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  1. Content Article
    Concerns about painful hysteroscopy 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. In a blog late last year, we reflected on some key patient safety concerns relating to these procedures in the NHS: Despite a significant number of women who undergo this procedure and experience high levels of pain, in many cases their remains little or no access to pain relief. 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.[2] A growing number of women do not believe they were given sufficient information about this procedure beforehand and were therefore unable to provide informed consent. Patient experiences and concerns are not being adequately captured, recognised or listened to. Some women have been left traumatised by their experience of hysteroscopy, fearful to access further gynaecological investigations or screenings. There are reports that the good practice guidance available from the Royal College of Obstetricians and Gynaecologists (RCOG) is not being adhered to.[3] We wrote to several key stakeholders in healthcare across England, Northern Ireland, Scotland and Wales highlighting these issues, including Nadine Dorries MP, Minister of State for Mental Health, Suicide Prevention and Patient Safety. Below, we reflect on the response we recently received from her on these issues, in the context of our five calls for action to improve hysteroscopy safety. We have also included our correspondence with her in full at the end of this blog. Nadine Dorries’ response to our five calls to action 1) National guidance for outpatient hysteroscopy to be consistently applied The Minister states her support for the NHS England and NHS Improvement position on this issue, specifically that the information leaflet produced by RCOG and the British Society for Gynaecological Endoscopy should be provided to all patients prior to their hysteroscopy. While her support for the use of this guidance is welcome, she does not address the problem that, in many cases, this guidance is simply not followed. She also advises that RCOG are now in the process of developing a second edition of its patient leaflet. However, while there remains barriers which may prevent clinicians from using this guidance, or where clinicians may be reluctant to follow the guidance, women will continue to be susceptible to varied standards of NHS hysteroscopy care. 2) Women to be provided with information and advice to inform their consent Nadine Dorries indicates her support that patients are provided with all the information they need prior to hysteroscopy procedures to help inform their consent. As with the previous point regarding the consistent application of the guidance, however the issue remains that support for this in principle does not necessarily translate into the experience of patients undergoing this procedure. We are disappointed that the Minister fails to acknowledge that this remains a significant issue and does not provide any assurance that action will be taken to address a failure of informed consent. 3) Women to be offered and provided with pain relief Her response notes support for women having the choice of a general or regional anaesthetic for the procedure. She also outlines forthcoming changes in the NHS that intend to remove the best practice tariff. This is important as this system has provided a financial incentive for hospital trusts to perform procedures, such as hysteroscopy, as outpatient services without a general anaesthetic, creating a perverse incentive against the use of pain relief. 4) Significant pain to be considered an adverse event and recorded and reported as such and 5) 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 and the appropriateness of financial incentives without proper safeguards Finally, on the issue of the pain experienced by a significant number of women who undergo a hysteroscopy procedure, in her response the Minister acknowledges that, in cases of severe pain, “it has become clear over the last few years that we can do better in terms of the services we provide for women”. However, on both this and the issue of further research, she does not make any specific commitments on hysteroscopy. Patient Safety Learning believes that significant pain resulting from procedures such as hysteroscopy should be considered as an adverse event, being recorded, reported and responded to appropriately. We also believe that there needs to be specific research into the scale of unsafe care and pain of these procedures. We recently shared a blog on the hub by Dr Richard Harrison, a pain researcher at the University of Reading, reflecting on his recent research on this issue.[4] Improved guidance requires practical implementation While the Department of Health and Social Care shows a clear recognition of concerns about hysteroscopy procedures in the NHS, the Minister’s response is focused on overarching principles and guidance, rather than how this is implemented in practice. We know that many women are still not being offered a choice of pain relief or given adequate information before consenting to the procedure. It remains unclear from this response whether any action will be taken to investigate the prevalence of these experiences and respond accordingly. This is an example of the type of patient safety issue that we believe the recently announced Patient Safety Commissioner for England should investigate, and is something we intend to promote with them when this role is introduced.[5] Patient Safety Learning is working collaboratively with patients, researchers and clinicians to understand the barriers to safe hysteroscopy care. We continue to speak to and support patient groups to help raise awareness of safety concerns and amplify their voices. Our aim is that all patients have access to pain relief and the information they need to properly consent to treatments. Read our initial email to Nadine Dorries MP (also attached) Read Nadine Dorries' full response (also attached) References [1] Patient Safety Learning, Improving hysteroscopy safety, Patient Safety Learning's the hub, 6 November 2020. [2] Harrison, Richard., Kuteesa, William., and Kapila, A, Pain-free day surgery? Evaluating pain and pain assessment during hysteroscopy, British Journal of Anaesthesia, 2020. [3] RCOG, Information for you: Outpatient hysteroscopy, December 2019. [4] Harrison, Richard, Pain free hysteroscopy, Dr Richard Harrison’s website, 2020. [5] Hughes, Helen, Early thoughts on a Patient Safety Commissioner for England (a blog by Helen Hughes, Chief Executive of Patient Safety Learning), Patient Safety Learning’s the hub, 23 December 2020.
