A lot has been written about empowering patients. Unfortunately, effective tools for making that possible still aren't widely available.
But that may soon change. Over the past 30 years, there has been a movement to develop educational materials that empowers patients to engage in shared decisionmaking with their physicians. Thanks to a recent CMS decision, the movement may finally be nearing a tipping point.
Last February, as part of its decision to pay for routine CT scans for people who have smoked at least a pack of cigarettes a day for 30 years, the CMS said physicians recommending the test must engage in shared decisionmaking with asymptomatic chronic smokers that uses a decision aid.
The aids must include a description of the benefits and harms of screening and follow-up diagnostic testing, the problem of overdiagnosis from false-positive results and total radiation exposure.
Patients tend to be conservative. In 2009, Group Health in Washington state made shared decisionmaking sessions mandatory between orthopedists and prospective knee and hip replacement patients.
A retrospective study published in Health Affairs found that making patients aware of the risks and benefits of the surgeries led to 26% fewer hip replacements and 38% fewer knee replacements at Group Health. The overall cost reduction from patients opting for less invasive approaches was 12% and 21%, respectively.
This paralleled the results of seven randomized trials that measured the effects of empowering patients with shared decisionmaking tools before elective surgeries. The use of decision aids, which are usually pamphlets or computer software accompanied by physician explanation, resulted in a 25% reduction in elective surgeries.
Medicare now proposes to expand use of shared decisionmaking. In November, the CMS added the requirement to its proposal to pay for insertions of a controversial new heart device from Boston Scientific called the Watchman, which is designed to prevent strokes in the 3 million Americans with atrial fibrillation.
The device is touted as an alternative to warfarin, a generic blood-thinning medication for stroke prevention in AFib patients that's been around for nearly 70 years. Warfarin's big problem is that in about 7% of patients, it causes internal bleeding, which can also trigger strokes.
When the U.S. Food and Drug Administration approved the Watchman for a limited set of AFib patients last March, it gave the device a decidedly mixed review. Two clinical trials suggested warfarin was better in preventing strokes caused by a clot that blocks a blood vessel in the brain. However, the number of strokes caused by bleeding in the brain was lower with the Watchman.
The CMS, in its call for shared decisionmaking before patients undergo the procedure, said the decision aid used by doctors and patients must be “evidence-based” and discuss “the benefits and harms.” That language raises an important issue: Who decides what evidence to include and who monitors the content of the discussion guide?
For 30 years, the creation of patient decision aids was left to their boosters, which included a few not-for-profits such as Healthwise, which is now part of the Informed Medical Decisions Foundation. The group has a library of 170 patient decision aids.
But in recent years, several for-profit companies such as Emmi and Health Dialog have gotten into the business. As Medicare raises the stakes, it's not hard to imagine self-interested parties—such as Boston Scientific, for instance—providing financial support to either for-profit or not-for-profit institutions that create patient decision aids. How risks and benefits are portrayed matters. Sadly, not every organization is immune from letting funders influence their choices.
That's why standards must be established for this emerging field. Great Britain and Canada are far ahead of the U.S. in the use of aids. More than a decade ago, researchers in the two countries spearheaded the creation of the International Patient Decision Aid Standards Collaboration, which has created standards for their content and development that include conflict-of-interest rules.
U.S. payers and providers seeking to boost patient satisfaction while holding down costs will reap enormous benefits from a wider use of patient decision aids. But they, along with regulators, need to unite around rules for their creation and dissemination that don't allow self-interested parties to turn this promising tool into another form of product marketing.
