Wednesday, December 26, 2012

The most unheralded posts of 2012

It is customary for bloggers to highlight their most popular posts at year's end (see, for example, this recent compilation of posts from the AFP Community Blog, several of which subsequently appeared on Common Sense Family Doctor), but this year I've decided to buck the trend. Instead, below are links to six of this year's "unheralded" posts that weren't read as much as I thought they deserved. If you missed any of these, I hope you enjoy them the second time around. Thank you for reading, and have a very happy New Year!

1. The best colorectal cancer screening test is the one that gets done (May 21)

Not only does screening colonoscopy cost a lot more money, it hasn't been shown to be more effective than flexible sigmoidoscopy. In fact, screening colonoscopy has never even been tested in a randomized trial, and may never be.

2. Changing unhealthy habits requires changing environments (June 4)

Strategies to stabilize, and eventually, reverse, national obesity rates will need to change obesity-promoting environments on the individual and community levels.

3. How would you rate your health care team? (June 7)

One 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.


To make a fully informed medical decision, whenever a doctor says, "Test X will reduce your risk of disease X (or death from disease X) by 20 percent," patients should always ask, "20 percent of what"?


Hospitals and large specialty practices have financial and material resources, while community health centers have the experience and know-how to manage care for high-risk patients with chronic conditions who generate a disproportionate share of health care costs.

People are fallible, but health systems need not be. Despite the staggering complexity involved in flying passenger jets and constructing skyscrapers, commercial airline accidents are rare and building collapses even rarer. (So it should be in health care, also.)

Saturday, December 22, 2012

False alarms and unrealistic expectations in preventive care

Shortly after we moved to Washington, DC eight years ago, my wife and I purchased a basic home security system, the kind with a programmable keypad, multiple door alarms and a motion sensor. The alarm has sounded about a dozen times since then. None of these times was a burglary actually in progress. On several particularly windy days, one of us forgot to lock the back door after leaving, and it blew open. Two or three other times, departing early for work, I accidentally hit "Away" on the keypad (arming the motion detector at the foot of the stairs) rather than "Stay," causing the klaxon to sound when my unsuspecting son or visiting mother-in-law came down the stairs later in the morning. We've also set off the fire alarm a few times while cooking. Although our security system cost little to purchase, at this point we've spent well over $3000 in monitoring fees, a sum that could easily surpass the value of what we might lose in an actual burglary.

There are, of course, intangible benefits to having a home security system - peace of mind being the most important. But our peace of mind has been achieved at the substantial cost of temporarily diverting multiple municipal police and fire units, disturbing our neighbors, receiving inconvenient cellular phone calls from the monitoring company, and briefly traumatizing a 5 year-old on his way to breakfast. All things considered, it's hard to argue that the benefits of this preventive measure have outweighed its cumulative harms.

I think about my home security system every time I'm asked to do a physical examination on an apparently healthy young adult. Although the periodic health examination is an established tradition in medicine, and probably builds trust and strengthens the doctor-patient relationship in preparation for future health crises, studies have shown that it doesn't help people live longer, or even better. The same may be said for many of the tests physicians routinely offer at these examinations - including blood pressure measurement (no benefit from treating mild hypertension) and diabetes screening (no benefit from nontargeted screening).

No doubt these routine examinations and tests (if normal), like my home security system, give patients peace of mind. And if patients had clear-eyed expectations of the small potential benefits of screening and preventive treatments, I would have no problem with continuing to do them. Unfortunately, a recent study in the Annals of Family Medicine showed that patients greatly overestimate the benefits of preventive interventions that primary care physicians commonly provide: breast cancer screening, colorectal cancer screening, and medications to prevent hip fractures and cardiovascular disease. In most cases, patients' "minimum acceptable benefit" (the lowest level of benefit that in their mind was required to justify the preventive intervention) far exceeded the actual benefit of the service established in randomized trials. Further, this study considered only the benefits of these services, and not the false alarms, which occur in more than 60 percent of women receiving annual mammography after 10 years.

Not only do inflated expectations of the benefits of preventive tests and treatments needlessly complicate shared decision making, they contribute to an environment where proposals to restrict screening tests of marginal benefit (such as the prostate-specific antigen test for prostate cancer) inevitably cause a political uproar. In the words of family physician and former U.S. Preventive Services Task Force member Steven Woolf:

If people are widely convinced that a screening test or drug is beneficial, confronting these beliefs can, if anything, engender suspicions about one's veracity and motives. Whether the messenger is one's physician, a health plan, or a government task force, attempts to set more realistic expectations about benefits, risks, and scientific validity are often taken as insensitivity to suffering, discrimination, or a pretext for cutting costs, rationing health care, or threatening personal autonomy. ... It is an increasingly difficult environment for the American public to receive, let alone absorb, undistorted scientific information from reputable bodies.

Unrealistic expectations therefore persist, surviving not only on misinformation but also by serving other purposes. For example, false beliefs meet the psychological needs of patients for hope and safety, as well as for action, agency, and a sense of control. They enable clinicians to feel they are making a difference; even physicians who know better order unnecessary tests to please their patients. False expectations fuel market demand for products, industries, and health delivery systems and can be fomented by misleading advertising. Confronting these expectations can not only dash hopes but potentially threaten profits, shareholders, clinical practices, industries, legislation, and political careers.


I recently had a testy social media exchange with an obstetrician-gynecologist who disagreed with my view that since cervical cancer screening is needed only every 3 to 5 years, and ovarian cancer screening is useless and potentially harmful, there is no good reason to do annual pelvic examinations in women at low risk for sexually transmitted diseases. However, a recent survey of U.S. gynecologists found that overwhelming numbers (including, presumably, this particular Ob/Gyn) continue to do these examinations despite the absence of proven health benefits. In my view, the only clear benefit (aside from "peace of mind") is financial - doctors can charge more for physicals that include a pelvic examination, payers will pay for them without question, and medical offices then have an easier time keeping their doors open.

Preventive health care has positive effects if offered to appropriately selected and informed patients. But the massive structure of "routine" preventive care, built upon a rotten foundation of false alarms and unrealistic expectations, only serves to increase harms and health care costs. It should be a New Year's resolution of conscientious physicians and policymakers everywhere to help people understand the difference.

Monday, December 17, 2012

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 late October and November:

1) Dollars and sense of rising health insurance costs (10/18/12)

2) Why primary care is the future of health care (10/31/12)

3) To protect patients, practice guidelines must meet higher standards (11/4/12)

4) Lockboxes, Medicare reform, and the myth of "free stuff" (11/11/12)

5) Dissecting a hepatitis C screening recommendation (11/28/12)

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

Wednesday, December 12, 2012

Cancer epidemiology 101 for urologists (and others)

I've had many Twitter conversations with prostate cancer screening advocates who fear that the U.S. Preventive Services Task Force's "D" (don't do it) recommendation against PSA-based screening for prostate cancer will lead to a dramatic spike in prostate cancer deaths as primary care physicians screen more selectively, or perhaps stop screening at all. I seriously doubt these apocalyptic forecasts (for one thing, prostate cancer causes only 3% of deaths in men, and the decline in the U.S. prostate cancer mortality rate since 1990 hasn't had any appreciable effect on overall life expectancy). However, I recognize that reasonable people disagree with my review and the USPSTF's interpretation of the evidence. The American Cancer Society, for example, continues to support screening if men are adequately informed of the known risks and uncertain benefits. But it's one thing to argue from evidence, and quite another to argue from ignorance. Many of the tweets I've seen from urologists, unfortunately, represent the latter.

When I went to medical school, biostatistics and epidemiology was the course that no one took seriously. Things have changed for the better over the years - today I teach a rigorous course in evidence-based medicine and population health at Georgetown University School of Medicine - but there's still an appalling lack of basic knowledge about these topics among practicing physicians of all specialties. Below are a few key concepts in cancer epidemiology that anyone should understand before getting into a dispute about the value of prostate cancer screening.

