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https://www.readbyqxmd.com/read/28724033/ethical-issues-on-the-synthetic-phosphoethanolamine-clinical-trial
#1
Francisco José Roma Paumgartten
Notwithstanding its approval by the National Committee for Ethics in Research (Conep) on April 19, 2016, a trial of the so-called "synthetic" phosphoethanolamine (syn-phospho) pill in cancer patients raises ethical concerns. An analysis by a laboratory contracted by the Ministry of Science, Technology and Innovation (MCTI) revealed that syn-phospho contained a great amount of impurities and did not meet standards of pharmaceutical quality required for an investigational drug. Cytotoxicity against human tumor cell lines and in vivo rodent xenograft tumor assays consistently failed to demonstrate a potential anticancer activity of syn-phospho...
May 2017: Revista da Associação Médica Brasileira
https://www.readbyqxmd.com/read/28724031/methodological-challenges-in-the-use-of-focus-groups-with-people-with-severe-mental-illness
#2
Rosana Teresa Onocko-Campos, Alberto Rodolfo Giovanello Díaz, Catarina Magalhães Dahl, Erotildes Maria Leal, Octavio Domont de Serpa
This study addresses the practical, methodological and ethical challenges that were found in three studies that used focus groups with people with severe mental illness, in the context of community mental health services in Brazil. Focus groups are a powerful tool in health research that need to be better discussed in research with people with severe mental illness, in the context of community mental health facilities. This study is based on the authors' experience of conducting and analyzing focus groups in three different cities - Campinas, Rio de Janeiro and Salvador - between 2006-2010...
July 13, 2017: Cadernos de Saúde Pública
https://www.readbyqxmd.com/read/28724001/food-marketing-targeting-children-unveiling-the-ethical-perspectives-in-the-discourse-on-self-regulation
#3
Dillian Adelaine Cesar da Silva, Antonio Carlos Rodrigues da Cunha, Thiago Rocha da Cunha, Caroline Filla Rosaneli
When it comes to food marketing, children are one of the major targets. Regulatory actions can play a strategic role in health protection. The objective of this research was to characterize the ethical perspective in the discourse against state regulatory actions on food marketing directed at children, aiming to understand the context of the discourse's production and how it creates meaning. The methodology adopted was qualitative, with documentary analysis and use of concepts and procedures from Discourse Analysis...
July 2017: Ciência & Saúde Coletiva
https://www.readbyqxmd.com/read/28723309/moral-distress-as-experienced-by-hospital-social-workers-in-south-korea-and-australia
#4
Patricia Fronek, Lynne Briggs, Myung Hun Kim, Hye Bin Han, Quinn Val, Sungmin Kim, Donna McAuliffe
This exploratory, qualitative research explored the ethical problems faced by hospital social workers in South Korea and Australia, and what and who influenced their decision making using a focus group design. Although dilemmas of boundaries, confidentiality, self-determination, and other complex scenarios found in practice were identified, moral distress, a consequence of the unresolvable conflicts, dominated participants' narratives. This was particularly the case for the Korean social workers in this sample...
July 19, 2017: Social Work in Health Care
https://www.readbyqxmd.com/read/28722552/evaluation-of-regional-project-to-strengthen-national-health-research-systems-in-four-countries-in-west-africa-lessons-learned
#5
Issiaka Sombié, Jude Aidam, Gabriela Montorzi
BACKGROUND: Since the Commission on Health Research for Development (COHRED) published its flagship report, more attention has been focused on strengthening national health research systems (NHRS). This paper evaluates the contribution of a regional project that used a participatory approach to strengthen NHRS in four post-conflict West African countries - Guinea-Bissau, Liberia, Sierra Leone and Mali. METHODS: The data from the situation analysis conducted at the start of the project was compared to data from the project's final evaluation, using a hybrid conceptual framework built around four key areas identified through the analysis of existing frameworks...
