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There are a few key phrases that we may hear or read if we are told we need a surgical procedure: ‘shared decision making’, ‘consent to treatment’ and ‘informed consent’ to name a few. A common reaction is to see these processes as the small print, not dissimilar to ticking a box to agree to terms and conditions we almost certainly haven’t read. We all know deep down we should read them, but really, what’s the harm? And who has the time? When it comes to a surgical procedure, the implications can be significant, and in this blog post I will attempt to explain why. I will describe what those terms really mean, and why, as patients, we must all take some time to familiarise ourselves with anything we are putting our signature to. Anecdotally, surgeons tell me that many patients defer to their expertise when it comes to making a decision about a surgical procedure. They are, after all, trained to a very high level and, by definition, experts in their field. We are right to trust and rely on them to give us all the information we need. However, we also need to understand any potential consequences so we can make a decision. While it’s appropriate to defer to the experts for information, they are not the ones making the decision to go ahead or not. Moving away from a paternalistic relationship This brings me to my first definition, ‘shared decision making’. The National Institute for Health and Care Excellence (NICE) defines it as: ‘…when health professionals and patients work together. This puts people at the centre of decisions about their own treatment and care.’ You can read the full NICE definition here. This means that the relationship between the health professional (in most surgical cases, this is the surgeon) and the patient should not be paternalistic. While it is accepted that the health professional is the expert in this scenario, it is not appropriate for him or her to tell the patient what to do. We now have the Montgomery ruling, which transformed the patient consent journey, shifting the power from the clinician to the patient. I don’t have the space to describe this in detail, but I would recommend taking five minutes to read about the Ruling and to watch the short interview with Nadine Montgomery. The resultant ruling of this case acknowledged the importance of ‘material risk’, stating: ‘Material risk is a risk that is deemed to be of significance by an individual patient rather than by a body of doctors.’ So, what does all of this actually mean for patients? Well, most importantly, it means the conversation about treatment has gone from largely being one way, to an open, two-way discussion. The result of this conversation should hopefully be ‘consent to treatment’ – my next definition. It really is what it says on the tin. But it goes much further than ticking a box or signing on the dotted line. Making a decision to have surgery may be the biggest decision you make in your life. You may not feel that you have a choice, and in many cases, if you don’t go ahead with it, the problem will continue, worsen and it may be life-threatening. This, however, does not mean you should just say ‘yes’ without giving it due consideration. Have you been told about alternatives to the surgery being offered? What about the risks and potential complications? What would happen if you said ‘no’, both in the near and distant future? What information should patients be given? This is where ‘informed consent’ comes in. Informed consent means the patient has been made aware of the Benefits, Risks, Alternatives and doing Nothing by a qualified health professional. This is known among health professionals as ‘BRAN’. BRAN is essential for equipping us to make decisions about our treatment. But how is this information actually prepared and presented to us? In my role as Content Director at EIDO Healthcare, I am responsible for getting the written versions of this information from the surgeon who writes it to the health professional sharing it with patients. But what is that information, and what part does it play in shared decision making and informed consent? In short, it is written information about the procedure your surgeon has recommended. Many hospitals and/or surgeons write their own information, but at EIDO we maintain one version of each document that is used by hundreds of hospitals and surgeons both here in the UK and elsewhere around the world. Either option is fine, as long as the information is reviewed and updated regularly. Don’t be shy in asking your surgeon about how the information you’ve been given has been prepared. Helping patients access clear information At EIDO, all of our leaflets are written by specialists, reviewed by other clinicians and edited by experts in plain English. They are regularly updated and, because they are stored online, updates can be made almost immediately. We also have accreditation from the Patient Information Forum and work with the Patients Association to ensure they are accessible. We offer large and giant print versions, screen readers, ‘Easy Reads’ and a number of translations. Whether the leaflet you see is an EIDO one or not, it should contain relevant information relating to BRAN. This is vital in terms of patient safety. How can someone be expected to make a decision on something so important without knowing all the facts? Risks and benefits are subjective Arguably, the benefits will be of most interest to patients. There is a problem somewhere in your body and you need it to be fixed. But what about the risks? You need to think about how the operation will affect your life in the future. You need to measure the risks against the benefits. If you are a singer, for example, you may not want to risk an operation on your thyroid that could change your voice. Using the same analogy, if you’d like to protect your voice, are there any alternatives that would be preferable specifically to you? What if you did nothing, or waited for a few months, or even years? All of this information should be supplied by the health professional who is advising you to have the surgery. The pre-written information will go into general details, but this alone is not enough. It needs to be a two-way conversation with the opportunity for both of you to ask and answer questions. You can ask for a copy of any notes made about your treatment options, so you can refer back to that conversation. Some people find it helps to talk it through with a friend or loved one. You will have time before the actual procedure to digest this information before signing the consent form. Read the information You should be given information to take home (or it may be emailed to you). I cannot stress enough how important it is that you read this carefully, make notes if you need to, and think about questions you might want to ask your surgeon. The reason for this is twofold. The first, most obvious one, is that you need to know how to prepare for the procedure, what to expect afterwards, and how to take care of yourself in the following weeks. The second reason takes us back to those pesky terms and conditions… Legal implications When you sign the consent form, you are effectively saying you have read and you understand the BRANs for your procedure. This means that if something goes wrong and it was not mentioned or clearly explained to you, you are in a good position to make a claim against the hospital. It also means that if the risk was in the document, you will have a weaker claim. While it is hard to prove that someone has actually read a leaflet, and your signature is not the only consideration, signed consent forms have been used in such cases to dismiss claims made by patients. These documents exist to protect both the patient and the healthcare provider. Litigation against health professionals and providers has grown in recent years, demonstrating an increased understanding by patients of the care we should expect to receive. We are not merely recipients of care; we should also be involved in the direction it takes. The knock-on effect of this growing number of informed patients has resulted in better information. Many patients still choose not to engage fully, and some will even ask their surgeon to make the decision for them (although they will still need to sign a consent form). This is also perfectly acceptable, if that is their preference. The important thing is that they have been offered the information and have been given the opportunity to ask questions, digest the information and then make an informed decision. Julie Smith, Content Director, EIDO Healthcare.

