Thaddeus Mason Pope, JD, PhD
Law and Ethics in Oncology explores the legal and ethical issues oncologists must be aware of in this era of precision medicine and changing health-care policy, both to protect patients’ rights and to safeguard against potential legal jeopardy.
Overwhelming evidence shows that patient decision aids, such as educational booklets, videos, or Web-based tools that take into account patients’ values and personal preferences, hold enormous promise for improving the informed consent process. Patient decision aids both reduce unwanted medical treatment and help ensure that care is value-congruent. Nevertheless, few clinicians use these aids with their patients. Here, we describe the expanding legal and policy incentives for clinicians to use patient decision aids.
Oncology Treatment Is Preference Sensitive
A substantial amount of cancer treatment is “preference sensitive.” As this term suggests, the patient’s personal values determine the optimal choice at decision junctures. There is no clear objective evidence to support one intervention over another. Take, for example, typical surgical options for the treatment of early-stage breast cancer: mastectomy and lumpectomy. Although the impact on survival is about the same, other more personal outcomes are quite different.1 There is no neutral and objective way to comparatively assess the advantages and disadvantages of these two options.
Early-stage breast cancer is not a unique example. Throughout cancer treatment, clinicians often cannot determine the “correct” or “best” option solely as a matter of medical science. Instead, there are legitimate alternative options that involve significant trade-offs. For example, some people will prefer to accept a small risk of death to improve their physical or mental function. Others will not make such a trade-off. Which option is best for any given patient is heavily value-laden. Consequently, decisions about these interventions should reflect the patient’s own values and preferences.
Quality of Informed Consent Is Abysmal
Unfortunately, clinicians rarely effectively assess whether the treatment they recommend matches the values and preferences of the patient receiving that treatment. In other words, clinicians fail to determine whether patients “want” the treatments they are receiving. Although they are skilled at diagnosing the patient’s body, they often devote far less effort to diagnosing the patient’s preferences.2 Clinicians elevate clinical diagnosis over preference diagnosis.
No matter what form they take, the best patient decision aids provide an appropriate presentation of the condition and treatment options, benefits, and harms.— Thaddeus Mason Pope, JD, PhD
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There is ample evidence of the problem, yet just a few examples suffice to describe the magnitude of the problem.3,4 Recent studies show, for example, that one-third of patients with advanced, incurable non–small cell lung cancer believe their cancer to be curable.5 One-half of patients do not know the stage of their cancer.6 Nearly 70% of patients hold opinions about their survival prognosis that differ from those of their oncologists.7 Finally, and perhaps most alarming, 95% of patients with advanced incurable cancer do not adequately understand their prognosis.8,9
What Are Patient Decision Aids?
Calls for improvement are widespread.10 One of the most promising paths forward is the use of patient decision aids. As previously described, these evidence-based educational tools take various forms, including educational literature with graphics, photographs, and diagrams11 as well as decision grids, videos, and Website-based interactive programs such as sequential questions with feedback.12 Patient decision aids might even include “structured personal coaching.” There are already more than 70 cancer-related patient decision aids available for clinical use.13
These decision aids help patients do three things. First, they help patients understand the various treatment options available to them, including the risks and benefits of each choice. Second, they help patients communicate their beliefs and preferences related to their treatment options. Third, they help patients decide, together with their clinicians, what treatments are best for them based on their treatment options, scientific evidence, circumstances, beliefs, and preferences.
No matter what form they take, the best patient decision aids provide an appropriate presentation of the condition and treatment options, benefits, and harms. They have three key advantages over the traditional informed consent process, which tends to be too lengthy and technical to facilitate patient engagement. First, the information in the patient decision aid is accurate, complete, and up to date. Second, it presents the information in a balanced manner. Third, it conveys the information in a way, often graphically, that helps patients understand and use it. In short, patient decision aids are truly patient-centered.
Patient Decision Aids Improve Shared Decision-Making
Robust evidence shows that shared decision-making using patient decision aids meaningfully empowers patients. Much of this evidence applies specifically to cancer treatment.14-17 In contrast to traditional informed consent, shared decision-making deliberately considers both the best scientific evidence available as well as the patient’s values and preferences.
Despite robust evidence of the effectiveness of patient decision aids as well as influential recommendations to expand their use, their widespread adoption has not materialized.— Thaddeus Mason Pope, JD, PhD
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Patient decision aids purposely inform and guide both these elements. First, they provide relevant information on health-care options, helping patients gain significant knowledge and understanding of their choices. Second, they give patients control over the pace and timing of their education, allowing them to absorb the information at their own comfort level.
