Schizophrenia is a serious mental disease whose pathogenesis has not been fully elucidated. Its clinical evaluation and diagnosis still highly depend on the clinical experience of doctors. It is of great scientific value and clinical significance to study the inducing factors and neuropathological mechanism of schizophrenia. Based on the four research problems of schizophrenia, this paper analyzes the data types that need to be stored in clinical trials and scientific research, including basic information, case report (...) data, neuropsychological and cognitive function evaluation, magnetic resonance data, electroencephalogram data, and intestinal flora data. Through the demand analysis of the system, including the data management part, data analysis part, the functional demand of the system management part, and the overall nonfunctional demand of the system, the overall architecture design, functional module division, and database table structure design of the system are completed. Adopting Browser/Server architecture and front-end and back-end separation mode and applying Java and Python programming language, based on spring framework and database, a multidimensional information management system for schizophrenia is designed and implemented, which includes four modules: data analysis, data management, system management, and security control. In addition, each functional module of the system is designed and implemented in detail, and the software operation flow of each module is illustrated with the sequence diagram. Finally, the multidimensional data of schizophrenia collected in our laboratory were used for system test to verify whether the system can meet the needs of clinical big data management of schizophrenia and the multidimensional information management system of schizophrenia can meet the needs of clinical big data management. The information management system helps schizophrenic researchers to carry out data management and data analysis. It also has advantages that are easy to use, safe, and efficient and has strong scalability in data management, data analysis, and scalability. It reflects the innovation of the system and provides a good platform for the management, research, and analysis of clinical big data of schizophrenia. (shrink)

The last two decades have witnessed a crescendo of allegations that clinical translation is rife with waste and inefficiency. Patient advocates argue that excessively demanding regulations delay access to life‐saving drugs, research funders claim that too much basic science languishes in academic laboratories, journal editors allege that biased reporting squanders public investment in biomedical research, and drug companies (and their critics) argue that far too much is expended in pharmaceutical development.But how should stakeholders evaluate the efficiency of translation and (...) proposed reforms to drug development? Effective reforms require an accurate model of the systems they aspire to improve—their components, their proper functions, and their pathologies. However, there is currently no explicit and well‐developed model of translation for evaluating such criticisms.In what follows, we offer an explicit model of clinical translation. Many discussions of clinical translation and its pathologies presume that its main output is tangible: new drugs, vaccines, devices, and diagnostics. We disagree. We argue that the principal output of clinical translation is information—in particular, information about the coordinated set of materials, practices, and constraints needed to safely unlock the therapeutic or preventive activities of drugs, biologics, and diagnostics. To develop this information calls for a process far different from a simple linear progression of clinical trials; it requires exploratory sampling of many different elements in this set. Our model points to some limitations and liabilities of influential proposals for reforming research. It also reveals some underrecognized opportunities for improving the efficiency of clinical translation. (shrink)

Obtaining a sufficient amount of measurable and reliable results of student surveys has always posed a challenge for university teams tasked with the provision of the quality of education. This is especially visible at faculties where education is based on the classic classroom-based model, which then transfers to clinical units, hospital wards, and specialist laboratories. The highly unpredictable pandemic situation caused by the SARS-CoV-2 virus raises the bar for the evaluation of didactics. Fortunately, the continuous technological progress in the (...) area of Artificial Intelligence makes it possible to design the implementation of tools that would improve the position of systems for the management of courses of studies. The evaluation survey for didactic classes, as one of the last output data obtained during the process, may finally become a fully recognized source of information about the conducted classes and the teachers themselves. On the other hand, it may become a tool for those surveyed to influence the quality of classes, express their opinion, present suggestions and propositions generally pertaining to changes in the process of education. New information technologies not only make it possible to improve the effectiveness of reaching the recipients, but also provide completely new, very reliable methods of acquisition of credible behaviour, used as integration data in solutions based on machine communication. Using Artificial Intelligence coupled with data may make it possible to use intelligent communication for effective management of the process of surveying – a solution that has so far been used in business, in the form of the so-called bots. As a result, this would lead to an ongoing, fully quantitative and qualitative, assessment of classes. (shrink)

