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In this blog we will focus on several issues where there is a clear overlap between pain and patient safety concerns, inviting further debate and collaboration on this important topic through a series of questions. Consenting to treatment Consenting to treatment is vital to respecting the rights of the patient and ensuring safe care. It is also one area where we see evidence of how patient safety and pain issues can overlap. A recent example of this can be found in the publication of last month’s report of the Independent Medicines and Medical Devices Safety Review, First Do No Harm. This highlighted a number of cases where women were unable to consent to treatment, undergoing pelvic mesh procedures without being aware that mesh would be used.[4][5] Many have since experienced adverse effects of the mesh, including severe and chronic pain, managed now by strong opioid painkillers. While in the above example lack of consent is linked to pain following treatment, there are other cases where patients lack the necessary information regarding pain during a procedure. Women who have undergone outpatient hysteroscopy procedures have highlighted concerns around informed choice, with many given little or no information beforehand about the risk of severe pain. Of those who did experience high levels of pain, some have reported that their doctor continued with the procedure despite their obvious agony, leaving them feeling traumatised and violated. [6-10] These examples go against the legal requirement for patients to be made aware of what a treatment will involve, including the associated risks.[11] They illustrate the relationship that can exist between consent, pain and patient harm. Patient safety points for further discussion: Are there other scenarios we can learn from to understand how consent impacts on pain experience and patient safety? What support do clinicians need to communicate the information in a way that is accessible, comprehensive and patient focussed? Where guidance for clinicians exists[12], why isn’t it being widely used? What can be done to make sure patients feel empowered and supported in halting procedures if the pain becomes unmanageable? Should severe procedural pain be recorded as a Serious Adverse Event? Communication In our report A Blueprint for Action we make clear the importance of engaging patients in patient safety, drawing on evidence that shows that ‘communication between clinicians and patients has a positive impact on health outcomes’.[13] When looking at issues of pain and communication, problems with the latter can often present a barrier to dealing appropriately with a patient’s pain issues. For example, evidence shows that pre-verbal children are far less likely to receive adequate pain control in comparison to their adult or older children counterparts.[14] Their inability to self-report has a direct impact on the level of pain they are likely to have to endure. Poorly managed pain in childhood can cause chronic pain, disability, and distress in adult life.[15] Similarly, there are calls for people with intellectual and developmental disability (IDD) to have their pain better managed, particularly pertinent where self-reporting is not feasible. Researchers have acknowledged the communication barriers faced by patients with IDD and highlight a need for evidence-based, stakeholder-informed methods to be used, in order to assess pain and prevent unnecessary suffering[16]. This raises further questions around disparities in pain relief for patients who may struggle to communicate for other reasons. For example, if being treated in the NHS and where English is not their first language. Patient safety point for further discussion: Can examples be shared where alternative pain assessment tools have been used to meet the needs of patients with communication challenges? Bias and gatekeeping Another overlap between pain and patient safety is when it comes to access to medication and clinicians holding a gatekeeping role in this respect. Here we will look at examples of this in three different health areas: 1) Maternity The pain that women can experience in childbirth is widely recognised. Some report that pain relief was either withheld or not given within a reasonable time when they requested it during labour.