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Overuse of Antibiotics

Thursday, May 5, 2016 // Uncategorized

Antibiotics are often prescribed for upper respiratory tract infections inappropriately.  According to the most recent study, 1/3 of antibiotics are prescribed inappropriately.  Overuse of antibiotics leads to resistance of bacteria.  Here is a summary of a recent JAMA article from Physicians First Watch.  Following that is the American College of Physicians informational page for patients on appropriate antibiotic use.

May 5, 2016 Population-Based Estimates of Appropriate and Inappropriate Antibiotic Prescribing Thomas L. Schwenk, MD reviewing Fleming-Dutra KE et al. JAMA 2016 May 3. Tamma PD and Cosgrove SE. JAMA 2016 May 3. Thomas L. Schwenk, MDThe U.S. annual antibiotic prescribing rate in 2010 was about 500 prescriptions per 1000 people; one third of prescriptions were judged to be inappropriate. Thomas L. Schwenk, MDResearch about inappropriate antibiotic prescribing usually focuses on specific conditions and age groups. However, these researchers used several national ambulatory care databases to provide overall population-based estimates that could guide government and professional mandates designed to reduce inappropriate antibiotic prescribing.Researchers assessed appropriateness of antibiotic use in about 184,000 ambulatory visits (not including urgent care centers, “minute” clinics, federal facilities, or long-term care facilities) in 2010 and 2011 using accepted clinical practice guidelines. If guidelines were not available (e.g., for sinusitis), the lowest regional level of antibiotic use was used as a surrogate for appropriateness (almost certainly still an overestimate). For some conditions (e.g., pneumonia), all antibiotic use was deemed to be appropriate.The overall annual rate of antibiotic use was 506 prescriptions per 1000 people, of which roughly two thirds of prescriptions (353 prescriptions/1000 people) were deemed to be appropriate. The overall rate ranged from 423 to 553 prescriptions per 1000 people in the West and South, respectively. Most inappropriate antibiotic use was for acute respiratory conditions (111 prescriptions/1000 people annually).Comment – See more at: http://www.jwatch.org/na41220/2016/05/05/population-based-estimates-appropriate-and-inappropriate#sthash.I2fvkBOG.dpuf

Appropriate Antibiotic Use for Acute Respiratory Tract Infection in Adults: Advice for High-Value Care From the American College of Physicians and the Centers for Disease Control and Prevention

 What are acute respiratory tract infections?

Acute respiratory tract infections (ARTIs) are common in adults. ARTIs include bronchitis, sinus infections, sore throat, and the common cold. Most are caused by a virus, not by bacteria.

What are harms related to antibiotic use?

Antibiotics are medicines used to treat illnesses that are caused by bacteria, such as strep throat (medical name: group A streptococcal pharyngitis) or pneumonia. Antibiotics will not work for illnesses caused by viruses, such as the common cold. Antibiotics can cause harm when they are not used the right way. These harms can include:

Side effects: These can be mild, such as upset stomach, diarrhea, or skin rash. However, in some cases they can be very serious and even life-threatening.

High costs: Prescriptions that are not needed increase patients’ out-of-pocket costs. It is estimated that 50% of antibiotic prescriptions are not needed, totaling more than $3 billion in wasted spending.

Antibiotic resistance: When antibiotics are used when they are not needed, germs and bacteria can become resistant to them. This means that common antibiotics will not be able to treat certain illnesses. Antibiotic-resistant bacteria cause more serious illnesses that are harder to cure and can be life-threatening.

Why are so many people prescribed antibiotics when they are not needed?

Because antibiotics have often been used when not needed, many patients expect to receive antibiotics for ARTIs and believe that they need them to feel better. In other cases, clinicians may prescribe antibiotics right away, rather than waiting or testing to see if they are needed.

How did the ACP develop this advice?

The authors looked at research and clinical guidelines related to antibiotic use for ARTIs. This information was used to develop advice for clinicians and patients.

What does the ACP recommend that patients and physicians do?

Reducing unneeded antibiotic prescribing will improve care, lower costs, and help to stop antibiotic resistance. In most patients, symptoms get better in 1 to 2 weeks. Coughs can sometimes last up to 6 weeks. The ACP recommends the following:

•Clinicians should not prescribe antibiotics for patients with bronchitis. Antibiotics should only be used if patients have pneumonia.

•Clinicians should test patients with symptoms that could be strep throat. Because symptoms alone are not reliable, antibiotics should only be prescribed when testing confirms strep throat. Other sore throat infections do not need antibiotics.

•Clinicians should not prescribe antibiotics for sinus infections unless patients have severe symptoms or symptoms that last more than 10 days. Patients whose symptoms improve but eventually get worse may also need antibiotics.

•Clinicians should not prescribe antibiotics for patients with the common cold.

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The Benefits of Quitting Smoking

Wednesday, March 2, 2016 // Uncategorized

It’s never too late.  From a recent review article on smoking cessation from the Annals of Internal Medicine. Even patients who have lung cancer have an average survival that is longer in those who quit smoking than those who continue to smoke.

The benefits of quitting begin immediately and last for decades. After 10 years of smoking cessation, the risk for lung cancer in former smokers was reduced up to 50% (1). Smoking cessation reduces risk for death from CAD by two thirds within 2–3 years of quitting, with risk approaching that of persons who have never smoked (12, 13). Circulation improves within weeks of quitting, and stroke risk is reduced to the level of that of nonsmokers in 2–4 years (14). Lung function improves within 3 months. Smoking cessation during the first 3–4 months of pregnancy reduces risk for low birthweight to that of never-smokers. Other benefits include reduced damaging effects on skin, breath, teeth and gums, smell, and taste. Finally, smokers and providers should be aware that tobacco use can affect metabolism of caffeine and commonly prescribed medications, including olanzapine, clozapine, and theophylline (15). Therefore, when smokers successfully quit, medication doses might be lowered.