Finally, patient decision aids prompt reflection, helping patients to form and clarify their values and preferences. Patient decision aids thereby enhance deliberation by helping patients discover and associate their values and preferences with their health-care options and then communicate those associations to their provider. Together, the provider and patient make a treatment choice that aligns with the patient’s values. Patient decision aids help the patient become “engaged, equipped, empowered, and enabled” in their care.18
More than 130 randomized clinical trials demonstrate that patient decision aids significantly enhance patients’ knowledge of treatment options, risks, and benefits. Summarizing the benefits identified in these studies, a recent review by Cochrane Library concluded that using patient decision aids leads patients to:
In short, once patients understand their treatment choices, they are better able to align their care with their preferences and values. For these reasons, influential health-care organizations, including the Institute of Medicine, The Joint Commission, and the National Quality Forum have recognized these benefits and have encouraged the widespread adoption of patient decision aids.20-22
Few Clinicians Use Patient Decision Aids With Their Patients
However, despite robust evidence of the effectiveness of patient decision aids as well as influential recommendations to expand their use, their widespread adoption has not materialized. Studies show the use of patient decision aids has “not become the norm”23; they remain “seldom adopted”24 and “rare in everyday practice.”25 Although the research is clear, implementation remains sparse and incomplete.26
Legal and Policy Incentives to Use Patient Decision Aids
To encourage clinicians to use patient decision aids with their patients, both payers and policymakers are developing a growing array of incentives. Notably, the Centers for Medicare & Medicaid Services (CMS) is increasingly predicating payment on the use of these aids. For example, CMS no longer reimburses lung cancer screening with low-dose computed tomography unless the patient has a “shared decision-making visit” with his or her physician that includes “the use of one or more decision aids.”27 The State of Washington is taking a different approach and incentivizing the use of patient decision aids by linking their use to enhanced liability protection. For example, a statute offers clinicians more protection against a failure-to-inform lawsuit if they engaged in shared decision-making with a patient decision aid.28
Policymakers, payers, medical malpractice insurers, and others will even more broadly link the use of patient decision aids to rewards and penalties once there is a certification process that assures their integrity. Just as drugs and medical devices must be approved by the U.S. Food and Drug Administration to ensure they are safe and effective for patients, regulatory oversight is also needed to ensure that patient decision aids meet a minimum level of quality and safety.11 Although the only operational certification process exists in the State of Washington, nationwide federal certification is coming.29,30
Today, there is a discernible, albeit slow, shift away from traditional informed consent processes toward shared decision-making processes incorporating the use of patient decision aids. To obtain the benefits of liability protection and reimbursement incentives, clinicians should prepare to modify their informed consent processes by supplementing traditional patient communication with patient decision aids. ■
Dr. Pope is Director of the Health Law Institute and Professor of Law at the Mitchell Hamline School of Law in Saint Paul, Minnesota (www.thaddeuspope.com).
Editor’s Note: The Law and Ethics in Oncology column is meant to provide general information about legal topics, not legal advice. The law is complex, varying from state to state, and each factual situation is different. Readers are advised to seek advice from their own attorney.
Disclaimer: This commentary represents the views of the author and may not necessarily reflect the views of ASCO or The ASCO Post.
DISCLOSURE: Dr. Pope reported no conflicts of interest.
1. Center for the Evaluative Clinical Sciences: Preference-Sensitive Care: A Dartmouth Atlas Project Topic Brief. Available at http://www.dartmouthatlas.org/downloads/reports/preference_sensitive.pdf. Accessed April 17, 2018.
2. Mulley AG, Trimble C, Elwyn G: Stop the silent misdiagnosis: Patients’ preferences matter. BMJ 345:e6572, 2012.
3. Temel JS, Shaw AT, Greer JA: Challenge of prognostic uncertainty in the modern era of cancer therapeutics. J Clin Oncol. August 22, 2016 (early release online).
4. Heckinger EA, Bennett CL, Davis T, et al: Health literacy and cancer care: Do patients really understand. J Clin Oncol 22:6045, 2004.
5. Temel JS, Greer JA, Admane S, et al: Illness understanding in patients with advanced lung cancer. J Clin Oncol 27(15 suppl):9515, 2009.
6. Sivendran S, Jenkins S, Svetec S, et al: Illness understanding of oncology patients in a community-based cancer institute. J Oncol Pract 13:e800-e808, 2017.
7. Gramling R, Fiscella K, Xing G, et al: Determinants of patient-oncologist prognostic discordance in advanced cancer. JAMA Oncol 2:1421-1426, 2016.
8. Epstein AS, Prigerson HG, O’Reilly EM, et al: Discussions of life expectancy and changes in illness understanding in patients with advanced cancer. J Clin Oncol 34:2398-2403, 2016.
