Journal of evaluation in clinical practice
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New therapies are increasingly approved by regulatory agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) based on testing in non-randomized clinical trials. These treatments have typically displayed "dramatic effects" (ie, effects that are considered large enough to obviate the combined effects of biases and random errors that may affect the study results). The agencies, however, have not identified how large these effects should be to avoid the need for further testing in randomized controlled trials (RCTs). We investigated the effect size that would circumvent the need for further RCTs testing by the regulatory agencies. We hypothesized that the approval of therapeutic interventions by regulators is based on heuristic decision making whose accuracy can be best characterized by the application of signal detection theory (SDT). ⋯ Drug developers and practitioners alike can use the change in one logarithm of effect size as a benchmark to decide if further testing in RCTs should be pursued, or as a guide to interpreting the results reported in non-randomized studies. However, further research would be useful to better characterize the threshold of effect size above which testing in RCTs is not needed.
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Hospitals were mandated to dramatically increase capacity during the Covid-19 crisis in New York City. Conversion of non-clinical space into medical units designated for Covid-19 patients became necessary to accommodate this mandate. ⋯ Converting non-clinical space to a medical unit was accomplished quickly with staffing, workflow for appropriate patients, few patients who returned to a higher level of care, and no respiratory or cardiac arrests or deaths on the unit.
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This article aims to identify the factors that affect physicians' experiences of receiving practice data and to use these data to develop a model describing how individuals interact with the data. ⋯ Our novel model depicts the relationship between data feedback systems and individuals' mindsets interact to augment or hinder clinical practice improvement. This model may provide leaders with a framework to examine their academic and administrative structures and how they might interface with performance feedback systems with clinicians.
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To explore rates and factors associated with mandatory vaccination support overall and intentions to get vaccinated specifically for COVID-19 among individuals in Greece. ⋯ The survey revealed that the majority of the Greek citizens favour mandatory vaccination overall and intend to get vaccinated for COVID-19, driven mostly by utilization of preventive services and trust in healthcare authorities. However, intention to get vaccinated for COVID-19 was lower relative to mandatory vaccination support. This suggests a need to intensify evidence-based yet simplified messaging by esteemed healthcare providers to inform the public on the risks and benefits of vaccines.
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Neonates with life-threatening conditions face complex clinical circumstances that confront parents and professionals with ethical decisions. Parents' participation in decision making has not gained sufficient attention in practice. Understanding factors affecting parents' participation is required. This study is part of a comprehensive project that explored the process of parents' participation in decision making for neonates with life-threatening conditions. The current study aimed to explore healthcare professionals-related factors affecting parents' participation in decision-making for neonates with life-threatening conditions. ⋯ Professionals should be aware of their role in involving parents in decision making. Training professionals on family centred care principle and communication skills contribute to support parents emotionally and respond empathically to their negative expressions. Training on ethics, development, and dissemination of guidelines and rules of conduct can make professionals more sensitive to ethical aspects of their work and may reduce their fear of litigation.