Monday, September 30, 2019
Statement on measuring the progress being made through implementing the FDA Food Safety Modernization Act - FDA Press Releases
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FDA and DEA warn website operators illegally selling opioids - FDA Press Releases
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Statement on continued efforts to evaluate materials in medical devices to address potential safety questions - FDA Press Releases
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Friday, September 27, 2019
FDA approves first treatment for children with rare diseases that cause inflammation of small blood vessels - FDA Press Releases
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Thursday, September 26, 2019
Muraminomicins, novel ester derivatives: in vitro and in vivo antistaphylococcal activity - Journal of Antibiotics
The Journal of Antibiotics, Published online: 27 September 2019; doi:10.1038/s41429-019-0235-3
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FDA approves treatment for adults and children with all genotypes of hepatitis C and compensated cirrhosis that shortens duration of treatment to eight weeks - FDA Press Releases
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Statement on new steps to advance digital health policies that encourage innovation and enable efficient and modern regulatory oversight - FDA Press Releases
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Wednesday, September 25, 2019
Remarks prepared for testimony before a U.S. House Energy and Commerce Subcommittee on FDA Regulation of Electronic Nicotine Delivery Systems and Investigation of Vaping Illnesses - FDA Press Releases
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Discovery and applications of nucleoside antibiotics beyond polyoxin - Journal of Antibiotics
The Journal of Antibiotics, Published online: 25 September 2019; doi:10.1038/s41429-019-0237-1
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Tuesday, September 24, 2019
Recent advances in the biosynthesis of nucleoside antibiotics - Journal of Antibiotics
The Journal of Antibiotics, Published online: 25 September 2019; doi:10.1038/s41429-019-0236-2
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FDA approves first live, non-replicating vaccine to prevent smallpox and monkeypox - FDA Press Releases
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Monday, September 23, 2019
Statement on FDA efforts to encourage patient engagement in medical device clinical investigations - FDA Press Releases
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Statement on final guidance to help advance development of novel treatments for ALS - FDA Press Releases
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Friday, September 20, 2019
Statement on continued efforts to increase availability of all forms of naloxone to help reduce opioid overdose deaths - FDA Press Releases
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FDA approves first oral GLP-1 treatment for type 2 diabetes - FDA Press Releases
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FDA issues proposed rule for premarket tobacco product applications as part of commitment to continuing strong oversight of e-cigarettes and other tobacco products - FDA Press Releases
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Contributors - Geriatrics
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Thursday, September 19, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death - FDA Press Releases
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Availability of Evidence‐Based Community Falls Prevention Programs: Considerations - American Geriatric Society
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Reply to: Availability of Evidence‐Based Community Falls Prevention Programs: Considerations - American Geriatric Society
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FDA continues to take steps to fulfill its commitment to strengthen and modernize the 510(k) medical device program - FDA Press Releases
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Wednesday, September 18, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions - FDA Press Releases
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Corrigendum - American Geriatric Society
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Antiviral effect of sinefungin on in vitro growth of feline herpesvirus type 1 - Journal of Antibiotics
The Journal of Antibiotics, Published online: 18 September 2019; doi:10.1038/s41429-019-0234-4
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Tuesday, September 17, 2019
Association Between Osteoarthritis and Social Isolation: Data From the EPOSA Study - American Geriatric Society
OBJECTIVE
To determine whether there is an association between osteoarthritis (OA) and incident social isolation using data from the European Project on OSteoArthritis (EPOSA) study.
DESIGN
Prospective, observational study with 12 to 18 months of follow‐up.
SETTING
Community dwelling.
PARTICIPANTS
Older people living in six European countries.
MEASUREMENTS
Social isolation was assessed using the Lubben Social Network Scale and the Maastricht Social Participation Profile. Clinical OA of the hip, knee, and hand was assessed according to American College of Rheumatology criteria. Demographic characteristics, including age, sex, multijoint pain, and medical comorbidities, were assessed.
RESULTS
Of the 1967 individuals with complete baseline and follow‐up data, 382 (19%) were socially isolated and 1585 were nonsocially isolated at baseline; of these individuals, 222 (13.9%) experienced social isolation during follow‐up. Using logistic regression analyses, after adjustment for age, sex, and country, four factors were significantly associated with incident social isolation: clinical OA, cognitive impairment, depression, and worse walking time. Compared to those without OA at any site or with only hand OA, clinical OA of the hip and/or knee, combined or not with hand OA, led to a 1.47 times increased risk of social isolation (95% confidence interval = 1.03‐2.09).
CONCLUSION
Clinical OA, present in one or two sites of the hip and knee, or in two or three sites of the hip, knee, and hand, increased the risk of social isolation, adjusting for cognitive impairment and depression and worse walking times. Clinicians should be aware that individuals with OA may be at greater risk of social isolation.
