The theory of granular partitions (TGP) is a new approach to the understanding of ontologies and other classificatory systems. The paper explores the use of this new theory in the treatment of task-based clinical guidelines as a means for better understanding the relations between different clinical tasks, both within the framework of a single guideline and between related guidelines. We used as our starting point a DAML+OIL-based ontology for the WHO guideline for hypertension management, comparing this (...) with related guidelines and attempting to show that TGP provides a flexible and highly expressive basis for the manipulation of ontologies of a sort which might be useful in providing more adequate Computer Interpretable Guideline Models (CIGMs) in the future. (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)

Outcomes research in healthcare has been a topic much addressed in recent years. Efforts in this direction have been supplemented by work in the areas of guidelines for clinical practice and computer-interpretable workflow and careflow models.In what follows we present the outlines of a framework for understanding the relations between organizations, guidelines, individual patients and patient-related functions. The derived framework provides a means to extract the knowledge contained in the guideline text at different granularities, in ways that (...) can help us to assign tasks within the healthcare organization and to assess clinical performance in realizing the guideline. It does this in a way that preserves the flexibility of the organization in the adoption of the guidelines. (shrink)

An important part of the Unified Medical Language System (UMLS) is its Semantic Network, consisting of 134 Semantic Types connected to each other by edges formed by one or more of 54 distinct Relation Types. This Network is however for many purposes overcomplex, and various groups have thus made attempts at simplification. Here we take this work further by simplifying the relations which involve the three Semantic Types – Diagnostic Procedure, Laboratory Procedure and Therapeutic or Preventive Procedure. We define operators (...) which can be used to generate terms instantiating types from this selected set when applied to terms designating certain other Semantic Types, including almost all the terms specifying clinical tasks. Usage of such operators thus provides a useful and economical way of specifying clinical tasks. The operators allow us to define a mapping between those types within the UMLS which do not represent clinical tasks and those which do. This mapping then provides a basis for an ontology of clinical tasks that can be used in the formulation of computer-interpretable clinical guideline models. (shrink)

Evidence-based medicine relies on the execution of clinical practice guidelines and protocols. A great deal of of effort has been invested in the development of various tools which automate the representation and execution of the recommendations contained within such guidelines and protocols by creating Computer Interpretable Guideline Models (CIGMs). Context-based task ontologies (CTOs), based on standard terminology systems like UMLS, form one of the core components of such a model. We have created DAML+OIL-based CTOs for the tasks (...) mentioned in the WHO guideline for hypertension management, drawing comparisons also with other related guidelines. The advantages of CTOs include: contextualization of ontologies, providing ontologies tailored to specific aspects of the phenomena of interest, dividing the complexity involved in creating ontologies into different levels, providing a methodology by means of which the task recommendations contained within guidelines can be integrated into the clinical practices of a health care set-up. (shrink)

The paper presents the outlines of an ontology of plans and guidelines, which is then used as the basis for a framework for implementing guideline-based systems for the management of workflow in health care organizations. The framework has a number of special features, above all in that it enables us to represent in formal terms assignments of work-items both to individuals and to teams and to tailor guideline to specific contexts of application in health care organizations. It is designed (...) also to enable implementations to do justice to the fact that the processes carried out in health care organizations may deviate in different ways from the norms set forth in corresponding guideline definitions. This means that implementations built in conformity with the framework will be marked by a type of flexibility that might make them more likely to be accepted by healthcare professionals than are standard guideline-based management systems. (shrink)

Ectopic pregnancy is defined as the fertilized ovum implants in a location outside the endometrial cavity, remains to be an important cause of maternal morbidity and mortality worldwide and is a health problem with incidence ranges between 0.25% and 2% of all pregnancies. In our study, in Izmir Katip Celebi University Ataturk Training and Research Hospital, Department of Obstetrics and Gynecology from 2011 to 2013, 96 cases with diagnosis of ectopic pregnancy managed by the adapted RCOG’s Guide were analyzed retrospectively. (...) The data were analyzed as follows: age, the history of operation, smoking, the presence of intrauterine device, blood groups, hemoglobin, platelets, values of B-hCG, the diagnostic interval, intra-abdominal free fluid and/or acute abdomen, the method of treatment and the success of treatment. (shrink)

Introduction: Clinical practice guidelines (CPGs) are an important source of justification for clinical decisions in modern evidence-based practice. Yet, we have given little attention to how they argue their evidence. In particular, how do CPGs argue for treatment with long-term medications that are increasingly prescribed to older patients? Approach and rationale: I selected six disease-specific guidelines recommending treatment with five of the medication classes most commonly prescribed for seniors in Ontario, Canada. I considered the stated aims (...) of these CPGs and the techniques employed towards those aims. Finally, I reconstructed and logically analysed the arguments supporting recommendations for pharmacotherapy. Analysis: The primary function of CPGs is rhetorical, or persuasive, and their means of persuasion include both a display of their credibility and their argumentation. Arguments supporting pharmacotherapy recommendations for the target population follow a common inductive pattern: statistical generalization from randomized controlled trial (RCT) and meta-analysis evidence. Two of the CPGs also argue their treatment recommendations for older patients in this style, while three fail to justify pharmacotherapy specifically for the older population. Discussion: The arguments analysed lack the auxiliary assumptions that would warrant making a generalization about the clinical effectiveness of medications for the older population. Guidelines reason using simple induction, while ignoring important inferential gaps. Future guidelines should aspire to be well-reasoned rather than simply evidence-based; argue from a plurality of evidence; be wary of hasty inductions; appropriately limit the scope of their recommendations; and avoid making law-like, prescriptive generalizations. (shrink)

