Monday, July 31, 2017

Man of Steel Issues Voluntary Nationwide Recall of Man of Steel 1 and Man of Steel 2 Due to Tainted Supplements - FDA Safety Alerts & Drug Recalls

Sacramento, California, Man of Steel is voluntarily recalling 175 lots of Man of Steel 1 and Man of Steel 2, 4000mg at the retail level. The products have been found to contained undeclared Sildenafil.

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Sunday, July 30, 2017

A Systematic Review and Meta-Analysis of The Effect of Low Vitamin D on Cognition - American Geriatric Society

Background/Objective

With an aging population and no cure for dementia on the horizon, risk factor modification prior to disease onset is an urgent health priority. Therefore, this review examined the effect of low vitamin D status or vitamin D supplementation on cognition in midlife and older adults without a diagnosis of dementia.

Design

Systematic review and random effect meta-analysis.

Setting

Observational (cross-sectional and longitudinal cohort) studies comparing low and high vitamin D status and interventions comparing vitamin D supplementation with a control group were included in the review and meta-analysis.

Participants

Studies including adults and older adults without a dementia diagnosis were included.

Measurements

Medline (PubMed), AMED, Psych INFO, and Cochrane Central databases were searched for articles until August 2016. The Newcastle-Ottawa Scale and Physiotherapy Evidence Database assessed methodological quality of all studies.

Results

Twenty-six observational and three intervention studies (n = 19–9,556) were included in the meta-analysis. Low vitamin D was associated with worse cognitive performance (OR = 1.24, CI = 1.14–1.35) and cognitive decline (OR = 1.26, CI = 1.09–1.23); with cross-sectional yielding a stronger effect compared to longitudinal studies. Vitamin D supplementation showed no significant benefit on cognition compared with control (SMD = 0.21, CI = −0.05 to 0.46).

Conclusion

Observational evidence demonstrates low vitamin D is related to poorer cognition; however, interventional studies are yet to show a clear benefit from vitamin D supplementation. From the evidence to date, there is likely a therapeutic age window relevant to the development of disease and therefore vitamin D therapy. Longitudinal lifespan studies are necessary to depict the optimal timing and duration in which repletion of vitamin D may protect against cognitive decline and dementia in aging, to better inform trials and practice towards a successful therapy.



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Saturday, July 29, 2017

Vibrant Health Products Issues Allergy Alert On Undeclared Egg In LiveGfree Gluten Free Classic Soft White Hamburger Buns - FDA Safety Alerts & Drug Recalls

Vibrant Health Products, a family-owned bakery in Abbotsford, B.C., Canada, has voluntarily recalled one lot of liveGfree Gluten Free Classic Soft White Hamburger Buns due to a packaging error. As a result, this product may contain undeclared egg.

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Asthma in the Elderly - Geriatrics

The older population has seen the greatest increase in the prevalence of current asthma in recent years. Asthma may begin at any age and when it occurs at an advanced as opposed to a young age, it is often nonatopic, severe, and unremitting. Unfortunately, geriatric-specific guidelines are not available for the diagnosis and treatment of asthma. However, with objective monitoring, avoidance of asthma triggers, appropriate pharmacotherapy, and patient education, the disease can be managed successfully.

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Friday, July 28, 2017

Accelerometer-Measured Moderate to Vigorous Physical Activity and Incidence Rates of Falls in Older Women - American Geriatric Society

Objectives

To examine whether moderate to vigorous physical activity (MVPA) measured using accelerometry is associated with incident falls and whether associations differ according to physical function or history of falls.

Design

Prospective study with baseline data collection from 2012 to 2014 and 1 year of follow-up.

Setting

Women's Health Initiative participants living in the United States.

Participants

Ambulatory women aged 63 to 99 (N = 5,545).

Measurements

Minutes of MVPA per day measured using an accelerometer, functional status measured using the Short Physical Performance Battery (SPPB), fall risk factors assessed using a questionnaire, fall injuries assessed in a telephone interview, incident falls ascertained from fall calendars.

Results

Incident rate ratios (IRRs) revealed greater fall risk in women in the lowest quartile of MVPA compared to those in the highest (IRR = 1.18, 95% confidence interval = 1.01–1.38), adjusted for age, race and ethnicity, and fall risk factors. Fall rates were not significantly associated with MVPA in women with high SPPB scores (9–12) or one or fewer falls in the previous year, but in women with low SPPB scores (≤ 8) or a history of frequent falls, fall rates were higher in women with lower MVPA levels than in those with higher levels (interaction P < .03 and < .001, respectively). Falls in women with MVPA above the median were less likely to involve injuries requiring medical treatment (9.9%) than falls in women with lower MVPA levels (13.0%) (P < .001).

Conclusion

These findings indicate that falls are not more common or injurious in older women who engage in higher levels of MVPA. These findings support encouraging women to engage in the amounts and types of MVPA that they prefer. Older women with low physical function or frequent falls with low levels of MVPA are a high-risk group for whom vigilance about falls prevention is warranted.



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ICU Medical Issues a Voluntary Nationwide Recall of One Lot of 0.9% Sodium Chloride Injection Due to the Presence of Particulate Matter - FDA Safety Alerts & Drug Recalls

ICU Medical, Inc. is voluntarily recalling one lot of 0.9% Sodium Chloride Injection, USP 1000 mL to the hospital/user level due to a confirmed customer complaint of particulate matter identified as stainless steel within a single flexible container.

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Bush Brothers & Company® Recalls Certain Baked Beans in 28 Ounce Cans Due to a Can Seam Issue - FDA Safety Alerts & Drug Recalls

Bush Brothers & Company® Recalls Certain Baked Beans in 28 Ounce Cans Due to a Can Seam Issue

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FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death - FDA Press Releases

The U.S. Food and Drug Administration today announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death. The approach places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts. The goal is to ensure that the FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act. To make certain that the FDA is striking an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes, the agency is also providing targeted relief on some timelines described in the May 2016 final rule that extended the FDA’s authority to additional tobacco products. The agency will also seek input on critical public health issues such as the role of flavors in tobacco products.

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Thursday, July 27, 2017

Apace Packaging LLC Issues Voluntary Nationwide Recall of Cyclobenzaprine HCL and Amantadine HCL (Lot 16710) Due to Potential Mislabeling - FDA Safety Alerts & Drug Recalls

Apace Packaging LLC is voluntarily recalling one lot of Cyclobenzaprine HCl Tablet, USP 5 mg 50ct Unit Dose, NDC# 50268-190-15, Lot Number 16710 and one lot of Amantadine HCl Capsule, USP 100 mg 50ct Unit Dose NDC# 50268-069-15, Lot Number 16710 to the Retail level. These products have been recalled due to a potential mislabeling. A small number of cartons containing Cyclobenzaprine HCl Tablets 5 mg UD Blister Cards may potentially be mislabeled as Amantadine HCl Capsules, USP 100 mg. The unit dose blisters inside the carton are correctly labeled as Cyclobenzaprine HCl Tablet, USP 5 mg.