RESUMEN El presente trabajo está dirigido a exponer elementos inherentes al modelo de superación profesional del tecnólogo de la salud en laboratorio clínico desde la integración ciencias básicas biomédicas-laboratorio. Entre los métodos teóricos empleados, el analítico-sintético permitió la determinación de los fundamentos epistemológicos y praxiológicos del proceso de superación, el inductivo-deductivo posibilitó la determinación de las categorías que surgen en el proceso investigativo, el sistémico estructural funcional para fundamentar el carácter de sistema del modelo y la modelación con la finalidad (...) de construirlo. Se concluye que se establecen como subsistemas del modelo, la proyección profesional de las ciencias básicas biomédicas, la contextualización profesional de la integración ciencias básicas biomédicas-laboratorio y la valoración contextual de la integración en el proceso de superación, lo que explica el proceso de superación del tecnólogo de la salud en laboratorio clínico. ABSTRACT This paper aims at setting out elements inherent to the health technologist in clinical laboratory’s professional training model from the integration of basic biomedical-laboratory sciences. Among the theoretical methods used, analysis-synthesis allowed establishing the epistemological and praxeological basis of the training process; the inductive-deductive method made it possible to determine the categories that result from the research process and the systemic-structural-functional method was used to support the system-like nature of the model and modelling with the end of building it. In conclusion, subsystems of the model are established: basic biomedical sciences professionals’ aims, professional conceptualization of the integration of basic biomedical-laboratory sciences and the contextual assessment of integration in the training process, which expounds the training process of the health technologist in clinical laboratory. (shrink)

Background Denmark has implemented a comprehensive, nationwide pharmaceutical information system, and this system has been evaluated by the Danish Council of Ethics. The system can be seen as an exemplar of a comprehensive health information system for clinical use. Analysis The paper analyses 1) how informed consent can be implemented in the system and how different implementations create different impacts on autonomy and control of information, and 2) arguments directed towards justifying not seeking informed consent in (...) this context. Results and Conclusion Based on the analysis a heuristic is provided which enables a ranking and estimation of the impact on autonomy and control of information of different options for consent to entry of data into the system and use of data from the system. The danger of routinisation of consent is identified. The Danish pharmaceutical information system raises issues in relation to autonomy and control of information, issues that will also occur in relation to other similar comprehensive health information systems. Some of these issues are well understood and their impact can be judged using the heuristic which is provided. More research is, however needed in relation to routinisation of consent. (shrink)

Most people are completely oblivious to the danger that their medical data undergoes as soon as it goes out into the burgeoning world of big data. Medical data is financially valuable, and your sensitive data may be shared or sold by doctors, hospitals, clinical laboratories, and pharmacies—without your knowledge or consent. Medical data can also be found in your browsing history, the smartphone applications you use, data from wearables, your shopping list, and more. At best, data about your health (...) might end up in the hands of researchers on whose good will we depend to avoid abuses of power.2 Most likely, it will end up with data brokers who might sell it to a future employer, or an insurance company, or the government. At worst, your medical data may end up in the hands of criminals eager to commit extortion or identity theft. In addition to data harms related to exposure and discrimination, the collection of sensitive data by powerful corporations risks the creation of data monopolies that can dominate and condition access to health care. -/- This chapter aims to explore the challenge that big data brings to medical privacy. Section I offers a brief overview of the role of privacy in medical settings. I define privacy as having one’s personal information and one’s personal sensorial space (what I call autotopos) unaccessed. Section II discusses how the challenge of big data differs from other risks to medical privacy. Section III is about what can be done to minimise those risks. I argue that the most effective way of protecting people from suffering unfair medical consequences is by having a public universal healthcare system in which coverage is not influenced by personal data (e.g., genetic predisposition, exercise habits, eating habits, etc.). (shrink)

Ontology has been proposed as a solution to the 'Tower of Babel' problem that threatens the semantic interoperability of information systems constructed independently for the same domain. In information systems research and applications, ontologies are often implemented by formalizing the meanings of words from natural languages. However, words in different natural languages sometimes subdivide the same domain of reality in terms of different conceptual categories. If the words and their associated concepts in two natural languages, or (...) even in two terminological traditions within the same language, do not have common referents in the real world, an ontology based on word meanings will inherit the 'Tower of Babel' problem from the languages involved, rather than solve it. In this paper we present evidence from a preliminary comparison of landscape terms in English with those in the Yindjibarndi language of northwestern Australia demonstrating that this problem is not just hypothetical. Some possible solutions are suggested. (shrink)

This insight to art came from chess composition concentrating art in a very dense form. To identify and mathematically assess the uniqueness is the key applicable to other areas eg. computer programming. Maximization of uniqueness is minimization of entropy that coincides as well as goes beyond Information Theory (Shannon, 1948). The reusage of logic as a universal principle to minimize entropy, requires simplified architecture and abstraction. Any structures (e.g. plugins) duplicating or dividing functionality increase entropy and so unreliability (eg. (...) British Airways IT system). The ideas here were verified by my chess compositions, art works and complex information system as an author of each co uk, and were presented at conferences in Santorini, Adelaide, Geneva, Daejon and virtually. (shrink)

This paper argues that the missing voice in clinical ethics is that of informal caregivers. Despite their substantial contribution to care provided to individuals with disabilities, chronic illness or dementia, informal caregivers are rarely thought of as members of the healthcare team and their narratives are rarely listened to and included in clinical and ethical decisions. Addressing this gap, this paper discusses the reasons for the systemic misrecognition of informal caregivers in healthcare systems and argues for their (...) greater narrative inclusion on the clinical, legal and social planes. (shrink)

