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AJOB Empirical Bioethics

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https://www.readbyqxmd.com/read/27547778/a-pilot-study-of-neonatologists-decision-making-roles-in-delivery-room-resuscitation-counseling-for-periviable-births
#1
Brownsyne Tucker Edmonds, Fatima McKenzie, Janet E Panoch, Douglas B White, Amber E Barnato
BACKGROUND: Relatively little is known about neonatologists' roles in helping families navigate the difficult decision to attempt or withhold resuscitation for a neonate delivering at the threshold of viability. Therefore, we aimed to describe the "decision-making role" of neonatologists in simulated periviable counseling sessions. METHODS: We conducted a qualitative content analysis of audio-recorded simulation encounters and post-encounter debriefing interviews collected as part of a single-center simulation study of neonatologists' resuscitation counseling practices in the face of ruptured membranes at 23 weeks gestation...
July 2016: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/26682239/lay-attitudes-toward-deception-in-medicine-theoretical-considerations-and-empirical-evidence
#2
Jonathan Pugh, Guy Kahane, Hannah Maslen, Julian Savulescu
Background: There is a lack of empirical data on lay attitudes toward different sorts of deception in medicine. However, lay attitudes toward deception should be taken into account when we consider whether deception is ever permissible in a medical context. The objective of this study was to examine lay attitudes of U.S. citizens toward different sorts of deception across different medical contexts. Methods: A one-time online survey was administered to U.S. users of the Amazon "Mechanical Turk" website. Participants were asked to answer questions regarding a series of vignettes depicting different sorts of deception in medical care, as well as a question regarding their general attitudes toward truth-telling...
January 2, 2016: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/27917391/adrift-in-the-gray-zone-irb-perspectives-on-research-in-the-learning-health-system
#3
Sandra Soo-Jin Lee, Maureen Kelley, Mildred K Cho, Stephanie Alessi Kraft, Cyan James, Melissa Constantine, Adrienne N Meyer, Douglas Diekema, Alexander M Capron, Benjamin S Wilfond, David Magnus
BACKGROUND: Human subjects protection in healthcare contexts rests on the premise that a principled boundary distinguishes clinical research and clinical practice. However, growing use of evidence-based clinical practices by health systems makes it increasingly difficult to disentangle research from a wide range of clinical activities that are sometimes called "research on medical practice" (ROMP), including quality improvement activities and comparative effectiveness research. The recent growth of ROMP activities has created an ethical and regulatory gray zone with significant implications for the oversight of human subjects research...
2016: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/27833931/patient-and-physician-views-about-protocolized-dialysis-treatment-in-randomized-trials-and-clinical-care
#4
Ashley Kraybill, Laura M Dember, Steven Joffe, Jason Karlawish, Susan S Ellenberg, Vanessa Madden, Scott D Halpern
BACKGROUND: Pragmatic trials comparing standard-of-care interventions may improve the quality of care for future patients, but raise ethical questions about limitations on decisional autonomy. We sought to understand how patients and physicians view and respond to these questions in the contexts of pragmatic trials and of usual clinical care. METHODS: We conducted scenario-based, semi-structured interviews with 32 patients with end-stage renal disease (ESRD) receiving maintenance hemodialysis in outpatient dialysis units and with 24 nephrologists...
2016: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/27800531/patients-views-concerning-research-on-medical-practices-implications-for-consent
#5
Kevin P Weinfurt, Juli M Bollinger, Kathleen M Brelsford, Travis J Crayton, Rachel J Topazian, Nancy E Kass, Laura M Beskow, Jeremy Sugarman
BACKGROUND: Comparative effectiveness research (CER) and pragmatic clinical trials commonly test interventions that are in routine use and pose minimal incremental risk or burdens to patients who participate in this research. The objective of this study was to elicit the range of patients' views and opinions regarding a variety of different types of research on usual medical practices, especially notification and authorization for them. METHODS: We conducted twelve focus groups with adults in five U...
2016: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/27747258/using-cognitive-interviews-to-enhance-measurement-in-empirical-bioethics-developing-a-measure-of-the-preventive-misconception-in-biomedical-hiv-prevention-trials
#6
Jeremy Sugarman, Damon M Seils, J Kemp Watson-Ormond, Kevin P Weinfurt
BACKGROUND: We describe our use of cognitive interviews in developing a measure of "preventive misconception" to demonstrate the importance of this approach to researchers developing surveys in empirical bioethics. The preventive misconception involves research participants' false beliefs about a prevention trial, including beliefs that the interventions being tested will certainly be effective. METHODS: We developed and refined a measure of the preventive misconception using qualitative interviews that focused on cognitive testing of proposed survey items with HIV prevention trial participants...
