Statement from Acting FDA Commissioner Ned Sharpless, M.D., and Deputy Commissioner Frank Yiannas on steps to usher the U.S. into a new era of smarter food safety - FDA Press Releases

FDA announces steps to usher the U.S. into a new era of smarter food safety

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FDA permits sale of IQOS Tobacco Heating System through premarket tobacco product application pathway - FDA Press Releases

FDA has authorized the marketing of new tobacco products manufactured by Phillip Morris Products S.A. for the IQOS “Tobacco Heating System.”

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FDA approves first treatment for all genotypes of hepatitis C in pediatric patients - FDA Press Releases

FDA approved Mavyret (glecaprevir and pibrentasvir) tablets to treat all six genotypes of hepatitis C virus (HCV) in children ages 12 to 17.

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FDA requires stronger warnings about rare but serious incidents related to certain prescription insomnia medicines - FDA Press Releases

FDA requires stronger warnings about rare but serious incidents related to certain prescription insomnia medicines - eszopiclone, zaleplon and zolpidem

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Statement from FDA Commissioner Scott Gottlieb, M.D. on new programs to promote the adoption of innovations in drug manufacturing that can improve quality and lower drug costs - FDA Press Releases

FDA announces programs to promote adoption of innovations in drug manufacturing

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FDA statement on approval of OTC Primatene Mist to treat mild asthma - FDA Press Releases

FDA approves new version of OTC Primatene Mist inhaler to treat mild, intermittent asthma for people who have been diagnosed with asthma by their physician

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FDA statement on FDA’s modern approach to advanced pharmaceutical manufacturing - FDA Press Releases

FDA issues information to industry on advanced pharmaceutical manufacturing

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FDA Statement on the FDA’s ongoing investigation into valsartan and ARB class impurities and the agency’s steps to address the root causes of the safety issues - FDA Press Releases

FDA describes the ongoing investigation into the ARB class impurities and agency’s steps to address the root causes of the safety issues

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La FDA emprende una campaña de educación ciudadana para instar a la eliminación segura de los analgésicos opiáceos sin usar del hogar - FDA Press Releases

La campaña “Elimine el Riesgo“ va dirigida a mujeres de entre 35 y 64 años de edad, quienes son las más proclives a participar en las decisiones de salud en el hogar, y con frecuencia son las que controlan el acceso de los opioides y otros medicamentos de prescripción médica en el hogar.

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FDA Statement on the agency’s list of known nitrosamine-free valsartan and ARB class medicines, as part of agency’s ongoing efforts to resolve ongoing safety issue - FDA Press Releases

FDA announces list of nitrosamine-free ARB medications confirmed by the agency to help patients and healthcare providers

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Feasibility of an Intervention to Support Hearing and Vision in Dementia: The SENSE‐Cog Field Trial - American Geriatric Society

Objectives

People with dementia (PwD) frequently experience hearing and vision impairment that is underrecognized and undertreated, resulting in reduced quality of life. Managing these impairments may be an important strategy to improve outcomes in PwD. Our objective was to field‐trial a multifaceted sensory intervention (SI) to enhance hearing and vision in PwD.

Design

An international single‐arm open‐label feasibility, acceptability, and tolerability study.

Setting

Home‐based setting in the United Kingdom, France, and Cyprus.

Participants

Adults aged 60 years and older with mild‐to‐moderate dementia and uncorrected or suboptimally corrected hearing and/or vision impairment, and their study partners (n = 19 dyads).

Intervention

A sensory intervention (SI), comprising assessment of hearing and vision, fitting of corrective devices (glasses, hearing aids), and home‐based support from a sensory support therapist for device adherence and maintenance, communication training, referral to support services, environmental sensory modification, and optimization of social inclusion.

Measurements

Ratings of study procedure feasibility, and intervention acceptability/tolerability, ascertained through questionnaires, participant diaries, therapist logbooks, and semistructured interviews.

Results

We successfully delivered all intervention components, and these were received and enacted as intended in all those who completed the intervention. No serious adverse events were reported. Acceptability (ie, understanding, motivation, sense of achievement) and tolerability (ie, effort, fatigue) ratings of the intervention were within a priori target ranges. We met recruitment and retention (93.8%) targets in two of the three sites. Participants completed more than 95% of diary entries, representing minimal missing data. Delays in the logistics circuit for the assessment and delivery of hearing aids and glasses were identified, requiring modification. The need for minor modifications to some outcome measures and the inclusion criteria were identified.

Conclusion

This is the first study combining home‐based hearing and vision remediation in PwD. The positive feasibility, acceptability, and tolerability findings suggest that a full‐scale efficacy trial, with certain modifications, is achievable.

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Spills of Age - American Geriatric Society

Journal of the American Geriatrics Society, Volume 67, Issue 5, Page 1096-1096, May 2019.

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Assessing the Scope and Appropriateness of Prescribing Cascades - American Geriatric Society

As originally defined, the term “prescribing cascade” describes a sequence of events that begins when an adverse drug event (ADE) occurs, is misinterpreted as a new medical condition, and a subsequent drug is then inadvertently prescribed to treat the new condition. We refine the definition to encompass both recognized and unrecognized ADEs because they can both contribute to problematic prescribing practices. In addition, we discuss that although prescribing cascades are most commonly viewed as problematic, they may be appropriate and therapeutically beneficial in certain clinical situations. We differentiate between appropriate and problematic prescribing cascades by adopting a similar approach to the framework proposed in the highly acclaimed King's Fund report Polypharmacy and Medicines Optimization. Practical considerations are also presented to aid clinicians in preventing the propagation of problematic prescribing cascades within their clinical practice. Providing new perspectives on the scope and appropriateness of the prescribing cascade concept is an important step in describing clinically relevant cascades and in encouraging safe prescribing practices. J Am Geriatr Soc 67:1023–1026, 2019.

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An Assessment of Oral Health Training Among Geriatric Fellowship Programs: A National Survey - American Geriatric Society

Oral health (OH) has profound effects on the overall health of elderly people. While oral disease is prevalent in the geriatric population and access to care is a major issue, it is unclear the extent of OH training among US geriatric fellowship programs. A 19‐item electronic survey was sent to all 148 accredited geriatric fellowship training programs via the Association of Directors of Geriatric Medicine. Directors were asked about hours of trainings, barriers, and evaluation of trainees among other topics. Univariate and bivariate analyses were performed. Seventy‐five directors completed the survey (51% response rate). Sixty‐three percent (46/73) report their fellows receive 1 to 2 hours of OH instruction (ie, lectures, workshops) during their training. Almost a quarter (23%; 17/73) reported 0 hours of OH content. Only 17% (13/75) have clinical experiences in a dental setting. Barriers to more OH education include competing priorities or lack of time (57%; 43/75), lack of faculty expertise (55%; 41/75), and no clear geriatric national educational competencies (44%; 33/75). Programs with an OH champion or dental school/residency affiliation had more hours of OH instruction. Geriatric fellowships appear to need more OH training, which could be achieved by creating OH champions and connecting fellowships with dental schools/residencies. Barriers could be overcome by exposing fellowships to existing resources and creating national competencies. J Am Geriatr Soc 67:1079–1084, 2019.

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Older Adults with Cancer: A Randomized Controlled Trial of Occupational and Physical Therapy - American Geriatric Society

OBJECTIVES

The impact of occupational therapy (OT) and physical therapy (PT) on functional outcomes in older adults with cancer is unknown.

DESIGN

Two‐arm single‐institution randomized controlled trial of outpatient OT/PT.

SETTING

Comprehensive cancer center with two off‐site OT/PT clinics.

PARTICIPANTS

We recruited adults 65 years and older with a recent diagnosis or recurrence of cancer within 5 years, with at least one functional limitation as identified by a geriatric assessment. Participants were randomized to OT/PT or usual care.

INTERVENTION

Rehabilitation consisted of individualized OT and PT that addressed functional activities and strength/endurance needs.

MEASUREMENTS

Primary outcome was functional status as measured by the Nottingham Extended Activities of Daily Living scale. Secondary outcomes were Patient‐Reported Outcomes Measurement Information System‐Global Mental Health (GMH) and Global Physical Health (GPH), ability to participate in Social Roles (SR), physical function, and activity expectations and self‐efficacy (Possibilities for Activity Scale [PActS]).

RESULTS

Among those recruited (N = 63), only 45 patients (71%) were evaluable due to loss of follow‐up and/or nonreceipt of intervention. The median age was 74 years; 53% were female, and 91% were white. Overall, 30% patients had hematologic malignancies, 30% breast cancer, and 16% colorectal cancers. A total of 65% were in active treatment; 49% had stage 3 or 4 disease. At follow‐up, both OT/PT (P = .02) and usual care (P = .03) groups experienced a decline in functional status. PActS scores between groups (P = .04) was significantly improved in the intervention group. GMH and SR met criteria for minimally important clinical difference favoring the intervention, but not statistical significance. Several barriers were noted in the implementation of the intervention program: recruitment, concerns about cost, distance, scheduling, and limited treatment provided.

CONCLUSION

OT/PT may positively influence activity expectations and self‐efficacy. Future research needs to address significant barriers to implementation to increase use of OT/PT services and access to quality care. J Am Geriatr Soc 67:953–960, 2019.

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Lessons Learned from Arti—Collaborating to Improve Care: the Past, Present, and Future of the Cancer and Aging Research Group - American Geriatric Society

Dr Arti Hurria, who died tragically in November 2018, was a driving force in the growing field of geriatric oncology. She led the field through her commitment to her goals, collaboration with her colleagues, and the creation of the Cancer and Aging Research Group (CARG). As two of her closest colleagues, we are carrying her work forward with our colleagues through an infrastructure grant we led with Arti from the National Institute on Aging (R21/33; CARinG). This grant will provide a national structure for continuing to build the field through research, mentorship, and dissemination. We miss our friend dearly but are committed to carrying her legacy forward through CARG. J Am Geriatr Soc 67:879–883, 2019.

