone pregnancy tests, sodium valproate and pelvic mesh implants, uncovering a truly shocking degree of avoidable harm over a period of decades.[7] Let’s look at the case of sodium valproate; an epilepsy treatment that is potentially harmful to the developing fetus and can lead to physical deformities and learning difficulties in children if taken when the woman is pregnant – a condition known as Fetal Valproate Syndrome. The IMMDS Review highlighted that many pregnant women who were taking sodium valproate as an epilepsy treatment did so without knowing that this could harm their unborn child. What is particularly concerning in this example is that it is not a historic problem. Despite national attention on the findings of this Review and the serious harm caused, there are still women taking sodium valproate during pregnancy today who are not aware of the associated risks. This has been identified as one of the three top priorities areas of work for Dr Henrietta Hughes, the new Patient Safety Commissioner for England.[8] Information and alternative treatments and options Having choices, and the opportunity to discuss different options, is an important part of informed consent. When considering healthcare treatment patients often find themselves reliant on healthcare professionals to tell them about the full range of options. An example of where having this choice may not always be the case, and can be detrimental to women’s health, is hysteroscopy. Hysteroscopy is a procedure used as a diagnostic tool which involves a long, thin tube being passed through the vagina and cervix, into the womb, often with little or no anaesthesia. While some women do not find the procedure painful, many experience severely painful and traumatic hysteroscopies, raising significant patient safety concerns.[9] One key issue commonly highlighted is that women are not always being told of the possibility of severe pain or are not being offered the full range of pain management options available to them for a hysteroscopy. Many are just told to expect mild period-like cramping and to take simple analgesics, such as paracetamol, beforehand.[10] [11] Patient feedback suggests that approaches to this across the country are not consistent. Some women receive no information about pain management options, while others are able to discuss various options, including a general anaesthetic. At Patient Safety Learning we have recently highlighted the need for improvements in this area, calling for an independent review of these services, including the application of informed consent.[9] There are also concerns that the choices offered to women may vary depending on their race. Last year the organisation Five X More published a survey into Black women’s experiences of maternity services in the UK which raised serious concerns about inconsistences in how Black and Black mixed women were approached compared to white women or their own family members who were white. Examples it highlighted included: "... some women felt that they were not always provided with the opportunity to make informed decisions (“I didn’t request pethidine yet I was given it”); that they were pressured into making decisions about treatment (“…I found the attitude for an induction to be very forceful”); that procedures were performed without consent (“…She said she wanted to see how dilated I was, but also carried out a cervical stretch without my prior knowledge or permission), and that medication was administered, sometimes by junior or student members of staff without permission”.[12] Impact after failures of informed consent As well as the concerns and issues around lack of informed consent at the time of care and treatment, it can also have long-reaching consequences afterwards for the patient. An example of this is women who have been harmed by surgical mesh. As noted in the IMMDS Review, many women reported a failure of informed consent: “… they never knew they had mesh inserted, or where they gave consent for ‘tape’ insertion they did not know they were being implanted with polypropylene mesh”.[7] Many women harmed by mesh have been forced to live with a constant reminder of this lack of consent and abuse of trust, as they deal with significant health problems and difficulties in accessing mesh removal through the NHS.[13] [14] [15] It is hard to overstate the emotional and psychological impact this can have on a patient. These experiences serve to significantly undermine trust in healthcare and healthcare professionals. Returning to the example of hysteroscopy procedures, in sharing their experiences with us on the hub many women spoke about ongoing feelings of violation following experiences of severe pain. These feelings of violation are often exacerbated by the fact that they were not informed of the risk of severe pain beforehand. Most shockingly perhaps, there are cases where women asked for the procedure to be stopped due to the level of pain and their wishes were not followed.