Lead-time bias - "Prostate cancer survival has improved since we started PSA screening, so screening must work!" The first clause of this sentence is absolutely true: in the 1970s, about 70 percent of men diagnosed with prostate cancer were still alive 5 years after diagnosis, while today that figure is closer to 99 percent. The second clause could be true, but does not invariably follow from the first. By finding prostate cancers in men long before they become symptomatic (if they ever become symptomatic), screening advances the time of diagnosis, but could have no impact on mortality. In other words, 5-year survival always increases when a screening test is implemented, but its effect might only be giving patients an earlier cancer diagnosis without affecting their disease course. See chest x-ray screening for lung cancer (which was unfortunately a common practice for years) for an example of this phenomenon.


A variation on the above statement is the observation made by older urologists that "Before PSA testing, we used to see men with prostate cancer only when they came in with metastatic disease; today we see them with much less advanced tumors so that they can be cured." Much of this clinical experience reflects the effect of lead time, as well as overdiagnosis of cancer that didn't need to be found in the first place. In the words of urologic oncologist Willet Whitmore, "For a patient with prostate cancer, if treatment for cure is necessary, is it possible? If possible, is it necessary?"

Association does not equal causation - "Prostate cancer mortality has declined by 30 percent since 1990, which must be due to PSA screening." It's tempting to make sweeping conclusions based on observational data - the press has been doing this forever, linking caffeine use to cancer today, then reversing itself when a new headline is needed tomorrow. It's certainly possible that some of the decline in mortality is due to screening, but it's just as likely that some other factor is responsible. For example, men who smoke are less likely then male non-smokers to die from prostate cancer. Does that mean that tobacco use has a protective effect? Of course not; these men are dying prematurely from heart attacks and chronic obstructive pulmonary disease, and therefore not dying of prostate cancer. Also, the temporal association between the mortality decline and the PSA screening doesn't make any sense, since the only randomized trial to show that PSA screening reduces prostate cancer mortality (more on this later) found that it takes at least 9 years to do so. Since PSA screening was not widespread in the U.S. until the early 1990s, any benefit of screening wouldn't have changed the mortality statistics until 2000. But that's not what happened.

The most favorable study represents "the truth" - "Prostate cancer screening reduces prostate cancer mortality by 20 percent." If you only speak to urologists, you might come away thinking that there's only been one randomized trial of PSA screening: the European Randomized Study of Screening for Prostate Cancer (ERSPC), which reported this result in 2009 and again in 2012 after 11 years of follow-up. The usual description of the ERSPC as a single "trial" is problematic (it's actually a combined analysis of screening results from 7 European countries), but even allowing for that, it's only one of 5 randomized trials of screening, and (guess what?) the only one of the 5 to show a benefit.

In the old days, the process of writing reviews and guidelines went as follows: write up recommendations that you already know to be correct from clinical experience, then go to the literature to select evidence that supports your positions. A less biased approach is to evaluate all of the available evidence, regardless of one's preexisting biases, which is what my colleagues and I did and what independent reviewers did for the both the Cochrane Collaboration and BMJ. Here's what the Cochrane reviewers concluded: "Prostate cancer screening did not significantly decrease all-cause or prostate cancer-specific mortality in a combined meta-analysis of five RCTs."

Specialist-authored guidelines are superior to generalist-authored guidelines - "The USPSTF guidelines are invalid because there were no urologists on the panel." Let's put aside for the moment the fact that more prostate cancer diagnoses invariably lead to more business for urologists, and that guidelines authored by specialty societies are of lower quality than those authored by generalists. Dismissing the USPSTF recommendation on the basis of its primary care membership is still nonsense, pure and simple. The vast majority of prostate cancer screening occurs in primary care settings, and therefore primary care clinicians are the most appropriate experts to evaluate and weigh the evidence about screening. (The same can be said about mammography guidelines and radiologists.) Several urologists were, of course, consulted at multiple stages during and after the writing of our evidence review to make sure that no important studies were missed.

As I've said, I welcome debates with well-informed advocates of PSA screening, who tend to view this imperfect test as a glass half-full rather than half-empty (or shattered beyond repair). For the less-informed, I get it that you don't have time to go back to medical school for remedial epidemiology lessons. So consider this post your Cliff's Notes.

Friday, December 7, 2012

Fasting lipids study is a potential practice-changer

When I last saw my personal physician for a checkup, she recommended that I undergo screening for lipid disorders, per the guidelines of the U.S. Preventive Services Task Force. Although the office had a phlebotomist on site, my appointment was in the afternoon, and I had already eaten breakfast and lunch. Consequently, she instructed me to make a separate morning appointment to have my blood drawn after an overnight fast. Due to my hectic schedule, several months passed before I finally got around to doing this (fortunately, the results were normal). As family physicians know, many patients who are sent for fasting tests never have those tests done at all.

A recent study published in the Archives of Internal Medicine suggests that there may be little reason for most patients to endure the inconvenience of fasting before lipid testing. The authors analyzed the relationship of fasting duration to variations in cholesterol levels obtained in more than 200,000 patients in and around Calgary (Alberta, Canada). In this population, the time since one's last reported meal had no effect on mean total cholesterol and high-density lipoprotein (HDL) cholesterol levels. Mean low-density lipoprotein (LDL) levels varied by up to 10 percent, while mean trigylceride levels varied by up to 20 percent. The authors and two editorialists conclude that for most purposes in primary care, including global cardiovascular risk assessment and monitoring response to pharmacologic treatment, nonfasting cholesterol measurements are likely to yield equivalent information to measurements from traditional fasting samples.

Rare is the single study in the medical literature that changes usual clinical practice on its own, and for good reason. Consistent evidence from multiple studies is usually needed to verify or refute impressive initial findings. Further, the cross-sectional design of this particular study might have masked unmeasured variables that would have been better controlled for in a randomized clinical trial. That being said, if any single study should be called a practice-changer, I think this one fits the bill.

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

Tuesday, December 4, 2012

In health care, little details make all the difference

When I heard in October that Superstorm Sandy was projected to make landfall somewhere in the vicinity of DC and Maryland, I prepared for the worst. I stocked up on non-perishable goods and evacuated to higher ground. (The rest of my family was already coincidentally out of town and harm's way.) I put fresh batteries into two flashlights and installed a flashlight app on my smartphone for good measure. Although I didn't give it much thought at the time, I assumed that hospitals in Sandy's path were taking similar precautions - stocking medical supplies, testing backup generators and so forth. So when a power failure at NYU Langone Medical Center forced an evacuation of the entire hospital, with heart-stopping scenes of neonatal ICU nurses cradling respirator-dependent newborns down several flights of stairs to safety, I couldn't understand what had happened. How had they not been better prepared? Had NYU administrators been the equivalent of residents of low-lying coastal areas who ignored repeated warnings and defied evacuation orders?


As it turned out, NYU did a lot of things right before the storm. According to an article in ProPublica, after the scare of last year's Hurricane Irene, the hospital moved its emergency generators from street level to the rooftop and thoroughly waterproofed the generators' fuel pumps. Unfortunately, they neglected to relocate or protect the electricity distribution circuits, which remained in the basement and were quickly disabled by the flooding. As in many areas of health care, doing everything "almost right" wasn't good enough.

All people are fallible, and health professionals no less so than others. But medicine is usually less forgiving of simple mistakes. A technically perfect surgery is a disaster because it was performed on the wrong body part. A patient develops a life-threatening infection because a doctor forgot to wash his hands. A child dies three days after being discharged from an emergency room because his parents were not notified of critical lab values that came back hours after they left.

People are fallible, but health systems need not be. Despite the staggering complexity involved in flying passenger jets and constructing skyscrapers, commercial airline accidents are rare and building collapses even rarer. Atul Gawande argues in The Checklist Manifesto that checklists are the best way to make sure that small but critical details of health care are addressed systematically, so that every member of a care team feels empowered to preempt potential disasters. I believe that checklists and decision support tools are applicable not only to surgery or intensive care settings, but to primary care as well.

Fortunately, the emergency evacuation of NYU Langone Medical Center went off smoothly, and none of the patients who were transferred seem to have suffered as a result. But the good outcome of this near-miss and the low likelihood of another Sandy in the near future should not make anyone at NYU - or in any hospital or health system, for that matter - complacent about addressing the little details and vulnerabilities of health care that make all the difference.