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Vitamin D and Falls in Older African American Women: The PODA Randomized Clinical Trial - American Geriatric Society

Background

Limited information is available on the influence of vitamin D on falls in older high‐functioning black American women. Endocrine Society guidelines propose serum 25(OH)D levels over 30 ng/mL.

Objective

To determine if maintenance of serum 25(OH)D above 30 ng/mL protects against falls.

Design

The Physical Performance, Osteoporosis and Vitamin D in African American Women (PODA) trial had a prospective, randomized, placebo‐controlled, double‐dummy design with two arms: one with placebo and one with vitamin D₃ adjusted to maintain serum 25(OH)D above 30 ng/mL. The primary outcomes were the prevention of bone loss and the decline in physical performance.

Patients

The target population was healthy black women older than 60 years with serum 25(OH)D between 8 and 26 ng/mL. The trial was 3 years in duration with a falls questionnaire administered every 3 months. A total of 260 women entered the study, and 184 completed the 3 years. Mean age was 68.2 years.

Setting

Research center in an academic health center.

Main Outcomes Measure

Prevention of falls.

Intervention

Participants were randomly assigned to placebo or active vitamin D. Vitamin D₃ dose was adjusted to maintain serum 25(OH)D above 30 ng/mL in the active group using a double‐dummy design.

Results

Baseline 25(OH)D was 22 ng/mL. Mean serum 25(OH)D reached 47 ng/mL in the active group compared with 21 ng/mL in the placebo group. There were 14.2% falls in the previous year recalled at baseline. During the study, 46% reported falling in the treatment group compared with 47% in the placebo group. There was no association of serum 25(OH)D or vitamin D dose with the risk of falling.

Conclusions

There is no benefit of maintaining serum 25(OH)D above 30 ng/mL compared with the Institute of Medicine recommendation (20 ng/mL) in preventing falls in healthy older black American women. J Am Geriatr Soc 67:1043–1049, 2019.

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Function, Survival, and Care Utilization Among Older Adults With Hematologic Malignancies - American Geriatric Society

BACKGROUND/OBJECTIVES

Cancer‐focused organizations now recommend routine assessment of instrumental activities of daily living (iADLs) for all older patients with cancer, along with assessment of basic activities of daily living (ADLs) if possible. However, little is known regarding the role of iADLs in predicting survival and acute‐care utilization in populations of older adults with different hematologic malignancies.

DESIGN

Prospective cohort study.

SETTING AND PARTICIPANTS

A screening geriatric assessment was conducted for adults 75 years and older with hematologic malignancies (n = 464) presenting for initial consultation at a large tertiary cancer hospital in Boston, MA.

MEASUREMENTS

Univariable and multivariable analyses assessed the association of dependency in ADLs and dependency in iADLs with survival and care utilization (emergency department [ED] visits and unplanned hospitalizations).

RESULTS

Subjects were a mean age of 79.7 years and had a mean follow‐up of 13.8 months. Overall, 11.4% had dependency in ADLs and 26.7% had dependency in iADLs. Only iADL dependency was associated with higher mortality (hazard ratio = 2.34 [95% confidence interval [CI] = 1.46‐3.74]) independently of age, comorbidity, cancer aggressiveness, and treatment intensity. The effect was dose dependent, and impairments in shopping, meal preparation, and housework were all independently associated with a higher hazard of death. iADL dependency was also associated with higher odds of ED visits (odds ratio [OR] = 2.76 [95% CI = 1.30‐5.84]) and hospitalizations (OR = 2.89 [95% CI = 1.37‐6.09]). Several geriatric domain impairments, including probable cognitive impairment and physical dysfunction, were associated with iADL dependency.

CONCLUSION

These findings suggest that older adults with hematologic malignancies and iADL dependency experience higher mortality and acute‐care utilization, arguing that iADLs should be formally assessed as part of routine oncology care. J Am Geriatr Soc 67:889–897, 2019.

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Heterogeneity in the Health and Functional Capacity of Adults Aged 85+ as Risk for Mortality - American Geriatric Society

OBJECTIVES

To examine whether older adults aged 85+, with different health and functional capacities, cluster in different ways and to demonstrate whether individuals within particular clusters report differential mortality risk.

DESIGN

Retrospective cohort study.

SETTING

The Dynamic Analyses to Optimize Aging (DYNOPTA) project is a harmonization project of nine Australian longitudinal surveys of health and well‐being in adults aged 50+ between 1991 and 2006.

PARTICIPANTS

Participants were 685 older adults (female = 52%) living in the community and aged 85 to 103 at baseline who were followed until death or December 31, 2006, for survivors.

MEASUREMENT

Latent class analysis (LCA) analyzed self‐reported information on physical health, mental health, and functional capacity to define homogeneous classes based on probable cognitive impairment and depression status, medical conditions, and number of activities of daily living and instrumental activities of daily living.

RESULTS

LCA discriminated four classes reflecting two main survival patterns. Two classes reported half the median survival days; differences between these classes were related to high vs moderate depression and extent of functional limitations. Two classes reported better survival; differences between these classes were related to functional limitations, but both had low proportions with depression and dementia. The classes with shorter survival were associated with substantively higher rates of depression and dementia.

CONCLUSION

Higher rates of baseline depression and dementia were unique characteristics of those individuals in the clusters that reported shorter survival. However, a substantial proportion of very old adults experience good mental health with better survival outcomes. J Am Geriatr Soc 67:1036–1042, 2019.

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Pharmacological Management of Delirium in the Intensive Care Unit: A Randomized Pragmatic Clinical Trial - American Geriatric Society

BACKGROUND/OBJECTIVE

Delirium in the intensive care units (ICUs) is prevalent, with both delirium duration and delirium severity associated with adverse outcomes. We designed a pragmatic trial to test the efficacy of a pharmacological management of delirium (PMD) bundle in improving delirium/coma‐free days and reducing delirium severity among ICU patients.

DESIGN

A randomized pragmatic clinical trial.

SETTING

Medical, surgical, and progressive ICUs of three tertiary care hospitals.

PARTICIPANTS

A total of 351 critically ill patients.

INTERVENTION

A multicomponent PMD bundle consisting of reducing the exposure to 20 definite anticholinergic medications and benzodiazepines and prescribing low‐dose haloperidol.

MEASUREMENTS

The primary outcomes were delirium/coma‐free days, measured through the Richmond Agitation‐Sedation Scale and the Confusion Assessment Method for the ICU (CAM‐ICU), and delirium severity, measured through Delirium Rating Scale‐Revised‐98 and the CAM‐ICU‐7. Secondary outcomes were in‐hospital and posthospital discharge 30‐day mortality, ICU and hospital lengths of stay, and delirium‐related hospital complications.

RESULTS

We randomized 351 critically ill delirious patients (mean age = 59.3 years [SD = 16.9 years]; 52% female, 42% African Americans) to receive the PMD bundle or usual care. There were no significant differences in median delirium/coma‐free days at day 8 (PMD vs usual care = 4 [interquartile range {IQR} = 2‐7] days vs 5 [IQR = 1–7] days; P = .888) or at day 30 (PMD vs usual care = 26 [IQR 19‐29] days vs 26 [IQR, 14–29] days; P = .991). There were no significant differences for decrease in delirium severity at day 8, but at hospital discharge, the intervention group showed a greater reduction in delirium severity (mean decrease in CAM‐ICU‐7 score for PMD vs usual care = 3.2 [SD = 3.3] vs 2.5 [SD = 3.2]; P = .046). No differences were observed between groups for ICU and hospital lengths of stay, mortality, and delirium‐related hospital complications. Similar results were observed when analyses were limited to patients 65 years or older and 75 years or older.

CONCLUSION AND RELEVANCE

Implementing the PMD bundle in the ICU did not reduce delirium duration or severity among critically ill patients.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00842608. J Am Geriatr Soc 67:1057–1065, 2019.

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Do Differences in Spatiotemporal Gait Parameters Predict the Risk of Developing Depression in Later Life? - American Geriatric Society

Background/Objectives

There is growing interest in the association between gait disturbance and depression in later life. The aim of this study is to clarify the longitudinal relationship between specific gait parameters and incident depression within a population‐representative sample of older people.

Design

Longitudinal analysis of spatiotemporal gait parameters at baseline (wave 1) and incident depression at 2 and 4 years (waves 2/3). Logistic regression models were used to assess the relationship between tertiles of gait parameters and incident depression.

Setting

The Irish Longitudinal Study on Aging.

Participants

Over 3600 nondepressed community‐dwelling people aged 50 years or older.

Measurements

A score of 9 or greater on the eight‐item Center for Epidemiological Studies Depression Scale at wave 2 or 3 was indicative of incident depression. The GAITRite system was used to measure gait speed, step length, step width, and double support phase during usual speed walking and under dual task conditions.

Results

Participants with incident depression (344/3615) had slower gait speed (129.9 [95% confidence interval {CI} = 127.2‐132.6] cm/s vs 134.1 [95% CI = 133.0‐135.1] cm/s; F = 8.82; P = .003) and shorter step length (68.0 [95% CI = 66.9‐69.2] cm vs 70.3 [95% CI = 69.9‐70.7] cm; F = 13.99; P < .001) at baseline than those who did not develop depression. Logistic regression models demonstrated that those within the slowest tertile for gait speed and shortest tertile for step length had significantly increased likelihood of incident depression in fully adjusted models, with odds ratios of 1.54 (95% CI = 1.08‐2.19) and 1.54 (95% CI = 1.01‐2.35), respectively. Measures of step width and double support time were not associated with depression.

Conclusions

This study demonstrates that older people with incident depression have significantly slower gait speed and shorter step length at initial assessment. These findings are clinically significant given the impact both conditions have on functional status in later life, as well as the possibility that gait problems may represent a potentially modifiable risk factor for depression. J Am Geriatr Soc 67:1050–1056, 2019.

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Treatment Modalities and Survival in Older Adults with Metastatic Colorectal Cancer in Real Life - American Geriatric Society

OBJECTIVES

Metastatic colorectal cancer (mCRC) is increasingly treated with targeted therapies, but little is known about real‐life mCRC treatment in older adults. The aims were to describe the real‐life first‐line treatment modalities in older adult mCRC patients, to identify factors associated with treatment modalities, and to evaluate survival with regard to treatment modalities.

