Friday, January 29, 2016

Patient-Reported Outcomes of Elderly Adults with Chronic Hepatitis C Treated with Interferon- and Ribavirin-Free Regimens - American Geriatric Society

The purpose of the study was to assess the effect of different treatment regimens for chronic hepatitis C on patient-reported outcomes (PROs) of individuals aged 65 and older with chronic hepatitis C. PRO data from eight multinational multicenter Phase 2 and 3 clinical trials were included. Of 3,120 participants in these clinical trials, 229 were aged 65 and older (67.8 ± 3.2, 57% male, 75% treatment-naïve, 22% cirrhotic), and 90 of those received ledipasvir plus sofosbuvir (LDV + SOF), 119 received SOF plus ribavirin (SOF + RBV), and 20 received pegylated IFN, SOF, and RBV (IFN + SOF + RBV). Participants aged 65 and older had slightly more pretreatment PRO impairment in their physical functioning than younger individuals (−3.1% on a normalized 0–100% PRO scale, P < .001). Despite this, these participants experienced significant PRO improvement during treatment with IFN-free RBV-free regimens (up to +8.0%, P < .001), similar to improvements in younger participants. In contrast, participants aged 65 and older experienced substantial decline in PROs while receiving IFN- or RBV-containing regimens (up to −18.9% in IFN + SOF + RBV, −10.4% in IFN-free SOF+RBV, P < .001), and some were greater than in the younger group. Nevertheless, after achieving sustained viral clearance at Posttreatment Week 12, PROs in participants aged 65 and older improved regardless of the regimen (up to +10.4%, P < .001). In multivariate analysis of the cohort aged 65 and older, the use of IFN and RBV was consistently associated with PRO impairment during treatment. The use of an IFN- and RBV-free anti-HCV regimen in older adults with hepatitis C results in significant improvement of PROs.



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Care of Older Adults: Role of Primary Care Physicians in the Treatment of Cataracts and Macular Degeneration - American Geriatric Society

This article aims to facilitate optimal management of cataracts and age-related macular degeneration (AMD) by providing information on indications, risk factors, referral guidelines, and treatments and to describe techniques to maximize quality of life (QOL) for people with irreversible vision loss. A review of PubMed and other online databases was performed for peer-reviewed English-language articles from 1980 through August 2012 on visual impairment in elderly adults. Search terms included vision loss, visual impairment, blind, low vision, QOL combined with age-related, elderly, and aging. Articles were selected that discussed vision loss in elderly adults, effects of vision impairment on QOL, and care strategies to manage vision loss in older adults. The ability of primary care physicians (PCPs) to identify early signs of cataracts and AMD in individuals at risk of vision loss is critical to early diagnosis and management of these common age-related eye diseases. PCPs can help preserve vision by issuing aptly timed referrals and encouraging behavioral modifications that reduce risk factors. With knowledge of referral guidelines for soliciting low-vision rehabilitation services, visual aids, and community support resources, PCPs can considerably increase the QOL of individuals with uncorrectable vision loss. By offering appropriately timed referrals, promoting behavioral modifications, and allocating low-vision care resources, PCPs may play a critical role in preserving visual health and enhancing the QOL for the elderly population.



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Exercise and Fall Prevention: Narrowing the Research-to-Practice Gap and Enhancing Integration of Clinical and Community Practice - American Geriatric Society

Falls in older adults are a global public health crisis, but mounting evidence from randomized controlled trials shows that falls can be reduced through exercise. Public health authorities and healthcare professionals endorse the use of evidence-based, exercise-focused fall interventions, but there are major obstacles to translating and disseminating research findings into healthcare practice, including lack of evidence of the transferability of efficacy trial results to clinical and community settings, insufficient local expertise to roll out community exercise programs, and inadequate infrastructure to integrate evidence-based programs into clinical and community practice. The practical solutions highlighted in this article can be used to address these evidence-to-practice challenges. Falls and their associated healthcare costs can be reduced by better integrating research on exercise intervention into clinical practice and community programs.



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Care of Older Adults: Role of Primary Care Physicians in the Treatment of Cataracts and Macular Degeneration - American Geriatric Society

This article aims to facilitate optimal management of cataracts and age-related macular degeneration (AMD) by providing information on indications, risk factors, referral guidelines, and treatments and to describe techniques to maximize quality of life (QOL) for people with irreversible vision loss. A review of PubMed and other online databases was performed for peer-reviewed English-language articles from 1980 through August 2012 on visual impairment in elderly adults. Search terms included vision loss, visual impairment, blind, low vision, QOL combined with age-related, elderly, and aging. Articles were selected that discussed vision loss in elderly adults, effects of vision impairment on QOL, and care strategies to manage vision loss in older adults. The ability of primary care physicians (PCPs) to identify early signs of cataracts and AMD in individuals at risk of vision loss is critical to early diagnosis and management of these common age-related eye diseases. PCPs can help preserve vision by issuing aptly timed referrals and encouraging behavioral modifications that reduce risk factors. With knowledge of referral guidelines for soliciting low-vision rehabilitation services, visual aids, and community support resources, PCPs can considerably increase the QOL of individuals with uncorrectable vision loss. By offering appropriately timed referrals, promoting behavioral modifications, and allocating low-vision care resources, PCPs may play a critical role in preserving visual health and enhancing the QOL for the elderly population.



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Exercise and Fall Prevention: Narrowing the Research-to-Practice Gap and Enhancing Integration of Clinical and Community Practice - American Geriatric Society

Falls in older adults are a global public health crisis, but mounting evidence from randomized controlled trials shows that falls can be reduced through exercise. Public health authorities and healthcare professionals endorse the use of evidence-based, exercise-focused fall interventions, but there are major obstacles to translating and disseminating research findings into healthcare practice, including lack of evidence of the transferability of efficacy trial results to clinical and community settings, insufficient local expertise to roll out community exercise programs, and inadequate infrastructure to integrate evidence-based programs into clinical and community practice. The practical solutions highlighted in this article can be used to address these evidence-to-practice challenges. Falls and their associated healthcare costs can be reduced by better integrating research on exercise intervention into clinical practice and community programs.



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Garden of Life, LLC Recalls Raw Meal Organic Shake & Meal Products Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Garden of Life LLC is voluntarily withdrawing a limited quantity of its Raw Meal Organic Shake & Meal Chocolate, Original, Vanilla and Vanilla Chai because they have the potential to contain Salmonella Virchow. Even though Garden of Life routinely performs pathogen testing on every finished good lot to ensure safety and no product has ever tested positive for the presence of Salmonella, the company felt it was in the public’s best interest to take this voluntary action.

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In these last days of Open Enrollment, immigrant families need to know affordable coverage options are available - CMS Blog

In these last days of Open Enrollment, immigrant families need to know affordable coverage options are available

Affordable coverage options are available in the Health Insurance Marketplace for eligible immigrant families. In fact, most people shopping for coverage on the Marketplace can find a plan with monthly premiums of $75 or less. But, act soon:  January 31, 2016 is the final deadline for you to sign up at HealthCare.gov or CuidadodeSalud.gov for 2016 coverage.  Don’t miss out on getting coverage for 2016 and risk owing a fee of $695 or more.

If you work with immigrant communities, we need your help to make sure people who are eligible for coverage understand that they should not be worried about applying for coverage if they have a family with mixed immigration status.

