American Academy of Pediatrics (AAP) and American College of Medical Genetics (ACMG) recently provided two recommendations about predictive genetic testing of children. The Clinical Sequencing Exploratory Research Consortium's Pediatrics Working Group compared these recommendations, focusing on operational and ethical issues specific to decision making for children. Content analysis of the statements addresses two issues: (1) how these recommendations characterize and analyze locus of decision making, as well as the risks and benefits of testing, and (2) whether the guidelines (...) conflict or come to different but compatible conclusions because they consider different testing scenarios. These statements differ in ethically significant ways. AAP/ACMG analyzes risks and benefits using best interests of the child and recommends that, absent ameliorative interventions available during childhood, clinicians should generally decline to order testing. Parents authorize focused tests. ACMG analyzes risks and benefits using the interests of the child and other family members and recommends that sequencing results be examined for additional variants that can lead to ameliorative interventions, regardless of age, which laboratories should report to clinicians who should contextualize the results. Parents must accept additional analysis. The ethical arguments in these statements appear to be in tension with each other. (shrink)

IntroductionThis study aimed to evaluate, in adults with mild cognitive impairment, the brain atrophy that may distinguish between three AT biomarker-based profiles, and to determine its clinical value.MethodsStructural MRI was employed to evaluate the volume and cortical thickness differences in MCI patients with different AT profiles, namely, A−T−−: normal AD biomarkers; A+T−−: AD pathologic change; and A+T++: prodromal AD. Sensitivity and specificity of these changes were also estimated.ResultsAn initial atrophy in medial temporal lobe areas was found in the A+T−− (...) and A+T++ groups, spreading toward the parietal and frontal regions in A+T++ patients. These structural changes allowed distinguishing AT profiles within the AD continuum; however, the profiles and their pattern of neurodegeneration were unsuccessful to determine the current clinical status.ConclusionsMRI is useful in the determination of the specific brain structural changes of AT profiles along the AD continuum, allowing differentiation between MCI adults with or without pathological AD biomarkers. (shrink)

The prospect of using genome technologies to modify the human germline has raised profound moral disagreement but also emphasizes the need for wide-ranging discussion and a well-informed policy response. The Hinxton Group brought together scientists, ethicists, policymakers, and journal editors for an international, interdisciplinary meeting on this subject. This consensus statement formulated by the group calls for support of genome editing research and the development of a scientific roadmap for safety and efficacy; recognizes the ethical challenges involved in (...) clinical reproductive applications of genome editing but, importantly, rejects the idea that human reproductive germline modification is necessarily morally unacceptable; and highlights the importance of meaningful engagement in discussions of genome editing and the development of regulation and oversight mechanisms to govern future uses of such technologies. (shrink)

Background: The health professionals are involved in the paths of care for patients with different medical conditions. Their life is frequently characterized by psychopathological outcomes so that it is possible to identify consistent burdens. Besides the possibility to develop pathological outcomes, some protective factors such as resilience play a fundamental role in facilitating the adaptation process and the management of maladaptive patterns. Personal characteristics and specific indexes such as burdens and resilience are essential variables useful to study in-depth ongoing conditions (...) and possible interventions. The study was aimed at highlighting the presence and the relations among factors as personal variables, burdens, and resilience, to understand health professionals' specific structure and functions.Methods: The observation group was composed of 210 participants, 55 males, and 155 females, aged from 18 to 30 years old with a mean age of 25.92 years old. The study considered personal characteristics of the subjects, such as age, gender, years of study, days of work per week, hours of work per week, and years of work. Our study had been conducted with the use of measures related to burdens and resilience.Results: The performed analyses consisted of descriptive statistics, correlations, and regressions among the considered variables. Several significant correlations emerged among personal characteristics, CBI, and RSA variables. Specifically, age and work commitment indexes appeared to be significantly related to the development of burdens, differently from the years of study. Significant correlations emerged among personal and RSA variables, indicating precise directions for both domains. Age and gender were identified as predictors to perform multivariate regression analyses concerning CBI factors. Significant dependence relations emerged with reference to all CBI variables.Conclusion: Pathological outcomes and resilience factors represent two sides of the health professionals' experiences, also known as “invisible patients.” Greater knowledge about present conditions and future possibilities is a well-known need in literature so that the current analyses considered fundamental factors. In line with state of the art, future studies are needed in order to deepen elusive phenomena underlying maladjustment. (shrink)