PATIENTS AND METHODS

A cohort of mCRC patients aged 65 years and older at diagnosis was identified between 2009 and 2013 using French national healthcare insurance system claims data. Treatment modalities were: treatment with one or more anticancer medication vs best supportive care and, among treated patients, treatment with targeted therapy vs conventional chemotherapy alone. Multivariate logistic regression was used to identify factors associated with treatment by anticancer medication and by targeted therapy. Cox proportional hazards models were used to assess the independent effect of treatment modalities on overall survival while adjusting for baseline covariates identified with logistic regression.

RESULTS

A total of 503 patients were included with a median age of 78 years (54% were men). Of these, 299 (59%) were treated with anticancer medications. Among treated patients, 131 (44%) received targeted therapy. In multivariate analysis, age 75 years or older, renal failure, malnutrition, and five or more concomitant medications were associated with a lower likelihood of treatment with anticancer medications. Among treated patients, age 75 years or older, history of cancer, lymph node metastases, and a single metastatic site were associated with a lower likelihood of treatment with targeted therapy. Multivariate Cox proportional hazards models found that treatment with any anticancer medication tended to be associated with a lower risk of death; treatment with targeted therapy was not significantly associated.

CONCLUSION

A more appropriate prescription of anticancer medications in the older adult will require the definition of more explicit criteria to avoid undertreatment. The real benefit of targeted therapies vs conventional chemotherapy alone needs to be confirmed in this population. J Am Geriatr Soc 67:913–919, 2019.

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Using Implementation Science to Promote the Use of the G8 Screening Tool in Geriatric Oncology - American Geriatric Society

OBJECTIVES

Evidence supports the integration of geriatric assessment in the care of older adults with cancer. The G8 screening tool is a validated instrument to target a geriatric assessment. Use of the G8 tool in clinical practice, however, is suboptimal. We systematically analyzed the barriers and facilitators to G8 tool use in oncology clinics and selected interventions tailored to the local context to enhance its uptake.

DESIGN

This qualitative study used semistructured interviews and site observations.

SETTING

St. Michael's Hospital, Toronto, Canada.

PARTICIPANTS

Ten participants including G8 tool adopters and stakeholders at St. Michael's Hospital were interviewed.

MEASUREMENTS

An interview guide based on the Theoretical Domains Framework (TDF) was developed to identify beliefs about G8 tool use. Barriers and facilitators to G8 tool use were mapped to the TDF domains and corresponding intervention functions from the Capability, Opportunity, Motivation, and Behavior model. Evidence‐based implementation strategies were selected from two databases.

RESULTS

Key TDF domains influencing G8 tool use behavior were social/professional role, goals, beliefs about consequences, and social influences. The behavior change domains were mapped to four mechanisms of change: persuasion (conduct local consensus discussions), modeling (identify and prepare a champion), education (distribute educational materials), and enablement (use materials to prepare patients to be active participants in understanding the evidence behind the G8 tool and answering questions accurately).

CONCLUSION

This study identified barriers to G8 tool use. Local consensus discussions, identifying and preparing a champion, using educational materials, and preparing patients to be active participants may be implementation strategies to improve G8 tool use. J Am Geriatr Soc 67:898–904, 2019.

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Post‐Acute Care After Joint Replacement in Medicare's Bundled Payments for Care Improvement Initiative - American Geriatric Society

IMPORTANCE

Bundled payments, in which services provided around a care episode are linked together, are being tested under Medicare's Bundled Payments for Care Improvement (BPCI) program. Reducing post‐acute care (PAC) is critical under bundled payment, but little is known about whether this is done through provider selection or consolidation, and whether particular patterns of changes in PAC are associated with success under the program.

OBJECTIVE

To characterize patterns of change in PAC under lower‐extremity joint replacement episodes in BPCI.

DESIGN

Retrospective difference‐in‐differences study.

SETTING

US Medicare, 2013 to 2015.

PARTICIPANTS

A total of 264 US hospitals participating in BPCI for lower‐extremity joint replacement and matched controls.

EXPOSURES

Participation in BPCI.

MEASUREMENTS

Use and duration of institutional PAC (proportion discharged to a skilled nursing facility, an inpatient rehabilitation facility, and a long‐term care hospital), dispersion of PAC (proportion of discharges to commonly used providers), and quality of PAC (Star Ratings, readmission rates, length of stay, and nurse staffing); part A Medicare payments.

RESULTS

BPCI participants decreased the use and duration of institutional PAC compared to controls: overall institutional PAC declined 4.4% in BPCI hospitals vs 2.1% in non‐BPCI hospitals (difference = −2.2%; P = .033), and duration decreased by 1.6 days in BPCI hospitals compared to 0.0 days in non‐BPCI hospitals (difference in differences = −1.5 days; P < .001). However, BPCI participants did not change their PAC referral patterns to reduce dispersion or refer patients to higher‐quality PAC providers. Hospitals that were more successful in reducing Medicare payments started with higher payments and higher use of institutional PAC settings and demonstrated greater drops in use and duration of institutional PAC, but no differences in dispersion or referral to high‐quality providers.

CONCLUSIONS AND RELEVANCE

Reductions in spending under BPCI were driven by a shift from higher‐ to lower‐cost discharge settings, and by shortening the duration of institutional PAC. Hospitals that reduced payments the most had the highest spending at baseline. J Am Geriatr Soc 67:1027–1035, 2019.

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Post‐Acute Care among Older Adults with Stage I to III Colorectal Cancer - American Geriatric Society

BACKGROUND

Little information is available on the long‐term use of post‐acute care among older patients with colorectal cancer (CRC), relative to individuals without cancer. This study examines the use of post‐acute care among older cancer survivors (>65 y) with CRC and compares it with noncancer patients up to 5 years from surgery.

DESIGN

Retrospective cohort.

SETTING

SEER‐Medicare.

PARTICIPANTS

Patients treated for stage I to III CRC between January 1, 2000, and December 31, 2011 (n = 40 812) and noncancer Medicare beneficiaries hospitalized for noncancer treatment matching on age, sex, race, comorbidity, and Medicaid dual eligibility.

MEASUREMENTS

Incident post‐acute care claims (skilled nursing, long‐term care facility, and home health) from 0 to 100 days, 101 to 365 days, and 1 to 5 years from hospitalization.

RESULTS

The median age was 77 years. All patients had surgery, 34% received chemotherapy, and 27% received surgery and adjuvant therapy. The cumulative incidence of any post‐acute care within 100 days of hospitalization was 45.7% for stage III, 37.9% for stage I/II, and 39% for controls (p < .001). Within the CRC cohort only, the cumulative incidence of post‐acute care was 2.9% (stage I/II) and 4.2% (stage III, p < .001) from 101 to 365 days and 15.8% (stage I/II) and 16.9% (stage III, p < .001) from 1 to 5 years. Increasing age, ostomies, and neoadjuvant or adjuvant therapy were associated with increased hazard of all post‐acute patients within 100 days from hospitalization. From 1 to 5 years from diagnosis, adjuvant therapy was associated with greater exclusive home health care use.

CONCLUSIONS

Survivorship planning among older CRC patients should include discussions of post‐acute care following cancer therapy, even several years after treatment. J Am Geriatr Soc 67:937–944, 2019.

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Immune Checkpoint Inhibitors in Real‐World Treatment of Older Adults with Non–Small Cell Lung Cancer - American Geriatric Society

OBJECTIVE

To evaluate the efficacy and toxicity of immune checkpoint inhibitors (ICIs) in older patients with advanced non–small cell lung cancer (NSCLC) seen in routine clinical practice.

DESIGN

Retrospective study.

SETTING

Single academic institution and its affiliated centers.

PARTICIPANTS

Patients 70 years or older with advanced‐stage NSCLC seen between April 1, 2015, and April 1, 2017, and treated with ICIs.

MEASUREMENTS

Efficacy data included overall survival (OS) and time to treatment failure (TTF), stratified by age, comorbidities (Charlson Comorbidity Index [CCI]), and Eastern Cooperative Oncology Group Performance Status (ECOG PS), and estimated using the Kaplan‐Meier method and log‐rank test. Toxicity data included immune‐related adverse events (irAEs), need for glucocorticoids, and hospitalization. The associations of toxicity with age, CCI, and ECOG PS were evaluated using the exact χ² test or Fisher exact test.

RESULTS

We included 75 patients (median age: 74 y; range, 70‐92 y); 53% had a CCI of 3 or higher; 49% had ECOG PS of 2 or higher. Median OS for the whole cohort was 8.2 months (ECOG PS 0‐1 vs ≥2: 13.7 vs 3.8 mo; p < .01). Median TTF was 4.2 months (ECOG PS 0‐1 vs ≥2: 5.6 vs 2.0 mo; p = .02). Overall, 37% of patients experienced irAE of any grade (a total of 37 events); 8% were grade 3 or higher (no ICI‐related deaths). Of those who discontinued ICIs (N = 64), 15% were due to irAEs. Of those who experienced irAEs, 64% required glucocorticoids. Hospitalizations during ICI treatment occurred in 72%. Toxicity generally did not differ by age, CCI, or ECOG PS.

CONCLUSIONS

Outcomes in our cohort were driven by ECOG PS rather than chronological age or comorbidities. The relatively high rates of ICI discontinuation, use of glucocorticoids, and hospitalization during ICI treatment in our study highlight the vulnerability of older adults with advanced NSCLC even in the immunotherapy era. J Am Geriatr Soc 67:905–912, 2019.

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Understanding Caregiver Quality of Life in Caregivers of Hospitalized Older Adults With Cancer - American Geriatric Society

BACKGROUND/OBJECTIVES

Caregivers of older adults with cancer assist both with cancer care and other health issues, which may make them vulnerable to consequences of caregiving. Hospitalization may represent a time when a caregiver's ability to provide care at home is exceeded. We sought to characterize caregivers of hospitalized older adults with cancer, determine their quality of life (QOL), and identify factors associated with caregiver QOL.

