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https://www.readbyqxmd.com/read/28820523/ethical-considerations-in-conducting-pragmatic-trials-in-oncology
#1
Marilyn J Hammer
Pragmatic trials evaluate interventions in real-life scenarios, which differ from explanatory trials that control for numerous factors and variables to best determine causal associations. Each approach has advantages and disadvantages. Conducting pragmatic research trials while maintaining the tenets of the ethical conduct of research can sometimes be challenging, particularly regarding informed consent. In this column, distinctions between pragmatic and explanatory trials are discussed from an ethical view...
September 1, 2017: Oncology Nursing Forum
https://www.readbyqxmd.com/read/28820522/results-of-an-oncology-clinical-trial-nurse-role-delineation-study
#2
Michelle A Purdom, Sandra Petersen, Barbara K Haas
PURPOSE/OBJECTIVES: To evaluate the relevance of a five-dimensional model of clinical trial nursing practice in an oncology clinical trial nurse population. 
. DESIGN: Web-based cross-sectional survey.
. SETTING: Online via Qualtrics.
. SAMPLE: 167 oncology nurses throughout the United States, including 41 study coordinators, 35 direct care providers, and 91 dual-role nurses who provide direct patient care and trial coordination...
September 1, 2017: Oncology Nursing Forum
https://www.readbyqxmd.com/read/28819068/rural-emergency-care-360%C3%A2-mobilising-healthcare-professionals-decision-makers-patients-and-citizens-to-improve-rural-emergency-care-in-the-province-of-quebec-canada-a-qualitative-study-protocol
#3
Richard Fleet, Gilles Dupuis, Jean-Paul Fortin, Jocelyn Gravel, Mathieu Ouimet, Julien Poitras, France Légaré
INTRODUCTION: Emergency departments (EDs) are an important safety net for rural populations. Results of our earlier studies suggest that rural Canadian hospitals have limited access to advanced imaging services and intensive care units and that patients are transferred over large distances. They also revealed significant geographical variations in rural services. In the absence of national standards, our studies raise questions about inequities in rural access to emergency services and the risks for citizens...
August 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/28818850/improved-pregnant-women-s-understanding-of-research-information-by-an-enhanced-informed-consent-form-a-randomised-controlled-study-nested-in-neonatal-research
#4
Nut Koonrungsesomboon, Chanchai Traivaree, Sangkae Chamnanvanakij, Pimchitr Rungtragoolchai, Yawana Thanapat, Juntra Karbwang
OBJECTIVE: This study aimed to test the applicability and effectiveness of the enhanced informed consent form (ICF) methodology, proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), in neonatal research requiring maternal consent. DESIGN: A single-centre open-label randomised controlled study. SETTING: Antenatal care clinics at Phramongkutklao Hospital, Thailand. PATIENTS: 234 pregnant women who were at risk of preterm labour were enrolled; 232 individuals completed the study...
August 17, 2017: Archives of Disease in Childhood. Fetal and Neonatal Edition
https://www.readbyqxmd.com/read/28818633/patient-and-caregiver-reported-assessment-tools-for-palliative-care-summary-of-the-2017-ahrq-technical-brief
#5
Rebecca Aslakson, Sydney M Dy, Renee F Wilson, Julie Waldfogel, Allen Zhang, Sarina R Isenberg, Alex Blair, Joshua Sixon, Karen A Robinson
CONTEXT: Assessment tools are data collection instruments that are completed by or with patients or caregivers and which collect data at the individual patient or caregiver level. OBJECTIVES: To (1) summarize palliative care assessment tools completed by or with patients or caregivers, and (2) identify needs for future tool development and evaluation. METHODS: We completed: (1) a systematic review of systematic reviews; (2) a supplemental search of previous reviews and websites, and/or (3) a targeted search for primary articles when no tools existed in a domain...