The UN Convention against Torture defines torture as “any act by which severe pain or suffering, whether physical or mental, is intentionally inflicted on a person” by someone acting in an official capacity for purposes such as obtaining a confession or punishing or intimidating that person.1 It is unethical for healthcare professionals to participate in torture, including any use of medical knowledge or skill to facilitate torture or allow it to continue, or to be present during torture.2-7 Yet medical participation (...) in torture has taken place throughout the world and was a prominent feature of the US interrogation practice in military and Central Intelligence Agency (CIA) detention facilities in the years after the attacks of 11 September 2001.8-11 Little attention has been paid, however, to how a regime of torture affects the ability of health professionals to meet their obligations regarding routine clinical care for detainees. -/- The 2016 release of previously classified portions of guideline from the CIA regarding medical practice in its secret detention facilities sheds light on that question. These show that the CIA instructed healthcare professions to subordinate their fundamental ethical obligations regarding professional standards of care to further the objectives of the torturers. (shrink)

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

Meta-analysis is a statistical analysis that combines the results of relevant studies performed for same purpose and is used as a tool for evidence-based medicine to support clinical decision making. Because a meta-analysis includes advanced statistical analysis, the report is not easily understandable to clinicians. In this study, we aimed to write a guideline for clinicians to help them understand the statistical analysis part of a meta-analysis and interpret graphs and results of a meta-analysis.

The International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) COVID-19 dataset is one of the largest international databases of prospectively collected clinical data on people hospitalized with COVID-19. This dataset was compiled during the COVID-19 pandemic by a network of hospitals that collect data using the ISARIC-World Health Organization Clinical Characterization Protocol and data tools. The database includes data from more than 705,000 patients, collected in more than 60 countries and 1,500 centres worldwide. Patient data are available (...) from acute hospital admissions with COVID-19 and outpatient follow-ups. The data include signs and symptoms, pre-existing comorbidities, vital signs, chronic and acute treatments, complications, dates of hospitalization and discharge, mortality, viral strains, vaccination status, and other data. Here, we present the dataset characteristics, explain its architecture and how to gain access, and provide tools to facilitate its use. (shrink)

Heart palpitations, while often benign, can sometimes be indicative of severe underlying conditions requiring immediate intervention. Accurate and swift diagnosis thus remains a clinical priority. "A CLIPS-Based Expert System for Heart Palpitations Diagnosis" represents a novel approach to addressing this challenge, harnessing the power of artificial intelligence and rule-based expert systems. Specifically, this system applies a suite of 7 if-then rules to evaluate potential heart palpitations causes and assign one of three outcomes: 1) A confirmed diagnosis of heart palpitations, (...) 2) A suspected link to cardiovascular diseases, and 3) A possible association with anxiety or stress disorders. The expert system offers an intuitive user interface, allowing for seamless symptom input and instant diagnosis based on user-provided information. This paper explores the various phases of this expert system's lifecycle, including design, implementation, and evaluation. Furthermore, the study situates the system within the broader discourse on rule-based expert systems for heart palpitations diagnosis, critically analyzing their efficiency, potential pitfalls, and ongoing challenges. Through this research, the value of integrating rule-based expert systems in clinical diagnostic processes is highlighted, illustrating its capacity to enhance diagnostic accuracy and patient outcomes. (shrink)

Brain tumors pose significant challenges in modern healthcare, with accurate and timely diagnosis crucial for determining appropriate treatment strategies. Artificial intelligence has made significant advancements in recent years. Rule-based expert systems (if-then rule-based systems) have emerged as a promising approach for clinical decision-making in brain tumor diagnosis. In this paper, we present "A CLIPS-Based Expert System for Brain Tumor Diagnosis," which leverages a set of 14 if-then rules to diagnose brain tumors with three possible outcomes: 1) Confirm the diagnosis (...) of a brain tumor, 2) Consider the possibility of a brain tumor that has metastasized, and 3) Consider the possibility of a brain tumor. Our expert system offers a user-friendly interface, enabling users to select symptoms and receive a diagnosis based on the provided information. This paper discusses the expert system's development, implementation, and evaluation, highlighting its potential to facilitate brain tumor diagnosis and decision-making in clinical settings. Additionally, we provide a literature review that contextualizes our expert system within the broader landscape of rule-based expert systems for brain tumor diagnosis, examining their effectiveness, limitations, and challenges. (shrink)

Background: Transgender health care is a subject of much debate among clinicians, political commentators, and policy-makers. While the World Professional Association of Transgender Health (WPATH) Standards of Care (SOC) establish clinical standards, these standards contain implied ethics but lack explicit focused discussion of ethical considerations in providing care. An ethics chapter in the SOC would enhance clinical guidelines. Aims: We aim to provide a valuable guide for healthcare professionals, and anyone interested in the ethical aspects of (...) class='Hi'>clinical support for gender diverse and transgender people of all ages. Recognizing that the WPATH is a global association, we address broad challenges. We offer a reflection on general ethical principles, providing conceptual tools for healthcare providers, patients, and families to navigate the specific challenges they might encounter in transgender health care, in line with WPATH’s worldwide mission and scope. Method: This article employs a descriptive analysis, and our framework of reference is the four principles of biomedical ethics: respect for autonomy, beneficence, nonmaleficence, and justice. Results: The article presents a discussion on the four ethical principles as applied to transgender health care. We address issues such as respect for patient autonomy in decision-making, the role of beneficence and nonmaleficence in clinical interventions, and the importance of justice in equitable treatment and access to care. Some of the ethical concerns we address in this article pertain to the current sociopolitical climate, where there has been increasing legal interference, internationally, for transgender and nonbinary people, particularly youth, seeking medical care. Discussion: We highlight the interplay between ethical principles and clinical practice, underscoring the need for ethical guidance in addressing the diverse challenges faced by healthcare providers and patients in transgender health care. We advocate for continuous refinement of ethical thinking to ensure that transgender health care is not only medically effective but also ethically sound. (shrink)