Here are 10 things immigrant families need to know about Marketplace coverage:

  1. To buy private health insurance through the Marketplace, you must be a U.S. citizen, a U.S. national, or be lawfully present in the United States. In addition, immigrants with certain other statuses are also eligible.  See a list of immigration statuses that qualify for Marketplace coverage.
  2. If you recently gained U.S. citizenship or had a change in your immigration status that makes you newly eligible to enroll in coverage through the Marketplace, you may qualify for a Special Enrollment Period. See if you can enroll in a Marketplace health plan outside Open Enrollment.
  3. Financial help is available. If you’re a lawfully present immigrant and meet other eligibility criteria, you can buy private health insurance through the Marketplace, and may be eligible for lower costs on monthly premiums and lower out-of-pocket costs based on your income. More than 8out of 10 people who have enrolled in a health insurance plan through the Marketplace have qualified for financial help. In fact, most people can find monthly premiums for $75 or less, after financial assistance. In general, individuals and families whose household income for the year is between 100 percent and 400 percent of the federal poverty line for their family size may be eligible for the premium tax credit or financial assistance to pay for your premium.  You can find the levels here based on the household size. If you make less than 100 percent of the federal poverty line, which is $11,770 for an individual or $24,250 for a family of 4 (higher in Alaska and Hawaii) and you aren’t eligible for Medicaid because of your immigration status, you may still qualify for lower costs on Marketplace coverage.
  4. If you’re a “qualified non-citizen” and meet your state’s income and other eligibility rules, you may be eligible for Medicaid or Children’s Health Insurance Program (CHIP) coverage. See a list of “qualified non-citizen” statuses and other important details.
  5. If you’re a “qualified non-citizen,” you may have a 5-year waiting period to get full Medicaid or CHIP coverage. This means you must wait 5 years after receiving “qualified” immigration status and meet all other eligibility rules in the state before being eligible for full Medicaid or CHIP. See a list of exceptions to the 5-year waiting period and other important details.
  6. Many immigrant families are of “mixed status,” with members having different immigration and citizenship statuses. Mixed status families can apply for financial assistance for private insurance for their dependent family members who are eligible for coverage through the Marketplace, or for Medicaid and CHIP coverage. Family members who aren’t applying for health coverage for themselves won’t be asked if they have eligible immigration status.
  7. Federal and State Marketplaces, as well as state Medicaid and CHIP agencies, can’t require you to provide information about the citizenship or immigration status of any family or household members who aren’t applying for coverage for themselves.
  8. States can’t deny you benefits because a family or household member who isn’t applying has not provided his or her citizenship or immigration status.
  9. Information that you provide to the Marketplace won’t be used for immigration enforcement purposes.
  10. If you’re not eligible for Marketplace coverage or you can’t afford a health plan, you can get low-cost health care at a nearby community health center. Community health centers provide primary health care services to all residents in the health center’s service area. Find more information here.

Filed under: Marketplace

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Lucy's Weight Loss System Issues Voluntary Nationwide Recall of Pink Bikini and Shorts on The Beach Dietary Supplements Due To Possible Undeclared Active Pharmaceutical Ingredient - FDA Safety Alerts & Drug Recalls

Lucy's Weight Loss System is voluntarily recalling all lots of Pink Bikini and Shorts on the Beach Capsules in all colors, 30 count (750MG per capsule) to the consumer level. Pink Bikini and Shorts on the Beach may contain an undeclared active pharmaceutical ingredient.

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Thursday, January 28, 2016

FDA approves Zepatier for treatment of chronic hepatitis C genotypes 1 and 4 - FDA Press Releases

The U.S. Food and Drug Administration today approved Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients.

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FDA approves first drug to show survival benefit in liposarcoma - FDA Press Releases

The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug.

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House of Flavors Issues Allergy Alert on Undeclared Pecans in Purple Cow Cookie Butter Ice Cream - FDA Safety Alerts & Drug Recalls

House of Flavors, Inc. is voluntarily recalling a small batch of 8 oz. cups of Purple Cow Limited Edition Cookie Butter Ice Cream, sold at Meijer stores, that contain Purple Cow Butter Pecan Ice Cream with a Purple Cow Butter Pecan lid. Consumers who may have a severe allergy or sensitivity to nuts run the risk of potentially life-threatening allergic reaction if they consume this product.

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Wednesday, January 27, 2016

Figi's Issues Recall Alert on Mislabeled Marzipan - FDA Safety Alerts & Drug Recalls

Figi's Companies, Inc. of Marshfield, WI is recalling 8 ounce packages of "Classic Marzipan" because the ingredients are not properly labeled and the product contains undeclared almonds. People who have allergies to almonds run the risk of serious or life-threatening allergic reaction if they consume these products.

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FDA Classifies St. Jude Medical Field Action For 447 Of The Company’s Optisure High Voltage Leads As A Class 1 Advisory In The U.S. - FDA Safety Alerts & Drug Recalls

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that a previously communicated voluntary global field safety action related to the company’s Optisure™ Dual Coil Defibrillation Leads has now been classified as a Class 1 Advisory by the U.S. Food and Drug Administration. The Class 1 Advisory relates to a limited and well-defined group of 447 Optisure leads, 278 of which were distributed in the U.S., which may have been damaged during a manufacturing step.

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Tuesday, January 26, 2016

Celebrating the 2015 Nobel Prize in Physiology or Medicine of Dr Satoshi Ōmura - Journal of Antibiotics

Celebrating the 2015 Nobel Prize in Physiology or Medicine of Dr Satoshi Ōmura

The Journal of Antibiotics 69, 1 (January 2016). doi:10.1038/ja.2015.113

Author: Kuniaki Tatsuta



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Acknowledgments - Journal of Antibiotics

Acknowledgments

The Journal of Antibiotics 69, 2 (January 2016). doi:10.1038/ja.2015.111

Author: Kuniaki Tatsuta



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An overproduction of astellolides induced by genetic disruption of chromatin-remodeling factors in Aspergillus oryzae - Journal of Antibiotics

An overproduction of astellolides induced by genetic disruption of chromatin-remodeling factors in Aspergillus oryzae

The Journal of Antibiotics 69, 4 (January 2016). doi:10.1038/ja.2015.73

Authors: Yasutomo Shinohara, Makoto Kawatani, Yushi Futamura, Hiroyuki Osada & Yasuji Koyama



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Biological evaluation and determination of the absolute configuration of chloromonilicin, a strong antimicrobial metabolite isolated from Alternaria sonchi - Journal of Antibiotics

Biological evaluation and determination of the absolute configuration of chloromonilicin, a strong antimicrobial metabolite isolated from Alternaria sonchi

The Journal of Antibiotics 69, 9 (January 2016). doi:10.1038/ja.2015.74

Authors: Alessio Cimmino, Gennaro Pescitelli, Alexander Berestetskiy, Anna Dalinova, Denis Krivorotov, Angela Tuzi & Antonio Evidente



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Conserved biosynthetic pathways for phosalacine, bialaphos and newly discovered phosphonic acid natural products - Journal of Antibiotics

Conserved biosynthetic pathways for phosalacine, bialaphos and newly discovered phosphonic acid natural products

The Journal of Antibiotics 69, 15 (January 2016). doi:10.1038/ja.2015.77

Authors: Joshua AV Blodgett, Jun Kai Zhang, Xiaomin Yu & William W Metcalf



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Actinoplanes bogoriensis sp. nov., a novel actinomycete isolated from leaf litter - Journal of Antibiotics

Actinoplanes bogoriensis sp. nov., a novel actinomycete isolated from leaf litter

The Journal of Antibiotics 69, 26 (January 2016). doi:10.1038/ja.2015.81

Authors: Arif Nurkanto, Puspita Lisdiyanti, Moriyuki Hamada, Shanti Ratnakomala, Chiyo Shibata & Tomohiko Tamura



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Total synthesis of avermectin B1a revisited - Journal of Antibiotics

Total synthesis of avermectin B1a revisited

The Journal of Antibiotics 69, 31 (January 2016). doi:10.1038/ja.2015.47

Authors: Shuji Yamashita, Daisuke Hayashi, Aoi Nakano, Yujiro Hayashi & Masahiro Hirama



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Cytosine-type nucleosides from marine-derived Streptomyces rochei 06CM016 - Journal of Antibiotics

Cytosine-type nucleosides from marine-derived Streptomyces rochei 06CM016

The Journal of Antibiotics 69, 51 (January 2016). doi:10.1038/ja.2015.72

Authors: Semiha Çetinel Aksoy, Ataç Uzel & Erdal Bedir



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Penicyrones A and B, an epimeric pair of α-pyrone-type polyketides produced by the marine-derived Penicillium sp. - Journal of Antibiotics

Penicyrones A and B, an epimeric pair of α-pyrone-type polyketides produced by the marine-derived Penicillium sp.

