ICAPP Voluntarily Recalls Certain Lots of Frozen Strawberries - FDA Safety Alerts & Drug Recalls

The International Company for Agricultural Production & Processing (ICAPP) is voluntarily recalling certain lots of its frozen strawberries out of an abundance of caution in response to a U.S. Food and Drug Administration (FDA) investigation of an outbreak of Hepatitis A.

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Mondelēz Global LLC Conducts Nationwide Voluntary - Recall of Oreo Fudge Cremes Product Sold in the U.S. Recall Due to Milk Allergen Not Listed in Ingredient Line - FDA Safety Alerts & Drug Recalls

Mondelez Global LLC of East Hanover, NJ, announced today a nationwide voluntary recall in the United States, including the U.S. Territories of Puerto Rico, St. Croix and St. Thomas, of certain Oreo Fudge Cremes product, Original and Mint varieties, due to milk allergen not being declared in the ingredient list. Mondelez Global LLC is taking this action out of an abundance of caution.

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FDA approves new device for prevention of recurrent strokes in certain patients - FDA Press Releases

The U.S. Food and Drug Administration today approved the Amplatzer PFO Occluder device. The PFO Occluder reduces the risk of a stroke in patients who previously had a stroke believed to be caused by a blood clot that passed through a small hole in the heart, called a patent foramen ovale (PFO), and then traveled to the brain.

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CMS Announces Updates to Dialysis Facility Compare: Patient Experience Ratings Now Available - CMS Blog

By: Kate Goodrich, M.D., Director, Center for Clinical Standards and Quality

Today, the Centers for Medicare & Medicaid Services (CMS) announced changes to the Dialysis Facility Compare (DFC) website on Medicare.gov, which provides information about thousands of Medicare-certified dialysis facilities across the country, including how well those centers deliver care to patients.

These changes are in direct response to the important feedback CMS has received from dialysis patients and their caregivers about what is most important to them in selecting their dialysis facility. CMS remains committed to seeking and incorporating input from all stakeholders, but especially patients, on an ongoing basis so that we can continually improve our Compare sites and make health care quality information more transparent and understandable for patients and their caregivers.

Since the initial release of the Dialysis Facility Compare website, patients have emphasized in their feedback to CMS that understanding how others like them view a dialysis center— in particular the cleanliness of the facility and how well the staff cares for them— is valuable information when choosing a facility. As a result, visitors to the updated Dialysis Facility Compare website will now be able to see how patients rate their experiences with dialysis facilities.

CMS collects patient experience data though the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH-CAHPS) Survey, which measures patients’ perspectives on the care they received at dialysis facilities. A total of six ratings on patients’ experiences with care will be reported, including three that cover specific aspects of patient experience and three overall patient ratings of the kidney doctors, the facility staff and the dialysis facilities. For each dialysis center on Dialysis Facility Compare, the site will include this patient experience information, the quality star rating, and detailed clinical quality information.

CMS is also adding two quality measures to Dialysis Facility Compare:

• The standardized infection ratio (SIR) is a ratio of the number of bloodstream infections that are observed at a facility versus the number of bloodstream infections that are predicted for that facility, based on national baseline data.
• The pediatric peritoneal dialysis Kt/V measure equals the percent of eligible pediatric peritoneal dialysis patients at the facility who had enough waste removed from their blood during dialysis.

Other major changes to the site include modifications to the methodology for calculating dialysis facility star ratings based on recommendations from a 2015 Technical Expert Panel. The updated methodology for calculating star ratings:

• Establishes a baseline to show improvement by taking into account year-to-year changes in facility performance on the quality measures compared to performance standards set in a baseline year. Star ratings will reflect if a facility improves (or declines) in performance over time.
• Limits the impact of a few very low scores by applying a statistical method called truncated z-scores to percentage measures. This ensures that star ratings are not determined by extreme outlier performance on a single measure.
• Ensures accuracy of ratings by keeping the continuity of the measures.

A final change to the DFC website relates to ratio measures:

• The Standardized Mortality Ratio, Standardized hospitalization Ratio, Standardized Transfusion Ratio, and Standardized Readmission Ratio will now be reflected as rates to display them more clearly.

These changes reflect CMS’ ongoing commitment to making sure that Dialysis Facility Compare meets the needs of individuals with kidney disease and their caregivers. This Compare website and today’s updates are part of the agency’s larger effort to make health care quality information more transparent and understandable for consumers.  As part of that effort, CMS also has other Compare websites to help in selecting providers across the continuum of care, including Home Health Compare, Hospital Compare, Nursing Home Compare, and Physician Compare.

For more information, see the fact sheet: http://ift.tt/2dORaF4

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Malnutrition and Risk of Structural Brain Changes Seen on Magnetic Resonance Imaging in Older Adults - American Geriatric Society

Objectives

To study the associations between protein energy malnutrition, micronutrient malnutrition, brain atrophy, and cerebrovascular lesions.

Design

Cross-sectional.

Setting

Geriatric outpatient clinic.

Participants

Older adults (N = 475; mean age 80 ± 7).

Measurements

Nutritional status was assessed using the Mini Nutritional Assessment (MNA) and according to serum micronutrient levels (vitamins B1, B6, B12, D; folic acid). White matter hyperintensities (WMHs), global cortical brain atrophy, and medial temporal lobe atrophy on magnetic resonance imaging (MRI) were rated using visual rating scales. Logistic regression analyses were performed to assess associations between the three MNA categories (<17, 17–23.5, ≥23.5) and micronutrients (per SD decrease) and WMHs and measures of brain atrophy.

Results

Included were 359 participants. Forty-eight participants (13%) were malnourished (MNA <17), and 197 (55%) were at risk of malnutrition (MNA = 17–23.5). Participants at risk of malnutrition (odds ratio (OR) = 1.93, 95% confidence interval (CI) = 1.01–3.71) or who were malnourished (OR = 2.80, 95% CI = 1.19–6.60) had a greater probability of having severe WMHs independent of age and sex than those with adequate nutritional status. Results remained significant after further adjustments for cognitive function, depressive symptoms, cardiovascular risk factors, history of cardiovascular disease, smoking and alcohol use, and micronutrient levels. Lower vitamin B1 (OR = 1.51, 95% CI = 1.11–2.08) and B12 (OR = 1.45, 95% CI = 1.02–2.04) levels were also related to greater risk of severe WMHs, independent of age and sex. Results remained significant after additional adjustments. MNA and vitamin levels were not associated with measures of brain atrophy.

Conclusion

Malnutrition and lower vitamin B1 and B12 levels were independently associated with greater risk of WMHs. Underlying mechanisms need to be further clarified, and whether nutritional interventions can modify these findings also needs to be studied.

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Back to Nature Issues a Product Recall and Allergy Alert for Chocolate Chunk Cookies, Mini Chocolate Chunk Cookies and Chocolate Granola Due to Undeclared Milk - FDA Safety Alerts & Drug Recalls

Back to Nature Foods, LLC is voluntarily recalling four (4) products because those products contain chocolate purchased from a third party supplier which was found to contain undeclared Milk that is not listed as an ingredient on the label.

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Development of Quality Indicators to Address Abuse and Neglect in Home-Based Primary Care and Palliative Care - American Geriatric Society

Objectives

To develop candidate quality indicators (QIs) for the quality standard of “addressing abuse and neglect” in the setting of home-based medical care.

Design

Systematic literature review of both the peer-reviewed and gray literature.

Setting

Home-based primary and palliative care practices.

Participants

Homebound community-dwelling older adults.

Measurements

Articles were identified to inform the development of candidate indicators of the quality by which home-based primary and palliative care practices addressed abuse and neglect. The literature guided the development of patient-level QIs and practice-level quality standards. A technical expert panel (TEP) representing exemplary home-based primary care and palliative care providers then participated in a modified Delphi process to assess the validity and feasibility of each measure and identify candidate QIs suitable for testing in the field.

Results

The literature review yielded 4,371 titles and abstracts that were reviewed; 25 publications met final inclusion criteria and informed development of nine candidate QIs. The TEP rated all but one of the nine candidate indicators as having high validity and feasibility.

Conclusion

Translating the complex problem of addressing abuse and neglect into QIs may ultimately serve to improve care delivered to vulnerable home-limited adults who receive home-based medical care.

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Regional Nerve Blocks Improve Pain and Functional Outcomes in Hip Fracture: A Randomized Controlled Trial - American Geriatric Society

Objectives

To compared outcomes of regional nerve blocks with those of standard analgesics after hip fracture.

Design

Multisite randomized controlled trial from April 2009 to March 2013.

Setting

Three New York hospitals.

Participants

Individuals with hip fracture (N = 161).

Intervention

Participants were randomized to receive an ultrasound-guided, single-injection, femoral nerve block administered by emergency physicians at emergency department (ED) admission followed by placement of a continuous fascia iliaca block by anesthesiologists within 24 hours (n = 79) or conventional analgesics (n = 82).

Measurements

Pain (0–10 scale), distance walked on Postoperative Day (POD) 3, walking ability 6 weeks after discharge, opioid side effects.

