Calls for public engagement on emerging agricultural technologies, including genetic engineering of farm animals, have resulted in the development of information that people can interact and engage with online, including “Frequently Asked Questions” (FAQs) developed by organizations seeking to inform or influence the debate. We conducted a frame analysis of FAQs webpages about genetic engineering of farm animals developed by different organizations to describe how questions and answers are presented. We categorized FAQs as having a regulatory frame (emphasizing or challenging (...) the adequacy of regulations), an efficiency frame (emphasizing precision and benefits), a risks and uncertainty frame (emphasizing unknown outcomes), an animal welfare frame (emphasizing benefits for animals) or an animal dignity frame (considering the inherent value of animals). Animals were often featured as the object of regulations in FAQs, and questions about animals were linked to animal welfare regulations. The public were represented using a variety of terms (public, consumer) and pronouns (I, we). Some FAQs described differences between technology terms (gene editing, genetic modification) and categorized technologies as either well-established or novel. This framing of the technology may not respond to actual public concerns on the topic. Organizations seeking to use FAQs as a public engagement tool might consider including multiple viewpoints and actual questions people have about genetic engineering. (shrink)

BackgroundThe U.S. Food and Drug Administration traditionally has kept confidential significant amounts of information relevant to the approval or non-approval of specific drugs, devices, and biologics and about the regulatory status of such medical products in FDA’s pipeline.ObjectiveTo develop practical recommendations for FDA to improve its transparency to the public that FDA could implement by rulemaking or other regulatory processes without further congressional authorization. These recommendations would build on the work of FDA’s Transparency Task Force in 2010.MethodsIn 2016-2017, we convened (...) a team of academic faculty from Harvard Medical School, Brigham and Women’s Hospital, Yale Medical School, Yale Law School, and Johns Hopkins Bloomberg School of Public Health to develop recommendations through an iterative process of reviewing FDA’s practices, considering the legal and policy constraints on FDA in expanding transparency, and obtaining insights from independent observers of FDA.ResultsThe team developed 18 specific recommendations for improving FDA’s transparency to the public. FDA could adopt all these recommendations without further congressional action.FundingThe development of the Blueprint for Transparency at the U.S. Food and Drug Administration was funded by the Laura and John Arnold Foundation. (shrink)

We welcome Ballantyne & Schaefer’s discussion of the issues concerning consent and use of health data for research. In response to their acknowledgement of the need for public debate and discussion, we provide evidence from our own public consultation on this topic.

Background Since the UK Abortion Act (1967), women have travelled from Ireland to the UK for legal abortion. In 2011 >4000 women did so. Knowledge and attitudes of medical students towards abortion have been published, however, this is the first such report from Ireland. Objective To investigate medical students’ attitudes towards abortion in Ireland. Methods All medical students at the University of Limerick, and physicians who graduated from the university within the previous 12 months, were invited via email to complete (...) an anonymous online survey. The questionnaire comprised 17 questions. Quantitative and qualitative analyses were performed. Results Response rate was 45% (n=169; 55% women; 88.2% <30 years of age; 66.7% Irish; 29.2% North American). Outcomes were: abortion should not be legally available (7.1%), abortion should be allowed in limited circumstances only (35.5%), abortion should be legally available upon request (55%). 72.8% of respondents were moderately/strongly prochoice (74% of women/71% of men/72% and 76% of Irish and North American respondents, respectively). Students aged >30 years were less likely to be prochoice (55%). While 95.2% believed that education on abortion should be offered within medical school curricula, 28.8% stated that they would decline to terminate pregnancies even if legally permitted. While 58.8% indicated that they might perform legal abortions once qualified, 25.7% would do so under limited circumstances only. Conclusions The majority of participants wanted education regarding abortion. Despite being predominantly prochoice, considerably fewer students, irrespective of nationality, indicated that they would perform abortions. (shrink)

Public Health Science and practice expanded during the course of the 20th century. Initially focused on controlling infectious disease through basic public health programs regulating water, sanitation and food, by 1988 the Institute of Medicine broadly declared that “public health is what we, as a society, do collectively to. assure the conditions for people to be healthy.” Commensurate with this definition, public health practitioners and policymakers today work on ;in enormous range of issues. The 2002 policy agenda of the American (...) Public Health Association reflects positions on genomics’ role in public health; national health and safety standards for child care programs; sodium in Americans’ diets; the health and safety of emergency rescue workers; and war in Central Asia and the Persian Gulf. (shrink)

Public Health Science and practice expanded during the course of the 20th century. Initially focused on controlling infectious disease through basic public health programs regulating water, sanitation and food, by 1988 the Institute of Medicine broadly declared that “public health is what we, as a society, do collectively to. assure the conditions for people to be healthy.” Commensurate with this definition, public health practitioners and policymakers today work on ;in enormous range of issues. The 2002 policy agenda of the American (...) Public Health Association reflects positions on genomics’ role in public health; national health and safety standards for child care programs; sodium in Americans’ diets; the health and safety of emergency rescue workers; and war in Central Asia and the Persian Gulf. (shrink)

We use a result due to Rolin, Speissegger, and Wilkie to show that definable sets in certain o-minimal structures admit definable parameterizations by mild maps. We then use this parameterization to prove a result on the density of rational points on curves defined by restricted Pfaffian functions.

