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consent vulnerable adult

Mary A Ott, Francis P Crawley, Xavier Sáez-Llorens, Seth Owusu-Agyei, David Neubauer, Gary Dubin, Tatjana Poplazarova, Norman Begg, Susan L Rosenthal
Children of minor parents are under-represented in clinical trials. This is largely because of the ethical, legal, and regulatory complexities in the enrolment, consent, and appropriate access of children of minor parents to clinical research. Using a case-based approach, we examine appropriate access of children of minor parents in an international vaccine trial. We first consider the scientific justification for inclusion of children of minor parents in a vaccine trial. Laws and regulations governing consent generally do not address the issue of minor parents...
February 23, 2018: Paediatric Drugs
Lucy November, Jane Sandall
BACKGROUND: In Sierra Leone, 34% of pregnancies and 40% of maternal deaths are in the adolescent population. Risks are known to be higher for younger adolescents, this being borne out by a household survey in Eastern Freetown in 2015. This current qualitative study, funded by Wellbeing of Women's international midwifery fellowship, was conducted to explore the causes of this high incidence of maternal death for younger teenagers, and to identify possible interventions to improve outcomes...
February 21, 2018: Reproductive Health
Gudrun S Freidl, Alma Tostmann, Moud Curvers, Wilhelmina L M Ruijs, Gaby Smits, Rutger Schepp, Erwin Duizer, Greet Boland, Hester de Melker, Fiona R M van der Klis, Jeannine L A Hautvast, Irene K Veldhuijzen
Asylum seekers are a vulnerable population for contracting infectious diseases. Outbreaks occur among children and adults. In the Netherlands, asylum seeker children are offered vaccination according to the National Immunization Program. Little is known about protection against vaccine-preventable diseases (VPD) in adult asylum seekers. In this 2016 study, we assessed the immunity of adult asylum seekers against nine VPD to identify groups that might benefit from additional vaccinations. We invited asylum seekers from Syria, Iran, Iraq, Afghanistan, Eritrea and Ethiopia to participate in a serosurvey...
February 14, 2018: Vaccine
N Gaspar, L V Marshall, D Binner, R Herold, R Rousseau, P Blanc, R Capdeville, J Carleer, C Copland, Y Kerloeguen, K Norga, L Pacaud, M-A Sevaux, C Spadoni, J Sterba, F Ligas, T Taube, M Uttenreuther-Fischer, S Chioato, M A O'Connell, B Geoerger, J-Y Blay, J C Soria, S Kaye, B Wulff, L Brugières, G Vassal, A D J Pearson
The impressive progress recently observed in adult cancers through the introduction of new drugs has not yet been translated to adolescents between 12 and 17 years of age. Currently adolescents are grouped with children, so their access to new, effective drugs already available for adults is delayed because paediatric drug development starts late relative to adult programmes. Moreover, specific early phase trials designed exclusively for adolescents in rare diseases recruit poorly, even if conducted internationally...
January 16, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Zohra S Lassi, Rehana A Salam, Zulfiqar A Bhutta
BACKGROUND: The health challenges faced by young people are more complex than adults and can compromise their full growth and development. Attention must be paid to the health of this age group, yet adolescents and youth remain largely invisible and often disappear from the major global datasets. OBJECTIVE: The aim of this paper is to discuss the global health challenges faced by adolescents and youth, global legislations and guidelines pertaining to this particular age group, recommendations to arrest these challenges, and research priorities...
September 2017: Annals of Global Health
Joanne Haviland, Samantha Sodergren, Lynn Calman, Jessica Corner, Amy Din, Deborah Fenlon, Chloe Grimmett, Alison Richardson, Peter W Smith, Jane Winter, Claire Foster
OBJECTIVE: Social support is acknowledged as important in cancer survivorship, but little is known about change in support after cancer diagnosis and factors associated with this, particularly in colorectal cancer. The CREW cohort study investigated social support up to 2 years following curative intent surgery for colorectal cancer. METHODS: A total of 871 adults recruited pre-treatment from 29 UK centres 2010 to 2012 consented to follow-up. Questionnaires at baseline, 3, 9, 15, and 24 months post-surgery included assessments of social support (Medical Outcomes Study-Social Support Survey, MOS-SSS) and health-related quality of life (HRQoL)...
December 2017: Psycho-oncology
Sarah Staveteig, Trevor N Croft, Kathryn T Kampa, Sara K Head
BACKGROUND: UNAIDS has recently proposed a set of three ambitious targets that, if achieved, are predicted to end the AIDS epidemic by 2030. The targets, known as 90-90-90, call for 90% of people living with HIV (PLHIV) to know their status, 90% of PLHIV to receive antiretroviral therapy, and 90% of those on antiretroviral therapy to achieve viral suppression by the year 2020. We examine the first of these targets, focusing on sub-Saharan Africa, the region of the world most affected by HIV, to measure the proportion of PLHIV estimated to know their HIV status, and to identify background and behavioral characteristics significantly associated with gaps in ever testing among PLHIV...
2017: PloS One
Nupur Singhal, Poornima Bhola
BACKGROUND: The growing interest in community-based research on non-suicidal self-injury (NSSI) reflects the high prevalence rates found among vulnerable adolescents and young adults. A significant concern in research with vulnerable populations, and on sensitive topics, is the development of an ethical framework that protects the needs and rights of the participants while responding to researchers' goals and limitations and the broader clinical and public health concerns. AIM: The aim of the present study was to review the ethical practices followed in community-based research on NSSI...
September 1, 2017: Asian Journal of Psychiatry
Wendy Si Hassen, Katia Castetbon, Eva Lelièvre, Aurélie Lampuré, Serge Hercberg, Caroline Méjean
BACKGROUND: Few studies have focused on the influence of retirement on dietary behaviors. Our study aimed at assessing the associations between transition to retirement and changes in dietary intake in French adults, particularly according to spousal retirement and baseline income. METHODS: This prospective study included 577 French participants from the NutriNet-Santé cohort who retired over a 5-year follow-up (2009-2014 or 2010-2015). At baseline and every year, dietary intakes were assessed using 24 h records...
May 30, 2017: International Journal of Behavioral Nutrition and Physical Activity
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...
September 8, 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
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