Results

Pain scores 2 hours after ED presentation favored the intervention group over controls (3.5 vs 5.3, P = .002). Pain scores on POD 3 were significantly better for the intervention than the control group for pain at rest (2.9 vs 3.8, P = .005), with transfers out of bed (4.7 vs 5.9, P = .005), and with walking (4.1 vs 4.8, P = .002). Intervention participants walked significantly further than controls in 2 minutes on POD 3 (170.6 feet, 95% confidence interval (CI) = 109.3–232 vs 100.0 feet, 95% CI = 65.1–134.9; P = .04). At 6 weeks, intervention participants reported better walking and stair climbing ability (mean Functional Independence Measure locomotion score of 10.3 (95% CI = 9.6–11.0) vs 9.1 (95% CI = 8.2–10.0), P = .04). Intervention participants were significantly less likely to report opioid side effects (3% vs 12.4%, P = .03) and required 33% to 40% fewer parenteral morphine sulfate equivalents.

Conclusion

Femoral nerve blocks performed by emergency physicians followed by continuous fascia iliaca blocks placed by anesthesiologists are feasible and result in superior outcomes.

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Reducing Hospital Readmission Disparities of Older Black and White Adults After Elective Joint Replacement: The Role of Nurse Staffing - American Geriatric Society

Objectives

To examine racial differences in readmissions of older adults undergoing elective total hip and knee replacement, to determine the relationship between nurse staffing and readmission, and to study whether the relationship between staffing and readmission differs for older black and white adults.

Design

Cross-sectional analysis of multiple linked secondary data sources.

Setting

Nonfederal acute care hospitals in California, Florida, New Jersey, and Pennsylvania (n = 483).

Participants

Patients aged 65 and older undergoing elective total hip or total knee replacement (N = 106,848; n = 102,762 white, n = 4,086 black).

Measurements

Unplanned readmission within 30 days of discharge.

Results

Older black patients were more likely to have an unplanned readmission (7.5%) than their white counterparts (5.6%). Even after adjusting for patient- and hospital-level factors, older black patients had 40% greater likelihood of readmission (odds ratio (OR) = 1.40, 95% confidence interval (CI) = 1.21–1.61). Each additional patient per nurse was associated with 8% greater odds of readmission for older white patients (OR = 1.08, 95% CI = 1.01–1.15) and 15% greater odds for older black patients (OR = 1.15, 95% CI = 1.08–1.22) after adjusting for patient- and hospital-level factors.

Conclusion

Older minorities are more likely than their white counterparts to experience an unplanned readmission after elective orthopedic surgery. More-favorable nurse staffing was associated with lower odds of readmission of older black and white patients, but better-staffed hospitals had a greater protective effect for older black patients.

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A Brief Dietary Assessment Predicts Executive Dysfunction in an Elderly Cohort: Results from the Einstein Aging Study - American Geriatric Society

Objectives

To examine the association between diet and executive function, episodic memory and global verbal cognition in the Einstein Aging Study (EAS) cohort and determine whether race modifies this relationship.

Design

Cross-sectional.

Setting

Community.

Participants

EAS participants without dementia who completed the Rapid Eating and Activity Assessment for Patients (REAP) (N = 492).

Measurements

The previously validated REAP is based on the 2000 U.S. dietary guidelines. REAP scores were dichotomized as less-healthy (<median) or healthier (≥median) diet. Nine neurocognitive tests underwent principle component analysis, revealing three significant orthogonal components: episodic memory, executive function, and global cognition. Impaired cognitive function in each domain was defined as 2 standard deviations (SD) or more below the mean on any task or a total score of 1.5 SD or more below the mean. Using logistic regression, the association between diet and cognitive impairment was assessed, adjusting for age, education, sex, cardiovascular comorbidities, hypertension, body mass index, diabetes mellitus, depressive symptoms, race, and the interaction between race and diet group.

Results

The sample was 60% female and 74% white and had a mean age of 80. In the entire sample, impaired executive function was associated with the interaction between race and diet group (P = .08), whereas other cognitive domains were not. In race-stratified analyses, healthier diet was associated with lower odds of impaired executive function in whites (odds ratio (OR) = 0.44, 95% confidence interval (CI) = 0.21–0.93, P = .03), as were healthier scores on the saturated fat subscale (OR = 0.34, 95% CI = 0.16–0.71, P = .004). In blacks, REAP scores were not associated with cognitive domains.

Conclusion

Healthy diet was associated with lower risk of executive dysfunction in whites. Race differences may be due to greater vascular risk in blacks or differences in generalizability of the REAP.

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Effect of a Long-Term Physical Activity Intervention on Resting Pulse Rate in Older Persons: Results from the Lifestyle Interventions and Independence for Elders Study - American Geriatric Society

Objectives

To assess the utility of a long-term physical activity (PA) intervention for reducing resting pulse rate (RPR) in older persons.

Design

Community.

Setting

Lifestyle Interventions and Independence for Elders Study.

Participants

Individuals aged 70 to 89 (N = 1,635, 67.2% women) were randomized to a moderate-intensity PA intervention (n = 818) or a health education–based successful aging (SA) intervention (n = 817).

Measurements

RPR was recorded at baseline and 6, 18, and 30 months. Longitudinal changes in RPR of intervention groups were compared using a mixed-effects analysis of covariance model for repeated-measure outcomes, generating least squares means with standard errors (SEs) or 95% confidence intervals (CIs).

Results

Mean duration of the study was 2.6 years (median 2.7 years, interquartile range 2.3–3.1 years). The average effect of the PA intervention on RPR over the course of the study period was statistically significant but clinically small (average intervention difference = 0.84 beats/min; 95% CI = 0.17–1.51; P_average = .01), with the most pronounced effect observed at 18 months (PA, 66.5 beats/min (SE 0.32 beats/min); SA, 67.8 beats/min (SE 0.32 beats/min); difference = 1.37 beats/min, 95% CI = 0.48–2.26 beats/min). The relationship became somewhat weaker and was not statistically significant at 30 months. There were no significant differences between several prespecified subgroups.

Conclusion

A long-term moderate-intensity PA program was associated with a small and clinically insignificant slowing of RPR in older persons. Whether PA can deliver a beneficial reduction in RPR requires further examination in older adults.

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Chemical and biological studies of reveromycin A - Journal of Antibiotics

Chemical and biological studies of reveromycin A

The Journal of Antibiotics 69, 723 (October 2016). doi:10.1038/ja.2016.57

Author: Hiroyuki Osada

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Crystal structure of SgcJ, an NTF2-like superfamily protein involved in biosynthesis of the nine-membered enediyne antitumor antibiotic C-1027 - Journal of Antibiotics

Crystal structure of SgcJ, an NTF2-like superfamily protein involved in biosynthesis of the nine-membered enediyne antitumor antibiotic C-1027

The Journal of Antibiotics 69, 731 (October 2016). doi:10.1038/ja.2016.88

Authors: Tingting Huang, Chin-Yuan Chang, Jeremy R Lohman, Jeffrey D Rudolf, Youngchang Kim, Changsoo Chang, Dong Yang, Ming Ma, Xiaohui Yan, Ivana Crnovcic, Lance Bigelow, Shonda Clancy, Craig A Bingman, Ragothaman M Yennamalli, Gyorgy Babnigg, Andrzej Joachimiak, George N Phillips & Ben Shen

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In vitro characterization and inhibition of the interaction between ciprofloxacin and berberine against multidrug-resistant Klebsiella pneumoniae - Journal of Antibiotics

In vitro characterization and inhibition of the interaction between ciprofloxacin and berberine against multidrug-resistant Klebsiella pneumoniae

The Journal of Antibiotics 69, 741 (October 2016). doi:10.1038/ja.2016.15

Authors: Xiao-Yuan Zhou, Xiao-Guang Ye, Li-Ting He, Su-Rong Zhang, Ruo-Lun Wang, Jun Zhou & Zhuo-Shan He

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Studies on novel HIF activators, A-503451s.I. Producing organism, fermentation, isolation and structural elucidation - Journal of Antibiotics

Studies on novel HIF activators, A-503451s.I. Producing organism, fermentation, isolation and structural elucidation

The Journal of Antibiotics 69, 747 (October 2016). doi:10.1038/ja.2016.17

Authors: Yuki Hirota-Takahata, Hideki Kobayashi, Masaaki Kizuka, Takao Ohyama, Michiko Kitamura-Miyazaki, Yasuhiro Suzuki, Mie Fujiwara, Mutsuo Nakajima & Osamu Ando

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Studies on novel HIF activators, A-503451sII: biological activities of A-503451A - Journal of Antibiotics

Studies on novel HIF activators, A-503451sII: biological activities of A-503451A

The Journal of Antibiotics 69, 754 (October 2016). doi:10.1038/ja.2016.20

Authors: Hideki Kobayashi, Takao Ohyama, Michiko Kitamura-Miyazaki, Yuki Hirota-Takahata & Osamu Ando

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Aureosurfactin and 3-deoxyaureosurfactin, novel biosurfactants produced by Aureobasidium pullulans L3-GPY - Journal of Antibiotics

Aureosurfactin and 3-deoxyaureosurfactin, novel biosurfactants produced by Aureobasidium pullulans L3-GPY

The Journal of Antibiotics 69, 759 (October 2016). doi:10.1038/ja.2015.141

Authors: Jong-Shik Kim, In-Kyoung Lee, Dae-Won Kim & Bong-Sik Yun

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AN483, a new anti-MRSA compound from Streptomyces sp. - Journal of Antibiotics

AN483, a new anti-MRSA compound from Streptomyces sp.

