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Taking pleasure seriously: Should alcohol research say more about fun?
Addiction
January 2025
Centre for Alcohol and Drug Research, Aarhus University, Aarhus, Denmark.
Background: This paper invites discussion on whether pleasure should receive more attention in public health-oriented research on alcohol. While there is a history of sociological and anthropological literature exploring alcohol and pleasure, this is much less common in public health-oriented alcohol research, and associated advocacy.
Argument: We propose three broad reasons why more extensive engagement with issues of pleasure may be important for public health-oriented research.
Demonstration of Major Therapeutic Advantage From a Review of EU Conditional Marketing Authorizations in Oncology and Hematology.
Clin Pharmacol Ther
January 2025
European Medicines Agency, Amsterdam, The Netherlands.
In the EU, conditional marketing authorization is a pragmatic tool for early approval of a medicine that fulfills an unmet medical need. In the pharmaceutical legislation, an unmet medical need means that a condition lacks a satisfactory method for diagnosis, prevention, or treatment. If such satisfactory methods exist, the new medicinal product must hold a major therapeutic advantage for those affected, meaning that it must demonstrate an improvement in efficacy or safety over existing methods or, in exceptional cases, a major improvement in patient care.
View Article and Find Full Text PDFModern trials are most useful when they are pragmatic and explanatory - there is no continuum.
J Clin Epidemiol
December 2024
Pragmatic Evidence Lab, Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel and University of Basel, Basel, Switzerland; Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland; Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, California, USA. Electronic address:
Background And Objectives: Over half a century ago, the terms "pragmatic" and "explanatory" were introduced to biomedicine by Schwartz and Lellouch, presenting two distinct conceptual approaches to trial design. Today, we frequently say that there are pragmatic trials and there are explanatory trials. Pragmatic trials inform decision-making in practice, and explanatory trials aim to understand the mechanism of an intervention.
View Article and Find Full Text PDFEffects of excess high-normal alanine aminotransferase levels in relation to new-onset metabolic dysfunction-associated fatty liver disease: Clinical implications.
World J Gastroenterol
July 2024
Department of Gastroenterology and Hepatology, North Bristol Trust, Southmead Hospital, Bristol BS10 5NB, United Kingdom.
In this editorial, we comment on the article by Chen recently published in 2024. We focus the debate on whether reducing the upper limit of normal of alanine aminotransferase (ALT) would effectively identify cases of fibrosis in metabolic-dysfunction associated fatty liver disease (MAFLD). This is important given the increasing prevalence of MAFLD and obesity globally.
View Article and Find Full Text PDFThe Language of the UDDA is Sufficiently Precise and Pragmatic.
Neurocrit Care
December 2024
Neurosciences Intensive Care Unit and Department of Neurology and Anesthesiology, Mayo Clinic Hospital, Saint Marys Campus, 200 First Street SW, Rochester, MN, 55905, USA.
We have a reason to value the Uniform Determination of Death Act (UDDA). Since enactment, the UDDA has been of paramount importance to US citizens, families of comatose patients, and the health care professionals who care for them. The UDDA sets forth two standards for determining death and leaves to the medical community to elaborate criteria by which physicians can determine when those standards have been met.
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