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)

The ever-increasing technological advances of modern medicine have increased physicians’ capacity to carry out a wide array of clinical interventions near the end-of-life. These new procedures have resulted in new “types” of living where a patient’s cognitive functions are severely diminished although many physiological functions remain active. In this biomedical context, patients, surrogate decision-makers, and clinicians all struggle with decisions about what clinical interventions to pursue and when therapeutic intent should be replaced with palliative goals of (...) care. For some patients and clinicians, religious teachings about the duty to seek medical care and the care of the dying offer ethical guidance when faced with such choices. Accordingly, this paper argues that traditional Sunni Islamic ethico-legal views on the obligation to seek medical care and Islamic theological concepts of human dignity and inviolability provide the ethical grounds for non-intervention at the end-of-life and can help calibrate goals of care discussions for Muslim patients. In closing the paper highlights the pressing need to develop a holistic ethics of healthcare of the dying from an Islamic perspective that brings together multiple genres of the Islamic intellectual tradition so that it can meet the needs of the patients, clinicians and Muslim religious leaders interacting with the healthcare system. (shrink)

The ever-increasing technological advances of modern medicine have increased physicians’ capacity to carry out a wide array of clinical interventions near the end of life. These new procedures have resulted in new “types” of living where a patient’s cognitive functions are severely diminished although many physiological functions remain active. In this biomedical context, patients, surrogate decision-makers, and clinicians all struggle with decisions about what clinical interventions to pursue and when therapeutic intent should be replaced with palliative (...) goals of care. For some patients and clinicians, religious teachings about the duty to seek medical care and the care of the dying offer ethical guidance when faced with such choices. Accordingly, this paper argues that traditional Sunni Islamic ethico-legal views on the obligation to seek medical care and Islamic theological concepts of human dignity and inviolability provide the ethical grounds for non-intervention at the end of life and can help calibrate goals of care discussions for Muslim patients. In closing, the paper highlights the pressing need to develop a holistic ethics of healthcare of the dying from an Islamic perspective that brings together multiple genres of the Islamic intellectual tradition so that it can meet the needs of the patients, clinicians, and Muslim religious leaders interacting with the healthcare system. (shrink)

Capacity evaluation has become a widely used assessment device in clinical practice to determine whether patients have the cognitive ability to render their own medical decisions. Such evaluations, which might be better thought of as “capacity challenges,” are generally thought of as benign tools used to facilitate care. This paper proposes that such challenges should be reconceptualized as significant medical interventions with their own set of risks, side effects, and potentially deleterious consequences. As a result, a cost–benefit analysis (...) should be implemented prior to imposing such capacity challenges, and efforts should be made to minimize such challenges in situations where they are unlikely to alter the course of treatment. (shrink)

Research has shown a direct relationship between infertility-related stress and anxiety in infertile patients. The present study goes into this relationship in depth, testing the moderating role of coping strategies in the associations between specific infertility-related stress dimensions and State-Anxiety among male and female partners of infertile couples. Gender differences were also explored. Both members of 254 infertile couples completed a questionnaire consisting of Socio-demographics, Fertility Problem Inventory–Short Form, Coping Orientation to Problem Experienced–New Italian Version, and State-Trait Anxiety Inventory-Y. The (...) results revealed that Social Concern and Couple’s Relationship Concern, in both partners, and Need for Parenthood, in female partners, had positive correlations with State-Anxiety. Seeking Social Support and Avoidant coping were related to increasing levels of State-Anxiety in both partners, whereas Positive Attitude coping strategies were related to lower levels of State-Anxiety in female partners. Problem-Solving and Avoidant coping played moderating roles between specific infertility-related stress dimensions and State-Anxiety in unexpected directions. Problem-Solving exacerbated the negative effects of Social Concern, whereas Avoidant coping buffered the negative effects of several infertility-related stress dimensions in both partners. Interventions to improve stress management and psychological health in infertile couples should consider that the adequacy of coping strategies is inherently situation specific. It therefore follows that patient-centered clinical interventions should consider the potential inadequacy of promoting Problem-Solving strategies, and that even Avoidance can be an efficient strategy for dealing with specific infertility-related stress dimensions. (shrink)

