CMS Releases Third Year of Open Payments Data - CMS Blog

By Shantanu Agrawal, M.D., CMS Deputy Administrator for Program Integrity

On June 30, 2016, the Centers for Medicare & Medicaid Services (CMS) posted the Open Payments data for program year 2015, along with newly submitted and updated 2013 and 2014 records.  Open Payments (sometimes called the “Sunshine Act”) is a national program, required by the Affordable Care Act, that promotes CMS’ commitment to transparency by providing data on the financial relationships between the health care industry – including pharmaceutical and medical companies – and health care providers.

In program year 2015, health care industry manufacturers reported $7.52 billion in payments and ownership and investment interests to physicians and teaching hospitals.  This amount is comprised of 11.90 million total records attributable to 618,931 physicians and 1,116 teaching hospitals.  Payments in the three major reporting categories are:

• $2.60 billion in general (i.e., non-research related) payments
• $3.89 billion in research payments
• $1.03 billion of ownership or investment interests held by physicians or their immediate family members

Over the course of the Open Payments program since 2014, we have published 28.22 million records, accounting for $16.77 billion in payments and ownership and investment interests.

Posting the Open Payments program 2015 year data is exciting not only because we’ve concluded the third reporting cycle for Open Payments, but also because we are now able to compare the data across years to identify trends.  We are also able to analyze payments related to covered drugs, devices, biologicals, and supplies.  For example, we were able to determine that for program year 2015, 2.26 percent (637,131 records) of all financial transactions between physicians and pharmaceutical companies was related to opioid medications.

The Open Payments program provides the public more information about the financial relationships between physicians and teaching hospitals and the health care industry. The Open Payments Program does not identify whether financial relationships are beneficial or may indicate conflicts of interest.  Rather, this transparency program was intended to shed light on the nature and extent of these relationships.

We found that while the totals by major reporting category remained relatively unchanged between 2014 and 2015, there were some shifts in who was paid and how the money was spent.  See Table 1 and Figure 1 below.  Transparency is empowering physicians to be purposeful about their financial relationships with companies, and there is a notable shift towards charitable contributions and away from other interactions such as honoraria and gifts. We also observed some shifts in the highest paid physician types that may be of interest to researchers and other stakeholders. Coming years will provide additional interesting trend information.

Table 1: Highest Paid Physician Types, 2014 and 2015

Figure 1: Percent Change of Total Dollar Value by Nature of Payment, 2014 – 2015

Health care industry manufacturers must report to the Open Payments program annually, while participation by physicians and teaching hospitals is voluntary and encouraged.  If physicians or teaching hospitals disagree with what’s been reported, they can initiate a data dispute against the record and work with the reporting entity to resolve the discrepancy before the data is published. This process helps verify the accuracy of the Open Payments data. Registered physicians and teaching hospitals disputed 0.13 percent of Open Payment records (16,653 disputed records) that were eligible for review and dispute, representing 1.95 percent of total value of the published records.  Additionally, 0.22 percent of records (28,955 records) were affirmed by physicians and teaching hospitals, accounting for 0.76 percent of total value of the published records. Registered physicians and teaching hospitals with data attributed to them in the Open Payments system account for 35.45 percent of the total value of their published data. This does not include research-related payments made to non-covered recipients that employed physician principal investigators, which accounted for 40.92 percent of the published payments value.

If disputes are not resolved by the end of the data correction period, those entries are published with a notation identifying them as “disputed.”  We encourage physicians to sign up for Open Payments and to actively monitor any financial data related to them that is being reported.

Open Payments is part of CMS’ ongoing effort to increase transparency and accountability in health care. Since last publication (June 30, 2015), Open Payments has been referenced over 2,600 times in broadcast placements, traditional print, and social media.  Open Payments has been highlighted as a resource for transparency and reporting in an industry with complex stakeholder relationships that traditionally have been difficult to quantify and qualify.

You can search the Open Payments data at: OpenPaymentsData.CMS.gov. We’re pleased that the public has searched Open Payments data more than 6.78 million times. If you’ve visited the Open Payments website in the past, you’ll notice that we’ve improved our data review tools and provided a number of ways to accommodate different users and their interests:

• Search Tool: Site visitors can get immediate results using this standard search interface to find detailed information on individual physicians, teaching hospitals, or companies making payments. Search results will now be aggregated in alphabetical order by the company reporting the payment.
• Data Explorer: You can select a dataset and customize the view using filters, sorts, and other actions to create your own, targeted views of the data along with visualizations, such as charts and graphs.
• Data downloads: You can download the data in comma-separated values (.csv) format, which allows you to open and explore the data using your own software on your own computer. With this option, you must have robust data viewing software that allows for downloading and viewing data in large datasets.

Open Payments continues to be an important program for health care transparency and we look forward to its on-going contributions to dialogue on the policy and clinical communities. We also invite input on how to continue to improve this program. You can learn more about Open Payments by visiting CMS.gov/openpayments.

 

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Self-Reported Napping Behavior Change After Continuous Positive Airway Pressure Treatment in Older Adults with Obstructive Sleep Apnea - American Geriatric Society

Objectives

To assess the effect of continuous positive airway pressure (CPAP) on napping behavior in adults aged 60 and older with obstructive sleep apnea–hypopnea syndrome (OSAHS).

Design

Retrospective cohort study using questionnaires.

Setting

Sleep center.

Participants

Individuals starting CPAP treatment between April 2010 and March 2012 (mean age 65.2 ± 4.7; M:F = 3.9:1; N = 107).

Measurements

All subjects underwent sleep studies, clinical reviews, and CPAP adherence checks and completed a questionnaire regarding CPAP adherence, current employment status, sleep patterns before and after CPAP, and factors affecting their current sleep patterns.

Results

CPAP treatment duration was 82.7 ± 30.0 weeks, and objective adherence was 5.4 ± 2.0 hours per night overall. Daytime nap frequency before CPAP treatment was higher in those with a history of stroke or cardiovascular disease. Both sexes had a significant reduction in daytime napping (men, P < .001; women, P = .008), evening napping (men, P < .001; women, P = .02), and daily nap duration (men, P < .001; women, P = .02). Logistic regression analysis showed that the reduction in self-reported daily nap duration was associated with younger age (odds ratio (OR) = 0.86, P = .04), a decrease in ESS score (OR = 1.20, P = .03), and longer self-reported daily nap duration at baseline (OR = 31.52, P < .001).

Conclusion

Long-term CPAP treatment in older adults with OSAHS can play a significant role in reducing nap frequency and daily nap duration. Aging or shorter baseline daily nap duration may attenuate this effect.

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FDA clears first test to detect specific genetic markers for certain antibiotic-resistant bacteria directly from clinical specimens - FDA Press Releases

The U.S. Food and Drug Administration today cleared for marketing the Xpert Carba-R Assay, an infection control aid that tests patient specimens to detect specific genetic markers associated with bacteria that are resistant to Carbapenem antibiotics. Carbapenem antibiotics are widely used in hospitals to treat severe infections. These resistant organisms are commonly referred to as Carbapenem-resistant Enterobacteriaceae, or CRE, and have been reported in almost all states within the U.S.

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FDA approves implantable device that changes the shape of the cornea to correct near vision - FDA Press Releases

The U.S. Food and Drug Administration today approved the Raindrop Near Vision Inlay, a device implanted in the cornea (the clear, front surface) of one eye to improve near vision in certain patients with presbyopia. It is the second FDA-approved implantable corneal device for correction of near vision in patients who have not had cataract surgery and the first implantable device that changes the shape of the cornea to achieve improved vision.