The Journal of Antibiotics 69, 57 (January 2016). doi:10.1038/ja.2015.82

Authors: Ying-Yue Bu, Hiroyuki Yamazaki, Ohgi Takahashi, Ryota Kirikoshi, Kazuyo Ukai & Michio Namikoshi



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Three novel polyene macrolides isolated from cultures of Streptomyces lavenduligriseus - Journal of Antibiotics

Three novel polyene macrolides isolated from cultures of Streptomyces lavenduligriseus

The Journal of Antibiotics 69, 62 (January 2016). doi:10.1038/ja.2015.76

Authors: Jiayue Yang, Zhijun Yang, Yu Yin, Min Rao, Yongheng Liang & Mei Ge



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MBJ-0110, a novel cyclopeptide isolated from the fungus Penicillium sp. f25267 - Journal of Antibiotics

MBJ-0110, a novel cyclopeptide isolated from the fungus Penicillium sp. f25267

The Journal of Antibiotics 69, 66 (January 2016). doi:10.1038/ja.2015.78

Authors: Teppei Kawahara, Masashi Itoh, Ikuko Kozone, Miho Izumikawa, Noriaki Sakata, Toshio Tsuchida & Kazuo Shin-ya



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Absolute configuration of NFAT-133, an aromatic polyketide with immunosuppressive and antidiabetic activity from actinomycetes - Journal of Antibiotics

Absolute configuration of NFAT-133, an aromatic polyketide with immunosuppressive and antidiabetic activity from actinomycetes

The Journal of Antibiotics 69, 69 (January 2016). doi:10.1038/ja.2015.80

Authors: Yanan Yang, Linkai Yu, Hisayuki Komaki, Naoya Oku & Yasuhiro Igarashi



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Baxter initiates Voluntary Nationwide Recall of Select Lots of IV Solutions Due to the Potential for Leaking Containers and Particulate Matter - FDA Safety Alerts & Drug Recalls

Baxter International Inc. announced today it is voluntarily recalling four lots of intravenous (IV) solutions to the hospital/user level due to the potential for leaking containers and particulate matter. Baxter was made aware of these issues as the result of two complaints for leaking containers and one customer complaint each for three lots due to particulate matter. In each case, the issue was discovered prior to patient administration and there have been no adverse events associated with these incidents reported to Baxter to date.

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Monday, January 25, 2016

AA USA Trading Inc. Issues Allergy Alert on Undeclared Sulfites and Colors in AA Brand Dried Kiwi and Dried Mango - FDA Safety Alerts & Drug Recalls

AA USA Trading Inc. of South River, NJ is recalling is recalling both dried kiwi and dried mango products packaged under the AA brand in 8-ounce plastic bags, because they may contain undeclared sulfites and colors. People who have an allergy or severe sensitivity to sulfites or food colors run the risk of serious or life-threatening allergic reaction if they consume these products.

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Comorbidity in Drivers with Parkinson's Disease - American Geriatric Society

Objectives

To determine the effect of comorbidity on fitness-to-drive recommendations that physicians and on-road driving assessors make and to investigate the agreement in fitness-to-drive recommendations between physicians and on-road driving assessors.

Design

Retrospective.

Setting

Data on comorbidities associated with Parkinson's disease (PD) and fitness-to-drive recommendations were investigated.

Participants

Individuals with PD who underwent an official on-road test in Belgium (N = 72).

Measurements

Correlations between comorbidity and fitness-to-drive recommendations were calculated. Stepwise logistic regression models were used to investigate whether comorbidity was an independent predictor of fitness-to-drive recommendations (pass/fail) that the physicians or the on-road assessors made. The percentage of agreement and the prevalence and bias-adjusted kappa (PABAK) were used to investigate agreement between the physicians and the on-road assessors.

Results

Moderate correlations were found between comorbidity and fitness-to-drive recommendations that the physicians (ρ = 0.34, P = .004) and the on-road assessors (ρ = 0.30, P = .01) made. Comorbidity was the most important determinant (coefficient of determination = 0.16, P = .005) of the physicians fitness-to-drive recommendations. No significant effect of comorbidity on the on-road recommendations was found. The physicians and the on-road assessors agreed in 46 (64%) of the cases (PABAK = 0.46, P < .001).

Conclusion

Comorbidity plays a role in physicians' recommendations of fitness to drive that may explain, in part, inconsistencies between physicians and on-road assessors' fitness-to-drive recommendations. This study indicates the need for an interdisciplinary dialogue between physicians and on-road assessors to reach a comprehensive fitness-to-drive decision.



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Obstetrician–Gynecologist Practices and Beliefs Regarding External Genitalia Inspection and Speculum Examinations in Healthy Older Asymptomatic Women - American Geriatric Society

Objectives

To understand obstetrician–gynecologist perceptions of the value of external genitalia inspection and speculum examinations in older and younger healthy women across the life span.

Design

National survey from May 2010 to January 2011 asking obstetrician–gynecologists about the need for and importance of external inspection and speculum examination in four scenarios of asymptomatic healthy women aged 70, 55, 35, and 18 who present for routine health visits. Separate questions asked about the importance of various reasons for these examinations.

Setting

Mail-in survey of a national sample of obstetrician–gynecologists.

Participants

Probability sample of obstetrician–gynecologists from the American Medical Association Physician Masterfile (N = 521).

Measurements

Proportion of obstetrician–gynecologists who would perform external inspection and speculum examinations and consider these examinations to be very important.

Results

The response rate was 62%. In a healthy 70-year-old woman, 98% of respondents would perform external inspection, and 86% would perform a speculum examination. Ninety percent would perform a speculum examination in a healthy 55-year-old woman after removal of her uterus, cervix, and ovaries. Respondents more often indicated that the external examination was very important in the 70-year-old (63%) than in younger women (46–53%). Reasons rated as very important included identifying cancers and benign lesions, reassuring women of their health, and adhering to standard of care.

Conclusion

Obstetrician–gynecologists would commonly perform external and speculum examinations in asymptomatic women and believe the external examination to be particularly important in older women for cancer detection. Clinicians should discuss limitations of screening pelvic examination guidelines and elicit health goals from older women to provide more person-centered gynecological care.



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Behind Closed Doors: Involuntary Treatment in Care of Persons with Cognitive Impairment at Home in the Netherlands - American Geriatric Society

Objectives

To explore the prevalence and associated factors of involuntary treatment (physical restraints, psychotropic medication, nonconsensual care) in persons with cognitive impairment receiving home care.

Design

Cross-sectional survey using association analyses.

Setting

Professional home care in the southern part of the Netherlands.

Participants

Data were collected on 837 persons with cognitive impairment (mean age 81.6; 60% female).

Measurements

Involuntary treatment was measured using a tool to identify physical restraints, psychotropic medication, and nonconsensual care. Activities of daily living (ADLs) were measured using the ADL Hierarchy subscale of the Resident Assistant Instrument—Minimum Data Set and cognitive status using the Cognitive Performance Scale. Informal caregiver burden was assessed using the Self-Perceived Pressure from Informal Care Scale.

Results

Involuntary treatment was used in 39% of the total sample. Most common were nonconsensual care (79%; e.g., concealing medication in food, forcing hygiene) and psychotropic medication (41%). In 7% of the sample, physical restraints (e.g., deep or overturned chair, bilateral full-enclosure bedrails) were used. Caregiver burden, ADL dependency, cognitive status, living alone, and a diagnosis of dementia were strongly associated with involuntary treatment. The family of the person with cognitive impairment most often requested the use of involuntary treatment.

Conclusion

Involuntary treatment is often used in persons with cognitive impairment receiving home care in the Netherlands. Future research should focus on understanding and preventing inappropriate involuntary treatment in home care.



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Emergency Care Use and the Medicare Hospice Benefit for Individuals with Cancer with a Poor Prognosis - American Geriatric Society

Objectives

To compare patterns of emergency department (ED) use and inpatient admission rates for elderly adults with cancer with a poor prognosis who enrolled in hospice to those of similar individuals who did not.

Design

Matched case–control study.

Setting

Nationally representative sample of Medicare fee-for-service beneficiaries with cancer with a poor prognosis who died in 2011.

Participants

Beneficiaries in hospice matched to individuals not in hospice on time from diagnosis of cancer with a poor prognosis to death, region, age, and sex.

Measurements

Comparison of ED use and inpatient admission rates before and after hospice enrollment for beneficiaries in hospice and controls.

Results

Of 272,832 matched beneficiaries, 81% visited the ED in the last 6 months of life. At baseline, daily ED use and admission rates were not significantly different between beneficiaries in and not in hospice. By the week before death, nonhospice controls averaged 69.6 ED visits/1,000 beneficiary-days, versus 7.6 for beneficiaries in hospice (rate ratio (RR) = 9.7, 95% confidence interval (CI) = 9.3–10.0). Inpatient admission rates in the last week of life were 63% for nonhospice controls and 42% for beneficiaries in hospice (RR = 1.51, 95% CI = 1.45–1.57). Of all beneficiaries in hospice, 28% enrolled during inpatient stays originating in EDs; they accounted for 35.7% (95% CI = 35.4–36.0%) of all hospice stays of less than 1 month and 13.9% (95% CI = 13.6–14.2%) of stays longer than 1 month.

