How politically unpopular research from AHRQ helps us make better medical decisions

The health services research world is reeling today from the inclusion of draft language in a House of Representatives appropriations bill that would eliminate the entire budget of the Agency for Healthcare Research and Quality starting on October 1, 2012. Below is a screenshot from page 90 of the bill:

As most readers know, I was employed by AHRQ from 2006 to 2010, as a Medical Officer supporting the work of the U.S. Preventive Services Task Force, which recently recommended against PSA screening for prostate cancer on the grounds that the downstream harms of the service outweigh any potential benefits. As documented in an October 2011 New York Times Magazine story, the USPSTF deliberately withheld its initial conclusions on PSA screening, fearing a politically-driven backlash against it and AHRQ. Despite the long delay, as well as a carefully orchestrated scientific communications campaign that enlisted the support of powerful allies such as the American Cancer Society's chief medical officer, Otis Brawley, the Agency once again finds itself at death's door. (For an in-depth history of AHRQ's first near-death experience in the mid-1990s at the hands of back surgeons and their supporters, read this Health Affairs article.)

For those of you who may be unfamiliar with AHRQ and the benefits of the research it supports, below is a Healthcare Headaches blog post I wrote last year for USNews.com. Its message is even more relevant now than it was then. Please call your Congressmen and women, spread the word to friends and colleagues, and help #SaveAHRQ from a fate that would have devastating effects on the future health of our nation.

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When a new drug goes on the market for, say, diabetes, doctors are typically bombarded by advertising messages that promote it. Patients may see television commercials touting the new drug’s advantages over older ones and advising them to "talk to your doctor" about obtaining a prescription. But since the U.S. Food and Drug Administration only requires drug companies to prove that new drugs work better than placebos (sugar pills), there’s often little or no reliable information about whether a new drug is actually an improvement over existing therapies.

How, then, can a doctor like me make good choices about which treatment to give each patient? To provide answers, last year's health reform law devoted billions of dollars over the next decade to "comparative effectiveness" research, or research that directly compares different tests and treatments to determine which are better at improving health in particular groups of patients.

Funding for comparative effectiveness studies was recently targeted for budget cuts by politicians who argue that such research may limit patients' treatment choices and lead to the withdrawal of insurance coverage for drugs that are found to be costly or ineffective. In reality, however, that’s not necessarily the case. For example, when the FDA recently concluded that the cancer drug Avastin does not help patients with breast cancer (and often causes serious side effects such as bleeding, heart attacks, and heart failure), officials were quick to assure the public that the Medicare program will continue to pay for it anyway.

What has been lost in the political debate is the value of comparative effectiveness studies in helping doctors and patients make better treatment decisions. For example, the Effective Health Care Program at the Agency for Healthcare Research and Quality (AHRQ), which sponsors comparative effectiveness research for many conditions that I commonly treat among my patients, recently published a patient-friendly guide to medicines for type 2 (adult-onset) diabetes that clearly spells out the advantages and disadvantages of the many drugs available to lower blood sugar. Patients can read this guide online or print out a copy to take with them to their doctor. (Full disclosure: I am a former employee of AHRQ, but was not involved with this program.)

Also, in a 2009 study published in the Archives of Internal Medicine, Mayo Clinic researchers concluded that a "decision aid" for patients with diabetes based on a previous version of the AHRQ medication guide improved patients' knowledge and involvement in their care. This decision aid consisted of six flash cards containing basic information about the effects of five types of diabetes drugs on weight change, blood sugar levels, side effects, and ease of use (when to take it and how often blood sugar testing is required).

In a highly charged political environment, it’s tempting to score points (and scare patients) by falsely equating comparative effectiveness research with “rationing.” But I believe that the valuable information obtained from this research, rather than restricting patients' treatment options, will instead empower them and their doctors to make better decisions about their health care.

Evidence that EHRs can promote better preventive care

In a previous post, I summarized the mixed evidence that using electronic health records with clinical decision support systems (CDSSs) improves processes and outcomes of preventive care. Most of the literature supporting a positive effect of EHRs with CDSSs is either anecdotal, observational, or limited to specific settings (namely, practices of employed physicians in large, integrated health systems). I concluded that it remained uncertain if these results could be duplicated in randomized trials in typical private practices.

Uncertain, that is, until last week, following a study by Alex Krist and colleagues, "Interactive Preventive Health Record to Enhance Delivery of Recommended Care: A Randomized Trial," in the Annals of Family Medicine. The authors randomized 4500 patients from 8 primary care practices in Virginia to usual care versus an invitation to use MyPreventiveCare, an interactive personal health record (IPHR) that generates a list of screening and counseling recommendations based on guidelines from the U.S. Preventive Services Task Force, as well as links to more detailed explanations of these preventive services and relevant decision aids. When patients used the IPHR, their physicians also received a summary of the recommendations in their EHRs.

Although only about 1 in 6 invited patients had actually used the personal health record 16 months later, it was enough to show a statistically significant difference between the proportion of patients in that group who were up-to-date on all recommended services, compared to the control group. After 4 months, colorectal, breast, and cervical cancer screening rates had increased by an impressive 13 to 19 percent among personal health record users. The authors concluded: "Information systems that feature patient-centered functionality, such as the IPHR, have potential to increase preventive service delivery. Engaging more patients to use systems could have important public health benefits." A how-to guide on the use of personal health records to promote uptake of recommended preventive services is available on the Agency for Healthcare Research and Quality website.

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A modified version of this post first appeared on the AFP Community Blog.

The end of the line on PSA screening

In the summer of 2007, then-U.S. Preventive Services Task Force member Russ Harris, MD, MPH approached me about taking on what he suggested would be a fairly quick and straightfoward project: summarizing the small amount of medical literature on the benefits and harms of the prostate-specific antigen (PSA) test that is commonly used to screen asymptomatic men for prostate cancer. Little did I know that this research and its implications would dominate the next five years of my career. There would be some good moments (my published systematic review of the topic was honored as AHRQ's Article of the Year award in 2009) as well as many bad ones (encapsulated in this series of posts that recount the reasons for my subsequent resignation from the Agency in 2010). This year, the USPSTF finally confirmed what had become clear to me and many other scholars of PSA screening: the test's harms outweigh its benefits for the vast majority of men, and therefore it should not be recommended.

Although the Medicare program and private insurance plans continue to pay for the PSA test, there is reason to hope that the new recommendation will eventually change medical practice. Despite the backlash that greeted the USPSTF's 2009 recommendation for individualized decision-making regarding mammography for women in their 40s, recent national data has demonstrated a 6 percent decline in screening rates in this age group - modest but notable evidence that more women are making thoughtful screening decisions that reflect their personal values and preferences. Based on the USPSTF's assessment, I now tell older male patients that the harms of the PSA test's downstream consequences are very likely to outweigh any potential health benefits. Some still request the test, but such requests are becoming less common.

During the past five years, I have given countless lectures and participated in many public debates about PSA screening. I recently agreed to address the subject once more in October at a panel discussion sponsored by the Department of Health Policy and Management of the Johns Hopkins University Bloomberg School of Public Health (where I am an adjunct instructor). And I have decided that for me, that event will be the end of the line for public speaking about PSA screening, at least until there is more evidence to discuss. It's time for me to move on, personally and professionally. Nonetheless, I hope that others will take up the essential task of communicating the flaws of this test to physicians and the public, so that someday we may reach the end of the line on PSA screening itself.

Rhythm or rate control for atrial fibrillation?

For many years, the standard thinking regarding treatment of patients with atrial fibrillation was that drug therapy to restore sinus rhythm (rhythm control) was superior to drug therapy to slow the ventricular response rate (rate control). That all changed in 2002, when a clinical trial found no difference in survival between patients randomized to rhythm or rate control, and a higher incidence of adverse effects in the rhythm control group.

This trial and other evidence led the American Academy of Family Physicians to issue a guideline that recommended rate control with chronic anticoagulation as the preferred strategy for most patients with atrial fibrillation. A recent AFP review article echoed this guidance, assigning an "A" strength of evidence rating to the following statement:  "Rate control is the recommended treatment strategy in most patients with atrial fibrillation. Rhythm control is an option for patients in whom rate control is not achievable or who remain symptomatic despite rate control."

