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Anahi Guedes de Mello
Anthropology has increasingly questioned the hegemony of biomedical knowledge in ethical review processes of social research projects prevailing in Brazil, which was governed until 2012 by the Human Research Ethics Committee of each institution under the auspices of the National Research Ethics Commission (CONEP). This was mandated through Resolution No. 196/1996 prevailing in 2012 when this field research was conducted. The scope of this study is to recount and reflect upon the barriers to obtaining approval in 2012 for my master's research project from the Human Research Ethics Committee of the Federal University of Santa Catarina (CEP/UFSC) in Florianopolis...
October 2016: Ciência & Saúde Coletiva
David C Classen, William Munier, Nancy Verzier, Noel Eldridge, David Hunt, Mark Metersky, Chesley Richards, Yun Wang, P Jeffrey Brady, Amy Helwig, James Battles
The explicit declaration in the landmark 1999 Institute of Medicine report "To Err Is Human" that, in the United States, 44,000 to 98,000 patients die each year as a consequence of "medical errors" gave widespread validation to the magnitude of the patient safety problem and catalyzed a number of U.S. federal government programs to measure and improve the safety of the national healthcare system. After more than 10 years, one of those federal programs, the Medicare Patient Safety Monitoring System (MPSMS), has reached a level of maturity and stability that has made it useful for the consistent measurement of the safety of inpatient care...
October 20, 2016: Journal of Patient Safety
(no author information available yet)
This document provides the final text of regulations governing employee protection (retaliation or whistleblower) claims under section 1558 of the Affordable Care Act, which added section 18C to the Fair Labor Standards Act to provide protections to employees who may have been subject to retaliation for seeking assistance under certain affordability assistance provisions (for example, health insurance premium tax credits) or for reporting potential violations of the Affordable Care Act's consumer protections (for example, the prohibition on rescissions)...
October 13, 2016: Federal Register
Vernon G Thomas, Robert H Hanner, Alex V Borisenko
Managing invasive alien species in Canada requires reliable taxonomic identification as the basis of rapid-response management. This can be challenging, especially when organisms are small and lack morphological diagnostic features. DNA-based techniques, such as DNA barcoding, offer a reliable, rapid, and inexpensive toolkit for taxonomic identification of individual or bulk samples, forensic remains, and even environmental DNA. Well suited for this requirement, they could be more broadly deployed and incorporated into the operating policy and practices of Canadian federal departments and should be authorized under these agencies' articles of law...
July 19, 2016: Genome Génome / Conseil National de Recherches Canada
R Sarlo, G Pereira, M Surica, D Almeida, C Araújo, O Figueiredo, E Rocha, E Vargas
Establishing an organization to promote organ donation and a good organ procurement team assure quality and improve performance on organ donation rates. Brazil's organ procurement structure is based on 2 models disseminated worldwide: the "Spanish model," based on in-house coordinators, and the "American organ procurement organization (OPO) model," with extra-hospital coordinators. In 2006, Brazil's Federal Government had formally introduced the in-house coordination model for every hospital equipped with a mechanical ventilator bed...
September 2016: Transplantation Proceedings
Sue Kildea, Sally Tracy, Juanita Sherwood, Fleur Magick-Dennis, Lesley Barclay
The well established disparities in health outcomes between Indigenous and non-Indigenous Australians include a significant and concerning higher incidence of preterm birth, low birth weight and newborn mortality. Chronic diseases (eg, diabetes, hypertension, cardiovascular and renal disease) that are prevalent in Indigenous Australian adults have their genesis in utero and in early life. Applying interventions during pregnancy and early life that aim to improve maternal and infant health is likely to have long lasting consequences, as recognised by Australia's National Maternity Services Plan (NMSP), which set out a 5-year vision for 2010-2015 that was endorsed by all governments (federal and state and territory)...
October 17, 2016: Medical Journal of Australia
Yves Bergevin, Bettina Habib, Keesa Elicksen-Jensen, Stephen Samis, Jean Rochon, Jean-Louis Denis, Denis Roy
A study on the impact of regionalization on the Triple Aim of Better Health, Better Care and Better Value across Canada in 2015 identified major findings including: (a) with regard to the Triple Aim, the Canadian situation is better than before but variable and partial, and Canada continues to underperform compared with other industrialized countries, especially in primary healthcare where it matters most; (b) provinces are converging toward a two-level health system (provincial/regional); (c) optimal size of regions is probably around 350,000-500,000 population; d) citizen and physician engagement remains weak...
