Common Sense Family Doctor

How do family physicians provide cost-effective care?

2013-05-22T13:11:00.002-04:00

Research studies have documented strong associations between U.S. primary care physician supply, better population health outcomes, and lower health care spending. Among adult primary care specialties, national survey data suggest that family physicians provide more cost-effective care. However, little research has examined how family physicians provide effective care at lower cost than other physicians. Is it because we are more likely to follow evidence-based guidelines? Order fewer inappropriate imaging tests? Are less likely to offer non-beneficial tests and treatments?

In the May issue of Family Medicine, Dr. Richard Young and colleagues reported a qualitative analysis of interviews with 38 Texas family physicians about decision-making practices that may contribute to delivery of cost-effective care. Participants provided examples of experiences that they felt exemplified differences in the ways they approached patients compared to approaches of less cost-effective specialists. Two major themes emerged from these interviews: 1) cost-effective care is an inherent value in family medicine; 2) knowledge of the whole patient through continuous relationships enabled efficient decision-making.

Family physicians in this study emphasized the importance of the history and physical examination, conservative testing strategies in low-risk patients, being comfortable with managing complexity, and assigning less importance to "making the diagnosis" than relieving patients' symptoms. Physicians were also attuned to potential behavioral causes of physical symptoms and placed considerable weight on financial and medical harms that could result from aggressive care.

As the authors point out, these findings are limited by the relatively small number of participants, who may or may not represent the general attitudes of family physicians in other areas of the U.S. Do you think that Dr. Young and colleagues identified all of the important ways that family physicians provide cost-effective care? If not, what other factors would you add from your own patient care experiences?

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

Vitamin D screening: few pros, many cons

2013-05-18T11:26:00.001-04:00

The U.S. Preventive Services Task Force recently announced its intent to review the evidence and issue recommendations about screening for vitamin D deficiency, after finding insufficient evidence to recommend routine supplementation for the prevention of fractures in adults. According to a 2009 review published in American Family Physician, up to half of U.S. adults 65 years and older have inadequate vitamin D levels, which places them at increased risk of falls and fractures. Two editorials in the April 15th issue of AFP debate the pros and cons of screening for vitamin D deficiency in asymptomatic persons.

Dr. Leigh Eck makes the case for targeted screening for vitamin D deficiency in at-risk populations, which include, but are not limited to, persons with malabsorption syndromes, persons with chronic kidney disease, pregnant and lactating women, and older persons with a history of falls. "Most of these factors put patients at risk of osteoporosis," Dr. Eck argues. "Given the role of vitamin D in bone mineralization, patients who are at risk of or who have osteoporosis should be considered as candidates for vitamin D screening."

On the other hand, Dr. Colin Kopes-Kerr identifies several problems with measurement of serum vitamin D levels in asymptomatic persons, regardless of risk level: lack of test standardization; disagreement about what constitutes a "normal" vitamin D level; unclear treatment implications; and uncertain cost-effectiveness. Finally, he points out, "No study has demonstrated that measurement of serum 25-hydroxyvitamin D levels offers outcome benefits over clinical assessment alone."

The Endocrine Society recommends against population-based screening for vitamin D deficiency, and the American Society for Clinical Pathology included this screening test in its list of "Five Things Physicians and Patients Should Question" for the Choosing Wisely campaign.

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

Breast cancer and the Angelina Jolie effect

2013-05-15T10:44:00.003-04:00

There is nothing like a celebrity to call attention to a preventable disease, especially if that disease is cancer. In March 2000, then-Today Show host Katie Couric, whose husband Jay Monahan died of colorectal cancer in 1998, underwent a live colonoscopy to promote uptake of colorectal cancer screening. Over the next 9 months, national colonoscopy utilization rates rose by 20 percent, a phenomenon that researchers dubbed "The Katie Couric effect." A decade later, a National Institutes of Health conference on enhancing use and quality of colorectal cancer screening identified few strategies that were as effective as this single celebrity endorsement at increasing appropriate use of screening.

Although many people undoubtedly benefited from the Katie Couric effect, one thing about it troubled me: at the time of her colonoscopy, Couric was only 43 years old. No major medical organization recommends that colorectal cancer screening start before age 50, absent certain risk factors (African American race or a first-degree relative diagnosed with colorectal cancer before age 60). The Katie Couric effect increased appropriate cancer screening, but probably promoted a lot of inappropriate screening too. For example. a 2005 Veterans Health Administration study found that one-third of fecal occult blood tests performed for colorectal cancer screening purposes were unnecessary, since they were performed in patients who were too young, too severely ill to benefit, or were within 5 years of a negative colonoscopy. Screening colonoscopy is also being performed too early and too often. Though the recommended repeat screening interval after a negative colonoscopy is 10 years, 1 in 4 Medicare patients underwent a repeat colonoscopy within 7 years without a medical indication. This isn't to say that only patients are responsible for excessive screening - doctors are certainly to blame, too.

Yesterday, the actress Angelina Jolie revealed in a New York Times Op-Ed that she had recently undergone a preventive double mastectomy after learning that she carried the BRCA1 gene, which increases a woman's lifetime risk for breast and ovarian cancer severalfold. Explaining why she chose to go public with this very personal decision, she wrote:

Cancer is still a word that strikes fear into people’s hearts, producing a deep sense of powerlessness. But today it is possible to find out through a blood test whether you are highly susceptible to breast and ovarian cancer, and then take action. ... I choose not to keep my story private because there are many women who do not know that they might be living under the shadow of cancer. It is my hope that they, too, will be able to get gene tested, and that if they have a high risk they, too, will know that they have strong options.

Will the Angelina Jolie effect turn out to be a spike in the rates of women being tested for the mutations in their BRCA genes? If so, it's likely that many more women will be harmed than helped. BRCA mutations are rare, affecting 2 to 3 per 1000 women. The vast majority of women who develop breast cancer do not carry these mutations and will not benefit from testing. Since the BRCA mutation test is costly, challenging to interpret, and likely to be positive only in women with a very strong family history of breast or ovarian cancer, the U.S. Preventive Services Task Force discourages routine genetic counseling or BRCA testing in most women. For women without Ashkenazi Jewish heritage, a "very strong family history" generally means a minimum of two affected first-degree relatives, three affected second-degree relatives (cousins don't count), a relative with bilateral breast cancer, a relative with breast and ovarian cancer, or a male relative with breast cancer. A patient with a family history that suggests a possible BRCA mutation should consult her family physician, complete a validated risk stratification tool, and receive genetic counseling from a trained professional before deciding to undergo testing. (It's unclear if Jolie's family history of cancer warranted BRCA testing - although she only mentions her mother in the Op-Ed, it is possible that other family members had breast or ovarian cancer also.)

Ample evidence indicates that most women overestimate both their personal risk of developing breast cancer and the potential benefits of screening, driven in part by well-intentioned advocacy campaigns to raise "cancer awareness." A recent New York Times Magazine article reviewed how these efforts can backfire, by exaggerating the modest benefits of screening and downplaying common psychological and physical harms of false positives and overdiagnosis.

This isn't to say that Jolie was wrong to speak out on behalf of women with BRCA mutations; patients who suffer from rare diseases suffer all the same. What we need to take away from this story - and what I encourage fellow physicians, journalists, and public health professionals to emphasize in communicating with patients about The Angelina Effect - is that screening for hereditary breast and ovarian cancer is beneficial only in very specific situations. Outside of these situations, screening is bad medicine, pure and simple.

Medicaid expansion is in the eye of the beholder

2013-05-12T22:04:00.000-04:00

To supporters of the Affordable Care Act, legislative expansion of the Medicaid program is a welcome financial and health care bonanza for states and uninsured patients. To the ACA's detractors, Medicaid expansion is a hostile government takeover that must be opposed in principle, regardless of potential benefits of an infusion of federal dollars. The stage for these state-level clashes was set by a surprising Supreme Court decision last summer that upheld most major provisions of the Affordable Care Act, but declared unconstitutional the mandatory Medicaid eligibility expansion that the law's authors had expected would extend coverage to millions of currently uninsured Americans. Instead, the Court gave individual states the option to accept or decline the expansion, which, though far more generous with federal matching funds than the existing program, would still require states to spend more within already strapped budgets.