[17] There can be different factors that also interact with this, with some women raising concerns around the role that racism or cultural assumptions may play in these circumstances. For example, there is a risk that black women could be denied pain relief because of a common perception that they are stronger and better able to cope.[18-19] Or, that loud vocalisations of pain may be more easily dismissed and wrongly attributed to differences in cultural expression[20], rather than seen as genuine and in need of immediate response. We have also spoken to women who felt that staff were ‘gatekeepers’ to pain relief during their labour, based on their preference leaning towards birthing with no medical intervention. The investigation into patient deaths at Morecambe Bay NHS Foundation Trust maternity and neonatal services found that the presence of such attitudes contributed to unsafe deliveries.[21] The Royal College of Midwives has also faced criticism over the language used in a campaign to encourage expectant mums to give birth without intervention, where vaginal deliveries were referred to as ‘normal births’. The College now uses the term ‘physiological births’. 2) Sickle cell anaemia Bias is evident in several patient groups, particularly in the sickle cell community. Mismanagement of pain in this group is frequent due to the assumptions held by clinicians and healthcare workers.[22] Sickle cell patients may be perceived as hypochondriacs, drug seeking or addicted to pain relief. This often leads to patients waiting long periods without (or with minimal) pain relief and can prevent them from seeking help early, potentially leading to further deterioration.[23] 3) Chronic pain Patients who suffer with chronic pain may also be waiting for long periods without adequate relief, whether attending hospital or seeing a GP. Studies have shown that up to a third of UK adults suffer from chronic pain[24] and, although guidance has been produced,[25-26] there is evidence that clinician assumptions continue. Some, for example, do not accept that Fibromyalgia (a condition that the patient suffers chronic pain) actually exists.[27] Attitudes like this can lead to patients being ignored, dismissed or sent away with minimal intervention. Sadly, for decades patients have been raising concerns around the dismissal, bias and lack of understanding surrounding the management of chronic pain.[28] A recent analysis of tweets from patients, many of whom had chronic pain, showed that harmful doctor-patient communication can impact on diagnostic safety.[29] Patient safety points for further discussion: What training is there for GPs and other clinicians regarding pain management, across different patient groups and demographics? To what extent do assumptions and biases impact how patients experience pain more broadly throughout health and social care? To what extent does institutional racism play a part? Differences in pain experience Research suggests that pain thresholds can vary. Low pain tolerance has been attributed to patients with fibromyalgia, chronic fatigue syndrome[30] and intellectual and developmental disabilities[31]. Studies have also shown that gender[32], ethnicity[33] and previous trauma[34] can all contribute to people experiencing pain differently. With research indicating there are notable differences in pain thresholds, it leads us to question whether all patients have equal access to the pain relief needed to reasonably ease suffering. Patient safety points for further discussion: Are some patients at greater risk of experiencing trauma-inducing levels of pain than others? Do the methods used for determining how much pain relief to give an individual adequately recognise differences in thresholds, across all demographics? We’d like to hear your views In some ways, we end as we began - with an understanding that pain is incredibly complex. The growing concerns around opioid reliance and over-prescription add another dimension to the conversation and will challenge our thinking further. Eliminating pain altogether would undoubtedly have implications for how we are able to listen to our bodies and adjust accordingly to recover or prevent damage. However, there is clearly much to learn in order to manage peoples’ pain needs safely, effectively and without perpetuating inequalities. And we cannot ignore the continued presence of both acute