[9] This raises serious questions around how patients are responded to when actively withdrawing their consent. In some cases the associated trauma has translated into a reluctance to attend other important appointments, such as cervical smear tests, potentially compromising their long-term health. This dangerous knock-on effect has also been raised by women who experienced painful contraceptive device (IUD) procedures, and again did not feel adequately informed beforehand.[16] Influence of paternalistic, sexist, and misogynist attitudes Absence of informed consent is not an issue that solely affects women. However, as we have shown, there are many examples of consent issues that relate to care and treatment predominantly affecting women. Failures of informed consent are driven by a range of factors, including a lack of training, extremely busy working environments and communication difficulties. However, in the cases discussed here where informed consent has failed, many of those women affected have spoken about this being interwoven with concerns about paternalistic, sexist and misogynistic treatment. There is now a wealth of evidence around this issue, and more broadly about a massive gender health gap which impacts on women’s care and treatment in a range of ways, from the point of diagnosis through to treatment and aftercare.[17] [18] Far too often women still find themselves met with defensive and unresponsive attitudes from the healthcare system and can often feel belittled, dismissed and patronised.[19] Women’s Health Strategy The gender health gap is becoming widely acknowledged and last year the UK Government published a new Women’s Health Strategy for England seeking to close this gap. One area this Strategy identifies is the need for improvements in informed consent and shared decision-making to support women to make informed decisions about their health and care. It also refers to ongoing work by the Royal College of Obstetricians and Gynaecologists to develop new consent guidance for nine gynaecological procedures. The Strategy includes a six-point long term plan for making a transformational change in women’s healthcare, and tying into the #EmbraceEquity theme of this year’s International Women’s Day one of these points is: “Ensuring women’s voices are heard – tackling taboos and stigmas, ensuring women are listened to by healthcare professionals, and increasing representation of women at all levels of the health and care system.”[20] The ambition behind this strategy is welcome, as is the Government’s decision to appoint a new Women’s Health Ambassador, Dame Lesley Regan, to drive system-level changes to close the gender health gap.[21] However, whether these good intentions will be translated into real progress and improvements in women’s health is yet to be seen. In talking about implementing changes, the Women’s Health Strategy notes the wide and varied range of stakeholders that will need to be involved in this effort and states that the Government ‘will develop a delivery plan for the commitments set out in this strategy’. However, there is currently no timetable for this or indication of what resources may be allocated to support this work. Improving informed consent Patient Safety Learning believes that plans to improve informed consent need to be a core part of the Government’s delivery plan for its Women’s Health Strategy. The Strategy refers to the increased use of patient decision aids and conversation aids to support informed consent, including a series of digital tools called iDecide to better support informed decision-making in labour.[22] While such tools are important, they need to form part of a wider programme of work to create meaningful change. The IMMDS Review highlighted some important points around this, which we believe should inform the Government’s approach in this area: Greater thought needs to be given to help patients better understand risk. Information around consent should be shared in way that is clear and meaningful. Talking to, or hearing from, others who have experienced the same intervention with or without complications could be hugely beneficial and should be considered as part of the informed consent process. Patient decision aids should be validated, standardised for each procedure and be jointly developed with patients, reflecting their experiences and outcomes. Commenting on this issue, Patient Safety Learning’s Chief Executive Helen Hughes said: “All too often, female patients are not given the information needed to make a truly informed decision about their own health. Not only is it unlawful, but it can lead to long-lasting physical and psychological harm. Through its Women’s Health Strategy, the Government has an opportunity to significantly improve informed consent across the NHS, ensuring patients receive consistent access to all the information and options they need in relation to their care. But these changes cannot take place in isolation, they must also form part of a wider change in