References
Informed consent: a changing paradigm?
From Volume 10, Issue 4, October 2017 | Pages 146-148
Article
Historically, healthcare professions were based upon a paternalistic doctor-patient relationship. The dentist or doctor was recognized as an expert who was trusted to use his/her specialist knowledge to direct or sometimes even dictate the treatment of patients. This was not always in-line with a patient's wishes and often restricted patient autonomy. The relationship was thought to resemble that of a father and child, hence the use of the term ‘paternalism’.
Over time healthcare has moved to a more patient-centred model, promoting self-determination and autonomy. The principle that patients have a right to decide what happens to their bodies underpins good practice in the medical and dental specialites.1,2 It is an ethical and legal obligation for clinicians to ensure that patients are fully informed and involved in the decision-making process.3
Practising clinicians need to have a thorough understanding of the principles of consent. The laws regarding consent are continually changing and clinicians must remain up-to-date with developments and understand the implications for their day-to-day practice. A recent landmark case has again emphasized the importance of fully informing patients regarding the risks of treatment. It has stressed the importance of patient autonomy and has continued the move away from the paternalistic, doctor knows best attitude. This paper aims to provide an overview of informed consent in the UK and the implications of recent changes in consent law for the orthodontic team.
Consent
Consent has been defined as:
‘The voluntary and continuing permission of the patient to receive particular treatments. It must be based upon adequate knowledge of the purpose, nature, likely effects and risks of that treatment, including the likelihood of its success, and a discussion of any alternative to it
The General Dental Council states that, in order for consent to be valid, the following principles must be adhered to:
What constitutes enough information has been cause for debate and has developed and changed as the courts interpret both the common law and legislation. It is generally accepted that the information should include:
How much a patient needs to know and how much a clinician should disclose regarding the risks of treatment has changed considerably over the last 60 years. Initially, clinicians utilized the Bolam principle6 when deciding what to discuss with their patients. It was seen as part of the clinicians' discretion and they were only ethically bound to disclose:
‘The information which a dentist in that situation would normally be expected to explain’7
This model of ‘a reasonable professional body’ remained for over 30 years until the case of Sidaway in 1985,8 which emphasized the importance of discussing material risks with patients and that these risks could be determined by probability. In addition to stating the probability of the risk arising, the clinician should also discuss the consequence of the risk and the potential impact for the patient.
The Montgomery case9 has further moved away from the Bolam principles and states that a clinician should base the discussion of consent upon the risks that the patient believes holds particular significance for themselves, ie what the ‘reasonable patient’ would want to know.
Montgomery vs Lanarkshire: the case9
In October 1999, Nadine Montgomery was pregnant with her first child. As Mrs Montgomery was a type 1 insulin-dependent diabetic, her pregnancy was regarded as high risk. Expectant mothers who are diabetic are more likely to have babies that are larger than average. This increases the risk of a complication that can occur during the birth process called shoulder dystocia. Shoulder dystocia is a complication that occurs when the shoulders of the baby are too wide to pass through the mother's pelvis without medical intervention. It is considered a major obstetric emergency which can be associated with short- and long-term neonatal and maternal morbidity.
During her pregnancy, Mrs Montgomery attended the obstetric and diabetic clinic for intensive monitoring. She was told that her baby was larger than average and this led Mrs Montgomery to raise concerns about possible compilations as she became anxious about the risks of a standard delivery. Despite this, her obstetrician did not warn her of the risks of shoulder dystocia, nor of any other risks that normal delivery carried. The obstetrician felt that, although the risk of shoulder dystocia was relatively high, 9−10%, if the grave risks were discussed with every diabetic mother, then everyone would opt for a caesarean.
‘…if you were to mention shoulder dystocia to every diabetic patient, if you were to mention to any mother who faces labour that there is a very small risk of the baby dying in labour, then everyone would ask for a caesarean section, and it's not in the maternal interests for women to have caesarean sections…’
Unfortunately, significant complications arose during Mrs Montgomery's birth and, as a result of shoulder dystocia, the baby was deprived of oxygen for a number of minutes and sustained significant trauma. As a direct result of these complications, the baby boy developed cerebral palsy and suffered the loss of the use of his arm due to damage to the brachial plexus sustained during the birth.