METHODS

Patients (n = 100), aged 65 years and older, with an unplanned hospitalization and their caregivers were included. Caregivers completed a questionnaire about their health, social support, caregiving relationship, QOL (Caregiver Quality of Life Index‐Cancer [CQOLC] tool), and patient function. Patient medical history was obtained via chart review. The association between patient, caregiving, and caregiver factors and CQOLC was determined using multivariate linear regression.

RESULTS

Most patients (73%) had metastatic/advanced disease, and 71% received treatment for their cancer within 30 days of hospitalization. Median Karnofsky Performance Status (KPS) was 60%, and 89% required help with instrumental activities of daily living, as reported by caregivers. Median caregiver age was 65 years (range = 29‐84 years). The majority (60%) had no major comorbidities and rated their health as excellent/good (79%), though 22% reported worsening health due to caregiving. Caregivers had a median Mental Health Inventory‐18 score of 70 (range = 0–97), a median Medical Outcomes Study (MOS)‐social activity score of 56 (range = 0–87.5), and a median MOS‐Social Support Survey score of 68 (range = 0–100). Caregivers provided a median of 35 hours of care per week (range = 0‐168 hours of care per week). Mean CQOLC was 84.6 ± 23.5. Lower caregiver QOL was associated with poorer caregiver mental health, less social support, and poorer patient KPS (P < .05).

CONCLUSION

Caregivers of hospitalized older adults with cancer are older but generally in good health. Those with poorer mental health, less social support, and caring for patients with poorer performance status are more likely to experience lower QOL. J Am Geriatr Soc 67:978–986, 2019.

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Differences in National Diabetes Treatment Patterns and Trends between Older and Younger Adults - American Geriatric Society

Background/Objectives

The treatment of type 2 diabetes in older adults requires special considerations including avoidance of hypoglycemia, yet variation in diabetes treatment with aging is not well understood. In this study, we compared nationally representative diabetes treatment patterns and trends between older adults (≥65 y) and younger adults (30‐64 y).

Design

Repeated cross‐sectional physician surveys from 2006 to 2015.

Setting

The National Ambulatory Medical Care Survey, an annual probability sample of visits to office‐based US physicians.

Participants

Adults with type 2 diabetes using one or more diabetes medications.

Measurements

Proportions of visits in which patients treated with each diabetes medication class were compared between older and younger adults in 2‐year intervals.

Results

From 2006 to 2015, the average number of yearly visits for older and younger adults was 25.4 million and 24.2 million, respectively. In 2014‐2015, visits for older compared with younger adults involved less use of metformin (56.0% vs 70.0%; p < .001) and glucagon‐like peptide 1 receptor agonists (2.9% vs 6.2%; p = .004), and more use of long‐acting insulin (30.2% vs 22.4%; p = .017); other classes were used similarly. During the study period, long‐acting insulin use increased markedly in older adults, particularly between 2010 and 2015 where it rose from 12.5% to 30.2% of visits (P‐trend <.001). In younger adult visits, long‐acting insulin use increased modestly (17.2% to 22.4%) and at a slower rate compared with older adult visits (p < .001).

Conclusion

The ambulatory treatment of type 2 diabetes differs between older and younger adults, with the treatment of older adults characterized by low use of newer diabetes medications and a greater and rapidly increasing use of long‐acting insulin. These findings call for further research clarifying the comparative effectiveness and safety of newer diabetes medications and long‐acting insulin to optimize diabetes care for older patients. J Am Geriatr Soc 67:1066–1073, 2019.

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Quality of Life of Caregivers of Older Patients with Advanced Cancer - American Geriatric Society

OBJECTIVES

To evaluate the relationships between aging‐related domains captured by geriatric assessment (GA) for older patients with advanced cancer and caregivers’ emotional health and quality of life (QOL).

DESIGN

In this cross sectional study of baseline data from a nationwide investigation of older patients and their caregivers, patients completed a GA that included validated tests to evaluate eight domains of health (eg, function, cognition).

SETTING

Thirty‐one community oncology practices throughout the United States.

PARTICIPANTS

Enrolled patients were aged 70 and older, had one or more GA domain impaired, and had an incurable solid tumor malignancy or lymphoma. Each could choose one caregiver to enroll.

MEASUREMENTS

Caregivers completed the Generalized Anxiety Disorder‐7, Distress Thermometer, Patient Health Questionnaire‐2 (depression), and Short Form Health Survey‐12 (SF‐12 for QOL). Separate multivariate linear or logistic regression models were used to examine the association of the number and type of patient GA impairments with caregiver outcomes, controlling for patient and caregiver covariates.

RESULTS

A total of 541 patients were enrolled, 414 with a caregiver. Almost half (43.5%) of the caregivers screened positive for distress, 24.4% for anxiety, and 18.9% for depression. Higher numbers of patient GA domain impairments were associated with caregiver depression (adjusted odds ratio [aOR] = 1.29; P < .001], caregiver physical health on SF‐12 (regression coefficient [β] = −1.24; P < .001), and overall caregiver QOL (β = −1.14; P < .01). Impaired patient function was associated with lower caregiver QOL (β = −4.11; P < .001). Impaired patient nutrition was associated with caregiver depression (aOR = 2.08; P < .01). Lower caregiver age, caregiver comorbidity, and patient distress were also associated with worse caregiver outcomes.

CONCLUSION

Patient GA impairments were associated with poorer emotional health and lower QOL of caregivers. J Am Geriatr Soc 67:969–977, 2019.

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Longitudinal Relationship Between Frailty and Cognition in Patients 50 Years and Older with Breast Cancer - American Geriatric Society

OBJECTIVES

To evaluate relationships between frailty and cognition longitudinally in adults 50 years and older with breast cancer receiving chemotherapy.

DESIGN

Secondary analysis of a prospective longitudinal observational study.

SETTING

University of Rochester NCI Community Oncology Research Program community oncology clinics.

PARTICIPANTS

Patients with breast cancer age 50 and older receiving adjuvant/neoadjuvant chemotherapy (n = 376) and age‐matched controls without cancer (n = 234).

MEASUREMENTS

Frailty was assessed using a modified frailty score from self‐reported assessments (weakness, exhaustion, physical activity, and gait speed). Cognition was assessed by patient report (Functional Assessment of Cancer Therapy‐Cognition [FACT‐Cog]) and objective measures. Frailty and cognition were measured at three time points (prechemotherapy [A1], postchemotherapy [A2], and 6 months postchemotherapy [A3]; similar time interval for controls). Linear regression models evaluated associations between frailty and cognition adjusting for covariates.

RESULTS

The average age was 59 years (standard deviation = 6.4 y). At baseline, patients with cancer had a higher mean frailty score (1.21 vs .73; P < .001) and lower mean FACT‐Cog score (158.4 vs 167.3; P < .001) compared with controls. Objective cognitive measures were not statistically different. Longitudinal decline in FACT‐Cog between A1 and A2 (P < .05) and between A1 and A3 (P < .01) was associated with increased frailty score in patients compared with controls. Longitudinal worsening in Controlled Oral Word Association (P < .05) and Trail‐Making Test (P < .01) were associated with an increase in frailty between A1 and A2 in patients compared with controls; longitudinal decline in the Delayed Match to Sample test was associated with an increase in frailty between A1 and A3 (P < .05) in patients compared with controls. This finding remained significant for a subset analysis of those aged 65 and older.

CONCLUSION

In patients with breast cancer aged 50 and older, longitudinal decline in FACT‐Cog and objective measures of attention and memory were associated with increased frailty during treatment and up to 6 months posttreatment. Overall, our study suggests cognition and frailty are both important factors to assess in breast cancer patients. J Am Geriatr Soc 67:928–936, 2019.

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Functional Decline and Resilience in Older Women Receiving Adjuvant Chemotherapy for Breast Cancer - American Geriatric Society

Objectives

To analyze self‐reported changes in physical function in older women with breast cancer receiving adjuvant chemotherapy.

Design

Secondary analysis of the Cancer and Leukemia Group B (CALGB) 49907 prospective randomized clinical trial.

Setting

CALGB institutions in the United States.

Participants

Women aged 65 and older with Stage I to III breast cancer enrolled in CALGB 49907 who had physical function data from before and after receipt of adjuvant chemotherapy (N=256; mean age 71.5, range 65–85).

Measurements

Participants were administered the physical function subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire before chemotherapy, at the end of chemotherapy, and 12 months after chemotherapy initiation. Functional decline was defined as a more than 10‐point decrease from baseline at each time point. Resilience was defined as return to within 10 points of baseline. Multivariable regression was used to examine pretreatment characteristics associated with physical function changes.

Results

Of 42% of participants who had physical function decline from before to the end of chemotherapy, 47% recovered by 12 months (were resilient). Almost one‐third experienced functional decline from before chemotherapy to 12 months later. Pretreatment fatigue was a risk factor for functional decline from before to the end of chemotherapy (P=.02). Risk factors for functional decline at 12 months included pretreatment dyspnea (P=.007) and being unmarried (P=.01).

Conclusion

Functional decline was common in older women receiving adjuvant chemotherapy for breast cancer in a clinical trial. Although half recovered their physical function, one‐third had a clinically meaningful decline at 12 months. Strategies are needed to prevent functional decline in older adults receiving chemotherapy. J Am Geriatr Soc 67:920–927, 2019.

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Aggressive Care near the End of Life for Cancer Patients in Medicare Accountable Care Organizations - American Geriatric Society

OBJECTIVES

To compare aggressiveness of end‐of‐life (EoL) care for older cancer patients attributed to Medicare Shared Savings Programs with that for similar fee for service (FFS) beneficiaries not in an accountable care organization (ACO) and examine whether observed differences in EoL care utilization vary across markets that differ in ACO penetration.

DESIGN

Cross‐sectional observational study comparing ACO‐attributed beneficiaries with propensity score–matched beneficiaries not attributed to an ACO.