and chronic pain in incidences of patient harm. Patients are describing their personal, and sometimes deeply traumatic, experiences to help key decision-makers identify where change may be needed and prevent future suffering. Their insight and lived-experience will prove crucial to this debate. The limited examples used in this blog are designed to trigger wider conversations about how we may work together to understand pain as a broader patient safety issue. We welcome the input of others who have an interest in this area. Please comment below or get in touch with the Patient Safety Learning team by emailing content@psl.org. References [1] British Pain Society, Useful definitions and glossary. [2] Katz N, The Impact of Pain Management on Quality of Life. Journal of Pain and Symptom Management 2002; 24; 38-47. [3] Twycross A, Forgeron P, Chorne J et al. Pain as the neglected patient safety concern: Five years on. Journal of Child Health Care. 2016; 20 (4): 537-541. [4] The Independent Medicines and Medical Devices Safety Review. First Do No Harm 2020. [5] Patient Safety Learning. Findings of the Cumberlege Review: informed consent. Patient Safety Learning’s the hub 2020. [6] Patient Safety Learning. Painful Hysteroscopy. Patient Safety Learning’s the hub, Community Forum. 2020. [7] Women’s Hour. Hysteroscopy. 2019. [8] Discombe M. Hundreds of women left ‘distressed’ by hysteroscopies. Health Service Journal 2019. [9] Care Opinion. Painful hysteroscopy and biopsy. 2019. [10] Hysteroscopy Action campaign website. [11] The Supreme Court. Montgomery v Lanarkshire Health Board. 2015. [12] Royal College of Obstetricians and Gynaecologists, Outpatient Hysteroscopy. 2018. [13] Patient Safety Learning. The Patient-Safe Future: A Blueprint For Action. 2019. [14] Kirkey S. Study suggests more can be done to control pain for children. Ottawa Citizen 2014. [15] Eccleston C, Fisher E, Howard R et al. Delivering transformative action in paediatric pain: a Lancet Child & Adolescent Health Commission 2020. [16] Barney, Chantel C, Andersen et al. Challenges in pain assessment and management among individuals with intellectual and developmental disabilities. PAIN Reports 2020; 4; 821. [17] Hill A. Women in labour being refused epidurals, official inquiry finds. The Guardian 2020. [18] Patient Safety Learning. Racial disparities in postnatal mental health: An interview with Sandra Igwe the Founder of The Motherhood Group. Patient Safety Learning’s the hub 2020. [19][19] Patient Safety Learning. Five X More campaign: Improving maternal mortality rates and health outcomes for black women. Patient Safety Learning’s the hub 2020. [20] Wyatt R. Pain and Ethnicity. Virtual Mentor. 2013; 15(5); 449-454. [21] Kirkup B. The Report of the Morcambe Bay Investigation. 2015. [22] Smith-Wynter L, van den Akker O. Patient perceptions of crisis pain management in sickle cell disease: a cross-cultural study. NT Research. 2000;5(3):204-213. [23] Hall S. “People with Sickle Cell are seen as hypochondriacs or drug addicts. Even a nine-year-old has to scream to get the care they need”. Picker. [24] NICE. Chronic pain: assessment and management. Guideline scope. 2018. [25] NICE. Analgesia - mild-to-moderate pain. Accessed 2020. [26] NICE. Chronic pain: assessment and management (in development). Page accessed 2020. [27] Häuser W, Fitzcharles MA. Facts and myths pertaining to fibromyalgia. Dialogues Clin Neurosci. 2018; 20 (1): 53-62. [28] Rehmeyer J. Bad science misled millions with chronic fatigue syndrome. Here’s how we fought back. Stat News. 2016. [29] Sharma AE, Mann Z, Cherian R et al. Recommendations From the Twitter Hashtag #DoctorsAreDickheads: Qualitative Analysis. J Med Internet Res 2020; 22 (10): e17595 [30] Dellwo A. Pain Threshold and Tolerance in Fibromyalgia and CFS. Verywell Health. 2020. [31] Barney, Chantel C, Andersen et al. Challenges in pain assessment and management among individuals with intellectual and developmental disabilities. PAIN Reports: 2020; 5 (4); 821 [32] Mogil J, Bailey A. Chapter 9 - Sex and gender differences in pain and analgesia. Progress in Brain Research 2010; 186;-157. [33] Wyatt R. Pain and Ethnicity. Virtual Mentor. 2013; 15(5); 449-454. [34] Mostoufi S, Godfrey KM, Ahumada SM, et al. Pain sensitivity in posttraumatic stress disorder and other anxiety disorders: a preliminary case control study. Ann Gen Psychiatry 2014; 13 (1): 31.

