Legal principles of shared decision-making for healthcare: what are we required to do?

A two-stage model of SDM from case law

In Montgomery v Lanarkshire Health Board, UKSC instructs HCPs to inform patients of ‘any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments’ (para 87). ³ Implicitly, the term ‘risk’ is used as shorthand for a risk-benefit discussion. Montgomery then sets out a ‘test of materiality’ for identifying ‘material risks’. By this test, patients must be informed of risks that would be considered significant by a reasonable person in their position, regardless of HCPs’ views. Notably, Montgomery has been cited by appellate courts internationally.^4,5

In addition to material risks, Montgomery emphasises that real patient choice requires information about reasonable alternatives to the recommended treatment. These alternatives could be another treatment, or dietary or lifestyle changes, or simply waiting and watching without any treatment. But Montgomery does not explain the process or criteria for selection of ‘reasonable’ alternatives. Who is to decide which options are ‘reasonable’, and how? This ambiguity was resolved subsequently in McCulloch v Forth Valley Health Board. ⁶ UKSC clarified that the identification of reasonable alternatives, or treatment options, was a matter for the treating HCP and not for the patient.

For assessing whether or not the treating HCP had correctly identified reasonable treatment options, McCulloch endorses the ‘professional practice test’ from Bolam v Friern Hospital. ⁷ By this test, the options that were identified by the treating HCP would be regarded as reasonable if these were approved by a group of that HCP’s colleagues (represented in litigation by expert witnesses). Notably, the options do not have to be approved by all colleagues. The approval of a group of colleagues is sufficient, so long as their reasoning is logical, even if other colleagues disagree.

The Montgomery–McCulloch case pair now supplies a two-stage model for SDM. A fundamental premise in this model is that SDM is not a free-ranging enterprise. Rather, SDM has certain pre-determined starting points – reasonable treatment options – that form the basis for patient choice. Accordingly, the HCP has to first select reasonable treatment options for each individual patient (McCulloch). Then, the HCP must discuss the material risks of these options so that the patient can make an informed choice (Montgomery).

The two-stage model is conceptually appealing.^8,9 But is it fair? This question is important because misguided laws can be formidable barriers to health justice. ² UKSC applies the principle of reasonableness, albeit differently, in both Montgomery and McCulloch. ⁹ This principle is considered fundamental to justice and is widely employed in law-making. But it poses two significant problems for SDM that we now discuss.

The problem of a ‘reasonable’ person

The idea of being reasonable is commonly personified as a ‘reasonable person’. ¹⁰ Critically, the reasonable person is not a real entity but a hypothetical or imaginary character who is placed in the individual circumstances, or position, of each real person. It is well accepted that for any action to be considered fair, it should be acceptable to this hypothetical reasonable person. Accordingly, Montgomery requires HCPs to consider a reasonable person when explaining risks. If this reasonable person is satisfied with the HCP’s explanation, then the patient’s autonomy would be fairly respected.

However, courts have never defined the characteristics of the hypothetical reasonable person. It is likely that this omission has been intentional, in order to retain flexibility for contextual assessments. That said, it is clear that the reasonable person does not demand perfection. As acknowledged by the General Medical Council, ‘it wouldn’t be reasonable to share every possible risk of harm, potential complication or side effect’ (para 22). ¹¹ At the same time, HCPs are obliged to provide information that would be important to each individual patient in decision-making, regardless of questioning by the patient. ³ In other words, HCPs are allowed to not share some possible risks but they must provide certain other information. Implicitly, HCPs have to make some assumptions about each patient’s informational requirements when conducting SDM.

In litigation, the reasonableness or otherwise of an HCP’s assumptions is determined after the event by a court. But case law provides only little and often conflicting direction on how HCPs should prospectively conceive each patient’s reasonable informational requirements. ¹⁰ However, Montgomery is clear that simply providing detailed information does not establish reasonable pratice. ³ As such, standardised disclosures in whatever form are unlikely to be sufficient. Rather, information has to be tailored for each individual patient, for which there is no formula. The reasonable person, while central to justice, remains a conundrum.