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FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma - FDA Press Releases
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Saturday, September 14, 2019
Reply to Acetaminophen Use and Stroke Risk - American Geriatric Society
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Acetaminophen Use and Stroke Risk - American Geriatric Society
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Comment on Physical Performance in Memory Clinic Patients: The Potential Role of the White Matter Network - American Geriatric Society
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Reply to: Comment on Physical Performance in Memory Clinic Patients: The Potential Role of the White Matter Network - American Geriatric Society
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Friday, September 13, 2019
Statement alerting patients and health care professionals of NDMA found in samples of ranitidine - FDA Press Releases
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Thursday, September 12, 2019
The “Fierce Urgency of Now”: Geriatrics Professionals Speaking up for Older Adult Care in the United States - American Geriatric Society
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Corrigendum - American Geriatric Society
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Tuesday, September 10, 2019
FDA approves first therapy for the treatment of adult patients with a rare blood clotting disorder - FDA Press Releases
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USDA and FDA Announce a Formal Agreement to Regulate Cell-Cultured Food Products from Cell Lines of Livestock and Poultry - FDA Press Releases
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FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk - FDA Press Releases
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FDA approves AspireAssist obesity device - FDA Press Releases
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FDA updates warnings for fluoroquinolone antibiotics - FDA Press Releases
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Federal court orders rice noodle company to stop selling products until it complies with food safety regulations - FDA Press Releases
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FDA takes action against Kansas food manufacturer for repeated food safety violations - FDA Press Releases
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La FDA aprueba el dispositivo AspireAssist contra la obesidad - FDA Press Releases
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La FDA moderniza la etiqueta de información nutricional de los alimentos empaquetados - FDA Press Releases
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FDA approves first intraocular lens with extended range of vision for cataract patients - FDA Press Releases
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FDA approves first generic Crestor - FDA Press Releases
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FDA targets unlawful internet sales of illegal prescription medicines during International Operation Pangea IX - FDA Press Releases
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FDA approves Epclusa for treatment of chronic Hepatitis C virus infection - FDA Press Releases
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FDA allows use of investigational test to screen blood donations for Zika virus - FDA Press Releases
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FDA takes significant steps to protect Americans from dangers of tobacco through new regulation - FDA Press Releases
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FDA approves first MRI-guided focused ultrasound device to treat essential tremor - FDA Press Releases
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La FDA impulsa la Iniciativa de la Medicina de Precisión emitiendo guías preliminares para las pruebas basadas en la secuenciación de nueva generación - FDA Press Releases
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FDA takes steps to withdraw approval of the swine drug carbadox due to safety concerns - FDA Press Releases
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FDA approves new diagnostic imaging agent to detect rare neuroendocrine tumors - FDA Press Releases
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FDA approves new medication for dry eye disease - FDA Press Releases
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FDA approves first drug to treat hallucinations and delusions associated with Parkinson’s disease - FDA Press Releases
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Federal court orders Alabama seafood company to cease production due to food safety violations - FDA Press Releases
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FDA allows marketing of first-of-kind tissue containment system for use with certain laparoscopic power morcellators in select patients - FDA Press Releases
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Supratherapeutic Psychotropic Drug Levels in the Emergency Department and Their Association with Delirium Duration: A Preliminary Study - American Geriatric Society
Objectives
Polypharmacy is associated with delirium, but the mechanisms for this connection are unclear. Our goal was to determine the frequency of supratherapeutic psychotropic drug levels (SPDLs) in older hospitalized patients and if it is associated with the duration of emergency department (ED) delirium.
Design
Secondary analysis of a prospective cohort study.
Setting
Tertiary care academic medical center.
Participants
ED patients 65 years or older who were admitted to the hospital.
Measurements
Delirium was assessed in the ED and during the first 7 days of hospitalization using the modified Brief Confusion Assessment Method. Drug concentrations were determined in serum samples collected at enrollment via a novel platform based on liquid chromatography–tandem mass spectrometry capable of identifying and quantitating 78 clinically approved medications including opioids, benzodiazepines, antidepressants, antipsychotics, and amphetamines. Patients with serum psychotropic drug concentrations above established reference ranges were considered supratherapeutic and have a SPDL. We performed proportional odds logistic regression to determine if SPDLs were associated with ED delirium duration adjusted for confounders. Medical record review was performed to determine if the doses of medications associated with SPDLs were adjusted at hospital discharge.
Results
A total of 158 patients were enrolled; of these, 66 were delirious in the ED. SPDLs were present in 11 (17%) of the delirious and 4 (4%) of the non‐delirious ED patients. SPDLs were significantly associated with longer ED delirium duration (adjusted proportional odds ratio = 6.0; 95% confidence interval = 2.1‐17.3) after adjusting for confounders. Of the 15 medications associated with SPDLs, 9 (60%) were prescribed at the same or higher doses at the time of hospital discharge.
Conclusion
SPDLs significantly increased the odds of prolonged ED delirium episodes. Approximately half of the medications associated with SPDLs were continued after hospital discharge at the same or higher doses.
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Monday, September 9, 2019
Measuring Quality in Home Healthcare - American Geriatric Society
BACKGROUND/OBJECTIVES
Improving quality performance in home health is an increasingly high priority. The objective of this study was to examine trends in industry performance over time using three quality measures: a composite quality metric (Q index), an infection prevention measure (vaccination verification), and an outcome measure (hospital avoidance).
DESIGN/SETTING/PARTICIPANTS/MEASURES
We linked Home Health Compare and Provider of Services data from 2012 to 2016, which included 39 211 observations during the 5‐year study period and 7670 agencies in 2016. The Q index was developed to allow comparability over time, equally weighting the contributions of each element. After examining summary statistics, we developed three regression models stratified by ownership (for‐profit/nonprofit agency) and included two constructs of nurse staffing, in addition to controlling for known confounders.
RESULTS
Most agencies (80.4%) were for‐profit agencies. The Q index and vaccination verification improved substantially over time, but there was no change in hospital avoidance. Ownership status was associated with all three measures (P < .001). Registered nurse staffing (relative to licensed practical nurses and home health aides) was associated with higher Q index and vaccination verification (P < .001).
