Current opinion in anaesthesiology
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Perioperative prediction models can help to improve personalized patient care by providing individual risk predictions to both patients and providers. However, the scientific literature on prediction model development and validation can be quite technical and challenging to understand. This article aims to provide the necessary insight for clinicians to assess the value of a prediction model that they intend to use in their clinical practice. ⋯ Clinicians can assess the value of a prediction model for their practice by first identifying what the usage of the model will be. Second, they can recognize which performance characteristics are relevant to their assessment of the model. Finally, they need to decide whether the available scientific evidence sufficiently matches their clinical practice to proceed with implementation.
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Curr Opin Anaesthesiol · Dec 2016
ReviewThe future of postoperative quality of recovery assessment: multidimensional, dichotomous, and directed to individualize care to patients after surgery.
Recovery after surgery is a complex interplay of the patient, the surgery, and the perioperative anaesthesia management. Assessment of recovery should address the needs of multiple stakeholders, including the institutions and healthcare providers, but primarily should be focused on the patients and their perception of quality of recovery and return to normalcy. This review will summarize the development of assessment of recovery to a multidimensional dichotomous construct that requires a real-time assessment tool validated for repeat measures and containing cognitive assessment. ⋯ Recovery is best defined as a multidimensional dichotomous construct encompassing nociceptive, emotive, functional, and cognitive domains. Its assessment tool should provide both real-time and restrospective recovery data, thus enabling clinical and research applications, and be validated for repeat measures over a breadth of multiple clinically relevant postoperative time points.
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The purpose of this article is to provide a structural and functional understanding of the systems used for the regulation of medical devices in the USA and European Union (EU). ⋯ The US and EU medical device regulatory systems are similar in many ways, but differ in important ways too, which impacts the afforded level of safety and effectiveness assurance. In both systems, medical devices are classified and regulated on a risk basis, which fundamentally differs from drug regulation, where uniform requirements are imposed. Anesthesia providers must gain knowledge of these systems and be active players in both premarket and postmarket activities, particularly with regard to vigilance and adverse event/device failure reporting.