Patient Information Leaflets - Why Are They Useful?

Informed consent is an integral part of medical practice. Practitioners will be acutely aware of the importance of ensuring that patients are active participants in their own treatment, and fully appraised of risks and benefits before making decisions about their care. The process of taking informed consent must be thorough, well documented and understood by the patient – these are professional and legal obligations. Any deficiencies can leave practitioners vulnerable to allegations of failure to obtain informed consent, potentially leading to clinical negligence claims (even if there was no negligence in the procedure itself), disciplinary action, suspension or withdrawal of practising privileges, or referral to the General Medical Council.

A patient information leaflet (‘PIL’) plays a key role in providing a general understanding of what will be involved in a prospective treatment or procedure, the recovery process and the associated risks. They are useful to provide necessary and consistent information to patients, in a format that they can refer back to. Importantly, they can also be held on the patient’s file as confirmation of the information provided. Some practitioners prefer to go through the PIL with the patient themselves during consultation. Others send a PIL separately and treat it as a supporting document to the individual discussion with the patient. Providers may also ask patients to sign the PIL to confirm they understand it and keep a copy on the patient’s file. Such practices are good methods of strengthening and evidencing, although not replacing, the wider consent process. They provide important protection for patients and practitioners.

Features of a good PIL

A sensible starting point for most PILs is background information on the diagnosed issue and the treatment being considered. Details such as a description of the medical problem, typical symptoms and causes, how it manifests and how it is typically treated should be included. Although the purpose of the PIL is often to provide information on a specific treatment or procedure, alternatives ranging from the least to the most invasive option should also be mentioned to ensure that the patient is aware that other choices are possible.

The PIL must set out a clear and thorough explanation into what the treatment or procedure will involve. It is of paramount importance that the patient knows what to expect. The PIL should include information about any steps that must be taken by the patient before or during treatment, explain what the treatment will entail and how long it will take, and what the expected outcomes are. If the treatment or procedure will involve a hospital stay, this should be included. If the patient will need to receive anaesthesia, this should also be stated along with whether a local or general anaesthesia can be administered.

Recovery process and after-care is another important area for a good PIL. Even for minor procedures, it is very risky to leave that information until after the treatment has taken place, because if a patient finds they can’t comply, they could be left with a poor outcome. Set out all essential, and recommended, actions the patient should take to ensure a smooth recovery. If the patient may not be able to partake in their usual activities for a time following treatment, this should be explained along with likely timescales. This has to be clear, because many patients will have to plan ahead to obtain time off work, arrange child or pet-care, or even rearrange holidays to accommodate the potential recovery time. Many patients find it helpful to be provided with a timeline of what to expect from the start of any preparatory steps, through treatment, to complete recovery. The timeline could also be used to convey information about follow up appointments, physiotherapy, exercises and normal reactions the patient could have, such as swelling.

For the patient to make an informed decision, they also need to understand what the unwanted outcomes and risks are. It would be good practice to set these out as two separate sections in the PIL. The first section can deal with the unavoidable but unwanted outcomes of treatment, such as scarring or a minimum recovery time. The PIL should make clear that the patient needs to consider whether they can live with the inevitable consequences of treatment when they are weighing up whether it would benefit them overall. Things like scarring or a week of bed rest might be almost irrelevant to one patient, but make the treatment entirely unacceptable for another. It all depends on what is ‘material’ to that particular patient, which will always depend on the patient’s own particular preferences and circumstances. The second section should address the risks of the treatment—complications that may occur in a certain percentage of cases but are not guaranteed outcomes. The risks section should include statistics on the likelihood of each potential risk wherever possible and provide a full picture of all possible negative outcomes of the treatment. There may be things that should appear in both sections – for example, scarring might be inevitable, but keloid scarring might be a risk that only manifests for some patients.

It is common for practitioners, from a variety of specialities, to be involved during the course of a particular treatment. But patients don’t differentiate between, for example, surgical risks and anaesthetic risks. If you are responsible for one type of risk but not another, make this clear in the PIL. For example, if you are a surgeon providing a PIL for a specific procedure, you should clearly state that the anaesthetist will discuss anaesthesia with the patient. It is important to clarify that the anaesthetist, not the surgeon, is responsible for advising on the risks related to anaesthesia.

