By Sarah Alwardt, PhD
Long a conceptual cornerstone of patient-centered care, shared decision-making is emerging as an increasingly valuable tool for strengthening the patient experience, enhancing patient engagement, and improving clinical outcomes.
Driving more collaborative relationships between the patient and physician are the growing complexities and expanding options surrounding disease treatment, as well as consumers’ increased access to clinical information and desire to exert greater control over their care.
Meaningful physician-patient communication regarding treatment decisions and patient preferences can generate multiple benefits. These include improved outcomes, greater patient engagement, better compliance, reduced anxiety, quicker recovery, and lower demand for healthcare resources (Agency for Healthcare Research and Quality, 2013).
Providers, payers, and pharmaceutical manufacturers consequently must consider and incorporate shared decision-making opportunities and mechanisms when developing therapeutic pathways, differentiated treatment options, and reimbursement strategies.
The limitations of informed consent
At its core, shared decision-making is about “respecting, protecting, and promoting patients’ autonomous choices” (Childress & Childress, 2020). The concept gained traction in the early 1980s in response to perceived shortcomings in the legal doctrine of informed consent. Widely used since the mid-1950s, informed consent requires physicians to disclose relevant treatment information and obtain patient permission before performing medical interventions.
Critics asserted that informed consent provided little or no guidance regarding how the patient might understand, process, or respond to the disclosed information, nor how they might weigh risks and benefits surrounding a particular treatment (Childress & Childress, 2020).
In 1982, a presidential commission considering ethical problems in medicine proposed that “ethically valid consent is a process of shared decision-making based upon mutual respect and participation,” and not simply the recitation of risks associated with a specific treatment (President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, 1982). The report built on the influential work of lawyer-psychiatrist Jay Katz, who espoused the idea that optimal medical relationships were joint undertakings based on the physician and patient sharing the burden of decisions (Childress & Childress, 2020).
The rise of the informed consumer
In the years since the commission’s report, shared decision-making has continued to gradually supplant the paternalistic, “clinician knows best” mindset that long dominated medicine. The proliferation of health information available via the internet, consumers’ increasing willingness to challenge medicine’s status quo, and the ever-expanding treatment options for many disease states have accelerated both the need for, and acceptance of, shared decision-making.
Options for treating many cancers in the past, for example, were frequently limited to chemotherapy and radiation. Now, modalities that include a range of hormonal, immuno-, and targeted therapies have dramatically increased available choices for some cancers.
Fundamentally, shared decision-making is about reducing treatment variations that result from physician preference, training, personal experience, or local norms. Instead, the only preferences driving variations of care should be those of the patient (Agency for Healthcare Research and Quality, 2017). The concept hinges on two simple premises:
- Consumers with access to clinical information can and will participate in the medical decision-making process by asking informed questions and expressing personal values and opinions about their conditions and treatment options
- Clinicians will respect patient goals and preferences and use them to guide recommendations and treatments
Experts say shared decision-making is most beneficial when there is no single right answer regarding treatment and tests and when:
- More than one reasonable treatment or screening option exists
- No one option presents a clear advantage
- The possible benefits and risks of each option impact patients differently (National Learning Consortium, 2013)
Diverse core values
A recent focus group study conducted by Avalere highlighted the value of shared decision-making by illuminating the extent to which patients confronting the same serious illness may have different treatment priorities.
The focus groups included patients with triple-negative breast cancer, which is among the most aggressive, difficult to treat, and frequently reoccurring of breast cancers. In response to questions about treatment options, patients identified multiple factors that influenced their decisions:
- 71% of participants said they considered longevity and survivability when making their initial treatment decisions
- 47% prioritized quality of life, which included overall health impacts and the ability to continue caring for children, spending time with family, and continuing to work
- 22% said limiting the duration of treatment was a factor in driving treatment choices
- 18% mentioned their provider’s medical opinion and trust in their care team as central to their treatment decision-making
The results belie the myth that extending life inevitably is the primary, if not sole, objective of patients facing life-threatening illness, and thus underscore the importance of uncovering and honoring differing priorities through joint decision-making.
Implementing shared decision-making
As self-evident as the concept may seem, effective shared decision-making requires that both providers and patients be equipped to meaningfully engage around health topics. For example, it is important that the topic be introduced effectively. The Informed Medical Decision Foundation offers physicians the following suggested language for initiating shared decision-making discussions (National Learning Consortium, 2013):
- “Sometimes things in medicine aren’t as clear as most people think. Let’s work together so we can come up with a decision that’s right for you.”
- “People have different goals and concerns. As you think about your options, what’s important to you?”
- “Do you want to think about this decision with anyone else? Someone who might be affected by the decision? Someone who might help sort things out?”
The Informed Medical Decision Foundation also has developed six steps to guide providers through the shared decision-making process (National Learning Consortium, 2013):
- Invite patients to participate: Let them know that they have options and that their goals and concerns are a key part of the decision-making process.
- Present options: Ensure patients are aware of all available options.
- Provide information on benefits and risks: Offer balanced information based on the best available scientific evidence. Check back with patients to be sure they understand.
- Assist patients in evaluating options based on their goals and concerns: To understand patients’ preferences, ask them what is most important to them and what they are concerned about.
- Facilitate deliberation and decision-making: Let patients know they have time to think things over and ask them what else they need to know or do before they feel comfortable making a decision.
- Assist patients in following through on the decision: Lay out the next steps, check for understanding, and discuss any possible challenges in carrying out the decision.
For their part, patients need to take responsibility for accessing information on a specific treatment topic and must be willing to convey their goals, fears, questions, and priorities to clinicians. Patient decision aids focused on specific disease states and treatments can improve medical literacy and advance shared decision-making.