July 12, 2017: Health Research Policy and Systems
https://www.readbyqxmd.com/read/28722516/pre-operative-obesity-does-not-predict-poorer-symptom-control-and-quality-of-life-after-lumbar-disc-surgery
#6
Paul M Brennan, James J M Loan, Neil Watson, Pragnesh M Bhatt, Peter Alwyn Bodkin
PURPOSE: We aimed to determine whether there was a difference in post-operative symptomatic control and quality of life (QoL) between patients who were obese (BMI >30) and non-obese (BMI <30) pre-operatively. This information may inform the decision making of Physicians and patients whether to proceed to surgery for management of symptomatic lumbar disc prolapse. METHODS: We conducted a prospective questionnaire-based study of QoL and symptom control in 120 patients with postal follow-up at 3 and 12 months after lumbar disc surgery...
July 19, 2017: British Journal of Neurosurgery
https://www.readbyqxmd.com/read/28721643/the-scientific-self-reclaiming-its-place-in-the-history-of-research-ethics
#7
Herman Paul
How can the history of research ethics be expanded beyond the standard narrative of codification-a story that does not reach back beyond World War II-without becoming so broad as to lose all distinctiveness? This article proposes a history of research ethics focused on the "scientific self," that is, the role-specific identity of scientists as typically described in terms of skills, competencies, qualities, or dispositions. Drawing on three agenda-setting texts from nineteenth-century history, biology, and sociology, the article argues that the "revolutions" these books sought to unleash were, among other things, revolts against inherited conceptions of scientific selfhood...
July 18, 2017: Science and Engineering Ethics
https://www.readbyqxmd.com/read/28720617/protocol-for-an-online-randomised-controlled-trial-to-evaluate-the-clinical-and-cost-effectiveness-of-a-peer-supported-self-management-intervention-for-relatives-of-people-with-psychosis-or-bipolar-disorder-relatives-education-and-coping-toolkit-react
#8
Fiona Lobban, Heather Robinson, Duncan Appelbe, Johanna Barraclough, Emma Bedson, Lizzie Collinge, Susanna Dodd, Sue Flowers, Mahsa Honary, Sonia Johnson, Ceu Mateus, Barbara Mezes, Valerie Minns, Elizabeth Murray, Andrew Walker, Paula Williamson, Catherine Wintermeyer, Steven Jones
INTRODUCTION: Despite clinical guidelines recommendations, many relatives of people with psychosis or bipolar disorder do not currently receive the support they need. Online information and support may offer a solution. METHODS AND ANALYSIS: This single-blind, parallel, online randomised controlled trial will determine clinical and cost-effectiveness of the Relatives Education And Coping Toolkit (REACT) (including an online resource directory (RD)), compared with RD only, for relatives of people with psychosis or bipolar disorder...
July 18, 2017: BMJ Open
https://www.readbyqxmd.com/read/28718349/relationship-between-moral-distress-and-ethical-climate-with-job-satisfaction-in-nurses
#9
Sharareh Asgari, Vida Shafipour, Zohreh Taraghi, Jamshid Yazdani-Charati
BACKGROUND: Moral distress and ethical climate are important issues in the workplace that appear to affect people's quality of work life. OBJECTIVES: This study was conducted to determine the relationship of moral distress and ethical climate to job satisfaction in critical care nurses. MATERIALS AND METHODS: This descriptive-correlation study was conducted on 142 critical care nurses, selected from five social security hospitals in north Iran through census sampling...
January 1, 2017: Nursing Ethics
https://www.readbyqxmd.com/read/28717341/-an-ethics-call-to-include-pregnant-women-in-research-reflections-from-the-global-forum-on-bioethics-in-research
#10
Carla Saenz, Jackeline Alger, Juan Pablo Beca, José M Belizán, María Luisa Cafferata, Julio Arturo Canario Guzmán, Jesica E Candanedo P, Lissette Duque, Lester Figueroa, Ana Garcés, Lionel Gresh, Ida Cristina Gubert, Dirce Guilhem, Gabriela Guz, Gustavo Kaltwasser, A Roxana Lescano, Florencia Luna, Alexandrina A M Cardelli, Ignacio Mastroleo, Irene N Melamed, Agueda Muñoz Del Carpio Toia, Ricardo Palacios, Gloria I Palma, Sofía P Salas, Xochitl Sandoval, Sergio Surugi de Siqueira, Hans Vásquez, Bertha Ma Villela de Vega
No abstract text is available yet for this article.