Sunday, December 2, 2012

Yes, family medicine is an affordable career choice

The inexorable yearly rise of medical school tuition has led to corresponding increases in medical student debt. According to the American Medical Association, 86 percent of graduating medical students in 2011 had loans to repay, and their average debt was more than $160,000. The greater long-term income potential from choosing a subspecialist rather than a primary care career is only one of many factors that influence medical students' specialty choices. That being said, my students increasingly ask if they will be able to repay their loans, support spouses and children, and save enough for retirement on a family physician's income - a question that would have been unlikely to come up a generation ago.

In an innovative analysis published in Academic Medicine, researchers from the American Association of Medical Colleges and Boston University concluded that the answer is "yes." Using economic modeling software, they examined variety of loan amounts and repayment scenarios projected against average household expenses in a high-cost urban area (Boston) and income levels for primary care and subspecialist physicians. The bottom line:

Our economic modeling of a physician's household income and expenses across a range of medical school borrowing levels in high- and moderate-cost living areas shows that physicians in all specialties, including primary care, can repay the current median level of education debt. At the most extreme borrowing levels, even for physicians in comparatively lower-income primary care specialties, options exist to mitigate the economic impact of education debt repayment.

The authors defined "extreme" borrowing levels as $250,000 or greater, and noted that options for these highly indebted physicians include extended repayment terms and federal loan forgiveness programs such as the National Health Service Corps. They also noted that physicians who choose to live in rural or low-cost areas will have considerably more discretionary income after expenses.

Although this analysis did not address the equally (and some would say, more) important question of why the primary care-subspecialist income gap exists and what can be done to reduce it, these findings should be reassuring to students considering family medicine careers.

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The above post first appeared in the AFP Community Blog.

Saturday, December 1, 2012

Some levity about the patient-centered medical home

In the past, I've written some serious posts about patient-centered medical homes here and here. This is not such a post, and I share it so that you know that primary care physicians doesn't always take themselves too seriously. Thanks to Georgetown Family Medicine colleague and Washington Post / Huffington Post columnist Ranit Mishori for calling this video to my attention. And by the way, please don't visit my office requesting an MRI scan without my having given you a diagnosis.

Wednesday, November 28, 2012

Dissecting a hepatitis C screening recommendation

After being banished from the public spotlight in 2010 and 2011 due to health reform politics, the evidence-generating operation known as the U.S. Preventive Services Task Force is finally making waves again. On Monday, the USPSTF got on board with a CDC guideline to screen all "baby boomers" born between 1945 and 1965. In their draft recommendation statement, the Task Force (which in 2004 found insufficient evidence for screening even patients with self-reported risk factors) assigned a level "C" rating to birth cohort screening for hepatitis C, which means they believe there is moderate certainty of at least a small net benefit. Although newspaper reports described this endorsement of the CDC's guideline as lukewarm, it is anything but that. For clinicians who have never given a thought to routinely screening my parents' generation for this virus, it is a sea change.

How beneficial a medical test or intervention would be for society is ultimately a subjective assessment. The CDC has argued that the prevalence of undiagnosed hepatitis C in baby boomers is higher than in the general population, and affected persons (who contracted the virus via intravenous drug use or tainted blood transfusions in the 1970s and 1980s) are more likely than younger people to be at risk for life-threatening problems such as cirrhosis and liver failure. Plus, treatments are more effective and less toxic than before. I'd still argue that the magnitude of benefit is less than either the CDC or Task Force say it is, but ultimately it's anyone's best guess.

The "moderate certainty" part bothers me more. Based on the USPSTF's extensive body of work and the evidence contained in two systematic reviews in the Annals of Internal Medicine, I don't see how they managed to get there. Generally, the first piece of evidence the Task Force looks for is a randomized clinical trial that compares a screened population to a non-screened population and follows them up long enough to see if fewer people in the screened population end up dying from the disease. It takes decades for hepatitis C to lead to premature death, though, so it's no surprise that the evidence review turned up no such trials.

Given the absence of "direct" evidence that screening for hepatitis C saves lives, the Task Force was forced to rely on an indirect chain of evidence, namely: screening tests detect hepatitis C, hepatitis C leads to bad outcomes for patients, treatment prevents these bad outcomes (or surrogate measures of these outcomes) without causing too much collateral damage in the process. This type of chain has been used in other recommendations; this is why, for example, the USPSPTF recommends screening older women for osteoporosis. For hepatitis C, this chain of evidence wasn't there in 2004. Now, the Task Force says it is.

The key point in the USPSTF's argument seems to be that two drugs that the FDA recently approved for hepatitis C infection, boceprevir and telaprevir, lead to a sustained virologic response (SVR) in substantially more patients (70 to 80 percent) than the previous treatment combo, pegylated interferon alfa plus ribavirin, which was not only poorly tolerated but led to SVR in fewer than half of patients. But how do we know that SVR from these new drugs is associated with fewer liver failures and deaths? Strictly speaking, we don't. The Task Force extrapolated from cohort studies that show that SVR was associated with lower mortality in patients who had been treated with interferon and ribavirin.

To summarize: there's no direct evidence that screening for hepatitis C saves lives. New treatments are more likely to lead to SVR, but there's no evidence that they save lives, either; the studies have not been done. We know that if patients stick out therapy with interferon and ribavirin and get a SVR, they seem to do better than patients who don't, but the Task Force knew that in 2004 and still declined to make a recommendation. To me, this chain of evidence doesn't hold up to scrutiny. In fact, it resembles screening for osteoporosis in men (which received an "I" rating from the USPSTF in 2011) more than screening in women. So for the second week in a row, I find myself saying that the Task Force missed the boat.

Sunday, November 25, 2012

Who should receive medications for influenza?

Flu season has begun in the U.S., and in addition to familiarizing themselves with the Advisory Committee on Immunization Practice's vaccination guidelines for the 2012-13 season (offer influenza vaccine to everyone 6 months of age or older), physicians should consider how they plan to diagnose patients with suspected influenza. Despite the availability of multiple antiviral medications for influenza, whom to treat remains a challenging question.

In a 2010 Cochrane for Clinicians commentary, Dr. William E. Cayley observed that the neuraminidase inhibitors oseltamivir and zanamivir provided limited benefits for prevention and treatment of otherwise healthy persons with influenza. However, this conclusion was based on incomplete data - that is, results from published trials only. Subsequently, the Cochrane review authors were able to access several unpublished "clinical study reports" from the manufacturers and modified the review to reflect these additional data. In an updated Cochrane for Clinicians, published in the October 1st issue of American Family Physician, Dr. Cayley finds that the evidence no longer supports using neuraminidase inhibitors to prevent influenza transmission:

The authors found that, based on clinical study reports, treatment with oseltamivir reduced the likelihood of an antibody response to influenza, the diagnostic marker that is typically used to determine the effectiveness of prophylaxis. In the absence of another way to measure the effectiveness of oseltamivir prophylaxis, it is uncertain whether the medication reduces the risk of influenza transmission.

Even for treatment of persons with influenza, the benefits of antivirals are modest: oseltamivir reduced the duration of symptoms by less than one day and had no effect on hospitalizations. Since these medications have side effects, physicians may reserve their use for persons at higher risk of complications, such as those with asthma or other chronic respiratory problems. As Dr. Cayley notes, existing guidelines are only as good as the evidence that supports them - and in the case of influenza treatments, not very good at all:

The contrast between the limited positive findings of this review and the strong support for treatment with neuraminidase inhibitors in public health guidelines (such as those from the CDC) highlights the importance of ongoing assessment of such recommendations and related educational materials, especially when evidence to support widespread implementation of an expensive intervention is lacking.

I have to admit that I prescribed antiviral medications for many "low risk" patients with influenza last year. After re-examining the weak evidence of benefit, I don't plan to do so again. But I doubt that studies like these actually change the way most clinicians practice, given that prescribing antivirals might be considered the lesser of two evils (the other being prescribing totally useless antibiotics) for patients with influenza who desire more than symptom-relieving medications.

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The above post first appeared in the AFP Community Blog.