Health Benefits of Quitting Tobacco

Symptoms: Minutes–days: Lower BP; lower carbon monoxide; better stamina, smell, tasteLung function

  • 2–4 weeks: Decreased respiratory infections

  • 4–12 weeks: Improved lung function

Cardiovascular disease

  • 2–3 months: Improved circulation

  • 1 year: 50% reduction for heart attack

  • 5–15 years: Cardiovascular risk equals that of never-smokers

Cancer: 10 years: Risk for lung cancer reduced by half

Is there an age after which smoking cessation no longer yields benefit?
Smoking cessation benefits people of all ages, regardless of smoking history (6, 7). Older smokers, despite smoking for many years, may have increased motivation from health concerns and symptoms of tobacco-related illness, experience with what has been successful in past quit attempts, and better access to treatment resources.
Two large, recent, retrospective cohort analyses showed that smokers who quit at age 55–64 years gained 4 years of life and that even those who quit after age 70 years had lower risk for mortality than those who continued to smoke (6, 7).
Clinical Bottom Line: Health Consequences of Smoking
Tobacco use affects nearly every organ system in the body and leads to numerous disorders, including heart disease, stroke, many types of cancer, vascular disease, respiratory infections, diabetes, and gastroesophageal reflux disease. The health benefits of quitting start within minutes and continue for years. These risk-reduction benefits are especially significant for smokers with CAD, COPD, or those who are pregnant by reducing preterm labor and low birthweight. Cessation for smokers with children can reduce exposure to and disease caused by environmental tobacco smoke. Even after decades of smoking, those who stop smoking significantly reduce their risk for death from certain diseases, such as lung cancer, and slow the deterioration of lung function in patients with COPD. One is never too old or young, too healthy or sick, to benefit from smoking cessation.
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“I Heard This on TV….”

Tuesday, February 23, 2016 // Uncategorized

We are constantly bombarded with medical news. It is part of the fodder of the news media.  The problem with this is that information is not all of the same caliber. It doesn’t all carry the same weight. Case in point, a recent study showed and association between proton pump inhibitors like Nexium and chronic kidney disease.  This is a summary from Journal Watch.

  • Proton-Pump Inhibitors Are Associated with Chronic Kidney Disease Thomas L. Schwenk, MD reviewing Lazarus B et al. JAMA Intern Med 2016 Jan 11. Schoenfeld AJ and Grady D. JAMA Intern Med 2016 Jan 11. Thomas L. Schwenk, MDA further reason to use PPIs only when their clinical benefits are clear Thomas L. Schwenk, MD Polypharmacy is one possible cause of the increasing prevalence of chronic kidney disease (CKD) in the U.S. population. Proton-pump inhibitor (PPI) use is associated with acute renal injury, but PPIs also have other biological effects, including hypomagnesemia, that can lead to excess risk for CKD. In a population-based, prospective cohort study, researchers followed 10,482 adults (mean age, 63; 80% white) with normal renal function (estimated glomerular filtration rate, >60 mL/minute/1.73 m2); at baseline, 322 participants used PPIs and 956 participants used histamine-2 (H2)–receptor antagonists. During the study (median follow-up, 14 years), PPI use increased markedly, to ≈27% of participants.At study end, the unadjusted incidence of CKD was significantly higher among baseline-PPI users than among baseline nonusers (14.2 vs. 10.7 cases per 1000 person-years); after statistical adjustment, the difference remained significant (hazard ratio, 1.5). CKD risk for baseline H2–antagonist users remained at baseline levels. A similar replication study in 249,000 participants who were followed for a median 6 years yielded similar results.Comment:These results add to increasing concerns about PPI use, including excess risks for Clostridium difficile infections, pneumonia, and fractures. Editorialists recommend monitoring renal function and magnesium levels in patients who are taking PPIs and who are at high risk for CKD; such patients should switch to H2-antagonists when possible and should not use PPIs for vague complaints of heartburn or dyspepsia. – See more at: http://www.jwatch.org/na40149/2016/01/12/proton-pump-inhibitors-are-associated-with-chronic-kidney#sthash.SV6vDFbi.dpuf

     

    The problem is that observational studies have inherent weaknesses. The following is from Wikepedia.

    Observational study

    From Wikipedia, the free encyclopedia

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    In fields such as epidemiology, social sciences, psychology and statistics, an observational study draws inferences from a sample to a population where the independent variable is not under the control of the researcher because of ethical concerns or logistical constraints. One common observational study is about the possible effect of a treatment on subjects, where the assignment of subjects into a treated group versus a control group is outside the control of the investigator.[1][2] This is in contrast with experiments, such as randomized controlled trials, where each subject is randomly assigned to a treated group or a control group.

     

    Weaknesses

    The independent variable may be beyond the control of the investigator for a variety of reasons:

    • A randomized experiment would violate ethical standards. Suppose one wanted to investigate the abortion – breast cancer hypothesis, which postulates a causal link between induced abortion and the incidence of breast cancer. In a hypothetical controlled experiment, one would start with a large subject pool of pregnant women and divide them randomly into a treatment group (receiving induced abortions) and a control group (not receiving abortions), and then conduct regular cancer screenings for women from both groups. Needless to say, such an experiment would run counter to common ethical principles. (It would also suffer from various confounds and sources of bias, e.g.,it would be impossible to conduct it as a blind experiment.) The published studies investigating the abortion–breast cancer hypothesis generally start with a group of women who already have received abortions. Membership in this “treated” group is not controlled by the investigator: the group is formed after the “treatment” has been assigned.[citation needed]
    • The investigator may simply lack the requisite influence. Suppose a scientist wants to study the public health effects of a community-wide ban on smoking in public indoor areas. In a controlled experiment, the investigator would randomly pick a set of communities to be in the treatment group. However, it is typically up to each community and/or its legislature to enact a smoking ban. The investigator can be expected to lack the political power to cause precisely those communities in the randomly selected treatment group to pass a smoking ban. In an observational study, the investigator would typically start with a treatment group consisting of those communities where a smoking ban is already in effect.[citation needed]
    • A randomized experiment may be impractical. Suppose a researcher wants to study the suspected link between a certain medication and a very rare group of symptoms arising as a side effect. Setting aside any ethical considerations, a randomized experiment would be impractical because of the rarity of the effect. There may not be a subject pool large enough for the symptoms to be observed in at least one treated subject. An observational study would typically start with a group of symptomatic subjects and work backwards to find those who were given the medication and later developed the symptoms. Thus a subset of the treated group was determined based on the presence of symptoms, instead of by random assignment.

