Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 2 Safety: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations.

The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research, established by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks, a public-private partnership with the US Food and Drug Administration, convened a second meeting of sedation experts from a variety of clinical specialties and research backgrounds to develop recommendations for procedural sedation research. The previous meeting addressed efficacy and patient- and/or family-centered outcomes. This meeting addressed issues of safety, which was defined as "the avoidance of physical or psychological harm." A literature review identified 133 articles addressing safety measures in procedural sedation clinical trials. After basic reporting of vital signs, the most commonly measured safety parameter was oxygen saturation. Adverse events were inconsistently defined throughout the studies. Only 6 of the 133 studies used a previously validated measure of safety. The meeting identified methodological problems associated with measuring infrequent adverse events. With a consensus discussion, a set of core and supplemental measures were recommended to code for safety in future procedural clinical trials. When adopted, these measures should improve the integration of safety data across studies and facilitate comparisons in systematic reviews and meta-analyses.

"Effects of floating aquatic vegetation and canal sediment on phosphorus in drainage discharges in agricultural canals: A case study in the everglades agricultural area, Florida".

Phosphorus (P) discharge from agricultural and urban drainage is known for causing downstream eutrophication worldwide. Agricultural best management practices that are designed to reduce P load out of farms target different P species from various sources such as fertilizers leaching and farm soil and canal sediment erosion, however, few studies have assessed the impact of floating aquatic vegetation (FAV) on canal sediment and farm drainage water quality. This study evaluated the impact of FAVs on canal sediment properties and P water quality in drainage canals in the Everglades Agricultural Area in south Florida, USA. Non-parametric statistical methods, correlation analysis, trend analysis and principal component analysis (PCA) were used to determine the relationship between FAV coverage with sediment properties and P water quality parameters. Results showed that FAV coverage was correlated with the highly recalcitrant and most stable form of P in the sediment layer (Residual P Pool). FAV coverage also correlated with the dissolved organic P (DOP) which was the smallest P pool (7 %) of total P concentration in drainage water, therefore FAV coverage had no correlation with farm P load. The trend analysis showed no trend in farm P loads, despite a decline in FAV coverage at farm canals over an 8-year period. Phosphorus content in the sediment surface layer was strongly associated with farm P load and had a significant correlation with particulate P (PP) and soluble reactive P (SRP) which constituted 47 % and 46 % of the total P concentration in the drainage water, respectively. Equilibrium P concentration assays also showed the potential to release SRP from the sediment layer. The P budget established for this study reveals that sediment stores the largest P mass (333 kg P), while FAVs store the smallest P mass (8 kg P) in a farm canal, highlighting the significant contribution of canal sediment to farm P discharges. Further research is required to evaluate the impact of sediment removal and canal maintenance practices that help reduce farm P discharges.

Capturing Flow-weighted Water and Suspended Particulates from Agricultural Canals During Drainage Events.

The purpose of this study is to describe the methods used to capture flow-weighted water and suspended particulates from farm canals during drainage discharge events. Farm canals can be enriched by nutrients such as phosphorus (P) that are susceptible to transport. Phosphorus in the form of suspended particulates can significantly contribute to the overall P loads in drainage water. A settling tank experiment was conducted to capture suspended particulates during discrete drainage events. Farm canal discharge water was collected in a series of two 200 L settling tanks over the entire duration of the drainage event, so as to represent a composite subsample of the water being discharged. Imhoff settling cones are ultimately used to settle out the suspended particulates. This is achieved by siphoning water from the settling tanks via the cones. The particulates are then collected for physico-chemical analyses.