  2. Content Article
    The link below takes you to a Choosing Wisely UK webpage dedicated to resources on shared decision making. These include: Leaflet for patients to help them make the right choices for them at their healthcare appointment using the BRAN questions.Poster to be displayed to encourage the patients to ask the BRAN questionsGuidance on professional standards and ethics for doctorse-learning and video resources for cliniciansLeaflet for healthcare professionals to understand shared decision making.
  3. Content Article
    There are a few key phrases that we may hear or read if we are told we need a surgical procedure: ‘shared decision making’, ‘consent to treatment’ and ‘informed consent’ to name a few. A common reaction is to see these processes as the small print, not dissimilar to ticking a box to agree to terms and conditions we almost certainly haven’t read. We all know deep down we should read them, but really, what’s the harm? And who has the time? When it comes to a surgical procedure, the implications can be significant, and in this blog post I will attempt to explain why. I will describe what those terms really mean, and why, as patients, we must all take some time to familiarise ourselves with anything we are putting our signature to. Anecdotally, surgeons tell me that many patients defer to their expertise when it comes to making a decision about a surgical procedure. They are, after all, trained to a very high level and, by definition, experts in their field. We are right to trust and rely on them to give us all the information we need. However, we also need to understand any potential consequences so we can make a decision. While it’s appropriate to defer to the experts for information, they are not the ones making the decision to go ahead or not. Moving away from a paternalistic relationship This brings me to my first definition, ‘shared decision making’. The National Institute for Health and Care Excellence (NICE) defines it as: ‘…when health professionals and patients work together. This puts people at the centre of decisions about their own treatment and care.’ You can read the full NICE definition here. This means that the relationship between the health professional (in most surgical cases, this is the surgeon) and the patient should not be paternalistic. While it is accepted that the health professional is the expert in this scenario, it is not appropriate for him or her to tell the patient what to do. We now have the Montgomery ruling, which transformed the patient consent journey, shifting the power from the clinician to the patient. I don’t have the space to describe this in detail, but I would recommend taking five minutes to read about the Ruling and to watch the short interview with Nadine Montgomery. The resultant ruling of this case acknowledged the importance of ‘material risk’, stating: ‘Material risk is a risk that is deemed to be of significance by an individual patient rather than by a body of doctors.’ So, what does all of this actually mean for patients? Well, most importantly, it means the conversation about treatment has gone from largely being one way, to an open, two-way discussion. The result of this conversation should hopefully be ‘consent to treatment’ – my next definition. It really is what it says on the tin. But it goes much further than ticking a box or signing on the dotted line. Making a decision to have surgery may be the biggest decision you make in your life. You may not feel that you have a choice, and in many cases, if you don’t go ahead with it, the problem will continue, worsen and it may be life-threatening. This, however, does not mean you should just say ‘yes’ without giving it due consideration. Have you been told about alternatives to the surgery being offered? What about the risks and potential complications? What would happen if you said ‘no’, both in the near and distant future? What information should patients be given? This is where ‘informed consent’ comes in. Informed consent means the patient has been made aware of the Benefits, Risks, Alternatives and doing Nothing by a qualified health professional. This is known among health professionals as ‘BRAN’. BRAN is essential for equipping us to make decisions about our treatment. But how is this information actually prepared and presented to us? In my role as Content Director at EIDO Healthcare, I am responsible for getting the written versions of this information from the surgeon who writes it to the health professional sharing it with patients. But what is that information, and