On occasion, however, evidence-based interventions achieve different results in primary care than in clinical trials. A study published earlier this month in the Archives of Internal Medicine used administrative databases in Quebec, Canada to compare mortality between older patients with atrial fibrillation who were initially prescribed rhythm or rate control therapy after their diagnoses. After experiencing similar mortality through 4 years of follow-up, patients in the rhythm control group had a significantly lower risk of death, with 23% lower relative mortality than patients in the rate control group at 8 years. These surprising results beg the question: was this new study somehow flawed? If not, as the subtitle of an accompanying editorial asked, can observational data trump randomized trial results?

Although it is unlikely that treatment guidelines will change any time soon, this study should remind clinicians that management of patients with newly diagnosed atrial fibrillation should be individualized, and the risks and benefits of different strategies discussed in detail before making treatment decisions.

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The above post was first published on the AFP Community Blog.

Public Speaking Update

Since I began blogging at Common Sense Family Doctor in July 2009, its posts have been featured in widely read blogs such as KevinMD.com, The Health Care Blog, and Gary Schwitzer's HealthNewsReview, as well as the websites of major national newspapers such as the New York Times, the Wall Street Journal, USA Today, and the Boston Globe. I also wrote the consumer health blog Healthcare Headaches for U.S. News and World Report from August 2010 through September 2011.

Like the vast majority of physicians who blog, I write in my spare time. I have never accepted advertising or paid web links on Common Sense Family Doctor, and the choices of topics for posts are my own and not influenced by financial or other conflicts of interest. In order to support the time I devote to blogging, and to encourage high-quality medical writing and clinical practice, I give lectures and workshops to medical and non-medical audiences on a variety of topics. These include the uses of social media tools in medicine and education, developing and implementing medical guidelines, and the evidence supporting specific prevention recommendations. If you or your organization would like to invite me to speak, please e-mail me at linkenny@hotmail.com or KWL4@georgetown.edu.

Upcoming events:

PSA Screening, Science, and Public Policy (panel discussion)
- Johns Hopkins University Bloomberg School of Public Health
- October 25, 2012

Screening for Osteoporosis: Who, When, and How Often?
Spanish Catholic Center of Catholic Charities of Washington DC
- September 2012

Screening Mammography for Women in their 40s: Exploring the Controversy
NCA Breast Healthcare Improvement Initiative
- July 23, 2012


Past events:

Why You Should Stop Screening Patients for Prostate Cancer
- Ephrata Community Hospital (PA)

Identifying and Using Good Practice Guidelines
- Temple University School of Medicine / Lancaster General Hospital

Cancer Screening: A Primer for Journalists
- National Press Foundation's Cancer Issues 2011

What to Do When Screening Guidelines Conflict: HIV and Mammography
- Grand Rounds, Georgetown University Department of Family Medicine

Overdiagnosed: Making People Sick in the Pursuit of Health
- William J. Bicknell Lecture (panelist)
- Boston University School of Public Health

For Geeks and Geezers: With Social Media Skills You Can Change the World
- Family Medicine Education Consortium Northeast Region Meeting

Screening for Diabetes: What Does the Evidence Say?
- Spanish Catholic Center of Catholic Charities of Washington, DC

Don't Do It! Preventive Health Services That Harm More Than They Help
- District of Columbia Academy of Family Physicians

Using the Medical Literature to Make Decisions About Preventive Health Services
- Medical Library Association Annual Meeting

Medical Blogging and Other Professional Uses of Social Media
- Grand Rounds, Virginia Commonwealth University Internal Medicine

Spilling Ink: An Expert's Guide to Getting Your Work Published
- Society of Teachers of Family Medicine Annual Meeting

Health Promotion and Disease Prevention in Clinical and Community Settings
- Uniformed Services University of the Health Sciences

The Value of Preventive Health Services
- Webinar for Employees of MetLife

COPD Update: A Prevention Perspective
- Maryland Academy of Family Physicians

Guest Post: Reports of the ACA's death were greatly exaggerated

Marya Zilberberg, MD, MPH is an independent physician health services researcher with a specific interest in healthcare-associated complications and a broad interest in the state of our healthcare system. I recently reviewed her excellent book on evidence-based medicine, Between the Lines. The following post was first published on her blog, Healthcare, etc.

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This was a big day for President Obama's signature legislation, the Affordable Care Act. The Supreme Court upheld its constitutionality, and the punditdom thinks that further challenges are unlikely. On the other hand, if Romney takes the White House in the next election... Well, you can guess what will happen then.

It has been interesting to watch the run-up to this decision. Most recently I have been amused by surveys finding that on the one hand, many American people are in favor of the pre-existing condition inclusion (this part of the bill forbids insurance companies to discriminate against people with prior health conditions), as well as the provision that allows young adults to stay on their parents' insurance policies through a certain age. On the other hand, the majority of Americans are against the healthcare law itself, and most also oppose the individual mandate provision (this is the part where everyone has to buy insurance or pay a tax). Given this imbalance in the public opinion, a more pertinent survey should have assessed how well people understand these provisions in the first place. And this would have had to establish how well the public gets our whole healthcare "system."

To start from the beginning, any healthcare system can be judged on three criteria:
1. How accessible is it?
2. Is it of adequate quality?
3. How expensive is it?

The answer to the first question provides one of the rationales for the individual mandate. Currently there are about 50 million people without health insurance in the US, and, hence, without adequate access to the system. Many of these people are the young and the healthy who gamble on staying young and healthy. And many are consigned to relying on expensive emergency care when this gamble fails. Some of them go bankrupt trying to pay for it, while others become "safety net" cases, where the institution that cares for them swallows the costs. These institutions do get some public dollars for providing safety net care, but not nearly enough to break even. Since many of the 50 million don't buy health insurance because they cannot afford it, the healthcare bill provides a way to create more affordable insurance products.

The answer to the second question is not related directly to the individual mandate. Since much of this blog is devoted to the issues of healthcare-associated harm, I do not wish to belabor this point here. Suffice it to say that the bill does try to address this catastrophic situation, though it remains to be seen if it will succeed.

The third question is the crux of the story. Many have said that the escalation of healthcare costs is unsustainable, and I subscribe to this notion: I am not sure how much more than $2.6 trillion/year we want to pay for this insatiable beast. Yet judging by the near-revolt that "death panels" rhetoric caused, the citizenry is not interested in being thoughtful about what services make sense. The vehement knee-jerk to the "R" word shuts down the discussion before it even starts. So, OK, how do we pay this ever-increasing bill? Moreover, since we are all happy with the government mandate for all insurance to pay for pre-existing conditions, how do we propose to pay for this additional coverage? Short of printing money (not generally a good idea) or creating a single-party payer system that regulates these expenditures, the only way is to broaden the pool of revenue. The way the ACA has proposed to broaden this pool is through the very individual mandate that is anathema to our American way of life. But without it, there is no broadening of coverage, and there is no paying for every intervention that we seem to feel entitled to.

I doubt very much that the ACA will substantively contain healthcare costs. I even doubt that it will solve the quality problems, but I am willing to wait and see on that. This bill is but a band-aid on an arterial bleed. However, I do believe that upholding this legislation allows us to take the first steps toward a reasonable national dialog about the kind of healthcare system we need. This dialog will not be helped by stupid surveys that reinforce our willful ignorance. We have the opportunity to move this conversation to a higher level, where people begin to understand the issues we are up against more deeply. Let's take it.

Family physicians and Communities of Solution

Every so often, American Family Physician reviews a public health topic, such as outdoor air pollutants, disaster preparedness and response, or reducing the effects of climate change. And occasionally we receive feedback from readers who suggest that these topics are not appropriate for a family medicine journal, since family physicians are practicing clinicians who provide direct care to individual patients, not public health professionals responsible for large populations. However, this view of the limited role of family physicians is by no means unanimous.

In response to concerns about the shrinking scope of family medicine, Dr. Joseph Scherger wrote on the Society of Teachers of Family Medicine blog that "family medicine today is more complex and expansive in some ways than ever before." Family physicians must learn advanced motivational counseling and information management skills to practice excellent preventive and chronic care. Also, the patient-centered medical home requires family physicians to take population-based approaches to managing chronic illnesses.