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

Dear Matt Hancock and Nadine Dorries, We ask the DHSC to make provision for all NHS Trusts to work with the RCoA and RCOG to establish safely monitored IV ‘conscious’ sedation with analgesia as a treatment option for hysteroscopy+/-biopsy. Currently, Trusts put almost all patients through Trial by Outpatient Hysteroscopy and only those patients who fail (usually due to acute pain) are allowed a GA. There is no routine option of IV sedation with analgesia or spinal anaesthesia. We ask too that NHS Trusts give all hysteroscopy patients upfront a fully informed ‘Montgomery’/ GMC CHOICE of: o no anaesthetic o LA / regional / epidural o IV sedation with analgesia o GA The choice should be made after thorough discussion with the patient about her medical history, risk factors and preferences. WHAT IS HYSTEROSCOPY? Hysteroscopy is endoscopy of the womb. Like colonoscopy, it’s used to detect cancer, pre-cancer and benign abnormalities. Hysteroscopy done in outpatients with miniature surgical tools enables the removal of polyps and small fibroids without an incision or general anaesthetic [GA]. Here the similarity with colonoscopy ends. For NHS colonoscopy, the patient is routinely offered a CHOICE of Entonox or IV sedation with analgesia. Some patients request and receive GA. The risk of perforation (and potential death) is less when performed on a patient under IV ‘conscious’ sedation than under GA. The NHS therefore wisely prefers colonoscopy under ‘conscious’ sedation to GA. NHS colonoscopy services aim to protect patients from severe pain. Apart from assuring basic human respect and dignity, the NHS recognises that people traumatised by a severely painful colonoscopy may delay or not return for vital cancer diagnosis or treatment. UPDATE FROM THE CAMPAIGN AGAINST PAINFUL HYSTEROSCOPY [CAPH] Severely painful outpatient hysteroscopy is the next medical scandal after vaginal mesh. Cheap, quick and easy-to-use NHS vaginal mesh kits helped the majority of patients, and saved precious time and resources. Cheap, quick and easy-ish NHS outpatient hysteroscopy [OPH] without anaesthesia/sedation causes severe pain/distress/trauma to approx. 25% patients and saves precious time and resources. Like the vaginal mesh campaigners, hysteroscopy patients who’d been seriously harmed by a flawed medical policy started asking questions. Hysteroscopists assured us that our excruciating and unforgettable pain was very ‘unusual’ and affected only 2% to 5% of patients. This statistic didn’t fit with patients’ observation of OPH clinics. So these ‘unusual’ women started googling, then exchanging stories via social media. Soon they formed into Facebook and Twitter groups. Involved politicians. Interrogated health authorities. Looked for medical explanations. Approached professional colleges and societies. Sought out empathetic and intelligent doctors. Studied the law of informed medical choice and consent. By 2014 a campaign was born, greatly assisted by Lyn Brown, MP (Lab, West Ham) who was prepared to stick her neck out for her constituents and for other women who’d been traumatised and dismissed as ‘incorrect’ in their perception of hysteroscopy pain. These women were clearly of the ‘wrong demographic’! Too anxious, had too narrow cervical canals, too tilted wombs, were too emotionally labile, too black, too white, too rich, too poor, too educated, too urban... By early 2020 the Campaign Against Hysteroscopy had amassed a google survey of 1,000+ hideous, predominantly NHS, stories. We sought stories of specifically painful hysteroscopy since our aim was to identify any common features in patients’ medical histories or the operating teams’ conduct of a painful procedure. We hoped that our findings would aid future patient selection and choice. We gave our results to the Presidents of RCOG and the British Society for Gynaecological Endoscopy. The survey’s free text was shocking: It was barbaric and one of the most painful experiences of my life including vaginal childbirth. I begged them to stop but they wouldn’t. It was like torture It was a terrible experience that I don’t think I will ever forget Just before lockdown, the Health Service Journal published an analysis of our survey [Matt Discombe, HSJ, 2 March 2020] “Around 520 women who attended NHS hospitals