Since its introduction just over two decades ago, evidence-based medicine (EBM) has come to dominate medical practice, teaching, and policy. There are a growing number of textbooks, journals, and websites dedicated to EBM research, teaching, and evidence dissemination. EBM was most recently defined as a method that integrates best research evidence with clinical expertise and patient values and circumstances in the treatment of patients. There have been debates throughout the early 21st century about what counts as good research evidence (...) between EBM proponents and philosophical critics and even within the EBM community itself. Similar controversy arises about the relative worth of patient values and clinical expertise (and how these can be integrated). EBM has also evolved in ways that have come under scrutiny. Specifically, policymakers have used EBM research methodology to increase the relative importance of clinical guidelines that some clinicians have argued are tyrannical. Philosophers have addressed all of these controversies, and with very few exceptions have been critical of EBM. In addition most philosophical attention has been on the epistemic role of Randomization and evidence hierarchies, with relatively little attention being paid to the role of Diagnosis, expertise, patient values, and Systematic Reviews within EBM. (shrink)

The evidence based medicine movement has championed the need for objective and transparent methods of clinical guideline development. The Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) framework was developed for that purpose. Central to this framework is criteria for assessing the quality of evidence from clinical studies and the impact that body of evidence should have on our confidence in the clinical effectiveness of a therapy under examination. Grades of Recommendation, Assessment, Development, and Evaluation has been (...) adopted by a number of professional medical societies and organizations as a means for orienting the development of clinical guidelines. As a result, the method of GRADE has implications on how health care is delivered and patient outcomes. In this paper, we reveal several issues with the underlying logic of GRADE that warrant further discussion. First, the definitions of the “grades of evidence” provided by GRADE, while explicit, are functionally vague. Second, the “criteria for assigning grade of evidence” is seemingly arbitrary and arguably logically incoherent. Finally, the GRADE method is unclear on how to integrate evidence grades with other important factors, such as patient preferences, and trade‐offs between costs, benefits, and harms when proposing a clinical practice recommendation. Much of the GRADE method requires judgement on the part of the user, making it unclear as to how the framework reduces bias in recommendations or makes them more transparent—both goals of the programme. It is our view that the issues presented in this paper undermine GRADE's justificatory scheme, thereby limiting the usefulness of GRADE as a tool for developing clinical recommendations. (shrink)

We introduce the Vital Sign Ontology (VSO), an extension of the Ontology for General Medical Science (OGMS) that covers the consensus human vital signs: blood pressure, body temperature, respiratory rate, and pulse rate. VSO provides a controlled structured vocabulary for describing vital sign measurement data, the processes of measuring vital signs, and the anatomical entities participating in such measurements. VSO is implemented in OWL-DL and follows OBO Foundry guidelines and best practices. If properly developed and extended, we believe the (...) VSO will find applications for the EMR, clinical informatics, and medical device communities. (shrink)

This paper aims to analyze the ethical challenges in experimental drug use during the early stage of the COVID-19 pandemic, using Germany as a case study. In Germany uniform ethical guidelines were available early on nationwide, which was considered as desirable by other states to reduce uncertainties and convey a message of unity. The purpose of this ethical analysis is to assist the preparation of future guidelines on the use of medicines during public health emergencies. The use of (...) hydroxychloroquine, remdesivir and COVID-19 convalescent plasma in clinical settings was analyzed from the perspective of the ethical principles of beneficence, non-maleficence, justice and autonomy. We observed that drug safety and drug distribution during the pandemic affects all four ethical principles. We therefore recommend to establish ethical guidelines (i) to discuss experimental treatment options with patients from all population groups who are in urgent need, (ii) to facilitate the recording of patient reactions to drugs in off-label use, (iii) to expand inclusion criteria for clinical studies to avoid missing potentially negative effects on excluded groups, and (iv) to maintain sufficient access to repurposed drugs for patients with prior conditions. (shrink)

Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The (...) standard view of the conditions for valid consent therefore implies that these people have failed to give valid consent to research participation. In this paper we argue that the standard view is false. The primary function of the requirement that researchers disclose information about a study is the avoidance of illegitimate control over someone’s consent decision, which is a form of fraud.We derive the content and manner of appropriate disclosure by analysing the ways in which the manipulation of information can invalidate consent. Our analysis shows that the informational requirements for valid consent are conceptually distinct and thus unlikely to have identical contents. This implies that consent can be valid when not everything that ought to be disclosed by the person asking for consent is understood by the person who proffers it. (shrink)

