The U.S. Food and Drug Administration announced today that the U.S. Marshals Service seized more than 4 million pounds of product produced by Valley Milk Products LLC (Valley Milk) of Strasburg, Virginia.
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Wednesday, November 30, 2016
Ultimate Body-Tox Issues a Nationwide Voluntary Recall of Ultimate Body Tox PRO Found to Contain Undeclared Sibutramine - FDA Safety Alerts & Drug Recalls
High Point, NC, Ultimate Body-Tox is voluntarily recalling all lots of Ultimate Body Tox PRO capsules to the consumer level. FDA analyses of this product found it to contain undeclared sibutramine. Sibutramine is a controlled substance that was removed from the U.S. market in October 2010 for safety reasons.
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MS Bionic, Inc. Issues a Voluntary Nationwide Recall of All Lots of Megajex Natural Male Sex Enhancer Dietary Supplement - FDA Safety Alerts & Drug Recalls
MS Bionic, Inc. announced today that it is conducting a voluntary nationwide recall of all lots of Megajex Natural Male Sex Enhancer capsules. FDA analysis has found the product to contain Tadalafil and Sildenafil.
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Team-Based Interprofessional Competency Training for Dementia Screening and Management - American Geriatric Society
As many as 50% of people satisfying diagnostic criteria for dementia are undiagnosed. A team-based training program for dementia screening and management was developed targeting four professions (medicine, nursing, pharmacy, social work) whose scope of practice involves dementia care. An interprofessional group of 10 faculty members was trained to facilitate four interactive competency stations on dementia screening, differential diagnoses, dementia management and team care planning, and screening for and managing caregiver stress. Registrants were organized into teams of five members, with at least one member of each profession per team. The teams rotated through all stations, completing assigned tasks through interprofessional collaboration. A total of 117 professionals (51 physicians, 11 nurses, 20 pharmacists, 24 social workers, 11 others) successfully completed the program. Change scores showed significant improvements in overall competence in dementia assessment and intervention (very low = 1; very high = 5; average change 1.12, P < .001), awareness of importance of dementia screening (average change 0.85, P < .001), and confidence in managing medication (average change 0.86, P < .001). Eighty-seven participants (82.9%) reported feeling confident or very confident using the dementia toolkit at their home institution. In a survey administered 3 months after the session, 48 respondents reported that they had changed their approach to administering the Mini-Cog test (78%), differential diagnosis (49%), assessment of caregiver stress (74%), and accessing community support and services (69%). In conclusion, team-based interprofessional competency training is a team teaching model that can be used to enhance competency in dementia screening and management in medical, nursing, pharmacy, and social work practitioners.
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Physical Activity and Other Determinants of Survival in the Oldest Adults - American Geriatric Society
Objectives
To determine the role of physical activity as a possible survival determinant in the oldest adults.
Design
Prospective, longitudinal, population-based cohort.
Setting
The Pianoro Study of community-dwelling older adults in three towns in northern Italy.
Participants
Noninstitutionalized individuals aged 85 and older (n = 500; mean age 89.6 ± 3.1, 65% female).
Measurements
Participants provided information on marital status, educational level, previous work activity, cardiovascular risk factors, previous cardiovascular events, self-rated health, joint pain, and functional status. Physical activity was quantified using the Physical Activity Scale for the Elderly. Seven-year mortality was known for all subjects.
Results
During the 7 years of follow-up, 365 subjects died. According to Cox proportional hazards regression, the following factors were found to be independently associated with mortality: PASE score (hazard ratio (HR) = 0.987, 95% confidence interval (CI) = 0.981–0.993, P < .001), male sex (HR = 1.642, 95% CI = 1.411–2.068, P < .001), age in years (HR = 1.077, 95% CI = 1.040–1.116, P < .001), previous stroke (HR = 1.908, 95% CI = 1.362–2.673, P < .001), poor self care (HR = 1.662, 95% CI = 1.231–2.246, P < .001), neck pain (HR = 0.649, 95% CI = 0.497–0.849, P = .002), self rated health (HR = 0.991, 95% CI = 0.985–0.997, P = .002).
Conclusion
In the oldest adults, accurate quantification of physical activity may provide important prognostic information. The predictive value of cardiovascular risk factors, except age, male sex, and prior stroke, was confirmed to be negligible. An unexpected inverse association between neck pain and mortality may require further investigation.
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Tuesday, November 29, 2016
Association Between Hospital Readmission and Acute and Sustained Delays in Functional Recovery During 18 Months After Elective Surgery: The Successful Aging after Elective Surgery Study - American Geriatric Society
Objectives
To examine the effect of hospital readmission on functional recovery after elective surgery in older adults.
Design
Prospective cohort of individuals aged 70 and older undergoing elective surgery, enrolled from June 2010 to August 2013.
Setting
Two academic medical centers.
Participants
Community-dwelling older adults (N = 566; mean age ± standard deviation 77 ± 5) undergoing major elective surgery and expected to be admitted for at least 3 days.
Measurements
Readmission was assessed in multiple interviews with participants and family members over 18 months and validated against medical record review. Physical function was assessed according to ability to perform instrumental activities of daily living (IADLs) and activities of daily living (ADL), Medical Outcomes Study 12-item Short-Form Survey Physical Component Summary score, and a standardized functional composite.
Results
Two hundred fifty-five (45%) participants experienced 503 readmissions. Readmissions were associated with delays in functional recovery in all measures of physical function. Having two or more readmissions over 18 months was associated with persistent and significantly greater risk of IADL dependence (relative risk (RR) = 1.8, 95% confidence interval (CI) = 1.5–2.3) and ADL dependence (RR = 3.3, 95% CI = 1.7–6.4). Degree of functional impairment increased progressively with number of readmissions. Readmissions within 2 months resulted in delayed functional recovery to baseline by 18 months, and readmissions between 12 and 18 months after surgery resulted in loss of functional recovery previously achieved.
Conclusion
Readmission after elective surgery may contribute to delays in functional recovery and persistent functional deficits in older adults.
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Monday, November 28, 2016
Calbee North America Issues Allergy Alert On Undeclared Milk In Harvest Snap Black Pepper Snap Pea Crisps - FDA Safety Alerts & Drug Recalls
Boardman, OR - Calbee is recalling 3,588 cases of Harvest Snap Black Pepper snap pea crisps are in 3.3 oz bags and have Lot Number MAR 31 17 0141 S. Harvest Snap Black Pepper snap pea crisps may actually contain Harvest Snap Wasabi Ranch snap pea crisps which contain dairy ingredients.