    Types of observational studies

    • Case-control study: study originally developed in epidemiology, in which two existing groups differing in outcome are identified and compared on the basis of some supposed causal attribute.
    • Cross-sectional study: involves data collection from a population, or a representative subset, at one specific point in time.
    • Longitudinal study: correlational research study that involves repeated observations of the same variables over long periods of time.
    • Cohort study or Panel study: a particular form of longitudinal study where a group of patients is closely monitored over a span of time.
    • Ecological study: an observational study in which at least one variable is measured at the group level.

    Degree of usefulness and reliability

    Although observational studies cannot be used as reliable sources to make statements of fact about the “safety, efficacy, or effectiveness” of a practice,[3] they can still be of use for some other things:

    “[T]hey can: 1) provide information on “real world” use and practice; 2) detect signals about the benefits and risks of…[the] use [of practices] in the general population; 3) help formulate hypotheses to be tested in subsequent experiments; 4) provide part of the community-level data needed to design more informative pragmatic clinical trials; and 5) inform clinical practice.”[3]

    Bias and compensating methods

    In all of those cases, if a randomized experiment cannot be carried out, the alternative line of investigation suffers from the problem that the decision of which subjects receive the treatment is not entirely random and thus is a potential source of bias. A major challenge in conducting observational studies is to draw inferences that are acceptably free from influences by overt biases, as well as to assess the influence of potential hidden biases.

    An observer of an uncontrolled experiment (or process) records potential factors and the data output: the goal is to determine the effects of the factors. Sometimes the recorded factors may not be directly causing the differences in the output. There may be more important factors which were not recorded but are, in fact, causal. Also, recorded or unrecorded factors may be correlated which may yield incorrect conclusions. Finally, as the number of recorded factors increases, the likelihood increases that at least one of the recorded factors will be highly correlated with the data output simply by chance.

    In lieu of experimental control, multivariate statistical techniques allow the approximation of experimental control with statistical control, which accounts for the influences of observed factors that might influence a cause-and-effect relationship. In healthcare and the social sciences, investigators may use matching to compare units that nonrandomly received the treatment and control. One common approach is to use propensity score matching in order to reduce confounding.[4]

    A report from the Cochrane Collaboration in 2014 came to the conclusion that observational studies are very similar in results reported by similarly conducted randomized controlled trials. In other words, it reported little evidence for significant effect estimate differences between observational studies and randomized controlled trials, regardless of specific observational study design, heterogeneity, or inclusion of studies of pharmacological interventions. It therefore recommended that factors other than study design per se need to be considered when exploring reasons for a lack of agreement between results of randomized controlled trials and observational studies.[5]

    In 2007, several prominent medical researchers issued the Strengthening the reporting of observational studies in epidemiology (STROBE) statement, in which they called for observational studies to conform to 22 criteria that would make their conclusions easier to understand and generalise.[6]

    Correlation does not imply causation” is a phrase used in statistics to emphasize that a correlation between two variables does not imply that one causes the other.[1][2] Many statistical tests calculate correlation between variables. A few go further, using correlation as a basis for testing a hypothesis of a true causal relationship; examples are the Granger causality test and convergent cross mapping.[clarification needed (hypothesis testing not well explained here)]

    The counter-assumption, that “correlation proves causation”, is considered a questionable cause logical fallacy in that two events occurring together are taken to have a cause-and-effect relationship. This fallacy is also known as cum hoc ergo propter hoc, Latin for “with this, therefore because of this”, and “false cause”. A similar fallacy, that an event that follows another was necessarily a consequence of the first event, is sometimes described as post hoc ergo propter hoc (Latin for “after this, therefore because of this”).

    For example, in a widely studied case, numerous epidemiological studies showed that women taking combined hormone replacement therapy (HRT) also had a lower-than-average incidence of coronary heart disease (CHD), leading doctors to propose that HRT was protective against CHD. But randomized controlled trials showed that HRT caused a small but statistically significant increase in risk of CHD. Re-analysis of the data from the epidemiological studies showed that women undertaking HRT were more likely to be from higher socio-economic groups (ABC1), with better-than-average diet and exercise regimens. The use of HRT and decreased incidence of coronary heart disease were coincident effects of a common cause (i.e. the benefits associated with a higher socioeconomic status), rather than a direct cause and effect, as had been supposed.[3]

    As with any logical fallacy, identifying that the reasoning behind an argument is flawed does not imply that the resulting conclusion is false. In the instance above, if the trials had found that hormone replacement therapy does in fact have a negative incidence on the likelihood of coronary heart disease the assumption of causality would have been correct, although the logic behind the assumption would still have been flawed.

    BOTTOM LINE: I don’t know if proton pump inhibitors cause kidney disease just like I don’t know if calcium supplements cause heart disease or statins cause ALS. All of these have been implicated in previous observational studies.  I do know that all medication should be used cautiously and not indiscriminately. It is worthwhile to periodically review the drugs that your are taking and discuss with your physician if they should be continued.

     

 

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“Medical Taylorism” or What is Wrong With Medicine Today

Monday, January 18, 2016 // Uncategorized

This is an excellent editorial from the most recent issue of the New England Journal of Medicine that resonated with me. I wanted to share it. It wasn’t surprising who authored it, two of my favorite authors.

Medical Taylorism

Pamela Hartzband, M.D., and Jerome Groopman, M.D.

N Engl J Med 2016; 374:106-108January 14, 2016DOI: 10.1056/NEJMp1512402

Frederick Taylor, a son of Philadelphia aristocrats who lived at the turn of the last century, became known as the “father of scientific management” — the original “efficiency expert.” He believed that the components of every job could and should be scientifically studied, measured, timed, and standardized to maximize efficiency and profit. Central to Taylor’s system is the notion that there is one best way to do every task and that it is the manager’s responsibility to ensure that no worker deviates from it. “In the past, the man has been first; in the future, the system must be first,” Taylor asserted.1

Toyota, inspired by these principles of “Taylorism,” successfully applied them to the manufacture of cars, thereby improving quality, eliminating waste, and cutting costs. As health care comes under increasing economic pressure to achieve these same goals, Taylorism has begun permeating the culture of medicine.