Chest pain is the pain felt in the chest by infants, children and adolescents. In most cases the pain is not associated with the heart. It is mainly recognized by the observance or report of pain by the infant, child or adolescent by reports of distress by parents or care givers. Chest pain is not unusual in children. Lots of children are seen in ambulatory clinics, emergency rooms and hospitals and cardiology clinics. Usually there is a benign cause for the (...) pain for utmost children. Certain patients have conditions that are serious and perhaps life-threatening. Chest pain in pediatric patients needs careful physical examination and a detailed history that would point to the possibility of a serious cause. Researches of pediatric chest pain are scarce. It has been difficult to create evidence-based guidelines for evaluation. In this paper we propose an expert system to help doctors and parents, and care giver in diagnosing chest pain in infants and children. This expert System is design and implemented in SL5 Object language. (shrink)

Chronic fatigue syndrome or myalgic encephalomyelitis remains a controversial illness category. This paper surveys the state of knowledge and attitudes about this illness and proposes that epistemic concerns about the testimonial credibility of patients can be articulated using Miranda Fricker’s concept of epistemic injustice. While there is consensus within mainstream medical guidelines that there is no known cause of CFS/ME, there is continued debate about how best to conceive of CFS/ME, including disagreement about how to interpret clinical studies (...) of treatments. Against this background, robust qualitative and quantitative research from a range of countries has found that many doctors display uncertainty about whether CFS/ME is real, which may result in delays in diagnosis and treatment for patients. Strikingly, qualitative research evinces that patients with CFS/ME often experience suspicion by health professionals, and many patients vocally oppose the effectiveness, and the conceptualization, of their illness as psychologically treatable. We address the intersection of these issues and healthcare ethics, and claim that this state of affairs can be explained as a case of epistemic injustice. We find evidence that healthcare consultations are fora where patients with CFS/ME may be particularly vulnerable to epistemic injustice. We argue that the marginalization of many patients is a professional failure that may lead to further ethical and practical consequences both for progressive research into CFS/ME, and for ethical care and delivery of current treatments among individuals suffering from this debilitating illness. (shrink)

It is widely agreed that the view of informed consent found in the regulations and guidelines struggles to keep pace with the ever-advancing enterprise of human subjects research. Over the last 10 years, there have been serious attempts to rethink informed consent so that it conforms to our considered judgments about cases where we are confident valid consent has been given. These arguments are influenced by an argument from Gopal Sreenivasan, which apparently shows that a potential participant's consent to (...) research participation can be perfectly valid even if she fails to understand the risk-benefit profile of the study. I argue that Sreenivasan's argument fails. The set of clinical trials that is supposed to be ethical in the face of this kind of ignorance is empty. However, I argue that his argument is nonetheless instructive in allowing us to identify three important but neglected areas for future conceptual research on informed consent. I close by arguing that research on these identified questions promises to yield a defensible view of consent, lessen the burden of ambiguity on researchers attempting to obtain consent to research participation, and facilitate socially valuable research. (shrink)

The increasing use of opioid treatment agreements has prompted debate within the medical community about ethical challenges with respect to their implementation. The focus of debate is usually on the efficacy of OTAs at reducing opioid misuse, how OTAs may undermine trust between physicians and patients and the potential coercive nature of requiring patients to sign such agreements as a condition for receiving pain care. An important consideration missing from these conversations is the potential for racial bias in the current (...) way that OTAs are incorporated into clinical practice and in the amount of physician discretion that current opioid guidelines support. While the use of OTAs has become mandatory in some states for certain classes of patients, physicians are still afforded great leeway in how these OTAs are implemented in clinical practice and how their terms should be enforced. This paper uses the guidelines provided for OTA implementation by the states of Indiana and Pennsylvania as case studies in order to argue that giving physicians certain kinds of discretion may exacerbate racial health disparities. This problem cannot simply be addressed by minimising physician discretion in general, but rather by providing mechanisms to hold physicians accountable for how they treat patients on long-term opioid therapy to ensure that such treatment is equitable. There are no data in this work. (shrink)

Sortition, i.e. random appointment for public duty, has been employed by societies throughout the years as a firewall designated to prevent illegitimate interference between parties in a legal case and agents of the legal system. In judicial systems of modern western countries, random procedures are mainly employed to select the jury, the court and/or the judge in charge of judging a legal case. Therefore, these random procedures play an important role in the course of a case, and should comply with (...) some principles, such as transparency and complete auditability. Nevertheless, these principles are neglected by random procedures in some judicial systems, which are performed in secrecy and are not auditable by the involved parties. The assignment of cases in the Brazilian Supreme Court is an example of such a procedure, for it is performed using procedures unknown to the parties involved in the judicial cases. This article presents a review of how sortition has been historically employed by societies and discusses how Mathematical Statistics may be applied to random procedures of the judicial system, as it has been applied for almost a century on clinical trials, for example. A statistical model for assessing randomness in case assignment is proposed and applied to the Brazilian Supreme Court. As final remarks, guidelines for the development of good randomization procedures are outlined. (shrink)

The coronavirus disease 2019 (COVID-19) pandemic has motivated medical ethicists and several task forces to revisit or issue new guidelines on allocating scarce medical resources. Such guidelines are relevant for the allocation of scarce therapeutics and vaccines and for allocation of ICU beds, ventilators, and other life-sustaining treatments or potentially scarce interventions. Principles underlying these guidelines, like saving the most lives, mitigating disparities, reciprocity to those who assume additional risk (eg, essential workers and clinical trial participants), (...) and equal access may compete with one another. We propose the use of a “categorized priority system” (also known as a “reserve system”) as an improvement over existing allocation methods, particularly because it may be able to achieve disparity mitigation better than other methods. (shrink)