The Journal of Antibiotics 69, 762 (October 2016). doi:10.1038/ja.2015.143

Authors: Yun J Kwon, Mi-Jin Sohn, Hiroyuki Koshino, Chang-Jin Kim & Won-Gon Kim

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Precursor-directed biosynthesis of new sansanmycin analogs bearing para-substituted-phenylalanines with high yields - Journal of Antibiotics

Precursor-directed biosynthesis of new sansanmycin analogs bearing para-substituted-phenylalanines with high yields

The Journal of Antibiotics 69, 765 (October 2016). doi:10.1038/ja.2016.2

Authors: Ningning Zhang, Li Liu, Guangzhi Shan, Qiang Cai, Xuan Lei, Bin Hong, Linzhuan Wu, Yunying Xie & Ruxian Chen

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Hetiamacin B–D, new members of amicoumacin group antibiotics isolated from Bacillus subtilis PJS - Journal of Antibiotics

Hetiamacin B–D, new members of amicoumacin group antibiotics isolated from Bacillus subtilis PJS

The Journal of Antibiotics 69, 769 (October 2016). doi:10.1038/ja.2016.3

Authors: Shaowei Liu, Xiaoyan Han, Zhongke Jiang, Gang Wu, Xinxin Hu, Xuefu You, Jiandong Jiang, Yubin Zhang & Chenghang Sun

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Albaflavenoid, a new tricyclic sesquiterpenoid from Streptomyces violascens - Journal of Antibiotics

Albaflavenoid, a new tricyclic sesquiterpenoid from Streptomyces violascens

The Journal of Antibiotics 69, 773 (October 2016). doi:10.1038/ja.2016.12

Authors: Dan Zheng, Nan Ding, Yi Jiang, Jiaoyue Zhang, Jian Ma, Xiu Chen, Jiang Liu, Li Han & Xueshi Huang

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Inhibition of protein SUMOylation by natural quinones - Journal of Antibiotics

Inhibition of protein SUMOylation by natural quinones

The Journal of Antibiotics 69, 776 (October 2016). doi:10.1038/ja.2016.23

Authors: Isao Fukuda, Mikako Hirohama, Akihiro Ito, Mohammad Tariq, Yasuhiro Igarashi, Hisato Saitoh & Minoru Yoshida

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Corrigendum: Natural product-derived quaternary ammonium compounds with potent antimicrobial activity - Journal of Antibiotics

Corrigendum: Natural product-derived quaternary ammonium compounds with potent antimicrobial activity

The Journal of Antibiotics 69, 780 (October 2016). doi:10.1038/ja.2016.97

Authors: Maureen D Joyce, Megan C Jennings, Celina N Santiago, Madison H Fletcher, William M Wuest & Kevin P C Minbiole

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Stewart's Shops Issues Allergy Alert On Undeclared Milk In Sportade Fruit Punch - FDA Safety Alerts & Drug Recalls

Saratoga Springs, NY-Stewart's Shops Corp. is recalling units of Stewart's Sportade Fruit Punch Isotonic Beverage 20 fluid oz. because they may contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

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Frailty Levels in Residential Aged Care Facilities Measured Using the Frailty Index and FRAIL-NH Scale - American Geriatric Society

Objectives

To compare the FRAIL-NH scale with the Frailty Index in assessing frailty in residential aged care facilities.

Design

Cross-sectional.

Setting

Six Australian residential aged care facilities.

Participants

Individuals aged 65 and older (N = 383, mean aged 87.5 ± 6.2, 77.5% female).

Measurements

Frailty was assessed using the 66-item Frailty Index and the FRAIL-NH scale. Other measures examined were dementia diagnosis, level of care, resident satisfaction with care, nurse-reported resident quality of life, neuropsychiatric symptoms, and professional caregiver burden.

Results

The FRAIL-NH scale was significantly associated with the Frailty Index (correlation coefficient = 0.81, P < .001). Based on the Frailty Index, 60.8% of participants were categorized as frail and 24.4% as most frail. Based on the FRAIL-NH, 37.5% of participants were classified as frail and 35.9% as most frail. Women were assessed as being frailer than men using both tools (P = .006 for FI; P = .03 for FRAIL-NH). Frailty Index levels were higher in participants aged 95 and older (0.39 ± 0.13) than in those aged younger than 85 (0.33 ± 0.13; P = .008) and in participants born outside Australia (0.38 ± 0.13) than in those born in Australia (0.34 ± 0.13; P = .01). Both frailty tools were associated with most characteristics that would indicate higher care needs, with the Frailty Index having stronger associations with all of these measures.

Conclusion

The FRAIL-NH scale is a simple and practical method to screen for frailty in residential aged care facilities.

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The Patient Health Questionnaire-9 as a Screening Tool for Depression in Individuals with Type 2 Diabetes Mellitus: The Maastricht Study - American Geriatric Society

Objectives

To assess the psychometric properties and identify the best cutoff value of the Patient Health Questionnaire-9 (PHQ-9) for depression screening in individuals with type 2 diabetes mellitus (T2DM).

Design

Observational population-based cohort study.

Setting

The Maastricht Study.

Participants

Individuals with and without T2DM (mean age 58.6 ± 8.1, 44.6% male) according to an oral glucose tolerance test (N = 2,997).

Measurements

Depressive disorder and depressive symptoms were measured using the Mini-International Neuropsychiatric Interview (MINI) as the reference and the PHQ-9. Cronbach alpha, Cohen's kappa and receiver operating characteristic (ROC) analyses were used. Differences in factorial structure between participants with and without T2DM were tested using multigroup confirmatory factor analysis.

Results

Based on the traditional PHQ-9 cutoff value, 133 (4.4%) participants had depressive symptoms (PHQ-9 score ≥10). Internal consistency of the PHQ-9 was good (Cronbach α = 0.87 with T2DM, 0.82 without T2DM), the kappa of agreement between the PHQ-9 and the MINI was moderate (0.40 with T2DM, 0.43 without T2DM). Area under the ROC curve for the PHQ-9 was 0.87 in participants with T2DM and 0.88 in those without. A PHQ-9 cutoff score of 5 provided the best sensitivity (92.3%), with acceptable specificity (70.4%), for T2DM, similar to sensitivity and specificity in individuals without T2DM. Factor analysis suggested a similar two-factor structure in both groups (affective and somatic symptoms).

Conclusion

Patient Health Questionnaire-9 performs well as a screening tool for depressive symptoms in individuals with and without T2DM based on the cutoff value of 5, indicating that the PHQ-9 can be used in two-stage screening in primary care to select individuals with T2DM for further psychological evaluation.

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Age and Sex Distributions of Age-Related Biomarker Values in Healthy Older Adults from the Long Life Family Study - American Geriatric Society

Objectives

To determine reference values for laboratory tests in individuals aged 85 and older.

Design

Cross-sectional cohort study.

Setting

International.

Participants

Long Life Family Study (LLFS) participants (N~5,000, age: range 25–110, median 67, 45% male).

Measurements

Serum biomarkers were selected based on association with aging-related diseases and included complete blood count, lipids (triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, total cholesterol), 25-hydroxyvitamin D2 and D3, vitamin D epi-isomer, diabetes mellitus–related biomarkers (adiponectin, insulin, insulin-like growth factor 1, glucose, glycosylated hemoglobin, soluble receptor for advanced glycation endproduct), kidney disease–related biomarkers (albumin, creatinine, cystatin), endocrine biomarkers (dehydroepiandrosterone, sex-hormone binding globulin, testosterone), markers of inflammation (interleukin 6, high-sensitivity C-reactive protein, N-terminal pro b-type natriuretic peptide), ferritin, and transferrin.

Results

Of 38 measured biomarkers, 34 were significantly correlated with age. Summary statistics were generated for all biomarkers according to sex and 5-year age increments from 50 and up after excluding participants with diseases and treatments that were associated with biomarkers. A biomarker data set was also generated that will be useful for other investigators seeking to compare biomarker levels between studies.

Conclusion

Levels of several biomarkers change with older age in healthy individuals. The descriptive statistics identified herein will be useful in future studies and, if replicated in additional studies, might also become useful in clinical practice. The availability of the reference data set will facilitate appropriate calibration of biomarkers measured in different laboratories.

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Shared Risk Factors for Constipation, Fecal Incontinence, and Combined Symptoms in Older U.S. Adults - American Geriatric Society

Objectives

To estimate the prevalence of constipation, fecal incontinence (FI), and combined symptoms and to identify shared factors associated with bowel symptoms in older U.S. men and women

Design

Population-based cross-sectional study.

Setting

National Health and Nutrition Examination Survey (2005–2010).

Participants

Women and men aged 50 and older.

Measurements

Constipation was defined as hard stool consistency on the validated Bristol Stool Form Scale or stool frequency of fewer than three bowel movements per week. FI was defined as at least monthly loss of solid, liquid, or mucus stool. Combined symptoms was defined as constipation and FI. Multinomial multivarible models adjusted for age, race, socioeconomic status, education, self-rated health, depression, impairments in activities of daily living, and number of comorbidities.

