Preference-sensitive treatment decisions involve making value trade-offs between benefits and harms that should depend on informed patient choice. There is strong evidence that patient decision aids not only improve decision quality but also prevent the overuse of options that informed patients do not value. This paper discusses progress in implementing decision aids and the policy prospects for reaching a "tipping point" in the adoption of "informed patient choice" as a standard of practice.

In law, with rare exception such as legislative action, change is evolutionary and methodical. Unlike biomedical science where a breakthrough can quickly lead to dramatic changes in medical practice, legal precedent is more adherent and must evolve either through the legislative process or on a court by court basis in case law. Nevertheless, compelling evidence will pave the road to change within the law. Health care research conducted over the last three decades has produced a body of empirical evidence that suggests an overhaul of our current legal standards of informed consent is overdue.This article uses health services research to examine the fundamental assumptions of our current informed consent laws and propose legal reform. Much has been written on how to bring the law to bear on medical practice in order to improve patient rights and protect physicians, but far less has been done to bring the practice of medicine to inform our legal standards. Prior legal scholarship on informed consent has made arguments regarding reform from both ethical and legal perspectives; however, only a small few have incorporated clinical and health services research as well as ethical and legal principles to analyze informed consent.

Clinical evidence suggests that many patients undergo surgery that they would decline if fully informed. Failure to communicate the relevant risks, benefits, and alternatives of a procedure violates medical ethics and wastes medical resources. Integrating shared decision-making, a method of communication between provider and patient, into medical decisions can satisfy physicians' ethical obligations and reduce unwanted procedures. This article proposes a three-step process for implementing a nationwide practice of shared decision-making: (1) create model integration programs; (2) provide legal incentives to ease the transition; and (3) incorporate shared decision-making into medical necessity determinations.

The recognition that informed patients often choose more conservative and hence less expensive medical options has made shared decision making a focus of valuebased care. 1 In 2007, Washington State passed legislation incentivizing shared decision making as an alternative to traditional informed consent procedures and forms for preference-based treatment decisions that include an elective procedure, such as joint replacement for hip or knee osteoarthritis. 2 To qualify as this alternative to traditional informed consent, clinicians are required to use a certified decision aid to facilitate discussion about the different treatment options and patients need to sign an attestation that they reviewed the decision aid with the clinician, discussed the alternatives, risks, and benefits, and decided on a specific course of action. Clinicians who practice shared decision making will be presumed to have engaged patients in an informed consent process regarding the elective procedure and will be provided with increased protection against potential ensuing litigation based on failure to inform. Specifically, the use of the tools and the process associated with this use would shift the burden in litigation to patients to demonstrate clear and convincing evidence that they were not informed. 2 In 2016, Washington State certified the first decision aids in maternal-fetal care related to decisions for birth options after cesarean delivery, for amniocentesis, and for genetic screening.Washington State's unprecedented legislation coincides with national activity. The National Quality Forum recently developed national certification standards for patient decision aids based on those used in Washington State. 3 The Centers for Medicare & Medicaid Services (CMS) announced shared decision making as a precondition for payment for low-dose computed tomography scans for lung cancer screening and for left atrial appendage closure, and recently announced 2 shared decision making models for beneficiary engagement that focus on 6 preference-sensitive conditions: stable ischemic heart disease; hip osteoarthritis; knee osteoarthritis; herniated disk and spinal stenosis; clinically localized prostate cancer; and benign prostatic hyperplasia. 4 Additionally, the recent Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) included shared decision making in 1 of 4 performance categories used to determine clinician reimbursement under the Merit-Based Incentive Payment System. Even as shared decision making expands, 5 most clinicians and health centers outside the research setting have limited experience with decision aids, which may undermine the potential for shared decision making to engage patients in an open, transparent manner about health care choices.Clinicians who will be incentivized to use shared decision making may have misconceptions about what it is and skepticism of its value. Well-defined standards are needed to help translate new policies into clinical prac-VIEWPOINT

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BackgroundTo explore the likely influence and impact of shared decision-making on medical malpractice litigation and patients’ intentions to initiate litigation.MethodsWe included all observational, interventional and qualitative studies published in all languages, which assessed the effect or likely influence of shared decision-making or shared decision-making interventions on medical malpractice litigation or on patients’ intentions to litigate. The following databases were searched from inception until January 2014: CINAHL, Cochrane Register of Controlled Trials, Cochrane Database of Systematic Reviews, EMBASE, HMIC, Lexis library, MEDLINE, NHS Economic Evaluation Database, Open SIGLE, PsycINFO and Web of Knowledge. We also hand searched reference lists of included studies and contacted experts in the field. Downs & Black quality assessment checklist, the Critical Appraisal Skill Programme qualitative tool, and the Critical Appraisal Guidelines for single case study research were used to assess the quality of included studies.Results6562 records were screened and 19 articles were retrieved for full-text review. Five studies wee included in the review. Due to the number and heterogeneity of included studies, we conducted a narrative synthesis adapted from the ESRC guidance for narrative synthesis. Four themes emerged. The analysis confirms the absence of empirical data necessary to determine whether or not shared decision-making promoted in the clinical encounter can reduce litigation. Three out of five included studies provide retrospective and simulated data suggesting that ignoring or failing to diagnose patient preferences, particularly when no effort has been made to inform and support understanding of possible harms and benefits, puts clinicians at a higher risk of litigation. Simulated scenarios suggest that documenting the use of decision support interventions in patients’ notes could offer some level of medico-legal protection. Our analysis also indicated that a sizeable proportion of clinicians prefer ordering more tests and procedures, irrespective of patient informed preferences, as protection against litigation.ConclusionsGiven the lack of empirical data, there is insufficient evidence to determine whether or not shared decision-making and the use of decision support interventions can reduce medical malpractice litigation. Further investigation is required.Trial registrationThis review was registered on PROSPERO. Registration number: CRD42012002367.Electronic supplementary materialThe online version of this article (doi:10.1186/s12913-015-0823-2) contains supplementary material, which is available to authorized users.

We conducted focus groups with 47 potential jurors who were presented with diferent scenarios in a hypothetical malpractice case involving failure to order a PSA test. Better documentation that a patient made an informed decision to decline a PSA test appeared to provide more medical‐legal protection for physicians, especially with the use of a decision aid.

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