Firearm injury in the United States is a public health crisis in which physicians are uniquely situated to intervene. However, their ability to mitigate harm is limited by a complex array of laws and regulations that shape their role in firearm injury prevention. This piece uses four clinical scenarios to illustrate how these laws and regulations impact physician practice, including patient counseling, injury reporting, and the use of court orders and involuntary holds. Unintended consequences on clinical practice of (...) laws intended to reduce firearm injury are also discussed. Lessons drawn from these cases suggest that physicians require more nuanced education on this topic, and that policymakers should consult front-line healthcare providers when designing firearm policies. (shrink)

Hacia fines del siglo XIX y principio del XX se desarrolla en la Argentina un importante debate en torno al derecho penal, en el que muchos intelectuales, formados bajo la influencia del biologicismo darwiniano, intervienen para cuestionar el Código Penal, vigente desde 1887. En nuestro trabajo analizamos los desarrollos de José Ingenieros sobre el tema, profundizando el estudio de los conceptos que propone y atendiendo a la transformación radical que éstos implican en lo que hace a la comprensión del derecho, (...) de la delincuencia y de su tratamiento. A lo largo del trabajo reconocemos en las formulaciones de Ingenieros una renovación del campo conceptual en el tratamiento del delito, de acuerdo con un nuevo esquema de estudio e investigación de la delincuencia, una nueva clasificación de los sujetos criminales y nuevo sentido para la institución jurídica. A partir de allí analizamos sus consecuencias en términos de un nuevo mapa disciplinar para el tratamiento de la delincuencia, en el que la psicología pasaría a ocupar un rol protagónico, poniendo de manifiesto sus potencialidades para la intervención normalizadora del campo social. In the end of 19th Century and the beginning of the 20th it develops in Argentine an important discussion around penal law, in which many intellectuals, under the influence of Darwinian biologicism, query the Penal Code, current since 1887. In our article we analyze Jose Ingenieros' explanations about this topic, studying the concepts that he proposes and attending to the radical transformation that they imply for the understanding of law, of crime and of its treatment. In this paper we recognize in Ingenieros' formulations a renovation of the conceptual field in the treatment of crime, according with a new outline of the study and investigation of crime, a new criminal's classification and a new sense for the legal institution. We also analyze its consequences in terms of a new disciplinary map for crime's treatment, in which psychology assumes a central place, showing its potentialities for the normalizing intervention in the social field. (shrink)

Mounting evidence suggests that participation in clinical trials confers neither advantage nor disadvantage on those enrolled. Narrow focus on the question of a “trial effect,” however, distracts from a broader mechanism by which patients may benefit from ongoing clinical research. We hypothesize that the existence of clinical trials infrastructure—the organizational culture, systems, and expertise that develop as a product of sustained participation in cooperative clinical trials research—may function as a quality improvement lever, improving the quality of (...) care and outcomes of all patients within an institution or region independent of their individual participation in trials. We further contend that this “infrastructure effect” can yield particular benefits for patients in low- and middle-income countries. The hypothesis of an infrastructure effect as a quality improvement intervention, if correct, justifies enhanced research capacity in LMIC as a pillar of health system development. (shrink)

BackgroundHow should clinical ethics support services such as clinical ethics committees (CECs) be implemented and evaluated? We argue that both the CEC itself and theimplementationof the CEC should be considered as ‘complex interventions’.Main textWe present a research project involving the implementation of CECs in community care in four Norwegian municipalities. We show that when both the CEC and its implementation are considered as complex interventions, important consequences follow – both for implementation and the study thereof. Emphasizing (...) four such sets of consequences, we argue, first, that the complexity of the intervention necessitates small-scale testing before larger-scale implementation and testing is attempted; second, that it is necessary to theorize the intervention in sufficient depth; third, that the identification of casual connections charted in so-called logic models allows the identification of factors that are vital for the intervention to succeed and which must therefore be studied; fourth, that an important part of a feasibility study must be to identify and chart as many as possible of the causally important contextual factors.ConclusionThe conceptualization of the implementation of a CEC as a complex intervention shapes the intervention and the way evaluation research should be performed, in several significant ways. We recommend that researchers consider whether a complex intervention approach is called for when studying CESS implementation and impact. (shrink)