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Quality of Care Provided by a Comprehensive Dementia Care Comanagement Program - American Geriatric Society

Multiple studies have shown that quality of care for dementia in primary care is poor, with physician adherence to dementia quality indicators (QIs) ranging from 18% to 42%. In response, the University of California at Los Angeles (UCLA) Health System created the UCLA Alzheimer's and Dementia Care (ADC) Program, a quality improvement program that uses a comanagement model with nurse practitioner dementia care managers (DCM) working with primary care physicians and community-based organizations to provide comprehensive dementia care. The objective was to measure the quality of dementia care that nurse practitioner DCMs provide using the Assessing Care of Vulnerable Elders (ACOVE-3) and Physician Consortium for Performance Improvement QIs. Participants included 797 community-dwelling adults with dementia referred to the UCLA ADC program over a 2-year period. UCLA is an urban academic medical center with primarily fee-for-service reimbursement. The percentage of recommended care received for 17 dementia QIs was measured. The primary outcome was aggregate quality of care for the UCLA ADC cohort, calculated as the total number of recommended care processes received divided by the total number of eligible quality indicators. Secondary outcomes included aggregate quality of care in three domains of dementia care: assessment and screening (7 QIs), treatment (6 QIs), and counseling (4 QIs). QIs were abstracted from DCM notes over a 3-month period from date of initial assessment. Individuals were eligible for 9,895 QIs, of which 92% were passed. Overall pass rates of DCMs were similar (90–96%). All counseling and assessment QIs had pass rates greater than 80%, with most exceeding 90%. Wider variation in adherence was found among QIs addressing treatments for dementia, which patient-specific criteria triggered, ranging from 27% for discontinuation of medications associated with mental status changes to 86% for discussion about acetylcholinesterase inhibitors. Comprehensive dementia care comanagement with a nurse practitioner can result in high quality of care for dementia, especially for assessment, screening, and counseling. The effect on treatment QIs is more variable but higher than previous reports of physician-provided dementia care.

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FDA requests additional information to address data gaps for consumer hand sanitizers - FDA Press Releases

The U.S. Food and Drug Administration today issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in topical consumer antiseptic rubs (including hand sanitizers) marketed over-the-counter (OTC). The FDA’s request for more data is intended to help the agency ensure that regular use of these products does not present unknown safety and efficacy concerns, and does not mean the FDA believes these products are ineffective or unsafe.

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Statement from FDA Commissioner Robert Califf, M.D. announcing the acting director of the FDA Oncology Center of Excellence - FDA Press Releases

The FDA is honored to be an integral part of the Vice President’s National Cancer Moonshot Initiative (“Cancer Moonshot”), which calls on the agency to leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics and devices to create the Oncology Center of Excellence (OCE). The OCE will expedite the development of novel combination products and support an integrated approach to tackle this devastating disease that touches so many American families.

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Advancing Health Equity for Sexual and Gender Minorities - CMS Blog

By: Cara V. James, Ph.D., Director of the Office of Minority Health at the Centers for Medicare & Medicaid Services

Each June we celebrate National Lesbian, Gay, Bisexual, and Transgender (LGBT) Pride Month by increasing awareness of sexual and gender minority populations’ health disparities and advances in promoting health equity for all.

However, despite making progress on a state and national level with inclusive policies, this June we have been reminded that there are still many challenges to overcome. In many places young people are still distanced from their families because of their sexual orientation and gender identity. For many sexual and gender minorities in the U.S. it is still difficult to be out to family, friends, and co-workers. A survey of U.S. adults found that more than 75% of lesbian, gay, or bisexual respondents reported experiencing discrimination in their lifetime. Experiences of discrimination and unfair treatment have been linked to poor health outcomes among older adults who identify as lesbian, gay, bisexual, and transgender (LGBT). These stressors and impacts are amplified when individuals identify with multiple marginalized groups (e.g., sexual, gender, and/or racial minority). That said, studies have shown that LGBT individuals who have good social support have higher self-esteem, a more positive group identity, and more positive mental health.

Although we commonly speak about the LGBT community as a single population it is important to remember that it is actually made up of many diverse individuals from many unique backgrounds and just about as many different ways of identifying themselves. At CMS it is especially important to remember that racial and ethnic minorities, people with disabilities, and older adults may also be sexual and gender minorities.

The CMS Office of Minority Health strives to increase understanding and awareness of disparities, create and share solutions to address those disparities, and implement effective actions to achieve health equity. To that end, we are developing a web-based training to aid providers in the collection of sexual orientation and gender identity (SOGI) data. We are working on a new best practices tool box for providing culturally and linguistically appropriate services (CLAS) with an emphasis on sexual and gender minorities and people with disabilities.

What can you do? Get informed. Learn more about health disparities for sexual minorities age 65 and older in CMS’ June data brief. Find out about the Office for Civil Rights’ rule highlighting your right to be free from discrimination in health careimplementing regulations under on the basis of sex, including sex stereotyping and gender identity. You can also learn more about LGBT health and well-being by looking at the work of our sister agencies within HHS. Think about how you can contribute to bringing health equity to your work. We encourage you to join us on the path to health equity by using the resources discussed in this blog, bookmarking the CMS OMH website, joining our listserv, and of course building on your own health equity activities!

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Hospital Characteristics, Inpatient Processes of Care, and Readmissions of Older Adults with Hip Fractures - American Geriatric Society

Objectives

To determine hospital-level predictors of readmission after hip fracture or potentially related inpatient care processes.

Design

Retrospective cohort study.

Setting

U.S. acute care hospitals.

Participants

Fee-for-service Medicare beneficiaries who underwent hip fracture surgery between 2007 and 2009 (N = 458,526).

Measurements

Information was obtained on hospital case volumes, teaching status, bed count, nurse staffing, and technological capabilities from Medicare files, and multivariable logistic regression was used to measure the association between these factors and an endpoint of readmission or death at 30 days and between these factors and the timing of surgery.

Results

Participants treated in the highest-volume hospitals (>175 cases for the study period) had lower odds of readmission or death at 30 days than those treated in low-volume hospitals (≤12; adjusted odds ratio (aOR) = 0.87, 95% confidence interval (CI) = 0.83–0.92, P < .001). Higher nurse skill mix (aOR = 0.88, 95% CI = 0.8–0.96; P = .007) and higher ratio of nurses to beds (aOR = 0.98; 95% CI = 0.97–0.99; P < .001) were also associated with better 30-day outcomes. Greater hospital case volume was associated with lower odds of surgical delay beyond 48 hours.

Conclusion

Better nurse staffing and higher case volumes are associated with lower rates of readmission and mortality after hip fracture surgery; individuals treated at high-volume centers experienced fewer delays in treatment, potentially indicating better inpatient care processes.

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Factors Influencing Outcomes of Older Adults After Undergoing Rehabilitation for Hip Fracture - American Geriatric Society

Objectives

To determine the contribution of cognitive impairment, prefracture functional impairment, and treatment as predictors of functional status and mobility 6 months after discharge from rehabilitation for older adults with hip fracture.

Design

Longitudinal.

Setting

Inpatient rehabilitation units of two community hospitals.

Participants

Adults with hip fractures aged 65 and older who were discharged from a rehabilitation unit and had been living in the community before the fracture (N = 133).

Measurements

Mini-Mental State Examination (MMSE) score at discharge from rehabilitation was used to identify the presence and severity of cognitive impairment. Outcomes were measured using questions from two subscales of the Functional Independence Measure (Self-Care Function and Functional Mobility) and the New Mobility Scale (NMS). Measurements were made at discharge from a rehabilitation setting and 3 and 6 months after discharge.

Results

Prefracture functional impairment was associated with worse outcomes throughout the 6 months after discharge and with lower rates of improvement, or in some cases decline, after discharge. Cognitive impairment was associated with worse outcomes throughout the 6 months after discharge but was only weakly associated with lower rates of improvement or decline. The Patient Centered Rehabilitation Model of care targeting persons with cognitive impairment (PCRM-CI) intervention group had higher NMS scores after discharge than a usual care group.

Conclusion

Although cognitive impairment and prefracture functional impairment contribute to poor outcomes, prefracture functional impairment was more strongly associated with poor outcomes than cognitive impairment. There is evidence to show that individuals with cognitive impairment are able to regain their mobility, which suggests a need for postdischarge targeted interventions that include a focus on activities of daily living for older adults with cognitive impairment and functional impairment to stabilize gains from inpatient rehabilitation.

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Self-Reported Sleep Duration, Napping, and Incident Heart Failure: Prospective Associations in the British Regional Heart Study - American Geriatric Society

Objectives

To examine the associations between self-reported nighttime sleep duration and daytime sleep and incident heart failure (HF) in men with and without preexisting cardiovascular disease (CVD).

Design

Population-based prospective study.

Setting

General practices in 24 British towns.

Participants

Men aged 60–79 without prevalent HF followed for 9 years (N = 3,723).

Measurements

Information on incident HF cases was obtained from primary care records. Assessment of sleep was based on self-reported sleep duration at night and daytime napping.

