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May 17, 2016

The New Era of Informed ConsentGetting to a Reasonable-Patient Standard Through Shared Decision Making

Author Affiliations
  • 1Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut
  • 2Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut
  • 3Informed Medical Decisions Foundation, Healthwise Research and Advocacy, Adjunct Harvard School of Public Health, Boston, Massachusetts
JAMA. 2016;315(19):2063-2064. doi:10.1001/jama.2016.3070

The right of patients to be informed about care decisions 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 self-determination—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, claimed that her obstetrician failed to communicate the risk of shoulder dystocia during vaginal delivery (a complication associated with fetal macrosomia) that ultimately resulted in severe fetal brain anoxia. She claimed that had she received full information about the risks, she would have opted for a cesarean delivery. Yet the treating obstetrician (and other expert physicians called to trial) claimed that the 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 process between clinicians and patients that integrates the 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.

Informed consent discussions are often devoid of details about the material risks, benefits, and alternatives that are critical to meaningful patient decision making. Informed consent documents for procedures, surgery, and medical treatments with material risks (eg, radiation therapy) tend to be generic, containing information intended to protect the physician or hospital from litigation. These documents are often written at a high reading level and sometimes presented in nonlegible print, putting a premium on health literacy and proactive information-seeking behavior.3 Moreover, informed consent documents are often signed minutes before the start of a procedure, a time when patients are most vulnerable and least likely to ask questions—hardly consistent with what a reasonable patient would deem acceptable. In the United States, with the exception of 1 state, Washington, that explicitly recognizes shared decision making as an alternative to the traditional informed consent process,4 the law has yet to promote a process that truly supports a reasonable-patient–centered standard through shared decision making.

Informed Consent and High-Value, Patient-Centered Care

According to the US Centers for Disease Control and Prevention, more than 50 million surgical and nonsurgical inpatient procedures are performed each year.5 For these patients, informed consent heralds a critical moment in the patient-physician relationship. In the process of communicating information about treatment options and the attendant risks, benefits, and alternatives, patients have an opportunity to reflect on their preferences, values, and goals; to learn more about their prognosis; and to signal concerns about safety and rehabilitation. Reasonably, patients may request more information, a second opinion, or support from a family member or friend in the decision-making process.

What would a high-value, patient-centered process for informed consent look like? A comprehensive, transparent, and hopefully bias-free communication with a trusted clinician is irreplaceable; however, it is not sufficient. Written information, whether presented on paper or mobile device, is still critical.6 Much attention has been given to patient decision aids, or enhanced informed consent tools with information about different options for treatment. High-quality decision aids are developed and tested with patients; thus, they are intended to conform to the standards of a reasonable patient. Patient decision aids can provide balanced, evidence-based information about treatment options and usually are easy to read, often with pictures and figures; some may include patient testimonials about different pathways.

In a 2012 review of 115 studies involving more than 33 000 patients, those who engaged in shared decision making and received a decision aid (either written, electronic, audiovisual, or web-based tool formats), as compared with usual care, had greater knowledge of the evidence, felt more clear about what mattered to them, had more accurate expectations about the risks and benefits, and participated more in the decision-making process.7 These are important outcomes of the consent process. Furthermore, early studies suggest that individuals who take a more active role in their health care decisions have a better understanding of their choices and are more likely to receive care consistent with their preferences, values, and goals.

Policy Initiatives to Advance Informed Consent With the Reasonable-Patient Standard

Why then have laws espousing a reasonable-patient standard not been successful in achieving a high-value, patient-centered approach to informed decision making? One explanation may be that the health system has not previously viewed informed consent as a value-based proposition. In a systematic review of the implementation of shared decision making,8 pervasive physician- and system-level barriers, summarized as “professional indifference” and “organizational inertia,” were found, including a lack of physician comfort with decision aids, time constraints and competing priorities, lack of reimbursement, perceived burden, and cost. Only recently have policy makers provided tangible incentives to promote informed consent that conform to a reasonable-patient standard. Washington State, for example, has enacted legislation linking shared decision making to informed consent and promoting the use of decision aids as an alternative to standard informed consent documents.4 Importantly, the state is partnering with stakeholders to establish certification criteria for patient decision aids, with the aim of endorsing only those decision aids that meet accepted standards for development and testing, are evidence based, and free of conflict of interest.7 Additionally, there is support for the concomitant training of health professionals to learn how to effectively engage in shared decision making.

