by Incision Indemnity - 11 mins read
Patient Information Leaflets - Why Are They Useful?
Informed consent is an integral part of medical practice. Practition...
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.