In March, the Institute of Medicine published a report on opportunities for integrating primary care and public health. Notably, the report did not advocate for large numbers of family physicians to obtain formal public health degrees. Just as an editorial in the Annals of Internal Medicine argued that the subspecialty of geriatric medicine would be best served by incorporating its unique resources and skills into primary care training, a group of family medicine leaders convened by the American Board of Family Medicine recently declared:

The modern primary care physician, who values “community participation, political involvement, and collective advocacy," can, in effect, be a true public health professional, forming partnerships with community-based organizations that facilitate healthy change. This paradigm shift includes the transition from treating individuals in isolation to treating people in the context of their lives in their communities, indeed, culminating in community-centered care.

In a publication in the Annals of Family Medicine, this group re-examined and updated the 1967 Folsom Report, which provided a blueprint for connecting the personal physician with community resources in "Communities of Solution." What do you think of this ambitious vision of the family physician as a public health professional? Is this a desirable goal, and if so, what would it take to achieve it?

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The above post first appeared in the AFP Community Blog.

What you could lose in the battle over health reform

Although I will refrain from predicting how the U.S. Supreme Court will rule this week on the legal challenge to the individual health insurance mandate provision of the Affordable Care Act (aka "Obamacare"), I strongly believe that striking down the entire law would do considerably more harm than good. To illustrate what could be lost in this political donnybrook, below is a post that originally appeared on my "Healthcare Headaches" blog on USNews.com a few months after the law's passage in 2010.

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4 Health Reform Changes to Expect At Your Doctor's Office

As a family physician, I've gotten used to attending dinner parties where relatives, friends, and sometimes complete strangers ask me about health reform, and how the new law might impact their relationship with their doctor. Unfortunately, because I'm well versed in all the complexities of the legislation, I can't come up with a simple sound bite. But a paper published in the Annals of Internal Medicine in August 2010 attempted to explain how the Affordable Care Act is likely to transform the practice of medicine and outlined what changes doctors will need to make in order to provide better care for their patients.

The authors highlighted a number of problems that exist: rates of re-admissions, medication errors, and infections are much too high at nationwide hospitals. And American patients fail to take full advantage of preventive services like counseling for smoking cessation and screening for cancer. "Physicians will need to embrace rather than resist change," the authors wrote, in order for the new legislation to successfully reverse these problems and reduce health care costs in the long term. That means doctors need to move away from a system where they're paid for ordering more tests and performing more procedures and toward one that reimburses them for coordinating care among a number of specialists and preventive health professionals like nutritionists and nurse practitioners. The goal is to keep you healthier and out of the hospital. Here's what you can expect at the doctor's office - if not now, soon.

1) You'll get the health care you need—no more, no less. It's surprising, and frankly shocking, how little doctors know about the effectiveness of the treatments they routinely prescribe for common conditions such as heart failure and diabetes. While studies are often lacking that help doctors determine which test or treatment is most appropriate for you, a new Patient-Centered Outcomes Research Institute will provide funding for studies to help doctors make more informed decisions. That should keep you from getting unnecessary medical care and provide you with care that's most effective. Since research takes time to perform and doctors are often slow to change their practices based on new research, this change may not happen immediately. While studies performed more than a decade ago showed that MRI scans provide no benefit for acute back pain and that antibiotics have no effect on acute bronchitis, doctors have only recently curtailed their use of them, and many still prescribe these costly tests and drugs when patients demand them.

2) You will receive healthcare from a team of health professionals. This "team care" will be in addition to, not subtracted from, the care you are already used to receiving from your personal doctor. The care team may include nurse practitioners, physician assistants, care managers, and nutritionists, depending on your individual health needs. The idea is that the more people who are working together to monitor your health conditions, the less likely a complication will be missed.

[Your Primary Care Team Will See You Now]

3) Your care team will reach out to you in an attempt to prevent future health problems. This may include reminding healthy people about the need for periodic health screenings, or a home visit from a nurse if you've been recently hospitalized for a chronic condition like heart failure. Rather than being paid only when patients get sick, doctors and care teams will be given financial incentives to keep patients well.

4) Technology will improve the efficiency of your health care. Gone will be the days when illegibly written prescriptions or blurry faxes of handwritten hospital progress notes led to thousands of medical errors each year. Doctors will be expected not only to exchange their paper charts for electronic medical records, but to use them meaningfully; that means improving the accuracy of the information in your health record and making sure these records will be accessible to you and the various professionals participating in your care. Of course, this transition will probably result in glitches at first. If doctors' early experiences with electronic health records are any indication, different computer systems may not be able to transfer information to each other, and enterprising hackers will no doubt try to breach the security of online health records, which could threaten your privacy.

[Electronic Medical Records: No Cure-All for Medical Errors]

Of course, it isn't possible at this early date to know how many of these hopes for health reform will actually happen. The ultimate goal, though, is something that I believe all doctors desire: for the health system of the future to give us the tools to provide you with the highest quality experience every time you need to seek health care.

Family medicine is "total medicine"

A terrific article in today's Huffington Post by two of my colleagues, Dr. Ranit Mishori and Family Medicine Education Consortium executive Larry Bauer, argues that family physicians need to "get out of the shadows" and advocate for a larger role in fixing America's health care problems. Instead of subdividing patients by age or body system, family medicine is the specialty trained to handle "diagnostic complexity," which requires a broad and varied skill set:

Every day we treat children, mend bones, manage chronic diseases, deal with hypertension, diagnose intestinal conditions, carry out eye exams, deliver babies, help control diabetes, take skin biopsies, inject aching joints, evaluate stroke victims, monitor depression and in some cases perform minor surgeries. And yes, this range of skills, while broad, does constitute a genuine and focused medical specialty -- the specialty of knowing your patient inside out and over years. We are meant to be experts as much in the person who comes to see as we are in the medical procedures we employ, to build a shared trust with our patients, to be partners with them toward the lifelong goal of staying healthy -- enough, by the way, to avoid too often the need for one those other specialists, whose practices often depend on people being very sick in the first place.

There is an odd logic that diminishes the status of family doctors. It is also faulty logic. People think that the more a physician knows about a specific medical problem or body part and the higher that physician's salary, the better care they will receive. Leaving aside whether that's actually true, it sets up a phony reverse corollary -- the belief that a doctor whose knowledge is more generalized, and whose pay scale is lower, is therefore providing inferior care. This is just wrong. As generalists, we believe the ability to see the patient's big picture; knowing "enough" about most problems; and understanding the preferences, past medical history and the resources of the person seeking care is far more important in most situations than narrow expertise.

Mishori and Bauer go on to ask whether family medicine (which not that long ago was called "family practice") should be renamed "total medicine" to better represent everything that family physicians do. But I think that family medicine needs more than a simple re-branding. When 1/3rd of the U.S. physician work force consists of generalists and 2/3rds consists of subspecialists, patients not only receive less value for their money (since subspecialists have higher salaries), but poorer health outcomes to show for it. A 50/50 ratio, which is the norm in much of the world, would not only save health care dollars, but likely result in fewer illnesses and deaths from preventable conditions. So let me say this as clearly as possible to those who are predicting a vast physician shortage in the upcoming years: America does not need more physicians, it needs more family physicians.

How would you rate your health care team?

Two recent commentaries in the Annals of Family Medicine and the New England Journal of Medicine argue that the performance of modern family doctors can only be as good as their practice teams. In "The Myth of the Lone Physician: Toward a Collaborative Alternative," George Saba and colleagues explain why the myth that a primary care physician can do it all alone is dysfunctional and outdated, and should be replaced with the paradigm of a "highly functioning health care team":

What will be the roles and responsibilities of each team member? What systems and skills are needed to ensure effective communication? How will decisions be shared? How will conflict be resolved? How will the team foster trust and respect? How will the team promote the development of meaningful healing relationships? How will the team evolve over time? The specific answers to these questions define the roles and tasks of each team member, and the collaborative process of working through these challenges strengthens team relationships.