Advocates lecture clinicians about Toyota’s “Lean” practices, arguing that patient care should follow standardized systems like those deployed in manufacturing automobiles. Colleagues have told us, for example, that managers with stopwatches have been placed in their clinics and emergency departments to measure the duration of patient visits. Their aim is to determine the optimal time for patient–doctor interactions so that they can be standardized.

Meanwhile, the electronic health record (EHR) — introduced with the laudable goals of making patient information readily available and improving safety by identifying dangerous drug–drug interactions — has become a key instrument for measuring the duration and standardizing the content of patient–doctor interactions in pursuit of “the one best way.” Encounters have been restructured around the demands of the EHR: specific questions must be asked, and answer boxes filled in, to demonstrate to payers the “value” of care. Open-ended interviews, vital for obtaining accurate clinical information and understanding patients’ mindsets, have become almost impossible, given the limited time allotted for visits — often only 15 to 20 minutes. Instead, patients are frequently given checklists in an effort to streamline the interaction and save precious minutes. The EHR was supposed to save time, but surveys of nurses and doctors show that it has increased the clinical workload and, more important, taken time and attention away from patients.

Physicians sense that the clock is always ticking, and patients are feeling the effect. One of our patients recently told us that when she came in for a yearly “wellness visit,” she had jotted down a few questions so she wouldn’t forget to ask them. She was upset and frustrated when she didn’t get the chance: her physician told her there was no time for her questions because a standardized list had to be addressed — she’d need to schedule a separate visit to discuss her concerns.

We believe that the standardization integral to Taylorism and the Toyota manufacturing process cannot be applied to many vital aspects of medicine. If patients were cars, we would all be used cars of different years and models, with different and often multiple problems, many of which had previously been repaired by various mechanics. Moreover, those cars would all communicate in different languages and express individual preferences regarding when, how, and even whether they wanted to be fixed. The inescapable truth of medicine is that patients are genetically, physiologically, psychologically, and culturally diverse. It’s no wonder that experts disagree about the best ways to diagnose and treat many medical conditions, including hypertension, hyperlipidemia, and cancer, among others.

To be sure, certain aspects of medicine have benefited from Taylor’s principles. Strict adherence to standardized protocols has reduced hospital-acquired infections, and timely care of patients with stroke or myocardial infarction has saved lives. It may be possible to find one best way in such areas. But this aim cannot be generalized to all of medicine, least of all to such cognitive tasks as eliciting an accurate history, synthesizing clinical and laboratory data to make a diagnosis, and weighing the risks and benefits of a given treatment for an individual patient. Good thinking takes time, and the time pressure of Taylorism creates a fertile field for the sorts of cognitive errors that result in medical mistakes. Moreover, rushed clinicians are likely to take actions that ignore patients’ preferences.

Part of the original promise of scientific management was that increased efficiency and standardization would not only result in a better product at lower cost, but would also give workers more free time to enjoy life. Lillian Gilbreth, who with her husband Frank championed motion studies of workers to boost their efficiency, called this outcome saving time for “happiness minutes”2 (see Perspective article by Gainty, pages xxx–xx). Similarly, some prominent policymakers have claimed that implementing scientific management in medicine would free doctors, nurses, and other members of the clinical team to spend more time with their patients.3 In fact, the opposite seems to be happening. Yet some of the greatest rewards of working in medicine come from spending unstructured time with our patients, sharing their joys and sorrows.

Instead of gaining happiness minutes, clinicians are increasingly experiencing dissatisfaction and burnout as they’re subjected to the time pressures of Taylorism and scientific management in the name of efficiency. We have watched colleagues fleeing to concierge practices, where they have control over their schedules. Others have taken early retirement, unwilling to compromise on what they believe is the time needed to deliver compassionate care. Some have moved into management or consulting positions, where they tell others how to practice while unburdening themselves of their clinical load. Just as Taylor enriched himself by consulting for companies, a growing and lucrative industry has emerged to generate and enforce metrics in medicine. By 2014, the Centers for Medicare and Medicaid Services alone had mandated the use of more than 1000 performance measures. As the Institute of Medicine recently reported, such metrics have proliferated, though many of them have little proven value.4

There is a certain hypocrisy among some of the most impassioned advocates for efficiency and standardization in health care, as Boston neurologist Martin Samuels recently pointed out. “They come from many different backgrounds: conservatives, liberals, academics, business people, doctors, politicians, and more often all the time various combinations of these. But they all have one characteristic in common. They all want a different kind of health care for themselves and their families than they profess for everyone else.”5 What they want is what every patient wants: unpressured time from their doctor or nurse and individualized care rather than generic protocols for testing and treatment.

Yet students are now taught the principles of Taylorism and Toyota Lean as early as their first year of medical school. They enter clinical rotations believing that there must be one best way to diagnose and treat every medical condition. In residency training and beyond, they discover that’s not the case, and they face a steep learning curve as they take on primary responsibility for patient care. We learn how to modify and individualize care in the real world, recognizing the variety of clinical presentations, the reality of multiple coexisting conditions, the variability of human biology, the effects of social and cultural contexts, and the diversity of patients’ preferences regarding risk and benefit, all of which defy rigid protocols.

Medical Taylorism began with good intentions — to improve patient safety and care. But we think it has gone too far. To continue to train excellent physicians and give patients the care they want and deserve, we must reject its blanket application. That we’re beginning to do so is shown, for example, by a bill before Congress that would delay implementation of the Meaningful Use Stage 3 criteria for information-technology use in health care. We need to recognize where efficiency and standardization efforts are appropriate and where they are not. Good medical care takes time, and there is no one best way to treat many disorders. When it comes to medicine, Taylor was wrong: “man” must be first, not the system.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

From Beth Israel Deaconess Medical Center and Harvard Medical School — both in Boston.