Monday, November 19, 2012

The case against universal HIV screening - Part 2 of 2

Although the U.S. Preventive Services Task Force is the most widely respected, unbiased organization producing evidence-based guidelines today, it isn't perfect. In 2002, the USPSTF recommended that women take aspirin to reduce their risk for heart attacks; later randomized trial evidence showed that aspirin only prevents heart attacks in men (it prevents strokes in women). More famously, the USPSTF once overestimated the benefits and underestimated the harms of mammography in women in their 40s, resulting an an apparent about-face in breast cancer screening recommendations in 2009 that made a great deal of political hay. This is the second of two posts explaining the reasons that I think the Task Force got it wrong when it recently endorsed screening all persons ages 15 to 65 years for HIV regardless of risk status. The first post is available here.

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Potential Harms and Competing Priorities

Potential harms of HIV testing include false positive results, anxiety, labeling, and adverse medication effects. True positive HIV results can be stigmatizing and lead to discrimination, loss of employment, verbal abuse, and physical assault in 1 to 4 percent of patients (18). A new HIV diagnosis does not seem to be associated with increased partner violence or dissolution of partner relationships in observational studies (18). Adverse effects of highly active antiretroviral therapies are less common today than in previous years, with more treatment options and simplified dosing schedules (19).

Although the overall magnitude of harms related to testing is thought to be small, the USPSTF judged in its 2005 guideline that the modest benefits of routinely screening persons without risk factors for HIV did not necessarily outweigh them (6). Furthermore, HIV testing does not occur in a clinical vacuum, but competes for time in the typical medical visit with many other pressing preventive, chronic, and acute care issues (20, 21). In medical practices that are not part of integrated health systems, the decision to implement or not implement routine opt-out screening for HIV may come down to individual clinicians’ judgments about the uncertain yield of such testing in their population versus competing clinical priorities. Or, as one author has argued: “It would be appropriate for those who want to prioritize preventive services based on proven benefits to adopt the USPSTF recommendation and individualize decisions about HIV screening of low-risk patients. … For clinicians who place a high value on potentially reducing HIV incidence and are more willing to accept plausible but unproven benefits, it might be reasonable to adopt the CDC recommendations” (9).

Altering the Balance of Benefits and Harms

Since the publication of the USPSTF guideline in 2005 and the CDC guideline in 2006, there have been important advances in HIV care that likely increase the relative benefits of universal screening. The improved tolerability of current HAART regimens, combined with evidence from observational studies that earlier initiation of HAART (rather than delayed initiation below a certain CD4 cell count) reduces mortality, led the Department of Health and Human Services to recommend treatment of all patients with CD4 counts below 500 cells/mm3, and to consider treatment for patients with higher CD4 counts (22). If earlier treatment of asymptomatic persons with HIV improves health outcomes compared to delayed treatment, then the benefits of earlier HIV detection through screening will be magnified.

In addition, a recent randomized controlled trial confirmed the benefits of HAART in reducing the risk of HIV transmission to sexual partners (23). This multicenter trial enrolled 1750 HIV-discordant heterosexual and male homosexual couples in sub-Saharan Africa, Asia, Latin America and the United States. All HIV-infected patients had a CD4 count of 350 to 550 cells/mm3 at baseline. In this trial, antiretroviral treatment of HIV-infected partners substantially reduced the incidence of seroconversion in uninfected partners, yielding a rate ratio of 0.04 (95% confidence interval, 0.00-0.27) (23). Even if patients with HIV do not change their sexual behaviors after being diagnosed, this study highlights the value of early diagnosis and initiation of HAART to reduce viral transmission – another reason to believe that expanded screening could yield population-level benefits.

Conclusion

In summary, this comparison of the effectiveness of targeted (risk factor-based) and universal (routine opt-out) screening for HIV has highlighted multiple areas of evidence relevant to determining the optimal approach in the U.S. Provided that most persons who are offered HIV screening accept it, and that persons newly diagnosed with HIV subsequently modify high-risk behaviors to reduce viral transmission, the CDC’s recommendation for routine opt-out screening of adolescents and adults appears to be cost-effective. However, studies of opt-out screening performed in emergency department settings have thus far yielded disappointing results, identifying few new cases of HIV in persons without known risk factors, many of whom were diagnosed in symptomatic or late stages of disease. Harms of HIV screening are small, but may not necessarily outweigh benefits in low-risk populations. Finally, evidence that earlier initiation of HAART improves individual health outcomes and is highly effective at interrupting viral transmission has increased the relative benefits of HIV screening. Based on existing data, then, a routine opt-out screening approach such as that endorsed by the CDC is warranted in high-prevalence clinical settings; however, pending further studies, a risk factor-based approach such as the USPSTF’s is still reasonable in average or low-prevalence settings.


References 18-23

18. Chou R, Huffman LH, Fu R, Smits AK, Korthuis PT. Screening for HIV: a review of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med 2005;143:55-73.
19. Reust CE. Common adverse effects of antiretroviral therapy for HIV disease. Am Fam Physician 2011;83:1443-51.
20. Pollack KI, Krause KM, Yarnall KS, et al. Estimated time spent on preventive care services by primary care physicians. BMC Health Serv Res 2008;8:245.
21. Yarnall KS, Pollack KI, Ostbye T, et al. Primary care: is there time enough for prevention? Am J Public Health 2003;93:635-41.
22. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. U.S. Department of Health and Human Services. October 14, 2011; 1–167. Available at http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf.
23. Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med 2011;365:493-505.

The case against universal HIV screening - Part 1 of 2

Today the U.S. Preventive Services Task Force released a draft statement that updates their previous (2005) recommendations on screening for HIV. Based on findings from a systematic review published in the Annals of Internal Medicine, the USPSTF now recommends routine HIV screening for all persons ages 15 to 65 years, regardless of risk status. Previously, the Task Force had only recommended screening in adolescents and adults at increased risk for HIV infection; this new statement, if finalized, makes the USPSTF's recommendations concordant with guidelines from the Centers for Disease Control and Prevention that have been in place since 2006.

I have had the privilege of caring for patients with HIV/AIDS since working in a Comprehensive Care Center during my family medicine residency. For the past eight years I have practiced  in and around Washington, DC, which has the highest prevalence of HIV infection (3 percent) of any city in the United States. It is clear to me that all adults and sexually active adolescents in the DC area are at increased risk for HIV and should be offered routine HIV screening. Further, I believe that screening for HIV should be provided to any patient who requests it. Nonetheless, I disagree with the USPSTF's new recommendation for universal HIV screening in adolescents and adults. My next two posts, drawn from an unpublished paper that I presented in part at a Family Medicine Grand Rounds in November, 2011, explain why.

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Although the introduction of highly active antiretroviral therapy has led to substantial declines in AIDS diagnoses and deaths from their peaks in the mid-1990s, an estimated 50,000 persons in the U.S. are infected with HIV each year, and more than 236,000 persons living with HIV are unaware of their diagnoses (1). Noting that many HIV infections occur in persons without identifiable risk factors, in 2006 the Centers for Disease Control and Prevention recommended routine opt-out testing of all persons between the ages of 13 and 64 in order to provide treatment at earlier stages of disease and curb behaviors associated with a high risk of HIV transmission (2). These recommendations, which have been endorsed by the American College of Physicians (3), the American Academy of Pediatrics (4), and the Office of National AIDS Policy (5), stand in contrast to those from the U.S. Preventive Services Task Force (USPTSF) (6) and the American Academy of Family Physicians (7), which support individualizing screening decisions in adolescents and adults not at increased risk of HIV infection.

Absent the USPSTF’s endorsement, routine HIV screening is not included in the list of preventive services that the 2010 Affordable Care Act requires health plans to cover without cost-sharing (8). Disagreements about the added value of a routine opt-out rather than risk factor-based screening approach may arise from differing interpretations of the former’s cost-effectiveness and potential benefits and harms (9). In this paper, I argue that while routine opt-out screening for HIV infection may be effective in many U.S. clinical settings, there is insufficient data to support universal implementation.