Objectives: To foster the development of a privacy-protective, sustainable cross-border information system in the framework of a European public health project. Materials and methods: A targeted privacy impact assessment was implemented to identify the best architecture for a European information system for diabetes directly tapping into clinical registries. Four steps were used to provide input to software designers and developers: a structured literature search, analysis of data flow scenarios or options, creation of an ad hoc questionnaire and (...) conduction of a Delphi procedure. Results: The literature search identified a core set of relevant papers on privacy. Technicians envisaged three candidate system architectures, with associated data flows, to source an information flow questionnaire that was submitted to the Delphi panel for the selection of the best architecture. A detailed scheme envisaging an “aggregation by group of patients” was finally chosen, based upon the exchange of finely tuned summary tables. Conclusions: Public health information systems should be carefully engineered only after a clear strategy for privacy protection has been planned, to avoid breaching current regulations and future concerns and to optimise the development of statistical routines. The BIRO project delivers a specific method of privacy impact assessment that can be conveniently used in similar situations across Europe. (shrink)

Objectives—To evaluate a departmental computer system.Design—a. Direct comparison of the time taken to use a manual system with the time taken to use a computer system for lung function evaluation, loan of equipment and production of correspondence. b. Analysis of the accuracy of data capture before and after the introduction of the computer system. c. Analysis of the comparative running costs of the manual and computer systems.Setting—Within a department of respiratory medicine serving a hospital of 1323 beds.Main Outcome Measures—a. (...) Time taken to perform functions with the assistance of computerised methods, in comparison to the manual method used alone. b. Accuracy of data capture. c. Relative running costs.Results—a. The computer system was significantly faster than the manual system for lung function evaluation, loan of equipment, and checking for overdue equipment. The production of correspondence was slightly slower with the computer. b. All outpatient episodes, but only 43 of 65 of inpatient episodes, were captured. Lung function and managerial report data were accurate using both manual and computerised methods. The manual system for equipment loans was inefficient, and use of the computer resulted in the recovery of 221 nebulisers. c. Development costs for 1988–1990 were high. Only £1200 to £1845 per year was recovered directly from staff time saved by the computer but larger savings resulted from changes in work practice. After 10 years the projected deficit is £10 000 per annum in running costs.Conclusions—In comparison with the manual methods, the computer system has shown significant advantages which provide accurate information, with significant favourable effects on working practices. In evaluating computer systems used in clinical practice it is essential to ensure that the projected work practice benefits are achieved without unacceptable costs in staff time, inaccurate data and high financial outlay. (shrink)

Objectives—To evaluate a departmental computer system.Design—a. Direct comparison of the time taken to use a manual system with the time taken to use a computer system for lung function evaluation, loan of equipment and production of correspondence. b. Analysis of the accuracy of data capture before and after the introduction of the computer system. c. Analysis of the comparative running costs of the manual and computer systems.Setting—Within a department of respiratory medicine serving a hospital of 1323 beds.Main Outcome Measures—a. (...) Time taken to perform functions with the assistance of computerised methods, in comparison to the manual method used alone. b. Accuracy of data capture. c. Relative running costs.Results—a. The computer system (CS) was significantly faster than the manual system (MS) for lung function evaluation (CS=7.63 min/test, MS=12.25 min/test), loan of equipment (CS=0.40 min/loan, MS=2.07 min/loan), and checking for overdue equipment (CS=0.49 s/record, MS=9 s/record). The production of correspondence was slightly slower with the computer (CS=9.30 min/letter, MS=8.54 min/letter). b. All outpatient episodes, but only 43 of 65 (66%) of inpatient episodes, were captured. Lung function and managerial report data were accurate using both manual and computerised methods. The manual system for equipment loans was inefficient, and use of the computer resulted in the recovery of 221 nebulisers. c. Development costs for 1988–1990 were high (£72 178). Only £1200 to £1845 per year was recovered directly from staff time saved by the computer but larger savings resulted from changes in work practice (£4049–4765). After 10 years the projected deficit is £10 000 per annum in running costs.Conclusions—In comparison with the manual methods, the computer system has shown significant advantages which provide accurate information, with significant favourable effects on working practices. In evaluating computer systems used in clinical practice it is essential to ensure that the projected work practice benefits are achieved without unacceptable costs in staff time, inaccurate data and high financial outlay. (shrink)

Background: Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical research in Germany, (...) Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki. Methods: For this analysis, we conducted a search of the legal databases “Gesetze im Internet” for Germany, “Internetowy System Aktow Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search was complemented by a review of secondary literature contained in the databases Google Scholar, PubMed, Polish National Library, and eLibrary ru. We have identified 21 normative regulations containing provisions on informed consent in clinical research in all three countries. The content of these documents was systematically categorized and analyzed. Results: The normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Nevertheless, provisions on informed consent vary between these three countries. The differences range from the method and language in which information should be provided, through the amount of information required to be disclosed, to the form of documenting consent or withdrawal. In the case of research on vulnerable groups, these differences are particularly visible. Conclusions: The identified differences can negatively impact the ethical conduct of international clinical studies. Attention needs to be paid that flexibilities within national regulations are not misused to undermine the protection of research subjects. Achieving global or regional legislative harmonization might prove impossible. Such lack of legal consensus reinforces the significance of the international ethical agreements. (shrink)