Results

Self-reported short nighttime sleep duration and daytime sleep of longer than 1 hour were associated with preexisting CVD, breathlessness, depression, poor health, physical inactivity, and manual social class. In all men, self-reported daytime sleep of longer than 1 hour duration was associated with significantly greater risk of HF after adjustment for potential confounders (adjusted hazard ratio (aHR) = 1.69, 95% CI = 1.06–2.71) than in those who reported no daytime napping. Self-reported nighttime sleep duration was not associated with HF risk except in men with preexisting CVD (<6 hours: aHR = 2.91, 95% CI = 1.31–6.45; 6 hours: aHR = 1.89, 95% CI = 0.89–4.03; 8 hours: aHR = 1.29, 95% CI = 0.61–2.71; ≥9 hours: aHR = 1.80, 905% CI = 0.71–4.61 vs nighttime sleep of 7 hours). Snoring was not associated with HF risk.

Conclusion

Self-reported daytime napping of longer than 1 hour is associated with greater risk of HF in older men. Self-reported short sleep (<6 hours) in men with CVD is associated with particularly high risk of developing HF.

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Antileukotriene Agents Versus Long-Acting Beta-Agonists in Older Adults with Persistent Asthma: A Comparison of Add-On Therapies - American Geriatric Society

Objectives

To compare the effectiveness and cardiovascular safety of long-acting beta-agonists (LABAs) with those of leukotriene receptor antagonists (LTRAs) as add-on treatments in older adults with asthma already taking inhaled corticosteroids (ICSs).

Design

Retrospective cohort study.

Setting

Medicare fee-for-service (FFS) claims (2009–10) for a 10% random sample of beneficiaries continuously enrolled in Parts A, B, and D in 2009.

Participants

Medicare beneficiaries aged 66 and older continuously enrolled in FFS Medicare with Part D coverage with a diagnosis of asthma before 2009 treated exclusively with ICSs plus LABAs or ICSs plus LTRAs (N = 14,702).

Measurements

The augmented inverse propensity-weighted estimator was used to compare the effect of LABA add-on therapy with that of LTRA add-on therapy on asthma exacerbations requiring inpatient, emergency, or outpatient care and on cardiovascular (CV) events, adjusting for demographic characteristics, comorbidities, and county-level healthcare-access variables.

Results

The primary analysis showed that LTRA add-on treatment was associated with greater odds of asthma-related hospitalizations or emergency department visits (odds ratio (OR) = 1.4, P < .001), as well as outpatient exacerbations requiring oral corticosteroids or antibiotics (OR = 1.41, P < .001) than LABA treatment. LTRA add-on therapy was also less effective in controlling acute symptoms, as indicated by greater use of short-acting beta agonists (rate ratio = 1.58, P < .001). LTRA add-on treatment was associated with lower odds of experiencing a CV event than LABA treatment (OR = 0.86, P = .006).

Conclusion

This study provides new evidence specific to older adults to help healthcare providers weigh the risks and benefits of these add-on treatments. Further subgroup analysis is needed to personalize asthma treatments in this high-risk population.

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Mainstream or Extinction: Can Defining Who We Are Save Geriatrics? - American Geriatric Society

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Urinary Incontinence and Social Function in Older Australian Women - American Geriatric Society

Objectives

To investigate the relationship between urinary incontinence (UI) and subsequent development of social dysfunction, using longitudinal data collected over 15 years from women aged 70 and older.

Design

Longitudinal data from the Australian Longitudinal Study on Women's Health.

Setting

Australia.

Participants

Women born between 1921 and 1926 (aged 70–75 in 1996, 85–90 in 2011) (N = 12,432).

Measurements

UI, social dysfunction, other health and demographic factors.

Results

Generalized estimating equations were used to examine the association between social dysfunction and UI over time, adjusted for time, health, and social covariates. Social dysfunction and UI increased over time in older women. UI was associated with 30% greater odds of social dysfunction (P < .001), adjusted for time, health, and social covariates in the model with no time lag. UI was also associated with social dysfunction measured one survey period later (forward time lag) (odds ratio (OR) = 1.23, 95% confidence interval (CI) = 1.13–1.34) and one survey period earlier (reverse time lag) (OR = 1.30, 95% CI = 1.19–1.43), indicating an absence of causality. Social dysfunction was associated with living in urban areas, more health conditions, poor mental health, providing care for other people, and poor physical function.

Conclusion

UI was associated with social dysfunction in older women, although the association did not appear to be causal but reflective of the women's overall level of function and general health. UI is not necessarily socially debilitating, unless a woman has other health problems.

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Etiology of Syncope and Unexplained Falls in Elderly Adults with Dementia: Syncope and Dementia (SYD) Study - American Geriatric Society

Objectives

To investigate the etiology of transient loss of consciousness (T-LOC) suspected to be syncope and unexplained falls in elderly adults with dementia.

Design

Prospective, observational, multicenter study.

Setting

Acute care wards, syncope units or centers for the diagnosis of dementia.

Participants

Individuals aged 65 and older with a diagnosis of dementia and one or more episodes of T-LOC of a suspected syncopal nature or unexplained falls during the previous 3 months were enrolled.

Measurements

The causes of T-LOC suspected to be syncope and unexplained falls were evaluated using a simplified protocol based on European Society of Cardiology guidelines.

Results

Of 357 individuals enrolled, 181 (50.7%) had been referred for T-LOC suspected to be syncope, 166 (46.5%) for unexplained falls, and 10 (2.8%) for both. An initially suspected diagnosis of syncope was confirmed in 158 (87.3%), and syncope was identified as the cause of the event in 75 (45.2%) of those referred for unexplained falls. Orthostatic hypotension was the cause of the event in 117 of 242 (48.3%) participants with a final diagnosis of syncope.

Conclusion

The simplified syncope diagnostic protocol can be used in elderly people with dementia referred for suspected syncope or unexplained falls. Unexplained falls may mask a diagnosis of syncope or pseudosyncope in almost 50% of cases. Given the high prevalence of orthostatic syncope in participants (~50%), a systematic reappraisal of drugs potentially responsible for orthostatic hypotension is warranted.

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FDA approves Epclusa for treatment of chronic Hepatitis C virus infection - FDA Press Releases

The U.S. Food and Drug Administration approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa is approved for use in combination with the drug ribavirin. Epclusa is a fixed-dose combination tablet containing sofosbuvir, a drug approved in 2013, and velpatasvir, a new drug, and is the first to treat all six major forms of HCV.

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Federal Court orders California soy company to cease production due to food safety violations - FDA Press Releases

The U.S. District Court for the Eastern District of California entered a consent decree of permanent injunction on Friday, June 24, 2016, between the U.S. Food and Drug Administration and Wa Heng Dou-Fu & Soy Sauce Corporation requiring the business to immediately cease manufacturing and distributing food until it comes into compliance with federal food safety laws.

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IKEA N.A. Services, LLC Issues Allergy Alert on Undeclared Milk, Almond, Hazelnut in the CHOKLAD MORK and CHOKLAD MORK 70% Dark Chocolate Bars, Net Wt. 3.5 oz. - FDA Safety Alerts & Drug Recalls

IKEA recalls CHOKLAD MORK UPC Code 100293927003 and CHOKLAD MORK 70% UPC Code 1203080940009 Dark Chocolate Bars, Net Wt. 3.5 oz. are being recalled due to undeclared Milk, Hazelnuts and Almonds.

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Purina Animal Nutrition Initiates Recall of Purina Medicated Sheep Feed due to Elevated Copper Level - FDA Safety Alerts & Drug Recalls

Purina Animal Nutrition LLC of Arden Hills, Minnesota, is voluntarily recalling one lot of Purina Lamb Grower B30 Medicated Sheep Feed packaged in the green and white generic paper LAND O LAKES Feed bags.

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Multimorbidity in Heart Failure: Effect on Outcomes - American Geriatric Society

Objectives

To investigate the effect of the number and type of comorbid conditions on death and hospitalizations in individuals with incident heart failure (HF).

Design

Population-based cohort study.

Setting

Olmsted County, Minnesota.

Participants

Olmsted County, Minnesota, residents with incident HF from 2000 to 2010 (mean age 76 ± 14, 56% female) (N = 1,714).

Measurements

The prevalence of 16 chronic conditions obtained at HF diagnosis classified into three groups: cardiovascular (CV) related, other physical, and mental.

Results

The mean number of conditions per participant was 2.6 ± 1.5 for CV-related conditions, 1.3 ± 1.1 for other physical conditions, and 0.30 ± 0.61 for mental conditions. After a mean follow-up of 4.2 years, 1,073 deaths and 6,306 hospitalizations had occurred. After adjustment for age, sex, ejection fraction, in- or outpatient status, and number of other conditions, an increase of one other physical condition was associated with a 14% (HR = 1.14, 95% CI = 1.08–1.20) greater risk of death and a 26% (HR = 1.26, 95% CI = 1.20–1.32) greater risk of hospitalization, and an increase of one mental condition was associated with a 31% (HR = 1.31, 95% CI = 1.19–1.44) greater risk of death and an 18% (HR = 1.18, 95% CI = 1.07–1.29) greater risk of hospitalization. In contrast, an increase of one CV-related condition was not associated with greater risk of death and was associated with a 10% (HR = 1.10, 95% CI = 1.06–1.15) greater risk of hospitalization.

