Coronavirus (COVID-19) Update: Daily Roundup March 31, 2020 - FDA Press Releases

Coronavirus (COVID-19) Update: Daily Roundup

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Both New and Chronic Potentially Inappropriate Medications Continued at Hospital Discharge Are Associated With Increased Risk of Adverse Events - American Geriatric Society

BACKGROUND

Admission to hospital provides the opportunity to review patient medications; however, the extent to which the safety of drug regimens changes after hospitalization is unclear.

OBJECTIVE

To estimate the number of potentially inappropriate medications (PIMs) prescribed to patients at hospital discharge and their association with the risk of adverse events 30 days after discharge.

DESIGN

Prospective cohort study.

SETTING

Tertiary care hospitals within the McGill University Health Centre Network in Montreal, Quebec, Canada.

PARTICIPANTS

Patients from internal medicine, cardiac, and thoracic surgery, aged 65 years and older, admitted between October 2014 and November 2016.

MEASURES

Abstracted chart data were linked to provincial health databases. PIMs were identified using AGS (American Geriatrics Society) Beers Criteria®, STOPP, and Choosing Wisely statements. Multivariable logistic regression and Cox models were used to assess the association between PIMs and adverse events.

RESULTS

Of 2,402 included patients, 1,381 (57%) were male; median age was 76 years (interquartile range [IQR] = 70‐82 years); and eight discharge medications were prescribed (IQR = 2‐8). A total of 1,576 (66%) patients were prescribed at least one PIM at discharge; 1,176 (49%) continued a PIM from prior to admission, and 755 (31%) were prescribed at least one new PIM. In the 30 days after discharge, 218 (9%) experienced an adverse drug event (ADE) and 862 (36%) visited the emergency department (ED), were rehospitalized, or died. After adjustment, each additional new PIM and continued community PIM were respectively associated with a 21% (odds ratio [OR] = 1.21; 95% confidence interval [CI] = 1.01‐1.45) and a 10% (OR = 1.10; 95% CI = 1.01‐1.21) increased odds of ADEs. They were also respectively associated with a 13% (hazard ratio [HR] = 1.13; 95% CI = 1.03‐1.26) and a 5% (HR = 1.05; 95% CI = 1.00‐1.10) increased risk of ED visits, rehospitalization, and death.

CONCLUSIONS

Two in three hospitalized patients were prescribed a PIM at discharge, and increasing numbers of PIMs were associated with an increased risk of ADEs and all‐cause adverse events. Improving hospital prescribing practices may reduce the frequency of PIMs and associated adverse events.

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Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19 - FDA Press Releases

FDA has stood up a new program to expedite the development of potentially safe and effective life-saving treatments for COVID-19.

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Clinician Perspectives on Overscreening for Cancer in Older Adults With Limited Life Expectancy - American Geriatric Society

BACKGROUND/OBJECTIVES

Guidelines recommend against routine screening for breast, colorectal, and prostate cancers in older adults with less than 10 years of life expectancy. However, clinicians often continue to recommend cancer screening for these patients. We examined primary care cliniciansʼ perspectives regarding overscreening, as defined by limited life expectancy.

DESIGN

Semistructured, in‐depth individual interviews.

SETTING

Twenty‐one academic and nonacademic primary care clinics in Maryland.

PARTICIPANTS

Thirty primary care clinicians from internal medicine, family medicine, medicine/pediatrics, and geriatric medicine.

MEASUREMENTS

Interviews explored whether the clinicians believed that overscreening for breast, colorectal, or prostate cancers existed in older adults and their views on using life expectancy to decide on stopping routine screening. Audio recordings of the interviews were transcribed verbatim. Two investigators independently coded all transcripts using qualitative content analysis.

RESULTS

Most clinicians were physicians (24/30) and women (16/30). Content analysis generated three major themes. (1) Many, but not all, clinicians perceived overscreening in older adults as a problem. (2) There was controversy around using limited life expectancy to define overscreening due to concerns that the guidelines did not capture potential nonmortality benefits of screening; that population‐based screening data could not be easily applied to individuals; that this approach failed to account for patient choice; and that life expectancy predictions were inaccurate. (3) Some clinicians worried that using life expectancy to define overscreening may inadvertently introduce bias and lead to unintended harms.

CONCLUSIONS

Several clinicians disagreed with guideline frameworks of using limited life expectancy to guide cancer screening cessation. Some disagreement stems from inadequate knowledge about the benefits and harms of cancer screening and indicates a need for education or decision support. Other reasons for disagreement highlight the need to refine the current recommended cancer screening approaches and identify strategies to avoid unintended consequences, such as introducing bias or exacerbating existing disparities.

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Laxaphycins B5 and B6 from the cultured cyanobacterium UIC 10484 - Journal of Antibiotics

The Journal of Antibiotics, Published online: 31 March 2020; doi:10.1038/s41429-020-0301-x

Laxaphycins B5 and B6 from the cultured cyanobacterium UIC 10484

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Coronavirus (COVID-19) Update: Daily Roundup March 30, 2020 - FDA Press Releases

Coronavirus (COVID-19) Update: Daily Roundup

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Associations of Social and Behavioral Determinants of Health Index with Self‐Rated Health, Functional Limitations, and Health Services Use in Older Adults - American Geriatric Society

OBJECTIVES

To characterize the cumulative risk factors of social and behavioral determinants of health (SDoH) and examine their association with self‐rated general health, functional limitations, and use of health services among US older adults.

DESIGN

Cross‐sectional analysis of the 2013‐2014 National Health and Nutrition Examination Survey.

SETTING

Nationally representative health interview survey in the United States.

PARTICIPANTS

Survey respondents aged 65 or older (n = 1,306 unweighted).

MEASUREMENTS

A cumulative risk score of SDoH, developed by the National Academy of Medicine expert panel, was assessed using validated measures. Outcome variables included self‐rated general health, functional limitations (eg, activities of daily living), and use of health services (eg, usual source of care and overnight hospitalization). We quantified the cumulative risk score of SDoH in older adults and used multivariable‐adjusted logistic and Poisson regression analyses to assess the association of SDoH with self‐rated health, functional limitations, and use of health services, adjusting for other covariates.

RESULTS

About 25.7% of older adults, representative of 11.0 million people nationwide, reported having three or more cumulative SDoH risk factors. These older adults were more likely to have functional limitations (eg, activities of daily living) and less likely to report their general health as “very good” or “excellent” than those with two or fewer cumulative SDoH risk factors (P < .001 for each). Each additional cumulative SDoH risk factor was associated with increased odds of not having a usual source of care (adjusted odds ratio = 1.57; 95% confidence interval = 1.09‐2.27).

CONCLUSION

The SDoH index score may be a useful tool to predict access to care and quality of care in older adults.

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A Novel Intervention to Identify and Report Suspected Abuse in Older, Primary Care Patients - American Geriatric Society

BACKGROUND

Previous research has identified several barriers faced by clinicians in detecting and reporting elder abuse, such as lack of knowledge about the process to report suspected cases of abuse and lack of access to experts to consult with. A novel intervention was designed and tested that embedded two Adult Protective Services (APS) specialists in a healthcare system operating primary care clinics serving a large Medicare population.

OBJECTIVES

To examine the types of roles the APS specialists played in the healthcare system and the number and types of cases of suspected abuse among older patients that clinicians consulted them about and reported to APS.

DESIGN

Cross‐sectional, exploratory study.

SETTING

Primary care clinics in five regions of Texas.

PARTICIPANTS

Older patients of primary care clinics.

INTERVENTION

APS specialists and project staff trained clinicians on how to identify and report abuse, neglect, and exploitation among older patients. The specialists were also available in person or by telephone and email to consult with clinicians about patients suspected of being abused by others or being self‐neglecting.

MEASUREMENTS

Data were obtained by conducting semistructured telephone interviews with APS specialists; and from APS specialistsʼ written documentation/notes of consultations with clinicians regarding suspicion of abuse among patients and whether a report to APS was warranted.

RESULTS

The APS specialists trained clinicians on abuse, consulted with clinicians, and served as a liaison between the healthcare system and APS. During the project, clinicians reported 529 older patients to APS, and 386 patients received one or more services documented by APS at case closure. These cases involved 902 allegations of various types of abuse, of which the most common was self‐neglect (617 or 68%).

CONCLUSION

Embedding APS specialists in a large healthcare system led to cliniciansʼ increased awareness of the importance of identifying and reporting elder abuse, particularly self‐neglect.

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Coronavirus (COVID-19) Update: FDA expedites review of diagnostic tests to combat COVID-19 - FDA Press Releases

: Coronavirus (COVID-19) Update: FDA expedites review of diagnostic tests to combat COVID-19

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FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User Fee Legislation - FDA Press Releases

The President signed into law a $2 trillion emergency relief bill that will continue to aid the response efforts and ease the economic impact of COVID-19.

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Local‐Migrant Gaps in Healthcare Utilization Between Older Migrants and Local Residents in China - American Geriatric Society

BACKGROUND

Older migrants in China without local resident registration (hukou) are a vulnerable population and face barriers to receiving local healthcare.

OBJECTIVES

We aimed to quantify the disparities in healthcare utilization between older migrants and local residents in Shanghai, China.

DESIGN

This was a cross‐sectional study.

SETTING

The study was conducted in Shanghai, China, in 2016.

PARTICIPANTS

Older adults (aged ≥60 years) were recruited based on a three‐stage stratified cluster sampling method (2571 older locals and 1920 older migrants).

MEASUREMENTS

We compared utilization of outpatient care, inpatient care, preventive care, emergency room (ER) admission, and dental care, as well as medication use between older migrants and local residents. The local‐migrant gap was parsed into observed and unobserved components using the Blinder‐Oaxaca decomposition method.