Medicaid Expansion map courtesy of Avalere Health via The Washington Post Wonkblog 5/5/13

In last month's Georgetown University Health Policy seminar, we discussed the complex role of the Medicaid state-federal partnership (which currently provides health insurance to 1 in every 5 Americans) in improving access to care and health outcomes. In fiscal year 2011, Medicaid spending totaled $414 billion, with two-thirds going to services for disabled elderly persons. Long-term care services (nursing homes, mental health, home health care) accounted for 3 in every 10 dollars that the program spent.

Currently, to qualify for Medicaid coverage, individuals must be not only poor, but belong to one of several "core eligibility groups" defined by federal law: children, pregnant women, people with disabilities, seniors, and adults with dependent children. Income thresholds vary widely across states, especially for working parents, who might find themselves eligible for coverage in more generous states but not in others. Few states provide significant coverage for non-disabled adults without dependent children, whose services were generally excluded from federal matching funds prior to the ACA.

In 2014, states that accept the ACA's Medicaid expansion will be required to extend eligibility to all adults (parents or not) earning less than or equal to 138 percent of the federal poverty level, which works out to annual incomes of $15,856 for an individual and $26,951 for a family of three. According to the Kaiser Family Foundation, more than half of today's 48 million uninsured have incomes below the new Medicaid threshold. In states that decline Medicaid expansion, there appear to be few feasible alternatives to leaving these persons without affordable coverage, except for those earning more than 100 percent of the federal poverty level who may be able to purchase subsidized private plans in state or federal health insurance exchanges. For example, in Florida, whose legislature rejected the Medicaid expansion against the wishes of Republican governor Rick Scott, only one quarter of the 1.3 million low-income residents who would have been covered by the expansion will be eligible for tax subsidies toward private coverage in the federal insurance exchange.

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The above post first appeared on The Health Policy Exchange.

The future of medicine is low-tech and high-touch

2013-05-08T10:46:00.000-04:00

Last month, one of my students told me about his experience at TEDMED, the future-oriented medical conference that bills itself as "a celebration of human achievement and the power of connecting the unconnected in creative ways to change our world in health and medicine." He recounted how one speaker showed off the Remote Presence Virtual + Independent Telemedicine Assistant, which news outlets quickly dubbed the "Robo-Doc." This high-priced gadget is designed to provide remote medical services to patients who wouldn't otherwise be able to see real-life doctors, but my student told me that the presentation didn't talk about that much. Instead, he felt, the speaker's message seemed to be: "Robots are cool, so let's make more of them."

Along similar lines, a recent TEDMED blog post on the smartphone physical describes how a team led by an enterprising Johns Hopkins University medical student created a virtual "checkup" from a combination of smartphone-powered devices. These devices measure standard physical examination parameters such as body mass index, blood pressure, and visual acuity; and less routine tests such as oxygen saturation, electrocardiography, lung function testing, and carotid artery visualization. In addition to collecting far more data than the traditional checkup, the smartphone physical touts the advantage of using devices that are "smaller and less invasive" - no more "fumbling" to take a patient's blood pressure, for example. One commenter gushed, "Getting a smart phone physical was so fun. I got an EKG and an ultrasound of my carotids in under three minutes." So what's not to like?

I'm hardly a Luddite when it comes to adopting the latest in medical technologies, including electronic health records and smartphone apps. But I think it's worth asking how likely it is that high-tech innovations such as robo-docs and smartphone physicals will actually improve patients' health outcomes. For the latter, the answer is not likely at all. A comprehensive review of the evidence on traditional checkups in adults found that they increase the number of diagnoses per patient, but have no effects on hospitalization, disability, worry, absence from work, morbidity, or mortality. Based on other systematic reviews, the U.S. Preventive Services Task Force recommends against doing EKGs, spirometry, or carotid artery ultrasound in healthy adults because the harms of these screening tests outweigh any benefits. False positive results on that 3-minute EKG and ultrasound may lead to an unstoppable cascade of costly cardiovascular stress testing and invasive coronary or carotid angiograms, which can cause serious adverse effects.

If you really want to see the future of medicine, skip TEDMED and head over to Camden, New Jersey, where a family physician named Jeffrey Brenner showed that providing intensive primary care to patients with the most complex illnesses dramatically improved disease outcomes, quality of life, and health care costs. Then hit the road for Lancaster, Pennsylvania, where a similar program empowers "super-utilizer" patients to take control of their health care by providing them with comprehensive, multi-disciplinary case management and social support. On your way, stop by Health Quality Partners in Doylestown, PA, which has improved outcomes and reduced hospitalizations and costs for the sickest Medicare patients through the revolutionary innovation of - wait for it - regular nurse home visits. Here's what Dr. Brenner told Washington Post Wonkblog columnist Ezra Klein when asked what he thought of the Doylestown program:

"There is a bias in medicine against talking to people and for cutting, scanning and chopping into them. If this was a pill or or a machine with these results it would be front-page news in the Wall Street Journal. If we could get these results for your grandmother, you’d say, ‘Of course I want that.’ But then you’d say, what are the risks? Does she need to have chemotherapy? Does she need to be put in a scanner? Is it a surgery? And you’d say, no, you just have to have a nurse come visit her every week."

Later in the column, Klein reflects:

We’ve been conditioned by “Grey’s Anatomy” and hospital rooms to believe that saving lives is a complicated, heroic business. And it is — after people get very sick. But keeping them from getting very sick doesn’t necessarily require the discovery of new molecules. It requires someone who has a relationship with them to stop by once a week to see how they’re doing. The problem is, it’s hard to make money off it.

Pop culture and perverse financial incentives inherent in fee-for-service payment reinforce a bias for health care services that are high-tech and low-touch. Yes, robots and smartphones can and will play vital roles in the future of medicine. But if we really want sick patients to have the best chance to get better - and healthy patients to avoid getting sick in the first place - then we should do everything in our power to support low-tech and high-touch interventions too. A logical first step would be for Medicare decision-makers (this means you, Marilyn Tavenner) to reconsider their short-sighted decision to cut off funding for the Health Quality Partners program in June.

Public Speaking Update

2013-05-03T09:29:00.000-04:00

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.

Past events:

Thinking Like An Editor
- Society of Teachers of Family Medicine Annual Spring Conference, Baltimore, MD

Politics of HIV Testing
- Georgetown University School of Medicine

Burnout Prevention for Healthcare Professionals
- Teaching Prevention 2013, Washington, DC

Evidence-Based Literature Searching: A Primer
- National Capital Consortium Family Medicine Residency, Fort Belvoir, VA

Policy and Funding for Preventive Care Programs
- Georgetown University Health Systems, Policy, and Public Health Elective

Less is More: New Approaches to Cancer Screening in Primary Care
- Primary Care Coalition of Montgomery County, Maryland

2012

Science and Public Policy in Conflict: PSA Screening
- Johns Hopkins University Bloomberg School of Public Health Fall Policy Seminar

Screening Mammography for Women in their 40s: Exploring the Controversy
- National Capital Area Regional Breast Healthcare Improvement Initiative

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

Identifying and Using Good Practice Guidelines
- Temple University School of Medicine 2012 Family Practice Review Course

2011

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

2008 - 2010

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

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

Making wise choices in diagnostic imaging

2013-04-29T14:31:00.002-04:00

Many of the primary care-relevant recommendations in the Choosing Wisely campaign advise physicians to think twice before reflexively ordering diagnostic imaging tests in certain clinical situations. Inappropriate imaging increases radiation exposure, leads to overdiagnosis and detection of incidentalomas, and increases costs for patients and health systems. In addition, as Drs. Brian Crownover and Jennifer Bepko observe in the April 1st issue of American Family Physician, increasing radiation exposure is likely to lead to higher rates of cancer diagnoses and deaths:

In 2006, 380 million radiologic procedures (including 67 million computed tomography [CT] scans) and 18 million nuclear medicine procedures were performed in the United States. To highlight the disproportionate use, U.S. patients received approximately one-half of all nuclear medicine procedures worldwide while making up only 4.6 percent of the global population. The volume represents a sixfold increase (from 0.5 to 3.0 mSv [millisieverts]) in annual per capita radiation exposure from 1980 to 2006. ... Increasing recognition of future cancer risk from radiation exposure was illustrated in a 2009 study showing that 2 percent of all future cancer cases will likely come from previous CT exposure, resulting in approximately 15,000 deaths annually.

