Bmc Med Ethics
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Increasing adoption of electronic health records in hospitals provides new opportunities for patient data to support public health advances. Such learning healthcare models have generated ethical debate in high-income countries, including on the role of patient and public consent and engagement. Increasing use of electronic health records in low-middle income countries offers important potential to fast-track healthcare improvements in these settings, where a disproportionate burden of global morbidity occurs. Core ethical issues have been raised around the role and form of information sharing processes for learning healthcare systems, including individual consent and individual and public general notification processes, but little research has focused on this perspective in low-middle income countries. ⋯ As reported in high income countries, learning healthcare systems in low-middle counties may generate a core ethical tension between supporting a public good and respecting patient autonomy and privacy, with the maintenance of public trust acting as a core requirement. While more evidence is needed on patient and public perspectives on learning healthcare activities, greater collaboration between public health and research governance systems is likely to support the development of efficient and locally responsive learning healthcare activities in LMICs.
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Randomized controlled trial (RCT) trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized by Schwartz and Lellouch in 1967, an explanatory approach to trial design emphasizes hypothesis testing about the mechanisms of action of treatments under ideal conditions (efficacy), whereas a pragmatic approach emphasizes testing effectiveness of two or more available treatments in real-world conditions. Interest in, and the number of, pragmatic trials has grown substantially in recent years, with increased recognition by funders and stakeholders worldwide of the need for credible evidence to inform clinical decision-making. This increase has been accompanied by the onset of learning healthcare systems, as well as an increasing focus on patient-oriented research. However, pragmatic trials have ethical challenges that have not yet been identified or adequately characterized. The present study aims to explore the views of key stakeholders with respect to ethical issues raised by the design and conduct of pragmatic trials. It is embedded within a large, four-year project that seeks to develop guidance for the ethical design and conduct of pragmatic trials. As a first step, this study will address important gaps in the current empirical literature with respect to identifying a comprehensive range of ethical issues arising from the design and conduct of pragmatic trials. By opening up a broad range of topics for consideration within our parallel ethical analysis, we will extend the current debate, which has largely emphasized issues of consent, to the range of ethical considerations that may flow from specific design choices. ⋯ We expect that the study outputs will be of interest to a wide range of knowledge users including trialists, ethicists, research ethics committees, journal editors, regulators, healthcare policymakers, research funders and patient groups. All publications will adhere to the Tri-Agency Open Access Policy on Publications.
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Vaccine hesitancy is a growing threat to public health. The reasons are complex but linked inextricably to a lack of trust in vaccines, expertise and traditional sources of authority. Efforts to increase immunization uptake in children in many countries that have seen a fall in vaccination rates are two-fold: addressing hesitancy by improving healthcare professional-parent exchange and information provision in the clinic; and, secondly, public health strategies that can override parental concerns and values with coercive measures such as mandatory and presumptive vaccination. ⋯ Efforts to address vaccine hesitancy need to avoid simple reliance on either parental values or coercive public policies. To do this effectively requires increasing citizen engagement on vaccination to help inform a parent-centered approach and legitimize public policy measures. In addition, cultivating a more ethically consistent strategy means moving beyond the current silos of health ethics - clinical and public health ethics.
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The 1981 Uniform Determination of Death Act (UDDA) established the validity of both cardio-respiratory and neurological criteria of death. However, many religious traditions including most forms of Haredi Judaism (ultra-orthodox) and many varieties of Buddhism strongly disagree with death by neurological criteria (DNC). Only one state in the U.S., New Jersey, allows for both religious exemptions to DNC and provides continuation of health insurance coverage when an exception is invoked in its 1991 Declaration of Death Act (NJDDA). There is yet no quantitative or qualitative data on the frequencies of religious exemptions in New Jersey. This study gathered information about the frequency of religious exemptions and policy in New Jersey that was created out of respect for religious beliefs. ⋯ Religious exemptions to DNC in New Jersey do occur, although very infrequently. Prior to this study, there was no information on their frequency. Considering religious exemptions do occur, there is a need for national or state policies that addresses both religious objections to DNC and hospital resources. More information is needed to better understand the impact of granting religious exemptions before new policy can be established.
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Due to the rapid changes in the medical world and the aging population, the need for advanced care planning grows. Despite efforts to make this topic discussed, only a minority of patients discusses the advance directive with their general practitioner (GP). This study aimed to map thresholds: What barriers are identified by GPs and patients in preparing and discussing an advance directive? ⋯ Preparing and drafting an advance directive is a time-consuming and difficult procedure. Patients and GP's have the right to be informed and instructed on how to prepare an advance directive.