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When someone needs a joint replacement, there are many factors that affect how well they will respond, how quickly they will recover from the procedure and the potential risks of surgery. Patient complexity is the term used to describe these factors and includes other health conditions, sometimes called co-morbidities, as well as local risk factors related to the specific joint needing to be replaced. In this interview, consultant orthopaedic surgeon Sunny Deo and engineer and founder of TCC-Casemix Matthew Bacon, discuss how new technology is allowing surgeons to more accurately predict the surgical risk and outcomes for patients having knee replacement surgery. They describe how a new approach to data modelling is allowing the orthopaedic team at Great Western Hospital NHS Foundation Trust to more accurately assess complexity for individual patients. This has benefits for patient care and outcomes, theatre productivity and the development of pathways that are more patient-centred. They also highlight some patient safety issues associated with elective surgical hubs, which were set up to deal with high volume low complexity patients, including the deprioritising of more complex patients who may be at greatest need of surgery. Finally, they discuss the applicability of this approach to other specialties and areas of healthcare. Read more about clinical complexity in joint replacement surgery in this presentation by Sunny Presentation - Overview of clinical complexity by Sunny Deo.pdf

The following account has been shared with Patient Safety Learning anonymously. We’d like to thank the patient for sharing their experience to help raise awareness of the patient safety issues surrounding IUD procedures. *Trigger warning: Some people may find the following account distressing to read. Please note that experiences of pain and the care given during gynaecological procedures vary greatly. I came across Patient Safety Learning's forum page about IUD experiences after having my first Mirena coil fitting. I felt unable to comprehend the sense of violation and trauma I had just experienced. A suspected cancer referral I was referred by my GP on the 'suspected cancer pathway' for some post menopausal bleeding. On a positive note, I cannot fault the system and the speed with which I was seen, but my treatment during the appointment was so awful I am actually shaking again as I write this. Although this was an urgent referral, I was not particularly anxious as I felt the erratic bleeding I was experiencing was likely due to my hormone replacement therapy (HRT) regime. I was expecting a consultation and a scan, possibly a hysteroscopy; with a change in my HRT regime being the likely outcome. Off to a bad start The appointment started off on the wrong foot with the consultant asking if I thought there was actually any benefit in taking HRT, likening it to long term antidepressant usage. I explained that, as a runner, I was largely taking it for the well researched bone health benefits but I found his question rather belittling with its implied suggestion of menopause being all in the mind. He went on to advise that a Mirena coil would be a better option for me for HRT which I agreed I would consider. He did not explain the procedure or the possible complications or risks. I will add here that I was sterilised at the age of 30 after my second child. Contraception wasn't something I'd had to consider for the past 23 years so it wasn't really something I'd chatted about with friends. I had heard rumours of bad experiences but took it with a pinch of salt - there are after all rumours of bad experiences in all walks of life. I could not have been more wrong. The procedure - I was frozen with shock I stripped to the waist, legs in stirrups and the consultant explained he would first perform a transvaginal ultrasound to check the thickness of the endometrium - this was reassuringly normal. Then without any warning, he told me he was just going to inject some anaesthetic into my cervix and fit a coil. I had no time to prepare myself at all for this - I didn't really feel I had consented but he and both nurses in the room were acting as though this was all very normal. The injections weren't pleasant in themselves, particularly as I wasn't expecting them. There was no pause at all before I felt awful searing pain and pulling sensations, nothing was being explained prior to it being performed. Something was said about my cervix needing to be dilated and it seemed to take forever. I didn't shout out, I didn't ask him to stop, i just let the tears come. I felt absolutely frozen with shock throughout the whole procedure - no one was asking if I was OK so I assumed I was being a bit of a baby. He announced the coil was in place and I was sat up. Lack of compassion Within seconds I was flooded with heat, I wanted to be sick and everything started to go black. The nurse laid me back down and I remember coming round with a fan on my face and my feet elevated on a stool. The nurse seemed very chilled about the whole thing and just said - oh you're a fainter! I am 53 and have only ever fainted once in my life and that was over 20 years ago. The consultant did not even look at me, let alone speak. I actually felt embarrassed and just wanted to get out as fast as possible. I was slowly sat up and the nurse went and got my daughter from the waiting room. My daughter was told that I felt a little bit wobbly and suggested we go get a coffee from the hospital coffee shop, no one checked my pulse or blood pressure and they seemed keen to get on so we dutifully left. I felt horrific. I couldn't make it to the coffee shop at first. I had