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Frog skin cultures secrete anti-yellow fever compounds - Journal of Antibiotics
Frog skin cultures secrete anti-yellow fever compounds
The Journal of Antibiotics 69, 783 (November 2016). doi:10.1038/ja.2016.16
Authors: Carolina Muñoz-Camargo, Margarita Correa Méndez, Vivian Salazar, Johanna Moscoso, Diana Narváez, Maria Mercedes Torres, Franz Kaston Florez, Helena Groot & Eduardo Mitrani
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Pairwise antibiotic interactions in Escherichia coli: triclosan, rifampicin and aztreonam with nine other classes of antibiotics - Journal of Antibiotics
Pairwise antibiotic interactions in Escherichia coli: triclosan, rifampicin and aztreonam with nine other classes of antibiotics
The Journal of Antibiotics 69, 791 (November 2016). doi:10.1038/ja.2016.26
Authors: Caroline Nguyen, Alice Zhou, Ayesha Khan, Jeffrey H Miller & Pamela Yeh
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Inhibition of bacterial undecaprenyl pyrophosphate synthase by small fungal molecules - Journal of Antibiotics
Inhibition of bacterial undecaprenyl pyrophosphate synthase by small fungal molecules
The Journal of Antibiotics 69, 798 (November 2016). doi:10.1038/ja.2016.35
Authors: Junji Inokoshi, Yuichiro Nakamura, Saori Komada, Katsuichiro Komatsu, Hideaki Umeyama & Hiroshi Tomoda
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MIC score, a new tool to compare bacterial susceptibility to antibiotics application to the comparison of susceptibility to different penems of clinical strains of Pseudomonas aeruginosa - Journal of Antibiotics
MIC score, a new tool to compare bacterial susceptibility to antibiotics application to the comparison of susceptibility to different penems of clinical strains of Pseudomonas aeruginosa
The Journal of Antibiotics 69, 806 (November 2016). doi:10.1038/ja.2016.38
Authors: Cédric Bretonnière, Adeline Maitte, Jocelyne Caillon, Gilles Potel, David Boutoille, Cédric Jacqueline & Christophe Guitton
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Synthesis and antibacterial activity of novel 11-[3-[(arylcarbamoyl)oxy]propylamino]-11-deoxy-6-O-methyl-3-oxoerythromycin A 11-N,12-O-cyclic carbamate derivatives - Journal of Antibiotics
Synthesis and antibacterial activity of novel 11-[3-[(arylcarbamoyl)oxy]propylamino]-11-deoxy-6-O-methyl-3-oxoerythromycin A 11-N,12-O-cyclic carbamate derivatives
The Journal of Antibiotics 69, 811 (November 2016). doi:10.1038/ja.2016.42
Authors: Zhonghui Zheng, Deping Du, Lili Cao, Jun Liu & Xiaofang Chen
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Anti-trypanosomal compound, sagamilactam, a new polyene macrocyclic lactam from Actinomadura sp. K13-0306 - Journal of Antibiotics
Anti-trypanosomal compound, sagamilactam, a new polyene macrocyclic lactam from Actinomadura sp. K13-0306
The Journal of Antibiotics 69, 818 (November 2016). doi:10.1038/ja.2016.28
Authors: Tōru Kimura, Masato Iwatsuki, Yukihiro Asami, Aki Ishiyama, Rei Hokari, Kazuhiko Otoguro, Atsuko Matsumoto, Noriko Sato, Kazuro Shiomi, Yōko Takahashi, Satoshi Ōmura & Takuji Nakashima
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Anti-Helicobacter pylori activity of some newly synthesized derivatives of xanthone - Journal of Antibiotics
Anti-Helicobacter pylori activity of some newly synthesized derivatives of xanthone
The Journal of Antibiotics 69, 825 (November 2016). doi:10.1038/ja.2016.36
Authors: Karolina Klesiewicz, Elżbieta Karczewska, Alicja Budak, Henryk Marona & Natalia Szkaradek
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Hangtaimycin, a peptide secondary metabolite discovered from Streptomyces spectabilis CPCC 200148 by chemical screening - Journal of Antibiotics
Hangtaimycin, a peptide secondary metabolite discovered from Streptomyces spectabilis CPCC 200148 by chemical screening
The Journal of Antibiotics 69, 835 (November 2016). doi:10.1038/ja.2016.29
Authors: Lijie Zuo, Bingya Jiang, Zhibo Jiang, Wei Zhao, Shufen Li, Hongyu Liu, Bin Hong, Liyan Yu, Limin Zuo & Linzhuan Wu
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Isolation and structural determination of a new antibacterial compound demethyl-L-681,217 from Streptomyces cattleya - Journal of Antibiotics
Isolation and structural determination of a new antibacterial compound demethyl-L-681,217 from Streptomyces cattleya
The Journal of Antibiotics 69, 839 (November 2016). doi:10.1038/ja.2016.53
Authors: Shogo Sugai, Hisayuki Komaki, Hikaru Hemmi & Shinya Kodani
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Sunday, November 27, 2016
High-Risk Medications in Hospitalized Elderly Adults: Are We Making It Easy to Do the Wrong Thing? - American Geriatric Society
Objectives
To examine dosages of high-risk medications administered to elderly adults who fall in the hospital and to determine whether electronic default doses are appropriate for elderly adults.
Design
Retrospective.
Setting
Large urban academic hospital.
Participants
Individuals aged 65 and older experiencing a fall.
Measurements
Prescribed daily dosages and use of high-risk medications (opiates, benzodiazepines, benzodiazepine-receptor agonists (BRAs), sleep medications, muscle relaxants, antipsychotics) administered within 24 hours before a fall were ascertained and compared with published recommended dosages for older adults and the hospital's electronic medical record (EMR) default doses for these drugs.
Results
Of 328 falls, 62% occurred in individuals administered at least one high-risk medication within the 24 hours before the fall, with 16% of the falls involving individuals receiving two, and another 16% in individuals receiving three or more. High-risk medications were often administered at higher-than-recommended geriatric daily doses, in particular benzodiazepines and BRAs, for which the dose was higher than recommended in 29 of 51 cases (57%). Hospital EMR default doses were higher than recommended for 41% (12/29) of medications examined.
Conclusion
High-risk medications were administered to older fallers. Doses administered and EMR default doses were often higher than recommended. Decreasing EMR default doses for individuals aged 65 and older and warnings about the cumulative numbers of high-risk medications prescribed per person may be simple interventions that could decrease inpatient falls.
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Changes in Drug Use and Polypharmacy After the Age of 90: A Longitudinal Study of the Danish 1905 Cohort - American Geriatric Society
Objectives
To determine the longitudinal development of drug use in very old adults.
Design
Longitudinal cohort study with waves in 1998, 2000, 2002, and 2005.
Setting
Nationwide study in Denmark.
Participants
All living Danes born in 1905 were approached in 1998; 2,262 responded at baseline.
Measurements
Self-reported use of regularly taken drugs. Mean and median number of drugs and growth curve models were used to identify the change in number of drugs as the cohort aged from 92 to 100.
Results
The within-person use of drugs increased with age for women (0.19 per year; 95% confidence interval (CI) = 0.15–0.24) and men (0.15 per year; 95% CI = 0.06–0.24). Persons leaving the study prematurely had higher baseline values and a steeper increase in their annual use of drugs. The population-level mean number of drugs increased from baseline (3.6 drugs) to the first follow-up (4.1 drugs) but thereafter remained stable at approximately 4 drugs. Women used more drugs than men at all waves.
Conclusion
In this first longitudinal study of drug use in nonagenarians, individuals used an increasing number of drugs as they aged. This increase is difficult to detect in cross-sectional analyses of the population-level mean. More efforts to understand what is reasonable prescribing at these older ages are needed.
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Interventions for the Management of Denture Stomatitis: A Systematic Review and Meta-Analysis - American Geriatric Society
Objectives
To assess the effectiveness of different interventions for treating or preventing denture stomatitis (DS).
Design
Systematic review.
Setting
Randomized controlled trials (RCTs) comparing any agent or procedure prescribed to treat or prevent DS in adults.
Participants
Older adults with denture stomatitis.
Measurements
There were two main outcomes reported in the trials included in this review: clinical signs of DS and remaining presence of yeast. There were no restrictions regarding language or date of publication. The search period was up to February 2016.
Results
Thirty-five studies were included in the systematic review, with 32 judged as having high risk of bias. Three RCTs compared nystatin with placebo and found a significant effect on the reduction of clinical signs of stomatitis (risk ratio (RR) = 0.51, 95% confidence interval (CI) = 0.36–0.72), four RCTs compared nystatin with placebo and found a significant effect on mycological assessment (RR = 0.61, 95% CI = 0.46–0.80). Five studies of disinfectant agents also showed a significant effect in comparison with an inactive agent (RR = 0.52, 95% CI = 0.30–0.92) in clinical assessment. No evidence was found of an effect of miconazole, amphotericin, or imidazolic drugs. No RCT evaluated the effectiveness of preventive approaches.
Conclusion
The results are supportive of the use of nystatin and disinfecting agents in the treatment of DS, but clinicians need to be aware that individual studies had high risk of bias and that the overall quality of the individual reports was judged to be low.
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Predictors of Long-Term Mortality in Older Patients Hospitalized for Acutely Decompensated Heart Failure: Clinical Relevance of Natriuretic Peptides - American Geriatric Society
Background
Acute heart failure is a common cause of hospitalization among older patients. Optimized risk stratification might improve the outcome for this subgroup of patients. Natriuretic peptides have been used in the diagnosis of heart failure and in evaluating the prognosis of patients hospitalized for heart failure. However, their utility in the elderly is still controversial.
Objective
To evaluate long-term survival and prognostic factors for elderly patients hospitalized for acutely decompensated heart failure and evaluate the prognostic utility of NT-proBNP.
Design
Retrospective, multicenter cohort study.
Setting
Two Italian hospitals.
Participants
Two hundred seventy-nine patients, aged >75 years; hospitalized for decompensation of chronic, established heart failure.
Methods
Baseline clinical data were recorded at admission. The primary outcome was long-term mortality.
