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Tuesday, December 31, 2019

JAMA Articles of the Decade-Happy New Year

We can look back and see the most important medical issues from 2012-2019 from the Journal of the American Medical Association.  This is an in-depth compilation of the most significant published articles from the peer-reviewed JAMAs

The articles have been selected by editors as the most important published by JAMA between 2010 and 2019. Click below to read them for free.

The Top Articles from 2010-2019

The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)

Mervyn Singer, MD, FRCP; Clifford S. Deutschman, MD, MS; Christopher Warren Seymour, MD, MSc; et alManu

Abstract
Importance  Definitions of sepsis and septic shock were last revised in 2001. Considerable advances have since been made into the pathobiology (changes in organ function, morphology, cell biology, biochemistry, immunology, and circulation), management, and epidemiology of sepsis, suggesting the need for reexamination.

Objective  To evaluate and, as needed, update definitions for sepsis and septic shock.

Process  A task force (n = 19) with expertise in sepsis pathobiology, clinical trials, and epidemiology was convened by the Society of Critical Care Medicine and the European Society of Intensive Care Medicine. Definitions and clinical criteria were generated through meetings, Delphi processes, analysis of electronic health record databases, and voting, followed by circulation to international professional societies, requesting peer review and endorsement (by 31 societies listed in the Acknowledgment).

Key Findings From Evidence Synthesis  Limitations of previous definitions included an excessive focus on inflammation, the misleading model that sepsis follows a continuum through severe sepsis to shock, and inadequate specificity and sensitivity of the systemic inflammatory response syndrome (SIRS) criteria. Multiple definitions and terminologies are currently in use for sepsis, septic shock, and organ dysfunction, leading to discrepancies in reported incidence and observed mortality. The task force concluded the term severe sepsis was redundant.

Recommendations  Sepsis should be defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. For clinical operationalization, organ dysfunction can be represented by an increase in the Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score of 2 points or more, which is associated with an in-hospital mortality greater than 10%. Septic shock should be defined as a subset of sepsis in which particularly profound circulatory, cellular, and metabolic abnormalities are associated with a greater risk of mortality than with sepsis alone. Patients with septic shock can be clinically identified by a vasopressor requirement to maintain a mean arterial pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol/L (>18 mg/dL) in the absence of hypovolemia. This combination is associated with hospital mortality rates greater than 40%. In out-of-hospital, emergency department, or general hospital ward settings, adult patients with suspected infection can be rapidly identified as being more likely to have poor outcomes typical of sepsis if they have at least 2 of the following clinical criteria that together constitute a new bedside clinical score termed quickSOFA (qSOFA): respiratory rate of 22/min or greater, altered mentation, or systolic blood pressure of 100 mm Hg or less.

Conclusions and Relevance  These updated definitions and clinical criteria should replace previous definitions, offer greater consistency for epidemiologic studies and clinical trials, and facilitate earlier recognition and more timely management of patients with sepsis or at risk of developing sepsis.

2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults: Report From the Panel Members Appointed to the Eighth Joint National Committee (JNC 8)

Paul A. James, MD; Suzanne Oparil, MD; Barry L. Carter, PharmD; et al

Audio Interview: 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults

Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis: The APPAC Randomized Clinical Trial

Paulina Salminen, MD, PhD; Hannu Paajanen, MD, PhD; Tero Rautio, MD, PhD; et al

Clinical Review Audio: Treating Appendicitis Without Surgery – 5-Year Follow-up From a Randomized Clinical Trial of Antibiotic Treatment

Intensive vs Standard Blood Pressure Control and Cardiovascular Disease Outcomes in Adults Aged ≥75 Years: A Randomized Clinical Trial

Jeff D. Williamson, MD, MHS; Mark A. Supiano, MD; William B. Applegate, MD, MPH; et al for the SPRINT Research Group

Video Interview: Intensive Blood Pressure Control in Adults Aged 75 Years or Older

Development and Validation of a Deep Learning Algorithm for Detection of Diabetic Retinopathy in Retinal Fundus Photographs

Varun Gulshan, PhD; Lily Peng, MD, PhD; Marc Coram, PhD; et al

Machine Learning Website

United States Health Care Reform: Progress to Date and Next Steps

Barack Obama, JD

Health Care Spending in the United States and Other High-Income Countries

Irene Papanicolas, PhD; Liana R. Woskie, MSc; Ashish K. Jha, MD, MPH

Video Interview: Health Care Spending in the United States and Other High-Income Countries

The Association Between Income and Life Expectancy in the United States, 2001-2014

Raj Chetty, PhD; Michael Stepner, BA; Sarah Abraham, BA; et al

JAMA Health Disparities Website

Audio Interview: Association Between Income and Life Expectancy in the United States

Video Interview: Association Between Income and Life Expectancy in the United States



Eliminating Waste in US Health Care

Donald M. Berwick, MD, MPP; Andrew D. Hackbarth, MPhil

Abstract
The need is urgent to bring US health care costs into a sustainable range for both public and private payers. Commonly, programs to contain costs use cuts, such as reductions in payment levels, benefit structures, and eligibility. A less harmful strategy would reduce waste, not value-added care. The opportunity is immense. In just 6 categories of waste—overtreatment, failures of care coordination, failures in the execution of care processes, administrative complexity, pricing failures, and fraud and abuse—the sum of the lowest available estimates exceeds 20% of total health care expenditures. The actual total may be far greater. The savings potentially achievable from systematic, comprehensive, and cooperative pursuit of even a fractional reduction in waste are far higher than from more direct and blunter cuts in care and coverage. The potential economic dislocations, however, are severe and require mitigation through careful transition strategies.

No matter how polarized politics in the United States have become, nearly everyone agrees that health care costs are unsustainable. At almost 18% of the gross domestic product (GDP) in 2011, headed for 20% by 2020,1,2 the nation's increasing health care expenditures reduce the resources available for other worthy government programs, erode wages, and undermine the competitiveness of US industry. Although Medicare and Medicaid are often in the limelight, the health care cost problem affects the private sector just as much as the public sector. Both need serious relief.

Obtaining savings directly—by simply lowering payments or paying for fewer services—seems the most obvious remedy. Programs designed to make cuts of this kind appear across the policy spectrum, from many, carefully sequenced provisions of the Patient Protection and Affordable Care Act (ACA), favored by the Obama Administration, to draconian proposed shifts of Medicare costs to beneficiaries and reductions in payments to physicians and hospitals, favored by several Republican congressional proponents.

The ACA, for example, gradually phases in well-warranted decreases in payments to Medicare Advantage plans. Some in Congress have proposed caps on federal Medicare payments (with beneficiaries picking up the difference). Many states, reeling from unprecedented budget deficits, are reducing Medicaid benefits and payments.

The cost reductions in the ACA are necessary and prudent, but if other initiatives to cut spending are taken too far or too fast, they become risky. Vulnerable Medicaid beneficiaries and seniors covered by Medicare with marginal incomes may find important care services out of reach, either because they cannot afford the new cost-sharing, because clinicians and hospitals have withdrawn from local markets, or both.


