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consent vulnerable adult

Farah Ahmad, Wendy Lou, Yogendra Shakya, Liane Ginsburg, Peggy T Ng, Meb Rashid, Serban Dinca-Panaitescu, Cliff Ledwos, Kwame McKenzie
BACKGROUND: Access disparities for mental health care exist for vulnerable ethnocultural and immigrant groups. Community health centres that serve these groups could be supported further by interactive, computer-based, self-assessments. METHODS: An interactive computer-assisted client assessment survey (iCCAS) tool was developed for preconsult assessment of common mental disorders (using the Patient Health Questionnaire [PHQ-9], Generalized Anxiety Disorder 7-item [GAD-7] scale, Primary Care Post-traumatic Stress Disorder [PTSD-PC] screen and CAGE [concern/cut-down, anger, guilt and eye-opener] questionnaire), with point-of-care reports...
January 2017: CMAJ Open
Stefania Schiavone, Margherita Neri, Cristoforo Pomara, Irene Riezzo, Luigia Trabace, Emanuela Turillazzi
Personalized medicine (PM) is becoming increasingly important in contemporary clinical and research scenarios. In the context of PM, pharmacogenomics and pharmacogenetics are aimed at the genetic personalization of drug response. Extrinsic and intrinsic factors may explain inter-individual variability in drug response. Among such factors, age seems to specifically intervene to modulate drug response since normal developmental changes may influence the exposure-response relation. Consequently, the potential benefit of pharmacogenomics (PGx) in the paediatric population is considerable...
February 7, 2017: Current Pharmaceutical Biotechnology
Laura Dean Albuja, Rosina Cianelli, Debbie Anglade, Brenda Owusu, Laly Joseph, Sonique Sailsman, Lilian Ferrer
PURPOSE: Women in developing countries usually encounter serious inequities in terms of women's health. To date, there is limited understanding of abortion from the perspective of Haitian women. As a limited-resource country, Haiti faces complex social issues and healthcare challenges. With abortion being illegal, many adult and teenage women seek clandestine abortions. The aim of this study was to explore and gain a greater understanding of women's and healthcare workers' beliefs and experiences about abortion in Haiti...
March 2017: Journal of Nursing Scholarship
Janet L Cunningham, Manuel Zanzi, Mimmie Willebrand, Lisa Ekselius, Mia Ramklint
BACKGROUND: Research in vulnerable individuals must insure voluntariness and minimize negative reactions caused by participation. This study aimed to describe consent and completion rate in young psychiatric patients in relation to study components, degree of disability and to compare response to research participation in patients and controls. METHODS: Between 2012 and 2015, 463 patients with psychiatric disorders between the ages of 18-25 from the Dept. of General Psychiatry at Uppsala University Hospital and 105 controls were recruited to donate data and samples to a biobank...
January 17, 2017: BMC Psychiatry
Jing-Xin Li, Li-Hua Hou, Fan-Yue Meng, Shi-Po Wu, Yue-Mei Hu, Qi Liang, Kai Chu, Zhe Zhang, Jun-Jie Xu, Rong Tang, Wen-Juan Wang, Pei Liu, Jia-Lei Hu, Li Luo, Rong Jiang, Feng-Cai Zhu, Wei Chen
BACKGROUND: The 2013-15 Ebola virus disease epidemic in west Africa greatly accelerated the development of Ebola vaccine. We aimed to analyse the immune persistence induced by one shot of an adenovirus type-5 vector-based Ebola virus vaccine up to 6 months and the effect of boosting with a homologous vector in healthy adults in China. METHODS: In a randomised, double-blind, placebo-controlled, phase 1 clinical trial in one site in Jiangsu Province, China, 120 healthy adults aged 18-60 years received an initial dose of intramuscular adenovirus type-5 Ebola virus vaccine of 4·0 × 10(10) viral particles, 1·6 × 10(11) viral particles, or placebo, and were followed up to day 168...
March 2017: Lancet Global Health
Timothy W Farrell, Eric Widera, Lisa Rosenberg, Craig D Rubin, Aanand D Naik, Ursula Braun, Alexia Torke, Ina Li, Caroline Vitale, Joseph Shega
In this position statement, we define unbefriended older adults as patients who: (1) lack decisional capacity to provide informed consent to the medical treatment at hand; (2) have not executed an advance directive that addresses the medical treatment at hand and lack capacity to do so; and (3) lack family, friends or a legally authorized surrogate to assist in the medical decision-making process. Given the vulnerable nature of this population, clinicians, health care teams, ethics committees and other stakeholders working with unbefriended older adults must be diligent when formulating treatment decisions on their behalf...
November 22, 2016: Journal of the American Geriatrics Society
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 O Awuor, Ellen Yard, Johnni H Daniel, Collen Martin, Christine Bii, Amelia Romoser, Elvis Oyugi, Sarah Elmore, Samwel Amwayi, John Vulule, Nicholas C Zitomer, Michael E Rybak, Timothy D Phillips, Joel M Montgomery, Lauren S Lewis
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, crossover clinical trial in 2014...
January 2017: 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...
August 24, 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...
April 2017: 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
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