From Volume 41, Issue 3, April 2014 | Pages 236-241
Valid consent is an absolute requirement of ethically correct treatment. This second article, in a series covering the management of risk, defines consent but also describes the role that appropriate consent, through good communication, plays in clinical and ethical risk management and the reduction of complaints.
Risk management relates to three factors:
All three actions must be performed to an appropriate standard.
However, valid consent is not just a verbal ‘yes’ or ‘no’ agreement, or a signed consent form, but an ongoing process of communication and understanding between the patient and clinician.
Moreover, if patients fully understand all of the implications of their treatments, including the disadvantages as well as the advantages, then they are likely to be more understanding if difficulties arise. Research into maxillofacial patients1 showed that many complaints, and potential legal claims, happen because of misunderstandings, rather than being directly as a result of clinical errors.
Appropriate consent is therefore not only essential, but invaluable, in reducing the risk of patient complaint.
But how is consent actually defined?
Consent is a continuous process, leading to patient understanding and permission for the clinician to deliver treatment. Effective dialogue, in the appropriate language and detail for the individual patient's needs, and understanding, is therefore vital. That communication must also continue for the duration of the treatment. General Dental Council (GDC) guidance2 clearly states: ‘Giving and obtaining consent is a process, not a one-off event. It should be part of on-going communication between patients and all members of the dental team involved in their care. You should keep patients informed about the progress of their care’.
But what is actually required to make the process of consent valid?
The following three conditions must be met:
Capability rests on two factors; authority and capacity. Authority is defined by the patient's age. In the United Kingdom the age of consent, for almost all procedures and circumstances, is 16 years. Capacity is the capability to understand and assimilate the implications of treatment and to take a decision then and to convey that decision to the clinician.
However, some patients below the age of consent may have the capacity to understand, whereas patients above that age may sometimes lack the capacity, despite having authority.
A patient's ability to give consent is not just solely dependent on his/her age. For example, a 14-year-old may have a much greater capability of understanding the implications of treatment than an 18-year-old.
The 18-year-old has the authority but may not have the capacity, whereas the 14-year-old may be considered to have the capacity, but clearly does not have the authority.
This produces a dilemma in respect of ‘child’ patients who may have a clear understanding of their treatment, despite being below the legal age of consent. It can also present problems with some adult patients who may have authority, but who lack the understanding to have capacity.
The anomaly of the ‘understanding child’, who is below the age of consent but understands the implications of treatment, was resolved in the case of Gillick.3 This case, although it concerned medical advice and treatment (contraception) for patients under 16 years of age, established the principle that patients could consent to their own treatment if, in the clinician's opinion, they understood the implications of that treatment, ie they had capacity.
This could then give rise to the view that a patient of any age can consent to treatment if he/she understands the implications. However, whilst the decision in the Gillick case confirmed the right of the ‘understanding child’ to give consent, it also stated that every effort should be made to encourage the patient to include his/her parents in the decision. In addition, whilst the understanding/capability of the patient must be taken into account, the legal age of consent still applies. The age of consent, but also the capacity to consent, must therefore run side by side and this is not always an easy dilemma for the treating dentist. These dilemmas are not common, but advice from an indemnity organization may be prudent before treatment is started.
Legislation4 also defines parental responsibility but with the proviso that the child's own understanding of, and consent to, treatment must be taken into account.
Adults, defined by the age of consent as being over 16, have the authority to consent to treatment, but what if they lack the capacity?
Current mental health legislation,5 permits only the patient's psychiatric condition to be compulsorily treated. Anything else, for example filling a tooth, cannot be carried out without the patient's consent, which of course he/she may still be considered to have the capability to give.
However, whilst mental health legislation is mainly applicable to patients with a serious psychiatric history, its principles can present problems when treating dental patients who clearly do not have the capacity to understand treatment and cannot therefore give valid consent themselves.
The issue has been assisted by a court case6 confirming that, if a clinician acts in what he or she feels is in the patient's best interests, despite the lack of consent by the patient him/herself, then the treatment would be lawful. In effect, a decision could be made to provide any treatment, as long as the ‘best interests’ rule was obeyed.
However, despite the ‘best interests’ principle, it must be remembered that all efforts should be made to find out what capacity patients may have, if any loss of capacity is simply temporary, or if they have signed a written advance directive of their wishes whilst still having the capacity to give consent. Written advance directives are not commonly seen for dental treatment, but will become more widespread with an increasingly elderly population.
These issues relating to adults with diminished, or absent, capacity to consent are now enshrined in law in the Mental Capacity Act7 which establishes five key general principles:
The Act provides the authority to treat adult patients who have insufficient understanding to consent themselves, by acting in their best interests, but still protecting their autonomy. It provides a legal framework for what was already good practice and also recognizes the validity of written advance directives, made by patients before their capacity to consent was lost.
The second condition for valid consent is acting under the patient's free will. This may seem straightforward, and usually is. The patient must be given sufficient time with no pressure exerted and no misrepresentation of the facts. This guidance applies even when a patient refuses to accept the advice that the clinician considers to be sensible and appropriate, and in the patient's best interests. If a patient has clear capability to refuse treatment, then his/her right to do so is absolute.
The final condition for valid consent is providing sufficient and appropriate information.