approach to tackle the persistence of paternalistic attitudes that treat women as passive participants in their care.” Work around informed consent in the Women’s Health Strategy, and this broader culture change, will need to be accompanied with clear leadership, delivery plans and effective resourcing if we are to move towards a safer healthcare system for women. Share your views We would love to hear your thoughts and feedback on the content of this blog. To leave your comments below, please sign up to the hub. If you would like to share your experiences and insights on any of the issues raised, you can also get in touch with the Patient Safety Learning team at content@pslhub.org. Related reading For International Women’s Day 2023, we have picked out seven resources to highlight and evidence some of the key patient safety issues concerning women’s health equity in our latest Top picks article. References Patient Safety Learning. Dangerous exclusions: The risk to patient safety of sex and gender bias, 8 March 2021. Patient Safety Learning. Medicines, research and female hormones: a dangerous knowledge gap, 8 March 2022. International Women’s Day 2023 Theme. Last Accessed 27 February 2023. NHS England. Consent to treatment. Last Accessed 27 February 2023. Julie Smith. Informed consent: what is it? 21 December 2020. UK Supreme Court, Montgomery v Lanarkshire Health Board, 2015. The IMMDS Review. First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review, 8 July 2020. Patient Safety Commissioner for England. Patient Safety Commissioner: 100 Days Report, 2 February 2023. Patient Safety Learning. Hysteroscopy: 6 calls for action to prevent avoidable harm, 1 March 2023. Campaign Against Painful Hysteroscopy. CAPH Survey Results – Hysteroscopy Action. Last accessed 27 February 2023. Patient Safety Learning’s the hub. Community Forum, Painful Hysteroscopy. Last accessed 1 March 2023. Five X More. The Black Maternity Experiences Survey: A Nationwide Study of Black Women’s Experiences of Maternity Services in the United Kingdom, 24 May 2022. Kath Sansom. ‘Mesh removal surgery is a postcode lotter’ – patients harmed by surgical mesh need accessible, consistent treatment, 2 December 2021. Anonymous. “There’s no problem with the mesh”: A personal account of the struggle to get vaginal mesh removal surgery, 1 May 2022. Patient Safety Learning and Sling the Mesh. Specialist mesh centres are failing to offer adequate support to women harmed by mesh, 25 August 2022. Sophie, Medical trauma from IUD fitting: it’s not just five minutes of pain for five years of gain, 10 January 2022. Sarah Graham. Rebel Bodies: A guide to the gender health gap revolution, 5 January 2023. Caroline Criado Perez. Invisible Women: Exposes data bias in a world designed for men, 5 March 2020. Sarah Graham. Gender bias: A threat to women’s health, 4 August 2020. Department of Health and Social Care. Women’s Health Strategy for England, 30 August 2022. Department of Health and Social Care. Dame Lesley Regan appointed Women’s Health Ambassador, 17 June 2022. iDecide. iDecide: Your birth, your decisions. Last Accessed 2 March 2023.

The definition of ‘success’ for incontinence mesh surgery was based on The British Society of Urogynaecology (BSUG) ‘pad test question’, which looked at whether a woman was using fewer incontinence pads after surgery. Like most women who had a mesh sling for incontinence implanted, I passed this test with flying colours. But the complications I experienced as a result of the surgery were painful, debilitating and life-changing, an experience shared by thousands of women who have had a pelvic mesh implant. For both incontinence and prolapse mesh, outcome logging merely looked at whether the prolapse had been fixed and did not query the onset of new pain or complications. Lack of follow-up, data collection and recognition of mesh as the cause of women's symptoms when they present with complications has led to a gross underestimation of the scale of pelvic mesh-related harm. So the prospect of an audit that would look to remedy this was a positive one. In 2020, the final report of the Independent Medicines and Medical Devices Safety (IMMDS) Review, ‘First Do No Harm’, called for “a retrospective audit and follow-up of women who had pelvic mesh surgery in 2010,” to be conducted by NHS Digital. The report highlighted that this should provide “far greater detail on mesh complications in the decade after surgery,” and that NHS Digital should make “every effort” to obtain sufficient data.[1] On 5 December 2022, the Minister for Women, Maria Caulfield MP, confirmed in the Commons that an audit had been completed following the acceptance of the IMMDS Review’s recommendation and would be published in 2023.[2] However, the record later had to be corrected, as it became clear in a further parliamentary question that, contrary to the stated intention of NHS Digital who conducted the audit, “...only Hospital Episode Statistic data was used in the audit and no other data was employed. Patients were not contacted as part of this audit.”