This article on the appropriate and safe use of diagnostic imaging goes on to review consensus indications for imaging in the central nervous system, chest, abdomen, and lumbar spine based on American College of Radiology appropriateness criteria. It includes a helpful Table on the average effective radiation doses of medical imaging procedures that clinicians may use to weigh the harm versus the potential benefit of a particular diagnostic imaging test. In general, the authors recommend discouraging patients from undergoing whole body scanning, which is associated with numerous health risks and no proven benefits.

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This post was first published on the AFP Community Blog.

Pink ribbons don't cure breast cancer

2013-04-25T07:30:00.001-04:00

"I used to believe that a mammogram saved my life," begins breast cancer survivor Peggy Orenstein in a revelatory New York Times Magazine story that every woman (and man) should read before making personal decisions about screening for cancer. Although the ubiquitous spectacle of pink ribbons for "cancer awareness" has certainly raised breast cancer's profile as disease, Orenstein raises serious concerns about whether these campaigns have been good for patients:

Before the pink ribbon, awareness as an end in itself was not the default goal for health-related causes. Now you’d be hard-pressed to find a major illness without a logo, a wearable ornament and a roster of consumer-product tie-ins. Heart disease has its red dress, testicular cancer its yellow bracelet. During “Movember” — a portmanteau of “mustache” and “November” — men are urged to grow their facial hair to “spark conversation and raise awareness” of prostate cancer (another illness for which early detection has led to large-scale overtreatment) and testicular cancer.

“These campaigns all have a similar superficiality in terms of the response they require from the public,” said Samantha King, associate professor of kinesiology and health at Queen’s University in Ontario and author of "Pink Ribbons, Inc.” “They’re divorced from any critique of health care policy or the politics of funding biomedical research. They reinforce a single-issue competitive model of fund-raising. And they whitewash illness: we’re made ‘aware’ of a disease yet totally removed from the challenging and often devastating realities of its sufferers.”

As I've blogged before, there are no easy victories in cancer screening and prevention. Physicians, researchers, politicians, and health advocates who exaggerate the benefits and minimize the harms of early detection of cancer with mammograms and other tests ultimately do patients a disservice. Orenstein makes this case on the personal and public health levels:

The idea that there could be one solution to breast cancer — screening, early detection, some universal cure — is certainly appealing. All of us — those who fear the disease, those who live with it, our friends and families, the corporations who swathe themselves in pink — wish it were true. Wearing a bracelet, sporting a ribbon, running a race or buying a pink blender expresses our hopes, and that feels good, even virtuous. But making a difference is more complicated than that.

It has been four decades since the former first lady Betty Ford went public with her breast-cancer diagnosis, shattering the stigma of the disease. It has been three decades since the founding of Komen. Two decades since the introduction of the pink ribbon. Yet all that well-meaning awareness has ultimately made women less conscious of the facts: obscuring the limits of screening, conflating risk with disease, compromising our decisions about health care, celebrating “cancer survivors” who may have never required treating. And ultimately, it has come at the expense of those whose lives are most at risk.

Read the full text of "Our Feel-Good War on Breast Cancer" here.

The worst kind of guideline

2013-04-18T13:54:00.003-04:00

Before critiquing the American College of Physicians' recent guidance statement on screening for prostate cancer, I will begin by saying that I generally hold the ACP's clinical guideline development process in high regard. They often base their guidelines on comprehensive and methodologically sound reviews of the evidence produced by Evidence-Based Practice Centers. In some cases, when several good-quality guidelines are already available, the ACP chooses not to reinvent the wheel and instead critically appraises the existing guidelines, as it did this time. The authors of the guidance statement are respected experts in evidence-based medicine, including Informed Medical Decisions Foundation president Michael Barry and current U.S. Preventive Services Task Force member Douglas Owens.

That being said, I won't mince words. On screening for prostate cancer, the ACP's guideline committee laid an egg.

The ACP's appraisal of the evidence on screening with the prostate-specific antigen (PSA) test was remarkably similar to the U.S. Preventive Services Task Force's assessment: harms of the test outweigh benefits. The ACP recommended that clinicians inform men between the age of 50 and 69 years of the rationale behind this conclusion, and provide a helpful, if overly extensive, list of "talking points with patients" which seem designed to discourage men from getting the test. All well and good. But what about men who absorb all of this information and still want to get screened? Well, the ACP says, go ahead and give them the test.

In what other area of medicine are physicians explicitly instructed to provide interventions that are judged do more harm than good because patients request them? To use a counter example, the vast majority of upper respiratory infections are due to viruses. Nonetheless, many of my patients request antibiotics. Antibiotics may benefit individual patients with upper respiratory infections in exceedingly rare cases, but on a population level clearly do more harm than good - leading, for example, to diarrhea, allergic reactions, and increasing bacterial resistance. But what if, after I finish patiently explaining all of these facts, the patient still "expresses a clear preference" for an ineffective and potentially harmful antibiotic prescription? Should I then go ahead and prescribe it? If I applied the ACP's approach to PSA screening, the answer would be yes.

In a thoughtful commentary published this week in JAMA Internal Medicine, L.A. County Department of Health Services Director Mitchell Katz asks the obvious question:

First, when as a profession did we decide that we had an ethical obligation to offer interventions that cause more harm than good? When we offer an intervention that is on the whole detrimental, are we not sending our patients a mixed message? Presumably there are any number of interventions that cause more harm than good. Should we be offering our patients a menu of ineffective interventions on the idea that they are better able than we are to determine effectiveness?

The ACP's guidance statement on PSA screening is even more perplexing when viewed in the context of the organization's participation in laudable efforts to prevent unnecessary or harmful medical care, including the High Value Care Initiative and the Choosing Wisely campaign. The success of these campaigns will depend on the ability of individual physicians and health systems to reduce waste and refocus resources on care that is most likely to benefit patients. Dr. Katz goes on to recount a conversation with a colleague about the hypothetical elimination of PSA screening tests in his health system:

If I cannot eliminate PSA testing, for which there is a USPSTF conclusion that the test cannot be recommended for men of any age, what is the likelihood that I could eliminate any low-value test, given that most things are not so well studied with such clear expert advice? ... Much of why the US health care system is so expensive for the benefits we gain is because we do not treat it like a system. If a new test or treatment is approved, we increase premiums to pay for it. Although we are slowly incorporating cost-effectiveness data into medical choices, especially when choosing among drugs used for the same indication or among diagnostic algorithms for evaluating a particular symptom, there is little dialogue about how to divert money from low-value care to higher-value care.

Good guideline recommendations must be concordant with the evidence upon which they are based. I may disagree vehemently with the American Urological Association about the value of PSA screening, but to their credit, their 2009 guideline at least interpreted the evidence as supporting a net benefit from the test. But to conclude, as the ACP did, that the PSA test causes more harm than good to patients, but allow physicians to provide it anyway, is nonsense. It is a huge step backward from high-value care. It is Choosing Unwisely. It is, in my opinion, the worst kind of guideline.

How to find good health information online

2013-04-16T15:44:00.000-04:00

A recent survey found that 60 percent of adults have gone online at least once in the past year to look up health information. Unfortunately, finding high-quality health websites is a challenge. Several years ago, a review of 79 studies published in the Journal of the American Medical Association concluded that online health information for consumers is frequently flawed, inaccurate, or biased. Based on my experience, the situation isn't any better today.

Why do some health websites contain misleading information? One reason is that the group or organization running the site may have a hidden agenda. Drug companies often create consumer demand for expensive new drugs by financing groups that promote awareness of a previously unrecognized health condition, a sales tactic known as "disease mongering." (For example, Dartmouth Medical School researchers have argued that restless leg syndrome became a disease only when a drug was developed to treat it.) Unfortunately, a study published in 2011 in the American Journal of Public Health found that most health advocacy groups that receive drug-company funding don't disclose that on their websites.

Another reason that websites may contain misinformation is that some groups willfully disregard scientific evidence to promote certain health beliefs. For example, even though the U.S. Institute of Medicine found in 2004, after an exhaustive review of the medical literature, that there is no relationship between childhood vaccines and autism, it's easy to find websites that claim otherwise. Similarly, although most researchers have concluded that Morgellons disease—a bizarre skin condition that sufferers believe to be caused by an undiagnosed parasitic infestation—is likely to be a psychiatric delusional disorder, you wouldn't know it by simply Googling "Morgellons."