CONCLUSION
The Q index allows for assessment of trends over time in home healthcare. Ownership and nurse staffing are important factors in the quality of care. The overall home care market is driven by for‐profit agencies, but their characteristics and outcomes differ from nonprofit agencies. J Am Geriatr Soc 67:1859–1865, 2019
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The MedSafer Study: A Controlled Trial of an Electronic Decision Support Tool for Deprescribing in Acute Care - American Geriatric Society
OBJECTIVES
Polypharmacy is common, costly, and harmful for hospitalized older adults. Scalable strategies to reduce the burden of potentially inappropriate medications (PIMs) are needed. We sought to leverage medication reconciliation in hospitalized older adults by pairing with MedSafer, an electronic decision support tool for deprescribing.
DESIGN
This was a nonrandomized controlled before‐and‐after study.
SETTING
The study took place on four internal medicine clinical teaching units.
PARTICIPANTS
Subjects were aged 65 years and older, had an expected prognosis of 3 or more months, and were taking five or more usual home medications.
INTERVENTION
In the baseline phase, patients received usual care that was medication reconciliation. Patients in the intervention arm also had a “deprescribing opportunity report” generated by MedSafer and provided to their in‐hospital treating team.
MEASUREMENTS
The primary outcome was ascertained at the time of hospital discharge and was the proportion of patients who had one or more PIMs deprescribed.
RESULTS
A total of 1066 patients were enrolled, and deprescribing opportunities were present for 873 (82%; 418 during the control and 455 during the intervention phases, respectively). The proportion of patients with one or more PIMs deprescribed at discharge increased from 46.9% in the control period to 54.7% in the intervention period with an adjusted absolute risk difference of 8.3% (2.9%‐13.9%). Not all classes of drugs in the intervention arm were associated with an increase in deprescribing, and new PIM starts were equally common in both arms of the study.
CONCLUSION
Using an electronic decision support tool for deprescribing, we increased the proportion of patients with one or more PIMs deprescribed at hospital discharge as compared with usual care. Although this type of intervention may help address medication overload in hospitalized patients, it also underscores the importance of powering future trials for a reduction in adverse drug events.
Trial registration: NCT02918058. J Am Geriatr Soc 67:1843–1850, 2019
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Subclinical Cardiovascular Disease and Fall Risk in Older Adults: Results From the Atherosclerosis Risk in Communities Study - American Geriatric Society
BACKGROUND/OBJECTIVES
Falls are frequent and often devastating events among older adults. Cardiovascular disease (CVD) is associated with greater fall risk; however, it is unknown if pathways that contribute to CVD, such as subclinical myocardial damage or wall strain, are related to future falls. We hypothesized that elevations in high‐sensitivity cardiac troponin T (hs‐cTnT) and N‐terminal pro‐B‐type natriuretic peptide (NT‐proBNP), measured in older adults, would be associated with greater fall risk.
DESIGN
Prospective cohort study.
SETTING AND PARTICIPANTS
Atherosclerosis Risk in Communities Study participants without known coronary heart disease, heart failure, or stroke.
MEASUREMENTS
We measured hs‐cTnT or NT‐proBNP in 2011 to 2013. Falls were identified from hospital discharge International Classification of Diseases, Ninth Revision (ICD‐9), codes or Centers for Medicare and Medicaid Services claims. We used Poisson models adjusted for age, sex, and race/study center to quantify fall rates across approximate quartiles of hs‐cTnT (less than 8, 8‐10, 11‐16, and 17 or greater ng/L) and NT‐proBNP (less than 75, 75‐124, 125‐274, and 275 or greater pg/mL). We used Cox models to determine the association of cardiac markers with fall risk, adjusted for age, sex, race/center, and multiple fall risk factors.
RESULTS
Among 3973 participants (mean age = 76 ± 5 years, 62% women, 22% black), 457 had a subsequent fall during a median follow‐up of 4.5 years. Incidence rates across quartiles of hs‐cTnT and NT‐proBNP were 17.1, 20.0, 26.2, and 36.4 per 1000 person‐years and 12.8, 22.2, 28.7, and 48.4 per 1000 person‐years, respectively. Comparing highest vs lowest quartiles of either hs‐cTnT or NT‐proBNP demonstrated a greater than two‐fold higher fall risk, with hazard ratios of 2.17 (95% confidence interval {CI} = 1.60‐2.95) and 2.34 (95% CI = 1.73‐3.16), respectively. In a joint model, the relationships of hs‐cTnT and NT‐proBNP with falls were significant and independent.
CONCLUSION
Subclinical elevations of cardiac damage and wall strain were each associated with a higher fall risk in older adults. Further research is needed to determine whether interventions that lower hs‐cTnT or NT‐proBNP also lower fall risk. J Am Geriatr Soc 67:1795–1802, 2019
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Factors Associated With Deprescribing Acetylcholinesterase Inhibitors in Older Nursing Home Residents With Severe Dementia - American Geriatric Society
BACKGROUND/OBJECTIVE
Uncertainty regarding benefits and risks associated with acetylcholinesterase inhibitors (AChEIs) in severe dementia means providers do not know if and when to deprescribe. We sought to identify which patient‐, provider‐, and system‐level characteristics are associated with AChEI discontinuation.
DESIGN
Analysis of 2015 to 2016 data from Medicare claims, Part D prescriptions, Minimum Data Set (MDS), version 3.0, Area Health Resource File, and Nursing Home Compare. Cox‐proportional hazards models with time‐varying covariates were used to identify patient‐, provider‐, and system‐level factors associated with AChEI discontinuation (30‐day or more gap in supply).
SETTING
US Medicare–certified nursing homes (NHs).
PARTICIPANTS
Nonskilled NH residents, aged 65 years and older, with severe dementia receiving AChEIs within the first 14 days of an MDS assessment in 2016 (n = 37 106).
