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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.

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

Over the past few years, Patient Safety Learning has heard from many patients about significant safety concerns relating to hysteroscopy procedures in the NHS.[1] From the countless women who have shared individual experiences on the hub to the conversations we have had with the patient group the Campaign Against Painful Hysteroscopy, it is clear that this is a topic needing further exploration and advocacy from a patient safety perspective. I therefore welcomed a recent opportunity to engage with healthcare professionals involved in hysteroscopy procedures and share these concerns when I was invited to attend the Association of Anaesthetists Winter Scientific Meeting 2023 last month. This is the Association’s flagship conference, attended by healthcare professionals from across the UK, and I was invited to contribute to a panel session. This was focused on differing approaches to sedation for hysteroscopy procedures in both operating theatres and outpatient settings. Healthcare professional perspective from Leeds Hysteroscopy is a procedure used as a diagnostic tool to identify the cause of common problems such as abnormal bleeding, unexplained pain or unusually heavy periods in women. It involves a long, thin tube being passed through the vagina and cervix, into the womb, often with little or no anaesthesia. The panel session started with a presentation about hysteroscopies from Dr John Dalton, Dr Tracy Jackson and Maria Chalmers, Specialist Nurse Hysteroscopist. Maria spoke about the approach to hysteroscopy at the Leeds Centre for Women’s Health, emphasising the importance of: appropriate patient consent for the procedure discussing the likelihood of pain in advance of obtaining consent the patient’s right to withdraw consent or stop the procedure at any time. They described how patients, if they wanted to, were invited to review the procedure on a screen, and reported that there had been positive feedback from patients who have undergone procedures with this option. They also spoke about the value of these procedures taking place in outpatient settings where possible, creating a quicker diagnostic assessment. In their presentation, they reflected on the importance of collecting data about patient outcomes and pointed to broadly positive satisfaction scores with their service. Reflections on consent It was positive to hear a strong emphasis on the importance of patient consent, both before and during a procedure. It is an area of concern that has been consistently raised with us by patients who have undergone hysteroscopy. Through our work, we know that a significant number of women are not given sufficient information beforehand about the nature of the procedure or the potential for high levels of pain. Many have told us they were not asked about their medical history or offered different options for pain relief. These patients often reflect that the consent they gave was therefore not informed. When a patient experiences unexpected levels of pain, they can understandably feel very unsafe. This can lead to lasting trauma and a fear of accessing further important procedures or screenings. It’s therefore essential to make sure women undergoing this procedure feel they have been given all the information available. Panel discussion I introduced the concerns being expressed by many women and this generated an open discussion with colleagues from Leeds and an engaged audience of anaesthetists, many of whom were unaware of the issues that patients are raising about outpatient hysteroscopy. In the panel discussion I spoke about the experiences that have been shared with us at Patient Safety Learning. Some women have described how the lack of forewarning about this procedure, coupled with the trauma of the experience itself, left them feeling that both their body and their trust had been violated. Many women have also described receiving little or no pain relief and not being given the information they needed to make an informed choice about their own care and their own bodies. More than 50,000 people have viewed our community discussion on the hub about hysteroscopy experiences, with many having shared awful experiences exhibiting bullying, lack of compassion, lack of information and horrendous pain. Recent research, published in the British Journal of Anaesthesia, shows that a significant number (17.6%) of women rate their pain during hysteroscopy as greater than 7/10, and only 7.8% report no pain at all.[2] We know that outpatient hysteroscopy is a valuable procedure when done right, with full information, appropriate pain relief options and informed consent. However, as we have heard all too often from patients, in many cases this is not what they are experiencing.[3] Similar concerns were raised this week in a debate in the House of Commons. When discussing the implementation of good practice in these procedures, Government Minister Maria Caulfield note that such guidance was only as effective as its implementation: “The royal college is important because it can bring clinical change on the ground, but it is not enough just to assume that its updated guidance will be enough to change what happens in practice.”