Protocol for a systematic scoping review of reasons given to justify the performance of randomised controlled trials.

IntroductionRandomised controlled trials (RCTs) are widely viewed to generate the most reliable medical knowledge. However, RCTs are not always scientifically necessary and therefore not always ethical. Unfortunately, it is not clear when an RCT is not necessary or how this should be established. This study seeks to systematically catalogue justifications offered throughout the medical and ethics literature for performing randomisation within clinical trials.Methods and analysisWe will systematically search electronic databases of the medical literature including MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Clinical Trials Register, Web of Science Proceedings, ClinicalTrials.gov; databases of philosophical literature including Philosopher's Index, Phil Papers, JSTOR, Periodicals Archive Online, Project MUSE, National Reference Centre for Bioethics; the library catalogue at the University of Ottawa; bibliographies of retrieved papers; and the grey literature. We will also pursue suggestions from experts in the fields of medical ethics, philosophy and clinical trial methodology. Article screening, selection and data extraction will be performed by two independent reviewers based on prespecified inclusion/exclusion criteria. A third reviewer will be consulted to resolve any discrepancies. We will then extract the reasons given to justify randomisation using methodology established to extract data in a defensible, systematic manner. We will track the reasons given, their frequency of use and changes over time. Finally, using grounded theory, we will combine the reasons into broader themes. These themes will form the foundation of our subsequent analysis from qualitative and quantitative perspectives. This review will map existing arguments that clinicians, ethicists and philosophers use to ethically justify randomisation in clinical trials.Ethics and disseminationNo research ethics board approval is necessary because we are not examining patient-level data. This protocol complies with the reported guidance for conducting systematic scoping reviews. The findings of this paper will be disseminated via presentations and academic publication. In a subsequent phase of this research, we hope to engage with stakeholders and translate any recommendations derived from our findings into operational guidelines

A case study in the history of neurology

We review the case of a young man who developed a constellation of symptoms and signs—bizarre behavior, seizures, abnormal movements, and autonomic instability—that evaded diagnosis at the time of presentation. We use this case to explore the way medical knowledge changes over time. Despite the dramatic advances in our understanding of neurological diseases in recent decades, physicians tend to approach diseases and diagnoses as if they were immutable. Our case reinforces how the diagnosis and treatment of disease are determined by an ever-changing historical context driven by the rapid expansion of medical knowledge. We discuss the implications of this realization and present strategies for navigating the boundaries of knowledge, both in practice and in principle

Advance consent in acute stroke trials: survey of Canadian Research Ethics Board chairs

dvance consent could allow individuals at high risk of stroke to provide consent before they might become eligible for enrollment in acute stroke trials. This survey explores the acceptability of this novel technique to Canadian Research Ethics Board (REB) chairs that review acute stroke trials. Responses from 15 REB chairs showed that majority of respondents expressed comfort approving studies that adopt advance consent. There was no clear preference for advance consent over deferral of consent, although respondents expressed significant concern with broad rather than trial-specific advance consent. These findings shed light on the acceptability of advance consent to Canadian ethics regulators

Acute Stroke Decision-Making in Historical and Philosophical Context, 1960-2014

This thesis applies approaches from the history and philosophy of science to explore the decision-making of contemporary physicians in a common clinical scenario: the treatment of patients with acute stroke. Acute stroke decision-making during the period 1960 to 2014 therefore serves as a case study to address broader questions about how doctors make decisions. I argue that acute stroke decision-making is dependent upon a historically-determined concept of the acute stroke, in that the contemporary meaning of the disease “acute stroke” was established in response to the efficacy of the drug tissue plasminogen activator (tPA) as its treatment. Moreover, I propose that treatment decisions about the use of tPA for acute stroke involve simultaneous and inter-related processes of epistemic and ethical evaluation. Acute stroke decision-making can therefore be conceived as a medical, epistemic and ethical process, occurring within a historical context. This interpretation of acute stroke decision-making argues for the necessary role of the humanities — and especially of the history and philosophy of science — in the study of modern medical practice

A call for change: the health humanities charter in medical education, an international experience