2016: HealthcarePapers
(no author information available yet)
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to implement Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), which amended provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that govern the approval of 505(b)(2) applications and abbreviated new drug applications (ANDAs). This final rule implements portions of Title XI of the MMA that pertain to provision of notice to each patent owner and the new drug application (NDA) holder of certain patent certifications made by applicants submitting 505(b)(2) applications or ANDAs; the availability of 30-month stays of approval on 505(b)(2) applications and ANDAs that are otherwise ready to be approved; submission of amendments and supplements to 505(b)(2) applications and ANDAs; and the types of bioavailability and bioequivalence data that can be used to support these applications...
October 6, 2016: Federal Register
Allison J Carroll, Darwin R Labarthe, Mark D Huffman, Brian Hitsman
The purpose of this review is to emphasize the role of tobacco prevention and control in cardiovascular health (CVH) promotion and cardiovascular disease (CVD) prevention, including the importance of these endpoints for measuring the full impact of tobacco-related policies, programs, and practices. In this review, we describe an overview of tobacco control interventions that have led to substantial declines in tobacco use and the relationship between these declines with CVH and CVD. We review interventions that have had success in high-income countries (HICs) as well as those that are gaining traction in low- and middle-income countries (LMICs)...
October 4, 2016: Preventive Medicine
Lauren Arnesen, Pablo Durán, Juan Silva, Luisa Brumana
Objective To consolidate available information from the Latin American and Caribbean (LAC) region on 1) national incidence of retinopathy of prematurity (ROP) and 2) national-level government inputs on ROP (existing national policies, guidelines, programs, and financing for ROP prevention, detection, and treatment, including ROP screening) in 2014. Methods In March and April 2015, a multi-country online survey was distributed to 56 medical and public health experts working on ROP in LAC countries. Respondents were instructed to provide quantitative and qualitative information representative of the national situation in 2014 for ROP incidence and national-level government inputs (existing national policies, guidelines, programs, and financing for ROP prevention, detection, and treatment, including ROP screening) in their country...
June 2016: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
Adam L Beckman, Alyssa Bilinski, Ryan Boyko, George M Camp, A T Wall, Joseph K Lim, Emily A Wang, R Douglas Bruce, Gregg S Gonsalves
Prisoners bear much of the burden of the hepatitis C epidemic in the United States. Yet little is known about the scope and cost of treating hepatitis C in state prisons-particularly since the release of direct-acting antiviral medications. In the forty-one states whose departments of corrections reported data, 106,266 inmates (10 percent of their prisoners) were known to have hepatitis C on or about January 1, 2015. Only 949 (0.89 percent) of those inmates were being treated. Prices for a twelve-week course of direct-acting antivirals such as sofosbuvir and the combination drug ledipasvir/sofosbuvir varied widely as of September 30, 2015 ($43,418-$84,000 and $44,421-$94,500, respectively)...
October 1, 2016: Health Affairs
T'Pring R Westbrook, Sarah A Avellar, Neil Seftor
BACKGROUND: The federal government's emphasis on supporting the implementation of evidence-based programs has fueled a need to conduct and assess rigorous evaluations of programs. Through partnerships with researchers, policy makers, and practitioners, evidence reviews-projects that identify, assess, and summarize existing research in a given area-play an important role in supporting the quality of these evaluations and how the findings are used. These reviews encourage the use of sound scientific principles to identify, select, and implement evidence-based programs...
September 30, 2016: Evaluation Review
Anne Kott, Rupali J Limaye
OBJECTIVE: During a disease outbreak, media serve as primary transmitters of information from public health agencies to the public, and have been shown to influence both behavior and perception of risk. Differences in news frequency, framing and information source can impact the public's interpretation of risk messages and subsequent attitudes and behaviors about a particular threat. The media's framing of an outbreak is important, as it may affect both perception of risk and the ability to process important health information...