In the past, hypothesis testing in medicine has employed the paradigm of the repeatable experiment. In statistical hypothesis testing, an unbiased sample is drawn from a larger source population, and a calculated statistic is compared to a preassigned critical region, on the assumption that the comparison could be repeated an indefinite number of times. However, repeated experiments often cannot be performed on human beings, due to ethical or economic constraints. We describe a new paradigm for hypothesis testing which uses only (...) rearrangements of data present within the observed data set. The token swap test, based on this new paradigm, is applied to three data sets from cardiovascular pathology, and computational experiments suggest that the token swap test satisfies the Neyman Pearson condition. (shrink)

In the present paper, we will show that, in their complementary approaches to indirect communication, Erickson and Kierkegaard have something important to offer to one another's theories. While Kierkegaard developed a framework by which Erickson can be more profoundly understood, Erickson's accounts offer clinical cases which support what Kierkegaard described. This mutual trade of benefits not only broadens and deepens the notion of indirect communication, but also alerts us to the fact that it was recognized and developed in two relatively (...) independent disciplines, almost a hundred years apart! This parallel implies that indirect communication is, at the very least, a phenomenon worth investigating from both perspectives. 2012 APA, all rights reserved). (shrink)

The arguments of Stoffregen & Bardy for studying perception based on the global array are intriguing. This theory can be examined in nonhuman species using nonverbal tasks. We examine how monkeys master a skill that incorporates a two-dimensional/three-dimensional interface. We feel this provides excellent support for Stoffregen & Bardy's theory.

Volume 20, Issue 5, June 2020, Page 38-40.

Importance Informed consent is essential to ethical, rigorous research and is important to recruitment and retention in cancer trials.Objective To examine cancer clinical trial (CCT) participants’ perceptions of informed consent processes and variations in perceptions by cancer type.Design and Setting and Participants Cross-sectional survey from mixed-methods study at National Cancer Institute–designated Northeast comprehensive cancer center. Open-ended and forced-choice items addressed: (1) enrollment and informed consent experiences and (2) decision-making processes, including risk-benefit assessment. Eligibility: CCT participant with gastro-intestinal or genitourinary, hematologic-lymphatic (...) malignancies, lung cancer, and breast or gynecological cancer (N = 334).Main Outcome Measures Percentages satisfied with consent process and information provided; and assessing participation’s perceptions of risks/benefits. Multivariable logistic or ordinal regression examined differences by cancer type.Results Most patient-participants felt well informed by the consent process (more than 90% overall and by cancer type) and. most (87.4%) reported that the consent form provided all the information they wanted, although nearly half (44.8%) reported that they read the form somewhat carefully or less. More than half (57.9%) said that talking to research staff (i.e., the consent process) had a greater impact on participation decisions than reading the consent form (2.1%). A third (31.1%) were very sure of joining in research studies before the informed consent process (almost half of lung cancer patients did—47.1%). Most patients personally assessed the risks and benefits before consenting. However, trust in physicians played an important role in the decision to enroll in CCT.Conclusions and Relevance Cancer patients rely less on written features of the informed consent process than on information obtained from the research staff and their own physicians. Research should focus on information and communication strategies that support informed consent from referring physicians, researchers, and others to improve patient risk-benefit assessment and decision-making. (shrink)

Despite the frequency of stillbirths, the subsequent implications are overlooked and underappreciated. We present findings from comprehensive, systematic literature reviews, and new analyses of published and unpublished data, to establish the effect of stillbirth on parents, families, health-care providers, and societies worldwide. Data for direct costs of this event are sparse but suggest that a stillbirth needs more resources than a livebirth, both in the perinatal period and in additional surveillance during subsequent pregnancies. Indirect and intangible costs of stillbirth are (...) extensive and are usually met by families alone. This issue is particularly onerous for those with few resources. Negative effects, particularly on parental mental health, might be moderated by empathic attitudes of care providers and tailored interventions. The value of the baby, as well as the associated costs for parents, families, care providers, communities, and society, should be considered to prevent stillbirths and reduce associated morbidity. (shrink)