RESULTS

Older migrants were less likely to utilize outpatient (odds ratio [OR] = 0.757; 95% confidence interval [CI] = 0.617‐0.928), inpatient (OR = 0.642; 95% CI = 0.443‐0.931), and preventive care (OR = 0.743; 95% CI = 0.643‐0.858) and were more likely to use medication (OR = 1.254; 95% CI = 1.089‐1.445) than local residents. Differences in ER admissions and dental care utilization were not significant in the regression analysis. The decomposition results indicated that 55% and 71% of the local‐migrant gap in outpatient and preventive care utilization were attributable to individual characteristics, like health insurance. Unobserved components, including hukou‐related factors and personal heterogeneous preferences, contributed 59% and 63% to utilization of inpatient care and medication use, respectively.

CONCLUSION

We identified local‐migrant gaps in healthcare utilization among older adults in China. Further research is needed into integration of the health insurance system, accessibility of public health welfare benefits, and reconstruction of social networks among older migrants.

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Coronavirus (COVID-19) Update: FDA takes further steps to help mitigate supply interruptions of food and medical products - FDA Press Releases

FDA takes further steps to help mitigate supply interruptions of food and medical products

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Coronavirus (COVID-19) Update: Daily Roundup March 27, 2020 - FDA Press Releases

Coronavirus (COVID-19) Update: Daily Roundup

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Coronavirus (COVID-19) Update: FDA takes action to help increase U.S. supply of ventilators and respirators for protection of health care workers, patients - FDA Press Releases

: FDA took action to help increase the supply of ventilators and respirators due to shortages during COVID-19

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A Practical Approach to Using Adjuvant Analgesics in Older Adults - American Geriatric Society

The adjuvant analgesics are a large and diverse group of drugs that were developed for primary indications other than pain and are potentially useful analgesics for one or more painful conditions. The “adjuvant” designation reflects their early use as opioid co‐analgesics for cancer pain. During the past 3 decades, their role in pain management has changed with the advent of many new entities, emerging data from numerous analgesic trials, and growing clinical experience. Many of these drugs are now used as primary analgesics for specific types of chronic pain. With proper patient selection and cautious administration, they can potentially contribute meaningfully to the management of chronic pain in older adults. A practical approach categorizes the many adjuvant analgesics by broad indications: multipurpose drugs and drugs that target neuropathic pain, musculoskeletal pain, and cancer pain, respectively. This article reviews the status of the evidence supporting the analgesic potential of the adjuvant analgesics and discusses best practices in terms of drug selection and dosing.

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Preventing the Spread of COVID‐19 to Nursing Homes: Experience from a Singapore Geriatric Centre - American Geriatric Society

Journal of the American Geriatrics Society, Accepted Article.

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Coronavirus (COVID-19) Update: Daily Roundup March 26, 2020 - FDA Press Releases

Coronavirus (COVID-19) Update: Daily Roundup

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FDA Continues to Support Transparency and Collaboration in Drug Approval Process as the Clinical Data Summary Pilot Concludes - FDA Press Releases

After receiving useful feedback as part of the Clinical Data Summary Pilot Program, FDA has decided to conclude the pilot. FDA continues to invest in our work with international partners.

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Optimizing Retention in a Pragmatic Trial of Community‐Living Older Persons: The STRIDE Study - American Geriatric Society

OBJECTIVES

The Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study is testing the effectiveness of a multifactorial intervention to prevent serious fall injuries. Our aim was to describe procedures that were implemented to optimize participant retention; report retention yields by age, sex, clinical site, and follow‐up time; provide reasons for study withdrawals; and highlight the successes and lessons learned from the STRIDE retention efforts.

DESIGN

Pragmatic cluster randomized trial.

SETTING

A total of 86 primary care practices within 10 US healthcare systems.

PARTICIPANTS

A total of 5451 community‐living persons, 70 years of age or older, at high risk for serious fall injuries.

MEASUREMENTS

Study outcomes were collected every 4 months by a central call center. Reconsent was required to extend follow‐up beyond the originally planned 36 months.

RESULTS

Over a median follow‐up of 3.2 years (interquartile range = 2.8‐3.7 y), 439 (8.1%) participants died and 600 (11.0%) withdrew their consent or did not reconsent to extend follow‐up beyond 36 months, yielding rates (per 100 person‐years) of deaths and withdrawals of 2.6 and 3.6, respectively. The withdrawal rate increased with advancing age, was comparable for men and women, and did not differ much by clinical site. The most common reasons for withdrawal were illness and unable to contact for reconsent at 36 months. Completion of the follow‐up interviews was greater than 93% at each time point. Most participants completed all (71.8%) or all but one (9.2%) of the follow‐up interviews. The most common reason for not completing a follow‐up interview was unable to contact, with rates ranging from 2.8% at 40 months to 4.6% at 20 months.

CONCLUSION

Completion of the thrice‐yearly follow‐up interviews in STRIDE was high, and retention of participants over 44 months exceeded the original projections. The procedures used in STRIDE, together with lessons learned, should assist other investigators who are planning or conducting large pragmatic trials of vulnerable older persons.

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Relationship of Age With the Hemodynamic Parameters in Individuals With Elevated Blood Pressure - American Geriatric Society

BACKGROUND

Age is known to be associated with the prevalence and pathophysiology of hypertension. However, there is little information on whether age stands as a good proxy for the specific hemodynamic profile of an individual with elevated blood pressure (BP), which could be important in the selection of therapy.

DESIGN

This is a cross‐sectional study.

SETTING

People who underwent a noninvasive, hemodynamic assessment using impedance cardiography at 51 sites of iKang Health Checkup Centers throughout China between January 2012 and October 2018.

PARTICIPANTS

We included 116,851 individuals, aged 20 to 80 years.

MAIN OUTCOMES AND MEASURES

Relationship between age and hemodynamic parameters (cardiac index, systemic vascular resistance index [SVRI]), among individuals with elevated BP (systolic BP ≥130 mm Hg or diastolic BP ≥80 mm Hg).

RESULTS

Final study population included 45,082 individuals with elevated BP: 29,194 men and 15,888 women with a mean (±SD) age of 48 (±13) and 54 (±12) years, respectively. Cardiac index was negatively associated with age with an adjusted, per decade decrease of 0.17 (95% confidence interval [CI] = 0.17‐0.18) L/min/m² in men and 0.24 (95% CI = 0.23‐0.25) L/min/m² in women. SVRI was positively associated with age with an adjusted, per‐decade increase of 174.2 (95% CI = 168.8‐179.7) dynes·s·cm⁻⁵·m² in men and 214.1 (95% CI = 204.3‐223.8) dynes·s·cm⁻⁵·m² in women. However, there was substantial overlap in the distribution of these parameters across different age groups in both sexes.

CONCLUSIONS

In this large study, we observed that cardiac index decreased and SVRI increased with age among individuals with elevated BP. Even though there was a general trend with age, we observed heterogeneity within age strata, suggesting that age alone is inadequate to indicate the hemodynamic profile for an individual.

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Coronavirus Disease 2019 in Geriatrics and Long‐term Care: The ABCDs of COVID‐19 - American Geriatric Society

ABSTRACT

The pandemic of coronavirus disease of 2019 (COVID‐19) has global impact unseen since the 1918 worldwide influenza epidemic. All aspects of life have changed dramatically for now. The group most susceptible to COVID‐19 are older adults and those with chronic underlying chronic medical disorders. The population residing in long‐term care facilities generally are those who are both old and suffering from multiple comorbidities. In this article we provide information, insights, and recommended approaches to COVID‐19 in the long‐term facility setting. Since the situation is fluid and changing rapidly, readers are encouraged to access the resources cited in this article frequently.

This article is protected by copyright. All rights reserved.

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Forthcoming Issues - Geriatrics

Diabetes in Older Adults

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Contents - Geriatrics

Dan G. Blazer and Susan K. Schultz

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Contributors - Geriatrics

DAN G. BLAZER, MD, MPH, PhD

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Copyright - Geriatrics

ELSEVIER

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Geriatric Psychiatry - Geriatrics

CLINICS IN GERIATRIC MEDICINE

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Cognitive Impairment and Dementia in Parkinson Disease - Geriatrics

In the comprehensive care of people with Parkinson disease (PD), recognition of cognitive impairment is essential. Cognitive impairment in PD can be varied in its clinical features and rates of progression and is now recognized to occur throughout the disease, from early, de novo to more advanced stages. However, the many factors related to the disease itself, underlying pathologies, comorbidities, and genetics may play a role in the development of mild cognitive impairment (PD-MCI) and dementia (PDD). To date, the field lacks curative or disease-modifying treatments for PD cognitive impairment and has few effective, robust symptomatic therapies for PDD or PD-MCI.

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Posttraumatic Stress Disorder in the Elderly - Geriatrics

Posttraumatic stress disorder (PTSD) can occur at any point in the life span and can last for decades. Chronic PTSD can affect quality of life and have a negative impact on physical function and health in the elderly and may be associated with premature aging and dementia. It is critical that clinicians screen for trauma-based symptoms and to treat as appropriate.

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Integrated Care for Older Adults with Serious Mental Illness and Medical Comorbidity - Geriatrics

The excess risk of early mortality, medical comorbidity, early institutionalization, and high costs among older adults with serious mental illness necessitates development and dissemination of effective and sustainable integrated care models that simultaneously address mental and physical health needs. This overview highlights current, evidence-based integrated care models, which predominantly adopt the following approaches: (1) psychosocial skills training, (2) integrated illness self-management, and (3) collaborative care and behavioral health homes. Finally, innovative models that build on these approaches by incorporating novel uses of telehealth, mobile health technology and peer support, and strategies from developing economies are discussed.