Listening effort has been known to characterize speech recognition in noise regardless of hearing sensitivity and age. Whereas the behavioral measure of dual-task paradigm effectively manifests the cognitive cost that listeners exert when processing speech in background noise, there is no consensus as to a clinical procedure that might best express LE. In order to assess the cognitive load underlying speech recognition in noise and promote counselling for coping strategies, a feasible clinical paradigm is warranted. The ecological validity (...) of such a paradigm might best be demonstrated in middle-aged adults, exhibiting intact hearing sensitivity on one hand, however, experiencing difficulties in degraded listening conditions, unaware of the implicated cognitive cost of speech recognition in noise. To this end, we constructed a dual-task paradigm that consists of a primary task of sentences-in-noise recognition and a secondary task of simple visual colored-shape matching. Research objective was to develop a clinical paradigm for the assessment of LE in middle-aged adults. Participants were 17 middle-aged adults and 23 young adults. All participants had normal hearing according to age. Speech stimuli consisted of the Hebrew Matrix sentences in noise test. SRTn was obtained for 80% correct identification. Visual stimuli were colored geometric shapes. Outcome measures were obtained initially for each task separately, to establish performance ability, and then obtained simultaneously. Reaction time and accuracy in the secondary task were the defined metrics for LE. Results: LE was indicated for both groups, however, was more pronounced in the middle-aged, manifested in the visual accuracy and reaction time metrics. Both groups maintained the 80% correct recognition-in-noise in the dual-task, however, the middle-aged group necessitated a better SNR of 1.4dB than the normal hearing group. Moreover, the middle-aged group was taxed in a greater prolongation of reaction time, in order to uphold the correct recognition. Conclusion: a dual-task paradigm consisting of sentences-in-noise primary task combined with a simple secondary task successfully showed different manifestations of LE in middle-aged adults compared to young adults, thus approximating the use of such a paradigm in a clinical setting. (shrink)

Current research suggests that there are three major groups of psychiatric conditions: the externalizing disorders (characterized by behavioural problems and lack of inhibition); the internalizing disorders (characterized by depression and anxiety) and the psychotic disorders (characterized by hallucinations and delusions, and typically leading to diagnoses such as schizophrenia and bipolar disorder). Abnormal conscious experience is evident in the latter two groups and especially the psychoses. Research shows that depression is associated with selective attention to negative information and a tendency to (...) ruminate (brood about negative lief events). Anxiety is associated with vigilance for threatening information and abnormal meta‐cognitive beliefs (beliefs and worries about the content of consciousness). In the case of the psychotic disorders, research suggests that hallucinations are associated with difficulties in source monitoring (discriminating between self‐generated and external stimuli) and trauma‐linked dissociative states. Some delusional beliefs appear to be associated with anomalous experiences and, although a range of cognitive biases are involved, may arise partly as an attempt to make sense of these experiences. (shrink)

The French medical context is characterized by institutionalization of the ethical reflection in health care facilities and an important disparity between spaces of ethical reflection. In theory, the healthcare professional may mobilise an arsenal of resources to help him in his ethical reflection. But what happens in practice? We conducted semi-structured interviews with 22 health-care professionals who did and did not have recourse to clinical ethical committees. We also implemented two focus groups with 18 professionals involved in various spaces (...) of ethical reflection in order to let them debate about a better way to organize ethical reflection in their institutional contexts. The qualitative analysis allows to us to underline the coexistence of different conceptions of ethics among health care professionals. We also observed that the participants in our study shared the experience of ethically problematic situations as roadblocks in the process of communication and decision-making. We therefore report the factors which favour or inhibit the ethical course leading to the resolution or at the very least soothing of the situation at hand. Finally, we discuss methodological issues and underline the fact that while the patient is at the heart of the professional’s ethical preoccupations, this does not imply that they are actors in decisions that concern them. (shrink)

In the rapidly evolving healthcare environment, perhaps no role is in greater flux and redefinition than that of the clinical bioethicist. The discussion of ethics consultation in the bioethics literature has moved from an ambiguous concern regarding its proper place in the clinical milieu to the more provocative question of which methods and theories should best characterize the intellectual and practical work it claims to do. The American Society for Bioethics and Humanities addressed these concerns in its 1998 (...) report, CoreCompetenciesforHealthCareEthicsConsultation. The report tries to answer the question as to what disciplinary training, background experience, and levels of knowledge in ethics the clinical ethics consultant should have, and what specific skills and character traits the clinical ethics consultant should cultivate. In addition to acquiring knowledge of common bioethical issues, theoretical concepts in ethical theory and moral reasoning, and health-related law and policy, the report also recommends that ethics consultants demonstrate knowledge of the health beliefs and perspectives of patients and healthcare providers. In our opinion, this recommendation underscores a crucial aspect of the practice of ethics consultation in the increasingly multicultural settings of healthcare institutions. Clearly, the dynamic of American life and culture is permeated with diversity and variety as new groups suffuse their own beliefs and faith perspectives into the health sector. New immigrant groups force society to question traditional healthcare practices and to accommodate changing medical needs. (shrink)

Subpart B of 45 Code of Federal Regulations Part 46 (CFR) identifies the criteria according to which research involving pregnant women, human fetuses, and neonates can be conducted ethically in the United States. As such, pregnant women and fetuses fall into a category requiring “additional protections,” often referred to as “vulnerable populations.” The CFR does not define vulnerability, but merely gives examples of vulnerable groups by pointing to different categories of potential research subjects needing additional protections. In this paper, I (...) assess critically the role of this categorization of pregnant women involved in research as “vulnerable,” both as separate entities and in combination with the fetuses they carry. In particular, I do three things: (1) demonstrate that pregnant women qua pregnancy are either not “vulnerable” according to any meaningful definition of that term or that such vulnerability is irrelevant to her status as a research participant; (2) argue that while a fetus may be vulnerable in terms of dependency, this categorization does not equate to the vulnerability of the pregnant woman; and (3) suggest that any vulnerability that appends to women is precisely the result of federal regulations and dubious public perceptions about pregnant women. I conclude by demonstrating how this erroneous characterization of pregnant women as “vulnerable” and its associated protections have not only impeded vital research for pregnant women and their fetuses, but have also negatively affected the inclusion of all women in clinical research. (shrink)