Silencing the Science on Gun Research

Arthur L. Kellermann, MD, MPH; Frederick P. Rivara, MD, MPH

2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults

Abstract
Hypertension is the most common condition seen in primary care and leads to myocardial infarction, stroke, renal failure, and death if not detected early and treated appropriately. Patients want to be assured that blood pressure (BP) treatment will reduce their disease burden, while clinicians want guidance on hypertension management using the best scientific evidence. This report takes a rigorous, evidence-based approach to recommend treatment thresholds, goals, and medications in the management of hypertension in adults. Evidence was drawn from randomized controlled trials, which represent the gold standard for determining efficacy and effectiveness. Evidence quality and recommendations were graded based on their effect on important outcomes.
There is strong evidence to support treating hypertensive persons aged 60 years or older to a BP goal of less than 150/90 mm Hg and hypertensive persons 30 through 59 years of age to a diastolic goal of less than 90 mm Hg; however, there is insufficient evidence in hypertensive persons younger than 60 years for a systolic goal, or in those younger than 30 years for a diastolic goal, so the panel recommends a BP of less than 140/90 mm Hg for those groups based on expert opinion. The same thresholds and goals are recommended for hypertensive adults with diabetes or nondiabetic chronic kidney disease (CKD) as for the general hypertensive population younger than 60 years. There is moderate evidence to support initiating drug treatment with an angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, calcium channel blocker, or thiazide-type diuretic in the nonblack hypertensive population, including those with diabetes. In the black hypertensive population, including those with diabetes, a calcium channel blocker or thiazide-type diuretic is recommended as initial therapy. There is moderate evidence to support initial or add-on antihypertensive therapy with an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker in persons with CKD to improve kidney outcomes.
Although this guideline provides evidence-based recommendations for the management of high BP and should meet the clinical needs of most patients, these recommendations are not a substitute for clinical judgment, and decisions about care must carefully consider and incorporate the clinical characteristics and circumstances of each individual patient.
Hypertension remains one of the most important preventable contributors to disease and death. Abundant evidence from randomized controlled trials (RCTs) has shown benefit of antihypertensive drug treatment in reducing important health outcomes in persons with hypertension.1-3 Clinical guidelines are at the intersection between research evidence and clinical actions that can improve patient outcomes. The Institute of Medicine Report Clinical Practice Guidelines We Can Trust outlined a pathway to guideline development and is the approach that this panel aspired to in the creation of this report.4

Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis
The APPAC Randomized Clinical  


Abstract
Importance  An increasing amount of evidence supports the use of antibiotics instead of surgery for treating patients with uncomplicated acute appendicitis.

Objective  To compare antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis confirmed by computed tomography (CT).

Design, Setting, and Participants  The Appendicitis Acuta (APPAC) multicenter, open-label, noninferiority randomized clinical trial was conducted from November 2009 until June 2012 in Finland. The trial enrolled 530 patients aged 18 to 60 years with uncomplicated acute appendicitis confirmed by a CT scan. Patients were randomly assigned to early appendectomy or antibiotic treatment with a 1-year follow-up period.

Interventions  Patients randomized to antibiotic therapy received intravenous ertapenem (1 g/d) for 3 days followed by 7 days of oral levofloxacin (500 mg once daily) and metronidazole (500 mg 3 times per day). Patients randomized to the surgical treatment group were assigned to undergo standard open appendectomy.

Main Outcomes and Measures  The primary endpoint for the surgical intervention was the successful completion of an appendectomy. The primary endpoint for antibiotic-treated patients was discharged from the hospital without the need for surgery and no recurrent appendicitis during a 1-year follow-up period.

Results  There were 273 patients in the surgical group and 257 in the antibiotic group. Of 273 patients in the surgical group, all but 1 underwent successful appendectomy, resulting in a success rate of 99.6% (95% CI, 98.0% to 100.0%). In the antibiotic group, 70 patients (27.3%; 95% CI, 22.0% to 33.2%) underwent appendectomy within 1 year of initial presentation for appendicitis. Of the 256 patients available for follow-up in the antibiotic group, 186 (72.7%; 95% CI, 66.8% to 78.0%) did not require surgery. The intention-to-treat analysis yielded a difference in treatment efficacy between groups of −27.0% (95% CI, −31.6% to ∞) (P = .89). Given the prespecified noninferiority margin of 24%, we were unable to demonstrate the noninferiority of antibiotic treatment relative to surgery. Of the 70 patients randomized to antibiotic treatment who subsequently underwent appendectomy, 58 (82.9%; 95% CI, 72.0% to 90.8%) had uncomplicated appendicitis, 7 (10.0%; 95% CI, 4.1% to 19.5%) had complicated acute appendicitis, and 5 (7.1%; 95% CI, 2.4% to 15.9%) did not have appendicitis but received appendectomy for suspected recurrence. There were no intra-abdominal abscesses or other major complications associated with delayed appendectomy in patients randomized to antibiotic treatment.

Conclusions and Relevance  Among patients with CT-proven, uncomplicated appendicitis, antibiotic treatment did not meet the prespecified criterion for noninferiority compared with appendectomy. Most patients randomized to antibiotic treatment for uncomplicated appendicitis did not require appendectomy during the 1-year follow-up period, and those who required appendectomy did not experience significant complications.

Intensive vs Standard Blood Pressure Control and Cardiovascular Disease Outcomes in Adults Aged ≥75 Years
A Randomized Clinical Trial

Abstract
Importance  The appropriate treatment target for systolic blood pressure (SBP) in older patients with hypertension remains uncertain.

Objective  To evaluate the effects of intensive (<120 75="" aged="" but="" compared="" diabetes.="" hg="" hypertension="" in="" mm="" older="" or="" p="" persons="" sbp="" standard="" targets="" with="" without="" years="">
Design, Setting, and Participants  A multicenter, randomized clinical trial of patients aged 75 years or older who participated in the Systolic Blood Pressure Intervention Trial (SPRINT). Recruitment began on October 20, 2010, and follow-up ended on August 20, 2015.

Interventions  Participants were randomized to an SBP target of less than 120 mm Hg (intensive treatment group, n = 1317) or an SBP target of less than 140 mm Hg (standard treatment group, n = 1319).

Main Outcomes and Measures  The primary cardiovascular disease outcome was a composite of nonfatal myocardial infarction, acute coronary syndrome not resulting in myocardial infarction, nonfatal stroke, nonfatal acute decompensated heart failure, and death from cardiovascular causes. All-cause mortality was a secondary outcome.

Results  Among 2636 participants (mean age, 79.9 years; 37.9% women), 2510 (95.2%) provided complete follow-up data. At a median follow-up of 3.14 years, there was a significantly lower rate of the primary composite outcome (102 events in the intensive treatment group vs 148 events in the standard treatment group; hazard ratio [HR], 0.66 [95% CI, 0.51-0.85]) and all-cause mortality (73 deaths vs 107 deaths, respectively; HR, 0.67 [95% CI, 0.49-0.91]). The overall rate of serious adverse events was not different between treatment groups (48.4% in the intensive treatment group vs 48.3% in the standard treatment group; HR, 0.99 [95% CI, 0.89-1.11]). Absolute rates of hypotension were 2.4% in the intensive treatment group vs 1.4% in the standard treatment group (HR, 1.71 [95% CI, 0.97-3.09]), 3.0% vs 2.4%, respectively, for syncope (HR, 1.23 [95% CI, 0.76-2.00]), 4.0% vs 2.7% for electrolyte abnormalities (HR, 1.51 [95% CI, 0.99-2.33]), 5.5% vs 4.0% for acute kidney injury (HR, 1.41 [95% CI, 0.98-2.04]), and 4.9% vs 5.5% for injurious falls (HR, 0.91 [95% CI, 0.65-1.29]).