Because advising my patients to make an appointment every time they have a health-related question isn't a practical solution, I refer them to websites that I trust or that have been certified by an independent, quality rating organization such as the Health on the Net Foundation. This organization's search engine only retrieves results from websites that have agreed to provide objective, scientifically sound information. One such website—Healthfinder.gov, which is a clearinghouse on a variety of general health topics— links to the latest health headlines, and provides interactive health tools that give personalized advice about screening tests and other preventive health issues. Content on Healthfinder.gov is periodically reviewed by U.S. government health experts to assure its accuracy and consistency with results from the latest scientific studies.

When I want to give patients a handout about the basics of a preventive test or newly diagnosed health condition, I turn to FamilyDoctor.org, a nonprofit website supported by the American Academy of Family Physicians. (Full disclosure: I edit a medical journal that is the source of many of these handouts.) One such handout advises that patients ask themselves three questions about every health-related website they visit:

1. Where did this information come from?
2. How current is this information?
3. Who is responsible for the content on this website?

As powerful a tool as the Internet can be in giving people access to health information, it is only a starting point. With few exceptions (for example, management of the common cold), patients should never use online information to self-diagnose or treat a medical problem. However, I believe that patients who visit high-quality health websites are usually better-informed and more capable of making complex choices, such as whether or not to get a screening test for cancer. And in my opinion, that's a good thing.

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The above post was first published on my Healthcare Headaches blog at USNews.com in June, 2011.

Politics and practice guidelines: a volatile mix

2013-04-11T09:07:00.001-04:00

Health services research in the United States has historically been the "poor cousin" of biomedical research in federal funding and support. The annual budget for the National Institutes of Health, for example, is typically around 100 times that of the Agency for Healthcare Research and Quality (AHRQ). In last month's Georgetown University Health Policy seminar, we discussed the financial and political challenges that AHRQ and its predecessor, the Agency for Health Care Policy and Research (AHCPR) have faced while trying to improve outcomes and effectiveness of medical care since the latter's founding during the first Bush Administration.

Citing John Wennberg's pioneering geographic analyses of medical practice variations and potentially inappropriate use of health services across the U.S., AHCPR's supporters wanted the new agency to produce practice guidelines to promote evidence-based care. However, when one of those guidelines suggested that spinal fusion surgery was unnecessary for most patients with acute low back pain, AHCPR found its budget under attack. It didn't help that the agency was also identified with the failed Clinton health reform plan and had few defenders left in a Republican Congress after the 1994 elections. Although the agency survived, this experience eventually drove it out of the guideline-producing business for good. When AHRQ was reauthorized in 1999, the word "policy" was removed from its name.

From 2010 AHRQ Annual Conference presentation by Dr. Francis Chesley, Jr.

It's understandable that this episode made future AHRQ leaders reluctant to wade into explosive scientific controversies, especially regarding sacred cows of medicine such as mammography and prostate cancer screening. When the AHRQ-supported U.S. Preventive Services Task Force chose to do so, the political fallout again put the agency in an uncomfortable position. Distancing itself from the USPSTF's recommendation against routine mammography in women younger than 50 and repeatedly delaying the release of another that advised clinicians to stop prostate-specific antigen testing altogether, AHRQ still found itself under heavy fire from health reform opponents on Capitol Hill. In July 2012, it was deja-vu all over again as AHRQ's budget was singled out for elimination by an appropriations subcommittee in the House of Representatives. Supporters of health services research in the U.S. lined up to defend the agency. The bill was not taken up by the Senate, and of this writing, AHRQ appears to have survived another "near death experience."

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The above post first appeared on The Health Policy Exchange. Note: I was employed as a medical officer at AHRQ from October 2006 through December 2010.

Book Review: Fractured

2013-04-08T13:38:00.000-04:00

Here are a few excerpts from my less-than-enthusiastic review of Fractured: America's Broken Health Care System and What We Must Do To Heal It, by Dr. Ted Epperly, which appears in the April 2013 issue of Family Medicine.

The book’s chapters on historical health reform efforts in the United States and comparisons to the health care systems of other countries are two of the most lucid that I’ve read. Entire volumes have been written on each of these topics, which the author manages to boil down to just over 50 pages of succinct text supported by a series of informative tables and figures. In one particularly strong passage, the book explains how the United States is effectively divided into the imaginary countries of “Richland” and “Poorland,” separated not only by enormous gaps in income but also life expectancy, out-of-pocket health spending, and access to primary and specialty care services.

By comparison, the chapter that explains “why America struggles with health care for all” is a confusing recitation of pro-ACA talking points. ... After assuring readers in the first chapter that his goal “is not to take one political side or another,” the author then proceeds to do exactly that. ... Aside from a passing mention in the first chapter, the book provides no sense of Dr Epperly’s presumably positive experiences as a military physician. A few representative patient anecdotes could have gone a long way toward distinguishing Fractured from the ever expanding library of tomes written by health policy wonks without the clinical experience of a family physician. As the director of a health policy fellowship program for family physicians, I would be unlikely to include this book on a required reading list.

You can also go to the Family Medicine website to read the full review.

The consensus in preoperative testing: less is more

2013-03-28T11:40:00.000-04:00

Family physicians are often asked for preoperative consultations prior to elective surgical procedures. Traditionally, the process of "clearing" patients for surgery has included performing an electrocardiogram, chest x-ray, and numerous laboratory tests. However, as Dr. Molly Feely and colleagues point out in the cover article of American Family Physician's March 15th issue, there is little evidence that routine preoperative testing is beneficial: "these tests often do not change perioperative management, may lead to follow-up testing with results that are often normal, and can unnecessarily delay surgery, all of which increase the cost of care." Instead, current guidelines recommend selective testing based on risk factors identified during the history or physical examination.

The following Choosing Wisely campaign recommendations from several medical specialty groups identify unwarranted preoperative tests to reduce waste and prevent harm to patients:

1. Avoid routine preoperative testing for low-risk surgeries without a clinical indication.
2. Avoid admission or preoperative chest x-rays for ambulatory patients with unremarkable history and physical exam.
3. Patients who have no cardiac history and good functional status do not require preoperative stress testing prior to noncardiac thoracic surgery.
4. Avoid cardiovascular stress testing for patients undergoing low-risk surgery.
5. Avoid echocardiograms for preoperative/perioperative assessment of patients with no history or symptoms of heart disease.
6. Don’t order coronary artery calcium scoring for preoperative evaluation for any surgery, irrespective of patient risk.
7. Don’t initiate routine evaluation of carotid artery disease prior to cardiac surgery in the absence of symptoms or other high-risk criteria.
8. Prior to cardiac surgery there is no need for pulmonary function testing in the absence of respiratory symptoms.

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The above post first appeared on the AFP Community Blog. A list of primary care-relevant Choosing Wisely recommendations organized by medical discipline is available on the AFP website.

The best recent posts you may have missed

2013-03-23T11:56:00.001-04:00

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 February and March:

1) The role of whistleblowing in health care (2/25/13)

2) Unintended consequences of "pregnancy prevention" (2/5/13)

3) Concerns about calcium supplements (2/8/13)

4) Choosing Wisely's curious omissions (3/3/13)

5) Do practice culture and clinician stress affect patient safety in primary care? (3/6/13)

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

Dangers of the incidentaloma: how CT scans can hurt you

2013-03-18T09:53:00.003-04:00

Mrs. Smith (not her real name) fidgeted in her chair in my examination room as I scanned the radiology report she had given me. She had visited the emergency room the previous evening with severe abdominal pain that had eventually been diagnosed as gastritis, or swelling of the stomach lining due to a virus. During her evaluation, the ER physician had ordered a CT scan of her abdomen and pelvis. Although Mrs. Smith's liver and intestines appeared normal, the radiologist had noted a tiny mass on one of her kidneys.

The report stated that the mass was consistent with a harmless cyst, but concluded with a statement that was all too familiar to me: "Cannot rule out malignancy. Clinical correlation required." Translation: it was almost certainly nothing serious, but there was a very small chance that it might be cancer, and now it was my job to make sure it wasn't. But further investigation of this incidental finding, which had no relationship to Mrs. Smith's original symptoms, would involve a painful biopsy, and if the biopsy was inconclusive, surgery to remove her kidney. In similar situations with other patients, I had suggested the alternative of regular monitoring with additional scans to make sure that the mass wasn't growing; however, this option requires that a patient live each day with the anxiety of not knowing if she has cancer.