Research on the use of propranolol as a pharmacological memory dampening treatment for post-traumatic stress disorder is continuing and justifies a second look at the legal and ethical issues raised in the past. We summarize the general ethical and legal issues raised in the literature so far, and we select two for in-depth reconsideration. We address the concern that a traumatized witness may be less effective in a prosecution emerging from the traumatic event after memory dampening treatment. We analyze this (...) issue in relation to sexual assault, where the suggestion that corroborating evidence may remedy any memory defects is less likely to be helpful. We also consider the clinical ethical question about a physician's obligation to discuss potential legal consequences of memory dampening treatment. We conclude that this latter question reflects a general problem related to novel medical treatments where the broader socio-legal consequences may be poorly understood, and suggest that issues of this sort could usefully be addressed through the promulgation of practice guidelines. (shrink)

An increasing number of European research projects return, or plan to return, individual genomic research results (IRR) to participants. While data access is a data subject’s right under the General Data Protection Regulation (GDPR), and many legal and ethical guidelines allow or require participants to receive personal data generated in research, the practice of returning results is not straightforward and raises several practical and ethical issues. Existing guidelines focusing on return of IRR are mostly project-specific, only discuss which (...) results to return, or were developed outside Europe. To address this gap, we analysed existing normative documents identified online using inductive content analysis. We used this analysis to develop a checklist of steps to assist European researchers considering whether to return IRR to participants. We then sought feedback on the checklist from an interdisciplinary panel of European experts (clinicians, clinical researchers, population-based researchers, biobank managers, ethicists, lawyers and policy makers) to refine the checklist. The checklist outlines seven major components researchers should consider when determining whether, and how, to return results to adult research participants: 1) Decide which results to return; 2) Develop a plan for return of results; 3) Obtain participant informed consent; 4) Collect and analyse data; 5) Confirm results; 6) Disclose research results; 7) Follow-up and monitor. Our checklist provides a clear outline of the steps European researchers can follow to develop ethical and sustainable result return pathways within their own research projects. Further legal analysis is required to ensure this checklist complies with relevant domestic laws. (shrink)

Resumen Ésta es la primera traducción al español de las guías “Atención después de la investigación: un marco para los comités de ética de investigación del National Health Service (NHS) (borrador versión 8.0)”. El documento afirma que existe una fuerte obligación moral de garantizar que los participantes enfermos de un estudio clínico hagan una transición después del estudio hacia una atención de la salud apropiada. Con “atención de la salud apropiada” se hace referencia al acceso para los participantes a la (...) atención de la salud, proporcionada principalmente por el National Health Service (en adelante NHS), el sistema de salud del Reino Unido, y/o a la intervención en estudio, también llamada producto o tratamiento en investigación. Las guías “Atención después de la investigación” están dirigidas principalmente a los miembros de los 79 comités de ética de investigación del NHS y a quienes presentan sus estudios de investigación ante estos comités. Se trata de un documento borrador muy avanzado, trabajado en numerosas reuniones, durante más de 3 años, que ha sido discutido por participantes de estudios y miembros de la comunidad, miembros y presidentes de comités de ética de investigación del Reino Unido, especialistas internacionales en ética de la investigación, representantes de la industria y otras partes interesadas. La redacción de las guías es producto de la colaboración de Neema Sofaer y Penney Lewis, ambas investigadoras del King’s College London, en el Centre of Medical Law and Ethics del Dickson Poon School of Law, y Hugh Davies, Asesor en Ética de la Investigación de la Health Research Authority (HRA) del NHS. El traductor del presente documento, Ignacio Mastroleo, participó del workshop en la Fundación Brocher (Ginebra, Suiza, diciembre de 2011) donde se revisó el borrador versión 7.0 y contribuyó en la revisión del borrador de la versión 8.0 durante el 2012. -/- Abstract This is the first Spanish translation of the guidelines “Care after research: a framework for NHS RECs (8th draft)”. The document states that there is a strong moral obligation to ensure that participants in a clinical study who are ill transition after the study to appropriate healthcare. The terms "appropriate healthcare" refer to participants’ access to health care, mainly provided by the National Health Service (NHS), the health system in the UK, and/or to the intervention study also named investigational treatment or product. The guides "Care after research" are mainly directed to members of the 79 NHS committees of research ethics (RECs) and to those who submit their research to these committees. This is a very advanced draft document, worked in several meetings, for more than three years, that has been discussed with study participants and community members, members and chairs of RECs in the UK, international specialists in research ethics, industry representatives and other stakeholders. The drafting of the guidelines is the result of the collaboration of Neema Sofaer and Penney Lewis, both researchers at King's College London, at the Centre of Medical Law and Ethics of Dickson Poon School of Law, and Hugh Davies, Research Ethics Advisor of the Health Research Authority (HRA) of the NHS. The translator of this document, Ignacio Mastroleo, attended the workshop at the Brocher Foundation (Geneva, Switzerland, December 2011) where draft version 7.0 was revised and contributed in the revision of draft version 8.0 during 2012. (shrink)