Conclusions and Relevance  Among ambulatory adults aged 75 years or older, treating to an SBP target of less than 120 mm Hg compared with an SBP target of less than 140 mm Hg resulted in significantly lower rates of fatal and nonfatal major cardiovascular events and death from any cause.

Development and Validation of a Deep Learning Algorithm for Detection of Diabetic Retinopathy in Retinal Fundus Photographs
Varun Gulshan, PhD1; Lily Peng, MD, PhD1; Marc Coram, PhD1; et al

Finding  In 2 validation sets of 9963 images and 1748 images, at the operating point selected for high specificity, the algorithm had 90.3% and 87.0% sensitivity and 98.1% and 98.5% specificity for detecting referable diabetic retinopathy, defined as moderate or worse diabetic retinopathy or referable macular edema by the majority decision of a panel of at least 7 US board-certified ophthalmologists. At the operating point selected for high sensitivity, the algorithm had 97.5% and 96.1% sensitivity and 93.4% and 93.9% specificity in the 2 validation sets.

Meaning  Deep learning algorithms had high sensitivity and specificity for detecting diabetic retinopathy and macular edema in retinal fundus photographs.

Abstract
Importance  Deep learning is a family of computational methods that allow an algorithm to program itself by learning from a large set of examples that demonstrate the desired behavior, removing the need to specify rules explicitly. The application of these methods to medical imaging requires further assessment and validation.

Objective  To apply deep learning to create an algorithm for automated detection of diabetic retinopathy and diabetic macular edema in retinal fundus photographs.

Design and Setting  A specific type of neural network optimized for image classification called a deep convolutional neural network was trained using a retrospective development data set of 128 175 retinal images, which were graded 3 to 7 times for diabetic retinopathy, diabetic macular edema, and image gradability by a panel of 54 US licensed ophthalmologists and ophthalmology senior residents between May and December 2015. The resultant algorithm was validated in January and February 2016 using 2 separate data sets, both graded by at least 7 US board-certified ophthalmologists with high intragrader consistency.

Exposure  Deep learning–trained algorithm.

Main Outcomes and Measures  The sensitivity and specificity of the algorithm for detecting referable diabetic retinopathy (RDR), defined as moderate and worse diabetic retinopathy, referable diabetic macular edema, or both, were generated based on the reference standard of the majority decision of the ophthalmologist panel. The algorithm was evaluated at 2 operating points selected from the development set, one selected for high specificity and another for high sensitivity.

Results  The EyePACS-1 data set consisted of 9963 images from 4997 patients (mean age, 54.4 years; 62.2% women; prevalence of RDR, 683/8878 fully gradable images [7.8%]); the Messidor-2 data set had 1748 images from 874 patients (mean age, 57.6 years; 42.6% women; prevalence of RDR, 254/1745 fully gradable images [14.6%]). For detecting RDR, the algorithm had an area under the receiver operating curve of 0.991 (95% CI, 0.988-0.993) for EyePACS-1 and 0.990 (95% CI, 0.986-0.995) for Messidor-2. Using the first operating cut point with high specificity, for EyePACS-1, the sensitivity was 90.3% (95% CI, 87.5%-92.7%) and the specificity was 98.1% (95% CI, 97.8%-98.5%). For Messidor-2, the sensitivity was 87.0% (95% CI, 81.1%-91.0%) and the specificity was 98.5% (95% CI, 97.7%-99.1%). Using a second operating point with high sensitivity in the development set, for EyePACS-1 the sensitivity was 97.5% and specificity was 93.4% and for Messidor-2 the sensitivity was 96.1% and specificity was 93.9%.

Conclusions and Relevance  In this evaluation of retinal fundus photographs from adults with diabetes, an algorithm based on deep machine learning had high sensitivity and specificity for detecting referable diabetic retinopathy. Further research is necessary to determine the feasibility of applying this algorithm in the clinical setting and to determine whether the use of the algorithm could lead to improved care and outcomes compared with the current ophthalmologic assessment.

United States Health Care Reform
Progress to Date and Next Steps
Barack Obama, JD1

Abstract
Importance  The Affordable Care Act is the most important health care legislation enacted in the United States since the creation of Medicare and Medicaid in 1965. The law implemented comprehensive reforms designed to improve the accessibility, affordability, and quality of health care.

Objectives  To review the factors influencing the decision to pursue health reform, summarize evidence on the effects of the law to date, recommend actions that could improve the health care system, and identify general lessons for public policy from the Affordable Care Act.

Evidence  Analysis of publicly available data, data obtained from government agencies, and published research findings. The period examined extends from 1963 to early 2016.

Findings  The Affordable Care Act has made significant progress toward solving long-standing challenges facing the US health care system related to access, affordability, and quality of care. Since the Affordable Care Act became law, the uninsured rate has declined by 43%, from 16.0% in 2010 to 9.1% in 2015, primarily because of the law’s reforms. Research has documented accompanying improvements in access to care (for example, an estimated reduction in the share of nonelderly adults unable to afford care of 5.5 percentage points), financial security (for example, an estimated reduction in debts sent to collection of $600-$1000 per person gaining Medicaid coverage), and health (for example, an estimated reduction in the share of nonelderly adults reporting fair or poor health of 3.4 percentage points). The law has also begun the process of transforming health care payment systems, with an estimated 30% of traditional Medicare payments now flowing through alternative payment models like bundled payments or accountable care organizations. These and related reforms have contributed to a sustained period of slow growth in per-enrollee health care spending and improvements in health care quality. Despite this progress, major opportunities to improve the health care system remain.

Conclusions and Relevance  Policymakers should build on progress made by the Affordable Care Act by continuing to implement the Health Insurance Marketplaces and delivery system reform, increasing federal financial assistance for Marketplace enrollees, introducing a public plan option in areas lacking individual market competition, and taking actions to reduce prescription drug costs. Although partisanship and special interest opposition remain, experience with the Affordable Care Act demonstrates that positive change is achievable on some of the nation’s most complex challenges.

Health Care Spending in the United States and Other High-Income Countries
Irene Papanicolas, PhD; Liana R. Woskie, MSc; Ashish K. Jha, MD, MPH
JAMA Articles of the Decade

Abstract
Importance of Health care spending in the United States is a major concern and is higher than in other high-income countries, but there is little evidence that efforts to reform US health care delivery have had a meaningful influence on controlling health care spending and costs.

Objective  To compare potential drivers of spending, such as structural capacity and utilization, in the United States with those of 10 of the highest-income countries (United Kingdom, Canada, Germany, Australia, Japan, Sweden, France, the Netherlands, Switzerland, and Denmark) to gain insight into what the United States can learn from these nations.

Evidence  Analysis of data primarily from 2013-2016 from key international organizations including the Organisation for Economic Co-operation and Development (OECD), comparing underlying differences in structural features, types of health care and social spending, and performance between the United States and 10 high-income countries. When data were not available for a given country or more accurate country-level estimates were available from sources other than the OECD, country-specific data sources were used.