Se realizó un estudio descriptivo transversal en la Facultad de Ciencias Médicas de Camagüey en el período comprendido entre septiembre del 2011 y marzo del 2012 con el objetivo de caracterizar el desarrollo de las habilidades de razonamiento clínico en los estudiantes de la carrera de Medicina. La muestra fue de 14 profesores de la disciplina de Medicina Interna y 110 estudiantes que terminaron recientemente el tercer año de la carrera de Medicina. La información fue recogida a través de una (...) entrevista a profundidad a informantes claves, un grupo focal con profesores del colectivo de la asignatura de Medicina Interna; además se encuestaron a través de un cuestionario con preguntas mixtas a la muestra de estudiantes seleccionada. Los profesores y alumnos coinciden en que hay deficiencias en el aprovechamiento del fondo de tiempo en la educación en el trabajo para el desarrollo de las habilidades de razonamiento clínico, así como insuficiencias en la orientación y evaluación de la actividad. A transverse descriptive study was conducted at the Faculty of Medical Sciences of Camagüey in the period between September 2011 and March 2012 with the aim of characterizing the development of the skills of clinical reasoning in medical students. The sample was composed by 14 teachers in the disciplines of Internal Medicine and 110 students who recently completed the third year of Medicine. The information was collected through an in-depth interview with key informants, a focus group with professors of the course of Internal Medicine;the sample of students selected was alsosurveyed through a questionnaire with mixed questions. Teachers and students agree that there are deficiencies in the use of the amount of time in education at work for the development of skills in clinical reasoning, as well as inadequacies in guidance and evaluation of the activity. (shrink)

The biopsychosocial model is characterized by the systematic consideration of biological, psychological, and social factors and their complex interactions in understanding health, illness, and health care delivery. This model opposes the biomedical model, which is the foundation of most current clinical practice. In the biomedical model, quest for evidence based medicine, the patient is reduced to molecules, genes, organelles, systems, diseases, etc. This reduction has brought great advances in medicine, but it lacks a holistic view of the person. To (...) solve the problem, we propose an early team based approach where the primary care physician leads a group of people that can help her/him address the psychosocial issues while she/he attends to the biomedical issues. This article addresses one case where the clinical ethicist facilitating a team based biopsychosocial model for the care of a patient worked as a bridge between the primary team, the critical care team, and the psychosocial team to advance the argument that good communication among the groups can lead to a true biopsychosocial model where the collaboration of the social worker, psychologist, chaplain, ethicist and the different medical teams can improve the overall patient experience. (shrink)

Background: SNOMED CT is a large terminology system designed to represent all aspects of healthcare. Its current form and content result from decades of bottom-up evolution. Due to SNOMED CT’s formal descriptions, it can be considered an ontology. The Basic Formal Ontology (BFO) is a foundational ontology that proposes a small set of disjoint, hierarchically ordered classes, supported by relations and axioms. In contrast, as a typical top-down endeavor, BFO was designed as a foundational framework for domain ontologies in the (...) natural sciences and related disciplines. Whereas it is mostly assumed that domain ontologies should be created as extensions of foundational ontologies, a post-hoc harmonization of consolidated domain ontologies in use, such as SNOMED CT, is known to be challenging. Methods: We explored the feasibility of harmonizing SNOMED CT with BFO, with a focus on the SNOMED CT Clinical Finding hierarchy. With more than 100,000 classes, it accounts for about one third of SNOMED CT’s content. In particular, we represented typical SNOMED CT finding/disorder concepts using description logics under BFO. Three representational patterns were created and the logical entailments analyzed. Results: Under a first scrutiny, the clinical intuition that diseases, disorders, signs and symptoms form a homogeneous ontological upper-level class appeared incompatible with BFO’s upper-level distinction into continuants and occurrents. The Clinical finding class seemed to be an umbrella for all kinds of entities of clinical interest, such as material entities, processes, states, dispositions, and qualities. This suggests the conclusion that Clinical finding would not be a suitable upper-level class from an BFO perspective. On closer inspection of the taxonomic links within this hierarchy and the implicit meaning derived thereof, it became clear that Clinical finding classes do not characterize the entity (e.g. a fracture, allergy, tumor, pain, hemorrhage, seizure, fever) in a literal sense but rather the condition of a patient having that fracture, allergy, pain etc. This gives sense to the current characteristic of the Clinical Finding hierarchy, in which complex classes are modeled as subclasses of their constituents. Most of these taxonomic links are inferred, as the consequence of the ‘role group’ design pattern, which is ubiquitous in SNOMED CT and has often been subject of controversy regarding its semantics. Conclusion: Our analyses resulted in the proposal of (i) equating SNOMED CT’s ‘role group’ property with the reflexive and transitive BFO relation ‘has occurrent part’; and (ii) reinterpreting Clinical Findings as Clinical Occurrents, i.e. temporally extended entities in an organism, having one or more occurrents as temporal parts that occur in continuants. This re-interpretation was corroborated by a manual analysis of classes under Clinical Finding, as well as the identification of similar modeling patterns in other ontologies. As a result, SNOMED CT does not require any content redesign to establish compatibility with BFO, apart from this re-interpretation, and a suggested re-labeling. Regarding the feasibility of harmonizing terminologies with principled foundational ontologies post-hoc, our results provide support to the assumption that this does not necessarily require major redesign efforts, but rather a careful analysis of the implicit assumptions of terminology curators and users. (shrink)

