In 2012, we described shared decision-making (SDM) between clinicians and patients as “the pinnacle of patient-centered care.” Since then, policy initiatives to facilitate SDM have proliferated, including coverage decisions from the Center for Medicare & Medicaid Services requiring a shared decision-making interaction and use of patient decision aids for certain tests and procedures, such as low-dose CT scans for lung cancer screening, or the Watchman left atrial appendage closure device.
The National Quality Forum (NQF) recently engaged a multidisciplinary group of stakeholders to come to a consensus on a definition of SDM:
Shared decision-making (SDM) is a process of communication in which clinicians and patients work together to make optimal health care decisions that align with what matters most to patients. SDM requires three components:
- clear, accurate, and unbiased medical evidence about reasonable alternatives — including no intervention — and the risks and benefits of each;
- clinician expertise in communicating and tailoring that evidence for individual patients; and
- patient values, goals, informed preferences, and concerns, which may include treatment burdens.
This definition keeps the focus on what is truly important: ensuring that patients have the knowledge and tools necessary to make the best health decisions with as much assistance as they want and need from their clinicians. Further, the definition highlights that SDM is not an end in itself, but a means to the end of better health decisions, those that align with what matters most to the patient.
The NQF definition does not specify how or where SDM might take place. Today, patients and clinicians can interact in many ways. Phone conversations, virtual visits, secure email, and web portals are all ways of communicating around a decision. Although face-to-face conversations are important, there are effective ways to inform and involve patients that do not even directly involve the clinician in real time. We believe there should be flexibility in the process of SDM, if there is evidence that the process used produces measurably better health decisions. Challenges with implementing the CMS requirements for SDM demonstrate the need for this flexibility.
For complicated or serious decisions, the decision-making process may unfold over time, through multiple interactions, sometimes with different clinicians, and often supported by information and counseling at multiple points along the way. A good shared decision-making approach should also facilitate involvement of friends and family members in the process, if the patient so desires. For simpler decisions, much less interaction may be required. For example, after viewing a patient decision aid prescribed by the clinical team, many patients may have all the information they need to make a decision without the need of further discussion.
In fact, we found that 38% of men who were given a decision aid on PSA screening for prostate cancer outside a visit wanted to make the decision themselves after viewing it. In the face of such strong data, should we still require these men to come in for an additional face-to-face visit to say that shared decision-making happened?
Patient decision aids (PDAs) can make important contributions to SDM. PDAs are tools to help make SDM practical in the busy world of health care delivery, where time to talk is so precious. The Cochrane Collaboration systematic review of trials of patient decision aids is now the most widely cited of all Cochrane reviews. One hundred and five trials of patient decision aids across dozens of clinical areas, and involving more than 30,000 participants, show that patients are consistently better informed when they use PDAs in the context of a health care decision in comparison to usual care. Moreover, the Cochrane review consistently shows that the use of patient decision aids is linked to improvements in decision quality in the domains we have discussed, including knowledge, involvement, and match between values and choices, without apparent harms.
These benefits were seen regardless of whether the patient decision aids were used within or outside of clinician visits. In the latter case, they are often used to prepare patients to have a better conversation about the decision with their clinicians. International standards have been developed for the development and evaluation of PDAs, and in the United States, NQF has led efforts to develop national certification standards for PDAs.
Developing Incentives and Measurements
If providers and hospitals were evaluated, and perhaps even paid, based on their ability to involve patients in medical decisions, or to tailor treatments to patients’ informed preferences, we might see more demand for PDAs and SDM. Providing clinicians with feedback about to what extent their patients feel involved in decision-making might highlight how rarely clinicians discuss the downsides of treatments or how often they misdiagnose their patients’ preferences and might motivate providers to change their communication style. Data showing how often patients have an elective surgery that they did not want might motivate administrators and health care systems to invest in effective decision-support tools and training.
Over and over, it has been shown that organizational change seldom occurs unless the desired performance is routinely measured. If we routinely implemented measures of the quality of health care decisions, in ways that would highlight how far routine care is from the SDM ideal, it would have the potential to make a huge impact on the quality of care. Practical and rigorous measures of the extent to which patients are informed, involved and receive treatments that match their preferences — that is, surveys of decision quality, now exist for a growing number of conditions. NQF recently endorsed two performance measures derived from the decision quality surveys (measures #2962 and #2958), which are available for use. The table shows items from the Shared Decision-Making Process survey that are used to assess key shared decision-making behaviors for measure #2962.
Remembering the Ethical Imperative: Informed Consent
Of course, one could raise the question of whether better decision quality without some corresponding improvement in a clinical outcome is enough. Should the impact of SDM and PDAs be ultimately assessed against traditional outcomes, such as mortality, functional status, and cost? The answer depends on whether informed consent for testing and treatment is seen as an ethical imperative. The 1982 President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research popularized the term shared decision-making as a necessary evolution of informed consent. SDM has more recently been called the “preferred standard for informed consent.”
Would we abandon the concept of informed consent for treatment if randomized trials did not show improvements in mortality or function or lower costs? We think not. The key to a patient-centered health care system is ensuring that patients are informed and involved in their health care decisions and can truly give informed consent; with further research, other beneficial outcomes may well follow, but we feel the ethical imperative is sufficient to justify the implementation of practices like shared decision-making to improve the quality of decisions.
In short, SDM is a process that helps people make better health decisions. Clinicians, payers and policymakers should neither over-specify how it should be done, nor confuse the means of SDM with the desired ends of better health decisions from the informed patient’s perspective.