Recently in Shared decision-making Category

The horse has left the barn. That's the conclusion of an editorial in response to the Archives of Internal Medicine study (see post below this one) on the relatively poor quality discussions men are having with their doctors on prostate cancer screening decisions.

Editiorial writers Steven Woolf and Alex Krist pose some tough questions:

"Some might even contend that the question addressed by (the study) (how often and how well is shared decision-making or SDM practiced) is beside the point--the horse having left the barn. The opportunity to embrace SDM occurs early in the diffusion of technologies, when they have not yet been adopted by the medical community as standards of care and when patients can freely choose among uncertain options. Prostate-specific antigen is at a different stage of diffusion. Today's practice environment presents few incentives or support tools for those clinicians and patients who prefer a discussion rather than simply marking a checkbox for PSA on a laboratory requisition form.

Promoting SDM under these conditions sets challenges for researchers and health care delivery systems. ...

Making SDM feasible also requires changes in the practice environment, beginning with tort reforms that protect clinicians who give patients an informed choice about cancer screening, as well as reimbursement reform to facilitate the time investment for such counseling. Procedures that allow for longer visits and access to counselors--either the primary care clinician, colleagues at practices, or "decision counselors" to whom patients can be referred--must be tested for feasibility and acceptability. Best practices for SDM should be detailed in practice guidelines for PSA screening, replacing the now vague language about informing patients before testing. In concert, messages from the public health community must do their part to shift public attitudes about screening to encourage getting facts over getting tests.

Without these efforts by researchers, health systems, public health leaders, payers, and the courts, SDM is unlikely to gain its footing in routine patient care. In the United States, where medical technologies are often adopted long before their effectiveness and safety are confirmed, the difficulties of implementing SDM for prostate cancer screening will likely recur with other modalities of care. What is ultimately required is a deeper change in culture among providers and consumers of health care to delay dissemination, resist the assumption that newer is better, wait for evidence, tolerate observation over intervention, and accept uncertainty."

An important paper in the Archives of Internal Medicine shows how the quality of the discussion men are having with their physicians about prostate cancer screening does not reflect shared decision-making. The discussion often focuses on the benefits of screening without mentioning the harms. And in fact many men weren't even asked about their preferences regarding screening.

From the paper describing the study:

The finding that 30.1% of subjects underwent PSA testing without first discussing screening... is a disconcerting finding. Only 20.6% of discussions presented both the pros and cons of screening and elicited the subject's preferences for testing.

The authors conclude:

Given the challenges of meeting these expectations in routine clinical encounters, alternative strategies, such as decision aids, need to be considered to ensure a process that engages patients in decision making, provides them with information about alternative strategies, and facilitates the incorporation of their preferences and values into the medical plan.

Disclosure: the study was funded in part by the Foundation for Informed Medical Decision Making, which supports my HealthNewsReview.org project.

Two important studies on health care decision-making in the journal PLoS Medicine were nicely summarized by MedPage Today. Excerpts:

How doctors portray clinical risks and benefits -- statistically and visually -- can influence the decisions patients make about healthcare, and whether those decisions reflect their own values, two randomized studies found. ...

One study asked patients whether they would take statins to prevent coronary heart disease (CHD) at a cost of $50 a month, knowing the risks and benefits of taking the drugs.

They found that people were more likely to choose treatment when the data were presented as relative risk reduction -- for example, telling patients they would be 30% less likely to develop CHD by taking statins -- rather than as absolute summary measures.

However, far more participants believed their understanding of and satisfaction with risk information -- and their confidence in their decisions -- were greater when natural frequency data were presented.

It seems like every day on HealthNewsReview.org we hammer away at stories that give only relative risk data - not absolute risk data as well. This is really important stuff - as shown in these studies.

The editors of the journal commented:

"It is clear ... that there is the potential for shared decision-making to be biased through the adoption of more persuasive presentations -- such as relative statistics. As a result, the underlying principle of shared decision-making -- that of empowering patients to make decisions most compatible with their values -- can be undermined."

Within the last two days, the Wall Street Journal had two stories focusing on shared decision-making in health care.

This one was on state law initiatives to support or encourage shared decision-making.

And Laura Landro wrote this piece with a more indepth look at the theory put into practice. Excerpt:

Preliminary data from the National Survey of Medical Decisions, conducted by researchers at the University of Michigan, showed that doctors are more likely to discuss the advantages of treatments while giving short shrift to the disadvantages. The study also found that doctors often offer their opinion but much less frequently ask the patient's own opinion.

"There are an increasing number of situations where there is not a clear-cut winner in terms of treatment, and patients don't get the information they should about side effects and things that could go wrong before making decisions," says Karen Sepucha, a scientist at the Health Decision Research Unit of Massachusetts General Hospital. "The result is a huge disconnect between what patients truly care about and what providers feel is most important for patients."