When drafting your PIL, keep in mind that patients represent a cross-section of society and the majority are not medically qualified. Avoid technical language where possible and ensure that any medical terms which may not be easily understood are properly explained. It may assist you to ask a non-medically qualified friend or family member to read the draft PIL and highlight to you anything unclear to them.

Finally, PILs should be periodically reviewed and updated to ensure that they remain current. PILs should include a date from which it is effective and a version number, both of which will need to be updated in any subsequent version. Where an older version of a PIL is taken out of use and replaced with an updated version, ensure that you keep a library of all archived versions. This enables you to check which version was provided to a patient, if a signed copy was not included in the records and claim is made years later.

Using your PIL effectively to protect yourself and patients

PILs are clearly a valuable tool in keeping patients informed and aiding the consent process. Aside from the content of the PIL itself, how you use the PIL is also crucial to maximise benefit to the patient and, importantly, to protect yourself as a practitioner.

Any patient who is considering whether to go ahead with a particular procedure or treatment should be sent a PIL as early as possible. If the patient is considering different options before making a choice, they should be sent a PIL for each potential treatment option. The intended purpose of a PIL is to properly inform the patient in deciding whether to proceed with a particular treatment, or about which procedure to choose. It is not to provide information once they have already decided to proceed.

Some providers ask patients to sign the PIL to indicate that they have read and understood the information contained. Whilst this would represent good practice, take care if you intend to go further and ask that the patient signs to indicate that they wish to proceed with the treatment or procedure. In these circumstances, you need evidence that the patient has had a full opportunity to discuss the matter and ask any questions they may have, before signing the statement. This may require carefully drafting the statement you're asking the patient to sign to confirm their agreement. The best practice is to have the patient sign the PIL as part of the final consent process, along with the consent form, and then file it in their notes, ensuring they receive a copy to take with them. This ensures there can be no doubt about the exact PIL the patient had, should unfortunate circumstances arise such as a complaint or medical negligence claim.

In light of the Equality Act, it is important to consider that some patients might have disabilities (including hidden disabilities such as poor eyesight or dyslexia) that could make it difficult for them to read or understand the whole PIL. Similarly, you can’t assume that all of your patients will be fluent in English. Consider what ‘accessibility’ options you can offer and make it clear that help is available if needed. This will provide an additional safeguard against potential complaints that a patient couldn’t access the necessary information to give informed consent.

The most important point to remember is that while PILs are a key part of the consent process, they can never replace direct communication with the patient. It's essential to understand their individual needs, concerns, and what is ‘material’ to them, providing tailored advice and recommendations accordingly. Patient needs differ, so informed consent cannot be properly managed with a ‘one size fits all’ approach. A signed PIL, even a brilliantly written one, should never replace a discussion with the patient, nor a formal signed clinical consent form at the end of the process.

What if the hospital prepared the PIL?

Sometimes a practitioner has practising privileges at a private hospital, and the hospital has standard PILs which it provides to patients. Often these are well written and comprehensive, but sometimes they are not, or they have become outdated.

If the patient alleges a lack of informed consent because a poorly-written hospital PIL failed to mention a particular risk, then the claim will be against the practitioner, not the hospital. Therefore, if your patients will be receiving a hospital’s PIL, then you need to take steps to protect your position and ensure your patients give properly informed consent.

You should keep your own copies of the hospital PILs, keeping a library of updated versions as they are introduced. This is important, because a claim could be made years after you stop working at the hospital and lost access to copies kept by them. Hospitals do not always keep a copy of the PIL on the patient’s individual records, so having your own copy of what the patient should have received can greatly assist your defence, if one is required. Carefully review the hospital’s PILs to ensure they cover all necessary information. If you believe improvements are needed, you can, of course, raise this with the hospital management. In the meantime, consider creating your own supplementary PIL to complement the hospital's version and address any gaps. You would need a robust system to make sure every patient received that additional PIL and to record that fact on their individual records. At the very least, you should ensure that any matters not covered by the PIL are directly discussed with the patient and carefully documented on the consent form before the patient signs it.