Findings  In 2016, the US spent 17.8% of its gross domestic product on health care, and spending in the other countries ranged from 9.6% (Australia) to 12.4% (Switzerland). The proportion of the population with health insurance was 90% in the US, lower than the other countries (range, 99%-100%), and the US had the highest proportion of private health insurance (55.3%). For some determinants of health such as smoking, the US ranked second-lowest of the countries (11.4% of the US population ≥15 years smokes daily; mean of all 11 countries, 16.6%), but the US had the highest percentage of adults who were overweight or obese at 70.1% (range for other countries, 23.8%-63.4%; mean of all 11 countries, 55.6%). Life expectancy in the US was the lowest of the 11 countries at 78.8 years (range for other countries, 80.7-83.9 years; mean of all 11 countries, 81.7 years), and infant mortality was the highest (5.8 deaths per 1000 live births in the US; 3.6 per 1000 for all 11 countries). The US did not differ substantially from the other countries in the physician workforce (2.6 physicians per 1000; 43% primary care physicians), or nursing workforce (11.1 nurses per 1000). The US had comparable numbers of hospital beds (2.8 per 1000) but higher utilization of magnetic resonance imaging (118 per 1000) and computed tomography (245 per 1000) vs other countries. The US had similar rates of utilization (US discharges per 100 000 were 192 for acute myocardial infarction, 365 for pneumonia, 230 for chronic obstructive pulmonary disease; procedures per 100 000 were 204 for hip replacement, 226 for knee replacement, and 79 for coronary artery bypass graft surgery). Administrative costs of care (activities relating to planning, regulating, and managing health systems and services) accounted for 8% in the US vs a range of 1% to 3% in the other countries. For pharmaceutical costs, spending per capita was $1443 in the US vs a range of $466 to $939 in other countries. Salaries of physicians and nurses were higher in the US; for example, generalist physicians' salaries were $218 173 in the US compared with a range of $86 607 to $154 126 in the other countries.

Conclusions and Relevance  The United States spent approximately twice as much as other high-income countries on medical care, yet utilization rates in the United States were largely similar to those in other nations. Prices of labor and goods, including pharmaceuticals, and administrative costs appeared to be the major drivers of the difference in overall cost between the United States and other high-income countries. As patients, physicians, policymakers, and legislators actively debate the future of the US health system, data such as these are needed to inform policy decisions.

The Association Between Income and Life Expectancy in the United States, 2001-2014
Raj Chetty, PhD; Michael Stepner, BA; Sarah Abraham, BA; et al

Abstract
Importance  The relationship between income and life expectancy is well established but remains poorly understood.

Objectives  To measure the level, time trend, and geographic variability in the association between income and life expectancy and to identify factors related to small area variation.

Design and Setting  Income data for the US population were obtained from 1.4 billion deidentified tax records between 1999 and 2014. Mortality data were obtained from Social Security Administration death records. These data were used to estimate race- and ethnicity-adjusted life expectancy at 40 years of age by household income percentile, sex, and geographic area, and to evaluate factors associated with differences in life expectancy.

Exposure  Pretax household earnings as a measure of income.

Main Outcomes and Measures  Relationship between income and life expectancy; trends in life expectancy by income group; geographic variation in life expectancy levels and trends by income group; and factors associated with differences in life expectancy across areas.

Results  The sample consisted of 1 408 287 218 person-year observations for individuals aged 40 to 76 years (mean age, 53.0 years; median household earnings among working individuals, $61 175 per year). There were 4 114 380 deaths among men (mortality rate, 596.3 per 100 000) and 2 694 808 deaths among women (mortality rate, 375.1 per 100 000). The analysis yielded 4 results. First, higher income was associated with greater longevity throughout the income distribution. The gap in life expectancy between the richest 1% and poorest 1% of individuals was 14.6 years (95% CI, 14.4 to 14.8 years) for men and 10.1 years (95% CI, 9.9 to 10.3 years) for women. Second, inequality in life expectancy increased over time. Between 2001 and 2014, life expectancy increased by 2.34 years for men and 2.91 years for women in the top 5% of the income distribution, but by only 0.32 years for men and 0.04 years for women in the bottom 5% (P < .001 for the differences for both sexes). Third, life expectancy for low-income individuals varied substantially across local areas. In the bottom income quartile, life expectancy differed by approximately 4.5 years between areas with the highest and lowest longevity. Changes in life expectancy between 2001 and 2014 ranged from gains of more than 4 years to losses of more than 2 years across areas. Fourth, geographic differences in life expectancy for individuals in the lowest income quartile were significantly correlated with health behaviors such as smoking (r = −0.69, P < .001), but were not significantly correlated with access to medical care, physical environmental factors, income inequality, or labor market conditions. Life expectancy for low-income individuals was positively correlated with the local area fraction of immigrants (r = 0.72, P < .001), fraction of college graduates (r = 0.42, P < .001), and government expenditures (r = 0.57, P < .001).

Conclusions and Relevance  In the United States between 2001 and 2014, higher income was associated with greater longevity, and differences in life expectancy across income groups increased over time. However, the association between life expectancy and income varied substantially across areas; differences in longevity across income groups decreased in some areas and increased in others. The differences in life expectancy were correlated with health behaviors and local area characteristics.

Silencing the Science on Gun Research . Arthur L. Kellermann, MD, MPH; Frederick P. Rivara, MD, MPH

On December 14, a 20-year-old Connecticut man shot and killed his mother in the home they shared. Then, armed with 3 of his mother's guns, he shot his way into a nearby school, where he killed 6 additional adults and 20 first-grade children. Most of those who died were shot repeatedly at close range. Soon thereafter, the killer shot himself. This ended the carnage but greatly diminished the prospects that anyone will ever know why he chose to commit such horrible acts.

In body count, this incident in Newtown ranks second among US mass shootings. It follows recent mass shootings in a shopping mall in Oregon, a movie theater in Colorado, a Sikh temple in Wisconsin, and a business in Minnesota. These join a growing list of mass killings in such varied places as a high school, a college campus, a congressional constituent meeting, a day trader's offices, and a military base. But because this time the killer's target was an elementary school, and many of his victims were young children, this incident shook a nation some thought was inured to gun violence.

As shock and grief give way to anger, the urge to act is powerful. But beyond helping the survivors deal with their grief and consequences of this horror, what can the medical and public health community do? What actions can the nation take to prevent more such acts from happening, or at least limit their severity? More broadly, what can be done to reduce the number of US residents who die each year from firearms, currently more than 31 000 annually?1

The answers are undoubtedly complex and at this point, only partly known. For gun violence, particularly mass killings such as that in Newtown, to occur, intent and means must converge at a particular time and place. Decades of research have been devoted to understanding the factors that lead some people to commit violence against themselves or others. Substantially less has been done to understand how easy access to firearms mitigates or amplifies both the likelihood and consequences of these acts.

