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consent vulnerable adult

Jordan P Davis, Emily A Lux, Douglas C Smith, Leah Cleeland
: Evidence suggests that vulnerable populations such as substance users, those involved in the criminal justice system, and those with cognitive deficits often fail to recall information regarding the informed assent process. This study investigated correlates of assent quiz errors (AQE) among adolescents enrolling in a substance use disorder treatment study. METHOD: Adolescents (age 13-19) entering substance use treatment completed a standard informed consent procedure to participate in a longitudinal research study, followed by a brief 6-item assent quiz...
2016: Journal of Child & Adolescent Substance Abuse
Jennifer A Price, Ana I F Sousa Soares, Augustine D Asante, Joao S Martins, Kate Williams, Virginia L Wiseman
BACKGROUND: Despite public health care being free at the point of delivery in Timor-Leste, wealthier patients access hospital care at nearly twice the rate of poorer patients. This study seeks to understand the barriers driving inequitable utilisation of hospital services in Timor-Leste from the perspective of community members and health care managers. METHODS: This multisite qualitative study in Timor-Leste conducted gender segregated focus groups (n = 8) in eight districts, with 59 adults in urban and rural settings, and in-depth interviews (n = 8) with the Director of community health centres...
September 30, 2016: BMC Health Services Research
John Muscedere, David Maslove, John Gordon Boyd, Nicole O'Callaghan, Francois Lamontagne, Steven Reynolds, Martin Albert, Rick Hall, Danielle McGolrick, Xuran Jiang, Andrew G Day
BACKGROUND: Nosocomial infections remain an important source of morbidity, mortality, and increased health care costs in hospitalized patients. This is particularly problematic in intensive care units (ICUs) because of increased patient vulnerability due to the underlying severity of illness and increased susceptibility from utilization of invasive therapeutic and monitoring devices. Lactoferrin (LF) and the products of its breakdown have multiple biological effects, which make its utilization of interest for the prevention of nosocomial infections in the critically ill...
September 29, 2016: Trials
Victoria Shepherd
BACKGROUND: Society is failing in its moral obligation to improve the standard of healthcare provided to vulnerable populations, such as people who lack decision making capacity, by a misguided paternalism that seeks to protect them by excluding them from medical research. Uncertainties surround the basis on which decisions about research participation is made under dual regulatory regimes, which adds further complexity. Vulnerable individuals' exclusion from research as a result of such regulation risks condemning such populations to poor quality care as a result of 'evidence biased' medicine...
2016: BMC Medical Ethics
Abigael Obura Awuor, Joel Montgomery, Ellen Yard, Collen Martin, Johnni Daniel, Nicholas Zitomer, Michael Rybak, Lauren Lewis, Timothy Phillips, Amelia Romoser, Sarah Elmore, Elvis Oyugi, Samwel Amwayi, Christine Bii, John Vulule
Acute aflatoxin exposure can cause death and disease (aflatoxicosis) in humans. Aflatoxicosis fatality rates have been documented to be as high as 40% in Kenya. The inclusion in the diet of calcium silicate 100 (ACCS100), a calcium montmorillonite clay, may reduce aflatoxin bioavailability; thus potentially decreasing the risk of aflatoxicosis. We investigated the efficacy, acceptability, and palatability of ACCS100 in a population in Kenya with recurring aflatoxicosis outbreaks. Healthy adult participants were enrolled in this double-blinded, cross-over clinical trial in 2014...
September 7, 2016: Food Additives & Contaminants. Part A, Chemistry, Analysis, Control, Exposure & Risk Assessment
Vicky Stergiopoulos, Agnes Gozdzik, Jason Tan de Bibiana, Tim Guimond, Stephen W Hwang, Donald A Wasylenki, Molyn Leszcz
BACKGROUND: Frequent users of hospital emergency departments (EDs) are a medically and socially vulnerable population. This article describes the rationale for a brief case management intervention for frequent ED users with mental health and/or addiction challenges and the design of a randomized trial assessing its effectiveness. METHODS/DESIGN: Eligible participants are adults in a large urban centre with five or more ED visits in the past year, with at least one prior visit for a mental health or addictions reason...