In 2018-2019, at the Keck School of Medicine of the University of Southern California, we developed and piloted a narrative-based health systems science intervention for patients living with HIV and medical students in which medical students co-wrote patients’ life narratives for inclusion in the electronic health record. The pilot study aimed to assess the acceptability of the “life narrative protocol” from multiple stakeholder positions and characterize participants’ experiences of the clinical and pedagogical implications of the LNP. Students were recruited (...) from KSOM. Patients and staff were recruited from the Maternal, Child, and Adolescent/Adult Center for Infectious Disease and Virology at Los Angeles County+USC Medical Center. Ten patients, seventeen students, and ten MCA staff participated in the pilot study. Qualitative methods were used to gather data from students’, patients’, and staff’s perspectives. Three themes emerged from the thematic analysis: patients’ life narratives conveyed their unique life experiences and voices; the protocol could result in wide-ranging effects on HIV care; the LNP enabled students to contribute value to patients’ healthcare. Across groups, participants considered the LNP an acceptable intervention. The LNP, its limitations, and implications for HIV care, narrative medicine, and health information technology are presented. (shrink)

Math difficulties manifest across various domain-specific and domain-general abilities. However, the existing cognitive profile of MD is incomplete and thus not applicable in typical settings such as schools or clinics. So far, no review has applied inclusion criteria according to DSM or ICD, summarized domain-specific abilities or examined the validity of response time scores for MD identification. Based upon stringent clinical criteria, the current meta-analysis included 34 studies which compared cognitive performances of a group with MD and a (...) group without MD. Criteria according to DSM and ICD were applied to identify MD. Effect sizes for 22 abilities were estimated and separated by their level and type of scoring. A cognitive profile of MD was identified, characterized by distinct weaknesses in: computation, number sense, and visual-spatial short-term storage [AC]. No particular strength was found. Severity of MD, group differences in reading performance and IQ did not significantly moderate the results. Further analyses revealed that effects are larger when dealing with numbers or number words than with quantities, MD is not accompanied by any weakness in abilities typically assigned to reading, and weaknesses in visual-spatial short-term storage emphasize the notion that number and space are interlinked. The need for high-quality studies investigating domain-general abilities is discussed. (shrink)

Reduced Environmental Stimulation Therapy (REST) alters the balance of sensory input to the nervous system by systematically attenuating sensory signals from visual, auditory, thermal, tactile, vestibular, and proprioceptive channels. Previous research from our group has shown that REST via floatation acutely reduces anxiety and blood pressure while simultaneously heightening interoceptive awareness in clinically anxious populations. Anorexia nervosa (AN) is an eating disorder characterized by elevated anxiety, distorted body representation, and abnormal interoception, raising the question of whether REST might positively (...) impact these symptoms. However, this approach has never been studied in eating disorders and it is unknown whether exposure to REST might worsen AN symptoms. To examine these possibilities we conducted an open-label study to investigate the safety and tolerability of REST in AN. We also explored the impact of REST on affective symptoms, body image disturbance, and interoception. Twenty-one partially weight-restored AN outpatients completed a protocol involving four sequential sessions of REST: reclining in a zero-gravity chair, floating in an open pool, and two sessions of floating in an enclosed pool. All sessions were 90 minutes, approximately one week apart. We measured orthostatic blood pressure before and immediately after each session (primary outcome), in addition to collecting blood pressure readings every 10 minutes during the session using a wireless waterproof system as a secondary outcome measure. Each participant's affective state, awareness of interoceptive sensations, and body image was assessed before and after every session (exploratory outcomes). There was no evidence of orthostatic hypotension following floating, and no adverse events (primary outcome). Secondary analyses revealed that REST induced statistically significant reductions in blood pressure, anxiety and negative affect, heightened awareness of cardiorespiratory but not gastrointestinal sensations, and reduced body image dissatisfaction. The findings from this initial trial suggest that individuals with AN can safely tolerate the physical effects of REST via floatation. Future randomized controlled trials will need to investigate whether these initial observations of improved anxiety, interoception, and body image disturbance can be effectively extended to acutely ill AN populations. (shrink)