Similarly, in "Sharing the Care to Improve Access to Primary Care," Amireh Ghorob and Thomas Bodenheimer assert that the only way for physicians to meet the health care needs of a burgeoning and increasingly complex patient population is to delegate many of their traditional responsibilities - such as "patient education, lifestyle counseling, medication titration, and medication-adherence counseling" - to other health professionals:

The paradigm (culture) shift transforms the practice from an “I” to a “we” mindset. Unlike the lone-doctor-with-helpers model, in which the physician assumes all responsibility, makes all decisions, and delegates tasks to team members, but the capacity to see more patients does not increase, the “we” paradigm uses a team comprising clinicians and nonclinicians to provide care to a patient panel, with a reallocation of responsibilities, not only tasks, so that all team members contribute meaningfully to the health of their patient panel. Non-clinician team members must add capacity in order to bring demand and capacity into balance.

In the current issue of Family Practice Management, Berdi Safford and Cynthia Manning discuss "Six Characteristics of Effective Practice Teams," which include shared goals; clearly defined roles; shared knowledge and skills; effective, timely communication; mutual respect; and an optimistic, can-do attitude. How many of these characteristics does your doctor's office embody? Would you say that they currently function as an effective health care team?

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A slightly modified version of the above post was first published on the AFP Community Blog.

Changing unhealthy habits requires changing environments

New York City Mayor Michael Bloomberg's recent proposal to ban sales of sugary beverages larger than 16 ounces has encountered opposition not only from soda manufacturers, but many others who are skeptical that such a ban would make any difference in the explosion in obesity rates. According to the Centers for Disease Control and Prevention, in 2010 the percentage of state residents classified as being obese ranged from 21% (Colorado) to a staggering 34% (Mississippi). By comparison, in 1990 no more than 15% of residents of ANY state were obese! But will banning the sale of extra-large sodas address this problem, the way that public smoking bans have helped to drive down smoking rates? In "Why Americans Need Bloomberg's Big Gulp Ban," TimeIdeas columnist Shannon Brownlee argues that the answer is yes:

When I was a kid, Coca-Cola came in 6-ounce glass bottles, and that seemed like plenty. It wasn’t all that long ago that a 12-ounce soda was considered perfectly sufficient—even large. But walk into any pizzeria or deli these days and you’ll have a very hard time even finding 12-ounce cans of anything. 20-ounce plastic bottles are now considered the standard single-serving size. ... As a result, we can no longer gauge what’s an appropriate amount of calories we should be drinking. The average American guzzles 52 gallons of soda, sweetened fruit juices, sports drinks, energy drinks, and sweetened tea and coffee per year. These drinks account for a third of the 156 pounds (pounds!) of added sugar each of us consumes on average each year. The ban on large drinks, on the other hand, could reset our notion of what a normal beverage serving looks like, and that could make all the difference. 

On the Washington Post's WonkBlog, Sarah Kliff reviews Bloomberg's accomplishments as a self-styled "public health autocrat": making NYC the first city to ban smoking in restaurants and bars, ban trans-fats in restaurant foods, and require chain restaurants to prominently post calorie count information. Numerous cities and states have since followed Bloomberg's lead, and the Affordable Care Act, if not struck down by the Supreme Court, will require calorie labeling at chain restaurants all over the country.

Critics argue that these well-intentioned initiatives infringe on freedom of choice and haven't been shown to improve health-related habits. For example, one study found that low-income people in NYC were no more likely to choose lower-calorie foods after the policy went into effect. This and other studies suggest that it takes more than data to affect food choices. After all, you may not know that a Big Mac with Cheese packs 704 calories and 44 grams of fat, but unless you're from another planet, you probably knew that it isn't good for you. On the other hand, when the Massachusetts General Hospital redesigned its cafeteria by implementing a simple color-coded scheme (red for unhealthy, yellow for less healthy, and green for healthy) and making healthy foods easier to see and reach, sales of healthy items (especially beverages) rose substantially. Changing the environment accomplished what calorie labeling couldn't.

Kudos to Mass General, but outside of deep-pocketed Harvard, where will the money come from to redesign hundreds of thousands of cafeterias? In the June issue of The Atlantic, David Freedman argues that obese and overweight people can change their microenvironments - and successfully change unhealthy eating and exercise behaviors - with the help of mobile technologies:

Today, for absolutely nothing, would-be weight-losers can download many of the key elements of a Skinnerian behavior-modification program directly to their phones and computers. One of the most popular options is Lose It, an app and Web site that allows users to pick a goal weight and a time line for reaching it, and then formulates a daily calorie count accordingly. Lose It then lets users track their eating and physical activity, which they can do by holding their phones up to a food package’s barcode, or by tapping the screen a few times at the start and end of a walk (the app offers a range of activity categories, including guitar strumming, household walking, and sex). Lose It uses this data to provide clear, graphic feedback on users’ daily progress—you might see at a glance that having dessert will send your numbers into the red, but that if you walk for 20 minutes after dessert, you’ll go back into the green.

As yet it remains uncertain if weight-loss apps will be able to replicate the results of more traditional, labor-intensive weight-loss interventions. And it's still reasonable to assume that strategies to stabilize, and eventually, reverse, national obesity rates will need to change obesity-promoting environments on the individual and community levels. The first step to a healthy weight may be disappointment at the inability to buy one's usual big sugary soda; the second one may be deciding, on second thought, not to purchase a soda at all.

The best recent posts you may have missed

Every other month or so, I post a list of my top 5 favorite posts since the preceding "best of" list on this blog, for those of you who have only recently started reading Common Sense Family Doctor or don't read it regularly. Here are my favorites from the past few months:

1) How much does it cost to have an appendectomy? (4/24/12)

2) Electronic health records: medical progress, not panacea (5/16/12)

3) My take on state health insurance exchanges (3-part series) (4/16/12)

4) Counterintuitive findings on quality incentives and patient satisfaction (4/20/12)

5) Don't confuse cardiovascular imaging with preventive medicine (3/27/12)

If you have a personal favorite that isn't on this list, please let me know. TGIF and thanks for reading!

Book Review: Between the Lines

Every year for the past several years, I have served as a faculty group leader for a course in "Evidence-Based Medicine" taught to first and second-year medical students. The course aims to provide students with basic tools to navigate the medical literature that we hope they will retain during their training and use to answer clinical questions long after they enter practice. Unfortunately, the course is a low priority for students in their preclinical years, and many of the epidemiology and statistics concepts we teach are far more advanced than what they will need to know as physicians.

It was a pleasure, then, to read Dr. Marya Zilberberg's Between the Lines: Finding the Truth in Medical Literature, a rare book that bridges the gulf between medical publications and the real world of practicing clinicians. Zilberberg, a physician and noted health services researcher who blogs at Healthcare, etc., distills her expertise from two decades of teaching evidence-based medicine into a concise text that is accessible not only to medical students and other health professionals, but to journalists and educated laypersons who want to look past the latest sensational headlines to uncover what we actually know about sickness and health. The book's conversational tone makes the reader feel as if Zilberberg herself is in the room giving a one-on-one tutoring session.

The book is divided into two parts: "Context" and "Evaluation." The first part was my favorite, containing a collection of short essays with provocative titles such as "Beware of What Seems Too Good to Be True" and "Assume a Spherical Cow." Here Zilberberg exposes the faulty reasoning behind certain health care beliefs shared by much of the general public and a good number of clinicians, as well. For example, a screening test that is touted as being highly sensitive for the condition it detects still may not be worth undergoing, depending on how common (or uncommon) the disease is and how many false positive results it generates.

The second part follows a more standard format for a book on the medical literature, moving logically through a traditional hierarchy of study designs and threats to the interpretation of study results. Zilberberg's writing is clear and straightfoward, and key points are helpfully highlighted in accompanying figures and tables. I recommend this book highly to all students of evidence-based medicine, regardless of occupation or professional degree.

"The best [colorectal cancer screening] test is the one that gets done"

Last week was a busy one for cancer screening. I could choose to criticize the Centers for Disease Control and Prevention's premature guidelines to screen all baby boomers for hepatitis C (which can lead to cirrhosis and liver cancer) or the less-than-sound recommendations of several major cancer organizations to screen present or former heavy smokers between ages 55 and 74 for lung cancer with CT scans. (As I've pointed out before, there are at least 4 good reasons not to reflexively follow the latter advice.) But instead, I would like to explore the irony that another screening test that has conclusively been shown to result in more health benefits than harms is on the verge of becoming extinct in the U.S. That test is screening for colorectal cancer with flexible sigmoidoscopy.