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Novel antibiotic screening methods to awaken silent or cryptic secondary metabolic pathways in actinomycetes - Journal of Antibiotics

Novel antibiotic screening methods to awaken silent or cryptic secondary metabolic pathways in actinomycetes

The Journal of Antibiotics 70, 865 (July 2017). doi:10.1038/ja.2017.51

Author: Hiroyasu Onaka



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Verification of oligomycin A structure: synthesis and biological evaluation of 33-dehydrooligomycin A - Journal of Antibiotics

Verification of oligomycin A structure: synthesis and biological evaluation of 33-dehydrooligomycin A

The Journal of Antibiotics 70, 871 (July 2017). doi:10.1038/ja.2017.48

Authors: Lyudmila N Lysenkova, Oleg Y Saveljev, Natalya E Grammatikova, Vladimir B Tsvetkov, Olga B Bekker, Valery N Danilenko, Lyubov G Dezhenkova, Eugene E Bykov, Olga A Omelchuk, Alexander M Korolev & Andrey E Shchekotikhin



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5-O-Mycaminosyltylonolide antibacterial derivatives: design, synthesis and bioactivity - Journal of Antibiotics

5-O-Mycaminosyltylonolide antibacterial derivatives: design, synthesis and bioactivity

The Journal of Antibiotics 70, 878 (July 2017). doi:10.1038/ja.2017.61

Authors: Akihiro Sugawara, Hitomi Maruyama, Sho Shibusawa, Hidehito Matsui, Tomoyasu Hirose, Ayumi Tsutsui, Robrecht Froyman, Carolin Ludwig, Johannes Koebberling, Hideaki Hanaki, Gerd Kleefeld, Satoshi Ōmura & Toshiaki Sunazuka



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Synthesis and structure–activity relationships of novel lincomycin derivatives. Part 4: synthesis of novel lincomycin analogs modified at the 6- and 7-positions and their potent antibacterial activities - Journal of Antibiotics

Synthesis and structure–activity relationships of novel lincomycin derivatives. Part 4: synthesis of novel lincomycin analogs modified at the 6- and 7-positions and their potent antibacterial activities

The Journal of Antibiotics 70, 888 (July 2017). doi:10.1038/ja.2017.54

Authors: Yoshinari Wakiyama, Ko Kumura, Eijiro Umemura, Kazutaka Ueda, Takashi Watanabe, Keiko Yamada, Takafumi Okutomi & Keiichi Ajito



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D-cycloserine increases the effectiveness of vancomycin against vancomycin-highly resistant Staphylococcus aureus - Journal of Antibiotics

D-cycloserine increases the effectiveness of vancomycin against vancomycin-highly resistant Staphylococcus aureus

The Journal of Antibiotics 70, 907 (July 2017). doi:10.1038/ja.2017.56

Authors: Fumiaki Tabuchi, Yasuhiko Matsumoto, Masaki Ishii, Keita Tatsuno, Mitsuhiro Okazaki, Tomoaki Sato, Kyoji Moriya & Kazuhisa Sekimizu



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Cladomarine, a new anti-saprolegniasis compound isolated from the deep-sea fungus, Penicillium coralligerum YK-247 - Journal of Antibiotics

Cladomarine, a new anti-saprolegniasis compound isolated from the deep-sea fungus, Penicillium coralligerum YK-247

The Journal of Antibiotics 70, 911 (July 2017). doi:10.1038/ja.2017.58

Authors: Konami Takahashi, Kazunari Sakai, Yuriko Nagano, Sakiko Orui Sakaguchi, Andre O Lima, Vivian H Pellizari, Masato Iwatsuki, Kiyotaka Takishita, Kenichi Nonaka, Katsunori Fujikura & Satoshi Ōmura



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A novel polycyclic meroterpenoid with aldose reductase inhibitory activity from medicinal mushroom Ganoderma leucocontextum - Journal of Antibiotics

A novel polycyclic meroterpenoid with aldose reductase inhibitory activity from medicinal mushroom Ganoderma leucocontextum

The Journal of Antibiotics 70, 915 (July 2017). doi:10.1038/ja.2017.57

Authors: Jinjin Zhang, Ke Ma, Hongyu Chen, Kai Wang, Weiping Xiong, Li Bao & Hongwei Liu



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Inhibition of DNA replication in Staphylococcus aureus by tegaserod - Journal of Antibiotics

Inhibition of DNA replication in Staphylococcus aureus by tegaserod

The Journal of Antibiotics 70, 918 (July 2017). doi:10.1038/ja.2017.65

Authors: Christopher J Lacriola, Shaun P Falk & Bernard Weisblum



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Corrigendum: Iminimycin A, the new iminium metabolite produced by Streptomyces griseus OS-3601 - Journal of Antibiotics

Corrigendum: Iminimycin A, the new iminium metabolite produced by Streptomyces griseus OS-3601

The Journal of Antibiotics 70, 921 (July 2017). doi:10.1038/ja.2017.68

Authors: Takuji Nakashima, Rei Miyano, Masato Iwatsuki, Tatsuya Shirahata, Toru Kimura, Yukihiro Asami, Yoshinori Kobayashi, Kazuro Shiomi, George A Petersson, Yōko Takahashi & Satoshi Ōmura



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Wednesday, July 26, 2017

Grande Produce Issues Voluntary Recall of Limited Quantity of Papaya “Caribeña” Due to Potential Health Risk - FDA Safety Alerts & Drug Recalls

Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain.