Evaluating clinical ethics support services has been hailed as important research task. At the same time, there is considerable debate about how to evaluate CESS appropriately. The criticism, which has been aired, refers to normative as well as empirical aspects of evaluating CESS. In this paper, we argue that a first necessary step for progress is to better understand the intervention in CESS. Tools of complex intervention research methodology may provide relevant means in this respect. In a first step, (...) we introduce principles of “complex intervention research” and show how CESS fulfil the criteria of “complex interventions”. In a second step, we develop a generic “conceptual framework” for “ethics consultation on request” as standard for many forms of ethics consultation in clinical ethics practice. We apply this conceptual framework to the model of “bioethics mediation” to make explicit the specific structural and procedural elements of this form of ethics consultation on request. In a final step we conduct a comparative analysis of two different types of CESS, which have been subject to evaluation research: “proactive ethics consultation” and “moral case deliberation” and discuss implications for evaluating both types of CESS. To make explicit different premises of implemented CESS interventions by means of conceptual frameworks can inform the search for sound empirical evaluation of CESS. In addition, such work provides a starting point for further reflection about what it means to offer “good” CESS. (shrink)

Participants in clinical research sometimes view participation as therapy or exaggerate potential benefits, especially in phase I or phase II trials. We conducted this study to discover what methods might improve cancer patients’ understanding of early-phase clinical trials. We randomly assigned 130 cancer patients from three U.S. medical centers who were considering enrollment in a phase I or phase II cancer trial to receive either a multimedia intervention or a National Cancer Institute pamphlet explaining the trial and its (...) purpose. Intervention participants were 32 times more likely to believe that the trial’s purpose was to examine safety and 60 % less likely to believe they would experience long-term benefit or cure. There was no difference in enrollment decision. However, while patients’ understanding of the trial’s purpose improved and expectations of long-term benefit diminished, half the respondents still believed they would experience long-term benefit or cure from participation. Therefore, we conclude that multimedia interventions such as this one may help oncologists to explain the risks and benefits of early-phase cancer trials in a way that patients can more easily understand, helping them to make more informed decisions about participation. But further research into other factors that influence patients’ beliefs about the outcome of enrollment is needed, both to modify the interventions and to determine how malleable patient beliefs are. (shrink)

Since the 1980s, there has been an increasing acknowledgement of the importance of recognising the ethical dimension of clinical decision-making. Medical professional regulatory authorities in some countries now include ethical knowledge and practice in their required competencies for undergraduate and post graduate medical training. Educational interventions and clinical ethics support services have been developed to support and improve ethical decision making in clinical practice, but research evaluating the effectiveness of these interventions has been limited. We (...) undertook a systematic review of the published literature on measures or models of evaluation used to assess the impact of interventions to improve ethical decision making in clinical care. We identified a range of measures to evaluate educational interventions, and one tool used to evaluate a clinical ethics support intervention. Most measures did not evaluate the key impact of interest, that is the quality of ethical decision making in real-world clinical practice. We describe the results of our review and reflect on the challenges of assessing ethical decision making in clinical practice that face both developers of educational and support interventions and the regulatory organisations that set and assess competency standards. (shrink)

The recent Ebola outbreak in West Africa began in the spring of 2014 and has since caused the deaths of over 6,000 people. Since there are no approved treatments or prevention modalities specifically targeted at Ebola Virus Disease , debate has focused on whether unproven interventions should be offered to Ebola patients outside of clinical trials. Those engaged in the debate have responded rapidly to a complex and evolving crisis, however, and this debate has not provided much opportunity (...) for in-depth analysis. Additionally, the existing literature on access to unproven therapies has focused on contexts like HIV/AIDS and oncology, which are very different than the Ebola epidemic. In this paper, we examine the ethical issues surrounding access to unproven therapies in the context of the recent Ebola outbreak to yield new insights about this controversial and unsettled issue. We argue first that, in this context, the interests of patients in obtaining access to unproven therapies are not fully aligned.. (shrink)