Flexible sigmoidoscopy is an uncomplicated office procedure that requires no anesthesia and was once commonly taught to, and performed by, thousands of family doctors and general internists in adults over the age of 50. But over the past decade, gastroenterologists have done a magnificent job convincing primary care physicians and the American public that colonoscopy is the "gold standard" for colorectal cancer screening. As a result, a recent national survey found that while 55 percent of respondents reported receiving a screening colonoscopy within the past 10 years, only 1.3 percent of respondents reported being screened recently with flexible sigmoidoscopy.

That's too bad, because not only does screening colonoscopy cost a lot more money, it hasn't ever been shown to be more effective than screening sigmoidoscopy. In fact, screening colonoscopy has never even been tested in a randomized trial, and may never be. In contrast, yesterday the lead researchers of the National Cancer Institute's Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (which previously found that prostate and ovarian cancer screening don't save lives) reported that having a flexible sigmoidoscopy every 3 to 5 years reduced deaths from colorectal cancer by 26 percent, even though nearly half of the control group underwent screening at least once. That's a big deal, since colorectal cancer is the third-leading cause of cancer death among U.S. women, and the second-leading cause of cancer death in men under age 75.

In an accompanying editorial, Dr. John Inadomi urges clinicians to reconsider flexible sigmoidoscopy as a preferred cancer screening strategy for three reasons: 1) it's more evidence-based than screening colonoscopy; 2) patients are more likely to be screened if multiple options are available; 3) screening resources are limited, and efficiency matters. He concludes:

Where does this leave us with regard to screening flexible sigmoidoscopy? First, it should be acknowledged that flexible sigmoidoscopy reduces colorectal-cancer incidence and mortality for the portion of the colon that it is designed to examine. Next, high-quality evidence must show the superiority of colonoscopy over other screening tests before we dismiss the use of flexible sigmoidoscopy and fecal occult-blood testing, both of which have randomized, controlled trials supporting their benefit. Especially critical are data that confirm the ability of colonoscopy to reduce mortality from proximal cancers. Finally, patient preferences for screening tests should be identified and respected — in this case, the best test is the one that gets done.

Electronic health records: medical progress, not panacea

Yesterday, the family medicine residency program where I serve as a faculty preceptor "went live" with their new electronic health record. They posted a sign at the front desk that read in part: "Pardon Our Progress," as if we were starting a major construction project - which in a way, we were. Instead of wading through stacks of unruly paper charts, my colleagues and I logged on to a sleek online portal via laptop computers to review and sign residents' progress notes. Thanks to months of meticulous preparation and the presence of onsite technical support, the day went relatively smoothly for physicians and patients.

By leaving paper behind, we looked forward to eliminating inconvenience and errors associated with lost charts and illegible or missing documentation. But the most important reason for the switch to an electronic health record was the unspoken presumption that it would allow us to provide better preventive and chronic care for patients. At the end of the afternoon session, I asked the residents how strong the evidence is that practices with electronic health records actually improve their quality of care.

The answer, it turns out, is not very strong at all. In an editorial published in the May 15th issue of American Family Physician, I review the small number of studies that have evaluated the effect of electronic clinical decision support systems (CDSSs) on processes and outcomes of preventive care. Whether the goal was to improve immunization or behavioral counseling rates, electronic health records have had, at best, modest effects:

In summary, the evidence is far from conclusive that EHRs and CDSSs improve preventive care processes and outcomes in primary care settings. The small number of mostly nonrandomized studies makes it hard to determine whether changes in physicians' behaviors were the result of implementing CDSSs, or if other factors were responsible. Also, the most promising studies to date were performed in large practices of employed physicians, rather than in small physician-owned practices. Finally, all but a few studies measured only guideline adherence, rather than patient-oriented health outcomes. To be worth the investment, EHR-enabled CDSSs must ultimately be shown to not only improve processes of preventive care, but also reduce morbidity and mortality and improve quality of life.

Similarly, a study published in this month's issue of the Annals of Family Medicine found that in a group of 42 similar primary care practices in the Northeast, those using EHRs were less likely than those without EHRs to meet three diabetes care quality measures (hemoglobin A1c, LDL cholesterol, and blood pressure), and that the gap did not narrow after 3 years.

So what are the chances that our residency's substantial investment (and the U.S. government's billions of dollars of incentives for physicians and hospitals to install and demonstrate "meaningful use" of electronic health records) will ultimately pay off for patients? The key to success for integrated health systems such as Kaiser Permanente and the Mayo Clinic has been to use the data from EHRs to manage population health. Rather than the traditional model of treating diabetes one patient at a time, for example, "panel managers" (registered nurses or other non-physician health professionals) can reach out to patients outside of the office visit and make sure that they are receiving recommended care. Who will pay these managers outside of the Kaisers and Mayo Clinics remains a largely unanswered question. The bottom line, though, is that it's not enough to just collect electronic data. For EHRs to transform primary care, we need to be able to use the data in new and creative ways, improving the health of large groups of patients - and eventually, entire communities - at the same time.

Effective health care for children with autism spectrum disorders

A recent report from the Centers for Disease Control and Prevention found that the prevalence of autism spectrum disorders (ASDs), estimated at 1 in 110 children in a 2010 American Family Physician article, may now have risen as high as 1 in 88. Previous AFP Community Blog posts have discussed potential explanations for the continuing increase in autism diagnoses, from the phenomenon of "diagnosis shift" to increased screening for ASDs at well-child visits, a controversial practice.

Although the etiology of ASDs remains unknown, there is evidence to support some treatments for affected children. In the May 1st issue of AFP, Dr. Corey Fogleman launched our "Implementing AHRQ Effective Health Care Reviews" series by summarizing key points from an Agency for Healthcare Research and Quality-sponsored review of the effectiveness, benefits, and harms of therapies for core and associated symptoms of ASDs in children two to 12 years of age. The review found that the antipsychotic drugs risperidone and aripiprazole reduce challenging behaviors in children with ASDs, but are associated with significant adverse effects. Also, intensive one-on-one behavioral interventions appear to improve outcomes if begun before four years of age.

The AHRQ review's conclusion that there is insufficient evidence to assess the benefits and harms of other treatments for ASD-associated repetitive behaviors was supported by a recent study published in Pediatrics. Dr. Melisa Carrasco and colleagues analyzed published and unpublished data on selective serotonin receptor inhibitors (SSRIs) and initially found that SSRIs were modestly helpful in reducing repetitive behaviors in children with ASDs. However, after they adjusted for the effect of publication bias (i.e., the tendency for trials showing a benefit to be published while those showing no benefit are not), the improvement was no longer statistically significant. This study illustrated how difficult it is for even the highest-quality reviews to determine what constitutes effective health care for patients when important data are unavailable for review.

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The above post was first published in the AFP Community Blog.

Job Posting: Primary Care Health Policy Fellow

The Department of Family Medicine at Georgetown University School of Medicine is currently seeking qualified applicants for its one-year fellowship in Primary Care Health Policy. This is a unique, full-time program that combines experiences in scholarly research, faculty development, and clinical practice. Fellows have the opportunity to interact with local and federal policymakers in Washington, D.C. and pursue original research projects with experienced mentors at the Robert Graham Center for Policy Studies in Family Medicine and Primary Care. They will join a dynamic group of faculty (including me) at one of the flagship departments for urban family medicine on the East Coast. Past Health Policy Fellows have gone on to hold leadership positions in federal health agencies, community health organizations, and academia. Applicants should be graduates of an accredited residency program in family medicine or expect to graduate in 2012. Please e-mail me at KWL4@georgetown.edu for additional information.

How much does it cost to have an appendectomy?

A few years ago, a good friend of mine who holds bachelor's and law degrees from Ivy League schools lost his job and became one of the estimated 50 million medically uninsured persons in the U.S. Over the course of several days, he developed increasingly severe abdominal pain, fever, and vomiting. Though reluctant to seek medical attention, he finally was persuaded to visit his local hospital's emergency department, where he was diagnosed with acute appendicitis. Despite his critical condition and the need for immediate surgery, he refused treatment until the hospital's billing department gave him an estimate of how much an emergency appendectomy would cost. Then, as he was being prepared for the operating room, he somehow managed to bargain with the surgeon to reduce his customary fees.