Conclusion

CV-related conditions are the most common type of comorbid conditions in individuals with HF, but other physical and mental conditions are more strongly associated with death and hospitalizations. This underscores the effect of non-CV conditions on outcomes in HF.

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Small molecules modulating tumor–stromal cell interactions: new candidates for anti-tumor drugs - Journal of Antibiotics

Small molecules modulating tumor–stromal cell interactions: new candidates for anti-tumor drugs

The Journal of Antibiotics 69, 411 (June 2016). doi:10.1038/ja.2016.37

Author: Manabu Kawada

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Anthelmintic closantel enhances bacterial killing of polymyxin B against multidrug-resistant Acinetobacter baumannii - Journal of Antibiotics

Anthelmintic closantel enhances bacterial killing of polymyxin B against multidrug-resistant Acinetobacter baumannii

The Journal of Antibiotics 69, 415 (June 2016). doi:10.1038/ja.2015.127

Authors: Thien B Tran, Soon-Ee Cheah, Heidi H Yu, Phillip J Bergen, Roger L Nation, Darren J Creek, Anthony Purcell, Alan Forrest, Yohei Doi, Jiangning Song, Tony Velkov & Jian Li

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A small-molecule compound belonging to a class of 2,4-disubstituted 1,3,4-thiadiazine-5-ones suppresses Salmonella infection in vivo - Journal of Antibiotics

A small-molecule compound belonging to a class of 2,4-disubstituted 1,3,4-thiadiazine-5-ones suppresses Salmonella infection in vivo

The Journal of Antibiotics 69, 422 (June 2016). doi:10.1038/ja.2015.131

Authors: Ludmila N Nesterenko, Nailya A Zigangirova, Egor S Zayakin, Sergey I Luyksaar, Natalie V Kobets, Denis V Balunets, Ludmila A Shabalina, Tatiana N Bolshakova, Olga Y Dobrynina & Alexander L Gintsburg

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Synthesis and structure–activity relationships of novel lincomycin derivatives. Part 2. Synthesis of 7(S)-7-deoxy-7-(4-morpholinocarbonylphenylthio)lincomycin and its 3-dimensional analysis with rRNA - Journal of Antibiotics

Synthesis and structure–activity relationships of novel lincomycin derivatives. Part 2. Synthesis of 7(S)-7-deoxy-7-(4-morpholinocarbonylphenylthio)lincomycin and its 3-dimensional analysis with rRNA

The Journal of Antibiotics 69, 428 (June 2016). doi:10.1038/ja.2015.125

Authors: Yoshinari Wakiyama, Ko Kumura, Eijiro Umemura, Satomi Masaki, Kazutaka Ueda, Takashi Watanabe, Mikio Yamamoto, Yoko Hirai & Keiichi Ajito

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Synthesis and antibacterial activity of novel lincomycin derivatives. I. Enhancement of antibacterial activities by introduction of substituted azetidines - Journal of Antibiotics

Synthesis and antibacterial activity of novel lincomycin derivatives. I. Enhancement of antibacterial activities by introduction of substituted azetidines

The Journal of Antibiotics 69, 440 (June 2016). doi:10.1038/ja.2015.134

Authors: Ko Kumura, Yoshinari Wakiyama, Kazutaka Ueda, Eijiro Umemura, Takashi Watanabe, Eiki Shitara, Hideki Fushimi, Takuji Yoshida & Keiichi Ajito

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New phenazine analogues from Streptomyces sp. IFM 11694 with TRAIL resistance-overcoming activities - Journal of Antibiotics

New phenazine analogues from Streptomyces sp. IFM 11694 with TRAIL resistance-overcoming activities

The Journal of Antibiotics 69, 446 (June 2016). doi:10.1038/ja.2015.129

Authors: Mohamed S Abdelfattah, Naoki Ishikawa, Utpal K Karmakar, Kazuki Yamaku & Masami Ishibashi

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Isolation of growth inhibitors of the snow rot pathogen Pythium iwayamai from an arctic strain of Trichoderma polysporum - Journal of Antibiotics

Isolation of growth inhibitors of the snow rot pathogen Pythium iwayamai from an arctic strain of Trichoderma polysporum

The Journal of Antibiotics 69, 451 (June 2016). doi:10.1038/ja.2015.130

Authors: Miyu Kamo, Motoaki Tojo, Yusuke Yamazaki, Takeshi Itabashi, Hisashi Takeda, Daigo Wakana & Tomoo Hosoe

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Unantimycin A, a new neoantimycin analog isolated from a microbial metabolite fraction library - Journal of Antibiotics

Unantimycin A, a new neoantimycin analog isolated from a microbial metabolite fraction library

The Journal of Antibiotics 69, 456 (June 2016). doi:10.1038/ja.2015.124

Authors: Chung Liang Lim, Toshihiko Nogawa, Akiko Okano, Yushi Futamura, Makoto Kawatani, Shunji Takahashi, Darah Ibrahim & Hiroyuki Osada

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Amethysione and amethysamide, new metabolites from Streptosporangium amethystogenes BCC 27081 - Journal of Antibiotics

Amethysione and amethysamide, new metabolites from Streptosporangium amethystogenes BCC 27081

The Journal of Antibiotics 69, 459 (June 2016). doi:10.1038/ja.2015.128

Authors: Chollaratt Boonlarppradab, Chanwit Suriyachadkun, Sumalee Supothina & Pattiyaa Laksanacharoen

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Cell wall-affecting antibiotics modulate natural transformation in SigH-expressing Staphylococcus aureus - Journal of Antibiotics

Cell wall-affecting antibiotics modulate natural transformation in SigH-expressing Staphylococcus aureus

The Journal of Antibiotics 69, 464 (June 2016). doi:10.1038/ja.2015.132

Authors: Le Thuy Nguyen Thi, Veronica Medrano Romero & Kazuya Morikawa

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Structure and absolute configuration of drimentine I, an alkaloid from Streptomyces sp. CHQ-64 - Journal of Antibiotics

Structure and absolute configuration of drimentine I, an alkaloid from Streptomyces sp. CHQ-64

The Journal of Antibiotics 69, 467 (June 2016). doi:10.1038/ja.2015.133

Authors: Qian Che, Jing Li, Dehai Li, Qianqun Gu & Tianjiao Zhu

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Physician Orders for Life-Sustaining Treatment Medical Intervention Orders and In-Hospital Death Rates: Comparable Patterns in Two State Registries - American Geriatric Society

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Sunflower kernel recall impacts Nature Valley Protein Chewy Bars & Nature Valley Simple Nut Bars - FDA Safety Alerts & Drug Recalls

General Mills announced today a voluntary national recall of four specific flavors of Nature Valley Protein Chewy Bars and Nature Valley Simple Nut Bars. The recall is being issued as part of sunflower kernel supplier SunOpta’s ongoing national recall for the potential presence of Listeria monocytogenes. General Mills has not received any direct consumer reports of confirmed illnesses related to this supplier issue.

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Recall For Undeclared Allergen Taken as Part of FDA's Safety Advisory Regarding Grain Craft Flour Recall - FDA Safety Alerts & Drug Recalls

The Father's Table of Sanford, Florida, is voluntarily recalling 2,099 cases of cheesecakes sold by Gordon Food Service through retail and food service outlets under the GFS label as a result of a recall by one of The Father's Table's flour suppliers, Grain Craft.

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Creative Snacks Co. Issues Allergy Alert on Undeclared Peanuts and Soy in Select The Fresh Market Smoked TFM Supreme Nut Mix Bags - FDA Safety Alerts & Drug Recalls

Creative Snacks Co. of Greensboro, North Carolina has issued a precautionary recall on a small quantity of The Fresh Market 12.3 ounce Smoked TFM Supreme Nut Mix bags (UPC 00737094218386) due to the possibility of a mislabeled back label which does not declare Peanuts and Soy on the allergen statement but are included in the contents of the trail mix. According to the company, a total of 186 cases (2,604 units) produced on June 3, 2016 containing The Fresh Market Smoked TFM Supreme Nut Mix could include a label for The Fresh Market Lightly Salted TFM Supreme Nut Mix.