SETTING

A total of 21 hospital referral regions (HRRs) in the United States.

PARTICIPANTS

Medicare FFS beneficiaries with a cancer diagnosis who were 66 years or older and died in 2013‐2014.

MEASUREMENTS

Outcome measures were claims‐based quality measures of aggressive EoL care: (1) one or more intensive care unit (ICU) admissions in the last month of life, (2) two or more hospitalizations in the last month of life, (3) two or more emergency department visits in the last month of life, (4) chemotherapy 2 weeks or less before death, and (5) no hospice enrollment or hospice enrollment within 3 days of death. Analyses were adjusted for demographic and clinical characteristics of beneficiaries and practice characteristics.

RESULTS

Compared with beneficiaries not in an ACO, ACO‐attributed beneficiaries had a higher rate of ICU admission during the last month of life (37.7% vs 34.0%; adjusted difference = +2.8 percentage points; 95% confidence interval (CI) = 1.0‐4.6) but fewer repeated hospitalizations (14.5% vs 15.2%; adjusted difference = −1.7 percentage points; CI = −3.1 to −.3). Other measures did not differ for the two groups. Although the ICU admission rates tended to decrease as ACO‐penetration rates increased (P < .01), ACO patients had higher rates of ICU admission than non‐ACO patients in both medium and high ACO‐penetration HRRs.

CONCLUSION

Cancer patients attributed to ACOs had fewer repeated hospitalizations but more ICU admissions in the last month of life than non‐ACO patients; they had similar rates of other measures of aggressive care at the EoL. This suggests opportunities for ACOs to improve EoL care for cancer patients. J Am Geriatr Soc 67:961–968, 2019.

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Comment on Association Between Functional Performance and Alzheimer's Disease Biomarkers in Individuals Without Dementia - American Geriatric Society

Journal of the American Geriatrics Society, Volume 67, Issue 5, Page 1098-1099, May 2019.

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Natural Disasters and Population Health Management for Homebound Older Adults - American Geriatric Society

Journal of the American Geriatrics Society, Volume 67, Issue 5, Page 1099-1101, May 2019.

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Reply to: The Interplay between Experiences of Abuse, Physical Activity, and Falls in Older Adults - American Geriatric Society

Journal of the American Geriatrics Society, Volume 67, Issue 5, Page 1097-1098, May 2019.

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The Interplay between Experiences of Abuse, Physical Activity, and Falls in Older Adults - American Geriatric Society

Journal of the American Geriatrics Society, Volume 67, Issue 5, Page 1097-1097, May 2019.

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Preferred Post‐Acute Care Providers in Bundled Payment: Implications for Patient Choice - American Geriatric Society

Journal of the American Geriatrics Society, Volume 67, Issue 5, Page 1020-1022, May 2019.

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Long‐Term Opioid Therapy in Older Cancer Survivors: A Retrospective Cohort Study - American Geriatric Society

OBJECTIVES

To examine the rates and predictors of long‐term opioid therapy in older cancer survivors.

DESIGN

Retrospective cohort study.

SETTING

Texas, United States.

PARTICIPANTS

Cancer survivors (5 years or more postcancer diagnosis) diagnosed from 1995 to 2008 and who were also Medicare Parts A, B, and D beneficiaries.

MEASUREMENTS

We used Medicare Part D event data to calculate the proportion of cancer survivors with a prolonged opioid prescription (90‐day or more supply of opioids/year). Adjusted odds ratios were calculated to identify predictors of prolonged opioid prescribing. All analyses were repeated with a subcohort of opioid‐naïve cancer survivors.

RESULTS

The rate of prolonged opioid therapy for cancer patients diagnosed in 2008 was 7.1% prior to cancer diagnosis; it rose to 9.8% within a year of cancer treatments, and to 13.3% at 5 years postdiagnosis. The rate at the sixth year varied by cancer sites: 19.4% in lung cancer and 9.6% in prostate cancer. Among opioid‐naïve survivors, the rate increased from 1.4% to 7.1%, from 5 to 18 years postcancer diagnosis. Cancer survivors diagnosed in 2004 to 2008 had higher rates of opioid prescribing compared to those diagnosed in 1995 to 1998 and 1999 to 2003. Years since diagnosis, a later year of diagnosis, female sex, urban location, lung cancer diagnosis, disability as reason for Medicare entitlement, Medicaid eligibility, one or more comorbidity, and history of depression or drug abuse were predictors of prolonged opioid therapy. Among opioid‐naïve cancer survivors, diagnosis in 2004 to 2008 was the strongest predictor, while a history of drug abuse was the strongest predictor for all the survivors.

CONCLUSION

The rates of prolonged opioid prescribing for older cancer survivors remained high at 5 or more years after cancer diagnosis. Our findings have potential to inform the development of clinical guidelines and public policy to ensure safer and more effective pain treatment in older cancer survivors. J Am Geriatr Soc, 1–8, 2019.

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REPLY TO: QIGONG AS A PROMISING MIND‐BODY EXERCISE FOR COGNITIVE FUNCTIONING - American Geriatric Society

Journal of the American Geriatrics Society, EarlyView.

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Qigong as a promising mind‐body exercise for cognitive functioning: Letter to Editor - American Geriatric Society

Journal of the American Geriatrics Society, EarlyView.

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Urgent: Curry Spice Recall - FDA Safety Alerts & Drug Recalls

This voluntary recall has been initiated by UBC Food Distributors Inc, due to a high level of lead found in the product after testing was done by the Michigan Department of Agriculture & Rural Development, which found high traces of lead.

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New Seasons Market Issues Allergy Alert on Undeclared Soy in Hot & Sour Broth - FDA Safety Alerts & Drug Recalls

New Seasons Market is recalling 193 jars of New Seasons Market Hot & Sour Broth because it contains undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

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Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

BazziniI LLC of Allentown, PA out of an abundance of caution, is recalling 4,000 pounds of Roasted and Salted Colossal Natural, Super Colossal Natural and Rams Head Natural in Shell Pistachios received from one of its suppliers because it has the potential to be contaminated with Salmonella. NO OTHE

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FDA approves device to help increase access to more lungs for transplant - FDA Press Releases

The device enables doctors to better assess lungs that were initially deemed to be unsuitable for transplant

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FDA approves first treatment for pediatric patients with lupus - FDA Press Releases

FDA approves Benlysta for treatment of children with systemic lupus erythematosus (SLE), a chronic disease causing inflammation and damage to tissue and organs

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FDA approves first treatment for rare blood disease - FDA Press Releases

The FDA approved Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years of age and older.

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Statement from Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health, on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data - FDA Press Releases

FDA provides updates to postmarketing studies that agency ordered three manufacturers of duodenoscopes to conduct to assess bacterial contamination of devices.

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FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation - FDA Press Releases

The FDA approved the first antibacterial drug under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). LPAD was created by Congress to spur development of drugs targeting serious infections in limited patient populations with unmet need.

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La FDA autoriza la primera prueba de comercialización directa al consumidor para la detección de variantes genéticas que pudieran estar relacionadas con la metabolización farmacológica - FDA Press Releases

La FDA autoriza la primera prueba de comercialización directa al consumidor para la detección de variantes genéticas que pudieran estar relacionadas con la metabolización farmacológica

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La FDA aprueba nuevo medicamento para tratar la influenza - FDA Press Releases

La FDA aprueba nuevo medicamento para tratar la influenza

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Statement from FDA Commissioner Scott Gottlieb, M.D., on meetings with industry related to the agency’s ongoing policy commitment to firmly address rising epidemic rates in youth e-cigarette use - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on meetings with industry related to the agency’s ongoing policy commitment to firmly address rising epidemic rates in youth e-cigarette use.

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FDA seizes food and medical products held under insanitary conditions at an Arkansas grocery warehouse - FDA Press Releases

U.S. Marshals Service has conducted a mass seizure of FDA-regulated products that were being held in an Arkansas grocery warehouse under insanitary conditions

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FDA approves new drug to treat travelers’ diarrhea - FDA Press Releases

FDA approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool.

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FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications - FDA Press Releases

FDA update on the ongoing investigation into angiotensin II receptor blocker impurities, recalls and current findings.

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FDA launches public education campaign to encourage safe removal of unused opioid pain medicines from homes - FDA Press Releases

“Remove the Risk” to raise awareness about proper disposal of prescription opioids

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Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Anna Abram on the FDA’s new plan to advance plant, animal biotechnology innovation - FDA Press Releases

FDA announces new plan to advance the development of plant and animal biotechnology innovation

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FDA warns company for selling e-liquids that resemble kid-friendly foods as part of the agency’s ongoing Youth Tobacco Prevention Plan - FDA Press Releases

FDA issued a warning letter to Electric Lotus LLC for selling nicotine-containing e-liquids used in e-cigarettes with labeling and/or advertising that cause them to resemble kid-friendly food products.

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Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices - FDA Press Releases

FDA provides updates on two elements in medical device safety action plan: modernizing 510(k) program and new process for establishing special controls.

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FDA Deputy Commissioner for Policy, Planning, Legislation, and Analysis Anna Abram, remarks prepared for testimony before a subcommittee of the U.S. House Committee on Energy and Commerce on the Pandemic and All-Hazards Preparedness Act - FDA Press Releases

FDA’s Anna Abram’s testimony for U.S. House Committee on Energy and Commerce Subcommittee on Health on the Pandemic and All-Hazards Preparedness Act

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Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new strategic framework to advance use of real-world evidence to support development of drugs and biologics - FDA Press Releases

FDA releases new strategic framework to advance use of real-world evidence to support development of drugs and biologics

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FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk - FDA Press Releases

FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk

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Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan.

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FDA provides update on its ongoing investigation into ARB drug products; reports on finding of a new nitrosamine impurity in certain lots of losartan and product recall - FDA Press Releases

FDA provides update on ongoing investigation into ARB drugs; new losartan recall announced

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Teva Pharmaceuticals USA, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium 25 mg and 100 mg Tablets USP, Sold Exclusively to Golden State Medical Supply - FDA Safety Alerts & Drug Recalls

Teva Pharmaceuticals USA, Inc. has initiated a voluntary recall in the United States, to the patient level, of 35 lots of bulk Losartan Potassium USP Tablets (6 lots of 25 mg strength and 29 lots of 100 mg strength).