To give substance to the rhetoric of ‘learning health systems’, a variety of novel trial designs are being explored to more seamlessly integrate research with medical practice, reduce study duration and reduce the number of participants allocated to ineffective interventions. Many of these designs rely on response adaptive randomisation. However, critics charge that RAR is unethical on the grounds that it violates the principle of equipoise. In this paper, I reconstruct critiques of RAR as holding that it is inconsistent (...) with five important ethical principles. I then argue that these criticisms rest on a faulty view of equipoise encouraged by the idea that a RAR study models the beliefs of a single rational agent about the relative merits of the interventions being studied. I outline a view in which RAR models an idealised health system in which diverse communities of fully informed experts shrink or grow as their constituent members update their expert opinions in light of reliable medical evidence. I show how a proper understanding of clinical equipoise can reconcile this conception of RAR with these five ethical principles. This analysis removes an in-principle objection to RAR and sheds important light on the relationship between clinical equipoise and transient diversity in the scientific community. (shrink)

Machine learning heralds highly transformative approaches to the automation of numerous clinical tasks, from diagnosis to risk assessment, and from prognosis to informing treatment decisions....

Scientific and medical practice both relate to and differ from each other, as do discussions of how to handle decisions under uncertainty in the laboratory and clinic respectively. While studies of science have pointed out that scientific practice is more complex and messier than dominant conceptions suggest, medical practice has looked to the rigour of scientific and statistical methods to address clinical uncertainty. In this article, we turn to epistemological studies of the laboratory to highlight how (...) class='Hi'>clinical practice already has strategies for dealing with messiness. We draw on Hans-Jo ̈rg Rheinberger’s Toward a History of Epistemic Things, in which he invokes the metaphor of a spider’s web to explain the role of tacit practices in experimental biochemistry for helping practitioners manage messiness. We argue that diagnostic practices in clinical medicine employ similar, albeit codified, procedures to evaluate epistemic significance, ensure sensitivity to the unforeseen, and allow focused grounds for action. We consider three practices: (a) the pre-set structure of medical records, ensuring broad coverage in initial anamnesis, (b) the use of lists of differential diagnoses and ongoing ‘anchoring and adjusting’ as inquiry progresses, and (c) shared decision-making as an occasion to synthesize empirical evidence and reopen inquiry for potential missed information. We end by suggesting that while philosophy of medicine may learn from laboratory epistemology, the sciences may learn something from medical practice. (shrink)

Clinical guidelines are special types of plans realized by collective agents. We provide an ontological theory of such plans that is designed to support the construction of a framework in which guideline-based information systems can be employed in the management of workflow in health care organizations. The framework we propose allows us to represent in formal terms how clinical guidelines are realized through the actions of are realized through the actions of individuals organized into teams. We (...) provide various levels of implementation representing different levels of conformity on the part of health care organizations. Implementations built in conformity with our framework are marked by two dimensions of flexibility that are designed to make them more likely to be accepted by health care professionals than standard guideline-based management systems. They do justice to the fact 1) that responsibilities within a health care organization are widely shared, and 2) that health care professionals may on different occasions be non-compliant with guidelines for a variety of well justified reasons. The advantage of the framework lies in its built-in flexibility, its sensitivity to clinical context, and its ability to use inference tools based on a robust ontology. One disadvantage lies in its complicated implementation. (shrink)

The acceptability of sentences in natural language is constrained not only grammaticality, but also by the relationship between what is being conveyed and such factors as context and the beliefs of interlocutors. In many languages the critical element in a sentence (its focus) must be given grammatical prominence. There are different accounts of the nature of focus marking. Some researchers treat it as the grammatical realization of a potentially arbitrary feature of universal grammar and do not provide an explicit account (...) of its origins; others have argued, however, that focus marking is a (grammaticalized) functional solution to the problem of efficiently transmitting information via a noisy channel. By adding redundancy to highlight critical elements in particular, focus protects key parts of the message from noise. If this information‐theoretic account is true, then we should expect focus‐like behavior to emerge even in non‐linguistic communication systems given sufficient noise and pressures for efficiency. We tested this in an experiment in which participants played a simple communication game in which they had to click cells on a grid to communicate one of two line figures drawn across the grid. We manipulated the noise, available time, and required effort, and measured patterns of redundancy. Because the lines in many cases overlapped, meaning that only some parts of each line could be used to distinguish it from the other, we were able to compare the extent to which effort was expended on adding redundancy to critical (non‐overlapping) and non‐critical (overlapping) parts of the message. The results supported the information‐theoretic account of focus and shed light on the emergence of information structure in language. (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)

