Reasonable Patient Standard and Informed Consent

The recent Singapore Court of Appeal (CA) decision in Hii Chii Kok v Ooi Peng Jin London Lucien and another has greatly shifted the legal standard for medical advice and information disclosure. Previously, what information needed to be disclosed to patients depended on what reasonable doctors would find relevant. The CA has endorsed a modified version of the test set out by the UK ruling in Montgomery v Lanarkshire Health Board, where disclosure depends on what a reasonable patient would find material, or what the doctor knows is important to that particular patient. Notably, the 2016 Singapore Medical Council’s Ethical Code and Ethical Guidelines endorsed a similar position.

Towards patient-centrism

Healthcare institutions and practitioners now face the question of the extent of change they need to implement to their informed consent processes to meet this new legal standard. It is a move towards “patient-centrism” and as such, “dumping” information on patients – disclosure of all risks and their probabilities, types and nature of complications, possible alternatives and letting them figure it out on their own – would be contrary to its spirit. As the CA pointed out, this would only engender confusion and uncertainty in patients rather than support them in their decision-making.

What is a reasonable patient

There is a degree of uncertainty on how much information a ‘reasonable person’ in a patient’s position would need to know if she should not be regarded as needing to know everything, in both the quantitative and qualitative (understanding) senses. As Beauchamp and Childress (Principles of Biomedical Ethics, 6th edition) said, “Whatever its merits, the reasonable person standard encounters conceptual, moral and practical

difficulties… its abstract and hypothetical character makes it difficultfor them [doctors and other healthcare professionals] to use because they have to project what a reasonable patient would need to know.” (p. 123). This should be taken as a practical challenge of the reasonable patient standard rather than an ethical flaw insofar as it meets the ethical goal of consent, i.e. properly balance patient autonomy and beneficence and (plausibly) demonstrate an improvement over the reasonable doctor standard in doing so.

It would appear that healthcare professionals need to pay more attention to the values, preferences and goals of patients, both in general as well as in specific situations, to make more accurate projections of the reasonable patient’s informational needs and expectations.

Sharing decision-making between doctor and patient

Hii Chii Kok calls for a “collaborative process involving the doctor and the patient” in treatment decisions although what ‘a collaborative process’ means is not well-defined. In the wake of the Montgomery decision, articles have been published to argue for the necessity of shared decision-making to meet the reasonable patient standard. For example, Coulter et al. argue that “The effect of the Montgomery decision is to require shared decision-making between a doctor and patient” (“Montgomery v Lanarkshire Health Board: Transforming Informed Consent”, RCS Bulletin 2017;99:36-8; at p. 37). They used this example: “… a small risk of injury to a little finger may not be of much significance to most patients but may be highly important to a musician. This can only be established by discussion and the sharing of information between a doctor and patient” (p. 37).

Patient’s responsibility to disclose pertinent information

Certainly, Hii Chii Kok does not prescribe an “open-ended duty to proactively elicit information from the patient”. The ball is in the patient’s court to raise particular questions or concerns, following “baseline” disclosure and advice i.e. a non-personalised set of information provided to all patients in a given situation that is necessary but may not be sufficient for materially informed decision-making. Let us assume that the small risk of little finger injury is not within this baseline information for the above musician patient. If this patient did not inform the doctor that she is a musician before or after baseline disclosure, or after the doctor asked her if she had any specific concerns, then the doctor would not have failed in her standard of care in omitting to disclose the injury risk. There is no duty to conduct extensive background or character analyses in day-to-day patient encounters under Hii Chii Kok. (Things might be different if the doctor had seen the patient playing air guitar – is there a duty to ask at least circumstantial questions e.g. whether she likes music, her job, the instrument she plays, to ascertain the materiality of the finger injury risk?)

It is important to distinguish, as Beauchamp and Childress argue, between “informational exchanges through which patients elect medical interventions from acts of approving and authorising those interventions” (Principles of Biomedical Ethics, 6th edition, p. 119). Shared decision-making could assist with obtaining “reasonable/particular patient” informed consent, particularly in situations of high risk

or uncertainty with treatment choices of similar therapeutic aims but different risk profiles or invasive characters. owever, it is not always necessary or appropriate – not every treatment or patient requires the doctor to “deliberate with the patient” for the patient to provide materially informed consent.

The way forward to better understanding of patient needs and concerns

What might be necessary and appropriate is to make the reasonable patient less abstract and hypothetical and more ’empirical’ and evidence-based. Yek et al. conducted a cross-sectional study to find out what patients in Singapore would regard as material risk for undergoing anaesthesia, and found that they ranked heart attack (59.3 per cent), death (53.8 per cent) and stroke (52.7 per cent) as the most significant risks that they wanted to know more in detail (“Defining reasonable patient standard and preference for shared decision making among patients undergoing anaesthesia in Singapore”, BMC Medical Ethics 2017;18: 6). There are certainly limitations to the empirical approach in establishing the “reasonable patient” but it points the way forward in making this standard more objective and responsive to patients’ actual informational needs.