in England to undergo hysteroscopies — a procedure which uses narrow telescopes to examine the womb to diagnose the cause of heavy or abnormal bleeding — have told a survey their doctors carried on with their procedures even when they were in severe pain.” We continued our on-going survey, asking about pre/post-menopausal status; vaginal/caesarean delivery/nulliparity; endometriosis/dysmenorrhea/previous traumatic gynae; mental health; hospital information about pain risk; choice of LA/GA/IV sedation; pain-scores at different OPH stages; whether the hysteroscopist stopped if the patient was in pain/distressed; preferred mode of future hysteroscopy, etc. At the end of the survey we asked, “Is there anything else you’d like to tell us?” I was given a brown paper bag to breath into as I hyperventilate with the pain. The male consultant made fun of me. Anaesthetic should be compulsory, I have a high pain threshold but was most painful thing I have ever felt, still feeling traumatised after the event. Staff were appalling. 5 nurses and doctor laughed when they could see I was in terrible pain, shocking The pain after the procedure was finished, was excruciating, body started to go into shock. Ended up in A&E pumped full of morphine and admitted overnight for observation. Never again unless under GA. Ask them if they are in pain rather than asking them about their last holiday whilst their uterus is dilated. I am a midwife myself and spoke to the consultant explaining how anxious I felt regarding the procedure, as I had had a very painful / difficult removal of mirena coil previously and been told I had a cervical stenosis: I asked could I have sedation and was declined saying it would only be “ brief discomfort” and to just take painkillers a couple of hours before At one point that evening I was so confused and in pain, feeling sick and with a high resting heart rate that I nearly called an ambulance. I was alone. Nobody suggested I should have someone at home with me. Felt embarrassed because of yelling (due to the incredibly sharp pain) The doctor and nurse were fine but I was screaming in pain and doctor counted down from 10 to 1 to try to get me to hold on until she could finish it Gas and air made me feel light headed but made absolutely no difference to the pain I experienced. The Cumberlege Review ‘First Do No Harm’ of July 2020 categorised breaches of patient safety into themes. [https://www.immdsreview.org.uk/Report.html] Three of these themes sum up the current harms caused by an over-zealous, blanket NHS policy of reduced-cost OPH: Cumberlege Theme 1, "No-one is listening" – Hysteroscopists lack empathy; they ignore patients’ requests for GA and fail to stop when the patient is in distress. Cumberlege Theme 3, "I was never told" - Hysteroscopists fail to warn patients of the risk of severe pain and don’t tell patients upfront that they have the option of GA. Cumberlege Theme 10, "Collecting what matters" - Hysteroscopists are wilfully blind to Patient Reported Outcomes – they belittle and don’t record the patients’ own short-term, medium-term and long-term outcomes when these cause severe pain and PTSD. CAPH has frequently heard of hysteroscopists telling GPs that a crying patient “tolerated the procedure well”. WHAT IS THE DATA ON HYSTEROSCOPY PAIN? Just as with vaginal mesh, very few gynaecologists have systematically collected pain scores from all their OPH patients. When OPH pain-scores are reported in English journals usually only the median or mean scores are given. Hundreds of members of our Action/Support group were never asked for a pain-score. NHS OPH pain audits obtained by CAPH under the Freedom of Information Act shows that currently 1 in 4 NHS England hysteroscopy outpatients typically suffers severe pain of 7/10 or more. [ www.whatdotheyknow.com - see ‘Outpatient hysteroscopy/biopsy’] The British Society for Gynaecological Endoscopy’s 2019 bespoke 81-hospital survey of 5,000+ hysteroscopy patients from BSGE members’ own NHS clinics reports a mean pain-score of 5.2/10. So clearly it’s not the “mild discomfort” that most patient leaflets claim. Nor is it now feasible to say that severe pain is experienced by only 2-5% of patients. [ www.bsge.org.uk BSGE Ambulatory Care Network Meeting Feb 2020] CAPH has asked for the full range of BSGE members’ OPH pain-scores under FOIA. The British Journal of Anaesthesia this year published a review evaluating patients’ reported pain compared with hysteroscopists’ assessment of OPH pain over 8 years at Royal Berkshire Trust – a good clinic which is barely mentioned in our survey. [Harrison, Salomons 2020]. 