RESULTS
The sample was primarily white (78.7%), female (75.5%), and aged 80 years or older (77.4%). The most commonly prescribed AChEIs were donepezil (77.8%), followed by transdermal rivastigmine (14.6%). The cumulative incidence of AChEI discontinuation was 29.7% at the end of follow‐up (330 days), with mean follow‐up times of 194 days for continuous users of AChEIs and 105 days for those who discontinued. Factors associated with increased likelihood of discontinuation were new admission, older age, difficulty being understood, aggressive behavior, poor appetite, weight loss, mechanically altered diet, limited prognosis designation, hospitalization in 90 days prior, and northeastern region. Factors associated with decreased likelihood of discontinuation included memantine use, use of strong anticholinergics, polypharmacy, rurality, and primary care prescriber vs geriatric specialist.
CONCLUSION
Among NH residents with severe dementia being treated with AChEIs, the cumulative incidence of AChEI discontinuation was just under 30% at 1 year of follow‐up. Our findings provide insight into potential drivers of deprescribing AChEIs, identify system‐level barriers to deprescribing, and help to inform covariates that are needed to address potential confounding in studies evaluating the potential risks and benefits associated with deprescribing. J Am Geriatr Soc 67:1871–1879, 2019
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Physical Performance in Memory Clinic Patients: The Potential Role of the White Matter Network - American Geriatric Society
BACKGROUND/OBJECTIVES
Memory clinic patients commonly also have declined physical performance. This may be attributable to white matter injury, due to vascular damage or neurodegeneration. Quantifying white matter injury is made possible by new magnetic resonance imaging (MRI) techniques, including diffusion‐weighted imaging (DWI) of network connectivity. We investigated whether physical performance in memory clinic patients is related to white matter network connectivity.
DESIGN
Observational cross‐sectional study.
SETTING
Memory clinic.
PARTICIPANTS
Patients referred to a memory clinic with vascular brain injury on MRI (n = 90; average age = 72 years; 60% male; 34% with diagnosis Alzheimer disease).
MEASUREMENTS
We reconstructed structural brain networks from DWI with fiber tractography and used graph theory to calculate global efficiency, fractional anisotropy (FA), and mean diffusivity (MD) of the white matter, and nodal strength (mean FA or MD of all white matter tracts connected to a node). Assessment of physical performance included gait speed, chair stand time, and Short Physical Performance Battery (SPPB) score.
RESULTS
Lower global efficiency, lower FA, and higher MD correlated with poorer gait speed, SPPB scores, and chair stand times (R range = 0.23‐0.42). Global efficiency and FA explained 5% to 16% of the variance in gait speed, chair stand times, and SPPB scores, independent of age and sex. Moreover, global efficiency and FA explained an additional 4% to 5% of variance on top of lacunar infarcts and white matter hyperintensities. Regional analyses showed that, in particular, the connectivity strength of prefrontal, occipital, striatal, and thalamic nodes correlated with gait speed.
CONCLUSION
Poorer physical performance is related to disrupted white matter network connectivity in memory clinic patients with vascular brain injury. The associations of these network abnormalities are partially independent of visible vascular injury. J Am Geriatr Soc 67:1880–1887, 2019
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Prospective Associations of Diet Quality With Incident Frailty in Older Adults: The Health, Aging, and Body Composition Study - American Geriatric Society
OBJECTIVE
To examine associations of diet quality indicators with 4‐year incidence of frailty in community‐dwelling older adults.
DESIGN
Prospective cohort study.
SETTING
Health, Aging, and Body Composition Study, United States.
PARTICIPANTS
Community‐dwelling men and women, aged 70 to 81 years in 1998 to 1999 (first follow‐up, present study's baseline; n = 2154).
MEASUREMENTS
At first follow‐up, dietary intake over the preceding year was assessed with a food frequency questionnaire. Indicators of diet quality include the Healthy Eating Index (categorized as poor, medium, and good), energy intake, and protein intake (a priori adjusted for energy intake using the nutrient residual model). Frailty status was determined using Fried's five‐component frailty phenotype and categorized into “robust” (0 components present), “pre‐frailty” (1 ‐ 2 components present), or “frail” (3‐5 components present). Cox proportional hazards analysis was used to examine associations of the diet quality indicators with 4‐year incidence of (1) frailty and (2) pre‐frailty or frailty. Competing risk analysis was used to examine associations with frailty by accounting for competing risks of death.
RESULTS
During the 4‐year follow‐up, 277 of the 2154 participants, robust or pre‐frail at baseline, developed frailty, and 629 of the 1020 participants, robust at baseline, developed pre‐frailty or frailty. Among the robust and pre‐frail, after adjustment for confounders including energy intake, those consuming poor‐ and medium‐quality diets had a higher frailty incidence than those consuming good‐quality diets (hazard ratio [HR] = 1.92 [95% confidence interval {CI} = 1.17‐3.17] and HR = 1.40 [95% CI = 0.99‐1.98], respectively). No associations for energy or protein intake were observed. Competing risk analyses yielded similar results. Among the robust, those with lower vegetable protein intake had a higher “pre‐frailty or frailty” incidence (per −10 g/d: HR = 1.20; 95% CI = 1.04‐1.39). No other associations were observed.
CONCLUSION
Poorer overall diet quality and lower vegetable protein intake may increase the risk of becoming frail in old age. We found no association for intakes of energy, total protein, or animal protein. J Am Geriatr Soc 67:1835–1842, 2019
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Impact of Social Network on the Risk and Consequences of Injurious Falls in Older Adults - American Geriatric Society
OBJECTIVES
A smaller social network is associated with worse health‐related outcomes in older people. We examined the impact of social connections and social support on the risk of injurious fall and on fall‐related functional decline and mortality.
