Search the hub

Problems related to the care home and the company were known well before the Panorama expose in 2016. When the Panorama programme was aired it resulted in immediate closure of one home and all the homes which were operated by Morleigh being transferred to new operators. The Review includes reports of abuse against residents; residents being left to lie in wet urine-soaked bedsheets; concerns from relatives about their loved ones being neglected; reports of there being insufficient food for residents, no hot water and no heating; claims that dozens of residents were sharing one bathroom. Here's a summary of the report's findings: More than 100 residents had concerns raised more than once. More than 200 safeguarding alerts were made for individuals but only 16 went through to an individual adult safeguarding conference. More than 80 whistleblower or similar reports were made concerning issues that put residents at risk. 44 inspections were undertaken at Morleigh Group homes in the three-year period, the vast majority identifying breaches. There was a period of at least 12 months when four of the homes had no registered manager in place. During the three-year period reviewed the police received 130 reports relating to the care homes. A spokesperson for Cornwall Council said: “We have different procedures and policies in place and have invested time, money and staffing into making sure that we can respond better when concerns are raised.'' “One of the problems was that all the partners had their own policies and procedures but they weren’t integrated. That is probably one of the key issues that we have now addressed.” “The assessment is so different now and the organisations are working much more closely that it reduces the risk dramatically.'' This is an important and long-awaited review. This situation echoes other care home scandals across the UK. I urge everyone to read the full report and reflect on the real root causes of the problem, which I believe go well beyond failings in inter-agency policies and communication. What would your action plan be? How would you monitor it?

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

The review looked back over the period from 2013 to 2016 and catalogues a number of failings and missed opportunities to address the situation. Among its findings are: More than 100 residents had concerns raised more than once. More than 200 safeguarding alerts were made for individuals but only 16 went through to an individual adult safeguarding conference. More than 80 whistleblower or similar reports were made concerning issues that put residents at risk. 44 inspections were undertaken at Morleigh Group homes in the three-year period, the vast majority identifying breaches. There was a period of at least 12 months when four of the homes had no registered manager in place. During the three-year period reviewed the police received 130 reports relating to the care homes. In total there are 15 recommendations made by the review which have been accepted by Cornwall Council and the Safeguarding Adults Board. These include changes to contract management for the provision of care services so that they link with safeguarding and inspections. On whistleblowing the review says there needs to be a clear whistleblowing process for all staff, residents, families and professionals to follow and to ensure that information is shared across all agencies. Other recommendations include better enforcement to ensure action is taken when breaches are identified. And it calls for a “front door” for all alerts made about care providers so that there is no confusion about who should take responsibility to deal with concerns.

Dr Jake Suett: My experience of suspected 'Long COVID' I have been unwell for 109 days now, and the entire illness has been incredibly frightening, with episodes of severe shortness of breath, cardiac-type chest pains and palpitations to name a few. I think I am slowly improving but am left with residual symptoms that have never gone away entirely but regularly return strongly in waves. In March, I was working as a staff grade intensive care doctor. I was working closely with patients with COVID-19 and had an illness that began with fever, dry cough and shortness of breath. I had braced myself for the coming wave of COVID-19 and was helping my hospital to prepare. I had studied the mortality data from a paper in The New England Journal of Medicine1 and had concluded that, as a young, healthy and active 31-year old doctor I would likely survive (very likely) or die (really quite unlikely) if I became exposed to the virus. I had not anticipated the existence of this strange third possibility of still feeling extremely ill nearly 16 weeks later. I realised that I was not alone with my symptoms when I read Professor Paul Garner’s blog in the BMJ2 about six weeks into my illness. I joined some of the support groups on Facebook including 'Long Covid Support Group' and was suddenly faced with the realisation that there were thousands of us in the same position. It was a bittersweet moment as it helped me to feel less alone, but on the other hand confronted me with a tremendous volume of genuine human suffering that was going unrecorded and unnoticed due to the circumstances of the crisis. People are experiencing incredibly frightening symptoms but some have found it hard to access healthcare as the NHS was being protected from being overwhelmed. Most have remained at home and have not been admitted to hospital. Many were unable to access testing in the first month of their illness, and most were never admitted to hospital. I wrote a letter (attached at the bottom of this blog) that other people could send to their MPs in an attempt to raise awareness of the situation of people suffering persistent symptoms. Here are my current thoughts on the issue of 'Long COVID' and what the next practical steps should be in addressing the problem for sufferers and society in general. 'Long COVID' In some people, there are prolonged symptoms of COVID-19, which have been called 'Long COVID' or 'Post-acute COVID-19'. There is a growing body of evidence that a significant minority of patients are suffering persisting and distressing symptoms that in ordinary times would represent 'red-flag' symptoms requiring urgent investigation. Data from the COVID-19 symptom tracker app shows that 1 in 10 patients are having symptoms for longer than three weeks3. The British Lung Foundation and Asthma UK’s post-COVID survey4 of over 1000 patients, of which over 800 had not been admitted to hospital, found that: “…many people who had mild – moderate COVID are now on a long road to recovery, affecting both their physical and mental health” and “When asked what symptoms most affect them, the top five were: breathing problems (90%), extreme tiredness (64%), sleep problems (22%), cough (22%) and changes in mood, or anxiety or depression (22%). The majority of people had not experienced these symptoms before having COVID.” The symptoms experienced by these patients are frightening and are consistent with other serious differential diagnoses that would usually warrant urgent investigation to rule out serious causes. These symptoms include shortness of breath, chest pain and various neurological symptoms (numbness, weakness, visual disturbances etc). Many people report emergence of new symptoms late in the course of their illness, a relapsing-remitting pattern to their symptoms, and many have reported a mild initial illness, all of which adds to the distress and uncertainty of the condition. Tim Spector writes, “There is a whole other side to the virus which has not had attention because of the idea that ‘if you are not dead you are fine”3. Some patients have reported requiring treatment for con-current bacterial pneumonia, urinary tract infections and pulmonary emboli. Some have reported other serious outcomes such as strokes and cholecystitis. Some that have had investigations have reported serious abnormalities on blood tests, echocardiograms and CTs. Most of these patients have not required hospital admission and many have not been able to access PCR testing at the early stage of their illness. At the moment, this data is not being collected in a scientific fashion, which is an impairment to building up an evidence base around the topic. This data urgently needs to be moved from anecdote into scientific studies and then applied clinically to help people. Some high-profile figures have spoken out about their experiences with a prolonged illness including two Professors of Infectious Diseases and an MP5,6,7. There are many examples of people remaining