2016: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/27570793/-prefacing-the-script-as-an-ethical-response-to-state-mandated-abortion-counseling
#7
Mara Buchbinder, Dragana Lassiter, Rebecca Mercier, Amy Bryant, Anne Drapkin Lyerly
BACKGROUND: Laws governing abortion provision are proliferating throughout the United States, yet little is known about how these laws affect providers. We investigated the experiences of abortion providers in North Carolina practicing under the 2011 Women's Right to Know Act, which mandates that women receive counseling with specific, state-prescribed information at least 24 hours prior to an abortion. We focus here on a subset of the data to examine one strategy by which providers worked to minimize moral conflicts generated by the counseling procedure...
2016: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/27529075/concerns-about-genetic-testing-for-schizophrenia-among-young-adults-at-clinical-high-risk-for-psychosis
#8
Ryan E Lawrence, Phoebe Friesen, Gary Brucato, Ragy R Girgis, Lisa Dixon
BACKGROUND: Genetic tests for schizophrenia may introduce risks and benefits. Among young adults at clinical high-risk for psychosis, little is known about their concerns and how they assess potential risks. METHODS: We conducted semi-structured interviews with 15 young adults at clinical high-risk for psychosis to ask about their concerns. RESULTS: Participants expressed concerns about test reliability, data interpretation, stigma, psychological harm, family planning, and privacy...
2016: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/27004235/adolescent-research-participants-descriptions-of-medical-research
#9
Christine Grady, Isabella Nogues, Lori Wiener, Benjamin S Wilfond, David Wendler
BACKGROUND: Evidence shows both a tendency for research participants to conflate research and clinical care and limited public understanding of research. Conflation of research and care by participants is often referred to as the therapeutic misconception. Despite a lack of evidence, few studies have explicitly asked participants, and especially minors, to explain what they think research is and how they think it differs from regular medical care. METHODS: As part of a longer semi-structured interview evaluating assent and parental permission for research, adolescent research participants, including adolescents with illnesses and healthy volunteers (N=177), and their parents (N=177) were asked to describe medical research in their own words and say whether and how they thought being in medical research was different from seeing a regular doctor...
January 1, 2016: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/26752784/perspectives-of-decisional-surrogates-and-patients-regarding-critical-illness-genetic-research
#10
Bradley D Freeman, Dragana Bolcic-Jankovic, Carie R Kennedy, Jessica LeBlanc, Alexander Eastman, Jennifer Barillas, Catherine M Wittgen, Kathryn Indsey, Rumel S Mahmood, Brian R Clarridge
BACKGROUND: Critical illness research is challenging due to disease severity and because patients are frequently incapacitated. Surrogates called upon to provide consent might not accurately represent patient preferences. Though commonplace, genetic data collection adds complexity in this context. We undertook this investigation to understand whether surrogate decision makers would be receptive to permitting participation in a critical illness genetics study and whether their decision making was consistent with that of the patient represented...
January 1, 2016: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/26709382/an-exploratory-study-of-therapeutic-misconception-among-incarcerated-clinical-trial-participants
#11
Paul P Christopher, Michael D Stein, Sandra A Springer, Josiah D Rich, Jennifer E Johnson, Charles W Lidz
BACKGROUND: Therapeutic misconception, the misunderstanding of differences between research and clinical care, is widely prevalent among non-incarcerated trial participants. Yet little attention has been paid to its presence among individuals who participate in research while incarcerated. METHODS: This study examined the extent to which seventy-two incarcerated individuals may experience therapeutic misconception about their participation in one of six clinical trials, and its correlation with participant characteristics and potential influences on research participation...
2016: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/26709381/cancer-clinical-trial-participants-assessment-of-risk-and-benefit
#12
Connie M Ulrich, Sarah J Ratcliffe, Gwenyth R Wallen, Qiuping Pearl Zhou, Kathleen Knafl, Christine Grady
BACKGROUND: The purpose of this article is to examine the extent to which cancer clinical trial participants assess the benefits and risks of research participation before enrollment. METHODS: One hundred and ten oncology research participants enrolled in cancer clinical research in a large Northeastern cancer center responded to a self-administered questionnaire on perceptions about cancer clinical trials. RESULTS: Of the participants, 51...
2016: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/26740962/a-pharmaceutical-bioethics-consultation-service-six-year-descriptive-characteristics-and-results-of-a-feedback-survey
#13
Luann E Van Campen, Albert J Allen, Susan B Watson, Donald G Therasse
Background: Bioethics consultations are conducted in varied settings, including hospitals, universities, and other research institutions, but there is sparse information about bioethics consultations conducted in corporate settings such as pharmaceutical companies. The purpose of this article is to describe a bioethics consultation service at a pharmaceutical company, to report characteristics of consultations completed by the service over a 6-year period, and to share results of a consultation feedback survey...