2016: BMC Health Services Research
Alexandre Marchac, Tomasine Kuschner, John Paris, Arnaud Picard, Marie Paule Vazquez, Laurent Lantieri
BACKGROUND: In 2005, face transplantation ceased to be fiction and became a scientific reality. Today, 10 teams from six different countries have performed 32 face transplantations. Immunosuppressive treatments are similar to other solid organ transplants, and patients have experienced a significant functional improvement. The authors are logically considering expanding face transplantation to children; however, children are not simply small adults. METHODS: The authors searched for pediatric patients in need of restoration of fundamental functions of the face, such as orbicularis oris or oculi muscle closure by, first, selecting cases from a pediatric plastic surgery reference center and, second, analyzing the feasibility of face transplantation in those patients...
August 2016: Plastic and Reconstructive Surgery
Berliz Adato, Gal Dubnov-Raz, Hadas Gips, Yuval Heled, Yoram Epstein
UNLABELLED: A common and unfortunate cause for heat stroke-related deaths in children is entrapment in closed vehicles. The aim of this study was to analyze the pathological consequences of such grave events. Autopsy reports of all children that were brought to a national forensic medicine center after being found dead in closed vehicles over a 21-year period (1995-2015) were reviewed. Data extracted were the circumstances of the events, child age, sex, height and weight, time, date and duration of entrapment, and environmental temperatures at the time of entrapment and the autopsy findings...
September 2016: European Journal of Pediatrics
Rosemary Purcell, Susy Harrigan
OBJECTIVE: Research on crime victimisation in the mentally ill has focused on middle aged cohorts with long-standing illness and functional disability. The rates and correlates of victimisation in young cohorts is largely unknown. METHODS: Participants (n=776) were aged 12-25 years attending headspace centres in Australia, who consented to a clinical interview and provided self-reported data regarding lifetime victimisation. RESULTS: A quarter of the sample (24...
July 12, 2016: Australasian Psychiatry: Bulletin of Royal Australian and New Zealand College of Psychiatrists
Tina Malan, Keymanthri Moodley
Although clinical research in oncology is vital to improve current understanding of cancer and to validate new treatment options, voluntary informed consent is a critical component. Oncology research participants are a particularly vulnerable population; hence, therapeutic misconception often leads to ethical and legal challenges. We conducted a qualitative study administering semi-structured questionnaires on 29 adult, Phase 3, oncology clinical trial participants at three different private oncology clinical trial sites in South Africa...
February 2016: Journal of Empirical Research on Human Research Ethics: JERHRE
Md Iqbal Kabir, Md Bayzidur Rahman, Wayne Smith, Mirza Afreen Fatima Lusha, Abul Hasnat Milton
BACKGROUND: Bangladesh is facing the unavoidable challenge of adaptation to climate change. However, very little is known in relation to climate change and health. This article provides information on potential climate change impact on health, magnitude of climate-sensitive diseases, and baseline scenarios of health systems to climate variability and change. DESIGN: A cross-sectional study using multistage cluster sampling framework was conducted in 2012 among 6,720 households of 224 rural villages in seven vulnerable districts of Bangladesh...
2016: Global Health Action
Zahra Nozhat, Mehdi Hedayati
Thyroid carcinoma is the most common malignancy of the endocrine system and it accounts approximately 1%-3% of all human cancers. Among the three subtypes of thyroid cancers, medullary thyroid carcinoma (MTC) is the most common cause of death in patients with multiple endocrine neoplasia (MEN) type 2A (MEN2A), MEN type 2B (MEN2B) and familial medullary thyroid carcinoma (FMTC). Generally, MTC accounts for up to 10% of all types of thyroid cancers. It is one of the aggressive forms of thyroid carcinoma which is manifested in childhood ages more than adults, and it comprises about 17% of all pediatric thyroid cancer...
June 1, 2016: Journal of Pediatric Endocrinology & Metabolism: JPEM
Rachel Jenkins, Caleb Othieno, Linnet Ongeri, Peter Sifuna, Michael Ongecha, James Kingora, David Kiima, Raymond Omollo, Bernhards Ogutu
BACKGROUND: Repeat household surveys are useful to assess change in prevalence over time, but there have been no repeat surveys of common mental disorder (CMD) in Kenya, or indeed sub-Saharan Africa. Therefore a repeat household survey of CMD and its associated risk factors was conducted in Maseno area, Kisumu county in Kenya, using a demographic surveillance site as the sample frame, in order to test the hypotheses that (a) the prevalence of CMD would increase between 2004 and 2013 due to the intervening political, social and economic pressures; (b) as in 2004, there would be no gender difference in prevalence of CMD...