Results

Women (n = 3,078) reported higher prevalence of bowel symptoms than men (constipation 11.8% vs 4.7%%, FI 11.2% vs 8.6%, combined symptoms 1.4% vs 0.4%). In adjusted models, women had greater odds of having constipation (odds ratio (OR) = 3.0, 95% confidence interval (CI) = 2.3–3.8), FI (OR = 1.4, 95% CI = 1.1–1.8), and combined symptoms (OR = 4.6, 95% CI = 2.0–10.2) than men. Shared risk factors included poor self-rated health and depression symptoms (constipation: OR = 1.8, 95% CI = 1.4–2.4 and OR = 1.8, 95% CI = 1.0–3.2; FI: OR = 1.6, 95% CI = 1.2–2.2 and OR = 2.3 95% CI = 1.4–3.6; combined symptoms: OR = 2.6 95% CI = 1.5–4.8 and OR = 4.6, 95% CI = 1.3–16.4).

Conclusion

When defining constipation and FI using validated instruments, women had a much higher prevalence of constipation than men, whereas men had a higher prevalence of FI than constipation. Shared risk factors reflect the negative effect that bowel symptoms have on quality of life.

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Revascularization in Individuals Aged 90 and Older with Critical Lower Limb Ischemia - American Geriatric Society

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Age Differences in Sequential Speech Production: Articulatory and Physiological Factors - American Geriatric Society

Objectives

To explore age differences in speech production in relation to orofacial physiology.

Design

Cross-sectional quasi-experimental group study.

Setting

General community.

Participants

Physically and cognitively healthy volunteers recruited from the community (N = 30), including 15 young (18–39) and 15 older (66–85) adults.

Measurements

Accuracy and speech rate were calculated during the production of sequences of syllables containing oral vowels, nasal vowels, or both. Lip and tongue muscular strength, muscular endurance, and tactile sensitivity were also measured.

Results

Older adults had a slower speech rate than younger adults and greater difficulty articulating nasal vowels. Analyses revealed that age-related decline in lip endurance is associated with decline in accuracy during speech production.

Conclusion

Older adults are not just slower than younger adults, they also exhibit specific articulatory difficulties. Although many physiological changes in orofacial functions occur in aging, only muscular endurance of the lips is related to age-related differences in speech production. This information is important for the development of speech interventions targeting older adults with speech motor disorders.

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Reply to “Antipsychotics: Mortality Risk Themselves?” - American Geriatric Society

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Fear of Falling in Older Mexican Americans: A Longitudinal Study of Incidence and Predictive Factors - American Geriatric Society

Objectives

To determine predictors of fear of falling in older Mexican Americans over time.

Design

Longitudinal study.

Setting

Community-dwelling residents throughout California, Colorado, New Mexico, Arizona, and Texas.

Participants

Community-dwelling Mexican Americans aged 72 and older participating in the Hispanic Established Populations for the Epidemiologic Study of the Elderly from 2000–01 to 2010–11 (N = 1,682).

Measurements

Fear of falling was measured at baseline and at each subsequent wave. Baseline demographic and clinical variables included social support, fall history, depression symptoms, Mini-Mental State Examination (MMSE) score, activity of daily living (ADL) and instrumental ADL (IADL) limitations, and chronic health conditions.

Results

Nine hundred fifty three (56.7%) subjects reported fear of falling at baseline, 262 of whom reported severe fear of falling. The predictors of reporting any fear of falling over time included female sex, frequent familial interaction, depression, chronic health conditions, IADL limitations, higher MMSE score, and three or more falls in the last 12 months. Predictors of severe fear of falling included older age, female sex, married, depressive symptoms, chronic health conditions, IADL limitations, higher MMSE score, and fall history. Protective factors included frequent friend interaction and higher levels of education.

Conclusion

Fear of falling is prevalent in older Mexican-American adults. The presence of friends nearby was shown to be protective against, whereas the presence of family nearby was shown to be predictive of fear of falling.

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Antipsychotics: Mortality Risk Themselves? - American Geriatric Society

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Avian gyrovirus 2 in poultry, China, 2015–2016

Avian gyrovirus 2 in poultry, China, 2015–2016

Emerging Microbes & Infections 5, e112 (October 2016). doi:10.1038/emi.2016.113

Authors: Shuai Yao, Tianbei Tuo, Xiang Gao, Chunyan Han, You Li, Yulong Gao, Yanping Zhang, Changjun Liu, Xiaole Qi, Honglei Gao, Yongqiang Wang & Xiaomei Wang

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From discovery to outbreak: the genetic evolution of the emerging Zika virus

From discovery to outbreak: the genetic evolution of the emerging Zika virus

Emerging Microbes & Infections 5, e111 (October 2016). doi:10.1038/emi.2016.109

Authors: Hong Liu, Liang Shen, Xiao-Lin Zhang, Xiao-Long Li, Guo-Dong Liang & Hong-Fang Ji

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Mediation of Cognitive Function Improvements by Strength Gains After Resistance Training in Older Adults with Mild Cognitive Impairment: Outcomes of the Study of Mental and Resistance Training - American Geriatric Society

Objectives

To determine whether improvements in aerobic capacity (VO_2peak) and strength after progressive resistance training (PRT) mediate improvements in cognitive function.

Design

Randomized, double-blind, double-sham, controlled trial.

Setting

University research facility.

Participants

Community-dwelling older adults (aged ≥55) with mild cognitive impairment (MCI) (N = 100).

Intervention

PRT and cognitive training (CT), 2 to 3 days per week for 6 months.

Measurements

Alzheimer's Disease Assessment Scale–cognitive subscale (ADAS-Cog); global, executive, and memory domains; peak strength (1 repetition maximum); and VO_2peak.

Results

PRT increased upper (standardized mean difference (SMD) = 0.69, 95% confidence interval = 0.47, 0.91), lower (SMD = 0.94, 95% CI = 0.69–1.20) and whole-body (SMD = 0.84, 95% CI = 0.62–1.05) strength and percentage change in VO_2peak (8.0%, 95% CI = 2.2–13.8) significantly more than sham exercise. Higher strength scores, but not greater VO_2peak, were significantly associated with improvements in cognition (P < .05). Greater lower body strength significantly mediated the effect of PRT on ADAS-Cog improvements (indirect effect: β = −0.64, 95% CI = −1.38 to −0.004; direct effect: β = −0.37, 95% CI = −1.51–0.78) and global domain (indirect effect: β = 0.12, 95% CI = 0.02–0.22; direct effect: β = −0.003, 95% CI = −0.17–0.16) but not for executive domain (indirect effect: β = 0.11, 95% CI = −0.04–0.26; direct effect: β = 0.03, 95% CI = −0.17–0.23).

Conclusion

High-intensity PRT results in significant improvements in cognitive function, muscle strength, and aerobic capacity in older adults with MCI. Strength gains, but not aerobic capacity changes, mediate the cognitive benefits of PRT. Future investigations are warranted to determine the physiological mechanisms linking strength gains and cognitive benefits.

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T-Cell Phenotypes Predictive of Frailty and Mortality in Elderly Nursing Home Residents - American Geriatric Society

Objectives

To determine whether immune phenotypes associated with immunosenescence are predictive of frailty and mortality within 1-year in elderly nursing home residents.

Design

Cross sectional study of frailty; prospective cohort study of mortality.

Setting

Thirty-two nursing homes in four Canadian cities between September 2009 and October 2011.

Participants

Nursing home residents aged 65 and older (N = 1,072, median age 86, 72% female).

Measurements

After enrollment, peripheral blood mononuclear cells were obtained and analyzed using flow cytometry for CD4⁺ and CD8⁺ T-cell subsets (naïve, memory (central, effector, terminally differentiated, senescent), and regulatory T-cells) and cytomegalovirus (CMV)-reactive CD4⁺ and CD8⁺ T-cells. Multilevel linear regression analysis was performed to determine the relationship between immune phenotypes and frailty; frailty was measured at the time of enrollment using the Frailty Index. A Cox proportional hazards model was used to determine the relationship between immune phenotypes and time to death (within 1 year).

Results

Mean Frailty Index was 0.44 ± 0.13. Multilevel regression analysis showed that higher percentages of naïve CD4⁺ T-cells (P = .001) and effector memory CD8⁺ T-cells (P = .02) were associated with a lower mean Frailty Index, whereas a higher percentage of CD8⁺ central memory T-cells was associated with a higher mean Frailty Index score (P = .02). One hundred fifty one (14%) members of the cohort died within 1 year. Multivariable analysis showed a significant negative multiplicative interaction between age and percentage of CMV-reactive CD4⁺ T-cells (hazard ratio = 0.87, 95% confidence interval = 0.79–0.96). No other significant factors were identified.

Conclusion

Immune phenotypes found to be predictive of frailty and mortality in this study can help further understanding of immunosenescence and may provide a rationale for future intervention studies designed to modulate immunity.