Biomedical researchers claim there is significant biomedical information about humans which can be discovered only through experiments on intact animal systems (AMA p. 2). Although epidemiological studies, computer simulations, clinical investigation, and cell and tissue cultures have become important weapons in the biomedical scientists' arsenal, these are primarily "adjuncts to the use of animals in research" (Sigma Xi p. 76). Controlled laboratory experiments are the core of the scientific enterprise. Biomedical researchers claim these should be conducted (...) on intact biological systems, whole animals. By observing the effects of various stimuli in non-human animals, we can form legitimate expectations about the likely effects of these stimuli in humans. Perhaps more importantly, we can understand the biomedical condition's causal mechanisms. (shrink)

It is widely argued that the final decades of the twentieth century saw a fundamental change, marked by terms such as biomedicalization and geneticization, within the biomedical sciences. What unites these concepts is the assertion that a vast array of emerging technologies—in genomics, bioengineering, information technology, and so forth—are transforming understandings of disease, diagnosis, therapeutics, and working practices. While clearly important, these analyses have been accused of perpetuating theoretical trends that attribute primacy to the new over the old, discontinuity (...) over continuity, and the laboratory over the field. In this paper, I show that in the case of autism, the effects of genomic technologies can only be understood by simultaneously examining the role of questionnaires. Due to shortcomings in clinical diagnoses, genomic analyses could only progress once questionnaires had been developed to address a “reverse salient” within the “technological system.” Furthermore, I argue that questionnaires such as the Autism Quotient have a significance that surpasses the genomic classifications they were designed to undergird. I argue that to neglect the role of mundane technologies such as questionnaires in contemporary biomedicine is to miss complexity, bifurcate old and new, and do a disservice to innovation. (shrink)

Context: In this empirical and conceptual paper on the historical, philosophical, and epistemological backgrounds of second-order cybernetics, the emergence of a significant pedagogical component to Heinz von Foerster’s work during the last years of the Biological Computer Laboratory is placed against the backdrop of social and intellectual movements on the American landscape. Problem: Previous discussion in this regard has focused largely on the student radicalism of the later 1960s. A wider-angled view of the American intellectual counterculture is needed. However, (...) this historical nexus is complicated and more often dismissed than brought into clear focus. Method: This essay assembles a historical sequence of archival materials for critical analysis, linked to a conceptual argument eliciting from those materials the second-order cybernetic concepts of observation, recursion, and paradox. Results: In this period, von Foerster found the “positive of the negative” in the social and intellectual unrest of that moment and cultivated those insights for the broader constitution of a new cognitive orientation. Implications: As a successful student of his own continuing course on heuristics, von Foerster left the academic mainstream to ally his constructivist epistemology with the systems counterculture. (shrink)

Resnik and Pugh recently explored the ethical implications of routinely integrating environmental concerns into clinical decision-making. While we share their concern for the holistic well-being of patients, our response offers a different clinical and bioethical stance on green informed consent and patient autonomy. Contrary to the authors’ lack of data to support their concerns about provider and patient willingness to engage in climate-related conversations, we provide evidence supporting their sustainability engagement and stress the importance of a proactive, anticipatory (...) approach in healthcare to align with evolving societal values. If climate change is perceived as a politicised issue, though it is not inherently so, healthcare providers are professionally trained to address sensitive subjects and have a duty to inform patients about potential health risks. Recognising the environmental crisis as a health crisis underscores the direct connection between environmental hazards and patients’ well-being. Our perspective advocates for integrating individual considerations, societal responsibilities and systemic changes to promote environmentally sustainable healthcare. (shrink)

The quest for effective medicines is very old. In modern times two important tools have been developed to evaluate efficacy of drugs: superiority and non-inferiority types of clinical trials. The former tests the null hypothesis of μ (the difference between a tested drug and comparator) ≤ 0 against μ > 0; the latter tests the null hypothesis of μ ≤ - Δ against, μ > - Δ, where Δ is the clinical difference from the comparator. In a superiority (...) trial, a new drug is tested against a placebo; in a non-inferiority trial, a new drug is tested against active treatment. In this paper, arguments are presented to show that a superiority trial against a placebo is scientifically sound but ethically unacceptable, whereas a non-inferiority trial against active treatment is ethically sound but scientifically not reliable. Switching from a superiority type of trial with placebo to a non-inferiority trial with an active-control — following the latest revision of Declaration of Helsinki — is in practice switching from the violation of the uncertainty principle to uncertainty of results. Given human and financial resources, it appears an academic question as to which is more unethical: to violate patients’ rights or to produce results without scientific value. All presented considerations lead to the conclusion that the use of a superiority trial of design with an active control instead of placebo will satisfy scientific needs, expectation of patients, and the ancient quest for effective medicines. In the era of Good (Clinical, Laboratory, Manufacture) Practice, the attention of those performing clinical trials is focused on the procedure, not always on its essence. However even the excellent performance of a trial which is not worth doing is fruitless. (shrink)