Sharing this harrowing story weeks later, my friend, until then a strong believer in the power of the market to control rising health care costs, was justifiably proud that his negotiating skills had prevented the hospital bill from completely depleting his savings. On the other hand, he recognized the insanity inherent in trying to practice "consumer driven health care" during a medical emergency, especially given the lack of information about the pricing of health care services. I've written before about how difficult it was for my wife and I to estimate how much it would cost to have a baby (our son, incidentally, is now two months old and doing well). It turns out that variations in pricing for the diagnosis and treatment of acute appendicitis are even larger and less explicable.

A study published yesterday in the Archives of Internal Medicine reported that the hospital charges for patients hospitalized in California for acute uncomplicated appendicitis ranged from $1529 to $182,955, with a median charge of $33,611. Patient age, insurance type, and geographical location explained only about 2/3rds of the observed variations. My friend's experience in a different state confirmed what the authors of this study observed:

A patient with severe abdominal pain is in a poor position to determine whether his or her physician is ordering the appropriate blood work, imaging, or surgical procedure. Price shopping is improbable, if not impossible, because the services are complex, urgently needed, and no definitive diagnosis has yet been made. In our study, even if patients did have the luxury of time and clinical knowledge to "shop around," we found that California hospitals charge patients inconsistently for what should be similar services as defined by our relatively strict definition of uncomplicated appendicitis.

Given better transparency about pricing, perhaps there is a role for comparison shopping for predictable health care expenses, such as elective surgery or labor and delivery. But huge variations in pricing for emergency care illustrate how badly the consumer health care model fails. There are many flaws in the Affordable Care Act that Congress passed in 2010, but extending insurance to millions of currently uninsured Americans is not one of them. As this example shows, it is our country's broken health system, not the health law, that requires urgent repeal and replacement.

Counterintuitive findings on quality incentives and patient satisfaction

They've been repeated so often that many health care quality gurus take them for granted: 1) paying physicians for performance will improve quality of care; 2) increasing patient satisfaction will reduce care costs and improve outcomes.

Not necessarily, two recent studies suggest.

A Cochrane for Clinicians piece on financial incentives for improving the quality of care in the April 1st issue of American Family Physician concludes that despite their increasing popularity, there is actually "limited evidence" that pay-for-performance models are successful in primary care practice. When positive effects were seen in the studies examined in the Cochrane review, they were disappointingly modest. Further, writes commentator Elizabeth Salisbury-Afshar, MD, MPH, "In addition to costs, potential harms must be considered. For example, if financial incentives are provided only for certain health indicators, physicians may spend more time focusing on meeting those indicators while paying less attention to other important components of care." This commentary elicited several online comments from readers, ranging from a defense of the "tried and true" fee-for-service model to requests for better tools and systems to allow physicians to improve care quality without making unsustainable demands on their time.

In a similar vein, a study published in the Archives of Internal Medicine found that although higher patient satisfaction was associated with lower rates of emergency department use, it also was linked to several less desirable outcomes, including higher odds of any inpatient admission, greater total and prescription drug costs, and higher mortality. Is it possible, questions Dr. Brenda Sirovich an accompanying editorial, that patient satisfaction is driven by receiving more care, but not better care? She goes on to observe:

Practicing physicians have learned ... that they will be rewarded for excess and penalized if they risk not doing enough. More aggressive practice, therefore, improves not only patients' perceived outcomes, but also those of physicians (reimbursement, performance ratings, protection against lawsuits), and the positive feedback loop of health care utilization is fueled at two ends. ... A positive feedback system is not in fact positive (ie, favorable)—it represents an unstable system, one that cannot control its own growth, or demise. We, as a profession and as a society, can take responsibility for controlling this unrestrained system only if we commit to overcoming the widespread misconception that more care is necessarily better care, and to realigning the incentives that help nurture this belief.

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The above post was first published on the AFP Community Blog.

My take on state health insurance exchanges - Part 3

Regardless of whether or not the Supreme Court strikes down the individual mandate or the entire 2010 health reform law in June, state-based health insurance exchanges are a good idea and, if established, should benefit many working Americans who are too well-off to qualify for Medicaid but unable to otherwise afford health insurance coverage on their own. This is the last of three posts excerpted from an unpublished paper that I recently authored on this topic. You can read Parts 1 and 2 here and here.

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Exchanges will need to establish procedures for determining 1) citizenship or legal resident status; 2) income eligibility for premium tax credits and cost-sharing reductions; and 3) eligibility for the public insurance programs Medicaid and CHIP. Since the ACA also expands Medicaid eligibility, fluctuations in income over time will force millions of people to repeatedly transition from public insurance coverage to a subsidized exchange plan and vice versa, changing health provider networks and potentially disrupting continuity of care. Exchanges may help to facilitate these transitions by minimizing paper documentation, guaranteeing minimum eligibility periods regardless of interim income changes, and making it possible for at least some insurance plans to be offered under Medicaid and within the exchange (“dual certification”). As one expert advised, since the intent of the ACA was to expand insurance coverage, “Exchanges should see it as their responsibility to ensure the continued enrollment of eligible individuals and families for tax credits and public programs, rather than holding individuals responsible for continually having to work at maintaining their own eligibility.”

The Massachusetts Connector’s experience illustrates the challenges of managing transitions between private and public insurance plans, which often lead to gaps in coverage: “In particular, the dates for enrollment and disenrollment between public and private coverage are not aligned, so that individuals losing Medicaid eligibility early in a month must wait until the first of the following month to enroll in CommCare [exchange for individuals below 300% of the federal poverty line].” Consequently, California anticipated the problem of coordination with public insurance programs in the legislative language enabling its exchange, which requires that the governing board “ensure consistent eligibility and enrollment processes and seamless transitions between coverage.” However, the information technology needed to achieve this goal is still being developed. In December 2011, the Maryland Health Benefit Exchange Board set a goal of ensuring continuity of care between public and private programs by recommending: “The Exchange should require transition of care language in contracts as part of qualified health plan certification and work with Medicaid to promote reciprocal care transition provisions in the managed care organization contracts.”

In drafting the blueprints for their state health insurance exchanges, Maryland and California have largely followed the successful model of the Massachusetts Connector. Other states that are planning to set up their own exchanges will also need to grapple with the questions regarding governance; reducing adverse selection; making plan information available and accessible to consumers; determining eligibility; facilitating transitions between public insurance and subsidized private plans within the exchanges; and a host of other design issues.

Despite the similarities in the structures and functions of the three health insurance exchanges discussed here, characteristics of other state populations, local insurance markets, and existing regulatory institutions will likely lead to a diversity of other approaches. For example, Rhode Island, Utah and Vermont have located their exchanges entirely within state governments, while Hawaii has structured its exchange as an independent nonprofit. Reassuringly, a recent simulation study suggested that state-to-state variations in several critical exchange design elements (e.g., separating versus merging the individual and small-group markets) would have only small effects on overall coverage and cost outcomes nationwide. By establishing some basic requirements but granting states substantial leeway to operate (or not operate) their exchanges in accordance with local resources and preferences, the ACA will hopefully achieve its goal of providing access to affordable health coverage to millions of currently uninsured Americans.

My take on state health insurance exchanges - Part 2

Regardless of whether or not the Supreme Court strikes down the individual mandate or the entire 2010 health reform law in June, state-based health insurance exchanges are a good idea and, if established, should benefit many working Americans who are too well-off to qualify for Medicaid but unable to otherwise afford health insurance coverage on their own. This is the second of three posts excerpted from an unpublished paper that I recently authored on this topic. You can find my first post here.

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Adverse selection is a phenomenon in which higher-risk (and higher-cost) individuals become more likely to purchase insurance inside the exchanges, leading to premium increases within the exchanges, driving healthier (and lower-cost) individuals to purchase cheaper insurance outside the exchanges, leading to further exchange premium increases, and so on, until the exchange essentially becomes a high-risk pool. Thus, adverse selection is a serious threat to the viability of exchanges. One potential solution is to simply eliminate the market outside of the exchanges, but this option may not be feasible for most states. To reduce the risk of adverse selection, states should have identical rating rules for the markets inside and outside of the exchanges, and require all insurance plans of a certain size to participate in the exchanges. Massachusetts, for example, requires that all insurers with more than 5000 non-group enrollees submit bids to the Connector, and that prices for insurance products be the same inside and outside of it.