That episode happened a decade ago, but the dilemma that my patient faced is, if anything, much more common today. A study published recently in the journal Radiology found that children visiting U.S. emergency rooms had five times as many CT scans in 2008 as in 1995. By 2008, 6 percent of pediatric ER visits involved a CT scan. The same research group, led by Dr. David Larson at Cincinnati Children's Hospital Medical Center, previously found an even greater rise in scanning during adult ER visits, with 25 percent of patients age 65 and older, and 12 to 16 percent of younger adults, getting a CT scan in 2007.

In addition to increasing risks associated with radiation exposure, all of those CT scans turn up an awful lot of "incidentalomas," the term that doctors use for incidental findings that could be (but probably aren't) cancer. A study in the journal Archives of Internal Medicine found that nearly 40 percent of CT and MRI scans performed for research purposes at the Mayo Clinic from January through March 2004 turned up at least 1 incidental finding. In the 35 patients in whom doctors took further action (additional testing, specialist consultation, or surgery), only 6 were judged by researchers to have clearly benefited from an investigation, while in the rest there was no clear benefit or clear harm, such as complications from surgery for a benign tumor. Of all types of scans, CT of the abdomen and pelvis - the very same scan that my patient got - was the most likely to turn up an incidental finding.

In fact, the American College of Radiology has become so concerned about the problem of incidentalomas on CT scans of the abdomen and pelvis that they have published detailed guidance for clinicians about how to approach such findings. "Subjecting a patient with an incidentaloma to unnecessary testing and treatment can result in a potentially injurious and expensive cascade of tests and procedures," the radiology group warns, advising that doctors carefully consider an individual patient's risk for cancer in deciding whether or not to recommend further evaluation.

So what can you do to reduce the chance you will be harmed by an incidentaloma? Three experts in diagnostic medicine at the the Dartmouth Institute for Health Policy and Clinical Practice recommended that patients who are told about an incidental finding always seek a second opinion to verify that the radiologist's interpretation of their scan is correct, and understand that clinical observation of an incidentaloma is often a safer option than more testing or surgery. Also, they advise that patients adopt a "healthy skepticism" about testing and only consent to scans that are absolutely necessary to establish a diagnosis or plan of action, rather than ordered “just to be sure.”

To be honest, I don’t remember what Mrs. Smith chose to do about her incidentaloma. If I saw her as a patient today, I would definitely consult a second radiologist to be sure that the kidney mass was actually there. If it was, I would probably recommend a wait-and-see approach, given that additional testing could create more risk than reward.

And if I had the power to turn back to clock and warn my patient before she arrived in the ER, I’d advise her to ask the physician there if the CT scan was really needed at all.

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A slightly different version of the above post originally appeared in my Healthcare Headaches blog at USNews.com and in Common Sense Family Doctor in April, 2011.

Preventive health advice for the new Pope

2013-03-14T09:08:00.000-04:00

Congratulations to Cardinal Jorge Bergoglio from Argentina, who yesterday became Pope Francis, the new leader of the worldwide Catholic Church. The new Pope is 76 years old and in apparently good health. To ensure a long and productive reign, Pope Francis's personal physician would be wise to provide age-appropriate preventive care, which includes yearly influenza vaccination and a one-time dose of the pneumococcal vaccine if he hasn't already received it. He should forgo the PSA test for prostate cancer screening, which would cause more harm than good in a man of his age (or any age), and think carefully about continuing colorectal cancer screening, which adults between 76 and 85 years of age should not undergo routinely due to the close balance between benefits and harms, such as complications from anesthesia. If the Pope chooses to have a colonoscopy, he should select a specialist who will adhere to evidence-based guidelines on screening intervals, to avoid the practice of too-frequent colonoscopy that is unfortunately widespread in the United States.

Although Pope Francis is now a world leader with the status of monarchs and Presidents, he should decline any sort of Presidential Physical that includes screenings that are nonbeneficial (such as the aforementioned PSA test) or have insufficient supporting evidence. In fact, I would encourage him to use the pulpit of the Papacy to challenge the absurd notion that undergoing screening tests in men and women his age is "morally obligatory," which a recent study found is commonly held among U.S. seniors. Pope Francis could call into question the morality of for-profit companies, such as Life Life Screening, that prey on vulnerable seniors in their houses of worship by selling questionable or totally worthless tests outside of the context of the physician-patient relationship. Perhaps a Papal edict banning such groups from advertising in the bulletins of Catholic churches worldwide? Better yet, he could lead an inter-denominational campaign against such abuses in people of all faiths.

Extra diagnostic tests don't reassure: another reason to Choose Wisely

2013-03-11T10:11:00.002-04:00

Steering patients away from unnecessary and potentially harmful tests and treatments is an essential component of high-quality primary care. The March 1st issue of American Family Physician includes two articles that reflect this philosophy as embodied in the American Board of Internal Medicine Foundation's Choosing Wisely campaign. Four of the American Geriatrics Society's "Five Things Patients and Physicians Should Question" refer to medications that can be harmful to older patients in certain settings: antipsychotics, hypoglycemics, benzodiazepines, and antibiotics. Dr. Richard Pretorius and colleagues echo this advice and provide additional guidance and systematic approaches to reducing the risk of adverse drug events in older adults.

Sudden hearing loss is a distressing symptom that may prompt a physician to order a CT scan to look for a brain tumor or other cranial mass lesion. However, the American Academy of Otolaryngology - Head and Neck Surgery Foundation advises against ordering this diagnostic test in patients without focal neurologic findings, since the CT scan provides no useful information and exposes the patient to radiation and an expensive medical bill. More information on the evaluation and management of sudden hearing loss is available in AFP's Practice Guidelines summary of the AAO-HNSF's recent clinical guideline.

One reason that clinicians often give for ordering diagnostic tests in patients with a low pretest probability of serious disease is to "reassure the patient." This rationale is used to justify performing endoscopy in patients with dyspepsia but no alarm symptoms; x-rays or magnetic resonance imaging in patients with uncomplicated low back pain; or electrocardiography in patients with chest pain and a low likelihood of cardiac disease. It turns out, though, that negative tests aren't reassuring at all. A recent systematic review and meta-analysis of 14 randomized trials in JAMA Internal Medicine found that diagnostic tests did not reduce patients' illness worry, nonspecific anxiety, or symptom persistence. The only effect of the tests was a small reduction in subsequent primary care visits. Given the adverse effects of diagnostic testing in general, including false positives and overdiagnosis, this "benefit" does not warrant making unwise choices about non-indicated medical tests.

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

Do practice culture and clinician stress affect patient safety in primary care?

2013-03-06T16:35:00.003-05:00

Initiatives to reduce medical errors in inpatient settings have found that sustained improvements in safety cannot be achieved by simply exhorting health professionals to “try harder” or making evidence-based care protocols widely available (1, 2). One obstacle to implementing changes is a toxic “blame and shame” culture that discourages physicians and staff from identifying or admitting medical errors, and therefore resists strategies to isolate and address their causes (3). To overcome this obstacle, leaders need to find ways to systematically change the culture. For example, Pronovost and colleagues incorporated interventions to create a “culture of safety” in the Comprehensive Unit-Based Safety Program that reduced medication errors, lengths of stay, and bloodstream infections in intensive care units at Johns Hopkins Hospital (4) and throughout the state of Michigan (5).

Patient safety studies in outpatient settings have mostly concentrated on minimizing prescribing errors through computerized order entry and improving communication between providers about abnormal test results (6). Compared to the inpatient setting, there are significant gaps in our understanding of what elements of primary care practice cultures and/or organizational climates may affect the incidence of medical errors.

The most ambitious observational study of the impact of organizational climate and physician stress on medical errors and care quality was the Minimizing Error, Maximizing Outcomes (MEMO) study (7, 8). MEMO was a 3-year longitudinal study of 119 practices in New York, Chicago, and Wisconsin that involved collecting data from more than 400 primary care physicians. Investigators used a 4-item scale derived to assess working conditions and organizational climate of primary care practices, and asked physicians about past errors and the likelihood of making future errors. Data from 1795 adult patients with diabetes, hypertension, or heart failure (1 to 8 patients per physician) was reviewed and analyzed for associations between care quality, medical errors (defined as missing recommended processes of care), practice culture, and physician satisfaction.

