Benjamin W. Moulton

Rethinking Informed Consent: The Case for Shared Medical Decision-Making:

Health services research performed over the last three decades has established a body of evidence that undermines a number of the fundamental assumptions of our informed consent laws. Currently there is a divide among the states about what standard prevails in informed consent cases between physician-based states and patient-based states. In physician based states, the courts apply a standard of what information would the reasonable physician disclose to the patient under like or similar circumstances. In patient based states, the courts apply the standard of what information would the objective reasonable patient want under like or similar circumstances. Both standards fail but for different reasons. The physician based standard fails to recognize that there is no true objective standard that physicians follow and in fact there is large practice variation amongst physicians even in the same geographic region. The patient based standard fails to recognize that patients values and preferences vary widely depending on the individual patient. How a particular patient perceives the medical treatment information based upon their own, lifestyle, values and preferences will dictate what course of treatment to follow. Evidence suggests that informed medical decision making strengthens the therapeutic alliance and improves patient satisfaction. It also reduces in many instances costly surgical interventions. The health services research of Wennberg et al, accompanied with evidence of patient dissatisfaction with current disclosure practices suggests that an overhaul of our current informed consent system is necessary. Shared decision-making, a process that requires both the physician and the patient to engage in a discussion of all relevant information regarding the treatment options, including the risks, benefits and alternatives to treatment, as well as the individual patients lifestyle, values and preferences, offers a promising alternative to our current system. However, many physicians, lawyers and scholars argue that shared decision-making will consume too much time, money and scarce medical resources in an already overburdened medical system. This article examines these claims and concludes that despite the bureaucratic headaches, the enormous expenditure of financial and human resources, and the need for state by state adoption of new informed consent laws, the long-term benefits of shared decision-making and the use of evidence based decision aids to promote patient understanding of medical information to arrive at informed medical decision making far outweigh the costs for both patients and physicians.

Shared decision making in the United States: policy and implementation activity on multiple fronts

Shared decision making in the United States has become an important element in health policy debates. The recently passed federal health care reform legislation includes several key provisions related to shared decision making (SDM) and patient decision support. Several states have passed or are considering legislation that incorporates SDM as a key component of improved health care provision. Research on SDM is funded by a range of public and private organizations. Non-profit, for-profit, academic and government organizations are developing decision support interventions for numerous conditions. Some interventions are publicly available; others are distributed to patients through health insurance and healthcare providers. A significant number of clinical implementation projects are underway to test and evaluate different ways of incorporating SDM and patient decision support into routine clinical care. Numerous professional organizations are advocating for SDM and social networking efforts are increasing their advocacy as well. Policy makers are intrigued by the potential of SDM to improve health care provision and potentially lower costs. The role of shared decision making in policy and practice will be part of the larger health care reform debate.

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

This Viewpoint discusses the benefits of developing a patient-centered informed consent standard and the resources it would take to achieve it in practice.

The Potential of Shared Decision Making to Reduce Health Disparities

journal of law, medicine & ethics Current methods of obtaining an informed consent leave much to be desired. Patients rarely read consent forms or understand all of the risks, benefits, or alternatives associated with their treatment.1 Evaluating the advantages and disadvantages of treatment options often presents a more significant challenge for patients with lower levels of health literacy. This article reviews the evidence of shortcomings in our informed consent system and then explores the potential for a new approach to engage patients at all levels of health literacy in their treatment decisions. Specifically, the article will examine the potential of shared decision-making (SDM) to bridge gaps in knowledge, increase patient adherence to treatment, and improve health outcomes in low health literacy patient populations. Leveling barriers to treatment information for disadvantaged populations should be a public health imperative, especially if it can be shown to improve health outcomes and reduce health disparities. In general, physicians have legal and ethical obligations to obtain an informed consent from patients to engage in treatment. With notable exceptions for patients incapable of providing consent, informed consent typically occurs in three steps: (1) a brief conversation with the physician regarding the preferred treatment; (2) the provision of a form that lists the risks of treatment; and (3) execution of the consent form by the patient. Under this system, patients rarely make a truly informed decision. A review of over 540 informed consent forms at 157 randomly selected hospitals found that informed consent documents had limited informational value for the general patient population.2 More concerning, a study of surgical patients found that over 70% failed to read the consent form and did not comprehend the risks of surgery.3 This system also poorly elicits patient preferences regarding the relative risks and benefits of alternative treatment options. A more recent study at the University of Michigan, known as the DECISIONS study, provides significant clues about the epidemiology of decision-making in the United States.4 Through a nationwide random digit dial survey, DECISIONS researchers conducted telephone interviews with 2,575 participants, age 40 and older, to examine whether patients received basic information about their options prior to making health-related decisions. The DECISIONS study revealed a pattern of inadequate medical decision-making that spanned the country and nine common medical conditions. In the last two years, 56% of survey participants discussed medication changes, 72% discussed cancer screening, and 16% discussed surgery with their providers. A panel of experts articulated five essential facts deemed critical to decision making for each of the conditions surveyed. Researchers found that many patients were “lacking knowledge of key facts needed to make informed choices.”5 For eight of the nine decisions, less than 50% of patients could answer more than one basic question about their treatment. Furthermore, patients reported that physicians asked them for their preferences less than one-third of the time. These Jaime S. King, J.D., Ph.D., is an Associate Professor of Law at the University of California Hastings College of the Law. Mark H. Eckman, M.D., M.S., FACP, is in the Division of General Internal Medicine and Center for Clinical Effectiveness at the University of Cincinnati. Benjamin W. Moulton, J.D., M.P.H., is a Lecturer in Health Law at Harvard School of Public Health and a Senior Legal Advisor at the Foundation for Informed Medical Decision Making. The Potential of Shared Decision Making to Reduce Health Disparities