9. Cavallo J: Why patients’ understanding of their prognosis often differs from their oncologists’: A conversation with Ronald M. Epstein, MD. The ASCO Post, September 25, 2016.
10. Sekeres MA, Gilligan TD: Informed patient? Don’t bet on it. The New York Times, March 1, 2017.
11. Pope TM: Certified patient decision aids: Solving persistent problems with informed consent law. J Law Med Ethics 45:12-40, 2017.
12. Cavallo J: How video support tools help patients make informed decisions about end-of-life care: A conversation with Areej El-Jawahri, MD. The ASCO Post, November 25, 2016.
13. The Ottawa Hospital Research Institute: Patient decision aids: A to Z inventory of decision aids. Available at https://decisionaid.ohri.ca/AZsearch.php?criteria=cancer&search=Go. Accessed April 17, 2018.
14. Hawley ST, Li Y, An LC, et al: Improving breast cancer surgical treatment decision-making: The iCanDecide randomized clinical trial. J Clin Oncol 36:659-666, 2018.
15. Leighl NB, Butow PN, Tattersall MH: Treatment decision aids in advanced cancer: When the goal is not sure and the answer is not clear. J Clin Oncol 22:1759-1762, 2004.
16. Reuland DS, Cubillos L, Brenner AT, et al: A pre-post study testing a lung cancer screening decision aid in primary care. BMC Med Inform Decis Mak 18:5, 2018.
17. Martínez-Alonso M, Carles-Lavila M, Pérez-Lacasta MJ, et al: Assessment of the effects of decision aids about breast cancer screening: A systematic review and meta-analysis. BMJ Open 7:e016894, 2017.
18. Wisconsin Hospital Association: ‘e-Patient Dave’ Urges Patients to be Engaged, Equipped, Empowered and Enabled: Wisconsin Rural Health Conference, June 18–20, 2014. Available at www.wha.org/Data/Sites/1/education/2014Rural/deBronkart6-20-14.mp4. Accessed April 17, 2018.
19. Stacey D, Légaré F, Lewis K, et al: Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 4:CD001431, 2017.
20. The Joint Commission: Informed consent: More than getting a signature. Quick safety issue. February 21, 2016. Available at https://www.jointcommission.org/assets/1/23/Quick_Safety_Issue_Twenty-One_February_2016.pdf. Accessed April 20, 2018.
21. Institute of Medicine (US) Committee on Quality of Health Care in America: Crossing the quality chasm: A new health system for the 21st century; Washington, DC, National Academies Press, 2001.
22. National Quality Forum: National Quality Partners Shared Decision Making in Healthcare. Available at http://www.qualityforum.org/National_Quality_Partners_Shared_Decision_Making_Action_Team_.aspx. Accessed April 17, 2018.
23. Alston C, Berger Z, Brownlee S, et al: Shared decision-making strategies for best care: Patient decision aids. National Academy of Medicine, September 18, 2014. Available at http://nam.edu/perspectives-2014-shareddecision-making-strategies-for-best-care-patient-decisionaids. Accessed April 17, 2018.
24. Gillick MR: Re-engineering shared decision-making. J Med Ethics 41:785-788, 2015.
25. Hole-Marshall L: State legislation promotes use of shared decisionmaking through demonstration project, learning collaborative, and recognition of decision aids as informed consent. AHRQ Health Care Innovations Exchange, August 28, 2013. Available at https://innovations.ahrq.gov/profiles/state-legislation-promotes-use-shared-decisionmaking-through-demonstration-project-learning. Accessed April 17, 2018.
26. Durand MA, Barr PJ, Walsh T, et al: Incentivizing shared decision making in the USA–Where are we now? Healthc (Amst) 3:97-101, 2015.
27. Centers for Medicare & Medicaid Services: Decision memo for screening for lung cancer with low dose computed tomography (LDCT) (CAG-00439N). Available at www.cms.gov/medicare-coverage-database/details/nca-decisionmemo.aspx?NCAId=274. Accessed April 17, 2018.
28. Wash. Rev. Code § 7.70.060.
29. Washington State Health Care Authority: Shared decision-making: Helping patients make informed decisions about their health care. January 26, 2018. Available at www.hca.wa.gov/about-hca/shared-decision-making-helping-patients-make-informed-decisions-about-their-health-care. Accessed April 17, 2018.
30. National Quality Forum: National standards for the certification of patient decision aids, December 2016. Available at www.qualityforum.org/Publications/2016/12/National_Standards_for_the_Certification_of_Patient_Decision_Aids.aspx. Accessed April 17, 2018.