DESIGN
Prospective study with 6‐year follow‐up.
SETTING
Community.
PARTICIPANTS
A total of 2630 participants (aged ≥60 years) from the Swedish National Study on Aging and Care in Kungsholmen.
MEASUREMENTS
Social connections (social network size and contact frequency) and social support (social resource perception and satisfaction) were assessed through validated questionnaires. Data on injurious falls (falls requiring inpatient or outpatient care) and mortality came from official registers. We defined injurious falls as severe if they caused fracture and/or intracranial injury and as multiple if two or more occurred during the 6‐year follow‐up. Functional decline was defined as the loss of ability to perform one or more activities of daily living during the follow‐up.
RESULTS
During the follow‐up, 322 participants experienced injurious falls. After adjusting for potential confounders, the hazard ratio of injurious falls was 1.7 (95% confidence interval [CI] = 1.1‐2.4) for people with poor social connections and 1.5 (95% CI = 1.1‐2.1) for people with moderate social connections (reference: rich social connections). Social support was not associated with fall risk. The odds of functional decline among those with severe/multiple falls and (1) poor social connections (odds ratio [OR] = 5.2 [95% CI = 2.1‐12.9]) or (2) poor social support (OR = 4.5 [95% CI = 1.7‐12.0]) was up to twice as high as among those with severe/multiple falls and (3) rich social connections (OR = 2.5 [95% CI = .9‐6.6]) or (4) rich social support (OR = 2.7 [95% CI = 1.2‐6.3]). Similar but more attenuated results emerged for mortality.
CONCLUSIONS
Social network may influence fall risk and fall‐related functional decline and mortality. J Am Geriatr Soc 67:1851–1858, 2019
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Transitional Care Outcomes in Veterans Receiving Post‐Acute Care in a Skilled Nursing Facility - American Geriatric Society
BACKGROUND
As the veteran population ages, more veterans are receiving post‐acute care in skilled nursing facilities (SNFs). However, the outcomes of these transitions across Veterans Affairs (VA) and non‐VA settings are unclear.
OBJECTIVE
To measure adverse outcomes in veterans transitioning from hospital to SNF in VA and non‐VA hospitals and SNFs.
DESIGN
Retrospective observational study using the 2012 to 2014 Residential History File, which concatenates VA, Medicare, and Medicaid data into longitudinal episodes of care for veterans.
SETTING
VA and non‐VA hospitals and SNFs in four categories: non‐VA SNFs, VA‐contracted SNFs, VA Community Living Centers (CLCs), and State Veterans Homes.
PARTICIPANTS
Veterans, aged 65 years or older, who were acutely hospitalized and discharged to an SNF; one transition was randomly selected per patient.
MEASUREMENTS
Adverse “transitional care” outcomes were a composite of hospital readmission, emergency department visit, or mortality within 7 days of hospital discharge.
RESULTS
More than four in five veteran transitions (81.7%) occurred entirely outside the VA system. The overall 7‐day outcome rate was 10.7% in the 388 339 veterans included. Adverse outcomes were lowest in VA hospital–CLC transitions (7.5%; 95% confidence interval [CI] = 7.1%‐7.8%) and highest in non‐VA hospital to VA‐contracted nursing home transitions (17.5%; 95% CI = 16.0%‐18.9%) in unadjusted analysis. In multivariate analyses adjusted for patient and hospital characteristics, VA hospitals had lower adverse outcome rates than non‐VA hospitals (odds ratio [OR] = 0.80; 95% CI = 0.74‐0.86). In comparison to VA hospital–VA CLC transitions, non‐VA hospital to VA‐contracted nursing homes (OR = 2.51; 95% CI = 2.09‐3.02) and non‐VA hospital to CLC (OR = 2.25; 95% CI = 1.81‐2.79) had the highest overall adverse outcome rates.
CONCLUSION
Most veteran hospital‐SNF transitions occur outside the VA, although adverse transitional care outcomes are lowest inside the VA. These findings raise important questions about the VA's role as a provider and payer of post‐acute care in SNFs. J Am Geriatr Soc 67:1820–1826, 2019
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Creating the Next Generation of Translational Geroscientists - American Geriatric Society
Advances in understanding fundamental processes of aging have led to a variety of investigational therapies to delay or prevent age‐related diseases and conditions. These geroscience therapeutics hold the promise of revolutionizing medical care of older adults by treating the complex syndromes of aging and preserving health and independence. A crucial bottleneck is the study of geroscience therapeutics in early‐stage, first‐in‐human, or proof‐of‐concept clinical trials. There is a limited pool of clinical investigators with the combination of knowledge and skills at the interface of clinical research, care of older adults, and aging biology needed to successfully design, fund, and implement geroscience trials. Current training pipelines are insufficient to meet the need. The sixth retreat of the National Institute on Aging R24 Geroscience Network brought together basic scientists, gerontologists, clinicians, and clinical researchers from the United States and Europe to discuss how to identify, recruit, and train investigators who can perform early‐stage clinical trials in geroscience. We present herein the group's consensus on necessary subject domains and competencies, identification of candidate learners, credentialing learners, and the efficient and rapid implementation of training programs. Foundations and funding agencies have crucial roles to play in catalyzing the development of these programs. Geriatrician investigators are indispensable but cannot meet the need alone. Translational geroscience training programs can create a cadre of groundbreaking investigators from a variety of backgrounds and foster institutional cultures supportive of multidisciplinary translational aging research to turn innovative ideas into transformative therapeutics that can improve the health and independence of older adults. J Am Geriatr Soc 67:1934–1939, 2019
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White Matter Hyperintensities and Hippocampal Atrophy in Relation to Cognition: The 90+ Study - American Geriatric Society
OBJECTIVES
To study the interactive effect of white matter hyperintensities (WMH) and hippocampal atrophy on cognition in the oldest old.