BackgroundInformed consent, whose goal is to assure that participants enter research voluntarily after disclosure of potential risks and benefits, may be impossible or impractical in emergency research. In low resource settings, there is limited information on the experiences of the informed consent process for randomized clinical trials in the emergency care context. The objective of this study was to explore the experiences of the informed consent process and factors that motivated participation in two obstetrics and newborn care randomized (...) clinical trials (RCTs).MethodsThis was a qualitative study conducted among former participants of RCTs in the emergency obstetric care context, conducted at Kawempe National Referral Hospital, Uganda. It employed 30 in-depth interviews conducted from June 1, 2019 to August 30, 2019. Issues explored included attitudes about research, the purpose of the research in which they participated, motivations to take part in the study, factors that influenced enrolment decisions, and experiences of the informed consent process.ResultsRespondents felt that research was necessary to investigate the cause, prevention or complications of illness. The decisions to participate were influenced by hope for material or therapeutic benefit, trust in the healthcare system and influence of friends and family members. Many were satisfied with the informed consent process, though they did not understand some aspects of the research.ConclusionRespondents valued participation in RCTs in emergency obstetric and newborn care. Hope for benefit, altruism, desire to further scientific knowledge and trust in the investigators featured prominently in the motivation to participate. Both intrinsic and extrinsic factors were motivators for RCT participation. (shrink)

The exponential growth of genetic knowledge and precision medicine research raises hopes for improved prevention, diagnosis, and treatment options for children with behavioral and psychiatric conditions. Although well-intended, this prospect also raise the possibility — and concern — that behavioral, including psychiatric genetic data would be increasingly used — or misused — outside the clinical context, such as educational settings. Indeed, there are ongoing calls to endorse a “personalized education” model that would tailor educational interventions to children's behavioral and (...) psychiatric genetic makeup. This article explores the justifications for, and prospects and pitfalls of such endeavors. It considers the scientific challenges and highlights the ethical, legal, and social issues that will likely arise should behavioral genetic data become available and are routinely incorporated in student education records. These include: when to disclose students' behavioral and psychiatric genetic profile; whose genomic privacy is protected and by whom; and how students' genetic data may affect education-related decisions. I argue that the introduction of behavioral genetics in schools may overshadow the need to address underlying structural and environmental factors that increase the risk for psychiatric conditions of all students, and that the unregulated use of student behavioral genetic profiles may lead to unintended consequences that are detrimental for individuals, families and communities. Relevant stakeholders — from parents and students to health professionals, educators, and policy-makers — ought to consider these issues before we forge ahead with a genomically informed education system. (shrink)

Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions (...) pertain principally to individual participants: (1) providing transparency; (2) allowing control and authorization; (3) promoting concordance with participants' values; and (4) protecting and promoting welfare interests. Three other functions are systemic or policy focused: (5) promoting trust; (6) satisfying regulatory requirements; and (7) promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals. (shrink)

Regulators rely on clinical trials for drug approval and labeling decisions. Health systems and clinicians rely on the evidence from trials to determine treatment, and patients rely on it to decide which courses of care to undertake. Many of these stakeholders presume that the careful review of individual studies is enough to address the ethical and scientific questions that arise in clinical trials. In what follows, however, we demonstrate that explicit consideration of trial portfolios—series of trials that (...) are interrelated by a common set of objectives—is crucial. the ethical acceptability and evidentiary probity of individual trials can change depending on the characteristics of the portfolios in which they are embedded. Second, how trial portfolios are composed, how well they are coordinated, and how efficiently they use information determines the balance of risks and benefits they present as well as their different prospects for generating socially valuable information; these three factors also raise distinct questions of justice. (shrink)

This paper discusses how to apply a collective decision model of the principle of voluntary informed consent in African communitarian culture, in a culturally sensitive way, in order to protect research candidates from potential exploitations and abuses. Dismissing cultural and ethical skepticism surrounding the global application of the principle of voluntary informed consent, the paper ultimately concludes that international collaboration on diagnostic and therapeutic medical research in Africa, especially HIV vaccine trials, is a moral imperative.