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Managing Behavioral and Psychological Symptoms of Dementia - Geriatrics

Behavioral and psychological symptoms of dementia (BPSD) are universally experienced by people with dementia throughout the course of the illness and cause a significant negative impact on quality of life for patients and caregivers. Nonpharmacologic treatments have been recommended as first-line treatment of BPSD by multiple professional organizations and should target patients with dementia factors, caregiver factors, and environmental factors. Psychotropic medications are often prescribed off-label without significant evidence to support their use. The Describe, Investigate, Create, Evaluate approach can provide a structured method to investigate and treat BPSD with flexibility to use in multiple treatment settings.

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Older Age Bipolar Disorder - Geriatrics

Further understanding of older age bipolar disorder (OABD) may lead to more specific recommendations for treatment adjusted to the specific characteristics and needs caused by age-related somatic and cognitive changes. Late-onset mania has a broad differential diagnosis and requires full psychiatric and somatic work-up, including brain imaging. Research on pharmacotherapy in OABD is limited. First-line treatment of OABD is similar to that for adult bipolar disorder (BD), with specific attention to vulnerability to side effects and somatic comorbidity. Because findings in younger adults with BD cannot be extrapolated to OABD, more research in OABD is warranted.

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Anxiety Disorders in Late Life - Geriatrics

Anxiety disorders in later life are some of the most significant mental health problems affecting older adults. Prevalence estimates of anxiety disorders in late life vary considerably based on multiple methodological issues. Current diagnostic criteria may not adequately capture the nature and experience of anxiety in older people, particularly those in ethnic and racial minority groups. This article reviews late-life anxiety disorders. Pharmacologic and psychotherapy approaches to treat late-life anxiety are reviewed, including a summary of current innovations in clinical care across settings, treatment models, and treatment delivery.

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Hearing Loss - Geriatrics

Hearing loss is among the most frequent problems experienced by older adults, yet psychiatrists and other clinicians often ignore the problem as an aggravation rather than recognizing that the problem might benefit from appropriate hearing health care. Many psychiatric disorders have been associated with hearing loss, including depression, schizophrenia and other psychoses, anxiety, and neurocognitive disorders. In this article, hearing loss among older adults is reviewed, with special attention directed toward the recognition and proper referral to a hearing health care provider. Finally, major advances in hearing health care are discussed.

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Delirium in the Elderly - Geriatrics

Delirium is defined as an acute disturbance in attention and cognition, with significant associated morbidity and mortality. This article discusses the basic epidemiology of delirium and approaches to diagnosing, assessing, and working up patients for delirium. It delineates the pathophysiology and underlying predisposing and precipitating factors for delirium. It also discusses recent advances in prevention and treatment, particularly multicomponent, nonpharmacological interventions.

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Coronavirus (COVID-19) Update: Daily Roundup, March 25, 2020 - FDA Press Releases

Coronavirus (COVID-19) Update: Daily Roundup

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Action at a Distance: Geriatric Research during a Pandemic - American Geriatric Society

ABSTRACT

Background

“Action at a distance” may be the new norm for clinical researchers in the context of the COVID‐19 pandemic, which may require social distancing for the next 18 months. We must minimize face‐to‐face contact with vulnerable populations. But we must also persist, adapt, and help our older patients and study participants during the pandemic.

Methods

Clinical researchers have an obligation to help, and we can. Recommendations for clinical researchers working with older adults during the COVID‐19 pandemic are discussed.

Results

Implement technology now: Minimize face‐to‐face contact with participants by utilizing digital tools, such as shifting to electronic informed consent and digital HIPAA‐compliant tools like emailed surveys or telehealth assessments. Assess the psychological and social impact of COVID‐19: How are participants coping? What health or social behaviors have changed? How are they keeping up with current events? What are they doing to stay connected to their families, friends, and communities? Are their health care needs being met? Current studies should be adapted immediately to these ends. Mobilize research platforms for patient needs: Leverage our relationships with participants and rapidly deploy novel clinical engagement techniques such as digital tools to intervene remotely to reduce the negative effects of social isolation on our participants. Equip research staff with tangible resources, and provide timely population‐specific health information to support patients and healthcare providers.

Conclusions

We have an opportunity to make an impact on our older adult patients now, as this pandemic continues to unfold. Above all, clinical researchers need to continue working – to help as many people as possible through the crisis.

This article is protected by copyright. All rights reserved.

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FDA approves first U.S. treatment for Chagas disease - FDA Press Releases

The U.S. Food and Drug Administration today granted accelerated approval to benznidazole for use in children ages 2 to 12 years old with Chagas disease. It is the first treatment approved in the United States for the treatment of Chagas disease.

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FDA approves system for the delivery of ear tubes under local anesthesia to treat ear infection - FDA Press Releases

FDA has approved a new system, the Tubes Under Local Anesthesia (Tula) System, for the delivery of tympanostomy tubes, commonly referred to as ear tubes, that can be inserted into the eardrum to treat recurrent ear infections.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s important efforts to address the opioid crisis - FDA Press Releases

Today the Administration took a historic step to direct additional resources to help address the staggering human and economic toll created by the epidemic of opioid addiction.

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FDA expands approval of Sutent to reduce the risk of kidney cancer returning - FDA Press Releases

FDA approves first adjuvant treatment for adult patients who are at a high risk of kidney cancer returning after a kidney has been removed.

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FDA acts to protect kids from serious risks of opioid ingredients contained in some prescription cough and cold products by revising labeling to limit pediatric use - FDA Press Releases

The U.S. Food and Drug Administration announced today that it is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old because the serious risks of these medicines outweigh their potential benefits in this population. After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older. Labeling for the medications also is being updated with additional safety information for adult use – including an expanded Boxed Warning, the FDA’s most prominent warning ‒ notifying about the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone.

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FDA warns of fraudulent and unapproved flu products - FDA Press Releases

FDA warns of fraudulent and unapproved flu products

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FDA authorizes new use of test, first to identify the emerging pathogen Candida auris - FDA Press Releases

FDA authorized the first test to identify the emerging pathogen Candida auris, which can cause serious infections in hospitalized patients.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care

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FDA approves first generic version of EpiPen - FDA Press Releases

FDA approves the first generic version of EpiPen and EpiPen Jr for the emergency treatment of allergic reactions in adults and pediatric patients who weigh more than 33 pounds.

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FDA approves new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence - FDA Press Releases

FDA approved Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) for the maintenance treatment of opioid dependence.

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FDA approves first treatment for advanced form of the second most common skin cancer - FDA Press Releases

FDA approves Libtayo (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced CSCC.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s approval of Dsuvia and the FDA’s future consideration of new opioids - FDA Press Releases

FDA announces approval of Dsuvia and new steps the agency may be taking to evaluate opioids

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FDA awards 18 grants to stimulate product development for rare diseases - FDA Press Releases

The U.S. Food and Drug Administration today announced it has awarded 18 new research grants totaling more than $19 million to boost the development of products for patients with rare diseases, which affect the lives of nearly 30 million Americans. These new grants were awarded to principal investigators in ten states, with research spanning clinical sites domestically and internationally.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the agency’s process for issuing public warnings and notifications of recalls - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the agency’s process for issuing public warnings and notifications of recalls

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FDA approves first coagulation factor-albumin fusion protein to treat patients with hemophilia B - FDA Press Releases

The U.S. Food and Drug Administration today approved Idelvion, Coagulation Factor IX (Recombinant), Albumin Fusion Protein, for use in children and adults with Hemophilia B. Idelvion is the first coagulation factor-albumin fusion protein product to be approved, and the second Factor IX fusion protein product approved in the U.S. that is modified to last longer in the blood.

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Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas on new steps to strengthen FDA’s food safety program for 2020 and beyond - FDA Press Releases

New steps to strengthen FDA’s food safety program for 2020 and beyond

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La FDA toma medidas importantes para proteger a los estadounidenses de los peligros del tabaco a través de una nueva regulación - FDA Press Releases

La FDA toma medidas importantes para proteger a los estadounidenses de los peligros del tabaco a través de una nueva regulación

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Coronavirus (COVID-19) Update: Daily Roundup, March 24, 2020 - FDA Press Releases

Coronavirus (COVID-19) Update: Daily Roundup

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Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers - FDA Press Releases

Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers

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Coronavirus (COVID-19) Update: FDA Helps Facilitate Veterinary Telemedicine During Pandemic - FDA Press Releases

FDA intends to temporarily not enforce certain requirements in order to allow veterinarians to better utilize telemedicine to address animal health needs during the pandemic.

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Exploring metabolic adaptation of Streptococcus pneumoniae to antibiotics - Journal of Antibiotics

The Journal of Antibiotics, Published online: 24 March 2020; doi:10.1038/s41429-020-0296-3

Exploring metabolic adaptation of Streptococcus pneumoniae to antibiotics

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Inhibition of cellular inflammatory mediator production and amelioration of learning deficit in flies by deep sea Aspergillus-derived cyclopenin - Journal of Antibiotics

The Journal of Antibiotics, Published online: 24 March 2020; doi:10.1038/s41429-020-0302-9

Inhibition of cellular inflammatory mediator production and amelioration of learning deficit in flies by deep sea Aspergillus-derived cyclopenin

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Coronavirus (COVID-19) Update: Daily Roundup - FDA Press Releases

Coronavirus (COVID-19) Update: Daily Roundup

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Insulin Gains New Pathway to Increased Competition - FDA Press Releases

Today, insulin and certain other biologic drugs transition to a different regulatory pathway.