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Figi's Issues Recall Alert Due To Possible Health Risk - FDA Safety Alerts & Drug Recalls

Figi's Companies, Inc of Marshfield, WI is recalling the following 2 products that are related to the SunOpta sunflower kernel recall, because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

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Self-Reported Hearing in the Last 2 Years of Life in Older Adults - American Geriatric Society

Objectives

To assess the prevalence and correlates of self-reported hearing loss during the last 2 years of life.

Design

Observational cohort study.

Setting

The Health and Retirement Study (HRS), a longitudinal nationally representative cohort of adults aged 50 and older (2000–13).

Participants

Older adults (N = 5,895, mean age at death 78, 53% female, 20% nonwhite).

Measurements

The HRS interview closest to death was used (mean 12.2 months before death). Participants rated their hearing (excellent, very good, good, fair, poor) and indicated whether they used hearing aids. The prevalence and correlates of fair and poor ratings are described, adjusted for age and sex.

Results

Thirty-two percent (95% confidence interval (CI) = 31–34%) of all participants and 60% (95% CI = 57–64%) of the 7% of participants who used hearing aids rated their hearing as fair or poor. The prevalence of fair or poor hearing was highest in participants interviewed closest to death (29% 19–24 months before death, 36% 1–6 months before death, P for trend = .01). Correlates of fair or poor hearing during the last 2 years of life included age at death (50–59, 22%; 60–69, 21%; 70–79, 26%; 80–89, 38%; ≥90, 50%), sex (men 35%, women 30%), race and ethnicity (Hispanic 42%, white 33%), wealth (lowest quartile 38%, highest quartile 27%), history of heart disease (yes 38%, no 27%), activity of daily living dependence (yes 42%, no 26%), difficulty taking medications (yes 46%, no 29%), and probable dementia (yes 44%, no 24%).

Conclusion

Self-reported hearing loss increases during the last 2 years of life and is associated with physical and social vulnerability.

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Treatment Patterns with Antidementia Drugs in the United States: Medicare Cohort Study - American Geriatric Society

Objectives

To evaluate frequency of use of two anti-dementia drug classes approved for treatment of symptoms, whether populations most likely to benefit are treated, and correlates of treatment initiation.

Design

Nationally representative cohort study.

Setting

Fee-for-service Medicare.

Participants

Elderly adults with dementia enrolled in Medicare Parts A, B, and D in 2009 (N = 433,559) and a subset with incident dementia (n = 185,449).

Measurements

Main outcome was any prescription fill for antidementia drugs (cholinesterase inhibitors (ChEIs) or memantine) within 1 year.

Results

Treatment with antidementia drugs occurred in 55.8% of all participants with dementia and 49.3% of those with incident dementia. There was no difference between ChEIs and memantine use according to dementia severity (measured as death within first year or living in residential care vs in a community setting) even though memantine is not indicated in mild disease. In incident cases, initiation of treatment was lower in residential care (relative risk (RR) = 0.82, 95% confidence interval (CI) = 0.81–0.83) and with more comorbidities (RR = 0.96, 95% CI = 0.96–0.96). Sixty percent of participants were managed in primary care alone. Seeing a neurologist (RR = 1.07, 95% CI = 1.06–1.09) or psychiatrist (RR = 1.17, 95% CI = 1.16–1.19) was associated with higher likelihood of treatment than seeing a primary care provider alone, and seeing geriatrician was associated with with lower likelihood (RR = 0.96, 95% CI = 0.93–0.99). Across the United States, the proportion of newly diagnosed individuals started on antidementia treatment varied from 32% to 66% across hospital referral regions.

Conclusion

Antidementia drugs are used less often in people with late disease, but there is no differentiation in medication choice. Although primary care providers most often prescribe antidementia medication without specialty support, differences in practice between specialties are evident.

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Associations Between Delirium and Preoperative Cerebrospinal Fluid C-Reactive Protein, Interleukin-6, and Interleukin-6 Receptor in Individuals with Acute Hip Fracture - American Geriatric Society

Objectives

To examine whether delirium in individuals with hip fracture is associated with high C-reactive protein (CRP), interleukin-6 (IL-6), and soluble IL-6 receptor (sIL-6R) levels in the cerebrospinal fluid (CSF).

Design

Prospective cohort study.

Setting

Two university hospitals in Oslo, Norway, and Edinburgh, United Kingdom.

Participants

Individuals admitted with acute hip fracture (N = 151).

Measurements

Participants were assessed for delirium pre- and postoperatively using the Confusion Assessment Method. Prefracture cognitive impairment was detected using the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE). Serum was collected preoperatively and CSF just before the onset of spinal anesthesia. Cytokine levels in serum and CSF samples were determined using an enzyme-linked immunosorbent assay. Student t-tests or Mann–Whitney U-tests were used for between-group comparisons. Spearman rho was used for correlations.

Results

Sixty participants had prior cognitive impairment (IQCODE score ≥3.44). Delirium was diagnosed in 46 participants (77%) with prior cognitive impairment and 25 (29%) without. In participants without prior cognitive impairment, CSF CRP levels were higher in participants with delirium (median 0.05 μg/mL, interquartile range (IQR) 0.02–0.12 μg/mL) than in those without delirium (median 0.01 μg/mL, IQR 0.00–0.06 μg/mL) (P = .01); there were no differences in participants with prior cognitive impairment. In secondary analyses, in participants with prior cognitive impairment, the concentration of CSF sIL-6R was higher in those participants who developed delirium than in the other subgroups, but this difference was not statistically significant. Serum levels of CRP, IL-6, and sIL-6R were not different according to delirium in participants with or without prefracture cognitive impairment.

Conclusion

High CSF levels of CRP and sIL-6R may be associated with delirium. Different pathophysiological mechanisms may operate in different subgroups, notably in relation to the presence of prior cognitive impairment.

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Mondelēz Global LLC Conducts Nationwide Voluntary Recall of Limited Quantity of Honey Maid Teddy Grahams Cinnamon Cubs Product Sold in Foodservice Channels in the U.S. - FDA Safety Alerts & Drug Recalls

Mondelēz Global LLC announced today a nationwide voluntary recall in the United States of the Honey Maid Teddy Grahams Cinnamon Cubs Graham Snacks sold only in Foodservice channels (not supermarkets). This recall is being conducted out of an abundance of caution following notification of a wheat flour recall by Grain Craft, a third-party flour supplier to one of our external manufacturers due to the potential for undeclared low levels of peanut residue in the flour.

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Radagast Pet Food, Inc. Is Voluntarily Recalling Four Lots Of Frozen Rad Cat Raw Diet® Due To Possibly Salmonella And Listeria Monocytogenes Health Risk - FDA Safety Alerts & Drug Recalls

Radagast Pet Food, Inc. (Portland, OR) has announced a voluntary recall of four lots of frozen Rad Cat Raw Diet products, sold in 8oz., 16oz., and 24oz. tubs, and free 1oz sample cups, due to the potential to be contaminated with Salmonella and/or Listeria monocytogenes. Salmonella and Listeria monocytogenes can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

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Michael’s® Naturopathic Programs Issues Allergy Alert on Undeclared Milk and Soy in The Dietary Supplement Cholesterol Metabolism Factors™ - FDA Safety Alerts & Drug Recalls

Michael’s® Naturopathic Programs of San Antonio Texas is recalling certain lots of the dietary supplement Cholesterol Metabolism Factors™, because it may contain undeclared milk (in the form of calcium caseinate) and soy. People who have an allergy or severe sensitivity to milk and soy run the risk of serious or life-threatening allergic reaction if they consume these products.

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Atlantic Spice Recalls Sunflower Seeds Roasted Salted, Tropical Mix and Cranberry Health Mix Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Atlantic Spice Company Inc. of North Truro, MA, is recalling it’s 16 ounce packages of Sunflower Seeds Roasted Salted, Tropical Mix and Cranberry Health Mix snacks because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

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Bolthouse Farms Voluntarily Recalls Protein Beverages Due to Possible Spoilage - FDA Safety Alerts & Drug Recalls

Bolthouse Farms is voluntarily recalling a selection of protein drinks due to possible spoilage that may cause the beverages to appear lumpy, taste unpleasant and have an off odor.

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Snyder’s-Lance Is Issuing an Allergy Alert for Lance Oyster Crackers - FDA Safety Alerts & Drug Recalls

Snyder’s-Lance, Inc. is issuing a voluntary recall for certain code dates of their Lance brand Oyster Crackers. This action is the direct result of a recent recall by the wheat flour supplier, Grain Craft, due to certain lots of flour that may contain low levels of undeclared peanut residue. The Oyster Crackers subject to the recall may have been produced using the recalled flour and, as a result, this product may contain low levels of undeclared peanut residue.