Most clinical neurofeedback studies based on functional magnetic resonance imaging use the patient's own neural activity as feedback. The objective of this study was to create a subject-independent brain state classifier as part of a real-time fMRI neurofeedback system that can guide patients with depression in achieving a healthy brain state, and then to examine subsequent clinical changes. In a first step, a brain classifier based on a support vector machine was trained from the neural information of (...) happy autobiographical imagery and motor imagery blocks received from a healthy female participant during an MRI session. In the second step, 7 right-handed female patients with mild or moderate depressive symptoms were trained to match their own neural activity with the neural activity corresponding to the “happiness emotional brain state” of the healthy participant. The training was carried out using the rt-fMRI NF system guided by the brain-state classifier we had created. Thus, the informative voxels previously obtained in the first step, using SVM classification and Effect Mapping, were used to classify the Blood-Oxygen-Level Dependent activity of the patients and converted into real-time visual feedback during the neurofeedback training runs. Improvements in the classifier accuracy toward the end of the training were observed in all the patients [Session 4–1 Median = 6.563%; Range = 4.10–27.34; Wilcoxon Test, 2-tailed p = 0.031]. Clinical improvement also was observed in a blind standardized clinical evaluation [HDRS CE2-1 Median = 7; Range 2 to 15; Wilcoxon Test, 2-tailed p = 0.016], and in self-report assessments [BDI-II CE2-1 Median = 8; Range 1–15; Wilcoxon Test, 2-tailed p = 0.031]. In addition, the clinical improvement was still present 10 days after the intervention [BDI-II CE3-2_Median = 0; Range −1 to 2; Wilcoxon Test, 2-tailed p = 0.50/ HDRS CE3-2 Median = 0; Range −1 to 2; Wilcoxon Test, 2-tailed p = 0.625]. Although the number of participants needs to be increased and a control group included to confirm these findings, the results suggest a novel option for neural modulation and clinical alleviation in depression using noninvasive stimulation technologies. (shrink)

Recruitment processes for clinical trials are governed by guidelines and regulatory systems intended to ensure participation is informed and voluntary. Although the guidelines and systems provide some protection to potential participants, current recruitment processes often result in limited understanding and experiences of inadequate decision support. Many trials also have high drop-out rates among participants, which are ethically troubling because they can be indicative of poor experiences and they limit the usefulness of the knowledge the trials were designed (...) to generate. Drawing on recent social-psychological and philosophical-ethical research on trial recruitment and patient participation in treatment decision-making, this paper identifies possibilities for improving communicative support for both initial decisions and ongoing participation in clinical trials. It highlights the potential of a shift in thinking about ‘voluntariness’, underpinned by relational understandings of autonomy, to encourage more nuanced judgements about the ethics of communication between trial staff and (potential) participants. The paper suggests that the idea of responsively enabling people to consider invitations or requests to participate in particular trials could serve as a general guide to communication. This might help ensure decisions about trial participation are meaningfully informed and voluntary, and that relationships between trial staff and participants contribute to positive experiences of trial participation and ultimately to the generation of the robust knowledge. (shrink)

The objective of this research programme is to contribute to the establishment of the emerging science of Formal Ontology in Information Systems via a collaborative project involving researchers from a range of disciplines including philosophy, logic, computer science, linguistics, and the medical sciences. The re­searchers will work together on the construction of a unified formal ontology, which means: a general framework for the construction of ontological theories in specific domains. The framework will be constructed using the axiomatic-deductive method (...) of modern formal ontology. It will be tested via a series of applications relating to on-going work in Leipzig on medical taxonomies and data dictionaries in the context of clinical trials. This will lead to the production of a domain-specific ontology which is designed to serve as a basis for applications in the medical field. (shrink)

The conduct of most of social science occurs outside the laboratory. Such studies in field science explore phenomena that cannot for practical, technical, or ethical reasons be explored under controlled conditions. These phenomena cannot be fully isolated from their environment or investigated by manipulation or intervention. Yet measurement, including rigorous or clinical measurement, does provide analysts with a sound basis for discerning what occurs under field conditions, and why. In Science Outside the Laboratory, Marcel Boumans explores the (...) state of measurement theory, its reliability, and the role expert judgment plays in field investigations from the perspective of the philosophy of science. Its discussion of the problems of passive observation, the calculus of observation, the two-model problem, and model-based consensus uses illustrations drawn primarily from economics. Rich in research and discussion, the volume clarifies the extent to which measurement provides valid information about objects and events in field sciences, but also has implications for measurement in the laboratory. Scholars in the fields of philosophy of science, social science, and economics will find Science Outside the Laboratory a compelling and informative read. (shrink)

This article discusses the rights of patients who are attending hospital for the most common laboratory examinations and who may also be taking part in research studies. A distinction is made between five kinds of rights to: protection of privacy, physical integrity, mental integrity, information and self-determination. The data were collected ( n = 204) by means of a structured questionnaire specifically developed for this study in the clinical chemistry, haematological, physiological and neurophysiological laboratories of one randomly (...) selected university hospital in Finland. The analysis of the data was statistical. On the whole, patients’ rights were realized reasonably well. This was most particularly the case with protection of privacy, as well as with the rights of physical and mental integrity. The rights to information and self-determination were less well realized. There are various steps that health care professionals and organizations can take to make sure that patients can enjoy their full rights, by counselling the patient, by giving opportunities to plan the examinations in advance, and by arranging a sufficient number of small examination rooms. (shrink)