2015: BMC Psychiatry
Richard F Ittenbach, Elizabeth C Senft, Guixia Huang, Jeremy J Corsmo, Joan E Sieber
With passage and implementation of the Affordable Health Care Act, more vulnerable segments of the U.S. population will now have access to regular health care and increased opportunities to participate in biomedical research. Yet, access to new groups brings with it new responsibilities for investigators, most importantly, reducing burdens for participants. Data collected through this small pilot study suggest several preliminary but potentially important findings when working with adults from low-income populations: First, while all participants read some parts of the consent forms (55%), only a minority reported reading the entire form (45%); second, 73% of participants reported understanding the study very well whereas only 27% reported understanding the study "a little"; third, there was a slight reported advantage of the simplified form over the regular form; however, this difference varied by section...
December 2015: Journal of Empirical Research on Human Research Ethics: JERHRE
Karin Jongsma, Wendy Bos, Suzanne van de Vathorst
Children and adults with dementia are vulnerable populations. Both groups are also relatively seldom included in biomedical research. However, including them in clinical trials is necessary, since both groups are in need of scientific innovation and new therapies. Their dependence and limited decision-making capacities increase their vulnerability, necessitating extra precautions when including them in clinical trials. Beside these similarities there are also many differences between the groups. The most obvious one is that children have an entire life ahead of them and will become persons with certain ideals and preferences, while adults with dementia have lived a life in which they have expressed their ideals and preferences...
November 2015: Bioethics
Sophie Forsyth, Karen Rogstad
Adolescence is a time of sexual risk-taking and experimentation but also vulnerability. Young people may present to general physicians with systemic symptoms of sexually transmitted infections (STIs), such as arthritis, hepatitis or rash, but may not necessarily volunteer information about sexual activity. It is important for physicians to ask directly about sexual risks and if appropriate test for STIs and pregnancy. Knowing how to take a sexual history and consent a patient for an HIV test are core medical skills that all physicians should be trained to competently perform...
October 2015: Clinical Medicine: Journal of the Royal College of Physicians of London
Lauren R Fryling, Peter Mazanec, Robert M Rodriguez
BACKGROUND: Medicaid expansion under the Affordable Care Act (ACA) is intended to provide a framework for increasing health care access for vulnerable populations, including the 1.2 million who experience homelessness each year in the United States. OBJECTIVE: We sought to characterize homeless persons' knowledge of the ACA, identify barriers to their ACA enrollment, and determine access to various forms of communication that could be used to facilitate enrollment...
November 2015: Journal of Emergency Medicine
Bärbel Kästner, Simone Behre, Nadine Lutz, Friederike Bürger, Steffen Luntz, Katrin Hinderhofer, Martin Bendszus, Georg F Hoffmann, Markus Ries
BACKGROUND: Children and patients with cognitive deficits may find it difficult to understand the implication of research. In the European Union (EU), clinical studies outside the EU directives concerning medicinal products or medical devices, i.e., "miscellaneous clinical studies", have no legally mandated timelines for institutional review boards' (IRB) decisions. GOAL: To evaluate the review process of IRBs for two different "miscellaneous" multicenter clinical research protocols involving vulnerable subjects (children and adult stroke patients)...
2015: PloS One
Gerald Amandu Matua, Dirk Mostert Van der Wal
BACKGROUND: Ebola is a highly infectious disease that is caused by viruses of the family Filoviridae and transmitted to humans by direct contact with animals infected from unknown natural reservoirs. Ebola virus infection induces acute fever and death within a few days in up to 90% of symptomatic individuals, causing widespread fear, panic, and antisocial behavior. Uganda is vulnerable to future Ebola outbreaks. Therefore, the survivors of Ebola and their family caregivers are likely to continue experiencing related antisocial overtones, leading to negative health outcomes...
September 2015: Journal of Nursing Research: JNR
Caroline Mariano, Grant Williams, Allison Deal, Shani Alston, Ashley Leak Bryant, Trevor Jolly, Hyman B Muss
BACKGROUND: Geriatric assessment (GA) is an important tool for management of older cancer patients; however, GA research has been performed primarily in the outpatient setting. The primary objective of this study was to determine feasibility of GA during an unplanned hospital stay. Secondary objectives were to describe deficits found with GA, to assess whether clinicians recognized and addressed deficits, and to determine 30-day readmission rates. MATERIALS AND METHODS: The study was designed as an extension of an existing registry, "Carolina Senior: Registry for Older Patients...
July 2015: Oncologist
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