Although chaotic work environments and low control over their work were strongly associated with physician dissatisfaction, stress, and burnout in the MEMO study, and physicians perceived these factors as increasing their likelihood of making errors in the future (7), organizational climate had no consistent relationship with care quality or medical error scores (8). There are several possible explanations for the lack of association between organizational climate and patient outcomes in this study, including an overly restrictive definition of a medical error, too few patients analyzed per physician, and, of course, the possibility that practice culture did not affect the patient outcomes that were measured. Indeed, the MEMO investigators suggest that ”one interpretation of our findings is that physicians act as buffers between adverse work conditions and patient care – adverse working conditions affect them strongly, but their reactions do not translate into lower-quality care.”

There is considerably greater variation in size and structure among primary care practices than among intensive care units in the U.S., and that variation will likely make it more challenging to implement a “Comprehensive Primary Care-Based Safety Program” even if it proves possible to identify practice cultures that are more conducive to systematic interventions to reduce medical errors in outpatient settings. Nonetheless, several potential strategies have merit:

1) Experimenting with ways to permit primary care patients to report mistakes they observe in processes of care, no matter how inconsequential, so that practices can benefit from their additional perspectives.

2) Designing better systems, electronic or otherwise, to track pending test results to reduce harms associated with the failure to report abnormal results, such as delayed diagnoses.

3) Paying closer attention to adverse effects of clinicians’ chaotic work environments and sense of control (or lack thereof) over their work, two factors that track closely with career satisfaction.

4) Expanding the definition of a medical error in future studies to include not only acts of omission (e.g., not ordering a recommended test), but commission (e.g., unnecessary tests, drugs, or procedures).

5) Examining sources of variation in primary care culture across multiple practices and practice-based research networks.

Pronovost and Sexton observed several years ago about inpatient culture, “We must understand these sources of variation in order to target who to measure, how to score, where to focus efforts to improve culture, and [whom] to hold accountable for improving culture” (9). The same could certainly be said about the culture of primary care, where the science of patient safety is only beginning to move from making controlled observations of medical errors to designing interventions.

References
1. Woodward HI, Mytton OT, Lemer C, et al. What have we learned about interventions to reduce medical errors? Annu Rev Public Health 2010;31:479-97.
2. Curry LA, Spatz E, Cherlin E, et al. What distinguishes top-performing hospitals in acute myocardial infarction mortality rates? Ann Intern Med 2011;154:384-90.
3. Sexton JB, Thomas EJ, Helmreich RL. Error, stress, and teamwork in medicine and aviation: cross sectional surveys. BMJ 2000;320:745-49.
4. Pronovost P, Weast B, Rosenstein B, et al. Implementing and validating a comprehensive unit-based safety program. J Patient Saf 2005;1:33-40.
5. Sexton JB, Berenholtz SM, Goeschel CA, et al. Assessing and improving safety climate in a large cohort of intensive care units. Crit Care Med 2011;39:934-39.
6. Gandhi TK, Lee TH. Patient safety beyond the hospital. N Engl J Med 2010;363:1001-3.
7. Williams ES, Manwell LB, Konrad TR, Linzer M. The relationship of organizational culture, stress, satisfaction, and burnout with physician-reported error and suboptimal patient care: results from the MEMO study. Health Care Manage Rev 2007;32:203-12.
8. Linzer M, Manwell LB, Williams ES, et al. Working conditions in primary care: physician reactions and care quality. Ann Intern Med 2009;151:28-36.
9. Pronovost P, Sexton B. Assessing safety culture: guidelines and recommendations. Qual Safe Health Care 2005;14:231-33.

Choosing Wisely's curious omissions

2013-03-03T15:55:00.002-05:00

Last month, the American Board of Internal Medicine Foundation's Choosing Wisely Initiative announced the release of a second round of lists of 5 things that physicians and patients should question, based on evidence that certain tests or procedures are not beneficial in specific clinical situations. American Family Physician will soon be updating its list of primary care-relevant items from the Choosing Wisely campaign, and its Facebook and Twitter accounts will highlight old and new entries daily over the next few months. This AAFP News Now article provides more information about the American Academy of Family Physicians' most recent items, which include elective labor inductions and unnecessary cervical cancer screenings.

Notably absent from the lists of the primary care specialty societies and the American Urological Association is routine prostate-specific antigen (PSA) testing, which both the Cochrane Collaboration and the U.S. Preventive Services Task Force have concluded does not improve men's health outcomes. Even though the American Cancer Society and the AUA still support selective use of the PSA test in older men who have been adequately informed of its potential harms, no medical group supports the still-common practice of ordering PSA screening without first discussing it with the patient.

Another curious omission from the top 5 lists of cardiology and thoracic surgery organizations is angioplasty or coronary artery bypass surgery for stable coronary artery disease, which are frequently performed in the U.S. but have no clinical advantages over initial medical management.

From a population health perspective, curtailing prostate cancer overdiagnosis and unnecessary cardiac interventions would be worthy goals to add to a "don't do" list that collectively includes more than one hundred items. Instead, these omissions say quite a bit about the persistence of perverse financial and medicolegal incentives in primary and subspecialty medicine. After all, no one ever sued a doctor for diagnosing cancer (even if it didn't need to be diagnosed) or placing a stent in a partially occluded coronary artery (even if it didn't need to be placed), and insurers rarely (if ever) decline to pay for these wasteful tests and procedures.

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A shortened version of the above post first appeared on the AFP Community Blog.

The role of whistleblowing in health care

2013-02-25T10:32:00.000-05:00

The first instinct of a bureaucracy is self-preservation, and health care bureaucracies are no exception. This rule applies not only to government agencies, but to academic and industry settings as well. This was the conclusion I came to after listening to a panel of scientist and physician "whistleblowers" at last week's Selling Sickness 2013 conference in Washington, DC. One by one, they described their painful discoveries that widely prescribed medications such as the diabetes drug Avandia and the antibiotic Ketek were causing serious harm, and sometimes death, in thousands of patients. They talked about passing this knowledge on to supervisors and being ignored, rebuked, or ostracized. Protecting patients paled to the bureaucratic sin of rocking the boat.

For example, one academic researcher was fired by her institution, which seemed more interested in not jeopardizing the funding it received from a drug's manufacturer than evaluating evidence from her clinical trial that this drug was jeopardizing children's lives. A former Food and Drug Administration safety reviewer who determined that Avandia caused heart failure and heart attacks was verbally reprimanded and told to keep that conclusion to herself. (The FDA finally issued a safety alert more than a year later, after a study appeared in the New England Journal of Medicine supporting the reviewer's determination, but the agency did not restrict access to the drug until 4 years after her initial finding.)

I suppose that I consider myself a whisteblower, too, though what I did doesn't begin to compare with the courageous stories I heard last week. As readers of this blog know, I resigned from the Agency for Healthcare Research and Quality in November 2010 after senior health officials in the Obama Administration forced the cancellation of a U.S. Preventive Services Task Force meeting that was set to recommend against the use of prostate-specific antigen screening for prostate cancer because it led to more harm than good. The key vote was scheduled for the day of the midterm elections that the President's party would lose in a landslide, despite its desperate attempt to keep accusations of health care "rationing" off voters' minds. The cover-up included persuading Dr. Ned Calonge, the then-chairman of the USPSTF, to take personal responsibility for calling off the meeting, and circulating internal talking points that attributed the cancellation to logistical issues rather than Democratic Party politics. Nothing about this episode was illegal, but lying to the Task Force, its clinical partners, and press was definitely unethical. And from my perspective as a physician, withholding critical information from patients was immoral. Thousands more uninformed men received the PSA test before the USPSTF finally released its recommendation statement a year later. Many of them have already experienced anxiety, pain, and more permanent adverse effects of interventions such as prostate surgery that may not extend their lives by a single day.