Stress is increasingly being recognized as one of the main factors that is negatively affecting our health, and therefore there is a need to regulate daily stress and prevent long-term stress. This need seems particularly important for adults with mild intellectual disabilities who have been shown to have more difficulties coping with stress than adults without intellectual disabilities. Hence, the development of music therapy interventions for stress reduction, particularly within populations where needs may be greater, is becoming increasingly important. (...) In order to gain more insight into the practice-based knowledge on how music therapists lower stress levels of their patients with MID during music therapy sessions, we conducted focus group interviews with music therapists working with adults with MID from different countries and clinical institutions in Europe. Results provide an overview of the most-used interventions for stress reduction within and outside of music. Data-analysis resulted in the further specification of therapeutic goals, intervention techniques, the use of musical instruments, and related therapeutic change factors. The main findings indicate that music therapists used little to no receptive interventions for stress reduction, but preferred to use active interventions, which were mainly based on musical improvisation. Results show that three therapy goals for stress relief could be distinguished. The goal of “synchronizing” can be seen as a sub goal because it often precedes working on the other two goals of “tension release” or “direct relaxation,” which can also be seen as two ways of reaching stress reduction in adults with MID through music therapy interventions. Furthermore, the tempo and the dynamics of the music are considered as the most important musical components to reduce stress in adults with MID. Practical implications for stress-reducing music therapy interventions for adults with MID are discussed as well as recommendations for future research. (shrink)

In psychiatry, pharmacological research has played a crucial role in the formulation, revision, and refinement of neurobiological theories of psychopathology. Besides being utilized as potential treatments for various mental disorders, pharmacological drugs play an important epistemic role as experimental instruments that help scientists uncover the neurobiological underpinnings of mental disorders (Tsou, 2012). Interventions with psychiatric patients using pharmacological drugs provide researchers with information about the neurobiological causes of mental disorders that cannot be obtained in other ways. This important source (...) of evidence for the biological causes of mental disorder is often overlooked in philosophical analyses of psychiatry, especially in skeptical analyses that debase the biological aspects of psychopathology (e.g., Szasz, 1960; Scheff, 1963; Laing, 1967). In discussing pharmacological interventions as a form of evidence for the physical basis of mental disorders, this paper aims to clarify the nature, reliability, and limitations of this evidence. In addition, it illustrates the central role that pharmacological findings in applied clinical contexts play in the acquisition of neurobiological knowledge in research contexts. (shrink)

Background The intervention reported in this paper was a follow up to an empirical study conducted in Malawi with the aim of assessing trial participants’ understanding of randomisation, double-blinding and placebo use. In the empirical study, the majority of respondents (61.1%; n= 124) obtained low scores (lower than 75%) on understanding of all three concepts under study. Based on these findings, an intervention based on a narrative which included all three concepts and their personal implications was designed. The narrative used (...) daily examples from the field of Agriculture because Malawi has an agro-based economy. Methods The intervention was tested using a sample of 36 women who had been identified as low scorers during the empirical study. The 36 low scorers were randomly assigned to control (n=18) and intervention arms ( n =18). The control arm went through a session in which they were provided with standard informed consent information for the microbicide trial. The intervention arm went through a session in which they were provided with a narrative in ChiChewa, the local language, with the assistance of a power point presentation which included pictures as well as discussions on justification and personal implications of the concepts under study. Results The findings on the efficacy of the intervention suggest that the 3 scientific concepts and their personal implications can be understood by low literacy populations using simple language and everyday local examples. The findings also suggest that the intervention positively impacted on understanding of trial procedures under study, as 13 of the 18 women in the intervention arm, obtained high scores (above 75%) during the post intervention assessment and none of the 18 in the control arm obtained a high score. Using Fischer’s exact test, it was confirmed that the effect of the intervention on understanding of the three procedures was statistically significant (p=0.0001). Conclusions Potential trial participants can be assisted to understand key clinical trial procedures, their justification and personal implications by using innovative tailored local narratives. (shrink)

Criticisms of the traditional clinical research pathway and its extensive oversight often focus on proposals for deregulation or assert that as in clinical treatment, clinical research should always offer benefit to patient-subjects. Proponents of medical innovation take a different, middle path, arguing that innovation is distinguishable from both research and treatment. This article considers this third pathway by examining stem cell-based innovation.Stem cell-based medical innovation is one pathway toward clinical translation. In fact, such an approach was (...) taken in developing umbilical cord blood transplantation, which is now widely viewed as a safe and effective means for treating a range of malignant and non-malignant conditions. While the Guidelines for the Clinical Translation of Stem Cells created by the International Society for Clinical Research provide an approach to clinical translation that involves “responsible innovation” as an alternative to clinical research, there are at least four sets of unanswered questions regarding the use of an innovation pathway in this context that warrant careful attention. (shrink)