Conclusion

Most Medicare beneficiaries with cancer with a poor prognosis visited EDs at the end of life. Hospice enrollment was associated with lower ED use and admission rates. Many individuals enrolled in hospice during inpatient stays that followed ED visits, a phenomenon linked to shorter hospice stays. These findings must be interpreted carefully given potential unmeasured confounders in matching.



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Harnessing Protocolized Adaptation in Dissemination: Successful Implementation and Sustainment of the Veterans Affairs Coordinated-Transitional Care Program in a Non-Veterans Affairs Hospital - American Geriatric Society

The Department of Veterans Affairs (VA) Coordinated-Transitional Care (C-TraC) program is a low-cost transitional care program that uses hospital-based nurse case managers, inpatient team integration, and in-depth posthospital telephone contacts to support high-risk patients and their caregivers as they transition from hospital to community. The low-cost, primarily telephone-based C-TraC program reduced 30-day rehospitalizations by one-third, leading to significant cost savings at one VA hospital. Non-VA hospitals have expressed interest in launching C-TraC, but non-VA hospitals differ in important ways from VA hospitals, particularly in terms of context, culture, and resources. The objective of this project was to adapt C-TraC to the specific context of one non-VA setting using a modified Replicating Effective Programs (REP) implementation theory model and to test the feasibility of this protocolized implementation approach. The modified REP model uses a mentored phased-based implementation with intensive preimplementation activities and harnesses key local stakeholders to adapt processes and goals to local context. Using this protocolized implementation approach, an adapted C-TraC protocol was created and launched at the non-VA hospital in July 2013. In its first 16 months, C-TraC successfully enrolled 1,247 individuals with 3.2 full-time nurse case managers, achieving good fidelity for core protocol steps. C-TraC participants experienced a 30-day rehospitalization rate of 10.8%, compared with 16.6% for a contemporary comparison group of similar individuals for whom C-TraC was not available (n = 1,307) (P < .001). The new C-TraC program continues in operation. Use of a modified REP model to guide protocolized adaptation to local context resulted in a C-TraC program that was feasible and sustained in a real-world non-VA setting. A modified REP implementation framework may be an appropriate foundational step for other clinical programs seeking to harness protocolized adaptation in mentored dissemination activities.



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Effects of a Stepwise Multidisciplinary Intervention for Challenging Behavior in Advanced Dementia: A Cluster Randomized Controlled Trial - American Geriatric Society

Objectives

To assess whether implementation of a stepwise multicomponent intervention (STA OP!) is effective in reducing challenging behavior and depression in nursing home residents with advanced dementia.

Design

Cluster randomized controlled trial.

Setting

Twenty-one clusters (single independent nursing home units) in 12 nursing homes within the Netherlands.

Participants

Residents with advanced dementia (N = 288).

Intervention

Staff working on intervention units received comprehensive stepwise multidisciplinary training; the control condition received training on general nursing skills, dementia management and pain without the stepwise component.

Measurements

The primary outcome was agitation (Cohen-Mansfield Agitation Inventory (CMAI)). Secondary outcomes included psychotropic medication use, neuropsychiatric symptoms (Neuropsychiatric Inventory—Nursing Home version (NPI-NH)), and symptoms of depression (Cornell Scale for Depression in Dementia (CSDD), Minimum Dataset Depression Rating Scale (MDS-DRS)). Measurements were made at baseline and 3 and 6 months after the intervention. Multilevel analysis and logistical generalized estimating equations were used to test treatment and time effects. Analysis was on an intention-to-treat basis.

Results

Multilevel modeling revealed an overall effect of the intervention on challenging behavior and depression; CMAI (mean difference −4.07 points, 95% confidence interval = (CI) = −7.90 to −0.24, P = .02), NPI-NH (mean difference −3.57 points, 95% CI = −6.30 to −0.84, P = .005), CSDD (mean difference −1.59 points, 95% CI = −2.49 to −0.69, P < .001), and MDS-DRS (mean difference −0.96 points, 95% CI = −1.40 to −0.52, P < .001) scores were significantly lower in the intervention condition than the control condition. There was a significant reduction of antidepressants (N06A) (OR = 0.32); nonsignificant reductions of antipsychotics (N05A), anxiolytics (N05B), and hypnotic–sedatives (N05C) (odds ratios = 0.69 to 0.90).

Conclusion

For nursing home residents with advanced dementia and challenging behavior, providing staff with comprehensive training in behavioral management, resulted in improved behavior and less psychotropic medication use.



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Recent Literature on Medication Errors and Adverse Drug Events in Older Adults - American Geriatric Society

Medication errors and adverse drug events are common in older adults, but locating literature addressing these issues is often challenging. The objective of this article is to summarize recent studies addressing medication errors and adverse drug events in a single location to improve accessibility for individuals working with older adults. A comprehensive literature search for studies published in 2014 was conducted, and 51 potential articles were identified. After critical review, 17 studies were selected for inclusion based on innovation; rigorous observational or experimental study designs; and use of reliable, valid measures. Four articles characterizing potentially inappropriate prescribing and interventions to optimize medication regimens were annotated and critiqued in detail. The authors hope that health policy-makers and clinicians find this information helpful in improving the quality of care for older adults.



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A Geriatric Perspective on Benign Paroxysmal Positional Vertigo - American Geriatric Society

Benign paroxysmal positional vertigo (BPPV) is the most common cause of vertigo in older adults. Beyond the unpleasant sensation of vertigo, BPPV also negatively affects older adults' gait and balance and increases their risk of falling. As such it has a profound effect on function, independence, and quality of life. Otoconia are the inner ear structures that help detect horizontal and vertical movements. Aging contributes to the fragmentation of otoconia, whose displacement into the semicircular, most commonly posterior canals, can produce rotatory movement sensations with head movement. BPPV is more commonly idiopathic in older adults than in younger individuals, can present atypically, and has a more-protracted course and higher risk of recurrence. Medications such as meclizine that are commonly prescribed for BPPV can be associated with significant side effects. Dix-Hallpike and Head Roll tests can generally identify the involved canal. Symptoms resolve as otoconia fragments dissolve into the endolymph, but appropriate canalith repositioning (e.g., Epley maneuver) can expedite recovery and reduce the burden of this disorder. Observations suggesting an association between idiopathic BPPV and vitamin D deficiency and osteoporosis indicate that BPPV may share risk factors with other common geriatric conditions, which highlights the importance of moving beyond purely otological considerations and addressing the needs of older adults with vertigo through a systems-based multidisciplinary approach.



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Development of Personalized Health Messages to Promote Engagement in Advance Care Planning - American Geriatric Society

Objectives

To develop and test the acceptability of personalized intervention materials to promote advance care planning (ACP) based on the Transtheoretical Model (TTM), in which readiness to change is a critical organizing construct.

Design

Development study creating an expert system delivering TTM-personalized feedback reports and stage-matched brochures with more-general information on ACP and modifications based on participant reviews.

Setting

Senior centers.

Participants

Community-living persons aged 65 and older (N = 77).

Measurements

Participant ratings of length, attractiveness, and trustworthiness of and reactions to reports and brochures.

Results

The expert system assessed participants’ readiness to engage in each of four ACP behaviors: completion of a living will, naming a health care proxy, communication with loved ones about quality vs quantity of life, and communication with clinicians about quality vs quantity of life. The system also assessed pros and cons of engagement and values and beliefs that influence engagement. The system provided individualized feedback based on the assessment, with brochures providing additional general information. Initial participant review indicating unacceptable length led to revision of feedback reports from full-sentence paragraph format to bulleted format. After review, the majority of participants rated the materials as easy to read, trustworthy, providing new information, making them more comfortable reading about ACP, and increasing interest in participating in ACP.

Conclusion

Older adults found an expert system individualized feedback report and accompanying brochure to promote ACP engagement to highly acceptable and engaging. Additional research is necessary to examine the effects of these materials on behavior change.



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Achieving High-Quality Multicultural Geriatric Care - American Geriatric Society

As the ethnic diversity of the U.S. population increases, there is a growing awareness of healthcare disparities and the need to address them. This position statement that the American Geriatrics Society (AGS) Ethnogeriatrics Committee developed outlines healthcare disparities in the United States and the minimum quality indicators that healthcare organizations and healthcare providers should adopt to ensure that all older adults receive care that is culturally appropriate and takes into account level of health literacy.