what part does it play in shared decision making and informed consent? In short, it is written information about the procedure your surgeon has recommended. Many hospitals and/or surgeons write their own information, but at EIDO we maintain one version of each document that is used by hundreds of hospitals and surgeons both here in the UK and elsewhere around the world. Either option is fine, as long as the information is reviewed and updated regularly. Don’t be shy in asking your surgeon about how the information you’ve been given has been prepared. Helping patients access clear information At EIDO, all of our leaflets are written by specialists, reviewed by other clinicians and edited by experts in plain English. They are regularly updated and, because they are stored online, updates can be made almost immediately. We also have accreditation from the Patient Information Forum and work with the Patients Association to ensure they are accessible. We offer large and giant print versions, screen readers, ‘Easy Reads’ and a number of translations. Whether the leaflet you see is an EIDO one or not, it should contain relevant information relating to BRAN. This is vital in terms of patient safety. How can someone be expected to make a decision on something so important without knowing all the facts? Risks and benefits are subjective Arguably, the benefits will be of most interest to patients. There is a problem somewhere in your body and you need it to be fixed. But what about the risks? You need to think about how the operation will affect your life in the future. You need to measure the risks against the benefits. If you are a singer, for example, you may not want to risk an operation on your thyroid that could change your voice. Using the same analogy, if you’d like to protect your voice, are there any alternatives that would be preferable specifically to you? What if you did nothing, or waited for a few months, or even years? All of this information should be supplied by the health professional who is advising you to have the surgery. The pre-written information will go into general details, but this alone is not enough. It needs to be a two-way conversation with the opportunity for both of you to ask and answer questions. You can ask for a copy of any notes made about your treatment options, so you can refer back to that conversation. Some people find it helps to talk it through with a friend or loved one. You will have time before the actual procedure to digest this information before signing the consent form. Read the information You should be given information to take home (or it may be emailed to you). I cannot stress enough how important it is that you read this carefully, make notes if you need to, and think about questions you might want to ask your surgeon. The reason for this is twofold. The first, most obvious one, is that you need to know how to prepare for the procedure, what to expect afterwards, and how to take care of yourself in the following weeks. The second reason takes us back to those pesky terms and conditions… Legal implications When you sign the consent form, you are effectively saying you have read and you understand the BRANs for your procedure. This means that if something goes wrong and it was not mentioned or clearly explained to you, you are in a good position to make a claim against the hospital. It also means that if the risk was in the document, you will have a weaker claim. While it is hard to prove that someone has actually read a leaflet, and your signature is not the only consideration, signed consent forms have been used in such cases to dismiss claims made by patients. These documents exist to protect both the patient and the healthcare provider. Litigation against health professionals and providers has grown in recent years, demonstrating an increased understanding by patients of the care we should expect to receive. We are not merely recipients of care; we should also be involved in the direction it takes. The knock-on effect of this growing number of informed patients has resulted in better information. Many patients still choose not to engage fully, and some will even ask their surgeon to make the decision for them (although they will still need to sign a consent form). This is also perfectly acceptable, if that is their preference. The important thing is that they have been offered the information and have been given the opportunity to ask questions, digest the information and then make an informed decision. Julie Smith, Content Director, EIDO Healthcare.