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Hy-Vee, Inc. Issues Allergy Alert on Undeclared Soy in Hy-Vee Brand Pizzas - FDA Safety Alerts & Drug Recalls

Hy-Vee, Inc. based in West Des Moines, Iowa, is voluntarily recalling eight Hy-Vee brand pizzas that were sold at its six Minneapolis-area stores because they may contain undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

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A quantitative and efficient approach to select MIRU–VNTR loci based on accumulation of the percentage differences of strains for discriminating divergent Mycobacterium tuberculosis sublineages

A quantitative and efficient approach to select MIRU–VNTR loci based on accumulation of the percentage differences of strains for discriminating divergent Mycobacterium tuberculosis sublineages

Emerging Microbes & Infections 6, e68 (July 2017). doi:10.1038/emi.2017.58

Authors: Xin-Ling Pan, Chun-Lei Zhang, Chie Nakajima, Jin Fu, Chang-Xia Shao, Li-Na Zhao, Jia-Yi Cui, Na Jiao, Chang-Long Fan, Yasuhiko Suzuki, Toshio Hattori, Di Li & Hong Ling



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A two-step algorithm for rapid diagnosis of active pulmonary tuberculosis in entry applicants using the T-SPOT.TB and Xpert MTB/RIF assays in Shanghai, China

A two-step algorithm for rapid diagnosis of active pulmonary tuberculosis in entry applicants using the T-SPOT.TB and Xpert MTB/RIF assays in Shanghai, China

Emerging Microbes & Infections 6, e67 (July 2017). doi:10.1038/emi.2017.52

Authors: Chengyan Meng, Yaojie Shen, Jian Wang, Sen Wang, Xinchang Chen, Shenglei Yu, Wei Ye & Jing Wu



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Outer membrane vesicle-associated lipase FtlA enhances cellular invasion and virulence in Francisella tularensis LVS

Outer membrane vesicle-associated lipase FtlA enhances cellular invasion and virulence in Francisella tularensis LVS

Emerging Microbes & Infections 6, e66 (July 2017). doi:10.1038/emi.2017.53

Authors: Fei Chen, Guolin Cui, Shuxia Wang, Manoj Kumar Mohan Nair, Lihong He, Xinyi Qi, Xiangmin Han, Hanqi Zhang, Jing-Ren Zhang & Jingliang Su



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Coxsackievirus A16 utilizes cell surface heparan sulfate glycosaminoglycans as its attachment receptor

Coxsackievirus A16 utilizes cell surface heparan sulfate glycosaminoglycans as its attachment receptor

Emerging Microbes & Infections 6, e65 (July 2017). doi:10.1038/emi.2017.55

Authors: Xueyang Zhang, Jinping Shi, Xiaohua Ye, Zhiqiang Ku, Chao Zhang, Qingwei Liu & Zhong Huang



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Poor Appetite and Dietary Intake in Community-Dwelling Older Adults - American Geriatric Society

Background/objectives

Poor appetite in older adults leads to sub-optimal food intake and increases the risk of undernutrition. The impact of poor appetite on food intake in older adults is unknown. The aim of this study was to examine the differences in food intake among older community-dwelling adults with different reported appetite levels.

Design

Cross-sectional analysis of data from a longitudinal prospective study.

Setting

Health, aging, and body composition study performed in the USA.

Participants

2,597 community-dwelling adults aged 70–79.

Measurements

A semi-quantitative, interviewer-administered, 108-item food frequency questionnaire designed to estimate dietary intake. Poor appetite was defined as the report of a moderate, poor, or very poor appetite in the past month and was compared with good or very good appetite.

Results

The mean age of the study sample was 74.5 ± 2.8 years; 48.2% were men, 37.7% were black, and 21.8% reported a poor appetite. After adjustment for total energy intake and potential confounders (including biting/chewing problems), participants with a poor appetite had a significantly lower consumption of protein and dietary fiber, solid foods, protein rich foods, whole grains, fruits, and vegetables, but a higher consumption of dairy foods, fats, oils, sweets, and sodas compared to participants with very good appetite. In addition, they were less likely to report consumption of significant larger portion sizes.

Conclusion

Older adults reporting a poor appetite showed a different dietary intake pattern compared to those with (very) good appetite. Better understanding of the specific dietary intake pattern related to a poor appetite in older adults can be used for nutrition interventions to enhance food intake, diet variety, and diet quality.



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Tuesday, July 25, 2017

FDA Investigates Multiple Salmonella Outbreak Strains Linked to Papayas - FDA Safety Alerts & Drug Recalls

Please find more information about the Outbreak of Salmonellosis Linked to Papaya here:

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Cantrell Drug Company Issues Voluntary Nationwide Recall of All Sterile Drug Products Due to Lack of Sterility Assurance - FDA Safety Alerts & Drug Recalls

Cantrell Drug Company is voluntarily recalling all lots of unexpired sterile drug products to the hospital and user level due to lack of sterility assurance. The recalled products were distributed to health care facilities nationwide, except to the states of Connecticut, Hawaii, South Carolina and Vermont. To date, Cantrell has not received any reports of adverse events.

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Monday, July 24, 2017

EZ Weight Loss TX LLC Issues Voluntary Nationwide Recall of Atomic and Xplode Capsules Due to the Presence of Undeclared Sibutramine - FDA Safety Alerts & Drug Recalls

Corpus Christi, TX, EZ Weight Loss TX is voluntarily recalling all lots of La Bri's Body Health Atomic and Xplode capsules to the consumer level. FDA analysis has found the products to be tainted with sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons. The presence of sibutramine in these products renders it an unapproved drug for which safety and efficacy have not been established and, therefore subject to recall.

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Sunday, July 23, 2017

Tai Chi for Risk of Falls. A Meta-analysis - American Geriatric Society

Objectives

To analyze the effectiveness of tai chi for falls prevention.

Design

Systematic review and meta-analysis.

Setting

Pubmed, Scopus, CINHAL, and Physiotherapy Evidence Database (PEDro) were searched to May 26, 2016.

Participants

Older adult population and at-risk adults.

Intervention

Randomized controlled trials analyzing the effect of tai chi versus other treatments on risk of falls.

Measurements

The incidence rate ratio (IRR) for falls incidence and hazard ratio (HR) for time to first fall.

Results

The search strategy identified 891 potentially eligible studies, of which 10 met the inclusion criteria. There was high-quality evidence of a medium protective effect for fall incidence over the short term (IRR = 0.57; 95% CI = 0.46, 0.70) and a small protective effect over the long term (IRR = 0.87; 95% CI = 0.77, 0.98). Regarding injurious falls, we found very low-quality evidence of a medium protective effect over the short term (IRR = 0.50; 95% CI = 0.33, 0.74) and a small effect over the long term (IRR = 0.72; 95% CI = 0.54, 0.95). There was no effect on time to first fall, with moderate quality of evidence (HR = 0.98; 95% CI = 0.69, 1.37).

Conclusion

In at-risk adults and older adults, tai chi practice may reduce the rate of falls and injury-related falls over the short term (<12 months) by approximately 43% and 50%, respectively. Tai chi practice may not influence time to first fall in these populations. Due to the low quality of evidence, more studies investigating the effects of tai chi on injurious falls and time to first fall are required.



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Saturday, July 22, 2017

Effectiveness of Light Therapy in Cognitively Impaired Persons: A Metaanalysis of Randomized Controlled Trials - American Geriatric Society

Objectives

To explore the effects of light therapy on behavioral disturbances (BDs), sleep quality, and depression.