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Kellogg Company Voluntarily Recalls Certain Graham Products - FDA Safety Alerts & Drug Recalls

GRAND RAPIDS, Mich. Kellogg Company is voluntarily recalling certain graham crumbs because they were made using Grain Craft flour which may have contained undeclared allergen peanut residue. To date, there have been no reported illnesses related to the affected product.

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An immunogen containing four tandem 10E8 epitope repeats with exposed key residues induces antibodies that neutralize HIV-1 and activates an ADCC reporter gene

An immunogen containing four tandem 10E8 epitope repeats with exposed key residues induces antibodies that neutralize HIV-1 and activates an ADCC reporter gene

Emerging Microbes & Infections 5, e65 (June 2016). doi:10.1038/emi.2016.86

Authors: Zhiwu Sun, Yun Zhu, Qian Wang, Ling Ye, Yanyan Dai, Shan Su, Fei Yu, Tianlei Ying, Chinglai Yang, Shibo Jiang & Lu Lu

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An outbreak of cutaneous anthrax in Yunnan, China

An outbreak of cutaneous anthrax in Yunnan, China

Emerging Microbes & Infections 5, e64 (June 2016). doi:10.1038/emi.2016.65

Authors: Ying Huang, Yingrong Du, Yaling Wang, Ning Wang, Jinsong Bai, Haiyun Chen, Hua He, Jun Xu, Yan Wu, Yun Luo, Xiaolong Li & Guodong Liang

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The emergence and outbreak of multidrug-resistant typhoid fever in China

The emergence and outbreak of multidrug-resistant typhoid fever in China

Emerging Microbes & Infections 5, e62 (June 2016). doi:10.1038/emi.2016.62

Authors: Meiying Yan, Xinlan Li, Qiaohong Liao, Fang Li, Jing Zhang & Biao Kan

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Cooperative effect of the VP1 amino acids 98E, 145A and 169F in the productive infection of mouse cell lines by enterovirus 71 (BS strain)

Cooperative effect of the VP1 amino acids 98E, 145A and 169F in the productive infection of mouse cell lines by enterovirus 71 (BS strain)

Emerging Microbes & Infections 5, e60 (June 2016). doi:10.1038/emi.2016.56

Authors: Carla Bianca Luena Victorio, Yishi Xu, Qimei Ng, Tao Meng, Vincent TK Chow & Kaw Bing Chua

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Has Rift Valley fever virus evolved with increasing severity in human populations in East Africa?

Has Rift Valley fever virus evolved with increasing severity in human populations in East Africa?

Emerging Microbes & Infections 5, e58 (June 2016). doi:10.1038/emi.2016.57

Authors: Marycelin Baba, Daniel K Masiga, Rosemary Sang & Jandouwe Villinger

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Marin Foods Specialties, Inc. Recalls Raw Macadamia Nuts Sold at Whole Foods Market® Stores in CA, NV, OR, and WA Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

Marin Foods Specialties, Inc. of Byron, CA, is recalling packaged raw macadamia nuts sold in California, Nevada, Oregon, and Washington Whole Foods Market stores due to possible Salmonella contamination. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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Pinnacle Foods Inc. Voluntarily Recalls Limited Quantity of C&W Early Harvest Petite Peas and C&W Petite Peas Due to Possible Listeria Contamination - FDA Safety Alerts & Drug Recalls

Pinnacle Foods Inc. is voluntarily recalling a limited number of C&W Early Harvest Petite Peas and C&W Petite Peas because they may contain Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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Greenland Trading Corporation Recalls Al Rasheed Sardine Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Greenland Trading Corporation of Paterson, New Jersey is recalling AI Rasheed Sardine, because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

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Dutch Treat Foods Recalls Sweet Pea Pasta Salad Because of Potential Health Risk - FDA Safety Alerts & Drug Recalls

Dutch Treat Foods, Inc., of Zeeland, MI, is voluntarily recalling 3087 pounds of Sweet Pea Pasta Salad due to one ingredient in the product being recalled by one of its suppliers. The product is being recalled due to the potential of being contaminated with listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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Eillien's Candies Inc. Voluntarily Recalls Various Sizes and Brands of Snack Products Containing Roasted-Salted Sunflower Kernels and Roasted-Unsalted Sunflower Kernels Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

Eillien's Candies Inc. , GREEN BAY, WI, is voluntarily recalling various snack products containing Roasted-Salted Sunflower Kernels and Roasted-Unsalted Sunflower Kernels because they have the potential to be contaminated with Listeria monocytogenes, an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

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Molly & Drew Voluntarily Recalls Three Lots of American Original Beer Bread Mix Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Molly & Drew of Sac City, IA is recalling three lots (L1215A, L1215B, and L1215C) of AMERICAN ORIGINAL BEER BREAD MIX sold in retail because it may be contaminated with E. coli O121 bacteria.

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Let's Do Lunch, Inc., dba Integrated Food Service, Voluntarily Recalls Certain Ready-To-Eat Sandwiches Because Of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Let’s Do Lunch, Inc., dba Integrated Food Service (IFS), is voluntarily recalling certain ready-to-eat sandwiches because they have the potential to be contaminated with Listeria monocytogenes. No illnesses have been reported to date.

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Fresh Express Issues Precautionary Recall of a Small Quantity of Caesar Salad Kits Due to an Undeclared Walnut Allergen - FDA Safety Alerts & Drug Recalls

Fresh Express Incorporated issued a precautionary recall of a small quantity of 7.6 ounce net weight Fresh Express Caesar Salad Kits when it was learned that two bags of salad kits were mistakenly packed with incorrect condiments including walnuts, a tree nut allergen. According to the company, a total of 2,449 cases could possibly contain the wrong condiment packet and are subject to the precautionary recall.

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National Frozen Foods Corporation Recalls Frozen Green Peas and Frozen Mixed Vegetables Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

National Frozen Foods Corporation of Seattle, WA, is voluntarily recalling a limited quantity of Not-Ready-To Eat frozen green peas and frozen mixed vegetables because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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Green Cuisine Recalls Pesto Pasta Salad with Arugula Sold in Select Whole Foods Market Stores Due to Potential Health Risk - FDA Safety Alerts & Drug Recalls

Green Cuisine is initiating a voluntary recall of "Pesto Pasta Salad with Arugula" because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

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HP Hood LLC Voluntarily Recalls Protein Drinks From Its Sacramento Facility Due To Premature Spoilage - FDA Safety Alerts & Drug Recalls

Out of an abundance of caution and with an emphasis on its customers' wellness and safety, HP Hood LLC of Lynnefield, MA, is voluntarily recalling certain code dates of protein drinks from its Sacramento, CA, facility, due to the potential for premature product spoilage.

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Tippin's Gourmet Pies, LLC Announces the Recall of Tippin's Key Lime Pie for the Presence of Undeclared Peanut Residue Due to Supplier Recall - FDA Safety Alerts & Drug Recalls

Tippin’s Gourmet Pies, LLC of Kansas City, KS, today is voluntarily recalling select Key Lime Pies because they may contain flour with undeclared peanut residue. Tippin's initiated the recall after we became aware that our supplier, Kellogg Company, was conducting a recall of graham cracker crumbs because they may contain undeclared peanut residue.

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GMJ Natural Products, Inc. Issues Allergy Alert on Undeclared Whey Protein in "Jugo Moringa Plus Antioxidant 32 Fl Oz Jug" - FDA Safety Alerts & Drug Recalls

GMJ Natural Products Inc. of Anaheim, Ca, is recalling its 32 fl oz jugs of Jugo Moringa Plus Antioxidant because they may contain undeclared whey protein. People who have allergies to milk or soy lecithin run the risk of serious or life-threatening allergic reaction if they consume these products.

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Earnest Eats Recalls Earnest Eats Dark Chocolate Almond Chewy Granola Bars Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Earnest Eats of Solana Beach, CA, is voluntarily recalling Earnest Eats Dark Chocolate Almond Bars 6.2 oz. cartons only with the specific lot codes indicated below because they contain sunflower seeds that have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

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Gardner Pie Company Issues Allergy Alert on Cheesecakes and Key Lime Pies Sold Between 4/11/16 and 6/14/16 Due to Potential Undeclared Peanut Residue - FDA Safety Alerts & Drug Recalls

Gardner Pie Company of Akron, Ohio is recalling Cheesecakes and Key Lime Pies sold in our Retail Outlet store between 4/11/2016 and 6/14/2016, because they may contain undeclared peanut residue. While those who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume products containing peanut allergens, the FDA has stated that the amount of peanut exposure from use of the flours and affected products is considered to be low and not expected to cause adverse reactions in the vast majority of peanut allergic consumers.