California will require insurers inside and outside of its exchange to offer all four tiers of benefit coverage, and in addition, will only permit insurers to offer catastrophic plans if they participate in the exchange. In Maryland, insurers who currently collect more than $10 million in premium revenue from the individual market or more than $20 million in premium revenue from the group market must participate in the exchange, and insurers offering catastrophic plans outside of the exchange must also offer them within the exchange. Maryland’s exchange governing board is empowered to re-examine the participation revenue threshold and adjust it as needed over time to ensure that large insurers remain in the exchange.

In addition to offering subsidized and/or competitive coverage, the exchanges should offer consumers tools to make informed choices between different insurance plans and coverage tiers. To facilitate comparisons, all participating insurers could be required to disclose standard types of benefit information through a common Internet portal, including patient satisfaction scores, if available. Exchanges must strike a balance between ensuring transparency and overwhelming consumers with information, as Jon Kingsdale observes: “Given the (understandable) lack of excitement in the general populace for mastering the details of insurance, the danger of information overload is almost as great as that of knowing too little. Exchanges must learn what information consumers want and need and how best to package and present it – a challenge not unlike that confronted by retailers."

The Massachusetts Connector web site (http://www.mahealthconnector.org) allows consumers to easily compare up to three plans side-by-side on the basis of monthly cost, annual deductible, out of pocket maximum, and other cost variables. Although neither California’s nor Maryland’s benefits exchange portals are yet operational at the time of this writing, California’s current exchange home page (http://www.healthexchange.ca.gov/Pages/Default.aspx) promises that it will “support consumer choice” through a web-based eligibility portal, website that provides standardized plan comparison information, a cost-comparison calculator, and a toll-free assistance hotline.

My take on state health insurance exchanges - Part 1

Regardless of whether or not the Supreme Court strikes down the individual mandate or the entire 2010 health reform law in June, state-based health insurance exchanges are a good idea and, if established, should benefit many working Americans who are too well-off to qualify for Medicaid but unable to otherwise afford health insurance coverage on their own. This post and two to follow over the next week are excerpts from an unpublished paper that I recently authored on this topic.

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One of the key elements of the insurance coverage expansion contained in the Affordable Care Act (ACA) is the establishment of health benefits exchanges operated by individual states, groups of states, or the federal government, by January 1, 2014. These exchanges will offer competitive and/or subsidized insurance options for individuals whose employers do not provide insurance, as well as offer plans to small businesses (up to 100 employees) at reasonable rates. Prior to the ACA, Massachusetts and Utah had both operated state insurance exchanges with varying degrees of success. By outlining only basic requirements for the functions of the exchanges, the ACA left many important questions regarding their design unanswered. Some states appear to be pursuing a “wait and see” strategy, hoping that the U.S. Supreme Court will strike down the ACA prior to the January 2013 deadline for showing sufficient progress toward establishing an exchange or ceding control to the federal government. Others are at various stages of the planning process; as of January 2012, 13 states had formally established their exchanges through legislation or executive orders. Maryland and California are at the vanguard of this group.

The ACA mandated the creation of state-based exchanges for individuals (American Health Benefit Exchanges) and businesses with up to 100 employees (Small Business Health Options Program [SHOP] Exchanges), which may be separate markets or merged into a single exchange. Beginning in 2017, states may allow businesses with more than 100 employees to purchase coverage through the exchanges. Only U.S. citizens and legal immigrants will be permitted access to coverage through the exchanges. Individual and small group plans will include four tiers of coverage: bronze (60% of benefit costs), silver (70% of benefit costs), gold (80% of benefit costs), and platinum (90% of benefit costs). A catastrophic plan will be available for individuals up to age 30 and other persons who are financially exempt from the insurance purchase mandate. Carriers must guarantee insurance issue and only vary ratings based on age, premium rating area, family
composition, and tobacco use. Exchanges will be responsible for establishing enrollment procedures and determining eligibility for tax credits.

States may decide to locate exchanges within a government agency, in a quasi-governmental body, or an independent nonprofit organization. Although greater government control probably makes it easier for the exchanges to respond to the policy needs of their states (especially in exchanges that are designed as “active purchasers” of insurance rather than simple clearinghouses for any insurer that wants to participate), it also increases the risk of political interference favoring particular insurers. To date, most states have chosen the quasi-governmental model. For example, although it is governed by an 11-member Board of Directors that includes several state health officials, the Massachusetts Connector is by statute outside of the control of the executive branch of government.

California established a 5-member independent governing board for its exchange, consisting of its Secretary of Health and Human Services and four members appointed by the Governor and the state legislature. To avoid conflicts of interest, board members may not be health care providers or employees of health care facilities or insurance companies. To improve its responsiveness to the market, the exchange is exempted from most state administrative regulations on personnel and contracting. Similarly, Maryland’s quasi-governmental exchange is supervised by a 9-member board, including 3 state health officials and 6 appointed members. Conflict-of-interest provisions are similar to California’s.

The FDA fails to stop deceptive dementia drug advertising

In the March 15, 2011 issue of American Family Physician, Drs. Mark Graber, Robert Dachs, and Andrea Darby-Stewart analyzed an industry-funded trial that compared the effects of two daily doses of the Alzheimer's disease drug donepezil (Aricept): a new 23 mg version and the existing 10 mg version that would soon lose its patent protection. Despite the trial authors' finding that the higher dose of donepezil slightly improved cognitive outcomes, AFP Journal Club commentators determined that this difference was clinically unimportant, and was greatly outweighed by the higher frequency of adverse effects in patients using the higher dose:

First, the authors did four comparisons. Three were negative and only one was positive. And the one that was positive was only two points different on a 100-point scale. So, although this is statistically significant, it is clinically meaningless. There is no discernible benefit for the patient or caregivers. ... Also, the drop-out rate in this study was an astounding 30 percent in the higher-dose group and 18 percent in the lower-dose group.

Adverse effects of donepezil include bradycardia, falls, nausea, diarrhea, and anorexia. In fact, a recent study demonstrated that community-dwelling older persons with dementia who are taking currently available cholinesterase inhibitors have higher rates of hospitalization for syncope, bradycardia, pacemaker insertion, and hip fractures compared with similar patients with Alzheimer disease who are not taking these medications. So, the idea of increasing the dose to 23 mg, potentially resulting in more serious adverse events while achieving no clinical gain, is ill-conceived at best.

Nonetheless, based on this study, the U.S. Food and Drug Administration eventually approved the 23 mg dose of donepezil against the advice of its own medical reviewers. One year later, though, the Journal Club on donepezil has proved to be prescient. Last month, in a scathing editorial published in BMJ, noted physician-researchers Lisa Schwartz and Steven Woloshin echoed AFP's earlier critique. They also rebuked the FDA for allowing Eisai, the manufacturer of donepezil, to include a false statement on the drug label and physician advertisements that touted "important clinical benefits" on measures of cognition (which, as noted, were clinically meaningless) and global function (which were not even statistically significant). Schwartz and Woloshin concluded by calling on the FDA to exercise greater oversight of such ethically questionable practices:

Alzheimer's is an awful disease. Sadly, the available drugs don't work well. But that is no excuse for emotionally manipulating vulnerable patients, desperate family members, and their doctors to use a product that is more likely to add harm than benefit. Nowhere - not in the direct to consumer or the physician advertisements, nor even in the FDA approved label - are the great uncertainties about this drug explained. ... That it is so easy to send doctors and patients incomplete and distorted messages about drugs is depressing. To make good decisions about drugs, doctors and patients need the evidence. The FDA should not forget to give it to them.

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The above post originally appeared in the AFP Community Blog.

The best recent posts you may have missed

Every other month or so, I post a list of my top 5 favorite posts since the preceding "best of" list on this blog, for those of you who have only recently started reading Common Sense Family Doctor or don't read it regularly. Here are my favorites from the past few months:

1) How much does it cost to have a baby? (1/20/12)

2) Rethinking shared decisions in prostate cancer screening (2/28/12)

3) The reality behind "death panel" rhetoric (3/14/12)

4) Screening-illiterate physicians may do more harm than good (3/5/12)

5) Curbing overuse of CT scans (1/18/12)

If you have a personal favorite that isn't on this list, please let me know. See you on the other side of Spring Break!

