The paper offers a solution to the problem of specifying computational systems that behave in accordance with a given set of ethical principles. The proposed solution is based on the concepts of ethical requirements and ethical protocols. A new conceptual tool, called the Control Closure of an operation, is defined and used to translate ethical principles into ethical requirements and protocols. The concept of Generalised Informational Privacy (GIP) is used as a paradigmatic example of an ethical principle. GIP is defined (...) in such a way as to (i) discriminate specific cases in which an individual’s GIP can be infringed without accessing the individual’s data; (ii) separate unauthorised accesses to data that do not respect the right to GIP from access that do; and (iii) distinguish different degrees of GIP. Finally a camera phone is used to illustrate the proposed solution. (shrink)

Descriptive accounts of the nature of explanation in neuroscience and the global goals of such explanation have recently proliferated in the philosophy of neuroscience and with them new understandings of the experimental practices of neuroscientists have emerged. In this paper, I consider two models of such practices; one that takes them to be reductive; another that takes them to be integrative. I investigate those areas of the neuroscience of learning and memory from which the examples used to substantiate these models (...) are culled, and argue that the multiplicity of experimental protocols used in these research areas presents specific challenges for both models. In my view, these challenges have been overlooked largely because philosophers have hitherto failed to pay sufficient attention to fundamental features of experimental practice. I demonstrate that when we do pay attention to such features, evidence for reduction and integrative unity in neuroscience is simply not borne out. I end by suggesting some new directions for the philosophy of neuroscience that pertain to taking a closer look at the nature of neuroscientific experiments. (shrink)

This paper analyzes the investigation of the distribution of the protein tenascin-C in canine mammary tumors. The method involved immunohistochemistry of tissue slices, performed by the application of an antibody to tenascin-C that specifically can be made visible for microscopic inspection. The first phase of the project is the making of the protocol, the second the deduction of a pattern of tenascin-C distribution in tumors and the third the writing of a paper. Each of the phases is analyzed separately, (...) using the concept of resistance and accommodation. My purpose is to show that in each phase of the process of producing knowledge, the scientist meets resistances which force him to accommodate by changing his conceptual, technical and methodological approaches. In reverse, the details of the non-human agent have to be accommodated to the wishes and expectations of the scientist. Through this interaction a situation of stability of knowledge is reached at the end of each phase.In the protocol phase, resistance is found in the antibody and tissue slices. In the phase of pattern deduction the resistance is in the pathological diagnosis of the tumors and the expectations and hypothesis with which the scientist had entered the project; in the criteria to be used for assigning the slices to a tenascin-C pattern; and in the responses of colleagues and supervisor. In the paper-writing phase the interaction is between the scientist and the scientific community which should take on board the knowledge from the research project.When stabilization of knowledge is obtained in one of the phases, the agents of resistance turn into allies in the next phase, giving support to accommodating the resistances in this later phase. Second, the stabilization of knowledge of the protocol is further enhanced when stabilization of the pattern is achieved; in addition, knowledge of the pattern is more definite when it has become stabilized and closed knowledge within the science community. (shrink)

Substance-abusing women are vulnerable to specific kinds of epistemic injustice, including stigmatization and discrimination. This article examines the development of the epistemic agency of female substance abusers by asking: How does the use of a formal discussion protocol in community rehabilitation interaction alleviate epistemic injustice and strengthen the epistemic agency of substance abusers? The data were collected in a Finnish rehabilitation center by videotaping six group discussions between social workers, peer support workers, and rehabilitation clients with substance abuse problems. (...) Of these data, one recorded group discussion between four female participants—two rehabilitation clients, a peer support worker, and a social adviser—was used in this paper. Using conversational analysis, the findings indicate that, through the collaborative activities of sharing experiential knowledge about substance abuse and discussing the experiences of abuse in the rehabilitation interaction, substance abusers can develop novel ways to strengthen their epistemic agency by enhanced self-awareness. The discussion protocol is an epistemic tool that professionals and clients can learn to use in ethically and epistemologically successful ways in interaction. The use of a discussion protocol is an example of social professionals’ clinical knowledge of intensifying collaboration and sharing experiential knowledge in community rehabilitation and other substance abuse services. (shrink)

In the Netherlands fertility doctors increasingly formulate protocols, which oblige patients to quit their unhealthy lifestyle before they are admitted to IVF procedures. We argue that moral arguments could justify parenting protocols that concern all future parents. In the first part we argue that want‐to‐be parents have moral responsibilities towards their future children to prevent them from harm by diminishing or eliminating risk factors before as well as during the pregnancy. This is because of the future children's potential to become (...) of a certain type, more specifically: a person that will be the want‐to‐be parents' child. Want‐to‐be parents intend to become pregnant and therefore have an additional moral reason to diminish the risks. Also, people who become pregnant unintentionally have the responsibility to prevent their children from harm, unless they become pregnant due to contraception failure. All people not wanting to become pregnant should use contraception methods carefully.In the second part of this paper we translate the want‐to‐be parents' responsibilities into practice. We distinguish four determinants of risk factors: modifiability, chance, severity and effort. We examine some evidence‐based risk factors based on these variables and deduce levels of responsibility.In conclusion, formulating informal requirements for want‐to‐be parents is morally required and therefore also for want‐to‐be parents in need of medical assistance. The protocols developed by fertility doctors in the Netherlands could be seen as the precursor for a general, informal Parenting Protocol that could be developed on the basis of an extended and thoroughly debated risk‐responsibility analysis. (shrink)

The 2010 Nagoya Protocol is an international framework for access and benefit sharing (ABS) of the use of genetic and biological resources, with particular focus on indigenous communities. This is especially important in Africa, where local communities have a close reliance on environmental resources and ecosystems. However, national legislation and policies commonly lag behind international agreements, and this poses challenges for legal compliance as well as practical applications. This study reviews the academic literature on the Nagoya Protocol and (...) ABS applications, and then considers the implications of this analysis for research in Africa. Results show that there is uneven engagement with the principles of the Nagoya Protocol across different academic disciplines; local communities are sometimes sidelined in these studies; and only 8% of researchers in the literature analysed are located in Africa. Future developments should focus on ensuring national compliance with the Nagoya Protocol, and that researchers and industry work in partnership with local African communities on ABS issues. (shrink)

