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

Therightsofpatientstobeinformedaboutcaredecisions in clinical practice is yet again under scrutiny, both in the United States and around the world. The well-ingrained ethical-legalprocessof informedconsent, so fundamental to patient autonomy—or the patient’s right to selfdetermination—was the subject of a 2015 UK Supreme Courtcase (MontgomeryvLanarkshireHealthBoard).1 In that case, a woman with insulin-dependent diabetes, claimedthatherobstetricianfailedtocommunicatetherisk of shoulder dystocia during vaginal delivery (a complicationassociatedwith fetalmacrosomia) thatultimately resultedinseverefetalbrainanoxia.Sheclaimedthathadshe received full informationabout the risks, shewouldhave optedforacesareandelivery.Yetthetreatingobstetrician (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 Iraisedit [therisksofshoulderdystocia]withherthenyes, shewouldhavenodoubt requestedacaesareansection, aswould anydiabetic today.”1 In its finaldecision, theUKSupremeCourt ruled that the standard forwhat physicians should informpatients abouttherisks,benefits,andalternativesoftreatmentwill no longer be determined bywhat a responsible body of physiciansdeems importantbut ratherbywhatareasonablepatientdeems important. In rendering thisdecision, the court swept awaydecades ofmedical paternalism in theUnitedKingdomtoembraceanewpatient-centered standard.Perhapsmorecompelling, theheadoftheRoyal CollegeofSurgeonsurgedthattheonlywaytooperationalize such a substantial and needed change is through shared decisionmaking, a collaborative communication processbetweencliniciansandpatientsthat integratesthe bestevidenceavailablewiththepatients’valuesandpreferences, to promote high-quality health care decisions. The UK law is not unprecedented. In the United States,approximatelyhalfof thestateshaveadoptedthe reasonable-patient standard. The reasonable-patient standard views the informed consent communication process from the patient’s perspective. It requires physicians andotherhealth carepractitioners todisclose all relevant information about the risks, benefits, and alternativesof aproposed treatment thatanobjectivepatient would find material in making an intelligent decisionas towhether toagree to theproposedprocedure.2 Even in those states that apply the reasonable-patient standard, however, the informed consent process is often ill-configured tomeetpatients’ informationalneeds. Informedconsentdiscussionsareoftendevoidofdetailsaboutthematerialrisks,benefits,andalternativesthat arecriticaltomeaningfulpatientdecisionmaking.Informed consentdocuments forprocedures, surgery,andmedical treatmentswithmaterial risks(eg, radiationtherapy)tend tobegeneric, containing information intendedtoprotect thephysicianorhospital fromlitigation.Thesedocuments areoftenwrittenatahighreadinglevelandsometimespresented in nonlegible print, putting a premium on health literacy and proactive information-seeking behavior.3 Moreover, informedconsentdocumentsareoftensigned minutesbefore the start of aprocedure, a timewhenpatientsaremostvulnerableandleastlikelytoaskquestions— hardly consistent with what a reasonable patient would deemacceptable. IntheUnitedStates,withtheexception of1state,Washington,thatexplicitlyrecognizesshareddecisionmakingasanalternativetothetraditional informed consent process,4 the law has yet to promote a process thattrulysupportsareasonable-patient–centeredstandard through shareddecisionmaking.