The prolonged debate over who should pay for health care in U.S. has obscured the more important question of why the costs are much too high in the first place. One reason they're so high is because doctors like me order far too many tests and interventions that the scientific evidence shows are useless or potentially harmful, but also because health care institutions can get away with charging uninsured patients 20 or more times what these services actually cost. Time Magazine's Steven Brill recently did some whistleblowing of his own by exposing routine travesties such as a $21,000 emergency room heartburn bill and an $87,000 bill for outpatient surgery, inflated by charges such as $108 for a tube of Bacitracin or $1.50 for a single tablet of generic Tylenol. (Yes, a hot dog can cost $5 or more at ballgames and amusement parks, but you have a choice to go there and pay for those things. In health care, you may be too sick to shop around for the best deal on an appendectomy, or even if you know that you will experience a predictable health event such as having a baby, no one can tell you how much it will cost.) People may rail against the multi-million dollar compensation packages of investment banking CEOs, but executives at supposedly nonprofit hospitals are often paid on the same salary scale as professional sports stars.

To improve the health of all Americans, we need to stop political posturing over the pros and cons of "Obamacare" and instead empower more whistleblowers to pull back the curtains on the unscrupulous or corrupt practices of drug companies, government regulators, and venerable academic and health care institutions, who collectively constitute a "medical-industrial complex" that dwarfs the size of anything else in our economy. To quote my friend and family medicine colleague Pat Jonas (the blogosphere's Dr Synonymous), we need to keep pushing the Beast back. Common Sense Family Doctor is proud to be part of that effort.

Should screening mammography always be a shared decision?

2013-02-21T21:30:00.001-05:00

In the February 15th issue of American Family Physician, Dr. Maria Tirona reviews areas of agreement and disagreement in major organizational guidelines on screening for breast cancer. There is widespread consensus that annual or biennial mammography should be offered to women 50 to 74 years of age, and that teaching breast self-examination does not improve health outcomes. For women 40 to 49 years of age, in whom the risks and benefits of mammography are closely balanced on a population level, the U.S. Preventive Services Task Force and the American Academy of Family Physicians recommend shared decision making, taking into account individual patient risk and patients' values regarding benefits and harms of screening.

In an accompanying editorial, however, Drs. Russell Harris and Linda Kinsinger argue that shared decision making regarding breast cancer screening need not be limited to younger women:

More and more, the goal for breast cancer screening is not to maximize the number of women who have mammography, but to help women make informed decisions about screening, even if that means that some women decide not to be screened. ... The goal of improving patient decision making should be expanded to all women eligible for breast cancer screening (i.e., those 40 to 75 years of age who are in reasonable health), because the benefits and harms of screening are not very different among these age groups.

The primary benefit of screening mammography is an estimated 15 percent relative reduction in deaths from breast cancer; harms of mammography include false positive results, overdiagnosis, and overtreatment. A recent study published in BMJ explored the impact of overdiagnosis on attitudes toward mammography in several focus groups of Australian women 40 to 79 years of age. Few women had ever been informed about overdiagnosis as a potential harm of screening. Most women continued to feel that mammography was worthwhile if overdiagnosis was relatively uncommon (30 percent or less of all breast cancers detected). However, a higher estimate of overdiagnosis (50 percent) "made some women perceive a need for more careful personal decision making about screening."

Notably, a 2011 Cochrane Review estimated that 30 percent of breast cancers detected through screening are overdiagnosed:

This means that for every 2,000 women invited for screening over 10 years, one will have her life prolonged, and 10 healthy women who would not have been diagnosed if there had not been screening will be treated unnecessarily. Furthermore, more than 200 women will experience important psychological distress for many months because of false-positive findings.

Given this information, what approach should doctors take with screening mammography? Do you believe that this test should be routinely provided to women of eligible ages, a shared decision for some, or (as Drs. Harris and Kinsinger advocate), a shared decision for a woman at any age? Why is it often difficult to promote such shared decision making in clinical practice?

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

The Massachusetts Avenue of health reform

2013-02-19T15:09:00.002-05:00

In contrast to the personality-driven path that Lyndon Johnson took to navigate legislative obstacles to Medicare and Medicaid, former management consultant Mitt Romney charted a decidedly different course to expanding health insurance when he became governor of Massachusetts in 2003. This month's Georgetown University Health Policy Seminar explored the politics of "Romneycare," a state-level health reform which in many ways made possible the future Affordable Care Act. Both readings for this session, a New Yorker article and a Health Affairs paper, portrayed Romney as a “data wonk” who viewed the issue of the uninsured as a problem-solving challenge rather than a grand moral imperative. Yet much like LBJ's inspirational leadership, Romney's data-crunching approach produced tangible results.

In an Op-Ed about his nascent reform plan that appeared in the Boston Globe in November 2004, Governor Romney proposed applying "carrots and sticks" to persons who could afford private health insurance but had chosen not to purchase it. At that point, he had not yet committed to the individual health insurance mandate that made his reforms possible but later became a political liability during his Presidential campaigns. According to New Yorker columnist Ryan Lizza:

Romney and his aides had a lengthy debate about the merits of the mandate, which evolved into a broader philosophical discussion. Personal responsibility was important, some aides argued, but what about the libertarian view that the government had no business requiring people to buy something? It was one thing to ask drivers to buy car insurance. Owning a car is a choice. But the health-insurance mandate demanded the purchase of a product just for being alive.

Once he made the decision to incorporate the individual mandate into his reform plan, Governor Romney found an unlikely ally in Senator Ted Kennedy, whom he had tried unsuccessfully to unseat in 1994. Together, Romney and Kennedy approached the George W. Bush Administration and reached an agreement to redirect a multi-million dollar fund for Massachusetts hospitals to provide subsidized health insurance for lower income workers. Romney also alternately courted and cajoled the Democratic leaders of the Massachusetts legislature, whose support was essential to passing his plan.

Health reform in Massachusetts has been judged a mixed success. On one hand, the percentage of state residents who were uninsured fell from 6.4% in 2006 to 1.9% in 2010, as the national average rose from 15.2% to 16.3%. However, Romney's hope that insurance expansion would help control costs has not been fulfilled, as the percentage of the state budget spent on health services has risen from 29 to 43 percent.

Compared to the policy environment that confronted President Barack Obama in passing the Affordable Care Act, seminar participants identified some key advantages for Romney: Massachusetts's already low uninsurance rate provided a "fertile environment" for reform, and he could focus his attention on health care without having to simultaneously manage financial crises and war. Although Romney "had little choice as governor about grappling with health care," wrote Martha Bebinger in Health Affairs, "for the most part he embraced the issue. Aides say Romney was enticed by the challenge of solving a complex problem, one that had eluded politicians for decades." How critical do you think Romney's public embrace of health reform was to the law's eventual passage? Was it as important, for example, as LBJ's advocacy for Medicare?

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The above post first appeared on The Health Policy Exchange.

Lessons from the passage of Medicare

2013-02-13T12:37:00.000-05:00

"Don't let dead cats stand on your porch." This famous quotation, attributed to President Lyndon Johnson during his strenuous and ultimately successful efforts to pass the 1965 bills that established the Medicare and Medicaid programs, embodied his approach to arguably the most important U.S. health care legislation until the 2010 Affordable Care Act. Translated, it meant that the best strategy for passing health care (and other potentially controversial) legislation was to act quickly and move bills along in the Congressional process before political opponents or outside advocacy groups had time to organize themselves.

The legislative passage of Medicare was the subject of the first of a series of monthly one-hour health policy seminars for Family Medicine fellows and residents at Georgetown University School of Medicine. The goal of this monthly series is for participants to gain a better understanding of the policy process at the federal, state, and local levels by reading and discussing real-life examples in a small group. These seminars will be led by me and the current Robert L. Phillips, Jr. Health Policy Fellow as well as selected guest faculty. Participants complete one or two short readings prior to the seminar (this inaugural session's assignment was "The Secret History of Medicare" from David Blumenthal and James Morone's The Heart of Power, pictured above).

Remarkably, Medicare was fully implemented only 11 months after the bill's signing, overcoming obstacles such as hospital segregation in the South, resistance from physician organizations such as the American Medical Association, and the logistical issues involved in issuing insurance cards to 18 million eligible seniors. As Medicare approaches its 50th anniversary, it faces huge budgetary challenges driven by increasing costs of health care and the demographics of the enormous "Baby Boom" generation, the first member of whom became eligible for Medicare benefits in 2011. This short video produced by the Kaiser Family Foundation summarizes changes that occurred in the program in the intervening years.