Mrs Montgomery raised an action alleging clinical negligence against the Lanarkshire Health Board. She argued that, had she known of the risk and possible consequences of shoulder dystocia, she would have opted to undergo a caesarean section. Initially, Mrs Montgomery lost her case at trial, however, at a later appeal, the UK Supreme Court ruled in her favour and she was awarded £5.25 million in damages.
Implications for dentistry
The Montgomery case emphasizes that clinicians must recognize a patient's legal and ethical right to autonomy and continues the move away from the paternalistic doctor-patient relationship to a more patient-centred approach. The Montgomery case changes the standard upon which the consent process and the discussion of risk should be based. It is no longer up to the clinician to decide which risks should be disclosed (rejection of the Bolam standard) and it is no longer acceptable to base disclosure on the likelihood of a risk occurring as outlined in the Sidaway case. Instead, the law now requires that the clinician should reasonably be aware that the patient would likely attach significance to it.
In practice, it is unclear how much this will change the consent-taking process. For a number of years, the General Dental Council and British Orthodontic Society has encouraged its members to:
‘…Find out what your patients want to know as well as telling them what you think they need to know…’1
Clinicians have a professional obligation to explore the possible risks that would concern the individual patient they were proposing to treat. It is more likely that, for dentists, this ruling now brings about focused, legal obligations concerning consent with standards that were likely already being ethically practised.10
Implications for orthodontists
This case acts as a reminder to the orthodontic specialty of the principles underlying informed consent. It acts as a reminder that consent is a process that must be tailored to the individual needs for each patient.
It is likely that, as a result of this ruling, the way we, as orthodontists, communicate with our patients will evolve. It is no longer acceptable simply to quote a percentage for the risk of root resorption as part of the consent process for fixed orthodontic therapy. The significance of a given risk will be more effectively communicated by putting the risk into context by describing the possible consequences it could have upon that patient's life and well-being.
It is also likely that the specialty as a whole will need to develop strategies and tools to allow patients to become more involved in the consent process and methods to evaluate the effectiveness of our consent-taking process.11 Currently, within orthodontics the risks discussed with a patient are largely determined by the profession. Guidance has been produced by the British Orthodontic Society regarding both the consent process and the discussion of risks associated with orthodontic treatment.12 What constitutes a risk, however, has been determined by professionals and what and how much information to pass on to patients is still determined by orthodontic clinicians.
A more patient-focused method of evaluating risk could be assessed using orthodontic patient focus groups. Focus groups are a form of group interview that encourage communication between a diverse group of participants in order to explore people's knowledge, experiences and concerns.13 The utilization of such groups has been demonstrated as an effective way of determining what information patients want regarding their health and available treatment options. The use of such groups in orthodontics could improve the information provided to patients and produce a more patient-led consent process. Only once we know what risks and consequences patients feel are important, and how much information they want regarding their orthodontic treatment, can the effectiveness of our consenting process be assessed.
A number of medical specialties use decision aids to engage and encourage patients to evaluate what factors are important in deciding whether or not to proceed with treatment and help patients make decisions based on up-to-date evidence. Decision-aids are not yet widely available in orthodontics. They are often time consuming and labour intensive to produce, but may help orthodontic consent to become a more patient led process.14 Furthermore, the time taken to obtain valid consent will have cost implications; these are as yet unknown.
Conclusions
The Montgomery case emphasizes the importance of patient self-determination and a patient's right to autonomy more than ever before. Patients must be fully informed about the risks of any proposed orthodontic or dental procedures and their possible consequences.
On an individual basis, orthodontists must evaluate their own personal consent process and ensure that these are tailored to each individual patient. Enough time must be allocated to the consent discussion for the clinician to evaluate the concerns of each patient as well as his/her understanding of the risks posed by treatment. Meanwhile, within orthodontics more research is required to explore the factors that can affect a patient's decision to undergo orthodontic treatment. Efforts must be made to enable patients to make an informed decision about their health, based upon best available evidence.