Perspectives on research protocols on Indigenous conservation lands: Outcomes from a talking circle

Cognitive functions are essential in any form of exercise. Recently, interest has mounted in addressing the relationship between caffeine intake and cognitive performance during sports practice. This review examines this relationship through a structured search of the databases Medline/PubMed and Web of Science for relevant articles published in English from August 1999 to March 2020. The study followed PRISMA guidelines. Inclusion criteria were defined according to the PICOS model. The identified records reported on randomized cross-over studies in which caffeine intake (as drinks, capsules, energy bars, or gum) was compared to an identical placebo situation. There were no filters on participants’ training level, gender, or age. For the systematic review, 13 studies examining the impacts of caffeine on objective measures of cognitive performance or self-reported cognitive performance were selected. Five of these studies were also subjected to meta-analysis. After pooling data in the meta-analysis, the significant impacts of caffeine only emerged on attention, accuracy, and speed. The results of the 13 studies, nevertheless, suggest that the intake of a low/moderate dose of caffeine before and/or during exercise can improve self-reported energy, mood, and cognitive functions, such as attention; it may also improve simple reaction time, choice reaction time, memory, or fatigue, however, this may depend on the research protocols.

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Navigating uncharted waters: Developing a standardized approach for evaluating and implementing biosimilar products at a comprehensive cancer center

American Journal of Health-System Pharmacy ◽

10.1093/ajhp/zxaa373 ◽

2020 ◽

Author(s):

Mara N Villanueva ◽

Jennifer E Davis ◽

Stacey M Sobocinski

Keyword(s):

Transition Period ◽

Treatment Protocol ◽

Comprehensive Cancer Center ◽

Cancer Center ◽

Specific Product ◽

Team Members ◽

Research Protocols ◽

Institutional Review ◽

Multiple Challenges ◽

Coordinate Changes

Abstract Purpose The processes for formulary implementation and electronic health record (EHR) integration of biosimilar products at a comprehensive cancer center are described. Implications for research protocols are also discussed. Summary The existing literature focuses on practical considerations for formulary addition of biosimilar products, but there is a lack of guidance on how to implement the change, particularly within the EHR. Before building the ordering tools for biosimilars, the clinical and informatics teams should determine the role of biosimilars at the institution, identify drug-specific product characteristics that affect medication build, and characterize implications of future formulary changes or drug shortages. Leveraging an orderable record provides the ability to include logic that maps to multiple products and also allows for future implementation of changes within the medication record rather than requiring “swaps” at the treatment protocol level. The institutional review board should coordinate changes in affected research protocols and consent forms and work with principal investigators to amend protocols when necessary. Pharmacy leaders should develop processes to oversee inventory during the transition period and minimize the risk of errors. Conclusion The development of a standardized approach for evaluating and implementing biosimilar products improves efficiency and collaboration among the various team members responsible for the products’ integration into existing workflows, including implications for clinical research. Implementing biosimilars for agents used to treat cancer will pose new challenges and require additional considerations. Partial implementation of biosimilars continues to pose multiple challenges in the provision of patient care.

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