[3] History repeats itself - the NHS audits the same data I was horrified to find out that instead of making “every effort” to get accurate information, NHS Digital have simply repeated the same exercise they carried out in 2018 in their retrospective audit of annual Hospital Episode Statistics (HES) data on mesh implant procedures. For the 2023 audit, they used the same approach taken in the 2018 audit and exclusively used HES data. This approach was highlighted in ‘First Do No Harm’ as being “widely criticised for its omissions, [for example] lack of any private sector data and for its implied underestimate of long-term complications.”[1] I wrote to the Health and Social Care Select Committee on behalf of Sling the Mesh in December 2022 to highlight the shortcomings of using HES data in isolation.[4] The Committee shared our concerns, highlighting that: “Without records of which patient has undergone which procedure, or been prescribed which drug, the health system will continue to, in the words of the IMMDS review team, “fly blind”... Although the retrospective audit of mesh implants is an encouraging first step, it will be unlikely to reflect and take into account all of the adverse effects women have experienced due to the nature of data used in the audit. We therefore recommend that the Government consider an alternative strategy for how to proactively contact those who have had the procedure about their postoperative experiences and possible side effects.”[2] NHS Digital’s approach does not paint a true picture of the extent of the harm caused by pelvic mesh. There are many issues with using purely HES data for a mesh audit, namely that: HES data does not capture complications, as women have not been followed up and therefore the spectrum of suffering has not been logged. it does not take into account any data from GPs or primary care, where potentially thousands of women have sought help for their mesh complications. Most of these women will not yet have set foot in a hospital for consultation or treatment. it does not take into account data from private hospitals, which may be recorded differently or not have been logged at all. there are discrepancies in how pelvic mesh insertion and removal is logged by different trusts and healthcare professionals. HES data sometimes lacks necessary detail on the nature of treatment. For example, until recently, there was no specific HES code for rectopexy mesh insertion or removal, which means the specific issues associated with this surgery are difficult to identify through data. How should the Government conduct an audit of mesh patients? If the Government is serious about understanding the true extent of harm caused by pelvic mesh, it needs to contact all women who have had mesh surgery within a specific time period to establish whether they have had complications or injuries over the following years. Mesh has a ticking time bomb nature, in that it can be fine for many months or even years before causing problems like erosion, so this long term follow-up is crucial to gauge the extent of harm. Instead of using unreliable and incomplete data, an audit needs to take the approach of the Paterson Inquiry and recall all affected patients.[5] If the cost of such an exercise would be prohibitively high, they could take a sample of women from across the country and use their findings to estimate the extent and nature of harm caused by pelvic mesh. Why is a reliable pelvic mesh audit important? Being able to quantify the extent of the harm is important so that we can establish an accurate figure of risk; what percentage of women suffer harm due to pelvic mesh, and what is the likelihood of more of them developing complications in years to come? Until we have this knowledge, the Government and regulatory system can’t learn the necessary lessons from the mesh scandal to ensure other devices don’t cause this degree of harm. Health services will also continue failing women when they seek help for injuries and complications that are likely to have been caused by mesh. So many women have also been subject to the secondary harm of gaslighting and not having their symptoms taken seriously by healthcare professionals. Having accurate data on harm caused by mesh would help put an end to the healthcare system seeing women’s concerns as ‘hysterical hearsay’. It would also help women understand that their complications must be taken seriously and that their symptoms are not ‘all in their heads’. Why is the Government not pushing for an accurate audit? When compared to the Government response to Paterson, the retrospective mesh audit seems like a token effort. Why is the Government less willing to understand and tackle the issues associated with mesh complications? Perhaps because, rather than being the responsibility of “one bad apple”, the harm caused by pelvic mesh is the responsibility of a system that failed to research, regulate and monitor