Results
In-hospital, 12-month and 5-year mortality were, respectively, 10%, 36%, and 77%. NT-proBNP, eGFR, hemoglobin, diabetes, systolic blood pressure, and moderate to severe tricuspid regurgitation were independently associated with long-term prognosis and were entered into a multivariate model, with a C-index of 0.765 for the determination of high-risk patients. The C-index for NT-proBNP to predict mortality at 2 and 12 months was 0.740 and 0.756, respectively. The optimal cutoff point for predicting mortality at 2 and 12 months was 8,444 pg/mL (hazard ratio 5.33) and 8,275 pg/mL (hazard ratio 6.03), respectively.
Conclusion
Elderly patients hospitalized for acutely decompensated heart failure had a poor long-term outcome, especially in the subgroup with reduced ejection fraction (EF). In addition to EF and comorbidities, NT-pro-BNP remained independently prognostic among elderly patients hospitalized with heart failure.
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Self-Reported Masticatory Dysfunction and Mortality in Community Dwelling Elderly Adults: A 9-Year Follow-Up - American Geriatric Society
Objectives
To evaluate the association, if any, between masticatory dysfunction (MD) and mortality in older adults.
Design
The Invecchiare in Chianti (InCHIANTI) Study, a cohort study with 9-year follow-up.
Setting
Tuscany, Italy.
Participants
Individuals aged 65 and older (N = 1,155).
Measurements
MD was self-reported; Cox regression was used to assess the association between self-reported MD and 9-year all-cause mortality. This association was also evaluated after stratifying according to use of dentures. Analyses were adjusted for potential confounders, including demographic characteristics, lifestyle habits, comorbidities, nutrient intake, medications, and objective parameters.
Results
Four hundred five (35%) participants reported MD. Over the 9-year follow-up, 475 (41%) subjects died. According to Cox regression analysis, self-reported MD was associated with higher mortality (relative risk (RR) = 1.23, 95% confidence interval (CI) = 1.02–1.48), after adjusting for potential confounders. In participants with self-reported MD, uncorrected edentulism was the condition associated with the greatest risk of mortality (RR = 2.10, 95% CI = 1.07–4.14); use of dentures seemed to blunt this association (RR = 1.12, 95% CI = 0.87–1.44).
Conclusion
Self-reported MD, chiefly when due to uncorrected edentulism, is associated with 9-year all-cause mortality in community-dwelling elderly adults. Further studies are needed to evaluate whether the timely correction of MD using adequate dentures can increase the survival of older adults.
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Friday, November 25, 2016
JFC International Inc. Issues Allergy Alert On Undeclared Wheat In You-Ka Fresh Ramune And You-Ka Punch Ramune - FDA Safety Alerts & Drug Recalls
Los Angeles, CA - JFC International Inc. is voluntarily recalling the following confectionery products because they may contain undeclared wheat. People who have allergies to wheat run the risk of a serious or life-threatening allergic reaction if they consume the products.
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Anderson’s Frozen Custard issues Allergy Alert on Undeclared Peanuts in Pumpkin Ice Cream Pies - FDA Safety Alerts & Drug Recalls
Anderson’s Frozen Custard is recalling its “Pumpkin Ice Cream Pies” Because they 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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Thursday, November 24, 2016
Handy Seafood Recall: Product Label Missing Milk and Fish Allergen Advisory in Whole Foods Blue Crab Mini Crab Cakes - FDA Safety Alerts & Drug Recalls
Salisbury, Maryland - Handy Seafood Incorporated (“Handy”) is voluntarily recalling approximately 71 cases of Blue Crab Mini Crab Cakes, as identified on Attachment A. The voluntary recall is limited to this product which was distributed to Whole Foods stores in New Hampshire, Massachusetts, Maine, Connecticut, and Rhode Island between November 11, 2016 and November 23, 2016. Whole Foods has confirmed that less than 60 individual trays of the product have been sold to the public.
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Raritan Pharmaceuticals Inc. Issues a Voluntary Nationwide Recall of Products Containing Belladonna Extract Due to the Possibility of the Presence of Belladonna Alkaloids - FDA Safety Alerts & Drug Recalls
Raritan Pharmaceuticals, a contract manufacturer for Homeolab USA, is voluntarily recalling homeopathic products containing belladonna extract (see products below) due to the potential for variation in the content of belladonna extract in the products.
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Nutrivitashop, A DBA of Naturecom Inc is Requesting the Voluntarily Recall of DMAA Net Weight 500g Due to the Presence of DMAA that may Pose Possible Health Risk - FDA Safety Alerts & Drug Recalls
NutriVitaShop is a dba of Naturecom Inc. Lake Forest, CA is requesting the voluntary nationwide recall of its DMAA net weight 500g to include lot #20141102, 20150715, 20151022, 20160226, 20160701, 20161017 and 20150323 because there may be presence of DMAA. DMAA is also known as 1,3-dimethylamylamine, methylhexanamine, or geranium extract. DMAA is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products.
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Wednesday, November 23, 2016
Recall Announcement: Sabra Dipping Company’s Recall of Hummus Prompts Secondary Recall of Mediterranean Chicken Hummus Sandwich - FDA Safety Alerts & Drug Recalls
Fresh to Go Mediterranean Chicken Hummus” sandwiches (UPC 5254858888) manufactured solely for 7-Eleven Corporation are being recalled because Sabra Dipping Company has recalled the ingredient Red Pepper Hummus. Greencore, USA is voluntarily recalling these sandwiches. Sabra Dipping Company has recalled the Red Pepper Hummus ingredient used in this sandwich because of potential contamination with Listeria monocytogenes.
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National Recall by Sabra Dipping Company Leads to Secondary Recall of Deli Sandwich in Pittsburg (PA), Cleveland (OH) and Buffalo (NY) Markets - FDA Safety Alerts & Drug Recalls
Irving, TX - LSG Sky Chefs Supply Chain Solutions, Inc. (“LSG Sky Chefs”) announced today that it is issuing a voluntary recall for the 7-Eleven Chicken and Hummus sandwiches the company produces for 7-Eleven stores in the Pittsburgh, PA, Cleveland, OH, and the Buffalo, NY markets. The hummus spread used in the sandwiches is subject to a national recall issued by Sabra Dipping Company due to possible Listeria monocytogenes contamination.
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Sabra Dipping Company’s Recall Prompts Secondary Recall of Mediterranean Style Chicken With Hummus Sandwiches in Washington Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls
Irving, TX - LSG Sky Chefs Supply Chain Solutions, Inc. (“LSG Sky Chefs”) announced today that it is issuing a voluntary recall of 103 units of Mediterranean Style Chicken with Hummus sandwiches. The hummus spread used in the affected sandwiches was recalled by Sabra Dipping Company due to possible contamination 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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National Recall by Sabra Dipping Company Leads to Secondary Recall of Deli Sandwich in Northern California and Nevada - FDA Safety Alerts & Drug Recalls
Irving, Texas (November 23, 2016) – LSG Sky Chefs Supply Chain Solutions, Inc. (“LSG Sky Chefs”) announced today that it is issuing a voluntary recall for the Mediterranean Style Chicken with Hummus sandwiches the company produces for 7-Eleven stores. The hummus spread used in the sandwiches is subject to a national recall issued by Sabra Dipping Company due to possible Listeria monocytogenes contamination.
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Working to Achieve Health Equity: The CMS Equity Plan for Medicare One Year Later - CMS Blog
By: Cara V. James, Ph.D., Director of the Office of Minority Health at the Centers for Medicare & Medicaid Services
One year ago, the Centers for Medicare & Medicaid Services (CMS) launched its first ever Equity Plan for Improving Quality in Medicare at a conference commemorating the 50th anniversary of Medicare and Medicaid and the 30th anniversary of the Report of the Secretary’s Task Force on Black and Minority Health. The CMS Equity Plan for Improving Quality in Medicare is an action-oriented plan that focuses on six priority areas and aims to reduce health disparities among vulnerable populations including, racial and ethnic minorities, sexual and gender minorities, and people with disabilities.