Recognizing the importance of health‐promoting relationships in engaging people who are experiencing homelessness in care, most research on health clinics for homeless persons has involved some recognition of client–provider relationships. However, what has been lacking is the inclusion of a critical analysis of the policy context in which relationships are enacted. In this paper, we question how client–provider relationships are enacted within the culture of community care with people who are experiencing homelessness and how clinic‐level and broader social and health (...) policies shape relationships in this context. We explore these questions within a critical theoretical perspective utilizing a critical ethnographic methodology. Data were collected using multiple methods of document review, participant observation, in‐depth interviews and focus groups. The participants include both clients at a community health clinic, and all clinic service providers. We explore how clients and providers characterized each other as ‘good’ or ‘bad’. For providers, this served as a means by which they policed behaviours and enforced social norms. The means by which both providers’ and clients’ negotiated relationships are explored, but this is couched within both local and system‐level policies. This study highlights the importance of healthcare providers and clients being involved in broader policy and systemic change. (shrink)

The semantic fluency task is a widely used clinical tool in the diagnostic process of Alzheimer's disease. The task requires efficient mapping of the semantic space to produce as many items as possible within a semantic category. We examined whether healthy volunteers and patients with early Alzheimer's disease take advantage of and travel in the semantic space differently. With focus on the animal fluency task, we sought to emulate the detailed structure of the multidimensional semantic space by utilizing word2vec-method (...) from the natural language processing domain. To render the resulting multidimensional semantic space visually comprehensible, we applied a dimensionality reduction algorithm, which enabled a straightforward division of the semantic space into sub-categories. Moving in semantic space was quantified with the number of items created, sub-categories visited, and switches and returns to these sub-categories. Multinomial logistic regression models were used to predict the diagnostic group with these independent variables. We found that returning to a sub-category provided additional information, besides the number of words produced in the task, to differentiate patients with Alzheimer's dementia from both amnestic Mild Cognitive Impairment patients and healthy controls. The results suggest that the frequency of returning to a sub-category may serve as an additional aid for clinicians in diagnosing early Alzheimer's disease. Moreover, our results imply that the combination of word2vec and subsequent t-SNE-visualization may offer a valuable tool for examining the semantic space and its sub-categories. (shrink)

The target article discusses various aspects of the relationship between the sympathetic system and pain. To this end, the patients under study are divided into three groups. In the first group, called (RSD), the syndrome can be characterized by a triad of autonomic, motor, and sensory symptoms, which occur in a distally generalized distribution. The pain is typically felt deeply and diffusely, has an orthostatic component, and is suppressed by the ischemia test. Under those circumstances, the pain is likely (...) to respond to sympatholytic interventions. In a second group, called (SMP) syndrome, the principal symptoms are spontaneous pain, which is felt superficially and has no orthostatic component, and allodynia. These symptoms, typically confined to the zone of a lesioned nerve, may also be relieved by sympathetic blocks. Since the characteristics of the pain differ between RSD and SMP, the underlying kind of sympathetic–sensory coupling may also vary between these cases. A very small third group of patients exhibits symptoms of both RSD and SMP. The dependence or independence of pain on sympathetic function reported in most published studies seems to be questionable because the degree of technical success of the block remains uncertain. Therefore, pain should not be reported as sympathetic function independent until the criteria for a complete sympathetic block have been established and satisfied. (shrink)

In this study, we discuss the role of senior nurses who sit on clinical commissioning groups that now plan and procure most health services in England. These nurses are expected to bring a nursing view to all aspects of clinical commissioning group business. The role is a senior level appointment and requires experience of strategic commissioning. However, little is known about how nurses function in these roles. Following Barrientos' methodology, published policy and literature were analysed to investigate (...) these roles and National Health Service England's claim that nursing can influence and advance a nursing perspective in clinical commissioning groups. Drawing on work by Berg, Barry and Chandler on ‘new public management’, we discuss how nurses on clinical commissioning groups work at the alignment of the interests of biomedicine and managerialism. We propose that the way this nursing role is being implemented might paradoxically offer further evidence of the devaluing of nursing rather than the emergence of a strong professional nursing voice at the level of strategic commissioning. (shrink)

Critical reflection on clinical ethics consultation is essential to the field. Johnson and colleagues (2015) have helpfully summarized the consultation experience of a children's specialty hospital...

The definition of the study population for a clinical trial via the criteria for trial eligibility has implications for the validity of the study and its applicability to clinical practice. Though issues of equity regarding the selection of subjects for research have long been a concern of ethicists, issues regarding the impact of subject selection on a trial's generalizability have only recently attracted ethical scrutiny. After a review of the history of the ethics of subject selection, I focus (...) on three empirical questions regarding the generalizability of clinical trials. (1) What proportion of diseased populations are studied in clinical trials? (2) How are subjects selected for clinical trial participation (and what are the main barriers to participation)? (3) Are clinical trial participants comparable to non-participants? Finally, the role of the Institutional Review Board--Research Ethics Board in Canada--in assessing the generalizability of clinical research is discussed. (shrink)

Clinical Ethics and the Dynamics of Group Decision-Making: Applying the Psychological Data to Decisions Made by Ethics Committees Content Type Journal Article Pages 207-228 DOI 10.1007/s10730-009-9096-7 Authors Erica K. Rangel, Saint Louis University Department of Health Care Ethics 6333 North Rosebury Ave #3W St. Louis MO 63105 USA Journal HEC Forum Online ISSN 1572-8498 Print ISSN 0956-2737 Journal Volume Volume 21 Journal Issue Volume 21, Number 2.