unwell for three months and longer8 (see letter for more). Articles in the BMJ address the issue from the perspective of a GP9, and from the perspective of occupational health10. We already have emerging evidence of longer-term complications affecting the respiratory11, cardiovascular12, endocrine13, neurological14,15 and gastrointestinal16 systems in at least some patients after COVID-19 and a new Kawasaki disease type illness has been identified in children following infection17. There are also plenty of historical warnings about long-term effects from the SARS outbreak in 200318,19 as well as well documented complications of other viral illnesses. On the basis of this, it is important for us to keep an open mind about what the underlying pathophysiology is in 'Long COVID' patients and encourage further epidemiological, mechanistic and treatment studies by those with expertise in the field. It would be dangerous to assume that pathology that has been detected in hospital patients with COVID-19 can not also affect those who may have managed to avoid admission. Dealing with this issue will require research and collaboration between multiple different medical specialties. Perhaps collaboration and joint guidelines should be considered early on as well as urgently starting studies that capture this cohort. (The PHOSP-COVID study unfortunately only captures follow up in patients after hospitalisation, although of course is a welcome step in the right direction.) The issue has started to be talked about more widely this week. Andrew Gwynne MP asked the Leader of the House of Commons for a debate or statement on 'Long COVID' during business questions on 2 July 2020 and First Minister of Scotland Nicola Sturgeon discussed the issue at Wednesday 1 July’s daily briefing saying, “One of the things it took us longer to learn, and we are still learning, is that even for people who don’t become very seriously unwell and don’t die from it, it can still do really long-term damage.”20 On Sunday 5 July, it was announced that NHS England would be launching a tool to aid long-term recovery21 and a statement from NHS England said, “…evidence shows that many of those survivors are likely to have significant on-going health problems, including breathing difficulties, enduring tiredness, reduced muscle function, impaired ability to perform vital everyday tasks and mental health problems such as post traumatic stress disorder (PTSD), anxiety and depression.”22 This is a welcome step and provides recognition to those who have been left struggling with persisting symptoms. However, it is important that these services do not exclude those who did not require hospital admission nor those whose clinical features suggest COVID-19 but who may have had trouble accessing testing or have suspected false negative results for a variety of reasons23,24,25,26. Clinicians need to be able to access these services for their patients if they feel they would benefit from them. What is the danger? Of course, the pandemic is a crisis and resources have been stretched to the limits. There is no cure for COVID-19 and there is still little evidence to suggest what the pathophysiology of the prolonged symptoms are. It’s been a challenging time for politicians, healthcare professionals and patients alike. However, there are risks with the current situation for those with 'Long COVID' that can be solved now as we move away from the peak of the first wave of the pandemic. The risks are: That serious but treatable complications of COVID-19 may not be detected and managed, such as thromboses, secondary infections, or cardiovascular, endocrine or neurological sequelae etc. That serious but treatable pathology may go undetected if misattributed to COVID-19 and not investigated. There is a third danger from a public health perspective, which is to mistakenly consider outcomes in terms of death vs survival, and to not consider the possibility of long-term morbidity and delayed mortality in survivors of COVID-19, and therefore miscalculate the risk vs benefit calculations of easing lock-down and other public health measures. There is the danger that we miss this opportunity to have robust epidemiological studies to capture the entire spectrum of COVID-19 disease, and therefore any potential morbidity and mortality associated with “Long-COVID” symptoms will go undetected, along with any clues that may be gained regarding the pathophysiology of COVID-19 and treatment options. What needs to be done? I believe that dealing with the problem of 'Long-COVID' will require a response from government, public health bodies, healthcare systems, scientists and society. Collectively, we will need to: Establish a scientific approach to the study of patients undergoing prolonged COVID-19 symptoms (ensuring the cohort that was not hospitalised and has persisting symptoms is also captured in this data). This needs to include epidemiological, mechanistic and treatment studies. (The Long-term Impact of Infection with Novel Coronavirus (LIINC) study27 being carried out at University of California San Francisco is a good example of the type of study required for capturing objective data on the full spectrum of COVID-19 disease, including in those individuals with a prolonged illness. Maintain an open-minded approach to the underlying pathophysiology of the condition28,29, and avoid classifying it with existing names for diseases until there is sufficient evidence to make these statements. Include Long COVID patients in the study design stages. Raise awareness amongst health professionals and make arrangements so that treatable pathology is investigated and ruled out. Provide information and guidelines on how to manage long-term COVID19. Raise awareness amongst employers. Consider the medical, psychological and financial support that may be required by these patients. When considering measures to ease the lock-down, include a consideration of the risk of exposing additional people to prolonged COVID-19 symptoms and long-term health consequences. Ensure and clarify that the plans announced on 5 July 2020 for research and rehabilitation by NHS England do not inappropriately exclude those who have not required hospital admission and do not exclude those who have been unable to access testing early on, or in whom a false negative test is suspected. It is important that similar services are available throughout the UK. I have encouraged people with these persisting symptoms to write to their MPs to make clear the needs of this group. I have included a letter to explain the situation here in case they would find it helpful. Conclusion The Socratic paradox, "I know that I know nothing" must remind us to keep an open mind at this stage when dealing with a new disease. In his novel The Plague, Albert Camus wrote, “Everybody knows that pestilences have a way of recurring in the world; yet somehow we find it hard to believe in ones that crash down on our heads from a blue sky. There have been as many plagues as wars in history; yet always plagues and wars take people equally by surprise.” We have already been taken by surprise by this virus in many ways. It’s important that creating a huge pool of long-term suffering, of unclear aetiology and with unclear outcome, in up to 5-10% of the population does not become an additional surprise. Even if these patients are uncommon, given the number of SARS-CoV2 infections the country has now seen we must arm ourselves with robust studies and evidence to inform healthcare practices and government policy moving forwards. Unless we address this issue we will be left with a huge healthcare burden of chronic disease, and miss the opportunity to save lives and better understand this disease. Clinicians will face patients with these symptoms and have no access to evidence to help manage them. This will lead to bad health outcomes for both individual patients as well as causing significant impacts on society and public health in general. Additional reading: Patient safety concerns for Long COVID patients (6 July 2020) Press release: Patient Safety Learning calls for urgent action to ensure Long COVID patients are heard and supported (6 July 2020) Dismissed, unsupported and misdiagnosed: Interview with a COVID-19 ‘long-hauler’ References Wei-jie Guan, Ph.D., Zheng-yi Ni, M.D., Yu Hu, M.D., Wen-hua Liang, Ph.D., Chun-quan Ou, Ph.D., Jian-xing He, M.D., Lei Liu, M.D., Hong Shan, M.D., Chun-liang Lei, M.D., David S.C. Hui, M.D., Bin Du, M.D., Lan-juan Li, M.D., et al. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med 2020; 382:1708-1720. https://www.nejm.org/doi/full/10.1056/NEJMoa2002032 https://blogs.bmj.com/bmj/2020/05/05/paul-garner-people-who-have-a-more-protracted-illness-need-help-to-understand-and-cope-with-the-constantly-shifting-bizarre-symptoms/ https://covid19.joinzoe.com/post/covid-long-term https://www.blf.org.uk/media-centre/press-releases/%E2%80%9Cwe-have-been-totally-abandoned%E2%80%9D-people-left-struggling-for-weeks-as https://blogs.bmj.com/bmj/2020/06/23/paul-garner-covid-19-at-14-weeks-phantom-speed-cameras-unknown-limits-and-harsh-penalties/ https://www.theguardian.com/commentisfree/2020/jun/28/coronavirus-long-haulers-infectious-disease-testing https://andrewgwynne.co.uk/long-termer-my-struggle-with-post-covid-sickness-my-weekly-article-for-the-tameside-reporter/ https://www.bbc.co.uk/news/uk-wales-53169736 Helen Salisbury: When will we be well again? BMJ 2020;369:m2490 https://www.bmj.com/content/369/bmj.m2490 https://blogs.bmj.com/bmj/2020/06/23/covid-19-prolonged-and-relapsing-course-of-illness-has-implications-for-returning-workers/ Xiaoneng Mo, Wenhua Jian, Zhuquan Su, Mu Chen, Hui Peng, Ping Peng, Chunliang Lei, Shiyue Li, Ruchong Chen, Nanshan Zhong. Abnormal pulmonary function in COVID-19 patients at time of hospital discharge. European Respiratory Journal Jan 2020. https://erj.ersjournals.com/content/early/2020/05/07/13993003.01217-2020 Tomasz J Guzik, Saidi A Mohiddin, Anthony Dimarco, Vimal Patel, Kostas Savvatis, Federica M Marelli-Berg, Meena S Madhur, Maciej Tomaszewski, Pasquale Maffia, Fulvio D’Acquisto, Stuart A Nicklin, Ali J Marian, Ryszard Nosalski, Eleanor C Murray, Bartlomiej Guzik, Colin Berry, Rhian M Touyz, Reinhold Kreutz, Dao Wen Wang, David Bhella, Orlando Sagliocco, Filippo Crea, Emma C Thomson, Iain B McInnes. COVID-19 and the cardiovascular system: implications for risk assessment, diagnosis, and treatment options, Cardiovascular Research, cvaa106, https://doi.org/10.1093/cvr/cvaa106https://academic.oup.com/cardiovascres/article/doi/10.1093/cvr/cvaa106/5826160 Agarwal S, Agarwal SK. Endocrine changes in SARS-CoV-2 patients and lessons from SARS-CoV. Postgraduate Medical Journal 2020;96:412-416. https://pmj.bmj.com/content/96/1137/412 Antonino Giordano, Ghil Schwarz, Laura Cacciaguerra, Federica Esposito, Massimo Filippi. COVID-19: can we learn from encephalitis lethargica? The Lancet Neurology, 2020;19(7):570 https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(20)30189-7/fulltext#articleInformation Mark A Ellul, Laura Benjamin, Bhagteshwar Singh, Suzannah Lant, Benedict Daniel Michael, Ava Easton, Rachel Kneen, Sylviane Defres, Jim Sejvar, Tom Solomon. Neurological associations of COVID-19, Lancet Neurol 2020, https://doi.org/10.1016/S1474-4422(20)30221-0 https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(20)30221-0/fulltext Lijing Yang, Lei Tu. Implications of gastrointestinal manifestations of COVID-19. Lancet Gastroenterol Hepatol 2020; May 12, 2020. https://doi.org/10.1016/S2468-1253(20)30132-1https://www.thelancet.com/pdfs/journals/langas/PIIS2468-1253(20)30132-1.pdf Galeotti, C., Bayry, J. Autoimmune and inflammatory diseases following COVID-19. Nat Rev Rheumatol (2020). https://doi.org/10.1038/s41584-020-0448-7https://www.nature.com/articles/s41584-020-0448-7 Ngai, J.C., Ko, F.W., Ng, S.S., To, K.‐W., Tong, M. and Hui, D.S. The long‐term impact of severe acute respiratory syndrome on pulmonary function, exercise capacity and health status. Respirology, 2010, 15: 543-550. https://onlinelibrary.wiley.com/doi/full/10.1111/j.1440-1843.2010.01720.x Ong, Kian-Chung et al. 1-Year Pulmonary Function and Health Status in Survivors of Severe Acute Respiratory Syndrome. CHEST, 2005, Volume 128, Issue 3, 1393 - 1400 https://journal.chestnet.org/article/S0012-3692(15)52164-8/fulltext https://www.thecourier.co.uk/fp/news/politics/scottish-politics/1414976/100-days-ill-health-secretary-pledges-support-for-long-haul-covid-19-patients-who-never-got-better/ https://www.bbc.co.uk/news/health-53291925 https://www.england.nhs.uk/2020/07/nhs-to-launch-ground-breaking-online-covid-19-rehab-service/ Watson Jessica, Whiting Penny F, Brush John E. Interpreting a covid-19 test result. BMJ 2020; 369: m1808https://www.bmj.com/content/369/bmj.m1808 Fan Wu, Aojie Wang, Mei Liu, Qimin Wang, Jun Chen, Shuai Xia, Yun Ling, Yuling Zhang, Jingna Xun, Lu Lu, Shibo Jiang, Hongzhou Lu, Yumei Wen, Jinghe Huang. Neutralizing antibody responses to SARS-CoV-2 in a COVID-19 recovered patient cohort and their implications. medRxiv 2020.03.30.20047365; doi: https://doi.org/10.1101/2020.03.30.20047365 https://www.medrxiv.org/content/10.1101/2020.03.30.20047365v2 https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/890566/Evaluation_of_Abbott_SARS_CoV_2_IgG_PHE.pdf https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/891598/Evaluation_of_Roche_Elecsys_anti_SARS_CoV_2_PHE_200610_v8.1_FINAL.pdf https://www.liincstudy.org/en/study-information Dominique Batisse MD Assistance, Nicolas Benech MD, Elisabeth Botelho-Nevers MD, Kevin Bouiller MD, Rocco Collarino MD, Anne Conrad MD, Laure Gallay MD, Francois Goehringer MD, Marie Gousseff MD, Dr Cedric Joseph MD, Adrien Lemaignen MD, PhD, Franc¸ois-Xavier Lescure MD, Bruno Levy MD, PhD, Matthieu Mahevas MD, PhD, Pauline Penot MD, Bruno Pozzetto MD, PhD, Dominique Salmon MD, PhD, Dorsaf SLAMA , Nicolas Vignier MD, PhD, Benjamin Wyplosz. Clinical recurrences of COVID-19 symptoms after recovery: viral relapse, reinfection or inflammatory rebound? Journal of Infection (2020), doi: https://doi.org/10.1016/j.jinf.2020.06.073 https://www.sciencedirect.com/science/article/pii/S0163445320304540?fbclid=IwAR0WEEf9dNtmXmFuU-m67g-Fs5SLdckb1f-FnNzSnX1tT4dw3uGWmsfnS60 Ding, H., Yin, S., Cheng, Y., Cai, Y., Huang, W. and Deng, W. Neurologic manifestations of nonhospitalized patients with COVID‐19 in Wuhan, China. MedComm, 2020. doi:10.1002/mco2.13 https://onlinelibrary.wiley.com/doi/full/10.1002/mco2.13?fbclid=IwAR1yQ8DkVOCsIdonjuzl8tx7LlBp0_Lt6KgVUW79SrFwo-_9nyZmWiz7rsQ

In our recent blog Analysing the Cumberlege Review; Who should join the dots for patient safety? we identified a number of key patient safety issues which were reflected in the Review’s findings. One theme running throughout the Review was a failure to engage patients in their care, most noticeably around the issue of informed consent. What is informed consent? The NHS definition of informed consent is that “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”.[1] The landmark UK Supreme Court judgement 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 regarding risks.[2] Review findings Patients being unable to make decisions on the basis of informed consent was a recurring theme in the review, manifesting itself in several ways: Patients’ consent not being sought - the Review heard from patients where consent was not given for the procedure carried out, particularly in cases for implanting pelvic mesh. The authors of the Review state that they were “appalled by the numbers of women who have come forward to say they never knew they had had mesh inserted, or where they gave consent for ‘tape’ insertion they did not know they were being implanted with polypropylene mesh”.[3] Patients lacking information – this was a consistent issue concerning patients regarding the three interventions considered by the Review: hormone pregnancy tests, sodium valproate and pelvic mesh implants. One specific example of this is the case of pregnant women taking sodium valproate as an epilepsy treatment without knowing that doing so could harm their unborn child. Despite efforts to make patients aware of this, it remains an issue, with women who are taking sodium valproate as a epilepsy treatment “still becoming pregnant without any knowledge of the risks”, lacking the information to make the decision about whether to continue with this medication.[4] Patients not being involved in decision making – the Review also heard from patients who raised concerns about the failure of informed consent as a result of doctors choosing not to share relevant information with patients for their decision-making. They refer to cases where doctors did not discuss the risks with women taking sodium valproate prior to pregnancies and “gave advice based on their own assumptions, without involving patients in the decision-making process”.[5] Concerns around the absence of informed consent go beyond the procedures focused on in the Review. On the hub, we have featured community discussions and patient accounts of these issues in relation to hysteroscopy procedures, while earlier in the year the Paterson Inquiry highlighted concerns about this, recommending that a short period should be introduced into surgical procedures to allow for patients to provide their consent.