The foundation of the CMS Equity Plan for Improving Quality in Medicare, is our 3-part ‘path to equity’ framework. The path involves: (1) increasing understanding and awareness of disparities, (2) developing and disseminating solutions, and (3) taking sustainable action and evaluating progress. Our path to equity enables us to take a comprehensive approach to addressing health disparities because it promotes progress regardless of where stakeholders are in their efforts to achieve health equity. In addition, the path to equity can be adopted by a wide range of stakeholders and organizations and applied from the individual level up to the community, state, and policy levels. The priorities and activities described in the Equity Plan for Medicare were developed during a rigorous year-long process, which included examining evidence, identifying opportunities, and gathering input from a broad array of stakeholders across the country. The plan includes six priority areas and an array of activities. They are:
Priority 1: Expand the Collection, Reporting, and Analysis of Standardized Data
Priority 2: Evaluate Disparities Impacts and Integrate Equity Solutions across CMS Programs
Priority 3: Develop and Disseminate Promising Approaches to Reduce Health Disparities
Priority 4: Increase the Ability of the Health Care Workforce to Meet the Needs of Vulnerable Populations
Priority 5: Improve Communication and Language Access for Individuals with Limited English Proficiency and Persons with Disabilities
Priority 6: Increase Physical Accessibility of Health Care Facilities
Since the launch of the CMS Equity Plan for Improving Quality in Medicare, we have been actively working to increase our understanding of disparities among Medicare beneficiaries with limited English proficiency and disabilities, and our knowledge of how to better prepare our workforce to meet the needs of vulnerable populations. To assist stakeholders in identifying disparities at a local, state, or regional level, we launched our Mapping Medicare Disparities Tool earlier this year. The Mapping Medicare Disparities Tool is an interactive map, which can be used to identify areas of disparities between subgroups of Medicare beneficiaries in health outcomes, utilization, and spending. To assist in the identification of disparities within Medicare health plans, we released for the first time national and contract level quality data stratified by race and ethnicity.
We have been working to develop solutions to help spur sustainable action. As part of our Building an Organizational Response to Health Disparities portfolio, we released the Guide to Preventing Readmissions among Racially and Ethnically Diverse Medicare Beneficiaries. This guide gives an overview of key issues related to readmissions for racially and ethnically diverse Medicare beneficiaries, as well as useful resources for hospital leaders to take action to address readmission. Our guide offers case examples of strategies and initiatives. We also released a compendium of resources for standardized demographic and language data collection to help organizations collect and analyze their own data, so that they may begin to increase understanding and awareness of disparities that may exist within their own organization.
To ensure that actions around equity at CMS are sustainable, we have been working with our colleagues across the Agency to identify where equity can be embedded. To that end, reducing disparities, focusing on social determinants of health, and advancing health equity have been called out in a number of models and initiatives. Within the Merit‐Based Incentive Payment System (MIPS), achieving health equity is one of the areas for clinical practice improvement activities. At the heart of the Accountable Health Communities Model is identifying and addressing the health-related social needs of beneficiaries.
While we have reached a number of milestones this year, we know that there is still much work to be done to achieve health equity. As we continue implementing the CMS Equity Plan for Medicare, we will focus on building on our accomplishments, strengthening our partnerships, and monitoring and evaluating our progress. We cannot do this work alone, so we encourage you to join us on the path to equity. By working together, we can truly achieve care and services that are high quality, effective, and equitable.
To learn more about our accomplishments regarding achieving health equity in Medicare and other activities underway at the CMS Office of Minority Health, visit: go.cms.gov/omh.
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Association of Multimorbidity with Mortality and Healthcare Utilization in Chronic Kidney Disease - American Geriatric Society
Objectives
Chronic kidney disease (CKD) almost universally occurs in individuals with other medical problems. However, few studies have described CKD-related multimorbidity using a framework that identifies chronic conditions as concordant (having overlap in treatment goals) versus discordant (having opposing treatment recommendations) and unrelated (having no overlap, but contributing to complexity via different resource requirements).
Design
Retrospective cohort.
Setting
Veterans Affairs (VA) Medical Centers.
Participants
VA patients (n = 821,334) ages 18–100 years with at least one outpatient visit and incident CKD defined as an estimated glomerular filtration rate <60 mL/min/1.73 m2 for at least 3 months between January 1, 2005 and December 31, 2008 after excluding prevalent CKD.
Measurements
We determined the associations of number of chronic conditions (1, 2, 3, 4, 5, 6 or more) stratified by the presence of one or more discordant/unrelated conditions with mortality, hospitalizations and emergency department (ED) visits.
Results
There were 381,187 deaths over 6.8 median years of follow-up. Higher risks of death, hospitalization and ED visits were associated with higher number of chronic conditions, among those with and without discordant/unrelated conditions. However, the magnitudes of the associations were consistently larger when at least one discordant/unrelated condition was present. For example, compared to patients with one concordant condition, patients with six or more concordant conditions had an age-, race- and sex-adjusted hazard ratio (HR) for mortality of 1.72 (95% CI 1.64–1.80) whereas those with six or more conditions, at least one of which was discordant/unrelated, had a HR of 2.05 (2.01–2.09) (P-interaction <0.001).
Conclusions
The presence of one or more discordant/unrelated conditions was associated with increased risk for adverse health outcomes, beyond the effect of multimorbidity.
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Resistance Band Exercises Reduce Depression and Behavioral Problems of Wheelchair-Bound Older Adults with Dementia: A Cluster-Randomized Controlled Trial - American Geriatric Society
Objectives
To test the effects of a 15-month wheelchair-bound resistance band exercise program on depression and behavioral problems of wheelchair-bound older adults with dementia.
Design
Single-blind, cluster-randomized controlled trial with repeated measures.
Setting
Eight nursing homes in southern Taiwan.
Participants
Wheelchair-bound nursing home older adults with dementia who participated voluntarily (N = 150) were cluster-randomized to two groups (experimental or control group); 127 completed the study (experimental: four nursing homes, n = 65; control: four nursing homes, n = 62).
Intervention
The resistance band exercises were conducted three times per week in 40-minute sessions in the following two sequences: volunteer-led sessions for the first 6 months (Stage I) followed by DVD-guided sessions for the next 9 months (Stage II).
Measurements
Depression, as measured using the Cornell Scale for Depression in Dementia, and behavioral problems, as measured using the Clifton Assessment Procedures for the Elderly—Behavior Rating Scale, of participants were observed at six time points at 3-month intervals: pretest, two posttests at Stage I, and three posttests at Stage II.
Results
By the sixth month of the study, experimental group participants were significantly less depressed and had fewer behavioral problems than control group participants (all P < .05). These small but statistically significant differences persisted throughout the 9 months of the DVD-guided sessions (all P < .05).
Conclusion
Volunteer-led sessions followed by DVD-guided sessions of resistance band exercise is effective and practical in institutional settings.
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No End in Sight: Benzodiazepine Use in Older Adults in the United States - American Geriatric Society
Objectives
To establish the rate of new and continuation of benzodiazepine use in older adults seen by nonpsychiatrist physicians and to identify subpopulations at risk of new and continuation benzodiazepine use.
Design
Cross-sectional analysis.
Setting
National Ambulatory Medical Care Survey (2007–10).
Participants
Adults visiting office-based nonpsychiatrist physicians (n = 98,818) who were prescribed a benzodiazepine (new or continuation).
Measurements
Percentage of benzodiazepine visits of all outpatient encounters according to patient age and corresponding annual visit rate per 1,000 population. Analysis was then limited to adults aged 65 and older, demographic, clinical, and visits characteristics were used to compare visits of benzodiazepine users with those of nonusers and visits of continuation users with those of new users.
Results
The overall proportion of benzodiazepine visits ranged from 3.2% (95% confidence interval (CI) = 2.7–3.7) of those aged 18 to 34 to 6.6% (95% CI = 5.8–7.6) of those aged 80 and older, and the proportion of continuation visits increased with age, rising to 90.2% (95% CI = 86.2–93.1) of those aged 80 and older. The population-based visit rate ranged from 61.7 (95% CI = 50.7–72.7) per 1,000 persons in the youngest adults to 463.7 (95% CI = 385.4–542.0) in those aged 80 and older. Only 16.0% (95% CI = 13.5–18.8) of continuation users had any mental health diagnosis. Of all benzodiazepine users, fewer than 1% (95% CI = .4–1.8) were provided or referred to psychotherapy, and 10.0% (95% CI = 7. 2–13.3) were also prescribed an opioid.
Conclusion
In the United States, few older adult benzodiazepine users receive a clinical mental health diagnosis, and almost none are provided or referred to psychotherapy. Prescribing to older adults continues despite decades of evidence documenting safety concerns, effective alternative treatments, and effective methods for tapering even chronic users.
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Delirium: A Survey of Healthcare Professionals’ Knowledge, Beliefs, and Practices - American Geriatric Society
Objectives
To evaluate knowledge, beliefs, and practices regarding delirium of physicians, nurse practitioners (NPs), and registered nurses (RNs).
Design
Anonymous cross-sectional paper survey.