DESIGN
Ongoing longitudinal study.
SETTING
In Southern California, brain magnetic resonance imaging (MRI) scans were conducted between May 2014 and December 2017.
PARTICIPANTS
Individuals from The 90+ Study with a valid brain MRI scan (N = 141; 94 cognitively normal and 47 with cognitive impairment).
MEASUREMENTS
Cognitive testing was performed every 6 months with a mean follow‐up of 2 years and included these tests: Mini‐Mental State Examination (MMSE), modified MMSE (3MS), California Verbal Learning Test (CVLT) immediate recall over four trials and delayed recall, Digit Span Backward, Animal Fluency, and Trail Making Test (TMT) A, B, and C. We used one linear mixed model for each cognitive test to study the baseline and longitudinal association of WMH and hippocampal volume (HV) with cognition. Models were adjusted for age, sex, and education.
RESULTS
Mean age was 94.3 years (standard deviation [SD] = 3.2 y). At baseline, higher WMH volumes were associated with worse scores on the 3MS, CVLT immediate and delayed recall, and TMT B. Lower HVs were associated with worse baseline scores on all cognitive tests, except for the Digit Span Backward. Longitudinally, higher WMH and lower HVs were associated with faster decline in the 3MS and MMSE, and lower HV was also associated with faster decline in the CVLT immediate recall. No association was observed between WMH and HV and no interaction between WMH and HV in their association with baseline cognition or cognitive decline.
CONCLUSION
We show that WMH and hippocampal atrophy have an independent, negative effect on cognition that make these biomarkers relevant to evaluate in the diagnostic work‐up of the oldest‐old individuals with cognitive complaints. However, the predictive value of WMH for cognitive decline seems to be less evident in the oldest‐old compared with a younger group of older adults. J Am Geriatr Soc 67:1827–1834, 2019
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Analyzing Hospital Transfers Using INTERACT Acute Care Transfer Tools: Lessons from MOQI - American Geriatric Society
OBJECTIVES
We explored the differences in potentially avoidable/unavoidable hospital transfers in a retrospective analysis of Interventions to Reduce Acute Care Transfers (INTERACT) Acute Transfer Tools (ACTs) completed by advanced practice registered nurses (APRNs) working in the Missouri Quality Improvement (QI) Initiative (MOQI).
DESIGN
Cross‐sectional descriptive study of 3996 ACTs for 32.5 calendar months from 2014 to 2016. Univariate analyses examined differences between potentially avoidable vs unavoidable transfers. Multivariate logistic regression analysis of candidate factors identified those contributing to avoidable transfers.
Setting
Sixteen nursing homes (NHs), ranging from 120 to 321 beds, in urban, metro, and rural communities within 80 miles of a large midwestern city.
PARTICIPANTS
A total of 5168 residents with a median age of 82 years.
MEASUREMENTS
Data from 3946 MOQI‐adapted ACTs.
RESULTS
A total of 54% of hospital transfers were identified as avoidable. QI opportunities related to avoidable transfers were earlier detection of new signs/symptoms (odds ratio [OR] = 2.35; 95% confidence interval [CI] = 1.61‐3.42; P < .001); discussions of resident/family preference (OR = 2.12; 95% CI = 1.38‐3.25; P < .001); advance directive/hospice care (OR = 2.25; 95% CI = 1.33‐3.82; P = .003); better communication about condition (OR = 4.93; 95% CI = 3.17‐7.68; P < .001); and condition could have been managed in the NH (OR = 16.63; 95% CI = 10.9‐25.37; P < .001). Three factors related to unavoidable transfers were bleeding (OR = .59; 95% CI = .46‐.77; P < .001), nausea/vomiting (OR = .7; 95% CI = .54‐.91; P = .007), and resident/family preference for hospitalization (OR = .79; 95% CI = .68‐.93; P = .003).
CONCLUSION
Reducing avoidable hospital transfers in NHs requires challenging assumptions about what is avoidable so QI efforts can be directed to improving NH capacity to manage ill residents. The APRNs served as the onsite coaches in the use and adoption of INTERACT. Changes in health policy would provide a revenue stream to support APRN presence in NH, a role that is critical to improving resident outcomes by increasing staff capacity to identify illness and guide system change. J Am Geriatr Soc 67:1953–1959, 2019
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Frailty Is Related to Subjective Cognitive Decline in Older Women without Dementia - American Geriatric Society
OBJECTIVES
Physical frailty (or loss of physiologic reserve) is associated with cognitive impairment and dementia. Subjective cognitive decline (SCD) may represent early pathologic changes of dementia. The association between these disease markers is unclear.
DESIGN
Cross‐sectional analysis.
SETTING
Community‐based participants from the Vanderbilt Memory & Aging Project.
PARTICIPANTS
A total of 306 older adults with normal cognition (NC; n = 174) or mild cognitive impairment (MCI; n = 132).
MEASUREMENTS
Frailty was measured using standard methods, and a composite frailty score was calculated. SCD was quantified using the Everyday Cognition Scale (ECog; total score and four domain scores). Objective cognition was assessed with the Montreal Cognitive Assessment (MoCA). Proportional odds models, stratified by sex, related the frailty composite to MoCA and total ECog score adjusting for age, education, body mass index, cognitive diagnosis, depressed mood, Framingham Stroke Risk Profile, apolipoprotein E (APOE ε4) carrier status, and height (for gait speed models). Secondary models related individual frailty components to SCD domains and explored associations in NC only.