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Montefiore-Einstein Center for the Aging Brain: Preliminary Data - American Geriatric Society

Given the multifaceted nature of dementia care management, an interdisciplinary comprehensive clinical approach is necessary. We describe our one-year experience with outpatient based dementia care at the Montefiore-Einstein Center for the Aging Brain (CAB) involving an multispecialty team of geriatricians, neurologists, and neuropsychologists, supported by geriatric psychiatrists, physiatrists, and social services. The goals of the CAB is to maximize dementia outcomes, including regular monitoring of patient's health and cognition, education and support to patients, their families and caregivers; initiation of pharmacological and non-pharmacological treatments as appropriate, and the facilitation of access to clinical trials. The CAB follows a consultative model where patients referred to the center receive a comprehensive three step evaluation and management plan from Geriatric, Neuropsychology and Neurology specialists that is shared with patient, caregivers and primary care physicians. Of the 366 patients seen for cognitive complaints in our first year, 71% were women with a mean age of 74 years. Self-identified ethnicity of patients included Caucasian (26%), African-American (25%), Hispanic (18%) and multiracial (5%). Common final diagnoses assigned at the CAB included mild cognitive impairment syndromes (31%), Alzheimer's disease (20%), mixed dementia (11%), vascular dementia (9%), Frontotemporal dementia (4%) and dementia with Lewy bodies (4%). Our one-year progress report indicates that an interdisciplinary clinical dementia care model is feasible in the outpatient setting as well as highly accepted by patients, caregivers and referring physicians.

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Comparison of a Virtual Older Driver Assessment with an On-Road Driving Test - American Geriatric Society

Objectives

To design a low-cost simulator-based driving assessment for older adults and to compare its validity with that of an on-road driving assessment and other measures of older driver risk.

Design

Cross-sectional observational study.

Setting

Canberra, Australia.

Participants

Older adult drivers (N = 47; aged 65–88, mean age 75.2).

Measurements

Error rate on a simulated drive with environment and scoring procedure matched to those of an on-road test. Other measures included participant age, simulator sickness severity, neuropsychological measures, and driver screening measures. Outcome variables included occupational therapist (OT)-rated on-road errors, on-road safety rating, and safety category.

Results

Participants’ error rate on the simulated drive was significantly correlated with their OT-rated driving safety (correlation coefficient (r) = −0.398, P = .006), even after adjustment for age and simulator sickness (P = .009). The simulator error rate was a significant predictor of categorization as unsafe on the road (P = .02, sensitivity 69.2%, specificity 100%), with 13 (27%) drivers assessed as unsafe. Simulator error was also associated with other older driver safety screening measures such as useful field of view (r = 0.341, P = .02), DriveSafe (r = −0.455, P < .01), and visual motion sensitivity (r = 0.368, P = .01) but was not associated with memory (delayed word recall) or global cognition (Mini-Mental State Examination). Drivers made twice as many errors on the simulated assessment as during the on-road assessment (P < .001), with significant differences in the rate and type of errors between the two mediums.

Conclusion

A low-cost simulator-based assessment is valid as a screening instrument for identifying at-risk older drivers but not as an alternative to on-road evaluation when accurate data on competence or pattern of impairment is required for licensing decisions and training programs.

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Health Care for Older Adults in Uganda: Lessons for the Developing World - American Geriatric Society

Approximately two-thirds of the world's older adults live in developing nations. By 2050, as many as 80% of such older people will live in low- and middle-income countries. In sub-Saharan Africa alone, the number of individuals aged 60 and older is projected to reach 163 million. Despite this demographic wave, the majority of Africa has limited access to qualified geriatric health care.³ Although foreign aid and capacity-building efforts can help to close this gap over time, it is likely that failure to understand the unique context of Africa's older adults, many of whom are marginalized, will lead to inadequacies in service delivery and poor health outcomes.⁴ As the need for culturally competent care of older adults gains recognition in the developed world, research in geriatric care in developing countries should progress in tandem.⁴ By examining the multidimensional challenges that an older woman with the human immunodeficiency virus (HIV) in rural Uganda faces, this article makes contextualized policy recommendations for older adults in Africa and provides lessons for the developing world.

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Brownwood Farms Issues Allergy Alert On Undeclared Milk In Fruit Preserves And Fruit Butter Products - FDA Safety Alerts & Drug Recalls

Brownwood Farms of Williamsburg, MI is recalling approximately 260,000 total units of the listed products, because they contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction, if they consume these products.

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CMS Awards Special Innovation Projects to Quality Innovation Network-Quality Improvement Organizations Aimed to Drive Better Care, Smarter Spending, and Healthier People - CMS Blog

By: Patrick Conway, MD, MSc
Acting Principal Deputy Administrator
Deputy Administrator for Innovation and Quality
CMS Chief Medical Officer

Kate Goodrich, MD
Director
Center for Clinical Standards and Quality

Dennis Wagner, MPA
Director, Quality Improvement and Innovation Group
Centers for Clinical Standards and Quality

The Centers for Medicare & Medicaid Services (CMS) has taken another step toward ensuring that beneficiaries receive better care, better value, and achieve better overall care, smarter spending, and healthier people by awarding 20, two-year Special Innovation Projects (SIPs) to 12 regional Quality Innovation Network-Quality Improvement Organizations (QIN-QIOs). The SIPs offer QIN-QIOs and their partners, clinicians, schools of higher education, innovation labs, and Medicare beneficiaries and their families the opportunity to address critical health care issues important to their constituency in the areas of quality improvement that may be underutilized, but represent a significant opportunity if spread locally, regionally, or nationally. QIN-QIOs serve the Medicare population by working with Medicare beneficiaries, providers, and communities in data-driven initiatives that increase patient safety, make communities healthier, better coordinate post-hospital care, and improve clinical quality.  QIN-QIOs were eligible to submit proposals for two types of SIPs in 2016:

1. Projects addressing issues of quality occurring within the QIN-QIOs’ local service area: “Advance Local Efforts for Better Care at Lower Cost.”
2. Projects focusing on expanding the scope and national impact of quality improvement interventions that have proven success in limited areas or scope: “Interventions that are Ready for Spread and Scalability.”

Projects that “Advance Local Efforts for Better Care at Lower Cost” include:

• Great Plains QIN will work with 25 home health agencies in Kansas, Nebraska, North Dakota, and South Dakota to develop and test educational interventions to prevent and manage common infections observed in home health such as respiratory, urinary tract and wound infections.
• Health Services Advisory Group will be building capacity for telepsychiatry services in the Virgin Islands of St. Croix, St. John, and St. Thomas to address the lack of psychiatric specialty services available.
• TMF Quality Innovation Network will be working with 80 physician practices in Arkansas, Missouri, Oklahoma, and Texas to increase primary care physician knowledge of treatment for depression and alcohol use disorder through knowledge transfer from specialists to primary care physicians.

Topic areas for “Interventions that are Ready for Spread and Scalability” were identified through consultation with the Strategic Innovation Engine (SIE). The Strategic Innovation Engine (SIE) is a new endeavor that will advance CMS’ six quality goals by rapidly moving innovative, evidence-based quality practices from research to implementation throughout the QIN-QIO program and be made available to the greater health care community. The SIE will serve as an instrument in furthering the science of improvement to better inform quality improvement efforts in the future for QIOs and others that draws upon the literature, healthcare quality data, and experts and practitioners in the field to ensure safe, effective practices are available for use by providers seeking to improve quality and reduce costs.

These high leverage topic areas include streamlining patient flow in health care settings; working with health plans and care coordination providers on approaches to post-acute care that results in enhanced care management; increasing value, patient affordability, and appropriate use of specialty drugs by applying evidenced based criteria to prescribing practices; addressing acute pain management in sickle cell patients; and utilizing big data analytics to reduce preventable harm in health care. Examples of funded projects for “Interventions that are Ready for Spread and Scalability” include:

• Alliant Quality, utilizing the breakthrough collaborative model, will work with 30 emergency departments in Georgia and North Carolina to improve the triage, treatment, and quality of care received by patients with sickle cell disease who present to the emergency room in vaso-occlusive crisis (VOC). It is expected that interventions will result in appropriate and timely pain management and improved patient experience.
• Atlantic Quality Innovation Network, working in New York (Orange, Putnam, and Dutchess Counties) with physician offices, pharmacies, hospitals, nursing homes and county health departments, seeks to modify and standardize prescribing practices for managing anticoagulants during the periprocedural period to reduce anticoagulant adverse drug events in all patients, including Medicare Fee-for-Service beneficiaries. Interventions include the operationalization of a mobile/web-based application for clinical decision support in hospital/ambulatory surgery settings and optimization of patient education using health information technology.
• Qualis Health, working in Washington and Idaho, seeks to improve the quality, safety, and reliability of the care transition process by focusing on a comprehensive assessment of the social determinants impacting beneficiaries’ transitions from the hospital to the home and creating robust linkages to community social service providers for high-risk beneficiaries to improve care coordination and reduce avoidable medical care utilization.

CMS sought proposals with scientific rigor, a strong analytic framework and a reasonable, proposed intervention based on the supporting evidence. CMS looked for evidence of QIN-QIO partnerships at the community, regional and national levels, and inclusion of patients and families in each project as well as direct links to the CMS Quality Strategy goals.

A complete list of 2016 SIP awardees is located on the QIO Program website.

We are committed to innovation and are excited to study the results produced by these SIPs and to identify ways in which to incorporate them throughout the QIO Program based upon their results. The SIPs create an exciting opportunity for providers, professional organizations, innovation labs, and others to innovate and impact health care quality in the Medicare program at local, regional and national levels through the QIO Program.

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FDA grants accelerated approval to new treatment for advanced soft tissue sarcoma - FDA Press Releases

The U.S. Food and Drug Administration today granted accelerated approval to Lartruvo (olaratumab) with doxorubicin to treat adults with certain types of soft tissue sarcoma (STS), which are cancers that develop in muscles, fat, tendons or other soft tissues. Lartruvo is approved for use with the FDA-approved chemotherapy drug doxorubicin for the treatment of patients with STS who cannot be cured with radiation or surgery and who have a type of STS for which an anthracycline (chemotherapy) is an appropriate treatment.

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Remarks by Andy Slavitt: Meeting the health challenges of rural America - CMS Blog

The following are the remarks delivered by CMS Acting Administrator Andy Slavitt at the CMS Rural Health Summit on October 19, 2016 in Woodlawn, MD.

Somewhere in the country right now, of the 140 million people covered by Medicare, Medicaid, CHIP or the Marketplace, someone is having a care need met. Someone is having a tumor diagnosed by an excellent technician; someone is getting affordable asthma medication for their daughter; someone is meeting with a caring nursing home staff for the first time after their father-in-law moved in. Some parent is sleeping well for the first time because they have coverage through expanded Medicaid or the Exchange.

If we could give every American the best of what the health care system has to offer, we would improve health outcomes, enhance Americans’ financial and health security, and spend our precious resources more wisely. And we would be able to keep people healthier and more comfortable as they age. And there is clear evidence that we are making progress. The uninsured rate is down to 8.3%, cut nearly in half, with 20 million newly insured Americans; medical cost trends remain at record lows; and 95 out of 100 quality measures improved nationally.

But the great black mark on our health care system are the vast disparities in the care people receive. Not everyone has access to that ideal care experience. Among other factors, where you live matters. And for the millions of Medicare Americans who live in some towns and rural counties, lifespans are shorter by two years. All of which means we need to get to work. And we have some challenges I’d like to start with, but also things to be hopeful about.

***

So let me start with what I’m worried about.

For us at CMS, I always like to start with an understanding of the people we are serving. Rural health care issues are not monolithic. People in the rural South the economic challenges and poverty are dominant issues and people don’t seem to get nearly as good hospice care as people who live in the north. In rural New England, the disparities aren’t as significant but the aging of the population intensifies the needs. In the upper Midwest and Great Plains – isolation, loneliness, depression and substance abusers are prevalent. In the Mountain states, there are geographic challenges to access, and in the West, language and cultural barriers are more significant, particularly in the rural Southwest. All of which is to say, there is no “one” rural America. There are diverse issues that need airing.

There are, of course, some issues that hit all rural areas disproportionately. So forgive me for generalizing. Lower volumes, aging and limited infrastructure are real concerns and chronic disease rates and those treatment needs are higher. One significant source of coverage, care and funding aimed at addressing many of these issues is Medicaid expansion. But in almost all the states that have chosen not to expand Medicaid, they are either entirely rural or almost entirely rural. The uninsured rate in rural America is 11%+ where Medicaid has been expanded, but 14.6% where it hasn’t. Unfortunately, the impact of not expanding doesn’t end there. Insurance rates than become 7% higher and that of course has made markets less competitive and more expensive.

Workforce issues are also of great concern when I talk to physicians and community hospital executives. Approximately 10% of physicians practice in rural America, although nearly 20% of our population lives there. 65% of our health professional shortage is in rural areas. Physician assistants and nurse practitioners carry the lion share of the primary care load. This isn’t necessarily a bad thing, but we should note that in urban settings, that’s more like 8%. Access to specialists is one of the biggest challenges, and that becomes more important as the health needs of the population become more complex.

This really begins to stand out when it comes to behavioral health. With prescription drug abuse, increasing suicide rates, and the opioid epidemic taking its toll, our shortages of psychiatrists and psychologists– a problem everywhere– are deeper in rural counties. One in 8 rural counties are now without any behavioral health specialist and those that have them have between 1/3 and 1/2 of the levels of more urban areas.

We worry too about the nature of hospital economics and the impact of hospital closures. 78 rural hospitals have closed since 2010 and the obvious impact on the community is profound. And we are in need of a sustainable solution. The more remote a hospital, on average, the lower the operating margins. Other things hit the economics– higher uncompensated care due to lack of Medicaid expansion, fewer higher paying commercial payers, and continued declining utilization as we learn to take care of people in lower cost settings.

While these are real challenges, in many cases, given demographics– this is a boat we are in with you. As in some communities, it is Medicare and Medicaid that are becoming the principal financial resources. Which is why this February, we announced the formation of the Rural Health Council– to start putting together long term solutions with you.

I wanted to start with my concerns because we believe it’s important for CMS, for Cara and John and all our leaders, that we show you we understand the challenges you face. And so if we are missing something or don’t have it right, we want you to tell us.

Despite the challenges, what I believe is our best minds, working together, taking the long view give us a lot to be excited about. Will we wind back the clock to a day before these challenges exist? No. Is the answer to try to recreate what health care in rural America looked like 30 years ago? No. But just as challenges in rural America are unique, so too are the assets: the long-term relationships with patients and doctors, a care system that’s easier to navigate, and tighter communities that know how to pull together to solve problems.

Our initial focus is on access to care, the economics of care and innovations that fit right with the opportunities and needs in rural America.

And there is reason for optimism. To start with there have been great strides in access across rural community since the ACA.  The percent of uninsured adults in non-metropolitan areas decreased by 39% from 2010 to 2015. In 2016, 1.7 million people in rural areas signed up for coverage in just the Federal Marketplace states, an 11% increase from 2015– actually higher than from urban areas. And as I’m ever the optimist, there are still 19 state governors, I would dare to say virtually all of whom see the benefits of Medicaid expansion. They may have their own approaches, many of which we have shown ourselves to be open to. And they all have state legislatures to deal with, but at some point, the budget benefit, the economic benefit, and of course the benefit to state residents will be too much to pass up.

I’m also optimistic about the steps we are taking to make it easier to operate and improve the economic conditions of operating in rural communities. Our rural council is instituting a focus on elevating an understanding of the rural impact of all of our work and steps we can take to reduce burden.

Last week we announced a new initiative targeted at engaging physicians by focusing directly on burden reduction. We’ve reduced some of the restrictions on critical access hospitals, around both patient care policies and physician supervision. We’re finding places to simplify things where we can– from Meaningful Use to hospital organization flexibility to paperwork reduction and revisions to our approach to the 2 Midnights policy and auditing.

Each is a small step but there’s an increasing consciousness to reduce the burden and the cost. I know big administrative and legislative priorities remain on your list and there is always more we can do. But in addressing economics, we must have a dialogue about the longer term economics and allocation of resources in rural communities.

Mostly, I’m excited about our ability to innovate together. Telemedicine has been introduced into many of the new models in the CMS Innovation Center and advancing behavioral health through telehealth has great promise. Our innovation center is expressly focused on developing opportunities for rural care providers to find the models that will define the future. That means measures, programs, and technical assistance that are specific to local needs.

The ACO Investment Model was designed to help rural communities move down a path receiving better payment for delivering better healthcare — undoubtedly the key to managing through our economic challenges. In this rural-oriented model, we prepay shared savings to ACOs in rural areas – an oxymoron, but a clear acknowledgement that you need to invest when that’s not always easy and a sign of our willingness to invest along with you.

And in a report we released this morning indicates, for those rural hospitals that participate in value based initiatives, the results reflect many of the strengths we know are in these communities– rural hospitals perform better than urban counterparts and better on a host of safety measures.

And the Innovation Center is the key to unlocking more flexibility and finding and testing new ways at approaching opportunities to innovate. We invite your ideas so we can test them, pay for them, and grow what works. It’s what allows us to be nimble and invest alongside you.

We understand that all Americans deserve the best of the American health care system and that means tailoring solutions to the needs we see together.

***

And we are excited. I can tell you that the Rural Council has brought out the passion that exists all across CMS and HHS – especially HRSA- for rural health care. The “rural road show” that John leads in the Northwest every year and the various other things that are regions do represent our desire first to listen and understand; second, to work together with you on policy responses. Our commitment is to listen and respond and make sure there is a visible, vocal forum for the issues that matter to you.

As I close I want to extend my deep appreciation for the leadership that Secretary Burwell and Acting Deputy Secretary Mary Wakefield provide. Both growing up in rural towns, in different parts of the country, they carry that responsibility in to every decision that is made across HHS.

And while she could not be here today, the Secretary did record this welcome video for us to watch right now.

Thank you. Enjoy the day. And I can’t wait to hear what comes out of today and the listening sessions to follow.

###

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Gaps in Aging Research as it Applies to Rheumatologic Clinical Care - Geriatrics

The incidence and prevalence of rheumatologic conditions are increasing and the rheumatology workforce must be aware of aging-specific issues. This article reviews specific barriers to understanding the biology of aging and aging-related mechanisms that may underlie development of rheumatologic diseases in older adults. It summarizes gaps in the assessment, outcomes measurement, and treatment of these diseases in this unique population. It also highlights potential solutions to these barriers and suggests possible ways to bridge the gap, from a research and education standpoint, so that clinicians can be better prepared to effectively manage older adults with rheumatologic conditions.