Design

Meta-analysis of randomized controlled trials.

Setting

PubMed, Cochrane Library, Medline, EMBASE, Web of Science, and clinicaltrials.gov of selected randomized controlled trials and previous systematic reviews were searched.

Participants

Cognitively impaired persons.

Measurements

Information was extracted on study characteristics, quality assessment, and outcomes. Outcome measures included BDs, sleep quality, and depression.

Results

Nine randomized controlled trials were examined. The results showed that light therapy has a moderate effect on BD (g = −0.61) and depression (g = −0.58) and a small effect on total sleep time at night (g = 0.25). Subgroup analysis indicated that a light intensity of 2,500 lux or greater has a greater effect on depression than an intensity of less than 2,500 lux (P = .03), and the low risk of bias in blinding was superior to the RCTs deemed to be of high or unclear risk of bias in blinding in terms of BD (P = .02).

Conclusion

Light therapy can relieve BD, improve sleep quality, and alleviate symptoms of depression for cognitively impaired persons.



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Effect of a Community-Based Service Learning Experience in Geriatrics on Internal Medicine Residents and Community Participants - American Geriatric Society

Community-based service learning (CBSL) provides an opportunity to teach internal medicine residents the social context of aging and clinical concepts. The objectives of the current study were to demonstrate the feasibility of a CBSL program targeting internal medicine residents and to assess its effect on medical residents and community participants. internal medicine residents participated in a CBSL experience for half a day during ambulatory blocks from 2011 to 2014. Residents attended a senior housing unit or center, delivered a presentation about a geriatric health topic, toured the facility, and received information about local older adult resources. Residents evaluated the experience. Postgraduate Year 3 internal medicine residents (n = 71) delivered 64 sessions. Residents felt that the experience increased their ability to communicate effectively with older adults (mean 3.91 ± 0.73 on a Likert scale with 5 = strongly agree), increased their knowledge of resources (4.09 ± 1.01), expanded their knowledge of a health topic pertinent to aging (3.48 ± 1.09), and contributed to their capacity to evaluate and care for older adults (3.84 ± 0.67). Free-text responses demonstrated that residents thought that this program would change their practice. Of 815 older adults surveyed from 36 discrete teaching sessions, 461 (56%) thought that the medical residents delivered health information clearly (4.55 ± 0.88) and that the health topics were relevant (4.26 ± 0.92). Free-text responses showed that the program helped them understand their health concerns. This CBSL program is a feasible and effective tool for teaching internal medicine residents and older adults.



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ENabling Reduction of Low-grade Inflammation in SEniors Pilot Study: Concept, Rationale, and Design - American Geriatric Society

Objectives

To test two interventions to reduce interleukin (IL)-6 levels, an indicator of low-grade chronic inflammation and an independent risk factor for impaired mobility and slow walking speed in older adults.

Design

The ENabling Reduction of low-Grade Inflammation in SEniors (ENRGISE) Pilot Study was a multicenter, double-blind, placebo-controlled randomized pilot trial of two interventions to reduce IL-6 levels.

Setting

Five university-based research centers.

Participants

Target enrollment was 300 men and women aged 70 and older with an average plasma IL-6 level between 2.5 and 30 pg/mL measured twice at least 1 week apart. Participants had low to moderate physical function, defined as self-reported difficulty walking one-quarter of a mile or climbing a flight of stairs and usual walk speed of less than 1 m/s on a 4-m usual-pace walk.

Intervention

Participants were randomized to losartan, omega-3 fish oil (ω-3), combined losartan and ω-3, or placebo. Randomization was stratified depending on eligibility for each group. A titration schedule was implemented to reach a dose that was safe and effective for IL-6 reduction. Maximal doses were 100 mg/d for losartan and 2.8 g/d for ω-3.

Measurements

IL-6, walking speed over 400 m, physical function (Short Physical Performance Battery), other inflammatory markers, safety, tolerability, frailty domains, and maximal leg strength were measured.

Results

Results from the ENRGISE Pilot Study will provide recruitment yields, feasibility, medication tolerance and adherence, and preliminary data to help justify a sample size for a more definitive randomized trial.

Conclusion

The ENRGISE Pilot Study will inform a larger subsequent trial that is expected to have important clinical and public health implications for the growing population of older adults with low-grade chronic inflammation and mobility limitations.



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Hearing Impairment and Incident Dementia: Findings from the English Longitudinal Study of Ageing - American Geriatric Society

Objectives

To determine whether hearing loss is associated with incident physician-diagnosed dementia in a representative sample.

Design

Retrospective cohort study.

Setting

English Longitudinal Study of Ageing.

Participants

Adults aged 50 and older.

Measurements

Cross-sectional associations between self-reported (n = 7,865) and objective hearing measures (n = 6,902) and dementia were examined using multinomial-logistic regression. The longitudinal association between self-reported hearing at Wave 2 (2004/05) and cumulative physician-diagnosed dementia up to Wave 7 (2014/15) was modelled using Cox proportional hazards regression.

Results

After adjustment for potential confounders, in cross-sectional analysis, participants who had self-reported or objective moderate and poor hearing were more likely to have a dementia diagnosis than those with normal hearing (self-reported: odds ratio OR = 1.6, 95% CI = 1.1–2.4 moderate hearing; OR = 2.6, 95% CI = 1.7–3.9 poor hearing, objective: OR = 1.6, 95% CI = 1.0–2.8 moderate hearing; OR = 4.4, 95% CI = 1.9–9.9 poor hearing). Longitudinally, the hazard of developing dementia was 1.4 (95% CI = 1.0–1.9) times as high in individuals who reported moderate hearing and 1.6 (95% CI = 1.1–2.0) times as high in those who reported poor hearing.

Conclusion

Older adults with hearing loss are at greater risk of dementia than those with normal hearing. These findings are consistent with the rationale that correction of hearing loss could help delay the onset of dementia, or that hearing loss itself could serve as a risk indicator for cognitive decline.



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Friday, July 21, 2017

The Idaho Foodbank Recalls Coconut Beverage, Broccoli Cheddar Soup, Eggs, and Cheese Product Because Of Possible Health Risk - FDA Safety Alerts & Drug Recalls

The Idaho Foodbank is recalling approximately 27,000 pounds of Coconut Beverage, Broccoli Cheddar Soup, Eggs, and Cheese Product. These products are being recalled because they were not continuously maintained or stored at the required temperature due to a malfunction in the cooler. This could result in contamination by spoilage organisms or pathogens, which could lead to life-threatening illness if consumed.