For example, background checks have an effect on inappropriate procurement of guns from licensed dealers, but private gun sales require no background check. Laws mandating a minimum age for gun ownership reduce gun fatalities, but firearms still pass easily from legal owners to juveniles and other legally proscribed individuals, such as felons or persons with mental illness. Because ready access to guns in the home increases, rather than reduces, a family's risk of homicide in the home, safe storage of guns might save lives.2 Nevertheless, many gun owners, including gun-owning parents, still keep at least one firearm loaded and readily available for self-defense.3

The nation might be in a better position to act if medical and public health researchers had continued to study these issues as diligently as some of us did between 1985 and 1997. But in 1996, pro-gun members of Congress mounted an all-out effort to eliminate the National Center for Injury Prevention and Control at the Centers for Disease Control and Prevention (CDC). Although they failed to defund the center, the House of Representatives removed $2.6 million from the CDC's budget—precisely the amount the agency had spent on firearm injury research the previous year. Funding was restored in joint conference committee, but the money was earmarked for traumatic brain injury. The effect was sharply reduced support for firearm injury research.

To ensure that the CDC and its grantees got the message, the following language was added to the final appropriation: “none of the funds made available for injury prevention and control at the Centers for Disease Control and Prevention may be used to advocate or promote gun control.”4

Precisely what was or was not permitted under the clause was unclear. But no federal employee was willing to risk his or her career or the agency's funding to find out. Extramural support for firearm injury prevention research quickly dried up. Even today, 17 years after this legislative action, the CDC's website lacks specific links to information about preventing firearm-related violence.

When other agencies funded high-quality research, similar action was taken. In 2009, Branas et al5 published the results of a case-control study that examined whether carrying a gun increases or decreases the risk of firearm assault. In contrast to earlier research, this particular study was funded by the National Institute on Alcohol Abuse and Alcoholism. Two years later, Congress extended the restrictive language it had previously applied to the CDC to all Department of Health and Human Services agencies, including the National Institutes of Health.6

These are not the only efforts to keep important health information from the public and patients. For example, in 1997, Cummings et al7 used state-level data from Washington to study the association between purchase of a handgun and the subsequent risk of homicide or suicide. Similar studies could not be conducted today because Washington State's firearm registration files are no longer accessible.8

In 2011, Florida's legislature passed and Governor Scott signed HB 155, which subjects the state's health care practitioners to possible sanctions, including loss of license, if they discuss or record information about firearm safety that a medical board later determines was not “relevant” or was “unnecessarily harassing.” A US district judge has since issued a preliminary injunction to block enforcement of this law, but the matter is still in litigation. Similar bills have been proposed in 7 other states.

The US military is grappling with an increase in suicides within its ranks. Earlier this month, an article by 2 retired generals—a former chief and a vice chief of staff of the US Army— asked Congress to lift a little-noticed provision in the 2011 National Defense Authorization Act that prevents military commanders and noncommissioned officers from being able to talk to service members about their private weapons, even in cases in which a leader believes that a service member may be suicidal.9

Health researchers are ethically bound to conduct, analyze, and report studies as objectively as possible and communicate the findings in a transparent manner. Policy makers, health care practitioners, and the public have the final decision regarding whether they will accept, much less act on, those data. Criticizing research is fair game; suppressing research by targeting its sources of funding is not.

Efforts to place legal restrictions on what physicians and other health care practitioners can and cannot say to their patients crosses an even more important line. Yet this is precisely what Florida and some other states are seeking to do. Physicians may disagree on many issues, including the pros and cons of gun control, but are united in opposing government efforts to undermine the sanctity of the patient-physician relationship, as defined by the Hippocratic oath. While it is reasonable to acknowledge and accept the Supreme Court's recent decision regarding the meaning of the Second Amendment, it is just as important to uphold physicians' First Amendment rights.

Injury prevention research can have real and lasting effects. Over the last 20 years, the number of Americans dying in motor vehicle crashes has decreased by 31%.1 Deaths from fires and drowning have been reduced even more, by 38% and 52%, respectively.1 This progress was achieved without banning automobiles, swimming pools, or matches. Instead, it came from translating research findings into effective interventions.

Given the chance, could researchers achieve similar progress with firearm violence? It will not be possible to find out unless Congress rescinds its moratorium on firearm injury prevention research. Since Congress took this action in 1997, at least 427 000 people have died of gunshot wounds in the United States, including more than 165 000 who were victims of homicide.1 To put these numbers in context, during the same time period, 4586 Americans lost their lives in combat in Iraq and Afghanistan.10

The United States has long relied on public health science to improve the safety, health, and lives of its citizens. Perhaps the same straightforward, problem-solving approach that worked well in other circumstances can help the nation meet the challenge of firearm violence. Otherwise, the heartache that the nation and perhaps the world is feeling over the senseless gun violence in Newtown will likely be repeated, again and again.




  

Thursday, December 26, 2019

THE UNFORTUNATE RISE OF STEM CELL CLINICS

Stem Cell Therapy is not ready for widespread unregulated use.

MSCs and other stem cells offer remarkable potential but our understanding of their science and medical applications is not ready for unregulated, widespread use. The complexity of tissue repair and cell replacement makes it clear that the proliferation of questionable “stem cell clinics” and off-shore medical tourism offices promoting their autologous “stem cell treatments” of unknown and unproven efficacy will not solve patient maladies in a meaningful way. The divergence between reputable clinical trials and the premature marketing of stem cell products to the public has broadened the gap and led to confusion in the press as highlighted by Galipeau et al.15 There are over 700 clinics offering direct-to-consumer marketing of “stem cell” treatments.16 We cannot support or recommend any treatment utilizing MSCs that does not use characterized cell product, maintain accurate records, measure intermediate parameters, predetermined surrogate endpoints and track and report final patient outcome(s). These steps are common practice in FDA registered trials, but too demanding for under- or unregulated clinics. A recent study (see Murray et al.16 reference for details) has offered a consensus report on the parameters needed to improve cell therapy outcomes for both patients and practitioners using the acronym DOSES: D—Donor, O—Origin tissue, S—Separation Method, E—Exhibited Characteristics, S—Site of Delivery.

Stem Cell Clinics may reference their stem cell lineage as bone marrow stem cells, amniotic membrane stem cells, fat cell and mesenchymal in origin.





Adult/Tissue Stem Cells
Adult stem cells, or “tissue stem cells,” can come from different parts of the adult body. They are specific to a certain kind of tissue in the body: for instance, liver stem cells can regenerate liver tissue, and muscle stem cells can regenerate muscle fibers. But adult stem cells are limited to only becoming more of their specialized tissue—liver stem cells cannot make new muscle fibers, nor can muscle stem cells make new liver tissue.

Cells
The thousands of different cell types that make up our bodies all came from one single “master builder” cell, called a pluripotent stem cell.

Pluripotent stem cells can be thought of as “blank slates,” because of their ability to build any cell type in the body—skin cells, brain cells, muscle cells, etc. Unlike tissue stem cells, pluripotent stem cells are not limited to only becoming more of a certain tissue.
Pluripotent stem cells primarily consist of embryonic stem cells, but the term now also encompasses another type of cells, called “induced pluripotent stem cells.” More on that later.

Induced Pluripotent Stem Cells/iPSCs
Induced pluripotent stem (iPS) cells are pluripotent cells that are derived from adult tissue using new scientific technology. They share characteristics with embryonic stem cells in that they can become any cell type in the body.

Reprogramming stem cells to create iPSCs involves some genetic manipulation, and this may cause some differences that are not present in cells that are already embryonic in nature. It is essential to continue research using all cell types. Because the field of stem cell research is so new, it is critical to explore all avenues of stem cell research, from pluripotent to tissue stem cells.