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Effects of Device-Facilitated Isometric Progressive Resistance Oropharyngeal Therapy on Swallowing and Health-Related Outcomes in Older Adults with Dysphagia - American Geriatric Society

Swallowing disorders (dysphagia) are associated with malnutrition, aspiration pneumonia, and mortality in older adults. Strengthening interventions have shown promising results, but the effectiveness of treating dysphagia in older adults remains to be established. The Swallow STRengthening OropharyNGeal (Swallow STRONG) Program is a multidisciplinary program that employs a specific approach to oropharyngeal strengthening—device-facilitated (D-F) isometric progressive resistance oropharyngeal (I-PRO) therapy—with the goal of reducing health-related sequelae in veterans with dysphagia. Participants completed 8 weeks of D-F I-PRO therapy while receiving nutritional counseling and respiratory status monitoring. Assessments were completed at baseline, 4, and 8 weeks. At each visit, videofluoroscopic swallowing studies were performed. Dietary and swallowing-related quality of life questionnaires were administered. Long-term monitoring for 6–17 months after enrollment allowed for comparison of pneumonia incidence and hospitalizations to the 6–17 months before the program. Veterans with dysphagia confirmed with videofluoroscopy (N = 56; 55 male, 1 female; mean age 70) were enrolled. Lingual pressures increased at anterior (effect estimate = 92.5, P < .001) and posterior locations (effect estimate = 85.4, P < .001) over 8 weeks. Statistically significant improvements occurred on eight of 11 subscales of the Quality of Life in Swallowing Disorders (SWAL-QOL) Questionnaire (effect estimates = 6.5–19.5, P < .04) and in self-reported sense of effort (effect estimate = −18.1, P = .001). Higher Functional Oral Intake Scale scores (effect estimate = 0.4, P = .02) indicated that participants were able to eat less-restrictive diets. There was a 67% reduction in pneumonia diagnoses, although the difference was not statistically significant. The number of hospital admissions decreased significantly (effect estimate = 0.96; P = .009) from before to after enrollment. Findings suggest that the Swallow STRONG multidisciplinary oropharyngeal strengthening program may be an effective treatment for older adults with dysphagia.



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Friday, January 22, 2016

FDA resolves criminal and civil actions against cheese manufacturer - FDA Press Releases

Delaware-based cheese manufacturer Roos Foods, Inc. has pleaded guilty to one criminal misdemeanor count of violating the Federal Food, Drug, and Cosmetic Act (FFDCA) by introducing adulterated food into interstate commerce.

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Dole Fresh Vegetables Announces Voluntary Withdrawal for Salads - FDA Safety Alerts & Drug Recalls

Dole Fresh Vegetables, Inc., is temporarily suspending operations at its Springfield, Ohio production facility, and is voluntarily withdrawing from the market all Dole-branded and private label packaged salads processed at that location

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Carnivore Meat Company, LLC Voluntarily Issues a Recall for One Lot of Frozen Pet Food - FDA Safety Alerts & Drug Recalls

Carnivore Meat Company is recalling a single lot of Vital Essentials Frozen Chicken Patties Entree for Dogs, due to concerns of the possible presence of Salmonella. Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever.

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Washington MFFS Preliminary Evaluation Report - CMS Blog

By Patrick Conway, M.D., CMS Principal Deputy Administrator and Chief Medical Officer

Today we released a report summarizing preliminary results from the Washington Health Homes demonstration under the Medicare-Medicaid Financial Alignment Initiative. This demonstration, which began serving enrollees in July 2013, seeks to leverage Medicaid health homes to improve service quality and integration while reducing costs of care for high-risk, high-cost Medicare-Medicaid enrollees (sometimes referred to as “dual eligibles”) in Washington State.

More than 10.7 million Americans are enrolled in both the Medicare and Medicaid programs. A longstanding barrier to improving quality and reducing costs of care for Medicare-Medicaid enrollees has been a lack of alignment and cohesiveness between the two programs, including misaligned incentives for payers and providers. The Washington Health Homes demonstration tests new mechanisms to coordinate services across Medicare and Medicaid for Washington State Medicare-Medicaid enrollees, and allows the State and the Federal governments to share in savings resulting from quality improvements.

The preliminary results in this report are based on experience during the first demonstration performance period, from July 2013 – December 2014. Despite the relatively short time period, estimates show a reduction of $21.6 million in Medicare spending relative to a comparison group, representing more than 6% savings.  Future analysis will include Medicaid spending estimates as the data become available.

The report also includes early quality and utilization results, eligibility and enrollment data, characteristics of the population eligible for the demonstration, beneficiary focus group findings, and a discussion of the initial implementation experience.

While these findings are preliminary, they provide an encouraging first look at how efforts in Washington to improve quality of care by focusing on the needs of high-risk, high-cost members can reduce Medicare spending.

The first annual evaluation report on the Washington demonstration, scheduled for a 2016 release, will include additional information on the context and status of the demonstration, as well as analyses of quality, utilization, and cost measures for Medicare-Medicaid enrollees eligible for the demonstration and for a comparison group.

This model further supports delivery system reform aimed at achieving better care, smarter spending, and healthier people.  It is especially important to focus on the safety net population served by this model in order to reduce disparities and coordinate care for vulnerable populations.

This report is posted on the CMS website: http://ift.tt/1UgpQdL

Additional information about the Washington Health Homes demonstration is available on the Medicare-Medicaid Coordination Office website: http://ift.tt/1RYUCu0


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Thursday, January 21, 2016

Mahina Mele Farms, LLC Recalls Macadamia Nut Products Due To Possible Health Risk - FDA Safety Alerts & Drug Recalls

Mahina Mele Farms, LLC is recalling the following products after FDA testing found Salmonella in macadamia nuts. Salmonella is 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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Wednesday, January 20, 2016

Master Herbs, Inc. Issues Voluntary Nationwide Recall of All Lots of Licorice Coughing Liquid Due to the Presence of Morphine - FDA Safety Alerts & Drug Recalls

Pomona, CA, Master Herbs, Inc. is voluntarily recalling ALL LOTS of Licorice Coughing Liquid, cough syrup in 100 ml bottles to the consumer level. This product has been found to contain morphine, which is an opioid, and it is not declared on the label.

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Effects of a malaria elimination program: a retrospective study of 623 cases from 2008 to 2013 in a Chinese county hospital near the China – Myanmar border

Effects of a malaria elimination program: a retrospective study of 623 cases from 2008 to 2013 in a Chinese county hospital near the China – Myanmar border

Emerging Microbes & Infections 5, e6 (January 2016). doi:10.1038/emi.2016.6

Authors: Xinyu Wang, Linlin Yang, Tao Jiang, Bingyan Zhang, Shuqing Wang, Xingfen Wu, Tianying Wang, Yanlin Li, Min Liu, Quanbang Peng & Wenhong Zhang



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Identification of a second encephalitis-associated astrovirus in cattle

Identification of a second encephalitis-associated astrovirus in cattle

Emerging Microbes & Infections 5, e5 (January 2016). doi:10.1038/emi.2016.5

Authors: Torsten Seuberlich, Daniel Wüthrich, Senija Selimovic-Hamza, Cord Drögemüller, Anna Oevermann, Rémy Bruggmann & Ilias Bouzalas



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Tuesday, January 19, 2016

Clarifying, Eliminating and Enforcing Special Enrollment Periods - CMS Blog

Health Insurance Marketplace CEO Kevin Counihan

As the Health Insurance Marketplace grows and matures, we continue to listen and learn to find ways to make it work even better for consumers and those who serve consumers. We know that each year, as the Marketplace evolves, we must seek to continually adapt and refine the way we operate. In addition to continually improving the consumer experience, we also must make changes to keep the Marketplace vibrant, stable and strong.

The fundamental principles to achieve this are simple: the Marketplace must be attractive for consumers, and the Marketplace must be attractive for insurance companies that offer plans on it.

Consumers need to know that affordable options are available and that insurers are competing for their business. We know that consumers want affordable health care and value the insurance they’re finding at the Health Insurance Marketplaces. This Open Enrollment we’ve seen a significant influx of new consumers – many of them young – making it clear there is still a large untapped market for insurance companies to serve.

The Marketplace must also be attractive to insurers, so that they make quality plans available at affordable prices and continue to drive innovation, and so consumers can find plans that meet their health and budget needs. Building an attractive Marketplace starts with establishing a predictable, stable set of rules that help to keep the risk pool balanced. As the Marketplace grows and evolves, we continue to analyze data to understand how our rules are impacting insurers and consumers and to make sure they are working to sustain a stable Marketplace. By having clear rules for how the Marketplace operates and making adjustments when needed, we are creating a more stable rate environment with more affordable plan choices for consumers.