the effects of medical devices designed to be implanted inside people’s bodies. There is also the fact that knowing the true extent of the harm caused by pelvic mesh has the potential to create a huge financial burden, if the Government ever agrees to fulfil its responsibility to set up a Redress Agency for women harmed by pelvic mesh surgery. Related reading The difficulty of medical negligence cases and why financial redress from the Government is so important for mesh victims (17 January 2023) Doctors’ shocking comments reveal institutional misogyny towards women harmed by pelvic mesh - a Patient Safety Learning blog (19 July 2022) “There’s no problem with the mesh”: A personal account of the struggle to get vaginal mesh removal surgery (1 May 2022) References 1 First Do No Harm. The report of the Independent Medicines and Medical Devices Safety Review, 8 July 2020 2 Health and Social Care Select Committee: Follow-up on the IMMDS report and the Government’s response Sixth report of session, 20 January 2023 3 Question on surgical mesh implants. Parallel Parliament, 14 December 2022 4 Letter to Health Select Committee December 2022. Sling the Mesh, December 2022 5 Government response to the independent inquiry report into the issues raised by former surgeon Ian Paterson. Department of Health and Social Care, 16 December 2021

Patient safety concerns We know that outpatient hysteroscopy is a valuable diagnostic procedure. When patients are given all of the available information, offered appropriate pain relief options and feel treated with respect and dignity, experiences of a hysteroscopy procedure can be good. But, as we have heard all too often, in many cases this is not what patients are experiencing and a number of significant safety concerns persist. Risk of severe pain There are hundreds of personal accounts from women who have experienced very high levels of pain and associated trauma during and/or following a hysteroscopy procedure[7-9] This is supported by research papers, showing unacceptable percentages of patients scoring their pain as medium-to high.[10][11] In addition, we have heard accounts of longer lasting pain and complications, physical harm and post-traumatic stress disorder following hysteroscopies.[12][13] Studies show clinician perception of patient pain is not an accurate measure, tending to underestimate the pain experienced.[14][15] This raises questions about the value of pain and tolerability assessments made by the clinicians undertaking hysteroscopy procedures and the impact this bias has on treatment. “After the procedure, Martha understandably felt violated, but sadly that was far from the end of her ordeal. She had burning pain for weeks, mixed with a loss of feeling in her groin. She developed repeated bladder infections and double incontinence, and her muscles started wasting. She had difficulty standing and walking. Eventually, Martha was told that she had post-operative nerve damage. To put the cherry on the cake, I understand that the doctor who did this to Martha recorded her pain score as just one out of 10.” Lyn Brown MP speaking in a House of Commons debate Absence of informed consent It has become clear that many women are not fully informed when consenting to a hysteroscopy procedure. As set out by national guidance, they should be given all of the options available to them beforehand. This should include information outlining the benefits, risks, alternatives and consequences of opting not to proceed with any procedures.[16-18] Women are not always being told of the possibility of severe pain or offered the range of pain management options available to them for a hysteroscopy. Many are told to expect mild period-like cramping and to take simple analgesics, such as paracetamol, beforehand.[19][20] Lack of guidance to support triage Although it is difficult to predict who will experience severe pain during a hysteroscopy, conversations between the patient and the clinician around medical history could help to identify who might be more susceptible. For example, women who have experienced sexual trauma, found gynaecological procedures very painful in the past and those who have not given birth may be more at risk.[21][22] There is little available guidance to support clinicians in having these conversations to help patients feel informed of their individual risks of pain. Physical and psychological violation Women have spoken about feelings of violation during and following their hysteroscopy procedure, particularly where they do not feel they have been adequately prepared and informed beforehand. There are also serious concerns that some women have not had their wishes listened to or acted on when they have asked for the procedure to be stopped. In such cases, the physical and psychological trauma becomes entwined and heightened, as many women feel that both their body and trust has been harmed. In addition, many women have described having their pain or concerns dismissed, belittled, or disbelieved, often linking this to misogynistic or paternalistic approaches and language.