Setting
New York metropolitan area tertiary care hospital.
Participants
RNs, NPs, and physicians (N = 164).
Measurements
The survey assessed knowledge, beliefs, and practices regarding delirium and prior delirium or geriatric training.
Results
Of the 200 surveys distributed, 164 were completed (82% response rate). Of these, 61.7% were RNs, 13.6% were NPs, and 20.7% were physicians. Mean participant age was 36.3. The majority (80.1%) were female; 56.5% were white, 18.1% Asian, 8.7% Hispanic, 8.0% black, and 8.7% other. Of the seven potential barriers to delirium screening assessed, the three most frequently reported were lack of conceptual understanding of delirium (48.0%), similarity of delirium and dementia (41.4%), and the fluctuating nature of delirium (38.1%). Physicians were more likely than NPs and RNs to report being confident in identifying delirium (P = .002) and to score higher on the delirium knowledge assessment (P < .001). Participants who received geriatrics training were significantly more likely than those who did not to be confident in identifying delirium (P = .005) and to score higher on overall delirium knowledge assessment (P = .003).
Conclusion
Geriatric training is associated with more confidence in delirium screening and higher delirium knowledge scores. There is an urgent need to broaden the approach to delirium education of nurses and physicians caring for hospitalized older adults using comprehensive multidisciplinary geriatric educational models.
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Expression and characterization of a Talaromyces marneffei active phospholipase B expressed in a Pichia pastoris expression system
Expression and characterization of a Talaromyces marneffei active phospholipase B expressed in a Pichia pastoris expression system
Emerging Microbes & Infections 5, e120 (November 2016). doi:10.1038/emi.2016.119
Authors: Yan He, Linghua Li, Fengyu Hu, Wanshan Chen, Huali Lei, Xiejie Chen, Weiping Cai & Xiaoping Tang
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Human papillomavirus prevalence and associated factors in women and men in south China: a population-based study
Human papillomavirus prevalence and associated factors in women and men in south China: a population-based study
Emerging Microbes & Infections 5, e119 (November 2016). doi:10.1038/emi.2016.118
Authors: Feixue Wei, Kai Yin, Xin Wu, Jian Lan, Shoujie Huang, Wei Sheng, Jun Zhao, Yingying Su, Ying Wang, Yanping Li, Rongcheng Li, Jun Zhang, Mingqiang Li, Ting Wu & Ningshao Xia
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First identification of NDM-4-producing Escherichia coli ST410 in China
First identification of NDM-4-producing Escherichia coli ST410 in China
Emerging Microbes & Infections 5, e118 (November 2016). doi:10.1038/emi.2016.117
Authors: Shangshang Qin, Mengmeng Zhou, Qijing Zhang, Hengxun Tao, Yafei Ye, Huizhi Chen, Lijuan Xu, Hui Xu, Ping Wang & Xianju Feng
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Genetic characterization of novel fowl aviadenovirus 4 isolates from outbreaks of hepatitis-hydropericardium syndrome in broiler chickens in China
Genetic characterization of novel fowl aviadenovirus 4 isolates from outbreaks of hepatitis-hydropericardium syndrome in broiler chickens in China
Emerging Microbes & Infections 5, e117 (November 2016). doi:10.1038/emi.2016.115
Authors: Yanke Liu, Wenyan Wan, Dongsheng Gao, Yongtao Li, Xia Yang, Hongying Liu, Huixia Yao, Lu Chen, Chuanqing Wang & Jun Zhao
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Tuesday, November 22, 2016
Rheumatic Diseases in Older Adults - Geriatrics
We are pleased to present this special issue of Clinics in Geriatric Medicine that is devoted to Rheumatic Diseases in Older Adults. To this end, we have assembled a broad range of expertise in order to highlight the latest diagnostic and therapeutic information in the field. Our agenda has not been to re-invent a general overview of geriatric rheumatology but rather to hone in on pragmatic as well as up-and-coming musculoskeletal issues facing gerontologists.
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Index - Geriatrics
Note: Page numbers of article titles are in boldface type.
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Cardiovascular Disease Risk in Patients with Rheumatic Diseases - Geriatrics
Evidence suggests the greater than 1.5 increased risk of cardiovascular disease (CVD) in rheumatoid arthritis (RA) is related to an accelerated burden of subclinical atherosclerosis that develops before the diagnosis of RA. Dyslipidemia in RA is better quantified by lipoproteins and apolipoproteins than cholesterol levels. Current risk factors likely underestimate CVD risk partly by underestimating prior risk factor levels. To reduce CVD risk in RA, control disease activity and aggressively treat CVD risk factors. Some of the two-fold higher risk of heart failure and total mortality in RA may be due to myocardial disease caused by inflammation.
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Sjögren Syndrome and Other Causes of Sicca in Older Adults - Geriatrics
Dry eye and dry mouth symptoms are each reported by up to 30% of persons more than 65 years of age, particularly in women. Medication side effects are the most common contributing factors. The evaluation of these symptoms requires measures of ocular and oral dryness. Sjögren syndrome is the prototypic disease associated with dryness of the eyes and mouth and predominantly affects women in their perimenopausal and postmenopausal years. In addition to topical treatment of the mucosal dryness, patients with Sjögren syndrome may require treatment with systemic immunomodulatory and immunosuppressive agents to manage a variety of extraglandular manifestations.
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Regional Rheumatic Disorders and Rehabilitation in Older Adults - Geriatrics
Musculoskeletal problems are the most frequently reported complaints among older adults living in the community. The impact of the aging process on skeletal muscles and joints can have a profound effect on the ability of individuals with and without disabilities to function. This article reviews the rehabilitation medicine approach to the evaluation of older adults with regional rheumatic disorders, and the rehabilitation medicine considerations for clinical interventions. Future research considerations are encouraged in order to gain a greater understanding of the subject matter and its impact on the provision of care and patients’ quality of life.
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A Review of Osteoporosis in the Older Adult - Geriatrics
Osteoporosis in the elderly population is common. It results in more than 1.5 million fractures per year in the United States. The goal of managing osteoporosis is to prevent fractures. In men, osteoporosis is underrecognized and undertreated. More men than women die every year as a consequence of hip fractures. A review of diagnosis and treatment of osteoporosis is described in this article. Bisphosphonates are the first-line treatment for men and women. In the past several years, advances in bone biology have resulted in major therapeutic advances.
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Pathogenesis and Management of Sarcopenia - Geriatrics
Sarcopenia represents a loss of muscle strength and mass in older individuals. Sarcopenia in the elderly has now become a major focus of research and public policy debate due to its impact on morbidity, mortality, and health care expenditure. Despite its clinical importance, sarcopenia remains under-recognized and poorly managed in routine clinical practice. This is, in part, due to a lack of available diagnostic testing and uniform diagnostic criteria. The management of sarcopenia is primarily focused on physical therapy for muscle strengthening and gait training. There are no pharmacologic agents for the treatment of sarcopenia.
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CMS Finalizes its Measures Under Consideration List for Pre-rulemaking - CMS Blog
By: Kate Goodrich, M.D., M.H.S., Director, Center for Clinical Standards & Quality, CMS
Medicare and other payers are rapidly moving toward a health care system that rewards high quality care while spending taxpayer dollars more wisely. Foundational to the success of these efforts is having quality measures that are meaningful to patients and providers alike, and that drive improvement and better outcomes for patients. Each year, CMS publishes a list of quality and cost measures that are under consideration for Medicare quality and value-based purchasing programs, and collaborates with the National Quality Forum (NQF) to get critical input from multiple stakeholders, including patients, clinicians, commercial payers and purchasers, on the measures that are best suited for these programs. Ultimately, these measures may help patients and families choose the nursing home, hospital, or clinician that is best for them, and can help providers deliver the highest quality of care to their patients.
I am happy to announce that CMS posted the final Measures under Consideration List on the CMS website and has sent them to NQF in preparation for this multi-stakeholder input. They can be found on the CMS website, at http://ift.tt/2gHHSwr and on the National Quality Forum’s (NQF) website, at http://ift.tt/2gj5945).
This year’s MUC list contains 97 measures that have the potential to drive improvement in quality across numerous settings of care. CMS is considering new measures for nursing homes, hospitals, clinician practices, and dialysis facilities, among other settings, and continues to focus on important measures of patient outcomes, appropriate use of diagnostics and services, cost, and patient safety. This year, 39 percent of measures on the Measures under Consideration List are outcome measures, and an increased number of measures were submitted for consideration by specialty societies. CMS is committed to working with specialty societies and other stakeholders on the development and use of measures that are most meaningful to patients and clinicians for our programs.