The Centers for Medicare & Medicaid Services (CMS) has several initiatives to support patient participation in decision making and higher-quality informed consent. For example, CMS will now reimburse for annual lung cancer screening with low-dose computed tomography, provided that a counseling and shared decision-making visit has occurred and is documented in the medical record.9 Accountable care organizations participating in the Medicare Shared Savings Program are being evaluated on 33 quality metrics, including patient and caregiver experiences with shared decision making. The benefits of these efforts for patients, physicians, and health systems need to be evaluated.

Opportunities

This is an important moment for revitalizing reasonable-patient standards for informed consent. First, operationalizing well-intended laws will require buy-in from physicians, health systems, and payers. A starting point is to be transparent about current practices for obtaining informed consent and the potential threat to high-value, patient-centered care. For example, informed consent obtained minutes before a procedure jeopardizes patient autonomy and can lead to waste, because patients may agree to a decision they never would have made if they had the opportunity to fully consider the risks, benefits, and alternatives of the procedure. Second, expanded policy efforts are needed, such as those taking place in Washington State, that embrace shared decision making with the use of certified patient decision aids as an acceptable and preferred standard for informed consent. Third, value-based payment models that recognize high-quality informed consent practices need to be implemented and studied.

The UK case serves as a reminder that at the heart of a reasonable-patient standard is respect for patients’ informational needs; preferences, values, and goals; safety; and autonomy. By truly embracing this standard through the promotion of shared decision making, patients, the health system, and society will benefit.

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Article Information

Corresponding Author: Erica S. Spatz, MD, MHS, Section of Cardiovascular Medicine, Yale University School of Medicine, One Church St, Ste 200, New Haven, CT 06510 (erica.spatz@yale.edu).

Published Online: April 21, 2016. doi:10.1001/jama.2016.3070.

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Drs Spatz and Krumholz report receiving support from the Centers for Medicare & Medicaid Services to develop and maintain performance measures used in public reporting programs and that they are currently developing a measure of informed consent document quality. Dr Krumholz reports receiving research agreements from Medtronic and from Johnson & Johnson (Janssen), through Yale University, to develop methods of clinical trial data sharing and chairing a cardiac scientific advisory board for UnitedHealth. Mr Moulton reports that he is employed by the nonprofit organization Healthwise Inc, which produces and distributes patient education materials, and serves on a technical expert panel to provide feedback on a measure of informed consent document quality, funded by the Centers for Medicare & Medicaid Services.

Funding/Support: Dr Spatz is supported by grant K12HS023000 from the Agency for Healthcare Research and Quality Patient-Centered Outcomes Research Institute (PCORI) Mentored Career Development Program. Dr Krumholz is supported by grant U01 HL105270-05 (Center for Cardiovascular Outcomes Research at Yale University) from the National Heart, Lung, and Blood Institute.

Role of the Funder/Sponsor: The funding organizations had no role in the preparation or review of the manuscript or the decision to submit the manuscript for publication.

Disclaimer: The views presented in this article reflect those of the authors and not those of the funders/sponsors.

References
1.
Montgomery (Appellant) v Lanarkshire Health Board (Respondent) (Scotland), [2015] UKSC 11, on appeal from [2013] CSIH 3; [2010] CSIH 104 (2015).
2.
Janine Harnish v Children's Hospital Medical Center & others, 387 Mass 152 (1982).
3.
Hopper  KD, TenHave  TR, Tully  DA, Hall  TE.  The readability of currently used surgical/procedure consent forms in the United States. Surgery. 1998;123(5):496-503.
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Washington State Legislature. Consent Form—Contents—Prima Facie Evidence—Shared Decision Making—Patient Decision Aid—Failure to Use. Title 7, Chapter 770, Section 770060. Washington State Legislature website. http://app.leg.wa.gov/rcw/default.aspx?cite=7.70.060. Accessed March 17, 2016.
5.
Centers for Disease Control and Prevention (CDC), National Center for Health Statistics (NCHS) Ambulatory and Hospital Care Statistics Branch. CDC/NCHS National Hospital Discharge Survey, 2010. CDC website. http://www.cdc.gov/nchs/data/nhds/4procedures/2010pro4_numberprocedureage.pdf. 2010. Accessed March 17, 2016.
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Krumholz  HM.  Informed consent to promote patient-centered care. JAMA. 2010;303(12):1190-1191.
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PubMed
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Elwyn  G, Scholl  I, Tietbohl  C,  et al.  “Many miles to go …”: a systematic review of the implementation of patient decision support interventions into routine clinical practice. BMC Med Inform Decis Mak. 2013;13(suppl 2):S14.
PubMedArticle
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Centers for Medicare & Medicaid Services (CMS). Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N). CMS website. https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274. 2015. Accessed March 11, 2016.
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