Shortages of generic, injectable chemotherapeutics have been increasing in prevalence since 2006. Due to the lack of access to first-line, lifesaving treatments, physicians have been forced to ration chemotherapy between patients. Although the scarcity has been managed with good intentions, it has been done in an ad hoc manner, without the benefit of an ethically grounded and standardized schema. Using an approach based on the “accountability for reasonableness” method by Daniel and Sabin, I establish a framework and protocol for (...) rationing that is specific to chemotherapy. Prior to the state of true shortage, I present guidelines for the use of an adequate supply of chemotherapy with knowledge of upcoming scarcity. Within the rationing framework itself, I first prioritize emergency use of chemotherapeutics and those already receiving treatment at the time of shortage. I advocate for stratifying patients based on the prognostic indicators of their cancer type, using a combination of clinical-trial-based initial response and longer term survival, followed by the patients’ line of treatment. All patients who are not able to receive their “best” treatment must receive a sequent, next-best treatment, and their treatment team must have the ability to appeal to a rationing committee in special circumstances. I reject the ideas of stratification based on the intention of the treatment, perceived quality of life, pre-existing condition not impacting performance status, the classical “sickest first” argument, and giving preference to pediatric cases. Lastly, I advocate for any system of rationing to be transparent to those it affects and acknowledge the difficulties it presents to patients and physicians alike. (shrink)

BackgroundThe use of genetic test results in risk-rated insurance is a significant concern internationally, with many countries banning or restricting the use of genetic test results in underwriting. In Australia, life insurers’ use of genetic test results is legal and self-regulated by the insurance industry (Financial Services Council (FSC)). In 2018, an Australian Parliamentary Inquiry recommended that insurers’ use of genetic test results in underwriting should be prohibited. In 2019, the FSC introduced an industry self-regulated moratorium on the use of (...) genetic test results. In the absence of government oversight, it is critical that the impact, effectiveness and appropriateness of the moratorium is monitored. Here we describe the protocol of our government-funded research project, which will serve that critical function between 2020 and 2023.MethodsA realist evaluation framework was developed for the project, using a context-mechanism-outcome (CMO) approach, to systematically assess the impact of the moratorium for a range of stakeholders. Outcomes which need to be achieved for the moratorium to accomplish its intended aims were identified, and specific data collection measures methods were developed to gather the evidence from relevant stakeholder groups (consumers, health professionals, financial industry and genetic research community) to determine if aims are achieved. Results from each arm of the study will be analysed and published in peer-reviewed journals as they become available.DiscussionThe A-GLIMMER project will provide essential monitoring of the impact and effectiveness of the self-regulated insurance moratorium. On completion of the study (3 years) a Stakeholder Report will be compiled. The Stakeholder Report will synthesise the evidence gathered in each arm of the study and use the CMO framework to evaluate the extent to which each of the outcomes have been achieved, and make evidence-based recommendations to the Australian federal government, life insurance industry and other stakeholders. (shrink)

The experimental practice in contemporary molecular biology oscillates between the creativity of the researcher in tinkering with the experimental system, and the necessity of standardization of methods of inquiry. Experimental procedures, when standardized in lab protocols, might definitely be seen as actual recipes. Considering these protocols as recipes can help us understand some epistemological characteristics of current practice in molecular biology. On the one hand, protocols represent a common ground, i.e. the possibility of reproducibility, which constitutes one of the essential (...) properties for contemporary science to define an actual discovery. At the same time, however, protocols are flexible enough to be adapted by the individual researcher (within a space of maneuver given by the experimental system and by the practices that each individual discipline gives to itself) to his/her specific needs. These variations, just like the recipes, remind us that the legitimacy of an experimental practice, involves both objective and subjective constraints and it is articulated on a fuzzy background rather than a rigid and clear context. Moreover, looking at experiments according to this perspective can provide a key to understanding how different forms of science (which adopt different methodologies but which investigate the same phenomena), such as computational biology, are precisely different in the use of a different “cookbook”.Indeed, given the procedural/operational realism of biologists towards phenomena, the clash of different procedures has opened a discussion also about the nature and the meaning of the obtained results. Thus, according to the recipe-perspective that, the methodological struggle over the nature of biological phenomena (and their ways of discovery) among scientists, might be seen as a not always explicit, epistemological debate, however coming from the practice of science itself. (shrink)

In the Netherlands fertility doctors increasingly formulate protocols, which oblige patients to quit their unhealthy lifestyle before they are admitted to IVF procedures. We argue that moral arguments could justify parenting protocols that concern all future parents. In the first part we argue that want-to-be parents have moral responsibilities towards their future children to prevent them from harm by diminishing or eliminating risk factors before as well as during the pregnancy. This is because of the future children's potential to become (...) of a certain type, more specifically: a person that will be the want-to-be parents' child. Want-to-be parents intend to become pregnant and therefore have an additional moral reason to diminish the risks. Also, people who become pregnant unintentionally have the responsibility to prevent their children from harm, unless they become pregnant due to contraception failure. All people not wanting to become pregnant should use contraception methods carefully.In the second part of this paper we translate the want-to-be parents' responsibilities into practice. We distinguish four determinants of risk factors: modifiability, chance, severity and effort. We examine some evidence-based risk factors based on these variables and deduce levels of responsibility.In conclusion, formulating informal requirements for want-to-be parents is morally required and therefore also for want-to-be parents in need of medical assistance. The protocols developed by fertility doctors in the Netherlands could be seen as the precursor for a general, informal Parenting Protocol that could be developed on the basis of an extended and thoroughly debated risk-responsibility analysis. (shrink)

In the Netherlands fertility doctors increasingly formulate protocols, which oblige patients to quit their unhealthy lifestyle before they are admitted to IVF procedures. We argue that moral arguments could justify parenting protocols that concern all future parents. In the first part we argue that want‐to‐be parents have moral responsibilities towards their future children to prevent them from harm by diminishing or eliminating risk factors before as well as during the pregnancy. This is because of the future children's potential to become (...) of a certain type, more specifically: a person that will be the want‐to‐be parents' child. Want‐to‐be parents intend to become pregnant and therefore have an additional moral reason to diminish the risks. Also, people who become pregnant unintentionally have the responsibility to prevent their children from harm, unless they become pregnant due to contraception failure. All people not wanting to become pregnant should use contraception methods carefully.In the second part of this paper we translate the want‐to‐be parents' responsibilities into practice. We distinguish four determinants of risk factors: modifiability, chance, severity and effort. We examine some evidence‐based risk factors based on these variables and deduce levels of responsibility.In conclusion, formulating informal requirements for want‐to‐be parents is morally required and therefore also for want‐to‐be parents in need of medical assistance. The protocols developed by fertility doctors in the Netherlands could be seen as the precursor for a general, informal Parenting Protocol that could be developed on the basis of an extended and thoroughly debated risk‐responsibility analysis. (shrink)

The authors interrogate genital examinations as events in which both client and practitioner are `produced' as relational subjects in quite specific ways. This article explores the way one female sex health worker talks about her work as a form of cultural exchange, noting what she requires of her clients and seeks to give of herself. Of particular importance is the way the practitioner produces the client as a social subject amenable to intimate examination, while resisting some traditional means for doing (...) so. The authors use a Foucauldian conceptual framework to signal their departure from feminist analyses which explain such practices in terms of a patriarchal medical system. (shrink)