Although research has been in progress for the past decade or more, we are just beginning to unravel how the embryonic ova differentiates with each cell division. Each division results in an exponential increase in the number of stem cells. With each division, the pluripotential of each cell decreases in an inverse manner. In other words, they will not have the same potential to make certain kinds of tissue (brain, skin, bones, liver, and other organ systems.  At maturity and at birth some organs contain a reservoir of stem cells particular to that tissue.  Organs with demand for higher cellular division to repopulate the organ such as skin, bone marrow.  Skin as an organ continuously requires replacement as the upper layers are shed.  The normal time of RBC senescent (age-related) death in adults is approximately 110 to 120 days through a process call erythropoiesis.

Blood Stem cells go on to differentiate as shown in the figure.(s)
Red blood cells are manufactured by a complex loop of protein regulation from the liver and kidneys. The rate is normally 2-3 million RBCs /second when the system is stable, with an equal amount of senescent RBCs being destroyed by eryptosis (scroll down)



This process is balanced by RBC senescence or eryptosis.  

Another stem cell line follows a journey much like the progenitor hemocytoblast. The basal layers of skin contain stem cells that begin the process. There are many skin products that claim to stimulate the process using DNA like analog molecules.

The production of a focused stem cell requires an arduous process of trial and error in the lab. Once this is accomplished a Clinical trial will be submitted to the FDA for approval to market the drug. They determine the safety, efficacy and side effects or complication by using the drug in humans.
Early pre-trial studies are done in mice when possible.





Biblio:

15 Galipeau, J., Weiss, D. J. & Dominici, M. Response to Nature commentary “Clear up this stem-cell mess”. Cytotherapy 21, 1–2 (2019).
16 Murray, I. R. et al. International expert consensus on a cell therapy communication tool: DOSES. J. Bone Jt. Surg.
* Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement







CMS Paid $93.6M in Incorrect Medicare EHR Incentive Payments


""CMS and Medicare often do foolish things that cost much more than what they recover.  This year the OIG audit discovered there were overpayments of the EHR incentives for hospitals.  It represented less than  1 % of the total amount paid to hospitals.  There was no mention in EHR intelligence that overpayment was made to providers (physicians).  CMS is being 'generous by reducing the number of deviant hospital amounts from 96 million to about 1.6 million for some obscure reason of their own about the dates of incentive.  (Merry Christmas) (humbug to CMS) . They requested a 'voluntary' refund from the remaining criminal element of hospitals if they would do   'DUE DILIGENCE' by examining their cost analysis of their hospital and provide it to CMS. EHR intelligence did not report if there is a hard deadline for the report, or face further penalties such as being terminated from CMS.
I realize that is a long stretch on my part, but worse things have occurred in the past year that makes this even pale in significance.""

HEALTH TRAIN EXPRESS disavows any payment, gratuities, and responsibility for the content published herein.

The remainder of the Health Train Express is copied from EHR Intelligence and is printed below. Attribution is given to John Lynn



The incorrect Medicare EHR incentive payments represented less than 1% of total payments to acute care hospitals, but OIG still recommends the recovery of some reimbursements.

An audit of 8,297 Medicare EHR incentive payments made to acute care hospitals from Jan. 1, 2013 to Sept. 30, 2017, revealed that CMS did not always make the payments in accordance with federal requirements. (ie, 4 years)


“The incorrect net incentive payments occurred because the Medicare administrative contractors did not review the supporting documentation for all hospitals to identify errors in the hospitals' cost-report numbers used to calculate the incentive payments, and CMS did not include labor and delivery services in the incentive payment calculations, which resulted in hospitals receiving inflated incentive payments,” described Joanne M. Chiedi, the acting inspector general of the Department of Health and Human Services (HHS) in the report.

OIG recommended that CMS recovery $1.3 million of the incorrect Medicare EHR incentive payments from acute care hospitals. These payments were made during the reopening period, so CMS has the authority to recoup the incorrect reimbursements.

For the remaining incorrect Medicare EHR incentive payments which were outside of the reopening period, OIG recommended that CMS notify the acute-care hospitals associated with the incorrect payments so that those hospitals can exercise reasonable diligence to investigate and return any identified similar incorrect payments.

OIG also advised CMS to attempt recovery of the nearly $93.6 million in estimated incorrect net incentive payments made during the audit period and to ensure that all final and non-final payments made after our audit period are correct. CMS should do this by instructing Medicare Administrative Contractors to review all hospitals’ supporting documentation to identify errors in the hospitals’ cost-report numbers used to calculate the incentive payments, including supporting documentation for labor and delivery inpatient bed-days for cost reports with cost-reporting periods beginning on or after October 1, 2013.

Let's do some simple math. (for some) $ 1.6 million divided by the 4 year period amounts to around $ 400,000 per annum The cost of recovery is nowhere near 100 percent forgiveness.  It amounts to a tax increase and an increase of bureaucratic overhead for the 'offending' hospitals. If CMS and HHS really want to save money for the weary taxpayer, they could fire the employees that would ordinarily have their work time filled with this sort of nonsense. However, they are undoubtedly civil service employees who cannot be fired, except for sexual deviancy.

A better way is for CMS (which it does for most things, as does the DOD), is to contract an accounting firm or use the IRS to process the paper pile swamp.

The OIG in its infinite wisdom recommended.  "CMS should do this by instructing Medicare Administrative Contractors to review all hospitals’ supporting documentation to identify errors in the hospitals’ cost-report numbers used to calculate the incentive payments, including supporting documentation for labor and delivery inpatient bed-days for cost reports with cost-reporting periods beginning on or after October 1, 2013".






















https://tinyurl.com/rolbskj

Friday, December 20, 2019

A Doctor’s Diary: The Overnight Shift in the E.R. -

In the typical emergency room, demand far outpaces the care that workers can provide. Can the E.R. be fixed?




Well, maybe.  Back in the day (1965) when I rotated through the emergency room (called emergency department) the same question arose. Since that time many solutions have been attempted, with varying success.

 
My choices as a doctor in the emergency room are up or out. Up, for the very sick. I stabilize things that are broken, infected or infarcted, until those patients can be whisked upstairs for their definitive surgeries or stents in the hospital. Out, for everyone else. I stitch up the simple cuts, reassure those with benign viruses, prescribe Tylenol and send home.
Up or out is what the E.R. was designed for. Up or out is what it’s good at. Emergency rooms are meant to have open capacity in case of a major emergency, be it a train crash, a natural disaster or a school shooting, and we are constantly clearing any beds we can in pursuit of this goal.



The problem is, traffic through the emergency room has been growing at twice the rate projected by United States population growth and has been for almost 20 straight years, despite the passage of the Affordable Care Act, and through both economic booms and recessions. Americans visit the E.R. more than 140 million times a year — 43 visits for every 100 Americans — which is more than they visit every other type of doctor’s office in the hospital combined.
The demand is such that new E.R.s are already too small by the time they are built. Emergency rooms respond like overbooked restaurants during a chaotic dinner rush, with doctors pressed to turn stretchers the way waiters hurriedly turn tables. The frantic pace leaves little time for deliberating over the diagnosis or for counseling patients. Up, out.
The underlying problem is a shortage of physicians.  Patients after discharge from a hospital may not be able to see a followup physician for two or three weeks, allowing a relapse into what originally brought them to an emergency department.

