The People and Evidence-Based Medicine: We are All Above Average

Jessie Gruman
September 1st, 2010

Jessie Gruman

From the August 30 New York Times:

“Every driver on average thinks he’s in the wrong lane, Dr. Redelmeier said.  “You think more cars are passing you when you’re actually passing them just as quickly.  Still, you make a lane change when the benefits are illusory and not real.”

Meanwhile, Katie Hafner, author of the article, notes that “changing lanes increases the chance of collision three-fold.”

“Out of 50,000 radical prostatectomies performed every year in the United States alone,” Dr. Scholz writes, “more than 40,000 are unnecessary.”

In his review of Dr. Schloz’s book, Invasion of the Prostate Snatchers: No More Unnecessary Biopsies, Radical Treatment or Loss of Sexual Potency, NYTimes writer Dana Jennings, asks: “Was my life worth the 47 other prostatectomies that probably didn’t need to be performed?  I don’t know.  I’m a man, not a statistic.”

These two adjacent articles remind me why the idea of acting on the basis of evidence is so emotionally fraught for us and for our physicians.  Evidence is produced based on averages.  Policies, rules, standards and guidelines are based on those averages.  We, however, experience traffic and illness and the events of our lives as unique individuals.

We see exceptions to the evidence everywhere: your 85-year-old, fit-as-a-fiddle neighbor who has smoked a pack a day since she was 12; your co-worker whose metastatic cancer was treated with an off-label drug two years ago and she’s doing great; my brother, a horrible driver who has never had an accident…

Further, we tend to see ourselves as exceptional: I can exceed the speed limit and change lanes because I am a better-than-average driver.  I don’t care if that drug didn’t stop most people’s cancer: it worked for a few of them and I believe it will work for mine.

Sometimes we experience evidence – and the laws and guidelines that they support – as an affront to our autonomy – to our ability to choose what we think is best for ourselves and our loved ones – regardless of the averages, regardless of the guidelines or regulations.  While this general belief may be tinged with partisan colors, it bears no political baggage when a father seeks the best care for his child’s pain or a woman tries to save the life of her beloved. It is a heavy lift for a person to endorse evidence-based approaches, when she feels such approaches pit her personal safety, life, and future against regulations and laws based on averages.

Many physicians also feel their personal and professional autonomy are undermined as they are forced through clinical policies and incentives to weigh evidence-based guidelines against their own experience and their responsibility to the patient in front of them, described in the NEJM by Jerome Groopman.

Comparative effectiveness research, evidence-based guidelines and performance standards are all tools aimed at improving the effectiveness of health care based on evidence.  In the coming months, they will be strengthened by the recently passed Patient Protection and Affordable Care Act.  These approaches are covered in the news and they are controversial; their shortcomings and flaws are the topic of blogs and political campaigns.

Despite the heated rhetoric and the admitted bluntness of the instruments of evidence-based clinical policy, it is difficult to imagine how progress toward more effective health care will be widely incorporated into delivery without them.  These are the tools available.  They must be constructed and implemented wisely, which means in part, that the perspectives and priorities of patients and families are incorporated at each step of their development and dissemination.

But the success of these approaches in achieving the aim of better health for each of us as individuals depends on our active participation in decisions about our care – learning, questioning and deliberating with our physician to find the delicate balance between the evidence and our unique needs to chart the course of treatment that will best ease our suffering.

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Matt Seeks Health Insurance: A Young Adult Falls Through the Cracks of Health Reform

Trudy Lieberman
August 26th, 2010

Trudy LiebermanA young man I know who is 25 finds himself in a health insurance pickle.  The much-touted provision of the new reform law that lets young adults stay on his parents’ insurance policy is no help, leaving him with the choice of very costly insurance or going without.

Matt had heard about the new law and checked in with his parents, both retired federal employees.  Neither is covered by Medicare.  That’s good because young adults whose parents are on Medicare are out of luck.  Matt’s parents get their retiree coverage from the Federal Employees Health Benefits Program (FEHBP), and it turns out that young adults are eligible under the new law to be added to their parents’ FEHBP plans.

But there’s a catch.  Even though the reform law says they have a right to coverage as of September 23, 2010, the law governing THE FEHBP says young adults cannot get FEHBP coverage until January 1, 2011 when a new plan year begins.  There’s a chance Congress may change the law when it returns from recess, but no guarantee. Matt turns 26 in May. Is it worth it to enroll?  What does he do in the meantime? 

He’s between jobs, having left a PhD engineering course to become a math teacher.  A year from now when he is employed by a school district, he’ll no doubt have insurance, but that can be an eternity if something goes wrong. He had insurance as a grad student and researcher but was not eligible for COBRA.  He says he couldn’t afford it anyway.

