“Empowered patients” and “patient-centered care” are key goals of the current health reform legislation. The idea is to get patients and their families intimately involved in making decisions about treatment and encouraging them to play a more proactive role in the course of their own medical care. In order to do this, patients must have access to up-to-date and evidence-backed information about the comparative risks and benefits associated with many interventions or diagnostic tests. Patient advocates call this the "quantitative imperative" and insist that access to such unbiased information is absolutely necessary to ensure truly shared decision-making.

But in a recent article in The Hastings Center Report, Peter H. Schwartz, an investigator at Indiana University’s Center for Bioethics, challenges this imperative. He raises the question of whether for some patients, there is such a thing as too much information. For individuals with a poor grasp of probability and mathematical concepts, argues Schwartz, quantitative risk and benefit information could actually be confusing and unhelpful; ultimately leading them to make irrational decisions about care. Mandating that all patients receive this information, he believes, is “deeply flawed” from an ethical perspective.

This is far from an academic argument. The Affordable Care Act directs the Secretary of Health and Human Services to establish standards and a certification process for educational tools to help patients and caregivers understand their treatment options. The legislation also provides grants for developing these so-called decision aids and sets up a network of “Shared Decisionmaking Resource Centers” that will provide advisory services to providers using certified aids. Eventually, provider reimbursement could be tied to use of these tools.

Groups like Dartmouth’s Center for Shared Decision Making and the Foundation for Medical Decision Making—as well as the related for-profit company Health Dialog—have been developing “decision aids” to help patients make informed choices about care that are consistent with their personal preferences. These aids can take the form of pamphlets, videos and computer programs that lay out various options for treatment or screening and then provide evidence-based information to help patients make informed—and personalized—choices. Usually viewed or read by patients outside of the doctor’s office, decision aids can provide a depth of information that would be impossible to convey in the rush of a typical 15-minute visit.

Decision aids are not widely used yet, but worldwide some 500 have already been created with the goal of helping patients make choices about treatment for early-stage breast cancer, spine surgery, bariatric (weight loss) surgery, and prostate cancer screening, among many other “preference-sensitive” medical issues. There have also been more than 55 randomized controlled trials studying the impact of these tools; a recent Cochrane review found that “decision aids improve knowledge and realistic expectations; enhance active participation in decision making; lower decisional conflict; decrease the proportion of people remaining undecided, and improve agreement between values and choice.”

In the future, it is likely that HHS-certified decision aids will have to conform to requirements drawn up by the International Patient Decision Aids Standards Collaboration (IPDAS), considered the gold-standard in the field. This group, made up of 100 participants from 14 countries, recommends that patients have access to a wealth of quantitative risk and related information.

Schwartz writes that “the IPDAS guidelines, for instance, recommend that decision aids:

• disclose the specific chances of all positive and negative outcomes from a proposed medical test or treatment,
• use ‘event rates in a defined group of patients for a specific time,’ and
• describe the chance of various outcomes in the treated (or screened) group and the untreated (or unscreened) group ‘using the same denominator’ and ‘over the same period of time’.

Schwartz continues, “For screening tests, the IPDAS guidelines assert, the decision aid should disclose the probability of a patient receiving a ‘true positive, true negative, false positive and false negative test result,’ as well as the ‘chance of disease being found with and without screening.’

Granted, this is a lot of quantitative information for the average person to digest. And as Schwartz points out, there is an epidemic of numerical illiteracy among Americans. “National surveys suggest that at least 22 percent of adults have only the most basic quantitative skills, such as counting, while another 33 percent possess only slightly more advanced skills, such as performing simple arithmetic,” he writes. “This means that more than half of adults do not have the ability to comprehend and utilize the key mathematical concepts used in quantifying risk and benefit— probability, percentage, and frequency.”

Schwartz argues that clinicians should not be required to disclose all quantitative information to all patients. Although it should be available on request, there is a subgroup of patients who cannot make a rational choice from this data, will be confused rather than enlightened and would much rather have their doctor simply make it for them. In short, this information should be optional, according to Schwartz and others who oppose what they call “mandatory autonomy.”

This makes a certain sense in theory. But in practice, the status quo illustrates just how far we are from achieving truly informed decision making or patient-centered care in all but a few select centers like Dartmouth. Rather than worrying about providing patients with too much information, Jesse Gruman, president and founder of the Center for Advancing Health—a research institute—is more worried about patients receiving too little.

In a recent post on her blog, “The Prepared Patient”, Gruman, who has been diagnosed and treated for four separate cancers, relays the story of “Sara,” a woman who had a persistent and worsening pain in her side for three days. After her primary care doctor sent Sara to the emergency room for further testing, a blood test and a chest X-ray both came back normal. “‘Do you want a CT scan?’ she was asked by an ED physician.  She replied, ‘Well I’ve already been here almost three hours. I might as well.’”