Though decision-aid programs cost money to deliver, they appear to save money in the long run. Studies show that when patients understand their choices and share in the decision-making process with their doctors, they tend to choose less-invasive and less-expensive treatments than they would have otherwise received. A number of states and policymakers in Washington are considering legislation that would provide funding to study the use of shared-decision-making programs and in some cases require such programs to be offered to patients as part of the informed-consent process.

A growing number of hospitals, medical groups and health plans are using decision aids offered by the Foundation for Informed Medical Decision Making, which grew out of research at Dartmouth University, for conditions where there is no consensus as to the best course of treatment.

That same Foundation supports my work on the HealthNewsReview.org project.

Should Obama Get a PSA Test? On Prostate Cancer Screening and Comparative Effectiveness. That's the headline of Dr. Bernadine Healy's blog entry on the US News & World Report website.

I felt obliged to respond online with a comment in reaction. I wrote:

Dr. Healy writes: "Prostate cancer mortality rates have plummeted in the United States over the past 20 years, coinciding with the widespread use of PSAs. (No such drop has occurred in Europe, where PSA screening, by policy, is uncommon.) This suggests—though it certainly doesn't prove—that PSA screening saves lives."

However, if more silent cancers that never would have killed American men are now being found because of more American PSA testing, then by default, the mortality rate would plummet. You're now calling more things "cancer" – many of which wouldn't have killed a man anyway. Dr. Barry Kramer of the National Institutes of Health calls it a pseudo-epidemic. So Dr. Healy’s example certainly DOESN'T prove that PSA screening saves lives.

And the entire premise of the article about whether the President should get a PSA test - while provocative and probably meant to catch eyeballs - misses the conclusion most experts reached after the recent studies. When evidence raises so many questions about PSA screening, it becomes essential that a man discuss the potential benefits AND harms with his own caregiver. It's not an item up for debate by a magazine or by a urologist who won't even see the President.

With all of the questions swirling around the issue of prostate cancer screening, there has never been a greater need for shared decision-making between physicians and their patients.

To set the scene for an informed physician-patient encounter, the Foundation for Informed Medical Decision Making - through its partner Health Dialog - now offers free online access to its excellent Shared Decision Making program, "Is a PSA Test Right For You?"

Disclosures: The Foundation funds my work on the HealthNewsReview.org project. And I worked for that Foundation throughout the 90s, and produced the original version of this prostate cancer decision aid 15 years ago.

The Foundation has been urged to make this program available to the general public for years. I'd be interested in hearing any reactions after you view it.

For years I have tried to reach journalists who unquestioningly promote prostate cancer screening in all men 50 or older - some have promoted it in all men even 40 or over. But the National Cancer Institute trial - the results of which were published today - shows that questions must be asked.

Read the study.

Read the news release from the National Cancer Institute.

AP's Lauran Neergaard wrote a good story about the shared decision-making focus of last week's Foundation for Informed Medical Decision Making (FIMDM) Policy & Research Forum in Washington, DC.

Excerpt:

A new University of Michigan study of how 3,000 patients made common medical choices suggests patients frequently have misinformation. Fewer than one in five could name the most common side effect of cholesterol-lowering statin drugs they were considering, for example. Moreover, patients said their doctors discussed treatment advantages more than the disadvantages.

As promised, I'll blog more about this Forum when I get the chance. Fascinating data worthy of more attention.

For now, you should go to the FIMDM website, and click on the middle section labeled, "Transforming the Patient Experience: Four stories of informed decision-making." The video available there is a terrific demonstration of shared decision-making through the words of four actual patient examples. Watch the video. It's time well spent.

An Australian pain specialist writes an intriguing letter to the BMJ this week, entitled, "What if back surgery was a drug?" He wrote:

"I find it fascinating that surgical treatments and medical treatments are evaluated very differently in the literature and by ethics committees. Let’s say you told a human research ethics committee (HREC) that you expected only a short to medium term reduction in radicular pain (editor's note: that means pain that radiates from the back to the legs - or sciatica) with no real improvement in disability or axial back pain for a drug treatment. You go on to say that treatment had a 70% chance of entrenching the axial back pain as permanent, a 5% chance of worsening the pain, 1% risk of permanent neurological damage, with lesser chances of major vessel damage or paraplegia, I wonder how many HRECs would approve it ? If you then presented a literature search that relied mainly on a 30 year old study with major design flaws and a couple of meta-analyses of poor data you could reasonably expect to be sent packing. By way of comparison, in Australia last year lumiracoxib was banned by the Therapeutic Goods Administration for causing fulminant hepatitis at a rate of one in 15,000, with two deaths out of an estimated 60,000 patients who received it.

Without a standard battery of outcome measures which can be used in both surgical and non-surgical trials, and without sham surgical studies, which must measure pain related disability and psychological outcomes (since there is clear evidence that these influence overall disability in a major way) it is difficult to interpret the vast but mostly useless back pain literature."

That is why evidence-based and shared decision-making - which presents a balanced presentation of tradeoffs, of harms & benefits, and of uncertainties - is so important.