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  • Informed consent: what is it?


    Julie EIDO Healthcare
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    Summary

    Julie Smith is Content Director for EIDO Healthcare, an organisation that provides health professionals with resources and support around informed consent. In this blog, Julie explains what it means to give your ‘informed consent’ as a patient, and why it is so important to read the information given to you. 

    Content

    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. 

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    Julie Smith, Content Director, EIDO Healthcare. 

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