Private exams on stretchers in hallways, patients languishing without attention for hours, nurses stretched to the breaking point; all of it has become business as usual. I think about this on nights like tonight, when I start my shift inheriting 16 patients in the waiting room. I think about what I will learn that these people need, and about what I will fail to provide.


Should the emergency room treat only emergencies? More than 80 percent of our patients arrive without sirens blazing, by walking in or after parking their cars with the valet out front. A rash that won’t stop itching, a lower back that won’t stop aching, a child who won’t stop vomiting. If their problems aren’t in our manual of emergency conditions, we say they are misusing the E.R. and try to dispense of them as quickly as we can. But here they are, having waited six hours to see me, asking for help. What to do for them?
I click a few perfunctory buttons in their charts. I say there’s nothing life-threatening going on as I hand them boilerplate discharge paperwork to sign. Someone calls me to see my next patient. I send them back to their families, jobs and responsibilities equipped with little more than these unceremonious goodbyes.

Almost one in 10 — 8.2 percent — of these discharged E.R. patients return to an E.R. within three days. What I leave unaddressed — persistent pain, nagging uncertainty about a diagnosis, a social dilemma — tends to stay that way, begetting yet another visit. An E.R.’s success is measured by how fast it sees these patients, not by whether it breaks these cycles.

Although the E.R. was built to quickly get the sick “up” into the hospital, it has exposed, better than anywhere else, what patients lack while “out” in their otherwise private lives. Patients like Cynthia and Jean-Luc will survive devastating diseases under our care “up” in the hospital, but we send them “out” unable to sustain their precarious conditions without us. Patients like Mariah make their needs clear in the E.R., but we are too busy to meet them, and by the time they come back it’s often too late.


 

Such matters now fall into the category Social Determinants of Health. This category may be the overriding cause of their disease(s). Homelessness, poverty, lack of social services, acute climactic events

These factors often contribute to 8.2% of the return visits to the emergency department of most hospitals.
Financial limitations, lack of social workers limit the services in the emergency department. Insurers, medicare will not reimburse for these services in the emergency department

From 2012 to 2014 the federal government, recognizing that neither up nor out was solving the problem for a growing group of patients, financed an experiment at the University of Colorado. The typical E.R. has surgeons on-call to treat patients with broken bones; following that model, the E.R. in Colorado set up a team on-call for patients with broken homes.

Disadvantaged patients who kept returning to the E.R. were matched to social workers, health coaches and doctors who visited them where they lived and kept in touch for several months. By staying involved after the E.R. visits and not letting details fall through the cracks, the team reduced these patients’ need to revisit the hospital by 30 percent compared with the need of those in a control group.

The E.R. at Yale, where I work, addressed a different group in need. Elderly patients who came to the E.R. after a fall were offered a follow-up at home. There, they were screened for risk factors that might lead to another fall, such as loose rugs, medications that increased their risk of balance problems, or lack of necessary equipment or support at home. Over the next month, those who received such visits called 911 about half as often as similar patients who did not participate in the program.
Programs like these are not considered the E.R.’s core business, so they often rely on grants — and they end if funding dries up. Of the slim resources that E.R.s do set aside to address patients’ barriers outside the hospital, most are put toward hiring social workers and care managers. But these employees, stymied by mountains of paperwork and unrealistic patient loads, never get outside the hospital to see their patients, either.
The programs at Colorado and Yale succeeded by framing the E.R.’s resources differently. They recognized that the E.R. staff could identify problems that were destined to arise after discharge — and empowered those employees to help. Both programs orchestrated follow-ups outside the E.R; those teams worked on the day-to-day problems at home that go unaddressed in hospitals and clinics and can cause catastrophes







A Doctor’s Diary: The Overnight Shift in the E.R. - The New York Times:

Original Publication of what would become Health Train Express Inland Empire Regional Health Information Organization: Two Important Legislative Actions (Federal)



Another time, another era. We here at Health Train have our own Wayback machine. I find it hard to believe it has over13 years since my idea to start a blog occurred.  



Two Important Legislative Actions (Federal)

House Subcommittee Passes Amended Health IT Bill

June 09, 2006


The House Energy and Commerce Subcommittee on Health on Thursday approved by voice vote a bill (HR 4157) that would promote the use of health care IT, CQ Today reports (Schuler, CQ Today, 6/8).

The legislation, sponsored by Reps. Nancy Johnson (R-Conn.) and Nathan Deal (R-Ga.), would codify the Office of the National Coordinator for Health IT within HHS and would establish a committee to make recommendations on national standards for medical data storage and develop a permanent structure to govern national interoperability standards. The bill also would clarify that current medical privacy laws apply to data stored or transmitted electronically (iHealthBeat, 6/8).

Prior to approval, the subcommittee approved a substitute amendment sponsored by Deal that removed two provisions from the legislation. The provisions would have increased the number of diagnosis and procedure codes from 24,000 to more than 200,000 and would have allowed federal medical privacy laws to pre-empt state laws (CQ Today, 6/8).

The subcommittee also approved an amendment sponsored by Rep. Diana DeGette (D-Colo.) that would require a study on the effect of the bill on the health care system (Povich, CongressDaily, 6/9).

The full committee plans to mark up the legislation on June 13, Deal said (CQ Today, 6/8).







 If you click on the hyperlink it will bring you to the beginning of my enlightenment.





Inland Empire Regional Health Information Organization: Two Important Legislative Actions (Federal)

Thursday, December 19, 2019

Measles on the Rise

  

The Global Measles Epidemic Isn’t (Just) About Measles

Strong health systems, along with immunization efforts, are key to fighting disease around the world.


Measles, once a common and deadly childhood illness which had been declared “eliminated” from many parts of the world including the United States, Canada and Europe nearly two decades ago, is back on the global health agenda.   Measles cases globally rose nearly 300 percent in the first quarter of 2019 as compared with the first quarter of 2018, according to surveillance data covering 190 countries released last week from the World Health Organization.
Over 112,000 cases were reported to start this year, as opposed to just over 28,000 from the beginning of 2018. That year likewise saw a significant gain as compared to 2017. Although still not close to the shocking levels of the mid-20th century, when tens of millions of children were infected and millions died, the trend for new measles infections seems to be inexorably and frustratingly on the rise.


This trend places children under the age of 10, particularly in poor and conflict-affected parts of the world, at increasing levels of entirely avoidable risk.