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FDA approves device to help increase access to more lungs for transplant - FDA Press Releases

The device enables doctors to better assess lungs that were initially deemed to be unsuitable for transplant

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FDA approves first treatment for pediatric patients with lupus - FDA Press Releases

FDA approves Benlysta for treatment of children with systemic lupus erythematosus (SLE), a chronic disease causing inflammation and damage to tissue and organs

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In vitro activity of eravacycline in combination with colistin against carbapenem-resistant A. baumannii isolates - Journal of Antibiotics

In vitro activity of eravacycline in combination with colistin against carbapenem-resistant A. baumannii isolates

In vitro activity of eravacycline in combination with colistin against carbapenem-resistant <i>A. baumannii</i> isolates, Published online: 26 April 2019; doi:10.1038/s41429-019-0188-6

In vitro activity of eravacycline in combination with colistin against carbapenem-resistant A. baumannii isolates

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Synergistic combinations of anthelmintic salicylanilides oxyclozanide, rafoxanide, and closantel with colistin eradicates multidrug-resistant colistin-resistant Gram-negative bacilli - Journal of Antibiotics

Synergistic combinations of anthelmintic salicylanilides oxyclozanide, rafoxanide, and closantel with colistin eradicates multidrug-resistant colistin-resistant Gram-negative bacilli

Synergistic combinations of anthelmintic salicylanilides oxyclozanide, rafoxanide, and closantel with colistin eradicates multidrug-resistant colistin-resistant Gram-negative bacilli, Published online: 26 April 2019; doi:10.1038/s41429-019-0186-8

Synergistic combinations of anthelmintic salicylanilides oxyclozanide, rafoxanide, and closantel with colistin eradicates multidrug-resistant colistin-resistant Gram-negative bacilli

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FDA launches public education campaign to encourage safe removal of unused opioid pain medicines from homes - FDA Press Releases

“Remove the Risk” to raise awareness about proper disposal of prescription opioids

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Three new meroterpenoids from culture broth of Perenniporia medulla-panis and their antioxidant activities - Journal of Antibiotics

Three new meroterpenoids from culture broth of Perenniporia medulla-panis and their antioxidant activities

Three new meroterpenoids from culture broth of <i>Perenniporia medulla-panis</i> and their antioxidant activities, Published online: 25 April 2019; doi:10.1038/s41429-019-0184-x

Three new meroterpenoids from culture broth of Perenniporia medulla-panis and their antioxidant activities

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Daily Use of Bilateral Custom‐Made Ankle‐Foot Orthoses for Fall Prevention in Older Adults: A Randomized Controlled Trial - American Geriatric Society

OBJECTIVE

To examine the effects of bilateral custom‐made ankle‐foot orthoses (AFOs) to prevent falls for older adults with concern about or at risk for falling over 12‐month daily use.

DESIGN

Secondary analysis of a randomized controlled trial.

SETTING

Community‐dwelling older adults.

INTERVENTION

Half of the participants were randomly allocated to an intervention group (IG) that received fitted walking shoes and bilateral custom‐made AFOs, and the other half were randomly allocated to a control group (CG) that only received fitted walking shoes.

MEASUREMENTS

Self‐reported fall history of 12‐month duration was investigated at baseline and 12‐month follow‐up for both groups. Fall incidence rate and proportion of fallers were used as outcome measures to determine effects of 12‐month footwear intervention in either group.

PARTICIPANTS

Adults aged 65 years and older with concern about or at risk for falling (n = 44).

RESULTS

No significant between‐group differences in participant characteristics were observed at the baseline (P = .144‐.882). Within the IG, significant reductions were found in the fall incidence rate (P = .039) and the proportion of fallers (P = .036) at the 12‐month follow‐up compared to the baseline. Within the CG, no significant change was found at the 12‐month follow‐up compared to the baseline for the fall incidence rate (P = .217) or the proportion of fallers (P = .757). When comparing the IG with the CG, there was no significant difference in the change from the baseline to the 12‐month follow‐up for the fall incidence rate (P = .572) or the proportion of fallers (P = .080).

CONCLUSION

This study failed to demonstrate a significant benefit of bilateral custom‐made AFOs to reduce falls compared to fitted walking shoes. However, the AFO users had significant reductions in falls compared to the preceding year. A future study with a larger sample size is recommended to confirm these observations.

CLINICAL TRIAL REGISTRATION—URL: http://www.clinicaltrials.gov. Unique identifier: NCT02819011.

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Legacy Pharmaceutical Packaging, LLC Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity Found in the Active Pharmaceutical Ingredient (API) - FDA Safety Alerts & Drug Recalls

Legacy Pharmaceutical Packaging, LLC is expanding its consumer-level recall of 3 repackaged lots Losartan Tablets USP 50mg to include one additional lot.

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Jurox Incorporated is Voluntarily Recalling Two Lots of Alfaxan Unpreserved, an Intravenous Injectable Anaesthetic - FDA Safety Alerts & Drug Recalls

This recall has been initiated due to an out of specification result for clarity observed in the stability program. The presence of the aluminum phosphate precipitate presents a potential risk that intravascular (I.V.) injection of product containing this precipitate could result in blood vessel in

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Home as a Place for Care of the Oldest Stroke Patients: A Pilot from the Catalan Stroke Program - American Geriatric Society

Journal of the American Geriatrics Society, EarlyView.

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The Montreal Cognitive Assessment After Omission of Hearing‐Dependent Subtests: Psychometrics and Clinical Recommendations - American Geriatric Society

Objectives

Hearing loss (HL) is the third most common chronic health condition in older adults, yet it is often undiagnosed and/or untreated. Given the association between HL and cognitive impairment, it is expected that many people undergoing cognitive screening may have HL. The Montreal Cognitive Assessment (MoCA) is a brief screening test that assesses a wide range of cognitive functions sensitive to Alzheimer's disease (AD) and mild cognitive impairment (MCI). Although MoCA items were carefully designed to be sensitive to deficits in MCI, they were not designed to take sensory declines into account. In the current investigation, we examined the MoCA's psychometric properties following omission of subtests primarily dependent on hearing status (memory, digit span, attention to letters, and sentence repetition).

Design

Cross‐sectional analytic design (retrospective analysis).

Setting

We used the original MoCA validation study data.#jgs15940-bib-0004

Participants

Groups consisted of healthy controls (N = 90), subjects with MCI (N = 94), and subjects with mild AD (N = 93).

Measurements

We assessed sensitivity and specificity using absolute and proportional cutoff score adjustments. We developed receiver operating characteristics curves to determine the best cutoff values for both MCI and AD patients using different combinations of auditory subtest omissions.

Results

Compared with the original MoCA (MCI sensitivity = 90%; specificity = 87%), MCI sensitivity was substantially reduced (absolute scoring = 43%; proportional scoring = 56%) when all auditory subtests were omitted, with the biggest contribution to the reduction coming from the delayed recall subtest. Excluding three subtests and maintaining the delayed recall had no effect on MCI sensitivity but reduced specificity (sensitivity = 94%, specificity: 71% using proportional scoring). AD sensitivity, in contrast, was not strongly influenced by our manipulation and remained relatively high through all three subtest omission combinations.

Conclusion

The current study highlights the contribution of hearing‐dependent subtests on the sensitivity and specificity of the MoCA. Clinical recommendations related to these findings are discussed.

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New preaustinoids from a marine-derived fungal strain Penicillium sp. SF-5497 and their inhibitory effects against PTP1B activity - Journal of Antibiotics

New preaustinoids from a marine-derived fungal strain Penicillium sp. SF-5497 and their inhibitory effects against PTP1B activity

New preaustinoids from a marine-derived fungal strain <i>Penicillium</i> sp. SF-5497 and their inhibitory effects against PTP1B activity, Published online: 24 April 2019; doi:10.1038/s41429-019-0187-7

New preaustinoids from a marine-derived fungal strain Penicillium sp. SF-5497 and their inhibitory effects against PTP1B activity

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Molecular targets of biofabricated silver nanoparticles in Candida albicans - Journal of Antibiotics

Molecular targets of biofabricated silver nanoparticles in Candida albicans

Molecular targets of biofabricated silver nanoparticles in <i>Candida albicans</i>, Published online: 24 April 2019; doi:10.1038/s41429-019-0185-9

Molecular targets of biofabricated silver nanoparticles in Candida albicans

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Hyponatremia and In‐Hospital Falls and Fractures in Older Adults - American Geriatric Society

Journal of the American Geriatrics Society, EarlyView.

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Systematic Advance Care Planning and Potentially Avoidable Hospitalizations of Nursing Facility Residents - American Geriatric Society

BACKGROUND/OBJECTIVES

The Optimizing Patient Transfers, Impacting Medical Quality, Improving Symptoms: Transforming Institutional Care (OPTIMISTIC) project is a successful, multicomponent demonstration project to reduce potentially avoidable hospitalizations of long‐stay nursing facility residents. Systematic advance care planning (ACP) is a core component of the intervention, based on research suggesting ACP is associated with decreased hospitalizations of nursing facility residents. The purpose of this study was to describe associations between ACP documentation resulting from the OPTIMISTIC intervention and hospitalizations.

DESIGN

Specially trained project nurses were embedded in 19 nursing facilities and systematically engaged in ACP as part of a larger demonstration project.

PARTICIPANTS

Residents (n = 1482) enrolled in the demonstration project for a minimum of 30 days between January 1, 2015, and June 30, 2016.

MEASUREMENTS

ACP status: (1) Physician Orders for Scope of Treatment (POST) comfort measures or do not hospitalize (DNH) orders; (2) ACP orders with no hospitalization limit (eg, code status only); and (3) no ACP (potentially avoidable and all‐cause hospitalizations per 1000 resident days).