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Antibiofilm activities of ceragenins and antimicrobial peptides against fungal-bacterial mono and multispecies biofilms - Journal of Antibiotics

The Journal of Antibiotics, Published online: 23 March 2020; doi:10.1038/s41429-020-0299-0

Antibiofilm activities of ceragenins and antimicrobial peptides against fungal-bacterial mono and multispecies biofilms

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Coronavirus (COVID-19) Update: FDA provides update on patient access to certain REMS drugs during COVID-19 public health emergency - FDA Press Releases

FDA provides update on patient access to certain REMS drugs during COVID-19

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Coronavirus (COVID-19) Update: FDA Continues to Facilitate Access to Crucial Medical Products, Including Ventilators - FDA Press Releases

Coronavirus (COVID-19) Update: FDA Continues to Facilitate Access to Crucial Medical Products, Including Ventilators

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Coronavirus (COVID-19) Update: FDA Issues first Emergency Use Authorization for Point of Care Diagnostic - FDA Press Releases

Coronavirus (COVID-19) Update: FDA authorizes first Point of Care Diagnostic

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Outcome of Older Patients with Acute Neuropsychological Symptoms Not Fulfilling Criteria of Delirium - American Geriatric Society

OBJECTIVES

Although delirium is often investigated, little is known about the outcomes of patients having acute neuropsychological changes at a single time point without fulfilling the criteria of full delirium. Our aim was to determine point prevalence, predictors, and long‐term outcomes of delirium and acute neuropsychological changes in patients aged 60 years and older across different departments of a university hospital with general inpatient care.

DESIGN

Prospective observational study.

SETTING

University hospital excluding psychiatric wards.

PARTICIPANTS

At baseline, 669 patients were assessed, and follow‐ups occurred at months 6, 12, 18, and 36.

MEASUREMENTS

Measurements were obtained using the Confusion Assessment Method (CAM), comprehensive geriatric assessment, health‐related quality of life, functional state (month 6), and mortality rates (months 6, 12, 18, and 36). Subjects were classified into (1) patients with delirium according to the CAM, (2) patients with only two positive CAM items (2‐CAM state), and (3) patients without delirium.

RESULTS

Delirium was present in 10.8% and the 2‐CAM state in an additional 12.7% of patients. Highest prevalence of delirium was observed in medical and surgical intensive care units and neurosurgical wards. Cognitive restrictions, restricted mobility, electrolyte imbalance, the number of medications per day, any fixations, and the presence of a urinary catheter predicted the presence of delirium and 2‐CAM‐state. The mean Karnofsky Performance Score and EuroQol‐5D were comparable between delirium and the 2‐CAM state after 6 months. The 6‐, 12‐, 18‐, and 36‐month mortality rates of patients with delirium and the 2‐CAM state were comparable. The nurses’ evaluation of distinct patients showed high specificity (89%) but low sensitivity (53%) for the detection of delirium in wide‐awake patients.

CONCLUSION

Patients with an acute change or fluctuation in mental status or inattention with one additional CAM symptom (ie, disorganized thinking or an altered level of consciousness) have a similar risk for a lower quality of life and death as patients with delirium.

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Associations Between Activities of Daily Living Independence and Mental Health Status Among Medicare Managed Care Patients - American Geriatric Society

BACKGROUND/OBJECTIVES

Although there is a strong cross‐sectional association between dependence in activities of daily living (ADLs) and decreased mental health, it is largely unknown how the loss of specific ADLs, or the combination of ADLs, influences mental health outcomes. We examined the effect of ADL independence on mental health among participants in a large survey of Medicare managed care recipients.

DESIGN/SETTING

Retrospective cohort study.

PARTICIPANTS

A total of 104,716 participants in cohort 17 of the Medicare Health Outcomes Survey, who completed the baseline and follow‐up surveys in 2014 and 2016.

MEASUREMENTS

Linear regression models estimated the effects of loss of ADL independence on change in Mental Component Summary (MCS) score.

RESULTS

In an adjusted model, loss of independence in eating, bathing, dressing, and toileting were associated with three‐ to four‐point declines in MCS, suggesting meaningful worsening. In a model that also included all six ADLs, loss of independence in each ADL was associated with declines in MCS, with the largest effects for eating and bathing. MCS decreased by 1.3 per each additional summative loss of ADL independence (P < .001).

CONCLUSION

Loss of ADL independence was associated with large declines in mental health, with personal care activities showing the largest effects. Additional research can help to characterize the causes of ADL loss, to explore how older adults cope with it, and to identify ways of maximizing resilience.

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Longitudinal Association Between Physical Activity and Frailty Among Community‐Dwelling Older Adults - American Geriatric Society

OBJECTIVES

To examine the longitudinal association between frequency of moderate physical activity (PA) and overall, physical, psychological, and social frailty among community‐dwelling older adults older than 70 years. Second, we assessed the association between a 12‐month change in frequency of moderate PA and frailty.

DESIGN

Longitudinal cohort study.

SETTING

Community settings in Spain, Greece, Croatia, the Netherlands, and the United Kingdom.

PARTICIPANTS

A total of 1735 participants (61.1% female; mean age = 79.6 years; SD = 5.5 years).

MEASUREMENTS

The frequency of self‐reported moderate PA was measured and classified into two categories: “regular frequency” and “low frequency.” The 12‐month change in frequency of moderate PA between baseline and follow‐up was classified into four categories: “continued regular frequency,” “decreased frequency,” “continued low frequency,” and “increased frequency.” The 15‐item Tilburg Frailty Indicator assessed overall, physical, psychological, and social frailty.

RESULTS

Participants who undertook moderate PA with a regular frequency at baseline were less frail at 12‐month follow‐up than participants with a low frequency. Participants who undertook moderate PA with a continued regular frequency were least frail at baseline and at 12‐month follow‐up. After controlling for baseline frailty and covariates, compared with participants with a continued regular frequency, participants with a decreased frequency were significantly more overall (B = 1.31; 95% confidence interval [CI] = 0.99‐1.63), physically (B = 0.80; 95% CI = 0.58‐1.03), psychologically (B = 0.43; 95% CI = 0.30‐0.56), and socially frail (B = 0.14; 95% CI = 0.04‐0.23) at 12‐month follow‐up; participants with a continued low frequency were significantly more overall (B = 1.16; 95% CI = 0.84‐1.49), physically (B = 0.73; 95% CI = 0.51‐0.96), psychologically (B = 0.42; 95% CI = 0.29‐0.55), and socially frail (B = 0.13; 95% CI = 0.04‐0.23) at 12‐month follow‐up; the 12‐month follow‐up frailty level of participants who undertook moderate PA with an increased frequency was similar to those with a continued regular frequency.

CONCLUSION

Maintaining a regular frequency of PA as well as increasing to a regular frequency of PA are associated with maintaining or improving overall, physical, psychological, and social frailty among European community‐dwelling older adults older than 70 years.

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Relationships Between Profiles of Physical Activity and Major Mobility Disability in the LIFE Study - American Geriatric Society

OBJECTIVES

To examine the relationship between time spent in light physical activity (LPA) and in moderate to vigorous physical activity (MVPA) and the pattern of accumulation on the risk for major mobility disability (MMD) in a large multicenter study of physical activity (PA) and aging, the Lifestyle Interventions and Independence for Elders (LIFE) study.

DESIGN

Data were collected from individuals randomized to a PA intervention as part of the LIFE study, an eight‐center single‐blind randomized clinical trial conducted between February 2010 and December 2013.

SETTING

Lifestyle Interventions and Independence for Elders Study

PARTICIPANTS

Older adult participants (78.4 years; N = 507) at risk for MMD.

INTERVENTION

All older adults included in these analyses were randomized to a structured PA intervention that included two center‐based plus three to four home‐based exercise sessions per week with a primary goal of walking for 150 minutes weekly. Participants attended the intervention for 2.5 years on average.

MEASUREMENTS

MMD was defined as the inability to complete a 400‐m walk within 15 minutes and without assistance. Physical function was assessed via the Short Physical Performance Battery (SPPB). Actigraph accelerometers were used to quantify amount and variability in LPA and MVPA.

RESULTS

In an adjusted Cox proportional hazards regression, we identified a significant interaction (P = .017) between SPPB score and LPA amount and variability such that more LPA was associated with a reduced risk for MMD among those with higher initial function, as was lower variability (eg, via distributing LPA across the day). The SPPB × MVPA interaction was significant (P = .04), such that more MVPA was associated with lower MMD risk among those with lower function. Finally, greater MVPA variability was associated with lower risk for MMD.

CONCLUSION

A prescription of PA for older adults should account for key factors such as physical function and emphasize both amount and pattern of accumulation of PA from across the intensity continuum.

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Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits - FDA Press Releases

FDA alerts Consumers about Unauthorized Fraudulent COVID-19 Test Kits.

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Coronavirus (COVID-19) Update: FDA allows expanded use of devices to monitor patients’ vital signs remotely - FDA Press Releases

Coronavirus (COVID-19) Update: FDA allows expanded use of devices to monitor patients’ vital signs remotely

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Coronavirus (COVID-19) Update: FDA provides guidance on production of alcohol-based hand sanitizer to help boost supply, protect public health - FDA Press Releases

FDA has issued two guidance documents to communicate its policy for the temporary manufacture of certain alcohol-based hand sanitizer products.

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Coronavirus (COVID-19) Update: FDA Continues to Facilitate Development of Treatments - FDA Press Releases

Coronavirus (COVID-19) Update: FDA Continues to Facilitate Development of Treatments

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Coronavirus (COVID-19) Update: Blood Donations - FDA Press Releases

Coronavirus (COVID-19) Update: Blood Donations

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FDA Approves New Treatment for Pediatric Patients with Any Strain of Hepatitis C - FDA Press Releases

FDA approved a supplemental application for Epclusa to treat HCV in children with any of the six HCV genotypes.