A well known and referenced global result is the nilpotent characterisation of the finite p-groups. This un doubtedly transends into neutrosophy. Hence, this fact of the neutrosophic nilpotent p-groups is worth critical studying and comprehensive analysis. The nilpotent characterisation depicts that there exists a derived series (Lower Central) which must terminate at {ϵ} (an identity), after a finite number of steps. Now, Suppose that G(I) is a neutrosophic p-group of class at least m ≥ 3. We show in this (...) paper that Lm−1(G(I)) is abelian and hence G(I) possesses a characteristic abelian neutrosophic subgroup which is not supposed to be contained in Z(G(I)). Furthermore, If L3(G(I)) = 1 such that pm is the highest order of an element of G(I)/L2(G(I)) (where G(I) is any neutrosophic p-group) then no element of L2(G(I)) has an order higher than pm. (shrink)

Background This article describes the issues encountered when designing a study to evaluate recruitment of minority ethnic groups into clinical cancer research in order to monitor adherence to the principles for good practice set out in the Department of Health, Research Governance Framework, England. Methods (i) A review of routine data sources to determine whether their usefulness as a source of data on prevalence of cancer in the population by ethnic category. (ii) A local case study at one hospital (...) trust to ascertain whether the ethnicity of cancer trial participants was representative of admitted cancer patients. Results (i) The lack of a comparator population makes it problematic to assess recruitment levels by ethnic group in clinical research. (ii) The odds of being in a trial were 30% lower for a member of a minority ethnic group compared to a white cancer patient after adjusting for disease, age and gender, OR 0.70 (0.53 to 0.94). These results differed for each ethnic group; Asian patients did not appear under-represented while Black and Chinese did so. However, there are important caveats to the findings based on the limited recording of ethnicity. Conclusions The lack of available data on the ethnicity of participants in clinical research and the prevalence of cancer in the population according to ethnicity makes it difficult to design a study to monitor representation of minority ethnic groups. This information is necessary to assess adherence to the Research Governance Framework principle that research evidence reflects the diversity of the population. (shrink)

(2011). The Children's Oncology Group Routinely Applies “Lack of Efficacy” Interim Monitoring to Its Randomized Clinical Trials. The American Journal of Bioethics: Vol. 11, No. 3, pp. 18-19.

How are “interesting” research problems identified and made durable by academic researchers, particularly in situations defined by multiple evaluation principles? Building on two case studies of research groups working on rare diseases in academic biomedicine, we explore how group leaders arrange their groups to encompass research problems that latch onto distinct evaluation principles by dividing and combining work into “basic-oriented” and “clinical-oriented” spheres of inquiry. Following recent developments in the sociology of valuation comparing academics to capitalist entrepreneurs in (...) pursuit of varying kinds of worth, we argue that the metaphor of the portfolio is helpful in analyzing how group leaders manage these different research lines as “alternative investment options” from which they were variously hoping to capitalize. We argue portfolio development is a useful concept for exploring how group leaders fashion “entrepreneurial” practices to manage and exploit tensions between multiple matrices of valuation and conclude with suggestions for how this vocabulary can further extend analysis of epistemic capitalism within science and technology studies. (shrink)

BackgroundNusinersen is one of an increasing number of new, expensive orphan drugs to receive authorization. These drugs strain public healthcare budgets and challenge principles for resource allocation. Nusinersen was introduced in the Norwegian public healthcare system in 2018. A national expert group consisting of physicians was formed to oversee the introduction and continuation of treatment in light of specific start and stop criteria.MethodsWe have studied experiences within the expert group with a special emphasis on their application of the (...) start and stop criteria, rationing of treatment, and experienced moral dilemmas. A research interview with six members of the national expert group was performed, then analysed with manifest content analysis. The analysis was supplemented with publically available sources on priority setting and the process leading up to the introduction of nusinersen and the establishment of the expert group.ResultsSixty-six patients have received treatment within the first 25 months since the national expert group’s establishment. Treatment has not been discontinued for any patient. No patients under 18 years of age have been denied treatment, as those who were referred at this age were all deemed to fulfill the start criteria. The expert group has, however, increased geographical treatment equity and facilitated important cooperation at the national level. Furthermore, it has enhanced open and critical discussions of both medical issues and new ethical dilemmas.ConclusionAlthough facilitating equal access to treatment for SMA patients, the national expert group has not discontinued treatment for any patient. It is suggested that in order for clinicians to be able to ration care for individual patients, they require both adequate support and sufficient formal authority. Start and stop criteria need to be re-evaluated as more knowledge and experience are gained regarding the treatment. (shrink)

It is shown that there is a formula σ(g) in the first-order language of group theory with the following property: for every finite group G, the largest soluble normal subgroup of G consists precisely of the elements g of G such that σ(g) holds.