Don't confuse cardiovascular imaging with preventive medicine

Despite the existence of well-established guidelines for clinicians on applying effective smoking cessation interventions in practice, one in five adults in the U.S. continues to smoke. This fact has led researchers to explore other ways to motivate smokers to quit, such as using imaging technology to show them the personal consequences of tobacco use. In a randomized trial recently published in the Archives of Internal Medicine, researchers tested the "pictures are worth a thousand words" theory by comparing cessation rates between smokers who received standard therapy plus carotid plaque ultrasonographic screening to smokers receiving standard therapy alone. The results were uniformly disappointing. Even though 58 percent of smokers in the intervention group were found to have carotid plaques, there was no statistical difference in cessation rates between the groups after one year, and patients with plaques were not more likely to quit smoking than those with normal ultrasound results.

In an accompanying editorial, Dr. Patrick O'Malley called for a renewed emphasis on developing communication skills throughout medical training:

We rely too much on technology and testing that are misapplied to problems that really should be addressed with cognitive, emotion handling, and relationship-centered skills. We need a paradigm shift in priorities and incentives to shift from excessive reliance on technologies, a terribly wasteful practice, to training and cultivation of communication- and relationship-based skills that are likely much more effective in the psychosocial domains of care.

Here are my two take-home points for physicians and patients:

1) To help smokers quit, talking trumps technology.
2) Don't confuse cardiovascular imaging with preventive medicine.

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Part of the above post was originally published on the AFP Community Blog.

Essential readings on health reform

Can't get a Supreme Court-side seat for next week's six hours of oral arguments on the constitutionality of the Affordable Care Act? Want to understand how the United States reached the point where the fate of a mostly yet-to-be-implemented 2010 federal law that extends health insurance coverage to nearly all of its citizens may rest on the Justices' interpretations of the Constitution's Commerce and Taxing and Spending clauses? You would do better to spend those six hours reading two essential books that shed a great deal of light on the legislative history and contemporary health policy issues that have shaped the current debate: Paul Starr's Remedy and Reaction and Douglas Kamerow's Dissecting American Health Care.

The authors of these two books have a wealth of experience as observers and participants in health reform efforts: Starr as a Princeton historian and sometime Democratic health policy advisor, and Kamerow as a former Assistant Surgeon General and Public Health Service officer. Both published in the last year, the books are complementary: while Starr's provides an overarching narrative history of health reform efforts from the 1920s through the present, Kamerow's is a collection of insightful short commentaries written for National Public Radio and BMJ starting in 2007. (Full disclosure: I have known and admired Doug Kamerow for several years in my capacity as a fellow adjunct faculty member in Georgetown University's Department of Family Medicine.)

Below are quotations from two excellent reviews of each of the books:

From JAMA (Remedy and Reaction):

By removing the elderly and much of the working population from the uninsured, Medicare and the tax exclusion also removed much of the impetus for extending coverage to those still lacking it. The direct cost of Medicare and employer-provided coverage of beneficiaries is obvious, supporting the sense that beneficiaries' benefits are earned, while the heavy government subsidies involved are all but invisible. Extending similar benefits to others thus not only threatens a tax increase for those already covered but also can readily be understood or characterized as “welfare” and incompatible with US political ideals. The piecemeal approach to health insurance coverage did little to address problems in health care delivery, but it increased vested interests in maintaining the status quo.

Over time, reform proposals tended to leave more and more of the enormously complicated web of health care subsystems in place. One result is the great complexity of the Affordable Care Act, which provides yet another reason for objecting to it. None of the numerous other histories of US health care policy develops these themes in such an illuminating fashion.

- Samuel Y. Sessions, MD

From Family Medicine (Dissecting American Health Care):

Finally, there are quite a few essays throughout the book commenting or reflecting on recent developments in U.S. health care reform - made all the more interesting by the author's inclusion of essays in which his predictions about the course of health care reform turned out to be incorrect. ... This is a short, portable, and easily readable volume. All the essays are brief, so the book is perfectly suited for keeping on hand for those times when a few minutes are available to sneak in some reading. This book would also be suited to use in teaching on medicine and politics or medicine and society - the essays would provide interesting discussion starters for student or resident discussion groups.

- William E. Cayley Jr., MD

Guest Post: PSA screening: does it or doesn't it?

Marya Zilberberg, MD, MPH is an independent physician health services researcher with a specific interest in healthcare-associated complications and a broad interest in the state of our healthcare system. She is also a Professor of Epidemiology at the University of Massachusetts, Amherst. The following post was first published on her blog, Healthcare, etc.

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A study in the NEJM reports that after 11 years of follow up in a very large cohort of men randomized either to PSA screening every 4 years (~73,000 subjects) or to no screening (~89,000 subjects) there was both a reduction in death and no mortality advantage. How confusing can things get? Here is a screenshot of the headlines about it from Google News:

How can the same test cut prostate cancer deaths and at the same time not save lives? This is counter-intuitive. Yet I hope that a regular reader of this blog is not surprised at all. For the rest of you, here is a clue to the answer: competing risks.

What's competing risks? It is a mental model of life and death that states that there are multiple causes competing to claim your life. If you are an obese smoker, you may die of a heart attack or diabetes complications or a cancer, or something altogether different. So, if I put you on a statin and get you to lose weight, but you continue to smoke, I may save you from dying from a heart attack, but not from cancer. One major feature of the competing risks model that confounds the public and students of epidemiology alike is that these risks can actually add up to over 100% for an individual. How is this possible? Well, the person I describe may have (and I am pulling these numbers out of thin air) a 50% risk of dying from a heart attack, 30% from lung cancer, 20% from head and neck cancer, and 30% from complications of diabetes. This adds up to 130%; how can this be? In an imaginary world of risk prediction anything is possible. The point is that he will likely die of one thing, and that is his 100% cause of death.

Before I get to translating this to the PSA data, I want to say that I find the second paragraph in the Results section quite problematic. It tells me how many of the PSA tests were positive, how many screenings on average each man underwent, what percentage of those with a positive test underwent a biopsy, and how many of those biopsies turned up cancer. What I cannot tell from this is precisely how many of the men had a false positive test and still had to undergo a biopsy -- the denominators in this paragraph shape-shift from tests to men. The best I can do is estimate: 136,689 screening tests, of which 16.6% (15,856) were positive. Dividing this by 2.27 average tests per subject yields 6,985 men with a positive PSA screen, of whom 6,963 had a biopsy-proven prostate cancer. And here is what's most unsettling: at the cut-off for PSA level of 4.0 or higher, the specificity of this test for cancer is only 60-70%. What this means is that at this cut-off value, a positive PSA would be a false positive (positive test in the absence of disease) 30-40% of the time. But if my calculations are anywhere in the ballpark of correct, the false positive rate in this trial was only 0.3%. This makes me think that either I am reading this paragraph incorrectly, or there is some mistake. I am especially concerned since the PSA cut-off used in the current study was 3.0, which would result in a rise in the sensitivity with a concurrent decrease in specificity and therefore even more false positives. So this is indeed bothersome, but I am willing to write it off to poor reporting of the data.

Let's get to mortality. The authors state that the death rates from prostate cancer were 0.39 in the screening group and 0.50 in the control group per 1,000 patient-years. Recall from my meat post that patient-years are roughly a product of the number of subjects observed by the number of years of observation. So, again, to put the numbers in perspective, the absolute risk reduction here for an individual over 10 years is from 0.5% to 0.39%, again microscopic. Nevertheless, the relative risk reduction was a significant 21%. But of course we are only talking about deaths from prostate cancer, not from all other competitors. And this is the crux of the matter: a man in the screening group was just as likely to die as a similar man in the non-screening group, only causes other than prostate cancer were more likely to claim his life.

The authors go through the motions of calculating the number needed to invite for screening (NNI) in order to avoid a single prostate cancer death, and it turns out to be 1,055. But really this number is only meaningful if we decide to get into death design in a something like "I don't want to die of this, but that other cause is OK" kind of a choice. And although I don't doubt that there may be takers for such a plan, I am pretty sure that my tax dollars should not pay for it. And thus I cast my vote for "doesn't."