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Interplay between Socioeconomic Markers and Polygenic Predisposition on Timing of Dementia Diagnosis - American Geriatric Society

OBJECTIVES

Identifying the interplay between socioeconomic markers (education and financial resources) and polygenetic predisposition influencing the time of dementia and the diagnosis of clinical Alzheimerʼs disease (AD) dementia is of central relevance for preventive strategies.

DESIGN

Prospective cohort design.

SETTING

The English Longitudinal Study of Aging is a household survey data set of a representative sample.

PARTICIPANTS

A total of 7,039 individuals aged 50 years and older participated in the study. Of these, 320 (4.6%) were diagnosed with dementia over the 10‐year follow‐up.

MEASUREMENTS

Polygenic score (PGS) for Alzheimerʼs disease (AD‐PGS) was calculated using summary statistics from the International Genomics of Alzheimerʼs Project. An accelerated failure time survival model was used to investigate interactions between AD‐PGS and socioeconomic markers on the timing of dementia and clinical AD dementia diagnosis.

RESULTS

A one standard deviation increase in AD‐PGS was associated with an accelerated time to dementia diagnosis by 4.8 months. The presence of the apolipoprotein E gene (APOE‐ε4) was associated with an earlier dementia onset by approximately 24.9 months, whereas intermediate and low levels of wealth were associated with an accelerated time to dementia diagnosis by 12.0 months and 18.7 months, respectively. A multiplicative interaction between AD‐PGS and years of completed schooling in decelerating the time to clinical AD dementia by 3.0 months suggests educational attainment may serve as a protective mechanism against AD diagnosis among older people with a higher polygenic risk. Interaction between AD‐PGS and lower wealth accelerated the time to clinical AD dementia diagnosis by 21.1 to 24.1 months.

CONCLUSION

Socioeconomic markers influence the time to dementia and clinical AD dementia diagnosis, particularly in those with a higher polygenic predisposition.

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Industry incentives and antibiotic resistance: an introduction to the antibiotic susceptibility bonus - Journal of Antibiotics

The Journal of Antibiotics, Published online: 19 March 2020; doi:10.1038/s41429-020-0300-y

Industry incentives and antibiotic resistance: an introduction to the antibiotic susceptibility bonus

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Residential Setting and the Cumulative Financial Burden of Dementia in the 7 Years Before Death - American Geriatric Society

OBJECTIVES

Care for older adults with dementia during the final years of life is costly, and families shoulder much of this burden. We aimed to assess the financial burden of care for those with and without dementia, and to explore differences across residential settings.

DESIGN

Using the Health and Retirement Study (HRS) and linked claims, we examined total healthcare spending and proportion by payer—Medicare, Medicaid, out‐of‐pocket, and calculated costs of informal caregiving—over the last 7 years of life, comparing those with and without dementia and stratifying by residential setting.

SETTING

The HRS is a nationally representative longitudinal study of older adults in the United States.

PARTICIPANTS

We sampled HRS decedents from 2004 to 2015. To ensure complete data, we limited the sample to those 72 years or older at death who had continuous fee‐for‐service Medicare Parts A and B coverage during the 7‐year period (n = 2909).

MEASUREMENTS

We compared decedents with dementia at last HRS assessment with those without dementia across annual and cumulative 7‐year spending measures, and personal characteristics. We present annual and cumulative spending by payer, and the changing proportion of spending by payer over time, comparing those with and without dementia and stratifying results by residential setting.

RESULTS

We found that, consistent with prior studies, people with dementia experience significantly higher costs, with a disproportionate share falling on patients and families. This pattern is most striking among community residents with dementia, whose families shoulder 64% of total expenditures (including $176,180 informal caregiving costs and $55,550 out‐of‐pocket costs), compared with 43% for people with dementia residing in nursing homes ($60,320 informal caregiving costs and $105,590 out‐of‐pocket costs).

CONCLUSION

These findings demonstrate disparities in financial burden shouldered by families of those with dementia, particularly among those residing in the community. They highlight the importance of considering the residential setting in research, programs, and policies.

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Home Health Rehabilitation Utilization Among Medicare Beneficiaries Following Critical Illness - American Geriatric Society

OBJECTIVES

Medicare beneficiaries recovering from a critical illness are increasingly being discharged home instead of to post‐acute care facilities. Rehabilitation services are commonly recommended for intensive care unit (ICU) survivors; however, little is known about the frequency and dose of home‐based rehabilitation in this population.

DESIGN

Retrospective analysis of 2012 Medicare hospital and home health (HH) claims data, linked with assessment data from the Medicare Outcomes and Assessment Information Set.

SETTING

Participant homes.

PARTICIPANTS

Medicare beneficiaries recovering from an ICU stay longer than 24 hours, who were discharged directly home with HH services within 7 days of discharge and survived without readmission or hospice transfer for at least 30 days (n = 3,176).

MEASUREMENTS

Count of rehabilitation visits received during HH care episode.

RESULTS

A total of 19,564 rehabilitation visits were delivered to ICU survivors over 118,145 person‐days in HH settings, a rate of 1.16 visits per week. One‐third of ICU survivors received no rehabilitation visits during HH care. In adjusted models, those with the highest baseline disability received 30% more visits (rate ratio [RR] = 1.30; 95% confidence interval [CI] = 1.17‐1.45) than those with the least disability. Conversely, an inverse relationship was found between multimorbidity (Elixhauser scores) and count of rehabilitation visits received; those with the highest tertile of Elixhauser scores received 11% fewer visits (RR = .89; 95% CI = .81‐.99) than those in the lowest tertile. Participants living in a rural setting (vs urban) received 6% fewer visits (RR = .94; 95% CI = .91‐.98); those who lived alone received 11% fewer visits (RR = .89; 95% CI = .82‐.96) than those who lived with others.

CONCLUSION

On average, Medicare beneficiaries discharged home after a critical illness receive few rehabilitation visits in the early post‐hospitalization period. Those who had more comorbidities, who lived alone, or who lived in rural settings received even fewer visits, suggesting a need for their consideration during discharge planning.

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Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections - FDA Press Releases

Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections

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Coronavirus (COVID-19) Update: FDA Issues Guidance for Conducting Clinical Trials - FDA Press Releases

Coronavirus (COVID-19) Update: FDA Issues Clinical Trial Guidance

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A novel chresdihydrochalcone from Streptomyces chrestomyceticus exhibiting activity against Gram-positive bacteria - Journal of Antibiotics

The Journal of Antibiotics, Published online: 18 March 2020; doi:10.1038/s41429-020-0298-1

A novel chresdihydrochalcone from Streptomyces chrestomyceticus exhibiting activity against Gram-positive bacteria

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Coronavirus (COVID-19) Update: FDA Issues Temporary Policy for FSMA Onsite Audit Requirements - FDA Press Releases

Coronavirus (COVID-19) Update: FDA Issues Temporary Policy for FSMA Onsite Audit Requirements

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Multinational Investigation of Fracture Risk with Antidepressant Use by Class, Drug, and Indication - American Geriatric Society

OBJECTIVES

Antidepressants increase the risk of falls and fracture in older adults. However, risk estimates vary considerably even in comparable populations, limiting the usefulness of current evidence for clinical decision making. Our aim was to apply a common protocol to cohorts of older antidepressant users in multiple jurisdictions to estimate fracture risk associated with different antidepressant classes, drugs, doses, and potential treatment indications.

DESIGN

Retrospective (2009–2014) cohort study.

SETTING

Five jurisdictions in the United States, Canada, United Kingdom, and Taiwan.

PARTICIPANTS

Older antidepressant users—subjects were followed from first antidepressant prescription or dispensation to first fracture or until the end of follow‐up.

MEASUREMENTS

The risk of fractures with antidepressants was estimated by multivariable Cox proportional hazards models using time‐varying measures of antidepressant dose and use vs nonuse, adjusting for patient characteristics.

RESULTS

Between 42.9% and 55.6% of study cohorts were 75 years and older, and 29.3% to 45.4% were men. Selective serotonin reuptake inhibitors (SSRIs) (48.4%‐60.0%) were the predominant class used in North America compared with tricyclic antidepressants (TCAs) in the United Kingdom and Taiwan (49.6%‐53.6%). Fracture rates varied from 37.67 to 107.18 per 1,000. The SSRIs citalopram (hazard ratio [HR] = 1.23; 95% confidence interval [CI] = 1.11‐1.36 to HR = 1.43; 95% CI = 1.11‐1.84) and sertraline (HR = 1.36; 95% CI = 1.10‐1.68), the SNRI duloxetine (HR = 1.41; 95% CI = 1.06‐1.88), TCAs doxepin (HR = 1.36; 95% CI = 1.00‐1.86) and imipramine (HR = 1.16; 95% CI = 1.05‐1.28), and atypicals (HR = 1.34; 95% CI = 1.14‐1.58) increased fracture risk in some but not all jurisdictions. In the United States and the United Kingdom, fracture risk with all classes was higher when prescribed for depression than chronic pain, a trend that is likely explained by drug choice.

CONCLUSION

The fracture risk for patients may be reduced by selecting paroxetine, an SSRI with lower risk than citalopram, the SNRI venlafaxine over duloxetine, and the TCA amitriptyline over imipramine or doxepin. There is uncertainty about the risk associated with the atypical antidepressants.

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State Variability in the Prevalence and Healthcare Utilization of Assisted Living Residents with Dementia - American Geriatric Society

OBJECTIVES

Almost 1 million older and disabled adults who require long‐term care reside in assisted living (AL), approximately 40% of whom have a diagnosis of Alzheimer's disease and related dementias (ADRD). States vary in their regulations specific to dementia care that may influence the presence of residents with ADRD in AL and their outcomes. The objectives of this study were to describe the state variability in the prevalence of ADRD among Medicare beneficiaries residing in larger (25+ bed) ALs and their healthcare utilization.