In recent years, there has been a particular emphasis placed on conducting randomized controlled trials (RCTs) that compare the relative efficacy of psychosocial and pharmacological interventions. This article addresses relevant ethical considerations in the conduct of these treatment trials, with a focus on RCTs with children. Ethical concerns, including therapeutic misconception, treatment preference, therapeutic equipoise, structure of treatments, and balancing risks versus benefits, are introduced through a clinical scenario and discussed as they relate to psychotherapy versus medication RCTs. (...) In each case, suggestions are made for researchers seeking to minimize the impact of these ethical concerns on research participants. (shrink)

Many abused women from patriarchal collectivistic societies that are subjected to social control seek help in community health clinics. The article is based on a qualitative study, which consisted of 24 interviews with 12 abused Israeli Arab women who sought the help of social workers in community health clinics. A central theme that emerged from the interviews was the women’s wish to maintain their self-determination in retaining the power to determine the boundaries of the intervention within the professional relationship. The (...) discussion focuses on the dialectical consequences of maintaining the women’s self-determination—empowering them, on one hand, and limiting them, on the other. (shrink)

Extreme rates of premature death prior to the advent of modern medicine, very low rates of premature death in First World nations with low rates of prayer, and the least flawed of a large series of clinical trials indicate that remote prayer is not efficacious in treating illness. Mass contamination of sample cohorts renders such clinical studies inherently ineffectual. The required supernatural and paranormal mechanisms render them implausible. The possibility that the latter are not benign, and the potentially (...) adverse psychological impact of certain protocols, renders these medical trials unethical. Resources should no longer be wasted on medical efforts to detect the supernatural and paranormal. (shrink)

Stem cell-based innovation is one pathway to clinical translation that stands in contrast to clinical research and medical treatment. After reviewing recently issued guidelines for responsible innovation, this article examines the potential benefits and harms of using this pathway as well as practical barriers and conceptual concerns regarding it.

Evaluation of clinical ethical case consultations has been discussed as an important research task in recent decades. A rigid framework of evaluation is essential to improve quality of consultations and, thus, quality of patient care. Different approaches to evaluate those services appropriately and to determine adequate empirical endpoints have been proposed. A key challenge is to provide an answer to the question as to which empirical endpoints—and for what reasons—should be considered when evaluating the quality of a service. In (...) this paper, we argue for an approach that adopts the role of ethics consultants as its point of departure. In a first step, we describe empirical and ethical characteristics of evaluating clinical ethical case. We show that the mode of action and the explicit normative character of the interventions constitute two characteristics which pose challenges to the selection of appropriate quality criteria and require special attention. In a second step, we outline the way in which an analysis of the role of ethics consultants in the context of a clinical ethical case consultation services can account for the existing challenges by linking empirically measurable endpoints with normative theory. Finally, we discuss practical implications of our model for evaluation research. (shrink)

Background: COVID-19 has taken many lives worldwide and due to this, millions of persons are in grief. When the grief process lasts longer than 6 months, the person is in risk of developing Complicated Grief Disorder. The CGD is related to serious health consequences. To reduce the probability of developing CGD a preventive intervention could be applied. In developing countries like Mexico, the psychological services are scarce, self-applied interventions could provide support to solve this problem and reduce the health (...) impact even after the pandemic has already finished.Aims: To design and implement a self-applied intervention composed of 12 modules focused on the decrease of the risk of developing CGD, and increasing the life quality, and as a secondary objective to reduce the symptomatology of anxiety, depression, and increase of sleep quality. The Intervention Duelo COVID follows the principles of User Experience and is designed according to the needs and desires of a sample of the objective participants, to increase the adherence to the self-applied intervention, considered one of the main weaknesses of online interventions.Methods: A Randomized Controlled Trial will be conducted from the 22nd of December of 2020 to the first of June 2021. The participants will be assigned to an intervention with elements of Cognitive Behavioral Therapy, Acceptance and Commitment Therapy, Mindfulness and Positive Psychology. The control group will be a wait-list condition, that will receive the intervention 1.5–2 months after the pre-measurement were taken. The Power Size Calculation conducted through G*Power indicated the need for a total of 42 participants, which will be divided by 21 participants in each group. The platform will be delivered through responsive design assuring with this that the intervention will adapt to the screen size of cellphones, tablets, and computers.Ethics and Dissemination: The study counts with the approval of the Research Ethics Committee of the Autonomous University of Ciudad Juárez, México, and it is registered in Clinical Trials. The article is sent and registered in clinical trials before the recruitment started. The results will be reported in future conferences, scientific publications, and media. (shrink)

An amendment to this paper has been published and can be accessed via the original article.

