Bmc Med
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Randomized Controlled Trial
The effectiveness of reduction in alcohol consumption achieved by the provision of non-alcoholic beverages associates with Alcohol Use Disorders Identification Test scores: a secondary analysis of a randomized controlled trial.
The Alcohol Use Disorders Identification Test (AUDIT) is commonly used in clinical settings to assess the severity of alcohol-related problems, with the effectiveness of alcohol reduction interventions varying across this spectrum. In a recent study, we demonstrated that a 12-week intervention involving the provision of free non-alcoholic beverages reduced alcohol consumption among heavy drinkers for up to 8 weeks post-intervention. However, it remains unclear whether this effect was consistent across different AUDIT score ranges. Therefore, this secondary analysis aimed to examine whether the severity of alcohol-related problems, as indicated by AUDIT scores, influences the effectiveness of non-alcoholic beverage provision in reducing alcohol consumption. ⋯ These findings suggest that individuals with higher AUDIT scores may experience a reduced benefit from a 12-week non-alcoholic beverage intervention in terms of alcohol consumption reduction. Nevertheless, this intervention appears to be a safe and effective strategy for reducing alcohol consumption in heavy drinkers who do not have alcohol dependence.
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Accelerated biological aging has been verified to be a critical risk factor for a number of age-related diseases, but its role in dementia remained unclear. Whether it modified the effects of genetic factors was also unknown. This study evaluated the associations between accelerated biological aging and dementia and the moderating role of accelerated biological aging in the genetic susceptibility to the disease. ⋯ Accelerated biological aging could bring the extra risk of dementia but attenuate the effects of genetic risk on dementia. These findings provide insights for precise prevention and intervention of dementia.
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Randomized Controlled Trial Multicenter Study Pragmatic Clinical Trial
Effectiveness of comprehensive geriatric assessment adapted to primary care when provided by a nurse or a general practitioner: the CEpiA cluster-randomised trial.
The benefits of comprehensive geriatric assessment (CGA) are well established for hospital care but less so for primary care. Our primary objective was to assess the effect of two multifaceted interventions based on a CGA adapted for primary care on a composite criterion combining all-cause mortality, emergency department visits, unplanned hospital admissions, and institutionalisation. ⋯ Our study led in community-dwelling older patients with chronic conditions found no significant effect of a CGA adapted for primary care on mortality, functional independence and quality of life, but suggests that a GP-led CGA may reduce the risk of unplanned hospital admission. Our study demonstrates the feasibility of incorporating CGA into clinical practice and highlights its potential benefits when applied on a case-by-case basis, guided by the GPs who develop the resulting PCP.
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Randomized Controlled Trial Multicenter Study Comparative Study
Bivalirudin versus heparin in patients with or without bail-out GPI use: a pre-specified subgroup analysis from the BRIGHT-4 trial.
Conflicting results comparing bivalirudin versus heparin anticoagulation in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), in part due to the confounding effect of glycoprotein IIb/IIIa inhibitors (GPI). The aim of the study was to compare the safety and effectiveness of bivalirudin plus a post-PCI high-dose infusion vs heparin with or without bail-out GPI use. ⋯ Bivalirudin plus a post-PCI high-dose infusion was associated with significantly reduced 30-day composite rate of all-cause death or BARC types 3-5 bleeding compared with heparin monotherapy in STEMI patients undergoing primary PCI without GPI use. However, these benefits might be less pronounced in patients requiring bail-out GPI due to thrombotic complications during primary PCI.
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The use of digital health technologies to measure outcomes in clinical trials opens new opportunities as well as methodological challenges. Digital outcome measures may provide more sensitive and higher-frequency measurements but pose vital statistical challenges around how such outcomes should be defined and validated and how trials incorporating digital outcome measures should be designed and analysed. ⋯ The impact of key issues highlighted by the eight questions on a primary analysis of a trial are illustrated through a simulation study based on the 2019 Bellerophon INOPulse trial which had time spent in MVPA as a digital outcome measure. These eight questions present broad areas where methodological guidance is needed to enable wider uptake of digital outcome measures in trials.