However, if you have copies of a hospital PIL, take care to only use them for that hospital’s patients, and don’t ‘cut and paste’ information from them to use in your own PILs for other patients. There have been cases where a hospital has learned that a practitioner is using the hospital’s PIL for other patients, and made allegations of Intellectual Property law breaches!

How can Incision help you?

Ensuring that a robust patient consent process is in place can be a source of stress for busy practitioners, but we are here to help. Our dedicated medico-legal team can give you guidance and answer any queries you may have on the legal aspects of informed consent, including providing assistance with the drafting and content of PILs.

If you receive a complaint, notification of investigation or claim, whether related to patient consent and PILs or otherwise, then you should call our medico-legal team right away. We can assist you with the matter, make sure that your insurers are notified if necessary, and arrange for you to have formal legal advice and representation where necessary.

Contact us on our 24/7 helpline for expert guidance and support from our knowledgeable medico-legal advisors.

The Coroner's Court investigates sudden, unexplained, or suspicious deaths to determine the cause of death. Healthcare professionals may be called to provide witness evidence, which can be a stressful experience. As a medical indemnity provider, we understand the emotional and professional pressures this process can bring, especially when it may lead to a General Medical Council (GMC) investigation or clinical negligence claim. Our medico-legal team is staffed with dual-qualified doctors and lawyers, so they also fully understand the emotional impact that a patient death can have on a healthcare professional. This article aims to provide you with a clear understanding of what to expect and how to prepare, and to ensure you feel supported and informed every step of the way.

This guidance note relates only to Coroner’s Courts in England, Wales and Northern Ireland, and not to Fatal Accident Enquiries in Scotland, although similar principles apply.

Role of the Coroner's Court

The Coroner’s Court aims to establish who the deceased was, and when, where, and how they died. The Coroner does not attribute blame or liability, but can criticise individuals involved the patient’s care. As a healthcare professional, you may be asked to provide a statement and potentially be called to give witness evidence if you were involved in the clinical care of the deceased.

Legal Advice and Witness Statements

The Coroner can request a factual statement about your involvement with the patient. This must be based on your personal knowledge and medical records. It's important not to let anyone influence your statement or attempt to influence others, as this could lead to professional misconduct investigations by the GMC.

Although patient confidentiality remains important, there is an exception when providing information to the Coroner. Your statement will be shared with the deceased’s family and other legal representatives, and you may be questioned on its content during the inquest.

If you are a pure witness, legal advice may not be required. However, it’s recommended to seek medico-legal guidance to ensure your statement is clear, accurate, and appropriate. On the other hand, if there’s a possibility you might be considered an Interested Person (i.e. someone potentially responsible for contributing to the death), it’s crucial to seek formal legal advice before submitting your statement. Interested Persons may be involved in future investigations or claims, so accuracy is vital.

To avoid any missteps, we advise contacting the Incision medico-legal team as soon as you're asked for a statement.

Giving Evidence as a Witness

In most cases, if you're called as a witness, it means you’re not considered to have contributed to the death. You won't have the right to question other witnesses or make legal submissions. Even though this can be intimidating, you are simply expected to provide factual evidence about your involvement. Our medico-legal team can offer support and tips for preparing to give evidence.

Interested Persons: Legal Representation Required

An Interested Person is someone who may have contributed to the death. Under the Coroners and Justice Act 2009, these individuals have additional rights in the inquest process, such as receiving witness statements, cross-examining witnesses, and making submissions on evidence and legal points. If you are designated as an Interested Person, it’s crucial to have formal legal representation to ensure your rights are protected.