As neural implants transition from engineering design and testing into human subjects research, careful consideration must be paid to the ethical elements in developing research protocols. Although these ethical aspects may be framed by the design choices of the engineering, a number of challenging choices arise. In spite of many ethical considerations for neural implant technologies being shared with generic research ethics questions, there are subsets needing special attention. Even in considerations requiring increased attention, substantial overlap can be found with (...) research ethics questions for general medical implants and for psychiatric pharmaceuticals. The special attention to specific ethical questions in neural implants exists because of the value placed on preserving cognition and control as well as our continued memory of significant past research abuses in neurosurgery. This paper focuses on three issues of particular saliency to neural implant testing: inclusion/exclusion of subjects with psychiatric conditions, consent withdrawal of research subjects, and enhancement as a goal. (shrink)

The Pittsburgh protocol relies heavily on traditional moral distinctions, particularly the principle of double effect, to justify "managing" the dying process of a prospective organ donor in order to yield viable organs for transplantation. These traditional moral distinctions can be useful, particularly in casuistic or case-specific moral analysis, but their invocation here is unpersuasive, and potentially dangerous. The protocol relies on elaborate apologetics to avoid a candid confrontation with the moral challenge it poses—society's willingness to bring about the (...) death of one patient (in isolation and with potential discomfort) in order to benefit another patient. Not only will this protocol fail to solve the problem it purports to address, it threatens to undermine the delicate social accommodations by which we distinguish the living from the dead, permissible "allowings to die" from impermissible killings, and those from whom organs may be removed from those whose bodies must remain inviolate. (shrink)

The emergence of the new coronavirus at the beginning of 2020, considered a public health emergency due to its high transmission rate and lack of specific treatment, led many countries to adhere to social isolation. Although necessary, social isolation causes important psychological changes, negatively affecting the health of the population, including the older population. The aim of this study is to propose a 4-week, home-based physical exercise protocol for older people in social isolation and evaluate whether will promote positive (...) changes in psychological variables such as anxiety, mood, depression, and stress, and in the variables sleep, quality of life, and physical capacities in the older adults. The sample will be selected in a probabilistic way from individuals aged 60 years or more from the city of Itajaí. Of these, half will perform a home-based resistance training protocol, with 3 weekly sessions, for 4 consecutive weeks. For group allocation, patients will be randomized with a computer-generated 1:1 allocation to the physical exercise group or control group. Outcomes will be depressive symptoms, sleep quality, quality of life, stress, mood states, anxiety, and functional capacity, evaluated at baseline, after 4 weeks, and after 15 days of follow-up. This study will offer a home-based exercise protocol for older adults, with load progression and remote monitoring, thus filling a gap in the provision of PE in this population. The results will be able to identify possible improvements not only in physical health, but also in quality of life and mental health.Clinical Trial Registration: The trial registration was carried out in the Brazil Clinical Trials Registry.. (shrink)

The central aim of this paper is to explain how protocol sentences establish a specific space for scientific discussion at the level of observation in the social sciences. In this space, the four levels of the theory of protocol sentences work as a coordinate system that allows to specify the degree of quality of data production. To do so, we elaborate upon Jean-Claude Passeron’s epistemology by combining it with Otto Neurath’s theory of protocol sentences. We start by (...) discussing Passeron’s interpretation of Neurath’s work in Le raissonnement sociologique and then present Neurath’s theory, following Thomas Uebel’s interpretation, with the purpose of developing the potential of Passeron’s epistemology in this regard. (shrink)

For much of 2021, allocating the scarce supply of Covid‐19 vaccines was the world's most pressing bioethical challenge, and similar challenges may recur for novel therapies and future vaccines. In the United States, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) identified three fundamental ethical principles to guide the process: maximize benefits, promote justice, and mitigate health inequities. We argue that critical components of the recommended protocol were internally inconsistent with these principles. Specifically, the (...) ACIP violated its principles by recommending overly broad health care worker priority in phase 1a, using being at least seventy‐five years of age as the only criterion to identify individuals at high risk of death from Covid‐19 during phase 1b, failing to recommend place‐based vaccine distribution, and implicitly endorsing first‐come, first‐served allocation. More rigorous empirical work and the development of a complete ethical framework that recognizes trade‐offs between principles may have prevented these mistakes and saved lives. (shrink)

A novel Protocol Ethics Tool Kit (‘Ethics Tool Kit’) has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women9s Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between (...) clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. (shrink)

This response considers the question whether empiricists are condemned to silence about the epistemic agency their theories attribute or presuppose. It is argued that, unlike Reichenbach or Carnap, Neurath allowed for and indeed provided specifications of the role of epistemic agency in scientific inquiry. If this is correct, it underscores once more the need to distinguish between the various strands of logical positivism which show different strengths and weaknesses.

Earthquakes, which can cause widespread territorial and socio-economic destruction, are life-threatening, unexpected, unpredictable and uncontrollable events caused by the shaking of the surface of the earth. The psychological consequences, such as PTSD, anxiety, depression, and suicidal ideation, are well-known to clinicians and researchers. This study was conducted with the aim of evaluating the use of the Eye Movement Desensitization and Reprocessing (EMDR) Integrative Group Treatment Protocol (IGTP) on a sample of adolescents, after the earthquake in Central Italy on 24 (...) August 2016. The objective of the EMDR intervention was to reduce PTSD symptoms. Before and after EMDR, specific assessment to find changes in PTSD symptoms was made using the IES-R (Impact of Event Scale Revised) and through the analyses of the Subjective Units of Disturbance (SUD). The EMDR treatment was given in three sessions (T1, T2, T3), each lasting 90 minutes, and the results at follow-up phase (T4) were also monitored. The results are very encouraging, showing significantly reduced PTSD symptoms in the majority of the subjects. The clinical implications and limitations will be discussed. (shrink)

At the height of the COVID-19 crisis in the Netherlands a shortness of intensive care beds was looming. Dutch professional medical organizations asked a group of ethicists for assistance in drafting guidelines and criteria for selection of patients for intensive care treatment in case of absolute scarcity, when medical selection criteria would no longer suffice. This article describes the Dutch context, the process of drafting the advice and reflects on the role of ethicists and lessons learned. We argue that timely (...) interaction between clinical and ethical expertise is necessary since the distinction between medical and non-medical considerations is not as clearcut as sometimes assumed. Furthermore, pragmatic considerations related to the specifics of an epidemic are of importance, for example, in relation to prioritizing health care workers. As a consequence, any protocol already present before the pandemic would need alterations to fit the current situation. The ‘fair innings’ criterion we proposed, rephrased as an argument of intergenerational solidarity, was considered reasonable by professionals as well as patient organizations. While it is desirable to draft ethical guidelines in ‘peacetime’ as a matter of pandemic preparedness, the pressure of an actual crisis facilitates decision-making, although it will also complicate a more democratic approach. (shrink)