[6] How can we ensure informed consent is gained? The Cumberlege Review notes that, since the Montgomery ruling in 2015, there has been a significant increase in patient safety leaflets sharing information on risks of specific treatments, but that the sheer variety of these and differing consent forms can be “bewildering and a major source of confusion”.[7] The Review is supportive of an approach where information is conveyed in a clear and direct way, and where patient decision aids are used in complex conversations to support the consent process.[8] At Patient Safety Learning, we believe it is important that patients are not simply treated as passive participants in the process of their care. Informed consent is vital to respecting the rights of the patient, maintaining trust in the patient-clinician relationship and ensuring safe care. We have identified three calls for action which we believe are needed to tackle the failure of informed consent: All patient information should be co-produced with patients to ensure that it meets patient needs for decision-making. Repositories of information and good practice are put in place so that organisations don’t have to re-invent the wheel but instead can learn from experience. Patient information for medication and medical devices should be reviewed and signed off by the NHS to ensure that it is not solely the responsibility of manufacturers. What are your thoughts on this issue? Have you had an experience where you feel that you have not given informed consent before receiving medical care? Are you a healthcare professional who can share resources for good practice? Let us know in the comments below to ensure our calls for action are informed by your experience and insights. References NHS England, Consent to treatment, Last Accessed 16 July 2020. https://www.nhs.uk/conditions/consent-to-treatment/ UK Supreme Court, Montgomery v Lanarkshire Health Board, 2015. https://www.supremecourt.uk/cases/docs/uksc-2013-0136-judgment.pdf; Lee, Albert. “'Bolam' to 'Montgomery' is result of evolutionary change of medical practice towards 'patient-centred care'.” Postgraduate medical journal vol. 93,1095 (2017): 46-50. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5256237/#R3 The Independent Medicines and Medical Devices Safety Review, First Do No Harm, 8 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf Ibid. Ibid. Campaign Against Painful Hysteroscopy, Patients Stories Essay, September 2018. https://www.hysteroscopyaction.org.uk/wp-content/uploads/2018/10/sept-2018.pdf; The Right Reverend Graham Jones, Report of the Independent Inquiry into the Issues raised by Paterson, 2020. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/863211/issues -raised-by-paterson-independent-inquiry-report-web-accessible.pdf The Independent Medicines and Medical Devices Safety Review, First Do No Harm, 8 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf Ibid.

We need to listen to patients and commission research COVID-19 is a new virus and there is currently little understanding about long-term impacts[5] and why some people seem to recover quickly while others are left very unwell for months.[6] Prolonged symptoms vary greatly[7] but many are experiencing rashes, shortness of breath, neurological and gastrointestinal problems, abnormal temperatures, cardiac symptoms and extreme fatigue. Recent studies indicate COVID-19 can cause organ damage even where patients have been asymptomatic.[8] Research into the Long COVID cohort of patients is needed as a high priority. Without this, we won’t be able to assess the impact on patients, identify the causes and develop treatments with appropriate advice and support. This knowledge gap deserves immediate attention so that we can better understand how and why the virus has presented itself differently in these patients, many of whom are young and were previously fit and healthy.[9] Thousands of patients are reporting their experiences through social and mainstream media. Patients need to be assured that they are being listened to and that their insights and symptoms are being captured to better understand this disease. Without engaging with patients who are living through this, it will be impossible to gain the full picture and know how best to provide care and keep them safe. Call for action: There needs to be a scientific and global approach to the study of patients undergoing prolonged COVID-19 symptoms to understand the numbers affected, the causes, how long they remain contagious and to investigate possible treatments. Patients must be encouraged to speak up via their GPs, researchers and social media, and they must be listened to. Where patients are dissatisfied with the services and the support they are receiving, they should be encouraged to share this insight through online reporting and, if needed, the NHS complaints process. The Department of Health and Social Care should establish a Long COVID patient advisory group to inform the design of new services, support, research and patient communication. Urgent need for COVID-19 recovery guidance and support For ensuring an effective recovery from serious illnesses such as COVID-19, the importance of rehabilitation to long-term mental and physical health is widely recognised.[10] However, access to quality rehabilitation varies across the UK[11] and, during the pandemic, post COVID-19 support and rehabilitation have focused on the acutely unwell who have spent time in hospital.[12] Patient Safety Learning has heard testimonials from people with COVID-19 who are struggling to recover and have been unable to access support.[13] Although there has been an increase in guidance available for people recovering from COVID-19[14], these have in the main been designed for patients who have been acutely unwell and in hospital. If patients who are managing their illness and recovery from home don’t also receive the care and support they need, they face an increased risk that their physical and mental health outcomes could be adversely affected, limiting their future quality of life.[15] On 5 July 2020 it was announced that NHS England is launching a new service for people with on-going health problems after having COVID-19. "Your Covid Recovery" is an online portal for people in England to access tutorials, contact healthcare workers and track their progress. It is launching later this month and, ‘later in the summer’, tailored rehabilitation will also be offered to those who qualify, following an assessment (up to a maximum of 12 weeks).[16] Call for action: The development of national guidance co-produced with people who have lived experience of Long COVID, and the immediate and consistent application of this guidance. Quality rehabilitation support for Long COVID patients, whether they have confirmed or suspected COVID-19. Services to be provided for as long as people need them, wherever they live in the UK. The psychological impact of Long COVID on patients, with or without a formal diagnosis People who are experiencing prolonged symptoms of COVID-19 are telling us of the negative impact on their mental health and wellbeing.[17] We are hearing of huge variations in the care and advice these patients are being offered when accessing GP services. Many feel that they have been dismissed under catch-all diagnoses or made to question what they are feeling in their own bodies.[18] Frustrations around lack of clinical recognition for their illness is often exacerbated by receiving a negative test result. There is emerging evidence of the problematic nature of COVID-19 and antibody testing to accurately determine whether someone has or hasn’t been infected with COVID-19.[19] ‘False negatives’ can occur for a number of reasons including the challenging process of sample collection[20], the patient’s stage of illness and the failure rates of the tests themselves. Relapses seem common and many people are understandably worried that they may never return to their state of health pre-COVID. It may be that some of these patients are at the beginning of chronic illness, requiring appropriate physical and psychological support.[21] Are these patients’ experiences being believed by the healthcare system? If not, and this results in lack of access to support, then those experiencing long-term symptoms from COVID-19 are potentially at higher risk of developing mental health issues such as depression.