Group Health’s Participation In A Shared Decision-Making Demonstration Yielded Lessons, Such As Role Of Culture Change

In 2007 Washington State became the first state to enact legislation encouraging the use of shared decision making and decision aids to address deficiencies in the informed-consent process. Group Health volunteered to fulfill a legislated mandate to study the costs and benefits of integrating these shared decision-making processes into clinical practice across a range of conditions for which multiple treatment options are available. The Group Health Demonstration Project, conducted during 2009-11, yielded five key lessons for successful implementation, including the synergy between efforts to reduce practice variation and increase shared decision making; the need to support modifications in practice with changes in physician training and culture; and the value of identifying best implementation methods through constant evaluation and iterative improvement. These lessons, and the legislated provisions that supported successful implementation, can guide other states and health care institutions moving toward informed patient choice as the standard of care for medical decision making.

Reactions of Potential Jurors to a Hypothetical Malpractice Suit Alleging Failure to Perform a Prostate-Specific Antigen Test

We conducted focus groups with 47 potential jurors who were presented with different 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.

Prime Time for Shared Decision Making

The recognition that informed patients often choose more conservative and hence less expensive medical options has made shared decision making a focus of value-based 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.

Can shared decision-making reduce medical malpractice litigation? A systematic review

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.

Shared decision making as part of value based care: New U.S. policies challenge our readiness

Shared decision making in the United States is increasingly being recognized as part of value-based care. During the last decade, several state and federal initiatives have linked shared decision making with reimbursement and increased protection from litigation. Additionally, private and public foundations are increasingly funding studies to identify best practices for moving shared decision making from the research world into clinical practice. These shifts offer opportunities and challenges for ensuring effective implementation.

Valuing Health Care: Improving Productivity and Quality

This report addresses a deceptively simple question: How can the productivity of American health care be substantially improved? Productivity, in lay terms, is the ratio of output to inputs. A more colloquial rendition of the question might be: how can we get a lot more bang for our health care buck?By design, we have brought together a varied assortment of ideas and suggestions, illustrating the messy, grab-bag nature that effective changes often need to take. Yet our proposals do fall (albeit with some overlap) into four broad categories, which structure the recommendations section of this report.Harnessing information: how systematically gathering and sharing data can unlock knowledge that produces systematically better choices. The key here is to incentivize a new corps of data entrepreneurs to collect and analyze existing medical data to discover and then disseminate the use of new therapies.Improving research: encouraging more collaboration across institutions and funding more translational research (aimed at “translating” basic scientific discoveries into medicines and therapies). Legal and regulatory reform: modernizing medical malpractice systems, removing counter-productive restrictions on health insurance premiums, and streamlining new drug approvals.Empowering patients: there are large benefits of giving more power to the people who matter most — patients — to make informed decisions about their own care.The ideas here are not new, though many of them are familiar only to the cognoscenti. To the contrary, we have sought ideas that have showed promise in the field, and then attempted to set them in a context that exploits the adjacent possible.If this report can focus more minds in the health policy community and general public on finding and implementing those changes, in everything from clinical practices to regulatory structures, it will have succeeded.From the Kauffman Task Force on Cost-Effective Health Care Innovation.