Despite the importance of knowing the cognitive capabilities of children with neurodevelopmental conditions, less than one-third of children with cerebral palsy participate in standardized assessments. Globally, approximately 50% of people with cerebral palsy have an intellectual disability and there is significant risk for domain-specific cognitive impairments for the majority of people with cerebral palsy. However, standardized cognitive assessment tools are not accessible to many children with cerebral palsy, as they require manual manipulation of objects, verbal response and/or speeded response. As (...) such, standardised assessment may result in an underestimation of abilities for children with significant motor and/or speech impairment. The overall aim of the project is to examine and compare the psychometric properties of standardised cognitive assessment tools that have been accommodated for use with either a switch device or eye-gaze control technologies, with the specific aims to: Examine the psychometric properties of accommodated assessment tools by comparing the performance of typically developing children on six cognitive assessment tools administered via standardised versus accommodated administration; Describe and compare the performance and user experience of children with cerebral palsy on six accommodated cognitive assessments administered via switch or eye-gaze control technologies. Secondary aims are to: Describe the completion rates and time to complete assessments of participants in each group; Within the group with cerebral palsy, examine the effects of condition-specific characteristics and demographics on participation. This protocol paper describes a two-phase validation and acceptability study that utilizes a mixed-model design. This study will collect concurrent data from 80 typically developing children and 40 children with cerebral palsy, who use switch or eye-gaze control technology as alternate access communication methods. The set of instruments will measure receptive vocabulary, fluid reasoning, sustained attention, vision perception, visuospatial working memory and executive functions. Data analyses will be conducted using SPSS v. 25 and R v 4.1.0. SPSS Sample Power 3 was used for power computation and allows for a 10% drop out rate. Quantitative descriptive statistics, measurement agreement data plotting, bivariate and multiple regressions analysis will be conducted using appropriate methods. (shrink)

Multi-agent systems where the agents are developed by parties with competing interests, and where there is no access to an agent’s internal state, are often classified as ‘open’. The members of such systems may inadvertently fail to, or even deliberately choose not to, conform to the system specification. Consequently, it is necessary to specify the normative relations that may exist between the members, such as permission, obligation, and institutional power. We present a framework being developed for executable specification (...) of open multi-agent systems. We adopt a bird’s eye view of these systems, as opposed to an agent’s perspective whereby it reasons about how it should act. This paper is devoted to the presentation of various examples from the NetBill protocol formalised in terms of institutional power, permission and obligation. We express the system specification in the Event Calculus and execute the specification by means of a logic programming implementation. We also give several example formalisations of sanctions for dealing with violations of permissions and obligations. We distinguish between an open multi-agent system and the procedure by which an agent enters and leaves the system. We present examples from the specification of a role-management protocol for NetBill, and demonstrate the interplay between such a protocol and the corresponding multi-agent system. (shrink)

The large number of sensors and actuators that make up the Internet of Things obliges these systems to use diverse technologies and protocols. This means that IoT networks are more heterogeneous than traditional networks. This gives rise to new challenges in cybersecurity to protect these systems and devices which are characterized by being connected continuously to the Internet. Intrusion detection systems are used to protect IoT systems from the various anomalies and attacks at the network level. Intrusion Detection Systems can (...) be improved through machine learning techniques. Our work focuses on creating classification models that can feed an IDS using a dataset containing frames under attacks of an IoT system that uses the MQTT protocol. We have addressed two types of method for classifying the attacks, ensemble methods and deep learning models, more specifically recurrent networks with very satisfactory results. (shrink)

We present a technique for automatically verifying cryptographic protocols specified in the mainstream specification language CAPSL. We define a translation from CAPSL models into interpreted systems, a popular semantics for temporal-epistemic logic, and rewrite CAPSL goals as temporal-epistemic specifications. We present a compiler that implements this translation. The compiler links to the symbolic model checker MCMAS. We evaluate the technique on protocols in the Clark-Jacobs library and in the SPORE repository against custom secrecy and authentication requirements.

Efforts to build research capacity and capability in low and middle income countries (LMIC) has progressed over the last three decades, yet it confronts many challenges including issues with communicating or even negotiating across different cultures. Implementing global research requires a broader understanding of community engagement and participatory research approaches. There is a considerable amount of guidance available on community engagement in clinical trials, especially for studies for HIV/aids, even culturally specific codes for recruiting vulnerable populations such as the San (...) or Maori people. However, the same cannot be said for implementing research in global health. In an effort to build on this work, the Pakistan Institute of Living and Learning and University College London in the UK sought to better understand differences in beliefs, values and norms of local communities in Pakistan. In particular, they have sought to help researchers from high income countries (HIC) understand how their values are perceived and understood by the local indigenous researchers in Pakistan. To achieve this end, a group discussion was organised with indigenous researchers at Pakistan Institute of Living and Learning. The discussion will ultimately help inform the development of a cultural protocol for researchers from HIC engaging with communities in LMIC. This discussion revealed five common themes; (1) religious principles and rules, (2) differing concepts of and moral emphasis on autonomy and privacy, (3) importance of respect and trust; (4) cultural differences (etiquette); (5) custom and tradition (gift giving and hospitality). Based on the above themes, we present a preliminary cultural analysis to raise awareness and to prepare researchers from HIC conducting cross cultural research in Pakistan. This is likely to be particularly relevant in collectivistic cultures where social interconnectedness, family and community is valued above individual autonomy and the self is not considered central to moral thinking. In certain cultures, HIC ideas of individual autonomy, the notion of informed consent may be regarded as a collective family decision. In addition, there may still be acceptance of traditional professional roles such as ‘doctor knows best’, while respect and privacy may have very different meanings. (shrink)