The problem of healthcare inequalities

In McCulloch, UKSC’s focus of reasonableness – the audience to whom the treating HCP’s choice of treatment options should be acceptable – shifts from the hypothetical reasonable person to the HCP’s colleagues. ⁹ This shift in focus is in keeping with an influential sociological theory on healthcare professionalism. ¹² According to this theory, only HCPs can exercise judgements that are essential for identifying clinically appropriate or suitable options (which, as explained in McCulloch, are synonymous with ‘reasonable’ options). This is because such judgements require knowledge and skills that can only be obtained through professional education and training. Consequently, only the patient’s treating HCP can identify the options that are reasonable for that patient, and only the HCP’s colleagues can assess their clinical judgements.

Thus, society essentially delegates authority for deciding reasonable (and, therefore, fair) treatment options to HCPs, and the law expresses this delegation through the professional practice test. As discussed earlier, this test not only relies on HCPs but also accepts the existence of differences in opinion amongst HCPs. This latter concession reflects legal recognition of practical realities within healthcare professions. Yet, this concession is problematic because, now, patients with the same health condition can be offered different options as the starting points for SDM.

For example, one group of HCPs might identify treatment A or B or watchful waiting without treatment as reasonable options for a particular patient, when another group might support treatment A or B but not watchful waiting (these latter HCPs would accept the patient’s decision to forgo all treatment, but they would not propose no treatment as a reasonable option). Such differences in starting points can end up in different patient choices with significantly different health outcomes. Moreover, such differences are arbitrary because these depend simply on the judgements of the patient’s treating HCP and a group of fellow professionals, over which patients have little or no control. Consequently, professional differences have the potential to create invidious inequalities in healthcare and, consequently, in societal health. ¹³ Such unfairness is seemingly sanctioned by McCulloch.

How should HCPs conduct SDM?

UKSC makes it clear that SDM does not require HCPs to discuss all technically possible treatment options with the patient. ⁶ Rather, HCPs must exercise their clinical judgement to identify options that would be reasonable in the context of each patient’s individual circumstances and then discuss these reasonable options with the patient.

Having identified options that they regard as reasonable, we suggest that HCPs check the reasonableness of their selection by reflecting upon whether they would be able to justify it to a group of their colleagues. The law does not require reasonable options to be acceptable to all colleagues. ⁶ Yet, HCPs should remain alert to professional differences, which can result in healthcare inequalities.

One solution to the inequalities problem is to use a ‘test of availability’ that requires evidence-based options deemed clinically appropriate by all relevant HCPs to be offered to the patient. ¹⁴ This test simultaneously preserves the essence of professionalism and provides equal opportunities for healthcare. However, as alluded to in McCulloch, such a test could create significant ethical and practical difficulties. ⁶ Its widespread adoption would necessitate significant professional reorganisation.

Meanwhile, we would urge HCPs to include a wide range of professional views on reasonable options, as well as patient-requests for particular treatments. The law is clear that HCPs are not obliged to provide treatment that is contrary to their clinical judgement. But it is only fair that HCPs should consider whether a requested treatment that they and some colleagues do not regard as clinically appropriate would be approved by other colleagues with appropriate qualification and expertise in the relevant field. If so (and the option is evidence-based), then reasonable efforts should be made to accommodate the patient’s request.

Next, HCPs must imagine a reasonable person in the shoes of the actual patient and reflect upon what information this patient would expect about the selected, reasonable options. Apart from informational content, HCPs should reflect on the required style of SDM. ¹⁵ For some patients, it may be entirely informative: the HCP simply communicates facts, and the patient independently weighs up these facts and decides. For others, it may be deliberative: the HCP and the patient engage in a dialogue not simply about what can be done but also about what should be done. For many patients, it will be a hybrid style. There are no rigid rules. But an attentive conversation can be valuable in conceiving the patient’s requirements.

We suggest that HCPs remain in tune with evolving societal expectations and use common sense, as they might in other walks of life. The reasonable person is perhaps a salutary reminder that the art of healthcare remains as important as its rapidly expanding science and craft!