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Kashi Company Expands Date Codes of Two Products Related to Previously Announced Recall of Snack Bars and Bear Naked Granola - FDA Safety Alerts & Drug Recalls

Kashi Company of Solana Beach, Calif., is amending the date codes for Kashi GOLEAN Honey Pecan Baklava Bars and Bear Naked Soft Baked Granola, Cinnamon + Sunflower Butter related to its previously announced recall of snack bars and granola that contain ingredients made from sunflower seeds distributed by its supplier, SunOpta, that have the potential to be contaminated with Listeria monocytogenes.

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Zupan's Markets Initiates Voluntary Recall of Macaroni Salad With Cheddar Cheese Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Zupan's Markets is initiating a voluntary recall of its Macaroni Salad with Cheddar Cheese because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

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Essential Foods Recalls Four Flavors of Globespun Gourmet Wraps Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Essential Foods Inc. of Seattle, Washington is voluntarily recalling four flavors of Globespun Gourmet 8oz wraps because an ingredient (peas) has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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Kroger Supplier Expands Sunflower Products Recall - FDA Safety Alerts & Drug Recalls

The Kroger Co. of Cinncinati, OH, today announced it has expanded a recall of several products that may be contaminated with Listeria monocytogenes following supplier SunOpta's expansion of its voluntary recall this week. Earlier this month, SunOpta indicated its sunflower kernels may be contaminated with Listeria monocytogenes, an organism which could result in severe illness to those individuals who may consume these products.

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Crescent Specialty Foods Inc. Recalls Raw Pistachios Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Crescent Specialty Foods, Inc. of Everett, WA is voluntarily recalling 6 oz. bags of Crescent Pistachio Raw, UPC Code: 8 95296 00103 5 because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

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HelloFresh Recalls Frozen Peas Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

HelloFresh of New York, N.Y. is recalling frozen peas due to notification from a supplier that the peas have the potential to be contaminated with Listeria monocytogenes. The peas were included in HelloFresh recipe kits delivered the week of June 11-15, 2016 and the weeks of March 12-25, 2016.

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Disparities in Age-Associated Cognitive Decline Between African-American and Caucasian Populations: The Roles of Health Literacy and Education - American Geriatric Society

Objectives

To examine health literacy as a mediator of racial disparities in cognitive decline as measured by executive function in elderly adults.

Design

Prospective cohort study.

Setting

Secondary analysis of ElderWalk trial in Boston, Massachusetts.

Participants

English-speaking African-American and Caucasian individuals in a walking intervention for community-dwelling adults aged 65 and older without dementia at baseline who completed baseline and 12-month evaluations (N = 198).

Measurements

Health literacy was measured using the Short Test of Functional Health Literacy in Adults. Fluid and crystallized cognitive functions were measured at baseline and 12 months using the Trail-Making Test Part B minus Part B (TMT B–A) and the Controlled Oral Word Association Test (COWAT). Associations between health literacy and 12-month cognitive decline were modeled using multivariate linear regression.

Results

Participants with higher health literacy and education experienced less cognitive decline than those with limited health literacy according to the TMT B–A (P = .01). After adjusting for covariates, Caucasian participants (n = 63) experienced less decline than African-American participants (n = 135) on TMT B–A (P = .001) and COWAT (P = .001). Adjusting for health literacy led to a 25.3% decrease in the point estimate for racial difference in TMT B–A and a 19.5% decrease in COWAT. Although independently related to cognitive decline, educational attainment did not mediate racial differences.

Conclusion

Health literacy is a partial mediator of racial disparities in cognitive decline. These results indicate the need to develop interventions to mitigate cognitive decline that individuals with low heath literacy can use and to modify the healthcare environment to better accommodate this population.

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Identifying Patterns of Multimorbidity in Older Americans: Application of Latent Class Analysis - American Geriatric Society

Objectives

To define multimorbidity “classes” empirically based on patterns of disease co-occurrence in older Americans and to examine how class membership predicts healthcare use.

Design

Retrospective cohort study.

Setting

Nationally representative sample of Medicare beneficiaries in file years 1999–2007.

Participants

Individuals aged 65 and older in the Medicare Beneficiary Survey who had data available for at least 1 year after index interview (N = 14,052).

Measurements

Surveys (self-report) were used to assess chronic conditions, and latent class analysis (LCA) was used to define multimorbidity classes based on the presence or absence of 13 conditions. All participants were assigned to a best-fit class. Primary outcomes were hospitalizations and emergency department visits over 1 year.

Results

The primary LCA identified six classes. The largest portion of participants (32.7%) was assigned to the minimal disease class, in which most persons had fewer than two of the conditions. The other five classes represented various degrees and patterns of multimorbidity. Usage rates were higher in classes with greater morbidity, but many individuals could not be assigned to a particular class with confidence (sample misclassification error estimate = 0.36). Number of conditions predicted outcomes at least as well as class membership.

Conclusion

Although recognition of general patterns of disease co-occurrence is useful for policy planning, the heterogeneity of persons with significant multimorbidity (≥3 conditions) defies neat classification. A simple count of conditions may be preferable for predicting usage.

from Journal of the American Geriatrics Society http://ift.tt/1XrGdJb
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Associations Between Inflammation and Physical Function in African Americans and European Americans with Prevalent Cardiovascular Risk Factors - American Geriatric Society

Objectives

To examine associations between inflammation and physical function and potential mediation by white matter hyperintensities (WMHs) in African Americans (AAs) and European Americans (EAs).

Design

Cross-sectional analysis using linear and logistic models with generalized estimating equations to account for family clustering, reporting results as regression coefficients (β) and odds ratios (ORs) adjusted for education, alcohol, exercise, body mass index, hypertension, diabetes mellitus, heart disease, cognition, ankle–brachial index, race (site), and supported interactions.

Setting

Genetic Epidemiology Network of Arteriopathy-Genetics of Microangiopathic Brain Injury Study cohort.

Participants

AA and EA sibships with two or more siblings with hypertension before age 60 (N = 1,960; 65% female, 51% AA, aged 26–91, 50% obese, 72% hypertensive).

Measurements

Inflammation (C-reactive protein (CRP), interleukin-6 (IL6), soluble tumor necrosis factor receptors (sTNFRs) 1 and 2, WMH volume (cm³) according to magnetic resonance imaging), walking speed (cm/s) over 25 feet, and mobility difficulty (any self-reported difficulty walking half a mile).

Results

In separate models, inflammatory markers were associated with walking speed (sTNFR1: β = −2.74, P < .001; sTNFR2: β = −1.23, P = .03; CRP: β = −1.95, P = .001; IL6: β = −1.24, P = .03) and mobility difficulty (sTNFR1: OR = 1.36, P = .001; sTNFR2: OR = 1.25, P = .005; CRP: OR = 1.22, P = .005; IL6: OR = 1.18, P = .02); the association between WMH volume and sTNFR1 in AA (β = 0.07, P = .06) did not reach typical statistical thresholds. WMH volume was associated with walking speed in AA (β = −3.17, P = .02) but not with mobility difficulty (OR = 1.10, P = .54). Adjusting for WMH did not change associations.

Conclusion

In young, middle-aged, and older adults with prevalent cardiovascular risk factors, multiple inflammatory biomarkers were associated with slower walking speed independent of microvascular disease in the brain. There was little evidence of mediation by brain WMH volume. Inflammation may contribute to physical function impairments through pathways other than brain microvascular disease, particularly in AAs.

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Comparison of Frailty Phenotypes for Prediction of Mortality, Incident Falls, and Hip Fracture in Older Women - American Geriatric Society

Objectives

To compare the ability of the commonly used Women's Health Initiative (WHI) and Cardiovascular Health Study (CHS) frailty phenotypes to predict falls, hip fracture, and death in WHI Clinical Trial participants aged 65 and older.

Design

Longitudinal cohort study.

Setting

WHI Clinical Trial.

Participants

Participants with data for WHI and CHS frailty phenotypes (N = 3,558).