[4] Patients and campaigners are not unsupportive of hysteroscopy as a procedure. However, I shared our view, and that of many, that patients should not be expected to tolerate extreme pain or inconsistency of service. I emphasised a need for: increased efforts to ensure that good practice is shared widely and consistently applied. more research to better inform risk assessments about which women are most likely to affected by severe pain. ensuring that all those healthcare professionals involved in these procedures understand the importance of listening to and responding patients, giving women a range of pain relief options and providing the option to stop the procedure. It was useful to discuss with Maria and other clinical colleagues the value of hysteroscopy and the efforts that some centres are making to ensure that patients’ needs are met, and their voices heeded. It was helpful also to see in person the responses of anaesthetists in the room. There was, in some cases, clear concern about the negative experiences that have been shared with Patient Safety Learning by patients. Then we had some interesting reflections on the pain scores presented by the staff at Leeds. Many anaesthetists expressed shock that despite the good service being provided there, median pain scores are 5 out of 10. Some anaesthetists commented that patients wouldn’t be let out of recovery rooms by nursing staff with that extent of pain, and some said that they themselves wouldn’t want to undergo such a procedure in an outpatient setting with that median pain rating. The discussion was an important multi-disciplinary conversation of the value of hysteroscopy as a procedure while highlighting the very real concerns that women are experiencing when Royal College of Obstetricians and Gynaecologists guidelines are not being met consistently. The opportunity to engage in discussion with clinicians who are aiming to put patients’ experience at the heart of their service was much appreciated and we’re going to follow up with Maria and John to hear more about their service and the plans they have for continual improvement and for the best experience for women. We applaud the Association of Anaesthetists for highlighting these issues and aim to engage further to increase awareness of hysteroscopy pain and the need for urgent action. We look forward to sharing the recording of the session via the hub as soon as it becomes available. Join the conversation There is much work still needed to raise awareness of the patient safety issues concerning hysteroscopy procedures and to make the changes required to ensure good practice is applied consistently across the country. In the coming weeks, we will be publishing a new policy blog looking at this in greater detail and considering what more needs to be done to improve patient safety. In the meantime, if you have an experience you would like to share with us, please do get in touch. Perhaps you are a healthcare professional with insights to share on this topic? A patient who has had a hysteroscopy? A researcher? We'd love to hear from you if have a different perspective to add. You can join the conversation on the hub or get in touch with us directly by emailing content@pslhub.org. References 1. Campaign Against Painful Hysteroscopy, Open letter to the Department of Health and Social Care, 20 October 2020 2. Richard Harrison, William Kuteesa, Atul Kapila, Mark Little, Wiebke Gandhi, Deepak Ravindran, Carien M. van Reekum and Tim. V Salomons, Pain-free day surgery? Evaluating pain and pain assessment during hysteroscopy, 13 September 2020 3. Patient Safety Learning, Guidance for outpatient hysteroscopy: Consultation Response, 16 March 2022 4. House of Commons Debate, NHS hysteroscopy treatment, 31 January 2023

Hysteroscopy is a procedure used as a diagnostic tool to identify the cause of common problems such as abnormal bleeding, unexplained pain, or unusually heavy periods in women. It involves a long, thin tube being passed into the womb, often with little or no anaesthesia. Concerns about painful hysteroscopy Patients, patient groups and politicians have raised serious safety concerns about outpatient hysteroscopy procedures for several years, highlighting cases of avoidable harm. 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 their 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. On the hub we have highlighted concerns raised by the patient group the Campaign Against Painful Hysteroscopy[1] and individual patients who have shared their experiences with us. We also have the views of researchers[2] and healthcare professionals[3] on this issue. Informed by these insights, we identified several key patient safety concerns relating to these procedures in the NHS, around issues of informed consent, access to pain relief and the implementation of good practice guidance.[4] We’ve raised with these issues with the Department of Health and Social Care[5] and Health Ministers in Northern Ireland, Scotland and Wales(6), highlighting several key areas where we believe action is needed to improve hysteroscopy safety: 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 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, and to inform the implementation of national guidelines. New guidance for healthcare professionals This month the Royal College of Obstetricians and Gynaecologists (RCOG) held a consultation on the first edition of new guidance which has been “written for healthcare professionals who are involved in providing outpatient hysteroscopy with the aim of optimising a woman’s experience and clinical outcomes.”[7] Below we summarise the key points included in Patient Safety Learning’s consultation response. You can find the full consultation document and our response at the end of this blog. Positive reflections Given the significant concerns that have been raised by patients about outpatient hysteroscopy in the NHS, we welcome the recognition by RCOG of the need to provide updated guidance to healthcare professionals. We were pleased to see the following included: Recognition that for some, this procedure can be an “unpleasant, and even traumatic, experience because of the amount of pain induced” and the importance of having clear and accurate information available so that patients can make informed choices about their treatment. Inclusion in the guidance of a specific reference to providing opportunities to reschedule appointments for patients who may have been unaware they had been scheduled for a hysteroscopy procedure, or who need more time to consider the options. Reference to ensuring “privacy, dignity and comfort” for patients undergoing this