Bard College, where he is earning a master’s degree through the Math for America program, does offer students insurance.  Like a lot of university insurance plans, though, it doesn’t cover much.  I looked at it and think that no one who wants good coverage would be helped by this plan. The policy disclosed up front that it was intended to supplement a student’s other medical coverage and cover things the main insurance did not.  But that’s not useful if you have no other insurance.

The college’s limited benefits policy offers basic accident benefits up to $1,000.  It also pays a dismemberment benefit caused by an accident—for instance, up to $1,500 if he loses one hand and one foot or one hand and the sight of one eye.  Not a lot of compensation there.  Sickness benefits are similarly skimpy—a maximum of $750 for hospital care and a maximum of $1,000 if he needs surgery.  The insurer will pay up to $60 per day for the physician services if he lands in the hospital.

It’s not hard to see why he’s declining the coverage.

Matt next investigated Healthy New York, a state program designed to help poor people buy insurance.  The coverage is decent enough with premiums in the $200 to $300 range for individuals if they qualify.  However, his income is a few hundred dollars too much.  The state website I looked at says his monthly gross income cannot exceed $2,257.  The rules also say that his current employer (presumably Bard College) cannot offer coverage.  It does. Sort of.  Does that disqualify him?

The Healthy New York website says that even if he has a limited benefits policy, he might qualify anyway if the policy is not comprehensive.  According to the state, that means “it includes only medical benefits or only hospital benefits, but not both.”  The Bard policy offers skimpy benefits for both.  Another strike here?

His last option is an individual policy offered by a commercial insurance company.  In New York, anyone can get a policy even if they have serious health problems.  Matt has none.  The New York State Insurance Department says that premiums for an HMO, the least expensive choice, would range from $752 to $2,544 each month.  Even the lowest amount is a hefty percentage of his monthly salary.  If he doesn’t buy coverage, his last option is to seek care at one of the community clinics in the city that will treat him and ask him to pay on a sliding scale based on his income.  

Matt wants to have coverage.  He does not fit the insurance company stereotype of a dare devil or thrill seeker, willing to take chances.  He is simply another petitioner to a health insurance system that, despite the recent drive toward universal coverage, still leaves Matt and people like him falling through the cracks.

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Antibiotic Resistance, Evidence-Based Medicine and the End of the World as We Know It

Jessie Gruman
August 24th, 2010

Jessie GrumanDelivering evidence-based medicine is a deceptively elegant and simple goal.  But new findings about the increase in antibiotic resistance challenge us to consider just how complicated and challenging it is to actually define and deliver evidence-based care. 

 “Are we ready for a world without antibiotics?”  A recent paper, in Lancet Infectious Diseases, documented the spread of a gene (NDM1) that passes between certain types of common bacteria – such as E. coli and Klebisella pneumonia – and makes them resistant to all the powerful last-line antibiotics available to treat them.  Apparently, this gene is widespread in India and has arrived in the UK, thanks to the popularity of global travel and medical tourism for such procedures as pregnancy, cosmetic surgery and transplants. Next stop, big cities in the US, no doubt.

Tim Walsh, one of the authors of the study in an interview with The Guardian, said, “In many ways, this is it,” Walsh tells me. “This is potentially the end. There are no antibiotics in the pipeline that have activity against NDM 1-producing enterobacteriaceae. We have a bleak window of maybe 10 years, where we are going to have to use the antibiotics we have very wisely, but also grapple with the reality that we have nothing to treat these infections with.”

Well, that will send a chill up your spine, even when it is 97 degrees outside.

We have heard this news before.  Or news like it.  Why has so little changed?  Are we as individuals responsible for this?  If we act differently, can we affect it?

The answers to these questions are not simple, but they vividly illustrate the complex paths through which science shapes (and does not shape) health care, even in the face of the imperative of evidence-based medicine.

Start with the assumption that while resistance to antibiotics is impossible to prevent, it is possible to slow its progression that would allow for the development of effective new drugs. Consider also that there are two major contributors to antibiotic resistance:  poorly conceived and enforced public policies and individual practices related to the production of food, and health care practices.  Both patients and doctors fail to follow evidence-based guidelines on the appropriate use of antibiotics, and our excessive and unnecessary use of them promotes the development of antibiotic-resistant strains of bacteria. 