Key Stages and What to Expect before the Inquest Hearing

1. Written Statement Request: You may be contacted directly by the Coroner's court for a written statement, but it's more common for the clinic or hospital to request it from you, having had a request from the Coroner. At this early stage, it's unlikely that the Coroner, hospital, or family will know whose evidence will be important. Your statement will help the Coroner manage the Inquest and provide factual information on the care you gave. Even though it's unclear if you’ll be an Interested Person or face criticism, contact Incision’s medico-legal service for guidance and to assess if formal legal support is needed.
2. Notification of Hearing: Not all Inquests require a hearing; straightforward cases may be concluded on paper. If there is a hearing, it can be in person or via video, and you’ll be notified with the details if you’re required to give evidence. At this stage, you likely won't know if you're an Interested Person, as Coroners often decide this close to the hearing, leaving little time to appoint legal representation and prepare with them. If there's any risk you could be criticised, contact Incision's medico-legal team. They can help you assess if you need to apply for IP status or seek legal advice early, allowing time to prepare, secure legal representation, and minimise risks like a GMC referral or negligence claim.
3. Preparation: Thorough preparation is crucial. Review all relevant medical records and notes about the deceased. As a witness (not an IP), you won't have access to the full Inquest evidence, but obtaining the Post Mortem and hospital investigation reports can help you understand which aspects of your care might interest the Coroner and the family. Remember, you are a witness, not an expert witness, so stick to explaining what happened and why unless specifically asked for broader opinions.
4. Legal Representation: As mentioned, it’s wise to seek medico-legal advice if asked to provide a statement to a Coroner, and sometimes legal help is needed even at this early stage. If you're just a witness at the hearing, you can't have your own legal representation. However, if you're designated or expected to be an Interested Person, legal representation is essential. If you're concerned about possible criticism, contact Incision for advice on whether to apply for IP status. Another option could be having 'monitoring counsel' present to assess the evidence and assist if needed.
5. Pre-Inquest Review: Sometimes, a pre-inquest review hearing is held to discuss the issues that will be addressed during the inquest. This can provide a clearer picture of what to expect. If you are or should be made an IP, you would need representation at the pre-inquest review also, because significant decisions can be made about expert evidence and other key procedural questions.

Key stages and what to expect during the Inquest Hearing

1. Swearing In: Upon arrival at the Coroner's Court, you will be asked to take an oath or affirm that your evidence will be truthful.
2. Questioning: The coroner and sometimes other Interested Persons, such as legal representatives for the family, will ask you questions about your involvement in the deceased's care. Answer honestly, concisely, and based on the facts.
3. Presentation of Evidence: You may be asked to explain medical terminology or procedures to ensure that the court understands the medical aspects of the case. Maintain a professional demeanour throughout the proceedings. Speak clearly and avoid medical jargon unless you explain it for the benefit of non-medical attendees, such as the family of the deceased.

What comes after the Coroner's conclusion?

When to Notify Your Insurer

Incision provides indemnity for legal representation if you're an Interested Person (subject as always to the terms and conditions), whether the incident occurred in NHS or private practice.

Your Incision insurance requires you to promptly inform ("notify") your insurers of any issues, so do this as soon as you suspect you may be an Interested Person in an inquest. Timely notification ensures you avoid coverage problems and get the right medico-legal support when needed. Delaying offers no benefit. If in doubt, notify us early to avoid complications later. especially if the death was unexpected and you were involved in the patient's care. If someone at your hospital suggests you will be criticised for your care or that you need legal advice, notify Incision immediately.

If you contact Incision when first asked for a statement, they’ll handle any necessary notification for you. Early contact ensures the best support through the process, helping protect your reputation during what will be a stressful time following a patient's unexpected death.

Acting as an Expert Witness

Support from Incision

At Incision, we're here to support you through challenging times. Our services include:

• Legal Advice and Representation: Expert legal advice and representation if you are an Interested Person in an inquest.
• Emotional Support: Our 24/7 medico-legal helpline provides confidential advice during stressful and emotional periods.
• Educational Resources: Guidance on best practices to minimise risks in your professional practice.

Conclusion

Being called to a Coroner's Court to give witness evidence is a serious but manageable responsibility. By understanding the process, preparing thoroughly, and utilising the support available from your medical indemnity provider, you can navigate the inquest with confidence. Remember, our primary goal is to ensure you are well-supported and protected, allowing you to focus on providing the best possible care to your patients.

For further information or assistance, please contact our medico-legal helpline at medicolegal@incisionindemnity.com or 0333 010 2826. We are here to help you every step of the way.