procedure. However, there were also several areas where we felt this guidance could have been improved. Patient engagement Patient engagement is key to improving patient safety. In our report, A Blueprint for Action[8], we identify this as one of the six foundations of safe care. We believe that patients should be engaged for safety at the point of care, if things go wrong, in improving services, in advocating for changes and in holding the system to account. This is especially important in the case of procedures such as hysteroscopy where patients and patient groups have expressed significant concerns about existing processes. In our response, we queried the extent to which the RCOG had engaged with patients and groups such as the Campaign Against Painful Hysteroscopy to ensure that their views and experiences could help to shape this guidance. Communication The guidance emphasises the importance of patients being sent and having access to information and online resources to help inform their decision making. We suggested it would also be helpful to provide this to primary care providers such as GPs. We have heard feedback from both patients and healthcare professionals suggesting that the quality of information currently provided by GPs about hysteroscopy can be variable. We also underlined the importance of this information being produced to a standard that is easily accessible and understandable for patients, such as the Patient Information Forum’s PIF TICK quality mark.[9] Resources for healthcare professionals Discussing the role of safety checks in this procedure, the guidance suggests that healthcare professionals could consider using a specially adapted checklist to ensure that “essential elements such as patient identity checks and pregnancy tests are recorded where appropriate and any medical concerns identified.” We said it would be helpful for RCOG to share a good practice example of this type of checklist. Patient-reported outcome data In our response, we highlighted the importance of ensuring that patient-reported outcome data is routinely collected following hysteroscopy procedures to identify any emerging patient safety concerns, and that this is made publicly available. Currently, severe pain after these procedures is not regularly reported by healthcare professionals, nor are there the mechanisms available for patients to share their experience. We are concerned that this may potentially result in under-reporting and this limits our ability to understand the true scale of this patient safety issue. We also stated our belief that incidences of significant pain should be considered an adverse event, being recorded, reported, and responded to appropriately. Consent The guidance places a welcome emphasis on the importance of patients understanding they can stop the procedure at any point. We suggested it may be beneficial to include a reference to the concept of a ‘two-step stop’, which was explained by Dr Saira Sundar in an interview on the hub as follows: “She can ask for the procedure to pause at any time and then I will tell her what part of the procedure we are at/time left to complete. I then ask her if she would like the entire procedure to stop based on this information.”[3] Language We expressed concerns about the some of the language used in this guidance. On several occasions it refers to patients experiencing period-like pain, or a variant of this term. While we appreciate pain is a complex issue, this is quite an imprecise description that some women may not find helpful in making an informed decision about their care, as patients experience pain differently. We believe there needs to be significantly more research into the extent of pain around these procedures, and better ways of describing what the pain might be like without referring to it in such general terms. We also expressed concerns that in the conclusion it states that “a minority of women will feel severe pain.” The guidance itself acknowledges that one third of women reported pain scores of 7-10 out of 10. While this is technically a ‘minority’, we are concerned that use of this term underplays a significant proportion of women’s lived experiences. Training Towards the end of the document, there is a reference to the importance of training for those providing outpatient hysteroscopy services. However, specific training needs are not covered in this guidance. We believe it is important that staff who undertake these services 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 in assessing pain, the importance of listening to the patient throughout and the application of consent guidelines. Skills are clearly important, but so are the behaviours that support a patient’s decision making and their confidence in being able to say ‘no’ if they are uncomfortable, in pain and/or anxious. We believe that it is important that RCOG clarifies where this necessary work will be addressed, as a priority. 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? You can join the conversation here or get in touch with us directly by emailing content@pslhub.org References Campaign Against Painful Hysteroscopy, Open letter to the Department of Health and Social Care, 20 October 2020 Dr Richard Harrison, “Pain-free hysteroscopy”, 6 November 2020 Patient Safety Learning, Through the hysteroscope: Reflections of a gynaecologist, 26 January 2021 Patient Safety Learning, Improving hysteroscopy safety, November 2020 Patient Safety Learning, Minister acknowledges patients’ concerns about painful hysteroscopies; but will action be taken?, 20 January 2021 Patient Safety Learning, Ministers respond to patients’ concerns about painful hysteroscopies: Northern Ireland, Scotland and Wales, 15 February 2021 RCOG, Good Practice Paper: Pain relief and informed decision-making for outpatient hysteroscopy and procedures, February-March 2022 Patient Safety Learning, The Patient-Safe Future: A Blueprint For Action, 2019 Patient Information Forum, PIF TICK, Last Accessed 15 March 2022