  4. Content Article
    As an additional option to the text below, you might like to watch the following video from Stephanie O'Donohue, Content and Engagement Manager of Patient Safety Learning's the hub: Sharing patients’ experiences on the hub In February this year, we heard from the Campaign Against Painful Hysteroscopy (CAPH) about the high numbers of women experiencing painful hysteroscopies. This prompted us to start a new Community discussion on our patient safety platform, the hub, titled ‘Painful hysteroscopy’, asking members to share their experiences with us. This has, by far, been the most popular discussion on the hub. To date, there have been close to 100 comments made, over 30 members have contributed to the discussion, and the conversation itself has received nearly 6,000 page views, with people viewing the discussion daily. Engaging with patients, clinicians, researchers and leaders Through our contact with CAPH and hearing from patients, clinicians and researchers on the hub, we’ve identified the main patient safety issues to be around consent, access to pain relief and implementation of guidance. Since identifying these issues, we have written to key political stakeholders, including Nadine Dorries MP, Minister for Patient Safety, Suicide Prevention and Mental Health, and Jeremy Hunt MP, Chair of the Health and Social Care Select Committee. More recently, we have made a request for data from the National Reporting and Learning System (the central NHS database for patient safety incident reports) to understand whether the experiences we are hearing about are being accurately captured. We believe patients’ experiences of hysteroscopy should be proactively gathered and used to evidence and inform improvements. Looking forward In 2021, we will continue calling for patients’ experiences of hysteroscopy, and their concerns about this procedure, to be heard and responded to. We want to see systems put in place to support patient safety, and evidence-based conversations occurring between clinicians and patients before procedures take place. These conversations should aim to ensure patients are well-informed of the benefits, risks and alternatives of the procedure, as well as what impact it will have on them if they choose not to proceed. You can read more about the action we believe is needed to address the patient safety issues around painful hysteroscopies.
  5. News Article
    Patient Safety Learning Press Release 10th December 2020 Today the Independent review of maternity services at Shrewsbury and Telford Hospital NHS Trust published its first report on its findings.[1] The report made recommendations for actions to be implemented by the Trust and “immediate and essential actions” for both the Trust and the wider NHS. The Review was formally commissioned in 2017 to assess “the quality of investigations relating to new-born, infant and maternal harm at The Shrewsbury and Telford Hospital NHS Trust”.[2] Initially it was focused on 23 cases but has been significantly expanded as families have subsequently contacted the review team with their concerns about maternity care and treatment at the Trust. The total number of families to be included in the final report is 1,862. These initial findings are drawn from 250 cases reviewed to date. This is another shocking report into avoidable harm. We welcome the publication of these interim findings and the sharing of early actions that have been identified to make improvements to patient safety in NHS maternity services. We commend the ambition for immediate responses and action. Reflecting on the report, there are a number of broad patient safety themes, many of which have been made time and time again in other reports and inquiries. A failure to listen to patients The report outlines serious concerns about how the Trust engaged and involved women both in their care and after harm had occurred. This was particularly notable in the example of the option of having a caesarean section, where there was an impression that the Trust had a culture of wanting to keep the numbers of these low, regardless of patients’ wishes. They commented: “The Review Team observed that women who accessed the Trust’s maternity service appeared to have little or no freedom to express a preference for caesarean section or exercise any choice on their mode of deliver.” It also noted a theme in common with both Paterson Inquiry and Cumberlege Review relating to the Trusts’ poor response to patients raising concerns.[3] The report noted that “there have also been cases where women and their families raised concerns about their care and were dismissed or not listened to at all”. The need for better investigations Concerns about the quality of investigations into patient safety incidents at the Trust is another theme that emerges. The review reflected that in some cases no investigation happened at all, while in others these did take place but “no learning appears to have been identified and the cases were subsequently closed with it deemed that no further action was required”. One of the most valuable sources for learning is the investigation of serious incidents and near misses. If these processes are absent or inadequate, then organisations will be unable to learn lessons and prevent future harm reoccurring. Patient Safety Learning believes it is vital that Trusts have the commitment, resources, and frameworks in place to support investigations and that the investigators themselves have the right skills and training so that these are done well and to a consistently high standard. This has not formed part of the Report’s recommendations and we hope that this is included in their final report. Lack of leadership for patient safety Another key issue highlighted by the report is the failure at a leadership level to identify and tackle the patient safety issues. Related to this one issue it