“The CT scan showed a pulmonary embolism,” writes Gruman.

“What I find interesting about this story is not the near miss of a catastrophy but rather the fact that Sara was asked to make the decision about whether to have a CT scan or not. She was given no information about possible diagnoses; there was no discussion of guidelines; no risk statistics were provided; the price of the scan was never mentioned.  It was left to her to choose, based on what?  Her schedule for the afternoon?”

Gruman’s post goes on to describe what she says are “increasingly common” accounts from patients describing similar experiences in health care, including;  “‘Do you want to take a statin?’ (in response to a high LDL reading) and ‘Do you want a chest x-ray’ (in response to a persistent, violent 8-week-old cough). No risk information provided. No trade-offs explained. Just the question.”

Perhaps these experiences represent quick and dirty attempts by rushed doctors to “include” patients in decision-making. After all, it is the rare ED doctor who has time to sit down with a patient and discuss the pros and cons of a CT scan in sufficient detail to qualify as truly informed consent. But nevertheless, patient choice without guidance is a dangerous misinterpretation of the concept of patient-centered care, shifting all responsibility to an individual without giving him any tools with which to make that decision.

Gruman, like other patient advocates, is a big fan of “informed choice.” This is fundamentally different from “informed consent;” the current practice whereby a doctor or nurse provides a synopsis of risks and benefits for a particular procedure (often using vague language such as “you may be slightly more likely to” or “there is little risk of”) and then has the patient sign a form acknowledging that he or she has received this information. A physician can present the informed consent materials (consciously or not) in a way that highlights his preference for treatment—spine surgery rather than physical therapy for back pain, for example—without giving the patient enough information to make his own choice. The Dartmouth Institute’s Center for Informed Choice makes the distinction best on its website; “In order to make an informed choice, the patient must be given unbiased medical information, and allowed to consider their personal values and preferences for their own care.”

How might a decision aid help in this process? Take the case of the patient in Gruman’s post with high LDL cholesterol. Instead of asking her directly, “Do you want to take a statin?” what if the doctor provided the patient with a computer program to review before their next visit. Maybe she can access this program on-line and it clearly lays out the known evidence about statins and heart attacks. The patient might find out that in all the studies of statins involving many groups of patients it is clear that people who have not had heart attacks or show any other signs of heart disease other than elevated cholesterol levels benefit very little from taking statins. The program might include quantitative information similar to that laid out in a recent article in Health Affairs; “if 200 people with elevated cholesterol levels, but no other indications of heart disease, took a statin every day for five years, one of them would avoid a heart attack or death (199 would be unaffected). In contrast, if 200 people with a history of heart disease or heart attack took a statin for five years, between two and ten would avoid a heart attack or death, depending on their clinical profiles.” If this information was represented with simple pictographs it could be accessible as well as enlightening. The program would then present risk and benefit information for treatment options (including rates of side-effects) based on that particular patient’s age, sex, and lifestyle factors.

The Health Affairs authors, including Floyd J. Fowler Jr., senior scientific advisor at the Foundation for Informed Decision Making—a research and policy group that develops decision-making aids—write, “With or without heart disease, there is a decision to be made about whether or not to take a statin to lower cholesterol. The best option cannot be determined without the patient’s input to determine how much weight to assign to each component—benefits, risks, and financial costs of taking statins or incurring other health-related costs."

They continue, “Shared decision making recognizes that medical decisions require interaction between patients and their doctors; that decisions be informed by the best available clinical evidence; and that decisions reflect the individual patient’s well-considered goals and concerns.”

Schwartz supports this basic idea of shared decision making; he just wants doctors to be free to pick and choose which information to present to patients. “Simply attempting to present all information to all patients, possibly through the use of decision aids, could hurt rather than help medical decision-making. Instead, careful thought about the proper way to present such information—targeted to individuals’ abilities, interests, and situations—can make an important contribution to improving prevention and medical care more generally.”

Again, this makes a certain amount of sense in a perfect world where every doctor knows his or her patient intimately. But this simply is not the case in our highly fragmented health care system. Leaving it up to doctors to decide which information they present to individual patients will just serve to preserve the paternalistic undercurrent that has guided medicine for centuries.

The better suggestion comes from Peter A. Ubel, a professor of marketing, medicine and public policy at Duke University who wrote a commentary in the Hastings Report that accompanies Schwartz’s article. Ubel believes that the key will be to continue experimenting with, developing and refining decision aids as more evidence-based information becomes available. “The ethics of autonomy and informed consent are a moving target because behavioral scientists continue to find new ways to improve decision-making. We should not take people’s cognitive limitations as a fait accompli. Instead, we should experiment with ways of overcoming them.”