2017: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
https://www.readbyqxmd.com/read/28716977/vulnerability-of-pregnant-women-in-clinical-research
#11
Indira S E van der Zande, Rieke van der Graaf, Martijn A Oudijk, Johannes J M van Delden
BACKGROUND: Notwithstanding the need to produce evidence-based knowledge on medications for pregnant women, they remain underrepresented in clinical research. Sometimes they are excluded because of their supposed vulnerability, but there are no universally accepted criteria for considering pregnant women as vulnerable. Our aim was to explore whether and if so to what extent pregnant women are vulnerable as research subjects. METHOD: We performed a conceptual and empirical analysis of vulnerability applied to pregnant women...
July 17, 2017: Journal of Medical Ethics
https://www.readbyqxmd.com/read/28716797/a-pragmatic-phase-iii-multisite-double-blind-placebo-controlled-parallel-arm-dose-increment-randomised-trial-of-regular-low-dose-extended-release-morphine-for-chronic-breathlessness-breathlessness-exertion-and-morphine-sulfate-beams-study-protocol
#12
David Currow, Gareth John Watts, Miriam Johnson, Christine F McDonald, John O Miners, Andrew A Somogyi, Linda Denehy, Nicola McCaffrey, Danny J Eckert, Philip McCloud, Sandra Louw, Lawrence Lam, Aine Greene, Belinda Fazekas, Katherine C Clark, Kwun Fong, Meera R Agar, Rohit Joshi, Sharon Kilbreath, Diana Ferreira, Magnus Ekström
INTRODUCTION: Chronic breathlessness is highly prevalent and distressing to patients and families. No medication is registered for its symptomatic reduction. The strongest evidence is for regular, low-dose, extended- release (ER) oral morphine. A recent large phase III study suggests the subgroup most likely to benefit have chronic obstructive pulmonary disease (COPD) and modified Medical Research Council breathlessness scores of 3 or 4. This protocol is for an adequately powered, parallel-arm, placebo-controlled, multisite, factorial, block-randomised study evaluating regular ER morphine for chronic breathlessness in people with COPD...
July 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/28716796/clinical-and-cost-effectiveness-of-progressive-exercise-compared-with-best-practice-advice-with-or-without-corticosteroid-injection-for-the-treatment-of-rotator-cuff-disorders-protocol-for-a-2x2-factorial-randomised-controlled-trial-the-grasp-trial
#13
Sally Hopewell, David J Keene, Michael Maia Schlüssel, Melina Dritsaki, Susan Dutton, Andrew Carr, William Hamilton, Zara Hansen, Anju Jaggi, Chris Littlewood, Hessam Soutakbar, Peter Heine, Lucy Cureton, Karen Barker, Sarah E Lamb
INTRODUCTION: Shoulder pain is very common, with around 70% of cases due to disorders of the rotator cuff. Despite widespread provision of physiotherapy, there is uncertainty about which type of exercise and delivery mechanisms are associated with best outcomes. There is also uncertainty around the long-term benefits and harms of corticosteroid injection therapy, which is often used in addition to physiotherapy. The Getting it Right: Addressing Shoulder Pain trial will assess the clinical and cost-effectiveness of individually tailored, progressive exercise compared with best practice advice, with or without corticosteroid injection, in adults with a rotator cuff disorder...
July 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/28716784/protocol-for-a-prospective-observational-study-to-improve-prehospital-notification-of-injured-patients-presenting-to-trauma-centres-in-india
#14
Biswadev Mitra, Joseph Mathew, Amit Gupta, Peter Cameron, Gerard O'Reilly, Kapil Dev Soni, Gaurav Kaushik, Teresa Howard, Madonna Fahey, Michael Stephenson, Vineet Kumar, Sharad Vyas, Satish Dharap, Pankaj Patel, Advait Thakor, Naveen Sharma, Tony Walker, Mahesh Chandra Misra, Russell Gruen, Mark Fitzgerald
INTRODUCTION: Prehospital notification of injured patients enables prompt and timely care in hospital through adequate preparation of trauma teams, space, equipment and consumables necessary for resuscitation, and may improve outcomes. In India, anecdotal reports suggest that prehospital notification, in those few places where it occurs, is unstructured and not linked to a well-defined hospital response. The aim of this manuscript is to describe, in detail, a study protocol for the evaluation of a formalised approach to prehospital notification...