.References

1

Taylor FW. The principles of scientific management. New York: Harper & Brothers, 1911.

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2

Lepore J. Not so fast: scientific management started as a way to work. How did it become a way of life? New Yorker October 12, 2009:12-12

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3

Swensen SJ, Meyer GS, Nelson EC, et al. Cottage industry to postindustrial care — the revolution in health care delivery. N Engl J Med 2010;362:e12-e12
Free Full Text | Web of Science | Medline
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4

Blumenthal D, McGinnis JM. Measuring vital signs: an IOM report on core metrics for health and health care progress. JAMA 2015;313:1901-1902
CrossRef | Web of Science | Medline
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5

Samuels M. The anti-hypocrisy rule. Forbes 2014 (http://www.forbes.com/sites/davidshaywitz/2014/12/09/the-anti-hypocrisy-rule).

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Blood Pressure: How Low Do You Go? Our Four Cents from Dr. Thornton and Dr. Wallace

Wednesday, December 23, 2015 // Blood Pressure, Medication

Choosing the optimal blood pressure target to shoot for in managing hypertension requires that we apply the art of medicine, rather than just a cookbook approach. Over recent years, we have gotten dizzy keeping up with various recommendations which have swung back and forth between lower versus higher blood pressure goals. Last year a Joint National Committee on Hypertension recommended higher blood pressure targets: <140/90, but <150/90 in adults over 60 years old. Now we have a new large study published in November (the SPRINT study) which has caused the pendulum to swing back toward a goal of lower blood pressures, specifically in individuals at least 50 years old who already have cardiovascular disease, or who have at least one risk factor for developing it. The SPRINT study found that treating these patients aggressively, with a goal of achieving a systolic (top number) blood pressure <120, rather than to a more conservative target of <140, resulted in a significant decrease in the risk of cardiovascular events such as stroke or heart attack, and of death in general.

As usual, nothing is ever black or white. Getting to the lower target required more blood pressure medications (an average of 3, vs. 2 for the higher target), which increases the chance of side effects. The target of <120 also caused more incidence of blood pressure going too low, as one might expect. This increases the possibility of dizziness and falls which can be devastating, especially in our older patients.

So we must once again apply the art of medicine, treating each patient as an individual, and keeping new information in mind as we attempt to balance the risk of medication side effects against the risk of future adverse events.

Below is a summary published in Journal Watch of the findings of the SPRINT study, followed by some published comments:
SPRINT: A Trial of Intensive Blood Pressure Lowering Allan S. Brett, MD reviewing The SPRINT Research Group. N Engl J Med 2015 Nov 9. Chobanian AV. N Engl J Med 2015 Nov 9.Allan S. Brett, MD

Allan S. Brett, MDTreating to a systolic target of 120 mm Hg lowered the incidence of adverse cardiovascular events in a high-risk population. Allan S. Brett, MD

Treating to a systolic target of 120 mm Hg lowered the incidence of adverse cardiovascular events in a high-risk population. Allan S. Brett, MDFor years, clinicians have debated how far to lower blood pressure (BP) in hypertensive patients. The multicenter Systolic Blood Pressure Intervention Trial (SPRINT) now provides some guidance. SPRINT researchers enrolled 9361 patients (age, ≥50) with systolic BP of 130 to 180 mm Hg and high cardiovascular (CV) risk (defined as one or more of these: known symptomatic or asymptomatic CV disease, chronic kidney disease [CKD] with glomerular filtration rate ( a measure of kidney function) [GFR] 20–59 mL/minute/1.73 m2, 10-year Framingham CV risk ≥15%, or age ≥75). Patients with diabetes and stroke were excluded. Patients were randomized to either intensive or standard treatment (systolic BP targets, 120 or 140 mm Hg, respectively). The protocol included general guidelines for choice of antihypertensive agents, but researchers were permitted discretion in choosing drug regimens. Diuretics, angiotensin-converting–enzyme inhibitors or angiotensin-receptor blockers, calcium-channel blockers, and β-blockers were used extensively. During the trial, intensive- and

For years, clinicians have debated how far to lower blood pressure (BP) in hypertensive patients. The multicenter Systolic Blood Pressure Intervention Trial (SPRINT) now provides some guidance. SPRINT researchers enrolled 9361 patients (age, ≥50) with systolic BP of 130 to 180 mm Hg and high cardiovascular (CV) risk (defined as one or more of these: known symptomatic or asymptomatic CV disease, chronic kidney disease [CKD] with glomerular filtration rate ( a measure of kidney function) [GFR] 20–59 mL/minute/1.73 m2, 10-year Framingham CV risk ≥15%, or age ≥75). Patients with diabetes and stroke were excluded. Patients were randomized to either intensive or standard treatment (systolic BP targets, 120 or 140 mm Hg, respectively). The protocol included general guidelines for choice of antihypertensive agents, but researchers were permitted discretion in choosing drug regimens. Diuretics, angiotensin-converting–enzyme inhibitors or angiotensin-receptor blockers, calcium-channel blockers, and β-blockers were used extensively. During the trial, intensive- and standard-treatment patients required averages of three and two drugs, respectively. The trial was terminated early after median follow-up of 3.3 years, during which participants’ average systolic BPs were 121.5 mm Hg and 134.6 mm Hg in the intensive- and standard-treatment groups, respectively. The primary composite outcome (myocardial infarction [MI], non-MI acute coronary syndrome, stroke, heart failure, or CV-related death) occurred in 5.2% of intensive-treatment patients and 6.8% of standard-treatment patients (P<0.001). Relative reductions in this outcome were similar in subgroups of patients with CKD and of patients older than 75. Two individual components of the composite outcome were significantly lower with intensive treatment — heart failure (1.3% vs. 2.1%) and CV-related death (0.8% vs. 1.4%). All-cause mortality also was significantly lower with intensive treatment (3.3% vs. 4.5%).Several serious adverse events were significantly more common with intensive than with standard treatment: Incidences of hypotension (low blood pressure), syncope (passing out), and electrolyte abnormalities were each about 1 percentage point higher, and incidence of acute kidney injury was about 2 percentage points higher. Among patients without CKD at baseline, the incidence of a >30% decline in GFR was significantly greater with intensive treatment (3.8% vs. 1.1%).Comment — General Medicine Allan S. Brett, MD

Comment — General Medicine Allan S. Brett, MDSPRINT has demonstrated that aiming for a systolic BP of 120 mm Hg can lower the rate of adverse cardiovascular events; to prevent 1 event, 61 patients had to be treated for 3.3 years. Keep in mind that SPRINT was limited to middle-aged and older patients at above-average CV risk and that diabetic patients were excluded because the ACCORD BP researchers had examined this question (and showed no significant lowering of adverse CV events with intensive treatment; NEJM JW Cardiol Apr 2010 and N Engl J Med 2010; 362:1575). Whether the decline in GFR (kidney function) associated with intensive treatment represents a harmless hemodynamic effect or

SPRINT has demonstrated that aiming for a systolic BP of 120 mm Hg can lower the rate of adverse cardiovascular events; to prevent 1 event, 61 patients had to be treated for 3.3 years. Keep in mind that SPRINT was limited to middle-aged and older patients at above-average CV risk and that diabetic patients were excluded because the ACCORD BP researchers had examined this question (and showed no significant lowering of adverse CV events with intensive treatment; NEJM JW Cardiol Apr 2010 and N Engl J Med 2010; 362:1575). Whether the decline in GFR (kidney function) associated with intensive treatment represents a harmless hemodynamic effect or more-serious renal injury is unclear. Because this trial will change practice, clinicians must understand how BP was measured in the study. At each visit, patients were seated in a quiet area for 5 minutes. Then, BP was recorded by a commercially available automated unit that recorded three readings, separated by several minutes, with no clinician in the room. Decisions were based on the average of the three readings. Other studies have shown that this method of BP measurement yields substantially lower readings than does the single rushed measurement typical in many practices. If SPRINT is applied without attention to proper BP measurement, substantial overtreatment — with a higher rate of adverse events — likely will occur .Finally, note that the average achieved systolic BP in the intensive-treatment group (121.5 mm Hg) remained higher than the 120 mm target. This likely represents judicious balancing by treating clinicians who tried to approximate the 120 mm goal while avoiding side effects and excessive polypharmacy. Thus, an editorialist concludes reasonably that “the results from SPRINT warrant reducing the treatment goal for systolic blood pressure to less than 130 mm Hg” in patients who meet SPRINT’s enrollment criteria. – See more at: http://www.jwatch.org/na39551/2015/11/09/sprint-trial-intensive-blood-pressure-lowering#sthash.lYs1viqL.dpuf

Generalizability of the SPRINT Results

Harlan M. Krumholz, MD,

SM reviewing Bress AP et al. J Am Coll Cardiol 2015 Nov 9.

An analysis of NHANES data shows how many U.S. adults with hypertension meet SPRINT eligibility criteria. Harlan M. Krumholz, MD, SMThe SPRINT trial (N Engl J Med 2015 Nov 9; [e-pub]), which tested a blood pressure goal of <120 mm Hg against the standard goal of <140 mm Hg, was released amid much fanfare, but a relevant question is its generalizability. Non-SPRINT investigators used data from the National Health and Nutrition Examination Survey to estimate the prevalence, number, and characteristics of U.S. adults who would meet SPRINT inclusion criteria.They found that in the years 2007–2012, an estimated 7.6% of U.S. adults (17 million people) — including 16.7% of those with treated hypertension (8 million) and 5.0% of those not being treated (8.5 million) — met SPRINT eligibility criteria. Among all U.S. adults with hypertension, an estimated 20% met eligibility criteria.

Comment : Many Americans meet SPRINT eligibility criteria and might benefit from the blood pressure goal of <120 mm Hg. However, importantly, 5 of 6 people with treated hypertension do not meet the eligibility criteria. Decisions about treatment goals for these patients will be based on greater uncertainty than for the patients who meet the eligibility criteria. – See more at: http://www.jwatch.org/na39586/2015/11/09/generalizability-sprint-results#sthash.V6eg6DGx.dpuf

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Prostate Cancer Screening

Wednesday, December 23, 2015 // Cancer, Prostate

PSA Police?

Screening for prostate cancer is controversial for reasons outlined in this article from the Wall Street Journal, but now the controversy is taking a new turn. The government is becoming more aggressive in determining what high-quality care is. In the past, Medicare and private insurers would not pay for certain tests or medications that were unapproved. Now, Medicare will actually penalize doctors for ordering such tests. This goes way beyond educating the public. It interferes with shared decision making by patients and their doctors.

Doctors Could be Penalized for Ordering This Test

Wall Street Journal
November 20, 2015
By Melinda Beck

Medicare officials are considering a measure that would penalize doctors who order routine prostate-cancer screening tests for their patients, as part of a federal effort to define and reward quality in health-care services.The proposal, which hasn’t been widely publicized, has prompted a flurry of last-minute comments to the Centers for Medicare and Medicaid Services, including more than 200 in the past two days, virtually all in opposition. The official comment period began Oct. 26 and ends Friday.

The proposal, which hasn’t been widely publicized, has prompted a flurry of last-minute comments to the Centers for Medicare and Medicaid Services, including more than 200 in the past two days, virtually all in opposition. The official comment period began Oct. 26 and ends Friday.Many of those commenting said the measure would discourage doctors from discussing the pros and cons of screening for prostate-specific antigen (PSA) with their patients and allowing them to decide, as several major medical groups recommend.

Many of those commenting said the measure would discourage doctors from discussing the pros and cons of screening for prostate-specific antigen (PSA) with their patients and allowing them to decide, as several major medical groups recommend.“PSA screening is a very controversial topic. The debate is ongoing and people feel very strongly about it, one way or another,” said David Penson, chair of public policy and practice support for the American Urological Association, which urged CMS to reject the proposal. “To make it a quality measure would say, ‘You’re a poor quality doctor if your patients get this test.’ ”

“PSA screening is a very controversial topic. The debate is ongoing and people feel very strongly about it, one way or another,” said David Penson, chair of public policy and practice support for the American Urological Association, which urged CMS to reject the proposal. “To make it a quality measure would say, ‘You’re a poor quality doctor if your patients get this test.’ ”The proposed measure is part of continuing federal efforts to develop ways to identify and reward value in health care. The Obama administration has said it plans to tie 50% of Medicare payments to such quality measures by 2018.

The proposed measure is part of continuing federal efforts to develop ways to identify and reward value in health care. The Obama administration has said it plans to tie 50% of Medicare payments to such quality measures by 2018.Since 2012, the U.S. Preventive Services Task Force has recommended against routine screening for prostate cancer for men of any age on the grounds that the benefits don’t outweigh the harms.

Since 2012, the U.S. Preventive Services Task Force has recommended against routine screening for prostate cancer for men of any age on the grounds that the benefits don’t outweigh the harms.Studies have shown that screening reduces the risk of death from prostate cancers only minimally, if atStudies have shown that screening reduces the risk of death from prostate cancers only minimally, if at all, because most grow so slowly they effectively are harmless.

Yet many men diagnosed with prostate cancer undergo surgery and radiation, which can have lifelong side effects.

Meanwhile, about 28,000 U.S. men die annually from aggressive prostate cancers, often despite getting regular PSA tests and fast treatment. (This is not substantiated).

Both the rate of PSA testing, and diagnoses of early-stage prostate cancer, have declined significantly in the U.S. in recent years, according to studies published in the Journal of the American Medical Association this week. But whether treating fewer cancers early results in more deaths from late-stage prostate cancer later won’t be known for many years.

A CMS official said that as currently drafted, the proposed measure addresses only “non-recommended PSA screenings”—that is, “men who get PSA screening when, under current clinical guidelines, it is not recommended for them.” She said it wouldn’t restrict needed or medically necessary PSA tests.

“Physicians can still order PSA tests if they feel the test is recommended or if the patient requests it,” she said.

The proposal lists some categories of men who would be excluded from the measure, including those with a history of prostate cancer or enlarged prostate, prior elevated PSA levels, or those taking certain medications for prostate issues. It doesn’t mention men at high risk for prostate cancer due to family history or African-American heritage. Some experts say the benefits of screening may outweigh the harms for such patients.

Wanda Flier, president of the American Academy of Family Physicians, which is working with CMS on other quality measures, said it planned to urge the agency to adopt a more flexible measure for PSA screening that would allow for shared decision-making between a patient and physician based on individual circumstances.

“Our goal, as we move to value-based care, is to get to a system that is based on evidence and individual circumstances and not create harm to the patient or undue economic harm to the country,” she said.

Here is the bottom line on prostate cancer screening from the most recent Annals of Internal Medicine:

Clinical Bottom Line: Screening

Screening for prostate cancer and active treatment may prevent some prostate cancer deaths, mostly a decade or more later. However, screening also produces false-negative and false-positive results and over diagnosis. Cancer treatments cause sexual dysfunction in most men and distinct patterns of urinary and bowel symptoms. Therefore, harm is much more likely than benefit. Because men differ in how they weigh these outcomes, a shared decision-making process that reviews benefits and harms is essential to any informed decision to screen. However, providers should recommend against screening for men who have no risk factors and are younger than 50 years, most men older than 69 years, and those with a life expectancy less than 10 years.

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Flu Vaccine

Wednesday, December 16, 2015 // Flu, Vaccines

Everyone over the age of 6 months should get the flu vaccine. It used to be so simple; there was just one flu vaccine.  Now we have high dose, trivalent, quadrivalent, intranasal and intradermal, to name a few.  Here is a list of the vaccines available and their indications:

flu-vaccine

To avoid ordering multiple types of flu vaccine we have chosen the vaccine that would suit the needs of the majority of our patients, the standard dose trivalent vaccine.  Some patients have asked about the high dose vaccine–it contains much more antigen than the standard dose, but studies so far show that it is no more effective, or may be only marginally better, depending on which study one reads.

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Patient Portal Instructions Redux

Wednesday, December 16, 2015 // Patient Portal

These are the instructions for retrieving your blood test results from the secure patient portal.

Here is it how it works:

  1. We collect your personal email address and enter that into our computer system
  2. We register you for the Patient Portal and assign you your own unique PIN.
  3. To complete the registration process, log into the CGM PATIENTPORTAL at https://phr.cgmus.com/. a. Please use Chrome as the web browser of choice for this site.
  4. The first time you access the Patient Portal, you will be required to “Create your account”, which is where you will need your PIN (noted below). a. If you lose your PIN, you may contact your doctor’s office to have it provided to you.
  5. Select “Create your account”, where you will be asked to enter your PIN, the first three letters of your first name, the first three letters of your last name, and your date of birth. a. NOTE: when creating your account or when using the Forgot Password function are the only two times that you need your PIN. Your password is used for login to the portal.
  6. Click “Next”, and you will be asked to create a password for your Patient Portal account.
    1. Enter a Password that you will remember.
    2. If you forget your password, you may select the “Forgot Password?” link on the homepage of the Patient Portal. i. NOTE: Your doctor’s office will not know your password and will not be able to change it for you. You must use the “Forgot Password?” link to recover your password.
  1. Back at the login screen you will enter the following details to login:
    1. Email Address = your personal email address that you provided to your doctor’s office.
    2. Password = the password you just created.
  1. You now have access to the Patient Portal, and you are on your way to communicating directly, and securely, with your doctor! a. NOTE: You may only send messages from the Patient Portal to someone who has a specific secure email address.

Every time we send you a secure message via the Patient Portal, you will receive a notification in your personal email account. This way, you know when you have something new in your Patient Portal in-box. In these emails sent to your personal account, you are provided with the URL/hyperlink to the Patient Portal. Each time you access the Patient Portal (after your initial login) you are asked to login with your personal email address and your password (the password you entered during account creation at first login).

  • The URL for the Patient Portal is https://phr.cgmus.com/.
  • REMEMBER: The Patient Portal is not the place to report to us any emergency concerns. If you are experiencing any emergency, please dial 911. The Patient Portal messages we receive from you will be checked throughout the day on regular business days.
  • We can use the Patient Portal for the following purposes and as applicable:
    • Sending you a summary of your recent office visit
    • Providing you with a URL to review any patient-specific education resources
    • Informing you of other medical items, such as lab results

We look forward to communicating with you on-line!

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New Mammography Guidelines

Wednesday, December 16, 2015 // Women's Health

Here is a summary from the publication Journal Watch:

American Cancer Society Updates Mammography Guidelines for Average-Risk Women
American Cancer Society Updates Mammography Guidelines for Average-Risk WomenRecommendations move closer to those of the USPSTF — but differences remain.
Recommendations move closer to those of the USPSTF — but differences remain.
Andrew M. Kaunitz, MD

Based on input from clinicians, public health specialists, laypeople, and a commissioned review, the American Cancer Society (ACS) has issued its first guideline update since 2003 regarding screening mammography for average-risk women (no personal history of breast cancer, known mutation associated with excess risk, or history of chest wall radiation at a young age). Recommendations are delineated as strong (consensus that the benefits of adhering to the recommendation outweigh undesirable effects) or qualified (clear evidence of benefits but less certainty about benefit–harm balance or women’s preferences that could influence their decisions). The new guidelines are as follows:Age

  • Age 40–44: Optional annual screening mammography (qualified)
  • Age 45: Begin screening (strong)
  • Age 45–54: Annual screening (qualified)
  • Age ≥55: Biennial screening with option to continue annual screens (qualified)
  • Continue screening as long as overall health is good and life expectancy is ≥10 years (qualified).
  • Any age: Clinical breast examination (CBE) for screening is not recommended (qualified).

Comment: The updated ACS recommendations reduce the potential for harms (overdiagnosis and unnecessary additional imaging and biopsies) and move closer to the guidelines of the U.S. Preventive Services Task Force (USPSTF; i.e., begin biennial screening at age 50; NEJM JW Womens Heath Dec 2009 and Ann Intern Med 2009; 151:716).As one editorialist points out, the ACS recommendation to begin screening at age 45 is based on observational comparisons between screened and unscreened cohorts, a type of analysis the USPSTF does not consider because of concerns about bias. The ACS’s recommendation for annual screening in women aged 45–54 is based in part on the findings of a recent study showing that, for premenopausal (but not postmenopausal) women, tumor stage was higher and size larger for screen-detected lesions among women undergoing biennial screens. The ACS recommendation against screening CBE, stemming from the absence of data supporting CBE’s benefits (alone or with screening mammography), represents a dramatic change from the society’s prior stance. Moreover, in leaving their 2003 guidance regarding breast self-examination unchanged, the ACS continues to recommend against this latter practice. Overall, these updated guidelines should result in more women starting screening mammograms later in life as well as opting for biennial screening, meaning fewer lifetime screens. Also, fewer breast examinations during well-woman visits will allow clinicians more time to assess family history and other risk factors for breast cancer, as well as to maintain dialog about screening recommendations. In my practice, I will continue to encourage screening per USPSTF guidance (begin biennial screens at age 50) for my average-risk patients, while recognizing that many will be more comfortable starting screening at an earlier age and annually thereafter. – See more at: http://www.jwatch.org/na39390/2015/10/22/american-cancer-society-updates-mammography-guidelines#sthash.I7aWUyaH.dpuf

My two cents from Dr. Jennifer Wallace:

Previously the standard of practice was for women to have annual mammograms starting at age 40. We now have two agencies who have recommended reduced frequency of screening mammograms for average risk women. The difficulty with screening procedures, as always, is to find the right balance between screening frequently enough to detect problems at an easily curable stage vs. screening too often, leading to further possibly unnecessary testing and anxiety.

Previously the standard of practice was for women to have annual mammograms starting at age 40. We now have two agencies who have recommended reduced frequency of screening mammograms for average risk women. The difficulty with screening procedures, as always, is to find the right balance between screening frequently enough to detect problems at an easily curable stage vs. screening too often, leading to further possibly unnecessary testing and anxiety.

The new recommendations by the American Cancer Society for less frequent mammograms are somewhat “soft”, leaving us a lot of wiggle room. Their recommendations, other than to start screening at age 45, are “qualified”, meaning that the benefits are known, but there is less certainty about whether the harms of screening on the proposed schedule outweigh the benefits. Further, since we have recently started using “3D mammograms”, which are less likely to miss small or early cancers, I wonder if the “benefit vs. harm” calculation could possibly change in favor of annual screening again.

Unfortunately, it may take years before the harms, if any, of the reduced screening are known. I will look forward to finding out those results. Meanwhile, for now I am leaning toward continuing annual mammograms, particularly in women who are taking postmenopausal hormone replacement. As always, I will be open to discussion with my patients about their preferences, and stay open to change as more information becomes available.

Jennifer Wallace MD

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Insurance Conundrum

Wednesday, December 16, 2015 // Insurance

BCBS (Blue Cross Blue Shield) has canceled all their PPO plans in Texas and are only offering HMO plans through the federal website, Healthcare.gov. In addition, other insurers are canceling their PPO products. This will leave patients with more restrictions on the doctors that they are able to see. From our standpoint, HMO’s are less desirable because they require us to obtain authorizations or referrals for our patients to see any other physician. If many of our patients choose HMO’s we will have to hire someone to just take care of the paperwork. It is like having an unfunded mandate from Congress. It increases the hassle factor of obtaining needed care. If you are having difficulty obtaining insurance, I think it makes sense to use an agent. There are a number of independent insurance agencies which have agents who can assist in sorting through all the options. Wortham, Catto and Catto and Sanger and Altgelt all have agents who can assist in this. The key points are: 1) to look at a plan’s website and see if we are on it. It seems logical that we would know every plan that we are on, but that’s not the case given the turmoil in this industry. 2) Look for something that contains the phrase “Open Access”. This generous access to specialists than a traditional HMO.

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