[23-25] Negative impact on future health outcomes The loss of trust that comes from feeling uninformed before experiencing high levels of pain during a hysteroscopy, can understandably impact the relationship a patient has with our healthcare system. This has inevitably left some fearful to attend important appointments in future, for example cervical smear screenings. The stark reality is that these harmful experiences have potential to negatively impact future diagnoses, treatments and health outcomes. Patient Safety Learning has provided an online forum for women to share their experiences of hysteroscopy. This has had over 60,000 views to date, helping amplify the voices of many women who have often been dismissed or left unheard. These testimonies have informed our work on this topic, helping us to understand the key safety concerns and indicating what actions may be needed to prevent future avoidable harm. Patient Safety Commissioner and discussions in the House of Commons Patient Safety Commissioner’s first 100 days report Last year Dr Henrietta Hughes was appointed as the first Patient Safety Commissioner for England. She is an independent champion for patients and seeks to drive improvements in the safety of medicines and medical devices.[26] In a recent report reflecting on her first 100 days in post, she highlighted that 6% of the initial correspondence she received related to painful experiences of gynaecological procedures, such as hysteroscopy.[27] Although her initial priorities for this year do not include this topic, this is one of the issues on her radar and we look forward to hearing more detail about the concerns raised and how she plans to address these moving forward. Discussions in Parliament In addition to patients and campaigners raising safety concerns relating to hysteroscopy procedures, this was also the subject of a recent debate in the House of Commons, [28] led by Lyn Brown MP. It was the 10th time she has brought the issue before Parliament. In her speech, Lyn Brown noted that a third of women experience very high levels of pain, and drew on the case of ‘Martha’ who was seriously injured during her hysteroscopy. She also expressed concern that a proposed target of aiming for 90% of hysteroscopy happening within outpatient rooms, suggested by the Getting It Right First Time programme, could exacerbate the number of cases where patients do not receive appropriate pain relief options. Lyn Brown also raised concerns around: The lack of formal data collection by the NHS on cases of painful hysteroscopy. Potentially embedded views among gynaecologists regarding pain and patient experiences of this procedure. Patients who have negative experiences in relation to hysteroscopy being afraid to access important health procedures in future, with a long-term impact on their health. This debate was responded to on behalf of the Government by Maria Caulfield MP, Minister for Mental Health and Women’s Health Strategy. In her response, Maria Caulfield stated that she would be meeting with patient group, The Campaign Against Painful Hysteroscopy, to discuss the issues further. She also said that she had asked the Women’s Health Ambassador, Dame Lesley Regan, to discuss the issues surrounding hysteroscopies further with the Patient Safety Commissioner for England, Dr Henrietta Hughes. The Minister also highlighted the importance of translating the imminent Royal College of Obstetricians and Gynaecologists (RCOG) guidance into clinical practice. Westminster_Hall_31_01_23_15_39_50 (1).mp4 Maria Caulfield MP New guidance The new guidance referred to by the Minister was subsequently published by RCOG on 7 February 2023. This good practice paper, Pain relief and informed decision making for outpatient hysteroscopy, has been written for healthcare professionals who are involved in providing outpatient hysteroscopy.[29] Patient Safety Learning submitted a response to the consultation on this Paper last year, with the aim of supporting safer hysteroscopy care and improved patient experience.[30] Reflections on the new good practice paper We welcome the publication of this new paper for healthcare professionals, to help them understand some of the steps they can take to improve hysteroscopy safety. We were pleased to see this paper acknowledge that a third of women experience significant pain during hysteroscopy, scoring their pain at 7 out of 10 or higher. There was also a clear effort to include advice around compassionate care before, during and after the procedure. We also welcome the emphasis on the importance of ensuring women have full information beforehand and have been told of all of the available options. We do however note the following concerns in relation to the guidance: There are several references made to using simple over-the-counter painkillers beforehand ‘unless there are contraindications’. A contraindication is when a patient has