17.6% of patients reported severe pain of 7/10 or more, while 7.8% reported no pain. The authors concluded that since patients were likely to experience pain then they should be warned of this. WHAT DOES THE NHS TELL PATIENTS ABOUT HYSTEROSCOPY PAIN? NHS hysteroscopy services appear to follow ex-Cancer Tsar Prof Sean Duffy’s opinion “Overall we think that too much emphasis is put on the issue of pain surrounding outpatient hysteroscopy.” [BMJ. 2001 Jan 6; 322(7277): 47] Patient leaflets almost invariably tell women to expect “mild discomfort”, on a par with moderate period pain. So, without any pre-op assessment the NHS pushes almost all women through Trial by Outpatient Hysteroscopy and reserves GA for those who ‘fail’. The womb endoscopy patient is NOT routinely offered the option of GA. If she asks for one, the request is usually declined – even before the covid-19 pandemic. Thus the vast majority of NHS clinics wilfully ignore the RCOG/BSGE 2018 statement instructing gynaecologists to offer all hysteroscopy patients the choice of GA up-front, and to stop an OPH if the patient is distressed. [https://www.rcog.org.uk/en/guidelines-research-services/guidelines/gtg59/] Yes, there are some excellent, highly skilled and compassionate OPH clinics but, sadly, most put cost-effectiveness before compassion or ‘Montgomery’ informed patient choice, thus denying patients genuine informed consent. Most hospital leaflets tell patients to take over-the-counter meds from home. There is no pre-med in clinic. The woman gets a ‘vocal local’ – hairdresser chit-chat- pioneered in rural Kenya by Marie Stopes. The woman is sometimes held down if distressed and agitated. She may receive potentially painful injections into the cervix as ‘rescue analgesia’. Unfortunately the cervical LA doesn’t anaesthetise the top of the womb, from which the cancer-detecting biopsy is taken. [www.bsge.org.uk Ambulatory Care Network 2020 Keynote Speaker on ‘patchy and unpredictable’ cervical LA] WHAT DOES THE CAMPAIGN AGAINST PAINFUL HYSTEROSCOPY WANT? 1. Every single NHS hospital to use – at the very least – the RCOG patient leaflet (CAPH helped write) which mentions the risk of SEVERE pain outlines clinical risk-factors for severe pain offers patients upfront the option of a GA/IV sedation with analgesia 2. The DHSC and RCOG to work with the Royal College of Anaesthetists to train hysteroscopy teams and establish safe IV conscious sedation with analgesia as a CHOICE available to all womb endoscopy patients. 3. The DHSC to permanently remove any Best Practice Tariff or financial incentive which removes timely access to GA, IV sedation with analgesia or other anaesthetist supported service. 4. A pre-op assessment for all hysteroscopy patients, meaning an end to ‘See & Treat’ clinics, which often coerce women into polyp and fibroid removal without patients having time to consider whether they’d prefer GA/ IV sedation/ regional anaesthesia rather than a local which doesn’t anaesthetise the top of the womb. The current ‘One-Stop’ clinic endangers women who attend the clinic alone and then have to drive or travel home on their own, often in severe pain, bleeding and traumatised. This is unacceptable and must stop. 5. Standardised, regulated, updated high quality training and accreditation for all hysteroscopists together with up to date equipment. Hysteroscopists should be taught to recognise cohorts at high risk of severe pain, develop listening skills and treat women with respect. 6. Full transparency about the financial sponsorship of NHS hysteroscopists’ training by the medical devices industry and the resulting bias towards particular manufacturers’ preferences and cost-effectiveness rather than patient experience. 7. Severe procedural pain to be classed and recorded as a Serious Adverse Event. Yours faithfully, Elaine Falkner (Chair), Pamela Howe (Secretary), Jocelyn Lewis, Lorraine Shilcock, Denise Shafeie, Gill Johnson, Katharine Tylko (on behalf of) The Campaign Against Painful Hysteroscopy www.hysteroscopyaction.org.uk Twitter: @hysteroscopyA Facebook: Campaign Against Painful Hysteroscopy