ABSTRACT
Background and objective: The Plasma-Lyte 148 versus Saline (PLUS) study is a prospective, multicentre, parallel-group, concealed, blinded, randomised controlled trial comparing the effect of Plasma-Lyte 148 versus 0.9% sodium chloride (saline) for fluid resuscitation and other fluid therapy on 90-day mortality among critically ill adults requiring fluid resuscitation. The original target for recruitment was 8800 participants, which was reduced to 5000 participants following the onset of the coronavirus disease 2019 (COVID-19) pandemic in 2020. This article describes the statistical analysis plan for the PLUS study. Methods: The statistical analysis plan was developed by the study statistician, chief investigator, and project manager, and was approved by the Management Committee before unblinding. The plan describes in detail the analysis of baseline characteristics, process measures, and outcomes, including covariate adjustments, subgroup analyses, missing data handling, and sensitivity analyses. Results and conclusions: A statistical analysis plan for the PLUS study was developed. This pre-specified plan accords with high quality standards of internal validity and should minimise future analysis bias. © 2021, College of Intensive Care Medicine. All rights reserved.
ABSTRACT
This assessment by the Environmental Effects Assessment Panel (EEAP) of the United Nations Environment Programme (UNEP) provides the latest scientific update since our most recent comprehensive assessment (Photochemical and Photobiological Sciences, 2019, 18, 595-828). The interactive effects between the stratospheric ozone layer, solar ultraviolet (UV) radiation, and climate change are presented within the framework of the Montreal Protocol and the United Nations Sustainable Development Goals. We address how these global environmental changes affect the atmosphere and air quality; human health; terrestrial and aquatic ecosystems; biogeochemical cycles; and materials used in outdoor construction, solar energy technologies, and fabrics. In many cases, there is a growing influence from changes in seasonality and extreme events due to climate change. Additionally, we assess the transmission and environmental effects of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which is responsible for the COVID-19 pandemic, in the context of linkages with solar UV radiation and the Montreal Protocol.