Start with shared decision making

The process starts with unbiased conversations about all reasonable options available to patients and their potential risks and benefits, including the option to take no action. This discussion should include expected outcomes for varying options to support a shared understanding between patient and practitioner about the expectations and limitations of the available options.

Individualise the risks and benefits

Risks and benefits should be individualised to the (clinical and personal) circumstances of the individual patient and communicated in a way that supports understanding, including what risk (s) they would be prepared to take in order to achieve a desired outcome. Patients should be supported to consider the options in the context of their own lives and their preferences and values. When a patient is not able to consent or understand the risks and benefits, conversations about options should involve the family, friends of the patient or advocate.

Ensure it is a continuous process

Decision-making and consent should be seen as a continuous process which may be distributed between multiple professionals across time and location, through which a patient can fully understand the options available to them, is supported to deliberate on these options and then freely give their consent to proceed with their chosen course of action, unless the decision is to take no action. Some patients may be supported by their friends or family or have someone making decisions on their behalf.

Conclude with consent

Once a decision has been reached through shared decision-making, there should follow a conversation that confirms this decision, answers any outstanding questions and provides any additional information required (including any risks that the patient is likely to attach significance to not previously discussed).

Patients are equal partners

Patients are equal partners and active participants in the decision-making and consent process. Practitioners should encourage and support patients to ask questions and share their thoughts and opinions. Patients should not be pressured into making any decision and they should be free to change their mind at any stage. Consent is given by patients, not taken by practitioners.

One in 7 adults in the UK have the reading age of between 9 and 11 years old.[1] This is a significant proportion of the population, and likely to be over-represented in the hospital setting (there is a direct proven link between health and education status[2,3]).

According to the National Literacy Trust, 1 in 5 people in the UK have ‘very poor literacy skills’.[4] So, it is imperative that we write patient information with this in mind.

People with higher literacy skills will also appreciate the clear and simple approach.

How to create accessible information

Your information may be written by an expert health professional (if it is not, it should be reviewed by at least one, to ensure its clinical accuracy). Health professionals are not trained writers, and so their writing style may need work to make it accessible. The following techniques can help you with this.

Use ‘Plain English’

Plain English must be used at all times. Some key facets of this are:

• Short sentences (UK government guidance recommends a maximum of 25 words[5])
• No jargon. Where certain medical terms cannot be avoided, they should be explained
• Clear illustrations that add to/aid the patient’s understanding. If online, these should include alt text for patients with impaired sight
• Tables, flow charts and bullet points to break up chunks of text, but only when appropriate and useful
• Appropriate font (Royal National Institute of Blind People (RNIB) recommends Arial 14 point or bigger)[6]
• Accessible formats: large print, giant print, screen readers and translations
• Easy Read versions of the information[7]
• Consistent style, point of view (first or third person) and tone of voice
• Animated/video content where possible and appropriate. This format can be adapted with voiceovers and subtitles in different languages to increase its reach.

Get expert support

There are several organisations that offer a review service for patient information, including:

• the Plain English Campaign (PEC)
• the Patient Information Forum (PIF)
• Patients Association
• the RNIB
• Mencap
• Making It Clear.

This not only helps you to create the best possible content, it also reassures patients and clinicians. Some offer accreditation based on a review of content and processes. By adding their logos to your content, you are reminding those reading it of the stringent processes it has been through.

Sign up for training

Anyone responsible for writing and/or editing patient information should also be trained appropriately. There are lots of great courses out there that can be done remotely and over a few days. If you go down this route, you and/or your colleagues should attend refresher courses at least every 2 years.

Involve patients

Where possible, patients should also be included in the process of creating information. This can happen while the information is being produced but it does not have to stop there. Once the information is out there, you can ask patients to give you feedback on it.

How can we assess understanding?

Demonstrating that patients understand information about a particular operation or procedure can be a challenge. People tend to only remember about 50% of the information given to them in a medical consultation[8]. Again, this is even lower for patients with limited education.[1]

This is why written information is often provided, so patients can go home and read it in their own time, in a space they feel is safe and comfortable, and with loved ones, so they can talk it through.

It is the responsibility of the information provider to produce content that meets all the requirements outlined above. It is the responsibility of the clinician to speak to the patient about it both before and after they have had a chance to read it. The clinician should ask questions to check the patient’s understanding and, more importantly, allow the patient to ask any questions of their own.

EIDO’s digital informed consent platform can produce timing reports that show how long a patient has spent on each page or section of the information. This can help direct that conversation as the clinician is able to see how engaged the patient has been with the information ahead of the consent session.

Final thoughts

Producing patient information must be thorough, but it does not need to be arduous. If you set up the process at the very start, you just need to follow it every time you produce something new. There are many resources out there to help and I would urge anyone involved in patient information to use them. This is how you can contribute to patients making truly informed decisions about their care. 

References

1.  National Literacy Trust.  What do adult literacy levels mean? Accessed online 15/03/23.
2.  Health Action Campaign. The role of education in reducing health inequalities. July 2021.
3.  NICE. NICE impact people with a learning disability. November 2021. 
4.  National Literacy Trust. What is literacy? Accessed online 15/03/23.
5.  Government Digital Service. Content design: planning, writing and managing content. Updated 17 January 2023. Accessed   online 15/03/23. 
6.  RNIB. Understanding the Accessible Information Standard. Accessed online 15/03/2023.
7.  Easy Read information may not meet the medicolegal standards needed to support informed consent. However, it can be   used to help a patient who lacks decision-making capacity to understand what will happen. In these cases, a health   professional or legal guardian will likely make the decision on their behalf.
8.  Patient Engagement Hit. Patient Recall Suffers as Patients Remember Half of Health Info. Patient Data Access News.   26/03/18.
9.  Laws MB, Lee Y, Taubin T, Rogers WH et al. Factors associated with patient recall of key information in ambulatory specialty care visits: Results of an innovative methodology. PLoS ONE. 2018:13(2)

Opinions expressed in blogs and other content are those of the author. Patient Safety Learning welcomes sharing content and opinions that promotes safer patient care and for the reduction of avoidable harm.  The views expressed on the hub however do not necessarily represent Patient Safety Learning's views or values. References to a specific product or service does not imply a recommendation or endorsement.

1. Small changes can make a big difference. Adding short explanations about the way patient data is used to inform health information had an influential impact on the readers’ perception of the health advice. 
2. Explaining can help build trust. Including explanations about the use of patient data can help increase levels of trust and credibility of the information provided.
3. Improving awareness of how the system works. Including explanations of patient data use was linked with increasing the reader’s knowledge about how data is used beyond providing their own care.
4. Prompting curiosity. Explanations of how patient data is used also encouraged further interest from participants about the use of data and increased the likelihood of the reader seeking more information.

• Leaflet for patients to help them make the right choices for them at their healthcare appointment using the BRAN questions.
• Poster to be displayed to encourage the patients to ask the BRAN questions
• Guidance on professional standards and ethics for doctors
• e-learning and video resources for clinicians
• Leaflet for healthcare professionals to understand shared decision making.

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. 

To download the full guidance, follow the link below.