Este trabajo es un comentario sobre la primera traducción al español de las guías del Reino Unido “Atención después de la investigación: un marco para los comités de ética de investigación del NHS (borrador versión 8.0)”. El comentario se divide en tres partes. En la primera parte, se busca resumir la información básica necesaria para mejorar la lectura comprensiva de la traducción de las guías. En la segunda parte, se analiza una selección de la normativa argentina que trata sobre atención (...) después de la investigación. En la tercera parte, se presentan las principales limitaciones del borrador de las guías y su traducción. El propósito de este comentario es que los futuros lectores y lectoras puedan hacer un uso crítico y deliberado de las guías, en la evaluación de estudios clínicos o como base para la redacción de guías propias sobre atención después de la investigación. ***This work is a commentary on the first Spanish translation of the UK guidelines “Care after research: a framework for NHS research ethics committees (draft version 8.0)”. The commentary is divided into three parts. The first part seeks to summarize the basic information needed to improve reading comprehension of the translation of the guidelines. The second part analyzes a selection of Argentinean regulations dealing with care after research. The third part presents the main limitations of the guidelines draft and its translation. The purpose of this commentary is that future readers can make a critical and deliberate use of guidelines in the assessment of clinical studies or as a basis for drafting their own guidelines on care after research. (shrink)

In Canada, there are currently no guidelines at either the federal or provincial level regarding the provision of kidney transplantation services to foreign nationals (FN). Renal transplant centres have, in the past, agreed to put refugee claimants and other FNs on the renal transplant waiting list, in part, because these patients (refugee claimants) had health insurance through the Interim Federal Health Programme to cover the costs of medication and hospital care. However, severe cuts recently made to this programme have (...) forced clinicians to question whether they should continue with transplants for FNs, for financial and ethical reasons. This paper first examines different national policies (eg, in Canada, USA, France and the UK) to map the diversity of approaches regarding transplantation for FNs, and then works through different considerations commonly used to support or oppose the provision of organs to these patients: (1) the organ shortage; (2) the free-rider problem; (3) the risk of becoming a transplant destination; (4) the impact on organ donation rates; (5) physicians’ duties; (6) economic concerns; (7) vulnerability. Using a Canadian case as a focus, and generalising through a review of various national policies, we analyse the arguments for and against transplantation for FNs with a view to bringing clarity to what is a sensitive political and clinical management issue. Our aim is to help transplant centres, clinicians and ethicists reflect on the merits of possible options, and the rationales behind them. (shrink)

Innovative practice involves medical interventions that deviate from standard practice in significant ways. For many patients, innovative practice offers the best chance of successful treatment. Because little is known about most innovative treatments, clinicians who engage in innovative practice might consider including extra procedures, such as scans or blood draws, to gather information about the innovation. Such information-gathering interventions can yield valuable information for modifying the innovation to benefit future patients and for designing scientific studies of the innovation. However, existing (...) guidelines do not say when or whether it is appropriate to add potentially risky information-gathering interventions for these purposes. As a result, clinicians may assume that information-gathering interventions are ethically inappropriate and should not be used in innovative practice. This assumption can lead to seriously negative consequences, such as increasing the likelihood that harmful or ineffective innovations will be adopted and creating new barriers to the development of genuinely beneficial treatments. We argue that health care institutions need to promote the responsible use of information-gathering interventions as an adjunct to innovative practice, and that these interventions are not clinical research and should not be subject to research oversight. (shrink)

This topic focuses on the problems that arise in providing medical care to the population during armed conflict or martial law. Under such conditions, hospitals, clinics, and other healthcare facilities have to work in challenging circumstances with limited resources and reduced security for medical personnel. This topic explores such issues as how martial law affects the work of medical institutions, what problems arise in providing medical care to the population in war, how war affects the health of the people, and (...) what consequences it may have in the long term. Research in this area will help to understand how to organize better and prepare medical facilities to work in war conditions and ensure high-quality medical care to the population in emergencies. The methods used to write this article were analysis, synthesis, generalization, explanation, and data qualification. The primary and fundamental sources for writing an article may vary depending on the topic, but generally, the following sources can be recommended. Academic studies: these can be scholarly articles, monographs, dissertations, conference papers, and other materials related to the topic of your article. These sources can help you find information about the latest research in the field and allow you to see the approaches and methodologies used in the studies. Official sources: These can be legal documents, reports, regulations, guidelines, and other materials issued by government agencies, ministries, and other departments. These sources can help you understand the rules and regulations governing your article's topic. Expert reviews: these can be interviews with experts in the field, articles, and other materials written by well-known specialists. These sources can help you understand the views and opinions of well-known experts on the issues related to your paper. (shrink)

Our main objective is to locate and analyze some philosophical issues about the concept of mental illness and the manner it is used, especially in contemporary psychiatry. It is even difficult to find a standard meaning in the main psychiatric textbooks; and, when there is some exposition of the concept, it is sparse, uncritical and vague. As an immediate consequence of these issues, practical guidelines and protocols for the clinic arise, which become almost “automatic”, unreflective behaviors, practices translated as (...) health interventions and public mental health policies. An example is the problem of overdiagnosis, in which the use of medical technology (categories, drugs, clinical exams, etc.) has generated more harm and risks to the subject's health than benefits. Exposing these issues from a philosophical perspective can eventually contribute to the field of mental health. For this work, the main manuals and textbooks of psychiatry were selected to analyze how they deal with the concept of mental illness or disorder, in addition to locating the present discussion in authors from both philosophy and the psychiatric field and how they contribute to its clarification. (shrink)

Chest pain is the pain felt in the chest by infants, children and adolescents. In most cases the pain is not associated with the heart. It is mainly recognized by the observance or report of pain by the infant, child or adolescent by reports of distress by parents or care givers. Chest pain is not unusual in children. Lots of children are seen in ambulatory clinics, emergency rooms and hospitals and cardiology clinics. Usually there is a benign cause for the (...) pain for utmost children. Certain patients have conditions that are serious and perhaps life-threatening. Chest pain in pediatric patients needs careful physical examination and a detailed history that would point to the possibility of a serious cause. Researches of pediatric chest pain are scarce. It has been difficult to create evidence-based guidelines for evaluation. In this paper we propose an expert system to help doctors and parents, and care giver in diagnosing chest pain in infants and children. This expert System is design and implemented in SL5 Object language. (shrink)