The Affordable Care Act (ACA) (P.L. 111-148, enacted on March 23, 2010) added Section 1890A to the Social Security Act (the Act), which requires that the Secretary of the Department of Health and Human Services (HHS) establish a federal “pre-rulemaking process” for the selection of certain categories of quality and efficiency measures for use in various Medicare quality programs. These measures and programs are described in section 1890(b)(7)(B) of the Act. One of the steps in this process requires that the Secretary make publicly available a list of quality and efficiency measures by December 1st that CMS is considering for adoption, through the annual rulemaking process, for use in these Medicare programs. Additionally, this provision requires HHS to contract with a consensus-based entity (currently the National Quality Forum) to “convene multi-stakeholder groups to provide input on the selection of quality measures” for the programs specified in the law.
Subsequent to the posting of the Measures under Consideration List, NQF will accept comments on the list and convene the multi-stakeholder from the public on behalf of and for consideration by the Measure Applications Partnership (MAP) to review and provide input on which measures are most suitable for Medicare’s quality and value-based purchasing programs. This is the sixth year that CMS has collaborated with NQF on this pre-rulemaking process, and together we have worked to make the process more efficient and the feedback more meaningful. The input that we receive from the MAP is invaluable, and reflects the viewpoints of many experts in the field of quality and value, most importantly patients and consumers.
We invite you to review the Measures under Consideration List in detail and to participate in the public process during the MAP review. We believe it is critically important to hear all voices in the selection of quality and efficiency measures that are used for accountability and transparency purposes and look forward to another successful pre-rulemaking season. We are committed to working with patients, clinicians and others on how to best measure the quality and value of care while reducing burden on providers and driving improved outcomes for patients at lower costs.
For more information regarding the MAP’s purpose, meetings, 2016 Measures under Consideration List deliberations and voting, visit the NQF website, at http://ift.tt/IXUWWv.
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Sabra Dipping Company’s Recall Prompts Secondary Recall of Vegetable Products - FDA Safety Alerts & Drug Recalls
Following the Sabra Dipping Co., LLC’s ("Sabra’s") recall where select Sabra's products were recalled due to the potential of being contaminated with Listeria monocytogenes, Taylor Farms Tennessee, Inc., Taylor Farms Texas, Inc. and Taylor Farms Pacific, Inc. (all collectively referred to as “Taylor Farms”) are voluntarily recalling a limited number of products that contain Sabra's recalled products.
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Relationship Between Age and Trajectories of Rehospitalization Risk in Older Adults - American Geriatric Society
Objectives
To characterize the magnitude and duration of risk of rehospitalization according to age after hospitalization for heart failure (HF), acute myocardial infarction (AMI), or pneumonia.
Design
Retrospective cohort study.
Setting
U.S. hospitals (n = 4,767).
Participants
All Medicare fee-for-service beneficiaries aged 65 and older surviving hospitalization for HF, AMI, or pneumonia between October 2012 and December 2013.
Measurements
Daily risk of first rehospitalization for 1 year after hospital discharge was calculated according to age category (65–74, 75–84, ≥85) after adjustment for sex, race, comorbidities, and median ZIP code income. Time required for adjusted rehospitalization risk to decline 50% from maximum value after discharge, time required for adjusted risk to approach a plateau period of minimal day-to-day change, and degree to which adjusted risk was higher in recently hospitalized individuals than in the general elderly population were identified.
Results
There were 414,720 hospitalizations for HF, 177,752 for AMI, and 568,304 for pneumonia. The adjusted risk of rehospitalization declined with increasing age after HF hospitalization (P < .001), rose with increasing age after AMI hospitalization (P < .001), and was slightly lower with increasing age after pneumonia hospitalization (P = .002). Adjusted risks of rehospitalization were high beyond 30 days after hospitalization for all ages.
Conclusion
Although older age has heterogeneous relationships with rehospitalization risk, risk of readmission remains high for an extended time after discharge regardless of age or admitting condition. Condition-specific data on risk can be used to guide discussions on advanced care planning and strategies for longitudinal follow-up after hospitalization.
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AGS Position Statement: Making Medical Treatment Decisions for Unbefriended Older Adults - American Geriatric Society
In this position statement, we define unbefriended older adults as patients who: (1) lack decisional capacity to provide informed consent to the medical treatment at hand; (2) have not executed an advance directive that addresses the medical treatment at hand and lack capacity to do so; and (3) lack family, friends or a legally authorized surrogate to assist in the medical decision-making process. Given the vulnerable nature of this population, clinicians, health care teams, ethics committees and other stakeholders working with unbefriended older adults must be diligent when formulating treatment decisions on their behalf. The process of arriving at a treatment decision for an unbefriended older adult should be conducted according to standards of procedural fairness and include capacity assessment, a search for potentially unidentified surrogate decision makers (including non-traditional surrogates) and a team-based effort to ascertain the unbefriended older adult's preferences by synthesizing all available evidence. A concerted national effort is needed to help reduce the significant state-to-state variability in legal approaches to unbefriended patients. Proactive efforts are also needed to identify older adults, including “adult orphans,” at risk for becoming unbefriended and to develop alternative approaches to medical decision making for unbefriended older adults. This document updates the 1996 AGS position statement on unbefriended older adults.
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Translating Delirium Prevention Strategies for Elderly Adults with Hip Fracture into Routine Clinical Care: A Pragmatic Clinical Trial - American Geriatric Society
Objectives
To compare the feasibility (adherence) and effectiveness (prevalence of delirium, length of stay, mortality, discharge site) of delirium-friendly preprinted postoperative orders (PPOs) for individuals with hip fracture, administered by regular orthopedic nurses, with routine postoperative orders.
Design
Pragmatic clinical trial to evaluate a quality improvement intervention.
Setting
Tertiary care hospital.
Participants
Individuals aged 65 and older admitted for hip fracture repair (N = 283).
Intervention
PPOs with delirium-friendly options and doses for nighttime sedation, analgesia, and nausea and attention to catheter removal and bowel movements.
Measurements
Adherence to PPO was compared with adherence to routine orders. Drug doses were recorded. Presence of delirium was documented using the Confusion Assessment Method and the Mini-Mental State Examination on postoperative Days 1, 3, and 5. Length of stay, discharge site, and in-hospital mortality were recorded.
Results
Orthopedic nurses adhered reasonably well with delirium-friendly PPOs. Of 283 participants, 42% developed postoperative delirium, with significantly less delirium in the intervention group (intervention 33%, control 51%, P = .001). The effect of the intervention was stronger in individuals with preexisting dementia (intervention 60%, control 97%, P < .001). Participants with postoperative delirium had longer hospital stays and were more likely to die or be discharged to a nursing home, but there was no significant between-group difference in these outcomes.
Conclusion
It is possible to introduce delirium-friendly PPOs into routine post-hip fracture care in a representative elderly population including individuals with dementia. Delirium-friendly PPOs executed by regular nursing staff resulted in a significant reduction in postoperative delirium but no difference in other outcomes.
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Effects of Tai Chi on Cognition and Fall Risk in Older Adults with Mild Cognitive Impairment: A Randomized Controlled Trial - American Geriatric Society
Objectives
To examine whether combined center- and home-based Tai Chi training can improve cognitive ability and reduce physiological fall risk in older adults with amnestic mild cognitive impairment (a-MCI).
Design
Randomized controlled trial.
Setting
Chiang Mai, Thailand.
Participants
Adults aged 60 and older who met Petersen's criteria for multiple-domain a-MCI (N = 66).
Intervention
Three weeks center-based and 12 weeks home-based Tai Chi (50 minutes per session, 3 times per week).
Measurements
Cognitive tests, including Logical Memory (LM) delayed recall, Block Design, Digit Span forward and backward, and Trail-Making Test Part B–A (TMT B–A), and fall risk index using the Physiological Profile Assessment (PPA).
Results
At the end of the trial, performance on LM, Block Design, and TMT B–A were significantly better for the Tai Chi group than the control group after adjusting for baseline test performance. The Tai Chi group also had significantly better composite PPA score and PPA parameter scores: knee extension strength, reaction time, postural sway, and lower limb proprioception.
Conclusion
Combined center- and home-based Tai Chi training three times per week for 15 weeks significantly improved cognitive function and moderately reduced physiological fall risk in older adults with multiple-domain a-MCI. Tai Chi may be particularly beneficial to older adults with this condition.