RESULTS

Residents with POST comfort measures/DNH orders (33.2% or n = 493) were less likely than residents with no ACP (14.7% or n = 218) to experience a potentially avoidable hospitalization (P = .001) or all‐cause hospitalization (P = .001). These differences became statistically nonsignificant after adjusting for age, functional status, and cognitive functioning.

CONCLUSION

In this successful multicomponent demonstration project to reduce potentially avoidable hospitalizations, ACP outcomes were not associated with hospitalization rates of nursing facility residents after adjusting for resident characteristics. These findings highlight the challenge of measuring the contributions of individual components of complex, multicomponent interventions. Associations between lower hospitalization rates and ACP completion may be influenced by contextual factors, such as clinical expertise and resources to manage acute conditions leading to hospitalization, in addition to interventions to increase ACP.

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The Burden of Breast Cancer Predisposition Variants Across The Age Spectrum Among 10 000 Patients - American Geriatric Society

BACKGROUND/OBJECTIVES

Women diagnosed with breast cancer (BC) at an older age are less likely to undergo genetic cancer risk assessment and genetic testing since the guidelines and referrals are biased toward earlier age at diagnosis. Thus, we determined the prevalence and type of pathogenic cancer predisposition variants among women with a history of BC diagnosed at the age of 65 years or older vs younger than 65 years.

DESIGN

Prospective registration cohort.

SETTING

The Clinical Cancer Genomics Community Research Network, including 40 community‐based clinics in the United States and 5 in Latin America.

PARTICIPANTS

Women with BC and genetic testing results.

MEASUREMENTS

Sociodemographic characteristics, clinical variables, and genetic profiles were compared between women aged 65 years and older and those younger than 65 years at BC diagnosis.

RESULTS

Among 588 women diagnosed with BC and aged 65 years and older and 9412 diagnosed at younger than 65 years, BC‐associated pathogenic variants (PVs) were detected in 5.6% of those aged 65 years and older (n = 33) and 14.2% of those younger than 65 years (n = 1340) (P < .01). PVs in high‐risk genes (eg, BRCA1 and BRCA2) represented 81.1% of carriers among women aged 65 years and older (n = 27) and 93.1% of those younger than 65 years (n = 1248) (P = .01). BRCA2 PVs represented 42.4% of high‐risk gene findings for those aged 65 years and older, whereas BRCA1 PVs were most common among carriers younger than 65 years (49.7%). PVs (n = 7) in moderate‐risk genes represented 21.2% for carriers aged 65 years and older and 7.3% of those younger than 65 years (n = 98; P < .01). CHEK2 PVs were the most common moderate‐risk gene finding in both groups.

CONCLUSION

Clinically actionable BC susceptibility PVs, particularly in BRCA2 and CHEK2, were relatively prevalent among older women undergoing genetic testing. The significant burden of PVs for older women with BC provides a critical reminder to recognize the full spectrum of eligibility and provide genetic testing for older women, rather than exclusion based on chronological age alone.

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Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, on new steps to help reduce risks associated with surgical staplers for internal use and implantable staples - FDA Press Releases

Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, on new steps to help reduce risks associated with surgical staplers for internal use and implantable staples

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Statement from FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier, on agency’s new steps to strengthen the process of initiating voluntary recalls - FDA Press Releases

New steps to strengthen the process of initiating voluntary recalls

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Effects of Interval Training on Visceral Adipose Tissue in Centrally Obese 70‐Year‐Old Individuals: A Randomized Controlled Trial - American Geriatric Society

OBJECTIVE

To investigate the effects of 10 weeks of progressive vigorous‐intensity interval training as a single intervention on body composition among 70‐year‐old individuals with central obesity.

DESIGN

Randomized controlled trial (ClinicalTrials.gov registration No. NCT03450655).

SETTING

Community‐dwelling 70‐year‐old men and women living in the Umeå municipality in Sweden.

PARTICIPANTS

Seventy‐seven 70‐year‐old men and women with central obesity (greater than 1 kg visceral adipose tissue [VAT] for women and greater than 2 kg VAT for men).

INTERVENTION

Participants allocated to the intervention group were offered a 10‐week progressive concurrent exercise program performed three times per week. All participants in both groups had received tailored lifestyle recommendations focused on diet and physical activity at one occasion within 12 months prior to trial initiation.

MEASUREMENTS

The primary outcome was changes in VAT, and secondary outcomes included changes in total fat mass (FM), total lean body mass (LBM), and body mass index.

RESULTS

Comparing the groups, there were no significant differences in decrease of VAT mass (P = .10), although the intervention group significantly decreased FM by 716 g (P = .01) and gained LBM by 508 g (P = .03), compared to the control group. Furthermore, the effects of the training were significantly greater in the male subcohort (P < .05 for interaction), with positive effects also on VAT and FM, where men in the intervention group decreased VAT by 175 g (P < .05) and FM by 1364 g (P = .004), compared to the male controls.

CONCLUSIONS

The present trial demonstrates that 10 weeks of progressive vigorous interval training is sufficient to significantly decrease FM in older adults with central obesity, with positive effects also on LBM.

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Using Team Training to Transform Practice within a Geriatrics‐Focused Patient‐Centered Medical Home - American Geriatric Society

Journal of the American Geriatrics Society, EarlyView.

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Geriatric Oncology: Getting Even Better with Age - American Geriatric Society

Journal of the American Geriatrics Society, EarlyView.

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Statement from Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research, on FDA’s continued confidence in the safety and effectiveness of the measles, mumps, and rubella (MMR) vaccine - FDA Press Releases

The FDA wants to underscore our continued confidence in the safety and effectiveness of the vaccines that are highly successful at preventing – in some cases, nearly eradicating – preventable diseases. Large well-designed studies have confirmed the safety and effectiveness of the MMR vaccine and have demonstrated that administration of the vaccine is not associated with the development of autism. MMR vaccine has been approved in the United States for nearly 50 years to prevent measles, mumps and rubella (also known as German Measles). As a result of its use, measles and rubella were completely eradicated in the United States, and mumps cases decreased by 99%.

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Alvogen Inc. Issues Voluntary Nationwide Recall of Fentanyl Transdermal System Due to Product Mislabeling - FDA Safety Alerts & Drug Recalls

Alvogen, Inc. is voluntarily recalling two lots of Fentanyl Transdermal System 12 mcg/h transdermal patches to the consumer level.

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FDA permits marketing of first medical device for treatment of ADHD - FDA Press Releases

FDA permits marketing of first medical device for treatment of ADHD

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Taking Care of the Dyad: Frequency of Caregiver Assessment Among Veterans with Dementia - American Geriatric Society

Objectives

This study assessed frequency of caregiver identification and needs of a sample of persons with dementia (PWDs) and their caregivers to determine whether needs were addressed and whether documentation increased with growing levels of self‐reported relationship problems and burden.

Design

Cross‐sectional design using data from electronic medical record (EMR) review and baseline research assessments (Burden Interview and Mutuality Scale). Items from a caregiver assessment tool were used to identify documentation of important factors in clinical guidelines.

Setting

Michael E. Debakey VA Medical Center, Houston, TX.

Participants

A total of 211 PWDs from a randomized controlled trial testing a psychosocial intervention for preventing aggression in PWDs.

Measurements

EMRs for 12 months before participation in the original study were abstracted, using a tool created by the authors to assess documentation of information deemed important to caregiver assessment in clinical guidelines (eg, caregiver needs, caregiver well‐being, and caregiving context). The first two authors reviewed the EMRs, adjusting the tool, based on questions that arose.

Results

Of 211 EMRs of PWDs reviewed, 177 (89%) identified caregivers. Of these, 88% identified the caregiver by name or relation to the PWD, 28% assessed caregiver well‐being, and 41% assessed caregiver needs. All EMRs assessing caregiver needs showed provision of caregiver support (including psychoeducation, skills training, or referrals for additional aid). Levels of self‐reported caregiver burden were not associated with documentation of assessment; however, higher levels of self‐reported relationship problems were positively associated with increased caregiver contact documentation and negatively associated with caregiver need documentation and Alzheimer Association referrals.

Conclusion

Healthcare providers identified caregivers in most of the sample, but less than 50% assessed their well‐being and needs.

from Wiley: Journal of the American Geriatrics Society: Table of Contents http://bit.ly/2IO6Vu2
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FDA approves first generic naloxone nasal spray to treat opioid overdose - FDA Press Releases

FDA granted approval of the 1st generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose

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Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP - FDA Safety Alerts & Drug Recalls

Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The Recall is expanded to include an additional 36 lots of Losartan potassium Tablets USP and 68 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP

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Weis Markets Issues Recall for Undeclared Egg Allergen In WQ Banana Puddin Ice Cream - FDA Safety Alerts & Drug Recalls

Weis Markets today said it has issued a recall for its Weis Quality Banana Puddin Ice Cream (48oz) since the product’s ingredient label fails to list an egg allergen due to a supplier error. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products. There have been no reports of illness from customer’s consuming this product to date.

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Mondelēz Global LLC Conducts Voluntary Recall of Certain Chewy Chips Ahoy 13oz Due to Unexpected Solidified Ingredient in Product in the US - FDA Safety Alerts & Drug Recalls

Mondelēz Global LLC announced today a limited voluntary recall in the United States of certain Chewy Chips Ahoy 13oz cookies. This voluntary recall is being conducted because of the potential for certain product to contain an unexpected solidified ingredient. Some reports of potential adverse health effects have been received.

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Jensen Tuna of Louisiana is Voluntarily Recalling Frozen Ground Tuna Imported from JK Fish, Because it may Potentially be Contaminated with Salmonella - FDA Safety Alerts & Drug Recalls

Jensen Tuna of Louisiana is Voluntarily Recalling Frozen Ground Tuna Imported from JK Fish, Because it may Potentially be Contaminated with Salmonella. The frozen product, individually packaged in clear plastic one-pound bags, is sold in white wax 20 lb. boxes. The product is only sold as a wholesale case with twenty bags in each case. The lot numbers are z266, z271 and z272.