BackgroundInternationally, clinical ethics support has yet to be implemented systematically in community health and care services. A large-scale Norwegian project attempted to increase ethical competence in community services through facilitating the implementation of ethics support activities in 241 Norwegian municipalities. The article describes the ethics project and the ethics activities that ensued.MethodsThe article first gives an account of the Norwegian ethics project. Then the results of two online questionnaires are reported, characterizing the scope, activities and organization of the ethics (...) activities in the Norwegian municipalities and the ethical topics addressed.ResultsOne hundred and thirty-seven municipal contact persons answered the first survey, whereas 217 ethics facilitators from 48 municipalities responded to the second. The Norwegian ethics project is vast in scope, yet has focused on some institutions and professions whilst seldom reaching others. Patients and next of kin were very seldom involved. Through the ethics project employees discussed many important ethical challenges, in particular related to patient autonomy, competence to consent, and cooperation with next of kin. The “ethics reflection group” was the most common venue for ethics deliberation.ConclusionsThe Norwegian project is the first of its kind and scope, and other countries may learn from the Norwegian experiences. Professionals have discussed central ethical dilemmas, the handling of which arguably makes a difference for patients/users and service quality. The study indicates that large scale implementation of CES structures for the municipal health and care services is complex, yet feasible. (shrink)

IntroductionClassifying the ethical issues in clinical ethics consultations is important to clinical practice and scholarship. We conducted a systematic review to characterize the typologies used to analyze clinical ethics consultations.MethodsWe identified empirical studies of clinical ethics consultation that reported types of ethical issues using PubMed. We screened these articles based on their titles and abstracts, and then by a review of their full text. We extracted study characteristics and typologies and coded the typologies.ResultsWe reviewed 428 articles; (...) 30 of the articles fulfilled our inclusion criteria. We identified 27 unique typologies. Each typology contained five to 47 categories (mean = 18). The most common categories were do-not-attempt-resuscitation orders (19 typologies, 70 percent), capacity (18 typologies, 67 percent), withholding (18 typologies, 67 percent), withdrawing (17 typologies, 63 percent), and surrogate or proxy (16 typologies, 59 percent). Only seven (26 percent) of the typologies contained all five of the most common categories. The typologies we used to characterize clinical ethics consultations exhibit significant heterogeneity and several conceptual limitations. A common typology is needed whose development may require multi-institutional collaboration and could be facilitated by professional organizations. (shrink)

Objectives: To describe the concerns and priorities of key stakeholders in a developing country regarding ethical obligations held by researchers and perceptions of equity or “what is fair” for study participants in an HIV/AIDS clinical drug trial. Design: Qualitative study with focus groups. Setting: Teaching and referral hospital and rural health centre in western Kenya. Participants: Potential HIV/AIDS clinical trial participants, clinician researchers, and administrators. Results: Eighty nine individuals participated in a total of 11 focus groups over a (...) four month period. The desire for continued drug therapy, most often life long, following an HIV/AIDS clinical trial was the most common priority expressed in all focus groups. Patients with and without HIV/AIDS also thought subsidisation of drug therapies and education were critical forms of compensation for clinical trial participation. Financial incentives were considered important primarily for purchasing drug therapy as well as obtaining food. Patients noted a concern for the potential mismanagement of any money offered. Clinician researchers and administrators felt strongly that researchers have a moral obligation to participants following a trial to provide continued drug therapy, adverse event monitoring, and primary care. Finally, clinician researchers and administrators stressed the need for thorough informed consent to avoid coercion of study participants. Conclusions: Kenyan patients, clinician researchers, and administrators believe that it would be unfair to stop antiretroviral therapy following an HIV/AIDS clinical trial and that researchers have a long term obligation to participants. (shrink)

In this paper we report findings from a commissioned report to the COVID-19 Clinical Research Coalition on approaches to streamline multinational REC review/approval during public health emergencies. As currently envisioned in the literature, a system of REC mutual recognition is theoretically possible based on shared procedural REC standards, but raises numerous concerns about perceived inequities and mistrust.

We show that every ℵα can be characterized by the Scott sentence of some countable model; moreover there is a countable structure whose Scott sentence characterizes ℵ1 but whose automorphism group fails the topological Vaught conjecture on analytic sets. We obtain some partial information on Ulm type dichotomy theorems for the automorphism group of Knight's model.

