Abstract
Strengthening informed consent
It is generally accepted that valid consent must be obtained before providing invasive or risky treatment – indeed it is a legal and ethical requirement – but there is much debate about how best to do it in clinical practice. 1 In England, the Department of Health and the General Medical Council (GMC) have provided guidance on the general principles, but there is no consensus on how much information about treatment benefits and harms should be provided, how these should be communicated, or whether, when and how information about alternative treatments should be made available.2,3 English law remains uncertain on these issues and it is left up to healthcare organizations to determine how to do it and how to record details of what information patients have been given and what they have consented to. 4 There is no clear requirement to check that the information has been absorbed and understood and there has been surprisingly little research into the practice of informed consent that might help to clarify these issues. Recent developments in the USA encouraging the use of certified high-quality patient decision aids when obtaining informed consent may provide a useful pointer on how to progress this issue in the UK.
Shared decision-making
Shared decision-making involves
US developments
Policymakers in the USA have now recognized that informed consent could be enhanced by the use of tools and techniques developed for shared decision-making. Five US states, Maine, Minnesota, Oregon, Vermont and Washington, have enacted legislation designed to promote the use of shared decision-making supported by patient decision aids as an effective way of ensuring that patients are informed about treatment options and risks. 8 Washington state was the first to do so in 2007 when the Health Care Authority, Washington's state agency, was mandated to implement a shared decision-making demonstration programme and to establish shared decision-making and certified patient decision aids as prima facie evidence of informed consent. 9 Failure to engage in shared decision-making is not deemed admissible as evidence of failure to obtain informed consent, but it is hoped that encouraging its use in this way will help to promote evidence-based clinical practice leading to better decisions and ultimately to better health outcomes.
Legal standards
Conceptually, informed consent has been viewed as distinct from shared decision-making. Shared decision-making aims to ensure that patients are active participants in decisions about their care unless they make it clear that they do not want to play an active role. In contrast, the process of gaining informed consent can mean that patients are viewed mere as recipients of treatment to whom certain information about risks must be disclosed; 10 patients and clinicians often experience the consent process simply as a bureaucratic hurdle that ultimately fails to achieve its aim of informing and involving. 4 Shared decision-making goes beyond legal definitions of informed consent because it allows a nuanced conversation about the patient's subjective concerns and what options might be best for them, based on their individual values and preferences and the clinician's expertise. 11
In England, the standard for informed consent is physician-based; in other words, clinicians must provide patients with the same information that a responsible body of medical opinion would consider appropriate under similar circumstances. 2 Department of Health advice states that patients should be able to understand the nature and purpose of a recommended procedure and any associated risks in order to make an informed choice about whether to agree to it. Clinicians should ‘give information about all significant possible adverse outcomes and make a record of the information given’. 2 As it currently stands, English law assumes that the doctor selects the treatment and the patient's role is merely to consent to, or refuse, the doctor's recommendation. There is no specific requirement in law to provide information about alternative treatment options, or to elicit patients' values and preferences and support them in a process of deliberation. 12
In the US, the legal requirement differs from state to state, being divided between two standards: physician-based and patient-based. In patient-based states, doctors must provide patients with all the information that an objective ‘reasonable patient’ would want under similar circumstances. 11 In physician-based states, the physician is obligated to discuss those benefits and harms that another ‘average qualified physician’ would discuss in similar circumstances. The issue of whether the standard has been met is a jury question and subject to expert testimony at trial.
Both physician-based and patient-based standards are insufficient for similar reasons. The physician-based standard does not acknowledge that often no true objective standard for physicians exists – ‘reasonable physicians’ exhibit wide variations in practice patterns. 13 Likewise, the ‘objective patient’ standard fails to acknowledge that individual values and preferences vary widely.