These aids can be presented in many forms, including web copy, infographics, printed material, videos, and webinars. Regardless of the delivery, decision aids should “explain the issues fairly and clearly, highlighting the pros and cons of each option, and providing support for users to clarify and express their personal goals and preferences” (Agency for Healthcare Research and Quality, 2017). The aids also should be balanced and not encourage or emphasize one approach over another.
Barriers to shared decision-making
One of the challenges facing clinicians is ensuring decision aids are up-to-date and have kept pace with changing treatment protocols. Additionally, it is important that the clinician develop strategies for communicating with all patients effectively, regardless of a given patient’s socioeconomic status or level of medical literacy.
More broadly, challenges to shared decision-making include “the fundamental power differential between doctors and patients in clinical care or research, residual paternalistic tendencies among many clinicians, and the fears of many patients that they will be labeled ‘difficult’ and receive less adequate care if they participate too actively or assertively in decision making” (Childress & Childress, 2020).
Many clinicians likewise may assume they already practice shared decision-making, “but evidence suggests a perception-reality gap because of misconceptions about the nature of shared decision-making, the skill it requires, the time it takes, and the degree to which patients, families, and [caregivers] wish to share in decision making” (Agoritsas et al., 2015).
A broader framework for incorporating the patient voice
In 2019, Avalere convened a panel of industry representatives to collaboratively develop guidance for more effectively incorporating patient perspectives into healthcare decision-making. While not a shared decision-making tool per se, the framework does create a vehicle for reflecting patient preferences at the population and individual level.
The framework was designed to address the absence of routine collection of patient-centered data and concurrent lack of standardized methods for incorporating patient-defined value into the larger value-based care environment.
The framework identifies six focus areas that researchers, regulators, providers, payers, and other stakeholders can pursue to expand the breadth of patient-centered data and better reflect the patient perspective. These include:
- Quality of Life (QoL): Selection of validated QoL instruments to support collection of QoL data for value assessment calculations and treatment decision-making
- Real-World Evidence (RWE) and Guidance for Utilizing Patient-Reported Outcomes: Evaluation of the current state of RWE and identification of ways RWE can encourage incorporation of the patient perspective into value assessments
- Patient Preferences: Integration of patient preference data at point of care and in value-assessment methodologies
- Patient-Centered Data Structure for QoL and Real-World Data (RWD): Structural modifications to the existing patient-centered data architecture to promote RWD collection
- Evolution of FDA Requirements: Identification of regulatory channels to advance appropriate aggregation of RWD
- Increased Availability of Patient-Centered Data: Support of initiatives and tools that can promote the availability of data related to treatment costs, complexity of various medication regimens, and patient preferences
Within each focus area, the panel developed consensus-based recommendations that stakeholders may pursue to expand the breadth of patient-centered data and to better reflect the patient perspective in their respective workstreams. To ensure their practicality, the guidelines were evaluated in collaboration with two cancer-focused value assessment organizations, the American Society of Clinical Oncology and the National Comprehensive Cancer Network.
The evolving ecosystem
As healthcare continues to transition to a patient-centered approach that can effectively address social determinants of health, shared decision-making must play an expanding role at each step in the care process. Incorporating patient preferences may prove especially important for pharmaceutical manufacturers, as both the costs and diversity of treatment pathways increase—notably in the areas of cancer care.
It is not inconceivable, for example, that reimbursements for some medications may eventually be tied to demonstrated shared decision-making or clinical pathways that better take patient preferences into account. However, creating this kind of ecosystem requires consensus among all stakeholders regarding the intrinsic value of shared decision-making and a commitment to developing financial and quality metrics that both demonstrate and enforce its importance.
Sarah Alwardt, PhD, is a senior vice president at Avalere Health leading Avalere’s healthcare transformation practice. An accomplished leader with multinational experience in strategy, research, operations, and technology innovation, Alwardt delivers data-driven insights and real-world evidence to stakeholders across the healthcare ecosystem.
Agency for Healthcare Research and Quality. (2013, June). Strategy 6I: Shared decisionmaking. https://www.ahrq.gov/cahps/quality-improvement/improvement-guide/6-strategies-for-improving/communication/strategy6i-shared-decisionmaking.html
Agency for Healthcare Research and Quality. (2017, July). The CAHPS ambulatory care improvement guide: Section 6.I. Shared decision-making. https://www.ahrq.gov/sites/default/files/wysiwyg/cahps/quality-improvement/improvement-guide/6-strategies-for-improving/communication/cahps-strategy-section-6-i.pdf
Agoritsas, T., Heen, A. F., Brandt, L., Alonso-Coello, P., Kristiansen, A., Akl, E. A., Neumann, I., Tikkinen, K. A. O., van der Weijden, T., Elwyn, G., Montori, V. M., & Guyatt, G. H. (2015, February 10). Decision aides that really promote decision making: The pace quickens. The BMJ, 350, g7624. https://doi.org/10.1136/bmj.g7624
Childress, J. F., & Childress, M. D. (2020, May). What does the evolution from informed consent to shared decision making teach us about authority in health care? AMA Journal of Ethics, 22(5), E423-E429. https://doi.org/10.1001/amajethics.2020.423
National Learning Consortium. (2013, December). Shared decision making fact sheet. https://www.healthit.gov/sites/default/files/nlc_shared_decision_making_fact_sheet.pdf
President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. (1982, October). Making health care decisions: The ethical and legal implications of informed consent in the patient practitioner relationship. https://repository.library.georgetown.edu/bitstream/handle/10822/559354/making_health_care_decisions.pdf