Background If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical - trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities (...) of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial's stages. Findings Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research. (shrink)

Research on individuals at clinical high risk for psychological and physical disorders has grown exponentially in recent years, with a variety of new screening tools and early intervention techniques being implemented. One recent example is Attenuated Psychosis Syndrome, a diagnosis for individuals who are at clinical high risk for psychosis, which was recently included in Section III of the Diagnostic and Statistical Manual of Mental Disorders. Given the focus on prevention at early stages, at-risk individuals will continue to (...) be a topic of significance not only in psychosis research but also in other illnesses. This document provides a comprehensive summary of the ethical dilemmas that clinicians or researchers may encounter in this domain, and possible actions consistent with the current Canadian Code of Ethics for Psychologists. We use clinical high risk for psychosis and the Canadian Code of Ethics for Psychologists as a way to illuminate these ethical issues; however, application to other jurisdictions and disciplines, as well as other high-risk populations, is also of relevance. (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)

This symposium of the Journal of Bioethical Inquiry illustrates structural competency: how clinical practitioners can intervene on social and institutional determinants of health. It will require training clinicians to see and act on structural barriers to health, to adapt imaginative structural approaches from fields outside of medicine, and to collaborate with disciplines and institutions outside of medicine. Case studies of effective work on all of these levels are presented in this volume. The contributors exemplify structural competency from many angles, (...) from the implications of epigenetics for environmental intervention in personalized medicine to the ways clinicians can act on fundamental causes of disease, address abuses of power in clinical training, racially desegregate cities to reduce health disparities, address the systemic causes of torture by police, and implement harm-reduction programs for addiction in the face of punitive drug laws. Together, these contributors demonstrate the unique roles that clinicians can play in breaking systemic barriers to health and the benefit to the U.S. healthcare system of adopting innovations from outside of the United States and outside of clinical medicine. (shrink)

Background This pilot study evaluated the speaking book ‘What it means to be part of a clinical trial’. The book aims at empowering populations with information on their rights and responsibilities when enrolled in clinical research. Wide publication of the book—at significant cost—is anticipated. It is important that the book is evaluated within the communities for whom it is intended, and the necessary changes (if any) are made, before translation and large-scale publication takes place. Objective The objective of (...) the study was to measure the efficacy and ease of use of the book. Methods Participants were recruited from a catering company. Participants were questioned on their knowledge of clinical trials and were then given the book. Instructions for use of the book were given to one group (‘experimental’ group). The other group (‘control’ group) was not given any instructions. A week later, the investigators returned, repeated the knowledge questions and asked ‘ease of use’ questions. Results A two-way repeated measure of covariants showed a statistically significant positive increase in knowledge of clinical trials among the intervention group (p=0.02). Results for the control group displayed trends that were not statistically significant. Percentage analysis of ‘ease of use’ questions proved that the book is easy to use, although some changes would be beneficial. Conclusion This study revealed that the speaking book is easy to use. It significantly increased knowledge of clinical trials among the study sample if instructions on use of the book were provided. (shrink)

There has been a growing concern over establishing norms that ensure the ethically acceptable and scientifically sound conduct of clinical trials. Among the leading norms internationally are the World Medical Association's Declaration of Helsinki, guidelines by the Council for International Organizations of Medical Sciences, the International Conference on Harmonization's standards for industry, and the CONSORT group's reporting norms, in addition to the influential U.S. Federal Common Rule, Food and Drug Administration's body of regulations, and information sheets by the Department (...) of Health and Human Services. There are also many norms published at more local levels by official agencies and professional groups.Any account of international standards should cover both scientific and ethical norms at once – the two are conceptually intertwined. Recent sources recognize that “[s]cientifically unsound research on human subjects is unethical in that it exposes research subjects to risks without possible benefit.”. (shrink)