something (such as a symptom or condition) that makes a particular treatment or procedure inadvisable. There is however no guidance around what should be considered a ‘contraindication’ in relation to a hysteroscopy procedure, and how best to triage patients accordingly when it comes to pain relief options and individual risk of severe pain. On several occasions it refers to patients experiencing period-like pain, or a variant of this term. This is quite an imprecise description that some women may not find helpful in making an informed decision about their care, as patients experience period pain very differently. Asked for their thoughts on the new guidance, Katharine Tylko from the Campaign Against Painful Hysteroscopy, also highlighted shortcomings in this new paper, stating: "This guidance does not cover all of the options for hysteroscopy including IV sedation with analgesia, procedural sedation analgesia, spinal anaesthesia and light general anaesthetic. Instead it continues to promote a 'trial by outpatient hysteroscopy’ approach, where many women suffer such intolerable pain that the procedure has to be abandoned. Often, it is only then they are allowed to arrange a hysteroscopy with the aid of an anaesthetist". Translating guidance to practice Despite the issues we’ve highlighted, if implemented consistently and well, the good practice paper has the potential to raise standards of hysteroscopy care and reduce the current postcode lottery of experiences patients have of this procedure. However, we know from patient feedback that previous hysteroscopy guidance has not been consistently followed, leading to unacceptably poor experiences and unsafe care. This failure to translate what we know will improve patient safety to what is done in practice is not unique to hysteroscopies. It happens in a range of other areas, as detailed in our report last year Mind the implementation gap'[31] Questions therefore remain around how effectively the new RCOG guidance will be implemented and whether this will lead to improvements in patient safety. Following on from this good practice paper, RCOG have now launched a consultation into a new Green Top Guideline on hysteroscopy.[32] Green Top Guidance is comprised of evidence-based recommendations that are intended to assist clinicians and individuals in making decisions about appropriate tests or treatment for specific conditions or circumstances. This could potentially have a significant impact on how hysteroscopies are approached in the NHS.[33] This consultation is open to patients and professionals and provides further opportunity to influence and inform hysteroscopy practice. Building on our comments here, we will be formally submitting a response prior to the deadline on the 13 March 2023. We would welcome hearing your thoughts on this to help inform our response, which you can share with us directly by emailing hello@patientsafetylearning.org. Find out more about the consultation. Calls for action Considering the patient safety concerns detailed in this blog, in the context of recent policy developments nationally, Patient Safety Learning is calling for the following to improve patient safety in hysteroscopy procedures: An independent review of hysteroscopy services in the NHS. This should assess the scale of psychological and physical harm, the application of informed consent, barriers to safe care and the role of sexism and misogyny in the treatment of women undergoing hysteroscopy procedures. We believe it would be beneficial for this to be supported by the Patient Safety Commissioner for England and the Healthcare Safety Investigation Branch. Publication of a clear implementation plan for the new RCOG good practice and green-top guidance. This should include timeframes for implementation, measures of success, plans for working with patients and other key stakeholders, details of associated staff requirements and training, and information on how progress will be reviewed, monitored and reported on. NHS England should mandate the collection of patient reported outcome measures for all hysteroscopy procedures and make this data publicly available. Severe pain during hysteroscopy procedures, as reported by patients, to be recorded by healthcare professionals as a patient safety incident. Examples of hysteroscopy good practice should be published by NHS England and shared widely to clinicians, service managers and patient safety specialists, to inform improvements in outpatient hysteroscopy so that all patients can benefit. Research should be commissioned to identify the factors that lead to patients being at greater risk of experiencing high levels of pain during outpatient hysteroscopy. This should then be used by NHS England and RCOG to create evidence-based guidance to support clinicians in identifying patients most at risk of severe pain during hysteroscopy. Final thoughts Recent activity surrounding hysteroscopy safety has kept these important conversations going among clinicians, patients