[22] Call for action: Patients recovering from suspected Long COVID should be given the same support, regardless of whether they have had COVID-19 confirmed by a test result or not. Appropriate psychological support needs to be available to help patients come to terms with the impact of long-term illness. We need to learn whether unconscious bias about chronic illness is affecting professionals’ decision-making and patients’ access to services. If so, guidance, advice, training and support should be provided. Are serious conditions being overlooked? There is a risk that patients who are suspected or confirmed to have had COVID-19 may not have ‘red-flag’ symptoms (indicative of serious conditions) investigated in the way they would have done pre-pandemic[23], their symptoms instead being attributed to COVID-19. Many members of COVID-19 support groups report having to fight for referrals to rule out other pathologies. This is particularly worrying for people who have a history of cancer or other hereditary illnesses in their family. Their concern is that potential delays to diagnosis and treatment could have an adverse effect on a patient’s health outcomes.[24] Call for action: ‘Red flag’ symptoms that may be indicative of other conditions should be appropriately investigated in Long COVID patients. A second pair of ears Patients with prolonged symptoms are often experiencing what they describe as ‘brain-fog’[25], difficulties with memory or finding the right words, for example. Patient Safety Learning is hearing from those who have expressed a need to have another person attend their appointments to help communicate and to help them process everything in relation to their care. Due to concerns around infection control during the pandemic, such support isn’t always allowed, so there is a risk that patients could be left confused and overwhelmed, unable to engage actively in their care. This could significantly compromise their ability to keep themselves safe.[26] If this is recognised as an issue for those with prolonged COVID-19 symptoms, steps could be taken to ensure they are able to access support in the same way as those with other conditions that result in cognitive impairment. Call for action: Reasonable adjustments should be considered to allow a companion to accompany patients with debilitating symptoms (including ‘brain-fog’) to appointments, or to speak with a clinician over the phone. Health inequalities We now know from recent research that people from Black and Ethnic Minority backgrounds and people who live in deprived areas have been disproportionately affected by COVID-19.[27] There is a significant amount of research looking at the difficulties people from ethnic minority backgrounds and deprived areas face with regard to accessing health services. The concern is that inequalities have the potential to widen if people with Long COVID are not appropriately supported. Call for action: Long COVID patients should be included in research and action being taken to address health inequalities and COVID-19. Rehabilitation outcomes should be monitored and reported so that learning can be captured and so that any emerging inequalities in access to services are identified and addressed quickly. Next steps Patient Safety Learning is calling for the safety of Long COVID patients to be considered as a matter of urgency. Our Chief Executive Helen Hughes comments: "It is understandable that the initial focus of care during the COVID-19 pandemic has been on acutely unwell and hospitalised patients. However, there is growing evidence that there are many patients recovering in the community with long-lasting symptoms who are feeling abandoned, confused and without support. We must take action to better understand the needs of these patients and provide them with safe and effective care for as long as they need." Patient Safety Learning is also supporting the broader calls for action by Dr Jake Suett, set out in his blog post on the hub. These call on Government, public health bodies, healthcare systems, sciences and society to take the following actions: Establish a scientific approach to the study of patients undergoing prolonged COVID-19 symptoms (ensuring the cohort that was not hospitalised and has persisting symptoms is also captured in this data). This needs to include epidemiological, mechanistic and treatment studies. The Long-term Impact of Infection with Novel Coronavirus (LIINC) study[28] being carried out at University of California San Francisco is a good example of the type of study required for capturing objective data on the full spectrum of COVID-19 disease, including in those individuals with a prolonged illness. Maintain an open-minded approach to the underlying pathophysiology of the condition and avoid labelling it with existing names until there is sufficient evidence to make these statements. Include Long COVID patients in the study design stages. Raise awareness amongst health professionals and make arrangements so that treatable pathology is investigated and ruled out. Provide information and guidelines on how to manage long-term COVID19. Raise awareness amongst employers. Consider the medical, psychological and financial support that may be required by these patients. When considering measures to ease the lock down, include a consideration of the risk of exposing additional people to prolonged COVID-19 symptoms and long-term health consequences. Ensure and clarify that the plans announced on 5 July 2020 for research and rehabilitation by NHS England do not inappropriately exclude those who have not required hospital admission, and do not exclude those who have been unable to access testing early on, or in whom a false negative test is suspected. It is important that similar services are available throughout the UK. We will continue to use the hub to highlight patients’ experiences and concerns about this issue. We will also be working with others to seek support for these actions and raise awareness of the patient safety implications of Long COVID with policymakers in Government and the health and social care system. References [1] Forbes, Report Suggests Some ‘Mildly Symptomatic’ COVID-19 Patients Endure Serious Long-Term Effects, 13 June 2020. https://www.forbes.com/sites/joshuacohen/2020/06/13/report-suggests-some-mildly-symptomatic-COVID-19-patients-endure-serious-long-term-effects/#216f1aa35979; COVID Symptom Study, How long does COVID last?, 8 June 2020. https://COVID.joinzoe.com/post/COVID-long-term; Huffington Post, ‘Long COVID’ – The Under-The-Radar Coronavirus Cases Exhausting Thousands, 2 June 2020. https://www.huffingtonpost.co.uk/entry/what-is-long-COVID-and-how-many-people-are-suffering_uk_5efb3487c5b612083c52d91d?guccounter=1; The Independent, ‘The fatigue has lasted for months and months’: Meet the ‘long haulers’ living with the long-term impact of COVID-19, 12 June 2020. https://www.independent.co.uk/life-style/health-and-families/coronavirus-long-tail-patients-symptoms-lockdown-a9563681.html [2] Facebook, Long COVID Support Group, Last Accessed 3 July 2020. https://www.facebook.com/groups/longCOVID; Facebook, Positive Path Of Wellness – (COVID UK Long Haulers), Last Accessed 3 July 2020. https://www.facebook.com/groups/1190419557970588; Coronavirus – Survivors Group – COVID-19, Last Accessed 3 July 2020. https://www.facebook.com/groups/CVsurvivors [3] Asthma UK, “We have been totally abandoned” people left struggling for weeks as they recover from COVID at home, Last Accessed 3 July 2020. https://www.asthma.org.uk/about/media/news/post-COVID-abandoned/ [4] Dr Jake Suett, My experience of suspected 'Long COVID', Patient Safety Learning's the hub, 6 July 2020. https://www.pslhub.org/learn/coronavirus-covid19/273_blogs/my-experience-of-suspected-long-covid-r2547/ [5] The Guardian, The coronavirus ‘long-haulers’ show how little we still know, 28 June 2020. https://www.theguardian.com/commentisfree/2020/jun/28/coronavirus-long-haulers-infectious-disease-testing; BBC News, Coronavirus: Calls for awareness of long-term effects, 19 June 2020. https://www.bbc.co.uk/news/uk-england-south-yorkshire-53084368 [6] BBC News, Coronavirus doctor’s diary: Why does COVID-19 make some health young people really sick?, 31 May 2020. https://www.bbc.co.uk/news/health-52853647 [7] The Independent, Coronavirus: Lesser-known symptoms that could be linked to COVID-19, 1 June 2020. https://www.independent.co.uk/life-style/health-and-families/coronavirus-symptoms-loss-smell-taste-delirium-COVID-toe-syndrome-a9520051.html [8] Quan-Xin Long et al, Clinical and immunological assessment of asymptomatic SARS-CoV-2 infections, Nature Medicine, 18 June 2020. https://www.nature.com/articles/s41591-020-0965-6.pdf [9] NewsLetter, A ‘fit and healthy’ 25 year old COVID-19 patient is urging young people to take coronavirus seriously, 31 March 