One of the areas we have been reviewing closely is the special enrollment periods we offer. Special enrollment periods are an important way to make sure that people who lose their health insurance during the year or who experience a major life change like getting married or having a child, have the opportunity to enroll in coverage through the Marketplaces. People who experience these qualifying events have the opportunity to enroll in coverage outside of the normal Open Enrollment period from November 1 to January 31, similar to how enrollment works in the employer market. In addition, in the first two years of the Marketplace, a number of special enrollment periods were created for consumers who were still learning how to enroll in coverage for the first time.

As the Marketplace matures and consumers learn more about how and when to enroll, we continue to review the rules around special enrollment periods in order to keep them fair for consumers and for issuers. We are taking initial steps in adjusting how special enrollment periods work – and will continue to make further adjustments in the future based on what we learn from continued monitoring and analysis of special enrollment period usage and compliance.

The action we are taking today announces the elimination of several unnecessary special enrollment periods, clarifies the definitions of other special enrollment periods, and provides stronger enforcement so that special enrollment periods serve the purpose for which they are intended and do not provide unintended loopholes.

  1. Eliminating Unnecessary Special Enrollment Periods: Last month, we announced that the Tax Season special enrollment period will no longer be offered. Today we are announcing the elimination of six other special enrollment periods that are no longer needed. Just as the Marketplace evolves, so too does consumer behavior. The rules we use to operate the Marketplace need to keep up with these changes. As such, special enrollment periods are no longer available for:
    • Consumers who enrolled with too much in advance payments of the premium tax credit because of a redundant or duplicate policy
    • Consumers who were affected by an error in the treatment of Social Security Income for tax dependents
    • Lawfully present non-citizens that were affected by a system error in determination of their advance payments of the premium tax credit
    • Lawfully present non-citizens with incomes below 100% FPL who experienced certain processing delays
    • Consumers who were eligible for or enrolled in COBRA and not sufficiently informed about their coverage options
    • Consumers who were previously enrolled in the Pre-Existing Condition Health Insurance Program

We’ll continue to monitor how special enrollment periods are used and may make changes in the future as Marketplace systems and operations continue to improve.

  1. Clarifying Eligibility: Our review of current special enrollment periods also showed that some of the eligibility guidelines need to be further clarified so consumers can understand the intent and so they will not be abused. Today we are updating guidance to more clearly define the special enrollment period that is available to consumers who permanently moved, and as a result, gained access to new health plans. Specifically, we clarify that this special enrollment period cannot be used for a short-term or temporary move where the consumer doesn’t plan to stay in their new location, including situations in which a consumer is admitted to a hospital for treatment in a different area. This clarification is intended to assist consumers, brokers, issuers and others in understanding who is eligible for this special enrollment period.

If we identify other areas where the rules for special enrollment periods are unclear, we will issue additional clarifying guidance as needed.

  1. Enforcing the Rules: Finally, we will take steps to make sure that consumers understand and comply with the rules. We will conduct an assessment of plan selections that are made through certain special enrollment periods to evaluate whether consumers properly accessed coverage. Our program integrity team will pull samples of consumer records nationally and may request additional information from some consumers or take other steps to validate that consumers properly qualified for these special enrollment periods. The findings from the assessment will help us to inform future policy and operational improvements to enhance program integrity. Additional details will be provided in the coming weeks.

 We will also emphasize more strongly to applicants that the law requires that consumers provide accurate information to the Marketplace, and they may be subject to penalties under federal law if they intentionally provide false or untrue information.

There is still time for consumers who need coverage to enroll during the Open Enrollment period that ends on January 31st. While there will continue to be special enrollment periods for people who lose coverage mid-year or experience other life changes, this channel for enrollment will not be available for the vast majority of consumers. For example, special enrollment periods are not allowed for people who choose to remain uninsured and then decide they need health insurance when they get sick.  Consumers who do not currently have other health insurance coverage should enroll through the Marketplace now during these last two weeks of Open Enrollment, to make sure they have coverage if they get sick and to avoid the tax penalty.


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EHR Incentive Programs: Where We Go Next - CMS Blog

By Andy Slavitt and Karen DeSalvo

Where We’ve Been

As we mentioned in a speech last week, the Administration is working on an important transition for the Electronic Health Record (EHR) Incentive Program. We have been working side by side with physician organizations and have listened to the needs and concerns of many about how we can make improvements that will allow technology to best support clinicians and their patients. While we will be putting out additional details in the next few months, we wanted to provide an update today.

In 2009, the country embarked on an effort to bring technology that benefits us in the rest of our lives into the health care system. The great promise of technology is to bring information to our fingertips, connect us to one another, improve our productivity, and create a platform for a next generation of innovations that we can’t imagine today.

Not long ago, emergency rooms, doctor’s offices, and other facilities were sparsely wired. Even investing in technology seemed daunting. There was no common infrastructure. Physician offices often didn’t have the capital to get started and it was hard for many to see the benefit of automating silos when patient care was so dispersed. We’ve come a long way since then with more than 97 percent of hospitals and three quarters of physician offices now wired.

It’s taken a tremendous commitment by physicians, hospitals, technologists, patient groups and experts from all over the country to make the progress we’ve made together in a few short years. The EHR Incentive Programs were designed in the initial years to encourage the adoption of new technology and measure the benefits for patients. And while it helped us make progress, it has also created real concerns about placing too much of a burden on physicians and pulling their time away from caring for patients.

Transitioning From Measuring Clicks to Focusing on Care

Last year, the Administration and Congress took two extraordinary steps to put patients at the center of how we pay for care and support physicians. First, the Administration set a goal that 30 percent in 2016 and 50 percent in 2018 of Medicare payments will be linked to getting better results for patients, providing better care, spending healthcare dollars more wisely, and keeping people healthy.  And, second, Congress advanced this goal through the passage of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which considers quality, cost, and clinical practice improvement activities in calculating how Medicare physician payments are determined. While MACRA also continues to require that physicians be measured on their meaningful use of certified EHR technology for purposes of determining their Medicare payments, it provides a significant opportunity to transition the Medicare EHR Incentive Program for physicians towards the reality of where we want to go next.

What Comes Next

We have been working side by side with physician and consumer communities and have listened to their needs and concerns. As we move forward under MACRA, we will be sharing details and inviting comment as we roll out our proposed regulations this spring. All of this work will be guided by several critical principles:

  1. Rewarding providers for the outcomes technology helps them achieve with their patients.
  2. Allowing providers the flexibility to customize health IT to their individual practice needs. Technology must be user-centered and support physicians.
  3. Leveling the technology playing field to promote innovation, including for start-ups and new entrants, by unlocking electronic health information through open APIs – technology tools that underpin many consumer applications.  This way, new apps, analytic tools and plug-ins can be easily connected to so that data can be securely accessed and directed where and when it is needed in order to support patient care.
    Prioritizing interoperability by implementing federally recognized, national interoperability standards and focusing on real-world uses of technology, like ensuring continuity of care during referrals or finding ways for patients to engage in their own care. We will not tolerate business models that prevent or inhibit the data from flowing around the needs of the patient.

What This Means for Doctors and Hospitals 

As we work through a transition from the staged meaningful use phase to the new program as it will look under MACRA, it is important for physicians and other clinicians to keep in mind several important things:

  1. The current law requires that we continue to measure the meaningful use of ONC Certified Health Information Technology under the existing set of standards. While MACRA provides an opportunity to adjust payment incentives associated with EHR incentives in concert with the principles we outlined here, it does not eliminate it, nor will it instantly eliminate all the tensions of the current system. But we will continue to listen and learn and make improvements based on what happens on the front line.
  2. The MACRA legislation only addresses Medicare physician and clinician payment adjustments. The EHR incentive programs for Medicaid and Medicare hospitals have a different set of statutory requirements. We will continue to explore ways to align with principles we outlined above as much as possible for hospitals and the Medicaid program.
  3. The approach to meaningful use under MACRA won’t happen overnight. Our goal in communicating our principles now is to give everyone time to plan for what’s next and to continue to give us input. We encourage you to look for the MACRA regulations this year; in the meantime, our existing regulations – including meaningful use Stage 3 – are still in effect.
  4. In December, Congress gave us new authority to streamline the process for granting hardship exception’s under meaningful use. This will allow groups of health care providers to apply for a hardship exception instead of each doctor applying individually. This should make the process much simpler for physicians and their practice managers in the future. We will be releasing guidance on this new process soon.