Cost Effectiveness

Any screening approach that tests more people is likely to diagnose more infections than a targeted approach. However, to be preferred to less intensive approaches, universal screening should also be cost-effective (diagnosing and treating additional infections at reasonable societal cost) and lead to improved health outcomes for infected patients and uninfected partners. To support its 2006 recommendations, the CDC relied on a mathematical model (10) that estimated that one-time universal HIV screening met a traditional cost-effectiveness threshold ($50,000 per quality-adjusted life-year) in settings with a HIV prevalence as low as 0.2 percent. The CDC suggests that routine opt-out screening can be discontinued when HIV prevalence is documented to be lower than 0.1 percent (2). In settings of higher HIV prevalence, universal screening every 3 or 5 years appears to be cost-effective (10). A key variable in this model is the impact of increasing diagnoses on changing risky behaviors and reducing HIV transmission rates, which has not been studied directly (11). A subsequent analysis projected that while expanded HIV screening alone will prevent few new infections, earlier initiation of antiretroviral therapy and modifications in risky sexual behavior together could reduce new infections by up to 65 percent (12).

In contrast, others have argued that the programmatic expense of fully implementing the 2006 CDC recommendations offers poor value relative to spending additional funds on pre- and post-test counseling within the existing risk factor-based screening infrastructure. According to a 2007 analysis, for the $864 million cost of offering routine opt-out testing to every American between the ages of 13 and 64, targeted counseling could potentially diagnose and prevent as 3 times as many HIV infections (13). This analysis was limited by its assumption that a substantial minority of patients offered HIV testing would decline it; the CDC, in contrast, observed that pregnant women rarely opt out of routine HIV testing, and asserted that uptake of testing in non-pregnant persons could be similarly high (2).

The vast majority of persons with HIV infection who are not diagnosed via screening will ultimately be diagnosed when they present to care with symptomatic AIDS. Therefore, a major benefit of routine opt-out testing is tied to identifying such persons earlier in the course of their infections, when antiretroviral medications and prophylaxis against opportunistic infections will prevent morbidity and mortality. The CDC guideline (2) and mathematical models that have postulated large benefits of expanded screening (10, 12) assume that a large number of persons will be diagnosed at early stages of disease.

Studies of Opt-Out Screening Effectiveness

Unfortunately, studies of routine opt-out HIV screening in emergency department settings have challenged this assumption. In a quasi-experimental time-samples study at a large emergency department in Denver, Colorado, researchers compared the effectiveness of opt-out rapid HIV testing with physician-directed diagnostic rapid HIV testing (14). More than 75 percent of eligible patients were either not offered or declined screening during the opt-out phase of the study; of the 6702 patients who received HIV testing, 10 (0.15%) tested positive. In contrast, 5 of 231(2.2%) patients who received HIV testing during the physician-directed phase tested positive for HIV. Moreover, 6 of 10 patients who tested positive during the opt-out phase had established risk factors for HIV infection (and would have been eligible for targeted screening) and 6 of 10 patients had CD4 counts lower than 350/┬ÁL. Similarly, in a study of opt-out rapid HIV testing in 29 emergency departments in metropolitan Paris, France, only 27% of 78,000 eligible patients were offered testing and only 16% (12,754) were actually tested (15). Of the 18 patients (0.14%) who tested positive, all but 1 belonged to a high-risk group, and 8 already had symptoms suggestive of opportunistic infections or AIDS.

One could argue that despite the large sample sizes of these two studies, the effectiveness of universal HIV screening can only be evaluated on a national level. The CDC recently reported the results of its Expanded HIV Testing Initiative, a program that provided more than $100 million from 2007-2010 to health departments in 24 U.S. states and the District of Columbia to increase screening rates and linkages to care among populations disproportionately affected by HIV, such as African Americans (16). To qualify for funding, health departments had to have reported at least 140 AIDS diagnoses among African Americans in 2005. Of more than 2.7 million HIV tests performed during the initiative, nearly 30,000 (1.1%) were positive, and the majority of patients with positive tests had not previously been aware of their HIV diagnosis (16). As encouraging as these results are, they are more supportive of the effectiveness of targeted testing (mostly performed in communities with well above-average HIV prevalence) than universal screening.

In 2009, the Veterans Administration implemented a new HIV testing policy in its health system that is consistent with the CDC’s 2006 recommendations for routine opt-out testing. Between 2009 and 2010, among VA patients with at least one outpatient visit, an electronic health record analysis indicated significant increases in the percentages of patients who had ever been tested for HIV (9.2 to 13.5 percent) and those who had been tested during that calendar year (2.9 to 5.8 percent) (17). Positive results were reported in 0.7 to 1.2 percent of tested patients; data was not available on how many of these patients were previously undiagnosed, would have been eligible for testing in a risk factor-based approach, or were diagnosed at preclinical stages of HIV infection (17).

- continued in my next post -

References 1-17

1. Centers for Disease Control and Prevention. HIV surveillance - United States, 1981-2008. MMWR Morb Mortal Wkly Rep 2011;60:689-93.
2. Centers for Disease Control and Prevention. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep 2006;55(RR-14):1-17.
3. Qaseem A, Snow V, Shekelle P, et al. Screening for HIV in health care settings: a guidance statement from the American College of Physicians and HIV Medicine Association. Ann Intern Med 2009;150:125-31.
4. American Academy of Pediatrics. Adolescents and HIV infection: the pediatrician’s role in promoting routine testing. Pediatrics 2011;128:1023-29.
5. Office of National AIDS Policy. National HIV/AIDS Strategy. Washington, DC: Office of National AIDS Policy; 2010. Available at: http://www.whitehouse.gov/administration/eop/onap/nhas
6. U.S. Preventive Services Task Force. Screening for HIV: recommendation statement. Ann Intern Med 2005;143:32-7.
7. Rodnick JE. The CDC and USPSTF recommendations for HIV testing. Am Fam Physician 2007;76:1456-59.
8. Bayer R, Oppenheimer GM. Routine HIV screening – what counts in evidence-based policy? N Engl J Med 2011;365:1265-8.
9. Chou R. Routine screening for chronic human immunodeficiency virus infection: why don’t the guidelines agree? Epidemiol Rev 2011;33:7–19.
10. Paltiel AD, Walensky RP, Schackman BR, et al. Expanded HIV screening in the United States: effect on clinical outcomes, HIV transmission, and costs. Ann Intern Med 2006;145:797-806.
11. Chou R, Huffman L. Screening for human immunodeficiency virus: focused update of a 2005 systematic evidence review for the U.S. Preventive Services Task Force. AHRQ Pub No. 07-0597-EF-1. Agency for Healthcare Research and Quality, April 2007. Available at: http://www.ncbi.nlm.nih.gov/books/NBK33475/
12. Long EF, Brandeau ML, Owens DK. The cost-effectiveness and population outcomes of expanded HIV screening and antiretroviral treatment in the United States. Ann Intern Med 2010;153;778-89.
13. Holtgrave DR. Costs and consequences of the US Centers for Disease Control and Prevention’s recommendations for opt-out HIV testing. PLoS Med 2007;4:e194.
14. Haukoos JS, Hopkins E, Conroy AA. Routine opt-out rapid HIV screening and detection of HIV infection in Emergency Department patients. JAMA 2010;304:284-92.
15. Wilson d’Almeida K, Kierzek G, Truchis P, et al. Modest public health impact of nontargeted human immunodeficiency virus screening in 29 emergency departments. Arch Intern Med 2011 Oct 24 [Epub ahead of print] doi:10.1001/archinternmed.2011.535
16. Centers for Disease Control and Prevention. Results of the expanded HIV testing initiative – 25 jurisdictions, United States, 2007-2010. MMWR Morb Mortal Wkly Rep 2011;60:805-10.
17. Halloran J, Czarnogorski M, Dursa EK, et al. HIV testing in the Department of Veterans Affairs, 2009-2010. Arch Intern Med 2011 Oct 24 [Epub ahead of print] doi:10.1001/archinternmed.2011.510

Wednesday, November 14, 2012

Strategies for preventing physician burnout

Although they probably came as little surprise to physicians who practice primary care, the results of a national survey of physician burnout in the Archives of Internal Medicine earlier this year made headlines in The New York Times and The Atlantic. This study found that 1) physicians are more likely to experience symptoms of burnout than similarly educated workers in the U.S. general population; and 2) physicians on the front lines of care access - family physicians, general internists, and emergency medicine physicians - had the highest rates of burnout.