and MPs. Positive steps have been taken and verbal commitments have been made. Momentum must not stop here. Every week, patients continue to share experiences of severe pain, uninformed consent, misogynistic care and lasting psychological trauma. There is clearly much more to be done to ensure patients have access to safe, respectful hysteroscopy care and are always provided with the information and options necessary to be able to provide truly informed consent. The RCOG guidance aims to achieve optimal outcomes for women. But without a robust implementation strategy, associated resources and genuine engagement with patients, hysteroscopy experiences will inevitably continue to vary and harm will persist. Share your insights If you would like to share your insights around hysteroscopy, please contact us at content@PSLhub.org. References Harrison, R, Kuteesa, W, Kapila, A. Pain-free day surgery? Evaluating pain and pain assessment during hysteroscopy. Journal of Anaesthesia. 2020. Royal College of Obstetricians and Gynaecologists. Pain relief and informed decision making for outpatient hysteroscopy (Good Practice Paper No. 16). 2023. Morgan M, Dodds W, Wolfe C at al Women's views and experiences of outpatient hysteroscopy: implications for a patient-centered service. Nurs Health Sci. 2004 Dec;6(4):315-20. Patient Safety Learning. Improving hysteroscopy safety. 2020. Hansard. House of Commons Debate – NHS hysteroscopy treatment. 31 January 2023. Patient Safety Learning. Improving hysteroscopy safety. 2020. Patient Safety Learning’s the hub, Community Forum, Painful Hysteroscopy. 2020. Hysteroscopy Action. CAPH Survey Results – Hysteroscopy Action. Accessed 27 February 2023. Patient Safety Learning YouTube channel. 2020: Raising awareness about painful hysteroscopies - YouTube (see comments below the video). Accessed 27 February 2023. Harrison, R, Kuteesa, W, Kapila, A. Pain-free day surgery? Evaluating pain and pain assessment during hysteroscopy. Journal of Anaesthesia. 2020. Morgan M, Dodds W, Wolfe C at al Women's views and experiences of outpatient hysteroscopy: implications for a patient-centered service. Nurs Health Sci. 2004 Dec;6(4):315-20. Hansard. House of Commons Debate – NHS hysteroscopy treatment. 31 January 2023. Grandmother-of-three, 67, was left with PTSD after routine NHS medical check | Daily Mail Online Morgan M, Dodds W, Wolfe C at al Women's views and experiences of outpatient hysteroscopy: implications for a patient-centered service. Nurs Health Sci. 2004 Dec;6(4):315-20. Maguire K, Morrell K, Westhoff C, Davis A. Accuracy of providers' assessment of pain during intrauterine device insertion. Contraception. 2014 Jan;89(1):22-4 General Medical Council. Decision making and consent - ethical guidance. Accessed 27 February 2023. Royal College of Obstetricians and Gynaecologists. Pain relief and informed decision making for outpatient hysteroscopy (Good Practice Paper No. 16). 2023. NHS. Consent to treatment. Accessed 27 February 2023. Hysteroscopy Action. CAPH Survey Results – Hysteroscopy Action. Accessed 27 February 2023. Patient Safety Learning’s the hub, Community Forum, Painful Hysteroscopy. 2020. Havard Health publishing. When a pelvic exam is traumatic. 2019. Zayed S, Elsetohy K, Zayed M, et al. Factors affecting pain experienced during office hysteroscopy. Middle East Fertility Society Journal. 2015 Sep Vol. 20 (3): 154-158 Patient Safety Learning YouTube channel. 2020: Raising awareness about painful hysteroscopies - YouTube (see comments below the video). Accessed 27 February 2023. Patient Safety Learning’s the hub, Community Forum, Painful Hysteroscopy. 2020. Hansard. House of Commons Debate – NHS hysteroscopy treatment. 2023. Department of Health and Social Care. First ever Patient Safety Commissioner appointed. 2022. Patient’s Association. Patient Safety Commissioner for England, Patient Safety Commissioner: 100 Days Report. 2 February 2023. Hansard. House of Commons Debate – NHS hysteroscopy treatment. 2023. Royal College of Obstetricians and Gynaecologists. Pain relief and informed decision making for outpatient hysteroscopy (Good Practice Paper No. 16). 2023. Patient Safety Learning. Guidance for outpatient hysteroscopy: Consultation Response. 2022. Patient Safety Learning. Mind the implementation gap: The persistence of avoidable harm in the NHS. 2022. Royal College of Obstetricians and Gynaecologists. Green-top Guidelines No. 59 Outpatient Hysteroscopy 2nd Edition. Accessed 27 February 2023. Royal College of Obstetricians and Gynaecologists.. Developing a Green-top Guideline: Guidance for developers. 2020. Related reading House of Commons Debate – NHS hysteroscopy treatment (31 January 2023) Improving hysteroscopy safety, 6 November 2020. Through the hysteroscope: Reflections of a gynaecologist, 26 January 2021. Guidance for outpatient hysteroscopy: Consultation Response, 16 March 2022. Richard Harrison, “Pain-free hysteroscopy”, a blog by Dr Richard Harrison, 6 November 2020. Related video resources