2020. https://www.newsletter.co.uk/read-this/fit-and-healthy-25-year-old-COVID-19-patient-urging-young-people-take-coronavirus-seriously-2523383 [10] Chartered Society of Physiotherapy, The importance of community rehabilitation, Last Accessed 3 July 2020. https://www.csp.org.uk/professional-clinical/improvement-innovation/community-rehabilitation/importance-community [11] Chartered Society of Physiotherapy, Rebab Matters, Last Accessed 3 July 2020. https://www.csp.org.uk/campaigns-influencing/campaigns/rehab-matters [12] NHS England, After-care needs of inpatients recovering from COVID-19, 5 June 2020. https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/06/C0388-after-care-needs-of-inpatients-recovering-from-COVID-19-5-june-2020-1.pdf [13] Barbara Melville, Dismissed, unsupported and misdiagnosed: Interview with a COVID-19 ‘long-hauler’, Patient Safety Learning’s the hub, 24 June 2020. https://www.pslhub.org/learn/coronavirus-COVID19/patient-recovery/resources-for-patients/dismissed-unsupported-and-misdiagnosed-interview-with-a-COVID-19-%E2%80%98long-hauler%E2%80%99-r2461/ [14] Patient Safety Learning’s the hub, Resources for patients, Last Accessed 3 July 2020. https://www.pslhub.org/learn/coronavirus-COVID19/patient-recovery/resources-for-patients/ [15] Health Awareness, Rehabilitation: making quality of life better for patients, 14 August 2019. https://www.healthawareness.co.uk/rehabilitation/rehabilitation-making-quality-of-life-better-for-patients/# [16] NHS England and NHS Improvement, NHS to launch ground breaking online COVID-19 rehab service, 5 July 2020. https://www.england.nhs.uk/2020/07/nhs-to-launch-ground-breaking-online-covid-19-rehab-service/ [17] CTV News, ‘Great medical mystery’ as COVID-19 ‘long-haulers’ complain of months-long symptoms, Last Updated 19 June 2020. https://www.ctvnews.ca/health/great-medical-mystery-as-COVID-19-long-haulers-complain-of-months-long-symptoms-1.4981669; Anonymous, ‘False negative’ and the impact on my mental health, Patient Safety Learning’s the hub, 22 May 2020. https://www.pslhub.org/learn/coronavirus-COVID19/273_blogs/false-negative-and-the-impact-on-my-mental-health-r2297/ [18] Barbara Melville, Dismissed, unsupported and misdiagnosed: Interview with a COVID-19 ‘long-hauler’, Patient Safety Learning’s the hub, 24 June 2020. https://www.pslhub.org/learn/coronavirus-COVID19/patient-recovery/resources-for-patients/dismissed-unsupported-and-misdiagnosed-interview-with-a-COVID-19-%E2%80%98long-hauler%E2%80%99-r2461/ [19] Financial Times, COVID-19 antibody test raise doubts over accuracy and utility, study finds, 26 June 2020. https://www.ft.com/content/dc4b97a9-d869-40bc-950a-60f9f383bed0; The Guardian, Doctors condemn secrecy over false negative COVID-19 tests, 25 May 2020. https://www.theguardian.com/world/2020/may/25/doctors-condemn-secrecy-over-false-negative-COVID-19-tests [20] Patient Safety Learning, COVID-19 tests: The safety implications of false negatives, Patient Safety Learning’s the hub, 22 May 2020. https://www.pslhub.org/learn/coronavirus-COVID19/273_blogs/COVID-19-tests-the-safety-implications-of-false-negatives-r2309/ [21] Psychology Today, Chronic Illness, Last Accessed 3 July 2020. https://www.psychologytoday.com/us/basics/chronic-illness [22] National Institute of Mental Health, Chronic Illness & Mental Health, Last Accessed 2 July 2020. https://www.nimh.nih.gov/health/publications/chronic-illness-mental-health/index.shtml [23] Dr Jake Suett, My experience of suspected 'Long COVID', Patient Safety Learning's the hub, 6 July 2020. https://www.pslhub.org/learn/coronavirus-covid19/273_blogs/my-experience-of-suspected-long-covid-r2547/ [24] The Guardian, Thousands of cancer patients could die early due to coronavirus delays, study finds, 20 May 2020. https://www.theguardian.com/society/2020/may/20/thousands-of-cancer-patients-could-die-early-due-to-coronavirus-delays-study-finds [25] Daily Mail, How coronavirus can attack the brain: From exhaustion and depression to even DEMENTIA symptoms… the effects COVID-19 can have on one of our most vital organs, 16 June 2020. https://www.dailymail.co.uk/health/article-8424649/How-coronavirus-attack-brain.html [26] Sign up to Safety Patient Engagement in Patient Safety Group, Patient Engagement in Patient Safety: A Framework for the NHS, May 2016. https://www.england.nhs.uk/signuptosafety/wp-content/uploads/sites/16/2016/05/pe-ps-framwrk-apr-16.pdf [27] Public Health England, Disparities in the risk and outcomes of COVID-19, June 2020. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/892085/disparities_review.pdf [28] Long-term impact of Infection with Novel Coronavirus, Study Information, Last Accessed 6 July 2020. https://www.liincstudy.org/en/study-information

“After he died, the little plastic ID band that was around his tiny wrist should have been slipped onto mine. There was nothing more that could have been done for him, but there was plenty that needed to be done for me. I needed an infusion of truth and compassion. And the nurses and doctors who took care of him, they needed it too." Leilani Schweitzer[1] When someone is hurt, it is reasonable to expect the healthcare system to provide care to alleviate symptoms or to cure. It is also reasonable to expect those providing the care to be adequately trained and supported to do so. Yet, when harm is caused by healthcare, the spectrum of harm suffered is not well understood, care needs are not fully recognised and, therefore, the care needed to facilitate optimum recovery is not being provided.[2] In fact, with outrageous frequency, at a time when exceptional care is so desperately needed, those hurting describe how they are further harmed from ‘uncaring’ careless and injurious responses. Healthcare harm is a ‘double whammy’ for patients Healthcare harm is a ‘double whammy’. There’s the primary harm itself – to the patient and/or to those left bereaved – but there is also the separate emotional harm caused specifically by being let down by the healthcare professionals/system in which trust had to be placed.[3] This additional emotional harm has been described as being the damage caused to the trust, confidence and hope of the patient and/or their family.[4] Trust – you rely on professionals to take responsibility for what you cannot do yourself. Confidence - you believe that the system will protect you from harm. Hope – you have the conviction that things will turn out well. Anderson-Wallace and Shale[4] For the patient and family to be able to heal from healthcare harm, appropriate care must be provided not only for the primary injury and any fall out from this, but also this additional emotional injury (being let down by healthcare) and any fall out from that. For example, a parent who loses a child as a result of failures in care will need help to cope with the loss of their child and all of the processes that occur as a result. But they will also need support to cope with having had to hand over responsibility for their child’s safety to healthcare professionals, only to be let down, and all the feelings and processes associated with that. Much needs to happen to restore that parent’s trust, confidence and hope in our healthcare system and the staff within it. This is different to the parent of a child who has passed away from an incurable illness despite exemplary healthcare. A parent let down by healthcare has specific additional care and support needs that need to be met to help them cope and work towards recovery. Healthcare harm also causes emotional harm to the staff involved In 2000, Albert Wu introduced the phrase ‘second victim’ in an attempt to highlight the emotional effects for staff involved in a medical error and the need for emotional support to help their recovery.[5] The term has recently been criticised, since families should be considered the second victim,[6] and the word victim is believed “incompatible with the safety of patients and the accountability that patients and families expect from healthcare providers.”[7] While the term itself may be antagonistic, or misrepresentative, the sentiment – that staff involved in incidents need support to cope with what has happened, and to give them the confidence to do what is needed to help the patient/family heal – certainly stands. When staff are involved in an incident of patient harm, they may lose trust in their own ability and the systems they work in to keep patients safe, and they may worry about their future.