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Using the 4 Pillars Practice Transformation Program to Increase Pneumococcal Immunizations for Older Adults: A Cluster-Randomized Trial - American Geriatric Society

Objectives

To test the effectiveness of a step-by step, evidence-based guide, the 4 Pillars Practice Transformation Program, to increase adult pneumococcal vaccination.

Design

Randomized controlled cluster trial (RCCT) in Year 1 (June 1, 2013 to May 31, 2014) and pre-post study in Year 2 (June 1, 2014 to January 31, 2015) with data analyzed in 2016. Baseline year was June 1, 2012, to May 31, 2013. Demographic and vaccination data were derived from deidentified electronic medical record extractions.

Setting

Primary care practices (n = 25) stratified according to metropolitan area (Houston, Pittsburgh), location (rural, urban, suburban), and type (family medicine, internal medicine), randomized to receive the intervention in Year 1 (n = 13) or Year 2 (n = 12).

Participants

Individuals aged 65 and older at baseline (N = 18,107; mean age 74.2; 60.7% female, 16.5% non-white, 15.7% Hispanic).

Intervention

The 4 Pillars Program, provider education, and one-on-one coaching of practice-based immunization champions. Outcome measures were 23-valent pneumococcal polysaccharide vaccine (PPSV) and pneumococcal conjugate vaccine (PCV) vaccination rates and percentage point (PP) changes in vaccination rates.

Results

In the Year 1 RCCT, PPSV vaccination rates increased significantly in all intervention and control groups, with average increases ranging from 6.5 to 8.7 PP (P < .001). The intervention was not related to greater likelihood of PPSV vaccination. In the Year 2 pre-post study, the likelihood of PPSV and PCV vaccination was significantly higher in the active intervention sites than the maintenance sites in Pittsburgh but not in Houston.

Conclusion

In a RCCT, PPSV vaccination rates increased in the intervention and control groups in Year 1. In a pre-post study, private primary care practices actively participating in the 4 Pillars Practice Transformation Program improved PPSV and PCV uptake significantly more than practices that were in the maintenance phase of the study.

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Yoma Myanmar Tea Co. Issues Allergy Alert on Undeclared Peanuts in Yoma Myanmar Tea Salad Snack - FDA Safety Alerts & Drug Recalls

Yoma Myanmar Tea Co. of Allston, MA is voluntarily recalling the Yoma Myanmar brand "Tea Salad Snack" in Regular and Spicy, 7 oz., because the products may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

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Diagnosis of Elder Abuse in U.S. Emergency Departments - American Geriatric Society

Objectives

To estimate the proportion of visits to U.S. emergency departments (EDs) in which a diagnosis of elder abuse is reached using two nationally representative datasets.

Design

Retrospective cross-sectional analysis.

Setting

U.S. ED visits recorded in the 2012 Nationwide Emergency Department Sample (NEDS) or the 2011 National Hospital Ambulatory Medical Care Survey (NHAMCS).

Participants

All ED visits of individuals aged 60 and older.

Measurements

The primary outcome was elder abuse defined according to International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes. The proportion of visits with elder abuse was estimated using survey weights. Odds ratios (ORs) were calculated to identify demographic characteristics and common ED diagnoses associated with elder abuse.

Results

In 2012, NEDS contained information on 6,723,667 ED visits of older adults, representing an estimated 29,056,673 ED visits. Elder abuse was diagnosed in an estimated 3,846 visits, corresponding to a weighted diagnosis period prevalence of elder abuse in U.S. EDs of 0.013% (95% confidence interval (CI) = 0.012–0.015%). Neglect and physical abuse were the most common types diagnosed, accounting for 32.9% and 32.2% of cases, respectively. Multivariable analysis showed greater weighted odds of elder abuse diagnosis in women (odds ratio (OR) = 1.95, 95% CI = 1.68–2.26) and individuals with contusions (OR = 2.91, 95% CI = 2.36–3.57), urinary tract infection (OR = 2.21, 95% CI = 1.84–2.65), and septicemia (OR = 1.92, 95% CI = 1.44–2.55). In the 2011 NHAMCS dataset, no cases of elder abuse were recorded for the 5,965 older adult ED visits.

Conclusion

The proportion of U.S. ED visits by older adults receiving a diagnosis of elder abuse is at least two orders of magnitude lower than the estimated prevalence in the population. Efforts to improve the identification of elder abuse in EDs may be warranted.

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Medtronic Announces Voluntary Recall of its Pipeline Embolization Device, Alligator Retrieval Device, X-Celerator Hydrophilic Guidewire, Ultraflow and Marathon Flow Directed Micro Catheters - FDA Safety Alerts & Drug Recalls

This voluntary recall is being conducted due to the potential separation and detachment of the polytetrafluoroethylene (PTFE) coating on parts of these devices. Should the PTFE separate from the delivery wire or stylets, PTFE particulate could enter the blood stream of the patient.

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Medicare’s investment in primary care shows progress - CMS Blog

By Dr. Patrick Conway, CMS Principal Deputy Administrator and Chief Medical Officer

Today, the Centers for Medicare & Medicaid Services (CMS) announced the Comprehensive Primary Care (CPC) initiative’s second round of shared savings results, with nearly all practices (95 percent) meeting quality of care requirements and four out of seven regions sharing in savings with CMS. These results reflect the work of 481 practices that served over 376,000 Medicare beneficiaries and more than 2.7 million patients overall in 2015.

As the largest test of advanced primary care in U.S. history, CPC demonstrates the potential of primary care clinicians redesigning their practices to deliver better care to their patients, and provides clinicians support to innovate and deliver care in ways that better meet their patients’ needs and preferences.

During 2015, its second shared savings performance year, CPC generated a total of $57.7 million gross savings in Part A and Part B expenditures. These savings are essentially equivalent to the $58 million paid in care management fees to the practices. Four of the seven regions participating in CPC – the states of Arkansas, Colorado, and Oregon, and the Greater Tulsa region in Oklahoma – realized net savings (after accounting for the care management fees paid) and will share in those savings with CMS. Although three of the CPC regions had net losses, the savings generated in the other four regions covered those losses, such that care management fees across CPC were offset by reduced spending on Medicare Part A and Part B services. Further, more than half of participating CPC practices will receive a share of over $13 million in earned shared savings.

In addition to the gross Medicare savings, CPC practices showed positive quality, with lower than expected hospital admission and readmission rates, and favorable performance on patient experience measures. CPC practices’ performance on electronic Clinical Quality Measures (eCQMs) also exceeded national benchmarks, particularly on preventive health measures.

This is the first year CMS has included eCQM performance in Medicare shared savings determinations for CPC. eCQM reporting covering the entire practice population at the practice site level is critical to using health information technology as a tool to support care delivery transformation. eCQM data are recorded in the electronic health record in the routine course of clinical care, allowing practices to engage in real time quality improvement efforts that drive population health. As we move to a health care system that rewards value over volume, CPC practices are at the forefront of using eCQMs for quality improvement, measurement, and reporting.

Quality highlights from the 2015 shared savings performance year include:

• 97 percent of CPC practices successfully reported 9 eCQMs. For ten out of the eleven eCQMs in the CPC measure set, the majority of CPC practices who reported surpassed the median national performance.
• Nearly all (99 percent) practices reported higher levels of colorectal cancer screening and influenza immunization compared to national benchmarks. Additionally, 100 percent of practices who reported on screening for clinical depression surpassed national benchmarks.
• Compared to 2014, most regions maintained or improved their scores on hospital readmissions and admissions for chronic obstructive pulmonary disorder and congestive heart failure.
• Patients rated the care they receive from their CPC practitioners highly, particularly on how well practitioners supported them in taking care of their own health and the attention they paid to care from other providers.

The positive performance is a testament to the efforts CPC practices have made to provide truly “comprehensive primary care.”

CPC is a multi-payer partnership launched by the Center for Medicare and Medicaid Innovation (Innovation Center) in October 2012 to advance primary care by paying clinicians to deliver accessible, comprehensive, and coordinated care in seven regions across the country. CPC supports advanced primary care as the foundation of our health system. In addition to attending to patients’ acute, chronic, and preventive health care needs, primary care practices act as the quarterback of each patient’s health care team. CPC practices help patients navigate their care, communicate with specialists and hospitals, and ensure that patients with complex social and medical needs do not “fall through the cracks” of the health care system.

These results build on the first shared savings performance year in 2014. Gross savings nearly doubled from the first performance year to the second and practices in four regions were eligible to receive shared savings, compared to one region in 2014. Primary care transformation takes time, and it is especially encouraging that CPC practices maintained such positive quality of care results while also seeing gross Medicare savings in the 2015 performance year.