to sit down with my head between my legs twice in the hospital corridor as I felt so faint, sick and hot. I've no idea how I dragged myself to the cafe as I continued to feel so awful. After 30 minutes of this my daughter went to get help. She was advised to get a wheelchair and take me back to the clinic which she did. We were laughingly told by the receptionist that I wasn't the first and wouldn't be the last and that we were welcome to sit in a quiet room until I felt better. She brought me a cup of tea but no nurse checked on me at all. It took almost an hour after the fitting before I could stand for long enough to get out to the car. We just sort of slunk out and that was it. Later when I felt better, I checked my sports watch data. My heart rate had averaged 46 for over 30 minutes with the lowest reading being 38 beats per minute. Left in disbelief but inspired to advocate for change How is this happening in 2024? The thought of ever having another pelvic exam, smear test or anything else makes me feel sick and shaky. Where do people go for support with this? It's not ok. I work in Primary Care and often refer women on the same pathway I have just been through. I will absolutely be raising my concerns with the care provider involved. I also have since spoken to a number of women of perimenopausal age and have been horrified to hear so many upsetting experiences from others. It does seem that there is an embedded culture within gynaecological care within which women are neither heard nor permitted agency over their own bodies. Two weeks on and I am feeling far less traumatised, but incredibly inspired to help bring an end to this poor treatment of women. It can be easier to speak up in advocacy than solely for oneself. Share your experience Have you had a gynaecological procedure recently? Would like to share your experience - positive or negative? What makes the difference when it comes to feeling safe or unsafe when accessing these services? You can comment below (sign up first for free), or contact our editorial team at [email protected]. You can also add your experience of a hysteroscopy or IUD procedure to our community forum. Pain during IUD fitting Painful hysteroscopy Related reading Pain experiences during intrauterine device procedures: a thematic analysis of tweets (11 June 2024) Failures of informed consent and the impact on women’s health: a Patient Safety Learning blog Gynecology has a pain problem Our discomfort is routine. What if it didn’t have to be? (1 June 2022) Fitting coils: developing a safe and supportive service The ripples of trauma caused by severe pain during IUD procedures (BMJ Opinion, July 2021)

The 2024 EIDO conference, ‘The Consent Conundrum: Legal Insights and Practical Solutions’, explores medical consent through various lenses. Taking place on Tuesday 26 November at the East Midlands Airport Raddison Blu Hotel, this FREE event is open to surgeons, consultant nurses, legal service managers and anyone with an interest in shared decision making and informed consent. Reasons to attend the EIDO conference: Get FREE access to EIDO’s CPD-certified e-learning course The Legal Aspects of Informed Consent: Foundation Course after the event Gain insight into medical negligence, international perspectives on consent, and collaboration in patient information. Listen to expert speakers discuss digital transformation in patient care, system interoperability and consent issues in recent inquiry reports. Earn CPD points and receive a CPDUK certificate after the event. Register for the conference

Dan Cohen is an international consultant in patient safety and clinical risk management, and a Trustee for Patient Safety Learning. In this blog, Dan discusses the four principles of medical ethics, specifically focusing on how each applies to providing safe patient care. Our moral imperative Having spent more than 50 years as a doctor, I have come to appreciate that everything in my, and our, professional life comes back to the basics of why we entered the healthcare professions in the first place. We genuinely wanted to help people, to keep them healthy and to return them to their maximum healthy state when they became ill. We wanted to serve our patients by being helpful. This has been our moral imperative and our beacon. This moral imperative is the reason we get up every day and go about our jobs, often working under stressful circumstances confounded by environmental stressors, liabilities related to human factors and process inefficiencies. All of these factors have an impact on our effectiveness in clinical settings, with stress and burnout also trickling over into our personal lives. Providing healthcare is challenging, especially when so much of our work environment is seemingly out of our control. Yet we keep coming back for more because we really care. Healthcare professionals may be viewed as special and unique people by many in society, sometimes even put on a pedestal. But really, they are mostly ordinary women and men, drawn by an important calling with highly specific and serious responsibilities. What we do is special and unique! Healthcare professionals try to provide the highest quality care, focusing on optimal clinical outcomes while avoiding mistakes, errors and harm to patients. We also acknowledge that what matters most to patients influences our approach to their care. How we satisfy our moral imperative is governed substantially by adhering to the medical ethics; i.e., the behaviours, actions and deeds that are held within the moral imperative. Behaviours that do not align with the moral imperative are considered unethical. The principles of medical ethics The principles of medical ethics have been best characterised by four foundational pillars, first elucidated by Tom L. Beauchamp and James F. Childress in 1979 in their seminal book, Principles of Biomedical Ethics.