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IntroductionEquipoise, generally defined as uncertainty about the relative effects of the treatments being compared in a trial, is frequently referenced as an ethical standard for the conduct of randomized clinical trials. However, it seems to be defined in several different ways and may be used differently by different individuals. We explored how clinical researchers, chairs of research ethics boards, and philosophers of science define and reason with this term.MethodsWe completed semi-structured interviews about clinical trial ethics with 15 clinical researchers, 15 research ethics board chairs, and 15 philosophers of science/bioethicists. Each participant was asked a standardized set of 10 questions, 4 of which were specifically about equipoise. All interviews were conducted telephonically and transcribed. Responses were grouped and analysed via a modified grounded theory method.ResultsForty-three respondents defined equipoise in 7 logically distinct ways, and 2 respondents could not explicitly define it. The most common definition, offered by 14 respondents (31%), defined "equipoise" as a disagreement at the level of a community of physicians. There was significant variability in definitions offered between and within groups. When asked how they would "operationalize" equipoise - i.e. check or test for its presence - respondents provided 7 alternatives, the most common being in relation to a literature review (15/45, 33%). The vast majority of respondents (35/45, 78%) felt the concept was helpful, though many acknowledged that the lack of a clear definition or operationalization was problematic.ConclusionThere is significant variation in definitions of equipoise offered by respondents, suggesting that parties within groups and between groups may be referring to different concepts when they reference "equipoise". This non-uniformity may impact fairness and transparency and opens the door to potential ethical problems in the evaluation of clinical trials - for instance, a patient may understand equipoise very differently than the researchers enrolling her in a trial, which could cause her agreement to participate to be based upon false premises.

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.

Family involvement is widely considered an important part of patient care in the intensive care unit. From professional health care organizations, government, and hospital associations, there has been a cultural shift toward family presence as part of a wider commitment to patient-centered care. At the same time, the meaning and impact of family involvement in the intensive care unit setting remain opaque and under-studied. This study employed an ethnographic approach to better understand family involvement in practice and from the perspective of health care professionals and family members by studying an implementation trial of a family involvement tool in two intensive care units over 2 years. The findings revealed that an expanded and self-defined role for family members as carers in the intensive care unit challenged the current configuration of the nurse patient/family relationship and that family members were aware of these dynamics. While the intensive care unit implementation teams were both motivated to implement a novel way of facilitating family involvement, the processual, organizational, and contextual factors in the intensive care units largely determined the possibilities of its application. This suggests that interventions should address the specific context in which they are employed. [ABSTRACT FROM AUTHOR]

In 2007 the Cancer Care Ontario Hepatobiliary-Pancreatic (HPB) Community of Practice was formed during the wake of provincial regionalization of HPB services in Ontario, Canada. Despite being conceptualized within the literature as an educational intervention, communities of practice (CoP) are increasingly being adopted in healthcare as quality improvement initiatives. A qualitative case study approach using in-depth interviews and document analysis was employed to gain insight into the perceptions and attitudes of the HPB surgeons in the CoP. This study demonstrates how an engineered formal or idealized structure of a CoP was created in tension with the natural CoPs that HPB surgeons identified with during and after their training. This tension contributed to the inactive and/or marginal participation by some of the surgeons in the CoP. The findings of this study represent a cautionary tale for such future engineering attempts in two distinct ways: (1) a CoP in surgery cannot simply be created by regulatory agencies, rather they need to be supported in a way to evolve naturally, and (2) when the concept of CoPs is co-opted by governing bodies, it does not necessarily capture the power and potential of situated learning. To ensure CoP sustainability and effectiveness, we suggest that both core and peripheral members need to be more directly involved at the inception of the COP in terms of design, organization, implementation and ongoing management.