DESIGN

Retrospective observational national study.

PARTICIPANTS

National cohort of 293,336 Medicare fee‐for‐service enrollees residing in larger (25+ bed) ALs in 2016 and 2017 including 88,867 (30.3%) residents with ADRD. We compared this cohort's characteristics and healthcare utilization with that of individuals with ADRD who resided in nursing homes (NHs; n = 602,521) and the community (n = 2,074,420).

METHODS

Medicare enrollment data, claims, and the NH Minimum Data Set were used to describe differences among ADRD patients in AL, NHs, and the community. We present rates of NH admission and hospitalization, by state, adjusting for age, sex, race, dual eligibility, and chronic conditions.

RESULTS

The prevalence of ADRD among AL residents varied by state, ranging from 24% to 47%. In 2017, AL residents with ADRD had higher rates of NH admission than their community‐dwelling counterparts (adjusted national average = 24%, ranging from 14% to 35% among states). AL residents with ADRD had higher rates of hospitalization (38%) than populations in either NHs (29%) or the community (34%), and ranged from 29% to 45% of residents among states.

CONCLUSION

These findings have implications for states as they regulate AL and for healthcare professionals whose patients reside in AL. Future work is needed to understand specific elements of states’ regulatory environments and local markets that may impact access and outcomes for this vulnerable population of residents with ADRD.

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FDA requires new health warnings for cigarette packages and advertisements - FDA Press Releases

: FDA issued a final rule to require new health warnings on cigarette packages and in cigarette advertisements.

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Coronavirus (COVID-19) Update: FDA Issues Diagnostic Emergency Use Authorization to Hologic and LabCorp - FDA Press Releases

Coronavirus (COVID-19) Update: FDA Issues Two More EUAs

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Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite Availability of Diagnostics - FDA Press Releases

Coronavirus Update: FDA Continues to Expedite Availability of Diagnostics

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What Is the Relationship Between Orthostatic Blood Pressure and Spatiotemporal Gait in Later Life? - American Geriatric Society

BACKGROUND/OBJECTIVES

Little work to date has examined the relationship between gait performance and blood pressure (BP) recovery after standing in later life. The aim of this study is to clarify the association of orthostatic BP with spatiotemporal gait parameters in a large cohort of older people.

DESIGN

Cross‐sectional study using multilevel linear regression to ascertain the difference in orthostatic BP patterns across tertiles of gait speed, and linear regression to analyze the association of orthostatic hypotension 30 seconds after standing (OH‐30) with specific gait characteristics.

SETTING

The Irish Longitudinal Study on Ageing.

PARTICIPANTS

A total of 4311 community‐dwelling adults, aged 50 years or older (mean age = 62.2 years; 54% female), one fifth (n = 791) of whom had OH‐30.

MEASUREMENTS

Continuous orthostatic BP was measured during active stand. OH‐30 was defined as a drop in systolic BP of 20 mm Hg or more or drop in diastolic BP of 10 mm Hg or more at 30 seconds.

Spatiotemporal gait was assessed using the GAITRite system, reporting gait speed, step length, step width, and double support time in both single and dual (cognitive task) conditions.

RESULTS

OH‐30 was associated with slower gait speed (β = −3.01; 95% confidence interval [CI] = −4.46 to −1.56) and shorter step length (β = −.73; 95% CI = −1.29 to −.16) in fully adjusted models during single task walking. Similar findings were observed in dual task conditions, in addition to increased double support phase (β = .45; 95% CI = .02‐.88).

Multilevel models demonstrated that participants in the slowest tertile for gait speed had a significantly larger drop in systolic BP poststanding compared to those with faster gait speeds in single and dual task conditions.

CONCLUSIONS

This study demonstrates that slower recovery of BP after standing is independently associated with poorer gait performance in community‐dwelling older adults.

Given the adverse outcomes independently associated with OH and gait problems in later life, increasing awareness that they commonly coexist is important, particularly as both are potentially modifiable.

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Caregiver Needs Assessment in Primary Care: Views of Clinicians, Staff, Patients, and Caregivers - American Geriatric Society

OBJECTIVES

To understand current practices, challenges, and opportunities for a systematic assessment of family caregiversʼ needs and risks in primary care.

DESIGN

Qualitative study consisting of in‐depth semi‐structured interviews.

SETTING

Four primary care practices located in urban and rural settings.

PARTICIPANTS

Primary care clinicians, staff, and administrators (N = 30), as well as older adult patients and family caregivers (N = 40), recruited using purposive and maximum variation sampling.

MEASUREMENTS

Current experiences, challenges, and opportunities for integrating standardized caregiver assessment into primary care delivery. Interviews were audio‐recorded and transcribed; transcripts were analyzed using the constant comparative method of data analysis.

RESULTS

Participating clinicians had been in practice for an average of 12.8 years (range = 1‐36 y). Patients had a mean age of 84.0 years (standard deviation [SD] = 9.7); caregivers had a mean age of 67.0 years (SD = 9.3). There was wide variability in current practices for identifying caregiversʼ needs and risks, encompassing direct and indirect approaches, when such issues are considered. Participants posited that integrating standardized caregiver assessment into primary care delivery could help improve patient care, enhance clinician‐caregiver communication, and validate caregiversʼ efforts. Barriers to assessment included insufficient time and reimbursement, liability concerns, lack of awareness of community resources, and concerns about patient autonomy. To facilitate future uptake of caregiver assessment, participants recommended brief self‐administered assessment tools and post‐screen discussions with practice staff.

CONCLUSION

Identification of caregiversʼ needs and risks in primary care is highly variable. Integration of standardized caregiver assessment into practice requires coordinated changes to policy, revision of practice workflows, and an interdisciplinary approach to the development of appropriate assessment tools.

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Thyroid Function and Sarcopenia: Results from the ELSA‐Brasil Study - American Geriatric Society

OBJECTIVES

We aimed to investigate the association of subclinical thyroid disease and thyroid hormone levels with sarcopenia and its defining components in community‐dwelling middle‐aged and older adults without overt thyroid dysfunction.

DESIGN

Cross‐sectional study.

SETTING

Active and retired employees from public institutions located in six Brazilian cities.

PARTICIPANTS

A total of 6974 participants from the ELSA‐Brasil study's second wave, aged 50 years and older, without overt thyroid dysfunction and with complete data for exposure, outcome, and covariates.

METHODS

Serum levels of thyrotropin (TSH), free thyroxine, and free triiodothyronine (FT3) were measured and divided in quintiles for the analyses. Participants were classified with euthyroidism, subclinical hypothyroidism, and subclinical hyperthyroidism. Muscle mass was assessed by bioelectrical impedance analysis and muscle strength by handgrip strength. Sarcopenia was defined according to the Foundation for the National Institutes of Health criteria. Possible confounders included sociodemographic characteristics, clinical conditions, and lifestyle. Analyses were performed separately for middle‐aged and older adults (≥65 y).

RESULTS

The frequencies of sarcopenia, low muscle mass, low muscle strength, subclinical hypothyroidism, and subclinical hyperthyroidism were 1.5%, 20.8%, 3.8%, 9.1%, and .9%, respectively. Subclinical thyroid dysfunction was not associated with sarcopenia and its defining components. Among older adults, TSH had a U‐shaped association with sarcopenia and low muscle strength. The odds ratios (ORs) (95% confidence intervals [CIs]) for the associations of the first, second, fourth, and fifth quintile with sarcopenia, respectively, were 5.18 (1.47‐18.28), 6.28 (1.82‐21.73), 4.12 (1.15‐14.76), and 4.81 (1.35‐17.10), and with low muscle strength was (OR (95% CI) for the first, second, and fifth quintiles, respectively: 1.43 (1.16‐5.07), 2.07 (1.24‐4.70), and 2.18 (1.03‐4.60). Additionally, FT3 had a negative association with muscle mass in both age strata.

CONCLUSION

Subtle thyroid hormone alterations are associated with sarcopenia or its defining components in middle‐aged and older adults without overt thyroid dysfunction.

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Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Thermo Fisher - FDA Press Releases

Coronavirus (COVID-19) Update: FDA Issues EUA to Thermo Fisher

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Coronavirus (COVID-19) Update: FDA gives flexibility to New York State Department of Health, FDA issues Emergency Use Authorization diagnostic - FDA Press Releases

Coronavirus Update: FDA gives flexibility to New York State Department of Health, grants Roche EUA

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FDA Launches New Campaign to Help Consumers Use the New Nutrition Facts Label - FDA Press Releases

FDA has launched an initiative to help consumers use the new Nutrition Facts label that appears on packaged foods to maintain healthy dietary practices. The campaign has the tagline “What’s In It For You?”

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Stereochemical determination of four 10-membered ring resorcylic acid lactones from the desert plant endophytic fungus Chaetosphaeronema hispidulum - Journal of Antibiotics

The Journal of Antibiotics, Published online: 11 March 2020; doi:10.1038/s41429-020-0297-2

Stereochemical determination of four 10-membered ring resorcylic acid lactones from the desert plant endophytic fungus Chaetosphaeronema hispidulum

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Coronavirus Disease 2019 (COVID-19) Update: Foreign Inspections - FDA Press Releases

Coronavirus (COVID-19) Update: Foreign Inspections

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FDA Warns Retailers, Manufacturers to Remove Unauthorized E-Cigarette Products from Market - FDA Press Releases

FDA issued 22 warning letters to online & brick-and-mortar e-cigarette product retailers/manufacturers across the country who sell flavored, cartridge-based electronic nicotine delivery system products advising them that selling these products, which lack marketing authorization, is illegal.