Background: Post-traumatic stress disorder is a prevalent, debilitating, and costly psychiatric disorder. Evidenced-based psychotherapies, including Cognitive Processing Therapy, are effective in treating PTSD, although a fair proportion of individuals show limited benefit from such treatments. CPT requires cognitive demands such as encoding, recalling, and implementing new information, resulting in behavioral change that may improve PTSD symptoms. Individuals with PTSD show worse cognitive functioning than those without PTSD, particularly in acquisition of verbal memory. Therefore, memory dysfunction may limit treatment gains in (...) CPT in some individuals with PTSD. Methods and Analysis: Here, we present a protocol describing the Cognition and PsychoTherapy in PTSD study, a prospective, observational study examining how cognitive functioning affects treatment response in CPT for PTSD. The study aims to recruit 105 outpatient veterans with PTSD between the ages of 18 and 70 years. Prior to beginning 12 sessions of CPT, Veteran participants will have standardized assessments of mood and functioning and complete a comprehensive neurocognitive battery assessing episodic learning, attention and speed of processing, language ability, executive control, and emotional functioning. This study aims to fill gaps in the current literature by: examining the specificity of memory effects on treatment response; exploring how baseline cognitive functioning impacts functional outcomes; and examining potential mechanisms, such as memory for treatment content, that might explain the effects of baseline memory functioning on PTSD symptom trajectory. Discussion: If successful, this research could identify clinically relevant neurocognitive mechanisms that may impact PTSD psychotherapy and guide the development of individualized treatments for PTSD. (shrink)

BackgroundCaregivers may play a fundamental role in the clinical pathway of cancer patients. They provide emotional, informational, and functional support as well as practical assistance, and they might help mediate the interaction and communication with the oncologists when care options are discussed, or decisions are made. Little is known about the impact of dyadic dynamics on patient-doctor communication, patient's satisfaction, or adherence to the therapies. This study protocol aims to evaluate the efficacy of a psychological support intervention on patients-caregivers (...) relationship and their alignment in the treatment decision-making process and estimate related improvement in patient' compliance/adherence to treatments.MethodsA total of 102 patients-caregivers' dyads will be involved, among breast and prostate cancer patients. The study entails a pre- post- evaluation through psychological questionnaires, with a randomization of participants in two conditions, the experimental one in which subjects participate in a psychological support consultation, and the control one, where dyads do not receive any intervention. A follow up after 6 months from the enrollment is planned.DiscussionA positive impact of the psychological support intervention on patients' anxiety, depression, distress, and perceived social support is expected. Such improvements can directly affect patients' satisfaction and adherence to treatments. Data gathered from this study may inform health care providers, policy makers, and public health managers about the importance of caregiver's involvement in the cancer care pathway, and the best way to manage it. A further impact is to develop a specific intervention protocol to support caregivers' involvement in cancer care pathway, improve patient's wellbeing, the interaction with physicians and the compliance with the cancer treatment. (shrink)

Most model checking techniques for security protocols make a number of simplifying assumptions on the protocol and/or on its execution environment that greatly complicate or even prevent their applicability in some important cases. For instance, most techniques assume that communication between honest principals is controlled by a Dolev-Yao intruder, i.e. a malicious agent capable to overhear, divert, and fake messages. Yet we might be interested in establishing the security of a protocol that relies on a less unsecure channel (...) (e.g. a confidential channel provided by some other protocol sitting lower in the protocol stack). In this paper we propose a general model for security protocols based on the set-rewriting formalism that, coupled with the use of LTL, allows for the specification of assumptions on principals and communication channels as well as of complex security properties that are normally not handled by state-of-the-art security protocol analysers. By using our approach we have been able to formalise all the assumptions required by the ASW protocol for optimistic fair exchange and some of its key security properties. Besides the previously reported attacks on the protocol, we report a new attack on a patched version of the protocol. (shrink)

IntroductionA symptom cluster is very common among oncological patients: cancer-related fatigue, emotional distress, sleep difficulties, pain, and cognitive difficulties. Clinical applications of interventions based on non-ordinary states of consciousness, mostly hypnosis and meditation, are starting to be investigated in oncology settings. They revealed encouraging results in terms of improvements of these symptoms. However, these studies often focused on breast cancer patients, with methodological limitations. Another non-ordinary state of consciousness may also have therapeutic applications in oncology: self-induced cognitive trance. It seems (...) to differ from hypnosis and meditation, as it involves the body more directly. Thus, investigating its clinical applications, along with hypnosis and meditation interventions, could improve available therapeutic options in oncology. This article details the study protocol of a preference-based longitudinal controlled superiority trial aiming to assess the effectiveness of 3 group interventions to improve oncological patients’ quality of life, and more specifically CRF, emotional distress, sleep, pain, and cognitive difficulties.Methods and analysisA power analysis required a total sample of 160 patients. Main inclusion criteria are: cancer diagnosis, active treatments completed for less than a year, no practice of hypnosis, meditation, or SICT, and presence of at least one of these four symptoms: fatigue, sleep difficulties, depression, or anxiety. Each participant will choose the intervention in which they want to participate. To test the effectiveness of the interventions, data will be collected by questionnaires and neurobiological measures and directly from the medical record at four time points: before inclusion in the study ; immediately after the intervention; and at 3- and 12-month follow-up. The longitudinal data in each group will then be measured.DiscussionIn addition to standard cancer therapies, there is a growing interest from patients in complementary approaches, such as hypnosis, meditation, and SICT. The results of this study will be useful to increase knowledge about short- and long-term effectiveness of 3 group interventions for CRF, emotional distress, sleep, pain, and cognitive difficulties in patients with different cancers.Clinical Trial RegistrationClinicalTrials.gov/. Retrospectively registered on the 29th of April 2021. url: https://clinicaltrials.gov/ct2/show/NCT04873661. (shrink)

This article examines the ACPA/NASPA Competencies as functional protocol of the neoliberal state. Described as ‘not a checklist’, Competencies structure rubrics, conferences, jobs, and performance as static, indicative of a power/knowledge rooted in protocol. We utilize post qualitative thinking, specifically poetics, to create a series of experimentations (in)tension with Competencies. This micropolitical practice disrupts protocol, opening imaginative space for subversion, movement, and becoming ∼ professional.

The prevalence of cognitive impairment in hemodialysis patients is extremely high. Despite the well-documented benefits of interventions on cognitive function, there is a widespread call for effective strategies that will show the long-term consequences in patients undergoing dialysis. The aim of this research protocol was to investigate the effect of cognitive training combined with physical exercise on cognitive function, physical performance, and frailty indicators in the HD population. We will conduct a randomized controlled intervention trial to examine the effects (...) of a combined non-pharmacological intervention in the form of intradialytic physical exercise and intradialytic cognitive training on cognitive function, indicators of frailty, and physical performance measures in HD patients. The group of patients receiving the study intervention will be compared to the control group receiving standard HD care. The duration of the intervention will be 12 weeks. We will use sensitive instruments to assess cognitive functions. The primary outcome of the study at 12 weeks will be performance on the Alertness subtest of the computerized Test of Attentional Performance. Secondary study outcomes are: Performance in other domains of cognitive function, physical fitness, and assessment of frailty. Study outcomes will be assessed at baseline, immediately after the 12-week intervention, and 6 months after the end of the study without specific further intervention. This study will be among the first to test the synergistic effects of a uniquely designed physical exercise and cognitive training intervention on functional status in HD patients. We believe our results will contribute to dementia prevention research by demonstrating the long-term efficacy of our combined intervention.Clinical Trial Registration:ClinicalTrials.Gov, NCT05150444. (shrink)