Recruiting research participants based on genetic information generated about them in a prior study is a potentially powerful way to study the functional significance of human genetic variation, but it also presents ethical challenges. To inform policy development on this issue, we conducted a survey of U.S. institutional review board chairs concerning the acceptability of recontacting genetic research participants about additional research and their views on the disclosure of individual genetic results as part of recruitment. Our findings suggest there is (...) unlikely to be a “one-size-fits-all” solution, but rather several ethically acceptable approaches to genotype-driven recruitment, depending on context. Disclosures made during the consent process for the original study and the clinical validity of the results are key considerations. Researchers must be prepared to communicate and answer questions in clear lay language about what is known and not known regarding the role of genetics in their proposed area of research. (shrink)

The authors of this article are previous or current members of the Clinical Ethics Consultation Affairs (CECA) Committee, a standing committee of the American Society for Bioethics and Humanities (ASBH). The committee is composed of seasoned healthcare ethics consultants (HCECs), and it is charged with developing and disseminating education materials for HCECs and ethics committees. The purpose of this article is to describe the educational research and development processes behind our teaching materials, which culminated in a case studies book called (...) A Case-Based Study Guide for Addressing Patient-Centered Ethical Issues in Health Care (hereafter, the Study Guide). In this article, we also enumerate how the Study Guide could be used in teaching and learning, and we identify areas that are ripe for future work. (shrink)

Over 40 years of research have shown that traumatic brain injury affects brain volume. However, technical and practical limitations made it difficult to detect brain volume abnormalities in patients suffering from chronic effects of mild or moderate traumatic brain injury. This situation improved in 2006 with the FDA clearance of NeuroQuant®, a commercially available, computer-automated software program for measuring MRI brain volume in human subjects. More recent strides were made with the introduction of NeuroGage®, commercially available software that is based (...) on NeuroQuant® and extends its utility in several ways. Studies using these and similar methods have found that most patients with chronic mild or moderate traumatic brain injury have brain volume abnormalities, and several of these studies found—surprisingly—more abnormal enlargement than atrophy. More generally, 102 peer-reviewed studies have supported the reliability and validity of NeuroQuant® and NeuroGage®. Furthermore, this updated version of a previous review addresses whether NeuroQuant® and NeuroGage® meet the Daubert standard for admissibility in court. It concludes that NeuroQuant® and NeuroGage® meet the Daubert standard based on their reliability, validity, and objectivity. Due to the improvements in technology over the years, these brain volumetric techniques are practical and readily available for clinical or forensic use, and thus they are important tools for detecting signs of brain injury. (shrink)

Primary progressive aphasia is a clinical syndrome in which patients progressively lose speech and language abilities. Three variants are recognized: logopenic, associated with phonology and/or short-term verbal memory deficits accompanied by left temporo-parietal atrophy; semantic, associated with semantic deficits and anterior temporal lobe atrophy; non-fluent associated with grammar and/or speech-motor deficits and inferior frontal gyrus atrophy. Here, we set out to investigate whether the three variants of PPA can be dissociated based on error patterns in a single language task. We (...) recruited 21 lvPPA, 28 svPPA, and 24 nfvPPA patients, together with 31 healthy controls, and analyzed their performance on an auditory noun-to-verb generation task, which requires auditory analysis of the input, access to and selection of relevant lexical and semantic knowledge, as well as preparation and execution of speech. Task accuracy differed across the three variants and controls, with lvPPA and nfvPPA having the lowest and highest accuracy, respectively. Critically, machine learning analysis of the different error types yielded above-chance classification of patients into their corresponding group. An analysis of the error types revealed clear variant-specific effects: lvPPA patients produced the highest percentage of “not-a-verb” responses and the highest number of semantically related nouns ; in contrast, svPPA patients produced the highest percentage of “unrelated verb” responses and the highest number of light verbs. Taken together, our findings indicate that error patterns in an auditory verb generation task are associated with the breakdown of different neurocognitive mechanisms across PPA variants. Specifically, they corroborate the link between temporo-parietal regions with lexical processing, as well as ATL with semantic processes. These findings illustrate how the analysis of pattern of responses can help PPA phenotyping and heighten diagnostic sensitivity, while providing insights on the neural correlates of different components of language. (shrink)

There is growing interest in tissue procurement for cancer research through autopsy. Establishing an autopsy/tissue donation programme for breast cancer research within an academic medical centre i...

lecting statistics about missing bindings and macros, and other errors. This guides debugging and development efforts, leading to iterative improvements in both the tools and the quality of the converted corpus. The build system thus serves as both a production conversion engine and software test harness. We have now processed the complete arχiv collection through 2006 consisting of more than 400,000 documents (a complete run is a processor-yearsize undertaking), continuously improving our success rate. We are now able to convert more (...) than 90% of these documents to XHTML+MathML. We consider over 60% to be successes, converted with no or minor warnings. While the remaining 30% can also be converted, their quality is doubtful, due to unsupported macros or conversion errors. (shrink)