Ethical standards
Over the last three decades, medical ethicists have shifted their priorities from a primary focus on beneficence (doing good) towards a more subjective and patient-centred practice, which prioritizes patient autonomy in decision-making. 14 While this shift is well represented in ethical guidance, it has proved difficult to strike the ideal balance between the ethical principles of patient autonomy and beneficence. Recent studies have found that many clinicians undervalue the provision of information and underestimate variability in patient preferences. 15 Patients frequently receive either too little medical information or too little support to feel confident in their choice.
Ethical guidance on informed consent is provided by the UK's GMC and by the American Medical Association (AMA). In both cases, they come close to advocating shared decision-making. GMC guidance states: ‘The doctor explains the options to the patient, setting out the potential benefits, risks, burdens and side effects of each option, including the option to have no treatment … The patient weighs up the potential benefits, risks and burdens of the various options as well as any non-clinical issues that are relevant to them. The patient decides whether to accept any of the options and, if so, which one …’. 3 It goes on to recommend the provision of full information about the treatment or management options and tells doctors to ‘explore these matters with patients, listen to their concerns, ask for and respect their views, and encourage them to ask questions.’ The AMA’s code of ethics acknowledges that ‘[t]he patient's right of self-decision can be effectively exercised only if the patient possesses enough information to enable an informed choice’ and that ‘the patient should make his or her own determination about treatment’. 16 The AMA requires doctors to disclose ‘all relevant medical information to patients’ to enable them to make decisions based upon their personal beliefs, values and life goals. But in neither case does the published guidance make reference to the extensive research on shared decision-making, risk communication, preference elicitation and measurement of decision quality that has underpinned the development of patient decision aids and the practice of shared decision-making.
Towards a new legal and ethical standard
We believe the time has come to develop a common ethical and legal standard for informed consent. That new standard should reflect the ethical principles of balancing beneficence and respect for patient autonomy and should therefore be informed by the principles of shared decision-making, where possible supported by the use of evidence-based patient decision aids.
It is unrealistic to assume that most doctors can hold all relevant facts and figures in their heads, including age-related prevalence and outcome probabilities, and be able to clearly communicate complex risks, benefits and uncertainties to patients unaided. In the absence of adequate information, individuals frequently opt for procedures they would not otherwise choose or delegate the decision to the clinician. Evidence suggests that the number of surgical procedures performed, even when justified by practice guidelines, exceeds patients’ desires when they are fully informed through shared decision-making.17,18 This incongruence occurs most often in cases of preference-sensitive (elective) care, where for a specific condition the patient faces multiple treatment options with varied risks and benefits. Selecting between preference-sensitive treatment options involves significant trade-offs that may affect the patient's quality or length of life. Not all clinically appropriate patients will prefer to have surgery over less invasive treatments if the long-term outcomes are similar or the surgery has significant side-effects. 19 Inadequate information and lack of effective decision support can result in costly, unwanted and unnecessary procedures often accompanied by significant complications or side-effects, hence failing the beneficence test. In short, despite the ethical and legal mandates, patients are routinely asked to make decisions about treatment choices in the face of what can only be described as avoidable ignorance.
To satisfy their professional and ethical obligations, clinicians are required to implement a system of decision-making that balances the importance of autonomy and beneficence. Shared decision-making can accomplish this goal by promoting patient autonomy, while also leaving room for physician guidance and beneficence. Professional bodies, politicians and crucially patients, are seeking a process that promotes greater involvement in treatment decisions. This is clearly at odds with the current process of consent which even if ‘informed’ does not demonstrate that it is the patient who is central to the decision-making process. ‘Consenting’ implies passive acquiescence in the doctor's decision, not an active informed choice on the part of the patient. We concur with the view that ‘informed request’ would be a better way to describe what's needed, ascribing an active role to the patient and acknowledging their decision-making role. 20 The shift to ‘informed request’ precisely captures the essence of shared decision-making: ‘I have considered my options, reflected on my own values and preferences, and would now like you to proceed with surgery’. We believe this would offer a better fit with modern notions of ethical practice than the approach that currently prevails in the English courts.
Footnotes
Declarations
Funding
None declared