Curbside Consultation in the November 1st issue of American Family Physician discussed the distinct but closely related problem of demoralization in a family physician who serves as the part-time medical director for a financially troubled clinic for children with developmental disorders. This physician was forced to accept layoffs of several key staff members without a corresponding decrease in workload:

She recognized the great need of these children and families, and had talked with other staff and administration about additional programs she wanted to develop. She now would have to say good-bye to coworkers and abandon her hopes for a larger and more robust program. She realized that the remaining staff, herself included, would have to work harder, and that she would have less time to spend with patients, the part of the work she found most fulfilling. Patients who needed the most help would, in fact, get less help. ... Over the next week, she became dejected and sad.

In the accompanying commentary, Dr. Stewart Gabel connected the often temporary state of demoralization to the more serious and persistent state of burnout:

Demoralization is a state of hopelessness and helplessness that is akin to, but separable from, depression. It is associated with a sense of subjective incompetence, the belief that a person is unable to express his or her values and achieve his or her goals. Demoralization has an existential dimension that is associated with the affected person's experienced losses. ... Moving past demoralization involves remoralization, or the renewal of one's personal values and the activities that stem from these values. ... However, if not addressed, persistent feelings of demoralization are likely to result in or contribute to burnout.

How can physicians prevent the demands of practicing present-day medicine from leading them down the road to burnout? An article in Family Practice Management suggested eight ideas, including joining a physician support group; strengthening interpersonal communication skills; and making it a priority to address the spiritual needs of patients and themselves.

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The above post first appeared on the AFP Community Blog.

Sunday, November 11, 2012

Lockboxes, Medicare reform, and the myth of "free stuff"

Recently, I had an interesting conversation with my dad about the current policy debates involving the Medicare program. Since he, along with my mother, is one of the two most important Medicare beneficiaries in my life, hearing his perspective was immensely valuable. Essentially, my dad said that what really upsets him when politicians describe Medicare is the use of the term "entitlement," which implies that people like my parents who paid Medicare taxes for several decades doesn't deserve to reap the full benefits of that investment.

I pointed out that the reason Medicare is running out of money is that the dollar value of health benefits that seniors use today far exceeds the amount they paid in to the system thirty, twenty, or even ten years ago, since Medicare only began to pay for prescription drugs in 2006 and annual increases in the cost of health care have exceeded inflation since, well, forever. He countered that it was totally appropriate for retirees to get back more than they put in, since all good investors expect their money to grow over time. He's right. The problem with this argument isn't his fault: the federal government doesn't put revenue from Medicare payroll taxes into the stock market, a savings account, or even the "lockbox" that Al Gore made famous during the 2000 presidential campaign. It spends those dollars, immediately, often on programs that have nothing to do with health care for seniors.

As a nation, we can and should debate the best ways to keep Medicare solvent for my generation and my children's generation. The President and Congress could, for example, turn the program into one with fixed costs but not necessarily fixed benefits. They could agree to large increases in the payroll tax that funds the program, rather than continuing the temporary payroll tax holiday put in to place to cushion families from the worst of the recession. They could cut Medicare payments to doctors by 30 percent, cross their fingers, and hope that at least a few of us would continue to see Medicare patients anyway. They could do some or all of these things at the same time.

What we as citizens cannot do is allow them to continue to point fingers at each other and, for purely political  reasons, avoid the question of what to do. Which brings me to one of my pet peeves about health reform in general, and the Affordable Care Act in particular: the selling of reforms as good because they provide people who already have health insurance with more "free stuff." Thanks to the ACA / Congressional Democrats / President Obama, a typical political ad will say, women can now get free mammograms, Pap smears, cholesterol tests, and birth control pills! Isn't that great? This kind of ad is misleading because none of the preventive health services defined by the bill have suddenly become free. In fact, some cost hundreds or even thousands of dollars. Instead, the costs of these (often but not always worthwhile) services have just been shifted - into higher insurance premiums, on to an employer, or to the federal government (and therefore the individual taxpayer or an international investor that holds some portion of the U.S.'s $16 trillion national debt).

The above discussion notwithstanding, my fellow blogger Josh Freeman recently made the very good point that health should generally not be considered a commodity, but a social good. I supported most provisions of the Affordable Care Act because its implementation will eventually allow millions more Americans to more reliably access health care, especially primary care, when they need it. As a family physician, I do not believe that any group of people "deserves" health care any more than others. My dad and mom deserve their health care. But so do I, so do my wife and kids, and so do you and your loved ones. And our country will never have an honest debate about health reform as a social good and a shared sacrifice if we let politicians of both parties, only concerned about the next election, portray it as a false choice between rationing and free stuff.

Wednesday, November 7, 2012

Redefining Alzheimer's dementia: for better or for worse?

Last year, the National Institute on Aging and the Alzheimer's Association published new criteria for the diagnosis of Alzheimer's disease that include biomarker measurements in addition to traditional clinical criteria. The rationale for the new guideline was that more sensitive criteria were needed in order to test interventions to prevent Alzheimer's disease; by the time symptoms are obvious, proponents argue, it is likely too late to alter the patient's prognosis. However, the downside to creating a new category of "pre-symptomatic Alzheimer's" is that many otherwise healthy adults could now receive an Alzheimer's diagnosis when there is no effective treatment - a label that leads to no health benefit and possible psychological harm. Therefore, experts recommend that this category only be used for patients who are enrolled in clinical trials of Alzheimer's prevention.

In an editorial in American Family Physician, Drs. Carla Perissinotto and Victor Valcour reviewed the numerous gaps in the evidence for preventing dementia that complicate public health strategies for reducing the rising incidence and morbidity from this chronic disease. They argued that current knowledge supports a tertiary prevention strategy:

It is reasonable to look to prior public health campaigns as models for our educational and prevention efforts for dementia. Educational efforts should first focus on ensuring that the public understands that a diagnosis of dementia represents a spectrum of cognitive impairment, and that Alzheimer disease is only one of several subtypes. Until strategies targeting primary and secondary prevention emerge, our greatest impact may be in tertiary prevention—in the prevention of dementia morbidity. Such work may require early recognition, in which strategies targeting home and financial safety have a clear impact on those at highest risk.

Family physicians have always played an important role in caring for patients with dementia and their caregivers. In addition to prevention, Alzheimer's patients must make difficult decisions about the initiation and discontinuation of drug therapies, which have modest, time-limited benefits that are frequently exaggerated in deceptive advertisements.

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

Tuesday, November 6, 2012

Why you should vote in today's elections

- President Abraham Lincoln at Gettysburg, Pennsylvania, November 19, 1863

Four score and seven years ago our fathers brought forth on this continent a new nation, conceived in liberty, and dedicated to the proposition that all men are created equal.

Now we are engaged in a great civil war, testing whether that nation, or any nation, so conceived and so dedicated, can long endure. We are met on a great battle-field of that war. We have come to dedicate a portion of that field, as a final resting place for those who here gave their lives that that nation might live. It is altogether fitting and proper that we should do this.

But, in a larger sense, we can not dedicate, we can not consecrate, we can not hallow this ground. The brave men, living and dead, who struggled here, have consecrated it, far above our poor power to add or detract.
African-American Civil War Memorial

The world will little note, nor long remember what we say here, but it can never forget what they did here. It is for us the living, rather, to be dedicated here to the unfinished work which they who fought here have thus far so nobly advanced.

It is rather for us to be here dedicated to the great task remaining before us—that from these honored dead we take increased devotion to that cause for which they gave the last full measure of devotion—that we here highly resolve that these dead shall not have died in vain—that this nation, under God, shall have a new birth of freedom—and that government of the people, by the people, for the people, shall not perish from the earth.