The experience in CPC has contributed to our continued efforts to support primary care going forward in the Innovation Center’s Comprehensive Primary Care Plus (CPC+), which will begin on January 1, 2017 and for which we recently announced the 14 selected regions and are currently reviewing practice applications. CMS anticipates that CPC+ could meet the criteria to qualify as an Advanced Alternative Payment Model (Advanced APM) under the recently finalized Quality Payment Program rule, which implements the Medicare Access and CHIP Reauthorization Act of 2015. A robust primary care system is essential to achieve better care, smarter spending, and healthier people. For this reason, CMS is committed to supporting primary care clinicians to deliver the best, most comprehensive primary care possible for their patients.

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Voluntary Recall Notice of McCormick 24 oz. Club Size Original Taco Seasoning Mix Due to Unlabeled Milk Allergen - FDA Safety Alerts & Drug Recalls

SPARKS, Md., October 5, 2016 - McCormick & Company, Incorporated is initiating a voluntary class I recall of 24 oz. Club Size McCormick® Original Taco Seasoning Mix, UPC 52100302461 with best by date codes between June 27, 2018 and September 16, 2018 due to an unlabeled milk allergen

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FDA awards 21 grants to stimulate product development for rare diseases - FDA Press Releases

The U.S. Food and Drug Administration today announced that it has awarded 21 new clinical trial research grants totaling more than $23 million over the next four years to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and industry with research spanning domestic and international clinical sites.

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Problem Drinking and Depression in Older Adults with Multiple Chronic Health Conditions - American Geriatric Society

Objectives

To examine the intersection of depression and alcohol use among older adults with multiple chronic health conditions (MCCs).

Design

Wave 1 data from the National Social Life, Health and Aging Project (2005–06).

Setting

Community-based sampling throughout the United States.

Participants

Individuals aged 57 to 85 who identified as active alcohol consumers (N = 1,643).

Measurements

Participants reported whether they currently had MCCs, problem drinking (defined as affirming two or more of the four CAGE screening questions), symptoms associated with depression, and other social and health measures.

Results

Although older adults with MCCs were no more likely to be problem drinkers than those with no MCCs, those with MCCs and depression were nearly five times as likely to experience problem drinking as older adults with MCCs and no depression.

Conclusion

Older adults with MCCs have differences that have implications for health, including mental health problems. Implementing screening and assessment in medical care settings for problem drinking and improving self-management interventions to include consequences of alcohol use components are critical avenues for reducing healthcare expenditures and improving quality of life of individuals with MCC.

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Understanding the Continuation of Potentially Inappropriate Medications at the End of Life: Perspectives from Individuals and Their Relatives and Physicians - American Geriatric Society

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Turkey Hill Dairy Issues Class I Voluntary Recall of Select Dutch Chocolate Premium Ice Cream - 48 oz. size - FDA Safety Alerts & Drug Recalls

Lancaster County, PA - Turkey Hill Dairy of Conestoga, Pa., is recalling select 48 oz. containers of its Dutch Chocolate Premium Ice Cream because the package may contain Rocky Road Premium Ice Cream instead of Dutch Chocolate Premium Ice Cream. These packages may include undeclared ingredients of ALMONDS and EGGS, and could be harmful to consumers with food sensitivity or allergy to these ingredients.

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A Letter from CMS to Medicare Clinicians in the Quality Payment Program: We Heard You and Will Continue Listening - CMS Blog

By Andy Slavitt, Acting Administrator

Today, we are finalizing policies to implement the new Medicare Quality Payment Program. Part of the bipartisan Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), the Quality Payment Program aims to create a more modern, patient-centered Medicare program by promoting quality patient care while controlling escalating costs through the Merit-Based Incentive Payment System (MIPS) and incentive payments for Advanced Alternative Payment Models (Advanced APMs).

After issuing our proposal for how to implement the new program earlier this spring, we held a listening tour across the country to hear your thoughts and concerns first-hand about the Quality Payment Program. Whether you formally submitted one of the over 4,000 comments we received, or were one of the nearly 100,000 attendees at our outreach sessions, there have been record levels of clinician engagement. The interactions reflect the importance you place on serving the more than 55 million individuals that have Medicare coverage.

We found an eagerness to help the Medicare program improve and an interest in being engaged in how we address the challenges and opportunities ahead. We also heard concerns, which is not surprising, given the challenge of changing something as large and important as the Medicare program. But, we found that there is near-universal support for moving towards a future focused on patient care that pays for what works, reduces clinician burden, and better supports and engages the medical community.

The policy released today is the first step in a multi-year journey in which we are particularly focused on allowing clinicians to transition at their own pace, continuing to get feedback from the field, providing meaningful support, and improving the program over time. As we read your comments, engaged directly with many of you, sought guidance from Congress, and considered all the options, we identified these priorities for the design of the program.

Focus on the patient

Patients tell us they want and expect us to pay for what works and for higher-quality outcomes. Clinicians tell us that they want to focus on delivering the care that is best for their patients, not on reporting or paperwork. For example, one physician group in Texas urged us to concentrate on quality metrics “that are most meaningful to our practices and our patients.” For this reason, we have reduced the number of required measures and provided practices more flexibility to select the measures that they believe best represent their patients’ needs. And, to free up more time for clinicians to spend on patient care, we announced yesterday an initiative to reduce burden and improve physician engagement with CMS, including a regulatory review to begin reducing unnecessary documentation.

Start out gradually

Other than a 0.5 percent fee schedule update in 2017 and 2018, there are very few changes when the program first begins in 2017. If you already participate in an Advanced APM, your participation stays the same. If you aren’t in an Advanced APM, but are interested, more options are becoming available. If you participate in the standard Medicare quality reporting and Electronic Health Records (EHR) incentive programs, you will find MIPS simpler. And, if you see Medicare patients, but have never participated in a Medicare quality program, there are paths to choose from to get started. The first couple of years are aimed at getting physicians gradually more experienced with the program and vendors more capable of supporting physicians. We have finalized this policy with a comment period so that we can continue to improve the program based on your feedback.

More pathways to participate in Advanced Alternative Payment Models (APMs)

In listening to many of you and working with the Congress, we have heard strong interest in providing more opportunities for physicians to participate in Advanced APMs. Our goal over the next few years is to have more options that fit the diversity of practices and care across the nation, while maintaining robust models that actively encourage high-value care – the best care at the best price – for our Medicare beneficiaries.

In today’s rule, for both Medicare primary care clinicians and specialists, we are announcing our intent to explore testing a new Advanced APM in 2018 – ACO Track 1+ — which has lower levels of risk than other Accountable Care Organizations (ACO). Specifically for specialists, in addition to oncology and nephrology, we recently proposed allowing participants in new cardiac and orthopedic bundled payment models the possibility to qualify as Advanced APMs beginning in 2018. We are also reviewing the other models established through the CMS Innovation Center and are in the process of updating and possibly re-opening them to allow for more participation. And physicians can soon submit proposals for new models to the new Physician Focused Payment Model Technical Advisory Committee, which can now be designed with a lower level of risk than we had originally proposed, which may make more Advanced APMs available to small practices.

With these new Advanced APMs, we estimate that about 25 percent of eligible Medicare clinicians could be in an Advanced APM by the second year of the program.

Adapt for small and rural practices

We know that small practices deliver the same high-quality care as larger ones. Yet at every practice we visited or event we held, we heard from physicians in small and rural practices concerned about the impact of new requirements.

We heard these concerns and are taking additional steps to aid small practices, including: reducing the time and cost to participate, excluding more small practices (the new policy will exclude an estimated 380,000 clinicians), increasing the availability of Advanced APMs to small practices, allowing practices to begin participation at their own pace, changing one of the qualifications for participation in Advanced APMs to be practice-based as an alternative to total cost-based, and conducting significant technical support and outreach to small practices using $20 million a year over the next five years, as well as through the Transforming Clinical Practice Initiative. Due to these changes, we estimate that small physicians will have the same level of participation as that of other practice sizes.

Simplified reporting and scorekeeping in MIPS

Many of you asked us for simplified scoring, better feedback, and clear rules. The policies finalized today begin that alignment and simplification process, which we intend to continue as the program matures.

First, we are simplifying requirements for the two quality components of the program – the quality measures and practice-specific improvement activities. Second, we are moving to align the measurement of certified EHR technology with the improvement activities. This will begin 2017 with a portion of the Advancing Care Information measures; we intend to align more of these measures with quality in later years, to further ensure that certified EHRs are being used to support high-quality care. We also narrowed the focus to those measures that support hospitals and physicians safely and securely exchanging information, and we expect both registries and certified EHRs to move to make reporting more “push button,” making such reporting easier for clinicians. Finally, we are rolling out the new Quality Payment Program website, which will explain the new program and help clinicians easily identify the measures and activities most meaningful to their practice or specialty.

Overall, we are deeply appreciative to everyone, from the Congress to practicing physicians, patient advocates, people with Medicare and their families, and technology companies, who provided input into the launch of the program. We listened and made changes based on your input.

There are a number of ways to learn more about the details and how you can get help in the Quality Payment Program: here. We want everyone to participate over time and will provide intensive support to clinicians through our new Quality Payment Program website, as well as directly through in-person and virtual educational sessions and webinars.

Through this process and the input you have given us, CMS is becoming even more open, transparent, and responsive. We are committed to paying close attention to the impact of our policies on care delivery and adjusting along the way. By working together, we can all make real progress in improving the delivery of care in our country.

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