ObjectivesTo determine to which degree industry partners in randomised clinical trials own the data and can constrain publication rights of academic investigators.MethodsCohort study of trial protocols, publication agreements and other documents obtained through Freedom of Information requests, for a sample of 42 trials with industry involvement approved by ethics committees in Denmark. The main outcome measures used were: proportion of trials where data was owned by the industry partner, where the investigators right to publish were constrained and if this was (...) mentioned in informed consent documents, and where the industry partner could review data while the trial was ongoing and stop the trial early.ResultsThe industry partner owned all data in 20 trials (48%) and in 16 trials (38%) it was unclear. Publication constraints were described for 30 trials (71%) and this was not communicated to trial participants in informed consent documents in any of the trials. In eight trials (19%) the industry partner could review data during the trial, for 20 trials (48%) it was unclear. The industry partner could stop the trial early without any specific reason in 23 trials (55%).ConclusionsPublication constraints are common, and data is often owned by industry partners. This is rarely communicated to trial participants. Such constraints might contribute to problems with selective outcome reporting. Patients should be fully informed about these aspects of trial conduct. (shrink)

BackgroundClinical ethics case consultations (CECCs) provide a structured approach in situations of ethical uncertainty or conflicts. There have been increasing calls in recent years to assess the quality of CECCs by means of empirical research. This study provides detailed data of a descriptive quantitative and qualitative evaluation of a CECC service in a department of cardiology and intensive care at a German university hospital.MethodsSemi-structured document analysis of CECCs was conducted in the period of November 1, 2018, to May 31, 2020. (...) All documents were analysed by two researchers independently.ResultsTwenty-four CECCs were requested within the study period, of which most (n = 22; 92%) had been initiated by physicians of the department. The patients were an average of 79 years old (R: 43–96), and 14 (58%) patients were female. The median length of stay prior to request was 12.5 days (R: 1–65 days). The most frequent diagnoses (several diagnoses possible) were cardiology-related (n = 29), followed by sepsis (n = 11) and cancer (n = 6). Twenty patients lacked decisional capacity. The main reason for a CECC request was uncertainty about the balancing of potential benefit and harm related to the medically indicated treatment (n = 18). Further reasons included differing views regarding the best individual treatment option between health professionals and patients (n = 3) or between different team members (n = 3). Consensus between participants could be reached in 18 (75%) consultations. The implementation of a disease specific treatment intervention was recommended in five cases. Palliative care and limitation of further disease specific interventions was recommended in 12 cases.ConclusionsTo the best of our knowledge, this is the first in-depth evaluation of a CECC service set up for an academic department of cardiology and intensive medical care. Patient characteristics and the issues deliberated during CECC provide a starting point for the development and testing of more tailored clinical ethics support services and research on CECC outcomes. (shrink)

We designed a new protocol requiring French adult participants to group a large number of Munsell colour chips into three or four groups. On one, relativist, view, participants would be expected to rely on their colour lexicon in such a task. In this framework, the resulting groups should be more similar to French colour categories than to other languages categories. On another, universalist, view, participants would be expected to rely on universal features of perception. In this second framework, the (...) resulting groups should match colour categories of three and four basic terms languages. In this work, we first collected data to build an accurate map of French colour terms categories. We went on testing how native French speakers spontaneously sorted a set of randomly presented coloured chips and, in line with the relativist prediction, we found that the resulting colour groups were more similar to French colour categories than to three and four basic terms languages. However, the same results were obtained in a verbal interference condition, suggesting that participants rely on language specific and nevertheless perceptual, colour categories. Collectively, these results suggest that the universalist/relativist dichotomy is a too narrow one. (shrink)

Metacognition, the cognition about cognition, is closely linked to intelligence and therefore understanding the metacognitive processes underlying intelligence test performance, specifically on Raven’s Progressive Matrices, could help advance the knowledge about intelligence. The measurement of metacognition, is often done using domain-general offline questionnaires or domain-specific online think-aloud protocols. This study aimed to investigate the relationship between metacognitive awareness and intelligence via the design and use of a novel Meta-Cognitive Awareness Scale – Domain Specific that encourages reflection of task strategy processes. (...) This domain-specific scale was first constructed to measure participants’ awareness of their own metacognition linked to Raven’s Progressive Matrices. Following discriminatory index and Exploratory Factor Analysis, a 15-item scale was derived. Exploratory Factor Analysis showed five factors: Awareness of Engagement in Self-Monitoring, Awareness of Own Ability, Awareness of Responding Speed/Time, Awareness of Alternative Solutions and Awareness of Requisite Problem-Solving Resources. The intelligence level of ninety-eight adults was then estimated using Raven’s Standard Progressive Matrices. Participants also completed the MCAS-DS, and further items that examined their test-taking behavior and Confidence level. Metacognitive awareness was positively correlated to standardized IQ scores derived from the SPM whilst Over-Confidence derived using the Confidence level measure was negatively correlated to SPM. Despite some limitations, this study shows promise for elucidating the relationship between metacognitive awareness and intelligence using the task-specific scale. (shrink)

Background: Chronic Pain (CP) has serious medical and social consequences, and leads to economic burden that threatens the sustainability of healthcare services. Thus, optimized management of pain tools to support CP patients in adjusting to their condition and improving quality of life is timely. Although Acceptance and Commitment Therapy (ACT) is considered an evidence-based psychological approach for CP, evidence for the efficacy of online-delivered ACT for CP is still scarce. At the same time, studies suggest that self-compassion mediates the change (...) in disability and psychopathological symptoms in ACT interventions for CP, although self-compassion is not a specific target in ACT. Thus, an explicit focus on self-compassion might increase the efficacy of ACT interventions for CP, although this hypothesis has not been tested. This study aims to develop an eHealth ACT and compassion-based self-management intervention for CP, the iACTwithPain, and to compare its efficacy in improving health outcomes to a similar ACT-only intervention and a waiting list group. Methods: The eHealth platform that will host the interventions will be developed using a flat design identity and will be interactive. The iACTwithPain intervention will comprise 8 weekly self-management sessions, and will be developed taking into consideration the psychological flexibility model applied to CP, with the addition of explicit compassion-based components. To analyse whether the iACTwithPain intervention will present superiority in improving CP’s impact and related health markers over the two other conditions, this study will follow a RCT design with three arms. CP patients will be recruited through direct contact with patient associations and healthcare services and a national press release in Portugal. Outcome measurement will be conducted at baseline, post-intervention and at 3- and 6-months follow-ups. The interventions’ acceptability will also be assessed. Discussion: The iACTwithPain intervention is expected to improve CP patients’ psychosocial functioning, quality of life, and empowerment, by promoting adaptive disease management and regulation of pain-related internal experiences. Results will contribute to a better understanding on the pertinence of adding compassion elements to ACT for CP and to reach an optimized intervention for CP. (shrink)