Sunday, November 4, 2012

To protect patients, practice guidelines must meet higher standards

Recent news stories have suggested that many of the ills of our health system could be prevented if more physicians followed guidelines on appropriate indications for tests and treatments. For example, a Wonkblog post by The Washington Post's Sarah Kliff noted that 43 percent of cardiac surgeries performed in Michigan were unnecessary, according to practice guidelines. Kliff attributed the disconnect between guidelines and physicians' behavior to two factors: 1) surgeons who perform more surgery earn more income for themselves and their institutions; and 2) the "oculostenotic reflex," which Kliff defined as "the 'irresistible temptation' on the part of interventional cardiologists to expand narrowed coronary arteries, despite ... guidelines suggesting the use of a different intervention, such as medication (which comes with fewer risks and at a lower cost)." Extended across other medical specialties that tend to provide too many aggressive (and profitable) interventions, another way to say this is that if you've got a hammer, everything looks like a nail.

But how can clinicians be sure that a practice guideline is any good? In an article published in American Family Physician a few years ago, family medicine professor David Slawson and I proposed several attributes that health professionals should use to identify good clinical practice guidelines. Here's our list, which became the basis for a lecture I gave in the spring and fall of this year at the Temple University Family Practice Review Course:

1. Comprehensive, systematic evidence search with end date noted
2. Evidence linked directly to recommendations via strength of recommendation grading system
3. Recommendations based on patient-oriented rather than disease-oriented outcomes
4. Transparent guideline development process
5. Potential conflicts of interest identified and addressed
6. Prospectively validated (i.e., guideline use has been shown to improve patient-oriented outcomes)
7. Recommendations offer flexibility in various clinical situations

In 2011, an Institute of Medicine panel published an important report titled Clinical Practice Guidelines We Can Trust. Despite not having consulted Dr. Slawson or me, they produced a longer list of standards for developing trustworthy clinical practice guidelines that was nonetheless very similar to ours. Later that year, the American Cancer Society announced that it would revise its methods for creating cancer screening guidelines to be consistent with the IOM's standards.

That's a positive step, especially for a group that has produced some poor-quality guidelines in the past, but are others doing the same? Unfortunately, no. A recent study in the Archives of Internal Medicine surveyed a random sample of 130 guidelines in AHRQ's National Guideline Clearinghouse for adherence to the IOM's standards. The findings were disappointing, to say the least: "Fewer than half of the guidelines surveyed met more than 50% of the IOM standards. Barely a third of the guidelines produced by subspecialty societies satisfied more than 50% of the IOM standards surveyed." In the straightforward words of an editorial that accompanied the study, "guidelines are still not following guidelines."

In a fee-for-service payment system, doctors already have few incentives to follow practice guidelines, resulting not only in unnecessary heart surgery, but other abuses of patients such as excessive rates of screening colonoscopy. And as the Archives study showed, even conscientious physicians who provide guideline-concordant care may in fact be relying on documents that are worth little more than the paper they are printed on, especially if they were written by specialists whose incomes depend on doing more consultations and procedures.

The bottom line is that all of us - patients, advocates, policymakers, and health professionals alike - must demand that guideline-producing organizations meet higher standards. Groups that continue to convene guideline panels with financial and other conflicts of interest; continue to value the opinions of specialists more than those of generalists; and continue to make strong recommendations based on disease-oriented evidence or, worse yet, no evidence at all; should be called out for what they are: a clear and present danger to the health and well-being of every person who seeks health care.

Wednesday, October 31, 2012

Why primary care is the future of health care

Several weeks ago, Primary Care Progress asked me to serve as one of their guest bloggers for this year's National Primary Care Week, writing on the theme: "Why is primary care the future of health care?" I didn't end up contributing a post, for a few reasons: 1) not enough time; 2) concern that the question was too physician-centric (rather than patient-centered); 3) the feeling that I had nothing new to say on the topic that I hadn't already written before. Today, however, while teaching a group of first-year medical students about the Patient-Centered Medical Home and its potential to put primary care back in the center of the health system (in my opinion, exactly where it belongs), I had second thoughts. As the "Healthcare Headaches" blogger for U.S. News and World Report from 2010-11, I often wrote about the future of health care though my perspective as a family physician. Below I've assembled some links to, and excerpts from, posts that I think do a good job of describing why primary care is the future of health care.

1. Your Primary Care Team Will See You Now - the future of health care includes working in integrated teams, which will allow primary care physicians to meet current and future increased demand for medical services.

In the primary care team model, the receptionist or a medical assistant could ask each patient to fill out a form with the necessary information. The medical assistant could then input this information into the tool and create a customized list of preventive recommendations. A medical assistant or nurse could then counsel patients about exercise habits, dietary practices, and smoking cessation before they even saw the doctor. They could also provide basic information about screening tests and immunizations, leaving the doctor to answer any remaining questions. If a referral was needed to obtain, say, a mammogram or a colonoscopy, the assistant could start the necessary paperwork while the doctor performed the examination.

2. New Electronic Medical Records Software Could Improve Your Health - Used properly, electronic health records will allow primary care practices to create registries to proactively manage the health of populations of patients.

The latest research suggests that electronic health records don't necessarily improve care unless they include interactive features: They should make it easier for doctors to implement proven guidelines for good care, providing the necessary shots and screenings, follow-up exams and treatments to help patients live longer with chronic diseases or to prevent these diseases altogether. Ideally, these records should include a software tool that periodically culls through patients' records looking for gaps in care such as who is overdue for a cholesterol screening or flu vaccine. The system would then send out reminders to patients to come in for a test or appointment.


3. Healthy Habits Are Hard to Maintain - Even If You Know What Lies Ahead - Genomic medicine is overrated, and will never be able to replace commonsense advice from a trusted family physician.

The take-home message is that providing personalized health information to my patients based on the “old fashioned” collection of family history data is likely to be at least as good, if not better, than sequencing their genomes. A potential reason for why participants in the New England Journal study weren’t able to change their health habits is that high-tech genetic profiles can’t substitute for personal contact. Much of the training primary care physicians receive is geared toward learning how to help people make good decisions about their health. So if you fear that your New Year’s resolution may be falling by the wayside, I encourage you to make an appointment to see your family doctor to discuss small, realistic steps that you can take to get back on track. Obviously, your doctor can only do so much by outlining your personal health risks and suggesting ways you can reduce them. The rest is up to you.

4. How to See A Doctor - Stat - New scheduling models such as open-access and technology such as secure patient portals will make it more convenient to consult a primary care physician than ever before.

Primary care offices have historically handled patients with urgent problems by assigning one doctor "acute care" responsibilities for the day or squeezing extra patients into already crammed schedules. The downside: Patients can end up seeing doctors who are unfamiliar with their medical histories, harried due to time pressures, or both, which raises the risk of misdiagnosis or improper treatment. That's why some practices (including the federally funded Veterans Heath Administration clinics) have switched to "advanced" or "open-access" scheduling. Rather than scheduling a visit weeks or months in advance, patients can call for an urgent or routine appointment the day before or the same day they want to be seen. A recent review of 28 studies found that advanced-access scheduling increases the chance that a patient will be able to see his or her doctor and reduces no-show rates.

5. Diabetes Prevention Starts With Your Doctor - Substitute "any chronic condition" for diabetes, and the primary care physician is the first line of defense, as the doctor that people are most likely to see when they are healthy. Good primary care, prevention, and health promotion go hand-in-hand.

Recent research confirms the huge impact that convincing people to change their lifestyles can have on lowering their future diabetes risk. A study of more than 200,000 adults found that the odds of developing diabetes over an 11-year time frame were 30 to 40 percent lower for older adults with one or more good habits: healthy eating, moderate alcohol consumption, and being smoke-free and physically active. For you to benefit personally from this research, though, you need to make sure that your doctor isn't just going through the motions of lifestyle counseling, electronic medical record or not. Given the myriad agenda-items doctors must squeeze into a 15-minute office visit, skipping counseling can be an easy way to cut corners and stay on schedule. Don't let it be. There can be no better use of your visit than to discuss how to stay healthy and lower your risk of health problems down the road.

So there you have it. Primary care is the future of health care because we will function in teams; use electronic registries to practice proactive rather than reactive care; make it more convenient for patients to see, speak to, or message us; provide personalized health counseling; and assist patients in making lifestyle changes to avoid preventable chronic conditions. And as regular readers of this blog know, these reasons represent only the tip of the iceberg.