These principles we’ve outlined here reflect the constructive and clear articulation of issues and open sharing of views and data by stakeholders across the health care system, but they also promote our highest priority – better care for the beneficiaries of the Medicare and Medicaid program and patients everywhere.

The challenge with any change is moving from principles to reality. The process will be ongoing, not an instant fix and we must all commit to learning and improving and collaborating on the best solutions. Ultimately, we believe this is a process that will be most successful when physicians and innovators can work together directly to create the best tools to care for patients. We look forward to working collaboratively with stakeholders on advancing this change in the months ahead.


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Fresh Express Announces Precautionary Recall of a Limited Quantity of 12 oz. Baby Spinach Due to Possible Allergen Exposure - FDA Safety Alerts & Drug Recalls

Fresh Express Incorporated is voluntarily issuing a precautionary recall of 350 cases of 12 oz. Fresh Express Baby Spinach with a Product Code of G010A17A and Use-By Date of January 24 due to a possible exposure to a tree nut allergen (almond). Fresh Express representatives are already coordinating with stores to remove the recalled product from retail stores where distributed, primarily in Eastern and Southeastern states.

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Issue Information-About the AGS - American Geriatric Society



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Issue Information-Masthead - American Geriatric Society



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Issue Information-Officers of the AGS - American Geriatric Society



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Issue Information-TOC - American Geriatric Society



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Issue Information-IFA - American Geriatric Society



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Predictive Validity of the Beers and Screening Tool of Older Persons’ Potentially Inappropriate Prescriptions (STOPP) Criteria to Detect Adverse Drug Events, Hospitalizations, and Emergency Department Visits in the United States - American Geriatric Society

Objectives

To compare the predictive validity of the 2003 Beers, 2012 American Geriatrics Society (AGS) Beers, and Screening Tool of Older Persons’ potentially inappropriate Prescriptions (STOPP) criteria.

Design

Retrospective cohort.

Setting

Managed care administrative claims data from 2006 to 2009.

Participants

Commercially insured persons aged 65 and older in the United States (N = 174,275).

Measurements

Association between adverse drug events (ADEs), emergency department (ED) visits, and hospitalization outcomes and inappropriate medication use using time-varying Cox proportional hazard models. Measures of model discrimination (c-index) and hazard ratios (HRs) were calculated to compare unadjusted and adjusted models for associations.

Results

The prevalence of inappropriate prescribing was 34.1% for the 2012 AGS Beers criteria, 32.2% for the 2003 Beers criteria, and 27.6% for the STOPP criteria. Each set of criteria modestly discriminated ADEs in unadjusted analyses (STOPP criteria: hazard ratio (HR) = 2.89, 95% confidence interval (CI) = 2.68–3.12, C-index = 0.607; 2012 AGS Beers criteria: HR = 2.51, 95% CI = 2.33–2.70, C-index = 0.603; 2003 Beers criteria: HR = 2.65, 95% CI = 2.46–2.85, C-index = 0.605). Similar results were observed for ED visits and hospitalizations. The c-indices increased to between 0.65 and 0.70 in adjusted analyses. The kappa for agreement between criteria was 0.80 for the 2003 and 2012 AGS Beers criteria, 0.58 for the 2012 AGS Beers and STOPP criteria, and 0.59 for the 2003 Beers and STOPP criteria. For the three outcomes, the 2012 AGS Beers criteria had the highest sensitivity (61.2–71.2%) and the lowest specificity (41.2–70.7%), and the STOPP criteria had the lowest sensitivity (53.8–64.7%) but the highest specificity (47.8–78.1%).

Conclusion

All three criteria were modestly prognostic for ADEs, EDs, and hospitalizations, with the STOPP criteria slightly outperforming both Beers criteria. With low sensitivity, low specificity, and low agreement between the criteria, they can be used in a complementary fashion to enhance sensitivity in detecting ADEs.



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Rehabilitation of Older Adults with Dementia After Hip Fracture - American Geriatric Society

Objectives

To evaluate the effects of postoperative rehabilitation on the outcomes of older adults with dementia who experienced hip fracture.

Design

Retrospective cohort study.

Setting

Ontario, Canada.

Participants

Community-dwelling adults with dementia who underwent hip fracture surgery between 2003 and 2011. Participants were categorized as no rehabilitation, complex continuing care (CCC), home-care based rehabilitation (HCR), and inpatient rehabilitation (IPR).

Measurements

Time to long-term care (LTC) placement, mortality, and risk of repeat hip fracture and falls.

Results

Of 11,200 individuals with dementia who experienced a hip fracture during the study period, 4,494 (40.1%) received no rehabilitation, 2,474 (22.1%) were admitted to CCC, 1,157 (10.3%) received HCR, and 3,075 (27.4%) received IPR. HCR and IPR were associated with less risk of LTC admission after discharge from hospital than no rehabilitation. All three forms of rehabilitation were associated with lower risk of mortality than no rehabilitation, with the greatest effect observed with IPR. HCR was associated with a higher risk of falls than no rehabilitation (P = .03); there were no other significant between-group differences in risk of falls or repeat fractures (P > .05).

Conclusion

Postfracture rehabilitation for older adults with dementia is associated with lower risk of LTC placement and mortality. Improving access to rehabilitation services for this vulnerable population may improve postfracture outcomes.



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Effects of a High-Intensity Functional Exercise Program on Dependence in Activities of Daily Living and Balance in Older Adults with Dementia - American Geriatric Society

Objectives

To investigate the effects of a high-intensity functional exercise program on independence in activities of  daily living (ADLs) and balance in older people with dementia and whether exercise effects differed between dementia types.

Design

Cluster-randomized controlled trial: Umeå Dementia and Exercise (UMDEX) study.

Setting

Residential care facilities, Umeå, Sweden.

Participants

Individuals aged 65 and older with a dementia diagnosis, a Mini-Mental State Examination score of 10 or greater, and dependence in ADLs (N = 186).

Intervention

Ninety-three participants each were allocated to the high-intensity functional exercise program, comprising lower limb strength and balance exercises, and 93 to a seated control activity.

Measurements

Blinded assessors measured ADL independence using the Functional Independence Measure (FIM) and Barthel Index (BI) and balance using the Berg Balance Scale (BBS) at baseline and 4 (directly after intervention completion) and 7 months.

Results

Linear mixed models showed no between-group effect on ADL independence at 4 (FIM=1.3, 95% confidence interval (CI)=−1.6–4.3; BI=0.6, 95% CI=−0.2–1.4) or 7 (FIM=0.8, 95% CI=−2.2–3.8; BI=0.6, 95% CI=−0.3–1.4) months. A significant between-group effect on balance favoring exercise was observed at 4 months (BBS=4.2, 95% CI=1.8–6.6). In interaction analyses, exercise effects differed significantly between dementia types. Positive between-group exercise effects were found in participants with non-Alzheimer's dementia according to the FIM at 7 months and BI and BBS at 4 and 7 months.

Conclusion

In older people with mild to moderate dementia living in residential care facilities, a 4-month high-intensity functional exercise program appears to slow decline in ADL independence and improve balance, albeit only in participants with non-Alzheimer's dementia.



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Response of Vitamin D Concentration to Vitamin D3 Administration in Older Adults without Sun Exposure: A Randomized Double-Blind Trial - American Geriatric Society

Objectives

To determine the dose-response relationship between 25-hydroxyvitamin D (25(OH)D) and supplemental vitamin D3 in elderly nursing home residents.

Design

Randomized double-blind investigation.

Setting

Nursing home.

Participants

Of 81 women (n = 51) and men (n = 30) (mean age 87.4 ± 8) enrolled, 72 completed the study.

Intervention

Sixteen weeks of oral vitamin D3 at 800, 2,000, or 4,000 IU/d or 50,000 IU/wk.

Measurements

The main outcome was 25(OH)D concentrations (tandem mass spectrometry) after 16 weeks. Free 25(OH)D and intact parathyroid hormone (iPTH) were also analyzed. Safety monitoring of calcium and estimated glomerular filtration rate was performed, and adherence and clinical status were measured.

Results

25(OH)D concentrations increased with dose (P < .001) and were higher with 50,000 IU/wk (P < .001) than other doses and with 4,000 IU/d than 800 or 2,000 IU/d, but 800 IU and 2,000 IU/d did not differ. One subject receiving 800 IU/d had concentrations less than 20 ng/mL. All subjects receiving more than 2000 IU/d had concentrations of 20 ng/mL and greater. Free 25(OH)D concentrations rose with total 25(OH) vitamin D. Total and free 25(OH)D were related to calcium concentrations; only free 25(OH)D was related to iPTH.