BackgroundMultiple sclerosis, the most common neurological disease that causes disability in youth, does not only affect physical functions but is also associated with cognitive impairment, fatigue, depression, and anxiety and can significantly impact health-related quality of life. Since MS is generally diagnosed at a young age—a period of great significance for personal, relational, and professional development—adaptation can become highly challenging. Therefore, enhancing the competence of young people to adaptively cope with these potential challenges is of utmost importance in order to (...) promote their potentialities and talents. It has been shown that psychological interventions targeting MS patients can enhance resilience and HRQoL and that regular physical activity and social engagement can improve psychological well-being. However, literature on the development of global interventions based on the bio-psycho-social model of the disease is missing. Even less attention has been paid to interventions dedicated to young adults with MS and to the involvement of patients in the development of such programs.AimsIn collaboration with MS patients, this study aims to develop a bio-psycho-social intervention for YawMS, aiming to improve their HRQoL and to explore its feasibility, acceptability, and effects.MethodsTo tailor the intervention to the specific needs of YawMS, “patient engagement principles” will be adopted in the co-creation phase, performing a web survey and focus groups with patients and healthcare professionals. In the intervention phase, a pilot sample of 60 young adults with MS will be enrolled. The co-created intervention, composed of group sessions over a 12-week period, will cover psycho-social strategies and include physical activities. Adopting a longitudinal, pre–post evaluation design, self-report questionnaires measuring HRQoL and other bio-psycho-social features will be administered, the quantity and quality of PA will be measured, and a questionnaire developed by the authors will be used to evaluate the feasibility and acceptability of the ESPRIMO intervention. (shrink)

Healthcare professionals often face ethical conflicts and challenges related to decision-making that have necessitated consideration of the use of conscientious objection (CO). No current guidelines exist within Spain’s healthcare system regarding acceptable rationales for CO, the appropriate application of CO, or practical means to support healthcare professionals who wish to become conscientious objectors. As such, a procedural framework is needed that not only assures the appropriate use of CO by healthcare professionals but also demonstrates its ethical validity, legislative compliance through (...) protection of moral freedoms and patients’ rights to receive health care. Our proposal consists of prerequisites of eligibility for CO (individual reference, specific clinical context, ethical justification, assurance of non-discrimination, professional consistency, attitude of mutual respect, assurance of patient rights and safety) and a procedural process (notification and preparation, documentation and confidentiality, evaluation of prerequisites, non-abandonment, transparency, allowance for unforeseen objection, compensatory responsibilities, access to guidance and/or consultative advice, and organizational guarantee of professional substitution). We illustrate the real-world utility of the proposed framework through a case discussion in which our guidelines are applied. (shrink)

Background Clinical trials throughout the world must be evaluated by research ethics committees. No one has yet attempted to clearly quantify at the national level the activity of ethics committees and describe the characteristics of the protocols submitted. The objectives of this study were to describe 1) the workload and the activity of Research Ethics Committees in France, and 2) the characteristics of protocols approved on a nation-wide basis. Methods Retrospective cohort of 976 protocols approved by a representative sample of (...) 25/48 of French Research Ethics Committees in 1994. Protocols characteristics (design, study size, investigator), number of revisions requested by the ethics committee before approval, time to approval and number of amendments after approval were collected for each protocol by trained research assistant using the committee's files and archives. Results Thirty-one percent of protocols were approved with no modifications requested in 16 days (95% CI: 14–17). The number of revisions requested by the committee, and amendments submitted by the investigator was on average respectively 39 (95% CI: 25–53) and 37 (95% CI: 27–46), per committee and per year. When revisions were requested, the main reasons were related to information to the patient (28%) and consent modalities (18%). Drugs were the object of research in 68% of the protocols examined. The majority of the research was national (80%) with a predominance of single-centre studies. Workload per protocol has been estimated at twelve and half hours on average for administrative support and at eleven and half hours for expertise. Conclusion The estimated workload justifies specific and independent administrative and financial support for Research Ethics Committees. (shrink)

Randomized controlled trial trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized by Schwartz and Lellouch in 1967, an explanatory approach to trial design emphasizes hypothesis testing about the mechanisms of action of treatments under ideal conditions, whereas a pragmatic approach emphasizes testing effectiveness of two or more available treatments in real-world conditions. Interest in, and the number of, pragmatic trials has grown substantially (...) in recent years, with increased recognition by funders and stakeholders worldwide of the need for credible evidence to inform clinical decision-making. This increase has been accompanied by the onset of learning healthcare systems, as well as an increasing focus on patient-oriented research. However, pragmatic trials have ethical challenges that have not yet been identified or adequately characterized. The present study aims to explore the views of key stakeholders with respect to ethical issues raised by the design and conduct of pragmatic trials. It is embedded within a large, four-year project that seeks to develop guidance for the ethical design and conduct of pragmatic trials. As a first step, this study will address important gaps in the current empirical literature with respect to identifying a comprehensive range of ethical issues arising from the design and conduct of pragmatic trials. By opening up a broad range of topics for consideration within our parallel ethical analysis, we will extend the current debate, which has largely emphasized issues of consent, to the range of ethical considerations that may flow from specific design choices. Semi-structured interviews with key stakeholders, across multiple jurisdictions, identified based on their known experience and/or expertise with pragmatic trials. We expect that the study outputs will be of interest to a wide range of knowledge users including trialists, ethicists, research ethics committees, journal editors, regulators, healthcare policymakers, research funders and patient groups. All publications will adhere to the Tri-Agency Open Access Policy on Publications. (shrink)

Personality traits describe dispositions influencing individuals' behavior and performance at work. However, in the context of personnel selection, the use of personality measures has continuously been questioned. To date, research in selection settings has focused uniquely on predicting task performance, missing the opportunity to exploit the potential of personality traits to predict non-task performance. Further, personality is often measured with self-report inventories, which are susceptible to self-distortion. Addressing these gaps, the planned study seeks to design new personality measures to be (...) used in the selection context to predict a wide range of performance criteria. Specifically, we will develop a situational judgment test and a behavior description interview, both assessing Big Five personality traits and Honesty-Humility to systematically compare these new measures with traditional self-report inventories regarding their criterion-related validity to predict four performance criteria: task performance, adaptive performance, organizational citizenship behavior, and counterproductive work behavior. Data will be collected in a simulated selection procedure. Based on power analyses, we aim for 200 employed study participants, who will allow us to contact their supervisors to gather criterion data. The results of this study will shed light on the suitability of different personality measures to predict an expanded range of performance criteria. (shrink)