August 14, 2017: Journal of Pain and Symptom Management
https://www.readbyqxmd.com/read/28817972/real-world-research-and-the-role-of-observational-data-in-the-field-of-gynaecology-a-practical-review
#6
Oskari Heikinheimo, Johannes Bitzer, Luis García Rodríguez
OBJECTIVES: In the context of women's health, we examine (1) the role that observational ('real-world') studies have in overcoming limitations of randomised clinical trials, (2) the relative advantages and disadvantages of different study designs, (3) the importance of outcome data from observational studies when making health-economic or clinical decisions, and (4) provide insights into changing perceptions of observational clinical data. METHODS: PubMed and internet searches were used to identify (i) guidance and expert commentary on designing, conducting, analysing, and reporting clinical trials or observational studies, (ii) supporting evidence of the rapid growth of observational ('real world') studies and publications since the turn of millennium in the fields of contraception, reproductive health, obstetrics or gynaecology...
August 17, 2017: European Journal of Contraception & Reproductive Health Care
https://www.readbyqxmd.com/read/28817507/comparison-of-consent-models-in-a-randomized-trial-of-corticosteroids-in-pediatric-septic-shock
#7
Kusum Menon, Katharine O'Hearn, James Dayre McNally, Anand Acharya, Hector R Wong, Margaret Lawson, Tim Ramsay, Lauralyn McIntyre, Elaine Gilfoyle, Marisa Tucci, David Wensley, Ronald Gottesman, Gavin Morrison, Karen Choong
OBJECTIVES: To describe the use of deferred and prior informed consent models in the context of a low additional risk to standard of care, placebo-controlled randomized controlled trial of corticosteroids in pediatric septic shock. DESIGN: An observational substudy of consent processes in a randomized controlled trial of hydrocortisone versus placebo. SETTING: Seven tertiary level PICUs in Canada. PATIENTS: Children newborn to 17 years inclusive admitted to PICU with suspected septic shock between July 2014 and March 2016...
August 16, 2017: Pediatric Critical Care Medicine
https://www.readbyqxmd.com/read/28816200/institutional-ethics-committee-regulations-and-current-updates-in-india
#8
Amit V Mahuli, Simpy A Mahuli, Shankargouda Patil, Shilpa Bhandi
AIM: The aim of the review is to provide current updates on regulations for ethics committees and researchers in India. BACKGROUND: Ethical dilemmas in research since time immemorial have been a major concern for researchers worldwide. The question "what makes clinical research ethical" is significant and difficult to answer as multiple factors are involved. REVIEW RESULTS: The research involving human participants in clinical trials should follow the required rules, regulations, and guidelines in one's own country...
August 1, 2017: Journal of Contemporary Dental Practice
https://www.readbyqxmd.com/read/28816053/in-vitro-exposure-systems-and-dosimetry-assessment-tools-for-inhaled-tobacco-products-workshop-proceedings-conclusions-and-paths-forward-for-in-vitro-model-use
#9
Holger Behrsing, Erin Hill, Hans Raabe, Raymond Tice, Suzanne Fitzpatrick, Robert Devlin, Kent Pinkerton, Günter Oberdörster, Chris Wright, Roman Wieczorek, Michaela Aufderheide, Sandro Steiner, Tobias Krebs, Bahman Asgharian, Richard Corley, Michael Oldham, Jason Adamson, Xiang Li, Irfan Rahman, Sonia Grego, Pei-Hsuan Chu, Shaun McCullough, Rodger Curren
In 2009, the passing of the Family Smoking Prevention and Tobacco Control Act facilitated the establishment of the FDA Center for Tobacco Products (CTP), and gave it regulatory authority over the marketing, manufacture and distribution of tobacco products, including those termed 'modified risk'. On 4-6 April 2016, the Institute for In Vitro Sciences, Inc. (IIVS) convened a workshop conference entitled, In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products, to bring together stakeholders representing regulatory agencies, academia and industry to address the research priorities articulated by the FDA CTP...