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Hercules Candy LLC Issues Allergy Alert on Undeclared Peanuts in Cashew Brittle Bits - FDA Safety Alerts & Drug Recalls

Hercules Candy LLC . of East Syracuse, NY, is recalling its 4 ounce packages of Cashew Brittle Bits because they may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product. The recalled Cashew Brittle Bits were distributed from the brick and mortar retail in East Syracuse and nationally through the website www.herculescandy.com.

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Unilever Issues Allergy Alert on Undeclared Tree Nut in Limited Quantities of Ben & Jerry’s Coconut Seven Layer Bar Bulk and Chunky Monkey Pint - FDA Safety Alerts & Drug Recalls

Unilever is voluntarily recalling a limited quantity of Ben & Jerry’s Coconut Seven Layer Bar bulk and Ben & Jerry’s Chunky Monkey pints, which may inadvertently contain tree nuts including almonds, Brazil nuts, and hazelnuts that are not declared in the ingredient list or allergy information list. Both affected products include a “Contains Walnuts” and a “May contain other tree nuts” label on the back of the pack. Persons who have an allergy or severe sensitivity to these undeclared tree nuts run the risk of a serious or life-threatening allergic reaction if they consume the recalled products.

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FDA Statement from Deputy Commissioner for Food Policy and Response Frank Yiannas on new steps to protect consumers from unlawful ingredients in dietary supplements - FDA Press Releases

FDA Statement from Deputy Commissioner for Food Policy and Response Frank Yiannas on new steps to protect consumers from unlawful ingredients in dietary supplements

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FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to remove all devices from the market - FDA Press Releases

FDA informs companies that the agency is not approving their PMA applications and that they will have to remove their products from the market

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Exploring Disparities in Influenza Immunization for Older Women - American Geriatric Society

OBJECTIVES

While women obtain most recommended preventive health interventions more often than men, evidence is mixed regarding influenza vaccination for older adults. Therefore, we evaluated sex differences in influenza vaccination among older adults.

DESIGN

Nationally representative cross‐sectional survey.

SETTING

United States.

PARTICIPANTS

A total of 1 252 705 adults, aged 65 years and older, responding to 2013 to 2017 Medicare Consumer Assessment of Healthcare Providers and Systems surveys.

MEASUREMENTS

The dependent variable was Healthcare Effectiveness Data and Information Set self‐reported influenza immunization. The primary predictor was sex. Covariates included general health status, education, race/ethnicity, and Medicare Advantage (MA; managed care) vs Fee‐for‐Service (FFS) coverage.

RESULTS

After adjusting for health status and other sociodemographic factors, women's immunization was 2% lower than men's immunization in MA, with no significant overall sex difference in FFS. Women were immunized less often than men in 95% of MA health plans, with the largest gaps in low‐immunizing plans. Further analyses revealed variation in sex differences by health status, education, and race/ethnicity in both MA and FFS. Notably in MA, women in poor health were immunized less often than men in similar health (−4%; P < .001). Black women were immunized much less often than black men in both MA and FFS (−5%; P < .001 for each). Hispanic women were immunized less often than Hispanic men in MA (−4%; P < .001) but not within FFS.

CONCLUSION

Women in MA experience small disparities overall in influenza immunization, with larger disparities for black and Hispanic women. Providers and MA plans should increase efforts to recommend and monitor immunization for older women, especially black and Hispanic women and those in poor health. Given the potential to reduce morbidity and mortality, equitable access to a critical preventive health service, such as influenza immunization, is crucial for all older adults.

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To the Future of Ethnogeriatric Research and Publication - American Geriatric Society

The reinstatement of the Journal of the American Geriatrics Society Section on Ethnogeriatrics coincides with more rapid growth in older populations that are classified as ethnic and racial minorities in the United States than those classified as non‐Hispanic white. By 2060, 40% of older Americans are predicted to belong to a minority. Important needs for ethnogeriatric research and publication include: making sure research populations are meaningful and precise rather than using categories that include many unrelated groups; and increasing research among smaller ethnic populations of older adults. Topics in need of attention include epidemiology of common geriatric illness among the smaller populations, and social determinants for those in which disparities have been established; the extent and effectiveness of use of Culturally and Linguistically Appropriate Services Standards in geriatric care; examination of communication strategies used in provider/patient interaction, especially use of interpreters; ethnic differences in treatment of older patients; and models of use of community health workers from older patients' own cultural communities. Stresses related to caregiving in cultures emphasizing the importance of family care are important to understand acceptable models of long‐term care for diverse families. The new Ethnogeriatric Section opens the opportunity for geriatric researchers, especially those from diverse backgrounds, to explore important issues in cross‐cultural geriatric care; their findings can then form the basis of expanded ethnogeriatric curriculum for training future providers for the growing population of diverse older Americans.

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Synthesis of chemically edited derivatives of the endogenous regulator of inflammation 9-PAHSA - Journal of Antibiotics

Synthesis of chemically edited derivatives of the endogenous regulator of inflammation 9-PAHSA

Synthesis of chemically edited derivatives of the endogenous regulator of inflammation 9-PAHSA, Published online: 15 April 2019; doi:10.1038/s41429-019-0180-1

Synthesis of chemically edited derivatives of the endogenous regulator of inflammation 9-PAHSA

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Targeting adenylate-forming enzymes with designed sulfonyladenosine inhibitors - Journal of Antibiotics

Targeting adenylate-forming enzymes with designed sulfonyladenosine inhibitors

Targeting adenylate-forming enzymes with designed sulfonyladenosine inhibitors, Published online: 15 April 2019; doi:10.1038/s41429-019-0171-2

Targeting adenylate-forming enzymes with designed sulfonyladenosine inhibitors

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Cumulative Prognostic Score Predicting Mortality in Patients Older Than 80 Years Admitted to the ICU - American Geriatric Society

OBJECTIVES

To develop a scoring system model that predicts mortality within 30 days of admission of patients older than 80 years admitted to intensive care units (ICUs).

DESIGN

Prospective cohort study.

SETTING

A total of 306 ICUs from 24 European countries.

PARTICIPANTS

Older adults admitted to European ICUs (N = 3730; median age = 84 years [interquartile range = 81‐87 y]; 51.8% male).

MEASUREMENTS

Overall, 24 variables available during ICU admission were included as potential predictive variables. Multivariable logistic regression was used to identify independent predictors of 30‐day mortality. Model sensitivity, specificity, and accuracy were evaluated with receiver operating characteristic curves.

RESULTS

The 30‐day‐mortality was 1562 (41.9%). In multivariable analysis, these variables were selected as independent predictors of mortality: age, sex, ICU admission diagnosis, Clinical Frailty Scale, Sequential Organ Failure Score, invasive mechanical ventilation, and renal replacement therapy. The discrimination, accuracy, and calibration of the model were good: the area under the curve for a score of 10 or higher was .80, and the Brier score was .18. At a cut point of 10 or higher (75% of all patients), the model predicts 30‐day mortality in 91.1% of all patients who die.

CONCLUSION

A predictive model of cumulative events predicts 30‐day mortality in patients older than 80 years admitted to ICUs. Future studies should include other potential predictor variables including functional status, presence of advance care plans, and assessment of each patient's decision‐making capacity.

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Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Product Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Caito Foods is voluntarily recalling fresh cut watermelon, fresh cut honeydew melon, fresh cut cantaloupe and fresh cut mixed fruit containing one of these melons, produced at the Caito Foods facility in Indianapolis because these products have the potential to be contaminated with Salmonella Carrau, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

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Statement from Jeff Shuren, M.D., director of the Center for Devices and Radiological Health, on agency efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Illinois sterilization facility - FDA Press Releases

FDA efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Illinois sterilization facility

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FDA approves first targeted therapy for metastatic bladder cancer - FDA Press Releases

The FDA granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy.

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Statement from Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on continued efforts to assess duodenoscope contamination risk - FDA Press Releases

FDA provides updates on post-marketing study that agency ordered three manufacturers of duodenoscopes to conduct to prevent bacterial contamination of devices.

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Effect of Subjective and Objective Sleep Quality on Subsequent Peptic Ulcer Recurrence in Older Adults - American Geriatric Society

OBJECTIVE

To examine the effect of subjective and objective sleep quality on subsequent recurrence of peptic ulcer disease (PUD) among older patients after Helicobacter pylori eradication.

SETTING

Eight grade A hospitals in China.

PARTICIPANTS

Of 1689 older Chinese with H. pylori–infected PUD recruited between January 2011 and October 2014, H. pylori were eradicated and PUD was cleared in 1538 patients by the end of 2014; 1420 of these patients were followed up for up to 36 months.

MEASUREMENTS

Using multiple measures at 6‐month intervals, PUD recurrence was determined with esophagogastroduodenoscopy. Subjective sleep quality was measured using the Pittsburgh Sleep Quality Index. Objective sleep quality domains were measured using an accelerometer, including sleep onset latency, sleep efficiency, total sleep time, and number of awakenings.

RESULTS

This study documented a 36‐month cumulative PUD recurrence of 8.3% (annual rate = 2.8%). Multivariate analyses showed that participants who reported poorer sleep quality were more likely to experience PUD recurrence during the 36‐month follow‐up period (hazard ratio [HR] = 1.895; 95% confidence interval [CI] = 1.008‐3.327). Regarding objective sleep quality domains, longer sleep onset latency (HR = 1.558; 95% CI = 1.156‐2.278) and more nighttime awakenings (HR = 1.697; 95% CI = 1.168‐2.665) increased the risk of PUD recurrence. However, a longer total sleeping time protected against PUD recurrence (HR = 0.768; 95% CI = 0.699‐0.885).

CONCLUSIONS

Poor sleep quality predicts a greater risk of PUD recurrence. Accurate diagnosis and effective treatments should, therefore, be provided for older adults afflicted with poor sleep, particularly for those who previously had PUD. It is equally important to include sleep assessment as an integral part while dealing with these patients.

from Wiley: Journal of the American Geriatrics Society: Table of Contents http://bit.ly/2UcuQWf
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