This article analyzes the bioethical implications of using a control/placebo group when conducting clinical trials (CTs) investigating the treatment of periodontitis. For this, the deductive method was used, proposing the interrelation of values, and a scoping systematic review was carried out. A total of 53% of the CTs reviewed were performed in low- and middle-income (LMI) countries, and 92% used a control/placebo group as a comparison group. Although there is a gold standard for the adjunctive treatment (...) of periodontitis, the research ethics committees of most of the analyzed studies approved the use of control/placebo groups for the performance of CTs that did not explore new therapeutic alternatives. In some cases, the CT protocols were not approved by ethics committees, nor was informed consent used. In the LMI countries, a shorter period of recruitment was observed for patients who attended universities and public hospitals. Likewise, most of the CTs reviewed had public funding, a significant amount of which came from the pharmaceutical industry. Only one CT reported the low economic and educational level of its participants. Furthermore, none of the authors of the reviewed CTs declared conflicts of interest. Although the axiology of techno-science always takes into account at least the epistemic, technical and economic value systems, the hegemony of the economic values imposed by the pharmaceutical industry is evident in the performance of CTs investigating the treatment of periodontitis in LMI countries. (shrink)

This article analyzes the bioethical implications of using a control/placebo group when conducting clinical trials (CTs) investigating the treatment of periodontitis. For this, the deductive method was used, proposing the interrelation of values, and a scoping systematic review was carried out. A total of 53% of the CTs reviewed were performed in low- and middle-income (LMI) countries, and 92% used a control/placebo group as a comparison group. Although there is a gold standard for the adjunctive treatment (...) of periodontitis, the research ethics committees of most of the analyzed studies approved the use of control/placebo groups for the performance of CTs that did not explore new therapeutic alternatives. In some cases, the CT protocols were not approved by ethics committees, nor was informed consent used. In the LMI countries, a shorter period of recruitment was observed for patients who attended universities and public hospitals. Likewise, most of the CTs reviewed had public funding, a significant amount of which came from the pharmaceutical industry. Only one CT reported the low economic and educational level of its participants. Furthermore, none of the authors of the reviewed CTs declared conflicts of interest. Although the axiology of techno-science always takes into account at least the epistemic, technical and economic value systems, the hegemony of the economic values imposed by the pharmaceutical industry is evident in the performance of CTs investigating the treatment of periodontitis in LMI countries. (shrink)

This article analyzes the bioethical implications of using a control/placebo group when conducting clinical trials (CTs) investigating the treatment of periodontitis. For this, the deductive method was used, proposing the interrelation of values, and a scoping systematic review was carried out. A total of 53% of the CTs reviewed were performed in low- and middle-income (LMI) countries, and 92% used a control/placebo group as a comparison group. Although there is a gold standard for the adjunctive treatment (...) of periodontitis, the research ethics committees of most of the analyzed studies approved the use of control/placebo groups for the performance of CTs that did not explore new therapeutic alternatives. In some cases, the CT protocols were not approved by ethics committees, nor was informed consent used. In the LMI countries, a shorter period of recruitment was observed for patients who attended universities and public hospitals. Likewise, most of the CTs reviewed had public funding, a significant amount of which came from the pharmaceutical industry. Only one CT reported the low economic and educational level of its participants. Furthermore, none of the authors of the reviewed CTs declared conflicts of interest. Although the axiology of techno-science always takes into account at least the epistemic, technical and economic value systems, the hegemony of the economic values imposed by the pharmaceutical industry is evident in the performance of CTs investigating the treatment of periodontitis in LMI countries. (shrink)

This article analyzes the bioethical implications of using a control/placebo group when conducting clinical trials (CTs) investigating the treatment of periodontitis. For this, the deductive method was used, proposing the interrelation of values, and a scoping systematic review was carried out. A total of 53% of the CTs reviewed were performed in low- and middle-income (LMI) countries, and 92% used a control/placebo group as a comparison group. Although there is a gold standard for the adjunctive treatment (...) of periodontitis, the research ethics committees of most of the analyzed studies approved the use of control/placebo groups for the performance of CTs that did not explore new therapeutic alternatives. In some cases, the CT protocols were not approved by ethics committees, nor was informed consent used. In the LMI countries, a shorter period of recruitment was observed for patients who attended universities and public hospitals. Likewise, most of the CTs reviewed had public funding, a significant amount of which came from the pharmaceutical industry. Only one CT reported the low economic and educational level of its participants. Furthermore, none of the authors of the reviewed CTs declared conflicts of interest. Although the axiology of techno-science always takes into account at least the epistemic, technical and economic value systems, the hegemony of the economic values imposed by the pharmaceutical industry is evident in the performance of CTs investigating the treatment of periodontitis in LMI countries. (shrink)

Detection of Alzheimer’s disease in an early stage is receiving increasing attention for a number of reasons, such as the failure of drug trials in more advanced disease stages, the demographic evolution, the financial impact of AD, and the approval of amyloid tracers for clinical use. Five focus group interviews with stakeholders were conducted.. The verbatim transcripts were analysed via the Nvivo 11 software. Most stakeholder groups wanted to know their own amyloid PET scan result. However, differences occurred (...) between FGs: two groups wanted to know, whilst in the three other groups FG members opted not to know or were still in doubt about their decision. Stakeholders provided insight into their reasons for wanting to know their amyloid PET scan result, for not wanting to know their result, or why they were in doubt about their decision. Several advantages and disadvantages were mentioned as part of knowing their amyloid PET scan result. Certain considerations were clustered in a grey zone, in between advantage and disadvantage, such as the emotional consequences. Clinicians, researchers, and policymakers ought to be aware of the diversity of reasons for wanting to know their result and how possible benefits and risks can be viewed differently. The current findings are of importance for future early diagnosis and disclosure of results in the research setting. (shrink)