There is increasing global pressure to ensure that pregnant women are responsibly and safely included in clinical research in order to improve the evidence base that underpins healthcare delivery during pregnancy. One supposed barrier to inclusion is the assumption that pregnant women will be reluctant to participate in research. There is however very little empirical research investigating the views of pregnant women. Their perspective on the benefits, burdens and risks of research is a crucial component to ensuring effective recruitment. (...) The Research In Pregnancy Ethics study set out to ascertain the views of pregnant women about research participation using an inductive thematic analysis. We conducted semi-structured interviews with 20 women who had participated in a double-blind randomised placebo controlled trial in Wellington while pregnant. Our results show that at least some pregnant women recognise the value and importance of research during pregnancy. The women we interviewed were deeply invested in the research process and outcomes. Key motivations for participating were altruism, playing a valuable civic role and the importance of research. The main perceived burdens related to inconvenience and time commitment. For some women, possible randomization to the placebo arm was regarded as a burden or disadvantage. (shrink)

BackgroundThe aim of this study was to investigate the effectiveness of psychotherapeutic interventions for clinically referred adolescents, as well as to examine whether sociodemographic, clinical, or treatment-related variables and patients’ role expectations predict treatment outcome or are possible predictors of treatment dropout.MethodThe study comprised 58 adolescents suffering from diverse psychiatric disorders referred to psychotherapeutic interventions conducted in outpatient care. The outcome measures, The Beck Depression Inventory, and the Clinical Outcomes in Routine Evaluation – Outcome Measure were (...) filled in at baseline and at 3-, 6-, and 12-month follow-ups. Possible predictors were assessed at baseline.ResultsThe results indicate that the mean level of symptoms and psychological distress decreased during the treatment, most reduction occurring in the first 6 months. The frequency of treatment sessions was the strongest predictor of good outcome. Adolescents with a higher level of externalizing problems or lower level of expectations for their own active role in treatment seem to have a higher risk of dropping out.ConclusionOffering intensive treatment for a shorter period might be the most efficient way to gain symptom reduction and decrease psychological distress in psychotherapeutic interventions with adolescents. Being aware of externalizing behavior and increasing the adolescents’ own agency during the assessment could strengthen commitment and result in the adolescent benefiting more from treatment. (shrink)

The effects of research ethics training on medical students' attitudes about clinical research are examined. A preliminary randomized controlled trial evaluated 2 didactic approaches to ethics training compared to a no-intervention control. The participant-oriented intervention emphasized subjective experiences of research participants (empathy focused). The criteria-oriented intervention emphasized specific ethical criteria for analyzing protocols (analytic focused). Compared to controls, those in the participant-oriented intervention group exhibited greater attunement to research participants' attitudes related to altruism, trust, quality of relationships with researchers, (...) desire for information, hopes about participation and possible therapeutic misconception, importance of consent forms, and deciding quickly about participation. The participant-oriented group also agreed more strongly that seriously ill people are capable of making their own research participation decisions. The criteria-oriented intervention did not affect learners' attitudes about clinical research, ethical duties of investigators, or research participants' decision making. An empathy-focused approach affected medical students' attunement to research volunteer perspectives, preferences, and attributes, but an analytically oriented approach had no influence. These findings underscore the need to further examine the differential effects of empathy-versus analytic-focused approaches to the teaching of ethics. (shrink)

The effects of research ethics training on medical students' attitudes about clinical research are examined. A preliminary randomized controlled trial evaluated 2 didactic approaches to ethics training compared to a no-intervention control. The participant-oriented intervention emphasized subjective experiences of research participants. The criteria-oriented intervention emphasized specific ethical criteria for analyzing protocols. Compared to controls, those in the participant-oriented intervention group exhibited greater attunement to research participants' attitudes related to altruism, trust, quality of relationships with researchers, desire for information, hopes (...) about participation and possible therapeutic misconception, importance of consent forms, and deciding quickly about participation. The participant-oriented group also agreed more strongly that seriously ill people are capable of making their own research participation decisions. The criteria-oriented intervention did not affect learners' attitudes about clinical research, ethical duties of investigators, or research participants' decision making. An empathy-focused approach affected medical students' attunement to research volunteer perspectives, preferences, and attributes, but an analytically oriented approach had no influence. These findings underscore the need to further examine the differential effects of empathy-versus analytic-focused approaches to the teaching of ethics. (shrink)