Performance data and informed consent: a duty to disclose?

Evidence mounts for a legal duty to disclose performance data as part of informed consent

Hospitals, colleges and other institutions increasingly collect, analyse and disseminate data relating to the performance of individual health practitioners, particularly those undertaking surgical procedures. Arguments have long been made for an ethical duty to disclose information regarding a practitioner’s experience or skill to patients as part of the process of informed consent (Box 1).1 Significantly, recent developments suggest that practitioners may, in some circumstances, have a legal duty to disclose their performance data to patients (Box 2).

Duty to warn

The few cases in which Australian courts have considered a practitioner’s skill and experience as a “failure to warn” matter present an apparently inconsistent message. A case from 1998, Chappel v Hart,2 indicates that doctors may have a duty to disclose information about their experience relative to other practitioners. In her judgement, Justice Gaudron asserted:

A contrasting case is Brus v Australian Capital Territory,3 in which it was alleged that the patient had not been informed that the registrar would perform the operation, rather than the consultant, nor had she been informed of the registrar’s qualifications and experience. Negligence in this case was found not in a failure to warn, as the patient had been informed that a registrar might perform the operation, but rather in the hospital allowing the registrar to perform an operation that was beyond her capacity. The surgeon’s skill and experience was found to be relevant only to the extent that it was consistent with the skill and experience expected of a person employed in their position. The same criticism could arguably be made in relation to a fully qualified surgeon if the hospital knew that the surgeon had a complication rate for the procedure well in excess of that of his or her peers.

G & C v Down4 is significant for making use of adverse event rates as a measure of skill. During consultation with the patient, Dr Down described the risk of failure of tubal ligation as 1 in 2000. The doctor argued that he provided this figure based on personal experience, although the court did not accept this as proven on the evidence and suggested that he was not necessarily aware of his true failure rate. Published failure rates at the time ranged between 1 in 500 and 1 in 1000. The court found that where an individual’s failure rate was provided, the published rate should also be conveyed with appropriate context, noting that the “personal experience of the gynaecologist would be of great significance to the patient”.

Conversely, in Morocz v Marshman,5 the judge stated that the defendant did not have an obligation to reveal his surgical track record in performing the procedure under discussion, especially as the patient had not asked for it, but also indicated that a surgeon may refuse to provide the information, even when asked.

Legal foundations

Issues of duty and standard of care in medical negligence cases in Australia are decided with reference to the relevant jurisdiction’s civil liability legislation, and common law precedent.6 The law of negligence was reviewed in 2002, which among other things explicitly considered whether practitioners have a proactive duty to inform patients when other practitioners are more skilled or experienced in a particular treatment, and found that “[a]lthough, generally, such an obligation would not arise, there might be exceptional circumstances in which it would”.7

Cases considered to date align with this viewpoint. Courts have been reluctant to extend a duty to disclose data relating to experience or skill, and when a duty has been found to exist in a particular case, they have been careful to preclude a general duty.

Informed consent is intended to facilitate the personal autonomy of patients through the provision of information by their medical practitioner, who is required to do so with reasonable care and skill.8 The information that a practitioner is required to disclose to a patient is context specific:

Significantly, this list has been interpreted as an explication of the criteria for determining breach of duty, in which “the magnitude of the risk and the degree of the probability of its occurrence” is weighed against “the expense, difficulty and inconvenience of taking alleviating action and any other conflicting responsibilities which the defendant may have”.10 The fact that most people are likely to believe that information about their surgeon’s experience or skill is important is not sufficient in itself to establish it as material. The information needs also to convey some level of risk that is not outweighed by the costs involved in communicating that information.

Balancing risks and costs

Provision of information can be divided into an objective duty (what the hypothetical reasonable person would want to know) and a subjective duty (what a particular patient, with all their idiosyncrasies, wants to know).10 In the objective test of duty, the costs would be those incurred by the extra time and expense involved in disclosing performance data to every single patient; those associated with collection, analysis and dissemination of valid and reliable data; and those resulting from the impact of systematic disclosure on resource allocation, hospital waiting lists and training of junior doctors.

The costs of data collection, analysis and dissemination are rapidly falling as technology advances and as performance data are integrated into standardised administrative functions. With better quality data available, practitioners are increasingly well placed to share these data with their patients in a time- and cost-effective manner. At present, however, the costs associated with resource allocation, waiting lists and training of junior doctors remain significant in considering systematic disclosure.

In general, the risks conveyed to patients through disclosure of performance data would not be sufficient to cause them to change surgeons, as most surgeons have adverse outcome rates within acceptable limits, and most patients only require the services of surgeons performing at the accepted professional standard. The burden of disclosure, in general, currently exceeds the benefits. It is therefore reasonable to conclude that no objective duty currently exists for practitioners to systematically disclose performance data to their patients, although a duty may arise in future as the health care system evolves to meet these and other challenges.

In considering the subjective test, a case can easily be made for a particular patient attaching significance to information about their surgeon’s experience or skill. It is increasingly easy for practitioners to access data regarding their performance across a range of outcomes, and to compare it with the performance data of their colleagues. This means that the costs of disclosing these data to patients who specifically ask for it, exhibit particular anxiety, or otherwise demonstrate that they would attach a level of significance to the information above that of the average patient, could readily be less than the risk conveyed by the information.

Further, when an individual health professional’s outcomes for a procedure are substantially different from the average or published outcomes — and especially if substantially worse — a strong argument could be made for a more general duty to disclose this information to all their potential patients for that procedure.

The social utility of a procedure may also prove influential in determining the balance between risks and costs. For example, compared with urgent or life-saving interventions, procedures at the elective end of the spectrum (such as some cosmetic procedures) may require the disclosure of a greater range of information to facilitate patient autonomy.

Current trends and future scope

Collections of performance data have been made public in the United States and the United Kingdom, sparking controversy over the accuracy, validity and utility of the data for public use.11,12 There are moves towards greater transparency in Australia, including through the publication of surgical mortality reports13 and initiatives such as the health care directory Whitecoat (https://www.whitecoat.com.au). In this context, it would be reasonable to expect that failure to warn cases relating to surgical skill and performance data have the potential to greatly increase as the public have greater access to such data in the wake of negligent treatment.

Of particular relevance are the recently released Guidelines for registered medical practitioners who perform cosmetic medical and surgical procedures.14 Section 4.1 lists information that the medical practitioner must provide to the patient, including “the medical practitioner’s qualifications and experience”. These guidelines provide support for the contention that elective procedures may require a more extensive disclosure of relevant risks. Further, they suggest that widespread change in professional practice, while it might be slow and expensive, is not considered an insurmountable problem by the Medical Board of Australia.

It is possible that publication of performance data may lead to some health practitioners avoiding difficult or high risk cases. This outcome is more likely if publication is driven by third parties, with less concern for the reliability and validity of datasets or for the use of appropriate statistical methods. Medical bodies therefore need to ensure that publicly available data are high quality and presented correctly, and health practitioners need to provide appropriate context when disclosing information to patients.

Moves towards public reporting of surgical performance data are reflective of wider moves, both within medicine and medical law, away from practitioner-centred practice and towards a patient-centred model of care. Future decisions will clarify whether the present division between objective and subjective tests of duty are maintained, and the extent of the influence of social expectations on the development of the duty to warn. It would be wise for clinicians and medical bodies to take anticipatory action by establishing good data management and analysis systems, and by considering whether disclosure is appropriate in their practice.