[1] These principles remain as relevant today as they were when first described. I will discuss briefly these foundational pillars, specifically focusing on how each applies to providing safe patient care. Principle 1: Respect for patient autonomy Providing healthcare should be a collaborative process with professionals and patients working together to achieve the best outcomes. Therefore, patients’ needs, wants and expectations should be foremost. Optimal outcomes, especially in outpatient care, cannot be achieved without patient engagement, as the patients are generally the implementers of care, certainly after they leave their doctors’ surgeries. Patients are entitled to be informed about the risks and benefits of interventions that may cause them harm, surgical interventions most notably, and this requires discussions and sharing of information to ensure patients are appropriately involved in decision making. The practice of obtaining signed patient consent for surgical procedures acknowledges this. However, consent is often obtained in a 'slap-dash' way by having patients sign forms that may be incomplete or incompletely understood by patients. The informed consent process, as it has been operationalised, may satisfy legal requirements but is often flawed as it may not generally include a thoughtful doctor to patient discussion of risks and benefits. Respect for patient autonomy absolutely requires adherence to the principle of candour in healthcare. If mistakes are made in providing care, patients deserve to have these mistakes discussed with them in a timely fashion. This generally means shortly after the mistake has been discovered and is especially crucial with mistakes that have caused harm or may cause delayed harm. Until patients release us from our responsibilities as their care provider, we must remain committed to satisfying their healthcare needs. This cannot be accomplished if we are not honest and candid when discussing what has happened. There is now good evidence that candid discussions decrease the frequency of medical negligence claims and lawsuits and the size of healthcare injury claims paid.[2] [3] Caring for patients means respecting them and sharing information with them, whether that's for the better or worse. Principle 2: Beneficence Healthcare professionals are required to provide care that is intended to be beneficial to patients. It may seem counterintuitive to say this, but what this really means is that the care provided should be evidence-based and comply with the highest standards designed to achieve best outcomes. There are certainly instances where evidence is lacking or controversial or where doctors and/or professional groups may disagree regarding the best care and how to achieve best outcomes. Yet each healthcare professional must aspire to provide the best possible care, even in the face of uncertainty. And if there is uncertainty, then that uncertainty also should be discussed with our patients. This principle requires that healthcare professionals be willing to discuss "alternative approaches" to standard healthcare therapeutics if patients bring these options into the discussion, including the use of acupuncture, homeopathic and/or herbal products, and other approaches that patients may wish to consider. After all, patient autonomy must be respected, so professionals, regardless of their own opinions regarding these interventions, must be willing to listen and provide relevant information in a compassionate way. It is important to point out to patients when some of these alternative approaches may be harmful in certain situations. For example, certain herbal treatments may pose risks for patients taking oral anticoagulants. Healthcare professionals must share their concerns about what risks are known and mention when risks are not known. I have come across this dilemma in my own practice and I would be honest and say something like: “I cannot say with confidence that what you wish to do will be safe or unsafe, because I simply do not know the answer, although I will look into this more thoroughly. However, if I cannot find evidence of safety, then I cannot fully support you using 'XYZ' because I will be concerned that it may be harmful. The choice is always yours, and I respect your decision even if it is not one that I would make myself". Principle 3: Nonmaleficence This principle, which some have interpreted simply as "do no harm" is actually more complex than that. By their very nature, some of our recommendations cannot always avoid harm. So, by extension "do no harm” really means to avoid unnecessary harm to the extent that this is possible. For example, for a patient undergoing surgery, the surgeon will use a scalpel to perform the surgery. Hence the surgeon must actually harm the patient in order to perform the surgery, and that harm could lead to further harm (e.g., bleeding, infection, etc.) that was never the intention of the intervention. In the same way, chemotherapy to treat cancer may carry substantial risks of harm because of medication side effects that cannot always be avoided. This is the reason that informed consent must address the risks and benefits of the treatment, and professionals must make sure their patients fully understand these risks and benefits. Nonmaleficence means to avoid unnecessary harm whenever possible. Principle 4: Justice Sadly, even in our caring professions, not all of our patients are treated fairly and equitably. The principle of justice requires that all patients be treated without reference to their genetic, biological, social and economic backgrounds, gender or gender identity, and political views. The impacts of prejudices and biases against individuals of differing ethnicities, skin colours, social classes, political views, and coincidental health and lifestyle issues have adversely influenced both access to healthcare services and the quality and timeliness of healthcare services provided, possibly resulting in adverse healthcare outcomes.