Conclusion

25(OH)D increased linearly with 800 to 4,000 IU/d and 50,000 IU/wk of vitamin D3, without a ceiling effect. Data suggest that some elderly adults will require more than 800 IU/d of vitamin D3 to ensure adequate vitamin D levels. Changes in 25(OH)D with vitamin D3 were related to starting concentrations (greatest with the lowest concentrations and unchanged with 800 and 2,000 IU/d if 20–40 ng/mL). Relationships between serum calcium and iPTH and free 25(OH)D suggest the potential for free 25(OH)D in defining optimal 25(OH)D concentrations.



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Breathlessness in Elderly Adults During the Last Year of Life Sufficient to Restrict Activity: Prevalence, Pattern, and Associated Factors - American Geriatric Society

Objectives

To investigate relationships between age, clinical characteristics, and breathlessness sufficient to have people spend at least half a day a month in bed or to cut down on their usual activities (restricting breathlessness) during the last year of life.

Design

Secondary data analysis.

Setting

General community.

Participants

Nondisabled persons aged 70 and older (N = 754).

Measurements

Monthly telephone interviews were conducted to determine the occurrence of restricting breathlessness. The primary outcome was percentage of months with restricting breathlessness reported during the last year of life.

Results

Data regarding breathlessness were available for 548 of 589 (93.0%) participants who died (mean age 86.7, range 71–106; 38.8% male) between enrollment (March 1998 to October 1999) and June 2013; 311 of these (56.8%) reported restricting breathlessness at some point during the last year of life, but none reported it every month. Frequency increased in the months closer to death, irrespective of cause. Restricting breathlessness was associated with anxiety (0.25 percentage points greater in months with breathlessness per percentage point months reported anxiety, 95% confidence interval (CI) = 0.16–0.34, P < .001), depression (0.14, 95% CI = 0.05–0.24, P = .003), and mobility problems (0.07, 0.03–0.1, P < .001). Percentage months of restricting breathlessness was greater if chronic lung disease was noted at the most-recent comprehensive assessment (6.62 percentage points, 95% CI = 4.31–8.94, P < .001), heart failure (3.34 percentage points, 95% CI = 0.71–5.97, P = .01), and ex-smoker status (3.01 percentage points, 95% CI = 0.94–5.07, P = .004) but decreased with older age (−0.19 percentage points, 95% CI = −0.37 to −0.02, P = .03).

Conclusion

Restricting breathlessness increased in this elderly population in the months preceding death from any cause. Breathlessness should be assessed and managed in the context of poor prognosis.



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Survival Prognosis in Very Old Adults - American Geriatric Society

Objectives

To determine whether simple functional indicators are predictors of survival prognosis in very old adults.

Design

In-person survey conducted over a 3-month period in 1998; assessment of survival over a 15-year follow-up period.

Setting

Denmark.

Participants

All 3,600 Danes born in 1905 and living in Denmark in 1998, were invited to participate regardless of residence and health; 2,262 (63%) participated in the survey: 1,814 (80.2%) in person and 448 (19.8%) through a proxy.

Measurements

Socioeconomic factors, medications and diseases, activities of daily living, physical performance, cognition, depression symptomatology, self-rated health, and all-cause mortality, evaluated as average remaining lifespan and chance of surviving to 100 years.

Results

Men aged 92 to 93 had an overall 6.0% chance of surviving to 100 years, whereas the chance for women was 11.4%. Being able to rise without use of hands increased the chance for men to 11.2% (95% confidence interval (CI) = 7.7–14.7) and for women to 22.0% (95% CI = 18.9–25.1). When combining this with a Mini-Mental State Examination (MMSE) scores from 28 to 30, the chances were 21.7% (95% CI = 11.5–31.9) for men and 34.2% (95% CI = 24.8–43.5) for women.

Conclusion

Chair stand score combined with MMSE score is a quick and easy way to estimate overall chance of survival in very old adults, which is particularly relevant when treatment with potential side effects for nonacute diseases is considered.



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Effects of Changes in Number of Medications and Drug Burden Index Exposure on Transitions Between Frailty States and Death: The Concord Health and Ageing in Men Project Cohort Study - American Geriatric Society

Objectives

To investigate the effects of number of medications and Drug Burden Index (DBI) on transitions between frailty stages and death in community-dwelling older men.

Design

Cohort study.

Setting

Sydney, Australia.

Participants

Community-dwelling men aged 70 and older (N = 1,705).

Measurements

Self-reported questionnaires and clinic visits were conducted at baseline and 2 and 5 years. Frailty was assessed at all three waves according to the modified Fried frailty phenotype. The total number of regular prescription medications and DBI (a measure of exposure to sedative and anticholinergic medications) were calculated over the three waves. Data on mortality over 9 years were obtained. Multistate modeling was used to characterize the transitions across three frailty states (robust, prefrail, frail) and death.

Results

Each additional medication was associated with a 22% greater risk of transitioning from the robust state to death (adjusted 95% confidence interval (CI) = 1.06–1.41). Every unit increase in DBI was associated with a 73% greater risk of transitioning from the robust state to the prefrail state (adjusted 95% CI = 1.30–2.31) and a 2.75 times greater risk of transitioning from the robust state to death (adjusted 95% CI = 1.60–4.75). There was no evidence of an adjusted association between total number of medications or DBI and the other transitions.

Conclusion

Although the possibility of confounding by indication cannot be excluded, additional medications were associated with greater risk of mortality in robust community-dwelling older men. Greater DBI was also associated with greater risk of death and transitioning from the robust state to the prefrail state.



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Falls and Parkinson's Disease: Evidence from Video Recordings of Actual Fall Events - American Geriatric Society

Objectives

To compare the fall characteristics of individuals with and without Parkinson's disease (PD) through the analysis of real-life falls captured on video.

Design

Observational cohort study.

Setting

Two long-term care facilities in British Columbia, Canada.

Participants

Individuals living in long-term care (N = 306; 16 with PD).

Measurements

Falls captured on video and analyzed (N = 906; 71 in participants with PD). Generalized estimating equation models were used to examine differences in fall characteristics between participants with and without PD.

Results

Individuals with PD were 1.3 times as likely as those without PD to fall because of incorrect weight shifting (95% confidence interval (CI) = 1.03–1.65). Secondary steps during the fall event were 1.5 times as likely to be short in individuals with PD as in those without (95% CI = 1.23–1.78). Individuals with PD were also 1.6 times as likely to attempt to recover balance by reaching to grasp an external object (95% CI = 1.13–2.15) and 5.0 times as likely to secure grasp of the object (95% CI = 1.23–20.0).

Conclusion

Along with greater likelihood for individuals with PD to fall because of incorrect weight shifting, differences between groups were found in reactive stepping responses. This first detailed evidence of the characteristics of falls in PD should help to inform fall and injury prevention approaches for clinicians and rehabilitation professionals working with individuals with PD.



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Exercise Mode Moderates the Relationship Between Mobility and Basal Ganglia Volume in Healthy Older Adults - American Geriatric Society

Objectives

To examine whether 12 months of aerobic training (AT) moderated the relationship between change in mobility and change in basal ganglia volume than balance and toning (BAT) exercises in older adults.

Design

Secondary analysis of a randomized controlled trial.

Setting

Champaign-Urbana, Illinois.

Participants

Community-dwelling older adults (N = 101; mean age 66.4).

Intervention

Twelve-month exercise trial with two groups: AT and BAT.

Measurements

Mobility was assessed using the Timed Up and Go test. Basal ganglia (putamen, caudate nucleus, pallidum) was segmented from T1-weighted magnetic resonance images using the Oxford Centre for Functional Magnetic Resonance Imaging of the Brain Software Library Integrated Registration and Segmentation Tool. Measurements were obtained at baseline and trial completion. Hierarchical multiple regression was conducted to examine whether exercise mode moderates the relationship between change in mobility and change in basal ganglia volume over 12 months. Age, sex, and education were included as covariates.

Results

Exercise significantly moderated the relationship between change in mobility and change in left putamen volume. Specifically, for the AT group, volume of the left putamen did not change, regardless of change in mobility. Similarly, in the BAT group, those who improved their mobility most over 12 months had no change in left putamen volume, although left putamen volume of those who declined in mobility levels decreased significantly.

Conclusion

The primary finding that older adults who engaged in 12 months of BAT training and improved mobility exhibited maintenance of brain volume in an important region responsible for motor control provides compelling evidence that such exercises can contribute to the promotion of functional independence and healthy aging.



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