International audienceBackgroundHealth humanities are an interdisciplinary field that include the humanities, social sciences and arts, as well as the multiple ways they engage with health experiences, public health and health care practices. We believe that the principles of health humanities should be better incorporated in themedical student’s curricula to achieve a more relevant and contemporary medical education, which is an education that prepares for tomorrow’s ethical, ecological, and social accountability challenges. Summary Of WorkIn this optic, the Faculties of Medicine of Lyon-Est (France) and Ottawa (Canada) aligned their vision of this emerging area to create a unique charter, co-written with the help of patients, students, medical educators and philosophers, and adopted formally by each institution in 2021.Summary Of ResultsAccording to the charter, each Faculty should commit to not only promoting the teaching of health humanities throughout the curriculum but, in addition, to foster teaching initiatives and students' artistic activities. The Faculties also commits to promote a democratic and accountable approach,involving students and free of all discrimination. Aligned with their physician’s oath, the health humanities charter further empowers students byrequesting to abide to certain principles. They commit to respect the dignity of the human being, and to be available to and at the service of patients. The charter encourages students to maintain their independence and free will, while getting more involved in social responsibility. Discussion And ConclusionThe challenge will be to ensure that the students, medical educators and staff of the Faculties incorporate the charter within existing programs. We hope this integration will help other institutions to follow this path and foster new initiatives

A call for change: the health humanities charter in medical education, an international experience

International audienceBackgroundHealth humanities are an interdisciplinary field that include the humanities, social sciences and arts, as well as the multiple ways they engage with health experiences, public health and health care practices. We believe that the principles of health humanities should be better incorporated in themedical student’s curricula to achieve a more relevant and contemporary medical education, which is an education that prepares for tomorrow’s ethical, ecological, and social accountability challenges. Summary Of WorkIn this optic, the Faculties of Medicine of Lyon-Est (France) and Ottawa (Canada) aligned their vision of this emerging area to create a unique charter, co-written with the help of patients, students, medical educators and philosophers, and adopted formally by each institution in 2021.Summary Of ResultsAccording to the charter, each Faculty should commit to not only promoting the teaching of health humanities throughout the curriculum but, in addition, to foster teaching initiatives and students' artistic activities. The Faculties also commits to promote a democratic and accountable approach,involving students and free of all discrimination. Aligned with their physician’s oath, the health humanities charter further empowers students byrequesting to abide to certain principles. They commit to respect the dignity of the human being, and to be available to and at the service of patients. The charter encourages students to maintain their independence and free will, while getting more involved in social responsibility. Discussion And ConclusionThe challenge will be to ensure that the students, medical educators and staff of the Faculties incorporate the charter within existing programs. We hope this integration will help other institutions to follow this path and foster new initiatives

A call for change: the health humanities charter in medical education, an international experience

International audienceBackgroundHealth humanities are an interdisciplinary field that include the humanities, social sciences and arts, as well as the multiple ways they engage with health experiences, public health and health care practices. We believe that the principles of health humanities should be better incorporated in themedical student’s curricula to achieve a more relevant and contemporary medical education, which is an education that prepares for tomorrow’s ethical, ecological, and social accountability challenges. Summary Of WorkIn this optic, the Faculties of Medicine of Lyon-Est (France) and Ottawa (Canada) aligned their vision of this emerging area to create a unique charter, co-written with the help of patients, students, medical educators and philosophers, and adopted formally by each institution in 2021.Summary Of ResultsAccording to the charter, each Faculty should commit to not only promoting the teaching of health humanities throughout the curriculum but, in addition, to foster teaching initiatives and students' artistic activities. The Faculties also commits to promote a democratic and accountable approach,involving students and free of all discrimination. Aligned with their physician’s oath, the health humanities charter further empowers students byrequesting to abide to certain principles. They commit to respect the dignity of the human being, and to be available to and at the service of patients. The charter encourages students to maintain their independence and free will, while getting more involved in social responsibility. Discussion And ConclusionThe challenge will be to ensure that the students, medical educators and staff of the Faculties incorporate the charter within existing programs. We hope this integration will help other institutions to follow this path and foster new initiatives

Clinical trials involving hypertension [Correspondence]

No abstract available