[5],[8] They need care and support in order to recover themselves and, crucially, so that they feel psychologically safe and are fully supported to be open and honest about what has happened. They need to feel able to do this without fearing personal detrimental consequences for being honest, such as unfair blame or a risk to their career. This is essential to the injured patient/family receiving the full and truthful explanations and apologies they need in order to regain trust, confidence and hope, and, ultimately, to heal as best they can. So, in addition to patients and families there should be a ‘care pathway’ for staff involved in incidents of harm. A google search on ‘second victim’ reveals a wealth of research on the emotional effects of medical error for staff involved and the best ways to provide support for this, and this is resulting in the emergence of staff support provision to aid recovery.[9] In contrast, very little research has been done into the emotional effects and support needs of families and patients. How is ‘care’ for emotional harm given? The ‘treatment’ of the emotional harm has been described as ‘making amends’ – by restoring trust, confidence and hope.[4] Once a patient has been harmed by healthcare, every interaction (physical, verbal or written) they have with healthcare after that will either serve to help them heal or to compound the emotional harm already suffered. Trew et al.[10] describe harm from healthcare as a “significant loss” and conclude that “coping after harm in healthcare is a form of grieving and coping with loss”. In their model, harmed patients and families proceed through a ‘trajectory of grief’ before reaching a state of normalisation. Some can move further into a deeper stage of grief and seemingly become stuck in what is referred to as complicated grief. They can display signs of psychiatric conditions "if there are substantial unresolved issues, or where there is unsupportive action on the part of individuals associated with the healthcare system and the harm experience”. At the point of the harmful event, the patient/family experiences losses, including a drop in psychological wellbeing. From this point on, healthcare staff and organisations have opportunities to respond. If the response is supportive it may be helpful for the patient/family in coping with the losses. If the response is not supportive, this may cause ‘second harm’ complicating the healing process, leaving the patient/family with unresolved questions, emotions, anger and trust issues. The patient’s psychological wellbeing and ability to return to normal functioning are severely affected. “Most healthcare organizations have proved, in the past at least, extraordinarily bad at dealing with injured patients, resorting at times, particularly during litigation, to deeply unpleasant tactics of delay and manipulation which seriously compounded the initial problems. My phrase ‘second trauma’ is not just a linguistic device, but an accurate description of what some patients experience.” Charles Vincent[11] There is no shortage of individuals who have suffered extensive ‘second harm’ sharing their experiences in the hope this will lead to better experiences for others and some help for themselves to recover. Many are, wrongly, being ‘written off’ as historical cases that can no longer be looked at. This cannot be right – when these people are suffering and need appropriate responses to heal their wounds. The extent of suffering that exists now, in people who have been affected by both primary trauma and then second harm from uncaring defensive responses, or responses that have not taken into account the information patients and families themselves have, or relevant questions they ask, is no doubt nothing short of scandalous. There is a pressing urgency for the NHS to stop causing secondary trauma to affected patients and families. ‘Patient safety’ has to start applying to the harmed patient and their family members’ safety after an adverse event, and not just focus on preventing a repeat of the event in the future. Yes, future occurrences must be prevented, learning is crucial, but so is holistically ‘looking after’ all those affected by this incident. If they are not looked after, their safety is at risk as their ability to heal is severely compromised; in fact they are in danger of further psychological trauma. These same principles apply to affected staff. Avoiding second harm: what happens now and what is needed? This series of blogs will highlight that every interaction a harmed patient or family member has with staff in healthcare organisations (not just clinical staff) after a safety incident should be considered as ‘delivery of care’. With this view, the ‘care interaction’ should be carried out by someone trained and skilled and supported to do so, with the genuine intention of meeting the patient/families’ needs and aiding the patient/family to recover and heal (restore trust, hope and confidence). The interaction / response must not cause further harm. Stress or suffering, and the content of the interaction, for example a letter, should not have been compromised, as often occurs, by competing priorities of the organisation to the detriment of the patient/family. Thus, these blogs will look at: The processes that occur after an incident of harm (Duty of Candour, incident investigation, complaint, inquest) with the aforementioned focus. The care the patient and family need and the obligation (that ought to exist) to meet that need. Processes that are core to the package of ‘care’ to be provided to the harmed or bereaved and to be delivered by skilled and supported ‘care providers’. The blog series will seek to show that meaningful patient engagement in all of these processes is crucial for restoring trust, confidence and hope; therefore, aiding healing of all groups in the aftermath of harm. “It is important to respect and support the active involvement of patients and their families in seeking explanations and deciding how best they can be helped. Indeed at a time which is often characterised by a breakdown of trust between clinician and patient, the principle of actively involving patients and families becomes even more important.” Vincent and Coulter, 2002[3] It will also consider the additional care and support needs that might need to be met alongside these processes in a holistic package of care, such as peer support, specialist medical harm psychological support and good quality specialist advice and advocacy. It will describe what is currently available and what more is needed if healthcare is to provide adequate care for those affected by medical error in order to give them the best chance of recovery. Alongside this, the needs of the staff involved will also be considered. We welcome opinion and comments from patients, relatives, staff, researchers and patient safety experts on what should be considered when designing three harmed patient care pathways: for patients, families and staff. What is the right approach? What actions should be taken? How can these actions be implemented? What more needs to be done? Join in the discussion and give us your feedback so we can inform the work to design a harmed patient care pathway that, when implemented, will reduce the extra suffering currently (and avoidably) experienced by so many. Comment on this blog below, email us your feedback or start a conversation in the Community. References 1. Leilani Schweitzer. Transparency, compassion, and truth in medical errors. TEDxUniversityofNevada. 12 Feb 2013. 2. Bell SK, Etchegaray JM, Gaufberg E, et al. A multi-stakeholder consensus-driven research agenda for better understanding and supporting the emotional impact of harmful events on patients and families. J Comm J Qual Patient Saf 2018;44(7):424-435. 3. Vincent CA, Coulter A. Patient safety: what about the patient? BMJ Qual Saf 2002;11(1):76-80. 4. Anderson-Wallace M, Shale S. Restoring trust: What is ‘quality’ in the aftermath of healthcare harm? Clin Risk 2014;20(1-2):16-18. 5. Wu AW. Medical error: the second victim: The doctor who makes the mistake needs help too. BMJ 2000;320(7237):726-727. 6. Shorrock S. The real second victims. Humanistic Systems website. 7. Clarkson M, Haskell H, Hemmelgarn C, Skolnik PJ. Editorial: Abandon the term “second victim”. BMJ 2019; 364:l1233. 8. Scott SD, Hirschinger LE, Cox KR, McCoig M, Brandt J, Hall LW. The natural history of recovery for the healthcare provider “second victim” after adverse patient events. Qual Saf Health Care 2009;18(5):325-330. 9. Second victim support for managers website. Yorkshire Quality and Safety Research Group and the Improvement Academy. 10. Trew M, Nettleton S, Flemons W. Harm to Healing – Partnering with Patients Who Have Been Harmed. Canadian Patient Safety Institute 2012. 11. Vincent C. Patient Safety. Second Edition. BMJ Books 2010.