notes is high levels of turnover in the roles of Chief Executive, executive directors and non-executive directors. As part of its wider recommendations, the Report suggests trust boards should identify a non-executive director who has oversight of maternity services. Good leadership plays a key role in shaping an organisations culture. Patient Safety Leadership believes that leaders need to drive patient safety performance, support learning from unsafe care and put in place clear governance processes to enable this. Leaders need to be accountable for patient safety. There are questions we hope will be answered in the final report that relate to whether leaders knew about patients’ safety concerns and the avoidable harm to women and their babies. If they did not know, why not? If they did know but did not act, why not? Informed Consent and shared decision-making 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] The report highlights concerns around the absence of this, particularly on the issue of where women choose as a place of birth, noting: “In many cases reviewed there appears to have been little or no discussion and limited evidence of joint decision making and informed consent concerning place of birth. There is evidence from interviews with women and their families, that it was not explained to them in case of a complication during childbirth, what the anticipated transfer time to the obstetric-led unit might be.” Again this is another area of common ground with other recent patient safety reports such as the Cumberlege Review.[5] Patient Safety Learning believes it is important that patients are not simply treated as passive participants in the process of their care. Informed consent and shared decision making are vital to respecting the rights of patients, maintaining trust in the patient-clinician relationship, and ensuring safe care. Implementation for action and improved patient safety In its introduction, the report states: “Having listened to families we state that there must be an end to investigations, reviews and reports that do not lead to lasting meaningful change. This is our call to action.” Responding with an official statement in the House of Commons today, Nadine Dorries MP, Minister for Mental Health, Suicide Prevention and Patient Safety, did not outline a timetable for the implementation of this report’s recommendations. In 2020 we have seen significant patient safety reports whose findings have been welcomed by the Department of Health and Social Care but where there has subsequently been no formal response nor clear timetable for the implementation of recommendations, most notably the Paterson Inquiry and Cumberlege Review. Patient Safety Learning believes there is an urgent need to set out a plan for implementing the recommendations of the Ockenden Report and these other patient safety reports. Patients must be listened to and action taken to ensure patient safety. [1] Independent review of maternity services at Shrewsbury and Telford Hospital NHS Trust, Ockenden Report: Emerging findings and recommendations form the independent review of maternity services at Shrewsbury and Telford Hospital NHS Trust, 10 December 2020. https://www.ockendenmaternityreview.org.uk/wp-content/uploads/2020/12/ockenden-report.pdf [2] Ibid. [3] The Right Reverend Graham Jones, Report of the Independent Inquiry into the Issues raised by Paterson, 2020. https://assets.publishing.serv...; The Independent Medicines and Medical Devices Safety Review, First Do No Harm, 8 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf [4] NHS England, Consent to treatment, Last Accessed 16 July 2020. https://www.nhs.uk/conditions/consent-to-treatment/ [5] Patient Safety Learning, Findings of the Cumberlege Review: informed consent, Patient Safety Learning’s the hub, 24 July 2020. https://www.pslhub.org/learn/patient-engagement/consent-and-privacy/consent-issues/findings-of-the-cumberlege-review-informed-consent-july-2020-r2683/
  6. Event
    This conference focuses on delivering effective consent practice and ensuring adherence to the new 2020 guidance from the General Medical Council. This timely conference will focus on ensuring adherence to The Seven Principles as outlined by the New GMC Guidance. The conference will also update delegates on implications of recent legal developments. Further information and to book your place or email kate@hc-uk.org.uk Follow the conversation on Twitter #Consentpractice We are pleased to offer hub members a 10% discount. Email: info@pslhub.org for the code.
  7. Content Article
    The Optimising Shared decision-makIng for high RIsk Surgery (OSIRIS) programme is funded by the National Institute for Health Research and investigates different aspects of the decision making process for major surgery. Improving our knowledge of how patients and doctors make decisions about major surgery is an important step in designing and trialling ways of improving this process for patients. We know that a lot of surgery has been cancelled due to COVID-19 and this is a cause of great concern for both patients and healthcare professionals. However, looking to the future, this research it is important to ensure that we optimise decision making process once normal elective surgical services are resumed. We would like to invite you to take part in a research study run as part of OSIRIS Programme. We are looking for volunteers who are 50+ years old, live in the UK and are currently not contemplating undergoing surgery. This study involves an online questionnaire, where you will be presented with a hypothetical medical situation and asked to imagine how you would make decisions in that particular situation. The study will take approximately 25 min to complete. More information is available about the study before you commit to participating. If you are interested in taking part please follow the link below.