July 2017: Alternatives to Laboratory Animals: ATLA
https://www.readbyqxmd.com/read/28815982/bridge-the-gap-the-need-for-harmonized-regulatory-and-ethical-standards-for-postmarketing-observational-studies
#10
REVIEW
Hisashi Urushihara, Louise Parmenter, Shimon Tashiro, Kenji Matsui, Nancy Dreyer
Drug safety issues do not respect national borders. Hence, addressing a safety question may necessitate globally coordinated efforts between regulatory authorities and market authorization holders (MAHs) to draw reliable conclusions. Regulatory authorities have shared responsibility with MAHs sponsoring postmarketing nonintervention studies in determining study goals and design. Their shared accountabilities include what will be investigated and how the data will be retrieved to ensure appropriate study quality required for regulatory decision making...
August 16, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28815460/developing-a-system-for-processing-health-data-of-children-using-digitalized-toys-ethical-and-privacy-concerns-for-the-internet-of-things-paradigm
#11
REVIEW
María Luisa Martín-Ruíz, Celia Fernández-Aller, Eloy Portillo, Javier Malagón, Cristina Del Barrio
EDUCERE (Ubiquitous Detection Ecosystem to Care and Early Stimulation for Children with Developmental Disorders) is a government funded research and development project. EDUCERE objectives are to investigate, develop, and evaluate innovative solutions for society to detect changes in psychomotor development through the natural interaction of children with toys and everyday objects, and perform stimulation and early attention activities in real environments such as home and school. In the EDUCERE project, an ethical impact assessment is carried out linked to a minors' data protection rights...
August 16, 2017: Science and Engineering Ethics
https://www.readbyqxmd.com/read/28814542/fragile-x-newborn-screening-lessons-learned-from-a-multisite-screening-study
#12
Donald B Bailey, Elizabeth Berry-Kravis, Louise W Gane, Sonia Guarda, Randi Hagerman, Cynthia M Powell, Flora Tassone, Anne Wheeler
BACKGROUND: Delays in the diagnosis of children with fragile X syndrome (FXS) suggest the possibility of newborn screening as a way to identify children earlier. However, FXS does not have a proven treatment that must be provided early, and ethical concerns have been raised about the detection of infants who are carriers. This article summarizes major findings from a multisite, prospective, longitudinal pilot screening study. METHODS: Investigators in North Carolina, California, and Illinois collaborated on a study in which voluntary screening for FXS was offered to parents in 3 birthing hospitals...
June 2017: Pediatrics
https://www.readbyqxmd.com/read/28814441/left-of-bang-interventions-in-trauma-ethical-implications-for-military-medical-prophylaxis
#13
Neil Eisenstein, David Naumann, Daniel Burns, Sarah Stapley, Heather Draper
Advances in medical capability should be accompanied by discussion of their ethical implications. In the military medical context there is a growing interest in developing prophylactic interventions that will mitigate the effects of trauma and improve survival. The ethics of this novel capability are currently unexplored. This paper describes the concept of trauma prophylaxis (Left Of Bang Interventions in Trauma) and outlines some of the ethical issues that need to be considered, including within concept development, research and implementation...
August 16, 2017: Journal of Medical Ethics
https://www.readbyqxmd.com/read/28814140/ethical-sensitivity-burnout-and-job-satisfaction-in-emergency-nurses
#14
Cansu Atmaca Palazoğlu, Zeliha Koç
BACKGROUND: Rising levels of burnout and decreasing job satisfaction can inhibit healthcare professionals from providing high-quality care due to a corresponding decrease in their ethical sensitivity. AIM: This study aimed to determine the relationship between the level of ethical sensitivity in emergency service nurses and their levels of burnout and job satisfaction. RESEARCH DESIGN: This research employed a descriptive and cross-sectional design...
January 1, 2017: Nursing Ethics
https://www.readbyqxmd.com/read/28814139/validation-of-a-brazilian-version-of-the-moral-sensitivity-questionnaire
#15
Carlise R Dalla Nora, Elma Lcp Zoboli, Margarida M Vieira
BACKGROUND: Moral sensitivity has been identified as a foundational component of ethical action. Diminished or absent moral sensitivity can result in deficient care. In this context, assessing moral sensitivity is imperative for designing interventions to facilitate ethical practice and ensure that nurses make appropriate decisions. OBJECTIVE: The main purpose of this study was to validate a scale for examining the moral sensitivity of Brazilian nurses. RESEARCH DESIGN: A pre-existing scale, the Moral Sensitivity Questionnaire, which was developed by Lützén, was used after the deletion of three items...