Myths of pain: Myth 1: Pain meds compromise the abdominal exam. Myth 2: Treatment of pain will compromise a patient’s decision making capacity. Myth 3: Opiophobia: The fear of addiction Myth 4: She's not in pain! I just saw her sleeping! How can we improve? First: Stop saying that it’s not you. It is you! You suck at managing pain. Perhaps not in everyone, but you’re definitely mistreating someone. Once we accept this fact, we may become cognizant and then able to improve our practices. Second: Educate thyself. Tintinalli’s actually has a whole chapter on acute pain management. Studies show that short training sessions led providers to give more analgesia with improvement in patient satisfaction (5). Third: Simply ask. Ask your patients if they have pain and ask them if they want pain medication. Fourth: Don’t get caught up by stupid myths. Your patient is in pain, treat him! Last: Do not give in to the Great Opiophobia! We are emergency physicians and we aren’t afraid of anything!

My health has always been a ‘challenge’ as they say. I had a stoma in 1988, when I was 28 years old, for bowel disease. They were never sure if it was Crohn's disease or ulcerative colitis, but I was more than happy to kiss my rotten colon goodbye. It restored my bowel health and I carried on working and living my life with my husband and child. Two years after the ileostomy, I had further abdominal problems and a MRI suggested ovarian cancer. I had an emergency laparotomy which revealed severe endometriosis which had obliterated my whole pelvis and infiltrated my internal organs. The gynaecologist closed me up and said nothing could be done as my pelvis was ‘frozen’ and I would have to be treated medically. The condition plagued me for the next 20 years; I developed cysts in the pelvis which were drained repeatedly. My health was at times poor but I still managed to work and live my life. In 2010, my gynaecologist retired and I was referred to a new team. They were based 80 miles from where I lived, which was a nuisance but I felt it was worth the journey to have the best. They were adamant I needed a hysterectomy – they were not happy with the recent imaging and felt one of the cysts looked suspect. I spent years putting this off as I was very fearful. I had been told it could be very easy to make things much worse. In 2012 my mum had a massive brain haemorrhage and I became her carer, but by 2014 they were still saying I needed the surgery to find out what the suspect mass actually was so, reluctantly, I agreed. January 2015 The hysterectomy went ahead at a private hospital. I was in BUPA, my mother was brain damaged and I was her carer, I needed this op out of the way so I could go back to caring for her. I awoke from the surgery to be told it had been very difficult – I felt totally wiped out. Two days after the operation, there was no improvement. I was encouraged to get up from the bed; I could barely move but I managed a few steps when I felt something running down my legs forming a green puddle on the floor. My bowel had perforated and the contents were flooding out of my vagina. My consultant was away and I was transferred late at night to the local NHS hospital. That was a nightmare in itself as they at first wouldn’t accept me. I lay there in A&E with warm liquid pumping out of me with every spasm of my bowel. I was convinced it was blood and I tried not to think of my loved ones whom I thought I’d never see again. My poor husband looked on helplessly; he spent a freezing night in the car as he wanted to be near me. I spent 3 months in hospital being fed through my central vein. I was told I may never eat or drink again and my whole life just fell apart. It was explained the suspect mass was in fact a twisted mess of bowel, adhesions and goodness knows what possibly caused by the repeated aspirations I’d had for the endometriosis. I was told because of the perforation I now had a fistula which is essentially a connection between my small bowel and my skin. Despite my numerous surgical experiences, I had never heard of such a thing but Dr Google soon educated me and it did not make good reading. I became seriously depressed, wanting my life to end. I was discharged in the spring of 2015 to a totally different world. I could by now eat small amounts but the holes appearing on my abdominal wall were evidence the fistula had not healed. I was too afraid to move as any activity meant I’d have ominous discharges from various orifices. I totally lost confidence in myself, the doctors and the world in general… I became a recluse. Life with a fistula was difficult. Apart from the constant dressings required to contain the output, I was in permanent pain and suffered frequent infections. Considering I had gone into hospital reasonably well and come out like this was almost too much to bear. I tried to access mental health support but I was put on a waiting list whilst my mental state got progressively worse. I was told I would have to wait for two years for the fistula to be repaired. It was a long wait, my daughter had a baby so that kept me going and I looked forward to being free of this demon within. I missed the old capable me so much. March 2017 The repair op took place this time in the NHS hospital, albeit as a private patient again. I couldn’t wait any longer and so once again made use of my medical insurance. Again I had serious complications. The days that followed the surgery were horrific, I truly wanted to die. My gut had stopped working, a condition called ileus. Bile was building up in the stomach so I had a nasogastric tube inserted; the thirst was causing me to have hallucinations. I tried to impress upon everyone how ill I was feeling, but I didn’t feel believed; they told me I was anxious and all my problems were normal post op things. My husband called as usual to visit, getting more worried as each day was passing. I had spiked a temperature of 39.6⁰C. I cried into his chest as I tried to sit up to relieve the horrific symptoms I was experiencing. Next minute I had no breath, I was suffocating. My husband called for help and, even at that point, I was told I was having a panic attack until the nurse saw my oxygen levels – they were 71% which was dangerously low. I was having a stage 1 respiratory arrest, and I was rushed to ICU and spent days fighting for my life. A three month hospital stay followed and this further catastrophe had resulted in a fistula worse than the one I went in with. I now had to wear three stoma bags, two of which leaked constantly. I felt a mutilated mess. Again, I left hospital a broken shell, with no support apart from my family who were also finding it hard to accept what had happened to me. Life now... It’s now 3 years since the failed repair and I have never recovered. It actually made things much worse. As well as the fistulae and three stoma bags, I now have bladder problems as part of my bladder was excised during the last op and gallbladder disease thanks to the parenteral nutrition. The inflammation in my body has led to autoimmune diseases, such as scleritis, which is an agonising and destructive eye condition. The whole awful experience has left me a broken, psychological wreck. I finally accessed mental health support at the end of 2019 and have been diagnosed with post traumatic stress disorder (PTSD), anxiety and depression. Life is difficult. In my mind there are so many unresolved issues which have plunged me into a deep pit of depression I can’t get out of. The therapy I now receive is ‘systemic’ so basically addresses how my husband and I are responding to the trauma, rather than the trauma itself. The initial trauma of my surgery going so wrong has now been followed by a second trauma of lack of support, feelings of worthlessness and the consequences of having a complex condition whilst living in rural west Wales where my local hospital can’t treat me. How I wish I’d said NO to that fateful hysterectomy! But we don’t do we. The surgeons are the experts, they lead and we follow, that’s how it works. Lamb to the slaughter springs to mind. That is probably unfair, my surgical luck was bound to run out one day, but I am angry at losing one of life’s most important gifts – good health. To make matters worse I’ve discovered that the suspect mass that they told me had to come out, had actually been identified 30 years previously. It was a harmless benign fibroma. That makes things harder to bear as I realise I probably never even needed the surgery. I didn’t complain or even ask many questions as I was too ill, traumatised and exhausted. My mother ended up in a home, my marriage is understandably struggling, my husband and I no longer work. I had nothing left to challenge anyone. My psychologist says I need answers to help me move on but I’m now told it’s too late. I have to go back to that hospital because I am now so complex my local hospitals won’t treat me. It’s a 3 hour round trip to a place that absolutely terrifies me. An enterocutaneous fistula is a very rare complication of surgery. But as I told my Consultant, it’s only rare until it happens to you. Then statistics become irrelevant. They seem to overlook the fact that there is a person behind that tiny statistic, who has to somehow learn to live again with all the fallout of that disastrous surgical experience.