[4] [5] [6] For example, individuals with obesity and smoking related comorbidities and illnesses are often viewed as "responsible" for their health challenges and subject to biases, whereas recreational middle distance runners are rarely viewed negatively for their anterior cruciate ligament (ACL) injuries or joint osteoarthritis. Healthcare professionals thus have a moral obligation to acknowledge this vulnerability in themselves and to never let these biases or prejudices interfere with our provision of care. Our prejudices may well harm patients and/or prevent them from achieving optimal healthcare outcomes. This is particularly an issue when professionals are working under stress and task saturation, when we tend to take shortcuts in diagnosis and may rush to solutions or be less sympathetic and compassionate to those who are "not like us". Disparities in care are dangerous variables when providing safe, high-quality healthcare for everyone. Summary The principles of biomedical ethics apply directly to the fundamental moral imperative to provide the highest quality care while avoiding mistakes, errors and harm to patients. We must ensure that what matters most to patients influences our approach to their care and, thus, to adherence to this moral imperative. The foundational pillars of medical ethics also require professionals to be honest with patients when things go wrong and to focus on sustaining the relationships between patients and their care providers. Therefore, healthcare professionals are advised that before walking into their clinics, surgeries, hospitals, etc., they should stop and pause momentarily to reflect upon who they are as professionals, the moral imperative they work under and the professional behaviours that must align with the moral imperative. We must recognise the challenges of working in a complex environment and be especially careful. Stress degrades behaviour for all of us and, from time to time, I have been as much at fault as anyone. It’s called being human. Be part of the solution, not part of the problem. References Beauchamp TL, Childress JF. Principles of Biomedical Ethics, 8th Ed. Oxford University Press, USA, 2019. Kachalia A, Kaufman SR, Boothman R, et al. Liability claims and costs before and after implementation of a medical error disclosure program. Annals of Internal Medicine 2010; 153(4): 213–21. Kachalia A, Sands K, Van Niel M, et al. Effects Of A Communication-And-Resolution Program On Hospitals’ Malpractice Claims And Costs. Health Affairs 2018; 32(11): 1836–44. Lavizzo-Mourey RJ, Besser RE, Williams DR. A Half-Century of Progress in Health: The National Academy of Medicine at 50: Understanding and Mitigating Health Inequities — Past, Current, and Future Directions. N Engl J Med 2021; 384:1681–4. Sabin JA. Tackling Implicit Bias in Health Care. N Engl J Med 2022; 387:105–7. Fernandez A, Chin MH. Keep Your Eyes on the Prize – Focusing on Health Care Equity. N Engl J Med 2024; 390:1733–6. Further reading on the hub from Dan: Clarity and the Art of Communication for Patient Safety Late night reflections on patient safety: commentaries from the frontline (2014) Diagnostic errors and delays: why quality investigations are key Patient Safety Spotlight Interview with Dr Dan Cohen, Patient Safety Learning Trustee Structures, processes and outcomes for better or worse: Personal responsibility in patient safe care What does all this safety stuff have to do with me? How one professional’s arrogance led to new insights Interview with Dr Dan Cohen on human performance

EIDO Healthcare’s upcoming in-person conference on 26th November will focus on how improving informed consent practices can directly enhance patient safety. The event is organised by Julie Smith, EIDO’s Content Director and a topic lead for Patient Safety Learning's hub. ‘The Consent Conundrum: Legal Insights and Practical Solutions’ will explore how medicolegal expertise and practical approaches to informed consent can prevent medical negligence and improve patient outcomes. Discussions will include case studies highlighting patient experiences, the latest updates on consent, and the crucial link between informed consent and patient safety. Speakers include: Simon Hammond, Director of Claims at NHS Resolution Mr Parv Sains, Medicolegal Lead for RCS England and ASGBI Jonathan Webb, Head of Safety & Learning, Welsh Risk Pool Professor Vivienne Harpwood, Emerita Professor of Medical Law and Ethics, Cardiff University Helena Durham, Lay Patient Safety Partner and member of the Ethics of Clinical Practice Committee at Nottingham University Hospitals NHS Trust Attendees will receive a CPD Certificate and complimentary access to EIDO’s foundation e-learning course, “The Legal Aspects of Informed Consent” following the event. Spaces are limited and free, so don’t miss this opportunity to join vital discussions on improving patient safety through better informed consent practices. Register here.

This Patient Partnership Week webinar will ask the question, "Why aren't patients treated as equals in their own care?" Prof Havi Carel from the University of Bristol will discuss why some healthcare professionals ignore, dismiss or explain away patients' testimonies about their health. Register for the webinar