Sunday, October 28, 2012

Guest Post: Telling family medicine's stories

Richard Young, MD is a family physician educator and director of research at the John Peter Smith Hospital Family Medicine Residency in Fort Worth, Texas. He is the author of American HealthScare, a critically acclaimed book about the excesses of the current U.S. health system and potential primary care-based reforms. Dr. Young also regularly posts on his blog of the same name.

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I think one of the underlying reasons Family Medicine continues to be under-supported in the U.S. is the very nature of storytelling, and the media's preference for telling stories over reporting facts.

The ologists have it easy. Their stories go something like this: A mother has a child who isn't doing very well both at home and at school (protagonist). She goes from one doctor to another, and they tell her there is nothing physically wrong with the child and one even tells her that bad parenting is to blame (antagonist and conflict). She refuses to take no for an answer, and she scours the Internet and finds an ologist at a major medical center who thinks he has the answer. They travel to see this medical fairy godmother, he waves his magic wand (a complete battery of tests), and the boy is saved and becomes normal again (resolution). Nightly news and magazine shows (60 minutes, Dateline) love these stories.

Here is family medicine's story. A patient comes to the family physician with a list of physical symptoms. The physician listens to the patient (in itself therapeutic), orders a few basic lab tests that are normal, and essentially asks the patient to be patient -- the symptoms don't raise any red flags for a serious underlying disease and will probably resolve on their own. A month later the patient feels better. BORING. There's no action and no conflict.

Other medical nonsense is magnified on shows like Private Practice and Grey's Anatomy -- when the characters aren't banging each other and actually taking care of patients -- in dialogue where they scream at each other lines such as, "You have to let her go!", then "I will not let my patient die. I swore an oath to do everything in my power for my patients and I will not give up!" And so on.

Therefore, the story of family medicine isn't what it does as much as what it doesn't do. Our quality care is best understood as a counterpoint to ologist excess. This is why Shannon Brownlee's book Overtreated and the recent video about the harms of overtreatment are a step in the right direction to get the American people to understand the tremendous cost, waste, and harms caused by an over-ologized physician workforce, and an American medical culture that is locked into the overall ologist philosophy of what is standard of care.

Some colleagues and I have collected some great stories of how family physicians deliver better care at a lower cost. The power of some of the stories we heard had their greatest impact when set against the ologist alternative. For example, a patient was taking 13 pills and seeing 5 different doctors multiple times per year and still feeling sick. Then a family physician took over all her care and got her down to 8 pills and 4 visits per year, and the patient felt better.

Patients and storytellers want certainty, but family physicians are the masters of managing uncertainty. Americans want action and immediate answers, but family physicians are the masters of patience, judgment, and prudence. Let's face it, family medicine is just un-American.

That's why our healthcare system is so costly and inefficient and why our children will have worse lives than their parents. The task is enormous, but the culture of America must change to right the listing ship. Americans need to develop a different understanding of what a healthcare system should even provide in the first place.

Thursday, October 25, 2012

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 September and October:

1) Health communication: what not to do (9/11/12)

2) The spiritual assessment: unnecessary or essential? (10/4/12)

3) Prevention potpourri (9/25/12)

4) Reducing overtreatment is the other side of quality improvement (10/8/12)

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

Monday, October 22, 2012

End the war metaphors for cancer screening and treatment

Like millions of cycling fans all over the world, I was very disappointed about revelations that 7-time Tour de France champion and cancer survivor Lance Armstrong had been using banned performance-enhancing substances for most of his career, despite years of increasingly vigorous denials. To many people, Lance transcended his sport through his seemingly indomitable will to win - not only Tours, but a very public fight against advanced testicular cancer. Lance's words of encouragement to other people struggling with cancer were marked with war metaphors: personal battles, wars to be won at all costs against a tenacious and unyielding enemy. And while there's no such thing as cheating in the effort to beat a medical condition, the evidence now shows that Lance's determination to win at all costs in sports led him down a path that has resulted in his disgrace.

On Thursday I will speak about cancer screening at the Johns Hopkins Bloomberg School of Public Health's Fall Policy seminar on "Science and Public Policy in Conflict." One of the messages I hope to leave with the audience is that we need to end, or at least soften, the harsh war metaphors for cancer screening and treatment, which endow screening tests such as mammograms with far more power than they really have to affect patient outcomes, and leads to uninformed advocacy and public policy that ignores the harms of overdiagnosis and overtreatment that inevitably result. As I blogged last June (and have reposted below), there are "no easy victories" in cancer screening when it comes to the evidence.

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Nearly forty years ago, President Richard Nixon famously declared a "War on Cancer" by signing the National Cancer Act of 1971. Like the Manhattan Project, the Apollo program that was then landing men on the Moon, and the ongoing (and eventually successful) World Health Organization-led initiative to eradicate smallpox from the face of the Earth, the "War on Cancer" was envisioned as a massive, all-out research and treatment effort. We would bomb cancer in submission with powerful regimens of chemotherapy, experts promised, or, failing that, we would invest in early detection of cancers so that they could be more easily cured at earlier stages.

It was in the spirit of the latter that the National Cancer Institute launched the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening trial in 1992. This massive study, which eventually enrolled more than 150,000 men and women between age 55 and 74, was designed to test the widespread belief that screening and early detection of the most common cancers could improve morbidity and mortality in the long term. Not a few influential voices suggested that the many millions of dollars invested in running the trial might be better spent on programs to increase the use of these obviously-effective tests in clinical practice.

They were wrong. As of this week, the PLCO study is 0-for-2.

Miss #1 occurred in March of 2009 when the PLCO study first reported no mortality benefit from annual PSA testing, a test that a majority of men over 50 undergo routinely. Miss #2 occurred over the weekend, when the Journal of the American Medical Association published a landmark paper that ended with the following paragraph:

We conclude that annual screening for ovarian cancer as performed in the PLCO trial with simultaneous CA-125 and transvaginal ultrasound does not reduce disease-specific mortality in women at average risk for ovarian cancer but does increase invasive medical procedures and associated harms.

The lung and colorectal screening components of PLCO have not yet reported mortality data**, and there is reason to believe that at least the latter will likely yield some positive results. Although it has largely been supplanted by colonoscopy and CT colonography (aka "virtual colonoscopy") in the U.S., flexible sigmoidoscopy was already shown to reduce deaths from colorectal cancer in a randomized trial published in the Lancet last year. And PLCO's screening chest x-rays are probably a loser, but a preliminary report from NCI's National Lung Screening Trial suggest that screening CT scans can reduce lung cancer mortality in heavy smokers. (Even after this report is confirmed in a peer-reviewed scientific journal, there will still be plenty of reasons not to rush into lung cancer screening, as I outlined in a previous blog post.)

Still, these are hardly the magic bullets or the resounding victories that many expected from the "War on Cancer." The same can be said for chemoprevention, or the strategy of prescribing medications for healthy adults to prevent cancers from developing at all. The vast majority of "high risk" women have avoided breast cancer chemoprevention with tamoxifen and raloxifene due to their unpleasant side effects (which include hot flashes and life-threatening blood clots), despite a 2002 recommendation from the U.S. Preventive Services Task Force for clinicians to discuss these drugs with their patients. (This recommendation has not been updated since, largely due to politics, not science.) A new study published in the New England Journal of Medicine has reported that the drug exemestane reduces the risk of invasive breast cancer without the other drugs' side effects. But here's the rub: we can't be sure how many of those breast cancers are the ones that inevitably lead to symptoms and death, rather than the 1 in 3 that are thought to be overdiagnosed.

The bottom line from recent research is that there are no easy victories in cancer screening and prevention - just slow, incremental progress. Companies that have a profitable product to push would like you to believe otherwise, but when it comes to cancer prevention, there is no substitute for a healthy lifestyle: Don't Smoke. Drink in Moderation. Exercise. And Eat a Well-Balanced Plate.

** Note: the PLCO trial subsequently reported that chest x-ray screening did not reduce lung cancer deaths, while flexible sigmoidoscopy reduced colorectal cancer deaths by 26 percent. So PLCO's "final score" is 1 in 4 screening tests evaluated showing a positive effect on health.