This conference focuses on delivering effective consent practice and ensuring adherence to the new 2020 guidance from the General Medical Council. This timely conference will focus on ensuring adherence to The Seven Principles as outlined by the New GMC Guidance. The conference will also update delegates on implications of recent legal developments. Further information and to book your place or email kate@hc-uk.org.uk Follow the conversation on Twitter #Consentpractice We are pleased to offer hub members a 10% discount. Email: info@pslhub.org for the code.

Coping with complexity: how a human factors systems approach can support competency development for pharmacists. Support in clinical decision making is recognised as an educational development need for pharmacists. The health policy landscape puts the pharmacist in a central role for clinical management of long-term complex morbidities, making clinical decision making and taking responsibility for patient outcomes increasingly important. This is compounded by the COVID-19 pandemic, where healthcare environments have become more complex and challenging to navigate. In this environment, foundation pharmacists were unable to sit the GPhC registration assessment during the summer of 2020 but provisionally the registration assessment is due to take place online during the first quarter of 2021. In response to this, a suite of resources has been developed with collaboration between Chartered Institute of Ergonomics and Human Factors (CIEHF) and Health Education England (HEE). These resources are aimed in particular at early career pharmacists and their supervisors, especially those in foundation pharmacist positions managing the transition from education to the workplace environment. This session will act as the launch event for these resources and can support early career pharmacists and supervisors to navigate the CIEHF learning resources developed so far. Register

Let’s imagine that you’re in your early 70s and you have a few chronic health problems. Your mobility has been getting worse due to arthritis in your hip. You’ve tried pain killers, had some physiotherapy and now use a stick but the pain and restriction in your function is getting you down. Your GP refers you to your local hospital to see an orthopaedic surgeon to discuss surgery. How do you know if having surgery is the right decision for you? On the face of it the decision may seem easy; have the surgery to cure the problem. Indeed many, or even most of us, would choose this option to be rid of the pain. What, however, about the short- and long-term risks of surgery? We know that with increasing age, and in particular with increasing number of chronic health problems, the medical risks associated with surgery increase. That is to say, the surgical procedure, the hip replacement itself, may go smoothly but the overall process of surgery, anaesthesia and hospitalisation may make existing medical problems worse or create new ones. This is a situation that hundreds of older people face each week in the UK, and as the population ages and advances in medicine and surgery increase, will become even more common. However, quantifying these risks has been a major challenge for researchers to date. The Optimising Shared Decision Making In high RIsk Surgery (OSIRIS) research programme is funded by the National Institute of Health Research (NIHR). We’re focussing on the group of older patients who often have significant chronic health issues and are at greater risk of complications around and after surgery. We’re asking some big questions about how these patients and their doctors currently make decisions about major surgery and how we could improve that process. We are also looking at the data on over 5 million patients to truly understand what happens to older patients in the year after surgery. This will then allow us to develop a tool to forecast and present risks associated with surgery. This will be tested in a trial across UK hospitals, to see if it improves the decisions people make. Presenting a more detailed risk forecast to patients will help them to understand how the choice about surgery may specifically impact them and their lives and so support genuine shared decision-making. Surgery improves the lives of millions of people a year around the world, but it is not without risks and patients and doctors need to be more aware of these and be able to discuss them openly. The outputs of the OSIRIS research programme will help increase that awareness and allow people to make informed decisions where all the risks can be weighed up against all the benefits. Shared decision making and informed consent are hot topics right now in the health care professions and in the media. We’re 2 years into our 6-year research programme and we already know so much more about the decision-making process and how we might improve this. Ultimately, doctors need access to better, more individualised information and patients need to be presented this information in a way that is clear and comprehensible. We are very hopeful that OSIRIS will provide a model to empower patients to make a major decision that is right for them. Watch this space! You can find out more about the research by visiting the OSIRIS Programme website or following @osirisprogramme on Twitter. If you'd like to share your thoughts on any of the issues raised in the blog or another patient safety topic, please get in touch with Patient Safety Learning by emailing content@pslhub.org or leave a comment below.

The Optimising Shared decision-makIng for high RIsk Surgery (OSIRIS) programme is funded by the National Institute for Health Research and investigates different aspects of the decision making process for major surgery. Improving our knowledge of how patients and doctors make decisions about major surgery is an important step in designing and trialling ways of improving this process for patients. We know that a lot of surgery has been cancelled due to COVID-19 and this is a cause of great concern for both patients and healthcare professionals. However, looking to the future, this research it is important to ensure that we optimise decision making process once normal elective surgical services are resumed. We would like to invite you to take part in a research study run as part of OSIRIS Programme. We are looking for volunteers who are 50+ years old, live in the UK and are currently not contemplating undergoing surgery. This study involves an online questionnaire, where you will be presented with a hypothetical medical situation and asked to imagine how you would make decisions in that particular situation. The study will take approximately 25 min to complete. More information is available about the study before you commit to participating. If you are interested in taking part please follow the link below.