An ethical analysis of Jordan's Clinical Research Law, which became effective in 2001, was performed. Accordingly, this paper discusses the major components, key strengths and weaknesses of this law. As an initial effort, the Law addresses important aspects of research ethics and, hence, should serve as an example for other Arab Countries in the Middle East. Unique aspects of the Law include the requirement that those conducting any study have insurance that can compensate for research injuries and a system (...) of fines and punishments for noncompliance with the Law. There are, however, some key items missing in the Jordanian Law. For example, the Law does not mention the requirement of a favourable assessment of risks and benefits, the fair selection of subjects, or articles regarding the protection of the rights and welfare of children and other vulnerable subjects participating in research. The paper concludes with the suggestion that new amendments should be considered for future revisions of the Clinical Research Law in Jordan. (shrink)

Recent work on the quality assurance of the Gene Ontology (GO, Gene Ontology Consortium 2004) from the perspective of both linguistic and ontological organization has made it clear that GO lacks the kind of formalism needed to support logic-based reasoning. At the same time it is no less clear that GO has proven itself to be an excellent terminological resource that can serve to combine together a variety of biomedical database and information systems. Given the strengths of GO, (...) it is worth investigating whether, by overcoming some of its weaknesses from the point of view of formal-ontological principles, we might not be able to enhance a version of GO which can come even closer to serving the needs of the various communities of biomedical researchers and practitioners. It is accepted that clinical and bioinformatics need to find common ground if the results of data-intensive biomedical research are to be harvested to the full. It is also widely accepted that no single method will be sufficient to create the needed common framework. We believe that the principles-based approach to life-science data integration and knowledge representation must be one of the methods applied. Indeed in dealing with the ontological representation of carcinomas, and specifically of colon carcinomas, we have established that, had GO (and related biomedical ontologies) followed some of the basic formal-ontological principles we have identified (Smith et al. 2004, Ceusters et al. 2004), then the effort required to navigate successfully between clinical and bioinformatics systems would have been reduced. We point here to the sources of ontologically-related errors in GO, and also provide arguments as to why and how such errors need to be resolved. (shrink)

To maximize brain plasticity after stroke, several rehabilitation strategies have been explored, including the use of intensive motor training, motor imagery, and action observation. Growing evidence of the positive impact of virtual reality (VR) techniques on recovery following stroke has been shown. However, most VR tools are designed to exploit active movement, and hence patients with low level of motor control cannot fully benefit from them. Consequently, the idea of directly training the central nervous system has been promoted by utilizing (...) motor-imagery (MI) based brain-computer interfaces (BCIs). To date, detailed information on which VR strategies lead to successful functional recovery is still largely missing, and very little is known about how to optimally integrate BCI and VR paradigms for stroke rehabilitation. The purpose of this study was to examine the efficacy of a BCI-VR system using a MI paradigm for post-stroke upper limb rehabilitation on functional assessments, and related changes in MI ability and brain imaging. To achieve this, a 60 years old male chronic stroke patient was recruited. The patient underwent a 3-week intervention in a clinical environment, resulting in 10 BCI-VR training sessions. The patient was assessed before and after intervention, as well as on a one-month follow-up, in terms of clinical scales and brain imaging using functional MRI (fMRI). Consistent with prior research, we found important improvements in upper extremity scores (Fugl-Meyer) and identified increases in brain activation measured by fMRI that suggest neuroplastic changes in brain motor networks. This study expands on the current body of evidence as more data are needed on the effect of this type of interventions not only on functional improvement but also through brain imaging to study the effect of the intervention on plasticity. (shrink)

Most writing on informed consent in Africa highlights different cultural and social attributes that influence informed consent practices, especially in research settings. This review presents a composite picture of informed consent in Nigeria using empirical studies and legal and regulatory prescriptions, as well as clinical experience. It shows that Nigeria, like most other nations in Africa, is a mixture of sociocultural entities, and, notwithstanding the multitude of factors affecting it, informed consent is evolving along a purely Western model.Empirical studies (...) show that 70–95% of Nigerian patients report giving consent for their surgical treatments. Regulatory prescriptions and adjudicated cases in Nigeria follow the Western model of informed consent. However, adversarial legal proceedings, for a multiplicity of reasons, do not play significant roles in enforcing good medical practice in Nigeria. Gender prejudices are evident, but not a norm. Individual autonomy is recognized even when decisions are made within the family. Consent practices are influenced by the level of education, extended family system, urbanization, religious practices, and health care financing options available. All limitations notwithstanding, consent discussions improved with increasing level of education of the patients, suggesting that improved physician's knowledge and increasing awareness and education of patients can override other influences.Nigerian medical schools should restructure their teaching of medical ethics to improve the knowledge and practices of physicians. More research is needed on the preferences of the Nigerian people regarding informed consent so as to adequately train physicians and positively influence physicians’ behaviors. (shrink)