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COVID‐19 Presents High Risk to Older Persons - American Geriatric Society

Journal of the American Geriatrics Society, Volume 0, Issue ja, -Not available-.

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Antibiotics in the clinical pipeline in October 2019 - Journal of Antibiotics

The Journal of Antibiotics, Published online: 10 March 2020; doi:10.1038/s41429-020-0291-8

Antibiotics in the clinical pipeline in October 2019

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FDA Approves First Treatment for Group of Progressive Interstitial Lung Diseases - FDA Press Releases

The FDA approves treatment for patients with chronic fibrosing (scarring) interstitial lung diseases (ILD) with a progressive phenotype (trait).

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When Iʼm 84: What Should Life Look Like in Old Age? - American Geriatric Society

Housing and the built environment are well‐established social determinants of healthy longevity, yet no guidelines or standards exist for the design and construction of health‐promoting environments, especially for older adults who are at risk for functional decline and frailty. To envision what should be included in the design of healthy communities, it may help to reverse‐engineer what each of us would like our lives to look like in old age. In this special article, a geriatrician draws on his own personal aspirations and successful models of supportive community‐based programs to suggest key factors that should be considered in the design of future living environments. These include healthy housing that can enable aging in place without social isolation and loneliness; engagement in meaningful and productive work; financial, physical, transportation, food, and housing security; and affordable high‐quality home‐ and community‐based healthcare. By conceptualizing what we would like our later years to look like, future leaders can be more deliberate in creating living environments that promote a long and productive health span.

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Exceptional Siblings: The Andrade Brothers - American Geriatric Society

Journal of the American Geriatrics Society, EarlyView.

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Sarcopenia Definition: The Position Statements of the Sarcopenia Definition and Outcomes Consortium - American Geriatric Society

OBJECTIVES

To develop an evidence‐based definition of sarcopenia that can facilitate identification of older adults at risk for clinically relevant outcomes (eg, self‐reported mobility limitation, falls, fractures, and mortality), the Sarcopenia Definition and Outcomes Consortium (SDOC) crafted a set of position statements informed by a literature review and SDOC's analyses of eight epidemiologic studies, six randomized clinical trials, four cohort studies of special populations, and two nationally representative population‐based studies.

METHODS

Thirteen position statements related to the putative components of a sarcopenia definition, informed by the SDOC analyses and literature synthesis, were reviewed by an independent international expert panel (panel) iteratively and voted on by the panel during the Sarcopenia Position Statement Conference. Four position statements related to grip strength, three to lean mass derived from dual‐energy x‐ray absorptiometry (DXA), and four to gait speed; two were summary statements.

RESULTS

The SDOC analyses identified grip strength, either absolute or scaled to measures of body size, as an important discriminator of slowness. Both low grip strength and low usual gait speed independently predicted falls, self‐reported mobility limitation, hip fractures, and mortality in community‐dwelling older adults. Lean mass measured by DXA was not associated with incident adverse health‐related outcomes in community‐dwelling older adults with or without adjustment for body size.

CONCLUSION

The panel agreed that both weakness defined by low grip strength and slowness defined by low usual gait speed should be included in the definition of sarcopenia. These position statements offer a rational basis for an evidence‐based definition of sarcopenia. The analyses that informed these position statements are summarized in this article and discussed in accompanying articles in this issue of the journal.

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FDA Proposes Broad Approach for Conducting Safety Trials for Type 2 Diabetes Medications - FDA Press Releases

FDA released new draft guidance to solicit public comment on proposals for broader safety evaluations of new therapies to treat type 2 diabetes that look beyond ischemic cardiovascular disease and the inclusion of a broader scope of human subjects.

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Coronavirus Update: FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19 - FDA Press Releases

The FDA and the FTC issued warning letters to seven companies for selling fraudulent COVID-19 products.

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Deciphering colistin heteroresistance in Acinetobacter baumannii clinical isolates from Wenzhou, China - Journal of Antibiotics

The Journal of Antibiotics, Published online: 09 March 2020; doi:10.1038/s41429-020-0289-2

Deciphering colistin heteroresistance in Acinetobacter baumannii clinical isolates from Wenzhou, China

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Improvement of the novel inhibitor for Mycobacterium enoyl-acyl carrier protein reductase (InhA): a structure–activity relationship study of KES4 assisted by in silico structure-based drug screening - Journal of Antibiotics

The Journal of Antibiotics, Published online: 09 March 2020; doi:10.1038/s41429-020-0293-6

Improvement of the novel inhibitor for Mycobacterium enoyl-acyl carrier protein reductase (InhA): a structure–activity relationship study of KES4 assisted by in silico structure-based drug screening

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“iADL”: The New IADL? - American Geriatric Society

Journal of the American Geriatrics Society, EarlyView.

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FDA Approves New Treatment for Adults with Cushing’s Disease - FDA Press Releases

FDA approved a new treatment for adults with Cushing’s disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease.

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Dietary Fat Composition and Frailty in Oldest‐Old Men - American Geriatric Society

Journal of the American Geriatrics Society, EarlyView.

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Prevalence and Severity of Traumatic Intracranial Hemorrhage in Older Adults with Low‐Energy Falls - American Geriatric Society

BACKGROUND/OBJECTIVES

To determine the prevalence and severity of traumatic intracranial hemorrhage (tICH) in a large cohort of older adults presenting with low‐energy falls and the association with anticoagulation or antiplatelet medication.

DESIGN

Bicentric retrospective cohort analysis.

SETTING

Two level 1 trauma centers in Switzerland and Germany.

PARTICIPANTS

Consecutive sample of older adults (aged ≥65 y) presenting to the emergency department (ED) over a 1‐year period with low‐energy falls who received cranial computed tomography (cCT) within 48 hours of ED presentation.

MEASUREMENTS

The prevalence and severity of tICHs was assessed and the outcomes (in‐hospital mortality, admission to intensive care unit [ICU], or neurosurgical intervention) were specified. We used multivariate regression models to measure the association between anticoagulation/antiplatelet therapy and the risk for tICH after adjustment for known predictors.

RESULTS

The overall prevalence for tICH detected by cCT was 176 of 2567 (6.9%). Neurosurgical intervention was performed in 15 of 176 (8.5%) patients with tICH, 28 of 176 (15.9%) patients were admitted to the ICU, and 14 of 176 (8.0%) died in the hospital. CT‐detected skull fracture and signs of injury above the clavicles were the strongest predictors for the presence of tICH (odds ratio [OR] = 4.28; 95% confidence interval [CI] = 2.79‐6.51; OR = 1.88; 95% CI = 1.3‐2.73, respectively). Among 2567 included patients, 1424 (55%) were on anticoagulation/antiplatelet therapy. Multivariate regression models showed no differences for the risk of tICH (OR = 1.05; 95% CI = .76‐1.47; P = .76) or association with the head‐specific Injury Severity Scale (incident rate ratio = 1.08; 95% CI = .97‐1.19; P = .15) with or without anticoagulation/antiplatelet therapy.

CONCLUSION

Medication with anticoagulants or antiplatelet agents was not associated with higher prevalence and severity of tICH in older patients with low‐energy falls undergoing cCT examination. In addition to cCT‐detected skull fractures, visible injuries above the clavicles were the strongest clinical predictors for tICH. Our findings merit prospective validation.

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Intracranial Hemorrhage in Older Adults: Implications for Fall Risk Assessment and Prevention - American Geriatric Society

Journal of the American Geriatrics Society, EarlyView.

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Adverse Drug Events in Older Adults: Review of Adjudication Methods in Deprescribing Studies - American Geriatric Society

OBJECTIVES

Polypharmacy is common in older adults and associated with adverse drug events (ADEs). Several methods have been described in studies to help correlate ADE causation. We performed a narrative review to identify methods for ADE adjudication. We compared their strengths and limitations to assess their applicability to deprescribing studies (of which clinical trials are a subset) and to encourage the use of a standardized method in future studies.

DESIGN

We performed a review of original articles (1946‐2019) using the Medline (Ovid) and Cochrane databases. We also conducted a manual reference search of review articles. Abstracts were screened for relevance.

MEASUREMENTS

Adjudication methods were compared for advantages and limitations including validity, ease of use, and applicability to clinical trials with deprescribing as the primary intervention.

RESULTS

The search yielded 1881 articles of which 175 articles were included for full‐text review. Following in‐depth review, 135 were excluded: 79 had no ADE outcome data, 35 were not specific to older adults, 9 were not relevant, 6 were review articles, 5 contained duplicate data, and 1 was not written in French or English. Forty articles remained for analysis, from which we identified 10 unique ADE adjudication methods. No method was developed originally for use in a deprescribing setting.

CONCLUSION

A standard method to identify ADEs is important to capture the outcome reliably in deprescribing studies. All methods we identified had limitations in terms of capturing adverse events from the withdrawal of medications. Future work should focus on refining adjudication methods for capturing ADEs related not only to medication continuation and new drug starts but also to deprescribing and drug discontinuation.

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Clonocoprogens A, B and C, new antimalarial coprogens from the Okinawan fungus Clonostachys compactiuscula FKR-0021 - Journal of Antibiotics

The Journal of Antibiotics, Published online: 06 March 2020; doi:10.1038/s41429-020-0292-7

Clonocoprogens A, B and C, new antimalarial coprogens from the Okinawan fungus Clonostachys compactiuscula FKR-0021

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FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity - FDA Press Releases

FDA is providing updates on its efforts on the evaluation of cannabidiol products, including in areas of education, research and enforcement with the goal of continuing to protect public health and working to provide market clarity.