September 20, 2016: Social Science & Medicine
Carli Friedman
Rosa's Law, which changed references of "mental retardation" to "intellectual disability" within federal legislation, marked recognition by the federal government that the term "mental retardation" is outdated and pejorative. However, Rosa's Law did not apply to many notable federal programs related to disability, such as Medicaid. This article explores if and how the term "mental retardation" was used within Medicaid Home and Community Based Services 1915(c) waivers, as they are the most prevalent provider of long-term services and supports for people with intellectual and developmental disabilities...
October 2016: Intellectual and Developmental Disabilities
Marva M Moxey-Mims, Michael F Flessner, Lawrence Holzman, Frederick Kaskel, John R Sedor, William E Smoyer, Aliza M Thompson, Lynne Yao
Nephrology has conducted few high-quality clinical trials, and the trials that have been conducted have not resulted in the approval of new treatments for primary or inflammatory glomerular diseases. There are overarching process issues that affect the conduct of all clinical trials, but there are also some specialty-specific issues. Within nephrology, primary glomerular diseases are rare, making adequate recruitment for meaningful trials difficult. Nephrologists need better ways, beyond histopathology, to phenotype patients with glomerular diseases and stratify the risk for progression to ESRD...
September 26, 2016: Clinical Journal of the American Society of Nephrology: CJASN
Samantha Hollingworth, Jianzhen Zhang, Bharat Phani Vaikuntam, Claire Jackson, Geoffrey Mitchell
BACKGROUND: To plan integrated care at end of life for people with either heart failure or lung disease, we used a case conference between the patient's general practitioner (GP), specialist services and a palliative care consultant physician. This intervention significantly reduced hospitalisations and emergency department visits. This paper reports estimates of potential savings of reduced hospitalisation through end of life case conferences in a pilot study. METHODS: We used Australian Refined Diagnosis Related Group codes to obtain data on hospitalisations and costs...
2016: BMC Palliative Care
Won Kim Cook, Iyanrick John, Corina Chung, Winston Tseng, Juliet P Lee
Medicaid coverage increases access to care and improves health outcomes for disadvantaged populations. Yet disparities in enrollment and access to care persist. To understand the facilitators and barriers of Medicaid enrollment and accessing care under the Affordable Care Act for disadvantaged Asian Americans and Pacific Islanders. Focus groups and key informant interviews were conducted. Informational barriers to accessing care were pervasive among most new enrollees. Immigrants with limited English proficiency experienced disproportionate difficulties in enrolling and accessing care post enrollment...
September 20, 2016: Journal of Immigrant and Minority Health
Eric J Chan, Dale E McNiel, Renee L Binder
With most youths now using the Internet and social networking sites (SNSs), the public has become increasingly concerned about risks posed by online predators. In response, lawmakers have begun to pass laws that ban or limit sex offenders' use of the Internet and SNSs. At the time of this article, 12 states and the federal government have passed legislation attempting to restrict or ban the use of SNSs by registered sex offenders. These laws have been successfully challenged in 4 states. In this article, we discuss examples of case law that illustrate evolving trends regarding Internet and social networking site restrictions on sex offenders on supervised release, as well as those who have already completed their sentences...
September 2016: Journal of the American Academy of Psychiatry and the Law
Brian F Thomas, Gerald T Pollard
Cannabis is classified as a schedule I controlled substance by the US Drug Enforcement Agency, meaning that it has no medicinal value. Production is legally restricted to a single supplier at the University of Mississippi, and distribution to researchers is tightly controlled. However, a majority of the population is estimated to believe that cannabis has legitimate medical or recreational value, numerous states have legalized or decriminalized possession to some degree, and the federal government does not strictly enforce its law and is considering rescheduling...
2016: Frontiers in Pharmacology
Ratilal Lalloo, Jeroen Kroon
OBJECTIVE: Analyse the Queensland Dental Public Service waiting list from 2013 to 2015 while various funding agreements between the federal and state and territory governments were in place. METHODS: Queensland Public Dental Service waiting list is open data and is updated monthly. This analysis reports on the changing number of people waiting for care and the percentage of people waiting beyond the reasonable period. RESULTS: While the number of people waiting decreased when funding was specifically allocated to "blitz the dental public waiting list", these have since increased back to pre-blitz period numbers...
September 13, 2016: Australian and New Zealand Journal of Public Health
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