Measurements

Frailty was operationally defined in the CHS as the presence of three or more of weight loss, poor energy, weakness, slowness, and low physical activity. WHI operationalized frailty similarly but with the RAND-36 physical function scale substituted for slowness and weakness (RAND-36 physical function scale score <13 = 2 points, 13–78 = 1 point, >78 = 0 points). Frailty was defined as a summary score of 3 or greater, prefrailty as a score of 2 or 1, and nonfrailty as a score of 0. Outcomes were modeled using Cox regression. Harrell C-statistics were compared for models containing alternative instruments.

Results

Approximately 5% of participants were frail based on the CHS or WHI phenotype. The WHI frailty phenotype was associated with higher rates of falls (hazard ratio (HR) = 1.48, P = .003), hip fracture (HR = 1.87, P = .04), and death (HR = 2.32, P < .001). Comparable HRs in CHS-phenotype frail women were 1.32 (P = .04), 1.08 (P = .83), and 1.91 (P < .001), respectively. Harrell C-statistics revealed marked but insignificant differences in predicting abilities between CHS and WHI phenotype models (P > .50 for all).

Conclusion

The WHI phenotype, which does not require direct measurements of physical performance, might offer a practical advantage for epidemiological and clinical needs.

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Markers of Overall Nutritional Status and Incident Hearing Impairment in Community-Dwelling Older Japanese: The Kurabuchi Study - American Geriatric Society

Objectives

To examine the association between four markers of overall nutritional status (a serum biomarker (albumin) and three anthropometric indices (body mass index (BMI), midarm circumference (MAC), calf circumference (CC))) and incident hearing impairment in older Japanese adults.

Design

Community-based prospective cohort study.

Setting

Kurabuchi Town, Gunma Prefecture, Japan.

Participants

Individuals aged 65 and older (143 men, 195 women) without hearing impairment at baseline examination (2005–06) who participated in repeated examinations 4 years later (2009–10) (N = 338).

Measurements

The three anthropometric indices were measured at baseline, and nephelometry was used to assess serum albumin levels. Hearing impairment was defined as failure to hear a 30-dB hearing level signal at 1 kHz and a 40-dB signal at 4 kHz in the better ear on pure-tone audiometry.

Results

Over the 4-year period, 16.3% of participants developed hearing impairment. Those with lower marker values had greater risk of hearing impairment than those with higher marker values (multivariable adjusted odds ratio (aOR) = 2.18, 95% confidence interval (CI) = 1.05–4.57 for albumin ≤4.0 g/dL; aOR = 2.72, 95% CI = 1.10–6.71 for BMI <19.0 kg/m²). The pattern of association showed a similar tendency for MAC and CC. Excluding obese participants did not changed the results substantially.

Conclusion

Further research is needed to determine whether interventions that improve markers of nutritional status may help prevent age-related hearing loss in older adults.

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Armour-Eckrich Meats Recalls Armour Snackmakers Keebler Animal Crackers Due to the Presence of Undeclared Peanut Residue - FDA Safety Alerts & Drug Recalls

Armour-Eckrich Meats LLC, of Lisle, IL, today announced that it is voluntarily recalling Armour Snackmakers Keebler Animal Crackers because they contain animal cracker cookies with undeclared peanut residue.

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Better Outcomes for Dually Eligible Older Adults through Integrated Care - CMS Blog

By Sean Cavanaugh, CMS Deputy Administrator and Director, Center for Medicare; Tim Engelhardt, Director, Medicare-Medicaid Coordination Office; and Vikki Wachino, CMS Deputy Administrator and Director, Center for Medicaid and CHIP Services

For decades policymakers have hypothesized that better integration of Medicare and Medicaid services could help improve health outcomes for people enrolled in both programs. Since the passage of the Affordable Care Act, the Centers for Medicare & Medicaid Services (CMS) has focused on promoting integrated care and developing new payment and service delivery models for dually eligible beneficiaries. Now the evidence is stronger than ever: integrated care is improving outcomes.

Today, the Department of Health and Human Services (HHS) published a report about the Minnesota Senior Health Options (MSHO) program. CMS and the State of Minnesota started MSHO as a pilot in 1997 to better serve dually eligible beneficiaries age 65 and older. MSHO plans coordinate all the Medicare and Medicaid benefits their members receive, including Medicare coverage of acute medical care and Medicaid coverage of long-term services and supports. Over the years, MSHO has been a platform for delivery system reform within Minnesota.

The new report gives us the clearest view yet into MSHO’s effectiveness. The HHS Assistant Secretary for Planning and Evaluation contracted with RTI International to evaluate MSHO’s outcomes from 2010 to 2012. RTI compared the experiences of similar beneficiaries inside and outside of MSHO and found that MSHO enrollees were:

• 48 percent less likely to have a hospital stay, and those who were hospitalized had 26 percent fewer stays;
• 6 percent less likely to have an outpatient emergency department visit, and those who did visit an emergency department had 38 percent fewer visits; and
• 13 percent more likely to receive home and community-based long term care services.

In 2013, CMS made investments to further strengthen the existing MSHO program through increased alignment of Medicare and Medicaid program administration, federal-state data sharing, and beneficiary materials. CMS is also partnering with 12 other states to implement and evaluate new models of integrated care similar to MSHO through the Financial Alignment Initiative. From 2011 to 2015, the number of dually eligible beneficiaries served in integrated care programs across the country rose from approximately 162,000 to more than 650,000.

Integrated care is improving the lives of some of the most vulnerable Americans. These new findings from Minnesota affirm the promise of integrated care and reinforce the urgency with which we need to continue to develop, test, and scale successful models for better serving dually eligible individuals.

The report can be found at: http://ift.tt/1ZTP30g

Filed under: Uncategorized

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Sinosharp Issues Allergy Alert on Undeclared Milk Allergens in "Chocolate Flavored Cookies" - FDA Safety Alerts & Drug Recalls

Sinosharp Import & Export Co., Ltd of Ridgewood, NY, is recalling its 13.74 oz and 2.2 lbs packages of "Chocolate Flavored Cookies" because this product contains undeclared milk allergens. Consumers who are allergic to milk may run the risk of serious or life-threatening allergic reactions if they consume this product.

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Frito-Lay Issues Allergy Alert on Undeclared Milk In Select Spicy Sweet Chili Doritos Tortilla Chips - FDA Safety Alerts & Drug Recalls

Frito-Lay announced a limited voluntary recall of select Spicy Sweet Chili Doritos tortilla chips because they may contain undeclared milk ingredients. People who have an allergy or severe sensitivity to milk run the risk of a serious or life threatening allergic reaction if they consume the affected Spicy Sweet Chili Doritos tortilla chips. The recalled product also includes additional undeclared ingredients including Yellow 5, Artificial Flavor, Tomato Powder, other Artificial Color (including Yellow 6 and Red 40), Lactic Acid, Citric Acid and Red and Green Bell Pepper Powder.

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Skin Cancer in U.S. Elderly Adults: Does Life Expectancy Play a Role in Treatment Decisions? - American Geriatric Society

Objectives

To examine whether life expectancy influences treatment pattern of nonmelanoma skin cancer, or keratinocyte carcinoma (KC), the most common malignancy and the fifth most costly cancer to Medicare.

Design

Nationally representative cross-sectional study.

Setting

Nationally representative Health and Retirement Study linked to Medicare claims.

Participants

Treatments (N = 9,653) from individuals aged 65 and older treated for basal or squamous cell carcinoma between 1992 and 2012 (N = 2,702) were included.

Measurements

Limited life expectancy defined according to aged 85 and older, medical comorbidities, Charlson Comorbidity Index score of 3 or greater, difficulty in at least one activity of daily living (ADL), and a Lee index of 13 or greater. Treatment type (Mohs micrographic surgery (MMS) (most intensive, highest cost), excision, or electrodesiccation and curettage (ED&C) (least intensive, lowest cost)), according to procedure code.

Results

Most KCs (61%) were treated surgically. Rates of MMS (19%), excision (42%), and ED&C (39%) were no different in participants with limited life expectancy and those with normal life expectancy. For example, 19% of participants with difficulty or dependence in ADLs, 20% of those with a Charlson comorbidity score greater than 3, and 15% of those in their last year of life underwent MMS; participants who died within 1 year of diagnosis were treated in the same way as those who lived longer.

Conclusion

A one-size-fits-all approach in which advanced age, health status, functional status, and prognosis are not associated with intensiveness of treatment appears to guide treatment for KC, a generally nonfatal condition. Although intensive treatment of skin cancer when it causes symptoms may be indicated regardless of life expectancy, persons with limited life expectancy should be given choices to ensure that the treatment matches their goals and preferences.

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