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Slow Gait Speed and Risk of Long-Term Nursing Home Residence in Older Women, Adjusting for Competing Risk of Mortality: Results from the Study of Osteoporotic Fractures - American Geriatric Society
Objectives
To determine whether slow gait speed increases the risk of costly long-term nursing home residence when accounting for death as a competing risk remains unknown.
Design
Longitudinal cohort study using proportional hazards models to predict long-term nursing home residence and subdistribution models with death as a competing risk.
Setting
Community-based prospective cohort study.
Participants
Older women (mean age 76.3) participating in the Study of Osteoporotic Fractures who were also enrolled in Medicare fee-for-service plans (N = 3,755).
Measurements
Gait speed was measured on a straight 6-m course and averaged over two trials. Long-term nursing home residence was defined using a validated algorithm based on Medicare Part B claims for nursing home–related care.
Results
Participants were followed until long-term nursing home residence, disenrollment from Medicare plan, death, or December 31, 2010. Over the follow-up period (median 11 years), 881 participants (23%) experienced long-term nursing home residence, and 1,013 (27%) died before experiencing this outcome. Slow walkers (55% of participants with gait speed <1 m/s) were significantly more likely than fast walkers to reside in a nursing home long-term (adjusted hazards ratio (aHR) = 1.79, 95% confidence interval (CI) = 1.54–2.09). Associations were attenuated in subdistribution models (aHR = 1.52, 95% CI = 1.30–1.77) but remained statistically significant.
Conclusion
Older community-dwelling women with slow gait speed are more likely to experience long-term nursing home residence, as well as mortality without long-term residence. Ignoring the competing mortality risk may overestimate long-term care needs and costs.
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Association Between Chewing Difficulty and Symptoms of Depression in Adults: Results from the Korea National Health and Nutrition Examination Survey - American Geriatric Society
Objectives
To assess the association between chewing difficulty and symptoms of depression in a representative sample of the Korean population.
Design
Cross-sectional.
Setting
Korea National Health and Nutrition Examination Survey (KNHANES).
Participants
KNHANES participants (N = 5,158).
Measurements
Chewing difficulty was assessed according to the self-reported presence of chewing problems using a structured questionnaire. Symptoms of depression were defined as having feelings of sadness or depression consecutively over 2 weeks during the last 12 months. Multivariable logistic regression analysis was used to determine the adjusted odds ratios (AORs) and 95% confidence intervals (CIs) of the associations between chewing difficulty and symptoms of depression, adjusted for age; sex; monthly household income; education; number of teeth; number of decayed, missing, or filled permanent teeth; periodontitis; state of dentition; tooth brushing frequency; regular dental visits; smoking status; alcohol consumption; hypertension; diabetes mellitus; and obesity. The interaction effects between chewing difficulty and confounders were evaluated, and age- and sex-stratified analyses were performed.
Results
There was a significant positive association between chewing difficulty and symptoms of depression in the fully adjusted model (AOR = 1.86, 95% CI = 1.48–2.33). The strength of the association was highest in men aged 60 and older (AOR = 3.28, 95% CI = 1.54–7.00).
Conclusion
Chewing difficulty was independently associated with symptoms of depression in a representative sample of Korean adults.
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Monday, November 21, 2016
Tri-Coast Pharmacy Inc. Voluntarily Recalling All Sterile Products Prepared Between May 17, 2016 and November 17, 2016 Due to Concern Over Lack of Sterility Assurance - FDA Safety Alerts & Drug Recalls
Juno Beach, FL – Tri-Coast Pharmacy Inc. is voluntarily recalling all sterile products prepared between May 17, 2016 and November 17, 2016 and that remain within expiry (list is attached below) due to Food and Drug Administration’s (“FDA”) concerns over the lack of sterility assurance of the drugs named in this recall.
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Cantrell Drug Company Issues Voluntary Recall of Select Sterile Drug Products Due to Lack of Sterility Assurance - FDA Safety Alerts & Drug Recalls
Cantrell Drug Company is voluntarily recalling certain unexpired sterile drug products due to lack of sterility assurance.
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Allergy Alert Issued on Mislabeled Product for Undeclared Milk and Soy in Heinz Homestyle Bistro Au Jus Gravy - FDA Safety Alerts & Drug Recalls
Approximately 500 cases of Heinz HomeStyle Bistro Au Jus Gravy are voluntarily being recalled because some of the jars may be mislabeled as Heinz Pork Gravy and therefore not labeled as containing milk and soy.
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Physical Exercise for Late-Life Depression: Customizing an Intervention for Primary Care - American Geriatric Society
Objectives
To identify which individual- and context-related factors influence the translation into clinical practice of interventions based on physical exercise (PE) as an adjunct to antidepressants (AD) for the treatment of late-life major depression (LLMD).
Design
Secondary analysis of a randomized controlled trial.
Setting
Primary care with psychiatric consultation-liaison programs (PCLPs)—organizational protocols that regulate the clinical management of individuals with psychiatric disorders.
Participants
Individuals aged 65 and older with major depression according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (N = 121).
Intervention
Participants with LLMD were randomized to AD (sertraline) or AD plus PE (AD + PE).
Measurements
Participant characteristics that were associated with greater effectiveness of AD + PE (moderators) were identified, and effect sizes were calculated from success rate differences. Whether the characteristics of the study setting influenced participant flow and attendance at exercise sessions was then explored, and primary care physicians (PCPs) were surveyed regarding their opinions on PE as a treatment for LLMD.
Results
The following participant characteristics were associated with greater likelihood of achieving remission from depression with AD + PE than with AD alone: aged 75 and older (effect size 0.32), polypharmacy (0.35), greater aerobic capacity (0.48), displaying psychomotor slowing (0.49), and less-severe anxiety (0.30). The longer the PCLP had been established at a particular center, the more individuals were recruited at that center. After participating in the study, PCPs expressed positive views on AD + PE as a treatment for LLMD and were more likely to use this as a therapeutic strategy.
Conclusions
The combination of PE and sertraline could improve the management of LLMD, especially when customized for individuals with specific clinical features. Liaison programs might influence the implementation of similar interventions in primary care, and PCPs viewed them positively.
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Systematic Review of the Prevalence of Medication Errors Resulting in Hospitalization and Death of Nursing Home Residents - American Geriatric Society
Medication errors (MEs) result in preventable harm to nursing home (NH) residents and pose a significant financial burden. Institutionalized older people are particularly vulnerable because of various organizational and individual factors. This systematic review reports the prevalence of MEs leading to hospitalization and death in NH residents and the factors associated with risk of death and hospitalization. A systematic search was conducted of the relevant peer-reviewed research published between January 1, 2000, and October 1, 2015, in English, French, German, or Spanish examining serious outcomes of MEs in NHs residents. Eleven studies met the inclusion criteria and examined three types of MEs: all MEs (n = 5), transfer-related MEs (n = 5), and potentially inappropriate medications (PIMs) (n = 1). MEs were common, involving 16–27% of residents in studies examining all types of MEs and 13–31% of residents in studies examining transfer-related MEs, and 75% of residents were prescribed at least one PIM. That said, serious effects of MEs were surprisingly low and were reported in only a small proportion of errors (0–1% of MEs), with death being rare. Whether MEs resulting in serious outcomes are truly infrequent, or are underreported because of the difficulty in ascertaining them, remains to be elucidated to assist in designing safer systems.
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Changes in Care Goals and Treatment Orders Around the Occurrence of Health Problems and Hospital Transfers in Dementia: A Prospective Study - American Geriatric Society
Objectives
To explore changes in care goals and treatment orders around the occurrence of pneumonia and intake problems, and whether hospitalization is in line with earlier agreed-upon do-not-hospitalize orders.
Design
Data were collected as part of the Dutch End of Life in Dementia study (2007–2011), a longitudinal observational study with up to 3.5 years of follow-up.
Setting
Long-term care facilities (N = 28) in the Netherlands.
Participants
Newly admitted nursing home patients (N = 372) in various stages of dementia.
Measurements
Semiannually, physicians completed questionnaires about care goals and treatment orders, and they continuously registered episodes of pneumonia, intake problems and hospitalization. We report on changes in care goals and treatment orders during follow-up in relation to the developing of pneumonia and intake problems and on hospitalization and reasons for hospitalization.
