The New Era of Informed Consent: Getting to a Reasonable-Patient Standard Through Shared Decision Making

Abstract

The rights of patients tobeinformedaboutcaredecisions in clinical practice is yet again under scrutiny, both in the United States and around the world.The well-ingrained ethical-legal process of informed consent, so fundamental to patient autonomy-or the patient's right to selfdetermination-was the subject of a 2015 UK Supreme Court case (Montgomery v Lanarkshire Health Board). 1 In that case, a woman with insulin-dependent diabetes, claimedthatherobstetricianfailedtocommunicatetherisk of shoulder dystocia during vaginal delivery (a complication associated with fetal macrosomia) that ultimately resultedinseverefetalbrainanoxia.Sheclaimedthathadshe received full information about the risks, she would have opted for a cesarean delivery.Yet the treating obstetrician (andotherexpertphysicianscalledtotrial)claimedthatthe ensuing risk was very small and thus appropriately not communicated because a cesarean delivery is not in the maternal interest.The obstetrician reported that "…had I raised it [the risks of shoulder dystocia] with her then yes, she would have no doubt requested a caesarean section, as would any diabetic today." 1 In its final decision, the UK Supreme Court ruled that the standard for what physicians should inform patients about the risks, benefits, and alternatives of treatment will no longer be determined by what a responsible body of physicians deems important but rather by what a reasonable patient deems important.In rendering this decision, the court swept away decades of medical paternalism in the United Kingdom to embrace a new patient-centered standard.Perhaps more compelling, the head of the Royal College of Surgeons urged that the only way to operationalize such a substantial and needed change is through shared decision making, a collaborative communication processbetweencliniciansandpatientsthatintegratesthe best evidence available with the patients' values and preferences, to promote high-quality health care decisions.The UK law is not unprecedented.In the United States, approximately half of the states have adopted the reasonable-patient standard.The reasonable-patient standard views the informed consent communication process from the patient's perspective.It requires physicians and other health care practitioners to disclose all relevant information about the risks, benefits, and alternatives of a proposed treatment that an objective patient would find material in making an intelligent decision as to whether to agree to the proposed procedure.2 Even in those states that apply the reasonable-patient standard, however, the informed consent process is often ill-configured to meet patients' informational needs.