Liberal legislators saw Medicare as the first step toward enacting federally-administered universal health insurance for all Americans, while others saw it as a program, like health programs for active-duty military, veterans, and Native Americans, whose benefits were appropriately limited to specific groups and therefore must be defended against encroachment by future wide-ranging health reforms. Princeton professor Paul Starr has called this resistance to change by protected groups the "policy trap" that contributed to the defeat of the Clinton health reform proposal in 1994 and the near-defeat of the Affordable Care Act 16 years later.

Other points raised during the seminar included the book's observation that "an honest economic forecast would have very likely sunk Medicare." Like every federally financed health insurance initiative to come, Medicare ended up costing substantially more than initially projected. (In fact, the reason that most provisions of the ACA, passed in 2010, don't take effect until 2014 was to allow the Congressional Budget Office - which didn't exist in 1965 - to artificially score it as deficit-reducing over a 10-year time period.) Ethical or not, Lyndon Johnson's decision to "lowball" the estimated costs of Medicare was essential to getting it through Congress.

Was President Johnson - the last President to previously hold the position of Senate Majority Leader - a political anomaly, or can lessons from his deft management of the Congressional process be applied to national health care policy today? What do you think about Blumenthal and Marone's lessons for future Presidents, listed below?

1. Presidents must be deeply committed to health reforms.
2. Speed is essential. Waiting makes reforms a lot harder to win.
3. Presidents should concentrate on creating political momentum.
4. Presidents must actively manage the Congressional process.
5. Know when to compromise and know when to push.
6. Pass the credit.
7. Muzzle your economists. First expansion, then cost control.

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The above post was first published on The Health Policy Exchange.

Concerns about calcium supplements

2013-02-08T08:04:00.000-05:00

Until recently, the idea that calcium-containing supplements, which more than half of older adults in the U.S. consume regularly, could be harmful would have seemed absurd. Primary care clinicians have long recommended calcium supplements to reduce the risk of osteoporotic fractures in adults who are unable to meet the Institute of Medicine's Dietary Reference Intakes through diet alone. However, a large prospective study published this week in JAMA Internal Medicine demonstrated a statistically significant association between supplemental calcium (as opposed to dietary calcium) intake and a 20 percent higher relative risk of death from cardiovascular disease in men.

This troubling finding adds to the evidence base that suggests harmful cardiovascular effects of calcium-containing supplements. A timely pair of editorials in the February 1st issue of American Family Physician debates the population-level risk of widespread calcium supplementation. Arguing that this potential risk should be a serious concern, Drs. Ian Reid and Mark Bolland review the results of their previous randomized trial and meta-analysis that found 20 to 30 percent increases in the incidence of acute myocardial infarction in adults taking calcium supplements. In their view, these adverse effects are not worth the potential benefits to bone health:

In both of our meta-analyses, calcium supplementation was more likely to cause vascular events than to prevent fractures. Therefore, the bolus administration of this micronutrient should be abandoned in most circumstances, and patients should be encouraged to obtain their calcium intake from an appropriately balanced diet. For those at high risk of fracture, effective interventions with a fully documented safety profile superior to that of calcium are available. We should return to seeing calcium as an important component of a balanced diet and not as a low-cost panacea to postmenopausal bone loss.

In the second editorial, Dr. Rajib Bhattacharya points out that the Women's Health Initiative and other randomized trials did not indicate that calcium supplements increased cardiovascular risk. He argues that secondary analyses of trials designed with other primary outcomes in mind may have predisposed these analyses to unforeseen bias, and that there is "no compelling evidence" that calcium supplements at usual doses pose dangers to heart health.

Notably, a draft recommendation statement released by the U.S. Preventive Services Task Force last June stated that there was insufficient evidence that vitamin D and calcium supplementation prevent fractures or cancer in otherwise healthy older adults. Although the only adverse effects of supplements mentioned in the Task Force's evidence review were renal and urinary tract stones, none of the reviewed studies were specifically designed to assess cardiovascular harms. Is it time to abandon routine calcium supplementation in healthy adults? If not, what additional evidence do we need?

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The above post first appeared on the AFP Community Blog.

Unintended consequences of "pregnancy prevention"

2013-02-05T16:04:00.002-05:00

A provocative essay published a few days ago in the Wall Street Journal argued that America's falling fertility rate (which the author called the "baby bust") will make it difficult, if not impossible, to address challenges of anemic economic growth, an immense federal budget deficit, and the care needs of an exploding population of retiring "baby boomers." This piece has already inspired a good deal of back-and-forth debate - one columnist, for example, labeled it "a bunch of baloney" - and I don't intend to adjudicate that debate here. However, it is ironic that as a national conversation ensues about the pros and cons of having fewer children, the Obama Administration is struggling to placate religious and other employers which have objected to the Affordable Care Act's provision that requires them to provide and fully finance medications to prevent pregnancies.

Full disclosure: I am a practicing Catholic and father of three children. And I don't believe for a moment that our President intended to wage a secular "holy war" against institutional Catholicism, any more than I subscribe to the bogus liberal myth that faith-based groups that have moral qualms with hormonal contraception are bound and determined to block non-believers from accessing it. (If that was really the case, they'd be leading boycotts of Target and Walmart, which both sell a month's supply of birth control pills for $9, according to the Reproductive Access Project.) But the overheated rhetoric about what some simply term "the HHS Mandate" has, in my mind, obscured a critical point: "pregnancy prevention" is vitally different from the prevention of diseases.

The Department of Health and Human Services web page that summarizes preventive services covered by the ACA covers long list of conditions that no one would ever want or wish on their worst enemies: cancer, heart attacks, strokes, hip fractures, diabetes, depression, and a host of infectious diseases. And then there's pregnancy. "Unintended" pregnancy, to be sure, but its inclusion should be a bit jarring even to health advocates who believe that delaying or declining childbearing is associated with health benefits. But when the Institute of Medicine's Committee on Clinical Preventive Services for Women recommended that FDA-approved methods of contraception be called preventive, it effectively defined pregnancy as a disease.

Defining pregnancy as a disease to be prevented is not just a matter of semantics. I've written before about how an overly interventionist approach to pregnancy is largely responsible for the current U.S. rate of one in 3 babies being born by Cesarean section, and predictions that it may soon approach 50 percent. In most countries, prenatal care and labor are primarily managed by midwives - pregnancy generalists, if you will. In the U.S., most pregnant women are instead attended by obstetrician-gynecologists: specialists in surgical delivery. Imagine if every person with garden-variety back pain was advised to seek care from a spine surgeon, or every person with a sinus infection first consulted an otolaryngologist. Would you be surprised if the result was many more back and sinus surgeries? A recent article in Harvard Magazine encapsulated this problem of perspective:

Risk perception and tolerance help determine professional standards of care, influence hospital protocols, mold the media’s telling of stories, and even influence laws. All these forces interact in complex ways. ... Saying that a certain percentage of C-sections are unnecessary is fairly simple. But weighing risks and knowing whether surgery is necessary in a particular case—or even whether a surgery was necessary in retrospect—is much more complex, and fraught with emotion. The obstetrician sees C-sections as generally safe, and if the outcome he or she wants to avoid is dire, even devastating—such as a baby’s becoming stuck and deprived of oxygen, which could lead to cerebral palsy—why wait to find out what will happen, however unlikely that outcome may be?

Make no mistake, a zero percent rate of C-sections is neither achievable nor desirable. A small proportion of pregnancies are complicated by health risks to the mother and baby, and interventions are necessary to prevent bad outcomes. But much lower Cesarean rates can be achieved without sacrificing safety, simply by approaching pregnancy as a normal, healthy condition, rather than a disease. A recent study in the Annals of Family Medicine reported a 4 percent Cesarean rate and 95% successful VBAC (vaginal birth after Cesarean) rate at a Wisconsin birth center for Amish women over a 17-year period, with no maternal deaths and a neonatal death rate similar to that of Wisconsin and the U.S. Lest this result be attributed to a miracle of Amish genetics, an Indian Health Service hospital in New Mexico where I spent a month-long elective during my family medicine residency attributed its 7 percent Cesarean rate to a conservative approach to labor (managed exclusively by family physicians) and cultural attitudes that favored vaginal deliveries.

We can agree that in general, unmarried teenagers should not be conceiving babies, and that a few pregnancies do expose mothers and infants to serious complications. But classifying contraceptives as preventive services and treating pregnant women as if they have fatal diseases is not a rational way to go about improving women's and maternal health outcomes.