Here are just a few of the factors that complicate the straightforward implementation of evidence-based approaches to antibiotic use:[1]

  • Doctors believe their primary obligation is to the patient in front of them, not to the general public, so many of them will prescribe an antibiotic if there is a remote chance of it being effective for this patient today. 
  • The incentives for us as patients to refuse antibiotics are too weak to make us care about the effects of our behavior on others.  Our actions and the undesirable consequence of increased resistance are separate in time, so we don’t remember or recognize the connection.  Or, thinking of our own self-interest, we realize that no single act on our part can stop the growth of resistance. After all, why take the chance of missing out on possible benefit?  So we take the drug on the off chance it will help. 
  • Quality improvement efforts for doctors such as pay-for-performance may inadvertently contribute by providing an incentive for doctors to prescribe antibiotics for infectious diseases without penalizing their inappropriate administration. For example, one initiative focuses on early prescription of antibiotics for lower respiratory tract infection, particularly community-acquired pneumonia. So emergency department physicians prescribe antibiotics for any infection that might possibly fit that description, regardless of its location or that a specific bacterium is causing it. 
  • Reports of health-related behaviors and clinician practices that persist in the absence of evidence (and even in the presence of contradictory evidence) are fairly common. Medical regimens related to antibiotic use are among them. For example, physicians continue to order bowel cleansing that contains antibiotics prior to surgery despite lack of evidence of effectiveness and the possibility of harm.  And despite a weak scientific foundation, physicians routinely direct patients to “finish the course” of antibiotics. The popular press supports this notion. And we tend to believe it. 
  • Many of us still believe that an illness sufficiently serious to warrant the time and expense of a trip to the doctor should be treated by prescription of an antibiotic, and good number of us are willing to express our dissatisfaction with a physician who refuses to participate either directly or by finding a clinician who will.

We – us, our doctors, those who make and enforce clinical policies – are caught in a web of interdependence in which we act on the basis of inadequate information in the service of our individual interests, reinforced by the incentives, social norms and traditions of both American society and the health professions. As it stands, neither we nor our providers will make a change without the other, and while I’d like to think that an advance in diagnostic technology will soon make the accurate prescription and use of antibiotics a slam-dunk, I’m not hopeful.  Until then, I fear that none of us will change our behavior without an immediate, compelling equivalent of a whack upside the head.

I wonder what form that whack will take? 

[1]  These and other factors are identified and discussed in greater detail in a paper by the McDonnell Social Norms Group.

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New Solid Evidence Showing the Impact of Physician Communication on Our Engagement in Care

Jessie Gruman
August 19th, 2010

Jessie GrumanAsk us if we are more likely to use a medication as directed if our doctors explain why a specific drug might be helpful, how to take it so that it is most effective and what its possible side effects are and then discuss whether we think we are willing and able to take it.

“Of course,” most of us will say (especially in light of the worthlessness of drug package inserts to convey basic information).

An article in the June issue of Archives of Internal Medicine validates our response: Patients of physicians who score higher on tests of medical management and communication ability are more likely to be taking hypertension medication after six months than those whose physicians score lower.

This is a study about people working with their doctors to find a hypertension medication routine that works and sticking to it.

Adherence (or “persistence” as the researchers call it) to hypertension medication recommendations is a real problem. It’s tough to take a drug that has side effects for a disease that has no symptoms. In general, less than 75 percent of people who are prescribed hypertension medication are still taking it after six months.  This study found that patients of physicians with better medical management (particularly clinical decision-making) and communication (particularly data-collection skills) abilities were more likely to be engaged in treating their hypertension.

The researchers also found that specific aspects of the treatment itself influenced whether or not people stuck it out.  For example, people whose prescription was changed soon after starting were more likely to continue, as were those who had more frequent and earlier follow-up visits. Physicians with higher scores on the relevant tests were more likely to change their patients’ medications during the first two weeks and more likely to have follow-up visits with them during the first two months.

The study is remarkable for a couple reasons.  First, it is huge: over 13,000 people with hypertension were followed. Studies that look at behavior – ours or our providers’ – tend to be small.  The findings from such a large study can’t be easily dismissed.

Second, it is a population-based study: no intervention was implemented and tested. Rather, the researchers looked at the effect of independently assessed characteristics of doctors on the medication use of their patients, measured as part of an examination that doctors must take in order to be licensed to practice medicine in Canada.  The effects of these physician characteristics on patients’ behavior over the first six months of their treatment were measured by examining prescription and medical services databases.  Thus, the likelihood of bias influencing these measures is extremely small.

This study provides robust support for the role of providers in enabling us to more fully benefit from our care.  It reinforces the principles of some of the models of care delivery currently being implemented.  For example, the proactive, planned approach of the Chronic Care Model.  It has implications for training, certifying and licensing providers in the United States.  And it is too big to ignore.

This is a Canadian study.  Much is made in political circles of the differences between health care in Canada and America.  In this case, however, the crucial difference lies in the Canadian’s government support of databases that allow for the exploration of this kind of health care delivery question and not in the finding that we – Canadian and American alike – make better use of the care available to us when we work together with our providers to solve our health problems.

How will this data shape efforts to improve health care quality and support us in caring effectively for ourselves?

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