Results
The proportion of patients with palliative care goals and do-not-treat orders rose during follow-up, especially before death. Treatment orders most frequently referred to resuscitation and hospitalization (do-not order increased from 73% to 92%, and from 28% to 76%, respectively). The proportions of patients with a palliative care goal and do-not-treat orders were similar after developing pneumonia, but increased after intake problems. During follow-up, 46 patients were hospitalized one or more times. Hospitalization occurred despite a do-not-hospitalize order in 21% of decisions. The most frequently reported reason for hospitalization was a fracture, especially in patients with a do-not-hospitalize order.
Conclusion
Care plans, including global care goals (predominantly palliative care goals), are made soon after admission, and specific treatment orders are agreed upon in more detail when the condition of the patient worsens. Establishing care plans shortly after nursing home admission may help to prevent burdensome treatment.
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Brain Function Is Linked to LDL Cholesterol in Older Adults with Cardiovascular Risk - American Geriatric Society
Objectives
To determine how cardiovascular risk is associated with working memory task performance and task-related suppression of default-mode network (DMN) activity in cognitively intact older adults.
Design
A cross-sectional functional magnetic resonance imaging study of older adults with cardiovascular risk factors.
Setting
Rotman Research Institute, Baycrest Health Sciences.
Participants
Thirty older adults with cardiovascular risk factors.
Measurements
Participants provided health information and a blood sample, and underwent functional magnetic resonance imaging during a working memory task and during a breath-hold task to assess cerebrovascular reactivity.
Results
Higher plasma low-density lipoprotein cholesterol (LDL-C) was associated with poorer working memory task performance (P = 0.008) and reduced task-related DMN suppression (P = 0.005). A composite index of cardiovascular risk, the Framingham General Cardiovascular Risk Profile, showed no associations with task performance or task-related DMN suppression. These findings were independent of white matter burden and cerebrovascular reactivity and thus cannot be accounted for by individual differences in neurovascular health.
Conclusion
These findings suggest a deleterious effect of elevated LDL-C on working memory task performance and task-related DMN suppression in older adults with cardiovascular risk. The relations between the Framingham General Cardiovascular Risk Profile, cognitive task performance, and DMN function require further study.
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Cerebral Amyloid Deposition Is Associated with Gait Parameters in the Mayo Clinic Study of Aging - American Geriatric Society
Objectives
To determine the cross-sectional association between cerebral amyloid-beta (Aβ) deposition and gait.
Design
Cross-sectional.
Setting
Population-based cohort study in Olmsted County, MN.
Participants
Cognitively normal individuals (n = 611), aged 50 to 69 years, enrolled in the Mayo Clinic Study of Aging with concurrent PiB-PET imaging and gait assessment. Participants with a history of stroke, alcoholism, Parkinson's disease, subdural hematoma, traumatic brain injury, or normal pressure hydrocephalus were excluded.
Measurements
PiB-PET SUVR was measured in prefrontal, orbitofrontal, parietal, temporal, anterior cingulate, posterior cingulate, and motor-specific regions of interest (ROIs). Gait parameters (speed, cadence, stride length, double support time, and intra-individual stance time variability) were measured using GAITRite® instrumentation. Linear regression models were adjusted for age, sex, body mass index, education, APOE ε4 allele, Charlson comorbidity index, and depression. In secondary analyses, we additionally adjusted for neurodegeneration (hippocampal volume, FDG PET SUVR, and cortical thickness) in AD-associated regions.
Results
In fully adjusted models including neuroimaging measures of neurodegeneration, higher PiB-PET SUVR across all ROIs was associated with slower gait speed (P < .05 except for the parietal ROI), lower cadence and longer double support time (P ≤ .05 except for the motor ROI), and greater stance time variability (P < .05). In sex-stratified analyses, the association between higher PiB-PET SUVR across all ROIs and measures of gait was only present among women.
Conclusion
PiB-PET SUVR across ROIs, independent of general measures of AD-associated neurodegeneration, is associated with poorer performance on multiple gait parameters among cognitively normal women, aged 50 to 69 years. Longitudinal studies are needed to determine whether Aβ predicts gait decline in both women and men.
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Saturday, November 19, 2016
Sabra Dipping Company Issues Voluntary Recall Of Certain Hummus Products Because Of Possible Health Risks - FDA Safety Alerts & Drug Recalls
Sabra Dipping Co., LLC is voluntarily recalling certain hummus products made prior to November 8, 2016 due to concerns over Listeria monocytogenes, which was identified at the manufacturing facility but not in tested finished product. The recall includes the products listed below; these were distributed to retail outlets, including food service accounts and supermarkets, in the U.S. and Canada.
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H-E-B Issues Precautionary Baby Food Recall - FDA Safety Alerts & Drug Recalls
San Antonio, TX - H-E-B announced today that it has issued a precautionary recall of its entire H-E-B Baby Food 2 pack 4 oz. cups product line only. As of this afternoon, the H-E-B Baby Food 2 pack 4 oz. cups were removed from shelves out of an abundance of caution due to a customer report of a small piece of rubber found inside a single container of one variety of the product.
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Friday, November 18, 2016
Nutra Manufacturing, Inc. Announces Nationwide Voluntary Recall of One Lot of GNC Women’s Ultra Mega Time Release 180 count Dietary Supplement - FDA Safety Alerts & Drug Recalls
Pittsburgh, PA, Nutra Manufacturing, Inc. (“Nutra”) today announced that it is initiating a nationwide, voluntary recall of one lot of GNC Women’s Ultra Mega Time Release dietary supplement product sold in 180 count containers UPC 048107158910, lot number 3044FQ2024, with an expiration date of June 2018 due to the fact the product may contain an undeclared major food allergen, milk.
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Thursday, November 17, 2016
Request Foods, Inc. Issues Allergy Alert On Undeclared Eggs In GFS® Brand Cheese Manicotti - FDA Safety Alerts & Drug Recalls
Holland, MI - Request Foods, Inc. is recalling certain 68 oz. (4 LB 4 OZ) pans of GFS® Cheese Manicotti because the product inside may be Chicken Cannelloni, which contains egg allergen. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume this product.
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FDA research to help speed development of Zika virus vaccines and therapeutics - FDA Press Releases
A new mouse model developed by scientists at the U.S. Food and Drug Administration may help in exploring the potential activity of Zika virus vaccines and therapeutics. Published today in PLoS Pathogens, is the description of a neonatal mouse model that provides a platform for potentially improving and expediting studies to understand the causes and effects (pathology) of the Zika virus.
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FDA approves Intrarosa for postmenopausal women experiencing pain during sex - FDA Press Releases
The U.S. Food and Drug Administration approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is the first FDA approved product containing the active ingredient prasterone, which is also known as dehydroepiandrosterone (DHEA).
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Wednesday, November 16, 2016
Resting-State Functional Connectivity and Cognition After Major Cardiac Surgery in Older Adults without Preoperative Cognitive Impairment: Preliminary Findings - American Geriatric Society
Objectives
To look for changes in intrinsic functional brain connectivity associated with postoperative changes in cognition, a common complication in seniors undergoing major surgery, using resting-state functional magnetic resonance imaging.
Design
Objective cognitive testing and functional brain imaging were prospectively performed at preoperative baseline and 6 weeks after surgery and at the same time intervals in nonsurgical controls.
Setting
Academic medical center.
Participants
Older adults undergoing cardiac surgery (n = 12) and nonsurgical older adult controls with a history of coronary artery disease (n = 12); no participants had cognitive impairment at preoperative baseline (Mini-Mental State Examination score >27).
Measurements
Differences in resting-state functional connectivity (RSFC) and global cognitive change relationships were assessed using a voxel-wise intrinsic connectivity method, controlling for demographic factors and pre- and perioperative cerebral white matter disease volume. Analyses were corrected for multiple comparisons (false discovery rate P < .01).
Results
Global cognitive change after cardiac surgery was significantly associated with intrinsic RSFC changes in regions of the posterior cingulate cortex and right superior frontal gyrus—anatomical and functional locations of the brain's default mode network (DMN). No statistically significant relationships were found between global cognitive change and RSFC change in nonsurgical controls.
Conclusion
Clinicians have long known that some older adults develop postoperative cognitive dysfunction (POCD) after anesthesia and surgery, yet the neurobiological correlates of POCD are not well defined. The current results suggest that altered RSFC in specific DMN regions is positively correlated with global cognitive change 6 weeks after cardiac surgery, suggesting that DMN activity and connectivity could be important diagnostic markers of POCD or intervention targets for potential POCD treatment efforts.
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