If we already had a periodic table of mental illness in hand, there would be less need for a book of this type. Although some psychiatrists do think of themselves as chemists, the analogy is without warrant. Not only does psychiatry lack an analogue of the periodic table, its principal tool -- the Diagnostic and Statistical Manual of Mental Disorders (DSM) -- is a contentious document. Even subsequent to the publication of DSM-III in 1980, which was intended to serve as (...) an operational guideline for clinical practice, it and its heirs (DSM-V was published in 2013) have often fueled rather than quelled controversy. Although beginning with that third major revision of DSM a concerted effort has been made to ensure greater consistency in diagnoses, psychiatry remains beset by concerns that it is insufficiently scientific, unduly influenced by the pharmaceutical industry, indecisive as to whether it should focus on the mind or the brain, incapable of distinguishing among types of diseases, inclined to expand illness criteria without adequate justification, overly reliant on subjective judgments, wont to conflate clinical and ethical judgments, and engaged in indiscriminate use of psychoactive drugs. These worries concerning its scientific and ethical status are among the reasons that psychiatry attracts the attention of philosophers. (shrink)

CLE aims and clients’ needs conflict where students’ interests are put beyond clients’ needs. Students have interests in gaining employment, impressing instructors and supervisors, and experiencing the active application of law. Where the clients’ service-needs are subordinated to students’ interests, the relationship between the two—the ‘tension’—is tilted in a manner in which the clients are disserved through the fulfilment of students’ interests. This may be exacerbated by faulty institutional cultures where clinical faculty are treated differently, or as less accomplished (...) or ‘worthwhile’ than their ‘traditional’ counterparts. This also emphasizes that it is the clinical law faculty who may exacerbate or assuage the tension, as it is for clinical faculty to assure that clients’ needs are met on ethical grounds,20 and to equate the practice of law with excellence before students. (shrink)

Technologies to rapidly alert people when they have been in contact with someone carrying the coronavirus SARS-CoV-2 are part of a strategy to bring the pandemic under control. Currently, at least 47 contact-tracing apps are available globally. They are already in use in Australia, South Korea and Singapore, for instance. And many other governments are testing or considering them. Here we set out 16 questions to assess whether — and to what extent — a contact-tracing app is ethically justifiable.

Many extant theories of placebo focus on their causal structure wherein placebo effects are those which originate from select features of the therapy (e.g. client expectations or ‘incidental’ features like size, and shape). Although such accounts can distinguish placebos from standard medical treatments, they cannot distinguish placebos from everyday occurrences e.g. when positive feedback improves our performance on a task. Providing a social epistemological account of a treatment context can rule out such occurrences, and furthermore reveal a new way to (...) distinguish clinical placebos from standard medical treatments. (shrink)

Ontologies are being used increasingly to promote the reusability of scientific information by allowing heterogeneous data to be integrated under a common, normalized representation. Definitions play a central role in the use of ontologies both by humans and by computers. Textual definitions allow ontologists and data curators to understand the intended meaning of ontology terms and to use these terms in a consistent fashion across contexts. Logical definitions allow machines to check the integrity of ontologies and reason over data annotated (...) with ontology terms to make inferences that promote knowledge discovery. Therefore, it is important not only to include in ontologies multiple types of definitions in both formal and in natural languages, but also to ensure that these definitions meet good quality standards so they are useful. While tools such as Protégé can assist in creating well-formed logical definitions, producing good definitions in a natural language is still to a large extent a matter of human ingenuity supported at best by just a small number of general principles. For lack of more precise guidelines, definition authors are often left to their own personal devices. This paper aims to fill this gap by providing the ontology community with a set of principles and conventions to assist in definition writing, editing, and validation, by drawing on existing definition writing principles and guidelines in lexicography, terminology, and logic. (shrink)

Human embryo models formed from stem cells—known as embryoids—allow scientists to study the elusive first stages of human development without having to experiment on actual human embryos. But clear ethical guidelines for research involving embryoids are still lacking. Previously, a handful of researchers put forward new recommendations for embryoids, which they hope will be included in the next set of International Society for Stem Cell Research guidelines. Although these recommendations are an improvement over the default approach, they are (...) nonetheless unworkable, because they rely on a poorly conceived notion of an embryoid’s ‘potential’ to trigger stringent research regulations. (shrink)

The COVID-19 pandemic has been overwhelming public health-care systems around the world. With demand exceeding the availability of medical resources in several regions, hospitals have been forced to invoke triage. To ensure that this difficult task proceeds in a fair and organised manner, governments scrambled experts to draft triage guidelines under enormous time pressure. Although there are similarities between the documents, they vary considerably in how much weight their respective authors place on the different criteria that they propose. Since (...) most of the recommendations do not come with ethical justifications, analysing them requires that one traces back these criteria to their underlying theories of distributive justice. In the literature, COVID-19 triage has been portrayed as a value conflict solely between utilitarian and egalitarian elements. While these two accounts are indeed the main antipodes, I shall show that in fact all four classic theories of distributive justice are involved: utilitarianism, egalitarianism, libertarianism, and communitarianism. Detecting these in the documents and classifying the suggested criteria accordingly enables one to understand the balancing between the different approaches to distributive justice—which is crucial for both managing the current pandemic and in preparation for the next global health crisis. (shrink)