BackgroundIndividuals with early phase cognitive impairment are frequently affected by existential distress, social avoidance and associated health issues. The demand for efficient psychological support is crucial from both an individual and a societal perspective. We have developed a novel psychological intervention manual for providing a non-medical path to enhanced psychological health in the cognitively impaired population. The current article provides specific information on the randomized controlled trial -design and methods. The main hypothesis is that participants receiving PIPCI will increase their (...) psychological flexibility compared to participants in the active control group and the waiting list control group. The secondary hypotheses are that participants receiving PIPCI will improve psychological health compared to participants in the active control group and the waiting list control group.Materials and MethodsThis three-arm RCT will recruit participants from the cognitive centers at Karolinska University Hospital in Stockholm and randomize approximately 120 individuals in the early phase of cognitive impairment to either an experimental group, an active control group or a waiting list control group. Intervention outcome will be evaluated with self-report questionnaires on physical and psychological aspects of health, cognitive assessment, biological markers and health care costs. Assessments will be performed at pre- and post-intervention, as well as at a 6-month follow-up.DiscussionThe development of a potentially feasible and effective psychological intervention tailored for early phase cognitive impairment has the potential to advance the non-pharmacological intervention field. This is especially important given the extensive burden for many affected individuals and their families and the current lack of effective treatments. If the psychological intervention discussed here shows feasibility and efficacy, there is potential for far-reaching healthcare implications for patients with early cognitive impairment at risk of developing dementia.Clinical Trial RegistrationClinicalTrials.gov: NCT04356924. Date of registration: April 22, 2020. URL: https://clinicaltrials.gov/ct2/show/NCT04356924. (shrink)

The implementation of online technologies to promote wellbeing is increasingly becoming a worldwide priority. This study includes secondary analyses of data and examined drop-out rates in an online guided self-help intervention for patients with anorexia nervosa. Specifically, rates of drop-out at end of treatment (i.e. six-week assessment), as well as intervention adherence (minimum of four of six online guided sessions) and differences between completers and drop-outs were examined. Motivation to change and associated patient variables were assessed as predictors of drop-out (...) using structural equation modelling. Ninety-nine patients were randomised to the intervention arm of the trial. Data were available for 82 individuals, 67 of whom completed the six-week assessment and attended a minimum of four online sessions. No significant differences were found between completers and drop-outs at baseline. At the end of the first week of participation, drop-outs from the six-week assessment or the intervention reported less satisfaction with their work with the mentor delivering online guidance. Greater confidence in own ability to change and higher controlled motivation (willingness to change due to pressure from others) predicted lower drop-out rates from the six-week assessment. Stronger alliance with the therapist at the treatment centre and lower psychological distress were associated with greater autonomous motivation (self-directed motivation) and importance and ability to change. Data demonstrate that a novel online guided self-help intervention for patients with anorexia nervosa is feasible. Early satisfaction with the program and external pressure to change have a protective role against drop-out rates. (shrink)

IntroductionTranscranial magnetic stimulation is a consolidated procedure for the treatment of depression, with several meta-analyses demonstrating its efficacy. Theta-burst stimulation is a modification of TMS with similar efficacy and shorter session duration. The geriatric population has many comorbidities and a high prevalence of depression, but few clinical trials are conducted specifically for this age group. TBS could be an option in this population, offering the advantages of few side effects and no pharmacological interactions. Therefore, our aim is to investigate the (...) efficacy of TBS in geriatric depression.Clinical trial registration[https://clinicaltrials.gov/ct2/], identifier [NCT04842929]. (shrink)

The COVID-19 pandemic resulted in the abrupt closure of circus schools, venues, and companies, introducing a myriad of novel stressors. Performers and students must now attempt to maintain their technical, physical, artistic, creative, and cognitive abilities without in-person support from their coaches and must manage the isolation from their training and performing spaces. For circus artists, the transposition of the work space to a home environment is not possible, which creates novel stressors that could lead to the exacerbation and escalation (...) of mental health issues. The purpose of this study is to develop, implement and evaluate a holistic interventional program based on the socio-ecological model of resilience and operationalized through physical literacy. This will be a prospective longitudinal study with a retrospective comparison to data from a similar student cohort pre-pandemic. Interventions were designed using a population-specific, participant-based developmental model within a knowledge translation framework. The interventional program includes group webinars, small group information sessions, and one-on-one Zoom meetings, in addition to the distribution of electronic educational materials. The interventions will holistically provide psychological, physical, social, technical, artistic, and creative supports. Resources will be deployed throughout the closure period and through recovery, as transitions to return to training after prolonged hiatus will magnify known psychological and physical difficulties. Repeated, longitudinal assessment of students will be utilized to track changes over time at key transitions in the pandemic and school year and will be compared to a pre-pandemic school year. The framework for this program will be translatable to other performing arts and high-performance contexts. The program has implications for the mental health and overall wellbeing of artists and for cultural and economic recovery of the industry. (shrink)

BackgroundSelf-report multiple choice questionnaires have been widely utilized to quantitatively measure one’s personality and psychological constructs. Despite several strengths, self-report multiple choice questionnaires have considerable limitations in nature. With the rise of machine learning and Natural language processing, researchers in the field of psychology are widely adopting NLP to assess psychological construct to predict human behaviors. However, there is a lack of connections between the work being performed in computer science and that of psychology due to small data sets and (...) unvalidated modeling practices.AimsThe current article introduces the study method and procedure of phase II which includes the interview questions for the five-factor model of personality developed in phase I. This study aims to develop the interview and open-ended questions for the FFM-based personality assessments, specifically designed with experts in the field of clinical and personality psychology, and to collect the personality-related text data using the interview questions and self-report measures on personality and psychological distress. The purpose of the study includes examining the relationship between natural language data obtained from the interview questions, measuring the FFM personality constructs, and psychological distress to demonstrate the validity of the natural language-based personality prediction.MethodsPhase I study was conducted to fifty-nine native Korean adults to acquire the personality-related text data from the interview and open-ended questions based on the FFM of personality. The interview questions were revised and finalized with the feedback from the external expert committee, consisting of personality and clinical psychologists. Based on the established interview questions, a total of 300 Korean adults will be recruited using a convenience sampling method via online survey. The text data collected from interviews will be analyzed using the natural language processing. The results of the online survey including demographic data, depression, anxiety, and personality inventories will be analyzed together in the model to predict individuals’ FFM of personality and the level of psychological distress. (shrink)