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Clinical and Epidemiological Characteristics of Diabetic Ketoacidosis in Older Adults - American Geriatric Society

OBJECTIVES

Much of the research previously done on diabetic ketoacidosis (DKA) was based on a young population with type 1 diabetes mellitus (type 1 DM). But substantial numbers of DKA episodes occur in patients with a prior history of type 2 diabetes mellitus (type 2 DM). There is a lack of Data are lacking about DKA in older adults. The aims of this study were to analyze the clinical characteristics and outcomes of older adult patients with DKA.

DESIGN

Retrospective matched cohort study of adult patients hospitalized with DKA between 2004 and 2017.

SETTING

Soroka University Medical Center, Be'er Sheva, Israel.

PARTICIPANTS

The clinical characteristics of DKA patients 65 years and older were compared with patients younger than 65 years.

MEASUREMENTS

The primary outcome was in‐hospital mortality.

RESULTS

The study cohort included 385 consecutive patients for whom the admission diagnosis was DKA: 307 patients (79.7%) younger than 65 years (group 1), and 78 patients (20.3%) older than 65 years (group 2). Patients in group 2 compared with group 1 had a significantly higher Charlson index (6 [6–6] vs 6 [6–7]; P < .0001) and DM with target organ damage (24.4% vs 6.2%; P < .0001). Patients in group 2 compared with group 1 had more serious disease according to results of laboratory investigations. The total in‐hospital mortality rate of patients in group 2 was 16.7% compared with 1.6% in patients in group 1 in a sex and co‐morbidities matched analysis (P = .001).

CONCLUSIONS

DKA in older adults is a common problem. The serious co‐morbidities and precipitating factors such as infection/sepsis, myocardial infarction, and cerebrovascular accidents, may explain the severity of the problem of DKA in older adults and the high rate of mortality of these patients. DKA appears to be a lifethreatening condition in older adults. The alertness of physicians to DKA in older adults, timely diagnosis, proper treatment, and prevention are cornerstones of care.

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Streptomyces acidicola sp. nov., isolated from a peat swamp forest in Thailand - Journal of Antibiotics

The Journal of Antibiotics, Published online: 05 March 2020; doi:10.1038/s41429-020-0294-5

Streptomyces acidicola sp. nov., isolated from a peat swamp forest in Thailand

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Induction of secondary metabolite production by hygromycin B and identification of the 1233A biosynthetic gene cluster with a self-resistance gene - Journal of Antibiotics

The Journal of Antibiotics, Published online: 05 March 2020; doi:10.1038/s41429-020-0295-4

Induction of secondary metabolite production by hygromycin B and identification of the 1233A biosynthetic gene cluster with a self-resistance gene

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Courses and Conferences - American Geriatric Society

Journal of the American Geriatrics Society, Volume 68, Issue 3, Page 673-674, March 2020.

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Intensive vs Standard Blood Pressure Control in Adults 80 Years or Older: A Secondary Analysis of the Systolic Blood Pressure Intervention Trial - American Geriatric Society

OBJECTIVES

To evaluate the effect of intensive systolic blood pressure (SBP) control in older adults with hypertension, considering cognitive and physical function.

DESIGN

Secondary analysis.

SETTING

Systolic Blood Pressure Intervention Trial (SPRINT)

PARTICIPANTS

Adults 80 years or older.

INTERVENTION

Participants with hypertension but without diabetes (N = 1167) were randomized to an SBP target below 120 mm Hg (intensive treatment) vs a target below 140 mm Hg (standard treatment).

MEASUREMENTS

We measured the incidence of cardiovascular disease (CVD), mortality, changes in renal function, mild cognitive impairment (MCI), probable dementia, and serious adverse events. Gait speed was assessed via a 4‐m walk test, and the Montreal Cognitive Assessment (MoCA) was used to quantify baseline cognitive function.

RESULTS

Intensive treatment led to significant reductions in cardiovascular events (hazard ratio [HR] = .66; 95% confidence interval [CI] = .49‐.90), mortality (HR = .67; 95% CI = .48‐.93), and MCI (HR = .70; 95% CI = .51‐.96). There was a significant interaction (P < .001) whereby participants with higher baseline scores on the MoCA derived strong benefit from intensive treatment for a composite of CVD and mortality (HR = .40; 95% CI = .28‐.57), with no appreciable benefit in participants with lower scores on the MoCA (HR = 1.33 = 95% CI = .87‐2.03). There was no evidence of heterogeneity of treatment effects with respect to gait speed. Rates of acute kidney injury and declines of at least 30% in estimated glomerular filtration rate were increased in the intensive treatment group with no between‐group differences in the rate of injurious falls.

CONCLUSION

In adults aged 80 years or older, intensive SBP control lowers the risk of major cardiovascular events, MCI, and death, with increased risk of changes to kidney function. The cardiovascular and mortality benefits of intensive SBP control may not extend to older adults with lower baseline cognitive function.

Trial Registration

Clinicaltrials.gov identifier: NCT01206062. J Am Geriatr Soc 68:496–504, 2020

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Impact of Baseline Fatigue on a Physical Activity Intervention to Prevent Mobility Disability - American Geriatric Society

OBJECTIVES

Our aim was to examine the impacts of baseline fatigue on the effectiveness of a physical activity (PA) intervention to prevent major mobility disability (MMD) and persistent major mobility disability (PMMD) in participants from the Lifestyle Interventions and Independence for Elders (LIFE) study.

DESIGN

Prospective cohort of individuals aged 65 years or older undergoing structured PA intervention or health education (HE) for a mean of 2.6 years.

SETTING

LIFE was a multicenter eight‐site randomized trial that compared the efficacy of a structured PA intervention with an HE program in reducing the incidence of MMD.

PARTICIPANTS

Study participants (N = 1591) at baseline were 78.9 ± 5.2 years of age, with low PA and at risk for mobility impairment.

MEASUREMENTS

Self‐reported fatigue was assessed using the modified trait version of the Exercise‐Induced Feelings Inventory, a six‐question scale rating energy levels in the past week. Responses ranged from 0 (none of the time) to 5 (all of the time). Total score was calculated by averaging across questions; baseline fatigue was based on the median split: 2 or higher = more fatigue (N = 856) and lower than 2 = less fatigue (N = 735). Participants performed a usual‐paced 400‐m walk every 6 months. We defined incident MMD as the inability to walk 400‐m at follow‐up visits; PMMD was defined as two consecutive walk failures. Cox proportional hazard models quantified the risk of MMD and PMMD in PA vs HE stratified by baseline fatigue adjusted for covariates.

RESULTS

Among those with higher baseline fatigue, PA participants had a 29% and 40% lower risk of MMD and PMMD, respectively, over the trial compared with HE (hazard ratio [HR] for MMD = .71; 95% confidence interval [CI] = .57‐.90; P = .004) and PMMD (HR = .60; 95% CI = .44‐.82; P = .001). For those with lower baseline fatigue, no group differences in MMD (P = .36) or PMMD (P = .82) were found. Results of baseline fatigue by intervention interaction was MMD (P = .18) and PMMD (P = .05).

CONCLUSION

A long‐term moderate intensity PA intervention was particularly effective at preserving mobility in older adults with higher levels of baseline fatigue. J Am Geriatr Soc 68:619–624, 2020

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The Risk of Head Injuries Associated With Antipsychotic Use Among Persons With Alzheimer's disease - American Geriatric Society

BACKGROUND/OBJECTIVES

Antipsychotic use is associated with risk of falls among older persons, but we are not aware of previous studies investigating risk of head injuries. We studied the association of antipsychotic use and risk of head injuries among community dwellers with Alzheimer's disease (AD).

DESIGN

Nationwide register‐based cohort study.

SETTING

Medication Use and Alzheimer's Disease (MEDALZ) cohort, Finland.

PARTICIPANTS

The MEDALZ cohort includes Finnish community dwellers who received clinically verified AD diagnosis in 2005 to 2011. Incident antipsychotic users were identified from the Prescription Register and matched with nonusers by age, sex, and time since AD diagnosis (21 795 matched pairs). Persons with prior head injury or history of schizophrenia were excluded.

MEASUREMENTS

Outcomes were incident head injuries (International Classification of Diseases, Tenth Revision [ICD‐10] codes S00‐S09) and traumatic brain injuries (TBIs; ICD‐10 codes S06.0‐S06.9) resulting in a hospital admission (Hospital Discharge Register) or death (Causes of Death Register). Inverse probability of treatment (IPT) weighted Cox proportional hazard models were used to assess relative risks.

RESULTS

Antipsychotic use was associated with an increased risk of head injuries (event rate per 100 person‐years = 1.65 [95% confidence interval {CI} = 1.50‐1.81] for users and 1.26 [95% CI = 1.16‐1.37] for nonusers; IPT‐weighted hazard ratio [HR] = 1.29 [95% CI = 1.14‐1.47]) and TBIs (event rate per 100 person‐years = 0.90 [95% CI = 0.79‐1.02] for users and 0.72 [95% CI = 0.65‐0.81] for nonusers; IPT‐weighted HR = 1.22 [95% CI = 1.03‐1.45]). Quetiapine users had higher risk of TBIs (IPT‐weighted HR = 1.60 [95% CI = 1.15‐2.22]) in comparison to risperidone users.

CONCLUSIONS

These findings imply that in addition to previously reported adverse events and effects, antipsychotic use may increase the risk of head injuries and TBIs in persons with AD. Therefore, their use should be restricted to most severe neuropsychiatric symptoms, as recommended by the AGS Beers Criteria®. Additionally, higher relative risk of TBIs in quetiapine users compared to risperidone users should be confirmed in further studies. J Am Geriatr Soc 68:595–602, 2020

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