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Bhu Foods Voluntarily Recalls Protein Bars for Possible Health Risk - FDA Safety Alerts & Drug Recalls

Hudson Valley Foods, Inc. of Highland, NY has advised Bhu Foods of San Diego, CA that organic sunflower seeds sold to the company have been recalled. As a result of a recall of sunflower seeds from Hudson Valley Foods, Inc.,Bhu Foods’ supplier of organic sunflower seeds, advised Bhu Foods that ingredients sold to the company have the potential to be contaminated with Listeria monocytogenes.

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Ultra Shop Supplement Issues Voluntary Nationwide Recall of Super Panther 7K Due to Presence of Undeclared Sildenafil and Tadalafil - FDA Safety Alerts & Drug Recalls

Charlotte, NC, Ultra Shop Supplement is voluntarily recalling Super Panther 7K capsules, [1 count blister card Lot#: RO846356 and 6 count bottle Lot RO246852 within expiry], distributed by SX Power Co., Brooklyn, NY, to the consumer level. FDA analysis found samples of Super Panther 7K to be tainted with undeclared sildenafil and tadalafil, active ingredients in two FDA-approved prescription drug products, also known as phosphodiesterate 5-inhibitors (PDE-5), used to treat erectile dysfunction (ED).

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Thursday, July 20, 2017

FDA clears first neonatal magnetic resonance imaging device - FDA Press Releases

Today, the U.S. Food and Drug Administration cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU).

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Wednesday, July 19, 2017

Statement from FDA Commissioner Scott Gottlieb, M.D., on the Funding Awards to States for FDA Food Safety Modernization Act (FSMA) Produce Safety Implementation - FDA Press Releases

More than 3,000 Americans are estimated to die each year from foodborne illnesses and many more are hospitalized and sickened. Yet most of these illnesses and deaths are preventable. While the U.S. has one of the safest food supplies in the world, Congress entrusted the FDA with new authorities and resources – as part of the FDA Food Safety Modernization Act (FSMA) – to update and strengthen the FDA’s risk-based approach to the oversight of food safety.

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Tuesday, July 18, 2017

FDA approves Vosevi for Hepatitis C - FDA Press Releases

The U.S. Food and Drug Administration today approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis.

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Garden of Light Inc. Recalls Woodstock Organic Matcha Vanilla Oats Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Garden of Light, Inc. dba Gluten Free Solutions of East Hartford, CT, is voluntarily recalling the Woodstock Organic Matcha Vanilla Oats, 1.8 oz. which is manufactured by Garden of Light for Blue Marble Brands. The product has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. The recalled item, Woodstock Organic Matcha Vanilla Oats, was distributed nationwide in retail stores.

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Monday, July 17, 2017

Evaluation of Dyspnea in the Elderly - Geriatrics

Dyspnea is due to an imbalance between the demand to breathe and the ability to breathe. The prevalence is ∼30% for those 65 years or older with walking on a level surface or up an incline. Dyspnea is a strong predictor of mortality in elderly individuals. Anemia, cardiovascular disease, deconditioning, psychological disorders, and respiratory diseases are common causes of dyspnea. Initial treatments to relieve breathing discomfort should be directed toward improving the pathophysiology of the underlying disease. Simple and inexpensive strategies to relieve dyspnea are available. This article provides an update on the evaluation of chronic dyspnea in elderly individuals.

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FDA approves new treatment to reduce the risk of breast cancer returning - FDA Press Releases

The U.S. Food and Drug Administration today approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type of cancer, Nerlynx is the first extended adjuvant therapy, a form of therapy that is taken after an initial treatment to further lower the risk of the cancer coming back. Nerlynx is indicated for adult patients who have been previously treated with a regimen that includes the drug trastuzumab.

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Bestherbs Coffee LLC Issues Voluntary Nationwide Recall of New Kopi Jantan Tradisional Natural Herbs Coffee due to the Presence of Undeclared Active Pharmaceutical Ingredients and Undeclared Milk - FDA Safety Alerts & Drug Recalls

Grand Priarie, TX, Bestherbs Coffee LLC is voluntarily recalling all lots of New of Kopi Jantan Tradisional Natural Herbs Coffee, 13 grams to the consumer level. FDA laboratory analysis confirmed the presence of desmethyl carbodenafil. Desmethyl carbodenafil is structurally similar to sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for erectile dysfunction (ED). New of Kopi Jantan Tradisional Natural Herbs Coffee also contains undeclared milk.

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Weight and Body Mass Index in Old Age: Do They Still Matter? - American Geriatric Society



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Reply to: Efficacy and Safety of Mechanical Thrombectomy in Older Adults with Acute Ischemic Stroke: Two Methodological Concerns - American Geriatric Society

This letter comments on the Letter by Safiri et al.



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Efficacy and Safety of Mechanical Thrombectomy in Older Adults with Acute Ischemic Stroke: Methodological Concerns - American Geriatric Society

See the Reply by Motta et al.



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Friday, July 14, 2017

Epidemiology of Lung Disease in Older Persons - Geriatrics

Older persons frequently report respiratory risk factors and symptoms and have a high prevalence of symptomatic lung disease, most commonly obstructive airway disease, interstitial lung disease, and lung cancer. Notably, coexisting nonrespiratory risk factors are also prevalent and may misidentify or modify respiratory diagnoses and their clinical course.

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Inflammaging and the Lung - Geriatrics

With the coming of the “silver tsunami,” expanding the knowledge about how various intrinsic and extrinsic factors affect the immune system in the elderly is timely and of immediate clinical need. The global population is increasing in age. By the year 2030, more than 20% of the population of the United States will be older than 65 years of age. This article focuses on how advanced age alters the immune systems and how this, in turn, modulates the ability of the aging lung to deal with infectious challenges from the outside world and from within the host.

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Texas Legend Foods Issues Allergy Alert on Undeclared Cheese, Milk & Egg in "Silver Star Chipotle Dip" - FDA Safety Alerts & Drug Recalls

Texas Legend Foods of Austin, TX, is recalling its 16 ounce jars of Silver Star Chipotle Queso Dip because they contain undeclared cheese, milk and eggs. People who have allergies to cheese, milk and eggs run the risk of a serious or life-threatening allergic reaction if they consume this product.

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The Birder - American Geriatric Society



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Thursday, July 13, 2017

Statement from FDA Commissioner Scott Gottlieb, M.D., on National Academies of Sciences, Engineering, and Medicine report on pain management and prescription opioid abuse - FDA Press Releases

In March 2016, the FDA asked the National Academies of Sciences, Engineering, and Medicine (NASEM) to outline the state of the science regarding prescription opioid abuse and misuse, as well as the evolving role that opioids play in pain management. We greatly appreciate all the work done by NASEM over the past year to produce the comprehensive report released today, which includes recommendations for the FDA and others on this important issue.

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Statement from Alberto Gutierrez, Ph.D., Director, Office of In Vitro Diagnostics and Radiological Health, FDA’s Center for Devices and Radiological Health on the status of FDA’s investigation into inaccurate results from certain lead tests - FDA Press Releases

On May 17, the U.S. Food and Drug Administration warned Americans that Magellan Diagnostics’ LeadCare test systems performed on blood drawn from the vein (venous) may provide inaccurate results.

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Reply to OverREACHing Conclusions - American Geriatric Society



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Over-REACHing Conclusions - American Geriatric Society



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Zika, Ebola, and Age: Global and Cellular Aging and Their Catalytic Effect on These Infections - American Geriatric Society



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Wednesday, July 12, 2017

Sunneen Health Foods Issues Recall of Parfait Due to Undeclared Allergens - FDA Safety Alerts & Drug Recalls

Sunneen Health Foods is voluntarily recalling mislabeled Whole Foods Market PB&J parfaits sold at five Whole Foods Market stores in New York and New Jersey because the products contained soy and tree nut (almond and coconut) allergens that were not listed on the product label. People who have an allergy or severe sensitivity to soy or tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products.

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Antigens Rv0310c and Rv1255c are promising novel biomarkers for the diagnosis of Mycobacterium tuberculosis infection

Antigens Rv0310c and Rv1255c are promising novel biomarkers for the diagnosis of Mycobacterium tuberculosis infection

Emerging Microbes & Infections 6, e64 (July 2017). doi:10.1038/emi.2017.54

Authors: Liulin Luo, Lin Zhu, Jun Yue, Jianping Liu, Guoyuan Liu, Xuelian Zhang, Honghai Wang & Ying Xu



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Phylogenetic analysis reveals two genotypes of the emerging fungus Mucor indicus, an opportunistic human pathogen in immunocompromised patients

Phylogenetic analysis reveals two genotypes of the emerging fungus Mucor indicus, an opportunistic human pathogen in immunocompromised patients

Emerging Microbes & Infections 6, e63 (July 2017). doi:10.1038/emi.2017.51

Authors: Saad J Taj-Aldeen, Muna Almaslamani, Bart Theelen & Teun Boekhout



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Modelling person-to-person transmission in an Enterovirus A71 orally infected hamster model of hand-foot-and-mouth disease and encephalomyelitis

Modelling person-to-person transmission in an Enterovirus A71 orally infected hamster model of hand-foot-and-mouth disease and encephalomyelitis

Emerging Microbes & Infections 6, e62 (July 2017). doi:10.1038/emi.2017.49

Authors: Win Kyaw Phyu, Kien Chai Ong & Kum Thong Wong



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Salmonella enterica serovar Typhimurium ST34 co-expressing blaNDM-5 and blaCTX-M-55 isolated in China

Salmonella enterica serovar Typhimurium ST34 co-expressing blaNDM-5 and blaCTX-M-55 isolated in China

Emerging Microbes & Infections 6, e61 (July 2017). doi:10.1038/emi.2017.48

Authors: Lang Yang, Xiaofeng Hu, Xuebin Xu, Chaojie Yang, Jing Xie, Rongzhang Hao, Xinying Du, Ligui Wang, Leili Jia, Peng Li, Shaofu Qiu & Hongbin Song



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Tuesday, July 11, 2017

Andropharm Issues Voluntary Nationwide Recall of Sten Z and M1 Alpha Due to Labeling that it Contains Derivatives of Anabolic Steroids - FDA Safety Alerts & Drug Recalls

lorida- Andropharm is voluntarily recalling all lots of Sten Z and M1 Alpha capsules to the consumer level because these products contain derivatives of anabolic steroids rendering them unapproved drugs for which safety and efficacy have not been established and therefore subject to recall.

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Monday, July 10, 2017

Biohealth Nutrition Announces the Recall of Precision Blend Cookies and Cream Product for Undeclared Allergen - FDA Safety Alerts & Drug Recalls

Biohealth Nutrition of San Dimas, CA is recalling Precision Blend Cookies & Cream because product labels failed to declare the food allergen, wheat. People who have an allergy or severe sensitivity to wheat run the risk of a life threatening allergic reaction, anaphylaxis, that requires immediate medical attention should they consume products containing allergens.

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Coborn's, Inc. Issues Recall of Incorrectly Labeled Gluten Free Chocolate Chip Bars Due To Undeclared Milk - FDA Safety Alerts & Drug Recalls

Coborn's, Inc. of St. Cloud, Minn. is recalling packages of its Gluten Free Chocolate Chip Bars, some of which were incorrectly labeled as Gluten Free Fudge Brownies. The Gluten Free Fudge Brownie label does not indicate the product contains milk, however the Gluten Free Chocolate Chip Bars that are incorrectly labeled as Gluten Free Fudge Brownies do contain milk.

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The 2025 Big “G” Geriatrician: Defining Job Roles to Guide Fellowship Training - American Geriatric Society

Changes in health care that are already in progress, including value- and population-based care, use of new technologies for care, big data and machine learning, and the patient as consumer and decision maker, will determine the job description for geriatricians practicing in 2025. Informed by these future certainties, 115 geriatrics educators attending the 2016 Donald W. Reynolds Foundation Annual meeting identified five 2025 geriatrician job roles: complexivist; consultant; health system leader and innovator; functional preventionist; and educator for big “G” and little “g” providers. By identifying these job roles, geriatrics fellowship training can be preemptively redesigned.



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Big ‘G’ and Little ‘g’ Geriatrics Education for Physicians - American Geriatric Society

In the July 2016 issue of this journal, Dr. Mary Tinetti proposed that geriatric medicine abandon attempts to increase the numbers of board-certified geriatricians and change focus to the development of a “small elite workforce.” What would be gained and what sacrificed by accepting this challenge? We agree that the best clinical use of a scarce resource, specialty trained geriatricians, is to care for frail, complex, severely ill elderly adults and to help design and study novel interventions in research, education, and care models to improve the care of all older adults, but for this to happen, all other providers must attain specific competency in the care of older adults. This article responds and discusses alternative pathways for teaching geriatrics care, training specialists, and geriatrics fellows.



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Friday, July 7, 2017

FDA approves new treatment for sickle cell disease - FDA Press Releases

The U.S. Food and Drug Administration today approved Endari (L-glutamine oral powder) for patients age five years and older with sickle cell disease to reduce severe complications associated with the blood disorder.

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Index - Geriatrics

Note: Page numbers of articles titles are in boldface type.

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Forthcoming Issue - Geriatrics

Pulmonary Disease in the Aging Patient

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Contents - Geriatrics

John E. Morley

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Contributors - Geriatrics

JOHN E. MORLEY, MB, BCh

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Copyright - Geriatrics

ELSEVIER

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Rapid Geriatric Assessment - Geriatrics

CLINICS IN GERIATRIC MEDICINE

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The New Geriatric Giants - Geriatrics

In 1965, Bernard Isaacs coined the term “geriatric giants.” At that time, he named the geriatric giants as immobility, instability, incontinence, and impaired intellect/memory.1 Over the subsequent fifty years, geriatrics has evolved, and today, the understanding of the modern “geriatric giants” has evolved to encompass the four new syndromes of frailty,2 sarcopenia,3 the anorexia of aging,4 and cognitive impairment.5 These conditions are the harbingers of falls,6 hip fractures,7 depression,8 and delirium.

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Thursday, July 6, 2017

Predictors of Independent Aging and Survival: A 16-Year Follow-Up Report in Octogenarian Men - American Geriatric Society

Objectives

To examine the longitudinal associations between aging with preserved functionality, i.e. independent aging and survival, and lifestyle variables, dietary pattern and cardiovascular risk factors.

Design

Cohort study.

Setting

Uppsala Longitudinal Study of Adult Men, Sweden.

Participants

Swedish men (n = 1,104) at a mean age of 71 (range 69.4–74.1) were investigated, 369 of whom were evaluated for independent aging 16 years later, at a mean age of 87 (range 84.8–88.9).

Measurements

A questionnaire was used to obtain information on lifestyle, including education, living conditions, and physical activity. Adherence to a Mediterranean-like diet was assessed according to a modified Mediterranean Diet Score derived from 7-day food records. Cardiovascular risk factors were measured. Independent aging at a mean age of 87 was defined as lack of diagnosed dementia, a Mini-Mental State Examination score of 25 or greater, not institutionalized, independence in personal activities of daily living, and ability to walk outdoors alone. Complete survival data at age 85 were obtained from the Swedish Cause of Death Register.

Results

Fifty-seven percent of the men survived to age 85, and 75% of the participants at a mean age of 87 displayed independent aging. Independent aging was associated with never smoking (vs current) (odds ratio (OR) = 2.20, 95% confidence interval (CI) = 1.05–4.60) and high (vs low) adherence to a Mediterranean-like diet (OR = 2.69, 95% CI = 1.14–6.80). Normal weight or overweight and waist circumference of 102 cm or less were also associated with independent aging. Similar associations were observed with survival.

Conclusion

Lifestyle factors such as never smoking, maintaining a healthy diet, and not being obese at age 71 were associated with survival and independent aging at age 85 and older in men.



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Oscor Inc. Issues Nationwide Recall of ATAR Extension Cables - FDA Safety Alerts & Drug Recalls

During the use of some ATAR extension cables, the cable was separating from the connector at the proximal end. The analysis of the returned devices revealed a change in the manufacturing sequence attributed to the connector and wire separation, causing a fracture of the conductor cable from extensive use.

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Novo Nordisk Recalls Cartridge Holders In Certain Novopen Echo® Insulin Delivery Devices Due to Potential Health Risks - FDA Safety Alerts & Drug Recalls

Novo Nordisk is initiating a recall of insulin cartridge holders used in a small number of NovoPen Echo® batches because they may crack or break if exposed to certain chemicals, like certain cleaning agents. NovoPen Echo® is used for insulin treatment by people with diabetes. Using a device with a cracked/broken cartridge holder may result in the device delivering a reduced dose of insulin which could potentially lead to high blood sugar. Novo Nordisk believes the risk of experiencing high blood sugar when using a device with an affected cartridge holder is low.

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The Past Is How We Live the Future - American Geriatric Society



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How Hospital Clinicians Select Patients for Skilled Nursing Facilities - American Geriatric Society

Objective

To understand how hospital-based clinicians evaluate older adults in the hospital and decide who will be transferred to a skilled nursing facility (SNF) for postacute care.

Design

Semistructured interviews paired with a qualitative analytical approach informed by Social Constructivist theory.

Setting

Inpatient care units in three hospitals. Purposive sampling was used to maximize variability in hospitals, units within hospitals, and staff on those units.

Participants

Clinicians (hospitalists, nurses, therapists, social workers, case managers) involved in evaluation and decision-making regarding postacute care (N = 25).

Measurements

Central themes related to clinician evaluation and discharge decision-making.

Results

Clinicians described pressure to expedite evaluation and discharge decisions, resulting in the use of SNFs as a “safety net” for older adults being discharged from the hospital. The lack of hospital-based clinician knowledge of SNF care practices, quality, or patient outcomes resulted in lack of a standardized evaluation process or a clear primary decision-maker.

Conclusion

Hospital clinician evaluation and decision-making about postacute care in SNFs may be characterized as rushed, without a clear system or framework for making decisions and uninformed by knowledge of SNF or patient outcomes in those discharged to SNFs. This leads to SNFs being used as a “safety net” for many older adults. As hospitals and SNFs are increasingly held jointly accountable for outcomes of individuals transitioning between hospitals and SNFs, novel solutions for improving evaluation and decision-making are urgently needed.



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Selecting a Skilled Nursing Facility for Postacute Care: Individual and Family Perspectives - American Geriatric Society

Objectives

To describe individuals' experiences during the hospital discharge planning and skilled nursing facility (SNF) selection process.

Design

Semistructured interviews focusing on discharge planning and nursing facility selection, including how facilities were chosen, who was involved, and what factors were important in decision-making.

Setting

14 SNFs in five cities across the United States.

Participants

Newly admitted, previously community-dwelling SNF residents (N = 98) and their family members.

Measurement

Semistructured interviews were qualitatively coded to identify underlying themes.

Results

Most respondents reported receiving only a list of SNF names and addresses from discharge planners and that hospital staff were minimally involved. Proximity to home and prior experience with the facility most often influenced choice of SNF. Most respondents reported being satisfied with their placement, although many stated that they would have been willing to travel further to another SNF were it recommended. Many reported feeling rushed and unprepared, stating that they did not know where or how to get help.

Conclusion

SNF placement is a stressful transition, occurring when people are physically vulnerable and with limited guidance from discharge planners. Therefore, most people select a facility based on its location, perhaps because they are provided with no other information. Given Centers for Medicare and Medicaid Services' proposed changes to the discharge planning process, this research highlights the value of providing people and family caregivers with quality data and assistance in interpreting it.



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Need to Recalibrate Research Outcomes in Alzheimer's Disease: Focus on Neuropsychiatric Symptoms - American Geriatric Society

Objectives

To determine whether neuropsychiatric symptoms (NPSs) are adequately considered in clinical research on Alzheimer's disease (AD).

Design

Systematic review.

Setting

Randomized controlled trials (RCTs) recruiting individuals with AD and published during the last 10 years in 16 major general medicine, neurology, psychiatry, and geriatric psychiatry journals and RCTs registered on clinicaltrials.gov and currently enrolling individuals with AD.

Participants

Individuals with AD.

Measurements

Outcome measures adopted by the included studies.

Results

Only 21.4% of the included studies identified through the bibliographic searches had measures of NPSs as a primary outcome. Only 17.7% of the studies retrieved on clinicaltrials.gov made a specific effort to test the effect of pharmacological or nonpharmacological interventions on NPSs.

Conclusion

These findings show how rarely previous and current research on AD has considered NPSs as primary research targets. Although these symptoms are widely recognized as the most-stressful and -challenging manifestations of dementia, they are addressed much less often than other research targets.



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Federal judge enters consent decree against Alabama compounder Medistat - FDA Press Releases

U.S. District Judge William H. Steele entered a consent decree of permanent injunction yesterday between the United States and Medistat RX LLC of Foley, Alabama, the company’s co-owners, Mark D. Acker and Timothy L. Fickling, and quality manager and pharmacist-in-charge V. Elaine Waller.

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Wednesday, July 5, 2017

Voluntary Recall of CLIF BUILDER'S Bar Chocolate Mint Flavor, CLIF Kid Zbar Protein Chocolate Mint and CLIF Kid Zbar Protein Chocolate Chip Flavors - FDA Safety Alerts & Drug Recalls

Clif Bar & Company is initiating a voluntary recall of CLIF® BUILDER'S® Bar Chocolate Mint flavor, and CLIF Kid Zbar® Protein Chocolate Mint and CLIF Kid Zbar® Protein Chocolate Chip flavors due to possible presence of undeclared peanuts and some tree nuts, including almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, walnuts and coconuts. Clif Bar & Company is taking this precautionary safety step for people who are allergic to peanuts and these listed tree nuts. People with an allergy to peanuts and these specific tree nuts run the risk of a serious or life-threatening allergic reaction.

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Hardcore Formulations Issues Voluntary Nationwide Recall of Ultra-Sten and D-Zine Capsules Due to Labeling that it Contains Anabolic Steroids - FDA Safety Alerts & Drug Recalls

Hardcore Formulations is voluntarily recalling all lots and expiration dates of Ultra-Sten and D-Zine capsules to the consumer level. These products are labeled to contain methylstenbolone (Ultra-Sten) and dymethazine (D-Zine), which are considered to be derivatives of anabolic steroids. The presence of these anabolic steroids in Ultra-Sten and D-Zine render them unapproved drugs for which safety and efficacy have not been established and therefore subject to recall.

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Raja Foods Issues Allergy Alert on Undeclared Milk In "Anarkali Peshawari Naan Bread. Upc 0-51179-99605-2. Manufactured July 1st, 2015 Thru July 1st, 2017" - FDA Safety Alerts & Drug Recalls

Raja Foods LLC of Skokie, Il is recalling its 15 ounce package of "ANARKALI PESHAWARI NAAN" because they may contain undeclared MILK. People who have allergies to MILK run the risk of serious or life-threatening allergic reaction if they consume these products.

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Tuesday, July 4, 2017

Rates of Delirium Diagnosis Do Not Improve with Emergency Risk Screening: Results of the Emergency Department Delirium Initiative Trial - American Geriatric Society

Objectives

To determine whether a bundled risk screening and warning or action card system improves formal delirium diagnosis and person-centered outcomes in hospitalized older adults.

Design

Prospective trial with sequential introduction of screening and interventional processes.

Setting

Two tertiary referral hospitals in Australia.

Participants

Individuals aged 65 and older presenting to the emergency department (ED) and not requiring immediate resuscitation (N = 3,905).

Intervention

Formal ED delirium screening algorithm and use of a risk warning card with a recommended series of actions for the prevention and management of delirium during the subsequent admission

Measurements

Delirium diagnosis at hospital discharge, proportion discharged to new assisted living arrangements, in-hospital complications (use of sedation, falls, aspiration pneumonia, death), hospital length of stay.

Results

Participants with a positive risk screen were significantly more likely (relative risk = 6.0, 95% confidence interval = 4.9–7.3) to develop delirium, and the proportion of at-risk participants with a positive screen was constant across three study phases. Delirium detection rate in participants undergoing the final intervention (Phase 3) was 12.1% (a 2% absolute and 17% relative increase from the baseline rate) but this was not statistically significant (P = .29), and a similar relative increase was seen over time in participants not receiving the intervention

Conclusion

A risk screening and warning or action card intervention in the ED did not significantly improve rates of delirium detection or other important outcomes.



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Associations Between Self-Reported Physical Activity and Physical Performance Measures Over Time in Postmenopausal Women: The Women's Health Initiative - American Geriatric Society

Objectives

To examine prospective associations between changes in physical activity (PA) and changes in physical performance measures (PPMs) over 6 years in older women.

Design

Prospective cohort study.

Setting

Forty clinical centers in the United States.

Participants

Women aged 65 and older (mean age 69.8) enrolled in the Women's Health Initiative Clinical Trials with gait speed, timed chair stand, grip strength, and self-reported recreational PA data assessed at baseline (1993–98) and follow-up Years 1, 3, and 6 (N = 5,092).

Measurements

Mixed-effects linear regression models were used to determine the association between time-varying PA and change in each PPM. Potential interactions between time-varying PA and age (<70, ≥70) were also tested.

Results

Significan, dose-response associations between PA and improvements in all PPMs were observed over the 6 years of follow-up after adjusting for important covariates. High PA groups (≥1,200 metabolic equivalent (MET)-min/wk) had stronger grip strength (0.48 kg greater; P < .01), more chair stands (0.35 more; P < .001), and faster gait speeds (0.06 m/s faster; P < .001) than sedentary women (<100 MET-min/wk). Higher PA levels were associated with a greater increase in chair stands over time in women aged 70 and older (P < .001) than in those younger than 70 (Pinteraction for age = .01).

Conclusion

In postmenopausal women, maintaining high PA levels over time is associated with better lower extremity function. These data support the view that regular PA plays an important role in maintaining functional status during aging in older women.



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Monday, July 3, 2017

FDA clears expanded use of cooling cap to reduce hair loss during chemotherapy - FDA Press Releases

Today, the U.S. Food and Drug Administration cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss (alopecia) during chemotherapy. This is the first cooling cap cleared by the agency for use in cancer patients with solid tumors.

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