  8. Content Article
    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
  9. Event
    Whether your role is in the NHS or in private healthcare, it is vitally important to take consent for any intervention safely. This webinar brings together clinical and legal perspectives, advising healthcare professionals of all levels how to take consent safely to avoid litigation and improve patient safety. Receive guidance from NHS Consultant, Michael Kelly, who has provided expert witness evidence at Court, combined with input from Andrew Bershadski, a highly experienced Barrister who has proceeded to Trial and won for the medical profession on a number of separate informed consent cases. Ed Glasgow, a Partner specialising in Healthcare Law, will Chair the event, which it is hoped will provide valuable practical insight.
  10. News Article
    An urgent investigation into blanket orders not to resuscitate care home residents has been launched amid fears some elderly people may still be affected by the “unacceptable” practice. After COVID-19 cases rose slightly in care homes in England in the last week, with 116 residences handling at least one infection, the Care Quality Commission (CQC) said it was developing the scope of its investigation “at pace” and it would cover care homes, primary care and hospitals. In March and April, there were reports that some GPs had applied “do not attempt resuscitation” (DNAR) notices to groups of care home residents that meant people would not be taken to hospital for potentially life-saving care. This was being done without their consent or with little information to allow them to make informed decisions, the CQC said. Cases emerged in care homes in Wales and East Sussex. Care homes said the blanket use of the orders did not appear to be as prevalent ahead of a possible second wave of infections and families were reporting fewer concerns, although that could be because visiting restrictions meant they had less access to the homes and were getting less information. There are also concerns that steps may not have been taken to review DNAR forms added to care home residents’ medical files, and so they could remain in place, without proper consent. The CQC review will examine the use of “do not attempt cardiopulmonary resuscitation” (DNACPR) notices, which only restrict chest compressions and shocks to the heart. Dr Rachel Clarke, a palliative care expert in Oxford, has described the CPR process as “muscular, aggressive, traumatic” and said it often resulted in broken ribs and intubation. The review will also investigate the use of broader do not resuscitate and other anticipatory care orders. “We heard from our members about some pretty horrific examples of [blanket notices] early in the pandemic, but it does not appear to be happening now,” said Vic Rayner, the executive director of the National Care Forum, which represents independent care homes. “DNAR notices should not be applied across settings and must be only used as part of individual care plans.” It will also investigate the use of broader do not resuscitate and other anticipatory care orders. Read full story Source: The Guardian, 12 October 2020
  11. News Article
    For more than two decades, Derek McMinn harvested the bones of his patients, according to a leaked report – but it was not until last year that anyone challenged the renowned surgeon. The full scale of his alleged collection was apparently kept from the care regulator until just days ago, and thousands of those who went under his knife for hip and knee treatment still have no idea that their joints may have been collected in a pot in the operating theatre, and stored in the 67-year-old’s office or home. Clinicians and managers at the BMI Edgbaston Hospital, where McMinn carried out the majority of his operations, actively took part in the collection of bones and – even after alarms were raised – the hospital did not immediately act to stop the tissue being taken away, according to a leaked internal report seen by The Independent. An investigation found operating theatre staff at the private hospital left dozens of pots containing joints removed from patients femurs during hip surgery in a storage area, in some cases for months. According to the report, there had been warnings about their responsibilities under the Human Tissue Act when an earlier audit between 2010 and 2015 identified the storage of femoral heads, the joints removed in the procedure. The internal report said there was no evidence McMinn had carried out any research or had been approved for any research work – required by the Human Tissue Authority to legally store samples. It said one member of staff told investigators the samples were being collected for research on McMinn’s retirement. Although the Care Quality Commission knew about claims that a small number of bones being kept by McMinn, it is understood that the regulator received a copy of the BMI Healthcare investigation report only last Friday, after The Independent had made initial inquiries about the case. That report suggests a minimum of 5,224 samples had been taken by McMinn. The regulator confirmed to The Independent it had not been aware of the extent of McMinn’s supposed actions. An insider at BMI Healthcare accused the company of “covering up”, adding: “Quite senior staff at the hospital went along with it and just handed the pots over to his staff when they came to collect them.” Read full story Source: The Independent, 30 September 2020