However, the information should not be a ‘standard’ format but must relate to the individual, and his/her particular needs and circumstances. Further GDC guidance.8 states:
‘You should find out what your patients want to know as well as what you think they need to know. Things that patients might want to know include:
The necessary information is therefore an appropriate mix of what the clinician considers the patient needs to know, as well as what the patient would like to be told. A satisfactory combination is essential, as a frequent cause of complaint about dental treatment is not necessarily over what was done but what was, or was not, discussed. Patients may also have a feeling of being ignored.9
So what is the standard or level of information needed?
The best input of information will lead to the best output of understanding by the patient. The following are essential:
If sufficient information, in suitable and appropriate language, has been given, then hopefully the following output of understanding by the patient will be achieved. Patients should be able to confirm:
But a standard ‘balance sheet’ of input and output is not the whole picture. Nor does it mean that providing an excessive volume of information makes consent more valid. Patient understanding is central to the consent process and good communication is fundamental to achieving that understanding.
Effective communication in healthcare, and in many other fields, relies heavily on non-verbal messages. Medical research demonstrates that patients perceive healthcare workers who have good non-verbal skills as showing more care.10 Listening is often more valuable than talking, although the time needed to listen is not always easily available in a busy working day.
When speaking to patients, research by Mehrabian11 confirmed that tone, inflection and body language has much greater impact than the actual words used, in terms of what the listener concludes about the speaker. The delivery style seems to matter far more than the actual words, no matter how many and good the words are.
Nonetheless, the words used must also relate well to the patient. Matching the patient's rate and volume of speech is important and research, albeit medical,12 also shows that matching of vocabulary significantly improves patient satisfaction with his/her clinician.
A good explanation of the procedure, and verifying understanding, provides the best chance of clear agreement and consent by the patient. The information is not just given to the patient but the patient is a clear part of the process. The dentist and patient in effect then ‘own’ the treatment decision between them. Distrust and confusion are much less common and discontent is likely to decrease.
Confirmation, in the treatment notes, of the consent process and patient agreement, is essential. However, written and signed consent is not a legal or ethical requirement, unless general anaesthesia or sedation are being provided. As GDC guidance confirms,13 consent is a process of understanding, not a signed agreement. Moreover, obtaining written consent, when it is not needed, has no extra validity and can also carry hazards. Almost all patients will sign a document presented to them, with little or no question. After all, they want the treatment and they trust the dentist. They may also be in discomfort and want treatment quickly. However, their signature does not guarantee their understanding. Patients may not have read the information. Their reading skills may be poor; they may be dyslexic or English may not be the first language. There is also the temptation, on both sides, to assume that the signature completes the process, despite the patient's understanding being absent. Written information, as an addition or follow-up to the explanation, is extremely useful, and good practice, but a written and signed ‘contract’ of consent has many potential disadvantages.
The following case illustrates the importance of good communication and understanding in the consent process.
A 32-year-old male patient attended with intermittent toothache. He stated that he had not attended the dentist for ‘some years’. Radiographs showed considerable inter-proximal caries. In four of the molars the caries was very deep and the teeth would need root treatment.
The patient was very concerned about possible tooth loss. The situation was fully explained by the dentist who showed him the decay on the radiographs. She also stated that although she was happy to attempt root canal treatment, the other alternative would be the extraction of the four teeth in question.
The patient said that he wished to save the teeth. The root canal treatment was clearly explained, including time scales and advantages and disadvantages. It was also agreed that if no treatment was carried out, then the patient ran the risk of further, and possibly more severe, problems. He was also informed of the cost of the treatment. Finally, he was asked whether he understood the information given and whether he had any questions. Throughout the consultation the dentist's nurse was present. She (the nurse) also recorded details of the discussion, and agreement, in the clinical records.
The patient confirmed that he consented to the treatment, and was informed that if he had any further queries then he would raise them before, or at, the first treatment appointment.
There was, in fact, no more information requested by the patient and treatment was started. Two of the teeth were successfully root-filled and restored. Unfortunately, the other two had deeper caries than had been initially estimated. The patient was told that, as there was insufficient tooth tissue for the placement of a restoration, extraction was the only option.
The patient was most upset and said that he had agreed and consented to treatment to save his teeth, not to lose them. He then left the surgery abruptly stating that he wanted some time to ‘think about it’.
He returned two weeks later apologizing for his reaction but that he had been shocked at the thought of losing teeth. However, he agreed that he had received a full explanation of the problems present, and the care needed.
The two teeth were then removed and the remaining restorative treatment successfully completed. The patient now attends the same dentist regularly and has been a loyal and happy patient.
This case demonstrates that good communication produces clear patient understanding, and valid consent. The time spent giving information to the patient provided clear benefits to the dentist when unexpected problems arose. The case also shows the importance of the third person in the surgery, during the consultation. That third person, invariably the dental nurse, can then potentially confirm the discussion, as well as record in the clinical notes what was said and agreed with the patient. This is particularly important where there may be a dispute over what is one person's word against another, especially if the incident was some time in the past. However, written and signed consent was not necessary or required in this situation. Appropriate consent came from clear patient understanding, via good communication.
Valid consent is fundamental to clinical, as well as ethical and legal, risk management. However, it must be regarded as a process rather than a single event. Good communication is particularly important to provide the information that patients need, in a format that they can understand. When the patient has clearly understood, and consented to the treatment, then goodwill is invariably enhanced and discontent greatly reduced, even if problems occur.