RESULTS
In women, frailty composite was related to MoCA (odds ratio [OR] = .56; P = .04), a finding attenuated in sensitivity analysis (OR = .59; P = .08). Frailty composite related to ECog total (OR = 2.27; P = .02), planning (OR = 2.63; P = .02), and organization scores (OR = 2.39; P = .03). Increasing gait speed related to lower ECog total (OR = .06; P = .003) and memory scores (OR = .03; P < .001). Grip strength related to lower ECog planning score (OR = .91; P = .04). In men, frailty was unrelated to objective and subjective cognition (P values >.07). Findings were consistent in the NC group.
CONCLUSION
Frailty component and composite scores are related to SCD before the presence of overt dementia. Results suggest that this association is present before overt cognitive impairment. Results suggest a possible sex difference in the clinical manifestation of frailty, with primary associations noted in women. Further studies should investigate mechanisms linking early changes among frailty, SCD, and cognition. J Am Geriatr Soc, 1–9, 2019. J Am Geriatr Soc 67:1803–1811, 2019
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Social Media's Role in the Dissemination of Health Information - American Geriatric Society
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Reply to: Social Media's Role in the Dissemination of Health Information - American Geriatric Society
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Post–Hip Fracture Mortality in Nursing Home Residents by Obesity Status - American Geriatric Society
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Follow‐Up of a Virtual‐Group‐Exercise at Home Program to Reduce Fall Risks - American Geriatric Society
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Home as a Place for Care of the Oldest Stroke Patients: A Pilot from the Catalan Stroke Program - American Geriatric Society
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Reply to Artificial Nutrition Belongs on POLST - American Geriatric Society
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Artificial Nutrition Belongs on POLST - American Geriatric Society
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Falls, Subclinical Cardiovascular Disease, and a Nonagenarian's Sage Advice - American Geriatric Society
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Statement on improving adverse event reporting of compounded drugs to protect patients - FDA Press Releases
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FDA warns JUUL Labs for marketing unauthorized modified risk tobacco products, including in outreach to youth - FDA Press Releases
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Sunday, September 8, 2019
Engineering nucleoside antibiotics toward the development of novel antimicrobial agents - Journal of Antibiotics
The Journal of Antibiotics, Published online: 09 September 2019; doi:10.1038/s41429-019-0230-8
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Friday, September 6, 2019
How Do Frail Medicare Beneficiaries Fare Under Bundled Payments? - American Geriatric Society
BACKGROUND/OBJECTIVES
Bundled payments are an alternative payment model in which a hospital takes accountability for the costs of a 90‐day episode of care. Such models are meant to improve care through better coordination across care settings, but could have adverse consequences for frail adults if they lead to inappropriate cuts in necessary post‐acute care.
DESIGN
Retrospective claims‐based analysis of hospitals' first year of participation in Medicare's Bundled Payments for Care Improvement (BPCI) program.
SETTING
US hospitals.
PARTICIPANTS
A total of 641 146 Medicare beneficiaries admitted to 688 BPCI programs and 1276 matched control hospitals for myocardial infarction, heart failure, pneumonia, sepsis, chronic obstructive pulmonary disease, or major joint replacement of the lower extremity in 2012 to 2016.
INTERVENTION
Participation in BPCI.
MEASUREMENTS
Proportion of patients in each quartile of a validated claims‐based frailty index, total and setting‐specific standardized Medicare payments per episode, days at home, 90‐day readmissions, and 90‐day mortality.
RESULTS
Higher levels of frailty were associated with higher Medicare payments and worse clinical outcomes (for the medical composite, costs per episode were $11 921, $17 348, $22 828, and $29 157 across frailty quartiles; days at home were 70.1, 60.4, 54.3, and 51.5; 90‐day readmission rates were 16.0%, 27.0%, 38.2%, and 50.9%; and 90‐day mortality rates were 15.4%, 22.5%, 25.1%, 21.3%); patterns were similar for joint replacement. Under the BPCI program, there was no differential change in the proportion of highly frail patients at BPCI vs control hospitals. There were also no differential deleterious changes in payments or clinical outcomes for frail relative to nonfrail patients at BPCI vs non‐BPCI hospitals.
CONCLUSION
While frail patients had higher costs and worse outcomes in general, there was no evidence of changes in access or worsening clinical outcomes in BPCI hospitals for frail patients relative to the nonfrail in hospitals' first year of participation in the program. These findings may be reassuring for policy makers and clinical leaders.
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Thursday, September 5, 2019
Low‐Value Proton Pump Inhibitor Prescriptions Among Older Adults at a Large Academic Health System - American Geriatric Society
BACKGROUND
Older adults are particularly vulnerable to complications from proton pump inhibitor (PPI) drugs. We sought to characterize the prevalence of potentially low‐value PPI prescriptions among older adults to inform a quality improvement (QI) intervention.
METHODS
We created a cohort of patients, aged 65 years or older, receiving primary care at a large academic health system in 2018. We identified patients currently prescribed any PPI using the electronic health record (EHR) medication list (current defined as September 1, 2018). A geriatrician, a gastroenterologist, a QI expert, and two primary care physicians (PCPs) created multidisciplinary PPI appropriateness criteria based on evidenced‐based guidelines. Supervised by a gastroenterologist and PCP, two internal medicine residents conducted manual chart reviews in a random sample of 399 patients prescribed PPIs. We considered prescriptions potentially low value if they lacked a guideline‐based (1) short‐term indication (gastroesophageal reflux disease [GERD]/peptic ulcer disease/Helicobacter pylori gastritis/dyspepsia) or (2) long‐term (>8 weeks) indication (severe/refractory GERD/erosive esophagitis/Barrett esophagus/esophageal adenocarcinoma/esophageal stricture/high gastrointestinal bleeding risk/Zollinger‐Ellison syndrome). We used the Wilson score method to calculate 95% confidence intervals (CIs) on low‐value PPI prescription prevalence.