This global map diagrams the areas of the world where there are ongoing problems with measles

MEASLES, CONFLICT AND HEALTH SYSTEMS

In addition to the effect of vaccine hesitancy, we need look no further than the WHO’s own country-level data on the locations and growth trends of measles cases.
Almost all the enormous jump in measles cases from 2017 until the beginning of this year is attributable to a handful of places. This year, almost two-thirds of the entire reported global measles caseload is attributable to just two countries: Ukraine and Madagascar.  These two countries are highly instructive as to the true reasons why we should pay attention to measles as something like a “canary in the coalmine” for the underlying weaknesses of public health systems.
Let’s start with Ukraine, which may appear, at first glance, to be the most puzzling.
Why should a middle-income country on the edge of Europe, with a historically reliable, near-universal public health system, suddenly become a kind of poster child for the rampant spread of infectious childhood illnesses for which immunization exists? The answer is pretty simple: conflict.
Prior to 2014, Ukraine maintained a measles vaccination rate of 95 percent, generally considered the gold standard level for herd immunity. Then, conflict broke out between Ukraine and Russia. As a result, the Ukrainian Ministry of Health budget was frozen and measles vaccination procurement largely ceased until late 2015. By 2016, Ukraine’s vaccination rate had plunged to just 41 percent, one of the lowest rates on the planet.
In subsequent years, the vaccination rate in Ukraine crept back up close to its pre-conflict levels, with about 91 percent coverage achieved last year. But the damage had been done. A multi-year cohort of Ukrainian children had lost their immunity to the disease. Combined with widespread disruption of the primary health care system, and the physical effects of conflict on large numbers of communities, measles took root again quickly and began to spread.
Some of the migration of measles from the Ukraine epidemic has apparently gone international, with cases in New York, Israel and elsewhere traced directly to index cases of travelers from Ukraine.
Elsewhere, in places from Yemen to Nigeria, one can also detect the sharply negative impact of conflict on basic health system capacities and measles infection rates. The lessons of the Ukrainian measles epidemic, as is also the case with these other countries, are not only that it doesn’t take much to fundamentally disrupt a well-functioning health system and produce an otherwise preventable outbreak. Disruptions to health systems in one country, given high levels of global mobility through air travel, can quickly be felt in many places throughout the world.

THE GLOBAL MEASLES RESURGENCE

One of the most common explanations in the media for the measles resurgence has to do with a set of beliefs promoting reluctance to follow through with childhood vaccinations. The WHO earlier this year labeled this emerging reluctance one of the world’s “top ten” threats to global health.
The spread of misinformation about childhood vaccination is leading to a wave of what the World Health Organization calls “vaccine hesitancy.” Over time, declining tendencies to follow through on evidence-based public health recommendations may threaten long-established successful practices, which have improved the health of children since the mid-20th century.
In parts of California, New York, and Washington State, for instance, there is evidence that relatively small outbreaks have been correlated with reduced vaccination rates due to anti-vaccine misinformation combined with the novel introduction of the virus, often through travelers.
Globally, however, how can the disease’s resurgence be explained? Without question, the world needs to remain vigilant to any possibility that the consensus around childhood vaccination may be undermined over time by rising “vaccine hesitancy.” However, large numbers of people around the world are still not able to access the vaccinations they both want and need.  

Measles, respiratory illness with a characteristic rash, is extremely contagious. Although most people who contract the disease will recover, a small fraction of young children goes on to develop more severe complications, including pneumonia and encephalitis, a swelling of the brain that can cause permanent brain damage or even death. 

THE PERIL OF UNDER-FUNDING HEALTH CARE

The ongoing situation in Madagascar, which Direct Relief continues to respond to with local partners including the Ministry of Health, is quite different from that in Ukraine. Madagascar is one of the least developed countries, with a Human Development Index (HDI) that ranks 161st out of 189 measured countries. Its public health budget has been constantly under pressure for many years simply due to the tradeoffs required to manage multiple emerging health threats to rapidly changing communities. As a result, the measles vaccination rate in Madagascar has fallen to one of the world’s lowest at 58 percent.


Vaccination is not the only element of the health system that leads to an increased likelihood of measles contagion.  Poor nutrition leads to weakened immune systems for children and diminished capacity to resist infection. This is one of the key reasons why Direct Relief has been assisting with distributing of high-dose vitamin A to strengthen immune systems for vaccinated and unvaccinated children alike.
Weak primary care systems also present challenges to ensuring that all children are regularly seen by a physician and that suspect cases of measles are quickly identified and treated. Combined with low vaccination rates and persistent under-nutrition, weak primary care and disease surveillance can allow cases to multiply well before there is a chance to identify and intervene.

THE KINDLING THAT SPARKS AN OUTBREAK

Measles is well suited to epidemics given these system weaknesses. The reproduction rate for measles, the number epidemiologists use to measure the likelihood that one infected person infects others in the absence of counter-measures, is very high.
A systematic review in The Lancet from 2017 confirmed an average reproduction rate of 18, with considerable observed variance depending on contextual factors including poverty and the strength of health systems. That means a single measles infection may commonly produce at least 18 new infections in the absence of counter-measures. Likewise, measles is infectious for 7 days prior to the individual becoming symptomatic, which means that infections can easily spread undetected. That astonishing rate of transmission, including challenges with early detection, is what constantly threatens to transform measles outbreaks into exponentially growing epidemics.
In addition to defending the core public health value and practice of mass vaccination, we still have a long way to go to achieve a genuine universality of vaccine access, not to mention the related health systems interventions that maximize the chances of children to resist infectious diseases. That lack of equitable access threatens the most vulnerable in those countries most of all. But it threatens communities far outside their borders to given the fluency of global trade and travel.
Weak primary health systems, whether born of conflict, poverty or, as is often the case, a combination of both, remains among the greatest threats to human health everywhere.

Wednesday, December 18, 2019

Appeals court strikes down ACA's individual mandate

Appeals court strikes down ACA's individual mandate


Just about the time the House of Representatives voted to forward their  "Impeachment resolution to the U.S. Senate, a ghost of another haunting has risen from the dead.

The Individual Mandate of the ACA assures that no one can be denied health insurance based upon previous medical conditions.


A federal appeals court on Wednesday ruled that the Affordable Care Act's individual mandate is unconstitutional, but ordered a lower court to take a fresh look at how much of the rest of the law should fall along with it.
What's next: This decision will likely keep the ACA's protections for pre-existing conditions in legal limbo well past the 2020 election.
The intrigue: Republican attorneys general have argued that congressional Republicans’ 2017 tax law, which nullified the ACA's individual mandate, made that policy unconstitutional.
  • A panel of the 5th Circuit Court of Appeals said Wednesday that it agrees.
  • Republicans, and the Trump administration, have said the courts should strike down the entire law along with the mandate.
  • The 5th Circuit wrestled during oral arguments over how much of the law to strike down, ultimately deciding to kick that question back to the lower court for a new hearing. That lower court previously said the entire law would have to go.
Yes, but: The individual mandate is now essentially toothless, and it turned out not to be particularly effective when it was in effect.
  • So, if the court is inclined to strike down the mandate alone, letting the rest of the law stand, that would be a much safer proposition than it appeared to be in 2012.
Go deeper: Government funding bill deal will repeal key ACA taxes
Why it matters: The decision is a colossal win for the health care industry.
  • If this wasn't good enough news for the industry, the deal won't address surprise medical bills — and it avoids prescription drug prices except for the CREATES Act, which helps generics get to market faster.
  • The taxes have been repeatedly delayed. And while the industry has pushed for their repeal for years, it hasn't yet been successful.
Between the lines: Voters are decidedly not asking Washington to lift industry taxes while avoiding dealing with two of the most popular health care issues, but if that's how this plays out, it's a great indicator that the industry's lobbying strength is as good as ever.
  • It's also a good sign that cost control — the intention of the Cadillac tax, a 40% excise tax on the most generous employer plans — is still not very popular with lawmakers, even as health care costs continue to rise.
  • The tax was expected to raise $200 billion over 10 years.
The other side: The industry says that the ACA taxes end up getting passed along to patients.
Go deeper: