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Lisa Chamberlain
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Commentary
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I remember two things about my patient, Maria, a tiny baby who was born a little early. One was her large, beautiful eyes. The other was that when I put my stethoscope on her chest, I heard an enormous heart murmur. Maria had been born with a serious heart condition that would change her life and the life of her mom.

Good patient care at a time like this involves much more than treating a child’s heart. At that first appointment, Maria (not her real name), her mother and I began a long journey punctuated by multiple hospitalizations, surgeries and procedures.

Maria was born at Lucile Packard Children’s Hospital Stanford and lived with her mom in East Palo Alto. As her general pediatrician at Ravenswood Family Health Center, I came to know them both well. I focused on helping the tiny infant gain weight, so that she would be strong enough to undergo her heart surgeries. We brought in the Women, Infants and Children program to support her nutrition. I explained to her mom what the surgeries would do. I reviewed what Maria’s medicines were for, and when her mother couldn’t pay for them I helped gain authorization from county staff, who were able to get them dispensed at the pharmacy. When I realized Maria’s mom didn’t have enough money for food (due to many absences at work), I made sure she applied for food stamps.

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My experience with Maria coincided with my research at Stanford involving access to care for kids in California. As a result of the research, I spent part of my time in Sacramento, working with legislators on changes to the California Children’s Services program. This program is critical to the care of low-income children with serious medical conditions. My research, which involved analyzing data on publicly insured pediatric care like Maria’s, showed that access to high-quality care for low-income kids was pretty good in California compared with other states, but that there was variation among its 58 counties.

While working on the program’s reform in Sacramento, I spent time in countless staff meetings, public hearings and hallway discussions. I often thought about Maria, whose life depended on CCS. The research data I brought to these negotiations were as important as sharing Maria’s story — how her mother lost her job because of time spent caring for her fragile daughter, how the family sank more deeply into poverty and how services needed to be more focused on families. As changes to the CCS system were being discussed, I imagined how they would benefit or hinder Maria’s care and her future.

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Background

Prior studies have reported that more than 20% of implantable cardioverter-defibrillator (ICD) implantations in the United States do not adhere to trial-based criteria.

Objective

We sought to investigate the patient characteristics associated with not meeting the inclusion criteria of the clinical trials that have demonstrated the efficacy of primary prevention ICDs.

Methods

Using data from the National Cardiovascular Data Registry’s ICD Registry, we identified patients who received ICDs for primary prevention from January 2006 to December 2008. We determined whether patients met the inclusion criteria of at least 1 of the 4 ICD primary prevention trials: Multicenter Automatic Defibrillator Implantation Trial (MADIT), MADIT-II, Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), and the Multicenter Unsustained Tachycardia Trial (MUSTT).

Results

Among 150,264 patients, 86% met criteria for an ICD implantation based on trial data. The proportion of patients who did not meet trial-based criteria increased as age decreased. In multivariate analysis, the significant predictors for not meeting trial criteria included prior cardiac transplantation (odds ratio [OR] 2.1), pediatric electrophysiology operator (OR 2.0), and high-grade atrioventricular conduction disease (OR 1.4).

Conclusion

Among National Cardiovascular Data Registry registrants receiving first-time ICDs for primary prevention, the majority met trial-based criteria. Multivariate analyses suggested that many patients who did not meet the trial-based criteria may have had clinical circumstances that warranted ICD implantation. These findings caution against the use of trial-based indications to determine site quality metrics that could penalize sites that care for younger patients. The planned incorporation of appropriate use criteria into the ICD registry may better characterize patient- and site-level quality and performance.

 

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Heart Rhythm
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Paul A. Heidenreich
Mary K. Goldstein
Mintu Turakhia
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Objectives: Unwarranted geographic variation in spending has received intense scrutiny in the United States. However, few studies have compared variation in spending and surgical outcomes between the United States healthcare system and those of other nations. In this study, we compare the geographic variation in postsurgical outcomes and cost between the United States and Japan.

Study Design: This retrospective cohort study uses Medicare Part A data from the United States (2010-2011) and similar inpatient data from Japan (2012). Patients 65 years or older undergoing 1 of 5 surgeries (coronary artery bypass graft, abdominal aortic aneurysm repair, colectomy, pancreatectomy, or gastrectomy) were selected in the United States and Japan.

Methods: Reliability- and case-mix–adjusted coefficient of variation (COV) values were calculated using hierarchical modeling and empirical Bayes techniques for the following 5 outcomes: postoperative mortality, the development of a complication, death after complication (failure to rescue), length of stay, and the cost of the hospitalization. Sensitivity analyses were also performed by calculating patient demographic-and case-mix–adjusted COV values for each outcome using weighted age- and sex-standardized values.

Results: The variability of the postsurgical outcomes was uniformly lower in the United States compared with Japan. Cost variation was consistently higher in the United States for all surgeries.

Conclusions: Although the US healthcare system may be more inefficient regarding costs, the presence of higher geographic variation in postoperative care in Japan, relative to the United States, suggests that the observed geographic variation in the United States—both for health expenditures and outcomes—is not a unique manifestation of its structural shortcomings.

- See more at: http://www.ajmc.com/journals/issue/2016/2016-vol22-n9/geographic-variat…

Objectives: Unwarranted geographic variation in spending has received intense scrutiny in the United States. However, few studies have compared variation in spending and surgical outcomes between the United States healthcare system and those of other nations. In this study, we compare the geographic variation in postsurgical outcomes and cost between the United States and Japan.

Study Design: This retrospective cohort study uses Medicare Part A data from the United States (2010-2011) and similar inpatient data from Japan (2012). Patients 65 years or older undergoing 1 of 5 surgeries (coronary artery bypass graft, abdominal aortic aneurysm repair, colectomy, pancreatectomy, or gastrectomy) were selected in the United States and Japan.

Methods: Reliability- and case-mix–adjusted coefficient of variation (COV) values were calculated using hierarchical modeling and empirical Bayes techniques for the following 5 outcomes: postoperative mortality, the development of a complication, death after complication (failure to rescue), length of stay, and the cost of the hospitalization. Sensitivity analyses were also performed by calculating patient demographic-and case-mix–adjusted COV values for each outcome using weighted age- and sex-standardized values.

Results: The variability of the postsurgical outcomes was uniformly lower in the United States compared with Japan. Cost variation was consistently higher in the United States for all surgeries.

Conclusions: Although the US healthcare system may be more inefficient regarding costs, the presence of higher geographic variation in postoperative care in Japan, relative to the United States, suggests that the observed geographic variation in the United States—both for health expenditures and outcomes—is not a unique manifestation of its structural shortcomings.

- See more at: http://www.ajmc.com/journals/issue/2016/2016-vol22-n9/geographic-variat…

Objectives: Unwarranted geographic variation in spending has received intense scrutiny in the United States. However, few studies have compared variation in spending and surgical outcomes between the United States healthcare system and those of other nations. In this study, we compare the geographic variation in postsurgical outcomes and cost between the United States and Japan.

Study Design: This retrospective cohort study uses Medicare Part A data from the United States (2010-2011) and similar inpatient data from Japan (2012). Patients 65 years or older undergoing 1 of 5 surgeries (coronary artery bypass graft, abdominal aortic aneurysm repair, colectomy, pancreatectomy, or gastrectomy) were selected in the United States and Japan.

Methods: Reliability- and case-mix–adjusted coefficient of variation (COV) values were calculated using hierarchical modeling and empirical Bayes techniques for the following 5 outcomes: postoperative mortality, the development of a complication, death after complication (failure to rescue), length of stay, and the cost of the hospitalization. Sensitivity analyses were also performed by calculating patient demographic-and case-mix–adjusted COV values for each outcome using weighted age- and sex-standardized values.

Results: The variability of the postsurgical outcomes was uniformly lower in the United States compared with Japan. Cost variation was consistently higher in the United States for all surgeries.

Conclusions: Although the US healthcare system may be more inefficient regarding costs, the presence of higher geographic variation in postoperative care in Japan, relative to the United States, suggests that the observed geographic variation in the United States—both for health expenditures and outcomes—is not a unique manifestation of its structural shortcomings.

- See more at: http://www.ajmc.com/journals/issue/2016/2016-vol22-n9/geographic-variat…

OBJECTIVES:

Unwarranted geographic variation in spending has received intense scrutiny in the United States. However, few studies have compared variation in spending and surgical outcomes between the United States healthcare system and those of other nations. In this study, we compare the geographic variation in postsurgical outcomes and cost between the United States and Japan.

STUDY DESIGN:

This retrospective cohort study uses Medicare Part A data from the United States (2010-2011) and similar inpatient data from Japan (2012). Patients 65 years or older undergoing 1 of 5 surgeries (coronary artery bypass graft, abdominal aortic aneurysm repair, colectomy, pancreatectomy, or gastrectomy) were selected in the United States and Japan.

METHODS:

Reliability- and case-mix-adjusted coefficient of variation (COV) values were calculated using hierarchical modeling and empirical Bayes techniques for the following 5 outcomes: postoperative mortality, the development of a complication, death after complication (failure to rescue), length of stay, and the cost of the hospitalization. Sensitivity analyses were also performed by calculating patient demographic-and case-mix-adjusted COV values for each outcome using weighted age- and sex-standardized values.

RESULTS:

The variability of the postsurgical outcomes was uniformly lower in the United States compared with Japan. Cost variation was consistently higher in the United States for all surgeries.

CONCLUSIONS:

Although the US healthcare system may be more inefficient regarding costs, the presence of higher geographic variation in postoperative care in Japan, relative to the United States, suggests that the observed geographic variation in the United States-both for health expenditures and outcomes-is not a unique manifestation of its structural shortcomings.

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The American Journal of Managed Care
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Background. To characterize the association of antiretroviral drug combinations on risk of cardiovascular events.

Methods. Certain antiretroviral medications for human immunodeficiency virus (HIV) have been implicated in increasing risk of cardiovascular disease. However, antiretroviral drugs are typically prescribed in combination. We characterized the association of current exposure to antiretroviral drug combinations on risk of cardiovascular events including myocardial infarction, stroke, percutaneous coronary intervention, and coronary artery bypass surgery. We used the Veterans Health Administration Clinical Case Registry to analyze data from 24 510 patients infected with HIV from January 1996 through December 2009. We assessed the association of current exposure to 15 antiretroviral drugs and 23 prespecified combinations of agents on the risk of cardiovascular event by using marginal structural models and Cox models extended to accommodate time-dependent variables.

Results. Over 164 059 person-years of follow-up, 934 patients had a cardiovascular event. Current exposure to abacavir, efavirenz, lamivudine, and zidovudine was significantly associated with increased risk of cardiovascular event, with odds ratios ranging from 1.40 to 1.53. Five combinations were significantly associated with increased risk of cardiovascular event, all of which involved lamivudine. One of these—efavirenz, lamivudine, and zidovudine—was the second most commonly used combination and was associated with a risk of cardiovascular event that is 1.60 times that of patients not currently exposed to the combination (odds ratio = 1.60, 95% confidence interval, 1.25–2.04).

Conclusions. In the VA cohort, exposure to both individual drugs and drug combinations was associated with modestly increased risk of a cardiovascular event.

 

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Clinical Infectious Diseases
Authors
Eran Bendavid
Mark A. Hlatky
Mark Holodniy
Douglas K. Owens
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Importance:

Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United States, accounting for 1 of every 3 deaths among adults.

Objective:

To update the 2008 US Preventive Services Task Force (USPSTF) recommendation on screening for lipid disorders in adults.

Evidence Review:

The USPSTF reviewed the evidence on the benefits and harms of screening for and treatment of dyslipidemia in adults 21 years and older; the benefits and harms of statin use in reducing CVD events and mortality in adults without a history of CVD events; whether the benefits of statin use vary by subgroup, clinical characteristics, or dosage; and the benefits of various treatment strategies in adults 40 years and older without a history of CVD events.

Conclusions and Recommendations:

The USPSTF recommends initiating use of low- to moderate-dose statins in adults aged 40 to 75 years without a history of CVD who have 1 or more CVD risk factors (dyslipidemia, diabetes, hypertension, or smoking) and a calculated 10-year CVD event risk of 10% or greater (B recommendation). The USPSTF recommends that clinicians selectively offer low- to moderate-dose statins to adults aged 40 to 75 years without a history of CVD who have 1 or more CVD risk factors and a calculated 10-year CVD event risk of 7.5% to 10% (C recommendation). The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of initiating statin use in adults 76 years and older (I statement).

 

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Journal of the American Medical Association (JAMA)
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Douglas K. Owens
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19
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Importance  Elevations in levels of total, low-density lipoprotein, and non–high-density lipoprotein cholesterol; lower levels of high-density lipoprotein cholesterol; and, to a lesser extent, elevated triglyceride levels are associated with risk of cardiovascular disease in adults.

Objective  To update the 2007 US Preventive Services Task Force (USPSTF) recommendation on screening for lipid disorders in children, adolescents, and young adults.

Evidence Review  The USPSTF reviewed the evidence on screening for lipid disorders in children and adolescents 20 years or younger—1 review focused on screening for heterozygous familial hypercholesterolemia, and 1 review focused on screening for multifactorial dyslipidemia.

Findings  Evidence on the quantitative difference in diagnostic yield between universal and selective screening approaches, the effectiveness and harms of long-term treatment and the harms of screening, and the association between changes in intermediate outcomes and improvements in adult cardiovascular health outcomes are limited. Therefore, the USPSTF concludes that the balance of benefits and harms cannot be determined.

Conclusions and Recommendation  The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for lipid disorders in children and adolescents 20 years or younger. (I statement)

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Journal of the American Medical Association (JAMA)
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Douglas K. Owens
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6
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Background: The total population health benefits and costs of HIV preexposure prophylaxis (PrEP) for people who inject drugs (PWID) in the United States are unclear.

Objective: To evaluate the cost-effectiveness and optimal delivery conditions of PrEP for PWID.

Design: Empirically calibrated dynamic compartmental model.

Data Sources: Published literature and expert opinion.

Target Population: Adult U.S. PWID.

Time Horizon: 20 years and lifetime.

Intervention: PrEP alone, PrEP with frequent screening (PrEP+screen), and PrEP+screen with enhanced provision of antiretroviral therapy (ART) for individuals who become infected (PrEP+screen+ART). All scenarios are considered at 25% coverage.

Outcome Measures: Infections averted, deaths averted, change in HIV prevalence, discounted costs (in 2015 U.S. dollars), discounted quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios.

Results of Base-Case Analysis: PrEP+screen+ART dominates other strategies, averting 26 700 infections and reducing HIV prevalence among PWID by 14% compared with the status quo. Achieving these benefits costs $253 000 per QALY gained. At current drug prices, total expenditures for PrEP+screen+ART could be as high as $44 billion over 20 years.

Results of Sensitivity Analysis: Cost-effectiveness of the intervention is linear in the annual cost of PrEP and is dependent on PrEP drug adherence, individual transmission risks, and community HIV prevalence. Limitation: Data on risk stratification and achievable PrEP efficacy levels for U.S. PWID are limited.

Conclusion: PrEP with frequent screening and prompt treatment for those who become infected can reduce HIV burden among PWID and provide health benefits for the entire U.S. population, but, at current drug prices, it remains an expensive intervention both in absolute terms and in cost per QALY gained.

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Annals of Internal Medicine
Authors
Margaret L. Brandeau
Keith Humphreys
Eran Bendavid
Mark Holodniy
Douglas K. Owens
Jeremy Goldhaber-Fiebert
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Importance  Colorectal cancer is the second leading cause of cancer death in the United States. In 2016, an estimated 134 000 persons will be diagnosed with the disease, and about 49 000 will die from it. Colorectal cancer is most frequently diagnosed among adults aged 65 to 74 years; the median age at death from colorectal cancer is 68 years.

Objective  To update the 2008 US Preventive Services Task Force (USPSTF) recommendation on screening for colorectal cancer.

Evidence Review  The USPSTF reviewed the evidence on the effectiveness of screening with colonoscopy, flexible sigmoidoscopy, computed tomography colonography, the guaiac-based fecal occult blood test, the fecal immunochemical test, the multitargeted stool DNA test, and the methylated SEPT9 DNA test in reducing the incidence of and mortality from colorectal cancer or all-cause mortality; the harms of these screening tests; and the test performance characteristics of these tests for detecting adenomatous polyps, advanced adenomas based on size, or both, as well as colorectal cancer. The USPSTF also commissioned a comparative modeling study to provide information on optimal starting and stopping ages and screening intervals across the different available screening methods.

Findings  The USPSTF concludes with high certainty that screening for colorectal cancer in average-risk, asymptomatic adults aged 50 to 75 years is of substantial net benefit. Multiple screening strategies are available to choose from, with different levels of evidence to support their effectiveness, as well as unique advantages and limitations, although there are no empirical data to demonstrate that any of the reviewed strategies provide a greater net benefit. Screening for colorectal cancer is a substantially underused preventive health strategy in the United States.

Conclusions and Recommendations  The USPSTF recommends screening for colorectal cancer starting at age 50 years and continuing until age 75 years (A recommendation). The decision to screen for colorectal cancer in adults aged 76 to 85 years should be an individual one, taking into account the patient’s overall health and prior screening history (C recommendation).

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Journal of the American Medical Association (JAMA)
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Douglas K. Owens
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23
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With the future of U.S. health care in flux, questions abound about the incoming Republican administration's impact on federal programs like Medicare and Medicaid. Stanford University scholars Kate Bundorf and Jay Bhattacharya outline possible changes to these programs and their effects on health care for the elderly and the poor.

Kate Bundorf is the chief of the Division of Health Research and an associate professor of health research and policy. Her research focuses on health insurance markets, often including Medicare.

Jay Bhattacharya is a professor of medicine and, by courtesy, of economics. He studies Medicare's financial future -- and it's effect on physician's practices and patient outcomes -- and is currently assisting in the roll-out of MACRA, a new payment reform system for Medicare.

Medicare Post-election by Stanford Health Policy on Exposure

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Robert MacCoun, a professor of law and a senior fellow at the Freeman Spogli Institute for International Studies, relays the potential risks and benefits of legalizing marijuana. His research focuses on drug policy, and he has written extensively about the effects of marijuana from a legal and health perspective.

California, Massachusetts and Nevada all legalized marijuana in the last election. Does this mean the legalization movement has reached a tipping point?  

If Hillary Clinton had won the election, it would probably feel that way, not because she’s a legalization advocate, but because she’d have bigger fish to fry and would probably continue President Obama’s laissez-faire approach. With the Trump administration’s new cabinet, all bets are off. Still, one in five Americans now live in a state where recreational use of marijuana is legal, and that’s a big market. And as the market grows, the industry’s lobbying clout grows.

What are the health risks post-legalization?

That depends on how much consumption levels increase. There are good reasons to expect marijuana prices to fall, which will increase consumption. Because many people use marijuana without health consequences, I worry less about an increase in the number of people using marijuana than about an increase in the number who use it one or more times daily. There is growing evidence that heavy marijuana use is associated with an increased risk of psychosis. We don’t know if it is a true cause-and-effect relationship; let’s hope it is not. But I think the biggest health threat is dependence, which for marijuana is something like getting stuck in the La Brea tar pits — your world just gets smaller and smaller as you get more dysfunctional.

maccoun stanford9 20 14 727 head shot Robert MacCoun, PhD

How can legalizing states combat these risks?

The good news is that legalization makes possible all sorts of regulatory options that weren’t available under prohibition. States should insist that no marijuana products are to be packaged in a way that entices children. Doses should be standardized, and there should be accurate labeling about the THC content. States should discourage products with high levels of THC, and perhaps encourage products with higher levels of cannabidiol (CBD), an ingredient that seems to counteract some of the harmful effects of THC.

The bad news is that the state ballot initiatives didn’t do much more than give lip service to public health and safety, and industry entrepreneurs are pushing back hard against state regulators. I think the industry is being foolish here — they’ve won eight states but still have 42 states to go. I don’t think they realize how quickly a backlash could emerge if those eight states show rising rates of various adverse outcomes.

Could there be any positive health effects of marijuana use?

Absolutely. There are plenty of lines of evidence suggesting medical benefits for some patients. Intriguingly, several new studies suggest that medical marijuana states may be experiencing reduced levels of opioid use and opioid overdoses. The Catch 22 is that the DEA decided not to reschedule marijuana because there isn’t enough rigorous evidence, but there isn’t enough rigorous evidence because the Feds have made such studies almost impossible to conduct.

Some of the biggest health benefits of marijuana will occur if it turns out that marijuana use is a substitute for binge drinking. There are both physiological and economic reasons to think that might be the case, but while some studies show substitution, others show complementarity. For a researcher, one big benefit of legalization is that it is going to help us finally answer a lot of these research questions.

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