RESULTS
Among 69 352 older adults, 8729 (12.6%) were prescribed a PPI. In the sample of 399 patients prescribed PPIs, 63.9% were female; their mean age was 76.2 years, and they were seen by 169 PCPs. Of the 399 prescriptions, 143 (35.8%; 95% CI = 31.3%‐40.7%) were potentially low value—of which 82% began appropriately (eg, GERD) but then continued long term without a guideline‐based indication. Among 169 PCPs, 32 (18.9%) contributed to 59.2% of potentially low‐value prescriptions.
CONCLUSION
One in eight older adults were prescribed a PPI, and over one‐third of prescriptions were potentially low‐value. Most often, appropriate short‐term prescriptions became potentially low value because they lacked long‐term indications. With most potentially low‐value prescribing concentrated among a small subset of PCPs, interventions targeting them and/or applying EHR‐based automatic stopping rules may protect older adults from harm.
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Can Hearing Aids Delay Time to Diagnosis of Dementia, Depression, or Falls in Older Adults? - American Geriatric Society
OBJECTIVE
To examine the association between hearing aids (HAs) and time to diagnosis of Alzheimer disease (AD) or dementia, anxiety or depression, and injurious falls among adults, aged 66 years and older, within 3 years of hearing loss (HL) diagnosis.
DESIGN
Retrospective cohort study.
SETTING
We used 2008 to 2016 national longitudinal claims data (based on office visit, inpatient, or outpatient healthcare encounters) from a large private payer. We used Kaplan‐Meier curves to examine unadjusted disease‐free survival and crude and adjusted Cox regression models to examine associations between HAs and time to diagnosis of three age‐related/HL‐associated conditions within 3 years of HL diagnosis. All models were adjusted for age, sex, race/ethnicity, census divisions, and prior diagnosis of cardiovascular conditions, hypertension, hypercholesterolemia, obesity, and diabetes.
PARTICIPANTS
The participants included 114 862 adults, aged 66 years and older, diagnosed with HL.
MEASUREMENT
Diagnosis of (1) AD or dementia; (2) depression or anxiety; and (3) injurious falls.
INTERVENTION
Use of HAs.
RESULTS
Large sex and racial/ethnic differences exist in HA use. Approximately 11.3% of women vs 13.3% of men used HAs (95% confidence interval [CI] difference = −0.024 to −0.016). Approximately 13.6% of whites (95% CI = 0.13‐0.14) vs 9.8% of blacks (95% CI = 0.09‐0.11) and 6.5% of Hispanics (95% CI = 0.06‐0.07) used HAs. The risk‐adjusted hazard ratios of being diagnosed with AD/dementia, anxiety/depression, and injurious falls within 3 years after HL diagnosis, for those who used HAs vs those who did not, were 0.82 (95% CI = 0.76‐0.89), 0.89 (95% CI = 0.86‐0.93), and 0.87 (95% CI = 0.80‐0.95), respectively.
CONCLUSIONS
Use of HAs is associated with delayed diagnosis of AD, dementia, depression, anxiety, and injurious falls among older adults with HL. Although we have shown an association between use of HAs and reduced risk of physical and mental decline, randomized trials are needed to determine whether, and to what extent, the relationship is causal.
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Effect of Denosumab on Falls, Muscle Strength, and Function in Community‐Dwelling Older Adults - American Geriatric Society
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When It Comes to Images, Let's Not Crop Frail Older Adults Out of the Frame - American Geriatric Society
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Tuesday, September 3, 2019
The Prevention of Infections in Older Adults: Oral Health - American Geriatric Society
The oral cavity is exposed to the external environment and from a very young age is colonized by infectious agents. Under certain circumstances including poor oral hygiene, dry mouth, trauma, and the use of antibiotics, oral infections can occur. They can result in damage to the oral cavity including teeth and their support structures. Oral infections can also lead to the extension of infection into surrounding tissues and to systemic infections. Chronic oral infection is a recognized risk factor for heart disease. Older adults are at high risk for oral infections and associated complications. Tooth loss, for which infection is the most significant cause, leads to cosmetic changes and a decreased ability to masticate certain foods that can lead to malnutrition. Chronic oral infections and the manipulation of teeth and supporting structures can lead to the hematogenous spread of infection including the infection of artificial joints and endocardial implants. Good oral hygiene, the use of fluoride, regular dental care, and the appropriate use of antibiotics can all reduce oral infections and their associated complications.
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Monetizing the MoCA: What Now? - American Geriatric Society
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Inhibition of Mycobacterium abscessus, M. chelonae, and M. fortuitum biofilms by Methylobacterium sp - Journal of Antibiotics
The Journal of Antibiotics, Published online: 03 September 2019; doi:10.1038/s41429-019-0232-6
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Monday, September 2, 2019
Complete NMR assignment and absolute configuration of k4610422, a norditerpenoid inhibitor of testosterone-5α-reductase originally from Streptosporangium: rediscovery from a thermophilic Actinomadura - Journal of Antibiotics
The Journal of Antibiotics, Published online: 03 September 2019; doi:10.1038/s41429-019-0231-7
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Structure and biological activity of Metarhizin C, a stereoisomer of BR-050 from Tolypocladium album RK17-F0007 - Journal of Antibiotics
The Journal of Antibiotics, Published online: 03 September 2019; doi:10.1038/s41429-019-0229-1
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