April 3, 2015: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/26594648/exploring-institutional-research-ethics-systems-a-case-study-from-uganda
#14
Adnan A Hyder, Joseph Ali, Kristina Hallez, Tara White, Nelson K Sewankambo, Nancy E Kass
BACKGROUND: The increasing globalization of research drives a need for greater research ethics capacity in low resource countries. Several programs have attempted to expand research ethics capacity by training individuals, but few have focused on broader research ethics systems and institutions. This study describes and applies an institutional research ethics model to assess the institutional research ethics capacity of Makerere University College of Heath Sciences (MakCHS) in 2011. METHODS: Internal and external stakeholders conducted the assessment of MakCHS using the multidimensional Octagon framework...
2015: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/26495325/knowledge-of-federal-regulations-for-mental-health-research-involving-prisoners
#15
Mark E Johnson, Christiane Brems, Aaron L Bergman, Michael E Mills, Gloria D Eldridge
BACKGROUND: Given their vulnerability to coercion and exploitation, prisoners who participate in research are protected by Office for Human Research Protections (OHRP) regulations designed to ensure their safety and wellbeing. Knowledge of these regulations is essential for researchers who conduct and institutional review boards (IRBs) that oversee mental health research in correctional settings. METHODS: We explored depth of knowledge of OHRP regulations by surveying a nationwide sample of: (1) mental health researchers who have conducted research in correctional settings; (2) mental health researchers who have conducted research in non-correctional settings; (3) IRB members who have overseen mental health research in correctional settings; (4) IRB members who have overseen mental health research in in non-correctional settings; and (5) IRB prisoner representatives...
2015: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/26185771/old-questions-new-paradigms-ethical-legal-and-social-complications-of-noninvasive-prenatal-testing
#16
Marsha Michie, Megan Allyse
No abstract text is available yet for this article.
January 1, 2015: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/26101782/benefits-and-risks-in-secondary-use-of-digitized-clinical-data-views-of-community-members-living-in-a-predominantly-ethnic-minority-urban-neighborhood
#17
Robert J Lucero, Joan Kearney, Yamnia Cortes, Adriana Arcia, Paul Appelbaum, Roberto Lewis Fernández, Jose Luchsinger
BACKGROUND: There is potential to increase the speed of scientific discovery and implement personalized health care by using digitized clinical data collected on the patient care experience. The use of these data in research raises concerns about the privacy and confidentiality of personal health information. This study explored community members' views on the secondary use of digitized clinical data to (1) recruit participants for clinical studies; (2) recruit family members of persons with an index condition for primary studies; and (3) conduct studies of information related to stored biospecimens...
2015: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/25961066/demonstrating-patterns-in-the-views-of-stakeholders-regarding-ethically-salient-issues-in-clinical-research-a-novel-use-of-graphical-models-in-empirical-ethics-inquiry
#18
Jane Paik Kim, Laura Weiss Roberts
BACKGROUND: Empirical ethics inquiry works from the notion that stakeholder perspectives are necessary for gauging the ethical acceptability of human studies and assuring that research aligns with societal expectations. Although common, studies involving different populations often entail comparisons of trends that problematize the interpretation of results. Using graphical model selection - a technique aimed at transcending limitations of conventional methods - this report presents data on the ethics of clinical research with two objectives: (1) to display the patterns of views held by ill and healthy individuals in clinical research as a test of the study's original hypothesis and (2) to introduce graphical model selection as a key analytic tool for ethics research...
2015: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/25932463/-don-t-want-no-risk-and-don-t-want-no-problems-public-understandings-of-the-risks-and-benefits-of-non-invasive-prenatal-testing-in-the-united-states
#19
Megan Allyse, Lauren Carter Sayres, Taylor Goodspeed, Marsha Michie, Mildred K Cho
BACKGROUND: The recent availability of new non-invasive prenatal genetic tests for fetal aneuploidy has raised questions concerning whether and how these new tests will be integrated into prenatal medical care. Among the many factors to be considered are public understandings and preferences about prenatal testing mechanisms and the prospect of fetal aneuploidy. METHODS: To address these issues, we conducted a nation-wide mixed-method survey of 2,960 adults in the United States to explore justifications for choices among prenatal testing mechanisms...
2015: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/25177710/bidil-in-the-clinic-an-interdisciplinary-investigation-of-physicians-prescription-patterns-of-a-race-based-therapy
#20
Koffi N Maglo, Jack Rubinstein, Bin Huang, Richard F Ittenbach
BACKGROUND: The African American Heart Failure Trial (A-HeFT) and the FDA approval of BiDil for race-specific prescription have stirred the debate about the scientific and medical status of race. Yet there is no assessment of the potential fallouts of this dispute on physicians' willingness to prescribe the drug. We present here an analysis of the factors influencing physicians' prescription of BiDil and investigate whether exposure to the controversy has an impact on their therapeutic judgments about the drug...
October 2, 2014: AJOB Empirical Bioethics
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