January 1, 2017: Nursing Ethics
https://www.readbyqxmd.com/read/28814138/finnish-nurses-attitudes-towards-their-role-in-the-euthanasia-process
#16
Anja Terkamo-Moisio, Chris Gastmans, Olli-Pekka Ryynänen, Anna-Maija Pietilä
BACKGROUND: Nurses' voices remain unheard in most debates about euthanasia, although their crucial role in the euthanasia process is widely acknowledged. Moreover, in Canadian euthanasia law, nurses have a more active role, which further highlights the need for knowledge about nurses' attitudes towards their role in the euthanasia process. RESEARCH QUESTIONS: What are Finnish nurses' attitudes towards their potential role in the euthanasia process? Which characteristics are associated with those attitudes? RESEARCH DESIGN: Cross-sectional web-based survey...
January 1, 2017: Nursing Ethics
https://www.readbyqxmd.com/read/28813242/transcending-the-tragedy-discourse-of-dementia-an-ethical-imperative-for-promoting-selfhood-meaningful-relationships-and-well-being
#17
Peter Reed, Jennifer Carson, Zebbedia Gibb
Supporting people living with dementia in maintaining selfhood, relationships, and well-being requires seeing beyond the common negative focus on disability. Furthermore, prioritizing the person rather than the disease requires rejecting the tragedy discourse, which is the negative lens through which dementia is typically considered. In this paper, we highlight qualitative research on dementia involving people living with dementia as active participants. Recognizing that many people living with dementia remain capable of making decisions that affect their lives, we highlight a research-based approach to support known as "authentic partnerships" that includes people living with dementia as equal partners...
July 1, 2017: AMA Journal of Ethics
https://www.readbyqxmd.com/read/28812979/truth-in-research-labelling
#18
John H Noble
This report describes the background and context of a currently circulating petition to the US Congress that seeks amendment of Section 801 of the Public Health Services Act (42 U.S.C. 282) to close a loophole in existing law which makes possible post hoc adjustment of randomised controlled trial (RCT) results reported to the Food and Drug Administration that differ from those reported to ClinicalTrials.gov and to medical journals. The report describes the petition's rationale, underlying assumptions, and support for its proposed remedy in deontological, consequentialist, and casuist philosophical ethics theories...
July 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28812947/a-concept-analysis-of-professional-commitment-in-nursing
#19
Loreto García-Moyano, Rogelio Altisent, Begoña Pellicer-García, Sandra Guerrero-Portillo, Oihana Arrazola-Alberdi, María Teresa Delgado-Marroquín
BACKGROUND: The concept of professional commitment is being widely studied at present. However, although it is considered an indicator for the most human part of nursing care, there is no clear definition for it, and different descriptors are being used indiscriminately to reference it. OBJECTIVE: The aim of this study is to clarify the concept of professional commitment in nursing through the Rodgers' evolutionary concept analysis process. DESIGN: Systematic search using English and Spanish descriptors and concept analysis...
January 1, 2017: Nursing Ethics
https://www.readbyqxmd.com/read/28812946/nurse-researchers-perspectives-on-research-ethics-in-china
#20
Can Gu, Man Ye, Xiaomin Wang, Min Yang, Honghong Wang, Kaveh Khoshnood
BACKGROUND: In China, research ethics is a subject of increasingly formal regulation. However, little is known about how nursing researchers understand the concept of research ethics and the ways in which they can maintain ethical standards in their work. AIM: The aim of this study is to examine nursing researchers' perspectives on research ethics in China. RESEARCH DESIGN: We conducted a descriptive qualitative study. Qualitative research methods enabled us to gain an in-depth understanding of nursing researchers' views on research ethics...
January 1, 2017: Nursing Ethics
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