Psychiatry has witnessed a new wave of approaches to clinical phenotyping and the study of psychopathology, including the National Institute of Mental Health’s Research Domain Criteria, clinical staging, network approaches, the Hierarchical Taxonomy of Psychopathology, and the general psychopathology factor, as well as a revival of interest in phenomenological psychopathology. The question naturally emerges as to what the relationship between these new approaches is – are they mutually exclusive, competing approaches, or can they be integrated in some way (...) and used to enrich each other? In this opinion piece, we propose a possible integration between clinical staging and phenomenological psychopathology. Domains identified in phenomenological psychopathology, such as selfhood, embodiment, affectivity, etc., can be overlaid on clinical stages in order to enrich and deepen the phenotypes captured in clinical staging (‘high resolution’ clinical phenotypes). This approach may be useful both ideographically and nomothetically, in that it could complement diagnosis, enrich clinical formulation, and inform treatment of individual patients, as well as help guide aetiological, prediction, and treatment research. The overlaying of phenomenological domains on clinical stages may require that these domains are reformulated in dimensional rather than categorial terms. This integrative project requires assessment tools, some of which are already available, that are sensitive and thorough enough to pick up on the range of relevant psychopathology. The proposed approach offers opportunities for mutual enrichment: clinical staging may be enriched by introducing greater depth to phenotypes; phenomenological psychopathology may be enriched by introducing stages of severity and disorder progression to phenomenological analysis. (shrink)

This article addresses two areas of continuing controversy about consent in clinical research: the question of when consent to low risk research is necessary, and the question of when consent to research is valid. The article identifies a number of considerations relevant to determining whether consent is necessary, chief of which is whether the study would involve subjects in ways that would (otherwise) infringe their rights. When consent is necessary, there is a further question of under what conditions consent (...) is valid or successful in waiving a right. The most influential account of validity conditions is non-moralized, in the sense that the conditions make no essential reference to whether the researcher soliciting consent has obtained it in a way that wrongs the subject. The article examines the implications of this account, and compares it with recent accounts that moralize some of the validity conditions. -/- . (shrink)

The principle of clinical equipoise has been variously characterized by ethicists and clinicians as fundamentally flawed, a myth, and even a moral balm. Yet, the principle continues to be treated as the de facto gold standard for conducting randomized control trials in an ethical manner. Why do we hold on to clinical equipoise, despite its shortcomings being widely known and well-advertised? This paper reviews the most important arguments criticizing clinical equipoise as well as what the most prominent (...) proposed alternatives are. In the process, it evaluates the justification for continuing to use clinical equipoise as the gold standard for randomized control trials. (shrink)

Clinical Ethics Consultations are an important tool for physicians in solving difficult cases. They are extremely common in North America and to a lesser extent also present in Europe. However, there is little data on this practice in Poland. We present results of a survey of 521 physicians practising in Poland concerning their opinion on CECs and related practices. We analysed the data looking at such issues as CECs’ perceived availability, use of CECs, and perceived usefulness of such support. (...) Physicians in our study generally encounter hard ethics cases, even—surprisingly—those who do not work in hospitals. Most physicians have no CEC access, and those that do still do not employ CECs. However, physicians perceive this form of support as useful—even more so among actual users of CECs. We compared these findings with similar studies from other European countries and the North America. We point out peculiarities of our results as compared to those in other countries, with some possible explanations. We hope the results may encourage regulatory debate on the need to formally introduce CECs into the Polish healthcare system. (shrink)

We argue that charging people to participate in research is likely to undermine the fundamental ethical bases of clinical research, especially the principles of social value, scientific validity, and fair subject selection.

Machine learning algorithms may radically improve our ability to diagnose and treat disease. For moral, legal, and scientific reasons, it is essential that doctors and patients be able to understand and explain the predictions of these models. Scalable, customisable, and ethical solutions can be achieved by working together with relevant stakeholders, including patients, data scientists, and policy makers.

The desideratum of semantic interoperability has been intensively discussed in medical informatics circles in recent years. Originally, experts assumed that this issue could be sufficiently addressed by insisting simply on the application of shared clinical terminologies or clinical information models. However, the use of the term ‘ontology’ has been steadily increasing more recently. We discuss criteria for distinguishing clinical ontologies from clinical terminologies and information models. Then, we briefly present the role clinical ontologies play in (...) two multicentric research projects. Finally, we discuss the interactions between these different kinds of knowledge representation artifacts and the stakeholders involved in developing interoperational real-world clinical applications. We provide ontology engineering examples from two EU-funded projects. (shrink)

Abstract: In this article, we explore what are ethical forms of holding service users responsible in mental health care contexts. Hanna Pickard has provided an account of how service users should be held responsible for morally wrong or seriously harmful conduct within contexts of mental health care, called the clinical stance. From a clinical stance one holds a person responsible for harm, but refrains from emotionally blaming the person and only considers the person responsible for this conduct in (...) a detached sense. Her account is based on what are considered best practices in the treatment of people with borderline personality disorder and addiction. We ask if this account generalizes across different diagnostic criteria and different clinical contexts. To begin to answer this question, we compare the clinical stance to an account of what are considered best practices in the treatment of service users at a specialized clinic for people with autism spectrum disorder in the Netherlands. We refer to this alternative account as the nurturing stance and highlight relevant similarities and differences between the clinical stance and the nurturing stance. We conclude with suggestions for further research and theorizing. (shrink)