July 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/28716621/healthcare-professionals-attitudes-about-physician-assisted-death-an-analysis-of-their-justifications-and-the-roles-of-terminology-and-patient-competency
#15
Derek W Braverman, Brian S Marcus, Paul G Wakim, Mark R Mercurio, Gary S Kopf
CONTEXT: Healthcare professionals (HCPs) are crucial to physician-assisted death (PAD) provision. OBJECTIVES: To quantitatively assess the favorability of justifications for or against PAD legalization among HCPs, the effect of the terms "suicide" and "euthanasia" on their views, and their support for three forms of PAD. METHODS: Our questionnaire presented three cases: physician-assisted suicide, euthanasia for a competent patient, and euthanasia for an incompetent patient with an advance directive for euthanasia...
July 14, 2017: Journal of Pain and Symptom Management
https://www.readbyqxmd.com/read/28716312/ethical-considerations-in-noise-induced-hearing-loss-research
#16
Stéphane F Maison, Steven D Rauch
No abstract text is available yet for this article.
July 14, 2017: Lancet
https://www.readbyqxmd.com/read/28715491/towards-the-development-of-a-comprehensive-framework-qualitative-systematic-survey-of-definitions-of-clinical-research-quality
#17
Belinda von Niederhäusern, Stefan Schandelmaier, Marie Mi Bonde, Nicole Brunner, Lars G Hemkens, Marielle Rutquist, Neera Bhatnagar, Gordon H Guyatt, Christiane Pauli-Magnus, Matthias Briel
OBJECTIVE: To systematically survey existing definitions, concepts, and criteria of clinical research quality, both developed by stakeholder groups as well as in the medical literature. This study serves as a first step in the development of a comprehensive framework for the quality of clinical research. STUDY DESIGN AND SETTING: We systematically and in duplicate searched definitions, concepts and criteria of clinical research quality on websites of stakeholders in clinical research until no further insights emerged and in MEDLINE up to February 2015...
2017: PloS One
https://www.readbyqxmd.com/read/28714173/the-use-of-advanced-web-based-survey-design-in-delphi-research
#18
Christopher Helms, Anne Gardner, Elizabeth Mcinnes
AIM: A discussion of the application of metadata, paradata and embedded data in web-based survey research, using two completed Delphi surveys as examples. BACKGROUND: Metadata, paradata and embedded data use in web-based Delphi surveys has not been described in the literature. The rapid evolution and widespread use of online survey methods imply paper-based Delphi methods will likely become obsolete. Commercially-available web-based survey tools offer a convenient and affordable means of conducting Delphi research...
July 16, 2017: Journal of Advanced Nursing
https://www.readbyqxmd.com/read/28713517/developing-the-concept-of-caring-in-nursing-education
#19
Maryam Salehian, Abbas Heydari, Hossein Karimi Moonaghi, Nahid Aghebati
BACKGROUND: Caring is a value-based concept in the nursing field and in education. Exact understanding of caring in education and developing this concept in nursing will result in the evolution of the position of nursing science and profession. AIM: The aim of this study was to attempt to develop the concept of caring in nursing education. METHODS: This qualitative study was conducted in 2016 using directed content analysis. Participants were thirteen subjects (6 instructors and 7 senior and junior nursing students) who were selected using purposeful sampling method...
May 2017: Electronic Physician
https://www.readbyqxmd.com/read/28713147/to-enroll-or-not-to-enroll-a-researcher-struggles-with-the-decision-to-involve-study-participants-in-a-clinical-trial-that-could-save-their-lives
#20
Roberto Abadie
Hundreds of thousands of clinical trials are conducted annually around the world, working to further scientific knowledge and expand medical treatment. At the same time, clinical trials also present novel challenges to researchers who have access to large pools of research participants and are routinely approached by pharmaceutical companies seeking to recruit subjects for clinical trials. This case study discusses the ethical dilemmas faced by a community health investigator who received an invitation to enroll people who inject drugs (PWID) into a clinical trial of a drug that promised a new treatment option for Hepatitis C...
2017: Narrative Inquiry in Bioethics
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